Pharm Fox in the Health Henhouse!

In a last minute announcement under the Bush administration, one that leaves consumer advocates stunned,

our FDA (Foolish and Deteriorated Abysmally) has passed a ruling that allows pharmaceutical companies to directly market off-label (translation: unapproved) uses of drugs to doctors. The caveat that’s supposed to make this all okey-dokey (per the industry) is that marketing for unapproved uses must be done by handing out published studies from peer-reviewed journals that report conflicts of interest. Keep in mind, the exact phrase is: journals who “report” conflicts of interest, not BAN conflicts of interest. The Pharm news this year has been rife with reports of journal articles that are (yes, indeed) ghost-written by pharmaceutical companies, (here and here and here) and by horrific stories of researchers who out and out lied about the amount of money they were receiving from Big Pharm. It took a lone Republican Senator, Chuck Grassley (and his trusty six-shooter subpoena) to get some of them to finally admit to

the obscene amounts they were receiving under the table. Prominent researchers at Emory, University of Texas and Harvard Medical School were among those cited.

Given all that, how likely does it seem that these “studies” are an effective check and balance on the marketing of unapproved uses? Do I see any hands? Anyone?

But some of you may be asking – exactly why are unapproved, or off-label, uses of drugs so bad? Don’t they – like the drug companies claim – save the lives of people with incurable diseases? Um. No. If an amazing new, curative drug-use for a lethal disease is discovered, you don’t really have to market it. Not even by hand-passing-out “studies.” Heavy, expensive marketing is used for those problems and diseases (usually non-lethal) where nothing much works all that well – including the drug that’s being pushed. Check out what you see advertised on TV for a little slice of what I’m talking about. Doctors, in general, will all tell you that this marketing doesn’t work on them (“maybe on other doctors, but not me”) – despite numerous well-done, verified studies that prove pharm doctor-marketing is extremely effective. Even more convincing to me is the willingness of profit-rabid drug companies to fork over hundreds of millions for it – now there’s a litmus test for effectiveness if there ever was one. If you want a chilling overview of just how slimy, dangerous and effective the off-label ILLEGAL marketing of drugs was (even before this FDA Fox-In-The-Henhouse ruling), check out this very recent, succinct article about Eli Lilly’s $1.4 billion (yes, that’s a B – billion) dollar settlement for off-label marketing of the drug Zyprexa. Make sure you read all the way to the bottom of the article, where you’ll find that this whopper of a penalty doesn’t even come close to denting the $4 billion (yes, that’s another B – billion) dollars a year they made off this one drug.That’s just one example – and others abound.

All of which begs the question: If you were a rapacious drug company (some would say that’s a redundant phrase, but bear with me) and you can get all that mucho-money (even after the penalty), and now  marketing with sham studies is legal, why would anyone, ever, actually get a drug tested and verified as safe and effective? All you need is a low-paid ghost-writer, a researcher with queasy ethics, and some reps to hand out “studies.” Heck, why even have an FDA – let’s just go back the thalidomide days (shudder). Unless, that is, the in-coming administration might actually, in these darkened days where we all sit huddled together (heck, my feathers are ruffled!), step up and lock the door to our healthcare Henhouse. Let’s all hope for a new FDA (Fox Ditching Ahead).

Is there any clear sign that this might happen – that the corporate strangle-hold on even sane regulations might be weakening? As this recent article reports, Dr. Sidney Wolfe, a vocal critic of the FDA, was appointed in October to the FDA’s Drug Safety Committee. The Wall Street Journal says this is a move that has left industry insiders reeling from the potential fall-out. Hmm…do you think they should take Zyprexa for that?