Does the FDA Have a Conscience -- Or Are They Too Corrupt to Care About American Lives?

FDA approves potentially deadly drug against recommendations of their own committees, big pharma will do anything for money, and the FDA is in their pocket.

Zohydro ER photo: recoveryconnection.org

(MYRTLE BEACH, SC) - Congress has major concerns about the FDA's approval of a dangerous and highly addictive new opioid set to be prescribed in 2014.  The name of the painkiller is Zohydro ER. 

Their concern is primarily due to the epidemic of deaths and addictions in the past decade plus because of dangerous opioids -- in particular OxyContin.  Click on link to read the letter sent to the Health & Human Services (HHS) by members of Congress concerning the FDA approving Zohydro.  https://lynch.house.gov/press-release/congressman-lynch-leads-letter-hhs-secretary-sebelius-over-concerns-fda’s-recent

One of the concerns made by Congress in the letter to the HHS stated “Substance abuse is exacting a toll on America. The Centers for Disease Control and Prevention reported that there were 38,329 drug overdose deaths nationwide in 2010 and that prescription drugs were involved in nearly 60 percent of those deaths...... consistent with previous years, opioid drugs, which include OxyContin and Vicodin, contributed to 3 out of 4 medication overdose deaths.”

You may wonder how the FDA could approve another opioid when the U.S. is fighting a tsunami of deaths, addiction and abuse currently to the opioids they had previously approved. You may also wonder why the FDA has an Advisory Committee to review and approve the safety of drugs to be unleashed on the American people. In the case of Zohydro, the Advisory Committee voted 11–2, with one abstention, to recommend that the agency refuse to approve Zohydro ER because of concerns about the risk of misuse and abuse and the resulting potential impact on public health.

The FDA, in its approval of Zohydro ER, said “that the benefits of this product outweigh the risks." Morgan Liscinsky, an F.D.A. spokeswoman, said that advisory meetings for new drug approvals happen often and that the F.D.A. is not obligated to follow Advisory Committees’ recommendations.

Still wonder about the FDA? Let me add more clarity to the FDA's concerns for your family members -- and again throw the word "corrupt" out to Congress for their consideration.

“

In 2004, I was made aware that the maker of OxyContin, Purdue Pharma was set to launch yet another devastating opioid on the American people -- with FDA approval. I sent the below mailing by fax and email all over the country: TO: U.S. Senators, All Attorney Generals and Associated Press Offices RE: Purdue Pharma and OxyContin Purdue Pharma and Palladone Since the beginning of 2003, I have been waging a campaign of alerting all government agencies and news media of the mass marketing of a highly addictive Schedule II narcotic called OxyContin. This drug has been mass marketed by a privately held pharmaceutical company headquartered in Stamford, Connecticut called Purdue Pharma. I am sure you are well aware of the devastation this drug has caused throughout our country, but because of the brilliant marketing strategies used by Purdue Pharma, it is just now being exposed. My interest in holding Purdue Pharma accountable for the marketing of OxyContin is because my 29-year old daughter, Jill had the misfortune of being prescribed the drug in January 2002 and took it for four months before dying on April 29, 2002 leaving behind a 6 year old son, Brian. I would like to call your attention to a 5 part series the Orlando Sentinel started October 19, 2003 on OxyContin and Purdue Pharma. I am sure you will find it very informative and should raise quite a bit of concern for you. The concern for me is that Purdue Pharma is now attempting to get approval from the FDA for a drug called Palladone. If the FDA approves Palladone for moderate pain, I believe it will make OxyContin look like a day at the beach. Palladone will have 32 mg. of time released hydromorphine equal to 320 mgs of morphine. How much more devastation do we need to witness in families devastated by a corporation marketing profit – not pain management before they are stopped? For your information, the UK approved Palladone only for cancer pain. Please read the Orlando Sentinel 5 part series on the Internet this week to educate yourselves. In the meantime, if Palladone is approved for moderate pain and does in fact devastate this country as much as OxyContin has, I will remind you and every official in government that a whistleblower does not have to be an employee of a company – I am a mother who knows when something is very wrong with a drug company out of control – and I am a whistleblower. Her name was Jill Carol Skolek and she didn’t deserve to be prescribed OxyContin. Will one of your family members be prescribed Palladone and suffer a tragedy before the FDA is forced to weigh what OxyContin has done throughout this country before they give Purdue Pharma approval to market Palladone for moderate pain? Before Purdue Pharma begins a new campaign of abuse and diversion of Palladone, please hold Purdue Pharma accountable now and also the FDA.. Sincerely, Marianne Skolek

”

Below is the media release made by the FDA in 2005:

FDA NEWS RELEASE

FOR IMMEDIATE RELEASE P05-42 July 13, 2005

Media Inquiries: Suzanne Treviño, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

 

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.

Patients currently taking Palladone should consult with their physicians for alternative treatments. For additional information, please go to: http://www.fda.gov/cder/drug/infopage/palladone/default.htm

So in 2005, the FDA "pulls" a dangerous drug off the market called Palladone and eight years later approves another dangerous drug called Zohydro -- even with their own Advisory Committee recommending the drug not be approved. Is someone "paying to play" at the FDA because in the case of Zohydro, there has to be big time accountability to Congress and the American people -- and it can't be in a head count of deaths.

Next week more on the true meaning of the words "corrupt", "FDA", "Palladone" and Zohydro".

LP - The white swans flew off with Norman Bates even in the rain. Love the peace, the laughter and the love.

Marianne Skolek twitter.com/MarianneSkolek
Investigative Reporter for Salem-News.com on drug epidemic
www.salem-news.com/by_author.php?reporter=Marianne%20Skolek
www.youtube.com/watch?v=tmPG1VjD61U&list=UUWoHUEr4ZAbQOfIqtOArjgg&index=6&feature=plcp
judiciary.senate.gov/hearings/testimony.cfm?id=e655f9e2809e5476862f735da12c8394&wit_id=e655f9e2809e5476862f735da12c8394-2-1
www.vawd.uscourts.gov/PurdueFrederickCo/default.asp
www.oxydeaths.com908-285-1232