FDA Strips Critic of Voting Rights » Counterpunch

by MARTHA ROSENBERG

It’s said that it takes 22 FDA safety officers to change a light bulb: 12 to defend the decision to install it, 8 to call it another “lighting option,” 6 to quote drug industry studies and one to say it doesn’t need changing, it just needs a better label. This week’s hearings into birth control pills Yaz, Yasmin, Beyaz and Safyral confirm the FDA’s dedication to pharmalateralism.

Bayer launched Yaz in 2006 as a pill that goes “beyond birth control” to treat acne and severe PMS, all the while avoiding the water retention of traditional birth control pills. But soon, previously healthy teenagers experienced “beyond birth control” effects they hadn’t expected. Fifteen-year-old Katie Ketner had her gallbladder removed after taking Yaz, Susan Gallenos had a stroke and part of her skull removed and Michelle Pfleger, 18, collapsed and died of a pulmonary thromboemboli, according to published reports.

The FDA could have held hearings into the safety of the Yaz ingredient, drospirenone, as early as 2002, instead of this week. That’s when the newsletter, Worst Pills Best Pills, warned that drospirenone, just approved in the pill Yasmin, “has never before been marketed in the US,” and could cause “serious heart and other health problems such as a change in acid balance of the blood and muscle weakness.”

But instead of investigating the drug nine years ago, the FDA decided to ban the newsletter’s editor, Sidney Wolfe, MD, head of the Public Citizen Health Research Group from voting at this week’s Yaz hearings, because the newsletter had termed the drug a “do not use.” The FDA accused Wolfe of an “intellectual conflict of interest.”

This is not the first time the FDA has silenced Wolfe. During 2010 hearings about Jazz Pharmaceuticals’ fibromyalgia drug Rekinla, Wolfe’s microphone was turned off when he asked why the manufacturer’s guilty plea and $20 million penalty for illegal marketing a different drug was never brought up at the hearings. Was it not relevant?

Jazz’s off-label marketing, “is a matter related to compliance and it’s not a matter that’s related to the topic under discussion today,” explained Bob Rappaport, MD, director of the FDA Division of Anesthesia & Analgesia Products. The only significance of bringing up the wrongdoing case would be to, “impugn the sponsor in the hopes that the committee would be punitive towards them in your deliberations and recommendations regarding this application,” said Rappaport. Why should a $20 million guilty plea affect future approvals?

Not only was the Jazz guilty plea irrelevant, the FDA did not even know about it before Wolfe’s disclosure said published reports.

Nor is this the first time the FDA’s right hand does not know what the FDA’s left hand is doing. Just three months before a major label change for the antipyschotic drug Seroquel, Janet Woodcock, MD, head of the Center for Drug Evaluation and Research told Project on Government Oversight a warning about mixing drugs would not happen.

“At this point, there is agreement within CDER that an interaction between quetiapine [Seroquel] and methadone that confers unreasonable risks to patients is exceedingly unlikely and, therefore, no further action is indicated regarding the labeling for these products or for related communication initiatives,” she writes in a rambling, defensive letter. But the ink was barely dry on the letter before the FDA announced that Seroquel “should be avoided” in combination with at least 12 other medicines including heart rhythm drugs, synthetic opioids like methadone, antibiotics, anti-infectives and other antipsychotics. Families’ of soldiers and others who died while taking Seroquel had said exactly that for years.

When a reporter asked about the apparent egg on the FDA’s face, Sandy Walsh, an FDA spokesperson, said Woodcock’s letter was still correct, “because the F.D.A. had found no biological basis for a problem or unusual numbers of deaths at normal dosages.” In other words, the deaths were just from drug interactions and overdoses. Whew.

Still the FDA’s claim that Wolfe (who received a personal phone call from Jayne Peterson of the FDA’s Advisors and Consultants Office informing him that his voting rights on Yaz had been suspended. The suspension decision was agreed upon by Dr Woodcock) has an ”intellectual conflict of interest” reduces anyone who believes in consumer rights or governmental justice to the level of a six-digit pharma lobbyist. Holding an opinion, holding a lucrative pharma consultancy–same idea right?

In fact, FDA advisory committees are so packed with pharma consultants, its Psychopharmacologic Drugs Advisory Committee was actually chaired by a paid AstraZeneca speaker until 2009, even as it reviewed AstraZeneca drugs! The only reason AstraZeneca speaker Jorge Armenteros, MD was removed from voting and then his chairmanship was because the Philadelphia Inquirer exposed the extreme conflict of interest. The FDA would probably call the Inquirer’s reporting an “intellectual conflict of interest.

Martha Rosenberg’s first book, Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health, will be published by Prometheus Books next year.

via counterpunch.org

Posted via email from Jack's posterous

Dr Sidney Wolfe - Pharma defrauds government the most

http://www.citizen.org Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, talks about a new report that shows Big Pharma has overtaken the defense industry as the biggest defrauder of the government.

Pharmaceutical Industry Is Biggest Defrauder of the Federal Government Under the False Claims Act, New Public Citizen Study Finds

Civil, Criminal Settlements Have Increased Dramatically; Off-Label Promotion Largely Responsible

WASHINGTON, D.C. – The drug industry has now become the biggest defrauder of the federal government, as determined by payments it has made for violations of the False Claims Act (FCA), surpassing the defense industry, which had long been the leader, according to a new Public Citizen study released today.

The study found that pharmaceutical cases accounted for at least 25 percent of all federal FCA payouts over the past decade, compared with 11 percent by the defense industry.

The fraud results were a key finding from a Public Citizen analysis of all major pharmaceutical company civil and criminal settlements on the state and federal levels since 1991 and found that the frequency with which the pharmaceutical industry has allegedly violated federal and state laws has increased at an alarming rate. Of the 165 pharmaceutical industry settlements comprising $19.8 billion in penalties during the past 20 years, 73 percent of the settlements (121) and 75 percent of the dollar amount ($14.8 billion) have occurred during the past five years.

Many of the infractions, and the single largest category of financial penalties, stemmed from the practice of off-label promotion of pharmaceuticals – the illegal promotion of a drug for uses not approved by the Food and Drug Administration (FDA). Off-label promotion can be prosecuted as a criminal offense because of the potential for serious adverse health consequences to patients from such promotional activities. Another major category of federal financial penalties was purposely overcharging for drugs under various federal programs, which constitutes a violation of the FCA.

On the state level, the largest category of financial penalties has come from companies deliberately overcharging state health programs, such as Medicaid. Public Citizen’s study found this to be the most common category of violation among state settlements.

The increase in payments for fraud is likely attributable to drug companies engaging in more wrongdoing and better enforcement at the state and federal level, said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen.

“Desperate to maintain their high margin of profit in the face of a dwindling number of important new drugs, these figures show that the industry has engaged in such activities as dangerous, illegal promotion for unapproved uses of drugs and deliberately overcharging vital government health programs, such as Medicare and Medicaid,” said Wolfe. Wolfe compiled and analyzed the data with physicians from the Johns Hopkins General Preventive Medicine program, Drs. Sammy Almashat and Charles Preston, as well as Columbia University public health student Timothy Waterman, all of whom worked at Public Citizen.

Public Citizen’s study also found that more than one-half of the industry’s fines were paid by just a few companies – GlaxoSmithKline, Pfizer, Eli Lilly and Schering-Plough. These four companies accounted for more than half of all financial penalties over the past two decades, paying $10.5 billion in fines collectively. These pharmaceutical companies were among the largest in the world. The two largest criminal penalties ever assessed by the U.S. government against any companies were against Lilly ($515 million) and Pfizer ($1.2 billion), both in 2009.

To conduct the study, Public Citizen created a database of information about pharmaceutical companies’ civil and criminal settlements, including information about the type of alleged violation and the amount of money paid in settlements. This study is the first to attempt to document and analyze all major pharmaceutical company settlements with both federal and state governments, the authors said.

Nationally, former pharmaceutical company employees and other whistleblowers have been instrumental in bringing to light the most egregious violations; they have initiated the largest number of federal settlements in the past decade. The number of federal settlements arising from whistleblower cases has more than doubled over the past five years, yielding total payouts more than two and a half times higher than in the previous 15 years combined.

Needed remedies include imposing steeper financial penalties and criminally prosecuting company leadership, including jail sentences, if merited.

“The danger to public safety and loss of state and federal dollars that comes with these violations require a more robust response,” Wolfe said.

To read the full report, visit http://www.citizen.org/hrg1924.
###
Public Citizen is a nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org.

Nader names names concerning pharmaceutical industry fraud | Independent Political Report

Ralph Nader has run for President of the United States as a Green Party candidate, and more recently as an independent. The message below was sent out as an e-mail announcement to Nader lists, and also appears on his nonpartisan website, www.nader.org.

Pharmaceutical Industry Fraud
By Ralph Nader / Monday, December 27. 2010

The corporate defrauding of taxpayers (eg. Medicaid and Medicare) and prescription drugs with skyrocketing prices was the subject of a report by Public Citizen’s Dr. Sidney Wolfe and his associates (see Citizen.Org).

Dr. Wolfe’s team compiled a total of 165 federal and state settlements since 1991 totaling $19.8 billion in penalties. A key finding is that the drug industry’s penalties under the Federal False Claims Act exceed even those assessed against the overcharging defense industry for fraud.

Before we become overly impressed with the cumulative amount of the penalties, specialists in corporate crime law enforcement believe that adding more federal cops on the corporate crime beat, backed by a determined law and order Justice Department with White House backing, would have greatly increased the number of cases and imposition of penalties on these drug industry giants.

Nonetheless, Dr. Wolfe’s study shows that the pace of penalties has picked up over the past five years. This is due to “a combination of increased violations by companies and increased law enforcement on the part of federal and state governments,” says the report.

Many of these cases were initiated by company whistleblowers, who under the False Claims Act can receive a share of the settlements. Since the corporate bosses of these drug firms are almost never prosecuted, what these executives fear the most are company employees who go public with the evidence of corporate misdeeds.

These violations do more than financial damage to consumers and government health insurance programs. One of the worst violations involves companies promoting unproven, often dangerous uses for their medicines. Last year, Pfizer paid $1.2 billion for illegal off-label promotion -the largest criminal fine in U.S.history. Other major corporate violators were GlaxoSmithKline, Eli Lilly, Schering-Plough, Bristol-Myers Squibb, AstraZeneca, TAP Pharmaceutical, Merck, Serono, Purdue, Allergan, Novartis, Cephalon, Johnson & Johnson, Forest Laboratories, Sanofi-aventis, Bayer, Mylan, Teva and King Pharmaceuticals.

The violations by these and other drug companies point to the wide range of impacts, including taking many lives of patients, which stems from these recurrent activities. These criminal or civil illegalities cover (1) overcharging government health programs, (2) unlawful promotion, (3) monopoly practices, (4) kickbacks, (5) concealing study findings, (6) poor manufacturing practices, (7) environmental violations, (8) financial violations and (9) illegal distribution.

Outside the purview of the Public Citizen study are the ravages of counterfeit drugs and poorly inspected ingredients in drugs, now mostly coming from China and India, due to the outsourcing by U.S. and European drug companies in their thirst for even greater profits.

Drug company sales are huge, growing from $40 billion in 1990 to $234 billion in 2008, and far exceeding inflation with their annual price gouging. To make matters worse, in 2003, the Congressional Republicans, with decisive support from some Democrats, passed the drug benefit bill which explicitly prohibited Uncle Sam, the payer, from bargaining for volume discounts with drug companies.

With over 400 full-time drug company lobbyists putting pressure on Congress, and tens of millions of dollars flowing into the legislators’ campaign coffers, budgets for federal investigators, prosecutors and inspectors are kept to a minimum. Unfortunately, crime in the suites pays over and over again, despite occasional penalties.

A bright spot is the increasing enforcement action at the state level.

By last year, 32 states had enacted false claims acts, including fourteen states that qualified as strong laws by federal standards.

Still, the Wolfe report concludes that the “current system of enforcement is not working.” He gives the examples of the $7.44 billion in financial penalties assessed over the past twenty years on GlaxoSmithKline and Pfizer, as compared to their combined total of $16.5 billion in global net profits in one year alone.

What would deter these illegal practices and risks to public safety? Dr. Wolfe says “the lack of criminal prosecution that would result in jailing of company executives.” is key. Moreover, the report notes that “a felony conviction could result in their companies becoming ineligible for reimbursement from federal and state health programs, a critical
source of pharmaceutical company revenues.”

A flicker of hope that a little change is on the way came from the Food and Drug Administration’s Deputy Chief Counsel for Litigation, Eric Blumberg. He indicated that the government is considering going after drug company executives for violations such as off-label promotions. He stated: “.unless the government shows more resolve to criminally charge individuals-at all levels in the corporate hierarchy–.we can not expect to make progress in deterring off-label promotion.”

The problem is that the final operating decision is in the hands of the Justice Department-historically short-staffed and short-willed to entreaties for prosecution by the FDA and other regulatory agencies.

Furthermore, for over 30 years, the Justice Department has stone-walled requests that it start a corporate crime database as it has done with street crimes. Congress likes it this way, as it continues to cash corporate campaign checks.

Just last week, however, outgoing Judiciary Committee Chairman, Democrat John Conyers introduced a bill (H.R. 6545) to create such a corporate crime data base in the Justice Department. Well, as the saying goes, everything starts with a gesture!

via independentpoliticalreport.com

Posted via email from Jack's posterous

It's the Wolfe!

IN VIVO writes:

On August 8, FDA made long-time consumer advocate and pharma gadfly Sidney Wolfe (pic) a permanent four-year member of the Drug Safety & Risk Management Advisory Committee. His term began August 8 and lasts through May 31, 2012. The information was only recently posted publicly by the agency.

Wolfe has headed Public Citizen's Health Research Group for 36 years. There are only a handful of products during that period with safety issues, where the issues were not brought to the public attention by Wolfe. He earned a MacArthur genius award in 1990 acknowledging his ability to use the political/media/regulatory system to question the safety and use of pharmaceuticals.

Dr Sidney Wolfe retires with a bang!

Avandia: A Drug That Should Be Banned

Statement of Sidney M. Wolfe MD, Founder and Senior Adviser, Public Citizen’s Health Research Group

June 6, 2013

Contact: Angela Bradbery (202) 588-7741; Sam Jewler (202) 588-7779

Note: Dr. Sidney Wolfe is testifying today before two FDA advisory committees that are meeting to consider a range of actions on the dangerous diabetes drug Avandia (rosiglitazone), from lifting restrictions to banning it. Dr. Wolfe’s testimony is available at http://www.citizen.org/hrg2134.

According to U.S. Food and Drug Administration-acquired marketing data, since late 2010, when the diabetes drug Avandia was removed from the market in Europe because of its cardiovascular risks, approximately 132,000 Americans have been prescribed this dangerous drug, likely resulting in hundreds, or more, serious – and sometimes fatal – adverse reactions, including heart failure and heart attacks.

In September 2010, the FDA and the European Medicines Agency (EMA) reached very different conclusions about the fate of this once top-selling diabetes drug, although both authorities had access to the same safety studies. The EMA concluded that new data support an increased cardiovascular risk associated with Avandia, also known as rosiglitazone. Since they “could not identify additional measures that would reduce the cardiovascular risk,” they “therefore concluded that the benefits of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorisation of the medicine.”

The FDA, in contrast, decided in September 2010, after a July 2010 advisory committee meeting, not to ban the drug but instead to institute a risk evaluation and management strategy (REMS) to limit the use of the drug to those they believed could benefit from it. One excuse for not acting more forcefully was that the FDA wanted Avandia’s manufacturer, GlaxoSmithKline, to fund a study to re-evaluate a previous study (called RECORD) on heart risk. The company had been asked by the EMA to do the study shortly after Avandia’s approval by the FDA in 1999. That re-evaluation (re-adjudication) of RECORD is the main topic of today’s FDA advisory committee meeting.

The EMA was so appropriately concerned about Avandia’s dangers that it banned the drug, stating that the only way it could ever be marketed again in Europe was if Glaxo could “provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks.” It did not waste time with any further evaluation of the RECORD study it had required Glaxo to do.

The reckless FDA conclusion was to eventually institute a REMS (not approved until May 2011 and fully in place until six months later), although there has never been any evidence that those getting the drug were patients for whom its benefits outweighed the risks.

Once again, instead of banning a drug, as recommended by 12 FDA advisory committee members, and as the EMA has done (because the drug has no unique benefits but unique risks), the FDA hides behind a REMS program that has reduced the number of people using the drug in the U.S. to 665 in 2012. Unfortunately, in the interval since the EMA ban, 132,000 people used Avandia in the U.S., likely resulting in hundreds of preventable injuries and deaths. REMS should be reserved for drugs that need to remain available. By no stretch of the imagination is Avandia such a drug. Ask the EMA.

Sid Wolfe - Big Pharma is "well-organised crime"

The pharmaceutical industry has made major contributions to the health of the US public, but it must also be considered part of the nation’s well-organized crime, says an industry critic.

Last week’s $2.3 billion settlement between Pfizer and the US Justice Department for unlawful prescription drug promotion may sound large, but it is not enough to ensure drug companies will curb their bad behavior - in fact, it just shows there is competition in the pharmaceutical industry, according to Sidney Wolfe, director of US advocacy group Public Citizen’s Health Research Group.

Pfizer has broken a record set by Eli Lilly in January for what was then described by the Justice Department as the “largest individual corporate criminal fine” in U.S. history - more than $500 million in criminal penalties for off-label promotion of Zyprexa (olanzapine), its treatment for psychotic conditions including schizophrenia and bipolar disorder - but now, just seven months later, Pfizer has broken this record with a criminal fine of $1.2 billion, the largest ever imposed in the US for any matter, he says. The rest of the $2.3 billion represents civil penalties.

“The US pharmaceutical industry, long one of the most profitable in the country with profits last year of close to $50 billion, has engaged in an unprecedented amount of criminal activity in the past decade, all aimed at increasing sales, often by illegally promoting drugs for diseases for which evidence that benefits outweigh harm is lacking - also known as illegal off-label promotion,” says Dr Wolfe. When doctors are induced, either by being bribed or misled by drug companies, to prescribe drugs for such purposes, there is “a reasonable chance” that the drugs will do more harm than good and patients may be seriously injured or killed by such promotion, he warns. 


In addition to Pfizer - which also pleaded guilty to criminal charges for off-label promotion of its anticonvulsant Neurontin (gabapentin) in 2004 - and Lilly, other drug companies found to have engaged in criminal activity in the past 10 years include Abbott, Schering-Plough, AstraZeneca, Purdue and Bayer, says Dr Wolfe. However, he adds: “the ever-escalating fines are unlikely to stop drug companies from continuing to bribe doctors because they represent just a fraction of drug company profits and no one has gone to jail.”

Until “corporate titans are forced to fork over a much larger proportion of their illegally-gotten profits and are put behind bars, nothing will change,” he concludes.

By Lynne Taylor

PharmaTimes

OTC Mevacor....... steady, tiger!

Merck’s latest attempt to get the green light to market an over-the-counter version of its old cholesterol-lowering product Mevacor looks doomed after an advisory panel in the USA voted against recommending approval.

The US Food and Drug Administration's joint panel of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee voted 10-2, with one abstention, against recommending approval at this time of OTC use of Mevacor (lovastatin) 20mg taken once-daily.

The panel felt that Merck’s studies supporting the file failed to show that patients can make appropriate assessments about whether they require a cholesterol-lowering drug.The panel’s recommendation echoes the response the New Jersey-based drugmaker has received from the FDA in two previous bids to get approval for OTC Mevacor.

A similar application was made in January 2005 with then-partner Johnson & Johnson and this followed another unsuccessful bid in 2000 to sell an OTC 10mg version of the drug. This time, however, Merck submitted additional data but it would not appear to have done the trick. Edwin Hemwall, vice president of global OTC regulatory and scientific affairs for the firm, said that "we are disappointed in today's outcome [as] we felt we presented a compelling case to the committee”.

The firm still believes that non-prescription Mevacor 20mg would be “a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors, and are already talking with their healthcare provider", he added.

That view cut no ice with Sidney Wolfe, director of Health Research Group at influential consumer body Public Citizen. In his testimony to the committee, Dr Wolfe said that in the company’s new SELECT study, “the overwhelming majority of patients who, after reading the product label, made a decision on their own to purchase Mevacor, made the wrong decision”.

He added that the contrast between “rational and successful OTC use of analgesics and antihistamines versus a statin such as lovastatin could not be sharper”. For pain and allergies, the ability for people to make an accurate assessment of these symptoms, measure the success of the treatment and to adjust the dose accordingly “is quite clear”, Dr Wolfe noted. “For statins, none of these criteria are met”.

The FDA is not bound by the committee's recommendation, but its final decision, on January 28, is likely to be negative. That will be a blow not only to Merck but also to GlaxoSmithKline which little more than a fortnight ago has acquired exclusive OTC marketing rights in the USA for Mevacor.

Source: PharmaTimes

Wolfe chews GSK

Dr. Sidney Wolfe: GlaxoSmithKline Settlement Still Not Enough to Deter Illegal Behavior by Pharmaceutical Industry


Published on Jul 3, 2012 - 7:49:28 AM

July 2, 2012 - Statement of Dr. Sidney Wolfe, Director, Public Citizen's Health Research Group:

Today's announcement of the largest health fraud settlement ever reached between a pharmaceutical company and federal and state governments demonstrates that despite the seemingly large sums, the fines imposed on pharmaceutical companies for dangerous and illegal conduct pale in comparison to the profits generated from such activity. The industry is therefore tacitly encouraged to continue its illegal activity.

In the settlement, GlaxoSmithKline (GSK) has agreed to pay $3 billion to resolve allegations stemming from illegal activity spanning 10 years and involving several of its biggest-selling drugs. The settlement breaks the previous $2.3 billion settlement record set in 2009 by Pfizer and includes the second-highest criminal fine ($1 billion) ever imposed on a pharmaceutical company.

GSK pleaded guilty to illegal off-label promotion of two widely used antidepressants, the blockbuster drug Paxil and Wellbutrin, and concealing critical evidence from the Food and Drug Administration (FDA) relating to the dangerous diabetes drug Avandia. GSK paid doctors to promote Paxil to children and adolescents at lavish resort conferences, despite evidence known to the company that the drug did not benefit, and actually harmed, this population, causing suicidal thoughts. The company also hid critical safety information that revealed Avandia's deadly cardiovascular risks, which have since led to the drug's withdrawal in Europe and severe restrictions on its use in this country. False claims about Avandia and criminally withholding safety information about the drug accounted for $899 million of the $3 billion fine. Public Citizen had petitioned the FDA to ban Avandia in 2008.

Today's settlement of criminal and civil violations is nothing new for GSK. According to a 2010 Public Citizen report, GSK racked up more in fines and settlement payouts to the federal and state governments ($4.5 billion) than any other pharmaceutical company from 1991 through November 1, 2010.

Until more meaningful penalties and the prospect of jail time for company heads who are responsible for such activity become commonplace, companies will continue defrauding the government and putting patients' lives in danger.

Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org.

Pharmaceutical Industry Fraud - The Nader Page

nader.org

The corporate defrauding of taxpayers (eg. Medicaid and Medicare) and prescription drugs with skyrocketing prices was the subject of a report by Public Citizen's Dr. Sidney Wolfe and his associates (see Citizen.Org).

Dr. Wolfe's team compiled a total of 165 federal and state settlements since 1991 totaling $19.8 billion in penalties. A key finding is that the drug industry's penalties under the Federal False Claims Act exceed even those assessed against the overcharging defense industry for fraud.

Before we become overly impressed with the cumulative amount of the penalties, specialists in corporate crime law enforcement believe that adding more federal cops on the corporate crime beat, backed by a determined law and order Justice Department with White House backing, would have greatly increased the number of cases and imposition of penalties on these drug industry giants.

Nonetheless, Dr. Wolfe's study shows that the pace of penalties has picked up over the past five years. This is due to "a combination of increased violations by companies and increased law enforcement on the part of federal and state governments," says the report.

Posted via email from Jack's posterous

Sidney Wolfe - a public citizen

From the Wall Street Journal:

"The pharmaceutical industry has a recurring nightmare: Drug-safety crusader Sidney Wolfe becomes a player at the Food and Drug Administration.

Dr. Wolfe also has a nightmare: One of his children goes to work for a drug maker.

Of the two, the doctor is sleeping more soundly."

READ the Wall Street Journal story.
LEARN more on WorstPills.org.

Report: Company-funded studies of Pfizer epilepsy drug misleading | News from The Post-Standard -

Report: Company-funded studies of Pfizer epilepsy drug misleading

By The Associated Press

November 11, 2009, 8:16PM

Mark Lennihan / The Associated Press, 2009The Pfizer world headquarters in New York. Analysis of a dozen published studies testing possible new uses for a Pfizer Inc. epilepsy drug found that reporting of the results was often misleading, indicating the medicine worked better than internal company documents showed.Analysis of a dozen published studies testing possible new uses for a Pfizer Inc. epilepsy drug found that reporting of the results was often misleading, indicating the medicine worked better than internal company documents showed.

According to the report, when a company-funded study’s primary finding wasn’t favorable, that result was usually buried and something else positive was highlighted, without disclosing the switch.

The documents used in the review were obtained by lawyers suing Pfizer for refunds on prescriptions paid for by insurers and consumers. The lawyers, who are seeking class action status for the cases, claim Pfizer concealed evidence the epilepsy drug Neurontin didn’t work for those unapproved uses, including nerve pain, migraines and bipolar disorder.

One of the report’s authors is an expert witness for the plaintiffs; another has received fees from the lawyers.

Pfizer disputes the report’s conclusions, saying the company never “attempted to mislead the medical community about the effectiveness” of the drug for certain uses.

“We believe the review suffers from significant bias, insufficient data, poor methodology, and cannot pass the threshold of credible scientific research,” Pfizer said in a statement.

The report, by researchers at the University of California at San Francisco and the Johns Hopkins Bloomberg School of Public Health, comes two months after Pfizer was fined a record $2.3 billion — including an unprecedented $1.2 billion criminal fine — for illegally marketing other blockbuster drugs.

The report appears in Thursday’s New England Journal of Medicine.

Dr. Sidney Wolfe, head of health research at consumer group Public Citizen, called it the first comprehensive look “at studies in which a company and people working for it so maliciously manipulated the data to make a drug look more effective than it actually was.”

“In every instance, the published article made the drug look better than it would have,” said Wolfe, a member of the Food and Drug Administration’s drug safety advisory committee. “This results in harm.”

Neurontin was approved by the FDA a decade ago for treating seizures and later for pain caused by shingles — but not for other conditions. Its potential side effects include suicidal tendencies and depression.

While doctors can prescribe drugs for unapproved, or off-label uses, drug companies are legally barred from promoting their products for such uses. Drugmakers often test drugs for additional conditions and publicize the results. But they don’t always seek approval for those new uses, particularly if the new findings aren’t convincing.

Experts believe most Neurontin sales were for off-label uses — the ones in the reviewed studies. Sales peaked at $2.7 billion in 2004, when Pfizer paid $430 million in government fines to settle allegations it improperly marketed the epilepsy drug for unapproved uses. By last year, Neurontin sales fell to $387 million due to cheaper generic versions sold as gabapentin.

For the new review, the researchers examined 20 patient studies funded by New York-based Pfizer and its Parke-Davis unit on use of Neurontin for preventing migraines or treating nerve pain or bipolar disorder. The studies were published in medical journals or presented at conferences, mostly over the last decade.

In eight of the 12 published studies, the main outcome listed in internal documents differs from the one later given in the published report. In half the cases, a new primary outcome was substituted and in others, the original main outcome was instead reported as a secondary measure or wasn’t disclosed at all.

The authors cited some limitations to their review, including not knowing who made the changes.

“We cannot be certain that selective reporting was a decision made by employees of Pfizer and Parke-Davis, since the authors of the published reports included nonemployees,” the researchers wrote.

Arthur Caplan, director of the University of Pennsylvania’s Center for Bioethics, called the report “one of the most ethically disturbing papers I’ve read in some time” and “an indication that people have been playing fast and loose with studies,” particularly industry ones.

Caplan said the FDA should have the power to audit industry drug studies. Wolfe said there should be bigger fines and jail terms for manipulating study data, plus tougher rules for studies being published in journals.

Medical journals in recent years have required that studies be listed on a federal Web site, www.clinicaltrials.gov, to be eligible for publication. That move was made partly to make it harder for industry to hide studies on products that don’t pan out and only publish those with good results. The study descriptions also list their primary and secondary outcomes.

Pfizer said it now has 1,245 company-sponsored studies listed on the Web site.

via syracuse.com

Posted via web from Jack's posterous

Pfizer - Lyrica: the drug is working

For Pfizer, that is!

Dr. Frederick Wolfe, the director of the National Databank for Rheumatic Diseases and the lead author of the 1990 paper that first defined the diagnostic guidelines for fibromyalgia, says he has become cynical and discouraged about the diagnosis.

He now considers the condition a physical response to stress, depression, and economic and social anxiety.

“Some of us in those days thought that we had actually identified a disease, which this clearly is not,” Dr. Wolfe said. “To make people ill, to give them an illness, was the wrong thing.”

More at NYT

Public Citizen target canagliflozin

FDA Should Reject Dangerous Diabetes Medication, Public Citizen Tells Advisory Committee

Canagliflozin, Part of a New Class of Diabetes Drugs, Presents Too Many Risks to Patients

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should not approve the diabetes drug canagliflozin because it could significantly harm patients and does not present significant benefit over current medications, Public Citizen said today.

In testimony today before an FDA advisory committee, director of Public Citizen’s Health Research Group Dr. Sidney Wolfe warned that the new drug presents an unsafe increase of risk for low blood pressure symptoms, adverse cardiac events, and genital and urinary infections. He urged the panel to recognize that in no way do these risks outweigh potential benefit over existing diabetes treatments.

Canagliflozin is part of a new class of diabetes drugs called sodium glucose co-transporter-2 inhibitors that work by blocking re-absorption of glucose by the kidney and increasing glucose excretion in the urine to lower blood sugar. This results in a large loss of sugary fluids. Traditional diabetes treatments typically work by improving insulin secretion or insulin sensitivity.

“The fact that the drug works by a uniquely new mechanism to lower blood sugar has not spared of a whole set of unique new risks,” said Wolfe. “The FDA has previously made too many mistakes in approving drugs, including those for diabetes, with no unique clinical benefits and unique risks. The agency shouldn’t approve this one.”

To read today’s testimony, visit: http://www.citizen.org/hrg2091.

Merck - Vioxx: from dodgeball to hardball

Some "pundit" quotes:

Dr. Eric Topol, cardiologist and co-author of a paper in The Journal of the American Medical Association warning of the risks of Vioxx:

“I think they’ve gotten off quite easily, frankly, for the problems that they’ve engendered.”

Source

Ragnar Lofstedt, a risk expert at King’s College London, says: “We live in a post-Cox-2 [Vioxx] world and suddenly people don’t trust the FDA.

“Everyone has to work on a proactive risk-communication stategy and become more attuned to the public perception.”

FT

Sidney Wolfe of Public Citizen's Health Research Group pointed out that Merck's stock price rose after the deal was announced, hardly a penalty for the company.

"When the stock of a company goes up after a settlement, it is hardly to be confused with stiff punishment for a company," Wolfe said.

"Given what Merck knew, how it misled doctors and others, I don't think this company has been adequately punished for what it did."

WaPo

"It's actually a good settlement for Merck," said Benjamin Zipursky, a Fordham Law School professor who studies product liability.

Although the company has been hit with several multimillion-dollar verdicts, Merck won in 12 of the 17 trials to date and has yet to pay out anything while appealing its losses.

"Playing hardball can be a very smart idea sometimes," Zipursky said.

LA Times

Forest - Savella: not worth the risk say Public Citizen

Public Citizen Petition to FDA: Dangerous Fibromyalgia Drug Should Be Pulled From the Market

Medication Has Limited Efficacy, Risky Effects

WASHINGTON, D.C. – The fibromyalgia drug Savella should immediately be taken off the market because its dangers outweigh its benefits, Public Citizen said today in a petition to the Food and Drug Administration (FDA). The European regulatory authority, the European Medicines Agency (EMEA), rejected the drug’s approval for fibromyalgia in July 2009, stating that its benefits were “marginal” and “did not outweigh its risks.” This was shortly after the FDA approved the drug in January 2009. Since the drug went on the market in the U.S., approximately 250,000 prescriptions have been filled, with doctors writing more prescriptions every month.

In two randomized clinical trials, Savella, also known by its generic name milnacipran, was found to increase blood pressure, heart rate and suicidal thoughts, Public Citizen’s petition said. Among patients who had normal blood pressure at the beginning of the study, 19.5 percent of those who took Savella developed hypertension, compared to 7.2 percent of those on a placebo.

“Because Savella is a drug that produces only a marginal effect on pain, the main problem for which patients seek treatment, and has the potential to be quite dangerous, it is clear that it should not be sold,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “The FDA never should have approved Savella for fibromyalgia and should now immediately order the drug company to remove it from the market before large numbers of people suffer serious harm,” Wolfe said.

Based on the extent of increased blood pressure caused by Savella, the FDA medical officer who reviewed the drug estimated that persistent blood pressure hikes could increase the risk of a cardiovascular event (including death, myocardial infarction and stroke) by up to 50 percent.

Savella also puts patients at risk for other disorders, including seizures, addiction, excessive bleeding, mood disorders, fractures, glaucoma and gastrointestinal effects such as nausea and vomiting. In pregnant women, the drug also can lead to hazards for fetuses, newborns and nursing infants. Additional risks for men include testicular pain and problems with ejaculation.

The director of the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products stated that although the dominant symptom of fibromyalgia is pain, the drug did not relieve patients’ pain in the clinical trials.

Fibromyalgia is a chronic disease, but neither of the drug’s trials showed any statistical effectiveness beyond three months. And even within the trials’ three-month duration, more than 90 percent of users in the trial received no benefit from the drug at all.

Although not marketed as an antidepressant in the U.S., Savella is sold in Europe and Japan as such. The drug is required in the U.S. to have the “black box” warning for antidepressants, which points out an increased risk of suicide in children, adolescents and young adults. Manufactured by Cypress Bioscience Inc. and Forest Laboratories Inc., Savella has been sold in the U.S. since May 2009.

READ the petition.

Philadelphia is a hotbed for drug-industry whistleblower lawsuits | Philadelphia Inquirer

When three employees of a Schering-Plough Corp. subsidiary became convinced a decade ago that the company was committing fraud, they hired a lawyer and eventually ended up working with federal prosecutors in Philadelphia.

The result, in 2004, was a civil and criminal settlement totaling $345 million, resolving allegations that company officials overcharged the government for the allergy medicine Claritin.

It was among the first mega-cases brought against the pharmaceutical industry under what is known as the whistle-blower law. And for the U.S. Attorney's Office for the Eastern District of Pennsylvania, the case marked its emergence as a prime adversary of the industry.

Including the Schering case, the office has recovered nearly $4 billion from drugmakers since then, according to a summary released by the office last week. That's nearly a quarter of the total recouped from the industry by all state and federal prosecutors during that period, as tallied in a recent report by the nonprofit group Public Citizen.

"The Philadelphia office is considered one of the premier offices in the country for handling these kinds of whistleblower claims," said lawyer Steven J. Engelmyer, who helped represent the three employees of the Schering subsidiary.

The U.S. Attorney's Office for the District of Massachusetts is the other chief center for such cases, recovering even more - $6.5 billion - during the same period.

It's no surprise that the two offices play a lead role, as Boston and Philadelphia are hubs of the life-sciences industry. But cases involving national misconduct can be brought anywhere, so there are other factors in that kind of success, said Engelmyer - himself a former prosecutor in the Philadelphia office in the 1980s.

Speaking of that office, he said: "Bottom line, they've got a combination of people who know the area. They've devoted the resources to understand it and do it right. And success begat success."

Both nationally and in Philadelphia, the big-pharma settlements were nonexistent more than a decade ago, according to Justice Department statistics.

Asked about the reason for the increase, a lawyer with an industry group issued a statement describing companies' efforts to comply with the law. Fifty-five drug companies have signed a code that denounces improper marketing practices, according to Diane Bieri, general counsel of Pharmaceutical Research and Manufacturers of America.

"Our member companies devote significant resources to internal compliance programs and thorough investigations of any reported misconduct - activities that complement the government's enforcement efforts," Bieri said. "However, we can't speculate on trends in legal actions."

Sidney M. Wolfe, a physician and director of Public Citizen's health research group, said that the fines and penalties were not enough and that companies treat them as a cost of doing business.

He said the amounts should be equal to any profits that arise from illegal practices, whether overcharging the government or promoting drugs for "off-label" uses - those not sanctioned by the Food and Drug Administration.

"If they're going to get fined or assessed less than they made, they'll do it again," Wolfe said, adding that another deterrent would be to put executives in prison.

A clear driver of the upsurge in cases came in 1986, when Congress amended the False Claims Act to strengthen incentives and legal protections for whistleblowers - employees who allege that their company is involved in wrongdoing. The original law was passed during the Civil War to guard against dishonest defense contractors, but it had fallen into disuse after being gutted in the 1940s.

Companies that settle such cases have not necessarily done anything wrong. But if they choose to fight, they run a huge risk: If they lose, they can be banned from selling their products to the government.

Whistleblower cases have led to the bulk of the settlements won by the federal prosecutors in Philadelphia since 2004.

The total settlements against pharmaceutical makers and benefits managers represent more than the total haul for any other seven-year period in office history, officials said.

Margaret Hutchinson, chief of the office's civil division, said the office's accumulated expertise in dealing with the industry had played a big role.

"We certainly have, I would like to think, a very strong reputation for taking these allegations very, very seriously," Hutchinson said.

Whistleblowers receive a portion of civil settlements. In the Schering case, the three employees split $31.7 million. But Engelmyer, their attorney, cautioned that coming forward takes a lot of courage, because it is not always successful and because those who take the risk can find themselves unable to find a job in their industry.

All three of his clients had moved on from the Schering subsidiary by the time the complaint was unsealed. Engelmyer said he had had little contact with his former clients in the last few years.

But at least one of them, Charles Alcorn of Reading, apparently came away from the experience with a greater appreciation for the legal system.

He went to law school.

via philly.com

Posted via email from Jack's posterous

Press Conference Wednesday: In Wake of Controversy Over Unethical NIH-Funded Premature Baby Trial, HHS Seeks Way Forward

Family of a Baby Enrolled in the Trial to Attend; Outcome of Aug. 28 HHS Public Meeting Could Weaken Rules for Protecting Human Research Subjects

August 26, 2013

Contact: Angela Bradbery (202) 588-7741; Sam Jewler (202) 588-7779

What: Press conference to highlight the need for the U.S. Department of Health and Human Services (HHS) to strengthen the ethical standards by which human experiments are conducted and halt any ongoing trials in which parents were not properly informed of the risks to their babies or of the purpose and nature of the research.

Publicity in April over an unethical trial conducted on premature infants, called the SUPPORT study, sparked the convening of an unusual, daylong Aug. 28 public forum at (HHS). Public Citizen’s press conference will be held during the lunch break; speakers will include parents of a baby enrolled in that controversial trial, now a six-year-old who suffers from serious health problems. At the forum, Dr. Michael Carome and Dr. Sidney Wolfe, director and founder/senior adviser of Public Citizen’s Health Research Group respectively, will be the first two witnesses to testify when it starts at 9 a.m.

In the SUPPORT study, funded by the National Institutes of Health (NIH) and conducted from 2005-2009, premature infants were exposed to an increased risk of blindness, brain injury and death. In contrast to usual clinical care, the extremely premature infants enrolled in the SUPPORT study were randomly put in two groups that each received a different experimental target range of oxygen saturation. None of the consent forms signed by parents mentioned the risk of death, and only two out of 22 noted the risk of eye damage.

Since Public Citizen publicized that study, a controversy has raged in the scientific community over what kind of consent is needed in certain kinds of clinical trials. The debate goes to the heart of how research is conducted in the U.S. and could have far-reaching, negative implications if changes are made to weaken the ethical and regulatory standards by which trials are run.

Last week, Public Citizen publicized another, similar, NIH-funded trial that has just started and that also poses known risks to premature babies without fully informing the parents about those risks or the purpose and nature of the research. It is designed to determine which of two strategies for treating anemia with blood transfusions is more likely to result in death or neurologic injury in extremely premature infants who develop anemia.

Wednesday’s meeting will be livestreamed at www.HHS.gov/live.

When: Press conference: Noon (estimated time of lunch break) EDT, Wednesday, Aug. 28
Meeting runs 9 a.m. - 5 p.m.

Who: Dr. Michael Carome, director, Public Citizen’s Health Research Group
Dr. Sidney Wolfe, founder and senior adviser, Public Citizen’s Health Research Group
Carrie Pratt and Shawn Pratt, with their six-year-old daughter Dagen Pratt, who as a baby was experimented upon in the SUPPORT study
Alice Dreger, Ph.D., professor of clinical medical humanities and bioethics at the Feinberg School of Medicine at Northwestern University
George J. Annas, JD, MPH, the William Fairfield Warren Distinguished Professor and Chair in the Department of Health Law, Bioethics & Human Rights at the Boston University School of Public Health; professor at the Boston University School of Medicine and School of Law

Where: Press conference will be held outside the front of the HHS building, 200 Independence Ave SW, Washington, D.C.

Senior Doctor Raises Concern Over Advertising of Prescription Drugs

Contact: Dr. Sidney Wolfe (202) 588-7735; Sam Jewler (202) 588-7779

A senior doctor today questions a Los Angeles boutique turning shoppers into cheerleaders for serious drugs like Adderall by selling sweatshirts and T-shirts that look like football jerseys and have the products’ names emblazoned on them with descriptions such as, “Pop one on and you’ll feel better. Doctors orders.”

In his latest regular column in the British Medical Journal, Dr. Sidney Wolfe, founder and senior adviser for Public Citizen’s Health Research Group, explores the contradictions between the medication’s manufacturer Shire protesting the selling of these shirts and Shire overselling the substance several years ago, which resulted in ads being stopped by the FDA.

full article available now: http://www.bmj.com/content/347/bmj.f6215

Public Citizen Petitions FDA for a Black Box Warning on Testosterone Products

WASHINGTON - February 25 - Public Citizen today called on the U.S. Food and Drug Administration (FDA) to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S.

The urgent petition is based on growing evidence of the risks of heart attacks and other cardiovascular dangers from many individual randomized studies going back as far as 2010 and a recently published overall analysis (meta-analysis) of 27 studies going back as far as 20 years. Although 13 of these studies, funded by the drug industry, collectively showed no increased risk, the 14 studies not funded by the industry collectively showed a highly significant increased cardiovascular risk.

More than five million U.S. prescriptions for testosterone products were filled in 2013. The most common of those, making up more than 90 percent of the testosterone prescriptions filled in 2013, include Androgel, Axiron, Testim and Fortesta.

The petition also was prompted by the most recent study, involving the experience of 55,000 men before and after starting testosterone. The risk of heart attacks among men 65 and older during the first three months of using the drug was twice the risk seen in the year before use. Further, the study found, for the first time, a 2.9-fold increase in heart attack risk among men under 65 with a history of heart disease who took testosterone.

The FDA-approved labeling for testosterone-containing products does not mention testosterone-induced cardiovascular risk.

Despite all of these studies, the FDA stated on Jan. 31 that it “has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death.”

“In the face of this accumulating evidence, this statement is reckless and is a betrayal of the FDA’s role as an agency in the U.S. Public Health Service,” said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group. “It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks.”

Although the FDA agrees that testosterone is “only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition,” the hyped-up nature of the low-T[estosterone] advertising campaigns, not adequately regulated by the FDA, assures that many men in the U.S. prescribed testosterone do not meet the FDA-specified criteria of both low testosterone levels and an associated medical condition due to hypogonadism. Evidence can be seen in the recent finding that almost 25 percent of men prescribed testosterone in this country had not previously had a blood test to even determine if their testosterone level was low.

“Unless the FDA immediately begins to provide strong, adequate black-boxed warnings about the risks of heart attacks and other cardiovascular diseases, the continuing toll of heart attacks, many in people who are not even candidates for testosterone, will continue,” Wolfe said. “At the present rate of prescribing, almost 13,000 prescriptions a day are filled for testosterone products in this country. Each day of delay of the black box warning ensures much more exposure, too often for men who cannot benefit from the drug but will only be exposed to its risks.”

In addition, the petition urges the FDA to delay its decision date on approving a new long-acting injectable testosterone product Aveed (testosterone undecanoate, Endo), now set for Feb. 28, because its approval, absent the new black box warning, would cause further cardiovascular damage to new users.

The petition is available at http://www.citizen.org/hrg2184.

Public Citizen is a national, nonprofit consumer advocacy organization founded in 1971 to represent consumer interests in Congress, the executive branch and the courts.

http://www.commondreams.org/newswire/2014/02/25-4?

Public Citizen - Unacceptable Behavior: FDA Advisory Committee Chair to Give Drug Industry Tips on Getting Drugs Approved

FDA Should Tell Dr. Lynn Drake Not to Speak at Conference or Remove Her From the Committee

October 24, 2013

Contact: Angela Bradbery (202) 588-7741; Sam Jewler (202) 588-7779

WASHINGTON, D.C. – The chair of a Food and Drug Administration (FDA) advisory committee should not advise drug company representatives at an upcoming conference how to get drugs approved by FDA committees, Public Citizen told the agency today.

According to a conference brochure, Dr. Lynn Drake, chair of the FDA Dermatologic and Ophthalmic Drugs Advisory Committee and a lecturer at Harvard Medical School, will speak in February at a conference in Washington, D.C., titled “FDA Advisory Committee Prep: Real World Best Practices to Achieve Favorable Recommendations.”

Drake plans to give a talk titled, “Pitfalls to Avoid as You Prepare for, and Present to, an Advisory Committee.” The brochure says that attendees will “hear directly from an FDA advisory committee chairperson about what mistakes she has seen first-hand that she wishes the sponsoring companies had avoided.” The conference urges potential attendees to “learn from current and former [FDA] advisory board members.” Drake’s presentation will likely be a major attraction for the pharmaceutical industry.

“The decision of a current FDA advisory committee chair to speak at this conference reflects poor judgment and seriously undermines and demeans the important FDA advisory committee process, particularly when the chair seeks to help drug companies get drugs approved,” said Dr. Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group. Wolfe served on the FDA’s Drug Safety and Risk Management Advisory Committee from 2008-2012. “Dr. Drake’s participation in this conference raises concerns that she is approaching the work of the committee from a pro-industry perspective, rather than as an impartial expert.”

Public Citizen is calling on the FDA to tell Drake to pull out of the conference or remove her from the advisory committee. In addition, the FDA should develop a written policy for advisory committee members to curb such behavior.

Public Citizen also is questioning the FDA’s redaction of 32 items on Drake’s curriculum vitae from the webpage on which the agency has posted her CV.

The letter and brochure are available at http://www.citizen.org/hrg2166.