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Feb-28-2014 11:56printcomments

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

Zohydro ER

(MYRTLE BEACH, SC) - Link to Part 1 

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:
LP - your encouragement, your patience, and your peace all make our journey of faith filled with love.

Marianne Skolek
Investigative Reporter for on drug epidemic


Comments Leave a comment on this story.

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Michael Schubert April 10, 2014 9:19 pm (Pacific time)

SHAME ON YOU for blaming the loss on a loved one on a medicine that helps legitimate patients in severe pain. Your loved one CHOSE to obtain/use medicines not as prescribed illegally. I had NO CHOICE with my injury.

 I know you are in pain but you should be ashamed of yourself for what you wrote above.  Marianne's daughter had never used OxyContin, she used the prescribed amount and died of a respiratory failure.  

One capsule could kill a child!?!? So then one extended release morphine 200mg (non-abuse deterrent!!!) could kill 4 people by your math!! So can one bottle of vodka. What is a child doing around prescription medicines?!? Stop blaming the parent's complete failure to raise a child properly on inanimate objects. Did the medicine jump out of the bottle and go down the addicts throat?!?! Shame on you for neglecting to recognize the needs of 100 MILLION pain patients THAT HAD NO CHOICE to protect a comparatively few addicts from themselves. What a shame

All I can say is that your diatribe is beyond pathetic, you would have the whole country drugged, you are a terrible representative even for big pharma which you clearly represent the interests of.  There are already myriad painkillers on the market, the FDA approves drugs that are not fully tested, and they ignore their own findings.  It is taking everything I have to not lay into you and tell you what I really think.

David March 16, 2014 8:50 am (Pacific time)

I cant comment on losing a child over opiods or pain killers,for this I feel very sad.However for me its either I don't medicate and become very miserable and nasty to be around or I do medicate and its as if my pain isn't there and I can move on with my life,be productive,get things done.obviously I choose to medicate and be productive and get things done.Im greatfull for zohydro,thankyou zogenix.Sincerely David.

Lisa March 4, 2014 2:04 am (Pacific time)

I wonder if the heads of the FDA and the pharmaceutical companies who created this drug would let their children or loved ones be the ones to trial this drug before it hits the market. This does need to be reconsidered. SCPatterson is right, our country does not need another highly addictive and deadly drug! I was given Oxycontin for tennis elbow when it was first released. I contacted my doctor and told them that the drug was far to strong and scary for me. The doctor's response was "we can just give you the dose recommended for children".

SCPatterson March 2, 2014 3:47 am (Pacific time)

This needs to be reconsidered please. Our country does not need another highly addictive, deadly drug.

susan March 1, 2014 10:49 pm (Pacific time)

Before a newer, stronger, everything more drug is introduced, perhaps efforts should be made to carefully restrict opiate prescriptions. addiction is epidemic. many doctors are overprescribing, with disastrous results. while there may be legitimate recipients of the new mega-opiate, situations need to be controlled and assessed before this h its the market. and you, mr. steelmill retiree, are very lucky. guess your family has never had to deal with addiction.

Mario Nickenig March 1, 2014 6:25 pm (Pacific time)

I am a 69 year old man retired with Rheumatoid Arthritis all over my body since I was 32 years old,need knee replacement on both knees,just have surgery in left hand thumb taking 2 10mg.Norco per day I will love a medication that will take away the pain all day long with just one pill,why should I care about the drug addicts do they care about me??? I am retired from a steel mill where I work for 35 years don't I deserve to live the rest of my life pain free?????

clint March 1, 2014 6:19 pm (Pacific time)

we should ban alcohol. it is responsible for 3x the deaths, millions more addicted. remember personal responsibility is someone else's job.

Angela Palmer March 1, 2014 4:26 pm (Pacific time)

Does the percription come with a preplanned funeral? The FDA is more worried about money than taking into consideration the dangers of this drug. Contact your Attorney Generals and State Senators ASAP and have Zoyhdro banned.

Sheila Carter March 1, 2014 3:59 pm (Pacific time)

PLease- do NOT release this deadly Zohydro!!! More than enough have died from oxy- and this is MUCH worse!!! A drug like this will surely be misused and will kill thousands! I am begging you to please re-consider putting this on the market.

Traci March 1, 2014 3:53 pm (Pacific time)

This drug has got to be kept from the public. It will harm more than it will help! Oxycontin is what got my son started on Heroin. There is no doubt about that. Be responsible and stop it!

J Morgan February 28, 2014 2:43 pm (Pacific time)

About the FDA's pushing of the opioid drug OxyContin...that horror in a bottle should never have been released at all.
I have, of course, personal experience of the thing and will never go near it again.
Being prescribed OxyContin for intractable pain by a doctor who might also be called an intractable pain (yes, in the butt) I gave the stuff a chance.
Took one tablet. That night, I was NOT ALLOWED to sleep. What kept me from sleeping? The effects of OxyContin. My mind would not stop racing, my body was restless, I resolved to never again use that so-called "medicine" for anything.
A few days after that hell-night I told the doctor what had happened. His response? Upsetting and, unfortunately, predictable: "Oh you never could have reacted that way to OxyContin. I have never had any patient tell me about reactions like that."
Yes I quickly gathered my belongings, coat, bag, and so on, left his office and got very busy finding an adequate doctor."
If you are offered OxyContin and if you value your sanity, do not accept any such "medication" as OxyContin.

Stoppnow February 28, 2014 1:11 pm (Pacific time)

I agree 100%. The AG response to their nice letter asking the FDA received The response was that it is needed. And I think they're finished. Senator Manchin is investigating the FDA and all should contact their elected to support. Perhaps a call to the ONDCP to inquire why the FDA appointed to position to do not answer for their lethal votes. The Senate Investigation has been going on for years yes everyone should be mad as hell. When are they going to unveil the corruption and arrests made

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