New report on undisclosed clinical trial data

Nancy Watzman, How Congress and Special Interests Kept Clinical Trial Data Secret, Sunlight Foundation, October 28, 2009.

Meet Bray Patrick-Lake, a 39-year-old mother of two and director of a Colorado nonprofit serving the homeless. In 2008, she volunteered for a clinical trial, regulated by the Food and Drug Administration, testing a medical device designed to close a hole in her heart, in hope of putting an end to the migraine headaches that were ruining her life. Three months later, she found out over the Internet that St. Jude Medical Inc., the manufacturer of the device, had terminated the study. (Read all the details here.) …

Now Patrick-Lake can’t find out the results of that clinical trial. That’s because pharmaceutical and medical device industry lobbyists—including those representing St. Jude Medical, Inc. and its trade association, AdvaMed—convinced Congress in 2007 to insert a last-minute provision in the Food and Drug Administration Amendments Act that allows medical device manufacturers to withhold data disclosure to a public government database, ClinicalTrials.gov, when their products fail to make it to the market. …

For the lobbyists and members of Congress, it was business as usual in Washington. The lobbyists got a few phrases changed in a lengthy bill—phrases that would have required public access to results of clinical trials that did not lead to an approved medical device or drug. … For Patrick-Lake, Washington’s standard operating procedures have left her—and the public—in the dark about the device in her heart.

What is true for Patrick-Lake is true for the thousands of people who volunteer for studies of drugs or medical devices every year that companies for one reason or another do not bring to market. What industry claims is proprietary information could be useful to doctors and patients as they decide what sort of treatment is best for any number of conditions. As Steven Nissen, chairman of the cardiology department at the Cleveland Clinic, says, “If you expose human beings to an experimental treatment, the public has a fundamental right to see the results of those experiments.” …