How Congress and Special Interests Kept Clinical Trial Data Secret

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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.)

Watch the video to hear Patrick-Lake’s story in her own words:



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.

Did the device alleviate migraines in test subjects? Did any test subjects report side effects? Is the device that was implanted in Patrick-Lake’s heart a boon or an extraneous foreign body? Right now, she has no way of knowing. While she considers herself cured of her migraines, further tests showed that the device had not completely closed the hole in heart, leaving her vulnerable to strokes. To remove the device would require open heart surgery.

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. Members of the House and Senate rushed to vote on the bill with little time to note the change. (This is exactly why we believe that Congress should post bills online for at least 72 hours before debate, so we all have time to read legislation.) 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.”

This multi-media investigation is  part of a new series highlighting cases of secret government data that affect the public. Read our feature to get all the details.

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