Autism-Vaccine Cover-up Snowballs as Whistleblower’s Identity is Revealed—LATEST UPDATES

William W. Thompson, PhD—an epidemiologist at the CDC’s National Center of Birth Defects and Development Disabilities is alleging criminal wrongdoing on the part of his supervisors, and has expressed deep regret about his role in helping the CDC hide data: “It’s the lowest point in my career, that I went along with that paper.”

 

Posted By ANH-USA On August 26, 2014 @ 3:00 pm

Rumors are swirling as the world learns of the government’s deception. Here’s what we know for sure.

William W. Thompson, PhD—an epidemiologist at the CDC’s National Center of Birth Defects and Development Disabilities who received his doctorate in biochemical engineering—has been revealed as the CDC whistleblower. Thompson broke a decade of silence over the government’s deliberate concealment of the link between the MMR vaccine (for measles, mumps, and rubella) and a dramatically increased risk of autism, particularly in African American boys.

Thompson is alleging criminal wrongdoing on the part of his supervisors, and has expressed deep regret about his role in helping the CDC hide data: “It’s the lowest point in my career, that I went along with that paper.”

Here is a quick timeline of the scandal:

English: Preparation of measles vaccine at the...

Continue reading “Autism-Vaccine Cover-up Snowballs as Whistleblower’s Identity is Revealed—LATEST UPDATES”

US Health Agency Holds Patent on Ebola Strain Virus

Sunday, 03 August 2014

The U.S. Centers for Disease Control owns a patent on a particular strain of Ebola known as “EboBun.” It’s patent No. CA2741523A1 and it was awarded in 2010. You can view it here.

Patent applicants are clearly described on the patent as including:

The Government Of The United States Of America As Represented By The Secretary, Department Of Health & Human Services, Center For Disease Control.

It goes on to state, “The present invention is based upon the isolation and identification of a new human Ebola virus species, EboBun. EboBun was isolated from the patients suffering from hemorrhagic fever in a recent outbreak in Uganda.”

 

It’s worth noting, by the way, that EboBun is not the same variant currently believed to be circulating in West Africa. Clearly, the CDC needs to expand its patent portfolio to include more strains, and that may very well be why American Ebola victims have been brought to the United States in the first place. Read more below and decide for yourself… Continue reading “US Health Agency Holds Patent on Ebola Strain Virus”

Mysteriously high number of babies born without brain or skull part in Washington

18 February 2014, 08:34

Mysteriously high number of babies born without brain or skull part in Washington

© Photo: Flickr.com/sean dreilinger/cc-by-nc-sa 3.0

Fatal birth defects that leave babies born without part of their brain or skull have been striking three counties in rural Washington State at a rate at least four times the national average.

A rising number of defects among babies has been hitting rural Washington, with anencephaly — babies born without part of their brain or skull — being a leading problem. This outbreak of extreme health issues has led health officials to examine what might be causing this worrying trend, though the cluster—in Yakima, Franklin, and Benton counties—remains cloaked in mystery, with no single cause pinpointed. Continue reading “Mysteriously high number of babies born without brain or skull part in Washington”

WHO and the pandemic flu “conspiracies” – The BMJ and the Bureau of Investigative Journalism report that was covered up

Conflicts of Interest

A joint investigation by the BMJ and the Bureau of Investigative Journalism has uncovered evidence that raises troubling questions about how WHO managed conflicts of interest among the scientists who advised its pandemic planning

The secrecy of the committee is also fuelling conspiracy theories, particularly around the activation of dormant pandemic vaccine contracts. A key question will be whether the pharmaceutical companies, which had invested around $4bn (£2.8bn, 3.3bn) in developing the swine flu vaccine, had supporters inside the emergency committee

The original advisory opinion was requested by...

– Was it appropriate for WHO to take advice from experts who had declarable financial and research ties with pharmaceutical companies producing antivirals and influenza vaccines?

– Why was key WHO guidance authored by an influenza expert who had received payment for other work from Roche, manufacturers of oseltamivir, and GlaxoSmithKline, manufacturers of zanamivir?

– Why does the composition of the emergency committee from which Chan sought guidance remain a secret known only to those within WHO?

–  Our investigation has identified key scientists involved in WHO pandemic planning who had declarable interests, some of whom are or have been funded by pharmaceutical firms that stood to gain from the guidance they were drafting

– FDA’s advisory committee voted by 13 to 4 not to approve zanamivir on the grounds that it was no more effective than placebo when the patients were on other drugs such as paracetamol. He said that it didn’t reduce symptoms even by a day.

– conflicts of interest have never been publicly disclosed by WHO, and WHO has dismissed inquiries into its handling of the A/H1N1 pandemic as “conspiracy theories.”

– the advisory committee decided not to recommend zanamivir, the FDA’s management reassigned the oseltamivir review to someone else. Dr Elashoff believes that the approval of zanamivir paved the way for oseltamivir, which was approved by the FDA later that year.

– “WHO never publishes individual DOIs [declaration of interest], except after consultation with the Office of the Director-General.

Deborah Cohen, features editor, BMJ, Philip Carter, journalist, The Bureau of Investigative Journalism, London

dcohen@bmj.com

Key scientists advising the World Health Organization on planning for an influenza pandemic had done paid work for pharmaceutical firms that stood to gain from the guidance they were preparing. These conflicts of interest have never been publicly disclosed by WHO, and WHO has dismissed inquiries into its handling of the A/H1N1 pandemic as “conspiracy theories.” Deborah Cohen and Philip Carter investigate

Next week marks the first anniversary of the official declaration of the influenza A/H1N1 pandemic. On 11 June 2009 Dr Margaret Chan, the director general of the World Health Organization, announced to the world’s media: “I have conferred with leading influenza experts, virologists, and public health officials. In line with procedures set out in the International Health Regulations, I have sought guidance and advice from an Emergency Committee established for this purpose. On the basis of available evidence, and these expert assessments of the evidence, the scientific criteria for an influenza pandemic have been met…The world is now at the start of the 2009 influenza pandemic.” Continue reading “WHO and the pandemic flu “conspiracies” – The BMJ and the Bureau of Investigative Journalism report that was covered up”

Common plastics chemicals linked to ADHD symptoms – phthalate

Reposted at request:

Public release date: 19-Nov-2009 –

They found a significant positive association between phthalate exposure and ADHD, meaning that the higher the concentration of phthalate metabolites in the urine, the worse the ADHD symptoms and/or test scores.

Disney school supplies loaded with toxic phtha...
Disney school supplies loaded with toxic phthalates, next to petitions signed by 65,000 parents across the country (Photo credit: CHEJ)

 

Are phthalates really safe for children?

Philadelphia, PA, 19 November 2009 – Phthalates are important components of many consumer products, including toys, cleaning materials, plastics, and personal care items. Studies to date on phthalates have been inconsistent, with some linking exposure to these chemicals to hormone disruptions, birth defects, asthma, and reproductive problems, while others have found no significant association between exposure and adverse effects.

A new report by Korean scientists, published by Elsevier in the November 15th issue of Biological Psychiatry, adds to the potentially alarming findings about phthalates. They measured urine phthalate concentrations and evaluated symptoms of attention-deficit/hyperactivity disorder (ADHD) using teacher-reported symptoms and computerized tests that measured attention and impulsivity. Continue reading “Common plastics chemicals linked to ADHD symptoms – phthalate”

Brief fever common in kids given influenza, pneumococcal vaccines together

PUBLIC RELEASE DATE:
6-Jan-2014

– Parents should be made aware that their child might develop a fever following simultaneous influenza and pneumococcal vaccinations

– children who received simultaneous influenza and pneumococcal vaccines, about a third (37.6 percent) had a fever of 100.4 F (38 C) or higher on the day of or day after vaccination, compared with children who received only the pneumococcal (9.5 percent) or only the influenza (7.5 percent) vaccine.

Findings suggest utility of text messaging to monitor safety

NEW YORK, NY (Jan. 6, 2014) – Giving young children the influenza and pneumococcal vaccines together appears to increase their risk of fever, according to a study led by researchers from Columbia University Medical Center (CUMC) and the Centers for Disease Control and Prevention (CDC). However, the fever was brief, and medical care was sought for few children, supporting the routine immunization schedule for these vaccines, including the recommendation to administer them simultaneously. The study, which looked at children 6-23 months old, was published online on Jan. 6, 2014, in JAMA Pediatrics. Continue reading “Brief fever common in kids given influenza, pneumococcal vaccines together”

Pregnant nurse, 29, is FIRED after she refuses to have flu shot to protect her unborn child

  • Dreonna Breton from Pennsylvania, became alarmed after the packaging for a number of major brands of the flu vaccine warned it ‘should be given to a pregnant woman only if clearly needed
  • She showed no symptoms of having the flu and has suffered two miscarriages in four pregnancies so rejected the vaccine
  • But because the shot is compulsory for all staff at her workplace, Horizon Healthcare Services, was told to leave
  • It’s common for hospitals to enforce mandatory flu shots in an effort to prevent  staff spreading the bug to patients but they often allow exemptions for religious or medical reasons

By Helen Pow

PUBLISHED:    19:20 EST, 22 December 2013

 

A pregnant nurse in Pennsylvania has been fired after she refused a mandatory flu shot to protect her unborn baby.

Dreonna Breton, 29, learned she was pregnant with her second child in October, a month before all staff at her Lancaster employer, Horizon Healthcare Services, were required to have had a compulsory flu shot.

But she became alarmed after the packaging for a number of major brands of the vaccine warned it ‘should be given to a pregnant woman only if clearly needed,’ and other notifications highlighted that it’s unclear whether the shot can harm an unborn child.

She showed no symptoms of having the flu and having suffered two miscarriages since her son, Westen, was born 18 months ago, she didn’t want to take the chance so rejected the vaccine. But she was subsequently told to leave.

Fired: Dreonna Breton, pictured with her son Westen, was fired after she refused a mandatory flu shot to protect her unborn baby 

Fired: Dreonna Breton, pictured with her son Westen, was fired after she refused a mandatory flu shot to protect her unborn baby Continue reading “Pregnant nurse, 29, is FIRED after she refuses to have flu shot to protect her unborn child”

Vaccine’s, the Lucky Rabbits Foot, and Shhh No questions allowed ( Part 1 )

Vaccines are just a form of medicine like everything else. Some of them good, and some of them not so good. In any case you have a right to know.

Just remember Scientific Method – Observation, Hypothesis, and Theory as well as Risk to Benefit Ratio ..> But don’t get me started on Epigenetics

We should all have the freedom to inoculate ourselves based upon fact… The first one However, I threw in for fun ; )

There are many more as this is just part 1 …. Just sticking with RECENT Peer Review. But let the first Salvo fly

Change in human social behavior in response to a common vaccine and Funvax Using Vaccines to Alter Human Behavior VMAT2 Gene 

Pneumococcal vaccination in adults does not appear to work

Live Vaccination against ( German Measles ) Rubella caused Signifigant Depression up to 10 weeks – Vaccines/ Bacteria Can Alter Mood and Behavior

No significant influenza (FLU) vaccine effectiveness could  be demonstrated for any season, age or setting after adjusting for county, sex, insurance, chronic conditions recommended for influenza vaccination and timing of influenza vaccination

The Hidden Threat That Could Prevent Polio’s Global Eradication – Vaccinated Children that Become  “chronic excreters”

U.S. Court Confrims M.M.R. Vaccine Caused Autism or Cumulative  (Verified through Multiple Sources) From DEC 2012 Judgment

Pig Virus DNA Found in Rotavirus Vaccine : Millions of children worldwide, including 1 million in the U.S. exposed

Seasonal flu vaccination increase the risk of infection with pandemic H1N1 flu by 68%

Flu vaccine may not protect seniors well / Vaccine was totally ineffective

OHSU research suggests America may over-vaccinate

Some children vaccinated against hepatitis B may have an increased risk of MS

Flu shot does not cut risk of death in elderly / no decrease in hospital admissions or all-cause mortality

Measles, Mumps, Rubella vaccine linked with 2-fold risk of seizures

‘MMR vaccine causes autism’ claim banned – Followed by 15 studies that link Strong Correlation, it May

Influenza Vaccine Failure among Highly Vaccinated Military Personal, No protection against Pandemic Strains.

Live virus used in polio vaccine can evolve and infect, warns TAU researcher

India: Paralysis cases soar after oral polio vaccine introduced

Flu Vaccine offers no Protection in seniors

Common cold virus can cause polio in mice when injected into muscles

Flu shot does not reduce risk of death

Swine flu vaccine linked to child narcolepsy: EU Confirmation

WHO and the pandemic flu “conspiracies” – FULL report from the BMJ and The Bureau of Investigative Journalism  2010

A vaccine-derived strain of poliovirus that has spread in recent years is serious but it can be tackled with an existing vaccine

Dosing schedule of pneumococcal vaccine linked with increased risk of getting multiresistant strain

Expert questions US public health agency advice on influenza vaccines

Whooping Cough Vaccine is obsolete ” Bulk of the cases were in fully vaccinated children ” few cases among unvaccinated children

Flu vaccine backfires in pigs / vaccinated against H1N2 influenza were more vulnerable to the rarer H1N1 strain

Higher anaphylaxis rates after HPV vaccination: CMAJ study / significantly higher – 5 to 20 fold – than that identified in comparable school-based vaccination programs

Allergic to Gummy Bears? Be Cautious Getting the Flu Shot

Vaccination campaign doubles HBV mutations

Whooping cough vaccine antigen disappearing from bacteria in US

Contact: Jim Sliwa jsliwa@asmusa.org 202-942-9297 American Society for Microbiology

Vaccines for whooping cough contain three to five protective antigens, the presence of which are critical to the vaccine’s effectiveness. But one of the antigens, pertactin, which had been present in almost all isolates of Bordetella pertussis in the US as late as 2010, is now absent from more than half of them, according to a paper published ahead of print in Clinical and Vaccine Immunology. Continue reading “Whooping cough vaccine antigen disappearing from bacteria in US”

Personal care products are possible sources of potentially harmful parabens for babies

Contact: Michael Bernstein m_bernstein@acs.org 202-872-6042 American Chemical Society

Through lotions, shampoos and other personal care products (PCPs), infants and toddlers are likely becoming exposed to potentially harmful substances, called parabens, at an even higher level than adult women in the U.S., researchers have reported. They published their findings on parabens, which have been linked to reproductive and other health issues, in the ACS journal Environmental Science & Technology. Continue reading “Personal care products are possible sources of potentially harmful parabens for babies”

Allergic to Gummy Bears? Be Cautious Getting the Flu Shot

Those with gelatin allergy can have reaction from flu vaccinations

BALTIMORE, MD. (November 8, 2013) – Do marshmallows make your tongue swell? Gummy bears make you itchy? If you’ve answered yes and are allergic to gelatin, you will want to take some precautions when getting the flu shot. While the vaccine is recommended for those six months of age and older, a case report being presented at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting notes that individuals with a gelatin allergy can have a mild to severe reaction from the shot.

“Gelatin is used in the flu shot, as well as other vaccines, as a stabilizer,” said Stephanie Albin, MD, an allergist and ACAAI member. “Because it is found in the vaccine, those with a known allergy to gelatin can experience allergic reactions, such as hives, sneezing and difficulty breathing.”

There is a misconception about allergies and the flu shot, with many believing those with an egg allergy should not receive the vaccination. But last month, ACAAI published an update that found even those with a severe egg allergy can receive the vaccine without special precautions.

“Gelatin reactions can cause hives, swelling, itchiness, shortness of breath and a severe life-threatening reaction known as anaphylaxis,” explained Dr. Albin. “Because of this, precautions should be taken, such as having a board-certified allergist administer the vaccine in a person with known gelatin allergy in case a reaction occurs.”

Gelatin can contain proteins derived from cow, pig or fish. Gelatin can be found in a variety of foods and pharmaceuticals, including gummy vitamins, marshmallows and candy.

“Gelatin allergy is very rare,” said allergist Richard Weber, M.D., ACAAI president. “Many food intolerances can be mistaken as allergies. Those who believe they might have an allergy should be tested and diagnosed by an allergist before taking extreme avoidance measures or skipping vaccinations. The flu shot is an important vaccine and can even be life-saving for individuals that are at an increased risk for severe side effects associated with the flu.”

The Centers for Disease Control and Prevention (CDC) recommends receiving an annual flu shot, especially for high risk age groups as children and the elderly. The vaccination can be given either as a shot or a nasal spray, both of which can contain gelatin.

For more information about allergies and to locate an allergist in your area, visit AllergyandAsthmaRelief.org. The ACAAI Annual Meeting is being held Nov. 7-11 at the Baltimore Convention Center in Baltimore. For more news and research being presented at the meeting, follow the conversation on Twitter #ACAAI.

About ACAAI

The ACAAI is a professional medical organization of more than 5,700 allergists-immunologists and allied health professionals, headquartered in Arlington Heights, Ill. The College fosters a culture of collaboration and congeniality in which its members work together and with others toward the common goals of patient care, education, advocacy and research. ACAAI allergists are board-certified physicians trained to diagnose allergies and asthma, administer immunotherapy, and provide patients with the best treatment outcomes. For more information and to find relief, visit AllergyandAsthmaRelief.org. Join us on Facebook, Pinterest and Twitter.

78 percent of Americans say they weren’t inconvenienced by government shutdown: survey

  • Only 11 percent of Americans reported  being ‘majorly inconvenienced’ by the shutdown
  • Experts warn that another shutdown could  be on the horizon in coming months

By  Associated Press and Daily Mail Reporter

PUBLISHED: 18:08 EST, 23  October 2013 |  UPDATED: 18:08 EST, 23 October 2013

As politicians and cable news pundits spent  the 16-day shutdown of  the federal government describing the apocalyptic  scenario of the shutdown, the vast majority of ordinary citizens weren’t  even  phased by the fed being closed for business, according to a new  survey.

The Washington Post/ABC News survey, released  Tuesday, finds that  78-percent of those polled say they were not inconvenienced  by the  shutdown at all.

Of the 22-percent who said they were  inconvenienced, 11-percent described their troubles as a ‘minor  inconvenience.’

Barely missed: Only 11 percent of Americans say they were majorly inconvenienced by government shutdown 

Barely missed: Only 11 percent of Americans say they  were majorly inconvenienced by government shutdown

 

The survey was conducted October 17 through  the 20th – after the shutdown had come to an end.

The  surveyors polled 1,002 adults, asking the question ‘Were you  personally  inconvenienced by the partial shutdown of the federal  government or  not?’

If a respondent answered yes, they were asked  the followup question of ‘was it a major inconvenience or a minor  inconvenience?’

Prior to the shutdown, the Associated Press  explained how it would effect regular people, noting that it would have  far-reaching consequences for some, but minimal impact on others.

Deal: a deal to re-open the government was achieved on October 17 

Deal: a deal to re-open the government was achieved on  October 17

AIR TRAVEL

Federal air traffic controllers would remain  on the job and airport-screening staff would keep funneling passengers through  security checkpoints. Federal inspectors would continue enforcing safety  rules.

Shutdown: The tourist trips to Alcatraz would stop running if the federal shutdown goes ahead on Monday 

Shutdown: The tourist trips to Alcatraz would stop  running if the federal shutdown goes ahead on Monday

 

INTERNATIONAL TRAVEL

The State Department would continue  processing foreign applications for  visas and U.S. applications for passports,  since fees are collected to  finance those services. Embassies and consulates  overseas would continue to provide services to American citizens.

BENEFIT PAYMENTS

Social Security and Medicare benefits would  keep coming, but there could be delays in processing new disability  applications. Unemployment benefits would still go out.

FEDERAL COURTS

Federal courts would continue operating  normally for about 10 business days after the start of a shutdown, roughly until  the middle of October. If the shutdown continues, the judiciary would have to  begin furloughs of employees whose work is not considered essential. But cases  would continue to be heard.

MAIL

Deliveries would continue as usual because  the U.S. Postal Service receives no tax dollars for day-to-day operations. It  relies on income from stamps and other postal fees to keep running.

Lunch is served: School students who qualify for free school lunches and breakfast will not go hungry even if the shutdown goes ahead this week  

Lunch is served: School students who qualify for free  school lunches and breakfast will not go hungry even if the shutdown goes ahead  this week

 

RECREATION

All national parks would be closed, as would  the Smithsonian museums, including the National Zoo in Washington. Visitors  using overnight campgrounds or other park facilities would be given 48 hours to  make alternate arrangements and leave the park. Among the visitor centers that  would be closed: the Statue of Liberty and Ellis Island in New York,  Independence Hall in Philadelphia, Alcatraz Island near San Francisco and the  Washington Monument.

HEALTH

New patients would not be accepted into  clinical research at the National Institutes of Health, but current patients  would continue to receive care. Medical research at the NIH would be disrupted  and some studies would be delayed. The Centers for Disease Control and  Prevention would be severely limited in spotting or investigating disease  outbreaks, from flu to that mysterious MERS virus from the Middle  East.

FOOD SAFETY

The Food and Drug Administration would handle  high-risk recalls suspend most routine safety inspections. Federal meat  inspections would be expected to proceed as usual.

HEAD START

A small number of Head Start programs, about  20 out of 1,600 nationally, would feel the impact right away. The federal  Administration for Children and Families says grants expiring about Oct. 1 would  not be renewed. Over time more programs would be affected. Several of the Head  Start programs that would immediately feel the pinch are in Florida. It’s  unclear if they would continue serving children.

Safety first: Airport-screening staff will remain at work during the shutdown with safety being a top priority 

Safety first: Airport-screening staff will remain at  work during the shutdown with safety being a top priority

 

FOOD ASSISTANCE

The Special Supplemental Nutrition Program  for Women, Infants and Children, known as WIC, could shut down. The program  provides supplemental food, health care referrals and nutrition education for  pregnant women, mothers and their children.

School lunches and breakfasts would continue  to be served, and food stamps, known as the Supplemental Nutrition Assistance  Program, or SNAP, would continue to be distributed. But several smaller feeding  programs would not have the money to operate.

TAXES

Americans would still have to pay their taxes  and file federal tax returns, but the Internal Revenue Service says it would  suspend all audits. Got questions? Sorry, the IRS says taxpayer services,  including toll-free help lines, would be shut as well.

LOANS

Many low-to-moderate incomes borrowers and  first-time homebuyers seeking government-backed mortgages could face delays  during the shutdown. The Federal Housing Administration, which guarantees about  30 percent of home mortgages, wouldn’t underwrite or approve any new loans  during the shutdown. Action on government-backed loans to small businesses would  be suspended.

SCIENCE

NASA will continue to keep workers at Mission  Control in Houston and elsewhere to support the International Space station,  where two Americans and four others are deployed. The National Weather Service  would keep forecasting weather and issuing warnings and the National Hurricane  Center would continue to track storms. The scientific work of the U.S.  Geological Survey would be halted.

 

HOMELAND SECURITY

The majority of the Department of Homeland  Security’s employees are expected to stay on the job, including uniformed agents  and officers at the country’s borders and ports of entry, members of the Coast  Guard, Transportation Security Administration officers, Secret Service personnel  and other law enforcement agents and officers. U.S. Citizenship and Immigration  Services employees would continue to process green card applications.

MILITARY

The military’s 1.4 million active duty  personnel would stay on duty, but their paychecks would be delayed. About half  of the Defense Department’s civilian employees would be furloughed.

PRISONS

All 116 federal prisons would remain open,  and criminal litigation would proceed.

VETERANS SERVICES

Most services offered through the Department  of Veterans Affairs will continue because lawmakers approve money one year in  advance for the VA’s health programs. Veterans would still be able to visit  hospitals for inpatient care, get mental health counseling at vet centers or get  prescriptions filled at VA health clinics. Operators would still staff the  crisis hotline and claims workers would still process payments to cover  disability and pension benefits. But those veterans appealing the denial of  disability benefits to the Board of Veterans Appeals will have to wait longer  for a decision because the board would not issue any decisions during a  shutdown.

WORK SAFETY

Federal occupational safety and health  inspectors would stop workplace inspections except in cases of imminent danger.

Cultural abyss: The National Museum of Natural History at the Smithsonian Institution in Washington D.C. would be one of many to close during a shutdown 

Cultural abyss: The National Museum of Natural History  at the Smithsonian Institution in Washington D.C. would be one of many to close  during a shutdown

 

The deal to re-open the government was  reached on October 17. However, it is only temporary, and there potentially  could be another government shutdown in coming months

Read more: http://www.dailymail.co.uk/news/article-2474641/How-government-shutdown-affect-ordinary-Americans.html#ixzz2ib0ywWs2 Follow us: @MailOnline on Twitter | DailyMail on Facebook

Threatwatch: Disease may run amok while the CDC sleeps

 

Threatwatch is your early warning system for global dangers, from nuclear peril to deadly viral outbreaks. Debora MacKenzie highlights the threats to civilisation – and suggests solutions

“We are less safe.” So Tom Frieden, head of the US Centers for Disease Control and Prevention in Atlanta, Georgia, announced on Twitter last week, as he prepared to send 8754 of his staff – two-thirds of the world’s biggest body of disease-watchers – home on furlough due to lack of government funding. It was part of the massive shutdown of US federal agencies in the wake of political intransigence in Congress over a budget.

“They protected you yesterday, can’t tomorrow. Microbes [and] other threats didn’t shut down,” Frieden added. But are we really less safe? And if so, how, exactly?

Obviously, this makes less difference if you live outside the US, but the uniquely global reach of the CDC affects us all in some ways. Even in the US, the effect may be subtle, because state governments have primary responsibility for public health. But they have always needed the CDC to marshal them in the face of any threat that crosses state lines – and sometimes even those that don’t.

Salmonella outbreak

That became clear earlier this week when CDC had to call back 10 of the people who run PulseNet, a computerised system for genetically tracking germs carried on food. US agriculture inspectors – deemed too important to furlough – had announced that chicken producers in California were the probable source of an outbreak of Salmonella that the CDC had been tracking since March, which has sickened 278 people in 18 states.

The affected states were tracking their own strains. But the PulseNet platform allowed the CDC to put the data together, and find that four of the seven strains of bacteria in the outbreak are novel, many have multiple resistance to antibiotics, and all came from chicken plants in California that have spread some of these bacteria before.

Nearly half the people infected have been hospitalised, twice the usual rate, suggesting these are nastier bugs than normal. Thankfully no one has died in the outbreak, though Salmonella can leave lifelong, debilitating after-effects.

Tuberculosis cluster

James Wilson of Ascel Bio, an epidemiological consulting firm in Denver, Colorado, believes the CDC should focus its limited resource on the tuberculosis cluster left by a Nevada woman who died, along with her twin babies, of the infection in July.

Of 200 people who had contact with the woman and have been tested, 26 were infected. Nevada state officials had asked the CDC for help testing 140 babies who shared intensive care with the twins, says Wilson. But because of the shutdown, that is now on hold.

So is an investigation of evidence, published this week, that the mosquito-borne virus dengue fever has been spreading unrecognised in Houston, Texas, since 2002. Dengue kills 25,000 people a year across the tropics. It had been absent from the US since the 1950s – but sporadic cases recently have crept back into the south.

It is especially dangerous when people encounter one strain, then another, as this can trigger a deadly immune reaction. Worryingly, the Houston strain is different from one seen in Florida in 2010, meaning encountering both might now be a possibility if they have spread along the Gulf coast. Finding out if they have will require intensive surveillance of people and mosquitoes across the southern US, says Peter Hotez, head of tropical medicine at Baylor College of Medicine in Houston. Only the CDC can do that.

Global network

Outside the US, the CDC runs a network of 10 global disease-detection centres, of which eight are now closed. They are often the only modern epidemiology available in tropical countries where novel outbreaks could be brewing, such as the next flu pandemic, or something completely unexpected like MERS, the coronavirus that emerged in Saudi Arabia last year. The annual Hajj pilgrimage to Mecca is now under way, and the CDC would normally be first to help investigate any suspicious disease outbreaks in returning pilgrims across the world. But as long as the shutdown persists, it cannot.

The worst problem for the CDC, however, might turn out to be that nothing really severe happens while most of its staff are forbidden from coming to work.

Political ideologues committed to “small government” could claim that this shows that the world does not need a publicly funded agency like the CDC and its comprehensive disease monitoring and rapid-response capabilities. Yet as New Scientist has reported many times, rapid forms of travel, booming populations of humans and animals, ecological disruption and changing global climate add up to a myriad new disease threats waiting to happen. Electing to stop watching for them because of a political spat does not change that fact.

 

http://www.newscientist.com/article/dn24387-threatwatch-disease-may-run-amok-while-the-cdc-sleeps.html#.Uln-ycHn_Vg

Novel Strain of Clostridium botulinum That Produces Type B and Type H Botulinum Toxins

 

Jason R. Barash and

Stephen S. Arnon

+ Author Affiliations

Infant Botulism Treatment and Prevention Program, California Department of Public Health, Richmond, California

Correspondence: Stephen S. Arnon, MD, Infant Botulism Treatment and Prevention Program, California Department of Public Health, 850 Marina Bay Pkwy, Rm E-361, Richmond, CA 94804 (stephen.arnon@cdph.ca.gov).

Abstract

Background. Clostridium botulinum strain IBCA10-7060, isolated from a patient with infant botulism, produced botulinum neurotoxin type B (BoNT/B) and another BoNT that, by use of the standard mouse bioassay, could not be neutralized by any of the Centers for Disease Control and Prevention–provided monovalent polyclonal botulinum antitoxins raised against BoNT types A–G.

Methods and Results. The combining of antitoxins to neutralize the toxicity of known bivalent C. botulinum strains Ab, Ba, Af, and Bf also failed to neutralize the second BoNT. Analysis of culture filtrate by double immunodiffusion yielded a single line of immunoprecipitate with anti-A, anti-B, and anti-F botulinum antitoxins but not with anti-E antitoxin. A heptavalent F(ab’)2 botulinum antitoxin A–G obtained from the US Army also did not neutralize the second BoNT. An antitoxin raised against IBCA10-7060 toxoid protected mice against BoNT/B (Okra) and against the second BoNT but did not protect mice against BoNT/A (Hall) or BoNT/F (Langeland).

Conclusions. The second BoNT thus fulfilled classic criteria for being designated BoNT/H. IBCA10-7060 is the first C. botulinum type Bh strain to be identified. BoNT/H is the first new botulinum toxin type to be recognized in >40 years, and its recognition could not have been accomplished without the availability of the mouse bioassay.

 

http://jid.oxfordjournals.org/content/early/2013/10/07/infdis.jit449.short

40 years of CDC nutrition research fatally flawed

Contact: Jeff Stensland stenslan@mailbox.sc.edu 803-777-3686 University of South Carolina

40 years of federal nutrition research fatally flawed

University of South Carolina study shows flaws in NHANES data

Four decades of nutrition research funded by the Centers for Disease Control and Prevention (CDC) may be invalid because the method used to collect the data was seriously flawed, according to a new study by the Arnold School of Public Health at the University of South Carolina.

The study, led by Arnold School exercise scientist and epidemiologist Edward Archer, has demonstrated significant limitations in the measurement protocols used in the National Health and Nutrition Examination Survey (NHANES). The findings, published in PLOS ONE (The Public Library of Science), reveal that a majority of the nutrition data collected by the NHANES are not “physiologically credible,” Archer said.

These results suggest that without valid population-level data, speculations regarding the role of energy intake in the rise in the prevalence of obesity are without empirical support, he said.

The NHANES is the most comprehensive compilation of data on the health of children and adults in the United States. The survey combines interviews of self-reported food and beverage consumption over 24 hours and physical examinations to assess the health and nutritional status of the US population. Conducted by the CDC and the U.S. Department of Agriculture, the NHANES is the primary source of data used by researchers studying the impact of nutrition and diet on health.

The study examined data from 28,993 men and 34,369 women, 20 to 74 years old, from NHANES I (1971 – 1974) through NHANES (2009 – 2010), and looked at the caloric intake of the participants and their energy expenditure, predicted by height, weight, age and sex. The results show that — based on the self-reported recall of food and beverages — the vast majority of the NHANES data “are physiologically implausible, and therefore invalid,” Archer said.

In other words, the “calories in” reported by participants and the “calories out,” don’t add up and it would be impossible to survive on most of the reported energy intakes. This misreporting of energy intake varied among participants, and was greatest in obese men and women who underreported their intake by an average 25 percent and 41 percent (i.e., 716 and 856 Calories per-day respectively).

“Throughout its history, the NHANES survey has failed to provide accurate estimates of the habitual caloric consumption of the U.S. population,” Archer said. “Although improvements were made to the NHANES measurement protocol after 1980, there was little improvement to the validity of U.S. nutritional surveillance.”

These limitations “suggest that the ability to estimate population trends in caloric intake and generate public policy relevant to diet-health relationships is extremely limited,” said Archer, who conducted the study with colleagues at the Arnold School.

“The nation’s major surveillance tool for studying the relationships between nutrition and health is not valid. It is time to stop spending tens of millions of health research dollars collecting invalid data and find more accurate measures,” he said.

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To access the current study, please visit: http://dx.plos.org/10.1371/journal.pone.0076632.

Vaccination campaign doubles HBV mutations

Contact: Garth Hogan ghogan@asmusa.org 202-942-9389 American Society for Microbiology

WASHINGTON, DC – October 7, 2013 – A universal infant vaccination campaign in China has led the Hepatitis B virus (HBV) to more than double its rate of “breakout” mutations. These mutations may enable the virus to elude the vaccine, necessitating new vaccination strategies. Researchers at the Chinese Centers for Disease Control and Prevention and University of North Carolina, Chapel Hill, report their findings in an article published ahead of print in the Journal of Virology.

Until a universal vaccination program for infants was implemented in 1992, nearly ten percent of Chinese—children included—were infected with HBV. The vaccination campaign has protected an estimated 80 million children, dramatically reducing the percentage of children under 5 who are infected, from nearly 10 percent in 1992 to less than one percent in 2005. But these gains are in danger of being eroded as the virus develops surface mutations.

Taking advantage of 1992 and 2005 survey, investigators found that the prevalence of HBV escape mutants in children rose from 6.5 percent in 1992, before the start of the universal vaccination program, to nearly 15 percent in 2005. Among the control group of adults unaffected by the universal vaccination campaign, the rate of break-out mutants was virtually unchanged.

Hepatitis B is an infectious illness of the liver which can cause vomiting, inflammation, jaundice, and, rarely, death. About a third of the world’s population has been infected at some point in their lives. Transmission of hepatitis B virus results from exposure to infectious blood or bodily fluids containing blood. The infection is preventable by vaccination, which has been routinely used since the 1980s.

Researcher Tao Bian of Chapel Hill says that the vaccine remains quite effective, but that because escape mutants are likely to increase, public health officials need to track the rise of escape mutants, in order to know when it becomes time to consider new vaccination strategies. Measures that might be taken include boosting doses, adjusting the timing of vaccinations, or improving the vaccine. A next generation HBV vaccine has been invented, containing a second antigen in addition to the virus’ surface antigen. That means that both antigens would have to develop breakout mutations in order to elude the vaccine.

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A copy of the manuscript can be found online at http://bit.ly/asmtip0913e.  Formal publication is scheduled for the November 2013 issue of the Journal of Virology.

The Journal of Virology is a publication of the American Society for Microbiology (ASM). The ASM is the largest single life science society, composed of over 39,000 scientists and health professionals. ASM’s mission is to advance the microbiological sciences as a vehicle for understanding life processes and to apply and communicate this knowledge for the improvement of health and environmental and economic well-being worldwide.

High BPA levels in children associated with higher risk of obesity and abnormal waist circumference

Contact: Mary F. Masson mfmasson@umich.edu 734-764-2220 University of Michigan Health System

Effects of chemical used in products for kids like baby bottles, plastic toys examined in study published in Pediatrics

Ann Arbor, Mich. — Children who have higher levels of Bisphenol A (BPA), a chemical previously used in many products for kids, like baby bottle and plastic toys, had a higher odds of obesity and adverse levels of body fat, according to a new study from University of Michigan researchers.

The U-M team studied the levels of BPA found in children’s urine and then measured body fat, waist circumference, and cardiovascular and diabetes risk factors, in a study published today in Pediatrics.

BPA was previously widely used in the manufacturing of polycarbonate and epoxy resins used in a variety of products for children, including baby bottles, protective coatings on metal food containers, plastic toys, and dental sealants.

“Studies in adults had shown an association between high BPA levels and obesity, diabetes and cardiovascular disease, but little was known about its effects in children,” says Donna Eng, M.D., lead author of the study and recent graduate of the Pediatric Endocrinology Fellowship at C.S. Mott Children’s Hospital.

The study found that higher odds of obesity, defined as a BMI above the 95th percentile on Centers for Disease Control and Prevention growth curves, was associated with higher levels of urinary BPA. Researchers also found that children with higher BPA levels also were more likely to have an abnormal waist circumference-to-height ratio.

The study did not find significant associations of BPA with any other chronic disease factors, including abnormal levels of cholesterol, insulin or glucose levels.

“Our study suggests a possible link between BPA exposure and childhood obesity.  We therefore need more longitudinal studies to determine if there is a causal link between BPA and excess body fat.” says Eng.

Manufacturers have been voluntarily recalling BPA products due to suspicion about the toxic effects on children and other vulnerable populations. Many countries, including Canada and members of the European Union, as well as several U.S. states, have banned BPA use in products frequently used by infants and young children.

In July 2012, the U.S. Food and Drug Administration announced that baby bottles and children’s drinking cups could no longer contain BPA; however, this restriction does not apply to other BPA containing products.

“We were surprised that our study did not find an association between BPA and measures of cardiovascular and diabetes risk, which has been established among adults,” says Joyce Lee, M.D., M.P.H, associate professor of Pediatrics at C.S. Mott Children’s Hospital.

“Based on these results, BPA may not have adverse effects on cardiovascular and diabetes risk, but it’s certainly possible that the adverse effects of BPA could compound over time, with health effects that only later manifest in adulthood,” says Lee, an investigator in U-M’s Child Health Evaluation and Research Unit and assistant professor of Environmental Health Sciences in the U-M School of Public Health.

Investigators hope the study will prompt more research into BPA’s effects that can inform future policy regulating children’s consumer products.

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Additional authors: All of the University of Michigan.  Of the School of Public Health: John D. Meeker, ScD, Karen Peterson, DSc, and of the Medical School: Achamyeleh Gebremariam, M.S., Vasantha Padmanabhan, Ph.D.

Journal reference: doi:10.1542/peds.2013-0106

Funding: This work was supported by the Department of Pediatrics and the Office of the Vice President of Research, University of Michigan, by training grant support to

Dr. Eng ( DK071212-07 National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases), and by grants from the National Institute of Environmental Health Sciences (ES018171) and US Environmental Protection Agency (RD834800). Funded by the National Institutes of Health (NIH).

About C.S. Mott Children’s Hospital:

Since 1903, the University of Michigan has led the way in providing comprehensive, specialized health care for children. From leading-edge heart surgery that’s performed in the womb to complete emergency care that’s there when you need it, families from all over come to the University of Michigan C.S. Mott Children’s Hospital for our pediatric expertise. More information is available at http://www.mottchildren.org

About CHEAR:

The Child Health Evaluation and Research unit is a multi-disciplinary health services research unit, based in the Division of General Pediatrics that brings together faculty from multiple pediatric subspecialty disciplines, other departments from the Medical School and multiple schools and institutes at the University of Michigan. Through interdisciplinary collaboration, the CHEAR unit addresses the most pressing child health issues of the day.

More information is available at http://www.chear.org.

PFC exposure tied to altered thyroid function

Contact: Jenni Glenn Gingery
jgingery@endocrine.org
301-941-0240
The Endocrine Society

Endocrine-disrupting chemicals may increase odds of women developing mild hypothyroidism

Chevy Chase, MD—Exposure to perfluorinated chemicals is linked to changes in thyroid function and may raise the risk of mild hypothyroidism in women, according to a recent study accepted for publication in The Endocrine Society’s Journal of Clinical Endocrinology & Metabolism (JCEM).

Perfluorinated chemicals, or PFCs, are compounds used to manufacture fabrics, carpets, paper coatings, cosmetics and a variety of other products. Among humans and wildlife, PFC exposure is widespread, according to the National Institutes of Health’s National Institute of Environmental Health Sciences. Because these chemicals break down very slowly, it takes a long time for PFCs to leave the body.

“Our study is the first to link PFC levels in the blood with changes in thyroid function using a nationally representative survey of American adults,” said one of the study’s authors, Chien-Yu Lin, MD, PhD, of En Chu Kong Hospital in Taiwan.

Women who had higher levels of a PFC called perfluorooctanoate (PFOA) in their blood tended to have elevated levels of the thyroid hormone triiodothyronine (T3). The study also found an increase in levels of T3 and the thyroid hormone thyroxine (T4) in women with higher concentrations of the PFC perfluorohexane sulfonate (PFHxS) in their blood. The levels rose without the pituitary gland signaling the thyroid to produce more hormones, which is the body’s natural mechanism for adjusting thyroid hormone levels. Men exposed to higher amounts of PFHxS, however, tended to have lower levels of the T4 hormone.

Even though people with a history of thyroid diseases were excluded from the study, researchers found an association between subclinical, or mild, hypothyroidism and elevated levels of PFOA, PFHxS and perfluorooctane sulfonate (PFOS) in women. Hypothyroidism occurs when the thyroid gland does not produce enough hormones and can cause symptoms such as fatigue, mental depression, weight gain, feeling cold, dry skin and hair, constipation and menstrual irregularities. This relationship needs to be explored and confirmed through additional research, Lin said.

The researchers analyzed data from 1,181 participants in the 2007-2008 and 2009-2010 National Health and Nutrition Examination Survey (NHANES), a population-based survey conducted by the Centers for Disease Control and Prevention (CDC). The study reviewed levels of four different PFCs as well as thyroid function.

“Although some PFCs such as PFOS have been phased out of production by major manufacturers, these endocrine-disrupting chemicals remain a concern because they linger in the body for extended periods,” Lin said. “Too little information is available about the possible long-term effects these chemicals could have on human health.”

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Other researchers working on the study include: L. Wen of En Chu Kong Hospital, L. Lin and T. Su of National Taiwan University Hospital and P. Chen of National Taiwan University College of Public Health.

The article, “Association between Serum Perfluorinated Chemicals and Thyroid Function in U.S. Adults: the National Health and Nutrition Examination Survey 2007-2010,” was published online July 17.

Founded in 1916, The Endocrine Society is the world’s oldest, largest and most active organization devoted to research on hormones and the clinical practice of endocrinology. Today, The Endocrine Society’s membership consists of over 16,000 scientists, physicians, educators, nurses and students in more than 100 countries. Society members represent all basic, applied and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Maryland. To learn more about the Society and the field of endocrinology, visit our site at http://www.endocrine.org. Follow us on Twitter at https://twitter.com/#!/EndoMedia.

Study links chemicals widely found in plastics and processed food to elevated blood pressure in children and teens

Contact: Lorinda Klein lorindaann.klein@nyumc.org 212-404-3533 NYU Langone Medical Center / New York University School of Medicine

Data from nearly 3,000 children shows dietary exposure to certain plastics may play a hidden role in epidemic increases in childhood hypertension

NEW YORK, May 22, 2013. Plastic additives known as phthalates (pronounced THAL-ates) are odorless, colorless and just about everywhere: They turn up in flooring, plastic cups, beach balls, plastic wrap, intravenous tubing and—according to the Centers for Disease Control and Prevention—the bodies of most Americans. Once perceived as harmless, phthalates have come under increasing scrutiny. A growing collection of evidence suggests dietary exposure to phthalates (which can leech from packaging and mix with food) may cause significant metabolic and hormonal abnormalities, especially during early development.

Now, new research published this Wednesday in the Journal of Pediatrics suggests that certain types of phthalates could pose another risk to children: compromised heart health. Drawing on data from a nationally representative survey of nearly 3,000 children and teens, researchers at NYU Langone Medical Center, in collaboration with researchers at the University of Washington and Penn State University School of Medicine, have documented for the first time a connection between dietary exposure to DEHP (di-2-ethyhexylphthalate), a common class of phthalate widely used in industrial food production, and elevated systolic blood pressure, a measure of pressure in the arteries when the heart contracts.

“Phthalates can inhibit the function of cardiac cells and cause oxidative stress that compromises the health of arteries. But no one has explored the relationship between phthalate exposure and heart health in children” says lead author Leonardo Trasande, MD, MPP, associate professor of pediatrics, environmental medicine and population health at NYU Langone Medical Center. “We wanted to examine the link between phthalates and childhood blood pressure in particular given the increase in elevated blood pressure in children and the increasing evidence implicating exposure to environmental exposures in early development of disease.”

Hypertension is clinically defined as a systolic blood-pressure reading above 140 mm Hg. It’s most common in people over 50 years old, although the condition is becoming increasingly prevalent among children owing to the global obesity epidemic. Recent national surveys indicate that 14 percent of American adolescents now have pre-hypertension or hypertension. “Obesity is driving the trend but our findings suggest that environmental factors may also be a part of the problem,” says Dr. Trasande. “This is important because phthalate exposure can be controlled through regulatory and behavioral interventions.”

Researchers from NYU School of Medicine, the University of Washington and Penn State University School of Medicine examined six years of data from a nationally representative survey of the U.S. population administered by the National Centers for Health Statistics of the Centers for Disease Control and Prevention. Phthalates were measured in urine samples using standard analysis techniques. Controlling for a number of potential confounders, including race, socioeconomic status, body mass index, caloric intake and activity levels, the researchers found that every three-fold increase in the level of breakdown products of DEHP in urine correlated with a roughly one-millimeter mercury increase in a child’s blood pressure. “That increment may seem very modest at an individual level, but on a population level such shifts in blood pressure can increase the number of children with elevated blood pressure substantially,” says Dr. Trasande. “Our study underscores the need for policy initiatives that limit exposure to disruptive environmental chemicals, in combination with dietary and behavioral interventions geared toward protecting cardiovascular health.”

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This research was made possible through the generous support of KiDs of NYU Langone, an organization of parents, physicians, and friends that supports children’s health services at New York University Langone Medical Center through philanthropy, community service, and advocacy.

About NYU Langone Medical Center

NYU Langone Medical Center, a world-class, patient-centered, integrated, academic medical center, is one on the nation’s premier centers for excellence in clinical care, biomedical research and medical education. Located in the heart of Manhattan, NYU Langone is composed of four hospitals – Tisch Hospital, its flagship acute care facility; the Hospital for Joint Diseases, one of only five hospitals in the nation dedicated to orthopaedics and rheumatology; Hassenfeld Pediatric Center, a comprehensive pediatric hospital supporting a full array of children’s health services; and Rusk Rehabilitation, ranked the best rehabilitation program in New York and one of the top ten in the country since 1989, when U.S. News & World Report introduced its annual “Best Hospitals” rankings– plus NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history. The medical center’s tri-fold mission to serve, teach and discover is achieved 365 days a year through the seamless integration of a culture devoted to excellence in patient care, education and research. For more information, go to http://www.NYULMC.org

Expert questions US public health agency advice on influenza vaccines: “All influenza is “flu,” but only one in six “flus” might be influenza”

Contact: Emma Dickinson edickinson@bmj.com 44-020-738-36529 BMJ-British Medical Journal

Marketing influenza vaccines involves marketing influenza as a threat of great proportions, argues Johns Hopkins fellow

Promotion of influenza vaccines is one of the most visible and aggressive public health policies today, writes Doshi. Today around 135 million doses of influenza vaccine annually enter the US market, with vaccinations administered in drug stores, supermarkets – even some drive-throughs.

This enormous growth has not been fuelled by popular demand but instead by a public health campaign that delivers a straightforward message: influenza is a serious disease, we are all at risk of complications from influenza, the flu shot is virtually risk free, and vaccination saves lives.

Yet, Doshi argues that the vaccine might be less beneficial and less safe than has been claimed, and the threat of influenza appears overstated.

To support its case, the CDC cites two studies of influenza vaccines, published in high-impact, peer-reviewed journals and carried out by academic and government researchers with non-commercial funding. Both found a large (up to 48%) relative reduction in the risk of death.

“If true, these statistics indicate that influenza vaccines can save more lives than any other single licensed medicine on the planet,” says Doshi. But he argues that these studies are “simply implausible” and likely the product of the ‘healthy-user effect’ (in this case, a propensity for healthier people to be more likely to get vaccinated than less healthy people).

In addition, he says, there is virtually no evidence that influenza vaccines reduce elderly deaths – the very reason the policy was originally created.

He points out that the agency itself acknowledges the evidence may be undermined by bias. Yet, he says “for most people, and possibly most doctors, officials need only claim that vaccines save lives, and it is assumed there must be solid research behind it.”

He also questions the CDC’s recommendation that beyond those for whom the vaccine is contraindicated, influenza vaccine can only do good, pointing to serious reactions to influenza vaccines in Australia (febrile convulsions in young children) and Sweden and Finland (a spike in cases of narcolepsy among adolescents).

Doshi suggests that influenza is yet one more case of “disease mongering” – medicalising ordinary life to expand markets for new products. But, he warns that unlike most stories of selling sickness, “here the salesmen are public health officials, worried little about which brand of vaccine you get so long as they can convince you to take influenza seriously.”

But perhaps the cleverest aspect of the influenza marketing strategy surrounds the claim that “flu” and “influenza” are the same, he concludes. “All influenza is “flu,” but only one in six “flus” might be influenza. It’s no wonder so many people feel that “flu shots” don’t work: for most flus, they can’t.”

Earlier this year, the BMJ launched a ‘Too Much Medicine’ campaign to help tackle the threat to health and the waste of money caused by unnecessary care. The journal will also partner at an international conference Preventing Overdiagnosis to be held in September in the USA

Vitamin E identified as potential weapon against obesity

Contact: Angela Hopp ahopp@asbmb.org 713-471-4541 Federation of American Societies for Experimental Biology

BOSTON — A potential new way to fight obesity-related illness has been uncovered, thanks to serendipitous research led by investigators at the Case Western Reserve University School of Medicine.

The collaborators, from Case Western Reserve University, the Cleveland Clinic Foundation and Cornell University, discovered the essential nutrient vitamin E can alleviate symptoms of liver disease brought on by obesity. “The implications of our findings could have a direct impact on the lives of the approximately 63 million Americans who are at potential risk for developing obesity-related liver disease in their lifetimes,” says Danny Manor, an associate professor at the Case Western Reserve University School of Medicine.

On Wednesday, April 24, Manor and colleague Varsha Thakur will present the group’s findings at the annual meeting of the American Society for Biochemistry and Molecular Biology, held in conjunction with the Experimental Biology 2013 meeting in Boston.

As is often the case in science, Manor’s research team at Case Western stumbled upon the findings entirely by accident. While studying the effect of vitamin E deficiency on the central nervous system, “we used liver tissue to practice our surgical techniques,” recalled Manor, an associate professor of nutrition and pharmacology. To the team’s surprise, they realized that the mice were in fact in the advanced stages of nonalcoholic steatohepatitis. Known as NASH for short, it’s a common complication of obesity characterized by fat accumulation, oxidative stress and inflammation in the liver. It is the most severe form of nonalcoholic fatty liver disease and is a major cause of tissue scarring known as cirrhosis that leads to liver failure and may progress to liver cancer.

An essential antioxidant, vitamin E had been shown by recent studies to alleviate some symptoms of NASH in human patients, suggesting that there is a link between adequate vitamin E levels and liver disease. To test this hypothesis, the team studied a mouse that was engineered to lack a protein that regulates the levels of vitamin E in the body. As expected, they observed increased oxidative stress, fat deposition and other signs of liver injury in the mice. Importantly, points out Manor, “supplementation with vitamin E averted the majority of NASH-related symptoms in these animals, confirming the relationship between vitamin E deficiency and liver disease.”

The precise effects of vitamin E on health have previously been difficult to ascertain, though its antioxidative properties were suggested to offer some protection from a variety of well-known maladies, including heart disease, cancer and neurological diseases such as Alzheimer’s and Lou Gehrig’s disease (amyotrophic lateral sclerosis, or ALS).

“These findings may have a significant impact on public health,” says Manor, “as the vast majority of adults in the United States do not consume the amount of vitamin E recommended by the National Institute of Medicine.”

For adults, the recommended dietary allowance of vitamin E is 15 milligrams a day. Vegetable oils, nuts and seeds, leafy greens and fortified cereals commonly contain vitamin E.

“Simple and affordable dietary intervention may benefit people at risk for this debilitating disease,” Manor says.

There is currently no treatment for NASH, making it one of the most common reasons for liver transplantation. Manor also points out that “NASH piggybacks on the two great epidemics of our time: obesity and Type 2 diabetes.”

According to the Centers for Disease Control and Prevention, obesity affects more than one-third of adults and one-sixth of children in the U.S., while nearly one in 10 Americans today suffers from diabetes, rates that have been climbing over the past two decades. Thus, for Manor, the significance of his group’s findings is not only the possibility that they will aid those who are currently sick but that they may also “affect many people who are presently healthy, but are at risk for becoming obese or diabetic in the future.”

Moreover, Manor believes that his group’s discovery will be key to determining the molecular details of NASH itself. “Right now, we really don’t understand how NASH progresses from mild liver damage to severe liver failure,” he said. “Our results will enable us to dissect the different steps in this progression, as well as study how oxidative stress affects liver function more generally, giving possible insights into other related disorders.”

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The team’s work is supported by the National Institute of Diabetes and Digestive and Kidney Diseases.

About Experimental Biology 2013

Experimental Biology’s mission is to share the newest scientific concepts and research findings shaping future and current clinical advances – and to give scientists and clinicians an unparalleled opportunity to hear from colleagues working on similar biomedical problems using different disciplines. With six sponsoring societies and another 20 U.S. and international guest societies, the annual meeting brings together scientists from throughout the United States and the world, representing dozens of scientific areas, from laboratory to translational to clinical research. The meeting also offers a wide spectrum of professional development sessions.

About the American Society for Biochemistry and Molecular Biology

The ASBMB is a nonprofit scientific and educational organization with more than 12,000 members worldwide. Most members teach and conduct research at colleges and universities. Others conduct research in various government laboratories, at nonprofit research institutions and in industry. The Society’s student members attend undergraduate or graduate institutions.  For more information about ASBMB, visit http://www.asbmb.org.

110 million Americans infected with some type of STD

 

 

Wednesday, 27 March 2013

 

According to new data released by the federal Centers for Disease Control and Prevention, there were 19.7 million new venereal infections in the United States in 2008, bringing the total number of existing sexually transmitted infections (STIs) in the U.S. at that time to 110,197,000!

 

 

 

The 19.7 million new STIs in 2008 vastly outpaced the new jobs and college graduates created in the United States that year or any other year on record, according to government data. The competition was not close.

 

The STI study referenced by the CDC estimated that 50 percent of the new infections in 2008 occurred among people in the 15-to-24 age bracket. In fact, of the 19,738,800 total new STIs in the United States in 2008, 9,782,650 were among Americans in the 15-to-24 age bracket.

 

 

 

By contrast, there were 1,524,092 bachelor’s degrees awarded in the United States in the 2007-2008 school year, according to the National Center for Education Statistics. That means the total number of new STIs in 2008 outpaced the total number of new bachelor’s degrees by nearly 13 to 1, and the number of new STIs among Americans in the 15-to-24 age bracket outnumbered new bachelor’s degrees by more than 6 to 1.

 

 

 

While the CDC estimates that there were 19.7 million new STIs in the United States in 2008, data published by the Bureau of Labor Statistics indicated that the total number of people employed in the country actually declined by 2.9 million during that year.

 

The CDC said the new venereal infections contracted each year cost the nation about $16 billion.

 

“CDC’s new estimates show that there are about 20 million new infections in the United States each year, costing the American healthcare system nearly $16 billion in direct medical costs alone,” said a CDC fact sheet.

 

http://macedoniaonline.eu/content/view/23007/54/

Vial containing strain of potentially deadly virus missing from Texas laboratory

By  Daily Mail Reporter

PUBLISHED: 18:20 EST, 24  March 2013 |  UPDATED: 18:20 EST, 24 March 2013

 

A small vial containing a potentially harmful  strain of virus has gone missing from a Texas laboratory, it was revealed  today.

The vial, which contains a strain of the  Guanarito virus, had been locked in a bio-hazard freezer within the University  of Texas’ Medical Branch campus.

The strain of virus is part of a family of  diseases that caused deadly outbreaks in Venezuela and could cause hemorrhagic  fever.

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A small vial containing a potentially harmful strain of  virus has gone missing from a Texas laboratory (file photo)

Officials at the UTMB noticed that a single  vial of the substance was missing from the freezer early last week,  the Houston Chronicle reported.

UTMB director Scott Weaver told the paper  that Guanarito has been responsible for causing deadly diseases within the South  American country.

Government officials have made studying the  strain a priority as it can potentially be used by terrorists in a contagion  attack.

Upon discovery that one out of the five vials  at the lab was missing, officials contacted the Centers for Disease Control and  Prevention.

They said that there was no security breach  or break-in at the Texas facility, nor was there any suspicion of foul play.

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The vial was housed at the University of Texas Medical  Branch in Galveston; officials believe there was no foul play and that the vial  could have simply broken in the lab’s cleaning process

Officials further added that they believe the  vial could have been accidentally destroyed during the lab’s cleaning  process.

The virus is transmitted through contact with  infected Venezuelan rats, but scientists do not believe it can survive on U.S.  rats.

Read more: http://www.dailymail.co.uk/news/article-2298596/Vial-containing-strain-potentially-deadly-virus-missing-Texas-laboratory.html#ixzz2OVxn2OMz Follow us: @MailOnline on Twitter | DailyMail on Facebook

U.S. autism estimates climb to 1 in 50 school-age children: 72% increase since 2007

Thu, 21 Mar 2013 00:05 GMT

Reuters

* Boys four times more likely than girls to have diagnosis

* Milder cases made up much of the increase  (Adds CDC and expert interview, byline, background)

By Julie Steenhuysen

March 20 (Reuters) – As many as one in 50 U.S. school age children have a diagnosis of autism, up 72 percent since 2007, but much of the increase involves milder cases, suggesting the rise is linked to better recognition of autism symptoms and not more cases, government researchers said on Wednesday.

Overall, the telephone survey of more than 100,000 parents found about 2 percent of children ages 6 to 17 have autism, up from 1.16 percent in 2007, the last time the study was conducted.

“That translates to 1 million school age children ages 6 to 17 who were reported by their parents to have autism spectrum disorder,” said Stephen Blumberg, a senior scientist at the National Center for Health Statistics, a part of the U.S. Centers for Disease Control and Prevention, who led the study.

As with prior estimates, boys were much more likely to be diagnosed with autism than girls, with 1 in 31 school-age boys, or 3.2 percent, having an autism diagnosis, compared with 1 in 143, or 0.7 percent of girls, having a diagnosis.

“Boys were more than 4 times as likely as girls to have autism spectrum disorder,” Blumberg said.

He said the increase among boys accounted for nearly all of the overall increase in autism diagnoses.

DIFFERENT METHODOLOGY

The new findings differ sharply from autism data released just a year ago by the CDC, which said 1 in 88 children in the United States had autism, a spectrum of disabilities that can range from highly functioning individuals to those with severe speech and intellectual disabilities.

In general, individuals with autism struggle with difficulties in communication, behavior and social interaction.

In the current study, the researchers surveyed parents of children age 6 to 17 as part of the 2011-2012 National Survey of Children’s Health or NSCH. They compared their findings to the same study done in 2007, which found 1 in 86 children had an autism diagnosis.

The estimate from last year involved a review of medical and educational records of 8 year olds in 14 sites around the country. Data in the records were last collected in 2008, so the finding of 1 in 88 is not far off from the 1 in 86 figure in 2007, the starting point of the current study.

Blumberg said much of the increase in the estimates from the current parent survey was the result of diagnoses of children with previously unrecognized autism.

Increased awareness of autism differences in children and better detection of autism symptoms by doctors, especially in children with milder cases, likely accounts for the increased diagnoses.

“We think the improved recognition is really a recognition of autism spectrum disorders in children with previously unrecognized autism as opposed to new cases,” Blumberg said

Symptoms of autism can be seen in children as young as 18 months of age, and doctors are urged to conduct a screening for developmental delays on all children by age 2. But doctors often fail to detect mild cases of autism until children enter school, when parents become aware of their child’s troubles making friends and teachers notice differences in the child’s ability to interact socially, the team said.

“This is not saying anything about an increased risk for autism but rather that the NSCH is capturing more of the cases that had been missed previously,” said Michael Rosanoff of the advocacy group Autism Speaks.

For families, the findings mean detection of autism, particularly milder forms, is improving but could still happen earlier.

“Even mildly affected children who are in general education settings can struggle without and benefit from appropriate autism spectrum disorder services,” he said in an e-mail.

While scientists believe genetics account for 80 to 90 percent of the risk for developing autism, a growing number of studies are beginning to suggest that a father’s age at the time of conception may play a role by increasing risks for genetic mistakes in the sperm that could be passed along to offspring.

And new research by a British team found that older fathers are more likely to have grandchildren with autism, suggesting that risk factors for autism may build up over generations.

(Reporting by Julie Steenhuysen; Editing by Doina Chiacu and Cynthia Osterman)

http://www.trust.org/alertnet/news/us-autism-estimates-climb-to-1-in-50-school-age-children/

 

Study: Widespread ‘test-and-treat’ HIV policies could increase dangerous drug resistance

Contact: Robert Perkins perkinsr@usc.edu 213-740-9226 University of Southern California

Testing helps catch the disease early, but experts caution that aggressive use of antiretroviral drugs in asymptomatic patients could breed more resistant HIV

One of the most widely advocated strategies for dealing with HIV/AIDS could double the number of multi-drug-resistant HIV cases in the population of men who have sex with men (MSM) in LA County over the next 10 years, cautions a new study.

In the United States, LA County has the largest incident population of HIV positive individuals.

The so-called “test and treat” policy — which calls for universal testing for HIV as well as treatment with antiretroviral drugs for even those at the earliest stages of the disease — is popular because it has been shown to decrease the number of new HIV cases and deaths due to AIDS.

The problem, according to the study, is that such aggressive and widespread use of antiretroviral drugs would also rapidly and dramatically increase the prevalence of multiple-drug-resistant HIV (MDR).

“We’re not saying that testing everybody and treating everybody is bad. All we’re saying is that you should proceed with caution and closely monitor the prevalence of multi-drug-resistant HIV as you scale up the test and treat model,” said lead author Neeraj Sood, associate professor at the USC Schaeffer Center for Health Policy and Economics.

Sood collaborated with Zachary Wagner, also of the USC Schaeffer Center; USC Ph.D. student Emmanuel Drabo; and Raffaele Vardavas and Amber Jaycocks of the RAND Corporation. Their study received advance online publication by Clinical Infectious Diseases on March 13.

Sood and his colleagues studied the MSM population in LA County, which accounts for 82 percent of people living with HIV/AIDS countywide. They tracked how the disease was treated from 2000 to 2009 and how the virus responded.

Using data from the Centers for Disease Control and their own data, the researchers then generated a model of how the disease would respond under a more aggressive “test and treat” policy over the next 10 years.

The model showed the prevalence of MDR jumping from 4.79 percent to 9.06 percent by 2023.

A more cautious approach, Sood suggested, would be simply to aggressively test for the disease but to avoid prescribing antiretroviral drugs to asymptomatic patients. The modeling shows that strategy still making significant gains against HIV/AIDS, without the increase in MDR HIV.

“Prior studies show a dramatic reduction in risk-taking behavior by individuals once they know their HIV-positive status,” Sood said.

###

 

This work was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, grant # R01HD054877.

Folic acid supplements early in pregnancy may reduce child’s risk of autism by 40 percent

Contact: Timothy S. Paul tp2111@columbia.edu 212-305-2676 Columbia University’s Mailman School of Public Health

Large study in Norway finds early timing of supplements is critical

Prenatal folic acid supplements appear to reduce the risk for autistic spectrum disorders, according to a study published today (February 13) in the Journal of the American Medical Association (JAMA).

The Centers for Disease Control and Prevention estimate that about 1 in 88 children in the U.S. have been identified with an Autism Spectrum Disorder (ASD). ASDs are amongst the most heritable of mental disorders, but little is known about how the disorder develops. Consequently, methods for diagnosis, prevention, and treatment are limited.

Folic acid (Vitamin B9) is required for DNA synthesis and repair in the human body, and its naturally occurring form—folate—is found in leafy vegetables, peas, lentils, beans, eggs, yeast, and liver. Taking folic acid supplements during early pregnancy is known to protect against spina bifida and other neural tube defects in children. In the United States, Canada, and Chile, folic acid is added to flour, so as to automatically provide these supplements to consumers. Norway does not enrich its flour, and since 1998, the Norwegian Directorate of Health has recommended that all women planning to become pregnant take a daily supplement of folic acid from one month before the start of pregnancy through the first trimester.

Despite this policy, studies from North America and Europe have shown that many pregnant women have a lower dietary intake of folate than what is necessary to prevent neural tube defects.

The report in JAMA emerged from the Norwegian Mother and Child Cohort Study (MoBa) and its sub-study of autism, the Autism Birth Cohort (ABC) Study. This international collaboration (see list of members below) comprises the largest prospective birth cohort devoted to the investigation of gene-environment interactions and biomarker discovery for neuropsychiatric disorders.

A total of 85,176 MoBa babies—born from 2002-2008—and their parents participated in the study. Prenatal dietary habits were recorded, and families were regularly surveyed for 3-10 years to measure the development of autism spectrum disorders. A total of 270 cases of autism spectrum disorders were identified in the study population (114 autistic disorder; 56 Asperger syndrome; 100 atypical or unspecified autism; i.e., pervasive developmental disorder not otherwise specified, PDD-NOS).

Mothers who took folic acid supplements in early pregnancy had a 40% reduced risk of having children with autistic disorder compared with mothers who did not take folic acid. The reduction in risk was observed in those who took folic acid during the time interval from 4 weeks before to 8 weeks after the start of pregnancy. Autistic disorder is the most severe form of autism spectrum disorders in children. No reduction in risk was observed for PDD-NOS. For Asperger syndrome, the number of children was too low to obtain sufficient statistical power in the analyses.

The use of folic acid in early pregnancy increased substantially from 2002 to 2008 among women who participated in MoBa. In 2002, 43% of mothers took folic acid supplements; by 2008, 85% of mothers did. However, many women began taking folic acid later than recommended, and only half started before the beginning of pregnancy.

The timing of a mother’s intake of folate appears to be a critical factor. Her child’s risk of autism was reduced only when the supplements were taken between 4 weeks before to 8 weeks after the start of pregnancy.

“We examined the rate of autism spectrum disorders in children born to mothers who did or did not take folic acid during pregnancy. There was a dramatic reduction in the risk of autistic disorder in children born to mothers who took folic acid supplements,” says Pål Surén, first author and epidemiologist at the Norwegian Institute of Public Health (NIPH).

The researchers also analyzed whether the risk of autistic disorder was influenced by the use of other dietary supplements. They did not find any association between the mother’s use of fish oil supplements (cod liver oil and omega-3 fatty acids) in early pregnancy and the risk of autistic disorder, and no association for the mother’s use of other vitamins and minerals.

In recent years, researchers have started to investigate whether folic acid has other beneficial effects on the development of the fetus’ brain and spinal cord. A study of language development from MoBa, published in 2011, showed that children whose mothers took folic acid supplements in early pregnancy had only half the risk of severe language delay at age three years compared with other children. A separate 2011 study from the University of California, Davis, demonstrated a lower risk of autism spectrum disorders in children of mothers who had used prenatal vitamin supplements during pregnancy. Prenatal vitamin supplements contain folic acid in combination with other vitamins and minerals.

Joint senior author Ezra Susser, professor of Epidemiology at Columbia University’s Mailman School of Public Health and professor of Psychiatry at the College of Physicians and Surgeons, stated, “Our findings extend earlier work on the significance of folate in brain development and raise the possibility of an important and inexpensive public health intervention for reducing the burden of autism spectrum disorders.”

“This elegant work illustrates the power of the ABC cohort for not only chipping away at the riddle of what causes autism, but for developing new methods for early recognition, prevention and treatment,” says W. Ian Lipkin, John Snow Professor of Epidemiology at the Mailman School of Public Health and principal investigator of the ABC cohort.

###

About the study

The ABC Study is a collaboration between the Norwegian Institute of Public Health and Columbia University in New York funded by the National Institute of Neurological Disorders and Stroke of the U.S. National Institutes of Health.

The article was published in JAMA on February 13th, 2013. The authors are: Pål Surén, Christine Roth, Michaeline Bresnahan, Margaretha Haugen, Mady Hornig, Deborah Hirtz, Kari Kveim Lie, W. Ian Lipkin, Per Magnus, Ted Reichborn-Kjennerud, Synnve Schjølberg, George Davey Smith, Anne-Siri Øyen, Ezra Susser, and Camilla Stoltenberg.

Beta carotene may protect people with common genetic risk factor for type-2 diabetes

Contact: Bruce Goldman goldmanb@stanford.edu 650-725-2106 Stanford University Medical Center

STANFORD, Calif. — Stanford University School of Medicine investigators have found that for people harboring a genetic predisposition that is prevalent among Americans, beta carotene, which the body converts to a close cousin of vitamin A, may lower the risk for the most common form of diabetes, while gamma tocopherol, the major form of vitamin E in the American diet, may increase risk for the disease.

The scientists used a “big data” approach to hunt down interactions between gene variants previously associated with increased risk for type-2 diabetes and blood levels of substances previously implicated in type-2 diabetes risk. In people carrying a double dose of one such predisposing gene variant, the researchers pinpointed a highly statistically significant inverse association of beta carotene blood levels with type-2 diabetes risk, along with a suspiciously high positive association of gamma tocopherol with risk for the disease.

“Type-2 diabetes affects about 15 percent of the world’s population, and the numbers are increasing,” said Atul Butte, MD, PhD, associate professor of systems medicine in pediatrics. “Government health authorities estimate that one-third of all children born in the United States since the year 2000 will get this disease at some point in their lives, possibly knocking decades off their life expectancies.”

Butte is the senior author of the new study, which will be published online Jan. 22 in Human Genetics. The first author, Chirag Patel, PhD, is a former graduate student in Butte’s lab and now a postdoctoral scholar at the Stanford Prevention Research Center.

The findings point the way to further experiments that could establish whether beta carotene and gamma tocopherol are, respectively, protective and harmful themselves, or merely “markers” whose blood levels dovetail with the presence or absence of some other substance, process or defect that is a true causal factor.

Moreover, the fact that both beta carotene and gamma tocopherol interact with the same gene variant to influence diabetes risk, albeit in opposite directions, suggests that the protein the gene called, SLC30A4, codes for may play a crucial role in the disease. Indeed, that protein is relatively abundant in insulin-producing islet cells of the pancreas, where it aids the transport of zinc into those cells. This, in turn, triggers the release of insulin, whose adequate secretion by the pancreas and efficient uptake in muscle, liver and fat tissue counters the dangerous buildup of glucose in the blood and, in the long run, the onset of type-2 diabetes.

The genomes of some 50 to 60 percent of the U.S. population carry two copies of that very gene variant, which previous studies have shown to confer a slightly increased risk of contracting type-2 diabetes. This variant was one of 18, each found by other researchers to have a mild association with type-2 diabetes risk, that the Butte team incorporated into its analysis.

These gene/disease connections had been identified via so-called “genome-wide association studies,” or GWAS. In such analyses, the genomes of large numbers of people with a disease are compared with those of people without it to see if certain versions of any gene variants occur with substantially greater frequency in one group than in the other.

The most well-studied gene variations are substitutions of one type of chemical unit of DNA for another one at a single position along the genome. “It’s like a single-letter spelling change,” said Butte. “‘Grey’ versus ‘gray’ may not matter much, if at all. But when ‘grey’ turns into ‘grew,’ you might have some serious semantic issues.” The genome contains millions of spots at which such differences occur, so advanced statistical techniques must be employed to screen out “frequency differences” between the “diseased” and “healthy” groups that are, at bottom, the mere results of blind chance.

“While plenty of genetic risk factors for type-2 diabetes have been found,” said Butte, “none of them taken alone, and not even all of them taken together, comes close to accounting for the prevalence of type-2 diabetes.” But genes don’t act in a vacuum, he added. (If food is hard to find, nobody gets fat, obesity predisposition or not.)

A few years ago, Butte and his associates designed an approach analogous to the GWAS: the EWAS, or environment-wide association study. Unlike the genome, which is huge but finite (about 3 billion chemical units long), the environment contains an infinite number of substances, from dietary micronutrients to synthetic pollutants, to which a person might be exposed over a lifetime. But increasing numbers of exposures are being cataloged by investigators — including, for example, scientists at the federal Centers for Disease Control and Prevention who conduct massive biennial screenings to collect data that can guide public-health policy decisions. This ongoing endeavor, called the National Health and Nutrition Examination Survey, involves a detailed analysis of substances in blood drawn from thousands of volunteers along with their heights, weights, blood pressures, fasting blood-glucose levels and other indicators of their medical status.

In 2010, Patel, Butte and their colleagues published the results of the first-ever EWAS, in which they combed large public databases to compare people with or without high blood-glucose levels — a defining marker of type-2 diabetes — in pursuit of differences between the two groups’ exposures to myriad environmental substances. The analysis fingered five substances, including both beta carotene, found in carrots and many other vegetables, and gamma tocopherol, which is relatively abundant in vegetable fats such as soybean, corn and canola oils and margarine.

The Stanford investigators learned that the NHANES contained data on numerous individuals’ environmental exposures and, for many of the same individuals, their genomic compositions. This enabled the researchers to perform a novel study pairing each of the 18 type-2-diabetes-implicated gene variants with each of the five suspect environmental substances to see how, for individuals carrying a particular gene variant, different blood levels of a given substance correlated with those individuals’ blood-glucose levels.

None of the genetic factors studied in isolation had shown a particularly impressive impact on type-2 diabetes risk. But when they were paired off one by one with the environmental factors, a couple of statistically robust results jumped out. First, for those carrying two copies of the variant in SLC30A4, higher beta-carotene levels correlated with lower blood-glucose levels. “This vitamin was already known as being ‘good’ with respect to type-2 diabetes, so it was no surprise that we saw it, too,” said Butte. “But it was reassuring, as it suggested we were doing things right, and interesting to find it paired with SLC30A4.”

The second finding was at once novel and disconcerting. High blood levels of gamma tocopherol appeared to be associated with increased risk for the disease.

The Butte lab is now gearing up to perform studies in which purified beta carotene and gamma tocopherol will be fed to lab mice. This may show whether those substances themselves are critical to preventing or accelerating the onset of type-2 diabetes. It also may throw light on precisely how these substances affect the production or performance of the protein for which the implicated gene codes.

“We can’t say, based on just this study, that ‘vitamin E is bad for you,'” said Patel. He noted that blood levels of alpha tocopherol — another form of vitamin E that predominates in most supplements — showed no deleterious interaction with the predisposing gene variant in the new study.

But maybe it can’t hurt to eat a few more carrots.

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Other co-authors were John Ioannidis, MD, PhD, professor of medicine and of health research and policy; former staff bioinformatician Rong Chen, PhD; and research associate Keiichi Kodama, MD, PhD.

The Lucile Packard Foundation for Children’s Health, National Library of Medicine, National Institute of General Medical Sciences and other National Institutes of Health agencies funded the study.

Information about the medical school’s Department of Pediatrics, which also supported this work, is available at http://pediatrics.stanford.edu.

The Stanford University School of Medicine consistently ranks among the nation’s top medical schools, integrating research, medical education, patient care and community service. For more news about the school, please visit http://mednews.stanford.edu. The medical school is part of Stanford Medicine, which includes Stanford Hospital & Clinics and Lucile Packard Children’s Hospital. For information about all three, please visit http://stanfordmedicine.org/about/news.html.

Print media contact: Bruce Goldman (650) 725-2106 (goldmanb@stanford.edu)

Broadcast media contact: M.A. Malone at (650) 723-6912 (mamalone@stanford.edu)

Now, where did I put that Ebola? “pathogens were inadvertently released 639 times between 2004 and 2010”

18 Jan 2013 | 02:08 GMT | Posted by Helen Shen |

In the first study of its kind, the US Centers for Disease Control and Prevention (CDC) unveiled statistics on problems related to the handling of hazardous biological agents, such as Ebola, SARS and anthrax, at hundreds of academic and government research centres.

Laboratories that work with biological select agents and toxins — materials highly regulated for their potential to cause human disease — reported that pathogens were inadvertently released 639 times between 2004 and 2010. During the same period, laboratories also reported losing 88 samples, although bookkeeping errors accounted for all but one. The remaining lost sample was accidentally destroyed by a commercial courier.

The study, published in the current issue of Applied Biosafety, says that no occurrences of theft were reported.

Over the 7-year period, laboratories reported 11 lab-acquired infections, at an average annual rate of 1.6 per 10,000 authorized workers. Ten of the infections were traced to bacterial sources, and one was due to fungal exposure. None of the infections were fatal, and none were reported to have spread to other people.

The infections could not be linked to obvious breaches in personal protection, such as torn gloves or cuts from sharp objects. Instead, the authors suggest that workers probably acquired infections from the release of aerosols containing the harmful agents. The team says that it is continuing to analyse reports of pathogen releases and lab-acquired infections to identify possible gaps in safety procedures.

“The bottom line is we have a lot of success to report, if you consider that it’s a program that regulates over 300 [laboratories] across the US,” says report co-author Robbin Weyant, director of the CDC’s division of select agents and toxins.

Current regulations date back to counter-terrorism legislation passed in the wake of the 2001 anthrax attacks in the United States. A Federal Bureau of Investigation inquiry concluded that microbiologist Bruce Ivins, who worked at a government biodefence laboratory, was responsible for mailing anthrax spores that killed five people and sickened 17 others.

In recent years, government scrutiny and restriction of research on infectious agents has escalated to the point of slowing scientific progress, says Michael Buchmeier, deputy director of the Pacific Southwest Center for Biodefense and Emerging Infectious Diseases at the University of California, Irvine. He says the report suggests that theft and accidental loss of dangerous pathogens from research laboratories are not as widespread as some people have predicted.

http://blogs.nature.com/news/2013/01/now-where-did-i-put-that-ebola.html

Paradox of Vaccination: Is Vaccination Really Effective against Avian Flu Epidemics?

Abstract

Background

Although vaccination can be a useful tool for control of avian influenza epidemics, it might engender emergence of a vaccine-resistant strain. Field and experimental studies show that some avian influenza strains acquire resistance ability against vaccination. We investigated, in the context of the emergence of a vaccine-resistant strain, whether a vaccination program can prevent the spread of infectious disease. We also investigated how losses from immunization by vaccination imposed by the resistant strain affect the spread of the disease.

Methods and Findings

We designed and analyzed a deterministic compartment model illustrating transmission of vaccine-sensitive and vaccine-resistant strains during a vaccination program. We investigated how the loss of protection effectiveness impacts the program. Results show that a vaccination to prevent the spread of disease can instead spread the disease when the resistant strain is less virulent than the sensitive strain. If the loss is high, the program does not prevent the spread of the resistant strain despite a large prevalence rate of the program. The epidemic’s final size can be larger than that before the vaccination program. We propose how to use poor vaccines, which have a large loss, to maximize program effects and describe various program risks, which can be estimated using available epidemiological data.

Conclusions

We presented clear and simple concepts to elucidate vaccination program guidelines to avoid negative program effects. Using our theory, monitoring the virulence of the resistant strain and investigating the loss caused by the resistant strain better development of vaccination strategies is possible.

Citation: Iwami S, Suzuki T, Takeuchi Y (2009) Paradox of Vaccination: Is Vaccination Really Effective against Avian Flu Epidemics? PLoS ONE 4(3):          e4915.            doi:10.1371/journal.pone.0004915

Editor: Carl Kingsford, University of Maryland, United States of America

Received: November 12, 2008; Accepted: November 26, 2008; Published: March 18, 2009

Copyright: © 2009 Iwami et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: Research Fellowships of the Japan Society for the Promotion of Science for Young Scientists. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

* E-mail: takeuchi@sys.eng.shizuoka.ac.jp

Introduction

Highly pathogenic H5N1 influenza A viruses have spread relentlessly across the globe since 2003. They are associated with widespread death of poultry, substantial economic loss to farmers, and reported infections of more than 300 people with a mortality rate of 60% [1]. Influenza prevention and containment strategies can be considered under the broad categories of antiviral, vaccine, and non-pharmaceutical measures [2], [3], [4], [5], [6], [7], [8], [9], [10], [11], [12], [13]. A major public health concern is the next influenza pandemic; yet it remains unclear how to control such a crisis.

Vaccination of domestic poultry against the H5N1 subtype of avian influenza has been used in several countries such as Pakistan, Hong Kong, Indonesia, China, and Vietnam [14], [15], [16]. Using vaccination to reduce the transmission rate might provide an alternative to mass culling, by reducing both the susceptibility of healthy birds and the infectiousness of infected birds [14], [17], [18]. However, incomplete protection at the bird level can cause the silent spread of the virus within and among birds [11]. Furthermore, vaccines might provide immunological pressure on the circulating strains, which might engender the emergence of drifted or shifted variants with enhanced potential for pathogenicity in humans [1]. Therefore, although vaccination programs have been recommended recently, some field evidence indicates that vaccination alone will not achieve eradication. Moreover, if not used appropriately, vaccination might result in the infection becoming endemic [11], [17].

An important issue related to influenza epidemics is the potential for the emergence of vaccine-resistant influenza viruses. The vaccine-resistant strain, in general, causes a loss of the protection effectiveness of vaccination [19], [20], [21], [22] (there is experimental evidence of the loss of the protection effectiveness for antiviral-resistant strains [23]). Consequently, a vaccination program that engenders the emergence of the resistant strain might promote the spread of the resistant strain and undermine the control of the infectious disease, even if the vaccination protects against the transmission of a vaccine-sensitive strain [20], [21], [22].

For example, in China, despite a compulsory program for the vaccination of all poultry commencing in September 2005, the H5N1 influenza virus has caused outbreaks in poultry in 12 provinces from October 2005 to August 2006 [14], [15], [22]. Genetic analysis revealed that an H5N1 influenza variant (Fujian-like, FJ like), which is a previously uncharacterized H5N1 virus sublineage, had emerged and subsequently became the prevalent variant in each of the provinces, replacing those previously established multiple sublineages in different regions of southern China. Some data suggest that the poultry vaccine currently used in China might only generate very low neutralizing antibodies to FJ-like viruses (seroconversion rates remain low and vaccinated birds are poorly immunized against FJ-like viruses) in comparison to other previously cocirculating H5N1 sublineages [20], [22]. That evidence implies the possibility that the emergence and replacement of FJ-like virus was preceded by and facilitated by the vaccination program, although the mechanism remains unknown epidemiologically and virologically (some researchers consider that the emergence and replacement of FJ-like virus are questionable [24], [25]).

Furthermore, the H5N2 vaccines have been used in Mexico since 1995 [17], [19], [21]. Phylogenetic analysis suggests the presence of (previously uncharacterized) multiple sublineages of Mexican lineage isolates which emerged after the introduction of the vaccine. Vaccine protection studies further confirmed in vitro serologic results indicating that commercial vaccine was not able to prevent virus shedding when chickens were challenged with the multiple sublineage isolates [19], [21]. Therefore, the vaccine protective efficacy would be impaired and the use of this specific vaccine would eventually become obsolete. That fact also implies that the vaccine promotes the selection of mutation in the circulating virus.

The emergence of a vaccine-resistant strain presents the risk of generating a new pandemic virus that is dangerous for humans through an avian-human link because of the spread of vaccine-resistant strain. The dynamics of competition between vaccine-sensitive and vaccine-resistant strains is, in general, complex [8], [9]. Actually, outcomes of the dynamics might be influenced by several factors, including a loss of protection effectiveness, a competitive advantage of vaccine-resistant strain, and a prevalence rate of vaccination. Understanding the dynamics of a spread of vaccine-resistant is therefore crucial for implementation of effective mitigation strategies.

Several theoretical studies have investigated the impact of an emergence of a resistant strain of antiviral drug such as M2 inhibitors and NA inhibitors during an influenza pandemic among humans [2], [3], [8], [9], [10], [12], [26]. However, to our knowledge, no study has used a mathematical model to investigate the application of vaccination program among poultry in the context of an emergence of a vaccine-resistant strain. It remains unclear whether a vaccination program can prevent the spread of infectious disease when the vaccine-resistant strain emerges and how a loss of immunization by vaccination within birds infected with the vaccine-resistant strain affects the spread of infectious disease among birds. Nobody can give a simple and clear explanation to capture the problems described above in a theoretical framework (using numerical simulations, many qualitative and quantitative but sometimes very complex studies have investigated effects of antiviral drugs [3], [8], [9], [10], [12], [26]). Furthermore, we remain skeptical that a vaccination program can reduce the number of total infectious individuals even if the vaccination protects against transmission of a vaccine-sensitive strain. We developed a simple mathematical model to evaluate the effectiveness, as a strategy to control influenza epidemic, of a vaccination program among poultry which can engender the emergence of a vaccine-resistant strain.

Methods

Herein, we describe a homogeneous population model of infectious disease and its control using a vaccination program in the presence of a vaccine-resistant strain (Fig. 1).

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Figure 1. Model structure for the emergence of vaccine-resistant strain during a vaccination program: Susceptible birds (X) become infected with vaccine-sensitive (Y) and vaccine-resistant (Z) strains at rates in direct relation to the number of respective infectious birds.

We assume that vaccinated birds (V) can be protected completely from the vaccine-sensitive strain, but are partially protected from vaccine-resistant strains with a loss of protection effectiveness of the vaccination (σ). See the Mathematical model section for corresponding equations.

doi:10.1371/journal.pone.0004915.g001

All birds in the effective population are divided into several compartments, respectively including susceptible birds (X), vaccinated birds (V), birds infected with vaccine-sensitive strain (Y), and birds infected with vaccine-resistant strain (Z). We assume that susceptible birds are born or restocked at a rate of c per day and that all birds are naturally dead or removed from the effective population at a rate of b per day.

In the absence of vaccination, transmission occurs at a rate that is directly related to the number of infectious birds, with respective transmission rate constants ω and φ from infected birds with the vaccine-sensitive strain and with the vaccine-resistant strain. The infectiousness of vaccine-sensitive and vaccine-resistant strain are assumed to be exponentially distributed, respectively, with mean durations of 1/(b+my) and 1/(b+mz) days. Actually, my and mz respectively signify virulence of vaccine-sensitive and vaccine-resistant strains.

At the beginning of the vaccination program, X moves directly to V by the vaccination. However, after some period after the initial vaccination, the direct movement might vanish because almost all birds are vaccinated. Therefore, we can assume that vaccination is only administered to the newly hatched birds. The newly hatched birds are vaccinated at the rate 0≤p≤1 (more appropriately, p is proportional). Actually, p represents the prevalence rate of the vaccination program.

To simplify the theoretical treatment, as described in [11], we assume that the vaccinated birds can be protected completely from the vaccine-sensitive strain (note that the assumption is not necessary for our results: see Supplementary Information: Text S1, Fig. S10, S11). Actually, in laboratory experience, many avian influenza vaccines confer a very high level of protection against clinical signs and mortality (90–100% protected birds) [21]. However, many factors determine whether a vaccinated bird becomes infected, including age, species, challenge dose, health, antibody titre, infections of immunosuppressive diseases, and cross-reactivity of other avian influenza serotypes [11], [27], [28], [29]. On the other hand, we assume that the vaccinated birds are partially protected from the vaccine-resistant strain at the rate (proportion) 0≤1−σ≤1 because of cross-reactivity of immune systems [19], [20], [22], [23], [29] (e.g., σ = 0 represents complete cross immunity against vaccine-resistant strains). Actually, σ represents a loss of protection effectiveness of the vaccination caused by a vaccine-resistant strain.

Mathematical model

We extended the standard susceptible–infective model [30] including the effect of a vaccination program that can engender the emergence of a vaccine-resistant strain. Our mathematical model is given by the following equations: (1) Model (1) is a simplified one that is used in [31]. We considered a mechanism for the emergence and replacement of the FJ-like virus over a large geographical region in China using a more complex patch-structured model in the heterogeneous area [31]. Here we investigate the impact of the vaccination program in a homogeneous area and specifically examine the role of epidemiological parameters such as the prevalence rate of the vaccination program (p) and the loss of protection effectiveness of the vaccination (σ) in the spread of the disease.

Estimation of epidemiological parameters

Baseline values of model parameters and their respective ranges used for simulations are presented in Table 1 and 2. These parameters are based on avian influenza epidemics among poultry in The Netherlands in 2003 [32], [33], [34].

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Table 1. Description of physical characteristics, transmission, infectious, and vaccination parameters of the model with their baseline values and ranges used for simulations.

doi:10.1371/journal.pone.0004915.t001

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Table 2. Basic reproductive numbers and invasion reproductive numbers before the vaccination program.

doi:10.1371/journal.pone.0004915.t002

The initial population size was c/b = 984 birds at the 2003 epidemic [34]. Usually, the mean lifespan of poultry is about 2 years. However, we assume that the mean duration of a bird being in effective population is about 1/b = 100 days because of migration and marketing. Therefore, the birth or restocking rate of birds is c = 9.84 birds per day. Estimated infectious period and transmission parameters are 1/(b+my) = 13.8 days and ω = 4.78×10−4 day−1 individual−1, respectively, [34]. These physical characteristics, in addition to infectious and transmission parameters, are used in our model as parameters of the vaccine-sensitive strain.

The epidemiological and biological feature of antiviral drug-resistance is well reported in [23]. The transmissibility and virulence of drug-resistant strains are usually lower than those of the wild strain because of its mutation cost [8], [10], [23], [35]. Actually, antiviral drugs are also used for prophylaxis drug intervention as vaccination [8], [10], [12]. Herein, we use some reduced value of transmissibility (φ/ω = 0.58) and the increased value of infectious period of the vaccine-sensitive strain ((b+my)/(b+mz) = 1.32) for parameters of vaccine-resistant strain (sensitivity analyses are given in Supplementary Information: Text S1, Fig. S6, S7, S8, S9).

Reproductive numbers

A measure of transmissibility and of the stringency of control policies necessary to stop an epidemic is the basic reproductive number, which is the number of secondary cases produced by each primary case [30]. We obtain basic reproductive quantities of vaccine-sensitive strain and vaccine-resistant strain before vaccination program (superscript n means no vaccination). In fact, during the vaccination program, the basic reproductive numbers depend on the rate of prevalence of the vaccination program. We derived these basic reproductive numbers depending on the prevalence rate in Supplementary Information: Text S1. With the estimated parameters in Table 1 the basic reproductive number of vaccine-sensitive and vaccine-resistant strain are and , respectively (note that corresponds to an estimated value in [34]).

Furthermore, to clarify the concept of competition among strains simply, we introduce the invasion reproductive number for the vaccine-resistant strain before the vaccination program , which signifies an expected number of new infectious cases with the vaccine-resistant strain after a spread of a vaccine-sensitive strain among birds. The invasion reproductive number is considered as a competitive condition (relative fitness), which represents some advantage measure of the vaccine-resistant strain against the vaccine-sensitive strain. The estimated invasion reproductive number of the vaccine-resistant strain is . During the vaccination program, the invasion reproductive number also depends on the prevalence rate of the vaccination program (see Supplementary Information: Text S1).

Results

We consider a scenario in which a vaccine-resistant strain can emerge (i.e., be eventually selected) during a vaccination program designed to be effective against the spread of a vaccine-sensitive strain. This implies that : otherwise the vaccine-resistant strain can not emerge at all (see Supplementary Information: Text S1, Fig. S1, S2, S3). Acquisition of resistance ability usually engenders a strain which, in the absence of a pharmaceutical intervention, is less fit than the sensitive strain [8], [9], [12], [35]. Therefore, . We generally assume the following conditions for reproductive numbers before the vaccination program (our baseline parameter values are satisfied with these assumptions):

The assumption precludes the possibility that a pre-existing vaccine-resistant strain beats the vaccine-sensitive strain before the vaccination program because .

Evaluation of the effect of a vaccination program

Although vaccination is an important tool to control epidemics, the use of vaccination might engender a spread of a vaccine-resistant strain. To demonstrate the interplay between these opposing effects, we simulated our model to determine the final size of an epidemic (total infected individuals Y+Z at equilibrium level) over vaccination prevalence (0≤p≤1) in Fig. 2 (we use our baseline parameter values except for mz). We assume that the loss of the protection effectiveness is 35% (σ = 0.35: this value can be chosen arbitrarily with little effect on the meaning of the results). The estimated infectious period of the vaccine-sensitive strain is 13.8 days [34] (see Table 1). Therefore, the virulence of vaccine-sensitive strain is my = 0.062 day−1. Results show that the patterns of the final size can be divided into two cases, which depend strongly on the virulence of the vaccine-resistant strain. If the virulence of the vaccine-resistant strain is lower than that of vaccine-sensitive strain (e.g., we choose mz = 0.045), then increasing the prevalence rate of vaccination from 13.5% to 30.3% can increase the final size (green line at top figure in Fig. 2). On the other hand, if the virulence is higher (mz = 0.065), increasing the prevalence always decreases the final size (bottom figure in Fig. 2). These two patterns are qualitatively preserved for different virulence of the vaccine-resistant strain.

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Figure 2. Final size of epidemics related with the prevalence rate of the vaccination: The top figure represents that the vaccination is not always effective in the case of lower virulence of vaccine-resistant strain.

The bottom figure represents that the vaccination is always effective in the case of higher virulence of the vaccine-resistant strain. We assume that σ = 0.35, mz = 0.045 (top) and mz = 0.065 (bottom). These values of σ and mz are not so influential on the result. The blue, green, and red lines respectively signify situations in which only the vaccine-sensitive strain exists, both the vaccine-sensitive and the vaccine-resistant strains exist, and only the vaccine-resistant strain exists.

doi:10.1371/journal.pone.0004915.g002

In [8], [9], although they consider the emergence of an antiviral drug-resistant virus, a similar tendency (increasing the treatment level increases the final size of the epidemic) was obtained through complex models that are difficult to treat mathematically. The mathematical model presented herein demonstrates that the patterns of final size over vaccination prevalence only depend on the virulence of the vaccine-resistant strain as follows (see Supplementary Information: Text S1). Increasing the prevalence rate increases the final size when only both strains co-exist if the virulence of vaccine-resistant strain is lower than that of vaccine-sensitive strain (my>mz). That is to say, the vaccination is effective when either a vaccine-sensitive or a vaccine-resistant strain exists. On the other hand, if the virulence of vaccine-resistant strain is higher than that of vaccine-sensitive strain (my<mz), the final size always decreases as the prevalence rate increases. The other parameters can not change these patterns. In fact, many studies have ignored the impact of the virulence of the vaccine-resistant strain. In [7], we also found that the virulence of mutant strain determines a choice of the optimal prevention policy for avian influenza epidemic. Therefore, we suggest that, to monitor and investigate the virulence evolution between the vaccine-sensitive and vaccine-resistant strain is important to develop avian flu epidemic plans. In fact, if the vaccine-resistant strain has higher virulence than the vaccine-sensitive strain, the vaccination program is always effective, even though the program engenders the emergence of a vaccine-resistant strain. On the other hand, if the vaccine-resistant strain has lower virulence, we must carefully manage vaccination to prevent the spread of a vaccine-resistant strain.

Impact of loss of protection effectiveness of vaccination

To ensure an effective vaccination program, the vaccine must protect vaccinated animals against clinical signs of the disease and prevent mortality [21]. However, the vaccine-resistant strain causes a loss of the protection effectiveness of the vaccination [19], [20], [21], [22], [37]. We investigate an impact of the loss of the protection on change of final size of the epidemic over the vaccination prevalence. Assume, hereafter, that the virulence of vaccine-resistant strain is lower than that of vaccine-sensitive strain (my>mz): otherwise, the vaccination is always effective (our baseline parameter values are satisfied with my>mz). Actually, a resistant strain seems to have reduced virulence in general [8], [10], [23], [35].

We conduct a simulation using our model to elucidate the change of the final size with the loss of the protection effectiveness 5%, 15%, and 80% over vaccination prevalence in Fig. 3. Results showed that the patterns of the change are divisible into three cases. In theory, we can estimate the threshold values of the loss of the protection which determines the patterns (see Supplementary Information: Text S1, Fig. S4):

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Figure 3. Impact of the loss of the protection effectiveness of the vaccination on the change of the final size of the epidemic: The losses of the protection in the top, middle, and bottom figure are σ = 0.05, 0.15, and 0.8, respectively.

The top (0≤σσ*) and middle () figures portray the possibility of eradication of the infectious disease through the vaccination program. However, in the bottom figure (), the vaccination engenders a failure to prevent the spread of the disease. The patterns of the change are divisible into these three cases, depending on the loss of the protection. The blue, green, and red lines respectively correspond to the situation in which only the vaccine-sensitive strain exists, both the vaccine-sensitive and the vaccine-resistant strains exist, and only the vaccine-resistant strain exists.

doi:10.1371/journal.pone.0004915.g003

In fact, σ* = 0.056 and in our simulation from Table 1. When the loss of the protection is between 0% and σ* = 5.6% (5%: the top figure in Fig. 3), the vaccination can control the epidemic with the prevalence rate of 84.7% without the emergence of a resistant strain (a vaccine-resistant strain never emerges in the population). Therefore, increasing the prevalence rate of vaccination always decreases the final size of the epidemic. For the loss of the protection is between σ* = 5.6% and (15%: the middle figure in Fig. 3), the vaccination eventually prevents the spread of the disease with 94.1% of vaccination prevalence in spite of the emergence of the resistant strain. Increasing the prevalence rate from 31.5% to 44.1% increases the final size. Therefore, the vaccination is not always effective. However, when the loss of the protection is between and 100% (80%: the bottom figure in Fig. 3), the vaccination no longer controls the disease (even if the prevalence rate is 100%) and the vaccine-resistant strain spreads widely through the population instead of the vaccine-sensitive strain. In this case, the vaccination only slightly provides beneficial effects for preventing the spread of the disease. Therefore, the loss of the protection effectiveness of vaccination plays an important role in preventing the spread of the disease.

Vaccination can facilitate spread of disease

Sometimes a considerable spread of the resistant strain partially compromises the benefits of a vaccination program [19], [20], [22], [37]. For example, even if we can completely execute the vaccination program (p = 1), the final size of the epidemic can become larger than that before the vaccination program (p = 0) by the emergence of vaccine-resistant strain (bottom figure in Fig. 3). This implies that the vaccination, which is expected to prevent the spread of the disease, can instead help the spread of the disease. If the loss of the protection effectiveness of vaccination is high (σ*σ≤1), the vaccination might increase the final size over vaccination prevalence compared with that before the vaccination program (vaccination always decreases the final size if 0≤σσ* (top figure in Fig. 3)). Here we can also calculate such a risk of help, which depends on the loss of the protection (see Supplementary Information: Text S1). Let

Actually, σc = 0.236 in our simulation is from Table 1. When the loss of the protection is between 23.6% and 100%, we found that the vaccination program is attended by the risk that the final size becomes larger than that before the vaccination program (see Supplementary Information: Text S1).

Difficulty of prediction of a prevalent strain

Vaccination is well known to engender “silent carriers or excretors” if the vaccine can not completely protect the vaccinated animals against clinical signs of the disease [16], [21]. The existence of silent carriers or excretors is dangerous because they become a virus reservoir and shed the virus into their environment, causing potential outbreaks among their own and other species. Furthermore, even if a vaccination is effective in a bird (individual level), an incomplete vaccination program for all birds (population level) can engender the “silent spread” of an infectious disease [1], [11]. Additionally, we found that it is difficult for us to predict a prevalent strain even if we can completely estimate the basic reproductive number of vaccine-sensitive and vaccine-resistant strains during the vaccination program (although estimations, usually, are almost impossible). Even when the basic reproductive number of the vaccine-resistant strain is less than that of the vaccine-sensitive strain (), the vaccine-resistant strain can beat the vaccine-sensitive strain and spread widely through the population (see Supplementary Information: Text S1, Fig. S5). Therefore, a non-ideal vaccination program might make a prediction of prevalent strain difficult.

Optimal prevalence rate of vaccination program

In the absence of a vaccine-resistant strain, a goal of vaccination program is to reduce the basic reproductive number of vaccine-sensitive strain to be less than 1. We assume that . Therefore, the vaccination can eradicate the vaccine-sensitive strain if at least 84.7% of the birds in poultry are vaccinated effectively based on the fraction of [30]. However, in the presence of the resistant strain, the simple theory is inapplicable to an optimal prevalence rate of vaccination program. Here we define the optimal prevalence rate of a vaccination program which minimizes both the final size of the epidemic and the prevalence rate (see Supplementary Information: Text S1).

We calculate the optimal prevalence rate, which depends on the loss of the protection effectiveness of the vaccination in Fig. 4 (sensitivity analyses are given in Supplementary Information: Text S1, Fig. S6). At the point where the loss of the protection effectiveness is greater than some threshold value σo, the optimal prevalence rate changes catastrophically from high prevalence rate to a low prevalence rate. Here

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Figure 4. Optimal prevalence rate of vaccination program: Increasing of the loss of the protection effectiveness engenders a catastrophic change in the optimal prevalence rate.

The optimal rate increases as the loss increases if the loss of the protection effectiveness is small (0≤σσo). This implies that a small loss of the protection effectiveness can be compensated by a high optimal prevalence rate of the vaccination program. On the other hand, if the loss is large (σoσ≤1), the optimal rate decreases as the loss of the protection effectiveness increases. This eventuality implies that a large loss of the protection effectiveness is no longer compensated by the high optimal prevalence rate of the vaccination program. Therefore, a low prevalence rate, which does not engender the emergence of a vaccine-resistant strain becomes optimal because the poor vaccine engenders the increase of final size of the epidemic because of the spread of the resistant strain.

doi:10.1371/journal.pone.0004915.g004

Actually, σo = 0.461 in our simulation from Table 1. The optimal prevalence rate is 84.6% when the loss of the protection effectiveness is between 0% and 5.6%. In addition, if the loss rate is between 5.6% and 20.1%, then the optimal prevalence rate increases from 84.6% to 100%. Furthermore, if the loss rate is between 20.1% and 46.1%, then the optimal prevalence rate must always be 100%. Consequently, as long as the loss of the protection effectiveness is small (0%–46.1%), the loss can be compensated by a high optimal prevalence rate of the vaccination program. However, if the loss rate is greater than 46.1%, the loss is no longer compensated by the high prevalence rate of the vaccination program. The optimal prevalence rate changes catastrophically from 100% to 10.2%. Afterward, as the loss rate increases from 46.1% to 100%, the optimal prevalence rate decreases from 10.2% to 4.72% (the low prevalence rate becomes optimal). This is true because the poor vaccine (with a large loss of the protection) engenders the emergence of the vaccine-resistant strain for the high prevalence rate; in addition, the spread of the resistant strain increases the final size of the epidemic. Therefore, the loss of the protection effectiveness strongly impacts also on the optimal prevalence rate.

Variation of final size of epidemic according to the vaccination program

In countries where poultry are mainly backyard scavengers, optimum vaccination coverage might be difficult to achieve [21]. The final size of the epidemic might be increased and the program might fail if the optimal prevalence rate of the vaccination program can not be achieved. However, if we can achieve optimum vaccination coverage, the final size is greatly reduced. The final size of the epidemics can be variable depending on the prevalence rate. Here we calculate the optimal (smallest) and worst (largest) final size of the epidemic over the vaccination prevalence (see Supplementary Information: Text S1) in Fig. 5 (black and yellow bars respectively represent the optimal and worst final size). The variation of the final size is between black and yellow bars shown in Fig. 5 (sensitivity analyses are given in Supplementary Information: Text S1, Fig. S7).

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Figure 5. Variation of the final size of the epidemic over the vaccination prevalence: The black bar represents the optimal (smallest) final size of the epidemic.

The yellow bar represents the worst (largest) final size of the epidemic over the vaccination prevalence. The variation of the final size depending on the prevalence rate is between black and yellow bars. If the loss of protection effectiveness is small, then the variation is very large. On the other hand, if the loss becomes large, then the variation decreases. Therefore, the final size of the epidemic is strongly affected by the vaccination coverage and the loss of protection effectiveness: a bad vaccination program (far from the optimal prevalence rate) increases the final size and prevents eradication of the disease.

doi:10.1371/journal.pone.0004915.g005

If the loss of protection effectiveness is small, then the variation is very large. The vaccination program can eradicate the disease or reduce the final size of the epidemic to a very small size if we can execute the vaccination program near the optimal prevalence rate. The variation is sensitive for the prevalence rate. Therefore, we must carefully manage the vaccination program to control the disease when the loss is small. However, as the loss of protection effectiveness increases, the variation decreases. In particular, when the loss is medium, the reduction of the variation is remarkable. In addition, the reduction of the variation remains almost unchanged when the loss is large. This implies that the variation becomes insensitive if the loss is high. In this case, even if we can execute the vaccination program near the optimal prevalence rate, the effect of the program is not large. Therefore, although the final size is strongly affected by the vaccination coverage and a non-optimal vaccination program (far from the optimal prevalence rate) increases the final size, in general, good vaccine treatment with small loss of protection effectiveness has a great possibility for disease control. Demonstrably, poor vaccine application has little or no benefit.

Effects of non-pharmaceutical intervention

Avian influenza vaccination need not be used alone to eradicate the disease: additional non-pharmaceutical intervention is beneficial. Additional interventions must include culling infected animals, strict quarantine, movement controls and increased biosecurity, extensive surveillance [11], [16], [21], [34], [37]. We investigate the effects of some additional non-pharmaceutical intervention measures on the vaccination program. The effects are considered by changing model parameters (1).

In the European Union (EU), regulations for the control of avian influenza strains are imposed by EU council directive 92/40/EEC [34]. Virus output is reduced by the killing and removal of infected poultry flocks (culling). During the H7N7 epidemic in The Netherlands in 2003, this and other approaches were executed. To investigate the effectiveness of the control measures, A. Stegeman et al. quantified the transmission characteristics of the H7N7 strain before and after detection of the first outbreak of avian influenza in The Netherlands in 2003 [34]. In Table 1, we present the chosen epidemiological parameters, which are estimated on the H7N7 epidemic before notification of the circulation of the avian influenza (these parameters are not affected by the additional control measures). Here we choose other epidemiological parameters for vaccine-sensitive strain which are estimated by the H7N7 epidemic after the notification in [34] (these parameters are affected by the additional control measures) to evaluate an effect of the non-pharmaceutical intervention on the vaccination program. The estimate of the transmission parameter ω decreases considerably from 4.78×10−4 day−1 individual−1 to 1.70×10−4 day−1 individual−1 by the control measures. Furthermore, the estimate of the infectious period 1/(b+my) is also reduced from 13.8 days to 7.3 days. Therefore, control measures can reduce the basic reproductive number from 6.53 to 1.22 [34]. In addition, we assume, for example, that the relative transmissibility of vaccine-resistant strains is φ/ω = 0.7 and that the relative infectious period of vaccine-resistant strain is (b+my)/(b+mz) = 1.32 (these values are not strongly influential on our results).

We calculated the threshold values of the loss of protection effectiveness of the vaccination and present them in Table 3 when the vaccination program accompanies non-pharmaceutical intervention. Results show that the non-pharmaceutical intervention markedly reduces the risk of the emergence of the vaccine-resistant strain because σ* changes from 5.6% to 37.2%. In addition, the possibility that the vaccination program eventually eradicates the spread of the disease increases because changes from 20.1% to 88.6%. Furthermore, because σc changes from 23.6% to 100%, the vaccination program always decreases the final size of the epidemic compared with that before the vaccination program, even if the size increases when both strains co-exist. When the vaccination program accompanies non-pharmaceutical intervention, even if the loss of protection effectiveness is increased considerably by the vaccine-resistant strain, the loss can almost be compensated by the high optimal prevalence rate of the vaccination program: σo changes from 46.1% to 96.8%.

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Table 3. Threshold values of the loss of protection effectiveness of the vaccination.

doi:10.1371/journal.pone.0004915.t003

Figure 6 portrays the optimal prevalence rate of a vaccination program (top figure) and the optimal final size of the epidemic (bottom figure) with (pink curve and bar) or without (black curve and bar) the non-pharmaceutical intervention. The non-pharmaceutical intervention makes it easy to achieve an optimal prevalence rate and to prevent the spread of the disease. Moreover, catastrophic change does not occur until the loss of protection effectiveness becomes very high (top figure in Fig. 6). Furthermore, the optimal final size is also dramatically reduced by the additional intervention (bottom figure in Fig. 6). Even if vaccination without the additional intervention can not prevent the spread of the disease, the vaccination with the intervention can eradicate the disease (for example σ = 60%). Therefore, non-pharmaceutical intervention improves weak points of vaccination programs such as the difficult control of optimal vaccination coverage, the small applicability of the program with respect to the loss of protection effectiveness caused by the vaccine-resistant strain, and so on.

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Figure 6. Effects of non-pharmaceutical intervention: The top figure shows the optimal prevalence rate of the vaccination program with (pink curve) or without (black curve) non-pharmaceutical intervention.

The non-pharmaceutical intervention readily achieves the optimal prevalence rate and hinders the catastrophic change. The bottom figure shows the optimal final size of the epidemic with (pink bar) or without (black bar) the non-pharmaceutical intervention. The intervention also dramatically reduces the final size of the epidemic.

doi:10.1371/journal.pone.0004915.g006

Time-course of the spread of the disease

Finally, we investigate the time-course of spread of the disease according to vaccination and non-pharmaceutical interventions for 500 days in the presence of a vaccine-resistant strain. The results are presented in Fig. 7. We consider that the vaccination program and non-pharmaceutical interventions are executed after the vaccine-sensitive strain spreads and becomes endemic (around 200 days). Furthermore, the vaccine-resistant strain is assumed to occur in a few individuals after the start of the vaccination program (around 260 days). We assume that the prevalence rate of the vaccination program is p = 50%, the loss of protection effectiveness is σ = 80%; the other parameters are the same as those used in the descriptions above. These values of p and σ are not influential on our results (sensitivity analyses are shown in Supplementary Information: Text S1, Fig. S8, S9).

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Figure 7. Time-course of the spread of the disease with vaccination and non-pharmaceutical interventions: We calculate epidemic curves with a vaccination program for 500 days.

The vaccination program and non-pharmaceutical intervention are started after the vaccine-sensitive strain becomes endemic (around 200 days). We assume that the vaccine-resistant strain occurs after the start of vaccination (around 260 days). The top, middle, and bottom figures respectively depict time courses of infection without the vaccination program, with only the vaccination program, and with both the vaccination program and the non-pharmaceutical intervention. The blue and red curves respectively represent the number of infected individuals with vaccine-sensitive and vaccine-resistant strains. We assume that the prevalence rate of vaccination program is p = 0.5, the loss of protection effectiveness is σ = 0.8.

doi:10.1371/journal.pone.0004915.g007

The top figure in Fig. 7 depicts the epidemic curve without the vaccination program. It is apparent that the vaccine-sensitive strain (the blue curve) becomes endemic at around 200 days after a pandemic phase of the disease if we execute no intervention policy. The middle figure portrays the time-course of spread of the disease, assuming the vaccination program alone. A vaccine-resistant strain (the red curve) emerges and spreads widely through the population by replacing the vaccine-sensitive strain. It becomes endemic at around 450 days. This result shows the possibility that the emergence and replacement of the resistant strain can be facilitated by the vaccination program, as in some vaccination programs [19], [21], [22]. We can observe that it takes about several months for the resistant strain to beat the sensitive strain (see the middle figure in Fig. 7). Actually, the replacement time of the resistant strain was reported as several months in the China and Mexico epidemics [19], [21], [22]. The final size of the simulated epidemic is larger than that before (without) the vaccination program because the loss of protection effectiveness σ = 80% is greater than (see Fig. 3). In this case, the vaccination program negatively affects the control of infectious disease. The bottom figure presents the time-course of the spread of the disease with both the vaccination program and non-pharmaceutical interventions. The vaccine-sensitive strain is dramatically reduced and the vaccine-resistant strain hardly spreads in the population; therefore, both strains are eventually controlled at a low level by the interventions. Thus, non-pharmaceutical interventions can help the vaccination program and control the resistant strain to spread in the population.

Discussion

A serious problem of vaccination strategy is the emergence of vaccine-resistant strains [19], [20], [21], [22]. Even if a resistant strain emerges, a vaccination program must be managed to control the spread of the disease. In the absence of the resistant strain, our mathematical model certainly shows that a large prevalence of the vaccination program might markedly reduce an epidemic curve and the final size of the epidemic. Therefore, we can control infectious diseases as in previous models [30]. However, in the presence of the emergence of a vaccine-resistant strain, the vaccination program can not simply control the spread of the disease. The control of the infectious disease through vaccination becomes more difficult.

The paradoxical result obtained here is that if the virulence of vaccine-resistant strain is less than that of vaccine-sensitive strain, the final size of the epidemic might increase as the prevalence rate of the vaccination program increases (see Fig. 2). A vaccination that is expected to prevent the spread of the disease can instead foster the spread of the disease. Although qualitatively similar results were obtained through more complex models [8], [9], which can be treated analytically only to a slight degree, one of our important results is the clear and simple concept illustrating the value and pitfalls of vaccination programs; the concept can help farmers and administrators to avoid negative effects from paradoxical phenomena.

We investigated how the loss of protection effectiveness impacts a vaccination program’s results in the lower virulence case. If the loss of protection effectiveness is between 0 and , the vaccination program can eventually eradicate the disease, even if a vaccine-resistant strain emerges (see Fig. 3). In particular, if the loss is between 0 and σ*, the program prevents even the emergence of the resistant strain. However, when the loss is greater than , the program no longer prevents the wide spread of the resistant strain in spite of the large prevalence rate of the program. Furthermore, if the loss is between σc and 1, the program presents the risk that the final size will become larger than that without the vaccination program. Therefore, in the context of the emergence of the resistant strain, we must carefully execute the program to exercise a positive effect of the vaccine effectively. Additionally, we investigated the optimal prevalence rate of the vaccination program, its final size, and the worst-case final size (see Fig. 4, 5 and Supplementary Information: Text S1). The catastrophic change of the optimal prevalence rate and the variation of the final size depending on the loss of protection effectiveness were confirmed.

From our theoretical analysis, we propose that monitoring the virulence of the resistant strain and investigating the loss resulting from a resistant strain can have important consequences for developing a vaccination strategy. In particular, all thresholds derived herein are only constructed using basic reproductive numbers and transmissibilities that prevail before the vaccination program, which can be estimated using epidemiological data (it is usually almost impossible to estimate basic and invasion reproductive numbers during vaccination programs). Therefore, using our theory, we were able to calculate various risks in the vaccination program using the available data (Table 3) and propose how we might use a poor vaccine, which has a large loss of protection effectiveness, against the resistant strain to maximize the effects of the program (Fig. 4, 5, and 6). For the results reported here, we assumed that the vaccinated birds can perfectly protect the infection from the vaccine-sensitive strain. Although that assumption is not unreasonable [21], in Supplementary Information: Text S1, Fig. S10, S11, we present an investigation of the effect of the loss of protection effectiveness against the vaccine-sensitive strain. Qualitatively similar results were obtained using numerical simulations.

Vaccination is now being used extensively to aid the prevention of emergence or to control the spread of avian influenza [14]. However, if the vaccinations are not used appropriately, prevention and control will be negatively affected by the vaccination program [1], [11], [19], [21], [22]. Actually, when the vaccine-resistant strain emerges, our model predicts various risks in the program. Therefore, to eradicate the infectious disease effectively by vaccination, early detection of the resistant strain, monitoring of its virulence and loss of protection effectiveness of vaccination caused by the resistant strain, and attendance of non-pharmaceutical interventions, in addition to collaboration among farmers, industry, public health authorities, and the government are all required.

Supporting Information

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Figure S10.

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Figure S11.

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Text S1.

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Author Contributions

Analyzed the data: SI TS YT. Contributed reagents/materials/analysis tools: SI TS YT. Wrote the paper: SI.

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  27. Seo SH, Webster RG (2001) Cross-reactive, cell-mediated immunity and protection of chickens from lethal H5N1 influenza virus infection in Hong Kong poultry markets. J Virol  75: 2516–2525.                        Find this article online                    
  28. Swayne DE, Beck JR, Garcia M, Stone HD (1999) Influence of virus strain and antigen mass on efficacy of H5 avian influenza inactivated vaccines. Avian Pathol  28: 245–255.                        Find this article online                    
  29. van den Berga T, Lambrechta B, Marche S, Steenselsa M, Borma SV, et al.  (2007) Influenza vaccines and vaccination strategies in birds. Com Immunol Microbiol Infec Dis  31: 121–165.                        Find this article online                    
  30. Anderson RM, May RM (1991) Infectious disease of humans: dynamics and control. Oxford University Press.
  31. Iwami S, Takeuchi Y, Liu X, Nakaoka SA geographical spread of vaccineresistance in avian influenza epidemics, In Revision                        Find this article online                    
  32. Elbers AR, Fabri TH, de Vries TS, de Wit JJ, Pijpers A, Koch G (2004) The highly pathogenic avian influenza A (H7N7) virus epidemic in The Netherlands in 2003 – lessons learned from the first five outbreaks. Avian Dis  48: 691–705.                        Find this article online                    
  33. Elbers AR, Koch G, Bouma A (2005) Performance of clinical signs in poultry for detection of outbreaks during the avian influenza A (H7N7) epidemic in The Netherlands in 2003. Avian Pathol  34: 181–187.                        Find this article online                    
  34. Stegeman A, Bouma A, Elbers ARW, de Jong MCM, Nodelijk G, et al.  (2004) Avian influenza A virus (H7N7) epidemic in The Netherlands in 2003: course of the epidemic and effectiveness of control measures. J Infect Dis  190: 2088–2095.                        Find this article online                    
  35. Handel A, Regoes RR, Antia R (2006) The role of compensatory mutations in the emergence of drug resistance. PLoS Com Biol  2(10): e137.                        Find this article online                    
  36. Capua I, Alexander DJ (2004) Human Health Implications of Avian Influenza Viruses and Paramyxoviruses. Eur J Clin Microbiol Infect Dis  23: 1–6.                        Find this article online                    
  37. Webster RG, Kawaoka Y, Bean WJ, Beard CW, Brugh M (1985) Chemotherapy and vaccination: a possible strategy for the control of highly virulent influenza virus. J Virol  55: 173–176.                        Find this article online

US Nurses fired for refusing Flu vaccine: “the flu vaccine not just it doesn’t protect people from the flu, but it has complicated the health of thousands of people who took it”

Friday, 04 January 2013
An Indiana hospital has fired eight employees, including at least three veteran nurses, after they refused mandatory flu shots, stirring up controversy over which should come first: employee rights or patient safety. The hospital imposed mandatory vaccines, responding to rising concerns about the spread of influenza..
Ethel Hoover wore all black on her last day of work as a nurse in the critical care unit at Indiana University Health Goshen Hospital. She said she was in “mourning” because she would have been at the hospital 22 years in February, and she’s only called out of work four or five times in her whole career , she said.

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“This is my body. I have a right to refuse the flu vaccine,” Hoover, 61, told ABCNews.com. “For 21 years, I have religiously not taken the flu vaccine, and now you’re telling me that I believe in it.”

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More than 15,100 flu cases have been reported to the Centers for Disease Control and Prevention since Sept. 30, including 16 pediatric deaths. Indiana’s flu activity level is considered high, according to the CDC, which last month announced that the flu season came a month earlier than usual.

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When Hoover first heard about the mandate, she said she didn’t realize officials would take it so seriously. She said she filed two medical exemptions, a religious exemption and two appeals, but they were all denied. The Dec. 15 flu shot deadline came and went. Hoover’s last day of employment was Dec. 21.

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Fellow nurse Kacy Davis said she and her colleagues were “horrified” over Hoover’s firing, calling her their “go-to” nurse and a “preceptor.”
“It was a good place to work,” Hoover said. “We’ve worked together all these years. We’re like a family.”

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The hospital said in a statement that it implemented the mandate to promote patient safety based on recommendations from the American Medical Association, the American Nurses Association, and the Centers for Disease Control and Prevention. It announced the mandate in September. Of the hospital’s 26,000 employees statewide, 95 percent complied. That means 1,300 employees did not comply, but only eight were fired.

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As irony would have it, the flu vaccine not just it doesn’t protect people from the flu, but it has complicated the health of thousands of people who took it.

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Food allergies? Pesticides in tap water might be to blame

Contact: Christine Westendorf christinewestendorf@acaai.org 847-427-1200 American College of Allergy, Asthma, and Immunology

New study finds chemicals used for water purification can lead to food allergies

ARLINGTON HEIGHTS, Ill. (December 3, 2012) – Food allergies are on the rise, affecting 15 million Americans. And according to a new study published in the December issue of Annals of Allergy, Asthma and Immunology, the scientific journal of the American College of Allergy, Asthma and Immunology (ACAAI), pesticides and tap water could be partially to blame.

The study reported that high levels of dichlorophenols, a chemical used in pesticides and to chlorinate water, when found in the human body, are associated with food allergies.

“Our research shows that high levels of dichlorophenol-containing pesticides can possibly weaken food tolerance in some people, causing food allergy,” said allergist Elina Jerschow, M.D., M.Sc., ACAAI fellow and lead study author. “This chemical is commonly found in pesticides used by farmers and consumer insect and weed control products, as well as tap water.”

Among 10,348 participants in a US National Health and Nutrition Examination Survey 2005-2006, 2,548 had dichlorophenols measured in their urine and 2,211 were included into the study. Food allergy was found in 411 of these participants, while 1,016 had an environmental allergy.

“Previous studies have shown that both food allergies and environmental pollution are increasing in the United States,” said Dr. Jerschow. “The results of our study suggest these two trends might be linked, and that increased use of pesticides and other chemicals is associated with a higher prevalence of food allergies.”

While opting for bottled water instead of tap water might seem to be a way to reduce the risk for developing an allergy, according to the study such a change may not be successful.

“Other dichlorophenol sources, such as pesticide-treated fruits and vegetables, may play a greater role in causing food allergy,” said Dr. Jerschow.

According to the Centers for Disease Control and Prevention, an increase in food allergy of 18 percent was seen between 1997 and 2007. The most common food allergens are milk, eggs, peanuts, wheat, tree nuts, soy, fish, and shellfish.

Food allergy symptoms can range from a mild rash to a life-threatening reaction known as anaphylaxis. The ACAAI advises everyone with a known food allergy to always carry two doses of allergist prescribed epinephrine. A delay in using epinephrine is common in severe food allergic reaction deaths.

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For more information about food allergies, and to locate an allergist to find relief, visit www.AllergyAndAsthmaRelief.org.

About ACAAI

The ACAAI is a professional medical organization of more than 5,700 allergists-immunologists and allied health professionals, headquartered in Arlington Heights, Ill. The College fosters a culture of collaboration and congeniality in which its members work together and with others toward the common goals of patient care, education, advocacy and research. ACAAI allergists are board-certified physicians trained to diagnose allergies and asthma, administer immunotherapy, and provide patients with the best treatment outcomes. For more information and to find relief, visit  www.AllergyAndAsthmaRelief.org. Join us on Facebook and Twitter.

Press Note: This research was supported in part by the National Center for Research Resources and the National Center for Advancing Translational Sciences, components of the National Institutes of Health, through Clinical and Translational Science Award (grant numbers UL1 RR025750, KL2 RR025749, and TL1 RR025748)

WHO and the pandemic flu “conspiracies” – FULL report from the BMJ and The Bureau of Investigative Journalism 2010

2010 report posted for filing

Conflicts of Interest

WHO and the pandemic flu “conspiracies”

Deborah Cohen, features editor, BMJ, Philip Carter, journalist, The Bureau of Investigative Journalism, London

dcohen@bmj.com

Key scientists advising the World Health Organization on planning for an influenza pandemic had done paid work for pharmaceutical firms that stood to gain from the guidance they were preparing. These conflicts of interest have never been publicly disclosed by WHO, and WHO has dismissed inquiries into its handling of the A/H1N1 pandemic as “conspiracy theories.” Deborah Cohen and Philip Carter investigate

Next week marks the first anniversary of the official declaration of the influenza A/H1N1 pandemic. On 11 June 2009 Dr Margaret Chan, the director general of the World Health Organization, announced to the world’s media: “I have conferred with leading influenza experts, virologists, and public health officials. In line with procedures set out in the International Health Regulations, I have sought guidance and advice from an Emergency Committee established for this purpose. On the basis of available evidence, and these expert assessments of the evidence, the scientific criteria for an influenza pandemic have been met…The world is now at the start of the 2009 influenza pandemic.”

It was the culmination of 10 years of pandemic preparedness planning for WHO—years of committee meetings with experts flown in from around the world and reams of draft documents offering guidance to governments. But one year on, governments that took advice from WHO are unwinding their vaccine contracts, and billions of dollars’ worth of stockpiled oseltamivir (Tamiflu) and zanamivir (Relenza)—bought from health budgets already under tight constraints—lie unused in warehouses around the world.

 

A joint investigation by the BMJ and the Bureau of Investigative Journalism has uncovered evidence that raises troubling questions about how WHO managed conflicts of interest among the scientists who advised its pandemic planning, and about the transparency of the science underlying its advice to governments. Was it appropriate for WHO to take advice from experts who had declarable financial and research ties with pharmaceutical companies producing antivirals and influenza vaccines? Why was key WHO guidance authored by an influenza expert who had received payment for other work from Roche, manufacturers of oseltamivir, and GlaxoSmithKline, manufacturers of zanamivir? And why does the composition of the emergency committee from which Chan sought guidance remain a secret known only to those within WHO? We are left wondering whether major public health organisations are able to effectively manage the conflicts of interest that are inherent in medical science.

Already WHO’s handling of the pandemic has led to an unprecedented number of reviews and inquiries by organisations including the Council of Europe, European Parliament, and WHO itself, following allegations of industry influence. Dr Chan has dismissed these as “conspiracies,” and earlier this year, during a speech at the Centers for Disease Control and Prevention in Atlanta, she said: “WHO anticipated close scrutiny of its decisions, but we did not anticipate that we would be accused, by some European politicians, of having declared a fake pandemic on the advice of experts with ties to the pharmaceutical industry and something personal to gain from increased industry profits.”

The inquiry by British MP Paul Flynn for the Council of Europe Parliamentary Assembly—due to be published today—will be critical. It will say that decision making around the A/H1N1 crisis has been lacking in transparency. “Some of the outcomes of the pandemic, as illustrated in this report, have been dramatic: distortion of priorities of public health services all over Europe, waste of huge sums of public money, provocation of unjustified fear amongst Europeans, creation of health risks through vaccines and medications which might not have been sufficiently tested before being authorised in fast-track procedures, are all examples of these outcomes. These results need to be critically examined by public health authorities at all levels with a view to rebuilding public confidence in their decisions.”

The investigation by the BMJ/The Bureau reveals a system struggling to manage the inherent conflict between the pharmaceutical industry, WHO, and the global public health system, which all draw on the same pool of scientific experts. Our investigation has identified key scientists involved in WHO pandemic planning who had declarable interests, some of whom are or have been funded by pharmaceutical firms that stood to gain from the guidance they were drafting. Yet these interests have never been publicly disclosed by WHO and, despite repeated requests from the BMJ/The Bureau, WHO has failed to provide any details about whether such conflicts were declared by the relevant experts and what, if anything, was done about them.

It is this lack of transparency over conflicts of interests—coupled with a documented changing of the definition of a pandemic and unanswered questions over the evidence base for therapeutic interventions1—that has led to the emergence of these conspiracies.

WHO says: “Potential conflicts of interest are inherent in any relationship between a normative and health development agency, like WHO, and a profit-driven industry. Similar considerations apply when experts advising the Organization have professional links with pharmaceutical companies. Numerous safeguards are in place to manage possible conflicts of interest or their perception.”

Another factor that has fuelled the conspiracy theories is the manner in which risk has been communicated. No one disputes the difficulty of communicating an uncertain situation or the concept of risk in a pandemic situation. But one world expert in risk communication, Gerd Gigerenzer, director of the Centre for Adaptive Behaviour and Cognition at the Max Planck Institute in Germany, told the BMJ/The Bureau: “The problem is not so much that communicating uncertainty is difficult, but that uncertainty was not communicated. There was no scientific basis for the WHO’s estimate of 2 billion for likely H1N1 cases, and we knew little about the benefits and harms of the vaccination. The WHO maintained this 2 billion estimate even after the winter season in Australia and New Zealand showed that only about one to two out of 1000 people were infected. Last but not least, it changed the very definition of a pandemic.”

WHO for years had defined pandemics as outbreaks causing “enormous numbers of deaths and illness” but in early May 2009 it removed this phrase—describing a measure of severity—from the definition.2

 

The beginnings

The routes to the Council of Europe’s criticisms can be traced back to 1999, a pivotal year in the influenza world. In April that year WHO—spurred on by the 1997 chicken flu outbreak in Hong Kong—began to organise itself for a feared pandemic. It drew up a key document, Influenza Pandemic Plan: The Role of WHO and Guidelines for National and Regional Planning.

WHO’s first influenza pandemic preparedness plan was stark in the scale of the risk the world faced in 1999: “It is impossible to anticipate when a pandemic might occur. Should a true influenza pandemic virus again appear that behaved as in 1918, even taking into account the advances in medicine since then, unparalleled tolls of illness and death would be expected.”

In the small print of that document it states: “R Snacken, J Wood, L R Haaheim, A P Kendal, G J Ligthart, and D Lavanchy prepared this document for the World Health Organization (WHO), in collaboration with the European Scientific Working Group on Influenza (ESWI).” What this document does not disclose is that ESWI is funded entirely by Roche and other influenza drug manufacturers. Nor does it disclose that René Snacken and Daniel Lavanchy were participating in Roche sponsored events the previous year, according to marketing material seen by the BMJ/The Bureau.

Dr Snacken was working for the Belgian ministry of public health when he wrote about studies involving neuraminidase inhibitors for a Roche promotional booklet. And Dr Lavanchy, meanwhile, was a WHO employee when he appeared at a Roche sponsored symposium in 1998. His role at that time was in the WHO Division of Viral Diseases. Dr Lavanchy has declined to comment.

In 1999 other members of the European Scientific Working Group on Influenza included Professor Karl Nicholson of Leicester University, UK, and Professor Abe Osterhaus of Erasmus University in the Netherlands. These two scientists are also identified in Roche marketing material seen by this investigation which was produced between 1998 and 2000. Professor Osterhaus told the BMJ that he had always been transparent about any work he has done with industry. Professor Nicholson similarly has consistently declared his connections with pharmaceutical companies, for example, in papers published in journals such as the BMJ and Lancet.

Both experts were also at that time engaged in a randomised controlled trial on oseltamivir supported by Roche. The trial was subsequently published in the Lancet in 2000.3 It remains one of the main studies supporting oseltamivir’s effectiveness—and one that was subsequently shown to have employed undeclared industry funded ghostwriters.1

The influence of the European Scientific Working Group on Influenza would continue as the decade wore on and the calls for pandemic planning became more strident. Founded in 1992, this “multidisciplinary group of key opinion leaders in influenza aims to combat the impact of epidemic and pandemic influenza” and claims links to WHO, the Robert Koch Institute, and the European Centre for Disease Prevention and Control, among others.4 Despite the group’s claims of scientific independence its 100% industry funding does present a potential conflict of interest. One if its roles is to lobby politicians, as highlighted in a 2009 policy document.5

At a pre-pandemic preparation workshop of the European Scientific Working Group on Influenza in January last year, Professor Osterhaus said: “I can tell you that ESWI is working on that idea [that is, convincing politicians] quite intensively. We have contact with MEPs [members of the European Parliament] and with national politicians. But it is they who have to decide at the end of the day, and they will only act at the request of their constituencies. If the latter are not prompted, nothing will happen.”

The group’s policy plan for 2006-10 specifically stated that government representatives needed to “take measures to encourage the pharmaceutical industry to plan its vaccine/antivirals production capacity in advance” and also to “encourage and support research and development of pandemic vaccine” and to “develop a policy for antiviral stockpiling.” It also added that government representatives needed to know that “influenza vaccination and use of antivirals is beneficial and safe.” It said that the group provided “evidence based, palatable information”; and also “networking/exchange with other stakeholders (eg, with industry in order to establish pandemic vaccine and antivirals contracts).” In the meantime, in Roche’s own marketing plan, one goal was to “align Roche with credible third party advocates”. They “leveraged these relationships by enlisting our third-party partners to serve as spokespeople and increase awareness of Tamiflu and its benefits.”6

Barbara Mintzes, assistant professor in the Department of Pharmacology and Therapeutics at the University of British Columbia, is currently part of a group working with Health Action International and WHO developing model curricula for medical and pharmaceutical students on drug promotion and interactions with the industry, including conflicts of interest. She thinks that caution is advised when working with medical bodies of this sort.

“It is legitimate for WHO to work with industry at times. But I would have concerns about involvement with a group that looks like it is for independent academics that is actually mainly industry funded,” she told the BMJ/The Bureau, adding: “The Institute of Medicine has raised concerns about the need to have a firewall with medical groups. To me this does not sound like an independent group, as it is mainly funded by manufacturers.”

She also thinks that there is a difference between the conflict of interest in having a clinical trial funded by a company and the conflict of interest in being involved in marketing a drug—for example, on a paid speaker’s bureau or in marketing material. “Some academic medical departments, for example Stanford University, have banned staff from being involved in marketing or being on a paid speakers bureau,” she said.

The presence of leading influenza scientists at promotional events for oseltamivir reflected not just the concern of an impending pandemic, but the excitement over the potential of a new class of drugs—neuraminidase inhibitors—to offer treatment and protection against seasonal influenza.

In 1999 two new drugs first came to market: oseltamivir, from Roche; and zanamivir, manufactured by what is now GlaxoSmithKline. The two drugs would battle it out over the coming years, with oseltamivir—aided by its oral administration—trumping its rival in global sales as the decade wore on.

The potential was quickly grasped. Indeed, that year Professor Osterhaus published an article proposing the use of neuraminidase inhibitors in pandemics: “Finally, during a possible future influenza pandemic, in view of their broad reactivity against influenza virus neuraminidase subtypes and the expected lack of sufficient quantities of vaccine, the new antivirals will undoubtedly have an essential role to play in reducing the number of victims.”7

However, he also warned that antivirals should not be seen as a replacement for vaccinations. “Close collaboration and consultation between, on the one hand, companies marketing influenza vaccines and, on the other, those marketing antivirals will therefore be absolutely essential. It is important that a clear and uniform message indicating the complementary roles of vaccines and antivirals is delivered.”

That article appeared in the European Scientific Working Group on Influenza’s bulletin of April 1999; Professor Osterhaus signs off with the affiliation of WHO National Influenza Centre Rotterdam, The Netherlands.

Other experts soon followed suit—recommending the role neuraminidase inhibitors could play in any future pandemic—in both the academic literature and in the general media.

Food and Drug Administration

While the excitement over these drugs fuelled scientific symposiums, the US Food and Drug Administration (FDA) was less than convinced. The BMJ/The Bureau has since spoken to people from within the American and European drug regulators, the FDA and the European Medicines Agency (EMEA), who said that both regulators struggled with the paucity of the data presented to them for zanamivir and oseltamivir, respectively, during the licensing process. At the end of last year, the BMJ called for access to raw data for key public health drugs after the Cochrane Collaboration found the effectiveness of the drugs impossible to evaluate.8 The group are continuing to negotiate access to what they say they need to fully assess the effectiveness of antivirals.

In the US, the FDA first approved zanamivir in 1999.9 Michael Elashoff, a former employee of the FDA, was the statistician working on the zanamivir account. He told the BMJ how the FDA advisory committee initially rejected zanamivir because the drug lacked efficacy.

After Dr Elashoff’s review (he had access to individual patient data and summary study reports) the FDA’s advisory committee voted by 13 to 4 not to approve zanamivir on the grounds that it was no more effective than placebo when the patients were on other drugs such as paracetamol. He said that it didn’t reduce symptoms even by a day.

 

“When I was reviewing the data, I tried to replicate the analyses in their summary study reports. The issue was not of data quality, but sensitivity analyses showed even less efficacy,” he said. “The safety analysis showed there were safety concerns, but the focus was on if Glaxo had demonstrated efficacy.” Dr Elashoff’s view was that zanamivir was no better than placebo—and it had side effects. And when the FDA medical reviewer made a presentation, her conclusion was that it could either be approved or not approved. It was a fairly borderline drug.

There were influenza experts on the FDA’s advisory committee and much of the discussion hinged on why a drug that looked so promising in earlier studies wasn’t working in the largest trials in the US. One hypothesis was that people in the US were taking other drugs for symptomatic relief that masked any effect of zanamivir. So zanamivir might have no impact on symptoms over and above the baseline medications that people take when they have influenza.

Two other trials—one in Europe and one in Australia— showed a bit more promise. But there was a very low rate of people taking other medications. “So in the context of not being allowed to take anything for symptomatic relief, there might be some effect of Relenza. But in the context of a typical flu, where you have to take other things to manage your symptoms, you wouldn’t notice any effect of Relenza over and above those other things,” Dr Elashoff said. The advisory committee recommended that the drug should not be approved.

Nevertheless, FDA management decided to overturn the committee’s recommendation.

 

“They would feel better if there was something on the market in case of a pandemic. It wasn’t a scientific decision,” Dr Elashoff said.

While Dr Elashoff was working on the zanamivir review, he was assigned the oseltamivir application. But when the review and the advisory committee decided not to recommend zanamivir, the FDA’s management reassigned the oseltamivir review to someone else. Dr Elashoff believes that the approval of zanamivir paved the way for oseltamivir, which was approved by the FDA later that year.

 

European Medicines Agency

In Europe the EMEA was similarly troubled by the evidence for oseltamivir. By early 2002 Roche had sought a European Union-wide licence from the EMEA. It was a lengthy process, taking three meetings of the Committee for Medicinal Products for Human Use as well as expert panels, according to one of the two rapporteurs, Pekka Kurki of the Finnish Medicines Agency. Echoing the Cochrane Collaborations’s 2009 findings6 Kurki told us: “We discussed the same issues that are still discussed today: does it show clinically significant benefits in treatment and prophylaxis of flu and what was the magnitude of the benefits presented in the RCTs? Our assessment and Cochrane’s in 2009 are very similar with regard to the effect size in RCTs. The data show that the effects of Tamiflu were clear but not very impressive.

“What was unclear and is still unclear is what is the impact of Tamiflu on serious complications. Circulating influenza was very mild when Tamiflu was developed and therefore it is very difficult to say anything about serious complications. The data did not clearly show an effect on serious complications—it was not demonstrated by the RCTs.”

In documents obtained under the freedom of information legislation, two of the experts who provided opinions during the EMEA licensing process have also featured in Roche marketing material: Annike Linde and Rene Snacken. In Dr Snacken’s EMEA presentation dated 18 February 2002, he discussed the need for chemoprophylaxis and called for the use of oseltamivir during a pandemic. He made his presentation as a representative of the Belgian Ministry of Public Health. At the time Dr Snacken was also “liaison officer” for the European Scientific Working Group on Influenza. He also played a key role in the Belgian government during its pandemic planning, and he later became a senior expert at the Preparedness and Response Unit, European Centre for Disease Prevention and Control. We do not know what, if anything, he declared to the EMEA about his relationship with Roche.

Annike Linde has confirmed in an email that she has had connections with Roche over a number of years. She made a presentation to the EMEA on “influenza surveillance” in her capacity as a representative of the Swedish Institute for Infectious Disease. Again, it is not clear what, if anything, she declared to the EMEA concerning her previous relationship with Roche.

Dr Linde, now the Swedish state epidemiologist, has told the BMJ/The Bureau that she received payments from Roche International in respect of various pieces of work she did for the company until 2002. She has subsequently given occasional lectures for Roche Sweden. All money she has received from Roche was given, Dr Linde says, to the Swedish Institute for Infectious Disease Control.

We asked the scientists whether they declared their relationship with Roche at the time to the EMEA. Neither has answered that question entirely satisfactorily. Dr Snacken has not replied to repeated emails posing this question. Dr Linde responded by telling the BMJ/The Bureau: “We contribute with our expertise to the regulatory agencies when asked. When we do so, a declaration of interest, where e.g. participation at advisory meetings at Roche, is given and evaluated by the regulatory agency.” The BMJ/The Bureau requested Linde and Snacken’s declaration of interest statements for the 2002 meeting from the EMEA under the freedom of information act. The EMEA was unable to provide statements for those particular people at that time.

Developing the guidelines

In October 2002 WHO convened a meeting of influenza experts at its Geneva headquarters. Their purpose was to develop WHO’s guidelines for the use of vaccines and antivirals during an influenza pandemic.

Included at this meeting were representatives from Roche and Aventis Pasteur and three experts who had lent their name to oseltamivir’s marketing material (Professors Karl Nicholson, Ab Osterhaus, and Fred Hayden).

Two years later the WHO published a key report from that meeting, WHO Guidelines on the Use of Vaccines and Antivirals during Influenza Pandemics 2004. The specific guidance on antivirals, Considerations for the Use of Antivirals During an Influenza Pandemic, was written by Fred Hayden. Professor Hayden has confirmed to the BMJ/The Bureau in an email that he was being paid by Roche for lectures and consultancy work for the company at the time the guidance was produced and published. He also told us in an email that he had received payments from GlaxoSmithKline for consultancy and lecturing until 2002. According to Prof Hayden: “DOI [declaration of interest] forms were filled out for the 2002 consultation.”

The WHO guidance concluded that: “Based on their pandemic response goals and resources, countries should consider developing plans for ensuring the availability of antivirals. Countries that are considering the use of antivirals as part of their pandemic response will need to stockpile in advance, given that current supplies are very limited.” Many countries around the world would adopt this guidance.

The previous year Professor Hayden was also one of the main authors of a Roche sponsored study that claimed what was to become one of oseltamivir’s main selling points—a claimed 60% reduction in hospitalisations from flu, which the Cochrane Collaboration was later unable to verify.8

Our investigation has also identified relevant and declarable interests relating to the two other named authors of annexes to WHO’s 2004 guidelines. Arnold Monto was the author of the annexe dealing with vaccine usage in pandemics. Between 2000 and 2004—and at the time of writing the annexe—Dr Monto has consistently and openly declared honorariums, consultancy fees, and research support from Roche, 10 11 12 consultancy fees and research support from GlaxoSmithKline 10 12 13 14; and also research funding from ViroPharma.15

No conflict of interest statement was included in the annex he wrote for WHO. When asked if he had signed a declaration of interest form for WHO, Dr Monto told the BMJ/The Bureau: “Conflict of Interest forms are requested before participation in any WHO meeting”.

Professor Karl Nicholson is the author of the third annex, Pandemic Influenza. According to declarations made by Professor Nicholson in the BMJ16and Lancet in 2003,17 he had received travel sponsorship and honorariums from GlaxoSmithKline and Roche for consultancy work and speaking at international respiratory and infectious diseases symposiums. Before writing the annexe, he had also been paid and declared ad hoc consultancy fees by Wyeth, Chiron, and Berna Biotech.

Even though the previous year these declarations had been openly made in the Lancet and the BMJ, no conflict of interest statement was included in the annex he wrote for WHO. Professor Nicholson told the BMJ/The Bureau that he last had “financial relations” with Roche in 2001. When asked if he had signed a declaration of interest form for WHO, Prof Nicholson replied: “The WHO does require attendees of meetings, such as those held in 2002 and 2004, to complete declarations of interest.”

Leaving aside the question of what declarations experts made to WHO, one simple fact remains: WHO itself did not publicly disclose any of these conflicts of interest when it published the 2004 guidance. It is not known whether information about these conflicts of interest was relayed privately to governments around the world when they were considering the advice contained in the guidelines.

The year before WHO issued the 2004 guidance, it published a set of rules on how WHO guidelines should be developed and how any conflicts of interest should be handled. This guidance included recommendations that people who had a conflict of interest should not take part in the discussion or the piece of work affected by that interest or, in certain circumstances, that the person with the conflict should not participate in the relevant discussion or work at all. The WHO rules make provision for the director general’s office to allow declarations of interest to be seen if the objectivity of a meeting has been called into question.18

The BMJ/The Bureau has asked WHO for the conflict of interest declarations for the Geneva 2002 meeting and those related to the guidance document itself. WHO told us that the query went directly up to Margaret Chan’s office. “WHO never publishes individual DOIs [declaration of interest], except after consultation with the Office of the Director-General. In this case, we put in a request on your behalf but it was not granted. In more recent years, many WHO committees have published summaries of relevant interests with their meeting reports.”

In a BMJ interview (see film on bmj.com), WHO spokesperson Gregory Hartl reiterated the fact that Dr Margaret Chan, “is very committed personally to transparency.” Yet her office has turned down repeated requests for declaration of interest statements and declines to comment on the allegations that authors of the guidelines had declarable interests.

Nevertheless, Prof Hayden told the BMJ/The Bureau: “I strongly support transparency in declarations of interest, in part because this allows those reading documents, particularly ones authored by specific individuals (eg, Annex 5) [the part he wrote], to make their own judgments about the possible relevance of any potential conflicts.”

While experts need to work with industry to develop the best possible drugs for illnesses, questions remain about what level of involvement experts with industry ties should have in the formulation of public health policy decisions and guidelines. Professor Nicholson told the BMJ/The Bureau: “The WHO and decision makers must be informed of ongoing developments and research findings to ensure that they are as up to date as possible. Some of the most relevant expertise and information are held by companies or individuals with conflicts of interest. I understand the view that experts with conflicts of interest should not advise governments or organisations such as the WHO. But to exclude such people from discussions could deprive WHO and decision makers of important new information.”

But not everyone agrees. Barbara Mintzes is unequivocal about what role they should play. “No one should be on a committee developing guidelines if they have links to companies that either produce a product—vaccine or drug—or a medical device or test for a disease. It would be preferable that there are no financial ties when it comes to making big decisions on public health—for example, stockpiling a drug—and that includes if they have a currently funded clinical trial,” she said.

“Ideally, what you want are independent experts who are in the public sector to provide expertise on drugs and vaccines. But they can be hard to find. One solution is consult with the experts who are involved in industry, but not put them on any decision making committee. You need a firewall,” she added.

Indeed, Professor Harvey Fineberg, president of the Institute of Medicine and chairman of the panel reviewing WHO’s management of the pandemic, takes a similarly hard line. His own institution went through a detailed review of how they interact with industry and experts with conflicts of interests last year.19 “Sometimes publication of conflict of interests is enough—for example with a journal. But if you are giving expert judgment to influence policy, revealing is not enough,” he told the BMJ, referring to the Institute of Medicine’s policy.

WHO also says that it takes conflicts of interests seriously and has the mechanisms in place to deal with them. But what action does it take when a scientist declares a conflict of interest, and when does it judge a scientist to be too conflicted to play a leading role in the formulation of global health policy? Since WHO has not provided us with an answer to this question, we are left to guess.

As it stands, this situation is the worst possible outcome for WHO, according to Professor Chris Del Mar, a Cochrane Review author and expert on WHO’s Strategic Advisory Group of Experts on Immunization group. “If it proves to be the case that authors of WHO guidance which promoted the use of certain drugs were being paid at the same time by the makers of those drugs for other work they were doing for these companies that is reprehensible and should be condemned in the strongest possible terms.”

WHO’s endorsement of oseltamivir was not lost on Roche. In an advert placed by the company for the drug in the main conference programme of the European Scientific Working Group on Influenza’s 2005 conference in Malta, it says: “Antivirals will initially be the principal medical intervention in a pandemic situation and Roche is working as a responsible partner with governments to assist in their pandemic planning.” The source reference for this is the WHO Global Influenza Preparedness Plan.

Throughout the following years, WHO would appear to have been inconsistent in how it treated conflicts of interest. Updated pandemic plans would continue to be prepared by experts who openly had work funded and acted as consultants to manufacturers of vaccines and antivirals. WHO produced its global influenza preparedness plan in 2005, and in 2006 it constituted an interim Influenza Pandemic Task Force. No public declarations of interest have been made and to date no details have been provided by WHO in response to our requests.

WHO’s stance that it does not publish declarations of interest from its experts is far from consistent. It is undermined, for example, by the position WHO adopts in relation to the Strategic Advisory Group of Experts on Immunization, its standing vaccine advisory body. Here, contrary to its approach to pandemic planning advisers, WHO does publish summaries of declarations of interest.

Emergency Committee

These seeming inconsistencies in WHO’s approach to transparency and its handling of conflicts of interest extend into the workings of the Emergency Committee formed last year to advise the director general on the pandemic. The identities of its 16 members are unknown outside WHO. This secret committee has guided WHO pandemic policy since then—including deciding when to judge that the pandemic is over.

WHO says it has to keep the identities secret to protect the scientists from being influenced or targeted by industry. In a phone call to the BMJ/The Bureau in March, WHO spokesperson Gregory Hartl explained: “Our general principle is we want to protect the committee from outside influences.”

The committee advised the WHO director general on phase changes as well as temporary recommendations. According to WHO, When the Emergency Committee met to discuss a possible move to a declaration of a pandemic, the meeting additionally included members who represented Australia, Canada, Chile, Japan, Mexico, Spain, the UK, and the US, eight countries that experienced widespread outbreaks at the time. These national representatives were present to ensure full consideration of the views and possible reservations of the countries expected to bear the initial brunt of economic and social repercussions.

WHO says all members of the Emergency Committee sign a confidentiality agreement, provide a declaration of interests, and agree to give their consultative time freely, without compensation. However, only one member of the committee has been publicly named: Professor John MacKenzie, who chairs it.

This is a troubling stance: it suggests that WHO considers other advisory groups whose members are not anonymous —such as the Strategic Advisory Group of Experts on Immunization—to be potentially subject to outside influences, and it allows no scrutiny of the scientists selected to advise WHO and global governments on a major public health emergency.

Under the International Health Regulations framework, the membership of the Emergency Committee is drawn from a roster of about 160 experts covering a range of public health areas. This framework provides guidelines about how WHO deals with acute public health risks. The BMJ/The Bureau has identified approximately 15 scientists from the International Health Regulations roster with influenza expertise and has emailed them to ask if they were on the Emergency Committee. Under the framework at least some of these scientists are members of the Emergency Committee. Yet because of the confidentiality agreements they have signed, these scientists cannot acknowledge their membership of the committee, putting them in an invidious position.

David Salisbury, chair of WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) committee at the time of the pandemic and a member of the International Health Regulations, says the secrecy has caused problems for his group. “It certainly caused problems for SAGE. Since all of the details of SAGE are in the public domain, there was a perception that it had been SAGE that had given advice about the changing of definitions or the pandemic levels—when we had not done so. SAGE members came in for unfair personal abuse by journalists,” he told the BMJ/The Bureau.

“Given the importance of the advice, the transparency of the source of the advice was important. I believe it is necessary to keep confidential the source of advice if revealing details might put individuals at risk, for example when bioterrorism is being discussed. This does not seem to be the case for pandemic flu,” he added.

The secrecy of the committee is also fuelling conspiracy theories, particularly around the activation of dormant pandemic vaccine contracts. A key question will be whether the pharmaceutical companies, which had invested around $4bn (£2.8bn, 3.3bn) in developing the swine flu vaccine, had supporters inside the emergency committee, who then put pressure on WHO to declare a pandemic. It was the declaring of the pandemic that triggered the contracts.

The BMJ/The Bureau can confirm that Dr Monto, Dr John Wood, and Dr Masato Tashiro are members of the Emergency Committee.

Although Dr Monto did not answer the question directly, his Infectious Disease Society of America biography states that he is a member.20

Last year, according to figures made public in the US by GlaxoSmithKline, Professor Monto received $3000 speakers fees from the company in the period between the second quarter and the last quarter of 2009. As a national official of the Japanese government, Dr Tashiro says that he must “have nothing concerning conflict of interest with private companies”. Dr John Wood works for the UK National Institute for Biological Standards and Control (NIBSC). Dr Wood, like Dr Tashiro, has no personal conflict of interests but he told the BMJ/The Bureau that as part of its statutory role in developing standards for measurement of biological medicines to ensure accurate dosing and carrying out independent control testing to assure their safety and efficacy, the institute must work closely with the pharmaceutical industry. This is made clear on their website.

“The International Federation of Pharmaceutical Manufacturers and Associations has also made publicly available the nature of their close interaction with NIBSC and similar organisations in order to develop influenza vaccines,” he said.21

Those who said that they were not on the committee include David Salisbury, Alan Hampson, Albert Osterhaus, Donato Greco, and Howard Njoo. Maria Zambon, from the UK’s Health Protection Agency told the BMJ: “I undertake various advisory roles to WHO. Declaration of interest statements are prepared before undertaking such roles.

“The HPA Centre for Infection, as part of its role in national infectious disease surveillance, provision of specialist and reference microbiology and vaccine efficacy monitoring, works closely with vaccine manufacturers and biotechnology companies.”

International Health Regulations review

WHO’s own review into the operation of the International Health Regulations and WHO’s handling of the pandemic is now being conducted by Harvey Feinberg, president of the US Institute of Medicine, and will report its findings next year. Dr Chan and Professor Feinberg have both made clear the need for a thorough investigation. But questions are already arising about how independent the review will turn out to be. According to the International Health Regulations list in our possession, some 13 of the 29 members of the review panel are members of the International Health Regulations itself and one is the chair of the Emergency Committee. To critics that might suggest a somewhat incestuous approach.

Professor Mintzes does not agree with WHO’s explanation that secrecy was needed to protect against the influence of outside interest on decision making. “I can’t understand why the WHO kept this secret. It should be public in terms of accountability like the expert advisory committees. If the rationale of secret membership is not to be unduly influenced, there are other ways of dealing with this through strong conflict of interest provisions,” she said.

She also believes that the very nature of allowing a trigger point for vaccine contracts opens the system up unnecessarily to exploitation. “It seems a problem that this declaration might trigger contracts to be realised. There should be safeguards in place to make sure those with an interest in vaccine manufacturers can’t exploit the situation. The WHO will have to look long and hard at this in future,” she said.

The number of victims of H1N1 fell far short of even the more conservative predictions by the WHO. It could, of course, have been far worse.. Planning for the worst while hoping for the best remains a sensible approach. But our investigation has revealed damaging issues. If these are not addressed, H1N1 may yet claim its biggest victim—the credibility of the WHO and the trust in the global public health system.

Cite this as: BMJ 2010;340:c2912

——————————————————————————–

Competing interests: PC declares no competing interests. DC has been paid expenses by WHO for giving talks at two conferences.

Pesticides claim one life and sickens 129 others as people desperate to get rid of bed bugs use the outdoor toxins in their BEDROOMS

By  Daily Mail Reporter

PUBLISHED: 20:58 EST, 28 November 2012 |  UPDATED: 20:58 EST, 28 November 2012

 

No one likes bed bugs. But in recent years as the infestation rate explodes people are increasingly poisoning themselves in an attempt to get rid of the unwelcome house guests.

Over a 4 year period, 129 people suffered mild to serious health issues when outdoor pesticides were used inside, according to a health advisory issued by the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

Symptoms of  pesticide poisoning can include headache, nausea, vomiting, diarrhea,  dizziness and muscle tremors.

bed bug Reports of bed bug infestations have risen annually since 2006

 

The effects are so toxic one woman even died.

The unidentified 65-year-old North Carolina woman had a history of heart and kidney problems and became ill after  using the pesticides.

She and her husband went through nine cans of insecticide fogger, a separate kind of canned pesticide for their house’s walls and baseboards, and yet another type for the mattresses and box springs.

They reapplied everything to the mattresses and box springs just two days later, then went through another nine cans of yet another fogger.

Before she fell ill, the woman even put a flea and bedbug pesticide on her arms, sores on her chest, and her hair.

Two days after her second pesticide application she was found unresponsive by her husband.

She lingered in the hospital for nine days before passing away.

bed bug Read before you spray: CDC officials are asking people to be sure their pesticides are approved for indoor use after a rash of poisonings

‘Many people are somewhat desperate to find any solution,’ Bernadette Burden, a CDC spokeswoman, told NBC News. ‘This is something they’re not used to. Oftentimes, they’re tempted to use any insecticide that they can get their hands on.’

Bedbug victims with less tragic ends include Melissa Constantinou, 25, a personal  chef in Lowell, Mass..

Her  apartment was treated for infestation four times with Constantinou ever once worrying about the possible health effects.

‘Oh my gosh, it’s so emotionally  disturbing,’ she said. ‘I was willing to do whatever it took. I didn’t  think about the long-term effects at all.’

According to the National  Pesticide Information Center, inquiries about bedbugs nearly  doubled between 2007 and 2011, leading health agencies to view the issue as ‘an emerging national  concern.’

Especially as bedbug infestations have been on the rise.

bed bug Not in my bed: People often spray their homes multiple times over a short period to treat infestation

First-time service calls for bed bug treatment went from about 100 requests a month in January 2008 to roughly 300 per month by April 2012 according to a survey conducted by Jeff White,  technical director of the website BedBug Central.

‘Outdoor pesticides should not be used indoors under any circumstances,’ ATSDR officials warn.

The problems come from people using too much pesticide or applying it incorrectly.

‘A lot of them don’t understand that the label is the law,’ said David Stone director of the NPIC. ‘This product should not be applied  directly to the skin. That product should not be used on mattresses.’

In one example recorded by the CDC, an Ohio family – including four children and a roommate – became ill after an uncertified pesticide company used malathion to treat their apartment.

That pesticide is not registered for indoor use, but the crew used it so much they saturated the beds and floor coverings.

CDC experts said people should be careful to read the labels before using a pesticide indoors.

‘More importantly, follow the guidance  and make sure you’re using the right pesticide and that you’re treating  the right pest,’ said the CDC’s Burden, who noted that bedbugs often can resemble other critters at different stages in their life cycle.

 

http://www.dailymail.co.uk/news/article-2240148/Pesticides-claim-life-sickens-129-people-desperate-rid-bed-bugs-use-outdoor-toxins-BEDROOMS.html

Seasonal flu vaccination increase the risk of infection with pandemic H1N1 flu by 68%

2010 study posted for filing

Contact: Andrew Hyde press@plos.org 44-122-346-3330 Public Library of Science

Did seasonal flu vaccination increase the risk of infection with pandemic H1N1 flu?

Press release from PLoS Medicine

Did seasonal flu vaccination increase the risk of infection with pandemic H1N1 flu?

In September 2009, news stories reported that researchers in Canada had found an increased risk of pandemic H1N1 (pH1N1) influenza in people who had previously been vaccinated against seasonal influenza. Their research, consisting of four different studies, has now undergone further scientific peer review and is published in the open access journal PLoS Medicine.

Did previous vaccination against seasonal flu increase the risk of getting pH1N1 flu? Based on these studies – conducted by a large network of investigators across Canada led by Principal Investigator Danuta Skowronski of the British Columbia Centre for Disease Control in Vancouver, in collaboration with provincial leads Gaston De Serres in Quebec, Natasha Crowcroft in Ontario and Jim Dickinson in Alberta – the answer remains: “possibly.”

In a school outbreak of pH1N1 in spring 2009, people with cough and fever were found to have received prior seasonal flu vaccination more often than those without. Several public health agencies in Canada therefore undertook four additional studies during the summer of 2009 to investigate further. Taken together, the four studies included approximately 2,700 people with and without pH1N1.

The first of the studies used an ongoing sentinel monitoring system to assess the frequency of prior vaccination with the 2008󈝵 seasonal vaccine in people with pH1N1 influenza (cases) compared to people without evidence of infection with an influenza virus (controls). This study confirmed that the seasonal vaccine provided protection against seasonal influenza, but found it to be associated with an increased risk of approximately 68% for pH1N1 disease.

The further 3 studies (which included additional case-control investigations in Ontario and Quebec, as well as a transmission study in 47 Quebec households where pH1N1 influenza had occurred) similarly found between 1.4𔃀.5 times increased likelihood of pH1N1 illness in people who had received the seasonal vaccine compared to those who had not. Prior seasonal vaccination was not associated with an increase in hospitalization among those who developed pH1N1 illness.

These studies do not show whether there was a true cause-and-effect relationship between seasonal flu vaccination and subsequent pH1N1 illness (as might occur if, for example, the seasonal vaccine modified the immune response to pH1N1), or whether the observed association was not a result of vaccination, but was instead due to differences in some unidentified factor(s) among the groups being studied.

If the findings from these studies are real they raise important questions about the biological interactions between pre-existing and novel pandemic influenza strains. The researchers note, however, that the World Health Organization has recommended that pH1N1 be included in subsequent seasonal vaccine formulations. This will provide direct protection against pH1N1 and thereby obviate any risk that might have been due to the seasonal vaccine in 2009, which did not include pH1N1.

In an accompanying commentary in PLoS Medicine, Lone Simonsen and Cécile Viboud, who were not involved in the studies, write: “Given the uncertainty associated with observational studies, we believe it would be premature to conclude that increased the risk of 2009 pandemic illness, especially in light of six other contemporaneous observational studies in civilian populations that have produced highly conflicting results.” They conclude that “this perplexing experience should teach us how to best react to disparate and conflicting studies and prepare us for the next public health crisis, so that we can better manage future alerts for unexpected risk factors.”

###

Citation: Skowronski DM, De Serres G, Crowcroft NS, Janjua NZ, Boulianne N, et al. (2010) Association between the 2008󈝵 Seasonal Influenza Vaccine and Pandemic H1N1 Illness during Spring–Summer 2009: Four Observational Studies from Canada. PLoS Med 7(4): e1000258. doi:10.1371/journal.pmed.1000258

Funding: This project was funded by the Canadian Institutes of Health Research, the British Columbia Ministry of Health and the British Columbia Centre for Disease Control, Alberta Health and Wellness, the Ontario Agency for Health Protection and Promotion, the Ontario Ministry of Health and Long Term Care, the Ministère de la santé et des services sociaux du Québec, the Institut national de santé publique du Québec and the Fonds de la recherche en santé du Québec (FRSQ). Although agencies of the investigators provided infrastructure in support of the reported studies, the funders did not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing Interests: DMS has previously received research grant funding from GlaxoSmithKline and Sanofi-Pasteur for separate studies. GDS and NB have received research grant funding from GlaxoSmithKline and Sanofi-Pasteur for separate studies. GB has received funding from GlaxoSmithKline for unrelated projects. SAVOIR contributor Allison McGeer has received investigator initiated research grant funding from GlaxoSmithKline, and speaking honoraria from GlaxoSmithKline and Sanofi-Pasteur.

IN YOUR COVERAGE PLEASE USE THIS URL TO PROVIDE ACCESS TO THE FREELY AVAILABLE PAPER: http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000258

PRESS-ONLY PREVIEW OF THE ARTICLE: www.plos.org/press/plme-07-04-skowronski.pdf

CONTACTS:

Danuta Skowronski BC Centre for Disease Control Epidemiology Services
655 West 12th Avenue Vancouver, British Columbia V5Z 4R4 Canada
+1 604-707-2511 +1 604-707-2516 (fax) Danuta.Skowronski@bccdc.ca

Ritinder Harry Communications Leader, BC Centre for Disease Control (BCCDC) 655 West 12th Avenue Vancouver, BC V5Z 4R4 Canada +1 604 707-2412 ritinder.harry@bccdc.ca

Perspective article by Cecile Viboud:

Citation: Viboud C, Simonsen L (2010) Does Seasonal Influenza Vaccination Increase the Risk of Illness with the2009 A/H1N1 Pandemic Virus? PLoS Med 7(4): e1000259. doi:10.1371/journal.pmed.1000259

Competing Interests:CV declares no competing interests. LS is a paid consultant for SDI health (a health data business), and has received research support since 2008 from Wyeth (now Pfizer) for pneumococcal vaccine modelling.

IN YOUR COVERAGE PLEASE USE THIS URL TO PROVIDE ACCESS TO THE FREELY AVAILABLE PAPER: http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000259

PRESS-ONLY PREVIEW OF THE ARTICLE: http://www.plos.org/press/plme-07-04-viboud.pdf

CONTACT:

Cécile Viboud National Institutes of Health Fogarty International Center 16 Center Drive Bethesda, MD 20892 United States of America
1-301-496-2146 1-301-496-8496 (fax) viboudc@mail.nih.gov

Flame retardants linked to neurodevelopmental delays in children : PBDEs

Contact: Sarah Yang
scyang@berkeley.edu
510-643-7741
University of California – Berkeley

Berkeley — Prenatal and childhood exposure to flame retardant compounds are linked to poorer attention, fine motor coordination and IQ in school-aged children, a finding by researchers at the University of California, Berkeley, that adds to growing health concerns over a chemical prevalent in U.S. households.

The new study, to be published in the Nov. 15 issue of the journal Environmental Health Perspectives, focuses on PBDEs, or polybrominated diphenyl ethers, a class of persistent, endocrine-disrupting compounds widely found in foam furniture, electronics, carpets, upholstery and other consumer products. The chemicals easily leach out into the environment and are inhaled or ingested through dust, then accumulate in human fat cells.

The researchers collected blood samples taken from 279 women during pregnancy or at delivery, and from 272 of the children when they were 7 years old. Analyses of the blood samples were conducted at the U.S. Centers for Disease Control and Prevention (CDC) in Atlanta.

The children participated in a battery of standardized tests when they were 5 and 7 to assess their attention, fine motor coordination and IQ (verbal comprehension, perceptual reasoning, working memory, processing speed). Mothers and teachers also completed assessment questionnaires to help evaluate the children’s attention skills and behavior.

“This is the largest and most comprehensive study to date to examine neurobehavioral development in relation to body burden measures of PBDE flame retardants,” said study lead author Brenda Eskenazi, Jennifer and Brian Maxwell Professor of Maternal and Child Health and Epidemiology. “We measured PBDEs both in the mothers during pregnancy and in the children themselves. It shows that there is a relationship of in utero and childhood levels to decrements in fine motor function, attention and IQ.”

The new findings stem from a longitudinal study, the Center for the Health Assessment of Mothers and Children of Salinas (CHAMACOS), which examines environmental exposures and reproductive health. The study participants are primarily Mexican-Americans living in an agricultural community in Monterey County. Earlier studies found that children from the CHAMACOS group had PBDE blood concentrations seven times higher than children living in Mexico.

Evidence of adverse human health effects from PBDE exposure has been steadily building over the past decade. Other CHAMACOS studies have also revealed links between flame retardant concentrations in mothers’ blood and decreased fertility, lower birthweight babies and changes in thyroid hormone levels, even after controlling for exposure to pesticides and other environmental chemicals. And findings from other smaller studies have linked deficits in physical and mental development in young children to prenatal exposure to PBDEs.

“This new study is very important because it confirms earlier published research on the neurodevelopmental effects of PBDE exposure,” said Heather Stapleton, associate professor of environmental chemistry at Duke University and one of the nation’s leading experts on human exposure to flame retardant chemicals. Stapleton was not part of the UC Berkeley study.

Use of PBDEs increased in the 1970s in response to a California standard (Technical Bulletin 117) requiring that consumer furnishings be able to withstand a small open flame for 12 seconds without igniting.

Today, PBDEs can be found in the blood of up to 97 percent of U.S. residents, with those in California having levels nearly twice the national average, according to studies.

“Within the range of PBDE exposure levels, 5 percent of the U.S. population has very high exposure levels, so the health impact on children in these extremes could be even more significant,” noted Stapleton.

There are three formulations of PBDEs — pentaBDE, octaBDE and decaBDE — that have been developed for commercial use as flame retardants. Penta- and octaBDE have both been banned for use in several U.S. states, including California, but they are still present in products made before 2004. In addition, three major manufacturers have agreed to phase out production of decaBDE by 2013.

“Even though pentaPBDEs are not being used anymore, old couches with foam that is disintegrating will still release PBDEs,” said Eskenazi, director of the Center for Environmental Research and Children’s Health (CERCH) at UC Berkeley. “These chemicals will be in our homes for many years to come, so it’s important to take steps to reduce exposure.”

Examples of things that people can do at home include:

  • Seal any tears in couches and upholstered furniture
  • Damp mop and vacuum frequently
  • Wash hands frequently (especially important for children)

 

###

CERCH has also posted information about PBDEs online (http://cerch.org/environmental-exposures/pbde-flame-retardants/).

Co-authors of the study are Jonathan Chevrier, Stephen Rauch, Katherine Kogut, Kim Harley, Caroline Johnson, Celina Trujillo and Asa Bradman at CERCH; and Andreas Sjodin at the CDC’s Division of Laboratory Sciences.

The U.S. Environmental Protection Agency and the National Institute of Environmental Health Sciences provided major funding for this research.

U.S. sees diabetes rates skyrocket

By Agence France-Presse Thursday, November 15, 2012 20:56 EST

HHS

Topics:

The United States saw a dramatic rise in the number of adults suffering from diabetes between 1995 and 2010, according to official statistics released Thursday.

The prevalence of the disease increased by at least 50 percent in 42 of the country’s 50 states. In 18 of those, the rate at least doubled, according to a study by the Centers for Disease Control and Prevention.

“Regionally, we saw the largest increase in diagnosed diabetes prevalence in the South, followed by the West, Midwest, and Northeast,” said Linda Geiss, lead author of the report.

The states that saw the highest rise in cases included Oklahoma (226 percent), Kentucky (158 percent), Georgia (145 percent), Alabama (140 percent) and Washington (135 percent).

In 1995, only three states along with the District of Columbia — home of the nation’s capital, Washington — and Puerto Rico had a diagnosed diabetes prevalence of at least six percent.

But by 2010, all 50 US states recorded a prevalence of more than six percent, said Ann Albright, who heads the CDC’s Division of Diabetes Translation.

“These rates will continue to increase until effective interventions and policies are implemented to prevent both diabetes and obesity,” she said in a statement. More than a third of American adults are obese.

Type 2 diabetes, which accounts for 90-95 percent of all diabetes cases in the United States, could be prevented by making lifestyle changes, the statement said.

The CDC, together with its partners, is working on initiatives to prevent type 2 diabetes and minimize complications in those already diagnosed with the disease.

The study used data from an annual telephone survey of health behaviors and conditions of US adults aged 18 and older.

 

http://www.rawstory.com/rs/2012/11/15/u-s-sees-diabetes-rates-skyrocket/

77th Health Research Report 10 MAR 2010 – Reconstruction

 

 

In this issue:

  1. Foodborne illness costs US $152 billion annually, landmark report estimates
  2. Study shows pine bark reduces blood pressure, counteracts kidney damage caused by hypertension
  3. VITAMIN D LIFTS MOOD DURING COLD WEATHER MONTHS
  4. Hormone replacement therapy linked to increased lung cancer risk
  5. Virus infections may be contributing factor in onset of gluten intolerance
  6. Low levels of Vitamin D linked to muscle fat, decreased strength in young people
  7. Repeated anesthesia can affect childrens ability to learn
  8. Anti-depressants bring higher risk of developing cataracts: UBC-Vancouver Coastal Health research
  9. Exposure to BPA may cause permanent fertility defects, Yale researchers find
  10. Papaya extract thwarts growth of cancer cells in lab tests

Public release date: 3-Mar-2010

Foodborne illness costs US $152 billion annually, landmark report estimates

New analysis, interactive online map highlight the need to modernize the nation’s food-safety system

WASHINGTON, D.C. – A new study by a former U.S. Food and Drug Administration (FDA) economist estimates the total economic impact of foodborne illness across the nation to be a combined $152 billion annually.

The Produce Safety Project, an initiative of The Pew Charitable Trusts at Georgetown University, published the report, Health-Related Costs from Foodborne Illness in the United States. In addition, an interactive online map that graphically represents this cost information for every state in the nation is available at http://www.MakeOurFoodSafe.org/cost_map.

The report ranks states according to their total costs related to foodborne illness and cost per case for an individual, which is $1,850 on average nationwide. The ten states with the highest costs per case are: Hawaii, Florida, Connecticut, Pennsylvania, South Carolina, the District of Columbia, Mississippi, New York, Massachusetts and New Jersey.

The Centers for Disease Control and Prevention (CDC) estimates that approximately 76 million new cases of food-related illness – resulting in 5,000 deaths and 325,000 hospitalizations – occur in the United States each year. Continuing outbreaks every year show that this is not a problem that is going away.

“The costs associated with foodborne illness are substantial,” says report author Robert L. Scharff, a former FDA economist who is now an assistant professor in the Department of Consumer Sciences at The Ohio State University. “This study puts the problem of foodborne illness in its proper perspective and should help facilitate reasonable action designed to mitigate this problem.”

The release of the report comes as the U.S. Senate may soon vote on comprehensive food-safety legislation. The U.S. House of Representatives passed its food-safety bill (H.R. 2749) last July, and just before Thanksgiving, the U.S. Senate Committee on Health, Education, Labor & Pensions unanimously approved the FDA Food Safety Modernization Act (S. 510).

“This report makes it clear that the gaps in our food-safety system are causing significant health and economic impacts,” says Erik Olson, director of food and consumer product safety with the Pew Health Group. “Especially in challenging economic times we cannot afford to waste billions of dollars fighting preventable diseases after it is too late. The Senate needs to act on this now and pass legislation that will improve protections for public health.”

Public release date: 3-Mar-2010

Study shows pine bark reduces blood pressure, counteracts kidney damage caused by hypertension

Research reveals Pycnogenol lowers elevated urinary protein levels and improves blood flow to the kidneys

(March 3, 2010) – HOBOKEN, NJ – An estimated one in ten adults suffers from kidney disease, according to the National Institute of Diabetes and Digestive and Kidney Diseases. A leading cause of kidney disease is hypertension, which effects one out of every four U.S. adults. Chronically high blood pressure damages capillaries of the kidneys which in turn affects the organ’s ability to filter waste and remove excess fluids from the body. A study published in the March 2010 issue of the Journal of Cardiovascular Pharmacology and Therapeutics reveals Pycnogenol® (pic-noj-en-all), an antioxidant plant extract from the bark of the French maritime pine tree, counteracts kidney damage caused by hypertension, lowering urinary proteins and improving blood flow to the kidneys.

“Kidney disease is a common problem for people with hypertension and is an equally ‘silent’ threat to the body. There are no warning signals and inefficient fluid removal may further increase the blood pressure, causing a vicious circle to set in,” said Dr. Gianni Belcaro, a lead researcher of the study. “The results of this study demonstrated Pycnogenol®’s ability not only to reduce blood pressure, but also to relieve the kidney damage caused by chronic hypertension.”

The randomized, controlled study conducted by the G D’Annunzio University in Italy investigated 55 hypertensive patients who showed early signs of impaired kidney function, as judged by elevated amounts of proteins found in their urine. The patients were divided into two groups. Both groups were treated with anti-hypertensive medication Ramipril and one group of 29 patients took Pycnogenol in addition to the Ramipril. Urine was collected during a 24 hour period for quantification of protein (albumin) at baseline and again after six months of treatment.

All patients included in the study had an average urinary protein level of 89 mg per 24-hour period, significantly exceeding the 30 mg measure, up to which kidney function is considered sufficient. After six months of treatment with Ramipril, average protein levels decreased to 64 mg per 24-hour period, remaining well above an acceptable level. Conversely, the group taking Pycnogenol® as an adjunct to Ramipril had an average of only 39 mg per 24-hour period, a decrease of nearly double compared with anti-hypertensive medication taken alone.

The study also found a statistically significant decrease in patients’ blood pressure when taking Pycnogenol® in conjunction with Ramipril. When treated exclusively with Ramipril, systolic blood pressure values dropped by more than 30 percent and diastolic blood pressure values dropped approximately eight percent. The addition of Pycnogenol® decreased both systolic and diastolic pressures by an additional three to six percent. Pycnogenol® was also found to lower the patients’ elevated levels of inflammatory marker CRP, a blood protein associated with the risk for acute cardiovascular events such as heart attack, reducing values to a healthy level.

“While Ramipril represents an effective treatment for hypertension and its interrelated effects on kidney function, Pycnogenol® as an adjunct to the medication produced significantly greater results, particularly for kidney function restoration” said Dr. Belcaro. “Pycnogenol® continues to demonstrate its abilities as a natural solution for the complete cardiovascular system.”

Previous studies have revealed Pycnogenol® to favorably affect the normalization of blood pressure by releasing arterial constriction.

Public release date: 3-Mar-2010

VITAMIN D LIFTS MOOD DURING COLD WEATHER MONTHS

Loyola Researchers to Study Nutrient in Depression and Diabetes Patients

MAYWOOD, Ill. — A daily dose of vitamin D may just be what Chicagoans need to get through the long winter, according to researchers at Loyola University Chicago Marcella Niehoff School of Nursing (MNSON). This nutrient lifts mood during cold weather months when days are short and more time is spent indoors.

“Vitamin D deficiency continues to be a problem despite the nutrient’s widely reported health benefits,” said Sue Penckofer, PhD, RN, professor, MNSON. “Chicago winters compound this issue when more people spend time away from sunlight, which is a natural source of vitamin D.”

Diet alone may not be sufficient to manage vitamin D levels. A combination of adequate dietary intake of vitamin D, exposure to sunlight, and treatment with vitamin D2 or D3 supplements can decrease the risk of certain health concerns. The preferred range in the body is 30 – 60 ng/mL of 25(OH) vitamin D.

Loyola faculty members plan to take vitamin D research a step further by evaluating whether weekly vitamin D supplements improve blood sugar control and mood in women with diabetes. Depression is associated with increased insulin resistance, so people with diabetes have a greater risk for the disease than those without depression. Women also tend to have greater rates of depression and poorer blood sugar control than men with diabetes.

“There is evidence to suggest that vitamin D supplementation may decrease insulin resistance,” said Dr. Penckofer. “If we can stabilize insulin levels, we may be able to simply and cost effectively improve blood sugar control and reduce symptoms of depression for these women.”

Loyola is currently enrolling women in this clinical trial. In order to enter the study, they must be 18 to 70 years of age, have stable type 2 diabetes, signs of depression and no other major medical illness. Eighty women with type 2 diabetes and signs of depression will be given a weekly dose of vitamin D (50,000 IU) for a period of six months. Study participants will be evaluated at three points during this time.

“Vitamin D has widespread benefits for our health and certain chronic diseases in particular,” Dr. Penckofer said. “Our research may shed greater light on the role this nutrient plays in managing two conditions that impact millions of Americans. If proven to be successful, vitamin D may an important addition to care for diabetes and depression.”

Public release date: 3-Mar-2010

Hormone replacement therapy linked to increased lung cancer risk

New study finds prolonged use of HRT increases incidence of lung cancer by about 50 percent

PORTLAND, Ore. — Women aged 50 to 76 who take estrogen plus progestin may have an increased risk of lung cancer, according to a new study published in the pre-print online edition of the Journal of Clinical Oncology.

Although the risk is “duration-dependent,” with women taking HRT for 10-plus years at greatest risk of developing lung cancer, an acceptable length of HRT has yet to be determined, the researchers report.

While the risk of developing lung cancer for women using estrogen plus progestin HRT 10 years or longer was approximately 50 percent more than women not using HRT, this risk is actually quite small compared to the risk from smoking.

“Although HRT use has declined and is not recommended except for short-term treatment of menopausal symptoms, our results indicate millions of women may remain at risk of developing lung cancer,” said Chris Slatore, M.D., principal investigator and an assistant professor of medicine (pulmonary and critical care medicine) in the Oregon Health & Science University School of Medicine, Portland Veterans Affairs Medical Center; and a member of the OHSU Knight Cancer Institute.

To conduct this research, Slatore and colleagues reviewed data collected from 2000 to 2002 in the Vitamins and Lifestyle Study in Washington state. They identified 36,588 peri- and postmenopausal participants aged 50 to 76 who met their study criteria and followed them for six years using the Seattle-Puget Sound Surveillance, Epidemiology and End Results cancer registry.

At the end of the observation period, December 31, 2007, 344 of the participants had developed lung cancer. After adjusting for smoking, age and other factors that affect the risk of lung cancer, the researchers determined the use of estrogen and progestin for 10 or more years was associated with increased risk for lung cancer compared with no use of HRT. They also found duration of use was associated with an advanced stage of cancer at diagnosis.

Although the mechanisms underlying the association between HRT and lung cancer are still unknown, the researchers report that genetic and environment interactions likely play a role. They also suggest that estrogen plus progestin may lead to more aggressive disease or mask early symptoms, or HRT users may be less likely to see or receive medical care in a timely fashion.

“These findings may be useful in counseling women about their risk of developing lung cancer and prompt further research into the mechanisms underlying HRT and increased lung cancer risk,” said Slatore.

 

Public release date: 5-Mar-2010

Virus infections may be contributing factor in onset of gluten intolerance

Recent research findings indicate a possible connection between virus infections, the immune system and the onset of gluten intolerance, also known as coeliac disease. A research project in the Academy of Finland’s Research Programme on Nutrition, Food and Health (ELVIRA) has brought new knowledge on the hereditary nature of gluten intolerance and identified genes that carry a higher risk of developing the condition. Research has shown that the genes in question are closely linked with the human immune system and the occurrence of inflammations, rather than being connected with the actual breakdown of gluten in the digestive tract.

“Some of the genes we have identified are linked with human immune defence against viruses. This may indicate that virus infections may be connected in some way with the onset of gluten intolerance,” says Academy Research Fellow Päivi Saavalainen, who has conducted research into the hereditary risk factors for gluten intolerance.

Saavalainen explains that the genes that predispose people to gluten intolerance are very widespread in the population and, as a result, they are only a minor part of the explanation for the way in which gluten intolerance is inherited. However, the knowledge of the genes behind gluten intolerance is valuable in itself, as it helps researchers explore the reasons behind gluten intolerance, which in turn builds potential for developing new treatments and preventive methods. This is essential, because the condition is often relatively symptom-free, yet it can have serious complications unless treated.

Researchers have localised the risk genes by using data on patients and on entire families. The material in the Finnish study is part of a very extensive study of thousands of people with gluten intolerance and control groups in nine different populations. The research will be published in a coming issue of Nature Genetics.

Research into hereditary conditions has made great progress over the past few years. Gene researchers now face their next challenge, as a closer analysis is now needed of the risk factors in the genes that predispose people to gluten intolerance. It is important to discover how they impact on gene function and what part they play in the onset of gluten intolerance.

Gluten intolerance is an autoimmune reaction in the small intestine. Roughly one in a hundred Finns suffer from this condition. The gluten that occurs naturally in grains such as wheat, barley and rye causes damage to the intestinal villi, problems with nutrient absorption and potentially other problems too. Gluten intolerance is an inherited predisposition, and nearly all sufferers carry the genes that play a key part in the onset of the condition. The only known effective treatment is a lifelong gluten-free diet.
Public release date: 5-Mar-2010

Low levels of Vitamin D linked to muscle fat, decreased strength in young people

First-of-a-kind study by investigator at The Research Institute of the MUHC finds “epidemic” of Vitamin D insufficiency…

There’s an epidemic in progress, and it has nothing to do with the flu. A ground-breaking study published in the March 2010 Journal of Clinical Endocrinology and Metabolism found an astonishing 59 per cent of study subjects had too little Vitamin D in their blood.  Nearly a quarter of the group had serious deficiencies (less than 20 ng/ml) of this important vitamin. Since Vitamin D insufficiency is linked to increased body fat, decreased muscle strength and a range of disorders, this is a serious health issue.

“Vitamin D insufficiency is a risk factor for other diseases,” explains principal investigator, Dr. Richard Kremer, co-director of the Musculoskeletal Axis of the Research Institute of the MUHC. “Because it is linked to increased body fat, it may affect many different parts of the body. Abnormal levels of Vitamin D are associated with a whole spectrum of diseases, including cancer, osteoporosis and diabetes, as well as cardiovascular and autoimmune disorders.”

The study by Dr. Kremer and co-investigator Dr. Vincente Gilsanz, head of musculoskeletal imaging at the Children’s Hospital Los Angeles of the University of Southern California, is the first to show a clear link between Vitamin D levels and the accumulation of fat in muscle tissue – a factor in muscle strength and overall health.  Scientists have known for years that Vitamin D is essential for muscle strength. Studies in the elderly have showed bedridden patients quickly gain strength when given Vitamin D.

The study results are especially surprising, because study subjects  – all healthy young women living in California – could logically be expected to benefit from good diet, outdoor activities and ample exposure to sunshine – the trigger that causes the body to produce Vitamin D.

“We are not yet sure what is causing Vitamin D insufficiency in this group,” says Dr. Kremer who is also Professor of Medicine at McGill University. High levels of Vitamin D could help reduce body fat. Or, fat tissues might absorb or retain Vitamin D, so that people with more fat are likely to also be Vitamin D deficient.”

The results extend those of an earlier study by Dr. Kremer and Dr. Gilsanz, which linked low levels of Vitamin D to increased visceral fat in a young population. “In the present study, we found an inverse relationship between Vitamin D and muscle fat,” Dr. Kremer says. “The lower the levels of Vitamin D the more fat in subjects’ muscles.”

While study results may inspire some people to start taking Vitamin D supplements, Dr. Kremer recommends caution. “Obviously this subject requires more study,” he says. “We don’t yet know whether Vitamin D supplementation would actually result in less accumulation of fat in the muscles or increase muscle strength. We need more research before we can recommend interventions. We need to take things one step at a time.”

Public release date: 7-Mar-2010

Repeated anesthesia can affect childrens ability to learn

There is a link between repeated anaesthesia in children and memory impairment, though physical activity can help to form new cells that improve memory, reveals new research from the Sahlgrenska Academy at the University of Gothenburg, Sweden.

The study has been published in the Journal of Cerebral Blood Flow & Metabolism.

“Paediatric anaesthetists have long suspected that children who are anaesthetised repeatedly over the course of just a few years may suffer from impaired memory and learning,” says Klas Blomgren, professor at the Queen Silvia Children’s Hospital and researcher at the Sahlgrenska Academy. “This is a theory that is also supported by foreign research.”

His research team discovered, by chance, a link between stem cell loss and repeated anaesthesia when working on another study. They wanted to find out what happens to the brain’s stem cells when exposed to strong magnetic fields, for example during an MRI scan. The study was carried out using rats and mice, and showed that while the magnetic fields did not have any tangible effects on the animals, the repeated anaesthesia did.

“We found that repeated anaesthesia wiped out a large portion of the stem cells in the hippocampus, an area of the brain that is important for memory,” says Blomgren. “The stem cells in the hippocampus can form new nerve and glial cells, and the formation of nerve cells is considered important for our memory function.”

Their results could also be linked to impaired memory in animals as they got older. The effect was evident only in young rats or mice that had been anaesthetised, not when adult animals were anaesthetised. This may be because stem cells are more sensitive in an immature brain, even though there are fewer of them as we get older.

“Despite extensive attempts, we have not been able to understand exactly what happens when the stem cells are wiped out,” says Blomgren. “We couldn’t see any signs of increased cell death, but are speculating that the stem cells lose their ability to divide.”

Another treatment that wipes out the brain’s stem cells is radiotherapy, which is used with cancer patients. Blomgren and his research team have previously used animal studies to show that physical activity after radiotherapy can result in a greater number of new stem cells and partly replace those that have been lost.

“What’s more, the new nerve cells seem to work better in animals that exercise. Now that we know this, we can come up with treatments that prevent or reverse the loss of ostem cells after repeated anaesthesia,” says Blomgren, who believes that the findings will lead to greater awareness of the problems and inspire further research into the reasons for the loss of stem cells.

Public release date: 7-Mar-2010

 

Anti-depressants bring higher risk of developing cataracts: UBC-Vancouver Coastal Health research

 

Some anti-depressant drugs are associated with an increased chance of developing cataracts, according to a new statistical study by researchers at the University of British Columbia, Vancouver Coastal Health Research Institute and McGill University.

The study, based on a database of more than 200,000 Quebec residents aged 65 and older, showed statistical relationships between a diagnosis of cataracts or cataract surgery and the class of drugs called selective serotonin reuptake inhibitors (SSRIs), as well as between cataracts and specific drugs within that class.

Published online today in the journal Ophthalmology, the study does not prove causation but only reveals an association between the use of SSRIs and the development of cataracts. The study could not account for the possibility of smoking – which is a risk factor for cataracts – and additional population-based studies are needed to confirm these findings, the researchers say.

This study of statistical relationships is the first to establish a link between this class of drugs and cataracts in humans. Previous studies in animal models had demonstrated that SSRIs could increase the likelihood of developing the condition.

“When you look at the trade-offs of these drugs, the benefits of treating depression – which can be life-threatening – still outweigh the risk of

developing cataracts, which are treatable and relatively benign,” says Dr. Mahyar Etminan, lead author of the article, a scientist and clinical pharmacist at the Centre for Clinical Epidemiology at Vancouver Coastal Health Research Institute and an assistant professor in the Dept. of Medicine at UBC.

Researchers found patients taking SSRIs were overall 15 per cent more likely to be diagnosed with cataracts or to have cataract surgery.

The degree of risk among specific and different types of SSRIs varied considerably. Taking fluvoxamine (Luvox) led to a 51 per cent higher chance of having cataract surgery, and venlafaxine (Effexor) carried a 34 per cent higher risk. No connection could be made between fluoxetine (Prozac), citalopram (Celexa), and sertraline (Zoloft) and having cataract surgery.

Co-author Dr. Frederick S. Mikelberg, professor and head of the Dept. of Ophthalmology and Visual Sciences at UBC and head of the Dept. of Ophthalmology at Vancouver General Hospital, notes that the average time to develop cataracts while taking SSRIs was almost two years.

“While these results are surprising, and might inform the choices of psychiatrists when prescribing SSRIs for their patients, they should not be cause for alarm among people taking these medications,” Mikelberg says.

SSRIs, the third most prescribed class of drugs in the world, block the uptake of the neurotransmitter serotonin by neurons in the brain, thereby stimulating more impulses between neurons. Cataracts, a clouding of the eye’s lens that usually occurs in older people, are routinely treated through surgery. More than 1.5 million people undergo surgery for the condition every year in North America, according to the Canadian Ophthalmological Society.

 

Public release date: 8-Mar-2010

 

Exposure to BPA may cause permanent fertility defects, Yale researchers find

Researchers at Yale School of Medicine have discovered that exposure during pregnancy to Bisphenol A (BPA), a common component of plastics, causes permanent abnormalities in the uterus of offspring, including alteration in their DNA. The findings were reported in the March issue of Journal of the Federation of American Societies for Experimental Biology (FASEB J.).

Led by Hugh S. Taylor, M.D., professor in the Department of Obstetrics, Gynecology & Reproductive Sciences at Yale, the study is the first to show that BPA exposure permanently affects sensitivity to estrogen.

Taylor and his team used two groups of mice, one exposed to BPA as a fetus during pregnancy and another exposed to a placebo. They examined gene expression and the amount of DNA modification in the uterus. They found that the mice exposed to BPA as a fetus had an exaggerated response to estrogens as adults, long after the exposure to BPA. The genes were permanently programmed to respond excessively to estrogen.

“The DNA in the uterus was modified by loss of methyl groups so that it responded abnormally in adulthood,” said Taylor. “The gene expression was permanently epigenetically altered and the uterus became hyper-responsive to estrogens.”

Taylor said that exposure to BPA as a fetus is carried throughout adulthood. “What our mothers were exposed to in pregnancy may influence the rest of our lives. We need to better identify the effect of environmental contaminants on not just crude measures such as birth defects, but also their effect in causing more subtle developmental errors.”

Public release date: 9-Mar-2010

 

Papaya extract thwarts growth of cancer cells in lab tests

The humble papaya is gaining credibility in Western medicine for anticancer powers that folk cultures have recognized for generations.

University of Florida researcher Nam Dang, M.D., Ph.D., and colleagues in Japan have documented papaya’s dramatic anticancer effect against a broad range of lab-grown tumors, including cancers of the cervix, breast, liver, lung and pancreas. The researchers used an extract made from dried papaya leaves, and the anticancer effects were stronger when cells received larger doses of the tea.

In a paper published in the Feb. 17 issue of the Journal of Ethnopharmacology, Dang and his colleagues also documented for the first time that papaya leaf extract boosts the production of key signaling molecules called Th1-type cytokines. This regulation of the immune system, in addition to papaya’s direct antitumor effect on various cancers, suggests possible therapeutic strategies that use the immune system to fight cancers.

The papaya extract did not have any toxic effects on normal cells, avoiding a common and devastating consequence of many cancer therapy regimens. The success of the papaya extract in acting on cancer without toxicity is consistent with reports from indigenous populations in Australia and his native Vietnam, said Dang, a professor of medicine and medical director of the UF Shands Cancer Center Clinical Trials Office.

“Based on what I have seen and heard in a clinical setting, nobody who takes this extract experiences demonstrable toxicity; it seems like you could take it for a long time — as long as it is effective,” he said.

Researchers exposed 10 different types of cancer cell cultures to four strengths of papaya leaf extract and measured the effect after 24 hours. Papaya slowed the growth of tumors in all the cultures.

To identify the mechanism by which papaya checked the growth of the cultures, the team focused on a cell line for T lymphoma. Their results suggested that at least one of the mechanisms employed by the papaya extract is inducing cell death.

In a similar analysis, the team also looked at the effect of papaya extract on the production of antitumor molecules known as cytokines. Papaya was shown to promote the production of Th1-type cytokines, important in the regulation of the immune system. For that reason, the study findings raise the possibility of future use of papaya extract components in immune-related conditions such as inflammation, autoimmune disease and some cancers.

Bharat B. Aggarwal, Ph.D., a researcher at the University of Texas M.D. Anderson Cancer Center in Houston, already is so convinced of papaya’s restorative powers that he has a serving of the fruit every day.

“We have always known that papaya has a lot of interesting things in there,” said Aggarwal, a professor in the center’s department of experimental therapeutics who was not involved in the UF research. Foremost among papaya’s health-promoting agents is papain, papaya’s signature enzyme, which is found in both the fruit and the leaves.

“This paper has not gone too much into identifying the components responsible for the activity, which is just fine. I think that is a good beginning,” Aggarwal said.

Aggarwal also noted that papaya extract’s success in reducing cancer in laboratory cell cultures must next be replicated in animal and human studies.

“I hope Dr. Dang takes it further, because I think we need enthusiastic people like him to move it forward,” Aggarwal said.

________________________________

 

These reports are done with the appreciation of all the Doctors, Scientist, and other

Medical Researchers who sacrificed their time and effort. In order to give people the

ability to empower themselves. Without the base aspirations for fame, or fortune.

Just honorable people, doing honorable things.

Health Research Report

77th Issue 10 MAR 2010

Compiled By Ralph Turchiano

www.healthresearchreport.me www.vit.bz

www.youtube.com/vhfilm www.facebook.com/engineeringevil

www.engineeringevil.com

 

Study links reduced fertility to flame retardant exposure: PBDEs, or polybrominated diphenyl ethers

2010 study posted for filing

Contact: Sarah Yang scyang@berkeley.edu 510-643-7741 University of California – Berkeley

Berkeley – Women with higher blood levels of PBDEs, a type of flame retardant commonly found in household consumer products, took longer to become pregnant compared with women who have lower PBDE levels, according to a new study by researchers at the University of California, Berkeley.

The study, to be published Jan. 26 in the journal Environmental Health Perspectives, found that each 10-fold increase in the blood concentration of four PBDE chemicals was linked to a 30 percent decrease in the odds of becoming pregnant each month.

“There have been numerous animal studies that have found a range of health effects from exposure to PBDEs, but very little research has been done in humans. This latest paper is the first to address the impact on human fertility, and the results are surprisingly strong,” said the study’s lead author, Kim Harley, adjunct assistant professor of maternal and child health and associate director of the Center for Children’s Environmental Health Research at UC Berkeley’s School of Public Health. “These findings need to be replicated, but they have important implications for regulators.”

PBDEs, or polybrominated diphenyl ethers, are a class of organobromine compounds that became commonplace after the 1970s when new fire safety standards were implemented in the United States. The flame retardants are used in foam furniture, electronics, fabrics, carpets, plastics and other common items in the home.

Studies have found widespread contamination of house dust by PBDEs, which are known to leach out into the environment and accumulate in human fat cells. Studies also suggest that 97 percent of U.S. residents have detectable levels of PBDEs in their blood, and that the levels in Americans are 20 times higher than in their European counterparts. According to the researchers, residents in California are among those experiencing the highest exposures, most likely due to the state’s relatively stringent flammability laws.

The researchers measured PBDE levels in blood samples from 223 pregnant women enrolled in a longitudinal study at the Center for the Health Assessment of Mothers and Children of Salinas (CHAMACOS) that examines environmental exposures and reproductive health.

The median concentrations of the four PBDE chemicals in the analysis were slightly lower in this study population than in the general U.S. population, possibly because many of the participants had grown up in Mexico where PBDE exposures are limited, said the authors of the study. The median number of months it took to get pregnant was three, with 15 percent of the participants taking longer than 12 months to conceive.

When the analysis was limited to women who were actively trying to become pregnant, the researchers found that they were half as likely to conceive in any given month if they had high levels of PBDE in their blood. “We aren’t looking at infertility, just subfertility, because all the women in our study eventually became pregnant,” said Harley. “Had we included infertile couples in our study, it is possible that we would have seen an even stronger effect from PBDE exposure.”

It is not entirely clear how PBDEs might impact fertility. A number of animal studies have found that PBDEs can impair neurodevelopment, reduce thyroid hormones, and alter levels of sex hormones. Both high and low thyroid hormone levels can disrupt normal menstrual patterns in humans, but this study did not find a link between PBDE exposure and irregular menstrual cycles.

Because the participants were mostly young, Mexican immigrant women who lived in an agricultural community, the researchers controlled for exposure to pesticides in their analysis. The researchers also controlled for other variables known to impact fertility, such as irregularity of menstrual cycles, frequency of intercourse, pre-pregnancy body mass index, use of birth control pills in the year before conception, smoking, and alcohol and caffeine consumption.

There are some 209 different possible formulations of PBDEs, but only three mixtures – pentaBDE, octaBDE and decaBDE – have been developed for commercial use as flame retardants. The mixtures are distinguished by the average number of bromine atoms attached to each molecule. Like many other studies, the most prevalent PBDEs in the blood of women participating in the UC Berkeley study were four components of the pentaBDE mixture.

Penta- and octaBDE have both been banned for use in several U.S. states, including California, but they are still present in products made before 2004. Last month, the U.S. Environmental Protection Agency (EPA) announced an agreement with three major manufacturers of decaBDE to phase out its production by 2013.

“Although several types of PBDEs are being phased out in the United States, our exposure to the flame retardants is likely to continue for many years,” said the study’s principal investigator, Brenda Eskenazi, UC Berkeley professor of epidemiology and of maternal and child health at the School of Public Health. “PBDEs are present in many consumer products, and we know they leach out into our homes. In our research, we have found that low-income children in California are exposed to very high levels of PBDEs, and this has us concerned about the next generation of Californians.”

Keeping up with the ever-expanding range of chemicals in our environment is challenging, the researchers noted. As PBDEs are being phased out, they are being replaced with other brominated compounds. “We know even less about the newer flame retardant chemicals that are coming out,” said Harley. “We just don’t have the human studies yet to show that they are safe.”

A 2007 state assembly bill that would have banned all brominated and chlorinated chemical flame retardants from household furniture and bedding sold in California failed to pass.

###

 

Other co-authors of the study are Amy Marks, Jonathan Chevrier and Asa Bradman from the Center for Children’s Environmental Health Research at UC Berkeley’s School of Public Health; and Andreas Sjödin from the National Center for Environmental Health at the Centers for Disease Control and Prevention (CDC).

The National Institute of Environmental Health Science, the U.S. EPA and the CDC helped support this research.

Study examines associations between antibiotic use during pregnancy and birth defects: sulfonamides and nitrofurantoins

2009 study posted for filing

Contact: CDC Division of Media Relations
media@cdc.gov
404-639-3286
JAMA and Archives Journals

Penicillin and several other antibacterial medications commonly taken by pregnant women do not appear to be associated with many birth defects, according to a report in the November issue of Archives of Pediatrics & Adolescent Medicine, one of the JAMA/Archives journals. However, other antibiotics, such as sulfonamides and nitrofurantoins, may be associated with several severe birth defects and require additional scrutiny.

Treating infections is critical to the health of a mother and her baby, according to background information in the article. Therefore, bacteria-fighting medications are among the most commonly used drugs during pregnancy. Although some classes of antibiotics appear to have been used safely during pregnancy, no large-scale studies have examined safety or risks involved with many classes of antibacterial medications.

Krista S. Crider, Ph.D., of the Centers for Disease Control and Prevention, Atlanta, and colleagues analyzed data from 13,155 women whose pregnancies were affected by one of more than 30 birth defects (cases). The information was collected by surveillance programs in 10 states as part of the National Birth Defects Prevention Study. The researchers compared antibacterial use before and during pregnancy between these women and 4,941 randomly selected control women who lived in the same geographical regions but whose babies did not have birth defects.

Antibacterial use among all women increased during pregnancy, peaking during the third month. A total of 3,863 mothers of children with birth defects (29.4 percent) and 1,467 control mothers (29.7 percent) used antibacterials sometime between three months before pregnancy and the end of pregnancy.

“Reassuringly, penicillins, erythromycins and cephalosporins, although used commonly by pregnant women, were not associated with many birth defects,” the authors write. Two defects were associated with erythromycins (used by 1.5 percent of the mothers whose children had birth defects and 1.6 percent of controls), one with penicillins (used by 5.5 percent of case mothers and 5.9 percent of controls), one with cephalosporins (used by 1 percent of both cases and controls) and one with quinolones (used by 0.3 percent of both cases and controls).

Two medications—sulfonamides and nitrofurantoins (each used by 1.1 percent of cases and 0.9 percent of controls)—were associated with several birth defects, suggesting that additional study is needed before they can be safely prescribed to pregnant women.

“Determining the causes of birth defects is problematic,” the authors write. “A single defect can have multiple causes, or multiple seemingly unrelated defects may have a common cause. This study could not determine the safety of drugs during pregnancy, but the lack of widespread increased risk associated with many classes of antibacterials used during pregnancy should be reassuring.”

 

###

(Arch Pediatr Adolesc Med. 2009;163[11]:978-985. Available pre-embargo to the media at www.jamamedia.org.)

Editor’s Note: The National Birth Defects Prevention Study is funded by a cooperative agreement from the Centers for Disease Control and Prevention. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures,

 

American birth rate drops to lowest point ever… and 40 per cent of newborns are to unwed mothers

  • Per cent of  babies born to unmarried women was highest among teens
  • There were  3,953,593 births in the U.S. in 2011, one per cent less than 2010
  • More older  women having newborns as women delay families

By Daily Mail Reporter

PUBLISHED:15:03 EST, 2  November 2012| UPDATED:15:03 EST, 2 November 2012

 

The birth rate in the United States dropped  to an all-time low in 2011 with one percent fewer births than in the year  before, according to a report released this month by the Centers for Disease  Control and Prevention.

And of all the babies born last year, more  than 40 per cent were born to unmarried women.

The per cent of babies born to unmarried  women was highest among teens but the per cent delivered by unmarried women of  older ages increased from 2010 to 2011.

Dropped: The U.S. birth rate dropped one per cent from 2010 to 2011, the lowest ever recorded 

Dropped: The U.S. birth rate dropped one per cent from  2010 to 2011, the lowest ever recorded

Findings are based on approximately 100 per  cent of registered vital records occurring in calendar year 2011, which were  received and processed by the National Center for Health Statistics, the report  said.

The 2011 preliminary number of U.S. births  was 3,953,593 – one per cent less than 2010.

Rates varied depending on the woman’s  background.

There was a steep drop in births for women  15-19 years old where the rate declined from 34. 2 per cent to 31.3 per cent,  while in 20 to 24 year  old the decline was from 90.0 to 85.3 per  cent.

Where's daddy: Single mothers gave birth to more than 40 per cent of newborns last year 

Where’s daddy: Single mothers gave birth to more than 40  per cent of newborns last year

Older groups held steady with only a small  decline from 108.3 to 107.2 per cent for ages 25 to 29 and a steady 96.5 per  cent from year to year for those age 30-34.

Researcher said the data shows women are  choosing to have family later in life, and rates among older women actually  increased.

Births declined fro most race and Hispanic  origin groups and the birth rate declined for Hispanic, non-Hispanic, black and  American Indian and Alaskan native women.

Read more: http://www.dailymail.co.uk/news/article-2227070/American-birth-rate-drops-lowest-point-history.html#ixzz2B8c3Pwpf Follow us: @MailOnline on Twitter | DailyMail on Facebook

Drinking coffee slows progression of liver disease in chronic hepatitis C sufferers

2009 study posted for filing

Contact: Dawn Peters
medicalnews@wiley.com
781-388-8408
Wiley-Blackwell

Patients with chronic hepatitis C and advanced liver disease who drink three or more cups of coffee per day have a 53% lower risk of liver disease progression than non-coffee drinkers according to a new study led by Neal Freedman, Ph.D., MPH, from the National Cancer Institute (NCI). The study found that patients with hepatitis C-related bridging fibrosis or cirrhosis who did not respond to standard disease treatment benefited from increased coffee intake. An effect on liver disease was not observed in patients who drank black or green tea. Findings of the study appear in the November issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases.

Hepatitis C virus (HCV) infects approximately 2.2% of the world’s population with more than 3 million Americans infected. The Centers for Disease Control and Prevention (CDC) cites HCV as the leading cause of liver transplantation in the U.S. and accounts for 8,000 to 10,000 deaths in the country annually. Globally, the World Health Organization (WHO) estimates 3 to 4 million persons contract HCV each year with 70% becoming chronic cases that can lead to cirrhosis of the liver and liver cancer.

This study included 766 participants enrolled in the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) trial who had hepatitis C-related bridging fibrosis or cirrhosis and failed to respond to standard treatment of the anti-viral drugs peginterferon and ribavirin. At the onset of the study, HALT-C patients were asked to report their typical frequency of coffee intake and portion size over the past year, using 9 frequency categories ranging from ‘never’ to ‘every day’ and 4 categories of portion size (1 cup, 2 cups, 3-4 cups, and 5+ cups). A similar question was asked for black and green tea intake. “This study is the first to address the association between liver disease progression related to hepatitis C and coffee intake,” stated Dr. Freedman.

Participants were seen every 3 months during the 3.8-year study period to assess clinical outcomes which included: ascites (abnormal accumulation of fluid in the abdomen), prognosis of chronic liver disease, death related to liver disease, hepatic encephalopathy (brain and nervous system damage), hepatocellular carcinoma (liver cancer), spontaneous bacterial peritonitis, variceal hemorrhage, or increase in fibrosis. Liver biopsies were also taken at 1.5 and 3.5 five years to determine the progression of liver disease.

Results showed that participants who drank 3 or more cups of coffee per day had a relative risk of .47 for reaching one of the clinical outcomes. Researchers did not observe any association between tea intake and liver disease progression, though tea consumption was low in the study. “Given the large number of people affected by HCV it is important to identify modifiable risk factors associated with the progression of liver disease,” said Dr. Freedman. “Although we cannot rule out a possible role for other factors that go along with drinking coffee, results from our study suggest that patients with high coffee intake had a lower risk of disease progression.” Results from this study should not be generalized to healthier populations cautioned the authors.

 

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For the preceding study you may also contact:
NCI Office of Media Relations
301-496-6641
ncipressofficers@mail.nih.gov

Article: “Coffee Intake Is Associated with Lower Rates of Liver Disease Progression in Chronic Hepatitis C,” Neal D. Freedman, James E. Everhart, Karen L. Lindsay , Marc G. Ghany, Teresa M. Curto, Mitchell L. Shiffman, William M. Lee, Anna S. Lok, Adrian M. Di Bisceglie, Herbert L. Bonkovsky, John C. Hoefs, Jules L. Dienstag, Chihiro Morishima, Christian C. Abnet, Rashmi Sinha1, and the HALT-C Trial Group. Hepatology; Published Online: July 13, 2009 (DOI: 10.1002/hep.23162); Print Issue Date: November 2009. http://www3.interscience.wiley.com/journal/122511224/abstract

Media Advisory

What: The 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)

Founded in 1950, AASLD is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease. AASLD has grown into an international society responsible for all aspects of hepatology, and the annual meeting attracts 7,500 physicians, surgeons, researchers, and allied health professionals from around the world.

The Liver Meeting® is the premier meeting in the science and practice of hepatology, including the latest findings on new drugs, novel treatments, and the results from pilot and multicenter studies.

When: October 31 – November 3, 2009

Where : Hynes Convention Center
900 Boylston Street
Boston, Massachusetts

Contact: Please contact Ann Tracy at 703-299-9766 or atracy@aasld.org to obtain a press pass for this event

Plastics chemical retards growth, function of adult reproductive cells : Bisphenol A

2009 study posted for filing

Contact: Diana Yates

diya@illinois.edu

217-333-5802

University of Illinois at Urbana-Champaign

CHAMPAIGN, Ill. — Bisphenol A, a chemical widely used in plastics and known to cause reproductive problems in the offspring of pregnant mice exposed to it, also has been found to retard the growth of follicles of adult mice and hinder their production of steroid hormones, researchers report.

Their study is the first to show that chronic exposure to low doses of BPA can impair the growth and function of adult reproductive cells. The researchers will describe their findings this month at the annual meeting of the Society for the Study of Reproduction.

A healthy, mature follicle, called an antral follicle, includes a single egg cell surrounded by layers of cells and fluid which support the egg and produce steroid hormones, said University of Illinois veterinary biosciences professor Jodi Flaws, who led the study with graduate student Jackye Peretz.

“These are the only follicles that are capable of ovulating and so if they don’t grow properly they’re not going to ovulate and there could be fertility issues,” Flaws said. “These follicles also make sex steroid hormones, and so if they don’t grow properly you’re not going to get proper amounts of these hormones.” Such hormones are essential for reproduction, she said, “but they’re also required for healthy bones, a healthy heart and a healthy mood.”

BPA is widely used in plastics and is a common component of food containers and baby bottles.

The chemical structure of BPA is similar to that of estradiol, a key steroid hormone, and it can bind to estrogen receptors on the surface of some cells. It is not known whether BPA blocks, or mimics or enhances estrogen’s activity on these cells, Flaws said.

Human studies have found BPA in many tissues and fluids, including urine, blood, breast milk, the amniotic fluid of pregnant women and the antral fluid of mature follicles. A national survey conducted by the federal Centers for Disease Control and Prevention in 2003-2004 found BPA in 93 percent of the 2,517 people (age 6 and up) who were tested.

BPA has a short half-life, Peretz said, and the chemical is quickly eliminated from the body. The fact that so many people tested positive “probably means that we’re being constantly exposed to BPA,” she said. The new study found that follicle growth was impaired after 48 hours of exposure to BPA, Peretz said. Reductions in three key steroid hormones – progesterone, testosterone and estradiol – were also seen after 120 hours of exposure to BPA.

The drop in steroid hormone production was quite dramatic. After 120 hours in a medium that included 10 micrograms per milliliter of BPA, mouse follicle cells produced about 85 percent less estradiol, 97 percent less progesterone and 95 percent less testosterone. Lower doses of BPA had a less dramatic – but still considerable – dampening effect on steroid hormone levels. And at 120 hours, follicle cells grown in the BPA medium were 25 percent smaller than normal, the researchers report.

A review of the health risks of BPA by the National Toxicology Program of the U.S. Department of Health and Human Services concluded in 2008 that while BPA has been shown to harm the reproductive health of laboratory animals in some studies, such adverse effects “are observed at levels of exposure that far exceed those encountered by humans.”

However, the NTP reported that laboratory studies that showed effects in animals exposed to low doses of BPA led it to have “some concern for effects on the brain, behavior and prostate gland in fetuses, infants and children at current human exposures to bisphenol A.”

The new study points to possible concerns in adults as well, Flaws said.

“I think there’s a need for more studies where people look in adult humans to see if BPA is affecting follicle growth and steroid hormone levels,” she said. If it is, that might help explain some infertility or menopausal symptoms, she said.

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Editor’s note: To reach Jodi Flaws, call 217-333-7933; e-mail jflaws@illinois.edu.

Florida governor accidentally gives out PHONE SEX number instead of meningitis hotline… as death toll rises to 12

By Daily Mail Reporter and Reuters Reporter

PUBLISHED:17:14 EST, 10  October 2012| UPDATED:17:15 EST, 10 October 2012

Oops: Florida Gov Rick Scott accidentally gave out phone sex number instead of the state's meningitis hotline
Oops: Florida Gov Rick Scott accidentally gave out phone  sex number instead of the state’s meningitis hotline

Florida Gov Rock Scott sent thousands of  Floridians to a dirty phone sex line when he accidentally gave out the wrong  number for the state’s fungal meningitis hotline.

Anyone who dialed the number Gov Scott  offered was greeted with a sultry woman saying: ‘Hello boys, thank you for  calling me on my anniversary.’

The humorous goof was one of the few bright spots in the outbreak of a disease that was confirmed to have claimed another life on Tuesday, bringing to death toll to 12.

The Centers for Disease Control says 137  people have been infected in ten states.

Gov Scott gave out the phone number at a  Florida cabinet meeting on Tuesday, public radio station WUSFreported.

‘You can call the Department of Health’s  toll-free, 24 hour hotline set up in response to this,’ he said, reading off a  number.

Listeners quickly called in to the station  reporting that calls to that ‘hotline’ hadn’t been quite what they expected.

The correct number, 866-523-7339, had been  posted on the state’s website. Gov Scott’s office said he simply misspoke.

The toll of the outbreak, which was tied to  contaminated steroid shots, is expected to rise even higher.

On Tuesday, four more deaths were reported  and Florida became the latest state to report at least one death linked to the  illness in a widening health scare.

Since the September 25 recall of three lots  of a steroid produced by a Massachusetts company, the outbreak has spread to 10  states and infected 137 people, according to state health departments and the  Centers for Disease Control and Prevention.

Spreading: Meningitis cases have now been reported in ten states throughout the South and Midwest

 

Spreading: Meningitis cases have now been reported in  ten states — though Tennessee still bears the brunt of the infection

Leading U.S. House and Senate lawmakers from  both parties on Tuesday asked federal health officials for briefings on the  outbreak as a first step toward possible legislative action to strengthen  federal drug safety regulations.

Oversight committees in both the Senate and  House hope to learn more about the outbreak before October 12 from staff members  of the Food and Drug Administration and the CDC, aides said.

In five states — Tennessee, Michigan,  Maryland, Virginia, and Florida — the outbreak has claimed lives, with the  latest victim a 70-year-old man in Florida.

As many as 13,000 people received the  injections to relieve back pain and other complaints and are at risk of  infection, the CDC said.

The number ultimately stricken is likely to  be far fewer.

For the first time on Tuesday, Tennessee  state health officials gave an estimate of the rate of infection among those  patients who received injections from the recalled steroid supplies.

Approximately 5 percent of patients treated  with the suspect medication in Tennessee have contracted meningitis, said Dr  David Reagan, chief medical officer for the Tennessee Department of  Health.

‘We expect that most people who were exposed  to this will not develop a fungal infection,’ Reagan said.

The rate of infection overall is not  known.

Meningitis is an infection of the membranes  covering the brain and spinal cord. Symptoms include headache, fever and nausea.  Fungal meningitis, unlike viral and bacterial meningitis, is not  contagious.

The outbreak has highlighted a gap in  regulation of so-called pharmacy compounders, which are facilities that take  drug ingredients and package them into medications and dosages for specific  clients.

The federal Food and Drug Administration  regulates only the ingredients and not the compounders, which are subject to a  patchwork of state oversight.

Contaminated: These vials of steroids from the New England Compounding Center are among thousands that are thought to be the source of the fungal infections
Contaminated: These vials of steroids from the New  England Compounding Center are among thousands that are thought to be the source  of the fungal infections

George Cary, whose wife Lilian Cary is one of  three women to die in the outbreak from Michigan, said Tuesday that Americans  have a strong belief in their medical and political system and the outbreak  should be a wake-up call to the nation.

‘We don’t have expectations of a faulty  regulatory medical system that allows these types of mistakes to be made,’ Cary  told reporters on his front lawn after a memorial for his wife. ‘So perhaps the  message is, wake up America.’

Some of the thousands of people exposed may  have to wait anxiously for weeks because the incubation period of the disease is  up to a month, health experts said.

In Tennessee cases, officials said they have  found the average incubation period to be 16 days, but they caution that it  could range from six to 42 days for their patients.

Tennessee health officials believe they could  still see new cases into the early part of November, though that could change as  more information is collected, officials said.

The potentially tainted steroid vials, which  have been recalled, were shipped to 76 facilities in 23 states, the CDC has  said.

Tennessee has been the hardest hit state,  with six reported deaths and 44 cases of meningitis, followed by Michigan with  three deaths and 28 cases, Virginia with one death and 27 cases and Maryland  with one death and nine cases.

The other states with cases are Indiana (15),  Florida (6), Minnesota (3), North Carolina (2), New Jersey (2) and Ohio  (1)

Read more: http://www.dailymail.co.uk/news/article-2215879/Fungal-meningitis-outbreak-Florida-Gov-Rick-Scott-gives-phone-sex-line-mistake.html#ixzz28xS3Sg2C Follow us: @MailOnline on Twitter | DailyMail on Facebook

Recession pushes US birth rates to an all-time low

 

It’s looking like a bad time to invest in the diaper industry. Birth rates in the US reached an all-time low in 2011.

US fertility has been declining steadily since 2008, according to a report published last week by the US Centers for Disease Control and Prevention’s  National Center for Health Statistics (NCHS). The report was compiled from birth certificates registered across the US.

In 2008, the average number of children per woman was 2.1, roughly the figure needed to replace each parent and keep the population stable. In 2011, this figure dropped to 1.9.

“It’s not necessarily worrisome,” says Mark Mather of the Population Reference Bureau in Washington, DC. “But if we were to see a sustained drop over five to 10 years, that may be a concern.”

The falling fertility rate is tightly tied to the economic downturn during the past four years, Mather says. Couples are putting off having children, and women’s salaries have become more important to household income, he says.

Rebound effect?

If the economy bounced back, birth rates would probably increase, says Mather. But it is not clear whether that would be the case for long. It might be counterbalanced by the long-term increase in the number of women entering college and the workforce who are subsequently delaying having children or having fewer of them.

The report found that the number of women giving birth in their 30s increased by 3 per cent in 2011 compared with 2010. Women in their 40s also had more children than in 2010. “If you’re younger and the economy isn’t good, you have the option to delay having a child,” says Brady Hamilton, a co-author of the report, based at the NCHS headquarters in Hyattsville, Maryland. “For older women, that’s not a viable option.”

The US fertility rate is still far higher than those of most European countries: Germany, for instance, averages 1.36 children per woman. And the welfare problems caused by having an ageing population aren’t yet as urgent as they are in Japan, say, where nearly a quarter of the population is older than 65, Mather says

http://www.newscientist.com/article/dn22351-recession-pushes-us-birth-rates-to-an-alltime-low.html

 

 

Rochester study raises new questions about controversial plastics chemical: BPA metabolizes 8x slower than expected

2009 study posted for filing

Contact: Leslie Orr
Leslie_orr@urmc.rochester.edu
585-275-5774
University of Rochester Medical Center

A University of Rochester Medical Center study challenges common assumptions about the chemical bisphenol A (BPA), by showing that in some people, surprisingly high levels remain in the body even after fasting for as long as 24 hours. The finding suggests that BPA exposure may come from non-food sources, or that BPA is not rapidly metabolized, or both.

The journal Environmental Health Perspectives published the research online January 28, 2009.

Controversy around BPA is mounting. In December the U.S. Food and Drug Administration agreed to reconsider the health risks of the chemical, which is used to make plastic baby bottles, water bottles and many other consumer products. Scientific studies suggest that BPA may harm the brain and prostate glands in developing fetuses and infants; adults with higher BPA levels in their urine were linked to higher risks for heart disease and diabetes, according to a study published last September in the Journal of the American Medical Association.

The latest finding from Rochester is important because, until now, scientists believed that BPA was excreted quickly and that people were exposed to BPA primarily through food. Indeed, the FDA and the European Food Safety Authority have declared BPA safe based, in part, on those assumptions.

“Our results simply do not fit that picture,” said lead author Richard W. Stahlhut, M.D., M.P.H., of the University of Rochester’s Environmental Health Sciences Center. “The research community has clues that could help explain some of these results but to date the importance of the clues have been underestimated. We must chase them much more vigorously now.”

Manufacturers use BPA to harden plastics in many types of products. In addition to plastic bottles, BPA is used in PVC water pipes and food storage containers. BPA also coats the inside of metal food cans, and is used in dental sealants.

Stahlhut and colleagues obtained data for a sample of 1,469 American adults through the Center for Disease Control’s National Health and Nutrition Examination Survey (NHANES). The researchers sought to explore the link between BPA urine concentration and the length of time a person had been fasting.

Accepting the widely held assumption that food is the most common route of exposure to BPA, Stahlhut expected to see a relationship between the last food ingested, fasting time, and BPA levels. People who had fasted longest (15 to 24 hours), for example, should have had much lower BPA levels than people who had eaten more recently, Stahlhut said.

Instead, those who fasted had levels that were only moderately lower than people who had just eaten. This is significant because scientists expected BPA levels to decrease by about half, every five hours.

“In our data, BPA levels appear to drop about eight times more slowly than expected – so slowly, in fact, that race and sex together have as big an influence on BPA levels as fasting time,” Stahlhut said.

According to the authors, two possible explanations may exist for the higher-than-expected levels of BPA in people who fasted. One is that exposure to BPA might come through other means, such as house dust or tap water.

In addition, Stahlhut theorizes that BPA may seep into fat tissues, where it would be released more slowly. However, further study is needed to evaluate the effects of BPA on adipose tissue hormones and function, Stahlhut said, as well as more studies to compare BPA levels in fat versus blood and urine.

The Centers for Disease Control estimates that 93 percent of Americans have detectable levels of BPA in their urine.

The latest data also supports the idea that individuals might be re-exposed throughout the course of a day, Stahlhut said. In 2000 another research group found that BPA can migrate from PVC pipes or hoses into room temperature water, producing another potential route of exposure.

 

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The University of Rochester School of Medicine and Dentistry, and the National Institute of Environmental Health Sciences Training Grant, funded the research.

Study: Exposure to herbicide may increase risk of rare disorder: atrazine / choanal atresia

Contact: Dana Benson
benson@bcm.edu
713-798-4710
Baylor College of Medicine

HOUSTON – (Sept. 28, 2012) – A common herbicide used in the United States may be linked to an increased risk of a congenital abnormality of the nasal cavity known as choanal atresia, say researchers at Baylor College of Medicine and other Texas institutions.

The study by Dr. Philip Lupo, assistant professor of pediatrics – hematology/oncology at BCM and Texas Children’s Cancer Center, is scheduled for publication in The Journal of Pediatrics.

Choanal atresia is a disorder where the back of the nasal passage is blocked by tissue formed during fetal development. It is a rare condition but can be serious because it affects a baby’s ability to breath. It is typically treated through surgery.

Very few risk factors for choanal atresia have been identified, however chemicals that disrupt the maternal endocrine system may be associated with risk, according to Lupo. The study focused on atrazine, which is the most commonly used herbicide in the U.S. – especially in corn crops – and is believed to be an endocrine disrupter.

“Endocrine disrupters aren’t fully understood, but it is believed they interfere with or mimic certain hormones, thereby blocking their proper function and potentially leading to adverse outcomes,” Lupo said.

The study found that mothers who lived in Texas counties with the highest levels of estimated atrazine application were 80 percent more likely to have children with choanal atresia or stenosis compared to women who lived in the counties with the lowest levels. Choanal stenosis is a less severe form of the condition.

Data for the study was collected from the Texas Birth Defects Registry.

“Our results warrant more detailed exploration before any public health or policy-related recommendations are made,” Lupo said, “but this study is a good first step in trying to understand the origin of this birth defect, including a possible role of atrazine.”

 

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The study was funded in part by the Centers for Disease Control and Prevention-funded Texas Center for Birth Defects Research and Prevention through a cooperative agreement with Texas Department of State Health Services as well as the Title V Office of Texas DSHS. Others involved in the research included A. J. Agopian, Yi Cai, Peter H. Langlois, and Mark A. Canfield.

Rutgers College of Nursing Professor’s Research Links Increased Hospital Infections to Nurse Burnout

By Ferlanda Fox Nixon

September 27, 2012


According to the Centers for Disease Control and Prevention, each year nearly 100,000 hospitalized patients die from infections acquired while undergoing treatment for other conditions. While many factors may contribute to the phenomenon, nurse staffing (i.e., the number of patients assigned to a nurse) has been implicated as a major cause.

A recent study by Dr. Jeannie P. Cimiotti of Rutgers College of Nursing and co-researchers concludes that the degree of “burnout” experienced by nurses could relate directly to the frequency with which patients acquire infections during hospital stays. Focusing exclusively on urinary tract and surgical site infections, the researchers found that while a significant correlation existed between the occurrence of such infections and the number of patients assigned to nurses, nurse staffing became less of a factor after accounting for nurse burnout.

From a sample of 161 acute care hospitals in Pennsylvania and an average of 45 nurses working at each sampled hospital, Cimiotti and her team measured nurse burnout using the Maslach Burnout Inventory-Human Services Survey. According to Maslach’s theory, a critical component of burnout in nurses and other health care professionals is “emotional exhaustion.” Emotional exhaustion is associated with emotional and cognitive detachment from work as a mechanism for coping with the demands and responsibilities of the job.

“We hypothesize that the cognitive detachment associated with high levels of burnout may result in inadequate hand hygiene practices and lapses in other infection control procedures among registered nurses,” the researchers suggest. The researchers found that every 10 percent increase in burned-out nurses in an acute care hospital increases the rate of urinary tract infections by nearly one per 1,000 patients and increases the rate of surgical site infections by more than two per 1,000 patients.

“These findings are both statistically and clinically significant,” the researchers posit. “If the proportion of nurses with high burnout could be reduced to 10 percent from the average 30 percent, some 4,160 infections would be prevented …, leading to an estimated savings of $41 million.” Not to mention the saving of many lives.

To reduce nurse burnout, the researchers recommend the implementation of organizational changes that effectively build job engagement. Examples include educational interventions, performance feedback, and social support.

This study is quite significant since in represents the first time nurse burnout has been associated with secondary infections. Since its publication in the American Journal of Infection Control (AJIC), AJIC’s media tracker has traced more than 42 stories and 223 million impressions to the publication. Articles citing the study have appeared in USA Today, Daily Mail, NBCNews.com, The Philadelphia Inquirer, HealthLeaders Media, WTOP-FM, HealthDay, and Nurse.com, among others.

In addition to Cimiotti, the research team included Drs. Linda H. Aiken, Douglas M. Sloane, and Evan S. Wu, each from the Center for Health Outcomes and Policy Research at the University of Pennsylvania School of Nursing. The research was supported by funding from the National Institute of Nursing Research–National Institutes of Health.

Cimiotti is an associate professor at Rutgers College of Nursing and the executive director of the New Jersey Collaborating Center for Nursing. She came to Rutgers in 2011 from the University of Pennsylvania where she served as a senior fellow at the Leonard Davis Institute of Health Economics and a member of the research team at the Center for Health Outcomes and Policy Research. Clinically trained as a pediatric nurse, Cimiotti’s research interests focus on nurse workforce factors and the quality of patient care in the hospital setting for adult and pediatric clients. Of her many degrees, Cimiotti received her doctor of nursing science from Columbia University, her master of science in nursing from Rutgers University, Newark, and her bachelor of science in nursing from the University of the State of New York in Albany.

ABOUT THE COLLEGE OF NURSING AT RUTGERS UNIVERSITY

The Rutgers College of Nursing is recognized as one of the finest nursing schools in the nation. Formed in 1956, the college is accredited by the Commission on Collegiate Nursing Education and has campuses in Newark and New Brunswick. It offers generic, accelerated and baccalaureate programs ranging from bachelor of science to doctoral degrees (doctor of nursing practice and doctor of philosophy). Faculty and students participate in many federally funded research programs aimed at promoting healthy living among the state’s diverse populations, and improving the practice of nursing nationally. For more information about the Rutgers College of Nursing and its programs, visit https://nursing.rutgers.edu.

No significant influenza (FLU) vaccine effectiveness could be demonstrated for any season, age or setting after adjusting for county, sex, insurance, chronic conditions recommended for influenza vaccination and timing of influenza vaccination

2008 study posted for filing

Contact: Heather Hare
585-273-2840
JAMA and Archives Journals

Use of the influenza vaccine was not associated with preventing hospitalizations or reducing physician visits for the flu in children age 5 and younger during two recent seasons, perhaps because the strains of virus in the vaccine did not match circulating strains, according to a report in the October issue of Archives of Pediatrics & Adolescent Medicine, one of the JAMA/Archives journals.

Influenza causes substantial illness among young children; therefore, the United States and other countries have expanded their childhood vaccination requirements, according to background information in the article. As of June 2006, U.S. health officials recommend annual vaccinations for all children age 6 to 59 months. “An inherent assumption of expanded vaccination recommendations is that the vaccine is efficacious in preventing clinical influenza disease,” the authors write.

Peter G. Szilagyi, M.D., M.P.H., of the University of Rochester School of Medicine and Dentistry and Strong Memorial Hospital, Rochester, N.Y., and colleagues studied 414 children age 5 and younger who developed influenza during the 2003-2004 or 2004-2005 seasons (245 seen in hospitals or emergency departments, and 169 seen in outpatient practices). Their vaccination status was compared with that of more than 5,000 children from the same three counties who did not have influenza during those seasons.

Before the researchers considered any other factors, children with influenza appeared to have lower vaccination rates than children without influenza. “However, significant influenza vaccine effectiveness could not be demonstrated for any season, age or setting after adjusting for county, sex, insurance, chronic conditions recommended for influenza vaccination and timing of influenza vaccination (vaccine effectiveness estimates ranged from 7 percent to 52 percent across settings and seasons for fully vaccinated 6- to 59-month olds),” the authors write.

A suboptimal match between the strain of influenza in the vaccine and that circulating in the public during those two seasons may have contributed to the poor effectiveness, the authors note. In 2003-2004, 99 percent of circulating influenza strains were caused by the influenza A virus, but only 11 percent of influenza A strains across the United States were similar to those in the vaccine. “The 2004-2005 season was less severe and the vaccine was a better match to circulating strains than in 2003-2004, but still only 36 percent of virus isolates were antigenically similar to vaccine strains,” they write.

This study comparing cases with controls adds important information about vaccine effectiveness in children but should be combined with additional research, including studies of years with good vaccine match, they conclude. “Further studies of influenza vaccine effectiveness are needed using a variety of study designs (that adjust for confounders) to assess the yearly impact of influenza vaccination programs for children, particularly as higher rates of vaccination are achieved in the study population,” the authors write.

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(Arch Pediatr Adolesc Med. 2008;162[10]:943-951. Available pre-embargo to the media at www.jamamedia.org.)

Editor’s Note: This work was funded by the Centers for Disease Control and Prevention as part of the New Vaccine Surveillance Network and the National Vaccine Program Office, and some subjects in Cincinnati were recruited through a study funded by QuickVue Influenza Test (Quidel Corp., San Diego, Calif.). Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc

Survivors of 1918 flu pandemic protected with a lifetime immunity to virus

Contact: Mount Sinai Newsroom
newsmedia@mssm.edu
212-241-9200
The Mount Sinai Hospital / Mount Sinai School of Medicine

New research has discovered that infection and natural exposure to the 1918 influenza virus made survivors immune to the disease for the remaining of their lives. Antibodies produced by cells isolated from these survivors served as an effective therapy to protect mice from the highly lethal 1918 infection. The study entitled “Neutralizing antibodies derived from the B cells of 1918 influenza pandemic survivors,” was released for advanced online publication by the journal Nature. Researchers at Mount Sinai School of Medicine’s Department of Microbiology contributed to the research findings. An estimated 50 million people were killed by the 1918 flu pandemic worldwide.

“Ninety years after survivors encountered the 1918 pandemic influenza virus, we collected antibody-producing B cells from them, and successfully isolated B cells that produce antibodies that block the viral infection,” said contributing author Dr. Christopher Basler, PhD, Associate Professor of Microbiology at Mount Sinai School of Medicine. “The antibodies produced by these cells demonstrated remarkable power to block 1918 flu virus infection in mice, proving that, even nine decades after infection with this virus, survivors retain protection from it.”

“The fact that you can isolate these anti-1918 memory B cells so long after infection will hopefully provide the impetus to further study the mechanisms behind long lived immunity,” said Dr. Osvaldo Martinez, post-doctoral fellow at Mount Sinai School of Medicine.

For this study, 32 individuals who were born before 1918 and lived through the influenza pandemic were recruited by Dr. Eric Altschuler at the University of Medicine and Dentistry of New Jersey to donate blood which was tested by Dr. Basler’s lab for the presence of antibodies that recognize the 1918 virus. Dr. James Crowe and colleagues at Vanderbilt University produced antibodies from these individuals’ blood cells and provided these to Dr. Basler’s lab where the potent neutralizing activity against 1918 virus was demonstrated. Antibodies were also provided to Dr. Terrence Tumpey at the CDC to test in mice the strength of the antibodies derived from the 1918 survivors.

“Our findings show that survivors of the pandemic have highly effective, virus neutralizing antibodies to this powerful virus, and humans can sustain circulating B memory cells to viruses for up to 9 decades after exposure,” said Dr. Tshidi Tsibane, post-doctoral fellow, Department of Microbiology, Mount Sinai School of Medicine. “These findings could serve as potential therapy for another 1918-like virus.”

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Vanderbilt University, Mount Sinai School of Medicine, University of Medicine and Dentistry of New Jersey, Centers for Disease Control and Prevention and The Scripps Research Institute collaborated on this research study.

About The Mount Sinai Medical Center The Mount Sinai Medical Center encompasses The Mount Sinai Hospital and Mount Sinai School of Medicine. The Mount Sinai Hospital is one of the nation’s oldest, largest and most-respected voluntary hospitals. Founded in 1852, Mount Sinai today is a 1,171-bed tertiary-care teaching facility that is internationally acclaimed for excellence in clinical care. Last year, nearly 50,000 people were treated at Mount Sinai as inpatients, and there were nearly 450,000 outpatient visits to the Medical Center.

Mount Sinai School of Medicine is internationally recognized as a leader in groundbreaking clinical and basic-science research, as well as having an innovative approach to medical education. With a faculty of more than 3,400 in 38 clinical and basic science departments and centers, Mount Sinai ranks among the top 20 medical schools in receipt of National Institute of Health (NIH) grants

Flu Vaccine offers no Protection in seniors

Respost 2008

Contact: Rebecca Hughes hughes.r@ghc.org 206-287-2055 Group Health Research Institute

Flu vaccine may not protect seniors well

Group Health study in Lancet finds no less risk of pneumonia with vaccine

SEATTLE—A Group Health study in the August 2 issue of The Lancet adds fuel to the growing controversy over how well the flu vaccine protects the elderly.

The study of more than 3,500 Group Health patients age 65󈟊 found no link between flu vaccination and risk of pneumonia during three flu seasons. “This suggests that the flu vaccine doesn’t protect seniors as much as has been thought,” said Michael L. Jackson, PhD, MPH, a postdoctoral fellow at the Group Health Center for Health Studies.

“Ours is by far the largest case-control study of flu vaccine in the elderly,” Jackson added. This kind of study compares “cases” with “controls.” The cases were patients with “community-acquired” pneumonia treated in a hospital or elsewhere. The controls were people matched to cases by sex and age, but with no pneumonia. Both groups were found to have similar rates of flu vaccination. All had intact immune systems and none lived in a nursing home.

Jackson and his colleagues carefully reviewed medical records to reveal details of seniors’ health and ability to do daily activities. “We tried to overcome the limits of previous studies done by others,” he explained. “Those studies may have overestimated the benefits of the flu vaccine in the elderly for various reasons.” For instance, those studies looked only at pneumonia cases treated in a hospital. They also included seniors who had immune problems, which limit potential benefit from vaccination. And they didn’t review medical records to get information on chronic diseases, such as heart or lung disease, which raise the risk of pneumonia.

Most importantly, those previous studies also failed to account for differences between healthier seniors and those who were “frail,” Jackson said. Frail seniors are older and have chronic  diseases and difficulty walking. “They are less likely than younger, healthier seniors to go out and get vaccinated—and more apt to develop pneumonia,” he said.

Pneumonia is a common and potentially life-threatening complication of the flu, Jackson said. But pneumonia can happen without the flu. “That’s why our study used a control time period, after flu vaccine became available but before each flu season actually started,” he said. During those pre-flu-season periods, people who had been vaccinated were much less likely to get pneumonia. Why? “Because those who got the vaccine happened to be healthier—not because the flu vaccine was protecting them from pneumonia caused by the flu, since it wasn’t present yet,” he explained.

“Despite our findings, and even though immune responses are known to decline with age, I still want my grandmother to keep getting the flu vaccine,” said Jackson. “The flu vaccine is safe. So it seems worth getting, even if it might lower the risk of pneumonia and death only slightly.”

His co-author Lisa A. Jackson, MD, MPH (no relation), a senior investigator at the Group Health Center for Health Studies, agreed. “People age 65 and older should still get yearly flu vaccines as usual,” she advised. But she said that researchers should work to understand better how well the current flu vaccines work in seniors—and to explore other options for controlling flu in the “old old.” Examples include bigger doses or stronger types of vaccines, and conducting randomized controlled trials comparing them.

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Other co-authors are Group Health’s Jennifer C. Nelson, PhD and William Barlow, PhD; Noel S. Weiss, MD, DrPH of the Fred Hutchinson Cancer Research Center and University of Washington; and Kathleen M. Neuzil, MD, MPH, of the Program for Appropriate Technology in Health (PATH), University of Washington, and the Group Health Center for Health Studies, all in Seattle.

A fellowship grant from the Group Health Foundation and internal funds from the Group Health Center for Health Studies funded this study.

Group Health Center for Health Studies

Founded in 1947, Group Health Cooperative is a Seattle-based, consumer-governed, nonprofit health care system that coordinates care and coverage. For 25 years, the Group Health Center for Health Studies has conducted research on preventing, diagnosing, and treating major health problems. Government and private research grants provide its main funding.

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