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It's not all about 'Abuse' -- Let's tell it like it is -- It's 'Addiction' and pharma and the FDA is responsible for itMarianne Skolek Salem-News.com Investigative Reporter
Part 1 of a series
(MYRTLE BEACH, SC) - Physicians for Responsible Opioid Prescribing (PROP) have filed a Citizens Petition to the FDA putting pressure on the agency to change the labeling of Opioids.
Before the pharmaceutical companies such as Purdue Pharma, maker of their lethal drug, OxyContin continue their marketing of the word "abuse", let's throw out the word "addiction" to them. Opioids are not in short supply. After all, they are manufactured in huge quantities to find their way onto the streets. Victims of Opioid addiction should consider receiving help as soon as possible. It only takes a few moments to find local rehabs in your area, so make the first step before you or a loved one’s addiction worsens.
The Drug Enforcement Agency (DEA), the Federal Drug Administration (FDA) and law enforcement agencies know this. So in rides a professional organization called Physicians for Responsible Opioid Prescribing (PROP). Their website is shown here: www.supportprop.org/. They served the FDA with a Citizens Petition which I challenge the FDA to ignore -- as they have ignored the ever escalating deaths and addictions crippling this country and Canada.
Approximately 40 physicians, scientists and health officials filed a petition to the FDA this week requesting a label change be used on painkillers such as OxyContin and Vicodin. Many of the signers of the petition are connected with PROP, as well as the New York City Health Commissioner, the Cleveland Clinic, the Mayo Clinic, universities and Sidney Wolfe, M.D. watchdog group "Public Citizen". Dr. Wolfe has long been a nemesis of the FDA calling the agency out on dangerous drugs approved by the agency.
The Citizen Petition calls for changes to the labeling used on narcotic painkillers, which if approved, would make it more difficult for pharmaceutical companies to market the dangerous and addictive painkillers for chronic, noncancer pain.
Now be ready for the pharmaceutical companies such as Purdue Pharma to use their scare tactics through the media, public relations filings, their lobbying pain societies financed by pharma to focus on the word "abuse" and to have people already over-prescribed drugs such as OxyContin by their physicians who do not know the long-term effects of opioid therapy to scream "foul" -- they need their opiates.
In reality, this prescription drug epidemic is about the word "addiction" and lots of it in every single state in the country. Patients are being prescribed painkillers in record numbers by their primary care physicians who were "educated" by the drug companies pushing the painkillers for every level of non-cancer pain. The objective of the Citizen Petition filed with the FDA is to help reduce the overprescribing and the volume of patients with chronic noncancer pain [CNCP] becoming "addicted" to dangerous painkillers.
Chronic Opioid Therapy (COT) has never been shown to be both safe and effective over the long-term for many patients, especially in higher dosages. I'll save those chronic non-cancer patients "hooked" on painkillers the trouble of sending long-winded, rambling emails to me -- there are no studies for long-term use -- the FDA knows it and so does pharma. Studies of the treatment of noncancer pain with opioids is less than 12 weeks.
This unprecedented move to hold the FDA to the fire by medical professionals and health institutions comes after a sharp rise over the past decade of death and addiction which many attribute to physicians over-prescribing dangerous painkillers as a result of pharmaceutical companies encouraging treatment of non-cancer, moderate pain with narcotics intended for severe pain.
In the past decade, prescriptions for opioids have increased four times resulting in an epidemic of opioid related deaths and patients seeking treatment for addiction. The FDA is being challenged in the petition to reduce harm caused by painkillers responsible for the soaring mortality figures in every state in the country.
The Citizen Petition calls to strike the word "moderate" from the label and to include a maximum of the equivalent of 100 mg a day of morphine and a time period of no more than 90 days when used to treat noncancer pain.
A Purdue spokesman, noting that opioid use and dosing has been on the FDA's radar over the past decade, said "FDA, its advisory committees, and numerous medical experts maintain that the current indications for long-acting opioids are appropriate. We agree with the FDA that prescribing information for any medication should be subject to ongoing review and modification to the extent that compelling medical evidence emerges."
I'll remind the Purdue "spokesman" that you and your pharmaceutical company lied about the dangers of OxyContin -- remember?
You convinced the medical profession when OxyContin was unleashed on the unsuspecting public that your drug was less likely to be addictive. You were charged with a felony and sentenced in Federal Court -- oh and pleaded guilty to the charges.
Your actions are the direct cause of this Citizen Petition which is making a valiant effort to save lives. It is too late for the tens of thousands of individuals who have died or are fighting addiction because of your marketing lies -- so save the public relations blitz using the word "abuse."
Tell it like it is and use the word "addicted" -- you are responsible for being evil and putting billions of dollars in your pockets at the cost of ruining countless lives in the U.S. and Canada.
Public Citizen's Dr. Wolfe, said the next step is for the FDA to take action on the petition. He said they could simply grant the labeling changes or hold an advisory panel hearing on the issue. "They can't just write this off," he said.
If the agency does not take action in a reasonable amount of time, Public Citizen could take it to court to force a response, Dr. Wolfe said. May I suggest Dr. Wolfe bring Senator Charles Grassley of Iowa with him to court. Senator Grassley has been quoted as saying about the FDA "This is an agency that has gotten too big for its britches."
The FDA doesn't have their heads in the sand with the prescription drug epidemic -- they have their heads in the bank accounts of pharma and it's time for a massive withdrawal. Hopefully the Citizen Petition will snap Congress into investigating and demanding answers from the FDA about their lack of action in ending the prescription drug holocaust.
Next week -- Part 2 -- how many employees at the FDA approve dangerous drugs to be used on the American public and then leave the FDA to work for the pharmaceutical company whose drug they approved?
LP -- I thank God every day for the gift he has given us -- each other. I cherish you for what we bring to each other -- it's straight out "cosmo"
_______________________________________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.
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