It appears the new FDA leadership is not much different than the last administration, as the diabetes drug Avandia killed 304 people in the third quarter of 2009 while the FDA dragged its feet. The scandal is hitting a fever pitch as the New York Times and Washington Post feature stories on a bipartisan Senate investigatory report released over the weekend. It criticizes GlaxoSmithKline for failing to warn patients years earlier that Avandia was potentially deadly. “Instead, G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,” concludes the report, which was overseen by Senator Max Baucus, a Montana Democrat, and Senator Charles E. Grassley, an Iowa Republican.
In reality, the FDA is sitting on several dozen of these big-selling-drug time bombs. FDA management refuses to take action in a timely manner to protect Americans. The logical conclusion as to why the FDA behaves this way is to protect the drug company, in this case GlaxoSmithKline, from a flood of lawsuits. A second reason is that the FDA management knowingly approved a dangerous drug in the first place and now looks inept (which they are) taking it off the market. Back in 2006 the FDA management (headed by cancer biotech kingpin Andrew von Eschenbach) forced their own safety expert to retract the black box warning she wanted to place on Avandia for congestive heart failure. She was then stripped of her power to make such warnings and removed from supervision of the safety of Avandia.
The new FDA commissioner, Margaret Hamburg, doesn’t seem to have a clue. On Friday evening she said she was going to wait several more months until a new advisory committee (typically industry friendly) offered a new opinion on the issue, adding “Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved.” Is Dr. Hamburg willing to be personally responsible for all the needless deaths that occur in the meantime?
The Senate investigation showed that FDA safety scientists conducted a report on Avandia and concluded that it should be removed from the market. Their report was ignored by FDA management, as FDA commissioner Hamburg continues to do. It is pretty obvious that GlaxoSmithKline aggressively marketed Avandia knowing that it injured and killed, reaching peak sales in 2007 of 3.2 billion. When cardiovascular concerns began coming to public light worldwide profits fell, and were just over a billion last year.
The Senators think this problem of drug safety can be solved by placing the safety scientists in their own FDA entity, rather than having their findings overruled by managers who approved the drugs in the first place. While such a change may help, the FDA resists making such a move. I don’t think it would solve the problem.
The only way this problem is going to get solved is if criminal penalties are given to management at Big Pharma companies who knowingly withhold safety data and then Americans die. If they were tried for involuntary manslaughter, as they should be, then this nonsense would stop. FDA managers who overrule safety findings which then result in deaths of Americans should face the same penalty – and then the FDA management, often in a revolving door with the industry it is supposed to be regulating, would stop acting like the best friend of Big Pharma.
Avandia is the tip of the iceberg as far as FDA-approved blockbuster drugs that are injuring and killing Americans. If not for a few Senators trying to look out for the public this information would not see the light of day. The FDA is utterly incompetent at doing the job it is supposed to be doing. It does not need more money to do its job. It needs a legal and ethics overhaul. The next question the FDA should be forced to answer is, “How many other drugs have your safety scientists warned should not be on the market?” And what about the poisoning of our food supply with GMOs - didn’t your scientists warn they were unsafe to eat?