Wyeth Pharmaceuticals Inc., (now owned by Pfizer) a pharmaceutical company has agreed to pay $490.9 million to resolve the unlawful marketing of the prescription drug Rapamune. The U.S. Food and Drug Administration (FDA) did not approve it as safe and effective, the Justice Department announced the other day. Rapamune is an “immunosuppressive” drug that prevents the body’s immune system from rejecting a transplanted organ for patients 13 years or older.
The Federal Food, Drug and Cosmetic Act require companies, including Wyeth, to specify the intended use of a product in the new drug application to the FDA. Once approved, a drug may not be introduced into interstate commerce for unapproved or “off-label uses until the company receives FDA approval for the new intended uses. Rapmune was approved in 1999 for the use of renal (kidney) transplant of patients. However, Wyeth trained its national sales representatives to promote the use of the drug in non-renal transplant patients. The sales representatives were also trained on how to present the materials to physicians who make these transplants. Finally, Wyeth encouraged sales members, through bonuses and financial incentives, to target all transplant patient population to increase Rapamune sales.
Wyeth Pharmaceuticals is merely concerned about the profit the drug can make and not the risks or side effects of the patients. This was a systemic, corporate effort to seek profit over safety. Companies that ignore compliance with FDA regulations will face criminal prosecution and stiff penalties.
Wyeth has pleaded guilty for misbranding violation under the FDCA. The criminal fine and forfeiture total is $233.5 million. There is also a civil settlement with the federal government and the states that is $257.4 million. Wyeth has agreed to settle its potential civil liability in connection with its off label marketing of Rapamune. The unapproved uses included non-renal transplants, conversion use (switching a patient from another immunosuppressant to Rapamune) and using Rapamune in combination with other immunosuppressive agents not listed on the label.
The side effects of the unapproved uses include:
1. Peripheral edema (fluid retention in the lower limbs)
2. Stomatitis (inflammation of the mucus of the mouth)
4. Mouth ulceration
5. Elevated lipid concentrations
At times, being a patient is difficult. We trust our doctors, and nurses to do the right thing and provide the right care. The doctors and nurses trust the manufacturing company and pharmaceutical companies to produce the right product. Dishonesty and profit exceeding patient care and safety is occurring more often then not these days. Patients have to deal with the consequences of the unapproved prescription drugs or the product malfunction that therefore leads the patients to have severe side effects. These side effects certainly range from death to a stomach bug, but neither is acceptable or rightly deserved. All patients should be treated with the best care possible. Patients need to be health advocates and make sure what is going into their body is right. It is essential to ask different doctors about drugs and products, do research and constantly read about products. It is easier to be a health advocate then have to deal with the side effects later in life.
If you or a loved one had something like this or similar happen, you can seek justice. Please call for a free consultation. It is important to protect patient safety. Drug companies must only market and promote their drugs for FDA approved uses. The consequences do not exceed the patients life.