For years, the Food and Drug Administration has withheld information about drugs and medical devices from the public when their makers cite trade secrecy — even in cases where the agency suspects that the products are causing serious illness or death. Hopefully, the new leadership at the FDA will change that. The Obama Administration has set up a task force within the agency to recommend ways to reveal more information about FDA decisions, possibly including the disclosure of now secret data about drugs and devices under study.
The task force’s work will be complicated and rather difficult. Agency confidentiality decisions are governed by several interconnected laws, including the Federal Trade Secrets Act. Making all of the needed changes – which will take legislative action – won’t be easy. The goal is to open up a system in which the agency failed to inform the public about health and safety hazards. For example, the public should have been alerted that a widely-prescribed heartburn drug was especially toxic to babies; that a diabetes medicine and a painkiller increased heart attack risks; and that antidepressants increased suicidal thoughts and behavior in children and teenagers. Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who has campaigned for the release of such information, had this to say:
Many people have been harmed over the last decade because the FDA has treated clinical trial results of drugs and devices as trade secrets.
In 2007, Dr. Nissen published a study showing that Avandia, a popular diabetes medicine made by GlaxoSmithKline, increased the risk of heart attack by 42%. The data Dr. Nissen used was made public, but only because of a lawsuit. The FDA had known of the possible risk for nearly two years, but had not revealed that knowledge to the medical community or the public.
Dr. Catherine DeAngelis, editor of The Journal of the American Medical Association, told the New York Times that greater disclosure would allow researchers and publications like hers to help the FDA fulfill its mission. The agency “can’t possibly know of everything going on,” Dr. DeAngelis said, adding, “If they could be more transparent, we could really help them.” Dr. Hamburg and Dr. Sharfstein, in an opinion article in The New England Journal of Medicine signaling the new effort, wrote:
Whenever possible the FDA should provide data on which it bases its regulatory decisions.
The task force will be led by Joshua Sharfstein, the agency’s principal deputy commissioner, and will include other top officials. It will seek outside comment, including the views of supporters of strong protection for trade secrets. The task force is required to submit a written report to FDA Commissioner Margaret A. Hamburg in six months. The New York Times reported in its article:
Trade secrets can include company plans to test experimental medicines, the complete results of most clinical trials, and even the FDA’s reasons for rejecting a company’s application to market a product. Researchers have long complained that keeping such information secret can harm the public. A 2008 study published in The Journal of the American Medical Association found that in the 1990s, five different companies tested similar blood substitute products that were each found to increase the risk of death. Had the findings been made public, the authors argued, some of the companies might have known sooner that their products were dangerous, sparing the lives of some patients in the studies.
Hopefully, the work of the task force will increase the availability of information that the public needs to know about. It’s a worthy undertaking and one that’s long overdue. The new administration is to be commended for making the people’s interest a top priority.
Source: New York Times
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