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Is FDA's Margaret Hamburg, MD Contributing to the U.S. Heroin and Opioid Epidemic by Living in an Ivory Tower?Marianne Skolek Salem-News.com
In the past couple of weeks, the fires continue to rage at the FDA's approval of Zohydro.
(MYRTLE BEACH, SC) - Hamburg has lost touch with reality and is not protecting the country in the heroin/opioid epidemic killing and addicting in record numbers. Why it's time for Hamburg to be fired from her position and replaced with someone who has not profited financially from pharmaceuticals.
A controversial opioid by the name of Zohydro has been approved by the FDA and has hit pharmacy shelves. The debate is heated as to how a prescribed opioid nicknamed "heroin in a capsule" and without a tamper resistant formula built-in made it through FDA's approval stages. To shed a little light on some possibilities for the approval of Zohydro perhaps some little known facts should be considered.
Before Dr. Hamburg was confirmed as Commissioner of the FDA in 2009, she and her husband, Peter Fitzhugh Brown had to divest themselves of several hedge-fund holdings as well as some of Mr. Brown's inherited drug-company stocks so Dr. Hamburg could take the post as the nation's top food and drug regulator. The couple's assets were valued at between $21 million and $40 million. Hamburg's husband had to sell his pharmaceutical stocks in Abbott Laboratories, Johnson & Johnson, Merck and pharmacy-benefits manager Medco Health Solutions. Abbott Laboratories promoted OxyContin, or "hillbilly heroin" to anesthesiologists, surgeons, emergency physicians and pain management teams in hospitals and surgery centers throughout the country beginning in 1996 -- while Purdue Pharma marketed OxyContin to all other physicians. Medco Health Solutions is a pharmacy benefits managing company that handles drug benefits for over 60 million people.
So I have a couple of questions for Dr. Hamburg. First, have you lost touch with reality in the heroin/opioid epidemic destroying families throughout the country because you live in an ivory tower financed by the money you have made in pharmaceuticals? Second, why in 2005 was the FDA able to pull a dangerous drug off the market shortly after it was put on pharmacy shelves called "Palladone" - manufactured by the maker of OxyContin, Purdue Pharma? Below is the FDA press release pulling the dangerous opioid from further devastating the country as OxyContin was doing. What is the difference between Zohydro and Palladone, Dr. Hamburg?
FDA NEWS RELEASE
FDA Asks Purdue Pharma to Withdraw Palladone for Safety Reasons
After acquiring new information that serious and potentially fatal adverse reactions can occur when Palladone (hydromorphone hydrochloride) extended release capsules are taken together with alcohol, the U.S. Food and Drug Administration has asked Purdue Pharma L.P., the makers of the drug, to withdraw it from the market.
Palladone is a once-a-day pain management drug containing a very potent narcotic. New data gathered from a company-sponsored study testing the potential effects of alcohol use shows that when Palladone is taken with alcohol the extended release mechanism is harmed which can lead to dose-dumping. Dose-dumping is a term that describes the rapid release of the active ingredient from an extended release product into the blood stream. The consequences of dose dumping at the lowest marketed dose (12 mg.) of Palladone could lead to serious, or even fatal, adverse events in some patients and the risk is even greater for the higher strengths of the product. As a result of this potential serious safety risk, the FDA has asked Purdue Pharma, and they have agreed, to suspend all sales and marketing of Palladone in the U.S. pending further discussions with the agency.
"All powerful pain management drugs have serious risks if used incorrectly, but the current formulation of Palladone presents an unacceptably high level of patient risk" said Dr. Steven Galson, FDA Acting Director of the Center for Drug Evaluation and Research. "Although we have not received reports of serious problems, this product has so far been used in a relatively small number of patients. We are concerned that as more patients take this drug, safety problems will arise since even having one alcoholic drink could have fatal implications.”
The current labeling for Palladone, approved in September, 2004, already includes the standard opioid warning against the use of alcohol and Palladone. However, the FDA does not believe that the risk of serious, and potentially fatal, adverse events can be effectively managed by label warnings alone and a risk management plan.
In the past couple of weeks, the fires continue to rage at the FDA's approval of Zohydro. Their decision to approve Zohydro has been criticized by some legislators and public health groups and Dr. Hamburg has received letters protesting the decision from 28 state attorneys general and four senators, among others. In December 2012, a panel of experts assembled by the FDA voted against recommending approval of Zohydro. The panel cited concerns over the potential for addiction. In the 11-2 vote against approval, the panel said that while the company’s manufacturer, Zogenix, had met narrow targets for safety and efficacy, the painkiller could be used by people addicted to other opioids, including OxyContin.
Massachusetts Governor Deval Patrick ordered a ban on Zohydro in his state. Vermont Governor Peter Shumlin also recently announced an emergency order to put barriers in place to doctors prescribing Zohydro to the people in his state. Both governors are doing the job to protect their state from further deaths and addictions because the FDA and Dr. Hamburg have lost sight of reality.
A New Hampshire Senate committee is considering an amendment that would put an 18 month ban on Zohydro. A press release says the N.H. Senate Commerce Committee is holding a public comment on the amendment on Tuesday, April 15 at 3 p.m. “As the state continues to struggle with a growing heroin epidemic, driven in part by a widespread availability of cheap and addictive prescription painkillers over the last decade, I believe the legislature must take a close look at highly addictive drugs like this one that could pose serious new or additional health risks to our population,” said Senate Commerce Committee Chairman Andy Sanborn (R-Bedford).
Zogenix, the maker of Zohydro announced it had assembled an oversight board designed to spot misuse of the drug. I wrote about Zogenix's "oversight board" and some of the members questionable ties to the pharmaceutical industry. See link provided here http://www.salem-news.com/
Dr. Hamburg was quick to respond to elected officials stepping up to the plate to protect the residents of their states by blocking Zohydro from being prescribed. Hamburg felt the actions taken by individual states was "extremely troubling."
No what is troubling Dr. Hamburg is that you have profited from the pharmaceutical industry prior to your being appointed the head of the F.D.A. and have no concept of the destruction of families to the heroin/opioid epidemic from your ivory tower.
As the death and addiction toll continues to mount in all 50 states, my last question regarding Dr. Hamburg is -- What will it take to have Dr. Hamburg fired for her total indifference and incompetence as regards the health and safety of the American people? More body bags?
LP - said it, lived it, prayed it, laughed it and still have what an ATM can't buy -- love!
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