Drugmakers vow to post test results The voluntary disclosure plan using the Internet was intended to reassure patients and doctors about safety. Critics call the new guidelines insufficient.

Posted: January 07, 2005

The pharmaceutical industry pledged yesterday to release more data about drug trials and results over the Internet, saying more transparency would reassure patients and physicians about drug safety.

The voluntary disclosure plan, however, was immediately attacked by industry critics as insufficient. One congressman promised to reintroduce legislation that would require much more detailed disclosures than those announced yesterday.

Amid intensifying questions about drug safety, many experts, including a panel of medical-journal editors, have said that mandatory disclosure of all safety data - positive or negative - might help better protect the public from unsafe drugs.

Hoping to assuage critics and soothe the public, the London-based International Federation of Pharmaceutical Manufacturers and Associations, along with three associations representing U.S., European and Japanese drugmakers, drafted new disclosure guidelines for its members.

Under the new guidelines, companies must register their trials within 21 days of their start and give each one a unique identifier to ensure easy tracking through multiple databases. In the United States, the central database is accessible at www.clinicalstudyresults.org, which is run by the trade association Pharmaceutical Research and Manufacturers of America (PhRMA).

"Physicians and their patients stand to benefit from this international demonstration of the pharmaceutical companies' commitment to transparency," said Billy Tauzin, president of PhRMA.

Brian Ager, director general of the international organization, said the key was publicizing "not just the results of trials that have taken place - whether positive or negative - but also information on those that are just starting."

The guidelines do not call for total or immediate disclosure. There will be no information about drugs that have not yet been approved by government regulators. Data on approved drugs do not need to be published for one year after a medicine's approval.

The system will start July 1 for new drug trials and Sept. 13 for trials already under way as of yesterday.

There also will be no information on the registry about early-stage drug studies, which most companies consider competitive information that would help their rivals.

"There are issues around commercial sensitivities at the very early stage," said Richard Tiner, medical director of the Association of the British Pharmaceutical Industry, according to Reuters.

Of the Philadelphia region's major pharmaceutical firms, two - Wilmington-based AstraZeneca P.L.C. and GlaxoSmithKline P.L.C. in Philadelphia - said they would comply with the guidelines or even exceed them.

"We support and we encourage improving the transparency of clinical trial data," said Rick Koenig, a spokesman at GlaxoSmithKline, which has its own online registry at www.gsk.com that will share information with the international registry.

The FDA requires a drug company to turn over all data about a drug it is seeking approval to sell, but only after making its application. The only other requirement is for disclosure of trials on drugs to treat "serious" or "life-threatening" conditions.

Rep. Henry A. Waxman (D., Calif.), an outspoken critic of the pharmaceutical industry and sponsor of legislation to create a mandatory registry, dismissed the new guidelines.

"A voluntary proposal from the drug industry that is unenforceable and full of loopholes doesn't really move us forward," Waxman said in a statement. "Nothing in this announcement today is going to dissuade me . . . from reintroducing legislation creating a mandatory registry with results."

The British Medical Journal, while saying it "cautiously welcomed" the register, criticized its voluntary nature and the fact that only trials in the mid to late stages would be included.

The American Medical Association, in a statement, commended the industry effort, but said the association still believed "a mandatory, centralized registry is needed to fully inform" patients, physicians and researchers."

The Consumers Union, an advocacy group that publishes Consumer Reports, said the industry plan "falls far short of ensuring the safety of prescription drugs on the market, as drug companies still will not be legally required to make public the potentially negative results of their studies or the possible harmful side effects."

Contact staff writer Thomas Ginsberg at 215-854-4177 or tginsberg@phillynews.com.

This article contains information from the Associated Press and Reuters.

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