"The 2007 Golden Clipboard Awards"
The 2007 Golden Clipboard Awards is something DrugWonks came up with . . . I guess one person's hero is another person's villain, here are the uncensored but abbreviated views of Peter Pitts:
The Bronze Clipboard: Representative Henry Waxman
A perennial Golden Clipboard contender, Representative Henry Waxman is best remembered in 2007 as the conduit for Steve Nissen’s half-baked meta-analysis of Avandia. His oversight hearing – during which Mr. Waxman was both measured and civil in his handling of all witnesses – 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 FDA’s sound scientific policy towards “non-inferiority” 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.
The Silver Clipboard: Dr. Steven Nissen
Dr. Nissen’s persistent undermining of the FDA came close to winning him Clipboard top honors for 2007. Among many memorable exploits, Dr. Nissen’s most Clipboard-worthy moment was on ABC’s 20/20 program, where he pronounced Avandia to be responsible for “more deaths than 9/11.” A few days later, when asked by Congressman Waxman if he would recommend that doctors take their patients off that drug, he responded, “No.” What’s the frequency, Steve?
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 “conversations.” Setting aside Dr. Graham’s contribution to the Vioxx Populi literature -- which an FDA advisory committee considered to be a rather shoddy piece of research – 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 – the same sort of science that, when it came to Vioxx, he rejected as insufficient.
Dr. Graham is a man on a mission. AKA “Dr. Precautionary Principle,” 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.