Are Americans ready for a ‘Generation Rx’?

We consume more than 70% of the world’s opiates and are dying of overdoses at epidemic rates. Where is the oversight?


Feb. 7, 2011, 5:22AM

A decade after Congress began dramatically increasing imports into the United States, Americans are consuming more than 70 percent of the world’s legal medicinal supply of opiates — poppy-based pain drugs related to heroin, a Chronicle analysis of the Congressional Record and international treaty data shows.

The resulting wave of accidental prescription drug overdoses has been called a national epidemic, but the same federal agencies that license drugmakers and oversee imports and doctors have been slow to react to exponential increases in deaths reported in states like Texas, Florida, West Virginia and others from coast to coast.

“The truth is this is killing people and there are things that can be done,” says A. Thomas McLellan, a prominent addiction researcher who until September served as assistant director of the Office of National Drug Policy in Washington, D.C., better known as the office of the drug czar. “In 2008, there were 28,000 deaths and one of them was my son. It was one of the reasons that I took this job.”

Prescription drug overdoses nationwide have doubled in the past five years, according to the latest reports from emergency room doctors who participate in the government’s Drug Awareness Warning Network. Some hard-hit metro areas have seen even bigger increases in both nonfatal overdoses and deaths, Texas and national data shows.

McLellan was among a prominent group of health specialists who met last July in a summit organized by the Food and Drug Administration. A majority of that group urged the FDA to collaborate with other regulatory bodies to require specialized training on the dangers of pain drugs for all doctors who must get federal licenses to prescribe opioid medications, such as Vicodin (hydrocodone) and OxyContin (oxycodone).

McLellan considered the meeting historic. But so far, nothing has happened.

Too slow to react?

Dr. Sidney Wolfe, an expert with the nonprofit Public Citizen and a member of the FDA Drug Safety and Risk Management Advisory Committee, said the FDA has become too weak, overdependent on big pharma for funding and too slow to react to strong evidence of public health threats posed by pain drugs and other medicines.

In January, the FDA rejected a ban on the powerful opioid Vicodin and Percocet proposed by another panel of its own medical experts in 2009. The panel suggested banning the drugs because of concerns over deaths linked to popular and addictive pain pills that also contain acetaminophen (sold over the counter as Tylenol) and can cause liver failure or death in large doses.

Instead, the agency gave drug companies three years to gradually reduce acetaminophen content of pain pills – a step that Wolfe and others criticized as weak.

The FDA did not respond to requests for comment.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.