Dr. Weeks’ Comment: the welfare of the patient is not the highest concern for Big Pharma nor for the regulatory boards who are charged with protecting the patient.
Feds found Pfizer too big to nail
- Pfizer sales representatives illegally marketed painkiller Bextra
- Companies convicted of major health care fraud are excluded from Medicare, Medicaid
- Federal authorities allowed Pfizer subsidiary to plead guilty in fraud case
CNN’s Special Investigations Unit reveals internal company documents on Bextra and Pfizer’s health care fraud. Watch at 3 p.m. ET Saturday on CNN.
(CNN) — Imagine being charged with a crime, but an imaginary friend takes the rap for you.
That is essentially what happened when Pfizer, the world’s largest pharmaceutical company, was caught illegally marketing Bextra, a painkiller that was taken off the market in 2005 because of safety concerns.
When the criminal case was announced last fall, federal officials touted their prosecution as a model for tough, effective enforcement. “It sends a clear message” to the pharmaceutical industry, said Kevin Perkins, assistant director of the FBI’s Criminal Investigative Division.
But beyond the fanfare, a CNN Special Investigation found another story, one that officials downplayed when they declared victory. It’s a story about the power major pharmaceutical companies have even when they break the laws intended to protect patients.
Big plans for Bextra
The story begins in 2001, when Bextra was about to hit the market. The drug was part of a revolutionary class of painkillers known as Cox-2 inhibitors that were supposed to be safer than generic drugs, but at 20 times the price of ibuprofen.
Pfizer and its marketing partner, Pharmacia, planned to sell Bextra as a treatment for acute pain, the kind you have after surgery.
But in November 2001, the U.S. Food and Drug Administration said Bextra was not safe for patients at high risk of heart attacks and strokes.
The FDA approved Bextra only for arthritis and menstrual cramps. It rejected the drug in higher doses for acute, surgical pain.
Promoting drugs for unapproved uses can put patients at risk by circumventing the FDA’s judgment over which products are safe and effective. For that reason, “off-label” promotion is against the law.
–Mike Loucks, federal prosecutor