Wrong Answer Dr. Jenkins!

John Jenkins, M.D., director, Office of New Drugs, Center for Drug Evaluation and Research (CDER), FDA

(MYRTLE BEACH, S.C.) - I was invited - as credentialed media - to participate in a U.S. Food and Drug Administration (FDA) media briefing on November 19, 2010 to discuss a "drug safety issue".

Marianne Skolek

A controversial painkiller Darvocet or Darvon as well as other brand/generic drugs containing propoxyphene was being pulled by the FDA due to dangerous cardiac side effects.  New proof of heart side effects in studies of healthy people taking normal doses of the drug prompted the FDA to act.

The FDA action comes nearly six years after the drug was banned in the U.K., and nearly a year and a half after the European drug agency banned it.

The public interest group Public Citizen petitioned the FDA to ban the drug in 1978 and again in 2006. The latter petition caused the FDA to take the matter to an expert advisory committee, which in July 2009 voted 14-12 to ban the drug.

But the FDA overruled the panel, instead asking Darvon/Darvocet maker Xanodyne Pharmaceuticals Inc. to conduct studies of the drug's effects on the heart. The results of those studies led to the FDA ban. "The drug puts patients at risk of abnormal or even fatal heart rhythm abnormalities," John Jenkins, MD, director of the FDA's office of new drugs at the Center for Drug Evaluation and Research, said at a news conference. "Combined with prior safety data, this altered our risk assessment."

The FDA ban comes too late for Public Citizen, which blasted the FDA for waiting far too long to protect the public. "Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since the time the U.K. ban was announced," Sidney Wolfe, M.D., director of Public Citizen's health research group, said in a news release. Wolfe says Public Citizen will call for a congressional investigation into who at the FDA "was responsible for the loss of so many lives in this country." More information about the propoxyphene ban is available on the FDA web site -- including, for the first time, a video news release. When the media briefing ended, questions were taken from the call-ins. In a short time, I was given an opportunity to ask my question of Dr. Jenkins. It went like this -- Since the dangers of Darvocet/Darvon to the public were finally recognized by the FDA, would they also be considering reclassifying OxyContin to be prescribed for "severe pain only." It is currently being prescribed for moderate and severe pain. Dr. Jenkins replied that the FDA felt the benefits of OxyContin in the treatment of moderate pain outweighed the risks to the public.

Wrong answer Dr. Jenkins!

Here's the correct answer Dr. Jenkins.  OxyContin is responsible for scores of deaths, addictions and abuse to the public -- in every state in the country.  The public you have been entrusted to keep safe.  This epidemic has been going on for well over a decade now.  OxyContin has been compared to heroin -- our youth is dying every day because this drug was marketed by Purdue Pharma as less likely to be addictive or abused.

Your employee, Curtis Wright, MD was involved in the review and approval of OxyContin by your agency unleashing this drug on the unsuspecting American public -- and was approved for moderate pain treatment. Dr. Wright subsequently jumped ship with the FDA and went to work for a private pharmaceutical company. Care to guess the name, Dr. Jenkins? It was Purdue Pharma, maker of OxyContin. Conflict of interest? Obviously not to the FDA because OxyContin was allowed to line the pockets of Purdue Pharma to the tune of approximately $10 billion. And as for Dr. Wright? He was cut free by Purdue Pharma several years ago. Oh and there was a patent, Dr. Jenkins -- when Wright was employed by Purdue Pharma. Interested in the details of that patent? It was for a tamper-resistant oral opioid agonist formulation. The inventors on this patent were a Benjamin Oshlack, a J. David Haddox, MD who when OxyContin was launched tried to convince the medical profession that there was no such thing as "addiction" -- it was "pseudo-addiction." A word Haddox coined. And former FDA employee, Curtis Wright, MD was the third name on the patent.

In February 2010, the FDA issued a proposal entitled a "Risk Evaluation and Mitigation Strategy (REMS) for all extended release and long-acting opioid drugs.  The proposal was an effort to control the growing misuse and abuse of powerful opioids -- such as OxyContin.

But during a joint meeting of the FDA's Anesthetic Life Support Drugs and Drug Safety and Risk Management advisory committees, members voted 25 to 10 to recommend against the proposal.

"There was only one voting question, where they were asked to vote on whether they thought that the proposed REMS that the FDA had put forward was an appropriate approach to the problem we are trying to address," Dr. John Jenkins, said during a news conference after the vote.

"Ten voted yes to that question, and 25 voted no," he said. "Those who voted no agreed that a REMS was needed, but they voted no because they didn't think the proposal from the FDA was all that was needed."

The main stumbling block appeared to be that the panel members who voted against the plan wanted the training for prescribing doctors to be mandatory instead of voluntary, Jenkins said.

Jenkins noted the agency did not choose to make the training mandatory because it would have been too much for the agency to manage.

The FDA could make manufacturers run such training programs, Jenkins said. "There are approximately 750,000 prescribers who have a registration number with the DEA [Drug Enforcement Administration], and are therefore authorized to prescribe the products, and there are approximately 4 million patients who receive these drugs every year," he explained.

Sidney Wolfe, MD, Director, Public Citizen Health Research Group

So even considering having the "fox" in the hen house -- Purdue Pharma run training programs to control the growing misuse and abuse of powerful opioids after they criminally marketed OxyContin makes me question the FDA's intentions.

If Sidney Wolfe, MD of Public Citizen is calling for a congressional investigation as to why the FDA took so long to remove Darvocet/Darvon off the market, then I am calling for a congressional investigation as to why the FDA continues to allow OxyContin to be prescribed for moderate pain in light of the nationwide rate of addictions and deaths in 50 states.

And Curtis Wright, MD -- that just opens a whole new can of worms.  My guess is someone in Congress is going to want to use some of those worms to go fishing for piranha.

Wrong answer Dr. Jenkins!

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Salem-News.com Reporter Marianne Skolek, is an Activist for Victims of OxyContin 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 who pled 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 7-1/2 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.

oxydeaths.com/news_chilling.htm
nytimes.com/2007/05/10/business/11drug-web.html?
blog.nj.com/njv_bob_braun/2007/07/sometimes_only_justice_can_rel.html
judiciary.senate.gov/hearings/testimony.cfm?id=2905&wit_id=6612
You can send Marianne an email at: mskolek@aol.com
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