The lawyers are out to feed on the Avandia fiasco. It never fails. When a drug’s properties are revealed in phase 4 studies, or the manufacturer covered up some important information, the adverse effects become too visible to be “swept under the rug”. The thing that amazes me is the motive behind it all. I’ve been asked by patients, peers and non-pharmacy friends how this could happen. My answer: “Greed”.

It’s now known that there were problems uncovered in the clinical trials. These issues were buried when FDA approval was sought. Why? Well, it became a numbers game. It’s always about the numbers. Risk versus benefit. Profit over liability. In this case, Glaxo Smith-Kline (GSK) rolled the dice and may well come out ahead…even with the lawyers seeking compensation on behalf of their clients.

Make no mistake, lawyers are starving for cases and for jobs, just like the rest of the country. When a bleeding “big fish” (GSK) comes along with liability issues, it’s like chum in the water and invariably, the sharks are going to be circling for a piece. What I don’t think these personal injury attorneys realize is that the attorneys working for GSK can win this without ever going to trial. Avandia has issues, no doubt about it; however, to prove that it caused these problems is going to be very hard. Just one risk factor for heart disease will cause a shadow of a doubt which could legally cause the case to be thrown out. As a result, the liability expense will be reduced. GSK will probably feel the sting in punitive damages from the FDA for falsifying data to facilitate approval, but with intense lobbying and donations, these punitive fines will be blip on their balance sheets.

Forgetting the lost lives will be another issue. I sincerely doubt whether this is even a thought when approval is sought for a drug with clinical issues. And I’ve heard the opposing argument too – where the benefit outweighed the risk of no treatment, but in this case, Avandia was not the only drug on the market in this class. Also, the marketing information fed to physicians was tainted with misleading or absent facts. This is where GSK may feel their greatest pain – in losing the physician’s trust. And if you sense a deja vu feeling coming on, remember the Vioxx fiasco by Merck? That company is still reeling from litigation and mistrust. It seems that GSK didn’t learn that lesson from Merck.

Pharmaceutical manufacturers must realize that putting the patient first in thought and deed will be more rewarding in the long run; however, with Wall Street’s fickle memory lasting just a few quarters, they roll the dice again on the next new imperfect drug that will add more black than red to the bottom line.

Until next week, stay healthy.

Dion