PhRMA Announces Industry Plan To Post Clinical Trial Data on Web Site

The Pharmaceutical Research and Manufacturers of America, in conjunction with three other large pharmaceutical industry trade groups in Europe and Japan, on Thursday announced that their members plan to voluntarily post on a Web site more clinic trial results, the New York Times reports. In a joint statement, the four groups said that their members would post more data both when trials begin and when results are released. The pharmaceutical industry has received criticism over the past year for "highlighting positive trials while playing down or burying negative data," according to the Times (Meier, New York Times, 1/7).

For example, New York State Attorney General Eliot Spitzer (D) last year filed suit against GlaxoSmithKline for alleged concealment of negative trial results for Paxil, and trial attorneys allege that Merck concealed negative results for the COX-2 inhibitor Vioxx, which the company voluntarily withdrew from the market last September. In addition, the 11 members of the International Committee of Medical Journal Editors last year said they would only publish studies that are publicly disclosed when trials begin (Agovino, AP/Las Vegas Sun, 1/6).

Under current law, pharmaceutical companies only have to post data on www.clinicaltrials.gov for trials that involve treatments for life-threatening diseases or conditions (Rubin, USA Today, 1/7).

Under the plan announced by the four groups, scheduled to take effect July 1, member pharmaceutical companies will post data on the Web site when clinical trials begin and within one year of when medications are approved or trials end. The companies will post trial results on a publicly accessible database operated by the federal government, a company or a trade group.

PhRMA said that some pharmaceutical companies will exclude some trial data, as well as the results of Phase I trials, which test the safety of medications (New York Times, 1/7). Alan Goldhammer, associate vice president of regulatory affairs for PhRMA, said that the CEOs of member pharmaceutical companies will post trial results regardless of whether they are positive or negative (USA Today, 1/7). However, the Times reports that "in the past, the industry has not responded well to calls for voluntary trial registries -- or even to a federal mandate to list certain trials" (New York Times, 1/7).

Critics maintain that the plan announced by the four groups is inadequate. Rep. Maurice Hinchey (D-N.Y.), who said that he plans to introduce legislation to make all clinical trial results public, on Thursday said that the pharmaceutical companies "may decide to put some things up, they may decide not to put some things up."

Rep. Edward Markey (D-Mass.), who last year introduced legislation to establish a public registry of trial results for medications 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" (USA Today, 1/7).

Rep. Henry Waxman (D-Calif.), who said that he plans to introduce legislation to require public disclosure of all late-stage trial data, said, "A voluntary proposal for the drug industry that is unenforceable and full of loopholes doesn't really move us forward. We already know many companies ignore the current law" (Kaufman, Washington Post, 1/7).

Spitzer called the plan a "positive step forward," but he added, "It is impossible to know whether the proposal will truly provide a transparent window or one that is only somewhat less opaque" (USA Today, 1/7).

Some pharmaceutical companies have expressed support for the plan announced by the four groups, but others have not "completely embraced the idea," the AP/Sun reports. Rachel Bloom Baglin, a spokesperson for AstraZeneca, said that the company will post trial data "as appropriate," adding that the company will not post data that could reveal competitive information. Officials for Merck, which currently posts on a Web site late-stage trial data, on Thursday said that the company will begin to post mid-stage trial data.

Catherine DeAngelis, editor in chief of the Journal of the American Medical Association, called concerns that trial data posted on a Web site could reveal competitive information "hogwash" because medications remain in development for years before they reach clinical trials.

However, Christopher Milne, associate director of the Tufts Center for the Study of Drug Development, said that such a Web site of trial results could pose some competitive problems, such as when two companies have treatments in development in the same class for different uses.

Harvey Bale, director general of the International Federation of Pharmaceutical Manufacturers Associations, said, "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" (AP/Las Vegas Sun, 1/6).

Billy Tauzin, CEO of PhRMA, said, "We're doing this because our industry recognizes that sometimes what the law requires doesn't give patients all they need" (USA Today, 1/7).

Richard Barker, director general of the Association of the British Pharmaceutical Industry, said, "The pressures the companies bring to bear on each other, the pressure of the media and of the international medical journals mean that it is very much in a company's interest to do this" (New York Times, 1/7).

DeAngelis said that she is "a doubting Thomas," adding, "When you put the fox in charge of the hen house there is a problem" (AP/Las Vegas Sun, 1/6).

PBS' "NOW" on Friday will examine the role of FDA in prescription drug regulation. Guests on the program are scheduled to include David Graham, associate director of drug safety in the FDA Office of Drug Safety (Brancaccio, "NOW," PBS, 1/7). Check local PBS listings for show times. Video of program segments in RealPlayer, transcripts and Web-only features will be available online after the broadcast.