Sunday, September 27, 2009

A $2.3 Billion Dollar Boo-Boo

Here's my hypothesis about Pharmaceutical Companies...

Clearly, there is a major discrepancy in their level of "ethical behavior" before they get FDA approval vs. after. Pfizer just had to pay out $2.3 Billion dollars for "mis-marketing" the painkiller Bextra... which seems pretty steep to me (although admittedly I don't know crap about pharmaceutical annual profits). This is a result of some scam they cooked up to market an approved drug in an unapproved way. Of course they knew they'd get fined... but I'm assuming they figured that their fines would be off-set by the amount of revenue they could generate from the mis-marketing before they got wrapped up in litigation... if that ever occurred. I guess Obama got 'em good this time.

Now I've spent the last 3 years working VERY closely with tons of pharmaceutical companies, including Hoffman La-Roche, Eisai, Solvay, AstraZeneca, Sucampo, Cardiokine, Osiris, Debiopharm, Sanofi-Adventis, Johnson & Johnson, Takeda, and others. These are all considered "top" pharm companies. In my experience on the research side, I have honestly and truthfully NEVER seen anything that I considered unethical or questionable behavior. In fact, I have seen numerous examples of "over-cautiousness" by the project team managers, medical directors, etc... to the point of annoyance. Meaning that they have made me obtain waivers, submit protocol violations, and drop patients off the study medication at the first sign of ANY side effect. Do you know that if your patient is enrolled in a pharmaceutical study for a GERD medication and they slice their finger accidentally while chopping tomatoes at home, that MUST be reported as an "adverse event". EVERY adverse event has to be submitted to the pharmaceutical company and the institution's IRB for review and approval. I've had to have "meetings" with top dogs in the pharm company because I had patients who forgot to fill out their medication diaries correctly, or because after page 17 the informed consent was signed in blue ink instead of black (the pen ran out of ink??), or because my patients threw their empty med bottles away instead of returning them for count verification.

Anyway, my point is that in the research phase pharmaceutical companies are hyper-diligent... but when it comes to the marketing phase they've somehow managed to throw their ethical behavior out the window. Which leads me to believe that they clearly know what they're doing from day one.... and that all their pretenses about "ethics" are just to get the damn FDA approval. Duh.

That being said... Pharmaceutical companies are, in fact, a business. And although unethical, drug-rep promotion of a drug is just that. DRUG-REP promotion. It is the PHYSICIAN'S job to look at a drug and say "hey this is approved by the FDA for condition X only. Maybe I should look into this a little more before I prescribe it for condition Y just because the drug-rep "unofficially" said it was ok". Everybody's looking for someone to blame.

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