Parents Should be MAD as Hell Over 'Heroin in a Capsule' (Zohydro ER)

Deadly drug for Americans is Launched with the Approval of the FDA... Part 2 of a Series

Courtesy: americanlivewire.com

(MYRTLE BEACH, SC) - Link to Part 1 http://www.salem-news.com/articles/february172014/zohydro-er-ms.php 

In Part 1 of my article on Zohydro ER being available by prescription beginning in March, I received some comments from readers indicating I should suffer the pain they are experiencing. Since we are dealing with an opioid epidemic in the U.S. and Canada, I challenge these people in so much pain to experience the pain of the tens of thousands of families who have lost a loved one to the opioids in plentiful supply compliments of the FDA. Don't bother commenting to me that I am a bereaved mother with "an agenda". I am a mother who is fed up with the FDA and their ties to the pharmaceutical industry. Case in point - Zohydro ER being referred to as "heroin in a capsule" and the FDA stating the benefits outweigh the risks. How many dead bodies will be attributable to the FDA's reckless approval of an opioid so dangerous that one capsule could kill a child? The makers of Zohydro ER are sitting in their Board Room waiting for the launch of their killer drug while they think of ways to market their opioid -- how about for the pain of depression? Yes that is exactly what I said - pain of depression and it will be marketed for the pain of depression.

A few years ago a former DEA agent emailed me and advised that he had set up his own company and was offering his services as an "expert" in the opioid epidemic. Awhile later, much to my surprise, I received an email from him telling me that if I took painkillers away from his wife she would "bite my head off." Since I have never alluded to wanting to take any legitimate pain patient's painkillers away from them, I realized by his comment, he had entered the ugly world of addiction and was seeing it live in front of him.

Now I am going to challenge all those family members who have lost loved ones to heroin -- and save your blasting comments about heroin addicts -- we are now talking about a heroin-like opioid given to the country with a seal of approval by the FDA. Heroin equates to loss of lives in horrific addictions and deaths -- and now it will be available in the form of an approved opioid to be prescribed by physicians. There is a Facebook page called "The Addict's Mom" -- they have over 8,000 members on it and are setting up chapters all over the country every day. I compare it to when Mothers Against Drunk Drivers (MADD) organized years ago and made a huge impact on changing laws and saving lives. So to all the families who have lost or are losing family members every day to the horrors of heroin, I ask that you "get mad" -- never mind taking time to post poems and tributes to your lost loved ones -- the FDA does not care about your lost loved ones. They have proven it by approving Zohydro ER. I urge every family who has experienced the horrors of heroin to consider what I suggest to you further in this article - but first I will lay out just a part of the sordid story of Zohydro ER and you decide if you too are mad as hell.

Here's what a pain specialist who was involved with the clinical trials of Zohydro ER had to say about the prescribed heroin in a capsule opioid. "Zohydro ER fulfills a critical need among people living with chronic pain who meet the criteria for therapy with extended release opioids. It is the first extended-release hydrocodone medicine that is acetaminophen-free" said Dr. Srinivas Nalamachu, M.D., a pain specialist at the International Clinical Research Institute, Overland Park, Kansas. You see Dr. Natamachu is impressed with the fact that Zohydro ER is acetaminophen-free and therefore will cause less liver damage to patients. Obviously Natamachu is not concerned with the devastating deaths that will occur as result of the launch of this opioid. Care to answer why it doesn't concern you Dr. Natamachu?

Dr. Natamachu is a member of the American Pain Society. (The American Pain Society is under U.S. Senate investigation for possible financial ties to the pharmaceutical industry in the opioid epidemic). In addition, Natamachu is on the editorial board of a journal called Pain Clinician. Ask Dr. Natamachu who financially backs this journal he proudly serves on.

The makers of Zohydro TM set up an External Safe-Use panel. Here are the board members and some interesting information concerning the "qualifications" of some of these panel members:

Chairperson of the External Safe-Use Board, Jeffrey Gudin, MD, Director of Pain Management and Palliative Care at Englewood Hospital and Medical Center in New Jersey.

John J. Burke -- Law Enforcement Specialist

Mr. Burke promotes himself as a law enforcement officer with over 43 years experience. He is also one of the heads of an organization called National Association of Drug Diversion Investigators (NADDI) - financed by the maker of the killer opioid, OxyContin. Burke holds conferences all over the country at the best hotels to "educate" law enforcement about drug diversion as he is fed well by Purdue Pharma, maker of OxyContin. Burke has also become President of Pharmaceutical Diversion Education, Inc. and promotes his many talents. Which begs the question -- when does this guy sleep? All these hats worn and ties to the pharmaceutical industry -- I can see why the makers of Zohydro TM hand picked Burke for their External Safe-Use panel.

Debra Gordon, RN, DNP, FAAN -- Patient Advocate and Teaching Associate with the Department of Anesthesiology & Pain Medicine at the University of Washington (UW), Seattle.

Ms. Gordon served as a Co-Chairman of the American Pain Society. The American Pain Society is under U.S. Senate investigation for their financial ties to the pharmaceutical industry in the opioid epidemic.

Herbert Neuman, MD, MBA -- Pharmacovigilance Expert and President of R3xperts.

Scott Novak, PhD -- Surveillance Expert and RTI International.

Steven Passik, PhD -- Addiction Specialist and Director of Clinical Addiction Research and Education at Millennium Laboratories as well as Professor of Psychiatry and Anesthesiology at Vanderbilt University Medical Center in Nashville, TN.

In 2013, Dr. Passik published the below answer to this question in an article - "I’m very concerned about becoming addicted to my painkiller. What signs should I watch out for?"

Dr. Passik's reply -- "You’re not alone in being afraid of addiction; many patients share your fear. That often means they don’t advocate for themselves strongly enough to ensure they get adequate medication to control their pain. Rest assured, that fear is often unfounded." He continues with -- "Let’s begin with what you shouldn’t worry about: Patients often confuse physical dependence and tolerance with addiction. It’s true that abruptly stopping medication can lead to withdrawal (which indicates dependence), but that is a physiological issue, not a psychological one and should not be confused with addiction. Withdrawal and dependence aren’t limited to opioids, either, and dependence can develop in several weeks, or even days. Dependence isn’t something to be concerned about; you simply need to ensure you have enough medication to control your pain, and if you do decide to stop, do so gradually. Tolerance, on the other hand, simply means that more medication might be needed—that your body has built up a tolerance to a drug and/or a specific dose and you might need to increase your dosage or change drugs."

Anyone care to ask Passik how he sleeps at night saying "you might need to increase your dosage......?"

Any doubts yet why these cast of characters was hand picked by the maker of Zohydro ER to review the safety of the "heroin in a capsule" drug?

So if you are mad as hell that the FDA is digging into the billion dollar pockets of the pharmaceutical industry, here's what you can do about it. Call or email your U.S. Senator and Attorney General and demand a Senate hearing into the corrupt policies of the FDA. Send an email to the FDA's heads telling them that you have demanded action against them by your Senator and Attorney General. If you sit back and do nothing, be prepared to lose more family members. All the poems and posters of your children will not stop Zohydro ER from devastating this country because the FDA does not care about your children. They will care if they are held accountable for corrupt practices in approving "heroin in a capsule" -- are you mad as hell?

Here are the email address of the three heads of the FDA -- now it's up to you -- no one will do it for you. Do it for the family members you have lost and potentially will lose if Zohydro ER is not removed from the market:

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