Thursday, May 13, 2004

Pfizer Paying The Price

A funny thing happened one day during an ethics discussion. I took the side of a pharmaceutical company, whilst all others scorned and snarked. And now this from the WSJ:

A unit of Pfizer Inc. has agreed to plead guilty to criminal wrongdoing, and the pharmaceuticals giant will pay about $430 million in fines in a settlement that will end federal and state investigations into the marketing of the blockbuster drug Neurontin, according to people familiar with the matter.

The agreement, which could be announced as early as this week, represents one of the largest Medicaid-fraud settlements. Medicaid is the federal-and-state program that provides health-care coverage for low-income Americans.


[D]octors have grown accustomed to prescribing it for an array of unapproved, or off-label uses, including migraines, mental illness and a variety of pain conditions. More than 90% of Neurontin prescriptions are off-label, according to recent studies.

Once a drug is approved by the FDA, doctors are allowed to prescribe it any way they see fit. However, a drug maker can market the medication only for the approved use. Getting FDA approvals to market a drug for additional maladies involves costly and time-consuming clinical trials.


Mr. Franklin said Parke-Davis deliberately set out to market the drug to doctors for off-label uses. Parke-Davis used a variety of inducements to get doctors to prescribe Neurontin off-label, including tickets to the Olympics, trips to Disney World and retreats to golf resorts with their families, Mr. Franklin charged.

Mr. Franklin alleged there was little scientific basis for much of the off-label use and that company sales and medical personnel presented a distorted picture of the drug's effectiveness when talking to doctors. In the case of Neurontin for migraines, for instance, Mr. Franklin said the company suppressed the results of a study that found no difference between Neurontin and a placebo in treating the condition. Nonetheless, sales personnel continued promoting the drug for that use, he said.

Pfizer is certainly in the wrong here, but I would argue that said physicians are also to blame. What physician grabs the info sheet from the drug rep, takes his word that said drug is great for off-label use treating migraines, and then starts prescribing it without locating supporting research? I'm the first to scoff @ 'evidence-based' medicine when it compares the newest treatment to hardcore clinical wisdom, but what these physicians were doing is tantamount to prescribing St. John's Wort for treatment of bladder cancer.

Maybe I'm just naive at how things work outside a teaching hospital, but even so, this certainly puts a cloud over the profession with regards to how physicians go about treating patients.

Damnit, now I have to study. How depressing.