Sunday May 19, 2013
Marianne Skolek Salem-News.com Investigative Reporter
Margaret Hamburg, MD photo courtesy: 188.8.131.52
(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."
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, 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.
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 Salem-News.com's 24,000th article)