Are Addiction and Death the FDA's Counterproductive Prescription for Pain?

Talking heads from dozens of groups discuss, again... what is good and bad for patients suffering from pain.

FDA - public safety or a dollar-oriented illusion?

(MYRTLE BEACH, SC) - This article is dedicated to "Jason" a young man who was an artist, writer, musician and knew no strangers. He will be remembered for his humor and his love of family and animals. Your dad loved you so much. You will be missed Jason -- fly with the angels. You are safe now.

On May 30 and 31, the Federal Drug Administration (FDA) held a workshop to discuss the available data on the efficacy of analgesics in the treatment of chronic non-cancer pain (CNCP). The focus of the discussions by "scientific" experts -- not medical experts was on the available clinical data from random clinical trials and other studies of the efficacy of opioid analgesics, and comparison of that data to the data from studies of non-opioid analgesics used in the treatment of CNCP.

There are tens of thousands of families in the country dealing with the prescription drug epidemic in the U.S. (not to mention Canada), but the FDA did not offer these families the opportunity to participate by viewing the proceedings in webcam -- unless they had $140.00 to pay to view the workshop -- and that was $140.00 per day to a tune of $280.00 total to hear what the "watchdog" of America was doing to give hope to these families. See link to purchasing access to webcam of workshop.

http://www.fdalive.com/webcastselect.cfm?meetingkey=1361

You can see from the list of speakers who were given two minutes to discuss the subject of opioids in the treatment on non-cancer pain how many were affiliated with the pain foundations funded by pharma:

3:45 pm Cindy Steinberg, Massachusetts Pain Initiative (grants from Purdue Pharma, maker of OxyContin)
3:47 pm Andrew Kolodny, Physicians for Responsible Opioid Prescribing (PROP)
3:49 pm Pete Jackson, Advocates for Reform of Prescription Opioids
3:51 pm Phil Wiffen, Oxford University (Sackler brothers, founders of Purdue Pharma, maker of OxyContin-major donors to Oxford University)
3:53 pm Andrew Moore, Oxford University (Sackler brothers, founders of Purdue Pharma, maker of OxyContin-major donors to Oxford University)
3:55 pm Daniel Carr, American Society of Anesthesiologists (Income reported from Purdue Pharma, maker of OxyContin and member of American Academy of Pain Medicine (AAPM), under investigation by the U.S. Senate for financial ties to Purdue Pharma)
3:57 pm Bob Twillman, American Academy of Pain Managemen - AAPM under investigation by the U.S. Senate for financial ties to Purdue Pharma)
3:59 pm Betts Tully
4:01 pm Kathleen Zinno, Ehlers Danlos Syndrome (EDS) Patient
4:03 pm Lawrence Duda, Physicians for Responsible Opioid Prescribing
4:05 pm Jorge Chaum
4:07 pm Rene Cabral-Daniels, National Patient Advocate Association Health Service (supported by Purdue Pharma, maker of OxyContin)
4:09 pm Alan Trachtenberg, MD
4:11 pm Lynn Webster, MD, American Academy of Pain Medicine (under US Senate investigation and paid consultant to Purdue Pharma, maker of OxyContin)
4:13 pm John Carney, Center for Practical Bioethics (financially linked to Purdue Pharma and under investigation by the U.S. Senate Finance Committee)
4:15 pm Col. Walter Craig, Center for Practical Bioethics (financially linked to Purdue Pharma and under investigation by the U.S. Senate Finance Committee)
4:17 pm Harris Silver, MD
4:19 pm Mark Odden, Iowa Anesthesia, LC
4:21 pm Bernard Mullen
4:23 pm Larry Golbom, Prescription Addiction Radio Show
4:25 pm Shani Weber, EDS Patient
4:27 pm Heather Pierce, EDS Patient
4:29 pm Megan Karanfil, EDS Patient
4:31 pm Rebecca Peokowitz, EDS Patient
4:33 pm Sama Bellomo, EDS Patient
4:35 pm Kevin Zacharoff, Inflexxion
4:37 pm Martin Levine, American Osteopathic Association (Supported by a grant from Purdue Pharma, maker of OxyContin)
4:39 pm Judy Rummler, Steve Rummler Memorial Foundation
4:41 pm Lexi Reed, Steve Rummler Memorial Foundation
4:43 pm Robert Mitchell, DO

Some physicians, patients and advocacy groups attending the workshop were calling upon the FDA to have drug companies marketing prescription opioids to treat chronic, long term pain -- made to cease the push of opioids.

Andrew Kolodny, MD and president of Physicians for Responsible Opioid Prescribing stated that such a move would help curb the escalating increase of overdoses, deaths and addictions since the opioid push.

The Journal Sentinel in Milwaukee, Wisconsin has once again been a front runner in their reporting that opioids increasingly have been prescribed for chronic pain, an area where their safety and effectiveness are unproven, especially for older patients. They went on to report that since 2007 top-selling opioids dispensed to people 60 years and older have increased 32%, double the rate for those in the 40-to-59 age group.

Douglas Throckmorton, the FDA's deputy director of the Center for Drug Evaluation and Research stated "We need to start with science," "We know less than we would like to about chronic, non-cancer pain." Why Mr. Throckmorton -- how many more thousands of people do you need addicted or dead before you do your job of protecting the American people?

What we do know Dr. Throckmorton is that we are losing tens of thousands of victims to addiction and death because opioids are approved to treat moderate to severe pain, but the prescribing of these opioids for long periods of time do not indicate the safety of the drugs to patients.

Throckmorton said more evidence needs to be examined before a labeling change would be considered - "FDA can't solve this alone," he said. "Academics can't solve this alone. Patient groups can't solve this alone. We need to be doing a great many things and not a single thing."

And no Dr. Throckmorton, we don't need to start with "science" -- we need to start with medicine and the safety of that medicine to the American people. How much more "evidence" does the FDA need that we are immersed in a prescription drug epidemic and losing family members throughout the country at an alarming rate? A reclassification of highly addictive and dangerous opioids such as OxyContin for severe pain only would be a positive step taken by the FDA in saving lives.

Also, holding workshops with individuals and organizations funded by the pharmaceutical industry and under U.S. Senate investigation giving a slanted and biased push for the use of opioids makes me even more suspect of the FDA's ties to pharma and the push for opioids.

Advocates believe that making it clear opioids have not been proven safe and effective for treating chronic pain would limit prescribing of the drugs.

Doctors wrote recently in the New England Journal of Medicine that the opioid epidemic is closely tied to a quadrupling of prescriptions over a decade and liberalized use of the drugs due to heightened focus on pain management.

Artwork by Sean King Salem-News.com

Lynn Webster, MD, officer of the American Academy of Pain, funded by Purdue Pharma was quoted in Newsday in January 2012 as saying about the prescription drug epidemic in the U.S. and Canada -- "I am not sure I would use the word epidemic. There is a public health crisis, but not an epidemic." Webster said critics too often overstate the degree to which people are addicted. Since the Senate Finance Committee is investigating Webster and the American Academy of Pain for their financial ties to the pharmaceutical industry, the Senate may find the statement that we are in a "public health crisis" and "not an epidemic" as relates to the soaring addictions and deaths to opioids around the country criminal. Shame on Dr. Webster for minimizing the loss of human life due to the push for opioids. Is it all about profits for pharma and their pain organizations and not about lives? Next week I will be writing an expose about Lynn Webster, MD, Russell Portenoy, MD, Scott Fishman, MD all under Senate investigation for their ties to the push for prescribing opioids.

Salem-News.com 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.