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

2010 study posted for filing

Contact: Laura Gallagher l.gallagher@imperial.ac.uk 44-020-759-48432 Imperial College London

Polio research gives new insight into tackling vaccine-derived poliovirus

A vaccine-derived strain of poliovirus that has spread in recent years is serious but it can be tackled with an existing vaccine, according to a new study published today in the New England Journal of Medicine.

Vaccine-derived polioviruses can emerge on rare occasions in under-immunised populations, when the attenuated virus contained in a vaccine mutates and recombines with other viruses, to create a circulating vaccine-derived strain.

The researchers behind today’s study say their findings highlight the importance of completing polio eradication. They also say that should wild-type poliovirus be eradicated, routine vaccination with oral polio vaccines will need to cease, in order to prevent further vaccine-derived strains of the virus from emerging.

The study was carried out by researchers from the Medical Research Council Centre for Outbreak Analysis and Modelling at Imperial College London, working with the Government of Nigeria and the World Health Organization (WHO) research teams.

Poliovirus is highly infectious and primarily affects children under five years of age. Around one in 200 of the people infected with polio develop permanent paralysis, which can be fatal.

Polio was virtually wiped out by the early 2000s following a major vaccination drive by the Global Polio Eradication Initiative, but since then the number of cases of paralysis reported has plateaued, remaining roughly constant at between one and two thousand each year from 2003 to 2009, dropping only recently in 2010.

The first reported polio outbreak resulting from a circulating vaccine-derived poliovirus, known as a cVDPV, occurred in Hispaniola in 2000.  Prior to today’s study, there was little evidence available about the severity and potential impact of this kind of poliovirus.

Although billions of doses of oral vaccine have been distributed in the last decade, just 14 cVDPV outbreaks have been reported, affecting 15 countries. These outbreaks have usually been limited in size.

For the new study, researchers looked at the largest recorded outbreak of a cVDPV to date, which began to circulate in Nigeria in 2005. The authors examined data from 278 children paralysed by this cVDPV, and compared them with children paralysed by wild-type poliovirus in the country. Their analysis showed that this serotype 2 cVDPV is as easily transmitted and likely to cause severe disease as wild-type poliovirus of the same serotype.

The study also shows that vaccination with trivalent OPV, one of the main types of vaccine currently used to combat polio, is highly effective in preventing paralysis by this serotype 2 cVDPV.

The research shows that it is even more effective against cVDPV than against the wild-type polioviruses that are currently circulating, which can also be targeted with a different vaccine.

The new findings mean that it is particularly vital that efforts to vaccinate children with trivalent OPV continue in Nigeria and neighbouring countries, to protect children against all strains of polio. The scientists hope their findings will help countries to devise the right vaccine strategies to eradicate polio.

Helen Jenkins, the lead author of the study from the Medical Research Council Centre for Outbreak Analysis and Modelling at Imperial College London, said: “Our research shows that vaccine-derived polioviruses must be taken seriously and that we have the right tools to tackle them. We’ve had a lot of success against polio in the past and we’re optimistic that ultimately we should be able to eradicate it completely.

“However, our study shows that we can’t be complacent about the virus. It’s still vital for us to protect children from this dangerous and debilitating disease and we have to make sure we continue to vaccinate as many children as possible in affected countries for as long as wild-type poliovirus continues to circulate,” added Ms Jenkins.

Senior study author Dr Nicholas Grassly, also from the Medical Research Council Centre for Outbreak Analysis and Modelling at Imperial College London, added: “There has been some debate about the significance of circulating vaccine-derived polioviruses for the eradication initiative. Our research shows these viruses can be as pathogenic and transmissible as wild-type polioviruses and outbreaks must be responded to with just as much vigour.”

Dr Bruce Aylward, Director of the Global Polio Eradication Initiative at WHO, added:  “These new findings suggest that if cVDPVs are allowed to circulate for a long enough time, eventually they can regain a similar capacity to spread and paralyse as wild polioviruses.  This means that they should be subject to the same outbreak response measures as wild polioviruses.  These results also underscore the need to eventually stop all OPV use in routine immunization programmes after wild polioviruses have been eradicated, to ensure that all children are protected from all possible risks of polio in future.”

###

This study was funded by the Medical Research Council and the Royal Society.

For further information please contact:

Laura Gallagher Research Media Relations Manager Imperial College London email: l.gallagher@imperial.ac.uk Tel: +44(0)20 7594 8432 Out of hours duty press officer: +44(0)7803 886 248

Notes to editors:

1. “Implications of a circulating vaccine-derived poliovirus (cVDPV) in Nigeria for polio eradication” New England Journal of Medicine, Wednesday 23 June 2010

Lead author: Helen Jenkins, Imperial College London (for full list of authors please see paper) Download a proof copy of the study (strictly embargoed) using this link:  https://fileexchange.imperial.ac.uk/files/3eba66aa7b6/Nigeria%20cVDPV%20paper%20R2%20clean.doc

2. About the Global Polio Eradication Initiative (GPEI)

The GPEI is spearheaded by national governments, WHO, Rotary International, the US Centers for Disease Control and Prevention (CDC) and UNICEF. Since 1988 (the year the GPEI was launched), the incidence of polio has been reduced by more than 99%. In 1988, more than 350,000 children were paralyzed each year in more than 125 endemic countries. In 2010, 349 cases have been reported and four countries remain endemic: Nigeria, India, Pakistan and Afghanistan.

Further information can be found at www.polioeradication.org. A list of countries in which there have been cases of polio reported since 2009 can be found at http://www.polioeradication.org/casecount.asp

3. About Imperial College London

Consistently rated amongst the world’s best universities, Imperial College London is a science-based institution with a reputation for excellence in teaching and research that attracts 14,000 students and 6,000 staff of the highest international quality. Innovative research at the College explores the interface between science, medicine, engineering and business, delivering practical solutions that improve quality of life and the environment – underpinned by a dynamic enterprise culture.

Since its foundation in 1907, Imperial’s contributions to society have included the discovery of penicillin, the development of holography and the foundations of fibre optics. This commitment to the application of research for the benefit of all continues today, with current focuses including interdisciplinary collaborations to improve global health, tackle climate change, develop sustainable sources of energy and address security challenges.

In 2007, Imperial College London and Imperial College Healthcare NHS Trust formed the UK’s first Academic Health Science Centre. This unique partnership aims to improve the quality of life of patients and populations by taking new discoveries and translating them into new therapies as quickly as possible.

Website: www.imperial.ac.uk

4. For almost 100 years the Medical Research Council has improved the health of people in the UK and around the world by supporting the highest quality science. The MRC invests in world-class scientists. It has produced 29 Nobel Prize winners and sustains a flourishing environment for internationally recognised research. The MRC focuses on making an impact and provides the financial muscle and scientific expertise behind medical breakthroughs, including one of the first antibiotics penicillin, the structure of DNA and the lethal link between smoking and cancer. Today MRC funded scientists tackle research into the major health challenges of the 21st century. www.mrc.ac.uk

Early life exposure to BPA may affect testis function in adulthood

2010  study posted for filing

Contact: Aaron Lohr alohr@endo-society.org 240-482-1380 The Endocrine Society

Exposure to environmental levels of the industrial chemical bisphenol A, or BPA, in the womb and early life may cause long-lasting harm to testicular function, according to a new study conducted in animals. The results are being presented Monday at The Endocrine Society’s 92nd Annual Meeting in San Diego.

“We are seeing changes in the testis function of rats after exposure to BPA levels that are lower than what the Food and Drug Administration and Environmental Protection Agency consider safe exposure levels for humans,” said Benson Akingbemi, PhD, the study’s lead author and an associate professor at Auburn (Ala.) University. “This is concerning because large segments of the population, including pregnant and nursing mothers, are exposed to this chemical.”

Many hard plastic bottles and canned food liners contain BPA, as do some dental sealants. BPA acts in a similar manner as the female sex hormone estrogen and has been linked to female infertility. This chemical is present in placenta and is able to pass from a mother into her breast milk. In their study of the male, Akingbemi and colleagues saw harmful effects of BPA at the cellular level, specifically in Leydig cells. These cells in the testis secrete testosterone, the main sex hormone that supports male fertility. After birth, Leydig cells gradually acquire the capacity for testosterone secretion, Akingbemi explained.

The process of testosterone secretion was decreased in male offspring of female rats that received BPA during pregnancy and while nursing. The mothers were fed BPA in olive oil at a dose of either 2.5 or 25 micrograms of BPA per kilogram of body weight. Akingbemi said this is below the daily upper limit of safe exposure for humans, which federal guidelines currently put at 50 micrograms per kilogram of body weight. A control group of pregnant rats received olive oil without BPA. Male offspring, after weaning at 21 days of age, received no further exposure to BPA.

Using a combination of analytical methods, the investigators studied the development of Leydig cells in male offspring. The capacity for testosterone secretion was assessed at 21, 35 and 90 days of age. The amount of testosterone secreted per Leydig cell was found to be much lower in male offspring after early-life exposure to BPA than in offspring from control unexposed animals.

“Although BPA exposure stopped at 21 days of age, BPA’s effects on Leydig cells, which were seen immediately at the end of exposure and at 35 days, remained apparent until 90 days of age, when the rats reached adulthood,” Akingbemi said. “Therefore, the early life period is a sensitive window of exposure to BPA and exposure at this time may affect testis function into adulthood.”

###

Funding from this study came in part from the Graduate Research Scholars Program of Alabama EPSCoR (Experimental Program to Stimulate Competitive Research), Tuscaloosa, Ala., and the National Institute of Environmental Health Sciences.

Blueberry ameliorates hepatic fibrosis

2010 study posted for filing

Contact: Ye-Ru Wang wjg@wjgnet.com 86-105-908-0039 World Journal of Gastroenterology

Conventional drugs used in the treatment of liver diseases inevitably have side effects. An increasing number of natural substances have been studied to explore if they have protective effects on the liver. Blueberries have unique effects on human retinal, brain and tumor cells, but reports about the effects of blueberries on liver diseases are lacking.

A research article to be published on June 7, 2010 in the World Journal of Gastroenterology addresses this question. The research team led by Ming-Liang Cheng, MD, from Department of Infectious Diseases, Guiyang Medical College, Guiyang, presented some data from their research on the effectiveness of blueberries on liver fibrosis induced in laboratory animals.

Their study showed that blueberries could reduce liver indices, serum levels of hyaluronic acid and alanine aminotransferase, and increase levels of superoxide dismutase and decrease levels of malondialdehyde in liver homogenates compared with the model group. Meanwhile, the stage of hepatic fibrosis was significantly weakened. Blueberries increased the activity of glutathione-S-transferase in liver homogenates and the expression of Nrf2 and Nqo1 compared with the normal group, but there was no significant difference compared with the model group.

The authors suggest that blueberry consumption is beneficial for hepatic diseases (including fibrosis).

###

Reference: Wang YP, Cheng ML, Zhang BF, Mu M, Wu J. Effects of blueberry on hepatic fibrosis and transcription factor Nrf2 in rats. World J Gastroenterol 2010; 16(21): 2657-2663  http://www.wjgnet.com/1007-9327/full/v16/i21/2657.htm

Correspondence to: Ming-Liang Cheng, MD, Department of Infectious Diseases, Guiyang Medical College, Guiyang 550004, Guizhou Province, China. chengml@21cn.com Telephone: +86-851-6752795 Fax: +86-851-6741623

About World Journal of Gastroenterology

World Journal of Gastroenterology (WJG), a leading international journal in gastroenterology and hepatology, has established a reputation for publishing first class research on esophageal cancer, gastric cancer, liver cancer, viral hepatitis, colorectal cancer, and H pylori infection and provides a forum for both clinicians and scientists. WJG has been indexed and abstracted in Current Contents/Clinical Medicine, Science Citation Index Expanded (also known as SciSearch) and Journal Citation Reports/Science Edition, Index Medicus, MEDLINE and PubMed, Chemical Abstracts, EMBASE/Excerpta Medica, Abstracts Journals, Nature Clinical Practice Gastroenterology and Hepatology, CAB Abstracts and Global Health. ISI JCR 2008 IF: 2.081. WJG is a weekly journal published by WJG Press. The publication dates are the 7th, 14th, 21st, and 28th day of every month. WJG is supported by The National Natural Science Foundation of China, No. 30224801 and No. 30424812, and was founded with the name of China National Journal of New Gastroenterology on October 1, 1995, and renamed WJG on January 25, 1998.

Higher levels of vitamin B6, common amino acid associated with lower risk of lung cancer

2010 study posted for filing

Contact: Paul Brennan, Ph.D. Brennan@iarc.fr JAMA and Archives Journals

This release is available in Chinese.

An analysis that included nearly 400,000 participants finds that those with higher blood levels of vitamin B6 and the essential amino acid methionine (found in most protein) had an associated lower risk of lung cancer, including participants who were current or former smokers, according to a study in the June 16 issue of JAMA.

Previous research has suggested that defi­ciencies in B vitamins may increase the probability of DNA damage and subse­quent gene mutations. “Given their involvement in maintaining DNA integrity and gene ex­pression, these nutrients have a potentially important role in inhibiting cancer devel­opment, and offer the possibility of modi­fying cancer risk through dietary changes,” the authors write. They add that deficiencies in nutrient levels of B vitamins have been shown to be high in many western populations.

Paul Brennan, Ph.D., of the International Agency for Re­search on Cancer, Lyon, France, and colleagues conducted an investigation of B vitamins and me­thionine status based on serum samples from the European Prospective Inves­tigation into Cancer and Nutrition (EPIC) cohort study, which recruited 519,978 participants from 10 European countries between 1992 and 2000, of whom 385,747 donated blood. By 2006, 899 lung cancer cases were iden­tified and 1,770 control participants were individually matched by country, sex, date of birth, and date of blood collection.

After an analysis of the incidence rate of lung can­cer within the entire EPIC cohort and adjusting for various factors, the researchers found a lower risk for lung cancer among participants with increasing levels of B6 (comparing the fourth vs. first quartile of B6 levels). A lower risk was also seen for increasing methionine levels. “Similar and consistent decreases in risk were observed in never, former, and current smokers, indicating that results were not due to confounding [factors that can influence outcomes] by smoking. The magnitude of risk was also constant with increasing length of follow-up, indicating that the associations were not explained by preclinical disease,” the researchers write.

When participants were classified by median (midpoint) levels of serum methionine and B6, having above-median levels of both was associated with a lower lung cancer risk overall. A mod­erate lower risk was observed for increasing serum folate levels, although this association was restricted to former and current smok­ers, and was not apparent in never smokers.

“Our results suggest that above-median se­rum measures of both B6 and methionine, assessed on average 5 years prior to disease onset, are associated with a reduction of at least 50 percent on the risk of developing lung cancer. An additional association for se­rum levels of folate was present, that when combined with B6 and methionine, was associated with a two-thirds lower risk of lung cancer,” the authors write.

The researchers add that if their observations regarding serum methionine, B6, or both are shown to be causal, identifying optimum levels for re­ducing future cancer risk would appear to be appropriate.

“Lung cancer remains the most com­mon cause of cancer death in the world today and is likely to remain so for the near future. It is essential that for lung cancer prevention, any additional evidence about causality does not detract from the importance of reducing the numbers of individuals who smoke tobacco. With this in mind, it is important to recognize that a large proportion of lung cancer cases occur among former smokers, making up the majority in countries where tobacco campaigns have been particularly successful, and a non-trivial number of lung cancer cases oc­cur also among never smokers, particu­larly among women in parts of Asia. Clarifying the role of B vitamins and re­lated metabolites in lung cancer risk is likely therefore to be particularly relevant for former smokers and never smokers,” the authors conclude.

###

(JAMA. 2010;303[23]:2377-2385. Available pre-embargo to the media at www.jamamedia.org)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Polyphenols in red wine and green tea halt prostate cancer growth

2010 study posted for filing

Contact: Cody Mooneyhan cmooneyhan@faseb.org 301-634-7104 Federation of American Societies for Experimental Biology

New report in the FASEB Journal suggests that disrupting a particular cellular signaling pathway could stop or slow the initiation, promotion, and progression of prostate cancer

In what could lead to a major advance in the treatment of prostate cancer, scientists now know exactly why polyphenols in red wine and green tea inhibit cancer growth. This new discovery, published online in The FASEB Journal (http://www.fasebj.org), explains how antioxidants in red wine and green tea produce a combined effect to disrupt an important cell signaling pathway necessary for prostate cancer growth. This finding is important because it may lead to the development of drugs that could stop or slow cancer progression, or improve current treatments.

“Not only does SphK1/S1P signaling pathway play a role in prostate cancer, but it also plays a role in other cancers, such as colon cancer, breast cancer, and gastric cancers,” said Gerald Weissmann, MD, editor-in-chief of The FASEB Journal. “Even if future studies show that drinking red wine and green tea isn’t as effective in humans as we hope, knowing that the compounds in those drinks disrupts this pathway is an important step toward developing drugs that hit the same target.”

Scientists conducted in vitro experiments which showed that the inhibition of the sphingosine kinase-1/sphingosine 1-phosphate (SphK1/S1P) pathway was essential for green tea and wine polyphenols to kill prostate cancer cells. Next, mice genetically altered to develop a human prostate cancer tumor were either treated or not treated with green tea and wine polyphenols. The treated mice showed reduced tumor growth as a result of the inhibited SphK1/S1P pathway. To mimic the preventive effects of polyphenols, another experiment used three groups of mice given drinking water, drinking water with a green tea compound known as EGCg, or drinking water with a different green tea compound, polyphenon E. Human prostate cancer cells were implanted in the mice and results showed a dramatic decrease in tumor size in the mice drinking the EGCg or polyphenon E mixtures.

“The profound impact that the antioxidants in red wine and green tea have on our bodies is more than anyone would have dreamt just 25 years ago,” Weissmann added. “As long as they are taken in moderation, all signs show that red wine and green tea may be ranked among the most potent ‘health foods’ we know.”

###

Receive monthly highlights from The FASEB Journal by e-mail. Sign up at http://www.faseb.org/fjupdate.aspx. The FASEB Journal (http://www.fasebj.org) is published by the Federation of the American Societies for Experimental Biology (FASEB). The journal has been recognized by the Special Libraries Association as one of the top 100 most influential biomedical journals of the past century and is the most cited biology journal worldwide according to the Institute for Scientific Information.

FASEB comprises 23 societies with more than 100,000 members, making it the largest coalition of biomedical research associations in the United States. FASEB enhances the ability of scientists and engineers to improve—through their research—the health, well-being and productivity of all people. FASEB’s mission is to advance health and welfare by promoting progress and education in biological and biomedical sciences through service to our member societies and collaborative advocacy.

Details: Leyre Brizuela, Audrey Dayon, Nicolas Doumerc, Isabelle Ader, Muriel Golzio, Jean-Claude Izard, Yukihiko Hara, Bernard Malavaud, and Olivier Cuvillier. The sphingosine kinase-1 survival pathway is a molecular target for the tumor-suppressive tea and wine polyphenols in prostate cancer. doi:10.1096/fj.10-160838 ; http://www.fasebj.org/cgi/content/abstract/fj.10-160838v1

Healthy diet could slow or reverse early effects of Alzheimer’s disease

2010 study posted for filing

Contact: Preston M. Moretz pmoretz@temple.edu 215-204-4380 Temple University

Patients in the early to moderate stages of Alzheimer’s Disease could have their cognitive impairment slowed or even reversed by switching to a healthier diet, according to researchers at Temple University.

In a previous study [http://www.temple.edu/newsroom/2009_2010/12/stories/alzheimers.htm], researchers led by Domenico Praticò, an associate professor of pharmacology in Temple’s School of Medicine, demonstrated that a diet rich in methionine could increase the risk of developing Alzheimer’s Disease. Methionine is an amino acid typically found in red meats, fish, beans, eggs, garlic, lentils, onions, yogurt and seeds.

“The question we asked now as a follow-up is if, for whatever reason, you had made bad choices in your diet, is there a chance you can slow down or even reverse the disease or is it too late — that there is nothing you could do,” said Praticò.

As in the previous study, the researchers fed one group of mice a diet high in methionine and another group a regular, healthy diet. After five months, they split the group receiving the methionine-rich diet into two, with one group continuing the amino-heavy diet while the second switched to the healthy diet for an additional two months.

“At the end of the study, when we looked at these mice, what we found — very surprisingly — was that switching to a more healthy diet reversed the cognitive impairment that had built up over the first three months of eating the methionine-rich diet,” said Praticò. “This improvement was associated with less amyloid plaques — another sign of the disease — in their brains.

Pratico said that the cognitive impairment that had been observed in the mice after three months on the methionine-rich diet was completely reversed after two months on the healthier diet, and they were now able to function normally.

“We believe this finding shows that, even if you suffer from the early effects of MCI or Alzheimer’s, switching to a healthier diet that is lower in methionine could be helpful in that memory capacity could be improved,” he said.

Pratico stressed that this was not a drug therapy for curing MCI or Alzheimer’s, but that it did demonstrate that a lifestyle change such as diet can improve some of the impairments that have already occurred in the brain.

“What it tells us is that the brain has this plasticity to reverse a lot of the bad things that have occurred; the ability to recoup a lot of things such as memory that were apparently lost, but obviously not totally lost,” he said.

Pratico also emphasized that the researchers believe that in addition to switching to a healthy diet, patients diagnosed with MCI or Alzheimer’s also need a regiment of physical as well as mental exercises.

“This combination won’t cure you, but we believe, as we saw in this study, that it will be able to slow down or even possibly reverse the effects on the cognitive impairment,” he said.

###

The study, “Normalization of hyperhomocysteinemia improves cognitive deficits and ameliorates brain amyloidosis of a transgenic mouse model of Alzheimer’s disease,” is being published in the Journal of the Federation of American Societies for Experimental Biology (http://www.fasebj.org/). It was funded by a grant from the National Institutes of Health.

Copies of this study are available to working journalists and may be obtained by contacting Preston M. Moretz in Temple’s Office of University Communications at pmoretz@temple.edu.

Molecular link between diabetes and schizophrenia connects food and mood

2010 study posted for filing

 

Contact: Leigh MacMillan leigh.macmillan@vanderbilt.edu 615-322-4747 Vanderbilt University Medical Center

Defects in insulin function – which occur in diabetes and obesity – could directly contribute to psychiatric disorders like schizophrenia.

Vanderbilt University Medical Center investigators have discovered a molecular link between impaired insulin signaling in the brain and schizophrenia-like behaviors in mice. The findings, reported June 8 in PLoS Biology, offer a new perspective on the psychiatric and cognitive disorders that affect patients with diabetes and suggest new strategies for treating these conditions.

“We know that people with diabetes have an increased incidence of mood and other psychiatric disorders,” said endocrinologist Kevin Niswender, M.D., Ph.D. “And we think that those co-morbidities might explain why some patients have trouble taking care of their diabetes.”

“Something goes wrong in the brain because insulin isn’t signaling the way that it normally does,” said neurobiologist Aurelio Galli, Ph.D.

Galli’s group was among the first to show that insulin – the hormone that governs glucose metabolism in the body – also regulates the brain’s supply of dopamine – a neurotransmitter with roles in motor activity, attention and reward. Disrupted dopamine signaling has been implicated in brain disorders including depression, Parkinson’s disease, schizophrenia and attention-deficit hyperactivity disorder.

Now, Galli, Niswender, and colleagues have pieced together the molecular pathway between perturbed insulin signaling in the brain and dopamine dysfunction leading to schizophrenia-like behaviors.

The researchers developed mice with an insulin-signaling defect only in neurons (they impaired the function of the protein Akt, which transmits insulin’s signal inside cells). They found that the mice have behavioral abnormalities similar to those frequently seen in patients with schizophrenia.

They also showed how defects in insulin signaling disrupt neurotransmitter levels in the brain – the mice have reduced dopamine and elevated norepinephrine in the prefrontal cortex, an important area for cognitive processes. These changes resulted from elevated levels of the transporter protein (NET) that removes norepinephrine and dopamine from the synaptic space between neurons.

“We believe the excess NET is sucking away all of the dopamine and converting it to norepinephrine, creating this situation of hypodopaminergia (low levels of dopamine) in the cortex,” Galli explained. Low dopamine function in the cortex is thought to contribute to the cognitive deficits and negative symptoms – depression, social withdrawal – associated with schizophrenia.

By treating the mice with NET inhibitors (drugs that block NET activity), the investigators were able to restore normal cortical dopamine levels and behaviors. Clinical trials of NET inhibitors in patients with schizophrenia are already under way, Galli said, and these new data provide mechanistic support for this approach.

The findings also provide a molecular basis for interpreting previous reports of Akt deficiencies in patients with schizophrenia, as revealed by post-mortem, imaging and genetic association studies.

Galli and Niswender suggest that the insulin to Akt signaling pathway is critical for “fine-tuning” the function of monoamine neurotransmitters – dopamine, norepinephrine and serotonin – and that it can be impaired in many different ways.

“Dysregulation of this pathway – because of type 1 diabetes, because of a high-fat diet, because of drugs of abuse, because of genetic variations – may put a person on the road to neuropsychiatric disorders,” Galli said.

Understanding the molecular link between insulin action and dopamine balance – the connection between food and mood – offers the potential for novel therapeutic approaches, the researchers said. The mouse model described in the current studies may be useful for testing schizophrenia and cognition-enhancing treatments.

###

Michael Siuta and Sabrina Robertson are the lead authors of the study. Niswender is an assistant professor of Medicine and Molecular Physiology & Biophysics; Galli is a professor of Molecular Physiology & Biophysics.

The National Institutes of Health and the Vanderbilt University Silvio O. Conte Center for Neuroscience Research supported the research.

(HPV) Tumor virus is best predictor of throat cancer survival

2010 Study posted for filing

 

Contact: Darrell E. Ward
Darrell.Ward@osumc.edu
614-293-3737
Ohio State University Medical Center

 

COLUMBUS, Ohio – The presence of human papilloma virus, the virus that causes cervical cancer, in tumors is the most important predictor of survival for people diagnosed with oropharyngeal cancer (cancer of the back of the mouth), according to a new study led by a researcher at the Ohio State University Comprehensive Cancer Center-Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC-James).

Published online June 7 in the New England Journal of Medicine with a related editorial, this is the first study large enough to show that the presence of human papilloma virus (HPV) in tumors accounts for better response to therapy, rather than other favorable factors that may be present, such as young age and small tumors.

The second leading predictor of survival is lifetime smoking history, followed by cancer stage.

The findings suggest that the HPV status of a patient’s tumor and their smoking history may be used in the future, in addition to cancer stage, to determine the aggressiveness of a patient’s therapy.

“Previous studies indicated a relationship exited between the presence or absence of HPV in oropharyngeal tumors and patient survival, but they couldn’t determine if other favorable factors present in these patients were responsible for their better outcome,” says study leader Dr. Maura Gillison, a medical oncologist and head and neck cancer specialist at the OSUCCC-James.

“These findings close the door on these questions and will allow the field to move forward with clinical trials designed to determine how we should use molecular and behavioral factors to personalize therapy for patients.”

Gillison emphasized that there is insufficient data at this time to indicate how a specific patient’s cancer therapy should be tailored based on these factors.

Gillison and her colleagues analyzed the tumors and outcomes of 323 patients with stage III or IV oropharyngeal cancer who were part of a Radiation Therapy Oncology Group clinical trial. Of these patients, 206 had HPV-positive tumors and 117 had HPV-negative tumors.

At three years after treatment, 82 percent of patients with HPV-positive tumors were still alive, compared with 57 percent of patients with HPV-negative tumors. Rates of cancer relapse at three years for the groups were 43 percent and 74 percent, respectively.

The investigators determined that HPV presence in tumors accounted for most of the difference in therapy response and survival between patients with HPV-positive and HPV-negative tumors, while factors such as younger age, white race, better energy level, absence of anemia and smaller tumors were responsible for only about 10 percent of the difference.

Smoking history emerged as the second most important independent predictor of survival and cancer relapse for patients with oropharyngeal cancer. The risk of cancer relapse or death increased by one percent for each additional pack year of tobacco smoking (one pack year is equivalent to smoking one pack a day for a year).

The investigators found that at three-years, about 93 percent of patients with HPV-positive tumors who were never or light- smokers were alive, as compared to about 70 percent of patients with HPV-positive tumors who were smokers and about 46 percent of patients with HPV-negative tumors who were smokers.

“The two risk factors that place an individual at risk for oropharyngeal cancer are also the most important factors determining patient survival. This is probably because these factors determine the genetic profile of these cancers and how they respond to treatment,” Gillison says.

Gillison and her colleagues have since conducted a follow-up study to further investigate the influence of tobacco smoking on oropharyngeal cancer. She reported these findings June 7 at the 2010 annual meeting of American Society of Clinical Oncology.

###

 

Funding from the National Cancer Institute and the National Institute of Dental and Craniofacial Research supported this research.

 

Bothered by Negative, Unwanted Thoughts? Just Throw Them Away

11/26/12

COLUMBUS,  Ohio — If you want to get rid of unwanted, negative thoughts, try just ripping  them up and tossing them in the trash.

In  a new study, researchers found that when people wrote down their thoughts on a  piece of paper and then threw the paper away, they mentally discarded the  thoughts as well.

On  the other hand, people were more likely to use their thoughts when making  judgments if they first wrote them down on a piece of paper and tucked the  paper in a pocket to protect it.

petty
Richard Petty

“However  you tag your thoughts — as trash or as worthy of protection — seems to make a  difference in how you use those thoughts,” said Richard Petty, co-author of  the study and professor of psychology  at Ohio State University.

Some  types of psychological therapy use variations of this concept by trying to get  patients to discard their negative thoughts. But Petty said this is the first  study he is aware of that has validated that approach.

“At  some level, it can sound silly. But we found that it really works — by physically  throwing away or protecting your thoughts, you influence how you end up using  those thoughts. Merely imagining engaging in these actions has no effect.”

The  findings suggest that people can treat their thoughts as material, concrete  objects, Petty said. That is evident in the language we use.

“We  talk about our thoughts as if we can visualize them. We hold our thoughts. We  take stances on issues, we lean this way or that way. This all makes our thoughts  more real to us.”

Petty  conducted the research with Pablo Briñol, Margarita Gascó and Javier Horcajo,  all of the Universidad  Autónoma de Madrid in Spain.

The  results are published online in the journal Psychological  Science and will appear in a future print edition.

For  the study, the researchers conducted three related experiments.

In  the first experiment, 83 Spanish high school students participated in a study  they were told was about body image. Each participant was told to write down  either positive or negative thoughts about his or her body during a  three-minute period.

All  the participants were asked to look back at the thoughts they wrote. Researchers  told half of the students to contemplate their thoughts and then throw them in  the trash can located in the room, “because their thoughts did not have to  remain with them.” The other half were told to contemplate their thoughts and check  for any grammar or spelling mistakes.

The  participants then rated their attitudes about their own bodies on three 9-point  scales (bad-good, unattractive-attractive, like-dislike).

Results  showed that for those who kept their thoughts and checked them for mistakes, it  mattered whether they generated positive or negative thoughts about their bodies.  As would be expected, participants who wrote positive thoughts had more  positive attitudes toward their bodies a few minutes later than did those who  wrote negative thoughts.

However,  those who threw their thoughts away showed no difference in how they rated  their bodies, regardless of whether they wrote positive or negative thoughts.

“When  they threw their thoughts away, they didn’t consider them anymore, whether they  were positive or negative,” Petty said.

In  a second study, 284 students participated in a similar experiment, except this  time they were asked to write negative or positive thoughts about something  most people believe is good: the Mediterranean  diet (the diet emphasizes high consumption of fruits, vegetables, legumes  and unrefined cereals, with olive oil as the basic fat).

In  this case, some threw the thoughts away, some left them on their desk, and some  were told to put the paper in their pocket, wallet or purse and keep it with  them.

All  participants were then asked to rate their attitudes toward the diet and  intentions to use the diet for themselves.

As  in the first study, those who kept the list of thoughts at their desk were more  influenced by them when evaluating the diet than were those who threw them away.  However, those who protected their thoughts by putting them in a pocket or  purse were even more influenced than those who kept the thoughts on their desk.

In  other words, those who wrote positive thoughts about the Mediterranean diet and  put those thoughts in their pocket rated the diet more favorably than those who  wrote positive thoughts and simply kept those thoughts on their desk. And,  those who wrote negative thoughts and put them in their pocket rated the diet  more negatively than those who kept their thoughts on the desk.

“This  suggests you can magnify your thoughts, and make them more important to you, by  keeping them with you in your wallet or purse,” Petty said.

But  how important is the physical action of throwing these thoughts away or keeping  them in your pocket? To find out, the researchers conducted a third experiment  using computers. In this case, 78 Spanish college students wrote their thoughts  in a computer word-processing document. Some later used a mouse to drag the  file into the computer recycle bin, while others moved the file to a storage  disk.

Just  as in the previous studies, participants made less use of negative thoughts  that they had trashed — by dragging them to the recycle bin — than did those  who saved the thoughts by transferring them to a disk.

In  one other condition, some participants were told to simply imagine dragging  their negative thoughts to the recycle bin or saving them to a disk. But that  had no effect on their later judgments.

“The  more convinced the person is that the thoughts are really gone, the better,”  Petty said. “Just imagining that you throw them away doesn’t seem to work.

“Of  course, even if you throw the thoughts in a garbage can or put them in the  recycle bin on the computer, they are not really gone — you can regenerate  them. But the representations of those thoughts are gone, at least temporarily,  and it seems to make it easier to not think about them.”

Petty  said the researchers plan to see if this technique could work to help people  who have recurrent negative thoughts that are intrusive and bothersome, such as  thoughts about the death of a loved one.

“It  is often difficult to get rid of these thoughts. We want to find out if there  is a way to keep those thoughts from coming back, at least for longer periods  of time.”

The  study was supported by grants from the U.S. National  Science Foundation and the equivalent agency in Spain.

#

Contact:  Richard Petty, (614) 292-3038; Petty.1@osu.edu         Written  by Jeff Grabmeier, (614) 292-8457; Grabmeier.1@osu.edu

Green tea extract appears to keep cancer in check in majority of CLL patients

2010 study posted for filing

Contact: Karl Oestreich newsbureau@mayo.edu 507-284-5005 Mayo Clinic

Mayo Clinic has conducted the first clinical studies of tea extract in cancer patients

CHICAGO — ASCO Abstract Number: 6522 (http://abstract.asco.org/AbstView_74_47574.html). An extract of green tea appears to have clinical activity with low toxicity in chronic lymphocytic leukemia (CLL) patients who used it in a phase II clinical trial, say researchers at Mayo Clinic.

The findings, to be presented Monday, June 7, during the annual meeting of the American Society of Clinical Oncology (http://www.asco.org/) (ASCO), are the latest in a series of Mayo studies to show promise for use of the chemical epigallocatechin gallate (EGCG) — the major component of green tea — in reducing the number of leukemia cells in patients with CLL. Mayo first tested EGCG in a variety of laboratory assays about eight years ago, and it was found to reduce the survival of CLL leukemic cells. This laboratory finding was followed by a successful phase I clinical trial — the first time green tea extract had been studied in CLL patients.

“Although only a comparative phase III trial can determine whether EGCG can delay progression of CLL, the benefits we have seen in most CLL patients who use the chemical suggest that it has modest clinical activity and may be useful for stabilizing this form of leukemia, potentially slowing it down,” says Tait Shanafelt, M.D. (http://www.mayoclinic.org/bio/12787116.html), a Mayo Clinic hematologist (http://www.mayoclinic.org/hematology-rst/) and lead author of the study.

“These studies advance the notion that a nutraceutical like EGCG can and should be studied as cancer preventives,” says Neil Kay, M.D. (http://www.mayoclinic.org/bio/13445391.html), a hematology researcher whose laboratory first tested the green tea extract in leukemic blood cells from CLL patients. “Using nontoxic chemicals to push back cancer growth to delay the need for toxic therapies is a worthy goal in oncology research — particularly for forms of cancer initially managed by observation such as CLL.”

Drs. Shanafelt and Kay caution that EGCG is not a substitute for chemotherapy. All of the patients Mayo tested with EGCG were early stage, asymptomatic CLL patients who would not otherwise be treated until their disease progressed. The extract was supplied by the National Cancer Institute (http://www.nci.nih.gov/ )(NCI) and Polyphenon E International for these initial clinical trials.

CLL is a blood cancer that is a hybrid between leukemia and lymphoma. Progression of the disease is measured by the quantity of leukemia cells in the blood and bone marrow as well as enlargement of lymph nodes due to infiltration by the leukemia cells. In the phase I study, published in May 2009 in the Journal of Clinical Oncology, researchers found that the blood lymphocyte (leukemia cell) count was reduced in one-third of participants, and that the majority of patients who entered the study with enlarged lymph nodes due to involvement by CLL saw a 50 percent or greater reduction in their lymph node size.

Using the highest dose tested in the phase I study, the researchers launched their phase II clinical trial in an additional 36 patients. The results presented at the ASCO meeting evaluate the effects in these 36 patients as well as the six patients from the phase I trial treated at the same dose (total 42 patients). Results from 41 patients who have completed the study show that 31 percent of patients had a 20 percent or greater sustained reduction in blood leukemia count, and 69 percent of patients with enlarged lymph nodes saw a reduction of node size of 50 percent or greater.

In all, 69 percent of CLL patients had a biological response to EGCG as evidenced by a 20 percent or greater sustained reduction in blood lymphocyte count and/or a 50 percent or greater reduction in lymph node size, the researchers say.

Because EGCG was being studied in patients who did not otherwise need treatment, the researchers took a rigorous approach toward studying side effects. Most clinical trials of therapeutic agents only report grade 3 and higher side effects, but the researchers looked at and reported grade 1 and grade 2 as well. While a number of patients had transient grade 1 or 2 side effects, only three of 42 experienced a grade 3 side effect during their six months of treatment.

“All in all, the treatment was well tolerated with very mild side effects in most patients,” Dr. Shanafelt says.

The researchers say that the prior publications on the effects of EGCG on CLL leukemia cells in the laboratory and the data from the published phase I study have been widely disseminated via the Internet by patient advocacy groups. Based on information from patients and colleagues throughout the country, the Mayo researchers have become aware that many CLL patients nationwide have started to use EGCG supplements, which are readily available over the counter.

“Without a phase III clinical trial, we cannot make a recommendation that EGCG be used by CLL patients, but those who want to take supplements should consult with their oncologists and need to receive appropriate monitoring using laboratory tests,” Dr. Kay says.

###

 

The study was funded by grants from the NCI, the Mayo Comprehensive Cancer Center (http://mayoresearch.mayo.edu/mayo/research/cancercenter/index.cfm), and from donors and patient advocacy foundations. The authors declare no conflicts of interest.

About Mayo Clinic

For more than 100 years, millions of people from all walks of life have found answers at Mayo Clinic. These patients tell us they leave Mayo Clinic with peace of mind knowing they received care from the world’s leading experts. Mayo Clinic is the first and largest integrated, not-for-profit group practice in the world. At Mayo Clinic, a team of specialists is assembled to take the time to listen, understand and care for patients’ health issues and concerns. These teams draw from more than 3,700 physicians and scientists and 50,100 allied staff that work at Mayo Clinic’s campuses in Minnesota, Florida, and Arizona; and community-based providers in more than 70 locations in southern Minnesota, western Wisconsin and northeast Iowa. These locations treat more than half a million people each year.  To best serve patients, Mayo Clinic works with many insurance companies, does not require a physician referral in most cases and is an in-network provider for millions of people. To obtain the latest news releases from Mayo Clinic, go to www.mayoclinic.org/news. For information about research and education, visit www.mayo.edu. MayoClinic.com (www.mayoclinic.com) is available as a resource for your general health information.

VIDEO ALERT: Additional audio and video resources, including excerpts from an interview with Dr. Tait Shanafelt is available on the Mayo Clinic News Blog (http://newsblog.mayoclinic.org/2010/06/04/green-tea-extract-appears-to-keep-cancer-in-check-in-majority-of-cll-patients/).

Key nutrient in maternal diet promises ‘dramatic’ improvements for people with Down syndrome ( Choline )

2010 study posted for filing

Contact: John Carberry jjc338@cornell.edu 607-255-5353 Cornell University

ITHACA, N.Y. – A nutrient found in egg yolks, liver and cauliflower taken by mothers during pregnancy and nursing may offer lifelong “dramatic” health benefits to people with Down syndrome .

A new study done at Cornell University and published June 2 in the peer-reviewed journal Behavioral Neuroscience found that more choline during pregnancy and nursing could provide lasting cognitive and emotional benefits to people with Down syndrome. The work indicated greater maternal levels of the essential nutrient also could protect against neurodegenerative conditions such as Alzheimer’s disease.

“We found that supplementing the maternal diet with additional choline resulted in dramatic improvements in attention and some normalization of emotion regulation in a mouse model of Down syndrome,” said lead author Barbara Strupp, professor of nutritional sciences and of psychology.

In addition to mental retardation, Down syndrome individuals often experience dementia in middle age as a result of brain neuron atrophy similar to that suffered by people with Alzheimer’s disease. Strupp said the improved mental abilities found in the Down syndrome mice following maternal choline supplements could indicate protection from such neurodegeneration “in the population at large.”

Strupp and her co-authors tested Down syndrome-model mice born from mothers that were fed a normal diet versus those given choline supplements during their three-week pregnancy and three-week lactation period. They also examined normal mice born from mothers with and without additional choline. The choline-supplemented mothers received about 4.5 times more choline (roughly comparable to levels at the higher range of human intake) than unsupplemented mothers.

Beginning at 6 months of age, the mice performed a series of behavioral tasks over a period of about six months to assess their impulsivity, attention span, emotional control and other mental abilities. The researchers found the unsupplemented Down syndrome-model mice became more agitated after a mistake than normal mice, jumping repeatedly and taking longer to initiate the next trial. The choline-supplemented Down syndrome-model mice showed partial improvement in these areas.

“I’m impressed by the magnitude of the cognitive benefits seen in the Down syndrome-model mice,” Strupp said. “Moreover, these are clearly lasting cognitive improvements, seen many months after the period of choline supplementation.”

Strupp said the results are consistent with studies by other researchers that found increased maternal choline intake improves offspring cognitive abilities in rats. However, this is the first study to evaluate the effects of maternal choline supplementation in a rodent model of Down syndrome.

Previous studies of humans and laboratory animals have shown that supplementing the diets of adults with choline has proven to be largely ineffective in improving cognition.

“Although the precise mechanism is unknown, these lasting beneficial effects of choline observed in the present study are likely to be limited to increased intake during very early development,” Strupp said.

###

The study, funded in part by the National Institutes of Health, was part of the dissertation of Cornell doctoral candidate Jisook Moon. Other Cornell collaborators included Myla Strawderman, research associate in nutritional sciences, and David Levitsky, professor of nutrition and psychology. Strupp and collaborators have received additional NIH funding to study the neural mechanisms underlying the results observed in this study.

New evidence that chili pepper ingredient fights fat

2010 study posted for filing

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

Capsaicin, the stuff that gives chili peppers their kick, may cause weight loss and fight fat buildup by triggering certain beneficial protein changes in the body, according to a new study on the topic. The report, which could lead to new treatments for obesity, appears in ACS’ monthly Journal of Proteome Research.

Jong Won Yun and colleagues point out that obesity is a major public health threat worldwide, linked to diabetes, high blood pressure, heart disease, and other health problems. Laboratory studies have hinted that capsaicin may help fight obesity by decreasing calorie intake, shrinking fat tissue, and lowering fat levels in the blood. Nobody, however, knows exactly how capsaicin might trigger such beneficial effects.

In an effort to find out, the scientists fed high-fat diets with or without capsaicin to lab rats used to study obesity. The capsaicin-treated rats lost 8 percent of their body weight and showed changes in levels of at least 20 key proteins found in fat. The altered proteins work to break down fats. “These changes provide valuable new molecular insights into the mechanism of the antiobesity effects of capsaicin,” the scientists say.

###

 

ARTICLE FOR IMMEDIATE RELEASE “Proteomic Analysis for Antiobesity Potential of Capsaicin on White Adipose Tissue in Rats Fed with a High Fat Diet”

DOWNLOAD FULL TEXT ARTICLE http://pubs.acs.org/stoken/presspac/presspac/full/10.1021/pr901175w

CONTACT: Jong Won Yun, Ph.D. Department of Biotechnology Daegu University Kyungsan, Kyungbuk Korea Phone: 82-53-850-6556 Fax: 82-53-850-6559 Email: jwyun@daegu.ac.kr

Peaches, plums induce deliciously promising death of breast cancer cells

2010 study posted for filing

 

Contact: Kathleen Phillips ka-phillips@tamu.edu 979-845-2872 Texas A&M AgriLife Communications

      AUDIO:   Breast cancer cells — even the most aggressive type — died after treatments with peach and plum extracts in lab tests at Texas AgriLife Research recently, and scientists say the…Click here for more information.

 

COLLEGE STATION — Breast cancer cells – even the most aggressive type – died after treatments with peach and plum extracts in lab tests at Texas AgriLife Research recently, and scientists say the results are deliciously promising. Not only did the cancerous cells keel over, but the normal cells were not harmed in the process.

AgriLife Research scientists say two phenolic compounds are responsible for the cancer cell deaths in the study, which was published in the Journal of Agriculture and Food Chemistry. The phenols are organic compounds that occur in fruits. They are slightly acidic and may be associated with traits such as aroma, taste or color.

“It was a differential effect which is what you’re looking for because in current cancer treatment with chemotherapy, the substance kills all cells, so it is really tough on the body,” said Dr. David Byrne, AgriLife Research plant breeder who studies stone fruit. “Here, there is a five-fold difference in the toxic intensity. You can put it at a level where it will kill the cancer cells – the very aggressive ones – and not the normal ones.”

Byrne and Dr. Luis Cisneros-Zevallos originally studied the antioxidants and phytonutrients in plums and found them to match or exceed the blueberry which had been considered superior to other fruits in those categories.

“The following step was to choose some of these high antioxidant commercial varieties and study their anticancer properties,” Cisneros-Zevallos said. “And we chose breast cancer as the target because it’s one of the cancers with highest incidence among women. So it is of big concern.”

According to the National Cancer Institute, there were 192,370 new cases of breast cancer in females and 1,910 cases in males in 2009. That year, 40,170 women and 440 men died from breast cancer. The World Health Organization reports that breast cancer accounts for 16 percent of the cancer deaths of women globally.

      IMAGE:   Breast cancer cells — even the most aggressive type — died after treatments with peach and plum extracts in lab tests at Texas AgriLife Research.Click here for more information.

 

Cisneros-Zevallos, an AgriLife Research food scientist, said the team compared normal cells to two types of breast cancer, including the most aggressive type. The cells were treated with an extract from two commercial varieties, the “Rich Lady” peach and the “Black Splendor” plum.

“These extracts killed the cancer cells but not the normal cells,” Cisneros-Zevallos said.

A closer look at the extracts determined that two specific phenolic acid components – chlorogenic and neochlorogenic – were responsible for killing the cancer cells while not affecting the normal cells, Cisneros-Zevallos said.

The two compounds are very common in fruits, the researchers said, but the stone fruits such as plums and peaches have especially high levels.

“So this is very, very attractive from the point of view of being an alternative to typical chemotherapy which kills normal cells along with cancerous ones,” Byrne added.

The team said laboratory tests also confirmed that the compounds prevented cancer from growing in animals given the compounds.

Byrne plans to examine more fully the lines of the varieties that were tested to see how these compounds might be incorporated into his research of breeding plums and peaches. Cisneros-Zevallos will continue testing these extracts and compounds in different types of cancer and conduct further studies of the molecular mechanisms involved.

###

The work documenting the health benefits of stone fruit has been supported by the Vegetable and Fruit Improvement Center at Texas A&M University, the U.S. Department of Agriculture and the California Tree Fruit Agreement.

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.

Parkinson’s sufferer wins six figure payout from GlaxoSmithKline over drug that turned him into a ‘gay sex and gambling addict’

Father-of-two says he developed an uncontrollable passion for gay sex and gambling – at one point even selling his children’s toys to fund his addiction

Rob Williams

Thursday, 29 November 2012

A French appeals court has upheld a ruling ordering GlaxoSmithKline to pay €197,000 (£159,000) to a man who claimed a drug given to him to treat Parkinson’s turned him into a ‘gay sex addict’.

Didier Jambart, 52, was prescribed the drug Requip in 2003 to treat his illness.

Within two years of beginning to take the drug the married father-of-two says he developed an uncontrollable passion for gay sex and gambling – at one point even selling his children’s toys to fund his addiction.

He was awarded £160,000 in damages after a court in Rennes, France, upheld his claims.

The ruling, which is considered ground-breaking, was made yesterday by the appeal court, which awarded damages to Mr Jambart.

Following the decision Mr Jambart appeared outside the court with his wife Christine beside him.

Jambart broke down in tears as judges upheld his claim that his life had become ‘hell’ after he started taking Requip, a drug made by GSK.

Mr Jambart began taking the drug for Parkinson’s in 2003, he had formerly worked as a well-respected bank manager and local councillor, and is a father of two.

After beginning to take the drug he claimed he attempted to commit suicide eight times.

In total Mr Jambert said he gambled away 82,000 euros, mostly through internet betting on horse races. He also said he engaged in frantic searches for gay sex.

He started exhibiting himself on websites and arranging encounters, one of which he claimed resulted in him being raped.

He said his family had not understood what was going on at first.

Mr Jambert said he realised the drug was responsible when he stumbled across a website that made a connection between the drug and addictions in 2005. When he stopped the drug he claims his behaviour returned to normal.

“It’s a great day,” he said. “It’s been a seven-year battle with our limited means for recognition of the fact that GSK lied to us and shattered our lives.”

He added: ‘I am happy that justice has been done. I am happy for my wife and my children. I am at last going to be able to sleep at night and profit from life. ‘

He added that the money awarded would, ‘never replace the years of pain.’

The court heard that Requip’s side-effects had been made public in 2006, but had reportedly been known for years.

Mr Jambert said that GSK patients should have been informed earlier.

 

http://www.independent.co.uk/news/world/europe/parkinsons-sufferer-wins-six-figure-payout-from-glaxosmithkline-over-drug-that-turned-him-into-a-gay-sex-and-gambling-addict-8368600.html#

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

You have no natural right to food

2010 report posted for filing.

 

The Farm-to-Consumer Legal Defense Fund (FTCLDF), an organization whose mission includes “defending the rights and broadening the freedoms of family farms and protecting consumer access to raw milk and nutrient dense foods”, recently filed a lawsuit against the FDA for its ban on interstate sales of raw milk. The suit alleges that such a restriction is a direct violation of the United States Constitution. Nevertheless, the suit led to a surprisingly cold response from the FDA about its views on food freedom (and freedoms in general).

 

In a dismissal notice issued to the Iowa District Court where the suit was filed, the FDA officially made public its views on health and food freedom. These views will shock you, but they reveal the true evil intent of the FDA and why it is truly a rogue federal agency.

 

The FDA essentially believes that nobody has the right to choose what to eat or drink. You are only “allowed” to eat or drink what the FDA gives you permission to. There is no inherent right or God-given right to consume any foods from nature without the FDA’s consent.

 

This is no exaggeration. It’s exactly what the FDA said in its own words.

 

You have no natural right to food

 

The FTCLDF highlighted a few of the key phrases from the FDA’s response document in a recent email to its supporters. They include the following two statements from the FDA:

 

“There is no ‘deeply rooted’ historical tradition of unfettered access to foods of all kinds.” [p. 26]

 

“Plaintiffs’ assertion of a ‘fundamental right to their own bodily and physical health, which includes what foods they do and do not choose to consume for themselves and their families’ is similarly unavailing because plaintiffs do not have a fundamental right to obtain any food they wish.” [p.26]

 

 

 

There’s a lot more in the document, which primarily addresses the raw milk issue, but these statements alone clearly reveal how the FDA views the concept of health freedom. Essentially, the FDA does not believe in health freedom at all. It believes that it is the only entity granted the authority to decide for you what you are able to eat and drink.

 

The State, in other words, may override your food decisions and deny you free access to the foods and beverages you wish to consume. And the State may do this for completely unscientific reasons — even just political reasons — all at their whim.

Anti-aging supplements may be best taken not too late in life

2010 study posted for filing
Contact: Czerne M. Reid
czerne@ufl.edu
352-273-5810
University of Florida

Anti-aging supplements made up of mixtures might be better than single compounds at preventing decline in physical function, according to researchers at the University of Florida’s Institute on Aging. In addition, it appears that such so-called neutraceuticals should be taken before very old age for benefits such as improvement in physical function.

The findings from rat studies, published last week in the journal PLoS One, have implications for how dietary supplementation can be used effectively in humans.

“I think it is important for people to focus on good nutrition, but for those of advanced age who are running out of energy and not moving much, we’re trying to find a supplement mixture that can help improve their quality of life,” said Christiaan Leeuwenburgh, Ph.D., senior author of the paper and chief of the biology of aging division in the UF College of Medicine.

Scientists do not fully understand all the processes that lead to loss of function as people age. But more and more research points to the mitochondrial free radical theory of aging, that as people age, oxidative damage piles up in individual cells such that the energy-generation system inside some cells stops working properly.

To address that problem, many anti-aging studies and supplements are geared toward reducing the effects of free radicals.

The UF researchers investigated the potential anti-aging benefits of a commercially available mixture marketed for relieving chronic fatigue and protecting against muscle aging. The supplement contains the antioxidant coenzyme Q10, creatine — a compound that aids muscle performance — and ginseng, which also has been shown to have antioxidant properties.

The study gauged the effects of the mixture on physical performance as well as on two mechanisms that underlie the aging process and many age-related disorders: dysfunction of the cells’ energy producing powerhouses, known as mitochondria, and oxidative stress.

The researchers fed the supplement to middle-aged 21-month-old and late-middle-aged 29-month-old rats — corresponding to 50- to 65-year-old and 65- to 80-year-old humans, respectively — for six weeks, and measured how strongly their paws could grip. Grip strength in rats is analogous to physical performance in humans, and deterioration in grip strength can provide useful information about muscle weakness or loss seen in older adults.

Grip strength improved 12 percent in the middle-aged rats compared with controls, but no improvement was found in the older group.

Measurements of the function of mitochondria corresponded with the grip strength findings. Stress tests showed that mitochondrial function improved 66 percent compared with controls in middle-aged rats but not in the older ones. That suggests that supplementation might be of greater effect before major age-related functional and other declines have set in, the researchers said.

“It is possible that there is a window during which these compounds will work, and if the intervention is given after that time it won’t work,” said Jinze Xu, Ph.D., first author of the paper and a postdoctoral researcher at UF.

The researchers are working to identify the optimal age at which various interventions can enhance behavioral or physical performance. Very few studies have been done to show the effect of interventions on the very old.

Interestingly, although the older rats had no improvement in physical performance or mitochondrial function, they had lowered levels of oxidative damage.

That shows that reduction of oxidative stress damage is not always matched by functional changes such as improvement in muscle strength.

As a result, research must focus on compounds that promote proper functioning of the mitochondria, since mitochondrial health is essential in older animals for reducing oxidative stress, the researchers said. And clinical trials need to be performed to test the effectiveness of the supplements in humans.

“It’s going to be very important to focus less on oxidative stress and biomarkers, and focus on having sufficient energy,” Leeuwenburgh said. “If energy declines, then you have an increased chance for oxidative stress or failure of repair mechanisms that recognize oxidative damage — we’re seeing that the health of mitochondria is central to aging.”

It is possible that although the supplement could help reduce the oxidative stress damage, because damage in much older animals was too great, energy could not be restored.

The different compounds in the mixture acted to produce effects that single compounds did not, because each component affected a different biochemical pathway in the body, addressing both oxidative stress and mitochondrial function, researchers said.

“People are catching on that using a single compound is not a good strategy — you have to use multiple compounds and target one or multiple pathways,” Leeuwenburgh said.

###

The manufacturers of the supplement donated the quantity used in the study and provided support for the postdoctoral researcher and analyses. The animals used in the study were paid for through grants from the National Institute on Aging.

Prenatal exposure to endocrine-disrupting chemicals linked to breast cancer

2010 study for filing
Contact: Aaron Lohr
alohr@endo-society.org
240-482-1380
The Endocrine Society

A study in mice reveals that prenatal exposure to endocrine-disrupting chemicals, like bisphenol-A (BPA) and diethylstilbestrol (DES), may program a fetus for life. Therefore, adult women who were exposed prenatally to BPA or DES could be at increased risk of breast cancer, according to a new study accepted for publication in Hormones & Cancer, a journal of The Endocrine Society.

Endocrine-disrupting chemicals are substances in the environment that interfere with hormone biosynthesis, metabolism or action resulting in adverse developmental, reproductive, neurological and immune effects in both humans and wildlife. These chemicals are designed, produced and marketed largely for specific industrial purposes.

“BPA is a weak estrogen and DES is a strong estrogen, yet our study shows both have a profound effect on gene expression in the mammary gland (breast) throughout life,” said Hugh Taylor, MD, of the Yale University School of Medicine in New Haven, Conn. and lead author of the study. “All estrogens, even ‘weak’ ones can alter the development of the breast and ultimately place adult women who were exposed to them prenatally at risk of breast cancer.”

In this study, researchers treated pregnant mice with BPA or DES and then looked at the offspring as adults. When the offspring reached adulthood, their mammary glands still produced higher levels of EZH2, a protein that plays a role in the regulation of all genes. Higher EZH2 levels are associated with an increased risk of breast cancer in humans.

“We have demonstrated a novel mechanism by which endocrine-disrupting chemicals regulate developmental programming in the breast,” said Taylor. “This study generates important safety concerns about exposures to environmental endocrine disruptors such as BPA and suggests a potential need to monitor women exposed to these chemicals for the development of breast lesions as adults.”

 

 

###

 

 

Other researchers working on the study include Leo Doherty, Jason Bromer, Yuping Zhou and Tamir Aldad of the Yale University School of Medicine in New Haven, Connecticut.

The article, “In Utero Exposure to Diethylstilbestrol (DES) or Bisphenol-A (BPA) Increases EZH2 Expression in the Mammary Gland: An Epigenetic Mechanism Linking Endocrine Disruptors to Breast Cancer,” has been published online and can be found at: http://www.springerlink.com/content/547256j0g02073v5/?p=286f52b5d3c94d9f8dc4546af408af89π=0.

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 14,000 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 www.endo-society.org.

High-fat ketogenic diet effectively treats persistent childhood seizures

2010 study posted for filing

Contact: Ekaterina Pesheva
epeshev1@jhmi.edu
410-516-4996
Johns Hopkins Medical Institutions

The high-fat ketogenic diet can dramatically reduce or completely eliminate debilitating seizures in most children with infantile spasms, whose seizures persist despite medication, according to a Johns Hopkins Children’s Center study published online April 30 in the journal Epilepsia.

Infantile spasms, also called West syndrome, is a stubborn form of epilepsy that often does not get better with antiseizure drugs. Because poorly controlled infantile spasms may cause brain damage, the Hopkins team’s findings suggest the diet should be started at the earliest sign that medications aren’t working.

“Stopping or reducing the number of seizures can go a long way toward preserving neurological function, and the ketogenic diet should be our immediate next line of defense in children with persistent infantile spasms who don’t improve with medication,” says senior investigator Eric Kossoff, M.D., a pediatric neurologist and director of the ketogenic diet program at Hopkins Children’s.

The ketogenic diet, made up of high-fat foods and few carbohydrates, works by triggering biochemical changes that eliminate seizure-causing short circuits in the brain’s signaling system. It has been used successfully in several forms of epilepsy.

A small 2002 study by the same Hopkins team showed the diet worked well in a handful of children with infantile spasms. The new study is the largest analysis thus far showing just how effective the diet can be in children with this condition.

Of the 104 children treated by the Hopkins team, nearly 40 percent, or 38 children, became seizure-free for at least six months after being on the diet for anywhere from just a few days to 20 months. Of the 38, 30 have remained so without a relapse for at least two years.

After three months on the diet, one-third of the children had 90 percent fewer seizures, and after nine months on the diet, nearly half of the children in the study had 90 percent fewer seizures. Nearly two-thirds had half as many seizures after six months on the diet.

Nearly two-thirds of the children experienced improvement in their neurological and cognitive development, and nearly 30 percent were weaned off antiseizure medications after starting the diet.

Most of the children continued taking their medication even after starting the diet, the researchers say, because the two are not mutually exclusive and can often work in synergy.

Researchers also used the diet as first-line therapy in18 newly diagnosed infants never treated with drugs, 10 of whom became seizure free within two weeks of starting the diet. The finding suggests that, at least in some children, the diet may work well as first-line therapy, but the researchers say they need further and larger studies to help them identify patients for whom the diet is best used before medications. Hopkins Children’s neurologists are actively using the ketogenic diet as first-line treatment in children with infantile spasms with promising results.

Side effects, including constipation, heartburn, diarrhea and temporary spikes in cholesterol levels, occurred in one-third of the children, with six percent of them experiencing diminished growth.

Despite these side effects, a recent study by Kossoff and his team showed that the ketogenic diet is safe long term.

Conflict of interest disclosure: Dr. Kossoff has received grant support from Nutricia Inc., for unrelated research. The terms of these arrangements are being managed by the Johns Hopkins University in accordance with its conflict-of-interest policies.

 

###

The research was funded in part by the National Institutes of Health.

Co-investigators include Amanda Hong, Zahava Turner and Rana Hamdy, all of Hopkins.

Related on the Web:

High-Fat Ketogenic Diet to Control Seizures Is Safe Over Long Term http://www.hopkinschildrens.org/high-fat-ketogenic-diet-to-control-seizures-is-safe-over-long-term.aspx

Infantile Spasms Information (National Institute of Neurological Disorders and Stroke) http://www.ninds.nih.gov/disorders/infantilespasms/infantilespasms.htm

Daily Potassium Citrate Wards Off Kidney Stones in Seizure Patients on High-Fat Diet http://www.hopkinschildrens.org/Daily_Potassium_Citrate_Wards_Off_Kidney_Stones_in_Seizure_Patients_On_High-Fat_Diet.aspx

High Cholesterol Levels Drop Naturally in Children on High-Fat Antiseizure Diet http://www.hopkinschildrens.org/high-cholesterol-levels-drop-children-high-fat-anti-seizure-diet.aspx

Modified Atkins Diet Effectively Treats Childhood Seizures http://www.hopkinschildrens.org/Modified-Atkins-Diet-Treats-Childhood-Seizures.aspx

Carson Harris-A Patient Story http://www.hopkinschildrens.org/tpl_rlinks_nobanner.aspx?id=5972&terms=carson+harris

Journal Epilepsia http://www.epilepsia.com/

New evidence caffeine may slow Alzheimer’s disease and other dementias, restore cognitive function

2010 study posted fro filing

Contact: Astrid Engelen
a.engelen@iospress.nl
31-206-883-355
IOS Press

Researchers explore potential benefits of caffeine in special supplement to the Journal of Alzheimer’s Disease

Amsterdam, The Netherlands, May 17, 2010 – Although caffeine is the most widely consumed psychoactive drug worldwide, its potential beneficial effect for maintenance of proper brain functioning has only recently begun to be adequately appreciated. Substantial evidence from epidemiological studies and fundamental research in animal models suggests that caffeine may be protective against the cognitive decline seen in dementia and Alzheimer’s disease (AD). A special supplement to the Journal of Alzheimer’s Disease, “Therapeutic Opportunities for Caffeine in Alzheimer’s Disease and Other Neurodegenerative Diseases,” sheds new light on this topic and presents key findings.

Guest editors Alexandre de Mendonça, Institute of Molecular Medicine and Faculty of Medicine, University of Lisbon, Portugal, and Rodrigo A. Cunha, Center for Neuroscience and Cell Biology of Coimbra and Faculty of Medicine, University of Coimbra, Portugal, have assembled a group of international experts to explore the effects of caffeine on the brain. The resulting collection of original studies conveys multiple perspectives on topics ranging from molecular targets of caffeine, neurophysiological modifications and adaptations, to the potential mechanisms underlying the behavioral and neuroprotective actions of caffeine in distinct brain pathologies.

“Epidemiological studies first revealed an inverse association between the chronic consumption of caffeine and the incidence of Parkinson’s disease,” according to Mendonça and Cunha. “This was paralleled by animal studies of Parkinson’s disease showing that caffeine prevented motor deficits as well as neurodegeneration “Later a few epidemiological studies showed that the consumption of moderate amounts of caffeine was inversely associated with the cognitive decline associated with aging as well as the incidence of Alzheimer’s disease. Again, this was paralleled by animal studies showing that chronic caffeine administration prevented memory deterioration and neurodegeneration in animal models of aging and of Alzheimer’s disease.”

Key findings presented in “Therapeutic Opportunities for Caffeine in Alzheimer’s Disease and Other Neurodegenerative Diseases”:

 

  • Multiple beneficial effects of caffeine to normalize brain function and prevent its degeneration 

     

  • Caffeine’s neuroprotective profile and its ability to reduce amyloid-beta production 

     

  • Caffeine as a candidate disease-modifying agent for Alzheimer’s disease 

     

  • Positive impact of caffeine on cognition and memory performance 

     

  • Identification of adenosine A2A receptors as the main target for neuroprotection afforded by caffeine consumption 

     

  • Confirmation of data through valuable meta-analyses presented 

     

  • Epidemiological studies corroborated by meta-analysis suggesting that caffeine may be protective against Parkinson’s disease 

     

  • Several methodological issues must be solved before advancing to decisive clinical trials 

Mendonça and Cunha also observe that “the daily follow-up of patients with AD has taught us that improvement of daily living may be a more significant indicator of amelioration than slight improvements in objective measures of memory performance. One of the most prevalent complications of AD is depression of mood, and the recent observations that caffeine might be a mood normalizer are of particular interest.”

 

###

 

The supplement was funded by the Associação Industrial e Comercial do Café, while leaving full scientific independence to all contributors. The entire issue has been made available on a no-fee basis at http://iospress.metapress.com/content/t13614762731/.

Most patients survive common thyroid cancer regardless of treatment

2010 study posted for filing

Contact: David Corriveau
David.A.Corriveau@Dartmouth.edu
603-653-0771
JAMA and Archives Journals

Individuals with papillary thyroid cancer that has not spread beyond the thyroid gland appear to have favorable outcomes regardless of whether they receive treatment within the first year after diagnosis, according to a report in the May issue of Archives of Otolaryngology–Head & Neck Surgery, one of the JAMA/Archives journals.

Papillary thyroid cancer is commonly found on autopsy among individuals who died of other causes, according to background information in the article. “Studies published as early as 1947 demonstrated it, and more recently, a report has shown that nearly every thyroid gland might be found to have a cancer if examined closely enough,” the authors write. “The advent of ultrasonography and fine-needle aspiration biopsy has allowed many previously undetected cancers to be identified, changing the epidemiology of the disease. Over the past 30 years, the detected incidence of thyroid cancer has increased three-fold, the entire increase attributable to papillary thyroid cancer and 87% of the increase attributable to tumors measuring less than 2 centimeters.”

Louise Davies, M.D., M.S., of Dartmouth Medical School, Hanover, N.H. and Gilbert Welch, M.D., M.P.H., both also of Department of Veterans Affairs Medical Center, White River Junction, Vt., and The Dartmouth Institute for Health Policy and Clinical Practice, Hanover, studied cancer cases and individual treatment data from National Cancer Institute registries. They then tracked cause of death through the National Vital Statistics System.

The researchers identified 35,663 patients with papillary thyroid cancer that had not spread to the lymph nodes or other areas at diagnosis. Of these, 440 (1.2 percent) did not undergo immediate, definitive treatment. Over an average of six years of follow-up, six of these patients died of their cancer. This was not significantly different from the rate of cancer death among the 35,223 individuals who did undergo treatment (161 over an average of 7.6 years of follow-up).

The 20-year survival rate from cancer was estimated to be 97 percent for those who did not receive treatment and 99 percent for those who did. “These data help put management decisions about localized papillary thyroid cancer in perspective: papillary thyroid cancers of any size that are confined to the thyroid gland, have no lymph node metastases at presentation and do not show extraglandular extension [reach beyond the thyroid gland] are unlikely to result in death due to the cancer,” the authors write.

“Thus, clinicians and patients should feel comfortable considering the option to observe for a year or longer cancers that fall into this category,” they conclude. “When treatment is elected, the cancers in this category can be managed with either hemithyroidectomy [removal of part of the thyroid] or total thyroidectomy [removal of the complete gland], and the prognosis will be the same.”

 

###

(Arch Otolaryngol Head Neck Surg. 2010;136[5]:440-444. Available pre-embargo to the media at www.jamamedia.org.)

Editor’s Note: This study was supported in part by a Research Enhancement Award from the Department of Veterans Affairs and the Robert Wood Johnson Faculty Scholars Program. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Long-term use of vitamin E may decrease COPD risk

2010 study posted for filing

Contact: Keely Savoie
ksavoie@thoracic.org
212-315-8620
American Thoracic Society

ATS 2010, NEW ORLEANS— Long-term, regular use of vitamin E in women 45 years of age and older may help decrease the risk of chronic obstructive pulmonary disease (COPD) by about 10 percent in both smokers and non-smokers, according to a study conducted by researchers at Cornell University and Brigham and Women’s Hospital.

“As lung disease develops, damage occurs to sensitive tissues through several proposed processes, including inflammation and damage from free radicals,” said Anne Hermetet Agler, doctoral candidate with Cornell University’s Division of Nutritional Sciences. “Vitamin E may protect the lung against such damage.”

The results of the study will be presented at the ATS 2010 International Conference in New Orleans.

“The findings from our study suggest that increasing vitamin E prevents COPD,” said Ms. Agler. “Previous research found that higher intake of vitamin E was associated with a lower risk of COPD, but the studies were not designed to answer the question of whether increasing vitamin E intake would prevent COPD. Using a large, randomized controlled trial to answer this question provided stronger evidence than previous studies.”

Ms. Agler and colleagues reviewed data compiled by the Women’s Health Study, a multi-year, long-term effort ending in 2004 that focused on the effects of aspirin and vitamin E in the prevention of cardiovascular disease and cancer in nearly 40,000 women aged 45 years and older. Study participants were randomized to receive either 600 mg of vitamin E or a placebo every other day during the course of the research.

Although fewer women taking vitamin E developed COPD, Ms. Agler noted the supplements appeared to have no effect on asthma, and women taking vitamin E supplements were diagnosed with asthma at about the same rate as women taking placebo pills. Importantly, Ms. Agler noted the decreased risk of COPD in women who were given vitamin E was the same for smokers as for non-smokers.

Ms. Agler said further research will explore the way vitamin E affects the lung tissue and function, and will assess the effects of vitamin E supplements on lung diseases in men.

“If results of this study are borne out by further research, clinicians may recommend that women take vitamin E supplements to prevent COPD,” Ms. Agler noted. “Remember that vitamin E supplements are known to have detrimental effects in some people; for example vitamin E supplementation increased risk of congestive heart failure in cardiovascular disease patients. Broader recommendations would need to balance both benefits and risks. ”

 

###

 

“Randomized Vitamin E Supplementation and Risk of Chronic Lung Disease (CLD) in the Women’s Health Study” (Session C103, Tuesday, May 18, 1:30- 4:00 p.m., CC-Room 353-355 (Third Level), Morial Convention Center; Abstract 3727)

82nd Health Research Report 31 MAY 2010 – Reconstruction

Health Research Report

82nd Issue 31 May 2010

Compiled By Ralph Turchiano

www.healthresearchreport.me www.vit.bz

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

www.engineeringevil.com

In this Issue:

1. Long-term use of vitamin E may decrease COPD risk

2. Eating processed meats, but not unprocessed red meats, may raise risk of heart disease and diabetes

3. Most patients survive common thyroid cancer regardless of treatment

4. ‘Fountain of youth’ steroids could protect against heart disease. Such as Pregnenolone and DHEA

5. New evidence caffeine may slow Alzheimer’s disease and other dementias, restore cognitive function

6. High-fat ketogenic diet effectively treats persistent childhood seizures

7. Study: Yogurt-like drink DanActive reduced rate of common infections in daycare children

8. Estrogen-lowering drugs minimize surgery in breast cancer patients

9. Prenatal exposure to endocrine-disrupting chemicals linked to breast cancer

10. Anti-aging supplements may be best taken not too late in life

11. Folate prevents alcohol-induced congenital heart defects in mice

12. LSUHSC researcher finds surprising link between sugar in drinks and blood pressure

13. Dangerous lung worms found in people who eat raw crayfish

14. Some bisphosphonates users unfamiliar with drug’s possible side effects on oral health

15. You have no natural right to food

 

Public release date: 16-May-2010

Long-term use of vitamin E may decrease COPD risk

ATS 2010, NEW ORLEANS— Long-term, regular use of vitamin E in women 45 years of age and older may help decrease the risk of chronic obstructive pulmonary disease (COPD) by about 10 percent in both smokers and non-smokers, according to a study conducted by researchers at Cornell University and Brigham and Women’s Hospital.

“As lung disease develops, damage occurs to sensitive tissues through several proposed processes, including inflammation and damage from free radicals,” said Anne Hermetet Agler, doctoral candidate with Cornell University’s Division of Nutritional Sciences. “Vitamin E may protect the lung against such damage.”

The results of the study will be presented at the ATS 2010 International Conference in New Orleans.

“The findings from our study suggest that increasing vitamin E prevents COPD,” said Ms. Agler. “Previous research found that higher intake of vitamin E was associated with a lower risk of COPD, but the studies were not designed to answer the question of whether increasing vitamin E intake would prevent COPD. Using a large, randomized controlled trial to answer this question provided stronger evidence than previous studies.”

Ms. Agler and colleagues reviewed data compiled by the Women’s Health Study, a multi-year, long-term effort ending in 2004 that focused on the effects of aspirin and vitamin E in the prevention of cardiovascular disease and cancer in nearly 40,000 women aged 45 years and older. Study participants were randomized to receive either 600 mg of vitamin E or a placebo every other day during the course of the research.

Although fewer women taking vitamin E developed COPD, Ms. Agler noted the supplements appeared to have no effect on asthma, and women taking vitamin E supplements were diagnosed with asthma at about the same rate as women taking placebo pills. Importantly, Ms. Agler noted the decreased risk of COPD in women who were given vitamin E was the same for smokers as for non-smokers.

Ms. Agler said further research will explore the way vitamin E affects the lung tissue and function, and will assess the effects of vitamin E supplements on lung diseases in men.

“If results of this study are borne out by further research, clinicians may recommend that women take vitamin E supplements to prevent COPD,” Ms. Agler noted. “Remember that vitamin E supplements are known to have detrimental effects in some people; for example vitamin E supplementation increased risk of congestive heart failure in cardiovascular disease patients. Broader recommendations would need to balance both benefits and risks. ”

Public release date: 17-May-2010

Eating processed meats, but not unprocessed red meats, may raise risk of heart disease and diabetes

Boston, MA – In a new study, researchers from the Harvard School of Public Health (HSPH) have found that eating processed meat, such as bacon, sausage or processed deli meats, was associated with a 42% higher risk of heart disease and a 19% higher risk of type 2 diabetes. In contrast, the researchers did not find any higher risk of heart disease or diabetes among individuals eating unprocessed red meat, such as from beef, pork, or lamb. This work is the first systematic review and meta-analysis of the worldwide evidence for how eating unprocessed red meat and processed meat relates to risk of cardiovascular diseases and diabetes.

“Although most dietary guidelines recommend reducing meat consumption, prior individual studies have shown mixed results for relationships between meat consumption and cardiovascular diseases and diabetes,” said Renata Micha, a research fellow in the department of epidemiology at HSPH and lead author of the study. “Most prior studies also did not separately consider the health effects of eating unprocessed red versus processed meats.”

The study appears online May 17, 2010, on the website of the journal Circulation.

The researchers, led by Renata Micha, a research fellow in the department of epidemiology, and HSPH colleagues Dariush Mozaffarian, assistant professor in the department of epidemiology and Sarah Wallace, junior research fellow in the department of epidemiology, systematically reviewed nearly 1,600 studies. Twenty relevant studies were identified, which included a total of 1,218,380 individuals from 10 countries on four continents (United States, Europe, Australia, and Asia).

The researchers defined unprocessed red meat as any unprocessed meat from beef, lamb or pork, excluding poultry. Processed meat was defined as any meat preserved by smoking, curing or salting, or with the addition of chemical preservatives; examples include bacon, salami, sausages, hot dogs or processed deli or luncheon meats. Vegetable or seafood protein sources were not evaluated in these studies.

The results showed that, on average, each 50 gram (1.8 oz) daily serving of processed meat (about 1-2 slices of deli meats or 1 hot dog) was associated with a 42% higher risk of developing heart disease and a 19% higher risk of developing diabetes. In contrast, eating unprocessed red meat was not associated with risk of developing heart disease or diabetes. Too few studies evaluated the relationship between eating meat and risk of stroke to enable the researchers to draw any conclusions.

“Although cause-and-effect cannot be proven by these types of long-term observational studies, all of these studies adjusted for other risk factors, which may have been different between people who were eating more versus less meats,” said Mozaffarian. “Also, the lifestyle factors associated with eating unprocessed red meats and processed meats were similar, but only processed meats were linked to higher risk.”

“When we looked at average nutrients in unprocessed red and processed meats eaten in the United States, we found that they contained similar average amounts of saturated fat and cholesterol. In contrast, processed meats contained, on average, 4 times more sodium and 50% more nitrate preservatives,” said Micha. “This suggests that differences in salt and preservatives, rather than fats, might explain the higher risk of heart disease and diabetes seen with processed meats, but not with unprocessed red meats.”

Dietary sodium (salt) is known to increase blood pressure, a strong risk factor for heart disease. In animal experiments, nitrate preservatives can promote atherosclerosis and reduce glucose tolerance, effects which could increase risk of heart disease and diabetes.

Given the differences in health risks seen with eating processed meats versus unprocessed red meats, these findings suggest that these types of meats should be studied separately in future research for health effects, including cancer, the authors said. For example, higher intake of total meat and processed meat has been associated with higher risk of colorectal cancer, but unprocessed red meat has not been separately evaluated. They also suggest that more research is needed into which factors (especially salt and other preservatives) in meats are most important for health effects.

Current efforts to update the United States government’s Dietary Guidelines for Americans, which are often a reference for other countries around the world, make these findings particularly timely, the researchers say. They recommend that dietary and policy efforts should especially focus on reducing intake of processed meat.

“To lower risk of heart attacks and diabetes, people should consider which types of meats they are eating. Processed meats such as bacon, salami, sausages, hot dogs and processed deli meats may be the most important to avoid,” said Micha. “Based on our findings, eating one serving per week or less would be associated with relatively small risk.”

Public release date: 17-May-2010

Most patients survive common thyroid cancer regardless of treatment

Individuals with papillary thyroid cancer that has not spread beyond the thyroid gland appear to have favorable outcomes regardless of whether they receive treatment within the first year after diagnosis, according to a report in the May issue of Archives of Otolaryngology–Head & Neck Surgery, one of the JAMA/Archives journals.

Papillary thyroid cancer is commonly found on autopsy among individuals who died of other causes, according to background information in the article. “Studies published as early as 1947 demonstrated it, and more recently, a report has shown that nearly every thyroid gland might be found to have a cancer if examined closely enough,” the authors write. “The advent of ultrasonography and fine-needle aspiration biopsy has allowed many previously undetected cancers to be identified, changing the epidemiology of the disease. Over the past 30 years, the detected incidence of thyroid cancer has increased three-fold, the entire increase attributable to papillary thyroid cancer and 87% of the increase attributable to tumors measuring less than 2 centimeters.”

Louise Davies, M.D., M.S., of Dartmouth Medical School, Hanover, N.H. and Gilbert Welch, M.D., M.P.H., both also of Department of Veterans Affairs Medical Center, White River Junction, Vt., and The Dartmouth Institute for Health Policy and Clinical Practice, Hanover, studied cancer cases and individual treatment data from National Cancer Institute registries. They then tracked cause of death through the National Vital Statistics System.

The researchers identified 35,663 patients with papillary thyroid cancer that had not spread to the lymph nodes or other areas at diagnosis. Of these, 440 (1.2 percent) did not undergo immediate, definitive treatment. Over an average of six years of follow-up, six of these patients died of their cancer. This was not significantly different from the rate of cancer death among the 35,223 individuals who did undergo treatment (161 over an average of 7.6 years of follow-up).

The 20-year survival rate from cancer was estimated to be 97 percent for those who did not receive treatment and 99 percent for those who did. “These data help put management decisions about localized papillary thyroid cancer in perspective: papillary thyroid cancers of any size that are confined to the thyroid gland, have no lymph node metastases at presentation and do not show extraglandular extension [reach beyond the thyroid gland] are unlikely to result in death due to the cancer,” the authors write.

“Thus, clinicians and patients should feel comfortable considering the option to observe for a year or longer cancers that fall into this category,” they conclude. “When treatment is elected, the cancers in this category can be managed with either hemithyroidectomy [removal of part of the thyroid] or total thyroidectomy [removal of the complete gland], and the prognosis will be the same.”

Public release date: 17-May-2010

‘Fountain of youth’ steroids could protect against heart disease

Such as Pregnenolone and DHEA

A natural defence mechanism against heart disease could be switched on by steroids sold as health supplements, according to researchers at the University of Leeds.

The University of Leeds biologists have identified a previously-unknown ion channel in human blood vessels that can limit the production of inflammatory cytokines – proteins that drive the early stages of heart disease.

They found that this protective effect can be triggered by pregnenolone sulphate – a molecule that is part of a family of ‘fountain-of-youth’ steroids. These steroids are so-called because of their apparent ability to improve energy, vision and memory.

Importantly, collaborative studies with surgeons at Leeds General infirmary have shown that this defence mechanism can be switched on in diseased blood vessels as well as in healthy vessels.

So-called ‘fountain of youth’ steroids are made naturally in the body, but levels decline rapidly with age. This has led to a market in synthetically made steroids that are promoted for their health benefits, such as pregnenolone and DHEA. Pregnenolone sulphate is in the same family of steroids but it is not sold as a health supplement.

“The effect that we have seen is really quite exciting and also unexpected,” said Professor David Beech, who led the study. “However, we are absolutely not endorsing any claims made by manufacturers of any health supplements. Evidence from human trials is needed first.”

A chemical profiling study indicated that the protective effect was not as strong when cholesterol was present too. This suggests that the expected benefits of ‘fountain of youth’ steroids will be much greater if they are used in combination with cholesterol-lowering drugs and/or other healthy lifestyle strategies such as diet and exercise.

“These ‘fountain of youth’ steroids are relatively cheap to make and some of them are already available as commercial products. So if we can show that this effect works in people as well as in lab-based studies, then it could be a cost-effective approach to addressing cardiovascular health problems that are becoming epidemic in our society and world-wide,” Professor Beech added.

The paper is published in Circulation Research.

Public release date: 17-May-2010

New evidence caffeine may slow Alzheimer’s disease and other dementias, restore cognitive function

Researchers explore potential benefits of caffeine in special supplement to the Journal of Alzheimer’s Disease

Amsterdam, The Netherlands, May 17, 2010 – Although caffeine is the most widely consumed psychoactive drug worldwide, its potential beneficial effect for maintenance of proper brain functioning has only recently begun to be adequately appreciated. Substantial evidence from epidemiological studies and fundamental research in animal models suggests that caffeine may be protective against the cognitive decline seen in dementia and Alzheimer’s disease (AD). A special supplement to the Journal of Alzheimer’s Disease, “Therapeutic Opportunities for Caffeine in Alzheimer’s Disease and Other Neurodegenerative Diseases,” sheds new light on this topic and presents key findings.

Guest editors Alexandre de Mendonça, Institute of Molecular Medicine and Faculty of Medicine, University of Lisbon, Portugal, and Rodrigo A. Cunha, Center for Neuroscience and Cell Biology of Coimbra and Faculty of Medicine, University of Coimbra, Portugal, have assembled a group of international experts to explore the effects of caffeine on the brain. The resulting collection of original studies conveys multiple perspectives on topics ranging from molecular targets of caffeine, neurophysiological modifications and adaptations, to the potential mechanisms underlying the behavioral and neuroprotective actions of caffeine in distinct brain pathologies.

“Epidemiological studies first revealed an inverse association between the chronic consumption of caffeine and the incidence of Parkinson’s disease,” according to Mendonça and Cunha. “This was paralleled by animal studies of Parkinson’s disease showing that caffeine prevented motor deficits as well as neurodegeneration “Later a few epidemiological studies showed that the consumption of moderate amounts of caffeine was inversely associated with the cognitive decline associated with aging as well as the incidence of Alzheimer’s disease. Again, this was paralleled by animal studies showing that chronic caffeine administration prevented memory deterioration and neurodegeneration in animal models of aging and of Alzheimer’s disease.”

Key findings presented in “Therapeutic Opportunities for Caffeine in Alzheimer’s Disease and Other Neurodegenerative Diseases”:

•Multiple beneficial effects of caffeine to normalize brain function and prevent its degeneration

•Caffeine’s neuroprotective profile and its ability to reduce amyloid-beta production

•Caffeine as a candidate disease-modifying agent for Alzheimer’s disease

•Positive impact of caffeine on cognition and memory performance

•Identification of adenosine A2A receptors as the main target for neuroprotection afforded by caffeine consumption

•Confirmation of data through valuable meta-analyses presented

•Epidemiological studies corroborated by meta-analysis suggesting that caffeine may be protective against Parkinson’s disease

•Several methodological issues must be solved before advancing to decisive clinical trials

Mendonça and Cunha also observe that “the daily follow-up of patients with AD has taught us that improvement of daily living may be a more significant indicator of amelioration than slight improvements in objective measures of memory performance. One of the most prevalent complications of AD is depression of mood, and the recent observations that caffeine might be a mood normalizer are of particular interest.”

Public release date: 17-May-2010

 

High-fat ketogenic diet effectively treats persistent childhood seizures

The high-fat ketogenic diet can dramatically reduce or completely eliminate debilitating seizures in most children with infantile spasms, whose seizures persist despite medication, according to a Johns Hopkins Children’s Center study published online April 30 in the journal Epilepsia.

Infantile spasms, also called West syndrome, is a stubborn form of epilepsy that often does not get better with antiseizure drugs. Because poorly controlled infantile spasms may cause brain damage, the Hopkins team’s findings suggest the diet should be started at the earliest sign that medications aren’t working.

“Stopping or reducing the number of seizures can go a long way toward preserving neurological function, and the ketogenic diet should be our immediate next line of defense in children with persistent infantile spasms who don’t improve with medication,” says senior investigator Eric Kossoff, M.D., a pediatric neurologist and director of the ketogenic diet program at Hopkins Children’s.

The ketogenic diet, made up of high-fat foods and few carbohydrates, works by triggering biochemical changes that eliminate seizure-causing short circuits in the brain’s signaling system. It has been used successfully in several forms of epilepsy.

A small 2002 study by the same Hopkins team showed the diet worked well in a handful of children with infantile spasms. The new study is the largest analysis thus far showing just how effective the diet can be in children with this condition.

Of the 104 children treated by the Hopkins team, nearly 40 percent, or 38 children, became seizure-free for at least six months after being on the diet for anywhere from just a few days to 20 months. Of the 38, 30 have remained so without a relapse for at least two years.

After three months on the diet, one-third of the children had 90 percent fewer seizures, and after nine months on the diet, nearly half of the children in the study had 90 percent fewer seizures. Nearly two-thirds had half as many seizures after six months on the diet.

Nearly two-thirds of the children experienced improvement in their neurological and cognitive development, and nearly 30 percent were weaned off antiseizure medications after starting the diet.

Most of the children continued taking their medication even after starting the diet, the researchers say, because the two are not mutually exclusive and can often work in synergy.

Researchers also used the diet as first-line therapy in18 newly diagnosed infants never treated with drugs, 10 of whom became seizure free within two weeks of starting the diet. The finding suggests that, at least in some children, the diet may work well as first-line therapy, but the researchers say they need further and larger studies to help them identify patients for whom the diet is best used before medications. Hopkins Children’s neurologists are actively using the ketogenic diet as first-line treatment in children with infantile spasms with promising results.

Side effects, including constipation, heartburn, diarrhea and temporary spikes in cholesterol levels, occurred in one-third of the children, with six percent of them experiencing diminished growth.

Despite these side effects, a recent study by Kossoff and his team showed that the ketogenic diet is safe long term.

Conflict of interest disclosure: Dr. Kossoff has received grant support from Nutricia Inc., for unrelated research. The terms of these arrangements are being managed by the Johns Hopkins University in accordance with its conflict-of-interest policies.

Public release date: 19-May-2010

Study: Yogurt-like drink DanActive reduced rate of common infections in daycare children

Washington, DC – The probiotic yogurt-like drink DanActive reduced the rate of common sicknesses such as ear infections, sinusitis, the flu and diarrhea in daycare children, say researchers who studied the drink in the largest known probiotic clinical trial to be conducted in the United States. An additional finding, however, showed no reduction in the number school days missed. The study led by Daniel Merenstein of Georgetown University School of Medicine (GUSOM), was funded by The Dannon Company, Inc., and published today online in the European Journal of Clinical Nutrition.

Probiotic foods are continuing to increase in popularity and some are marketed for the potential benefits of probiotics such as Lactobacillus casei (L. casei) DN-114 001, the probiotic in DanActive. Studies in other countries have found that probiotics, which are live micro-organisms, produce positive health benefits in children, including the reduction of school days missed due to infections. However, most of the research was conducted outside the United States in structured conditions not comparable to normal everyday living.

“We were interested in a study that resembled how children in the U.S. consume drinks that are stored in home refrigerators and consumed without study personnel observation,” says the study’s lead author Daniel Merenstein, MD, director of research in the Department of Family Medicine at GUSOM.

“…To our knowledge this is the largest probiotic clinical trial conducted in the U.S. and provides much needed data,” say the authors of the study. “We studied a functional food, not a medicinal product; parents will thus feed their children without any physician input and we felt it was best to assess [the drink] under similar conditions.”

The study, titled DRINK (Decreasing the Rates of Illness in Kids), was a randomized, double-blind, placebo-controlled study – the gold standard in clinical research design. It included 638 healthy children, aged three to six, who attended school five days a week. Parents were asked to give their child a daily strawberry yogurt-like drink. Some of the drinks were supplemented with the probiotic strain L. casei DN-114 001 (DanActive), while others had no probiotics (placebo). Neither the study coordinators, the children, nor the parents knew which drink was given to which participant until the study ended. In addition to phone interviews with researchers, parents kept daily diaries of their child’s health and the number of drinks consumed.

Researchers found a 19 percent decrease of common infections among the children who drank the yogurt-like drink with L. casei DN-114 001 compared to those whose drink did not have the probiotic. More specifically, those who drank DanActive had 24 percent fewer gastrointestinal infections (such as diarrhea, nausea, and vomiting), and 18 percent fewer upper respiratory tract infections (such as ear infections, sinusitis and strep). However, the reduction in infections did not result in fewer missed school days or activities – also a primary outcome of the study.

“Our study had mixed results,” says Merenstein. “Children in school or daycare are especially susceptible to these illnesses. We did find some differences in infection rates but this did not translate to fewer missed school days or change in daily activity. It is my hope that safe and tolerable ways to reduce illnesses could eventually result in fewer missed school days which means fewer work days missed by parents.”

“It is important that more of these products are put under the microscope by independent academic researchers,” he concludes.

Public release date: 20-May-2010

Estrogen-lowering drugs minimize surgery in breast cancer patients

A nationwide study has confirmed the benefit of giving estrogen-lowering drugs before surgery to breast cancer patients. The treatment increased the likelihood that women could undergo breast-conservation surgery, also called lumpectomy, instead of mastectomy.

The study’s chair, Matthew J. Ellis, MD, PhD, the Anheuser-Busch Endowed Chair in Medical Oncology and a breast cancer specialist with the Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis, will present the findings June 7 at the annual meeting of the American Society of Clinical Oncology.

Sponsored by the American College of Surgeons Oncology Group, the study took place at 118 hospitals across the country and involved 352 postmenopausal women with estrogen-receptor positive (ER+) breast tumors. The participants received aromatase inhibitors for 16 weeks before surgery for breast cancer, and the extent of their tumors was monitored before and after the drug treatment.

The lead investigator at the Washington University site was Julie A. Margenthaler, MD, assistant professor of surgery and a breast surgeon at the Siteman Cancer Center.

Aromatase inhibitors are also referred to as estrogen-lowering agents because they interfere with the body’s production of estrogen, a hormone that stimulates the growth of ER+ breast tumors. ER+ is the most common breast cancer, accounting for three-quarters of cases.

All women in the study had stage II or III breast cancer, in which tumors are about an inch or larger in size and may have spread to the lymph nodes in the underarm area. Participants were placed in one of three groups at the study’s start:

•marginal, meaning breast-conservation surgery was possible but likely to be disfiguring or to require several surgical procedures;

•mastectomy-only, meaning breast-conservation surgery was not possible; and

•inoperable, meaning mastectomy would not completely remove the cancer.

After the 16-week aromatase inhibitor therapy, the women were reevaluated to see which surgical option was appropriate for them. The results showed that 82 percent of women in the marginal group, 51 percent in the mastectomy-only group and 75 percent in the inoperable group had successful breast-conservation surgery instead of mastectomy.

“Aromatase inhibitor therapy shrank the tumors in many of these women and improved surgical outcomes,” Ellis says. “These results will encourage a change in practice across the country so that more women can benefit from the currently underutilized approach of administering estrogen-lowering agents before surgery.”

The study participants were randomly assigned to receive one of three estrogen-lowering agents: exemestane (25 mg daily), letrozole (2.5 mg daily) or anastrozole (1 mg daily). No statistically significant difference in effectiveness was found among the three drugs.

Ellis explains that there are other benefits to using estrogen-lowering agents before surgery.

“ER+ breast cancer can be thought of as a chronic disease because patients generally take estrogen-lowering agents for many years after surgery to repress recurrence,” Ellis says. “In other chronic diseases, such as hypertension or diabetes, a patient’s response to treatment is continually monitored. But we’ve never done that with breast cancer. By treating breast cancer patients with estrogen-lowering drugs for three or four months before surgery, we can monitor treatment response and then specifically tailor surgical and post-surgical treatment based on this response.”

 

Public release date: 21-May-2010

Prenatal exposure to endocrine-disrupting chemicals linked to breast cancer

A study in mice reveals that prenatal exposure to endocrine-disrupting chemicals, like bisphenol-A (BPA) and diethylstilbestrol (DES), may program a fetus for life. Therefore, adult women who were exposed prenatally to BPA or DES could be at increased risk of breast cancer, according to a new study accepted for publication in Hormones & Cancer, a journal of The Endocrine Society.

Endocrine-disrupting chemicals are substances in the environment that interfere with hormone biosynthesis, metabolism or action resulting in adverse developmental, reproductive, neurological and immune effects in both humans and wildlife. These chemicals are designed, produced and marketed largely for specific industrial purposes.

“BPA is a weak estrogen and DES is a strong estrogen, yet our study shows both have a profound effect on gene expression in the mammary gland (breast) throughout life,” said Hugh Taylor, MD, of the Yale University School of Medicine in New Haven, Conn. and lead author of the study. “All estrogens, even ‘weak’ ones can alter the development of the breast and ultimately place adult women who were exposed to them prenatally at risk of breast cancer.”

In this study, researchers treated pregnant mice with BPA or DES and then looked at the offspring as adults. When the offspring reached adulthood, their mammary glands still produced higher levels of EZH2, a protein that plays a role in the regulation of all genes. Higher EZH2 levels are associated with an increased risk of breast cancer in humans.

“We have demonstrated a novel mechanism by which endocrine-disrupting chemicals regulate developmental programming in the breast,” said Taylor. “This study generates important safety concerns about exposures to environmental endocrine disruptors such as BPA and suggests a potential need to monitor women exposed to these chemicals for the development of breast lesions as adults.”

Ralph’s Note – How many more warnings do we need ? If this stuff is not banned now. We may be responsible for the deaths of many generations to come.

 

Public release date: 24-May-2010

Anti-aging supplements may be best taken not too late in life

Anti-aging supplements made up of mixtures might be better than single compounds at preventing decline in physical function, according to researchers at the University of Florida’s Institute on Aging. In addition, it appears that such so-called neutraceuticals should be taken before very old age for benefits such as improvement in physical function.

The findings from rat studies, published last week in the journal PLoS One, have implications for how dietary supplementation can be used effectively in humans.

“I think it is important for people to focus on good nutrition, but for those of advanced age who are running out of energy and not moving much, we’re trying to find a supplement mixture that can help improve their quality of life,” said Christiaan Leeuwenburgh, Ph.D., senior author of the paper and chief of the biology of aging division in the UF College of Medicine.

Scientists do not fully understand all the processes that lead to loss of function as people age. But more and more research points to the mitochondrial free radical theory of aging, that as people age, oxidative damage piles up in individual cells such that the energy-generation system inside some cells stops working properly.

To address that problem, many anti-aging studies and supplements are geared toward reducing the effects of free radicals.

The UF researchers investigated the potential anti-aging benefits of a commercially available mixture marketed for relieving chronic fatigue and protecting against muscle aging. The supplement contains the antioxidant coenzyme Q10, creatine — a compound that aids muscle performance — and ginseng, which also has been shown to have antioxidant properties.

The study gauged the effects of the mixture on physical performance as well as on two mechanisms that underlie the aging process and many age-related disorders: dysfunction of the cells’ energy producing powerhouses, known as mitochondria, and oxidative stress.

The researchers fed the supplement to middle-aged 21-month-old and late-middle-aged 29-month-old rats — corresponding to 50- to 65-year-old and 65- to 80-year-old humans, respectively — for six weeks, and measured how strongly their paws could grip. Grip strength in rats is analogous to physical performance in humans, and deterioration in grip strength can provide useful information about muscle weakness or loss seen in older adults.

Grip strength improved 12 percent in the middle-aged rats compared with controls, but no improvement was found in the older group.

Measurements of the function of mitochondria corresponded with the grip strength findings. Stress tests showed that mitochondrial function improved 66 percent compared with controls in middle-aged rats but not in the older ones. That suggests that supplementation might be of greater effect before major age-related functional and other declines have set in, the researchers said.

“It is possible that there is a window during which these compounds will work, and if the intervention is given after that time it won’t work,” said Jinze Xu, Ph.D., first author of the paper and a postdoctoral researcher at UF.

The researchers are working to identify the optimal age at which various interventions can enhance behavioral or physical performance. Very few studies have been done to show the effect of interventions on the very old.

Interestingly, although the older rats had no improvement in physical performance or mitochondrial function, they had lowered levels of oxidative damage.

That shows that reduction of oxidative stress damage is not always matched by functional changes such as improvement in muscle strength.

As a result, research must focus on compounds that promote proper functioning of the mitochondria, since mitochondrial health is essential in older animals for reducing oxidative stress, the researchers said. And clinical trials need to be performed to test the effectiveness of the supplements in humans.

“It’s going to be very important to focus less on oxidative stress and biomarkers, and focus on having sufficient energy,” Leeuwenburgh said. “If energy declines, then you have an increased chance for oxidative stress or failure of repair mechanisms that recognize oxidative damage — we’re seeing that the health of mitochondria is central to aging.”

It is possible that although the supplement could help reduce the oxidative stress damage, because damage in much older animals was too great, energy could not be restored.

The different compounds in the mixture acted to produce effects that single compounds did not, because each component affected a different biochemical pathway in the body, addressing both oxidative stress and mitochondrial function, researchers said.

“People are catching on that using a single compound is not a good strategy — you have to use multiple compounds and target one or multiple pathways,” Leeuwenburgh said.

Public release date: 24-May-2010

Folate prevents alcohol-induced congenital heart defects in mice

University of South Florida study suggests high dose needed very early in pregnancy to protect developing heart

Tampa, FL (May 24, 2010) — A new animal study has found that high levels of the B-vitamin folate (folic acid) prevented heart birth defects induced by alcohol exposure in early pregnancy, a condition known as fetal alcohol syndrome.

Researchers at the University of South Florida College of Medicine and All Children’s Hospital report that the protection was afforded only when folate was administered very early in pregnancy and before the alcohol exposure. The dose that best protected against heart defects in mice was considerably higher than the current dietary recommendation of 400 micrograms (0.4 milligrams) daily for women of child-bearing age.

The findings were published online earlier this month in the American Journal of Obstetrics and Gynecology.

While more research is needed, the study has implications for re-evaluating folate supplementation levels during early pregnancy, said principal investigator Kersti Linask, PhD, the Mason Professor of Cardiovascular Development at USF and Children’s Research Institute/All Children’s Hospital.

“Congenital heart defects can occur in the developing embryo at a time when women typically do not even know they are pregnant – 16 to 18 days following conception. They may have been drinking alcohol or using prescription drugs without realizing this could be affecting embryonic development,” Dr. Linask said.

“We found that we could prevent alcohol-associated defects from arising in the mice — provided folate was given in relatively high concentrations very early in pregnancy around conception.”

In the USF study, two randomly assigned groups of pregnant mice were fed diets supplemented by folate in adjusted doses known from epidemiological studies to rescue human embryos from craniofacial birth defects. From the day after conception, one group received a high dose of folate supplementation (10.5 milligrams/kilogram) and the second received a moderate dose (6.2 mg/kg). A third control group ate a normal folate-supplemented diet (3.3 mg/kg) determined to maintain the general health of the pregnant mice, but not to rescue embryos from birth defects.

During the first week of pregnancy, the mice in all three groups were then administered injections of alcohol simulating a single binge drinking event in humans.

Following this alcohol exposure, Doppler ultrasound confirmed that 87 percent of the embryos of pregnant mice in the third group – those not receiving folate supplementation beyond what was present in their normal diets – had developed heart valve defects. The affected embryos were also smaller in size and their heart muscle walls appeared thinner.

Between days 15 and 16 of pregnancy in the mice – equal to 56 days of gestation in humans — ultrasound also showed that the high-folate diet protected heart valve development against lasting defects and restored heart function and embryonic size to near-normal levels. The moderate-folate diet provided only partial protection; in this group 58 percent of the mouse embryos developed heart valves that functioned abnormally, with a back flow of blood.

The researchers suggest that folate fortification may be most effective at preventing heart birth defects when administered at significantly higher levels than the doses currently recommended to prevent pregnancy complications — both in normal women (0.4 milligrams recommended daily) and even in women who have delivered an infant with a spinal birth defect (4 milligrams daily). Although higher folate levels did not cause adverse side effects in the pregnant mice, Dr. Linask notes, the safety and effectiveness of higher doses must be proven with human trials.

The heart is the first organ to form and function during embryonic development of vertebrates. The USF researchers suggest that folate supplementation thwarts alcohol’s damaging effect on an important early signaling pathway that plays a vital role in early heart development and subsequently in valve formation.

 

Public release date: 24-May-2010

LSUHSC researcher finds surprising link between sugar in drinks and blood pressure

New Orleans, LA – Research led by Liwei Chen, MD, PhD, Assistant Professor of Public Health at LSU Health Sciences Center New Orleans, has found that there is an association between sugary drinks and blood pressure and that by cutting daily consumption of sugary drinks by just one serving a day, people can lower their blood pressure. The research is published online in Circulation: Journal of the American Heart Association.

“We found no association for diet beverage consumption or caffeine intake and blood pressure,” notes Dr. Chen, “suggesting that sugar may actually be the nutrient that is associated with blood pressure and not caffeine which many people would suspect.”

The research, which was supported by a grant from the National Heart, Lung, and Blood Institute of the National Institutes of Health, analyzed dietary intake and blood pressure of 810 adults measured at baseline, 6 and 18 months. After known risk factors of high blood pressure were controlled for, a reduction in sugar-sweetened beverage consumption of one serving per day was associated with a drop of 1.8 mm Hg in systolic pressure and 1.1 mm Hg in diastolic blood pressure over 18 months.

After additional adjustment for weight change over the same period, a reduction in the consumption of sugar-sweetened beverages was still significantly associated with blood pressure reduction.

“By reducing the amount of sugar in your diet, you are also reducing the number of calories you consume and may lose weight,” adds Dr. Chen. “But even among those whose weight was stable, we still found that people who drank fewer sugary sodas lowered their blood pressure.”

Elevated blood pressure continues to be one of the most common and important problems in the United States. According to the American Heart Association, about 74.5 million people in the United States, or one in three people, age 20 and older have high blood pressure. It is estimated that high blood pressure killed 56,561Americans in 2006. From 1996 to 2006, the death rate from high blood pressure increased 19.5 percent, and the actual number of deaths rose 48.1 percent.

Normal blood pressure, measured in millimeters of mercury, is defined as systolic (top number) less than 120 and diastolic (bottom number) less than 80. High blood pressure (hypertension) is a systolic pressure of 140 or higher and a diastolic pressure of 90 or higher. Pressures falling in the range between are considered to be prehypertension.

High blood pressure, which usually has few symptoms, if any, is an established risk factor for stroke, cardiovascular disease, kidney failure, and shortened life expectancy.

“More research is needed to establish the causal relationship, but in the meantime, people can benefit right now by reducing their intake of sugary drinks by at least one serving per day,” concludes Dr. Chen.

Public release date: 25-May-2010

Dangerous lung worms found in people who eat raw crayfish

If you’re headed to a freshwater stream this summer and a friend dares you to eat a raw crayfish – don’t do it. You could end up in the hospital with a severe parasitic infection.

Physicians at Washington University School of Medicine in St. Louis have diagnosed a rare parasitic infection in six people who had consumed raw crayfish from streams and rivers in Missouri. The cases occurred over the past three years, but three have been diagnosed since last September; the latest in April. Before these six, only seven such cases had ever been reported in North America, where the parasite, Paragonimus kellicotti, is common in crayfish.

“The infection, called paragonimiasis, is very rare, so it’s extremely unusual to see this many cases in one medical center in a relatively short period of time,” says Washington University infectious diseases specialist Gary Weil, MD, professor of medicine and of molecular microbiology, who treated some of the patients. “We are almost certain there are other people out there with the infection who haven’t been diagnosed. That’s why we want to get the word out.”

Paragonimiasis causes fever, cough, chest pain, shortness of breath and extreme fatigue. The infection is generally not fatal, and it is easily treated if properly diagnosed. But the illness is so unusual that most doctors are not aware of it. Most of the patients had received multiple treatments for pneumonia and undergone invasive procedures before they were referred to Barnes-Jewish Hospital or St. Louis Children’s Hospital at Washington University Medical Center.

The half-inch, oval-shaped parasitic worms at the root of the infection primarily travel from the intestine to the lungs. They also can migrate to the brain, causing severe headaches or vision problems, or under the skin, appearing as small, moving nodules.

Some of the patients had been in and out of the hospital for months as physicians tried to diagnose their mysterious illness and treat their symptoms, which also included a buildup of fluid around the lungs and around the heart. One patient even had his gallbladder removed, to no avail.

“Some of these invasive procedures could have been avoided if the patients had received a prompt diagnosis,” says Michael Lane, MD, an infectious diseases fellow at the School of Medicine who treated some of the patients. “We hope more doctors will now have this infection on their radar screens for patients with an unexplained lingering fever, cough and fatigue.”

Once the diagnosis is made, paragonimiasis is easily treated with an oral drug, praziquantel, taken three times a day for only two days. Symptoms begin to improve within a few days and are typically gone within seven to 10 days. All the patients have completely recovered, even one patient who temporarily lost his vision when parasites invaded the brain.

The recent infections, which occurred in patients ages 10-32, have prompted the Missouri Department of Health & Senior Services to issue a health advisory alerting doctors across the state. The department also printed posters warning people not to eat raw crayfish and placed them in campgrounds and canoe rental businesses near popular Missouri streams. Thoroughly cooking crayfish kills the parasite and does not pose a health risk.

Paragonimiasis is far more common in East Asia, where many thousands of cases are diagnosed annually in people who consume raw or undercooked crab that contain Paragonimus westermani, a cousin to the parasite in North American crayfish.

While the U.S. Centers for Disease Control and Prevention has an antibody test to identify Paragonimus westermani infection, the test is not sensitive for patients with P. kellicotti parasite, and this makes diagnosis a real challenge. Diagnostic clues include elevated levels of white blood cells called eosinophils. These cells typically are elevated in patients with worm parasites, but they can also occur in more common illnesses, including cancer, autoimmune disease and allergy. X-rays also show excess fluid around the lungs and sometimes the heart.

“You have to be a bit of a detective and be open to all the clues,” says Washington University infectious diseases specialist Thomas Bailey, MD, professor of medicine, who diagnosed and treated the first case at the School of Medicine.

As a case in point, the first patient who sought treatment at Washington University had had a fever and cough for several weeks. His chest X-ray showed fluid around the lungs, and blood tests showed elevated levels of eosinophils.

The “aha moment” for Bailey occurred when the patient’s wife mentioned that his symptoms developed about a week after he ate raw crayfish from a Missouri river, and Bailey recalled that in Asia eating raw or undercooked crabs can lead to a paragonimus infection. With a quick search of the medical literature, Bailey learned that rare cases of North American paragonimiasis had been described in patients eating raw crayfish. The scenario fit perfectly with his patient.

“That’s the interesting thing about being an infectious diseases doctor,” Bailey says. “Every time you see a new patient you have to be open to the possibility that the diagnosis could be something highly unusual.”

Crayfish are common throughout North America, where hundreds of species live in rivers, streams, lakes and ponds. The parasite P. kellicotti has a complex life cycle. It lives in snails and crayfish but only causes a dangerous infection if it ingested by mammals, including dogs, cats and humans, who eat it raw.

No one knows why more cases of paragonimiasis are being diagnosed now, but doctors and researchers at Washington University are studying the parasite and hope to develop a better diagnostic test for the infection. For now, the message for physicians is to consider paragonimiasis in patients with cough, fever and eosinophilia. The simple message for the public is: “Do not eat raw crayfish,” Weil says.

 

Public release date: 26-May-2010

Some bisphosphonates users unfamiliar with drug’s possible side effects on oral health

CHICAGO, May 26, 2010 – People undergoing bisphosphonate therapy to prevent or treat osteoporosis (a thinning of the bones) may be unfamiliar with the drug and possible adverse side effects on oral health, according to a study in the May issue of the Journal of the American Dental Association (JADA).

Use of bisphosphonates has been associated with a small risk of developing bisphosphonate-associated osteonecrosis of the jaw (BON) that occurs spontaneously or after the patient has undergone dental surgery. BON is a rare but serious condition that can cause severe damage to the jaw bone. The prevalence of BON is between three and 12 percent for patients who receive bisphosphonates intravenously for cancer therapy and less than one percent for patients who receive bisphosphonates orally for osteoporosis or osteopenia.

In the study, the authors sought to determine whether patients taking bisphosphonates had knowledge about the medical indication for the therapy and how long the treatment would last. They also wanted to know whether participants’ physicians told them about possible adverse reactions.

The researchers interviewed 73 participants (71 women, two men) seeking routine care in a dental clinic. These participants, with an average age of 66 years that ranged from 44 to 88 years, also were undergoing bisphosphonate treatment. Eighty-four percent of the participants stated they knew why they were receiving bisphosphonate therapy. However, 80 percent said they were unsure about the duration of the therapy and 82 percent could not recall receiving information about the risk of experiencing adverse reactions, including oral osteonecrosis, by their physicians.

“The results of our small study show that patients who take bisphosphonates may not be aware that BON can develop after they undergo invasive dental care,” the authors wrote. “We believe that a more effective communication process between prescribing physicians, dentists and patients using bisphosphonates is needed.”

The American Dental Association Advisory Committee on Medication-induced Osteonecrosis of the Jaw recommends that dental patients on bisphosphonate therapy advise their dentist. The Committee believes that it is always appropriate for physicians to encourage patients to visit the dentist regularly for professional cleanings and oral exams, as recommended by their dentist. This is especially important for patients whose oral health is put at risk from medications or medical problems.

Public release date: 26-May-2010

 

You have no natural right to food

The Farm-to-Consumer Legal Defense Fund (FTCLDF), an organization whose mission includes “defending the rights and broadening the freedoms of family farms and protecting consumer access to raw milk and nutrient dense foods”, recently filed a lawsuit against the FDA for its ban on interstate sales of raw milk. The suit alleges that such a restriction is a direct violation of the United States Constitution. Nevertheless, the suit led to a surprisingly cold response from the FDA about its views on food freedom (and freedoms in general).

In a dismissal notice issued to the Iowa District Court where the suit was filed, the FDA officially made public its views on health and food freedom. These views will shock you, but they reveal the true evil intent of the FDA and why it is truly a rogue federal agency.

The FDA essentially believes that nobody has the right to choose what to eat or drink. You are only “allowed” to eat or drink what the FDA gives you permission to. There is no inherent right or God-given right to consume any foods from nature without the FDA’s consent.

This is no exaggeration. It’s exactly what the FDA said in its own words.

You have no natural right to food

The FTCLDF highlighted a few of the key phrases from the FDA’s response document in a recent email to its supporters. They include the following two statements from the FDA:

“There is no ‘deeply rooted’ historical tradition of unfettered access to foods of all kinds.” [p. 26]

 

“Plaintiffs’ assertion of a ‘fundamental right to their own bodily and physical health, which includes what foods they do and do not choose to consume for themselves and their families’ is similarly unavailing because plaintiffs do not have a fundamental right to obtain any food they wish.” [p.26]

There’s a lot more in the document, which primarily addresses the raw milk issue, but these statements alone clearly reveal how the FDA views the concept of health freedom. Essentially, the FDA does not believe in health freedom at all. It believes that it is the only entity granted the authority to decide for you what you are able to eat and drink.

The State, in other words, may override your food decisions and deny you free access to the foods and beverages you wish to consume. And the State may do this for completely unscientific reasons — even just political reasons — all at their whim.

 

Ralph’s note – Who would of ever guessed that we would lose our freedom to eat? It’s not lost yet, but obviously some would let to see that happen.

________________________________

 

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.

India’s poster boy for vegetarianism – he’s just fathered a child at 96

Andrew Buncombe

Tuesday, 27 November 2012

The world’s oldest father has been recruited by activists in India who maintain lifelong vegetarians retain their “vigour” better than others.

Ramajit Raghav, who shot to celebrity two years ago at the age of 94 when he first became a father, features in a new campaign by for People for the Ethical Treatment of Animals (Peta) India.

A photograph of Mr Raghav, who recently fathered his second child, Ranjit, at the age of 96, shows him cradling the baby with the headline “Vegetarians Still Got It at Age 96”.

“I have been a vegetarian all my life, and I credit my stamina and virility to my diet,” said the elderly father from the state of Haryana. “Being a vegetarian is the secret to my strength and good health.”

Peta claims living a vegetarian life makes perfect sense and that India is increasingly seeing problems associated with heart disease, cancer and diabetes, which it says are associated with a meat-eating diet.

“And since each vegetarian saves the lives of more than 100 animals a year, their consciences are lighter, too,” it said. “Viagra and other anti-impotence drugs may get you through the night, but a vegetarian diet can get you through your life. Numerous physicians agree that the best way to prevent artery blockage and other conditions that cause impotence is to eat a diet high in fibre, including plenty of fruits, vegetables, and whole grains.”

When he was interviewed last month by The Times of India, Mr Raghav revealed he had been a bachelor until meeting his wife, Shakuntala Devi, ten years ago.

He has been a strict vegetarian and has never drank alcohol. Instead, his diet is made up of fresh milk, clarified butter, vegetables and chapattis.

“I wake up at five in the morning and go to bed before 8pm. During the day, I work in the fields and also take an afternoon nap,” he said.

http://www.independent.co.uk/news/world/asia/indias-poster-boy-for-vegetarianism–hes-just-fathered-a-child-at-96-8360464.html#

Drugs giant Novartis warns jobs may go overseas: said bringing a drug to an NHS trust, securing clinical trials and getting approval, is inefficient and takes too long

The Government must tackle the red-tape and research hold-ups hampering Britain’s pharmaceutical industry or risk seeing jobs and investment disappear overseas, one of the industry’s leading companies has warned.

pills

Novartis global finance director Jon Symonds said that while the UK has made “great strides” in supporting life sciences, the Government must be more radical and move far faster. Photo: REUTERS/Toby Melville

 

Louise Armitstead

By , Chief Business Correspondent

6:00AM GMT 26 Nov 2012

Swiss pharmaceuticals giant Novartis has arranged a crisis meeting of scientists, NHS trustees and Government officials starting today in London in a bid to streamline Britain’s “haphazard” approach to medical research and development (R&D).

Science Minister David Willetts is due to attend the meeting, thought to be the first to unite representatives of Big Pharma and the medical profession on a large scale. In a stark warning to the Government ahead of the Autumn Statement, Jon Symonds, global finance director of Novartis, which allocates $10bn in R&D a year, will say that Britain is losing competitiveness to emerging markets and Asia.

Ahead of the meeting, Mr Symonds told The Daily Telegraph, that while the UK has made “great strides” in supporting life sciences, the Government must be more radical and move far faster. He said bringing a drug to an NHS trust, securing clinical trials and getting approval, is inefficient and takes too long.

“It should be a seamless process but instead it takes an enormous amount of time and energy, during which we lose money,” he said. It can cost $1bn to bring a new drug to market, he said, but pharmaceutical companies usually just get a few months before a patent runs out so delays in getting trials and approval can be make or break. Yet often NHS trusts are slow to take-up new drugs or help organise trials.

“One of the characteristics of the UK is a very low up-take on innovation,” says Mr Symonds. “Sitting in another part of the business allocating my resources, if we don’t see the up-take in the UK resources will be allocated elsewhere.”

Rival pharmaceutical group Pfizer triggered a political row last year when it closed its only R&D facility in the UK, with the loss of 2,400 jobs.

In a speech at the meeting on Tuesday, Mr Symonds will say: “The placement of research is increasingly globally competitive: we can and must make choices over where we invest. In recent years, Novartis has made considerable investment decision in Shanghai, Russia and Brazil… one thing these markets have in common is that they have each recognised the need to shift from being a consumer of innovation to a generator of innovation.”

He will add: “The NHS seems to treat clinical trials as if they were a departure from the NHS core function – a departure that needs to be compensated with high charges.”

The pharmaceutical industry employs around 25,000 people in R&D in the UK and a total of 72,000 people in the industry as a whole. Globally it invests more in R&D than any other industry – £12.1m every day, according to the Association British Pharmaceutical Industries.

Last week at the CBI conference, David Cameron said Britain was in the “economic equivalent of war” and was in a “global race to succeed”.

The prime minister said the country needed “buccaneering, deal-making, hungry spirit now more than ever” and vowed to support it.

The Chancellor George Osborne is under pressure to produce measures to support business and industry in his Autumn Statement next Wednesday.

Mr Symonds said: “There are a number of challenges that need to be addressed in the UK for it to truly become a destination of choice for research.”

He added: “Generally the initiatives are there, we need to see them followed through. The Government needs to deliver on its initiatives and ideas and make them a reality. Then we can see a virtuous circle – more innovation, investment and research.”