Making Government Transparent and Accountable
The Sunlight Foundation uses cutting-edge technology and ideas to make government transparent and accountable. Underlying all of our efforts is a fundamental belief that increased transparency will improve the public's confidence in government
The Sunlight Foundation Blog
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How Congress and Special Interests Kept Clinical Trial Data Secret
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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Lunchtime Link Round-Up
Some open government/transparency posts from around the web:
The Food and Drug Administration, in conjunction with their Transparency Task Force, launched a transparency blog to discuss ways to make their operations more open to the public.
The White House is asking for more help on the Open Government Directive. They are looking for people to tell them the “three most important pieces of information you think every agency should be required to disclose about its operations.” Also, they are seeking input on how the private sector could help the government mash up data.
Utah launched a new state government web site that looks very cool. Let us know in the comments what you think about this as a state government portal.
And in today’s least surprising news, contracting in Iraq is plagued by a lack of oversight and corruption.
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FDA Creates Transparency Task Force
Following up on President Obama’s January 21 memo requiring agencies to promote transparency and openness, the Food and Drug Administration (FDA) has created a Transparency Task Force to create recommendations to make the FDA more open and transparent. The largely secretive process of review and approval for drugs and medical devices is garnering the most attention as any attempt to open up this process would greatly affect thousands of corporations and the entire American public.
The FDA has had serious problems in disclosing problems with medications, over-the-counter drugs, and devices to the public with troublesome results. The New York Times writes, “the goal is to open up a system in which the agency failed to inform the public 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.”
This transparency effort may be one of the more important ones for the administration, as most Americans rely on the FDA to provide accurate information as to whether a drug or device is not to be used, or what dangers may exist. An FDA that does not have the trust of consumers would assuredly cause increased risks in health decisions and lead to profit loses for companies manufacturing drugs and devices. Transparency is essential to instill trust in this area.
If the recommendations do include more transparency for drug and device reviews Congress would likely have to change laws that govern confidentiality at the agency. As the Times notes, passing a bill through Congress that the pharmaceutical industry has a great interest in derailing would be a difficult task.
The pharmeceutical industry spent a little more than $29 million on campaign contributions during the 2008 election cycle. The industry only spent more on campaign contributions in the 2002 cycle when Congress debated a bill to provide prescription drug coverage through Medicare. The industry spent a combined $234 million on lobbying in 2008 and has already spent $66 million this year. Any effort that is opposed by the pharmaceutical companies would have to overcome this juggernaut of political influence.
Transparency at the FDA is instrumental to a healthy and consumer confident country. The task force should ensure that the American consumer is readily and well information about the products they use.
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The Feds Embrace Social Media
Last week Doug Belzer at Federal Computer Week has an encouraging article about how Twitter, blogs and other Web 2.0 tools are revolutionizing government business. Belzer writes how government managers and elected officials are using social media to network and collaborate online, quickly connecting with audiences like never before.
“If they’re looking for information about an obscure contract vehicle, they can post a message on a messaging service such as Twitter and see if someone can help them learn about it,” he writes. “Or if they run across a particularly useful piece of information on a community-created Web page, they can give it a high rating so others can find it easily in the future.”
Belzer gives five examples of how bureaucrats have used social media “to take care of business,” contrasting this new and effective strategy with how they would have approached the project or problem before Web 2.0 tools were available and in use, with less impressive results.
One of Belzer’s examples, as a un-recovered peanut butter fan, is near and dear to my heart. When salmonella-tainted peanut butter was found in a number of food products, it was the responsibility of the Centers for Disease Control and the Food and Drug Administration to get the word out about the recalls. In the past, the agencies would attempt to raise the alarm by employing press releases, posts on Web sites, toll-free telephone lines, but the agencies never knew how effective these efforts were at alerting the public. But with this emergency the agencies are using Web 2.0 tools, such as a widgets, blogs, Twitter feeds and other social networks, as well as other social media outreach efforts. The CDC first offered their peanut-butter widget in early February. And since then, Belzer reports, about 16,000 sites, including newspapers, health agencies and personal Web sites, posted the widget, resulting in more than 6.8 million views. “That viral effect is really pretty amazing,” he quotes a CDC information officer as saying. “The reach of the widget grows exponentially.”
The promise of Government 2.0 is just beginning to dawn.
