Eleven of the world�s top medical journals are making the reporting of all clinical trial results a condition of publication in an attempt to remedy concerns about the selective disclosure of experimental data by pharmaceutical companies.
Eleven of the world’s top medical journals are making the reporting of all clinical trial results a condition of publication in an attempt to remedy concerns about the selective disclosure of experimental data by pharmaceutical companies.
The members of the International Council of Medical Journal Editors announced Wednesday that they would publish reports only if the results of those trials are registered in an online database, www.clinical trials.gov, which is run by the National Library of Medicine. This proposition has received much federal support and members of Congress intend to introduce legislation in the near future that will prevent pharmaceutical companies from withholding unfavorable information about their products.
“This decision will almost certainly change the behavior of the pharmaceutical companies,” said Gregory Curfman, executive editor of the New England Journal of Medicine. “As editors we will have a significant impact and create a strong incentive to register trials.”
This movement stems from the recent landmark lawsuit brought by New York Attorney General Elliot Spitzer against GlaxoSmithKline for the company’s failure to share the dangers of Paxil, a drug used to treat adolescent depression. The lawsuit contended that the results of completed studies were misrepresented and Paxil could potentially increase suicide rates in children and adolescents.
Once clinical trial data from any study is on the public record, it will be harder for researchers to bury negative results. In the past, many physicians and patients did not know that follow-up trials were conducted on drugs that had already received approval by the Food and Drug Administration and that controversial results may have been discovered.
“Every student starting school this fall knows they can’t pick and choose which tests will count and which won’t,” Rep. Edward Markey (D-Mass.) wrote in an e-mail. “Likewise, drug companies can’t be permitted to decide which trials to disclose and which to hide from the public. Doctors should never be put in the position of prescribing medications to a patient with only partial access to what is known about the drug’s effects.”
Pharmaceutical companies will have a grace period until 2005, at which point all trials will have to be registered. According to the “Joint Statement on Legislation to Establish a Clinical Trials Registry” by Markey and fellow Democrat Rep. Henry Waxman of California, researchers will have to disclose the objectives, eligibility criteria, sources of funding and anticipated timeline of clinical trials to satisfy the objectives set forth by the American Medical Association to protect patients and educate doctors.
Markey claims that companies and researchers have a moral and ethical responsibility to share their trials with the public, and failure to abide by the new regulations will result in civil penalties.
“The bill that we are going to be introducing will ensure that patients have the tools they need to make informed decisions, maintain the integrity of the medical community and protect the health of their patients and our families,” said Markey in his statement to the U.S. Congress last week.
Academics also agree on the pressing need for increased transparency in the pharmaceutical world. “We only know what works, but what doesn’t work is just as important,” said Elizabeth Vigdor, assistant professor of public policy. “Only printing what the pharmaceutical companies want creates a publication bias and we should put research into perspective.”
Pharmaceutical companies, including Eli Lilly, Forest Laboratories, GlaxoSmithKline and Merck, have reacted strongly and have offered counter-proposals such as optional registration, but Curfman and the other editors will not accept such propositions.
Vigdor attributed this suggestion of voluntary registration as just a way “to avoid being sued” and said the proposed legislation is necessary to rectify this controversy. “If it is not mandatory, it will be easy to just drop off and not publish in the database down the road,” she said. “Without Congress, it will be unlikely to hold up over time.”
David Pisetsky, professor of rheumatology and immunology, offers an alternative viewpoint. As editor of Arthritis & Rheumatism, the leading journal in the field, he questions the practicality of such a rigorous system.
“It is difficult for people to understand the true complexity of these data sets—we want fair presentation but in a journal only a very small data sample is scrutinized and published,” he said. “It requires an extraordinary time commitment to look at these data sets and protocols, which is only possible for large medical journals like the Journal of the American Medical Association, the New England Journal of Medicine and The Lancet—three of the big supporters of this decision.”
Smaller journals, including Pisetsky’s, rely on volunteer reviewers and do not have a full-time staff. “It will be very difficult to get people to analyze all this highly sophisticated data that would now be required,” he said. “I just don’t think this is necessarily the best way to accomplish this.”
Pisetsky, on the other hand, does agree with the other editors that the FDA needs to strengthen and expand its expertise in monitoring clinical trials. “It is not the journal’s responsibility to be a regulatory agent. The FDA has already established itself as the primary investigator of drug tests and it should stay that way,” he said.
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