Friday, October 28, 2005

Stranger than Fiction?

"That's a nasty hack - you better take some medicine for it!"
The Puffington Host already had this, and Sploid picked it up from there, but I don't know if all of my reader(s) would see it there. In short, a guy was hired by PhRMA to write a thriller about adulterated drugs from Canada, poisoned by nasty swarthy types. The plug was pulled, and PhRMA's management claims ignorance about this project, set up by a "lower-level employee who acted without authority." The juicy part at the end of this? The book is coming out anyway, supposedly with a drug company behind the poisoning conspiracy! Bitchin! Pre-order today!

The plot thickens....
A reader asked me about possible plot holes in "The Constant Gardener," and I'll try to reply. How can a company hope to market a drug that quickly maims or kills a number of patients? The answer depends on what the drug is for - how deadly is the disease you're trying to cure? Specifically, in the movie the drug is being used for tuberculosis, and there are hints that the drug just needs "fine-tuning" before it can be submitted to regulatory authorities for approval. This is only conceivable if the "fine-tuning" has to do with finding the optimum dose range for the drug. You can't just muck about with the molecule, adding or removing an atom here or there to make it safer. Not yet, anyway. The closest I've seen to that sort of chemistry is to take an isomer of a drug, and to market it as a different compound, after testing. See this article for a good description, and some examples. An example of a film with an outlandish plot revolving around a bad drug, see "The Fugitive" where a drug ("Provasic" - great name!) to clear out blocked arteries was destroying patient livers. This drug would have been pulled within a few months after launch - it made no sense to hide such deadly effects during the trials, since the costs of pulling the drug off the market, with all the associated lawsuits and bad publicity, would be far more than just cutting your losses during clinical trials, and canceling the program. The truly paranoid just don't get that - we can't hide all the dead bodies, you know.

Wednesday, October 26, 2005

What...Me Worry??

I had to take an annual compliance training courseonline today. It was the first time that I had evernoticed that it referenced bad acts by drug companies. For example, during the discussion of theAnti-kickback statute, it mentioned that "there hadbeen a number of high-profile case of pharmaceuticalcompanies..." who had violated various parts of theact. It also referred to "the corrupting influence ofmoney and gifts to the prescriber." I wonder how manyreps were able to to hear that with a straight face? After all, money and gifts to prescribers were theirbread and butter up until quite recently, andarguably, it still is. How else to bag the attentionof physicians on the go, if not for lunches anddinners? "I think you know my position on free food."- Kevin Costner, "The Upside of Anger"

Be Afraid...Be Very Afraid...of what?

A fabulous article that everyone should read appears in the NY Times today. Relative risk, folks. Thisarticle is for all of you idiots who stop using thesubway because you're afraid of terrorists, andinstead drive to work. Everyone I know needs a crashcourse on the statistics of harm (and lotteries too,but that's a topic for another day). Halloween isalso a good time to visit, not to mentionthe Department of Justice crime statistics. Acolleague of mine said today, "You just can't let kidsgo out trick-or-treating these days, like you couldwhen we were kids." Baloney. If it was safe ageneration ago, it's safe now. Our neighborhoods areno more infested with undesirables than they ever were- it's just that we can find out who they are, thanksto Megan's laws.

Monday, October 03, 2005

God bless the First Amendment

God, I am so screwed....(see above)

But I love my granny....

Merck has tried an interesting line of defense, though suitable only for public consumption. The Philadelphia Inquirer reported yesterday that several key executives have revealed that immediate family members of theirs took Vioxx, in an attempt to dissuade the casual non-thinker that the executives are, in the words of Opus, "Incompetent fibbing poopyheads."

This sort of thing is not admissable as a defense, because it assumes a) that Raymond Gilmartin did not intend to kill his wife, and b) that they didn't decide to take their chances just to avoid the $10 co-pay. In other words, there are lots of reasons someone might choose one drug over another.

Meanwhile, clean arteries.

The AP reports that the cardiologist who treated the plaintiff in the Atlantic City Vioxx trial had clean arteries, in the "top 5%." The stories do not mention who the physician was testifying for - the plaintiff, or the defense. This news indicates that the pool of possible plaintiffs might be smaller than just anyone who had a heart attack while on Vioxx, if they've also got some artery clogging. The goal of the plaintiffs is make Vioxx the proximate cause of the injury, and the evidence shows that it increases the risk of heart attacks, not plaque.