British Medical Journal: Something is rotten at the heart of FDA

[Guest guest]

SSRI-Research@

Sun, 5 Dec 2004 19:17:14 -0500

British Medical Journal: Something is rotten at the heart of

FDA / Glaxo faces class action suit

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness and Full Disclosure

www.ahrp.org

 

FYI

 

" 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

 

 

References:

1. Kamran Abbasi, Editor's choice: Is drug regulation failing? BMJ

2004;329

(27 November), doi:10.1136/bmj.329.7477.0-g

http://bmj.bmjjournals.com/cgi/content/full/329/7477/0-g?maxtoshow== & HITS==10 &

hits= & RESULTFORMAT== & author1=«basi & andorexactfulltext

 

2. Scientific Credibility is based upon Transparent Debate 4 December 2004

Stefan P. Kruszewski, M.D.

http://bmj.bmjjournals.com/cgi/eletters/329/7477/0-g#88013

 

3. 2. David Hellier, Glaxo faces threat of UK class action over Seroxat,

Independent, 04 December 2004

http://news.independent.co.uk/low_res/story.jsp?story=X9569 & host==3 & dir==94

 

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

http://emc.medicines.org.uk/emc/industry/default.asp?page==displaydoc.asp & doc

umentid= 57

 

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

 

http://www.earthchangestv.com/secure/2004/printer_5599.php

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

http://news.independent.co.uk/low_res/story.jsp?story=X9569 & host==3 & dir==94

 

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

 

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of

which

has not always been specifically authorized by the copyright owner. Such

material is made available for educational purposes, to advance

understanding of human rights, democracy, scientific, moral, ethical, and

social justice issues, etc. It is believed that this constitutes a 'fair

use' of any such copyrighted material as provided for in Title 17 U.S.C.

section 107 of the US Copyright Law. This material is distributed without

profit.