May 10, 2007 and revised May 14, 07

"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.

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."

Source: The F.D.A.
http://www.fda.gov/bbs/topics/NEWS/
2007/NEW01632.html

"The Food and Drug Administration (FDA) is advising consumers not to purchase or use "True Man" or "Energy Max" products promoted and sold as dietary supplements throughout the United States. Both products -- touted as sexual enhancement products and as treatments for erectile dysfunction (ED) -- are illegal drug products that contain potentially harmful, undeclared ingredients. The products contain substances called analogs that have similar structures to active ingredients in approved prescription drugs.

Consumers should discontinue use of True Man and Energy Max and consult their health care professional about approved treatments for ED. FDA encourages men who experience ED to seek guidance from a health care professional.

FDA has not approved True Man and Energy Max; therefore the safety and effectiveness of these products are unknown. Both products are often advertised as "all natural" alternatives to approved ED drugs in advertisements appearing in newspapers, retail stores,
and on the Internet.

"These products threaten the health of the people using them because they contain undeclared chemicals that are similar to the active ingredients used in FDA-approved prescription drug products," said Steven Galson, M.D., MPH, director of the FDA's Center for Drug Evaluation and Research." The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure."

The undeclared analog ingredients in True Man and Energy Max may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

FDA chemical analysis revealed that Energy Max contains thione analog of sildenafil, a substance with a structure similar to sildenafil, the active ingredient in Viagra, an FDA-approved drug for ED.Substances like this are called analogs because they have a structure similar to another drug and may cause similar side effects and drug interactions.

True Man contains a thione analog of sildenafil or piperadino vardenafil, an analog of vardenafil, the active ingredient in Levitra, another FDA-approved prescription drug for ED. Neither the thione analog of sildenafil nor piperadino vardenafil are components of approved drug products.

True Man is sold in boxes containing a 10-capsule blister pack. Energy Max is sold in boxes containing two 10-capsule blister packs. Both products are distributed and packed by America True Man Health, Inc., West Covina, Calif. A review of the ingredient statements for both products revealed that neither piperadino vardenafil nor thione analog of sildenafil are listed as an ingredient, even though one or more of those ingredients is present in the products."

Source:  The FDA
http://www.fda.gov/bbs/topics/
NEWS/2007/NEW01633.html

April 2007

"Almost one-fourth of all stays in the U.S. community hospitals for patients age 18 and older - 7.6 million of nearly 32 million stays - involved depressive, bipolar, schizophrenia, and other mental health disorders or substance use related disorders in 2004, according to a new report by the Agency for Healthcare Research and Quality.

This study presents the first documentation of the full impact of mental health and substance abuse disorders on U.S. community hospitals.  According to the report, about 1.9 million of the 7.6 million stays were for patients who were hospitalized primarily because of a mental health or substance abuse problem.  In the other 5.7 million stays, patients were admitted for another condition but they also were diagnosed as having a mental health or substance abuse disorder.

Nearly 2/3 of costs were billed to the government:  Medicare covered nearly half of the stays, and 18% were billed to Medicaid.  Roughly 8% of the patients were uninsured.  Private insurers were billed for the balance.  The study also found that one of every three stays of uninsured patients was related to a mental health or substance abuse disorder.

AHRQ found that most patients with mental health and substance abuse disorders were older.  For example, although people age 80 and older comprised only 5% of the US population in 2004, they accounted for nearly 21% of all hospital stays for these conditions- principally for dementia.  The most frequent admitting diagnosis for women was mood disorders, while that for men was substance abuse.

The report also indicates that patients who have been diagnosed with both a mental health condition and a substance abuse disorder - those with "dual diagnoses" - accounted for 1 million of the nearly 8 million stays.  Nearly half of these cases with dual diagnoses involved drug abuse.

Suicide attempts accounted for nearly 179,000 hospital stays.  Of these, 93% involved a mental health condition - most commonly mood disorders - and/or substance abuse.  Poisoning, by overdosing prescription medicines or ingesting a toxic substance was the most common way patients attempted suicide."

Source:  U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality (AHRQ).  No. 320, April 2007