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Jul-13-2012 19:59printcomments

Sleeping Watchdog?
FDA's Ridiculous Position on Drug Addiction

This article dedicated to the memory of Peter who died Dec 23, 2001 at age 25 - accidental Oxycontin overdose.

Margaret Hamburg, MD
Margaret Hamburg, MD photo courtesy:

(MYRTLE BEACH, SC) - As a teen and young adult Pete loved to watch football, wrestling and anything Star Wars. He enjoyed reading Stephen King novels and had an innate protective passion for anything vulnerable.

He loved animals, children and senior citizens.

Is the FDA still allowing the fox to guard the hen house in the prescription drug epidemic -- or is the fox in a new position -- inside the hen house?

Last week, the "watchdog" for the safety of the American people, the Federal Drug Administration (FDA) released a "tool" to better educate the medical profession and its patients concerning the addictive and abuse capabilities of dangerous painkillers such as OxyContin and Vicodin.

More than twenty manufacturers of dangerous painkillers contributing to the prescription drug epidemic in the U.S. will be required to incorporate information about abuse and safe use into existing continuing education programs for health-care providers.

Margaret Hamburg, MD, and FDA Commissioner stated that the tools implemented by the agency will help physicians "safely prescribe opioids and (make sure) that patients know how to safely use these drugs."

Tens of thousands of people have died or are currently addicted to these lethal painkillers and the FDA still focuses on pharma's press releases calling for proper disposal of prescription drugs --

Drug companies will also be required to provide "user-friendly guides" to patients on avoiding painkiller abuse and proper disposal of leftover medications.

Disposal of leftover medications? Tens of thousands of people have died or are currently addicted to these lethal painkillers and the FDA still focuses on pharma's press releases calling for proper disposal of prescription drugs -- not to mention pharma's continual marketing of the words "undertreatment of pain" in America.

Hamburg described prescription painkiller abuse as "America's fastest growing drug problem." No Dr. Hamburg the fastest growing drug problem in America is docs being encouraged to write prescriptions for these highly addictive painkillers for mild to moderate pain thus allowing patients to become addicted. There's that word "addicted" that you try to avoid by focusing on the word "abuse" Dr. Hamburg.

Have you seen these figures Dr. Hamburg? Use of painkillers have skyrocketed in the past decade, with doctors writing 22.9 million prescriptions in 2011 for OxyContin, Vicodin, Percocet and dozens of others.

Here's where the "watchdog" of the American people allows the fox into the hen house -- not just at the door. Manufacturers are expected to have the plan — officially a Risk Evaluation and Mitigation Strategy (REMS) — up and running by March 2013. So the drug companies and their funded "pain foundations" pushing painkillers to the medical profession will be sponsoring the education programs that are "mandatory" by the FDA and you can rest assured that the words "undertreatment of pain" will be contained in the "educational process." The plan is mandatory for drug manufacturers, but voluntary for prescribers because making it mandatory for prescribers would require congressional approval.

Andrew Kolodny, MD

FDA's Dr. John Jenkins

Andrew Kolodny, MD, Chair of Psychiatry at Maimonides Medical Center in New York City has concerns over this "educational process" by pharma and their pain groups and stated "Nowhere does it say that prescribers should tell patients these drugs are addictive. And these programs give the implied message that there's evidence for using opioids in long-term, noncancer chronic pain." He also referenced that this final REMS is the same one voted down two years ago by the FDA.

John Jenkins, MD, Director of the Office of new drugs at the FDA's Center for Drug Evaluation and Research (CDER) advised the education courses would last approximately 2 to 3 hours and would cover how to weigh the risks and benefits of opioid therapy and "how to recognize the potential for abuse and addiction."

Are you as outraged as I am Congresswoman Mary Bono Mack of California and Congressman Hal Rogers of Kentucky -- congressional leaders in this prescription drug epidemic? The FDA no longer has the fox lurking outside the hen house -- they have opened the door and the fox is now among the chickens. This country needs a true watchdog guarding the "hen house" (the American people) -- and it's not the FDA.

LP -- The journey is a mystery for both of us, but the shared love, support, encouragement, faith and peace will never be a mystery. Marianne Skolek

Investigative Reporter for and
Columnist for American News
Activist for Victims of OxyContin and Purdue Pharma - a criminally convicted pharmaceutical company

_______________________________________ Investigative Reporter Marianne Skolek, is an Activist for Victims of OxyContin and Purdue Pharma throughout the United States and Canada. In July 2007, she testified against Purdue Pharma in Federal Court in Virginia at the sentencing of their three CEO's - Michael Friedman, Howard Udell and Paul Goldenheim - who pleaded guilty to charges of marketing OxyContin as less likely to be addictive or abused to physicians and patients. She also testified against Purdue Pharma at a Judiciary Hearing of the U.S. Senate in July 2007. Marianne works with government agencies and private attorneys in having a voice for her daughter Jill, who died in 2002 after being prescribed OxyContin, as well as the voice for scores of victims of OxyContin. She has been involved in her work for the past 8-1/2 years and is currently working on a book that exposes Purdue Pharma for their continued criminal marketing of OxyContin.

Marianne is a nurse having graduated in 1991 as president of her graduating class. She also has a Paralegal certification. Marianne served on a Community Service Board for the Courier News, a Gannet newspaper in NJ writing articles predominantly regarding AIDS patients and their emotional issues. She was awarded a Community Service Award in 1993 by the Hunterdon County, NJ HIV/AIDS Task Force in recognition of and appreciation for the donated time, energy and love in facilitating a Support Group for persons with HIV/AIDS.

(Note: Congratulations to Marianne; this is's 24,000th article)

Comments Leave a comment on this story.

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Anonymous July 22, 2012 12:39 pm (Pacific time)

Good article found on Slate regarding Purdue and pain killers. Read this for a balance view of the issue.

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