1 Boring Old Man

My posts last week were meant to be a prequel to this one. In clinicaltrials.gov revisited… and drugs@FDA visited…, I tried to present a simple outline of the two agency online windows into the world of clinical trials for anyone who hasn’t already explored them. And in clinical trials visited again… and clinical trials – concordance…, I wanted to frame the giant loophole in our system of evaluating clinical trial data. Those posts were in anticipation of my being part of an initiative that I think might really help us get something done about finally plugging the loophole.

Back in May, in commenting here on why is that?…, Dr. Bernard Carroll had a spark of an idea about something that could lead us out of the morass of confusion and corruption that surrounds the industry-funded clinical trial reports that contaminate our literature and medical practices. In June, he expanded that initial comment into a blog post on Healthcare Renewal [see CORRUPTION OF CLINICAL TRIALS REPORTS: A PROPOSAL]. Over the summer, there’s been a lot of back and forth on this proposal and I’m grateful to be a part of the group that’s formed around deciding how to proceed. Also included in the group are John H. Noble Jr., a noted academic and longtime advocate for honesty in science and clinical trials, and Shannon Brownlee, well-known author, activist, and journalist, now with the Lown Institute and its Right Care Movement. Working through the Lown Institute, today we are launching a petition on Change.org designed to get this gaping loophole in government oversight and  the proposed solution into the place where it belongs, the United States Congress. Let me repeat that:

… TODAY WE ARE LAUNCHING A PETITION ON CHANGE.ORG DESIGNED TO GET THIS LOOPHOLE IN GOVERNMENT OVERSIGHT AND THE PROPOSED SOLUTION INTO THE PLACE IT BELONGS, THE UNITED STATES CONGRESS.

^{[click the ostriches to see and or sign the petition]}

"A Specific Proposal

We now petition Congress to require the FDA and NIH to coordinate their monitoring and sharing of key information through ClinicalTrials.gov. Working together, the two agencies could enable stakeholders to verify whether purported scientific claims are faithful to the a priori protocols and plans of analysis originally registered with the FDA. Publication of analyses for which such fidelity cannot be verified shall be prohibited unless the deviations are positively identified (as in openly declared unplanned, secondary analyses). This prohibition shall include scientific claims for on-label or off-label uses made in medical journals, archival conference abstracts, continuing education materials, brochures distributed by sales representatives, direct-to-consumer advertising, and press releases issued by companies or their academic partners. It shall extend to FDA Phase 2, Phase 3, and Phase 4 clinical trials. By acting on this petition, Congress will create a mechanism for stakeholders independently to verify whether inferences about clinical use suggested by the unregulated corporate statistical analyses can be trusted."

Even though petitioning Congress may seem like a long shot, this is the right time to take it. There is a general outrage at the behavior of the pharmaceutical industry over disreputable practices including clinical trials. The FDA, NIH, and clinicaltrials.gov just last week released their own planned reforms [see a blast off…]. And while they didn’t plug the giant loophole, their reforms will help [and they telegraph a willingness to go after a solution]. But as I said in clinical trials visited again…:

If our experience with previous reform efforts [particularly clinicaltrials.gov] has taught us anything, it’s that we need a mandate from Congress, the law of the land, behind any moves forward. An Act of Congress. And this petition is a first step in that direction.