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FDA Announces Results of Investigation Into Illegal Promotion of OxyContin-

May 10, 2007
Media Inquiries:
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FDA Announces Results of Investigation Into Illegal Promotion of OxyContin by The Purdue Frederick Company, Inc.

Company Misrepresented Prescription Pain Reliever to Health Care Professionals

The U.S. Food and Drug Administration's (FDA) Office of Criminal Investigations (OCI) announced today that The Purdue Frederick Company, Inc. has agreed to pay more than $600 million to resolve criminal charges and civil liabilities in connection with a long-term illegal scheme to promote, market and sell OxyContin, a powerful prescription pain reliever that the company produces.

An investigation by OCI uncovered an extensive, long-term scheme by The Purdue Frederick Company, Inc. to generate the maximum amount of revenues possible from the sale of OxyContin. To further this goal, Purdue trained its sales representatives to make false representations to health care providers about the difficulty of extracting oxycodone, the active ingredient, from the OxyContin tablet; trained its sales force to represent to health care providers that OxyContin did not cause euphoria and was less addictive than immediate-release opiates; and allowed health care providers to entertain the erroneous belief that OxyContin was less addictive than morphine. In addition, Purdue falsely labeled OxyContin as providing "fewer peaks and valleys than with immediate-release oxycodone," and falsely represented that patients taking lower dosages of the drug can always be discontinued abruptly without suffering withdrawal symptoms or tolerance.

"FDA will not tolerate practices that falsely promote drug products and place consumers at health risk," said Margaret O.K. Glavin, Associate Commissioner for Regulatory Affairs. "We will continue to do all we can to protect the public against drug companies and their representatives who are not truthful and bilk consumers of precious health care dollars."

To resolve the criminal charges, Purdue pled guilty to a felony count of misbranding a drug with intent to defraud and mislead. As part of the plea, Purdue will pay a $600 million settlement. That amount includes a criminal fine, restitution to government agencies, over $276 million in forfeiture, and a related civil settlement under which Purdue will pay $100.6 million to the United States.

In addition, Purdue's current and former executive employees, Michael Friedman, Howard Udell and Dr. Paul Goldenheim, pled guilty to a misdemeanor violation of misbranding OxyContin as being the responsible corporate officers during the long-term illegal promotion of the drug.

This case was prosecuted by the U. S. Attorney's Office for the Western District of Virginia and investigated by FDA's Office of Criminal Investigations; the Internal Revenue Service's Criminal Investigations Division; the U.S. Department of Health and Human Services' Office of Inspector General; and the State Police Departments of Virginia and West Virginia. This case serves as an excellent example of federal and state law enforcement cooperation.May 10, 2007 Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA... more

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Scientist, 94, Goes After the FDA for Misleading Trans Fat Food Labels

At 94, University of Illinois veterinary biosciences professor emeritus Fred Kummerow is an extraordinarily busy -- and determined -- man. Not only is he continuing to conduct research on how trans fats in the diet can harm health, he's taking on the Food and Drug Administration (FDA) and sounding the alarm that the federal agency is allowing inadequate and misleading trans fat food labels which are downright dangerous to health.

Last month, Dr. Kummerow filed a 3,000 word petition with the FDA that outlines why trans fats, long a part of the American diet of fast and processed foods, are extremely bad for the human body and why the FDA is doing a rotten job of warning the public about what foods contain these substances. His mission is nothing less than to eradicate trans fats from human consumption. "Everybody should read my petition because it will scare the hell out of them," Kummerow proclaimed in a statement to the press.

Trans fats (also known as trans fatty acids) are not found in nature. They are made through the chemical process of hydrogenating oils. Sometimes labeled as hydrogenated or partially hydrogenated fat or oil, trans fats are often used in baked goods like doughnuts, breads, crackers, potato chips, cookies, margarine and salad dressings.

So what's so bad about these processed fats? Plenty. They are known to be a factor in the build up of atherosclerosis, the accumulation of plaque in the arteries that interferes with blood flow, and they contribute to the formation of blood clots in coronary arteries that can lead to heart attacks and sudden death. What's more, trans fats are now also known to increase low-density lipoproteins (LDLs), the "bad" cholesterol, and to spur inflammation, which has been linked to a host of illnesses from heart disease to cancer.

Dr. Kummerow is no Johnny-come-lately to the field of trans fat research. He began publishing on the subject in 1957. And his crusade against trans fats in food began in earnest in 1968 when he insisted the American Heart Association urge members of the Institute of Shortening and Edible Oils to decrease the amount of trans fatty acids in shortenings and margarines and to replace them with essential fatty acids. "Even then, there was strong evidence that trans fatty acids increased plasma cholesterol levels," Kummerow said in the statement to the press.

The food oil industry dragged its heels but finally lowered the trans fatty acid content and increased essential fatty acids in some processed food products. Those changes coincided with a significant decline in coronary heart disease mortality after 1968. However, far too many trans fats have remained in the American diet and heart disease has continued to be a huge killer.

According to Dr. Kummerow's research, the latest published last month in the journal Artherosclerosis, trans fats displace the essential fatty acids linoleic acid (omega-6) and linolenic acid (omega-3), which the human body needs to be healthy. Dr. Kummerow's research has also found that trans fats interfere with the function of a key enzyme essential to blood flow regulation.

Faced with enormous evidence showing that trans fats are detrimental to health, the FDA finally required, starting in 2006, that trans fats are listed on food labels -- or at least the FDA gave the impression that trans fats had to be listed. Dr. Kummerow says the FDA put in loop-holes that allow food labels to be woefully inadequate and downright misleading. For example, anything less than one-half gram of trans fats per serving is listed as zero grams. Clearly, anyone reading such a label would get the wrong impression that the food product has zero trans fats. And that's a lie.

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