FDA often ignored or just not there for many drug approvals and trials

Study examines FDA influence on design of pivotal drug studies

An examination of the potential interaction between pharmaceutical companies and the U.S. Food and Drug Administration (FDA) to discuss future studies finds that one-quarter of recent new drug approvals occurred without any meeting, and when such meetings occurred, pharmaceutical companies did not comply with one-quarter of the recommendations made by the FDA regarding study design or primary outcome, according to a study in the November 26 issue of JAMA.

To enhance protocol quality, federal regulations encourage but do not require meetings between pharmaceutical companies and the FDA during the design phase of pivotal studies assessing drug efficacy and safety for the proposed indication. These meetings often generate FDA recommendations for improving research, although companies are not bound to follow them, according to background information in the article.

Steven Woloshin, M.D., M.S., of the Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, N.H., and colleagues reviewed and analyzed approximated 200 FDA documents (memos; meeting minutes; filing checklists; and medical, statistical, and summary reviews) for 35 new drugs approved between February 1, 2011, and February 29, 2012. The researchers identified all FDA comments and analyzed recommendations about pivotal study design or primary outcomes and characterized the effect of recommendations on study quality. Continue reading “FDA often ignored or just not there for many drug approvals and trials”

Discrepancies between trial results reported on clinical trial registry and in journals ( nearly all had discrepancies )

– nearly all had at least 1 discrepancy in the study group

– Our findings raise questions about accuracy of both ClinicalTrials.gov and publications, as each source’s reported results at times disagreed with the other.

Shhh...Can you keep a secret?

During a one year period, among clinical trials published in high-impact journals that reported results on a public clinical trial registry (ClinicalTrials.gov), nearly all had at least 1 discrepancy in the study group, intervention, or results reported between the 2 sources, including discrepancies in the designated primary end points for the studies, according to a study in the March 12 issue of JAMA.

The 2007 Food and Drug Administration (FDA) Amendments Act expanded requirements for ClinicalTrials.gov, mandating results reporting within 12 months of trial completion for all FDA-regulated medical products. “To our knowledge, no studies have examined reporting and accuracy of trial results information. Accordingly, we compared trial information and results reported on ClinicalTrials.gov with corresponding peer-reviewed publications,” write Jessica E. Becker, A.B., of the Yale University School of Medicine, New Haven, Conn., and colleagues. Continue reading “Discrepancies between trial results reported on clinical trial registry and in journals ( nearly all had discrepancies )”

Several FDA-approved anti-cancer drugs induce stem cell tumors, perhaps thwarting therapy

Several FDA-approved anti-cancer drugs induce stem cell tumors, perhaps thwarting therapy
Drosophila intestines provide ‘ready-made stem cell microenvironments’ that are ‘difficult-to-impossible’ to create in petri dishes, offering an unconventional screen that allows researchers to test drugs in vivo. Credit: University of Massachusetts Amherst        

                                

Using a new approach to systematically test chemotherapy drugs in an unusual animal model, a research team led by University of Massachusetts Amherst molecular biologist Michele Markstein, with Norbert Perrimon at Harvard Medical School, report that several have a serious side effect: Inducing hyper proliferation in stem cells that could lead to tumor recurrence.

Markstein says, “We discovered that several chemotherapeutics that stop fast growing tumors have the opposite effect on stem cells in the same animal, causing them to divide too rapidly. This was a surprise, because it showed that the same drug could have opposite actions on cells in the same animal: Suppressing tumor growth on one cell population while initiating growth in another. Not only is the finding of clinical interest, but with this study we used an emerging new non-traditional tool for assessing drugs using stem cells in the fruit fly gut.” Continue reading “Several FDA-approved anti-cancer drugs induce stem cell tumors, perhaps thwarting therapy”

Drug company CEO hangs up on charity head who called with offer to pay $50,000 for life-saving treatment for a dying 7-year-old boy

– the company received $72 million in federal funding to develop Brincidofovir

  • The CEO of  pharmaceutical company that could supply a life-saving anti-viral drugs to a 7-year-old cancer sufferer refuses to hand the drugs over
  • Chimerix chief Kenneth Moch hung up on charity that offered to pay $50,000 for Josh Hardy’s treatment
  • Hung up when asked if he would react the same if it was his own son
  • Hardy, seven, is battling a viral infection following a bone marrow transplant
  • A drug called Brincidofovir made by North Carolina company Chimerex could clear up the infection in two weeks
  • Brincidofovir has not received FDA approval but has been administered for ‘compassionate use’ to hundreds of patients
  • Chimerex CEO Kenneth Moch says the company no longer has a compassionate use program because it cannot afford it

By James  Nye and Alex Greig

PUBLISHED:          17:13 EST, 11 March 2014       | UPDATED:          19:06 EST, 11 March 2014

Denial:  Chimerix CEO Kevin Moch has refused to supply 7-year-old cancer sufferer Josh Hardy with the life-saving anti-viral drug he needs

Denial:  Chimerix CEO Kevin Moch has refused to supply 7-year-old cancer sufferer Josh Hardy with the life-saving anti-viral drug he needs

The CEO of a drug company that is refusing to supply lifesaving medication to a seven-year-old cancer survivor from Virginia hung up the phone to a charity that offered to buy it for the little boy.

Chimerix chief Kenneth Moch put down the phone on Richard Plotkin, vice chair of the Max Cure Foundation after he offered to pay the $50,000 needed to secure Brincidofovir – needed to help Josh Hardy fight off an infection he developed after a bone marrow transplant.

‘I spoke to Mr. Moch yesterday by phone.  I told him that we had the $50,000 that I thought he was claiming he needed to supply the drug,’ Richard Plotkin, vice chair of the Max Cure Foundation, said on Tuesday morning’s Fox and Friends.

‘He then told me it isn’t about money.  He told me it’s all about ethics.  I said, ‘Fine, tell me why you will not give it to this little boy.

‘If he does not get the drug, he will die this week, I’m told.  He said he cannot make an exception.’

Plotkin asked Moch what he would do if Josh was his child or grandchild, but Plotkin said Moch refused to answer this question and then hung up the phone.

‘As a result, it appears the final plea is to the board of directors at Chimerix…I ask the board to close their eyes, and as you close your eyes, assume there’s a little boy lying in a hospital bed who says to his father, ‘Daddy, am I going to die? And if I’m going to die, who will take care of me in heaven?’’ Plotkin said to Fox and Friends. Continue reading “Drug company CEO hangs up on charity head who called with offer to pay $50,000 for life-saving treatment for a dying 7-year-old boy”

CBS This Morning – “Says Supplements no good for the Heart” Silly Silly CBS

Quick rebuttal to the inaccurate statement that nutritional supplements are an ineffective tool against heart disease.

The CBS Doctor Tara Narula reading from a scripted source … Made the inaccurate statement that nutritional supplements have no positive impact on heart health. She made that statement with what appears to be 100% certainty. Which is cool, because it makes it so much easier to discredit… While my objective is not to prove to you that nutritional supplements are the way to go for heart health. My objective is simply to prove beyond 100% certainty that their statements are highly inaccurate as well as misleading. Thank You CBS for making this so easy… 😉

ScreenHunter_220 Feb. 19 10.22

 

A few Links to Confirming Research:

Mayo Clinic proceedings highlights research about cardiovascular benefits of omega-3 fatty acids Continue reading “CBS This Morning – “Says Supplements no good for the Heart” Silly Silly CBS”

Pharmaceuticals: A market for producing ‘lemons’ and serious harm

EEV: Re-Post Request

Public release date: 17-Aug-2010

– they spend two to three times more on marketing than on research to persuade doctors to prescribe these new drugs
– Doctors may get misleading information and then misinform patients about the risks of a new drug. It’s really a two-tier market for lemons.”
Three reasons why the pharmaceutical market produces “lemons” are: Having companies in charge of testing new drugs, providing firewalls of legal protection behind which information about harms or effectiveness can be hidden, and the relatively low bar set for drug efficacy in order for a new drug to be approved
Drugs Addiction and Pharma
Drugs Addiction and Pharma (Photo credit: DES Daughter)

Incentives and protections for industry encourage development of many drugs with few new benefits over existing pharmaceuticals, but with risk of serious harm to users Continue reading “Pharmaceuticals: A market for producing ‘lemons’ and serious harm”

FDA fails to withdraw unproven blood pressure drug that has been on the market for 18 years in spite of the manufacturer’s failure to submit evidence that it actually helps patients

Public release date: 16-Aug-2010

– HRR: UPDATE As of 15 FEB 2014 ProAmatine or generic versions are still on the market being prescribed

– According to the GAO, the FDA has never once pulled a drug off the market due to missing or unimpressive follow-up data

– company has never conducted a mandatory follow-up study to actually prove the long-term benefits of the drug

Fail Road

By MATTHEW PERRONE, AP Business Writer Matthew Perrone, Ap Business Writer

WASHINGTON – Federal health regulators are pushing to withdraw a blood pressure drug that has been on the market for 14 (Update that to 18 years )years in spite of the manufacturer’s failure to submit evidence that it actually helps patients. Continue reading “FDA fails to withdraw unproven blood pressure drug that has been on the market for 18 years in spite of the manufacturer’s failure to submit evidence that it actually helps patients”

After Avandia: Does the FDA Have a Drug Problem?

Thursday, Aug. 12, 2010

HRR: How a drug company intentionally kills thousands for profit and no one goes to jail.

– the agency decided to keep the drug on the market — a move worth billions of dollars to GSK but that also may have put millions of patients at risk.

– The FDA relies on industry “user fees” for 65% of its budget for postmarket monitoring of the drugs it approves

GlaxoSmithKline: Where Billions in Fines Don't...
 (Photo credit: watchingfrogsboil)

FDA had inspected only 1% of clinical-trial sites from 2000 to 2005 and lacked financial disclosure data for clinical investigators in half of all industry drug reviews.

– The company didn’t want to do a long-term safety test at all

– the FDA and the drugmaker negotiate which tests the company will perform once large numbers of people are taking it on the open market. Continue reading “After Avandia: Does the FDA Have a Drug Problem?”

Doctors Group Sues FDA over ( Daxas, Daliresp) , Roflumilast for COPD

Highlights:

-Physicians for Integrity in Medical Research says in its federal complaint against Food and Drug Administration Commissioner Margaret Hamburg

– best-case scenario showed that roflumilast reduced the number of exacerbations by one episode a year for every five patients treated

– the regulator ignored the “statistically significant increase in incidents of prostate and lung cancer in patients taking roflumilast.”

———- Possible safe Option Vinpocetine

-Published today in the Proceedings of the National Academy of Sciences vinpocetine has great potential for the treatment of COPD and other inflammatory diseases.”

-has no evidence of toxicity or noticeable side effects in human patients Continue reading “Doctors Group Sues FDA over ( Daxas, Daliresp) , Roflumilast for COPD”

Doctors Group Sues FDA, Saying Drug Does More Harm Than Good

roflumilast, a drug used to treat chronic obstructive pulmonary disease

English: Logo of the .
English: Logo of the . (Photo credit: Wikipedia)
 

By ELIZABETH WARMERDAM

 

LOS ANGELES (CN) – A physicians group sued the U.S. FDA, seeking revocation of FDA approval of roflumilast, a drug used to treat chronic obstructive pulmonary disease. Continue reading “Doctors Group Sues FDA, Saying Drug Does More Harm Than Good”

Poll: Americans want the government to stop banning everything they like

Posted By Breanna Deutsch On 6:40 PM  12/14/2013 In

Americans want the government to stop acting like their mother.

According to a Reason-Rupe poll, Americans do not want government to ban trans-fats, e-cigarettes, online poker, violent video games or genetic testing kits.

Many Americans are becoming frustrated with the government’s growing involvement in what they believe should be their personal decisions. Continue reading “Poll: Americans want the government to stop banning everything they like”

FDA’s Manure Proposal: What’s the Big Stink About? BYE BYE Large Organic Farming?

If you’ve caught wind of the controversy around proposed laws on food safety, then you know that a lot of folks are knee-deep in talks about manure. Black gold – as farmers have been known to call it – manure makes for a brilliant fertilizer. But unless it’s used correctly, it can lead to serious foodborne illnesses. So, in accordance with the 2011 Food Safety Modernization Act, the U.S. Food and Drug Administration issued a proposed rule on produce early this year to place restrictions on using manure.

Blue Cross Conspired to Destroy Company Serving Hemophiliacs, Firm Says

 

 

 

By IULIA FILIP

 

WEST PALM BEACH (CN) – Blue Cross Blue Shield destroyed a health care company by refusing to pay claims of its hemophiliac patients and conducting a “witch hunt” that destroyed its reputation, the company claims in court.

Factor Health Management sued The Blue Cross Blue Shield Association, six of its licensees, several employees, and pharmacy benefit management company Express Scripts Holding Co., in Palm Beach County Court. Factor subsidiaries FHM Group and FCS Pharmacy also are plaintiffs.

Factor Health was a disease management company and pharmaceutical wholesaler that provided specialty drugs and services to hemophiliacs.

FCS Pharmacy was a Boca Raton-based specialty pharmacy that focused on hemophilia, hepatitis and HIV treatments.

Factor Health claims that Blue Cross Blue Shield and its licensees conspired to drive it out of business and steer its hemophilia patients to pharmacy chains and pharmacy benefit management companies and to government programs such as Medicare and Medicaid.

According to the lawsuit, the conspirators falsely accused the FHM companies of fraud, reported them to state and federal law enforcement, fabricated reasons to deny payment of their patients’ claims, defamed them to patients, vendors, insurance companies and regulators, and harmed their relationships with customers.

They also reduced payouts to the FHM companies to sabotage a deal to sell FHM’s pharmacy business to a private equity firm and to force it out of business, according to the complaint.

Factor Health and FCS Pharmacy claim that before the defendants drove them out of business they were the preferred suppliers of drugs and disease management services for hemophiliacs in the United States.

Hemophilia, a hereditary genetic disorder, impairs the body’s ability to control blood clotting. It affects around 20,000 people in the United States. Hemophiliacs often suffer from spontaneous internal bleeding that can cause serious injuries or death, and rely on synthetic drugs, known as factor drugs, to replace the missing clotting factor in their blood.

Pharmaceutical companies developed the drugs, which can cost tens of thousands of dollars a month, after the 1990s, when the blood supply in the United States was contaminated with hepatitis and the HIV virus, infecting 6,000 to 10,000 hemophiliacs who used drugs derived from human blood plasma.

Most pharmacies do not stock synthetic clotting factor drugs, which are expensive and have a limited shelf life.

Factor Health and FCS Pharmacy claim they had experience in meeting the specific needs of patients with hemophilia, and also provided disease management services – including counseling, education and disease-tracking services – at no cost to patients or insurers.

Factor Health claims that by the end of 2009, Blue Cross Blue Shield, several of its licensees and affiliated pharmacies managed to destroy its once-profitable business through a series of investigations based on unfounded allegations and their refusal to pay its patients’ claims.

The complaint states: “In a concerted, calculated and intentional effort to neutralize and ultimately extinguish a quickly growing competitor, defendants, under the guise of completely bogus various and never-ending ‘investigations,’ actively participated in a scheme to: (a) drive plaintiffs out of business by improperly withholding millions of dollars in payments for factor drugs dispensed by plaintiffs to the licensees defendants’ insureds after the licensee defendants had specifically authorized the delivery of factor drugs to those insureds, (b) steer plaintiffs’ hemophilia patients to chain pharmacies and pharmacy benefit managers (‘PBMs’) from whom defendants receive a direct or indirect financial benefit and/or in which defendants have a financial interest, and (c) purge hemophiliacs from the rosters of their insureds and push plaintiffs’ hemophilia patients to government programs such as Medicare and Medicaid. Defendants accomplished this scheme by: (a) filing wild, baseless and completely false reports to state and federal law enforcement authorities alleging criminal conduct on the part of plaintiffs, (b) actively conspiring to create ways to avoid paying plaintiffs sums owed pursuant to health insurance contracts, (c) falsely and regularly defaming plaintiffs to patients, vendors, workers, insurance companies, regulators and others, (d) tortiously interfering in the existing and prospective business relationships plaintiffs enjoyed with their customers and potential customers, and (e) reducing payouts to the FHM parties in order to scuttle a deal to sell the FHM parties’ pharmacy business to a private equity firm and to force the FHM parties out of business.”

The Factor Health companies claim that Blue Cross Blue Shield, its licensees and pharmacy benefit management companies such as defendant Express Scripts conspired to drive hemophilia patients away from Factor Health’s business, to their own benefit.

Pharmacy benefits managers process and pay prescription drug claims on behalf of health insurance companies. They also oversee, and can investigate and audit, pharmacies on their own initiative or at the request of their health insurer clients, according to the complaint.

“PBMs therefore, on the one hand, directly compete with independent pharmacies by owning and operating their own retail and mail order pharmacies and, on the other hand, play a role in the adjudication of claims and the investigation of pharmacies by health insurers, including the investigation of the very pharmacies with whom the PBMs compete,” the complaint states.

“This conflict of interest is intensified when the health insurers own or have direct or indirect interests in PBMs. On information and belief, PBMs associated with defendants – including Express Scripts – participated in the ‘investigation’ of the FHM parties at the same time as the licensee defendants were ‘suggesting’ that patients switch to the pharmacies run by those same PBMs.”

Blue Cross Blue Shield of Florida and other Blue Cross licensees contacted the FBI, the Food and Drug Administration and other federal and state agencies with baseless allegations that Factor Health was diverting millions of dollars worth of factor drugs, according to the complaint.

Factor Health claims all the investigations were closed without any finding of wrongdoing.

It claims the defendants tried to persuade satisfied patients to switch to pharmacies preferred by the insurers, including by telling patients that they would process claims only from those pharmacies.

The 38 licensees of the Blue Cross Blue Shield Association insure more than 100 million Americans, about one-half of all Americans with private health insurance. They each have a license for an exclusive geographic area and an agreement not to compete with each other, according to the lawsuit.

Factor Health claims that some licensees tried to cancel health coverage for its employees, many of whom suffered from hemophilia.

It claims the investigations and audits triggered by the Blue Cross licensees and affiliates were “nothing more than a convenient excuse for defendants to use as cover for their witch hunt and as a reason to deny timely payment.”

Blue Cross Blue Shield and its licensees in fact were trying to purge their rolls of patients with hemophilia, to avoid “exposure” to claims for expensive drugs, according to the complaint.

Factor Health claims that Blue Cross and its licensees have a policy of denying claims for expensive medical treatment and trying to remove patients requiring expensive treatment from their insurance rolls.

The defendants’ refusal to reimburse Factor Health for millions of dollars worth of pre-authorized drugs, even after no evidence of wrongdoing was found, caused the company’s accounts receivable to spike and left it unable to pay its creditors, according to the lawsuit.

Factor Health claims that as a result of the conspiracy, its revenue dropped by nearly half in a very short time, it defaulted on loans, and reported millions of dollars in losses.

It claims it was forced out of business, its hemophilia patients were denied the services of the health care provider of their choice, and the market for hemophilia drugs and related disease management services was destroyed.

What’s more, independent pharmacies may not be willing to carry expensive specialty drugs to avoid being harassed by insurers, the complaint states.

Factor Health claims that by reducing the payout on claims, Blue Cross Blue Shield of Florida caused it to lose a deal with a private investment firm one day before the transaction was completed.

Factor Health seeks more than $100 million in damages for tortious interference with business relationships, civil conspiracy, defamation and unfair competition.

It is represented by Ryon McCabe with McCabe Rabin of West Palm Beach and Anthony Paduano and Jason Snyder with Paduano & Weintraub of New York City.

“Defendants have destroyed a once-thriving business and deprived the hemophilia community of a valued and trusted provider of life-saving medicine and disease management services,” attorney Jason Snyder said in a statement. “The FHM parties look forward to the opportunity to vindicate their rights, and the rights of the hemophilia community, in court.”

Representatives for the Blue Cross Blue Shield Association did not reply to requests for comment.

http://www.courthousenews.com/2013/11/13/62853.htm

Study examines expedited FDA drug approvals, safety questions remain / Avg. Drug is tested on only 104 patients prior to approval

Contact: Renee Brehio rbrehio@ismp.org 704-831-8822 The JAMA Network Journals

Fewer patients were studied as part of expedited reviews of new drugs approved by the U.S. Food and Drug Administration (FDA) in 2008 and some safety questions remain unanswered, according to a study published by JAMA Internal Medicine, a JAMA Network publication.

The FDA is authorized to make new drugs available more quickly if they would be a significant therapeutic advancement and if they fulfill unmet therapeutic needs for serious illnesses, according to the study background.

Thomas J. Moore, A.B., of the Institute for Safe Medication Practices, Alexandria, Va., and Curt D. Furberg, M.D., Ph.D., of the Wake Forest School of Medicine, Winston-Salem, N.C., examined development times, clinical testing, post-market follow-up and safety risks for the new drugs approved by the FDA in 2008, when most provisions of current law, regulation and policies were in effect.

That year, the FDA approved 20 therapeutic drugs (eight under expedited review and 12 under standard review). The study findings indicate that expedited drugs took a median (midpoint) of 5.1 years of clinical development to get marketing approval compared with 7.5 years for the drugs that underwent standard review, according to the study results.

The expedited drugs were tested for efficacy in a median 104 patients compared with a median 580 patients for standard review. By 2013, many postmarketing studies to gather additional evidence on the safety of expedited drugs had not been completed, according to researchers.

“The testing of new drugs has shifted from a situation in which most testing was conducted prior to initial approval to a situation in which many innovative drugs are more rapidly approved after a small trial in a narrower patient population with extensive additional testing conducted after approval,” the authors conclude. “Our findings suggest that the shift has made it more difficult to balance the benefits and risks of new drugs. Further systematic assessment of the standards and procedures for testing new drugs is needed.”

(JAMA Intern Med. Published online October 28, 2013. doi:10.1001/jamainternmed.2013.11813. Available pre-embargo to the media at http://media.jamanetwork.com.)

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

Commentary: Can Expedited Drug Approval Without Expedited Follow-up Be Trusted?

In a related commentary, Daniel Carpenter, Ph.D., of Harvard University, Boston, writes: “The findings of Moore and Furberg underscore the continuing importance of rigorous premarket studies of ample size. If the critical phrase ‘serious or life-threatening conditions that would address an unmet medical need’ is defined broadly enough (and there are lobbying efforts to define it as broadly as possible), the future of evidence for pharmaceuticals in the United States will look more like 100 patients for efficacy trials instead of 500 patients.”

“If the FDA’s requirements for new drugs, both premarket and postmarket, are weakened, trust in both the efficacy and safety of prescription drugs is likely to be weakened. The stakes of the current policy debates could not be higher. There is scarcely a feature of the American health care system that does not depend on evidence-based trust in prescription drugs, ratified and enforced by the FDA,” Carpenter concludes.

(JAMA Intern Med. Published online October 28, 2013. doi:10.1001/jamainternmed.2013.9202. Available pre-embargo to the media at http://media.jamanetwork.com.)

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

Ew! Injectable antibiotic ( VOLUNTARY ) recall prompted by floating bits of hair, cotton and metal inside drug vials

  • The FDA  announced a recall of cefepime, an intravenous drug used for pneumonia, urinary  tract, skin, and abdominal infections
  • The visible  particles in the drug, which was distributed nationwide, can cause blood clots,  strokes, and heart attacks, among other catastrophic  issue

By  Daily Mail Reporter

PUBLISHED: 08:14 EST, 16  October 2013 |  UPDATED: 10:04 EST, 16 October 2013

 

 

Recall: Drug maker B Braun has recalled its 1 gram dose antibiotic cefepime after they were found to contain dangerous particles of hair, cotton, and metal 

Recall: Drug maker B Braun has recalled its 1 gram dose  antibiotic cefepime after they were found to contain dangerous particles of  hair, cotton, and metal

 

U.S. government health officials are alerting  doctors to the recall of an injectable drug after vials of it were found to  contain bits of metal, cotton, and hair.

B. Braun Medical Inc. issued the voluntary  recall for its cefepime and dextrose antibiotic suspension used to combat  pneumonia, urinary tract, skin, and abdominal infections.

The Food and Drug Administration warned  Tuesday that the visible particles could cause catastrophic problems including  blood clots, stroke, and heart attack if injected.

The drug was distributed to hospitals,  pharmacies and medical suppliers nationwide, between February 4, 2013 and March  1, 2013.

The product affected by the recall comes from  lot H3A744.

While cefepime is generally administered to  hospitalized patients, some  patients may continue to receive the drug at home  after they leave the  hospital.

Patients  experiencing health problems should  contact their physician. B. Braun  asks that all quality issues of its product  be reported to the FDA’s  MedWatch Adverse Event Reporting program.

This is the first recall of cefepime, but it  is not the first warning issued by the FDA concerning the drug.

In June 2012, the agency released an updated  safety warning concerning the drug after research showed an increase risk of  seizure in users with  impaired kidney function.

The FDA suggested a cefepime dosage  adjustment for such patients.

Dangerous: The drug is used for infections such as pneumonia and was distrubted nationwide. Catastrophic events like heart attack and stroke could occur from using the tainted drug 

Dangerous: The drug is used for infections such as  pneumonia and was distrubted nationwide. Catastrophic events like heart attack  and stroke could occur from using the tainted drug

 

 

 

 

 

 

Read more: http://www.dailymail.co.uk/news/article-2462888/Ew-Injectable-antibiotic-recall-prompted-floating-bits-hair-cotton-metal-inside-drug-vials.html#ixzz2hwKxDKD1 Follow us: @MailOnline on Twitter | DailyMail on Facebook

INSIGHT-Big Pharma braces for retirement of favorite regulator

Source: Reuters – Thu, 10 Oct 2013 04:59 AM

Author: Reuters

 

By Toni Clarke

WASHINGTON, Oct 10 (Reuters) – The retirement of Dr. Janet Woodcock as head of the Food and Drug Administration’s pharmaceutical division is at least a year away, but already the industry she regulates is worrying about who will replace her.

Over the past 20 years Woodcock, who is 65, has reshaped the drug approval process, relaxing the criteria needed for certain drugs to reach the market – especially those that represent scientific breakthroughs. Last year, the agency approved 39 new drugs, the most since 1996.

That is good news for drug companies who depend on product approvals to fuel profit growth, and some fear that once Woodcock leaves the pace of drug approvals will slow. She also appears to have done little to develop a bench of potential successors – a challenge Woodcock acknowledges.

“No-one is seeing that luminous, next-generation leadership,” said Dr. Robert Meyer, a former top medical reviewer at the FDA who subsequently joined drug maker Merck & Co as a vice president and in March took an academic position at the University of Virginia.

According to interviews with some two dozen people inside and outside the agency who have worked with her, Woodcock is a force of nature. She moves from meeting to meeting – sometimes as many as 16 a day – with crisp efficiency, dealing one minute with a complex cancer drug and the next with an angry lawmaker. The learning curve for her successor will be steep.

“The thought of bringing someone in and expecting them to take over from Janet Woodcock any time soon is the ultimate absurdity,” said one former senior FDA official who asked not to be identified because he now works for a company that deals with the regulator.

Woodcock’s boss, FDA Commissioner Margaret Hamburg, acknowledges the difficulty.

“It’s very hard to parachute into these jobs,” she said in an interview, noting that a wide variety of skills – management, scientific and regulatory – are needed for the role.

INSTITUTIONAL MEMORY

Woodcock’s influence at the FDA, and by extension the global pharmaceutical industry which takes its lead from the United States, is hard to overstate. While the commissioner may be the agency’s public face, Woodcock is its institutional memory and drives pharmaceutical policy.

The office she runs, the Center for Drug Evaluation and Research, is by far the agency’s biggest, with a budget of more than $1 billion and a staff of 3,450. Her actions are scrutinized by companies, regulators, physicians, patients and investors around the world.

Yet she is struggling to come up with a deep pool of potential successors.

“We get people in, they almost take the ring, they’re at the altar, and then they realize they have to divest everything,” Woodcock said in an interview. Employees must eschew stocks and other investments in FDA-regulated companies because they are privy to market moving information.

In February, Woodcock hired Dr. Richard Moscicki, former head of clinical development at the biotechnology company Genzyme Corp as one of her top deputies. Moscicki said he would “welcome the chance, as daunting as it is to watch Janet,” to take over if the opportunity arose.

But installing any former pharmaceutical executive would almost certainly prompt criticism from drug safety watchdogs who already claim the FDA is too cozy with the drug industry – a charge Woodcock has heard many times and rejects.

“If industry wasn’t around, patients would be in deep trouble, many of them,” she said.

Woodcock, who trained as a rheumatologist, is a career civil servant. Petite, with short brown hair and eyebrows that rise in quizzical fashion, she does not tolerate fools gladly; and she can be weak at delegating, former colleagues say.

That may have limited the number of people able to advance into more senior roles, though possible candidates do exist, the former colleagues said. For a list of potential successors, click here.

Woodcock says her goal is to “put the right people in charge,” not micromanage, but she says finding those people is difficult.

“I know some of my senior office directors have tried to recruit in and they have gotten repeated turndowns from people who would be fabulous,” she said. “It’s mainly the money.”

Government salaries can be at least 10 times lower than the $1 million plus packages on offer at drug companies.

Woodcock said she has begun giving certain people within the FDA more responsibility but some say it is has been hard for talent to rise easily to the top. For example, a 2006 report by the Institute of Medicine described a work environment at the Center for Drug Evaluation and Research “that is not sufficiently supportive of staff.”

Even Woodcock’s most ardent admirers concede she can be intimidating.

“One thing every chief executive has to worry about is whether they scare the hell out of people,” said Dr. Robert Temple, one of Woodcock’s closest colleagues. She tries not to be frightening, he added, but is by nature “formidable.”

DRUG DEVELOPMENT PRIORITY

Woodcock has used her influence in part to bend the agency’s agenda to her own. She believes more new drugs mean greater choice and better patient outcomes, and has made drug development a central part of the FDA’s mission in a way that was not historically the case and that not everyone agrees with.

Some colleagues felt the agency should focus principally on drug safety and law enforcement.

“People who had been there a long time had a more old-school view, that our job when we got drug applications was just to look for safety and efficacy, and have that high bar,” said Meyer. “I never heard Janet articulate anything about lowering the bar, but there was a bit of a philosophical shift and I think she was ahead of the curve on that.”

Woodcock insists that the agency has not relaxed its safety standards, but there is some evidence to suggest it is more reluctant than other countries to withdraw or restrict potentially dangerous products.

A study published last year in the journal Innovations in Pharmacy found that of roughly 150 drugs that the United Nations lists as banned around the globe, 17 percent are available in the United States. Only 9 percent of drugs banned by the United States are available internationally.

“It shows that the U.S. may no longer be leader in observing, reporting and removing dangerous drugs from the market,” Albert Wertheimer, the study’s author, concluded. Wertheimer is a professor in the school of pharmacy at Temple University in Philadelphia.

Woodcock declined to comment on the report.

The FDA’s focus on new drug development has also angered generic drug companies, who face significant delays getting their products reviewed. The office that handles generic drugs is understaffed and overwhelmed by the number of new applications, which have risen from a couple of hundred a year to more than 1,000.

“To me, a good manager would divert some resources to an office that is struggling,” a former senior official in the division said. “The fact that 80 percent of drugs prescribed in the United States are generic doesn’t seem important to the center director.”

Woodcock says the generic drug office has not received the same kind of funding as the office in charge of novel drugs because until recently the FDA did not receive fees from generic drug makers, as it does from branded companies, to review applications within a set time period. She expects that to change.

As Woodcock moves towards the end of her career, she has one more major initiative up her sleeve: a plan to help the drug industry improve quality control by introducing, among other things, techniques to identify and remove the cause of defects during the manufacturing process.

“People are moving now to continuous manufacturing and really much more high tech modern ways and it doesn’t fit the way good manufacturing practice has been thought about over the years,” Woodcock said. “We have to forcibly make sure we allow the better to come about.”   (Editing by Edward Tobin, Martin Howell and Grant McCool)

 

http://www.trust.org/item/20131010045052-ql1s5/?source=hpbreaking

Drug companies paid big bucks to attend FDA painkiller meetings

  • Article by: Peter Whoriskey
  • Washington Post
  • October 6, 2013 – 11:15 PM

 

WASHINGTON – A scientific panel that shaped the federal government’s policy for testing the safety and effectiveness of painkillers was funded by major pharmaceutical companies that paid hundreds of thousands of dollars for the chance to affect the thinking of the Food and Drug Administration (FDA), according to hundreds of e-mails obtained by a public records request.

The e-mails show that the companies paid as much as $25,000 to attend any given meeting of the panel, which had been set up by two academics to provide advice to the FDA on how to weigh the evidence from clinical trials. A leading FDA official later called the group “an essential collaborative effort.”

Patient advocacy groups said the electronic communications suggest that the regulators had become too close to the companies trying to crack into the $9 billion painkiller market in the United States.

FDA officials who regulate painkillers sat on the steering committee of the panel, which met in private, and cowrote papers with employees of pharmaceutical companies.

The FDA has been criticized for not taking precautions that might have averted the epidemic of addiction to prescription drugs including OxyContin and other opioids.

“These e-mails help explain the disastrous decisions the FDA’s analgesic division has made over the last 10 years,” said Craig Mayton, the Columbus, Ohio, attorney who made the public records request to the University of Washington. “Instead of protecting the public health, the FDA has been allowing the drug companies to pay for a seat at a small table where all the rules were written.”

Even as the meetings were taking place, the idea of FDA officials meeting with firms that had paid big money for an invitation raised eyebrows for some. In an e-mail to organizers, an official from the National Institutes of Health worried whether the arrangements made it look as if the private meetings were a “pay to play process.”

FDA officials did not benefit financially from their participation in the meetings, the agency said. But two later went on to work as pharmaceutical consultants and more than this, the critics said, the e-mails portray an agency that, by allowing itself to get caught up in a panel that seemed to promise influence for money, had blurred the line between the regulators and the regulated.

In a statement, the FDA said “we take these concerns very seriously.” But, it said, “we are unaware of any improprieties” associated with the group.

http://www.startribune.com/business/226694611.html

 

© 2013 Star Tribune

Foot Cream Kills HIV by Tricking Cells to Commit Suicide

Ciclopirox is currently approved by the FDA as a topical antifungal cream (Credit: Fougera) A common drug that dermatologists turn to treat nail fungus appears to come with a not-so-tiny side effect: eradicating HIV .

CNET

Ciclopirox is currently approved by the FDA as a topical antifungal cream.

A common drug that dermatologists turn to treat nail fungus appears to come with a not-so-tiny side effect: eradicating HIV.

In a study performed at Rutgers New Jersey Medical School, not only does the drug Ciclopirox completely eradicate infectious HIV from cell cultures, but unlike today’s most cutting-edge antiviral treatments, the virus doesn’t bounce back when the drug is withheld. This means it may not require a lifetime of use to keep HIV at bay.

The same group of researchers had previously shown that Ciclopirox — approved by the FDA and Europe’s EMA as safe for human use to treat foot fungus — inhibits the expression of HIV genes in culture. Now they have found that it also blocks the essential function of the mitochondria, which results in the reactivation of the cell’s suicide pathway, all while sparing the healthy cells.

The researchers said that one aspect of HIV that makes it particularly persistent, even in the face of strong antiviral treatments, is its ability to disable a cell’s altruistic suicide pathway — which is typically activated when a cell is damaged or infected. In other words, infected cells that would normally commit suicide to spare healthy cells no longer pull any altruistic kamikaze missions. Ciclopirox tricks these cells back into their old ways with a double negative, disabling the disabling of the suicide pathway.

It’s obviously still going to take clinical trials on humans to study the safety and efficacy of Ciclopirox as a potential topical HIV treatment, but the fact that it’s already deemed safe for one type of human use could make the regulatory process faster than usual.

In fact, the researchers note that another FDA-approved drug now thought to help subdue HIV, called Deferiprone, skipped studies in animals and went straight from tests in culture to a phase I human trial in South Africa, possibly paving the way for other FDA-approved drugs to move faster through the study phases. (Unlike Ciclopirox, which is approved for topical treatment, Deferiprone is FDA- and EMA-approved for systemic use, meaning it effects more than just one part of the body.)

The new findings on Ciclopirox appear in the current issue of the journal PLOS ONE.

CNET ©2013 CBS Interactive Inc., a CBS Company. All rights reserved. Used by permission.

http://www.scientificamerican.com/article.cfm?id=foot-cream-kills-hiv-by-tricking-ce-2013-09

Could dog food additive prevent disabling chemotherapy side effect?

Contact: Stephanie Desmon sdesmon1@jhmi.edu 410-955-8665 Johns Hopkins Medicine

Johns Hopkins researchers find, in mice, that common preservative may thwart pain and damage of peripheral neuropathy

Working with cells in test tubes and in mice, researchers at Johns Hopkins have discovered that a chemical commonly used as a dog food preservative may prevent the kind of painful nerve damage found in the hands and feet of four out of five cancer patients taking the chemotherapy drug Taxol.

The Food and Drug Administration-approved preservative, an antioxidant called ethoxyquin, was shown in experiments to bind to certain cell proteins in a way that limits their exposure to the damaging effects of Taxol, the researchers say.

The hope, they say, is to build on the protective effect of ethoxyquin’s chemistry and develop a drug that could be given to cancer patients before taking Taxol, in much the same way that anti-nausea medication is given to stave off the nausea that commonly accompanies chemotherapy. While half of Taxol users recover from the pain damage, known as peripheral neuropathy, the other half continue to have often debilitating pain, numbness and tingling for the rest of their lives.

“Millions of people with breast cancer, ovarian cancer and other solid tumors get Taxol to treat their cancer and 80 percent of them will get peripheral neuropathy as a result,” says Ahmet Höke, M.D., Ph.D., a professor of neurology and neuroscience at the Johns Hopkins University School of Medicine and director of the Neuromuscular Division. “They’re living longer thanks to the chemotherapy, but they are often miserable. Our goal is to prevent them from getting neuropathy in the first place.”

A report on Höke’s research is published online in the Annals of Neurology.

Höke and his team knew from previous experiments that adding Taxol to a nerve cell line growing in a petri dish would cause neurodegeneration. In a series of experiments, they set out to hunt for compounds that might interrupt the degenerative process by adding Taxol to nerve cells along with some 2,000 chemicals — one at a time — to see which, if any, could do that.

Ethoxyquin did so, Höke says, apparently by making the cells resistant to the toxic effects of the Taxol.

Once they identified ethoxyquin’s effects, they gave intravenous Taxol to mice, and saw nerves in their paws degenerate in a couple of weeks. But when they gave ethoxyquin to the mice at the same time as the Taxol, it prevented two-thirds of the nerve degeneration, which Höke says would have a big impact on quality of life if the same effects were to occur in humans.

Specifically, Höke and his team discovered that molecules of ethoxyquin were binding to Hsp90, one of the so-called heat shock proteins that cells defensively make more of whenever they are stressed. Hsp90 acts as a cell’s quality control officer, determining whether a protein is properly formed before sending it out where it is needed.  When ethoxyquin binds to Hsp90, two other proteins — ataxin-2 and Sf3b2 — can’t bind to Hsp90. When they can’t bind, the cell senses that these two proteins are flawed, so they are degraded and their levels in the cell diminished.

Höke says his team is not certain why too much of those two proteins appears to have a negative effect on nerves, but reducing their levels clearly appears in their studies to make cells more resistant to Taxol toxicity.

Höke and his colleagues are looking into whether this medication could also make nerves more resistant to damage in peripheral neuropathy caused by HIV and diabetes, two other major causes of the pain. A previous study, Höke says, showed that ataxin-2 may cause degeneration in motor neurons in a rare form of ALS, commonly known as Lou Gehrig’s disease, suggesting that ethoxyquin or some version of it might also benefit people with this disorder.

Twenty to 30 million Americans suffer from peripheral neuropathy. Höke says it’s a “huge public health issue” that doesn’t get much attention because it is not fatal.

Höke’s team is hoping to conduct safety studies with ethoxyquin in animals in advance of possible testing in people. He says that while too much ethoxyquin is thought to be potentially harmful to dogs, the needed dose for humans would likely be 20-to-30-fold lower than what is found in dog food. Ethoxyquin was developed in the 1950s as an antioxidant, a compound to prevent pears and other foods from becoming discolored and spoiling.

###

Other Johns Hopkins researchers involved in the study include Jing Zhu, Ph.D.; Weiran Chen, M.D.; Ruifa Mi, M.D., Ph.D.; Chunhua Zhou, B.S.; and Nicole Reed, M.S.

The research was supported by the Foundation for Peripheral Neuropathy, Dr. Miriam and Sheldon G. Adelson Medical Research Foundation, the National Institutes of Health’s National Institute of Neurological Disorders and Stroke (R01 NS43991) and Johns Hopkins Brain Science Institute.

For more information about Höke, click here.

Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is a $6.5 billion integrated global health enterprise and one of the leading health care systems in the United States. JHM unites physicians and scientists of the Johns Hopkins University School of Medicine with the organizations, health professionals and facilities of the Johns Hopkins Hospital and Health System. JHM’s mission is to improve the health of the community and the world by setting the standard of excellence in medical education, research and clinical care. Diverse and inclusive, JHM educates medical students, scientists, health care professionals and the public; conducts biomedical research; and provides patient-centered medicine to prevent, diagnose and treat human illness.  JHM operates six academic and community hospitals, four suburban health care and surgery centers, and more than 30 primary health care outpatient sites. The Johns Hopkins Hospital, opened in 1889, was ranked number one in the nation from 1990 to 2011 by U.S. News & World Report.

Johns Hopkins Medicine Media Relations and Public Affairs Media Contacts:

Stephanie Desmon 410-955-8665; sdesmon1@jhmi.edu

Helen Jones 410-502-9422; hjones49@jhmi.edu

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

Antibodies against one strain increase risk of infection with another.

28 August 2013
Pigs vaccinated against H1N2 influenza were more vulnerable to the rarer H1N1 strain.

Andy Rouse/Photoshot

Preventing seasonal sniffles may be more complicated than researchers suspected. A vaccine that protects piglets from one common influenza virus also makes them more vulnerable to a rarer flu strain, researchers report today in Science Translational Medicine1.

The team gave piglets a vaccine against H1N2 influenza. The animals responded by making antibodies that blocked that virus — but aided infection with the swine flu H1N1, which caused a pandemic among humans in 2009. In the study, H1N1 infected more cells and caused more severe pneumonia in vaccinated piglets than unvaccinated ones.

The root of the different immune responses lies with the mushroom-shaped haemagglutinin protein found on the outside of influenza-virus particles, which helps them to attach onto cells in the airways. The protein occurs in all types of flu, but the make-up of its cap and stem vary between strains.

In the study, a vaccine for H1N2 spurred pigs to produce antibodies that bound the cap and the stem of that virus’s haemagglutinin. But some of those antibodies also targeted the stem of H1N1’s haemagglutinin protein, helping that virus fuse to cell membranes. That made H1N1 more efficient at infecting pigs and causing disease.

Stem vaccines

The finding may give some vaccine developers pause. Much of the work to develop a universal flu vaccine has targeted the stems of haemagglutinin proteins, because they are relatively consistent across many types of influenza viruses.

The new study suggests that such vaccines could also produce antibodies that enhance the ability of some viruses to infect new hosts, says James Crowe, an immunologist at Vanderbilt University in Nashville, Tennessee. But that does not mean that researchers should stop developing novel flu vaccines, including those that target haemagglutinin stems, he adds. “We should be very careful.”

Gary Nabel, a flu-vaccine researcher and chief scientific officer at the biotechnology firm Sanofi in Cambridge, Massachusetts, agrees. “It raises a warning flag, but at the same time it provides a tool to manage that risk,” he says of the new study’s results and methods.

Still, researchers have not yet tested whether human influenza vaccines can produce the same effect. And differences between pigs and humans make it difficult to interpret how relevant the findings are to the development of human vaccines, says Sarah Gilbert, a vaccine researcher at the University of Oxford, UK.

Lead author Hana Golding, a microbiologist at the US Food and Drug Administration in Bethesda, Maryland, agrees — and stresses that seasonal vaccines are still safe and effective. “This has no relevance to the regular vaccinations,” she says. “We think that people should definitely take them.”

Journal name:
Nature
DOI:
doi:10.1038/nature.2013.13621

References

  1. Khurana, S. et al. Sci. Transl. Med. 5, 200ra114 (2013).

 

http://www.nature.com/news/flu-vaccine-backfires-in-pigs-1.13621

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

###

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

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

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

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

About C.S. Mott Children’s Hospital:

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

About CHEAR:

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

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

Health Research Report 19 AUG 2013 – Video

 

Topics:

Sugar is Toxic, Doubles the Death rates in mammals * Aug 13 Journal of Nature Communications

6 Months of Fish Oil Reverses liver disease in Children * Online Journal of Parenteral and Enteral Nutrition — The Fish Oil report took extra time primarily because of two factors 1. The Soybean oil they give children causes Intestinal failure and liver disease

2. Insurance Companies will not cover Fish Oil because it is considered to expensive and experimental

3. Plus a few other reasons to they let children suffer and die because of bureaucracy.

 

Linked the Full Study as is…Please Read

 

Contact: Amy Albin aalbin@mednet.ucla.edu 310-794-8672 University of California – Los Angeles Health Sciences

6 months of fish oil reverses liver disease in children with intestinal failure, study shows

Children who suffer from intestinal failure, most often caused by a shortened or dysfunctional bowel, are unable to consume food orally. Instead, a nutritional cocktail of sugar, protein and fat made from soybean oil is injected through a small tube in their vein.

For these children, the intravenous nutrition serves as a bridge to bowel adaptation, a process by which the intestine recovers and improves its capacity to absorb nutrition. But the soybean oil, which provides essential fatty acids and calories, has been associated with a potentially lethal complication known as intestinal failure–associated liver disease, which may require a liver and/or intestinal transplant. Such a transplant can prevent death, but the five-year post-transplant survival rate is only 50 percent.

Previous studies have shown that replacing soybean oil with fish oil in intravenous nutrition can reverse intestinal failure–associated liver disease. However, the necessary duration of fish oil treatment had not been established in medical studies.

Now, a clinical trial conducted at the Children’s Discovery and Innovation Institute at Mattel Children’s Hospital UCLA has found that, compared with soybean oil, a limited duration (24 weeks) of fish oil is safe and effective in reversing liver disease in children with intestinal failure who require intravenous nutrition. The researchers believe that fish oil may also decrease the need for liver and/or intestinal transplants — and mortality — associated with this disease.

The researchers’ study, “Six Months of Intravenous Fish Oil Reverses Pediatric Intestinal Failure Associated Liver Disease,” is published online in the Journal of Parenteral and Enteral Nutrition.

“With this particular study, we set out to determine if a finite period of six months of intravenous fish oil could safely reverse liver damage in these children, and we have had some promising results,” said lead author Dr. Kara Calkins, an assistant professor in the department of pediatrics in the division of neonatology and developmental biology at UCLA. “But because intravenous fish oil is not yet approved by the Food and Drug Administration and is much more costly than soybean oil, it is typically not covered by insurance. As a result, this oil is considered experimental and is currently available only under special protocols. If it proves safe and effective for patients, we hope it would eventually be available for wider use.”

For the study, intravenous soybean oil was replaced with intravenous fish oil in 10 patients between the ages of 2 weeks and 18 years who had advanced intestinal failure–associated liver disease and who were at high risk for death and/or transplant. The researchers compared these subjects with 20 historical controls who had received soybean oil.

Results showed that the children receiving fish oil had a much higher rate of reversal of liver disease than those who received the standard soybean oil. In fact, after 17 weeks of fish oil, nearly 80 percent of patients experienced a reversal of their liver disease, while only 5 percent of the soybean patients saw a reversal.

The next phase of research will involve following children for up to five years after they stop fish oil to determine if their liver disease returns and if transplant rates are truly decreased, the study authors said.

“We are also trying to better understand how fish oil reverses this disease by investigating changes in proteins and genes in the blood and liver,” Calkins said. “These studies will provide the scientific and medical community with a better understanding of this disease and how intravenous fish oil works.”

For Isabella Piscione, who was one of the first patients at UCLA to receive the fish oil treatment under compassionate use, her outcome with the treatment paved the way for researchers to establish the six-month protocol. Because of multiple surgeries due to an obstruction in her intestines, Isabella was left with only 10 centimeters of intestine. She depended on intravenous nutrition for survival, which unfortunately resulted in liver damage.

When Isabella started the fish oil treatment, she was just over 6 months old and was listed for a liver and bowel transplant. Within a month of starting the treatment, her condition started to improve. By six months, her liver had healed, and she no longer needed a transplant.

“We cried tears of joy each week that we saw her getting better and better,” said her father, Laureano Piscione. “She is a success story.”

###

Study co-authors from UCLA included Dr. James Dunn; Dr. Stephen Shew; Laurie Reyen, R.N.; Dr. Douglas Farmer; Dr. Sherin Devaskar; and Dr. Robert Venick.

The study was funded by a grant from a National Institutes of Health (NIH/NCRR M01-RR00865). Calkins has received funding from NIH K12HD00140 and T32G075776. Calkins and Venick have received funding from the Today’s and Tomorrow’s Children Fund.

Intravenous fish oil was purchased with funds from the UCLA Department of Pediatric Surgery, the Women’s Auxiliary Club at UCLA and Dr. James Yoo of the UCLA Department of Surgery.

 

 

For more information on Mattel Children’s Hospital UCLA, visit http://www.uclahealth.org/mattel.

 

6 Months of Fish Oil Reverses Liver Disease

Caption: Isabella was born with short bowel syndrome which meant she could not eat food normally. She was given nutrition intravenously through a food substitute called total parenteral nutrition (TPN). But then, she developed liver damage probably caused by the soybean oil in the TPN. Her condition worsened and she was listed for a liver and bowel transplant. However, the doctors at Mattel Children’s Hospital UCLA offered an experimental treatment under compassionate use that replaced the soybean oil with fish oil. After six months, her liver had healed and she no longer needed a transplant. This photo shows Isabella in October 2009 after her treatment.

Credit: The Piscione family

 

Dr. Kara Calkins, University of California — Los Angeles Health Sciences

Caption: UCLA’s Dr. Kara Calkins and colleagues found that six months of fish oil treatment can reverse liver disease in children with intestinal failure.

Credit: UCLA

Cancer-causing arsenic retained in chicken meat – FDA

китай птица курица птичий грипп

Photo: EPA

After a year of dismissing the issue the FDA finally admitted that chicken meat sold in the United States does contain doses of arsenic – a highly poisonous cancer-causing chemical lethal in high does. Arsenic is reported to be added to the chicken feed purposely. According to the FDA’s own report, the arsenic is originally added to the bird feed later ending up in the meat that is sold in stores. In other words, the Americans who purchase regular chicken are forced to take dangerous amounts of arsenic along with, significantly increasing threat of developing cancer.

0Before the very recent study was conducted, the presence of the arsenic in the product was denied both by the FDA and the industry, with the explanation that the poison that had been fed to the birds actually was disposed of with the chicken feces. However, there was no scientific grounding for that claim.

0When the evidence became so undeniable and solid, Roxarsone, one of the chicken feed brands, was withdrawn off the shelves. Interestingly enough, the company which produces the Roxarsone feed is called Alpharma, LLC and is a subsidiary of Pfizer – a major pharmaceutical company.

0Though Alpharma made the decision to pull its product off the shelves across the country, it says it is not going to do so in other countries unless specifically ordered to.

0AP reports, “Scott Brown of Pfizer Animal Health’s Veterinary Medicine Research and Development division said the company also sells the ingredient in about a dozen other countries. He said Pfizer is reaching out to regulatory authorities in those countries and will decide whether to sell it on an individual basis.”

0With the arsenic-polluted feed removed from the stores, the FDA still stands its ground in protecting the product. It claims the amounts of the poison are too small to seriously harm the human system, at the same time admitting arsenic is a carcinogen, that is, cancer-provoking substance.

0The National Chicken Council is on the same page with the FDA, too, claiming the arsenic-fed chicken are safe to eat, not denying arsenic was fed to birds across the US.

0Surprisingly, along with the fight for the arsenic-filled chicken, the FDA at the same time is raiding elderberry juice manufacturers accusing them of selling “unapproved drugs. It also goes after raw milk and natural herbal products. In other words, it assures it is safe to consume arsenic, but raw milk or elderberry juice will kill you.

0Voice of Russia, Infowars

6 months of fish oil reverses liver disease in children with intestinal failure, study shows

Contact: Amy Albin aalbin@mednet.ucla.edu 310-794-8672 University of California – Los Angeles Health Sciences

Children who suffer from intestinal failure, most often caused by a shortened or dysfunctional bowel, are unable to consume food orally. Instead, a nutritional cocktail of sugar, protein and fat made from soybean oil is injected through a small tube in their vein.

For these children, the intravenous nutrition serves as a bridge to bowel adaptation, a process by which the intestine recovers and improves its capacity to absorb nutrition. But the soybean oil, which provides essential fatty acids and calories, has been associated with a potentially lethal complication known as intestinal failure–associated liver disease, which may require a liver and/or intestinal transplant. Such a transplant can prevent death, but the five-year post-transplant survival rate is only 50 percent.

Previous studies have shown that replacing soybean oil with fish oil in intravenous nutrition can reverse intestinal failure–associated liver disease. However, the necessary duration of fish oil treatment had not been established in medical studies.

Now, a clinical trial conducted at the Children’s Discovery and Innovation Institute at Mattel Children’s Hospital UCLA has found that, compared with soybean oil, a limited duration (24 weeks) of fish oil is safe and effective in reversing liver disease in children with intestinal failure who require intravenous nutrition. The researchers believe that fish oil may also decrease the need for liver and/or intestinal transplants — and mortality — associated with this disease.

The researchers’ study, “Six Months of Intravenous Fish Oil Reverses Pediatric Intestinal Failure Associated Liver Disease,” is published online in the Journal of Parenteral and Enteral Nutrition.

“With this particular study, we set out to determine if a finite period of six months of intravenous fish oil could safely reverse liver damage in these children, and we have had some promising results,” said lead author Dr. Kara Calkins, an assistant professor in the department of pediatrics in the division of neonatology and developmental biology at UCLA. “But because intravenous fish oil is not yet approved by the Food and Drug Administration and is much more costly than soybean oil, it is typically not covered by insurance. As a result, this oil is considered experimental and is currently available only under special protocols. If it proves safe and effective for patients, we hope it would eventually be available for wider use.”

For the study, intravenous soybean oil was replaced with intravenous fish oil in 10 patients between the ages of 2 weeks and 18 years who had advanced intestinal failure–associated liver disease and who were at high risk for death and/or transplant. The researchers compared these subjects with 20 historical controls who had received soybean oil.

Results showed that the children receiving fish oil had a much higher rate of reversal of liver disease than those who received the standard soybean oil. In fact, after 17 weeks of fish oil, nearly 80 percent of patients experienced a reversal of their liver disease, while only 5 percent of the soybean patients saw a reversal.

The next phase of research will involve following children for up to five years after they stop fish oil to determine if their liver disease returns and if transplant rates are truly decreased, the study authors said.

“We are also trying to better understand how fish oil reverses this disease by investigating changes in proteins and genes in the blood and liver,” Calkins said. “These studies will provide the scientific and medical community with a better understanding of this disease and how intravenous fish oil works.”

For Isabella Piscione, who was one of the first patients at UCLA to receive the fish oil treatment under compassionate use, her outcome with the treatment paved the way for researchers to establish the six-month protocol. Because of multiple surgeries due to an obstruction in her intestines, Isabella was left with only 10 centimeters of intestine. She depended on intravenous nutrition for survival, which unfortunately resulted in liver damage.

When Isabella started the fish oil treatment, she was just over 6 months old and was listed for a liver and bowel transplant. Within a month of starting the treatment, her condition started to improve. By six months, her liver had healed, and she no longer needed a transplant.

“We cried tears of joy each week that we saw her getting better and better,” said her father, Laureano Piscione. “She is a success story.”

###

Study co-authors from UCLA included Dr. James Dunn; Dr. Stephen Shew; Laurie Reyen, R.N.; Dr. Douglas Farmer; Dr. Sherin Devaskar; and Dr. Robert Venick.

The study was funded by a grant from a National Institutes of Health (NIH/NCRR M01-RR00865). Calkins has received funding from NIH K12HD00140 and T32G075776. Calkins and Venick have received funding from the Today’s and Tomorrow’s Children Fund.

Intravenous fish oil was purchased with funds from the UCLA Department of Pediatric Surgery, the Women’s Auxiliary Club at UCLA and Dr. James Yoo of the UCLA Department of Surgery.

For more information on Mattel Children’s Hospital UCLA, visit http://www.uclahealth.org/mattel.

Drugs now to be approved based on a educated guess that it will help the patient, not necessarily improved survival

U.S. drugmakers cheer ‘speed lane’ for breakthrough therapies

Source: Reuters – Wed, 24 Jul 2013 11:53 PM

Author: Reuters

By Toni Clarke

WASHINGTON, July 24 (Reuters) – A new regulatory pathway could shave years off the traditional drug approval process in the United States, according to some companies whose drugs have been given “breakthrough therapy” designation by the U.S. Food and Drug Administration.

Speaking at a briefing in Washington to raise awareness of the drug review process, Dr. Jay Siegel, head of global regulatory affairs at Johnson & Johnson, said he expects two years to be knocked off the time it would typically take the FDA to review ibrutinib, the company’s experimental cancer drug.

To be granted breakthrough designation, an experimental drug must show early indication of clinical improvement over existing therapies, even if the clinical trial is small. It might apply, for example, to a new type of cancer drug that shows strong early promise.

J&J’s ibrutinib, which it is developing with Pharmacyclics Inc, would be the first in a class of oral medicines that block a protein known as Bruton’s tyrosine kinase. It is being developed for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma and for patients with mantle cell lymphoma, both cancers of the blood.

Dr. Jeffrey Leiden, the chief executive of Vertex Pharmaceuticals Inc, who also spoke at the briefing and whose cystic fibrosis drug Kalydeco was approved under the designation, said his company’s experience working with the FDA was dramatically different from the normal drug approval process.

Under breakthrough designation, he said, “everything is on the table” for discussion in order to move the process along as quickly as possible. Communications that might typically take weeks and months, under the breakthrough pathway take minutes.

“We pick up the phone and talk in real time,” Leiden said. “It makes the process immeasurably smoother.”

The breakthrough pathway was spearheaded by Friends of Cancer Research, a patient advocacy organization. It received bipartisan support in Congress and was signed into law in July 2012. As of July 12, the FDA had received 67 requests for breakthrough designation. It had granted 24 and denied 18.

Dr. Janet Woodcock, director of the FDA’s drugs division, said during the discussion that the breakthrough pathway was designed to accommodate new science, particularly targeted therapies that may work in people with certain genetic mutations. She noted that just because the review process is speeded up there is no guarantee of approval.

In the 1990s, she said, the agency was not seeing drugs whose promise could be detected in early clinical trials.

“We didn’t see these therapies in Phase I or II where you said ‘bingo,’ you’ve got a likely winner,” she said.

Still, there are challenges associated with speeding up a drug’s development timeline. For one thing, other nations might not be willing to approve the products based on the FDA’s more flexible clinical trial standards under the breakthrough designation.

“Our hope is that foreign regulators will catch up,” Siegel said.

Moreover, he said, it is not clear that insurers will pay for drugs if the data do not show improved survival or other clear benefit they are used to seeing when drugs are approved. One task, he said is to figure out “how to bring payors on board.”

The panelists did not discuss what happens once a drug reaches the market under the breakthrough designation.

Under a separate pathway known as “accelerated approval” drugs may be approved based on a so-called surrogate endpoint – a measure, such as tumor shrinkage – that might reasonably be expected to confer a clinical benefit such as improved survival.

Companies that win approval for a product under the accelerated approval process are required subsequently to prove through further clinical trials that the surrogate measure does in fact correlate with improved survival or a reduction in disease symptoms.

“A discussion on this topic is reckless if it doesn’t discuss the next stage after the drug reaches the market,” said Sidney Wolfe, co-founder and senior adviser to Public Citizen’s Health Research Group, a watchdog organization that has frequently criticized the FDA for approving, or failing to withdraw, drugs it considers unsafe.

Woodcock said the FDA is now working to develop a mechanism to speed the development of breakthrough diagnostics that can be used in conjunction with new drugs to help identify which patients will respond to a particular therapy.

http://www.trust.org/item/20130724235354-sr8za/?source=hpbreaking

BPA and Chlorine Means Bad News: Modified Forms of Bisphenol A Found to Alter Hormone Signaling in New, Disturbing Ways

The ubiquity of the endocrine-disrupting chemical bisphenol A led researchers to ask what it might be doing in publicly supplied, chlorinated drinking water. The answer: Chlorinated BPA has different, but no less profound effects on cell-signaling networks than unmodified BPA. (Credit: © Artusius / Fotolia)

July 17, 2013 — The ubiquity of the endocrine-disrupting chemical bisphenol A led researchers to ask what it might be doing in publicly supplied, chlorinated drinking water. The answer: Chlorinated BPA has different, but no less profound effects on cell-signaling networks than unmodified BPA.

For years, scientists have been worried about bisphenol A. The chemical is known as an “endocrine disruptor,” a substance that interferes with the body’s hormone signaling system, and it’s found in everything from plastic drink bottles to the linings of food and drink cans to the thermal paper used for cash register receipts — not to mention the urine of 92.6 percent of Americans over the age of six. BPA has been associated with the development of chronic diseases such as diabetes, asthma and ovarian dysfunction. In 2012, the FDA banned BPA from use in the production of baby bottles and drinking cups.

BPA’s ubiquity in the environment led researchers to ask what it might be doing in publicly supplied drinking water, which is contaminated at its source by BPA-laden discarded plastic and later picks up more of the chemical when it passes through PVC plastic pipes. Most public water supplies are chlorinated to kill bacteria, and the BPA in the water also becomes chlorinated, acquiring one or more chlorine atoms from the water around it. The question was, how does this chlorinated BPA behave in the body?

The answer, generated from cell-culture experiments, was that it produced different but no less profound effects. “We found that when you modify the BPA it works just as dramatically but in different ways on the same systems,” said University of Texas Medical Branch at Galveston professor Cheryl Watson, senior author of a paper on the study now online in Endocrine Disruptors.

Watson and graduate student René Viñas examined both chlorinated BPA and BPA that had undergone sulfonation and glucuronodation — two processes the body uses to make a compound easier to excrete. In all three cases the modified forms of BPA worked through membrane estrogen receptors to deactivate key signaling enzymes known as ERK and JNK kinases.

“These kinases are major control centers, gathering all the cell signals, making decisions and then expediting them,” Watson said. “If you change the dynamic by inactivating kinases, you can mess up cell signaling.”

Very low levels of modified BPA were sufficient to produce the results — a phenomenon commonly seen with membrane receptors. The responses followed what is known as a non-monotonic pattern, varying irregularly when different concentrations of modified BPA were tested. The large number of experimental procedures this made necessary were facilitated by a BIOMEK-FX robot, which Viñas programmed to considerably increase the efficiency and precision of the process.

“The robot cuts down on the experimenter time required, because it does so much of the mechanical work, and it makes results more replicable, because the robot does things exactly the same every time,” Watson said. “It gives us hope that we can make an impact even with the sheer volume of chemicals that we have to study and the detail we have to study them in.”

http://www.sciencedaily.com/releases/2013/07/130717132420.htm

 

International Counterfeit Drug Ring Hit in Massive Sting / 1,677 illegal pharmacy Web Sites claiming to be CVS, Walgreens etc..

Pill of Goods: International Counterfeit Drug Ring Hit in Massive Sting

Court documents review process that led the FDA to shut down more than 1,600 illegal pharmacy Web sites

By Dina Fine Maron  | Wednesday, July 3, 2013 | 5


Pill of Goods Image: EssjayNZ

It may be the largest organized crime network that you have never heard of, and it deals in counterfeit drugs. So says the U.S. Food and Drug Administration, which seized and shut down 1,677 illegal pharmacy Web sites last month as part of the largest Internet-based counterfeit drug sting yet.

The shuttered Web sites all claimed to be “Canadian pharmacies” but the FDA says that not a single drug shipment actually came from the U.S.’s northern neighbor. And testing on the multiple undercover purchases of drugs made by FDA offices in Colorado, New Hampshire and western Pennsylvania—described in official court documents reviewed by Scientific American—found that the drugs were actually not cheap, generic versions of the drugs; they were all counterfeits.

The bust is expected to be a major blow to a complex web of online drug distribution that “appears to be highly nimble,” according to the agency. The FDA agent leading this operation believes that the Web sites are part of a major online drug distribution affiliate network that calls itself EvaPharmacy. That network processes roughly 30,000 orders and grosses around $2.7 million—monthly, according to earlier research (pdf) from of the University of California, San Diego. All the Web sites shut down by the FDA were displaying fake licenses and certifications to convince potential U.S. customers that the “FDA approved” and “brand name” drugs were legitimate.

The agency found “a clear linkage and presence of a large, organized online drug distribution network,” according to the affidavit of Daniel Burke, special agent in the FDA’s Office of Criminal Investigations. The crime network identified by the agency included 6,263 Web sites that all used one of at least eight site templates. Researchers believe the large international crime network is based in Russia and the Middle East, and that the seized Web sites were marketing directly to the U.S.

Most of the sites were slight adaptations of templates the network created, Burke said in his affidavit. (The agency declined to comment for this article.) They were carefully constructed to appear to be from real pharmacies like CVS, Walmart or Walgreens, according to the affidavit. In reality the shipments of counterfeit drugs came from India or Singapore instead of pharmacies in Canada. Federal agency warning banners displayed across Web sites like “www.walgreens-store.com” and “http://www.c-v-s-pharmacy.com/” now indicate that they are fraudulent and illegal. The U.S. government says it seized the domain names of the sites to prevent third parties from acquiring the Web site URLs and using them to commit additional crimes.

The FDA’s sting, which was carried out in conjunction with international partners, built on the work of academic researchers who have been carefully identifying these sites for the past several years. It took a coalition of computer scientists several years to identify the pages, as they worked through tracking which were legitimate Canadian pharmacies and which were illegal and did not ask for prescriptions. The only sure-fire test was to order drugs (pdf) and see how the Web site performed.  “Making the call” about whether a site was from a real Canadian pharmacy or was a fake “requires a little internet detective work,” says Chris Kanich, professor of computer science at the University of Illinois at Chicago, who led some of the research in this area.

Creating a complex computer algorithm that could capture all these sites is impossible, he says, because it remains too challenging to distinguish legitimate online pharmacies from fraudulent sites without making some online purchases. The FDA provides consumers with advice on how to find an online pharmacy through BeSafeRx: Know Your Online Pharmacy.

For this crime investigation there were no meetings in back alleys or surreptitious hand offs—just online purchases akin to what a consumer might do sitting at home. In one instance an FDA special agent purchased $105.45 of the diabetes drug Actos and arthritis medication Celebrex, and had them shipped to a U.S. address. As a free “bonus” the site offered to throw in four free pills of Viagra, according to official records. At no point during the purchase was the agent asked to provide a prescription from a licensed medical practitioner, complete a medical questionnaire or consult with a health professional.

Two weeks later, an agent received the purported drugs with a package postmarked from India. They were not the branded drugs as advertised; they were drugs that are illegal to sell in the U.S., and that purportedly contained the same active ingredient as the advertised drug. Some of the drugs came in a package simply labeled “sample-hermless [sic] medicine for personal use—‘Not for sale.’” Moreover, no directions for use or package inserts were included with the shipment.

Shutting down this slice of EvaPharmacy’s business amounts to a significant blow to the faux firm’s infrastructure, Kanich says. “They would need a really resilient business to recover from this.”

 

http://www.scientificamerican.com/article.cfm?id=pill-of-goods

Artificial Sweetener ( Mannitol ) a Potential Treatment for Parkinson’s Disease

Monday, June 17, 2013

TAU researcher says mannitol could prevent aggregation of toxic proteins in the brain

Mannitol, a sugar alcohol produced by fungi, bacteria, and algae, is a common component of sugar-free gum and candy. The sweetener is also used in the medical field — it’s approved by the FDA as a diuretic to flush out excess fluids and used during surgery as a substance that opens the blood/brain barrier to ease the passage of other drugs.

Now Profs. Ehud Gazit and Daniel Segal of Tel Aviv University’s Department of Molecular Microbiology and Biotechnology and the Sagol School of Neuroscience, along with their colleague Dr. Ronit Shaltiel-Karyo and PhD candidate Moran Frenkel-Pinter, have found that mannitol also prevents clumps of the protein α-synuclein from forming in the brain — a process that is characteristic of Parkinson’s disease.

These results, published in the Journal of Biological Chemistry and presented at the Drosophila Conference in Washington, DC in April, suggest that this artificial sweetener could be a novel therapy for the treatment of Parkinson’s and other neurodegenerative diseases. The research was funded by a grant from the Parkinson’s Disease Foundation and supported in part by the Lord Alliance Family Trust.

Seeing a significant difference

After identifying the structural characteristics that facilitate the development of clumps of α-synuclein, the researchers began to hunt for a compound that could inhibit the proteins’ ability to bind together. In the lab, they found that mannitol was among the most effective agents in preventing aggregation of the protein in test tubes. The benefit of this substance is that it is already approved for use in a variety of clinical interventions, Prof. Segal says.

Next, to test the capabilities of mannitol in the living brain, the researchers turned to transgenic fruit flies engineered to carry the human gene for α-synuclein. To study fly movement, they used a test called the “climbing assay,” in which the ability of flies to climb the walls of a test tube indicates their locomotive capability. In the initial experimental period, 72 percent of normal flies were able to climb up the test tube, compared to only 38 percent of the genetically-altered flies.

The researchers then added mannitol to the food of the genetically-altered flies for a period of 27 days and repeated the experiment. This time, 70 percent of the mutated flies could climb up the test tube. In addition, the researchers observed a 70 percent reduction in aggregates of α-synuclein in mutated flies that had been fed mannitol, compared to those that had not.

These findings were confirmed by a second study which measured the impact of mannitol on mice engineered to produce human α-synuclein, developed by Dr. Eliezer Masliah of the University of San Diego. After four months, the researchers found that the mice injected with mannitol also showed a dramatic reduction of α-synuclein in the brain.

Delivering therapeutic compounds to the brain

The researchers now plan to re-examine the structure of the mannitol compound and introduce modifications to optimize its effectiveness. Further experiments on animal models, including behavioral testing, whose disease development mimics more closely the development of Parkinson’s in humans is needed, Prof. Segal says.

For the time being, mannitol may be used in combination with other medications that have been developed to treat Parkinson’s but which have proven ineffective in breaking through the blood/brain barrier, says Prof. Segal. These medications may be able to “piggy-back” on mannitol’s ability to open this barrier into the brain.

Although the results look promising, it is still not advisable for Parkinson’s patients to begin ingesting mannitol in large quantities, Prof. Segal cautions. More testing must be done to determine dosages that would be both effective and safe

The shocking list of foods readily available in US grocery stores that are BANNED in other countries for containing dangerous chemicals

  • In Singapore, you  can get sentenced to 15 years in prison and a $500,000 fine for using a chemical  in food products that’s common in frozen dinners
  • Mtn Dew and  products used to keep carpets from catching on fire are made from the same  chemical
  • A chemical  found in Chex Mix is known to cause cancer in rats

By  Daily Mail Reporter

PUBLISHED: 22:06 EST, 20  June 2013 |  UPDATED: 01:00 EST, 21 June 2013

If you enjoy snacks and drinks like Mtn Dew,  Chex Mix, Hungry Man frozen dinners, or roughly 80 percent of all the packaged  foods sold in your average, American grocery store, you may want to sit down  before reading this.

Many of the chemicals found in America’s most  common foods are considered to be so unhealthy that they’re actually ILLEGAL in  other countries.

A new book on nutrition lists six food  additives that are found in a wide range of popular groceries sanctioned by the  Food and Drug Administration, but foreign governments have determined to be too  dangerous to allow their citizens to consume.

Extreme! Mt. Dew is made with a chemical that also is used to prevent carpets from catching on fire 

Extreme! Mt. Dew is made with a chemical that also is  used to prevent carpets from catching on fire

 

Bubble gag: Bubble Yum contains a chemical that is known to cause cancer in rats 

Bubble gag: Bubble Yum contains a chemical that is known  to cause cancer in rats

Rich Food, Poor Food‘ by Doctor Jayson Calton and Mira Calton, a  certified nutritionist, features a list of what the authors call ‘Banned Bad  Boys’ – a list of the ingredients, where they’re banned and what caused  governments to ban them.

One of the most common ‘Bad Boys’ is  different variations of food coloring, which actually is made from petroleum and  is found in everyday items like soda, sports drinks, mac and cheese, cake, candy  and several other common, American products.

The chemicals used to make these different  dyes have proven to cause various different cancers and can even potentially  mutate healthy DNA.

Olestra is a fat substitute. It also causes a dramatic depletion of fat-soluble vitamins and carotenoids  

Olestra is a fat substitute. It also causes a dramatic  depletion of fat-soluble vitamins and carotenoids

 

Petroleum Loops: fruit loops are delicious - and made from a product that's made out of the same stuff that makes gasoline 

Petroleum Loops: fruit loops are delicious – and made  from a product that’s made out of the same stuff that makes gasoline

European countries like Norway, Finland,  France and Austria all have banned at least one variation of  petroleum-containing food coloring.

Another common additive banned in other  countries but allowed in the U.S. is Olestra, which essentially is a fat  substitute found in products that traditionally have actual fat.

For example, low-fat potato chips like  Ruffles Lite, Lays Wow and Pringles fat-free chips all contain Olestra – which  is shown to cause the depletion of fat-soluble vitamins. Different brands of  fat-free ice cream and mayonnaise at one time also contain the chemical.

Olestra has been banned in several countries,  including the United Kingdom and Canada.

In 2003, the FDA lifted a requirement forcing  companies that use Olestra in their products to include a label warning  consumers that the food their eating could cause ‘cramps and diarrhea,’ despite  the fact that the agency received more than 20,000 reports  of gastrointestinal complaints among olestra eaters.

 

Do you like citrus drinks, like Mt. Dew,  Squirt or Fresca? Then you also like brominated vegetable oil, which is banned  in more than 100 countries because it has been linked to basically every form of  thyroid disease – from cancer to autoimmune diseases – known to man.

In Singapore you can get up to fifteen years in prison and penalized nearly half a million dollars in fines for using an ingredient found in common U.S. bread products 

In Singapore you can get up to fifteen years in prison  and penalized nearly half a million dollars in fines for using an ingredient  found in common U.S. bread products

 

Hungry? 1 1/2 pounds of food (and chemicals used to make bleach and rubber yoga mats) 

Hungry? 1 1/2 pounds of food (and chemicals used to make  bleach and rubber yoga mats)

Other products made from bromine: chemicals  used to keep carpets from catching on fire and for disinfecting swimming  pools.

Other food products made from brominated  vegetable oil include New York brand flatbreads, bagel chips, Baja Burrito wraps  and other bread products.

Of brominated vegetable oil, the FDA says it  is approved ‘for flavoring oils used in fruit-flavored beverages, for which any  applicable standards of identity do not preclude such use, in an amount not to  exceed 15 parts per million in the finished beverage.’

Then there’s things like Hungry Man frozen  dinners, which will fill you up – with azodicarbonamide, a chemical used make  things like bleach and rubber yoga mats.

Most frozen potato and bread products – like  different varieties of McCain brand french fries – contain the chemical, as well  as several store brand bread products.

Azodicarbonamide is known to induce asthma,  and has been banned in Australia, the U.K. and most other European countries. If  you were to use it as a food ingredient in Singapore, you could face up to 15  years in prison and a $500,000 fine.

According to the FDA, Azodicarbonamide is  ‘approved to be a bleaching agent in cereal flour’ and is ‘permitted for direct  addition to food for human consumption.’

The final chemicals on the list – butylated  hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) – are found in everyday  products like Post, Kellogs and Quaker brand cereals, as well as Diamond Nuts,  Chex Mix and gum brands like Wrigley’s, Trident, Bazooka and Bubble  Yum.

Both BHA and BHT are waxy solids made from  petroleum and are known to cause cancer in rats. It’s banned in Japan, England  and several other European countries.

Read more: http://www.dailymail.co.uk/news/article-2345564/Mt-Dew-Fruit-Loops-Chex-Mix-Wrigleys-gum-shocking-list-foods-allowed-U-S-BANNED-countries-containing-dangerous-chemicals.html#ixzz2Wpz7EXXk Follow us: @MailOnline on Twitter | DailyMail on Facebook

Off-Label Marketing Puts Novartis in Hot Water – Sold to Children and is a Carcinogen

Off-Label Marketing Puts Novartis in Hot Water

By ROSE BOUBOUSHIAN

(CN) – Novartis Pharmaceuticals must face claims that it promoted the use on infants of a drug that U.S. regulators have deemed harmful, a federal judge ruled.

While working as a senior sales consultant for Basel, Switzerland-based Novartis in its dermatology and respiratory division, from 2001 through 2006, Donald Galmines marketed and sold the atopic dermatitis drug, Elidel.

The Food and Drug Administration had authorized the marketing of Elidel as a second-line treatment for patients aged 2 and older after it found that the drug posed safety risks to infants in December 2000.

Though regulators refused to approve the drug for patients older than 3 months of age, Galmines said Novartis soon began marketing Elidel as safe for children under the age of 2 and as a first-line treatment.

This marketing allegedly continued even after the FDA revealed in 2005 that the drug increased the risk of cancer in animals and respiratory infections in children younger than 2.

Galmines said Novartis trained him and paid Dr. Lawrence Eichenfield, a pediatric dermatologist, to convince doctors that Elidel was safe for infants.

The drugmaker also allegedly funded and publicly touted Dr. Alexander Kapp’s report that Elidel was safe for children over 3 months old.

Galmines said Novartis created visual aids for him and other sales reps to engage in off-label marketing of the drug and had him host and pay for $1,000 dinners for doctors who prescribed high amounts of Elidel for chronic use. Novartis also allegedly had Galmines use “preceptorships” in which he followed a doctor for a few hours and paid him or her for prescribing the drug.

A federal judge unsealed the 2006 whistle-blower complaint Galmines filed against Novartis under the False Claims Act (FCA) in Philadelphia after the government declined to intervene.

Novartis responded with a 295-page motion to dismiss in May 2011, but U.S. District Judge Gene Pratter preserved some claims on Thursday.

“The first amended complaint plausibly suggests that at least some of the claims submitted to government healthcare programs for Elidel prescriptions were not reimbursable, because it also alleges that these programs do not pay for drugs that are ‘not prescribed for a medically accepted indication,’ and that at least 1.2 million Elidel prescriptions were written off-label in a manner that put the health of the children receiving those prescriptions at risk,” Pratter wrote. “Therefore, Mr. Galmines has sufficiently pled that false claims for Elidel prescription reimbursements were submitted to the government.”

Though another pair of former Novartis employees, Gina Moyer and Judith Shelton, also brought a 2005 qui tam action over Elidel in Michigan, the court found that the first-to-file rule bars only Galmines’ claims of kickbacks. He can still pursue claims over off-label-marketing because the Moyer complaint discusses the allegedly unlawful promotion of Elidel for psoriasis and seborrhea, and Galmines “makes almost no allegations about these diseases.”

“Mr. Galmines has injected precision into his off-label marketing allegations by pleading a myriad of details about how such marketing occurred,” Pratter wrote. “The first amended complaint details with specificity how Novartis trained its personnel to engage in off-label marketing, how it equipped those personnel with reports and visual aids to support such marketing, how it used medical experts to promote the off-label use of Elidel, and how Mr. Galmines was reprimanded when he declined to market Elidel for such uses. These allegations, together with the first amended complaint’s allegation that at least 1,218,000 off-label prescriptions were written for Elidel, ‘are sufficiently specific both to inform [Novartis] of the “precise misconduct” charged, and to make it unlikely that [Mr. Galmines] has commenced this action in bad faith.’ Therefore, the court will not dismiss the first amended complaint under Rule 9(b).”

Novartis reported nearly $56.7 billion in net sales for 2012

Exposed: Edward Erin, the doctor whose faked asthma drug test results proved fatal

Fabricated research was not discovered until Edward Erin tried to poison his girlfriend

John Lawless

Monday, 17 June 2013

A British doctor faked test results during clinical trials for an asthma drug in which one person died and others contracted cancer and pneumonia, The Independent has learnt.

Dr Edward Erin’s fabrications were not detected until he was arrested and jailed for six years for lacing his lover’s coffee with drugs in an attempt to have her miscarry.

His sentence was later extended by two years after it emerged that he had tried to persuade a former cellmate to kill the woman and their baby son, and he is still in prison.

The medical trial began in 2003, when a dozen researchers at Imperial College London began trialling a new drug on 38 asthma sufferers at St Mary’s Hospital, London, where Erin worked as a chest consultant. His faked research partly contributed to the trial being extended internationally before its deadly side-effects were discovered.

***

It began with good intentions, but turned into the medical experiment from hell: a search for a wonder cure for asthma attacks which left one man dead, 20 seriously ill with pneumonia and eight with cancer. But for Britain’s leading heart and lung scientists at Imperial College, London, it was to get even worse: a doctor on their 12-strong team had faked his research results.

What makes the disclosure of his crime even more extraordinary is the fact that Dr Edward Erin’s fabrications were not detected until he was arrested and jailed for six years for lacing his lover’s coffee with drugs so she would miscarry.

Only two of the scientists involved in the study were willing to talk to The Independent: Professor Peter Barnes, who for three decades has been the world’s most respected specialist in his field, and the US asthma specialist Dr Sally Wenzel.

The medical trials began in 2004, when researchers started testing 38 asthma sufferers at St Mary’s Hospital, London. They were trying to discover whether a new drug could prevent airways of asthma sufferers from becoming life-threateningly inflamed.

In Barnes, a professor of thoracic medicine and head of airway disease at the National Heart and Lung Institute, it had at its head a renowned name in respiratory medicine. Working alongside him was Professor Andrew Bush, Imperial College’s professor of paediatrics and professor of paediatric respirology, Dr Trevor Hansel, medical director of the Imperial Clinical Respiratory Research Unit, and Dr Onn Min Kon, consultant respiratory physician and lead clinician for tuberculosis services at St Mary’s and Hammersmith Hospitals.

The costs of the trial were part-funded by the American drugs company, Centocor, which manufactured the drug being tested. Success would mean that it owned a multibillion dollar medicine.

After the American Journal of Respiratory and Clinical Care (AMJCC) published a paper, prepared by the UK team, saying results of their clinical study of 38 asthmatics had been promising, it was extended from using modestly ill to severely asthmatic patients, in international experiment almost eight times as big.

But what the team did not realise was that the results had been partly based on bogus tests concocted by Erin, a chest consultant at St Mary’s. Although his findings did not directly contribute to the development of cancers in the asthma patients, his data was an important factor in extending what had been a limited UK experiment to a global search involving almost eight times as many – and much more seriously ill – asthma sufferers.

From 2004 to 2006, three-quarters of 309 patients with severe and uncontrolled asthma who had volunteered to take part were given the drug, known as Golimumab, in three different strengths; the rest were on placebos. Dr Sally Wenzel, professor of medicine and director of the Asthma Institute at Pittsburgh’s Montefiore Hospital, was put in charge of the new clinical trials in the US and several European countries, including the UK.

The scientists running the study were deliberately not allowed to see the results as they were compiled, so their judgements were not compromised until all the data had been collated up to the 24th week. It was not until 25 February 2007, when the data was unlocked, that the awful consequences of the drug were discovered.

“There were serious side effects,” Professor Barnes said. “Pneumonia and cancer.” Dr Wenzel added: “It is potentially one of the big finds if it works, but Golimumab had substantial side effects.”

The next day the US Food and Drug Administration ordered an immediate shut-down of the trials. But it was too late. “One death occurred in the 200mg group,” the AMJCC dispassionately reported. “This patient was hospitalised in an unresponsive state one week after receiving the fourth Golimumab dose. The patient’s respiratory status declined, requiring ventilatory support, and the patient died from septic shock following diagnosis of small-bowel pneumatosis.”

It continued: “Eight malignancies were reported in Golimumab-treated patients: breast cancer in the 50mg group; B-cell lymphoma and malignant melanoma in the 100mg group; and cervical carcinoma, renal cell carcinoma, colon cancer (stage 0), and two basal cell carcinomas in the 200mg group.” One female test subject had to have her breast removed, while another man had a fast-growing polyps.

What was not then known was that an analysis of one set of tests, which looked at the build up of mucus developing in the lungs of patients, was bogus. Those findings were the result of work done by Erin, whose name appeared first among all the study authors in four AMJCC reports monitoring its progress. In 2008 he was arrested on charges of having laced his lover’s drink with drugs to try to make her miscarry and was suspended from practising as a doctor. Professor Barnes immediately asked another member of their research team to check all of his findings, and discovered that a lot of his data had been fabricated. Some statistics had been inflated to several times their real value.

In 2009, Erin was given six years in jail for two counts of attempting to administer poison and ordered to pay £30,000 costs. Judge Richard Hone, QC, described him as an “egocentric” who had delusions of grandeur. “The trial process has exposed you,” he added, “stripped of your flummery, as a liar, a cheat and a predator.”

“Erin did not seem different to any to any other research fellow,” Professor Barnes said. “He worked there. Was always in and working.” He discovered that Erin had consistently changed results for about three years. “The judge was absolutely right about Erin,” he said. “He was a liar and a cheat. But psychopaths are very convincing. It could happen to anyone.”

He continued: “Before he was arrested, we had no suspicions. We only had concerns about Erin because he was arrested and convicted of a crime. The person in a related area was not getting similar results. We obtained the notebook which contained the original data that Erin had taken. He had systematically changed figures.”

Professor Barnes acknowledges that Erin, a 44-year-old father of two with a 20-year unblemished medical record, may have been driven by a desire to enhance his career. “It is very difficult to see why he would he did it. It is as if he had a compulsion to change things. These people lie about things they don’t need to lie about. We have never had anything like it in my 30 years.”

In September 2010 a letter, signed by Professor Barnes, Professor Andrew Bush, Dr Trevor Hansel and Dr Onn Min Kon was sent to AMJCC retracting the research. It cited, among other things, an example of the way Erin had altered his data. One figure had been changed from 3.81 to 23.81.

In 2012, Erin’s sentence was extended for a further two years after a former cellmate revealed that the doctor had asked him, as he was about to be released from prison, to kill his former mistress and their baby son, Ernie.

The plot: A deception that continued in jail

On the surface, Dr Edward Erin was a respected doctor and family man.  But the 47-year-old father of two was leading a double life. Dubbed “Dr Poison”, he was jailed in 2009 for trying to poison his secretary, Bella Prowse, when she became pregnant after an affair that began at a Christmas party.

He tried to lace two drinks – a coffee and an orange juice – with drugs that he hoped would induce a miscarriage. Noticing her drinks had been tampered with, Ms Prowse went to the police. A former consultant at St Mary’s Hospital in west London, Erin’s subsequent trial revealed a man described by Old Bailey judge Richard Hone, QC, as “a liar, a cheat and a predator” who exploited his position and his wealth to seduce women.

Even in prison, Erin continued to plot a web of deception that he hoped would clear his name. He convinced a fellow inmate, Joe Mallia, to steal Ms Prowse’s phone and to send a text from it “confessing” that she had made the whole thing up. But Mallia took his story to The Sun, who then secretly filmed Erin going over the plot with Mallia.

The video was used as evidence against the disgraced doctor and he was found guilty of perverting the course of justice.

The retraction: an extract from the letter

In September 2010, a letter was sent to the AMJCC, signed by Dr Hansel, Prof Bush, Dr Kon and Prof Barnes:

“In January 2008 we were presented with some individual immunoassay points provided by Dr Edward M. Erin. On 16th February 2008 another member of our research team highlighted serious concerns. This matter was immediately reported to the relevant authorities. Having reviewed all immunoassay data from relevant studies, the Committee confirmed there was an overwhelming case to answer.

In their report, the Committee stated that Dr Erin, the first author in these publications, is the most likely person to have been responsible for the inaccuracies in the date. The Committee noted Dr Erin has not provided a satisfactory explanation for any of the several hundred unambiguously detailed numerical faults identified, despite being given a chance to provide an explanation.

Dr Erin has denied any wrongdoing on his part in relation to the above clinical research matters, but we authors feel the strong need for withdrawal of the above paper due to the factual inaccuracies.

Investigation into safety of new diabetes drugs — will manufacturers release their data?

Contact: Emma Dickinson edickinson@bmj.com 44-207-383-6529 BMJ-British Medical Journal

Joint BMJ/Channel 4 Dispatches investigation

The BMJ and Channel 4 Dispatches investigated and found that evidence suggesting potential harm from the drugs in industry studies has not been published.

Some independent studies challenge the conclusions of the drugs manufacturers’ own research. Now some medical experts and patient groups are calling on the pharmaceutical companies to be more transparent in reporting of study data and to enter into dialogue about safety concerns.

As a result, millions of patients around the world have not been fully informed about some of the possible risks.

Some critics say the drug regulators in Europe and the US have been slow to pursue concerns about the potential adverse effects of these new diabetes drugs, despite the emerging warning signs in the medical literature, regulatory documents, and adverse event databases.

Full details will be published on bmj.com on Monday 10 June and broadcast in Diets, Drugs and Diabetes – Channel 4 Dispatches on Monday 10 June at 8pm on Channel 4.

GLP-1 based drugs are used to treat type 2 diabetes by regulating blood sugar. Some of these drugs also suppress appetite and are currently being tested as a possible treatment for obesity.

In the course of this investigation, the BMJ has reviewed thousands of pages of regulatory documents obtained under freedom of information and found unpublished data pointing to “unwanted proliferative or inflammatory pancreatic effects.”

The BMJ has also found that, despite published reports that indicated safety concerns, companies have not done certain critical safety studies; nor have regulators requested them yet. And access to raw data that might help resolve doubts about the safety of these drugs has been denied.

Dr Deborah Cohen, the BMJ‘s Investigation Editor, says: “On their own the individual pieces of unpublished evidence may seem inconclusive, but when considered alongside other emerging and long standing evidence, a worrying picture emerges, posing serious questions about the safety of this class of drug.”

Three publications this year have raised concerns long held by some experts about the potential side effects of GLP-1 based drugs, prompting both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to launch a review into whether the drugs may cause or contribute to the development of pancreatic cancer. And in America, hundreds of people are suing manufacturers alleging that the drugs caused pancreatitis and in some cases cancer.

Yet the evidence is fiercely contested amongst scientists and manufacturers stoutly defending the safety of their products.

Some argue that the published evidence against the drugs is weak, while others say we can’t yet be sure that these drugs are safe and are calling for all the study data to be made public for independent analysis.

Research by Professor Peter Butler at the University of California Los Angeles, for example, found worrying changes in the pancreases of animals that received a GLP-1 based drug. He has also found abnormal changes, including pre-cancerous lesions, in the pancreases of eight organ donors taking GLP-1 based drugs compared with patients taking other anti-diabetic drugs.

And studies of side effects reported to the regulators have also started turning up cases of pancreatic cancer among patients on GLP-1 based drugs. Both EMA and the FDA have confirmed to the BMJ that they have “signal” for pancreatic cancer – but this does not mean there is a causal link.

Together these findings raise important and troubling questions about a possible link between these diabetes drugs and pancreatic cancer, but no safety alert has yet been issued by the regulators.

More information is expected later this month, when the US National Institutes of Health hold a two-day meeting on possible links between diabetes, diabetes drugs and pancreatic cancer.

But some consumer groups are calling for the drugs to be withdrawn as a diabetes treatment to prevent potential harm to patients while we wait for this evidence – and they don’t want to see them licensed as an obesity treatment.

Writing in the BMJ, Dr Fiona Godlee, Editor in Chief said: “All drug licensing is about balancing benefits and risks. But instead of engaging in open debate about legitimate and important scientific questions, the manufacturers have been unwilling to share their data. Meanwhile patients and doctors have not been kept properly informed about the uncertainties surrounding these drugs.”

She adds: “The debate would be much easier to resolve if all the information was placed in the public domain so scientists, doctors and ultimately patients could make up their own minds.”

In an editorial in the BMJ, Edwin Gale, Professor of diabetic medicine, says this shows once again that current regulatory procedures are inadequate to deal with the challenge of drug treatments that have more than one biological target, which he calls “shotgun therapies.” He says: “Similar scenarios will be re-enacted while secrecy rules and the companies control access to the data.”

In statements to Channel 4 Dispatches airing tonight, the drug companies all maintain their commitment to patient safety. On monitoring, the companies all say they have regular, close and vigorous safety processes in place, including large scale, long term trials, and the results are routinely submitted to the regulatory authorities.

###

 

The BMJ is campaigning for improved access to data from clinical trials – see bmj.com/opendata

If patients have any concerns about the diabetes drugs they are taking, they are asked to consult with a doctor before changing their medication.

 

FDA – 2012 law now in effect which lifts conflict of interest restrictions on FDA advisory panels

Contact: Kathy Fackelmann kfackelmann@gwu.edu 202-994-8354 George Washington University School of Public Health and Health Services

Conflict-of-interest restrictions needed to ensure strong FDA review

Panel members with ties to industry might lead to approval of unsafe drugs, new analysis suggests

WASHINGTON, DC—A 2012 law that loosened conflict-of-interest restrictions for FDA advisory panels could weaken the agency’s review system and could allow more drugs with safety problems to gain market approval, says a new analysis published June 7 in Science by researchers at the George Washington  University School of Public Health and Health Services (SPHHS).

The 2012 legislation removed measures put in place by an earlier law passed in 2007, according to the report by Susan F. Wood, PhD, an associate professor of health policy at SPHHS and Jillian K. Mador, a medical student at the GW School of Medicine & Health Sciences (SMHS). The 2007 FDA Amendments Act put caps on the number of experts with conflict of interest who could serve on FDA advisory panels in order to ensure an impartial review of new drugs, the authors said.

They say there is good reason to worry about the revisions in the law that now allow FDA panels to have more members who report a conflict—such as consulting fees from drug companies.  The removal of the requirement for “caps” on advisory committee members with financial conflicts was seen as a top priority of the pharmaceutical industry during the 2012 passage of the FDA Safety and Innovation Act.

“Panels top-heavy with experts who have financial ties to industry might be more likely to dismiss or ignore scientific evidence of risks or other problems,” said Wood, who is a former FDA official and the lead author on the paper. “This analysis also suggests that loosening the restrictions could lead to an appearance of conflict—and to potentially biased recommendations for approval or disapproval of a FDA regulated product.”

The authors point to historical examples of cases in which loaded panels voted for drugs that were later found to have serious safety problems.

The 2012 law was passed after the drug industry complained that the conflict of interest restrictions slowed down the FDA approval process and made it hard to fill panel positions with qualified experts. But Wood and Mador looked at the evidence and concluded that there are plenty of scientists with expertise to fill these positions—without the ties to the industry.

The analysis goes on to say that the restrictions did not affect FDA’s productivity in the past and there is little reason to think that reinstituting the caps would slow down the process of bringing safe new drugs to market today.  The analysis also demonstrates that the caps have never been reached, so FDA had apparently been successful in identifying experts without financial conflicts.

The analysis concludes that the evidence does not support the decision to remove the caps on conflict of interest and points out that Congress will soon begin discussing reauthorization of the 2012 law which is revised every five years. The authors urge the scientific and medical community to weigh in early on those discussions in order to point out concerns—and to ensure that the FDA Advisory Committee and review process remains strong and effective.

Wood and Mador’s new analysis, “Uncapping Conflict of Interest,” appears in the June 7 issue of Science.

###

About the George Washington University School of Public Health and Health Services:

Established in July 1997, the School of Public Health and Health Services brought together three longstanding university programs in the schools of medicine, business, and education and is now the only school of public health in the nation’s capital. Today, more than 1,100 students from nearly every U.S. state and more than 40 nations pursue undergraduate, graduate, and doctoral-level degrees in public health. http://sphhs.gwu.edu/

Motorola shows off tattoo and swallowable password hardware

 

Mobe manufacturer playing long game for end times

By Iain Thomson in San Francisco

Posted in Security, 31st May 2013 19:26 GMT

Regcast training : Hyper-V 3.0, VM high availability and disaster recovery

Motorola has shown off an electronic authentication tattoo and an FDA-approved pill that uses the body to transmit passwords, and says it wants to see a new generation of smartphones geared towards such wearable – or edible – technology.

The Number of the BeastThe Number of the Beast

Speaking [1] at the D11 conference, Regina Dugan – the first female head of DARPA who moved [2] to the Chocolate Factory last year – argued that with our plethora of devices, authentication needs to be simplified. The average user has to sign-on 39 times a day, and it takes them 2.3 seconds a time to do it each time – and that’s if you remember the password.

To crack this, she suggests either getting tattooed or using authentication in pill form as a way of saving those precious seconds that are being so wastefully lost. The industry is still stuck with the same login technology that it has used for 40 years, she said, and Motorola has the answer – or at least the partners to provide it.

She showed off a stick-on electronic tattoo on her arm consisting of a wireless power coil, temperature, ECG, phone sensors, and a small LED with a wireless antenna border. Motorola is working with the inventors, Cambridge, Massachusetts firm MC10, on a version for authentication, she said, and they would be available in a wide variety of designs.

“It may be true that 10-20 year-olds don’t want to wear a watch on their wrist, but you can be sure they’ll be far more interested in wearing an electronics tattoo, if only to piss off their parents,” she said. So-called theologians might disagree*.

The stick-on circuitry would last about two weeks before needing to be replaced, and the connections between the silicon and sensors are designed to flex 200 per cent, she said. The system would be sprayed with a plastic composite to assure your morning shower doesn’t leave you a non-person.

Dugan also showed off a pill containing a switch and what she described as an “inside-out potato battery” that uses stomach acids as an electrolyte and causes the switch to flick on and off. The resulting “18-bit ECG-like signal” is then broadcast throughout your body for as long as the device remains in it.

Motorola authentication pill‘I crap authentication’

“It’s really true; it means that that becomes my first superpower. I really want this superpower,” she said. “It means my arms are like wires, my hands are like alligator clips, and when I touch my phone, my computer, my door, my car, I’m authenticated in.”

The system, developed by Proteus Digital Heath, was FDA-approved and CE-stamped for people to take up to 30 of these pills a day she said, for their rest of your lives, she said.

Interviewer Walt Mossberg declined to swallow a proffered sample.

“We’re not shipping that right away,” Motorola CEO Dennis Woodside said during the interview. But taking a long-game approach to the evolving mobile market is going to be key to reviving the company, he said. In 2010 Samsung was selling as many phones as Motorola is now, he said; there are opportunities to be had.

After Google bought Android it funded the team for two years before releasing the operating system, he said, a strategy some decried as madness. The results have been rather good, he pointed out, and Google’s willing to make a similar investment in the company that was there at the start of mobile computing.

The first stage of this is the Moto X, [3] due to launch in the autumn. Woodside said he had it in his pocket, but refused to get it out. The new handset will be 70 per cent assembled in the US, coming from a plant in Fort Worth, Texas, and having manufacturing close at hand would allow the company to try out new manufacturing processes such as 3D printing.

Motorola is cracking a long-standing problem in mobile electronics by enabling low-power motion sensors without needing to boot the full operating system, he said. Phones should detect your location and movement and adapt their interfaces to match the situation.

The price for this “contextually aware” feature is battery power, and the fact that phones can’t last a week without recharging is a major issue the company wants to solve. Larry Page is also apparently frustrated that phones still break, so the engineers are trying to toughen up smartphones. ®

* Bootnote

One marketing problem Motorola may not have anticipated is the reaction of biblical literalists to its wearable authentication systems.

A surprising number of people in the US still adhere to an apparent literal translation of the current version of the Bible. These include Jehovah’s Witnesses, who refuse blood transfusions and shun those who take them, to those who look to the finale of the New Testament: The Book of Revelation – or, for you believers of the Catholic persuasion, The Apocalypse.

The text, thought to be written about 60 years after the biblical death of Christ, is regarded as either a description of the end times of humanity, a satirical pastiche on the increasingly subverted tenants of Christian bureaucracy, or a really bad mushroom trip on a Greek island. Nevertheless it contains the following warning:

It causes all, both small and great, both rich and poor, both free and slave, to be marked on the right hand or the forehead, so that no one can buy or sell unless he has the mark, that is, the name of the beast or the number of its name. This calls for wisdom: let the one who has understanding calculate the number of the beast, for it is the number of a man, and his number is 666.

Be reassured that the majority of people of faith in the US and elsewhere aren’t quite so inflexible. Those that aren’t may be shrill, particularly in the US, but do not form a representative sample of Christianity.

Those expected to benefit the most from Avastin based on genetic testing had the worst survival rates. Yet they keep justifying its Use.

Avastin fails studies in new brain tumor patients

Associated PressBy MARILYNN MARCHIONE | Associated Press – 

CHICAGO (AP) — New research raises fresh questions about which cancer patients benefit from Avastin, a drug that lost its approval for treating breast cancer nearly two years ago.

Avastin did not prolong life when used as a first treatment for people with brain tumors like the one U.S. Sen. Edward Kennedy died of several years ago, two studies found. In one, patients who were expected to benefit the most from Avastin based on genetic testing had the worst survival rates. Side effects also were more common with Avastin.

The drug is approved for treating brain tumors that have recurred for people who already tried chemotherapy or radiation. But that approval was based on studies suggesting it briefly delayed the worsening of the disease. No definitive study shows it helps those patients live longer, either.

Something similar happened with breast cancer: Avastin won the Food and Drug Administration’s approval after studies suggested it delayed disease progression. But when later research showed it did not prolong life and brought more side effects, its approval for breast cancer was revoked.

However, many cancer experts say the same thing should not happen now, and that Avastin should retain its approval for brain cancer patients whose disease has recurred.

“I would definitely not want the FDA to take that away from patients,” said Dr. Deepa Subramaniam, director of the brain tumor center at Georgetown Lombardi Comprehensive Cancer Center in Washington, D.C. “That’s very different from the breast cancer story,” where there are many other drugs that can be tried, she said.

She had no role in the new studies, which were discussed Sunday at an American Society of Clinical Oncology conference in Chicago.

Avastin, made by Swiss-based Roche’s Genentech unit, acts by depriving tumors of a blood supply. It’s also sold for treating certain colon, lung and kidney tumors. Another study discussed Sunday and released previously showed it helped women with advanced cervical cancer live nearly four months longer.

The new brain cancer studies tested it as initial treatment for glioblastoma, the most common and deadly type of tumor. About 10,000 Americans each year are diagnosed with these tumors, which are nearly always incurable.

In one study, 637 patients received standard chemotherapy plus radiation, and half also received Avastin. Both groups lived about 16 months, and those on Avastin had more side effects — mostly low blood counts, blood clots and high blood pressure.

“Our study would strongly suggest that it is not beneficial to do it as front-line treatment but to reserve it as second-line or salvage therapy,” said study leader Dr. Mark Gilbert of the University of Texas MD Anderson Cancer Center in Houston. Federal grants and Genentech paid for the study, and Gilbert consults for the company.

More troubling, independent experts said, is that patients who were expected to do the best based on genetic and other tests surprisingly had a worse survival trend — 16 months versus 25 months for others in the study.

New research needs to be done to better define which patients benefit, said Rakesh Jain, a brain tumor expert at Massachusetts General Hospital in Boston.

“We just cannot give these agents to every patient,” he said.

A second study that tested Avastin as initial therapy with radiation and the drug Temodar found it did not prolong life, but patients on Avastin went nearly five months longer before their tumors appeared to worsen.

Avastin costs about $43,000 plus doctor infusion charges for a course of treatment for people whose brain tumors have recurred.

___

Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP

http://news.yahoo.com/avastin-fails-studies-brain-tumor-patients-133937951.html

 

Japan halts some U.S. imports after modified wheat found

By MARY CLARE JALONICK and NIGEL DUARA

Business May. 31, 2013 – 03:15PM JST ( 20 )

WASHINGTON —

Japan has suspended some imports of U.S. wheat after a genetically engineered version of the grain was found on a U.S. farm.

The Agriculture Department announced the discovery of the modified wheat on Wednesday. No genetically engineered wheat has been approved for U.S. farming.

Japan is one of the largest export markets for U.S. wheat growers. Katsuhiro Saka, a counselor at the Japanese Embassy in Washington, said Thursday that Japan had canceled orders of western white wheat from the Pacific Northwest and also of some feed-grade wheat. He said the country was waiting for more information from the Agriculture Department as it investigates the discovery.

“In most countries the unapproved genetically modified wheat would be a target of concern,” Saka said. “The Japanese people have similar kinds of concerns.”

USDA officials said the wheat was the same strain as a genetically modified wheat that was designed to be herbicide-resistant and was legally tested by seed giant Monsanto a decade ago but never approved. Monsanto stopped testing that product in Oregon and several other states in 2005.

The Agriculture Department said the genetically engineered wheat is safe to eat and there is no evidence that modified wheat entered the marketplace. But the department is investigating how it ended up in the field, whether there was any criminal wrongdoing and whether its growth is widespread.

The mystery could have implications on the wheat trade in the U.S. and abroad, as evidenced by Japan’s suspension of imports on Thursday.

Many countries around the world will not accept imports of genetically modified foods, and the United States exports about half of its wheat crop.

Japan imports 90% of its wheat, or about 5 million metric tons annually, including 3 million metric tons from the U.S., according to Toru Hisazome, an official with the Ministry of Agriculture in Tokyo.

Japan, which bans the import of genetically modified foods, suspended a tender for 25,000 metric tons of western white wheat, mainly used in Japan for making cakes, he said.

“We don’t have the exact information from the U.S. side yet,” Hisazome said.

Import orders for other types of U.S. wheat would not be affected, he said.

South’s Korea agriculture ministry said it will increase inspections of wheat imported from the U.S.

American consumers also have shown increasing interest in avoiding genetically modified foods. There has been little evidence to show that foods grown from engineered seeds are less safe than their conventional counterparts, but several state legislatures are considering bills that would require them to be labeled so consumers know what they are eating.

While most of the corn and soybeans grown in the United States are already modified, the country’s wheat crop is not. Many wheat farmers have shown reluctance to use genetically engineered seeds since their product is usually consumed directly, while much of the corn and soybean crop is used as feed.

The modified wheat was discovered when field workers at an Eastern Oregon wheat farm were clearing acres for the bare offseason when they came across a patch of wheat that didn’t belong. The workers sprayed it and sprayed it, but the wheat wouldn’t die. Their confused boss grabbed a few stalks and sent it to a university lab in early May.

A few weeks later, Oregon State wheat scientists made a startling discovery: The wheat was genetically modified, in clear violation of U.S. law. They contacted the USDA, which ran more tests and confirmed their discovery.

“It looked like regular wheat,” said Bob Zemetra, Oregon State’s wheat breeder.

The tests confirmed that the plants were a strain developed by Monsanto to resist its Roundup Ready herbicides and were tested between 1998 and 2005. At the time Monsanto had applied to the USDA for permission to develop the engineered wheat, but the company later withdrew its application.

The Agriculture Department said that during that seven-year period, it authorized more than 100 field tests with the same glyphosate-resistant wheat variety. Tests were conducted in in Arizona, California, Colorado, Florida, Hawaii, Idaho, Illinois, Kansas, Minnesota, Montana, Nebraska, North Dakota, Oregon, South Dakota, Washington and Wyoming.

During that testing and application process, the Food and Drug Administration reviewed the variety found in Oregon and said it was as safe as conventional varieties of wheat.

USDA officials declined to speculate whether the modified seeds blew into the field from a testing site or whether they were somehow planted or taken there, and they would not identify the farmer or the farm’s location. They said they had not received any other reports of discoveries of modified wheat.

Japan is regularly the top buyer of Northwest wheat, said Blake Rowe, CEO of the Oregon Wheat Commission. He said reductions in wheat sales would affect farmers in Idaho and Washington as well as Oregon, because the wheat is blended together.

Oregon sold $492 million in wheat in 2011, the most recent data available, and 90% of it went overseas, Oregon Department of Agriculture spokesman Bruce Pokarney said.

“If those markets are closed off – you can do the math,” Pokarney said.

 

http://www.japantoday.com/category/business/view/japan-suspends-some-u-s-imports-after-modified-wheat-found

Cholesterol-drugs cause unusual swellings within neurons resulting in cognitive disturbances

Contact: La Monica Everett-Haynes leverett@email.arizona.edu 520-626-4405 University of Arizona

Research reveals possible reason for cholesterol-drug side effects

University of Arizona researchers have identified a clue to explain the reversible memory loss sometimes caused by the use of statins, one of the most widely prescribed medications in the world.

             IMAGE:   Of 1,040 drugs tested, only four caused  nodules to form inside the neurites, resembling beads on a string. All four drugs were statins.

Click here for more information.     

The U.S. Food and Drug Administration and physicians continue to document that some patients experience fuzzy thinking and memory loss while taking statins, a class of global top-selling cholesterol-lowering drugs.

A University of Arizona research team has made a novel discovery in brain cells being treated with statin drugs: unusual swellings within neurons, which the team has termed the “beads-on-a-string” effect.

The team is not entirely sure why the beads form, said UA neuroscientist Linda L. Restifo, who leads the investigation. However, the team believes that further investigation of the beads will help inform why some people experience cognitive declines while taking statins.

“What we think we’ve found is a laboratory demonstration of a problem in the neuron that is a more severe version for what is happening in some peoples’ brains when they take statins,” said Restifo, a UA professor of neuroscience, neurology and cellular and molecular medicine, and principal investigator on the project.

Restifo and her team’s co-authored study and findings recently were published in Disease Models & Mechanisms, a peer-reviewed journal. Robert Kraft, a former research associate in the department of neuroscience, is lead author on the article.

Restifo and Kraft cite clinical reports noting that statin users often are told by physicians that cognitive disturbances experienced while taking statins were likely due to aging or other effects. However, the UA team’s research offers additional evidence that the cause for such declines in cognition is likely due to a negative response to statins.

The team also has found that removing statins results in a disappearance of the beads-on-a-string, and also a restoration of normal growth. With research continuing, the UA team intends to investigate how genetics may be involved in the bead formation and, thus, could cause hypersensitivity to the drugs in people. Team members believe that genetic differences could involve neurons directly, or the statin interaction with the blood-brain barrier.

“This is a great first step on the road toward more personalized medication and therapy,” said David M. Labiner, who heads the UA department of neurology. “If we can figure out a way to identify patients who will have certain side effects, we can improve therapeutic outcomes.”

For now, the UA team has multiple external grants pending, and researchers carry the hope that future research will greatly inform the medical community and patients.

“If we are able to do genetic studies, the goal will be to come up with a predictive test so that a patient with high cholesterol could be tested first to determine whether they have a sensitivity to statins,” Restifo said.

Detecting, Understanding a Drugs’ Side Effects

Restifo used the analogy of traffic to explain what she and her colleagues theorize.

The beads indicate a sort of traffic jam, she described. In the presence of statins, neurons undergo a “dramatic change in their morphology,” said Restifo, also a BIO5 Institute member.

“Those very, very dramatic and obvious swellings are inside the neurons and act like a traffic pileup that is so bad that it disrupts the function of the neurons,” she said.

It was Kraft’s observations that led to team’s novel discovery. Restifo, Kraft and their colleagues had long been investigating mutations in genes, largely for the benefit of advancing discoveries toward the improved treatment of autism and other cognitive disorders.

At the time, and using a blind-screened library of 1,040 drug compounds, the team ran tests on fruit fly neurons, investigating the reduction of defects caused by a mutation when neurons were exposed to different drugs. The team had shown that one mutation caused the neuron branches to be curly instead of straight, but certain drugs corrected this. The research findings were published in 2006 in the Journal of Neuroscience.

Then, something serendipitous occurred: Kraft observed that one compound, then another and then two more all created the same reaction – “these bulges, which we called beads-on-a-string,'” Kraft said. “And they were the only drugs causing this effect.”

At the end of the earlier investigation, the team decoded the library and found that the four compounds that resulted in the beads-on-a-string were, in fact, statins.

“The ‘beads’ effect of the statins was like a bonus prize from the earlier experiment,” Restifo said. “It was so striking, we couldn’t ignore it.”

             IMAGE:   Neurons whose mitochondria are labeled with green fluorescent protein (GFP) reveal that statins cause mitochondria to pile up inside the branches that neurons use to connect with each other.

Click here for more information.     

In addition to detecting the beads effect, the team came upon yet another major finding: when statins are removed, the beads-on-a-string effect disappears, offering great promise to those being treated with the drugs.

“For some patients, just as much as statins work to save their lives, they can cause impairments,” said Monica Chaung, who has been part of the team and is a UA undergraduate researcher studying molecular and cellular biology and physiology.

“It’s not a one drug fits all,” said Chaung, a UA junior who is also in the Honors College. “We suspect different gene mutations alter how people respond to statins.”

Having been trained by Kraft in techniques to investigate cultured neurons, Chuang was testing gene mutations and found variation in sensitivity to statins. It was through the work of Chuang and Kraft that the team would later determine that, after removing the statins, the cells were able to repair themselves; the neurotoxicity was not permanent, Restifo said.

“In the clinical literature, you can read reports on fuzzy thinking, which stops when a patient stops taking statins. So, that was a very important demonstration of a parallel between the clinical reports and the laboratory phenomena,” Restifo said.

The finding led the team to further investigate the neurotoxicity of statins.

“There is no question that these are very important and very useful drugs,” Restifo said. Statins have been shown to lower cholesterol and prevent heart attacks and strokes.

But too much remains unknown about how the drugs’ effects may contribute to muscular, cognitive and behavioral changes.

“We don’t know the implications of the beads, but we have a number of hypotheses to test,” Restifo said, adding that further studies should reveal exactly what happens when the transportation system within neurons is disrupted.

Also, given the move toward prescribing statins to children, the need to have an expanded understanding of the effects of statins on cognitive development is critical, Kraft said.

“If statins have an effect on how the nervous system matures, that could be devastating,” Kraft said. “Memory loss or any sort of disruption of your memory and cognition can have quite severe effects and negative consequences.”

Restifo and her colleagues have multiple grants pending that would enable the team to continue investigating several facets related to the neurotoxicity of statins. Among the major questions is, to what extent does genetics contribute to a person’s sensitivity to statins?

“We have no idea who is at risk. That makes us think that we can use this genetic laboratory assay to infer which of the genes make people susceptible,” Restifo said.

“This dramatic change in the morphology of the neurons is something we can now use to ask questions and experiment in the laboratory,” she said. “Our contribution is to find a way to ask about genetics and what the genetic vulnerability factors are.”

The Possibility for Future Research, Advice

The team’s findings and future research could have important implications for the medical field and for patients with regard to treatment, communication and improved personalized medicine.

“It’s important to look into this to see if people may have some sort of predisposition to the beads effect, and that’s where we want to go with this research,” Kraft said. “There must be more research into what effects these drugs have other than just controlling a person’s elevated cholesterol levels.”

And even as additional research is ongoing, suggestions already exist for physicians, patients and families.

“Most physicians assume that if a patient doesn’t report side effects, there are no side effects,” Labiner said. “The paternalistic days of medication are hopefully behind us. They should be.”

“We can treat lots of things, but the problem is if there are side effects that worsen the treatment, the patient is more likely to shy away from the medication. That’s a bad outcome,” he said. “There’s got to be a give and take between the patient and physician.”

Patients should feel empowered to ask questions, and deeper questions, about their health and treatment and physicians should be very attentive to any reports of cognitive decline for those patients on statins, she said.

For some, it starts early after starting statins; for others, it takes time. And the signs vary. People may begin losing track of dates, the time or their keys.

“These are not trivial things. This could have a significant impact on your daily life, your interpersonal relationships, your ability to hold a job,” Restifo said.

“This is the part of the brain that allows us to think clearly, to plan, to hold onto memories,” she said. “If people are concerned that they are having this problem, patients should ask their physicians.”

Restifo said open and direct patient-physician communication is even more important for those on statins who have a family history of side effects from statins.

Also, physicians could work more closely with patients to investigate family history and determine a better dosage plan. Even placing additional questions on the family history questionnaire could be useful, she said.

“There is good clinical data that every-other-day dosing give you most of the benefits, and maybe even prevents some of the accumulation of things that result in side effects,” Restifo said, suggesting that physicians should try and get a better longitudinal picture on how people react while on statins.

“Statins have been around now for long enough and are widely prescribed to so many people,” she said. “But increased awareness could be very helpful.”

###

Watchdogs Blast EPA for Allowing Arsenic in Chicken & Swine Feed

 

By REBEKAH KEARN

 

(CN) – Lax federal regulators allow arsenic-based additives in chicken and swine feed that can cause cancer in humans, the Center for Food Safety claims in court.

Eight other watchdogs joined the Center for Food Safety in suing Department of Health and Human Services Secretary Kathleen Sebelius, and U.S. Food and Drug Administration Commissioner Margaret Hamburg in San Francisco Federal Court.

“Petitioners are requesting immediate action because the use of arsenic-based feed additives in food-producing animals poses a serious yet completely avoidable health risk to humans,” the complaint states.

The FDA approved the use of arsenic-based food additives in animal feed in the 1940s. “More than seventy years later, arsenic-containing feed additives – namely Roxarsone, arsanilic acid, nitarsone, and carbarsone – are still used in chicken, turkey, and swine production,” the complaint states.

“In 2004 and 2005, plaintiff Institute for Agriculture and Trade Policy tested for total arsenic residues in retail packages of raw chicken and in ‘fast food’ chicken sandwiches and nuggets. Test results revealed detectable levels of arsenic in the majority of supermarket chicken and in all ‘fast food’ chicken. Arsenic levels in chicken from birds for which there was a claim of ‘no arsenic given’ contained no arsenic or such a small amount that it was below the detection limit. These results strongly suggest that the use of arsenic-containing compounds in poultry feed leads to arsenic residues in chicken marketed and eaten in the United States.

“Inorganic arsenic is a known human carcinogen. It can contribute to cancers, heart disease, diabetes, declines in intellectual function, and can decrease a body’s ability to respond to viruses. The organic form of arsenic – the form found in arsenic-containing compounds – was once considered safe at low levels. Recent studies show that organic arsenic can easily convert to inorganic arsenic. Further, organic arsenic may also be toxic in its own right, though an earlier history of organic arsenical toxicity has been largely overlooked by FDA.”

The plaintiffs say the FDA failed to respond to their request to revoke approval for New Animal Drug Applications that use “arsenic-containing compounds” in feed for chicken, turkeys and swine.”

Since they filed that petition in 2009, several “significant events have occurred” that failed to draw a response from a complacent FDA, the plaintiffs say.

Among other things, the FDA issued a report in February 2011 that found that chickens treated with Roxarsone had higher levels of inorganic arsenic in their livers than chickens not treated with the additive, the complaint states.

But the FDA has not taken Roxarsone off the market, nor has it studied the effects of treating animals with other arsenic-based compounds.

“FDA’s failure to act has completely failed to close the loophole on an avoidable exposure pathway to a known carcinogen,” the complaint states.

“Nearly three-and-a-half years have now passed since FDA docketed the 2009 petition for rulemaking. Not only has FDA failed to act under the FFDA [Federal Food, Drug and Cosmetic Act], the agency has not meaningfully responded to the 2009 petition and is in violation of the Administrative Procedure Act. In the interim, evidence of the negative effects of arsenic-based feed additives continues to mount.”

The groups ask the court to declare the FDA in violation of the Administrative Procedures Act and compel it to respond to the petition.

They are represented by Paige M. Tomaselli, in-house counsel for the Center for Food Safety.

Here are the plaintiffs: Center for Food Safety; Institute for Agriculture and Trade Policy; Center for Environmental Health; Center for Biological Diversity; Food Animal Concerns Trust; Food and Water Watch; Oregon Physicians for Social Responsibility; Health Care Without Harm; and San Francisco Bay Area Physicians for Social Responsibility

http://www.courthousenews.com/2013/05/02/57250.htm

Troubling levels of toxic metals found in lipstick

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

Berkeley — A new analysis of the contents of lipstick and lip gloss may cause you to pause before puckering.

Researchers at the University of California, Berkeley’s School of Public Health tested 32 different lipsticks and lip glosses commonly found in drugstores and department stores. They detected lead, cadmium, chromium, aluminum and five other metals, some of which were found at levels that could raise potential health concerns. Their findings will be published online Thursday, May 2, in the journal Environmental Health Perspectives.

Prior studies also have found metals in cosmetics, but the UC Berkeley researchers estimated risk by analyzing the concentration of the metals detected and consumers’ potential daily intake of the metals, and then comparing this intake  with existing health guidelines.

“Just finding these metals isn’t the issue; it’s the levels that matter,” said study principal investigator S. Katharine Hammond, professor of environmental health sciences. “Some of the toxic metals are occurring at levels that could possibly have an effect in the long term.”

Lipstick and lip gloss are of special concern because when they are not being blotted on tissue or left as kiss marks, they are ingested or absorbed, bit by bit, by the individual wearing them, the study authors said. The researchers developed definitions for average and high use of lip makeup based on usage data reported in a previous study. Average use was defined as a daily ingestion of 24 milligrams of lip makeup per day. Those who slather on the lip color and reapply it repeatedly could fall into the high use category of 87 milligrams ingested per day.

Using acceptable daily intakes derived from this study, average use of some lipsticks and lip glosses would result in excessive exposure to chromium, a carcinogen linked to stomach tumors. High use of these makeup products could result in potential overexposure to aluminum, cadmium and manganese as well. Over time, exposure to high concentrations of manganese has been linked to toxicity in the nervous system.

Lead was detected in 24 products, but at a concentration that was generally lower than the acceptable daily intake level. However, the lead levels still raised concerns for young children, who sometimes play with makeup, since no level of lead exposure is considered safe for them, the researchers said.

The study authors say that for most adults, there is no reason to toss the lip gloss in the trash, but the amount of metals found do signal the need for more oversight by health regulators. At present, there are no U.S. standards for metal content in cosmetics. The authors note that the European Union considers cadmium, chromium and lead to be unacceptable ingredients at any level in cosmetic products.

“I believe that the FDA (Food and Drug Administration) should pay attention to this,” said study lead author Sa Liu, a UC Berkeley researcher in environmental health sciences. “Our study was small, using lip products that had been identified by young Asian women in Oakland, Calif. But, the lipsticks and lip glosses in our study are common brands available in stores everywhere. Based upon our findings, a larger, more thorough survey of lip products and cosmetics in general is warranted.”

###

Ann Rojas-Cheatham, director of research and training at the Asian Communities for Reproductive Justice in Oakland, Calif., co-authored the study. The National Institutes of Health and the National Institute of Occupational Safety and Health Education Research Center helped support this research.

 

The real cancer killer: rip-off prices for drugs

Doctors say industry ‘profiteering’ threatens lives

Jeremy Laurance

Sunday, 28 April 2013

An influential group of cancer experts has warned that the high prices charged by pharmaceutical companies for cancer drugs are effectively condemning patients to death.

The group of more than 100 leading cancer physicians from around the world, including nine from the UK, accuse the drug industry of “profiteering” – making a profit by unethical methods such as by raising the cost of grain after a natural disaster.

Of the 12 drugs approved by the Food and Drug Administration in the US in 2012, 11 were priced above $100,000 (£65,000) per patient per year. In addition the price of existing drugs of proven effectiveness has been increased by up to threefold.

The specialists say: “What determines a morally justifiable ‘just price’ for a cancer drug? A reasonable drug price  should maintain healthy pharmaceutical industry profits without being viewed as ‘profiteering’. This term [profiteering] may apply to the trend of high drug prices where a life threatening medical condition is the disaster.”

The high prices mean the drugs may not be approved by the National Institute for Clinical Excellence in the UK forcing doctors to fill in a 14 page application apply to the Cancer Drugs fund for British patients who could benefit from them.

In addition, the rising cost of existing drugs in a cash limited health service such as the NHS means treatment is denied to other patients with other conditions.

The authors of the article, published in the journal Blood, are all specialists in blood cancers such as leukaemia, where cancer drugs have proved most effective.

One of the best known – imatinib, whose brand name is Glivec – has proved so successful in chronic myeloid leukaemia that patients who a decade ago survived for a few years can now look forward to a near-normal life expectancy.

But the cost of Glivec has risen from £18,000 per patient per year to around £21,000 in the UK, and from $30,000 to $92,000 in the US. This is despite the fact that all research costs were covered by the original price, and the number of patients treated and the length of time they are on the drug have both vastly increased because of the drug’s success.

Daniel Vasella, former chairman and chief executive of Novartis, the manufacturer, said the original price charged for Glivec in 2001 was considered “high but worthwhile” and was estimated to yield annual revenues of $900 million, enough to cover its development cost in two years. A decade later Its annual revenues in 2012 were $4.7 billion (£3 billion).

The cancer specialists say the revenue earned by Glivec over the last ten years “represent generous profits to the company”. But this has put heavy pressure on those who have to foot the bill. “Grateful patients may have become the financial victims of the treatment success, having to pay the high price annually to stay alive”.

In the US even those with health insurance may pay an average of 20 per cent of drug prices out of pocket. Drug prices are the single most frequent cause of personal bankruptcies in the US.

Three new drugs have been approved for chronic myeloid leukaemia in the last year by the FDA but the prices are “astronomical” the authors say at up to $138,000 a year per patient.

Worldwide only about a quarter of the patients with chronic myeloid leukaemia who could benefit have access to drugs because of the cost. “A small fraction are rich enough to pay individually, and most are treated intermittently or not at all. The effects of these financial pressures on long term survival… are yet unknown.”

In the UK, patients are shielded from the “direct economic anxieties of illness”, the article says.  But Professor Jane Apperley, chair of the Department of Haematology at Imperial College, London, and one of the authors, said high drug prices were still a cause of harm in Britain .

“The price of a drug heavily influences the decision of NICE whether we can prescribe it on the NHS. I am chief of service at Imperial College and we are constantly being asked to reduce our spending. We have to look very carefully at the cost of the drugs we use.”

“Of course we need the pharmaceutical industry to go on developing new drugs. It is very exciting that a number of cancers are now becoming susceptible to these new drugs. But the rising cost is unsustainable. “

“The drugs are very effective at keeping people alive. But if they are priced out of what you can afford you know that you can keep people alive but you can’t afford to do so. It is completely unsustainable for the NHS because the costs are going up every year. We need a serious dialogue about whether we can sustain these costs.”

The authors of the article in Blood conclude: “We believe the unsustainable drug prices may be causing harm to patients. Advocating for lower drug prices is a necessity to save the lives of patients who cannot afford them. We believe drug prices should reflect objective measures of benefit, but should not exceed values that harm our patients and societies.”

The group say they intend to organise regular meetings and campaign for lower cancer drug prices.

A spokesperson for the UK charity Beating Blood Cancers said: “As a charity we want to see an ethical approach to drug pricing . There is no point in us investing in research if the pricing policy means drugs won’t be available to patients.”

In a statement to The Independent, Novartis said: “We recognize that sustainability of health care systems is a complex topic and we welcome the opportunity to be part of the dialogue.  Our critical role, as one of many parties working towards improving cancer care, is to discover and develop innovative treatments.”

“ Novartis innovation in chronic myeloid leukemia (CML) has changed the course of the disease. Before Glivec(imatinib)* and Tasigna (nilotinib), the five-year survival in CML was only 30 percent. Today, nine out of ten patients with CML have a normal lifespan and are leading productive lives.”

“Over the years, our programs have evolved to improve patient access to our medicines. We work together with government health care systems, charities and other payers to build successful cost-sharing models.”

Expert view: ‘Price of drugs is harming patients’

The following is an extract from an article, contributed to by more than 100 leading cancer physicians from around the world, including nine from the UK, published in the journal, Blood.

This perspective reflects the views of a large group of CML experts, who believe the current [high] prices of drugs may compromise access of needy patients to highly effective therapy, and are harmful to the sustainability of our national healthcare systems…

If drug price reflects value, then it should be proportional to the benefit to patients in objective measures, such as survival prolongation, degree of tumour shrinkage, or improved quality of life. For many tumours, drug prices do not reflect these endpoints, since most anti-cancer drugs provide minor survival benefits, if at all.

As physicians, we… believe the unsustainable drug prices in CML and cancer may be causing harm to patients. Advocating for lower drug prices is a necessity to save the lives of patients who cannot afford them … For CML, and for other cancers, we believe drug prices should reflect objective measures of benefit, but should also not exceed values that harm our patients and societies.”

An ethical price tag? Cancer drugs

Brands used for the treatment of chronic myeloid leukaemia

Imatinib (Glivec) £21,000 per patient per year – Novartis Designed from first principles, it proved hugely effective and unexpectedly turned into a blockbuster, earning billions of pounds for its makers.

Nilotinib (Tasigna) £21,000 – Novartis Designed for patients who fail to respond to Glivec, Novartis reduced the cost to get it past Nice, whilst increasing the cost of Glivec.

Dasatinib (Sprycel) £31,000 – Bristol Myers Squibb Also designed for patients who cannot take Glivec. But it has not been approved by Nice for use on the NHS because of its high cost.

Bosutinib (Bosulif) £76,000 – Pfizer For patients who suffer side-effects from the other drugs. It won approval in the US in 2012 but is awaiting a licence in the UK.

Omacetaxine (Synribo) £100,000 – Teva For patients who cannot tolerate other drugs. Approved in US in 2012 but awaiting licence in the UK.

Ponatinib (Iclusig) £90,000 – Ariad A third-generation drug which works in a different way. Approved in the US in 2012 but awaiting a licence in the UK.

http://www.independent.co.uk/life-style/health-and-families/health-news/the-real-cancer-killer-ripoff-prices-for-drugs-8591825.html#

 

40 percent of parents give young kids cough/cold medicine that they shouldn’t

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

Many parents disregard label warnings, give children under age 4 common medicines, according to new U-M National Poll on Children’s Health

ANN ARBOR, Mich. – Children can get five to 10 colds each year, so it’s not surprising that adults often turn to over-the-counter cough and cold medicines to relieve their little ones’ symptoms. But a new University of Michigan poll shows that many are giving young kids medicines that they should not use.

More than 40 percent of parents reported giving their children under age 4 cough medicine or multi-symptom cough and cold medicine, according to the latest University of Michigan C.S. Mott Children’s Hospital National Poll on Children’s Health.  Twenty-five percent gave those children decongestants.

In 2008, the federal Food and Drug Administration issued an advisory that these over-the-counter medicines not be used in infants and children under age 2. They have not been proven effective for young children and may cause serious side effects, says Matthew M. Davis, M.D., M.A.P.P., director of the C.S. Mott Children’s Hospital National Poll on Children’s Health.

In response to the FDA, manufacturers of over-the-counter cough and cold products changed their labels back in 2008, to state that the medicines should not be used for children under 4 years old.

“These products don’t reduce the time the infection will lasts and misuse could lead to serious harm,” says Davis.  “What can be confusing, however, is that often these products are labeled prominently as ‘children’s’ medications. The details are often on the back of the box, in small print.  That’s where parents and caregivers can find instructions that they should not be used in children under 4 years old,” Davis says

The side effects from use of cough and cold medicines in young children may include allergic reactions, increased or uneven heart rate, drowsiness or sleeplessness, slow and shallow breathing, confusion or hallucinations, convulsions, nausea and constipation.

The poll found that use of the cough and cold medicines in children age four and under did not differ by parent gender, race/ethnicity or by household income.

“Products like these may work for adults, and parents think it could help their children as well. But what’s good for adults is not always good for children,” says Davis.

Davis says parents need to be vigilant about reading the directions and should always call their pediatrician or health care provider about questions regarding over-the-counter medications.

“Because young children often suffer from cold-like symptoms, more research is needed to test the safety and efficacy of these cough and cold medicines in our littlest patients,” Davis says.

###

Broadcast-quality video is available on request. See the video here:  http://www.youtube.com/watch?v=jRkQf1OUGJs

Full report: http://mottnpch.org/reports-surveys/parents-ignore-warning-labels-give-cough-cold-meds-young-kids

Website: Check out the Poll’s new website: MottNPCH.org. You can search and browse over 70 NPCH Reports, suggest topics for future polls, share your opinion in a quick poll, and view information on popular topics. The National Poll on Children’s Health team welcomes feedback on the new website, including features you’d like to see added. To share feedback, e-mail NPCH@med.umich.edu.

Facebook: http://www.facebook.com/mottnpch

Twitter: @MottNPCH

Purpose/Funding: The C.S. Mott Children’s Hospital National Poll on Children’s Health – based at the Child Health Evaluation and Research Unit at the University of Michigan and funded by the Department of Pediatrics and Communicable Diseases and the University of Michigan Health System – is designed to measure major health care issues and trends for U.S. children.

Data Source: This report presents findings from a nationally representative household survey conducted exclusively by GfK Custom Research, LLC GfK Custom Research, LLC (GfK), for C.S. Mott Children’s Hospital via a method used in many published studies.  The survey was administered in January 2013 to a randomly selected, stratified group of parents with a child age 0-3 (n=498) from GfK’s web-enabled KnowledgePanel® that closely resembles the U.S. population. The sample was subsequently weighted to reflect population figures from the Census Bureau. The survey completion rate was 57 percent among panel members contacted to participate. The margin of error is ± 8 to 11 percentage points.

Findings from the U-M C.S. Mott Children’s Hospital National Poll on Children’s Health do not represent the opinions of the investigators or the opinions of the University of Michigan.

Research suggests popular diabetes drugs can cause abnormal pancreatic growth in humans

Contact: Enrique Rivero erivero@mednet.ucla.edu 310-794-2273 University of California – Los Angeles Health Sciences

Individuals who had taken a type of drug commonly used to treat Type 2 diabetes showed abnormalities in the pancreas, including cell proliferation, that may be associated with an increased risk of neuroendocrine tumors, according to a new study by researchers from UCLA and the University of Florida. Their findings were published online March 22 in the journal Diabetes.

The researchers, from the Larry L. Hillblom Islet Research Center at UCLA and the Diabetes Center at the University of Florida, found that cell mass was increased approximately 40 percent in the pancreases of deceased organ donors who had Type 2 diabetes and who had been treated with incretin therapy. This widely used type of treatment takes advantage of the action of a gut hormone known as glucagon-like peptide 1 (GLP-1) to lower blood sugar in the body.

Although there have been conflicting reports on the effects of the incretin class of drugs on the pancreas in animal studies, this is the first study to note such changes in the human pancreas. The research was made possible by a unique research consortium called nPOD (Network for Pancreatic Organ Donors with Diabetes), led by Dr. Mark Atkinson, a professor of pathology and pediatrics at the University of Florida. The network, which is funded by the Juvenile Diabetes Research Foundation, obtains pancreases from deceased organ donors, with permission of their next of kin, to better understand diabetes by investigating tissues of those with the disease.

“There is an increasing appreciation that animal studies do not always predict findings in humans,” said Dr. Peter Butler, director of UCLA’s Hillblom Islet Research Center and chief of the endocrinology, diabetes and hypertension unit. “The nPOD program is therefore a very precious resource.”  The researchers examined the pancreases of 20 deceased organ donors with Type 2 diabetes. Eight had been treated for at least a year with incretin therapy, while the other 12 had received therapies that didn’t include incretin-based drugs. The researchers also evaluated 14 pancreases from a control group of non-diabetic individuals of similar age.

The pancreases of the individuals who had been on incretin therapy were larger than those of patients on other types of diabetes therapies, and this larger size was associated with increased cellular proliferation. Incretin-treated individuals showed an increase in pancreas dysplasia, an abnormal form of cell proliferation that is a risk factor for pancreatic cancer, as well as an expansion of alpha cells, endocrine cells that make the hormone glucagon.

This latter finding is likely a consequence of GLP-1–based therapies’ suppression of the release of glucagon by alpha cells, since decreasing the availability or action of the hormone glucagon has been shown in a variety of prior studies to induce a proliferation of pancreatic alpha cells. This alpha-cell expansion has been associated with the development of pancreatic neuroendocrine tumors. Three of the eight incretin-treated individuals had microadenomas and one has a neuroendocrine tumor composed of alpha cells.

Of the eight donors who were on incretin therapy, seven had been taking sitagliptin, sold in pill form as Januvia and marketed by Merck, and one had been on exenatide, sold as Byetta by Bristol-Myers Squibb. These and similar drugs are currently under investigation by the U.S. Food and Drug Administration for their possible links to pancreatitis and pancreatic cancer.

“These findings lend additional weight to concerns regarding the effects of long term GLP-1–related therapy, with respect to both unintended proliferative actions on the exocrine pancreas and now also a possible increased risk of neuroendocrine tumors,” the researchers write. “In addition to the surveillance previously recommended for the potential association of GLP-1– based therapy and pancreatic cancer risk, the current data imply that surveillance for a possible increased risk of pancreatic neuroendocrine tumors is warranted.”

Such surveillance approaches might include MRI imaging of the pancreas and screening for neuroendocrine tumors, Butler said.

“The present studies are only from a small number of individuals, and while the findings do raise concerns, it will be important that other approaches are now used in a larger group of living individuals to further investigate these findings,” he said.

A recent study led by Dr. Sonal Singh of Johns Hopkins University School of Medicine and Public Health and published in JAMA Internal Medicine suggested a doubling in the risk of hospitalization for acute pancreatitis with the GLP-1–based therapies and also recommended further research.

“Since most risk factors for acute pancreatitis are also linked to an increased risk of pancreatic cancer, these findings of changes in the human pancreas are very concerning,” said Singh, an assistant professor of medicine and international health. “Now that GLP-1–based therapies have been shown to increase the risk of pancreatic inflammation and abnormal cell proliferation, further studies are needed to urgently clarify whether these linkages lead to pancreatic cancer with long-term use.”

###

Study co-authors, in addition to Butler and Atkinson, are Alexandra  E. Butler, Tatyana Gurlo and David W. Dawson, all of UCLA, and Martha Campbell-Thompson of the University of Florida.

Grants from National Institute of Diabetes and Digestive and Kidney Diseases (DK059579, DK061539 and DK077967), the Hillblom Foundation, and the Peter and Valerie Kompaniez Foundation funded this study. The Juvenile Diabetes Research Foundation funds the nPOD program.

For more news, visit the UCLA Newsroom and follow us on Twitter.

FDA redactions policy violates Freedom of Information Act / Conceals Drug and Medical device dangers form the public

Open gov’t groups: FDA redactions rules skirt law

Transparency groups: Long-standing FDA redactions policy violates Freedom of Information Act

By Matthew Perrone, AP Health Writer | Associated Press – 22 hrs ago

 

WASHINGTON (AP) — A federal policy that allows the Food and Drug Administration to withhold key details about drugs, medical implants and other products is coming under new pressure from open government advocates.

A coalition of public interest groups asked the FDA on Friday to overturn the decades-old policy used to black out sections of federal documents before turning them over to journalists, investigators and others who request information from the government.

In a letter to the agency, OpenTheGovernment.org says that the FDA’s so-called “minor deletions” policy is illegal and undermines the Obama administration’s goal of making government more accountable.

“It is impossible to square the deletions policy with the President’s stated commitment to transparency,” said Patrice McDermott, the group’s president, in the letter obtained by The Associated Press. The letter comes a few days before the start of Sunshine Week, when transparency advocates promote freedom of information.

McDermott asks FDA Commissioner Margaret Hamburg to take action on a formal petition from Public Citizen that would do away with the deletion policy. The consumer advocacy group, founded by Ralph Nader in the 1970s, submitted the petition in September, but has not heard from the FDA. Public Citizen is a member of the OpenTheGovernment.org coalition.

Over the years, Public Citizen has drawn attention to dozens of drug safety issues by requesting FDA documents on patient side effects and clinical studies. In the case of the arthritis drug Bextra, Public Citizen’s disclosures brought to light information about blood clots that led to the drug’s market withdrawal in 2005 due to concerns about stroke and heart attack.

Public Citizen says the FDA has repeatedly redacted large portions of text from documents, in some cases blacking out a half-page or more.

The agency justifies this approach in its staff manual, saying that: “The overwhelming majority of requesters who receive documents with minor deletions are satisfied and do not request withheld material.”

Regardless of whether most requestors accept the deletions, Public Citizen and other critics say the FDA is still ignoring the law. In 1991 the federal government’s own watchdog arm, the Government Accountability Office, urged the FDA to do away with the policy, saying it conflicted with the Freedom of Information Act.

Under that law, anyone who seeks information from the federal government is supposed to get it unless disclosure would hurt national security, violate personal privacy or expose business secrets or confidential decision-making in certain areas. If any information is withheld, the government is supposed to give the requester an immediate option to appeal the decision. But the FDA requires requesters to make a second request to release the redacted information. Only after this second request is denied does the FDA inform the person of their right to an appeal.

Some FDA documents contain proprietary company information about drug testing or manufacturing techniques. The FDA claims the deletions policy actually benefits the public because it allows the agency to release documents that might have to be withheld indefinitely if they were not redacted.

But the agency’s critics say the policy is simply an extra logistical hurdle that is unprecedented in the federal government.

“The steps that the FDA has created leave requesters in a state of limbo and add a procedural barrier that is neither lawful nor necessary,” said Julie Murray, an attorney with Public Citizen who worked on the petition.

Murray said the deletions policy also distorts the FDA’s record of compliance with the Freedom of Information Act, which it must report annually. In 2011, the FDA reported that 97 percent of the documents it released under the Freedom of Information Act were “full releases.”

That number is higher than any other agency in the Department of Health and Human Services, which includes the Centers for Disease Control, the National Institutes of Health and other institutions. But Public Citizen says the FDA’s figure is likely inflated since the agency apparently doesn’t count “minor deletions” as withheld information.

An FDA spokesman said this week that the agency is still reviewing Public Citizen’s petition. Under FDA rules, the agency has 180 days to respond to petitions, placing a March 19 deadline on the group’s request.

http://news.yahoo.com/open-govt-groups-fda-redactions-192253137.html

 

Kraft under pressure over ‘cancer-causing’ yellow food coloring in Macaroni & Cheese after 41,000 sign petition to ban additive

  • Mothers Lisa  Leake and Vani Hari have generated 41,482 signatures on a Change.org petition  demanding that Kraft remove two food dyes from its Macaroni &  Cheese
  • The two dyes –  yellow 5 and yellow 6 – are used only in the American version of the product,  and have been linked to hyperactivity in children, asthma, migraines and  cancer

By  Sadie Whitelocks

PUBLISHED: 10:59 EST, 7  March 2013 |  UPDATED: 17:44 EST, 7 March 2013

 

Two mothers have launched a campaign  demanding that Kraft remove the artificial food dyes in the U.S. version of its  Macaroni & Cheese

Lisa Leake and Vani Hari, both from North  Carolina, noticed that the brightly-colored pasta contains two synthetic  substances – yellow 5 and yellow 6 – that  add nothing to the flavor and may be dangerous to children’s health.

They also discovered that the Illinois-based  food giant makes the same product for consumers in UK but because of stricter  regulations regarding additives, it is dye-free.

Scroll down  for video

Finishing touch: The dyes - yellow 5 and yellow 6 - are used in the U.S. version of Macaroni & Cheese for aesthetic purposes and now thousands are campaigning for them to be removed  

Finishing touch: The dyes – yellow 5 and yellow 6 – are  used in the U.S. version of Macaroni & Cheese for aesthetic purposes and now  thousands are campaigning for them to be removed

Mrs Leake,35, and Ms Hari, 33, have launched  a Change.org petition titled Kraft: Stop Using Dangerous Food Dyes in Our Mac & Cheese  which currently has 41,482 signatures.

In a video posted on the site they say that  the yellow dyes, which contain benzidine  4-amino-buphenyl, a man-made product derived from petroleum, are  used ‘solely for aesthetics’.

The go on to highlight that the colorants have  been linked to hyperactivity in children,  asthma, migraines and cancer.

Mrs Leake, whose children are aged five and  eight, said: ‘We  think this is an important issue to tackle because Kraft Macaroni & Cheese  is an iconic food product.

‘Everyone’s had it at one time or another. I  used to eat it… I used to feed it to my kids years ago and we think we deserve the same version that our friends overseas in the UK get  without artificial food dye.’

Spreading the word: Lisa Leake and Vani Hari, from North Carolina, have launched a campaign asking Kraft to remove the artificial food dyes in its U.S. version of Mac & Cheese 

Spreading the word: Lisa Leake and Vani Hari, from North  Carolina, have launched a campaign asking Kraft to remove the artificial food  dyes in its U.S. version of Mac & Cheese

Ms Hari points out that the dyes require warning labels in other countries outside of  the U.S. and have been in some European countries.

In the UK Kraft does not use the additives in  its version of Macaroni & Cheese, called Cheesy Pasta. Instead natural beta  carotene and paprika are added to achieve a yellow color.

In their home-made video the two women  taste-test both the U.S. and UK version of Kraft’s Macaroni & Cheese. They  conclude that the two taste ‘virtually the same’ and ‘barely’ look  different.

In response to the mothers’ petition Kraft  said it produces at  least 14 other  Macaroni & Cheese-inspired products, such as sauces and toppings, which only  contain natural food colors.

Kraft Macaroni and CheeseKraft's Mac & Cheese

The UK version of Kraft”s Macaroni & Cheese –  called Cheesy Pasta – (left) while the U.S. offering contains two additives  which have been linked to hyperactivity in children, allergies and cancer  (right)

Spot the difference: After taste-testing both versions of Kraft's Macaroni & Cheese the two women concluded that they tasted 'virtually the same' and 'barely' looked different 

Spot the difference: After taste-testing both versions  of Kraft’s Macaroni & Cheese the two women concluded that they tasted  ‘virtually the same’ and ‘barely’ looked different

A company spokesperson, Lynne Galia,  told  MailOnline: ‘The safety and quality of  our products is our highest priority and we take consumer concerns very  seriously.

‘We carefully follow the laws and regulations  in the  countries where our products are sold. So in the U.S., we  only use  colors that are approved and deemed safe for food use by the  Food and Drug  Administration.’

In the U.S. seven artificial colorings are  permitted by the FDA, which is  responsible for food safety, these  include blue 1, blue 2, green 3, red 40, red 3, yellow 5 and yellow  6.

‘I used to eat it, I used to feed it to my kids and we  think we deserve the same version that our friends overseas in the  UK’

‘All additives are subject to ongoing safety  review as scientific understanding and methods of testing continue to improve.

‘Consumers should feel safe about the foods  they eat,’ the FDA states on its website.

Ms Hari and Mrs Leake say that they want U.S.  regulations on food additives to fall in line with the UK.

‘It was shocking to see hundreds of  ingredients that were banned in other countries and were used in  American  products,’ Ms Hari said.

‘A can of Pringles in the U.S. looks the same  as in the U.K. or Europe and the ingredients are totally different.’

For example, French fries at McDonald’s  in  the UK contained only potatoes, oil and salt, but in the  U.S. a preservative  was added.

Food giant: Illinois-based Kraft Foods was founded in 1903  

Food giant: Illinois-based Kraft Foods was founded in  1903

The women cite a report from the Center for  Science in the Public Interest, titled Food Dyes: A Rainbow of Risks, which  outlines various studies on the health effects of food coloring.

The group concluded that the three most  widely used dyes – red 40, yellow 5, and yellow 6 – are contaminated with  cancer-causing substances, while red 3 has been identified as a carcinogen by  the FDA but is still in commercial use.

Michael F. Jacobson, who co-authored the  study, said: ‘These synthetic chemicals do absolutely nothing to improve the  nutritional quality or safety of foods.

‘The Food and Drug Administration should ban  dyes, which would force industry to color foods with real food ingredients, not  toxic petrochemicals.’

Mrs Leake said she no longer lets her  children eat Macaroni & Cheese, but if the UK version of the product were  available in the U.S., she would put it back on the menu.

Read more: http://www.dailymail.co.uk/femail/article-2289654/Kraft-pressure-cancer-causing-yellow-food-coloring-Macaroni-Cheese-41-000-sign-petition-ban-additive.html#ixzz2MvU09buV Follow us: @MailOnline on Twitter | DailyMail on Facebook

Johns Hopkins study: Risk of pancreatitis doubles for those taking new class of diabetes drugs

Contact: Stephanie Desmon sdesmon1@jhmi.edu 410-955-8665 Johns Hopkins Medicine

People who take the newest class of diabetes drugs to control blood sugar are twice as likely as those on other forms of sugar-control medication to be hospitalized with pancreatitis, Johns Hopkins researchers report.

In an article published online in JAMA Internal Medicine, the scientists say the new drugs — glucagon-like peptide-1-based therapies (GLP-1) — are associated with an increased risk of hospitalization for acute pancreatitis. The agents sitagliptin and exenatide — generic names for the drugs sold under the brand names Januvia and Byetta — appear to contribute to the formation of lesions in the pancreas and the proliferation of ducts in the organ, resulting in wellsprings of inflammation.

Physicians and regulators have been aware that pancreatitis could be a side effect of GLP-1 therapies, a risk that emerged in animal studies and reports to the U.S. Food and Drug Administration. But the Johns Hopkins investigators say their study is the first to accurately measure the strength of this risk in analyses that accounted for other pancreatitis risk factors, such as gallstones, obesity and heavy alcohol use.

“These agents are used by millions of Americans with diabetes. These new diabetes drugs are very effective in lowering blood glucose. However, important safety findings may not have been fully explored and some side effects such as acute pancreatitis don’t appear until widespread use after approval,” says study leader Sonal Singh, M.D., M.P.H., an assistant professor in the Division of General Internal Medicine at the Johns Hopkins University School of Medicine.

Patients should be alert to symptoms of pancreatitis — nausea, vomiting that won’t stop, abdominal pain — and seek treatment immediately if any symptoms noted on the drug label occur.

Pancreatitis is marked by inflammation of the pancreas, the organ that releases such hormones as insulin and glucagon, as well as enzymes that help digest food. A painful condition, pancreatitis can be dangerous if left untreated.

Singh and his colleagues based their findings on analysis of data from seven BlueCross BlueShield health insurance plans. They first identified 1,269 beneficiaries with type 2 diabetes who filled at least one prescription for any drug to treat the disease between 2005 and 2008. After matching them with 1,269 type 2 diabetics who had not, and controlling for the other known pancreatitis risk factors, the researchers found that people who took one of the GLP-1 therapies were twice as likely to be hospitalized with pancreatitis within 60 days of first taking the drugs as those who had taken a different medication.

In a healthy person, the pancreas releases insulin to help the body store and use sugar from food. Diabetes occurs when the pancreas does not produce the right amount of insulin or the body does not respond appropriately to the hormone. When there isn’t enough insulin, or the insulin is not used as it should be, glucose (sugar) can’t get into the body’s cells and builds up in the bloodstream instead. Because of the role of the pancreas in diabetes, people with diabetes are already at an increased risk for pancreatitis.

###

This research was supported by the Johns Hopkins Clinical Research Scholars Program, the National Institutes of Health’s National Center for Research Resources (1KL2RR025006-03) and the NIH Roadmap for Medical Research.

Other Johns Hopkins researchers involved in the study include Hsien-Yen Chang, Ph.D.; Thomas M. Richards, M.S.; Jonathan P. Weiner, Dr.Ph.; Jeanne M. Clark, M.D., M.P.H.; and Jodi B. Segal, M.D., M.P.H.

For more information: http://www.hopkinsmedicine.org/gim/faculty/Singh.html

BPA may affect the developing brain by disrupting gene regulation

Contact: Rachel Harrison rachel.harrison@duke.edu 919-419-5069 Duke University Medical Center

             IMAGE:   Exposure to BPA may disrupt development of the central nervous system by slowing down the removal of chloride from neurons. As an organism matures and the brain develops, chloride levels…

Click here for more information.     

DURHAM, N.C. — Environmental exposure to bisphenol A (BPA), a widespread chemical found in plastics and resins, may suppress a gene vital to nerve cell function and to the development of the central nervous system, according to a study led by researchers at Duke Medicine.

The researchers published their findings – which were observed in cortical neurons of mice, rats and humans – in the journal Proceedings of the National Academy of Sciences on Feb. 25, 2013.

“Our study found that BPA may impair the development of the central nervous system, and raises the question as to whether exposure could predispose animals and humans to neurodevelopmental disorders,” said lead author Wolfgang Liedtke, M.D., PhD, associate professor of medicine/neurology and neurobiology at Duke.

BPA, a molecule that mimics estrogen and interferes with the body’s endocrine system, can be found in a wide variety of manufactured products, including thermal printer paper, some plastic water bottles and the lining of metal cans. The chemical can be ingested if it seeps into the contents of food and beverage containers.

Research in animals has raised concerns that exposure to BPA may cause health problems such as behavioral issues, endocrine and reproductive disorders, obesity, cancer and immune system disorders. Some studies suggest that infants and young children may be the most vulnerable to the effects of BPA, which led the U.S. Food and Drug Administration to ban the use of the chemical in baby bottles and cups in July 2012.

While BPA has been shown to affect the developing nervous system, little is understood as to how this occurs. The research team developed a series of experiments in rodent and human nerve cells to learn how BPA induces changes that disrupt gene regulation.

During early development of neurons, high levels of chloride are present in the cells. These levels drop as neurons mature, thanks to a chloride transporter protein called KCC2, which churns chloride ions out of the cells. If the level of chloride within neurons remains elevated, it can damage neural circuits and compromise a developing nerve cell’s ability to migrate to its proper position in the brain.

Exposing neurons to minute amounts of BPA alters the chloride levels inside the cells by somehow shutting down the Kcc2 gene, which makes the KCC2 protein, thereby delaying the removal of chloride from neurons.

MECP2, another protein important for normal brain function, was found to be a possible culprit behind this change. When exposed to BPA, MECP2 is more abundant and binds to the Kcc2 gene at a higher rate, which might help to shut it down. This could contribute to problems in the developing brain due to a delay in chloride being removed.

These findings raise the question of whether BPA could contribute to neurodevelopmental disorders such as Rett syndrome, a severe autism spectrum disorder that is only found in girls and is characterized by mutations in the gene that produces MECP2.

While both male and female neurons were affected by BPA in the studies, female neurons were more susceptible to the chemical’s toxicity. Further research will dig deeper into the sex-specific effects of BPA exposure and whether certain sex hormone receptors are involved in BPA’s effect on KCC2.

“Our findings improve our understanding of how environmental exposure to BPA can affect the regulation of the Kcc2 gene. However, we expect future studies to focus on what targets aside from Kcc2 are affected by BPA,” Liedtke said. “This is a chapter in an ongoing story.”

###

 

In addition to Liedtke, study authors include Michele Yeo and Ken Berglund of the Liedtke Lab in the Division of Neurology at Duke Medicine; Michael Hanna, Maria D. Torres and Jorge Busciglio of the University of California, Irvine; Junjie U. Guo and Yuan Gao of the Lieber Institute for Brain Development and Johns Hopkins University in Baltimore, Md.; and Jaya Kittur, Joel Abramowitz and Lutz Birnbaumer of the National Institute of Environmental Health Sciences in Research Triangle Park, N.C.

The research received funding from Duke University, the Klingenstein Fund, the National Institutes of Health (R21NS066307, HD38466 and AG16573), and intramural funds from the National Institute of Environmental Health Sciences

Dairy Industry Wants to Put Aspartame in Milk ” would particularly benefit school children “

By NICK MCCANN

WASHINGTON (CN) – Dairy industry groups have asked the Food and Drug Administration to be able to put artificial sweeteners in milk, and not change the label, claiming that it is so consumers can “more easily identify its overall nutritional value”.

Read Courthouse News’ Environmental Law Review.

The Food and Drug Administration is asking for data related to those sweeteners.

The International Dairy Foods Association (IDFA) and the National Milk Producers Federation (NMPF) filed a petition in 2009 requesting that the FDA amend its standard of identity for milk.

The petition asked the agency to allow the use of “any safe and suitable” sweetener for milk and asked to amend the standards of identity for 17 other milk and cream products.

Those products include sweetened condensed milk, whipping cream, yogurt and eggnog, which the groups say should be allowed to have “safe and suitable” sweeteners.

The groups request that the FDA “allow optional characterizing flavoring ingredients used in milk (e.g. chocolate flavoring added to milk) to be sweetened with any safe and suitable sweetener – including non-nutritive sweeteners such as aspartame.”

FDA regulations currently only allow milk products to contain “nutritive sweeteners” (those with calories) which the agency generally recognizes as safe.

The groups say the amendments “would promote more healthful eating practices and reduce childhood obesity by providing for lower-calorie flavored milk products.”

“They state that lower-calorie flavored milk would particularly benefit school children who, according to IDFA and NMPF, are more inclined to drink flavored milk than unflavored milk at school,” the FDA wrote in its notice.

The groups also say they would help with programs that aim to improve nutrition in school meals and argue that the proposed amendments would promote “honesty and fair dealing in the marketplace,” the FDA wrote.

The agency published a notice of the petition on Wednesday requesting comments, data, and information about the proposed amendment to the identity of milk products. The comments are due by May 21

http://www.courthousenews.com/2013/02/21/55075.htm

Plastic packaging containing chemical BPA ‘harming brain and nerve cell growth in babies’

 

Steve Connor

Monday, 25 February 2013

A chemical widely used in plastic packaging and food containers may be toxic to the central nervous system by interfering with a key gene involved in the development of nerve cells, a study suggests.

Scientists have found that bisphenol A (BPA), which is used in a variety of consumer products ranging from fizzy-drink cans to food mixers, affects the function of a gene called Kcc2 which is involved in the growth of neurons, or nerve cells, in the brain and spinal cord.

The study, based on rats and human neurons grown in the laboratory, found female nerve cells more susceptible to BPA than male neurons. This might explain why certain neurodevelopmental disorders in humans are more common in females, such as Rett syndrome, a severe form of autism found only in girls, the scientists said.

“Our study found that BPA may impair the development of the central nervous system, and raises the question as to whether exposure could predispose animals and humans to neurodevelopmental disorders,” said Wolfgang Liedtke of Duke University Medical Centre in Durham, North Carolina.

“Our findings improve our understanding of how environmental exposure to BPA can affect the regulation of the Kcc2 gene. However, we expect future studies to focus on what targets aside from Kcc2 are affected by BPA,” said Professor Liedtke, who led the study published in the Proceedings of the National Academy of Sciences.

Other scientists have, however, criticised the study for exposing neurons to relatively high doses of BPA that would not normally be encountered by the human body. They believe that suggestions of a link between BPA and human disorders are not supported by the evidence when it comes to realistic exposure levels.

“Interesting though the effects are from a mechanistic point of view, they have no relevance to human health because the concentration of bisphenol A used exceeds human exposure by about 100,000 times – and this is probably a conservative estimate,” said Professor Richard Sharpe of Edinburgh University.

“This study is reminiscent of many similar studies with bisphenol A in vitro or in animal studies. Many show convincing effects on various biological processes relevant to human health, but they always involve doses that are in a different ballpark to human exposure,” he said.

Despite many scientists’ claims that there is no evidence that BPA is toxic at low doses, the European Commission banned the chemical in baby bottles in 2011 and the US Food and Drug Adminstration followed suit last year.

BPA is known to mimic oestrogen, the female sex hormone, but fertility experts such as Professor Sharpe have dismissed suggestions that it could explain the rise in male infertility, along with many other disorders, because it is quickly broken down in the body.

“Although we are all exposed to BPA, the rapid inactivation of BPA in the gut and liver means that exposure elsewhere in the body is so low as to be immeasurable. So although it appears we’re exposed, effectively we are not,” Professor Sharpe said.

Professor Andrew Bartholomaeus of the University of Canberra in Australia, said that any BPA consumed in food or drink is completely metabolised before it enters the blood stream, which means that cells within the body are not exposed to “free” BPA.

Bisphenol A what it’s used in

Food and drink containers

Many food and drink cans are lined with a BPA resin, some glass jars include the chemical inside their lids, and many plastic bottles use the substance too.

Electronics

BPA is in the casings of many products including CDs and DVDs, telephones, televisions, laptops and personal computers, printers, cameras, shavers, hairdryers, irons, food mixers, microwaves and kettles.

Sports equipment

Sports helmets, ski goggles, binocular housings and equipment used  for golf and tennis can all  contain BPA.

Till  receipts

BPA is used to make ink visible on thermal till receipts. Some people have  raised concerns about  shoppers handling the paper  and then touching their mouths  or their food.

http://www.independent.co.uk/news/science/plastic-packaging-containing-chemical-bpa-harming-brain-and-nerve-cell-growth-in-babies-8510638.html#

 

Fish mislabeling widespread in U.S. and 84% of ‘white tuna’ is a species which causes distressing gastrointestinal side effects

  • 59 percent of fish sold as ‘tuna’ in  restaurants and grocery stores is not actually tuna
  • Fish sold as ‘white tuna’ is usually escolar  which causes prolonged, oily, anal leakage when eaten in quantities more than  six ounces

By  Daily Mail Reporter

PUBLISHED: 17:44 EST, 24  February 2013 |  UPDATED: 17:44 EST, 24 February 2013

The mislabeling of fish is widespread across  the U.S., a shocking new study has revealed.

Ocean conservation group group Oceana analyzed the  DNA of 1,215 seafood samples from 674  retail outlets in 21 states between 2010 and 2012.

Their research, which was released on  Thursday, showed that 33 percent all samples were mislabeled, according to U.S.  Food and Drug Administration guidelines.

One alarming discovery shows that a huge  amount of fish sold as ‘white tuna’ is actually escolar, a fish that causes  uncontrollable, oily, orange diarrhea.

Doubtful: Fish was mislabeled 74 percent of the time in sushi venues
Doubtful: Fish was mislabeled 74 percent of the time in  sushi venues

The study found mislabeling  in 27 of the 46 seafood types tested. It  revealed that 59 percent of fish sold as tuna in U.S. restaurants and grocery stores is not actually tuna.

Only snapper, mislabeled 87 percent of the  time and in reality any one of six  different species, was sold fraudulently more often.

Disturbingly, 84 percent of fish samples described as  ‘white tuna’ were actually escolar.  Escolar is a type of snake mackerel  that has rich, buttery flesh, but  unpleasant side effects.

The diet of the escolar is rich in wax  esters, a mixture of fatty acids and fatty alcohol, that just builds up in the  body of the fish.

Unfortunately, when consumed by humans in  bigger quantities than six ounces (and less  in some cases), this fish can cause  prolonged, oily, anal leakage.

According to thekitchn.com, escolar, also known as butterfish, oilfish or walu,  is banned in Japan  and Italy, and requires warning labels in Canada, Sweden and  Denmark.

Dangerous game: 84 percent of fish sold as 'white tuna' is actually escolar (pictured) which causes deeply unpleasant side effects
Dangerous game: 84 percent of fish sold as ‘white tuna’  is actually escolar (pictured) which causes deeply unpleasant side  effects

By retail outlets, seafood was  mislabeled 18  percent of the time in grocery stores,  38 percent of the time in restaurants and 74 percent of the time in sushi  venues.

In major cities like Chicago, Austin, New  York and Washington DC, every single sushi restaurant that was tested sold  mislabeled tuna.

Oceana warn that currently more than 90  percent of seafood consumed in the U.S. is imported but less than 1 percent is  inspected by the government specifically for fraud.

The organization calls for a ‘comprehensive  and transparent traceability system that tracks fish from boat to plate’ to be  established at the national level.

Shocking statistics: Seafood was mislabeled 18 percent of the time in U.S. grocery stores
Shocking statistics: Seafood was mislabeled 18 percent  of the time in U.S. grocery stores

Read more: http://www.dailymail.co.uk/news/article-2283880/Fish-mislabeling-widespread-U-S-84-white-tuna-species-causes-distressing-gastrointestinal-effects.html#ixzz2LsIuguCL Follow us: @MailOnline on Twitter | DailyMail on Facebook

Almost one-third of chemotherapy used “off-label”

Photo
4:44pm EST

By Andrew M. Seaman

NEW YORK (Reuters Health) – About one-third of chemotherapies are used to fight cancers that drug regulators never approved them to treat, says a new study.

Chemotherapies – drugs that kill rapidly dividing cells – are approved by the Food and Drug Administration (FDA) to fight specific cancers, but there’s nothing stopping doctors from prescribing the drugs “off-label” to treat other types of tumors.

Some researchers have questioned whether doctors were prescribing the expensive and toxic drugs outside of their intended use, according to the study’s researchers, led by Rena Conti, an assistant professor of health policy and economics at the University of Chicago.

“The main criticism of off-label prescribing has been the concern that it jeopardizes patient safety because the full risk-benefit ratio is often not completely understood,” wrote the University of Toronto’s Dr. Monika Krzyzanowska, who published an editorial accompanying the study in the Journal of Clinical Oncology on Tuesday.

But that doesn’t mean the billions of dollars spent on off-label chemotherapies are wasted, according to Conti.

“We don’t know what the outcomes are. We can’t make a judgment of whether the off-label use we document… is appropriate or inappropriate,” said Conti.

For the new study, the researchers used a national prescription database from U.S. cancer doctors to estimate how the most common intravenous or injected chemotherapies were used in 2010.

They found ten chemotherapies that were still protected from competition by patents. They ranged from almost 500,000 doses of Genentech’s Avastin or bevacizumab – approved to treat brain, colorectal, lung and kidney cancers – to about 53,000 doses of Celegene’s Vidaza or azacitidine – used to treat certain blood disorders.

Overall, about 70 percent of the doses of the ten chemotherapies were used “on-label,” which means the doses were used in line with FDA approval. The other 30 percent was used to treat cancers the drug regulators never approved.

The researchers also looked at whether the off-label use of chemotherapies was supported by the National Comprehensive Care Network (NCCN), a group that publishes its own guidelines on cancer care.

They found that 14 percent of chemotherapies were prescribed off label but were supported by the NCCN’s expert opinion, and 10 percent were prescribed without NCCN or FDA support.

Conti told Reuters Health that doctors follow guidelines from expert organizations when there is not enough data for the FDA to make a decision, such as when rare diseases make it too difficult to conduct a clinical trial.

Conti and her colleagues point out, however, that some researchers have criticized NCCN recommendations, because of possible delays in guidelines based on the latest data, and possible conflicts of interests.

The total cost of chemotherapies for 2010 was $12 billion. Of that, $4.5 billion went toward off-label chemotherapies – $2.5 billion for non-NCCN supported uses.

‘A LITTLE TROUBLING’

“To me it’s a little troubling that so many drugs are given in areas where there is not a lot of data to back it up,” said Dr. Nancy Keating, a cancer researcher who was not involved with the new study.

“The tricky thing is patients with cancer and their doctors are looking for anything with a benefit. So I think they’re sometimes willing to try things where there isn’t as much data as you would like,” said Keating, from Boston’s Harvard Medical School and Brigham and Women’s Hospital.

But Conti said they can’t tell from their data whether patients prescribed on-label chemotherapy did better than patients receiving off-label chemotherapy.

“What our study basically does is highlight this proportion of use that is off-label and endorsed by expert opinion, or off-label and not endorsed by expert opinion,” Conti said.

She added that their study shows chemotherapy use is driven by FDA approval and expert opinion. The other chunk that’s prescribed without expert or FDA backing may be in response to a lack of available treatments, she said.

http://www.reuters.com/article/2013/02/19/us-chemotherapy-idUSBRE91I18T20130219