October 26

British Medical Journal: Something is rotten at the heart of FDA / Glaxo faces class action suit

British Medical Journal: Something is rotten at the heart of FDA / Glaxo faces class action suit

Sun, 5 Dec 2004

“Something is rotten at the heart of the FDA.” That’s the opening of an editorial in the British Medical Journal. [1]

Indeed, there is something rotten at the heart of the FDA: its failure to detect evidence of drug-related harm that could have saved lives worsened by its persecution of FDA medical officers who detected red flags signaling undisclosed hazardous–even lethal–drug effects.

The fact is, the FDA has abandoned its mission–its managerial officials avert the agency’s focus away from clinically significant red flags. FDA officials who have been caught disregarding evidence of life-threatening drug effects have attempted to trivialize the evidence–referring to thousands of victims who suffered fatal heart attacks as “not real deaths.”

FDA’s MedWatch database represents just 1% of adverse drug effects because so few physicians take responsibility to report adverse drug events.

Psychiatrist Dr. Stefan Kruszeuski, commenting in the BMJ, reminds his colleagues– individual practitioners–to “consider accepting a greater role and responsibility in airing their clinical observations to protect the regulatory process of drug approval and post-marketing surveillance.”

As a whistle-blower himself, Dr. Kruszeuski notes that “‘whistle-blowing’ could enhance the accumulation of scientific evidence—and therefore should not be the exception to the process, but the rule.”

“Scientific credibility is powered by transparency but disemboweled by conflicts of interest. In the debate about drug safety, those political, cultural and/or financial alliances that exist other than for the purpose of protecting and improving the public welfare are at odds with the pursuit of scientific discipline and the rigorous honesty that is necessary for its success.” [2]

An editorial in The Berkshire Eagle (below)–Save Us From the FDA–recounts the hurdles and intimidation that Dr. David Graham encountered for doing his job to protect the public health by alerting FDA officials, the medical community, and the public about the lethal risk of Vioxx.

Another example of FDA’s disregard of hazardous drug effects is its silence about reports of severe drug withdrawal symptoms–a sign of drug dependency:

The World Health Organization–but not the FDA–notes the unusually high rate of severe drug withdrawal symptoms in patients trying to stop taking the antidepressant, Paxil / Seroxat. “The World Health Organisation [sic] table of drugs that cause withdrawal difficulties puts Seroxat at the top, with twice as many reports as the next highest entry.” [3]

In June 2003 GlaxoSmithKline revised the Seroxat / Paxil UK label and patient information leaflet stating:
“Possible side-effects when stopping treatment: Studies show that 1 in 4 people notice some symptoms on stopping… When stopping Seroxat your doctor may ask you to reduce the dose very gradually using half tablets and then alternating days if necessary. If the dose is not reduced gradually there is more chance of experiencing side-effects. If you get severe unwanted side-effects when you stop taking Seroxat, please see your doctor.” [4]

That revision followed BBC’s Panorama expose which focused on the drug-induced severe withdrawal symptoms and suicide acts.

The Independent reports (below) that Glaxo is facing a class action lawsuit in Britain by 1,700 claimants alleging “withdrawal problems and/or aggression and/or suicidal acts.”

As of April 2004, the US Paxil label fails to disclose the true nature of the withdrawal risk. In the UK the risk is acknowledged as 1 in 4: the US label states that withdrawal syndrome occurs “infrequent[ly].” 25% is not infrequent.
See: http://www.fda.gov/medwatch/SAFETY/2004/Paxil_PI.pdf


1. Kamran Abbasi, Editor’s choice: Is drug regulation failing? BMJ 2004;329 (27 November), doi:10.1136/bmj.329.7477.0-g

2. Scientific Credibility is based upon Transparent Debate 4 December 2004 Stefan P. Kruszewski, M.D.

3. David Hellier, Glaxo faces threat of UK class action over Seroxat, Independent, 04 December 2004

4. See: Seroxat Patient Information Leaflet (UK), June 2003.

Contact: Vera Hassner Sharav

Save Us From the FDA
By Berkshire Eagle
Dec 4, 2004, 10:42

Federal whistle-blower laws have helped protect public health and safety as far back as Abraham Lincoln’s presidency, and now they need to be bolstered and wielded again. David Graham, the Food and Drug Administration research scientist who testified to Congress last month that the FDA has turned into a lackadaisical tool of the pharmaceutical industry, is under the gun at the agency and may be neutralized or even forced out. Congressional defenders and publicity that’s embarrassing to the White House may save Dr. Graham in the short term. But Dr. Graham and others like him need clear and unequivocal permanent backing if the cause of food and drug safety in the United States is not to be set back 100 years.

The arthritis drug Vioxx was withdrawn from the market voluntarily this fall after Merck Pharmaceuticals finally decided on its own that Vioxx was dangerous. Dr. Graham testified that the FDA had ample evidence of the drug’s risks long before Merck acted. So great were the cardiovascular dangers of Vioxx that tens of thousands of heart attacks, many thousands of them fatal, could have been prevented by timely FDA intervention, according to the researcher. When asked by a senator if other unsafe drugs remained on the market, Dr. Graham answered yes and named the drugs: the diet drug Meridia, the arthritis drug Bextra, the asthma medication Serevent, the acne treatment Acutane, and the cholesterol-lowering drug Crestor.

The Bush political hacks who run the FDA are having fits. Dr. Graham has been told he may be “reassigned” to what he says would be a do-nothing job in the commissioner’s office, where he would be far removed from research and analysis. His lawyer says Dr. Graham has received threatening anonymous calls from within the agency. Dr. Graham is trying to withstand the pressure and keep on with his life’s work, which is reviewing the safety of drugs on the market.

This conscientious patriot should be left to do his job, for the statistical evidence certainly suggests that for the past four years the FDA has been generous to a fault in accommodating the food and drug industries that fatten Republican-party accounts. During Bill Clinton’s second term, 10 drugs deemed dangerous by the FDA were taken off the market. In the Bush years, just three were, and one of those, Vioxx, was removed voluntarily and belatedly. Warning letters on dishonest drug advertising plummeted, too, from 480 cease-and-desist letters from the second Clinton administration FDA to 130 in the past four years.

Congress has alternately beefed up or watered down whistle-blower laws over the years, depending on who was in power. Currently the laws need stiffening, for Dr. Graham’s situation, his lawyer says, may not be covered. Iowa Republican Senator Charles Grassley has positioned himself as a temporary bulwark between Dr. Graham and oblivion. But even this influential senator may fade under the onslaught of the Bush anti-regulatory typhoon.

In addition to fixing inadequate whistle-blower laws, congressional reformers should attempt to remove the monitoring of problematic drugs from FDA jurisdiction. This month the Journal of the American Medical Association urged just such a move. Drug safety involves life-and-death decisions for millions of Americans and has no place in a process that has been so thoroughly politicized.


Glaxo faces threat of UK class action over Seroxat
By David Hellier
04 December 2004

Lawyers acting for 1,700 people in the UK have issued a pre-action letter of claim against GlaxoSmithKline alleging serious side-effects have been suffered by their clients taking one of its best-selling drugs, the anti-depressant Seroxat.

The legal case, which is being spearheaded by Mark Harvey, a partner at Hugh James Solicitors, represents an escalation of the challenges facing the drug.

Already, concerns over the addictive properties of Seroxat have led the UK Government to ban its prescription to people under the age of 18.

On Monday, the UK’s Medicines and Healthcare Products Regulatory Agency is expected to tighten up guidelines in the use of anti-depressants after a major safety review.

The drug is also facing challenges in the US, where it is marketed as Paxil. Regulators there want its labelling changed to highlight the risk factors more fully, while lawyers are looking to claim compensation on behalf of clients.

Mr Harvey says his 1,700 clients are of different age groups and were selected from about 4,000 people who contacted the firm with complaints about the drug. “We have screened the complainants carefully so as to include only those whose symptoms we strongly feel have been brought on by the use of the drug,” he said.

Mr Harvey is bringing the claim under the Consumer Protection Act 1987. The claimants allege withdrawal problems and/or aggression and/or suicidal acts. Mr Harvey thinks the case will take at least two years to get to trial. Funding comes from a mixture of public funds and from legal insurance policies.

Mr Harvey says he has never called for Seroxat to be withdrawn. “It’s a question of proper, informed choice. If doctors and patients are told the risks involved they can make an informed choice about whether to use the drug or not.”

Mr Harvey said he could not say what scale of damages he would be looking for.

A statement from Hugh James Solicitors notes that a World Health Organisation league table of the drugs that cause withdrawal difficulties puts Seroxat at the top, with twice as many reports as the next highest entry.

GlaxoSmithKline said yesterday it had received a letter of claim from Hugh James Solicitors on Thursday and it was considering it in detail.

The pharmaceuticals giant’s chief executive Jean-Pierre Garnier has spoken recently about the need to speed the development of other drugs, especially of a cervical cancer vaccine that he feels could be a blockbuster, because of safety concerns with other drugs.
© 2004 Independent Digital (UK) Ltd

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