And that gave us an idea â€“ a new award for those who impede (unwittingly or otherwise) the advance of medical progress -- "The Golden Clipboard."
Herewith our 2007 honorees â€¦
Honorable Mention: Representative Rosa DeLauro
An honorable mention goes to Representative Rosa DeLauro for her perplexing efforts to embog the work of the Reagan/Udall Critical Path Foundation. Ms. DeLauro has demonstrated a remarkable lack of understanding of the science of drug development and the purpose of the Critical Path in general. She has stated: â€œI believe the Reagan-Udall Foundation has the potential of endorsing the approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials. The Foundation could play a significant role in recommending the use of biomarkers and other measures that may not be true measures of efficacy.â€ This is all the more surprising and concerning considering the fact that Ms. DeLauro chairs the appropriations subcommittee that funds the FDA.
We hope that Ms. DeLauroâ€™s tenacity towards improving the FDA and passion for protecting the public health can be harnessed and redirected to better purposes in 2008.
The Bronze Clipboard: Representative Henry Waxman
A perennial Golden Clipboard contender, Representative Henry Waxman is best remembered in 2007 as the conduit for Steve Nissenâ€™s half-baked meta-analysis of Avandia. His oversight hearing â€“ during which Mr. Waxman was both measured and civil in his handling of all witnesses â€“ helped blow out of all appropriate proportion fear about drug safety in general and Avandia in particular. He also had a direct hand in undermining the FDAâ€™s sound scientific policy towards â€œnon-inferiorityâ€ trials for new antibiotics. The unintended (but not surprising) consequence is that several important antibiotics have been delayed or shelved. Congressman Waxman (we assume, again, unintentionally) helped to politicize the FDA by paving a separate and old score-settling path for those within the agency who disagree with scientific consensus.
In addition to his role as Congressional Oversighter-in-Chief, Mr. Waxman is one of the most knowledgeable members of Congress when it comes to how the FDA works and what it needs to succeed â€“ and we look forward to his efforts to help the agency pursue its mission of both protecting and advancing the public health in 2008.
The Silver Clipboard: Dr. Steven Nissen
Dr. Nissenâ€™s persistent undermining of the FDA came close to winning him Clipboard top honors for 2007. Among many memorable exploits, Dr. Nissenâ€™s most Clipboard-worthy moment was on ABCâ€™s 20/20 program, where he pronounced Avandia to be responsible for â€œmore deaths than 9/11.â€ A few days later, when asked by Congressman Waxman if he would recommend that doctors take their patients off that drug, he responded, â€œNo.â€ Whatâ€™s the frequency, Steve?
Regularly positioning himself as â€œDr. Transparency,â€ Dr. Nissen regularly neglected to come clean about his various consulting arrangements, conflicts and clinical trial activities. That, and his public flailing of drugwonks.com as â€œvile,â€ earns him this yearâ€™s Silver Clipboard and (at least hopefully) removes his name from any plausible consideration for FDA Commissioner anytime in the 21st century.
AND THE WINNER OF THE 2007 GOLDEN CLIPBOARD GOES TO
(Drum roll please â€¦)
2007 Golden Clipboard Winner: Dr. David Graham
David Graham ostensibly works for the FDA -- but he seems to spend a lot of time in the Halls of Congress advising members and staff about which FDA medical reviewers should be hauled in for polite â€œconversations.â€ Setting aside Dr. Grahamâ€™s contribution to the Vioxx Populi literature -- which an FDA advisory committee considered to be a rather shoddy piece of research â€“ he also helped push through the statistical analysis and organize the public outcry over SSRIs that resulted in a decline in antidepressant use and a corresponding increase in teen suicides. Graham still maintains that the lipid-lowering drug Crestor should be off the market despite the fact that it has recently received new indications for treatment of fatal heart diseases. And his assertion that Avandia should be taken off the market because an observational study showed that another drug was safer and more effective was both shoddy science as well as remarkably insouciant since he relied on observational data that did not have safety as a primary endpoint â€“ the same sort of science that, when it came to Vioxx, he rejected as insufficient.
Dr. Graham is a man on a mission. AKA â€œDr. Precautionary Principle,â€ he wants the FDA to use meta-analysis to generate safety signals early and often, and stop the clinical testing, prescribing and marketing of medicines until all such signals are explored using large scale randomized clinical trials that use safety as a primary endpoint. In short, he wants fulfillment of his vision at the expense of human life and medical progress.
For his persistence, zeal, and determination to damage not only the FDA but the public health, for his effectiveness in fear mongering and willingness to subordinate medical progress to his ascetic view of safety, we award Dr. David Graham the 2007 Golden Clipboard Award.