FDA Failed to Enforce Law Requiring Drugmakers to Disclose Test Data_WashPost

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> Tue, 6 Jul 2004 12:26:36 EDT

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> " veracare " <veracare

 

> FDA Failed to Enforce Law Requiring

> Drugmakers to Disclose Test Data_WashPost

> Tue, 6 Jul 2004 12:16:32 -0400

>

> ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

> Promoting openness and full disclosure

> http://www.ahrp.org

>

> FYI

>

> A front page article in The Washington Post reports

> that the FDA failed to

> enforce the law that requires drug companies to

> disclose ALL clinical drug

> trials and ALL trial findings-whether they're good

> or bad.

>

> In 1997, congress passed the FDA Modernization Act

> (FDAMA) which gave the

> pharmaceutical industry what it wanted: it helped

> speed up the drug testing

> and approval process, and it provided the

> pharmaceutical industry with huge

> financial incentives to test drugs in children. Drug

> companies receive a six

> month patent extension for a patented drug or a drug

> in the development

> stage if they conducted pediatric trials--even if

> the drug was not intended

> for pediatric use.

>

> The Post reports: " The FDA acknowledges it has not

> enforced the law --

> officials said the statute did not spell out

> penalties or explicitly give

> the agency authority to crack down on violators. "

>

> The drug industry's undue influence on government

> oversight agencies, and

> industry's control of drug trials--and what gets

> reported about those

> trials--has resulted in preventable harm and

> drug-related casualties.

> Industry's inordinate influence is also demonstrable

> in academic medicine:

> medical research and clinical practice have been

> corrupted from top to

> bottom, as researchers at universities and at the

> National Institutes of

> Health have become accomplices to concealment of

> evidence. [see today's

> companion AHRP Infomail]

>

> It's time to hold this lawless industry and the FDA

> accountable for

> deceiving physicians and the American public, and

> for the harm that resulted

> from the concealment of evidence. Thousands of

> people--including

> children--suffered, some lost their lives due to the

> combined failure of

> drug industry to comply with their legal

> responsibility, and government

> officials for the failure to enforce the law.

>

> Drug companies are legally obliged to disclose ALL

> adverse drug effects

> found in clinical trials. Hidden drug hazards affect

> millions of people's

> health-often, their lives. Disclosure should,

> therefore, not be a matter for

> negotiation.

>

> The Truth About the Drug Companies: How They Deceive

> Us and What to Do About

> It, is the title of a new book by Dr. Marcia Angell,

> the former editor of

> The New England Journal of Medicine. An article in

> the New York Review of

> Books provides a prelude to the book about the drug

> industry's corrosive

> effect on medicine:

>

> " Over the past two decades the pharmaceutical

> industry has moved very far

> from its original high purpose of discovering and

> producing useful new

> drugs. Now primarily a marketing machine to sell

> drugs of dubious benefit,

> this industry uses its wealth and power to co-opt

> every institution that

> might stand in its way, including the US Congress,

> the FDA, academic medical

> centers, and the medical profession itself. "

> See full article at:

> http://www.nybooks.com/articles/17244?email

>

> Dr. Angell makes the case that because of the

> importance of drugs for public

> health, the drug industry receives a host of special

> favors from the public

> that other industries do not: unprecedented periods

> of market exclusivity,

> multiple tax breaks, the rights to NIH-funded

> research findings, and the

> fact that the government is a major purchaser of

> this industry's products,

> guaranteeing drug companies a profit. For these

> reasons, she argues, the

> pharmaceutical industry should be regarded much as a

> public utility, and

> should be regulated as such.

>

> What's needed now is a complete re-vamping of the

> FDA to ensure that laws

> pertaining to the safety of drugs--are enforced.

> AHRP believes that medical

> research institutions and the medical profession

> should take stock and

> consider the cost of partnerships with drug

> companies whose disreputable

> practices will taint the reputations of all the

> partners involved--once

> these are fully revealed in court.

>

> The lawsuit filed by NYS Attorney General, Eliot

> Spitzer, promises to

> provide the necessary legal restraint on an industry

> that has deceived the

> public with false promises, delivering instead,

> harmful drugs that have

> undermined health, while depleting public healthcare

> budgets.

>

> Spitzer's suit addresses the essential legal

> violations that the

> pharmaceutical industry has been engaging in with

> impunity--due to FDA's

> failure to enforce federal laws and regulations.

>

>

> Contact: Vera Hassner Sharav

> Tel: 212-595-8974

> e-mail: veracare

>

>

>

>

http://www.washingtonpost.com/wp-dyn/articles/A29576-2004Jul5.html

> THE WASHINGTON POST

> Drugmakers Prefer Silence On Test Data

> By Shankar Vedantam

> July 6, 2004, front page

>

> The pharmaceutical industry has repeatedly

> violated federal law by failing

> to disclose the existence of large numbers of its

> clinical trials to a

> government database, according to the Food and Drug

> Administration.

>

> Doctors and patients say that compliance with the

> law would go a long way

> toward addressing their growing concerns that they

> are not being given the

> full picture about the effectiveness of many drugs

> because they are not told

> about drug trials that fail. The issue has gained

> urgency with recent

> disclosures that the publicly available research on

> treating children with

> antidepressants obscured the fact that in most

> studies, the drugs were no

> better than sugar pills. Drugmakers chose not to

> publish those studies.

>

> The 1997 law is so little known that scientific

> journal editors and

> professional medical associations have recently

> debated whether to create a

> system of private incentives for disclosure of

> trials. When she was told the

> law already requires companies to register trials,

> Catherine DeAngelis,

> editor in chief of the Journal of the American

> Medical Association, said,

> " That's a surprise to me. Tell me why it's not

> enforced. "

>

> Although the law was primarily passed for other

> reasons, DeAngelis said

> it could very well address her concerns.

>

> The FDA acknowledges it has not enforced the law --

> officials said the

> statute did not spell out penalties or explicitly

> give the agency authority

> to crack down on violators.

>

> An FDA analysis found that in 2002 only 48 percent

> of trials of cancer

> drugs had been registered, and a preliminary review

> now indicates the

> listing rate for drugs for some other serious

> diseases is in the single

> digits. Some companies have listed no studies; some

> trials are listed

> without identifying the sponsoring company or the

> drug being tested.

>

> As of Friday, the database, ClinicalTrials.gov,

> listed 5,754 ongoing

> studies, but only 13 percent were industry

> sponsored. The federal

> government, mainly the National Institutes of

> Health, accounted for 55

> percent. Those proportions are in stark contrast to

> the true picture,

> DeAngelis said. " Over 80 percent of trials are

> funded by for-profit

> companies, not by the government, " she said.

>

> FDA officials said they are re-examining whether

> they have the power to

> step in. Members of Congress are also considering

> adding enforcement

> provisions to the law, which was part of the FDA

> Modernization Act of 1997.

>

> The registry was begun in 1998 and the

> ClinicalTrials.gov site went online

> in February 2000, said Alexa McCray, director of

> biomedical communications

> at the National Library of Medicine, which hosts the

> registry. Since then,

> nearly 11,000 trials have been registered from all

> 50 states and 90

> countries. Virtually all studies sponsored by the

> National Institutes of

> Health are listed, and industry trials started

> coming in after March 2002,

> when the FDA issued a formal " guidance " on

> implementing the law.

>

> Although some companies say they are amenable to

> wider disclosure, the

> patient advocacy group that fought the hardest to

> create the requirement

> predicted it would never be enforced.

>

> " Obviously it needs an enforcement mechanism

> attached to it, " said Abbey S.

> Meyers, president of the National Organization for

> Rare Disorders. " I can

> guarantee you, however, that the full force of the

> drug industry will stop

> it. They don't want you to know about clinical

> trials that fail. They are

> afraid what it will do to their stock price. A lot

> of trials are for drugs

> already on the market, and it would ruin their sales

> if the news got out. "

>

> The Pharmaceutical Research and Manufacturers of

> America countered that the

> registry had initially been slow to list

> industry-sponsored trials, and that

> companies started supplying the information after

> the FDA issued its

> guidance. Alan Goldhammer, PhRMA's associate vice

> president for regulatory

> affairs, said he had heard anecdotally that

> companies are now fully

> complying with the law.

>

> But Theresa Toigo, director of the FDA's Office of

> Special Health Issues,

> painted a different picture. " Many pharmaceutical

> trials are not

> participating in ClinicalTrials.gov or are not fully

> participating, " she

> wrote in a recent report in the Journal of Biolaw

> and Business. Responding

> to assertions by PhRMA that the 2002 data do not

> reflect the current

> situation, she said, " It's not like we've seen a big

> increase in the monthly

> submissions of privately sponsored protocols. "

>

> Sen. Edward M. Kennedy (D-Mass.), who helped create

> the registry in 1997,

> plans to seek revisions to enforce the registration

> requirement and to find

> a way to report study results.

>

> Meyers and Paul Kim, a former Kennedy staff member

> who now works for the

> law firm Foley Hoag LLP, said the original purpose

> of the registry was to

> link patients who wanted to join clinical trials

> with the researchers.

>

> The law required companies to register all

> effectiveness trials, known as

> Phase 2, 3 or 4 studies, for serious and

> life-threatening diseases. In 2002

> , the FDA defined " serious " diseases broadly,

> including everything from AIDS

> and cancer to arthritis, depression and diabetes.

>

> Some companies have boasted to stockholders of

> having many ongoing studies

> in the pipeline but not listed any with the

> registry. Forest Laboratories

> Inc., which recently touted results for an

> Alzheimer's disease drug called

> memantine and last month published a children's

> depression study showing

> positive results for its antidepressant Celexa, has

> no trials registered.

> Company spokesman Charles Triano said the law does

> not require companies to

> register trials if other drugs are available for the

> same disease.

>

> Triano said the company did not need to list its

> trials of memantine, a new

> class of Alzheimer's drug, because the FDA had not

> given it the " fast-track "

> status reserved for breakthrough medicines and

> deadly diseases with limited

> treatments.

>

> The FDA's Toigo said the law required companies to

> register trials whether

> or not medicines exist for the disease. " It doesn't

> say anything about

> existing drugs on the market, " she said.

>

> Although 246 pharmaceutical and biotech companies

> had ongoing trials in the

> database Friday, about half listed just one.

> GlaxoSmithKline had five, but

> spokesman Rick Koenig said many of the company's

> trials are not listed under

> the company's name. " We didn't understand that to be

> a requirement or the

> sort of information that is of use to a patient

> looking into where that

> patient might enroll in a trial, " he said.

>

> Toigo said the FDA's 2002 guidelines called for

> companies to include their

> names.

>

> Journal editor DeAngelis, who is helping spearhead

> an editors' initiative

> to get all trials registered, said a

> government-enforced registry would be

> vastly superior to any system of private incentives.

> " It will come as a

> surprise to the vast majority of your readers, " she

> said about the law's

> requirements. " I had personally assumed it was only

> for federally funded

> clinical trials. "

>

> Toigo said her analysis of industry compliance,

> which she hopes to complete

> by the end of the year, will examine whether more

> than 2,000 trials

> submitted to the FDA by companies seeking approval

> for medicines in 2002 had

> been properly listed.

>

> Companies are hesitant to register trials because

> they want to control

> data, said Kay Dickersin, a professor at Brown

> University who has sought

> such data for two decades. Some are worried that

> trade secrets will leak

> out, or that a competitor will poach on patient

> networks. Others don't want

> patients to petition them for medicines on

> " compassionate grounds. "

>

> One way to increase registration, said Dickersin,

> is for patients to insist

> trials be registered before participating. Drummond

> Rennie, a professor at

> the University of California in San Francisco, added

> that physicians who

> conduct trials for companies " should examine their

> consciences " before

> agreeing to let trials be kept secret.

>

> " If I buy a camera and the thing falls apart, it's

> a lemon, I shrug and say

> I'm never going back to that firm, " said Rennie, who

> is also deputy editor

> at JAMA. " But if I get a drug and it makes me worse,

> it can kill me or maim

> me. "

>

> " We give pharmaceutical companies a lot of tax

> advantages and a whole lot

> of support in the Congress and a good business

> environment and patent

> protection, " he said. " They owe us more

> information. "

>

>

> C 2004 The Washington Post Company

>

>

>