Drugmakers Prefer Silence On Test Data

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> DARocksMom

> Tue, 6 Jul 2004 11:49:12 EDT

> Drugmakers Prefer Silence On Test Data

>

> Drugmakers Prefer Silence On Test Data

>

> By Shankar Vedantam

 

>

> 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 o

> r 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. "

>

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