Pfizer exaggerates Drug Studies

To get a drug approved for use for a specific disease or condition takes years of critical studies which must convince the Food & Drug Administration (FDA) that the drug works well for the purpose it is meant to be used for. This is an arduous process, as it should be.

But sometimes a drug will be prescribed by doctors for off-label use. That's when a study shows the drug is actually useful for something the FDA has not approved its use for. For instance, a drug approved for fever and headache use might be found to be effective for reducing swollen joints. The company cannot advertise the drug is good for the off-label purpose (reducing swollen joints), but doctors are not prohibited from prescribing the drug for that purpose.

That's why the drug companies will make these studies widely known, even though they have no intention of applying to the FDA to approve the drug for the new use. Using drugs for off-label purposes doesn't sound like a great idea, but it becomes even worse when the drug companies are not honest about a study's results.

And that's exactly what Pfizer has been doing. They have a drug called Neurontin, which was approved by the FDA to control epilepsy. But most of the drug's sales have been due to prescriptions for off-label use. The company released studies that showed the drug also worked for nerve pain, migraines and bipolar disorder.

Unfortunately, the company "doctored" the results of the studies, making the drug look like it was far more effective than it actually was. That meant the doctors that believed the fudged studies, were prescribing a medication that really didn't work for the use they intended it, and their patients were paying for a drug that provided them no benefit. The only real benefit was to provide more profits for Pfizer.

Researchers at the University of California at San Francisco and the Johns Hopkins Bloomberg School of Public Health learned about this by critically examining the studies done by the drug company. Their report, which appears in the newest issue of the New England Journal of Medicine, accuses Pfizer of releasing misleading study results in order to increase off-label sales of their drug.

Dr. Sidney Wolfe, head of health research at Public Citizen, says the company "maliciously manipulated the data to make a drug look more effective than it actually was." All of this comes on the heels of Pfizer being fined $2.3 billion for illegally marketing other drugs.

This doesn't inspire much confidence in Big Pharma does it? Are the other companies doing the same?