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Stop Drug Companies from Hiding Negative Results

Posted by medconsumers on July 1, 2005

Why Do We Need A Publicly Funded, Publicly Accessible Database Of Clinical Trials?

The short answer is this: To stop the pharmaceutical and device industries from hiding the results of clinical trials that did not show a benefit to their products. And to stop them from withholding findings that indicate significant harms associated with their products.

In a perfect world, an independent group of researchers would conduct the clinical trials designed to see whether a new drug is safer or more effective than the drugs already available for the same condition. A head-to-head comparison would be conducted for at least one year. If the new drug has no advantage over the older drugs, it wouldn’t be allowed on the market.

The real world scenario, unfortunately, is far less than perfect. To receive FDA approval, a drug company need only provide two trials that proved its drug is better than nothing (a placebo). Most trials last only a few months. In 2002, Washington Post reporter, Shankar Vedantam , described a new analysis of the trials conducted by drug companies that made drugs to treat depression, such as Prozac, Paxil, and Zoloft. The majority of these trials found that placebos were just as effective as the antidepressants, and in some trials, the placebos worked better. But the public never learned about the trials that found antidepressant were ineffective. The drug companies withheld their existence and submitted the FDA-required two trials that did show a benefit to their drug. The analysis described by the Washington Post reporter also revealed that the makers of Prozac had to conduct five trials to obtain two that were positive, and the makers of Paxil and Zoloft had to conduct even more.

The issue of drug companies withholding negative trial results has slowly become more acute in the last 15 years because government funding of trials has decreased considerably. The majority of all drug trials are now conducted by the sponsoring drug companies. And it is becoming increasingly evident that the drug companies get the results they want. A 2003 review published in the BMJ (British Medical Journal) found that studies sponsored by pharmaceutical companies were far more likely to have outcomes favoring the sponsor than were studies with other sponsors . The problem is not limited to pharmaceutical research. For example, in a 2003 review of all studies that looked at total hip arthroplasty implants, 75% were commercially sponsored, of which 93% reported positive outcomes; whereas independently funded researchers reported good results in only 37% of studies.

This critical issue did not begin to penetrate the public’s consciousness until June 2004, when New York State attorney general, Eliot Spitzer, filed a lawsuit against the British-based pharmaceutical company, GlaxoSmithKline. The pharmaceutical company, one of the world’s largest, was accused of “persistent fraud” for failing to tell doctors that some of its studies of the antidepressant Paxil showed that the drug didn’t work in adolescents and might lead to suicidal thoughts. The lawsuit has since been settled.

For more than a decade, a small group of medical journal editors and researchers has periodically offered a solution that has only now gained serious attention: All clinical trials should be registered at the onset. And the registry must be publicly available. Only then will doctors and the public have complete information about all the research that has been conducted on a particular drug or device. Predictably, there is a great deal of resistance to this idea from industry. Congress is considering legislation, entitled Fair Access to Clinical Trials Act, which will mandate the early registration of clinical trials. Unfortunately, there are many problems with this proposed legislation, not the least of which is the failure to include more than drug trials in the mandate.

Some journal editors have taken a strong stand on this issue. Last year, a new policy was announced by 11 editors of the world’s most prestigious journals, including the New England Journal of Medicine, The Lancet, Canadian Medical Association Journal, and the New Zealand Medical Journal. They will not publish results of any trial that has not been registered in a publicly available database before the first participant is enrolled. The policy is aimed at foiling researchers who change the goals of a study while it is in progress and to stop drug companies from withholding the existence of trials that show negative results.

In May 2005, the 11 editors, now called the International Committee of Medical Journal Editors, updated its policy about the registration of clinical trials. The journals represented by this committee will not publish trials that are not publicly registered by July 1, 2005. The editors have given the drug companies until September 13, 2005 to register ongoing trials. Other editors from other medical journals have now joined the committee. The policy will be successful only when all medical journals take a similar stand.

The Committee defined clinical trial this way: “Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. By ‘medical intervention’ we mean any intervention used to modify a health outcome. This definition includes drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, and the like.”

Consumers have a major stake in this issue. We cannot make informed medical decisions if we cannot trust the research. And clinical trials cannot be conducted without us. People who agree to participate in trial do so with the hope of helping themselves or future patients. To participate in a trial that never is made public means that people have risked the harm of the treatment to no benefit.

The Center for Medical Consumers recommends that people refuse to take part in any clinical trial that is not registered before recruitment. At present, the nearest thing to a publicly available registry is www.clinicaltrials.gov This Web site lists government-sponsored trials; it has been criticized for having incomplete information. Some pharmaceutical companies have begun to list their clinical trials on their respective Web sites.

Maryann Napoli, Center for Medical Consumers ©
July 2005

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