1. They switch standards of evidence based on what is politically expedient. Now meta-analysis is the gold standard for drug safety. That, and non-peer reviewed, noncomparable observational data of the drug not in question that appears safer than the drug you want to yank. But before that, short term data was insufficient. Question to David Graham and the media: would they accept from Aventis safety data on Ketek of the type and quality Graham introduced about Actos? Squirm out of that one you weasel. Oh, and that statement about metformin. I do recall a black box on that one regarding heart failure. It's ignored because of the same sort of observational data you dismissed about Avandia.
2. Let's see where the FDA Adcomm comes out on Tysabri and Crohn's Disease. Clinical trials show that this is a fast acting drug for a horrible illness with no cure. It has the same PML risk for folks with MS. It is already being used off-label. FDA staff (a different division) have issued CYA briefing papers and the media have already sent up the fear flags. Come on guys, you are all smart and excellent writers AND the public does depend on you.
3. Let's see where Nissen and the rest stand on all the lawsuits that will still be pursued. Will Furberg offer his services as an expert witness in such cases as he has in Rezulin and Zyprexa. Will the Government Accountability Project that Furberg advises and makes its money from such litigation go head and sue? What about the Prescription Project, all tort lawyer funded, which Furberg, Avorn and others have ties to? What about SKAPP at GW which is funded by breast implant lawsuit settlement money?
4. The tort lawyer -- public health purists connection is worth pursuing. First in terms of how the purists are corrupting science and seeking to hijack the FDA to undermine its authority -- all to the benefit of the tort bar. Second, in terms of the public health havoc it has wreaked. Let's stack up the death and suffering from the snap judgements and sound bite prescriptions Nissen, Avorn, Angell, Wolfe, Psaty, etc have peddled to the media through willing tabloid medical journals in the areas of women's health, pain, heart problems, depression, and diabetes. Let's look at the grand experiments they have gotten the government to pay for -- ALLHAT and CATIE -- and what the impact they would have had on human well-being -- and how proposed plans for comparative effectiveness would have in the future.
4. The body count -- teen suicides, increased heart attacks, more blindness, shorter lives (thanks to government formularies) because they have undermined science to the goal of screwing drug companies because the make money is considerable. These self-annointed regulators and health care policy elites should be held accountable for the chaos and carnage they have caused and will cause.
None of this will stand. The battle will be joined with renewed vigor. I follow the Patton approach: "Attack rapidly, ruthlessly, viciously, without rest, however tired and hungry you may be, the enemy will be more tired, more hungry. Keep punching."