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Oct-02-2012 11:17printcomments

Save the Michaels, ARPO, Other Advocacy Groups Protest FDA Failure to Protect Americans from Painkillers

The protest sponsors seek to compel the FDA to review the current labeling of prescription opioids...


(CHICAGO - On Monday, October 29, 2012 consumer advocacy groups from across the U.S. and Canada will stage a protest at the FDA’s White Oak campus in Silver Spring, Maryland to target FDA’s failure to protect Americans from harms associated with prescription painkillers. Over the last decade, the sale of prescription painkillers, also called opioids, has increased four-fold while over the same time period opioid-induced deaths have increased four-fold and treatments for opioid addictions have increased six-fold (CDC 2011). More than 15,000 Americans now die each year from prescription opioids (CDC 2011, 2012).

FDA plays a key role in its approval of painkillers. Under federal law, before the FDA can approve a drug for a given use the drug company must prove that the drug is safe and effective for that use (Hamburg 2010). Unfortunately, FDA approved most opioids for many different types and levels of pain, including chronic noncancer pain, for which long-term safety and effectiveness of opioids have not been established (Chou et al. 2009). Protest organizers indicate that the lax opioid approvals by FDA have led to pharmaceutical companies marketing opioids very aggressively for a broad range of pain, and the protest organizers believe that the lack of appropriate safeguards on opioids has fueled a dramatic increase in the sale of opioids.

Says protest organizer Avi Israel:

    “FDA has failed to protect American citizens from the epidemic of opioid deaths and addictions by refusing to implement policies that would reign in the relentlessly escalating sale of opioid painkillers. We’ve lost too many precious lives to sit back and allow this agency to continue to look the other way.”

The protest, which will take place from 7 a.m. to Noon, is being organized by Save the Michaels of the World, a New York-based group comprised of families of victims of prescription opioids, and Advocates for the Reform of Prescription Opioids, Inc. (ARPO), a bi-national organization in the U.S. and Canada dedicated to ending the epidemic of death and addiction caused by the oversupply of prescription opioid drugs. Many other advocate organizations have joined with Save the Michaels and ARPO; see list below.

The protest sponsors are not against the use of opioids for pain when used selectively, following appropriate diagnosis and where other treatments are ineffective. But the sponsors note that many victims of prescription opioid death and addiction started out on a doctor's prescription for an opioid. Studies indicate that as many as one third of patients on chronic opioid therapy may suffer from an opioid-related disorder (Boscarino et al. 2011).

Says ARPO President Pete Jackson:

    “In certain cases, such as acute pain from trauma or terminal cancer pain, these medications are very much needed. But once a patient is put on an opioid prescription for an extended period, they are at risk for addiction and overdose. The simple fact that a person is on a doctor’s prescription has no bearing on the risk of addiction or overdose.”

The protest sponsors seek to compel the FDA to review the current labeling of prescription opioids to ensure that they are consistent with medical evidence on safety and efficacy. The group supports a Citizen Petition ( ) recently filed with FDA by Physicians for Responsible Opioid Prescribing which seeks such a review. Re-scheduling of hydrocodone to Schedule II from Schedule III will also help as it will promote awareness of the danger of this narcotic and prevent automatic refills of the most abused opioid medication.

Save the Michaels of the World, Inc.

Advocates for the Reform of Prescription Opioids, Inc.

National Coalition Against Prescription Drug Abuse

Steve Rummler Hope Foundation

Mothers Against Prescription Drug Abuse

LICADD .org (Long Island, NY) on Facebook at push-LI


Heroin Action Coalition of Montgomery County


Boscarino JA, Rukstalis MR, Hoffman SN, Han JJ, Erlich PM, Ross S, Gerhard GS, Stewart WF. Prevalence of prescription opioid-use disorder among chronic pain patients: comparison of the DSM-5 vs. DSM-4 diagnostic criteria. Journal of Addictive Diseases 2011; 30: 185-194.

Centers for Disease Control. 2011. Vital Signs: Overdoses of Prescription Opioid Pain Relievers—United States, 1999-2008. MMWR; 60: 1-6

Centers for Disease Control. 2012. Policy impact: prescription painkiller overdoses.

Chou R, Ballantyne JC, Fanciullo GJ, Fine PG, Miaskowski C. Research gaps on use of opioids for chronic noncancer pain: findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine Clinical Practice Guideline. The Journal of Pain, Vol 10 No 2 (February) 2009: pp. 147-159

Hamburg, M.A. 2010. Innovation, regulation, and the FDA. N Engl J Med 363: 2228-2232.


Avi Israel, Save the Michaels of the World (716)-984-7432

Pete Jackson, Advocates for the Reform of Prescription Opioids
(847)-577-4438 evening
(312)-886-3894 daytime

_______________________________________ 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.



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