Yes indeed, we must give credit to Mr Reich, who writes for the American Prospect. In his article about the perverted juxtaposition of tort reform for companies who follow FDA regs for their products, and the poor quality of FDA oversight at the office of Drug Safety, Mr Reich echoed my blog of December 27 ("Pfizer Exec tells all"). Except that he wrote his article on the 22nd. Like John Kerry, we have written to the American Prospect to offer our concession. And to ask that they link to Pharmablogger. T.A.P. ROCKS!!
For a different tale of Drug Safety, we offer you a link to an article in The New Yorker concerning the testing of drug in pediatric populations. The article is long, and makes several important points. We would like to focus on the idea that any drug under consideration for approval should be highly scrutinized in vulnerable populations for safety, and indeed we have seen this for the hepatically impaired in recent years. Liver failure has been one of the most common reasons for drug withdrawals or non-approvals (see Duract and Exanta). The Duract example is good because no one could get doctors to stop over-prescribing that drug. You have to wonder, does a company in that position really try to get a warning message across, right down at the sales rep level, even when the FDA is breathing down their necks?
Anyway, we would expect that real pediatric studies would be expected for whoever brings forth the next anti-depressant, based on recent bad publicity of Paxil and other SSRIs (studies in which no one actually committed suicide, but had events coded to the term "suicidal ideation"). This is still a scattershot approach, however. Scrutiny will only be brought to bear on the categories of drugs that have already been demonstrated to be a hazard.
Lastly, for our daily dose of re-importation nonsense, see this article from CIPA, a Canadian mail-order pharmacy group, that contends President Bush is behind a new effort by the Health Ministry to shut down shipments to US addresses. We love the way they make us sound like an underprivileged country in this bit:
"Dosanjh (health minister) drafted the new regulations that, if implemented,will make it illegal for Canadian mail-order pharmacies to fill prescriptions for non-citizens, and leave millions of Americans without access to affordable medications."
Oh wait, I forgot. For health care coverage, we ARE a third world country.