Researchers Find Less Than Half of FDA Clinical Trial Results Are Published
Tuesday, September 23, 2008
Researchers have found that less than half of clinical supporting trials for newly FDA-approved prescription drugs were published in medical journals after the drugs were cleared for sale in the United States. The results of the research, which also found that encouraging drug test results were more likely to be published than negative or inconclusive findings, sends a troubling message to drug users and doctors.
If the results of supporting trials on newly approved drugs are not published in medical journals after the drugs have been in use for several years, patients and their doctors have no way of knowing the real-life benefits, risks, and side effects of new drugs. Consumers are left without important information that would allow them and their doctors to determine which drugs might be best for them.
Study Focuses on 3 Years of Approvals
Medical researchers at the University of California, San Francisco announced their research findings on September 23, 2008. The study focused on 90 new-drug approvals and 909 supporting clinical trials performed for those drugs during the three-year period from January 1998 to December 2000. The researchers then linked those new-drug approvals to the results of supporting trials published in medical journals within five years of the drugs being offered on the market.
The results were not encouraging. Of the 909 supporting clinical trials, only 394 had results published within five years after they were approved. That’s just 43%, hardly a passing grade.
Post-Consumer Studies Not Being Published
The study found that results of pivotal Phase II and Phase III trials, which are designed to determine the overall risks and benefits of a drug before it is approved, were published about 76 percent of the time. In most cases, the study results were published in medical journals within three years of the FDA approval, according to the researchers.
However, supporting trials of approved drugs after they have been on the market were only published within five years of the approval less than half the time.
Publication Bias Noted
The researchers also found that supporting trial studies which reached positive results about a drug’s performance were more likely to see the light of day than studies that came to negative conclusions or found that the new drug was no more effective than older drugs already on the market. When evidence of under-performing drugs is not published and only new drugs that outperform existing drugs are made public, medical journals contain an inaccurate record of medical literature. Physicians and patients who do not have all the facts will tend to favor the new, more expensive drugs, the study found.
FDA Now Requires Publication of Results
The FDA Amendments Act of 2007 was intended in part to improve the accuracy and completeness of drug trial reporting. The law requires that all trials supporting FDA-approved drugs be registered when they start and that all outcomes must be posted within a year of drug approval on the U.S. National Institutes of Health's clinical trials web site.
The law was not yet in effect and did not apply to the drug trials studied by the California university researchers.
Published Results are Essential to Consumer Safety
With so many prescription drugs now available to consumers, having all the information about a drug’s risks and benefits is essential in making decisions about which drug to use. Only when consumers and their physicians have all the data about a newly approved drug and how it compares to other drugs on the market can a truly informed treatment decision be made.
Posted under: Dangerous Drugs