FDA Will Vote to Limit Access to Painkillers

Five years later, Food & Drug Administration is given a chance to redeem past mistakes,

Courtesy: abc22.com

(MYRTLE BEACH, SC) - This past week the F.D.A. had an advisory panel of "experts" vote to restrict the use of painkillers containing hydrocodone such as Vicodin.

Andrew Kolodny, MD

Ultimately, the advisory panel made its recommendation by a vote of 19 to 10 to limit access to painkillers by making them accessible to patients needing them, but with closer scrutiny by the prescribing physician to the patient. The F.D.A. is likely to take the recommendation of their advisory panel in view of the addiction epidemic in every state in the country spiking every year since the 1990's.

If the F.D.A. goes along with the panel's recommendation, which is typical but not required, the drugs would be more stringently regulated, moving them to Schedule II drugs from Schedule III drugs.

This change to Schedule II painkillers would mean that physicians could only write prescriptions for a 30-day supply and these painkillers could no longer be called in to a pharmacy. Patients would need to make an appointment to see their physician and have their medical condition necessitating the painkillers reviewed by a medical professional. In other words, no carte blanche for patients to have renewal after renewal and have that word "addiction" rear its ugly head. In addition, nurse practitioners and physician assistants would no longer be able to prescribe these painkillers.

Lynn Webster MD

Many publications as well as the F.D.A. indicated that the hearings recently held leading to a vote were in an effort to deal with prescription drug "abuse." Pharma plays on the word "abuse" and not the word "addiction." I focus on the fact that addiction is the relevant word here -- and abuse is a resulting factor of addiction.

"I believe that this change will mark a turning point in the epidemic," said Andrew Kolodny, MD of the Maimonides Medical Center in Brooklyn, NY and President of Physicians for Responsible Opioid Prescribing (PROP). "It will lead to less people becoming addicted, which is the most important thing that needs to happen to bring this crisis under control."

On the opposition side is Lynn Webster, MD, President-Elect of the American Academy of Pain Medicine. Webster is quoted as saying "If the FDA agrees with the advisory committee, the decision will have far-reaching impact on access and cost to pain care. I hope people in pain won't suffer as a result."

Since Webster has benefited financially from his ties to the pharmaceutical industry and encouraged the use of opioids (painkillers) in his lectures and books and is under U.S. Senate investigation along with the American Academy of Pain Medicine, I can't help but think -- I wouldn't buy a used car from this guy.  Further he preys on scare tactics saying people in pain may suffer as a result of any controls on prescribing addictive painkillers. 

I recognize this is an emotional issue with families torn apart by death and addiction in every state in the country and pharma making huge profits pushing painkillers. Pharma and Webster can tout the word "abuse" and hand feed the F.D.A. with the word "abuse" -- but a rise of 300 to 400 percent in deaths and addictions can no longer be ignored.

Heads of the F.D.A. will be reviewing the Advisory Committee decision to regulate painkillers which will result in their making a recommendation to the Department of Health and Human Services.

Douglas Throckmorton, MD

Keep in mind that in 2008, the F.D.A. rejected a similar request by an advisory committee to regulate dangerous drugs so the "fat lady" has definitely not sung yet. I would like to be optimistic that the F.D.A. will right the wrong they did in 2008, but are there financial ties to the pharmaceutical industry and its deep pockets giving me cause to distrust the F.D.A? Call it their lack of conscience and integrity so prove me wrong F.D.A. and be the true watchdog of the American people -- and not a lapdog.

"We will pay close attention to everything we've heard as we proceed," the FDA's Douglas Throckmorton, MD and Deputy Director of the Center for Drug Evaluation and Research (CDER) told the panel at the conclusion of the hearing. This was after emotional testimony by families who have suffered the ultimate loss of loved ones. I recommend that Throckmorton pick up any major newspaper in every state in the country tomorrow and read how this epidemic of painkillers not being properly prescribed and/or monitored is killing and addicting at record numbers. To this point in time, the F.D.A. has lacked any conscience or soul. Let's end the incestuous relationship the F.D.A. has maintained with the pharmaceutical industry and do the job they were commissioned to do -- safeguard the American people.

I would like to think that the late President, Harry S. Truman's voice boomed through the corridors of the F.D.A. after the Advisory Committee vote -- "The buck stops here." The buck failed to stop in the F.D.A. when they saw the rise in addiction and death to dangerous drugs and chose to have pharma profit -- rather than act expeditiously to save lives

LP -- OJ, honey, cinnamon and pasta fagioli -- does it get much better than that? Nope "it works both ways." Love you, Nurse Ratched

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.

Marianne Skolek https://twitter.com/MarianneSkolek