Drugmakers to voluntarily post info online about clinical trials
Fri Jan 7, 6:55 AM ET Business - USATODAY.com
By Rita Rubin, USA TODAY
The prescription drug industry's main trade group announced Thursday that its member companies will begin voluntarily posting information about ongoing clinical trials for all diseases this summer on a government Web site.
Drug companies have come under fire in recent months for allegedly withholding unfavorable research findings, and the American Medical Association as well as some members of Congress have called for mandatory reporting of all clinical-trial results.
Under current law, drug companies are required to post information at www.clinicaltrials.gov
only about trials of drugs for serious or life-threatening diseases or conditions.
"We're doing this because our industry recognizes that sometimes what the law requires doesn't give patients all they need," Billy Tauzin, the former congressman who now serves as CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), said in a statement Thursday.
At least two congressmen on Thursday said PhRMA's voluntary plan, which is to go into effect July 1, is inadequate.
"They may decide to put some things up, they may decide not to put some things up," said Rep. Maurice Hinchey, D-N.Y., who says he will introduce legislation to mandate making all clinical trials public.
Rep. Edward Markey, D-Mass., who wrote legislation last year to establish a clinical-trials registry for drugs and medical devices, said: "A voluntary registry allows the drug industry to continue its game of hide and seek. The drug companies hide the negative drug trials and hope that the public can't seek them out."
New York Attorney General Eliot Spitzer, who sued GlaxoSmithKline last June, alleging that the company withheld studies linking its anti-depressant Paxil with suicidal behavior in children, called PhRMA's latest announcement "a positive step forward."
Still, Spitzer said in a statement, "It is impossible to know whether the proposal will truly provide a transparent window or one that is only somewhat less opaque." He urged the drug industry to support federal legislation that would mandate and implement disclosure of all clinical research.
Alan Goldhammer, PhRMA's associate vice president for regulatory affairs, said the CEOs of all of his organization's member companies - which include all U.S. and most foreign major prescription-drug makers - are committed to making public the results of all clinical trials, regardless of what they find.
In October, PhRMA launched www.clinicalstudyresults.org,
a Web site that lists information about clinical trials completed since Oct. 1, 2002, for drugs that are on the market. Goldhammer said he did not know what portion of those trials was never published. The www.clinicaltrials.gov
Web site lists ongoing trials for drugs that are not necessarily on the market yet.