The FDA Guerillas of Wonky DrugWonks - Part II

However, on July 24, 2008, Pharmalot’s Ed Silverman reported on data just released by the Agency for Healthcare Research and Quality, a unit of the US Health and Human Services Department that showed antidepressant prescriptions rose in 2005.

“The increase amounted to roughly 10 percent, and that occurred in a year in which new and controversial Black Box warnings were added to the labeling on the medications,” he wrote.

In addition, government statistics for 2005, the year the warnings were added, show there was no increase in suicides. In fact, suicide deaths were down in all age groups. For children aged 5 to 14, there were 285 in 2004, and 270 in 2005. In young people aged 15 and 24, the number of suicides was 4,316 in 2004, and dropped to 4,139 in 2005.

Much more evidence can able found in blogs beginning on December 10, 2007, which was another a memorable day at CMPI, when Mr Pitts announced that CMPI would present a new award called "The Golden Clipboard," to those "who stand in the way of medical progress."

Those "who stand in the way of medical progress," refers to persons involved in exposing the FDA’s failure to protect the public from drugs such as the diabetes drug Avandia, Vioxx, and SSRI antidepressants, due to cozy relationships with the makers of the drugs.

CMPI published the names for the top award, and the runner-up winners of the Bronze Clipboard and Silver Clipboard on DrugWonks on December 21, 2007, along with comments about why they were chosen.

The highest honor went to Dr Graham: "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."

"David Graham ostensibly works for the FDA," Mr Pitts said, "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," he explained.

Mr Pitts also credited Dr Graham for "his assertion that Avandia should be taken off the market," and said, Dr Graham is AKA (also known as) “Dr. Precautionary Principle.”

The Bronze award went to California Democratic Congressman Henry Waxman, who "is best remembered in 2007 as the conduit for Steve Nissen’s half-baked meta-analysis of Avandia," Mr Pitts pointed out.

His oversight hearing "helped blow out of all appropriate proportion fear about drug safety in general and Avandia in particular," the blog said.

Dr Nissen had to settle for the Silver Clipboard, but his "persistent undermining of the FDA came close to winning him Clipboard top honors for 2007," Mr Pitts pointed out.

Many of the blogs leading up to the awards seemed to indicate that Dr Graham, Dr Nissen and Rep Waxman were locked in a tight race. But a review of all the blogs on DrugWonks clearly showed that Senator Grassley was never ruled out as the top contender.

 1  |  2  |  3  |  4  |  5  |  6  |  7