The embattled pharmaceutical industry announced its intention Thursday to publish more data about clinical drug trials (search), despite skepticism about whether the initiative will really increase transparency and improve drug safety.
The International Federation of Pharmaceutical Manufacturers and Associations (search), along with three other industry associations covering Europe, the United States and Japan, said they will disclose a free, detailed registry of current and completed drug trials on the Internet. The decision comes amid revelations that the industry muzzled negative data about some of its products and growing questions about drug safety.
"The industry recognizes that there are important public health benefits associated with making clinical trial information more widely available to health care practitioners, patients and others," said Dr. Harvey E. Bale, director general of the international organization in a statement.
The industry said that by mid-2005 it will publish the results of completed trials as well as details about studies that are being initiated on publicly accessible databases. The Pharmaceutical Research and Manufacturers of America is recommending that its members post studies on an existing government-run web site, www.clinicaltrials.gov, starting on July 1. Drug companies are legally required to post trials dealing with serious or life-threatening diseases to that site.
The new initiative is voluntary and while companies have expressed support, it is unclear if they will comply to the degree deemed necessary by industry critics eager to improve transparency.
Critics say companies must register trials either before they begin or soon after so they can't squelch negative results. The issue gained prominence last year when New York State attorney general Eliot Spitzer (search) sued GlaxoSmithKline PLC (search) for suppressing negative clinical studies on their antidepressants. He also asked Forest Laboratories for information about studies of its antidepressants. Settlements were reached but the issue lingers.
Trial lawyers have accused Merck & Co. (search) of hiding negative information about Vioxx (search), the pain killer drug it pulled last year because it doubled patients risk of heart attack and strokes.
Last year, the 11 members of the International Committee of Medical Journal Editors (search) said they would not publish any studies that are not registered in a database as they are launched. The editors say trials that subject people to intervention to determine the cause and effect relationship between a medical treatment and outcome must be registered.
The American pharmaceutical association recommends registering mid-to-late stage trials.
It is unclear if the ideas are compatible, but the American association says it is open to discussion. Editor reaction was mixed.
"When you put the fox in charge of the hen house there is a problem," said Dr. Catherine D. DeAngelis, editor in chief of the Journal of the American Medical Association. "I'm a doubting Thomas."
Not all companies have completely embraced the idea.
AstraZeneca PLC (search) spokeswoman Rachel Bloom Baglin said they would list "as appropriate." She said the company doesn't want to post any information that might reveal proprietary information.
After Thursday's announcement Merck & Co., which has only been listing its late stage trials on the web-site, resolved to list its mid stage trials as well.
New England Journal of Medicine (news - web sites) editor-in-chief Dr. Jeffrey Drazen said he thought Merck's action's would meet the group's proposal.
"I think the industry is taking a step in the right direction," said Drazen.
DeAngelis said it is "hogwash" to say the registry would reveal any competitive information. She notes that drugs will have been in development for years before they needed to be listed on a trial registry so a competitor couldn't quickly match a study or idea.
Christopher Milne, associate director of the Tufts Center for the Study of Drug Development, said a registry could pose some competitive challenges. For example, if two companies are developing a medicine in the same class and one announces it is studying the product for a different use, the other firm may get a new idea.
Still, Milne said he didn't see the registry as a major competitive issue and that drug companies have to continue to do trials to survive.
"They live or die by their innovations," said Milne.
British Medical Journal acting editor-in-chief Cameron Abbasi criticized the lack of a single Internet location for the registry.
"Ideally, there should be a single location where people could go and access these findings ...," said Abbasi. "There are already many registers available and one of the problems with that is that you need to harmonize them and link them together."
Some companies have already begun to create their own clinical trial registries. GlaxoSmithKline, which launched its own register of the results of clinical trials of marketed medicines in September. The company has already stated its intention to post information about patient trials initiated on or after Nov. 1 2004 on a web site run by the U.S. National Institutes of Health.
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