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Feb-17-2014 16:37printcomments

First in a Series: Why did the FDA approve Zohydro ER?

Countdown to thousands of deaths and addictions with blood on the hands of the FDA!
Heroin in a capsule will be coming to your local pharmacy and medicine chest in 2 weeks -- it is called Zohydro ER!!!!

FDA approves Zohydro ER

(MYRTLE BEACH, SC) - Is the Federal Drug Administration (FDA) immersed in corruption with their approval of a highly dangerous opioid? I'll lay it out and you decide if there has to be a "showdown" at the FDA by every Attorney General in the country as well as the U.S Senate.

How could the FDA approve yet another dangerous opioid when the U.S. is fighting an epidemic of death, addiction, abuse and inadequate drug rehabilitation facilities to combat the addiction to opioids? Why would the FDA disregard their own Advisory Committee who reviewed the application of Zohydro ER and recommended 11-2 not to approve the dangerous opioid because of the Committee's concerns about the potential impact on public health?

Want an idea of why the FDA's own Advisory Committee did not approve Zohydro ER? Zohydro ER will be the first hydrocodone-only opioid in doses of 5 to 10 times more heroin-like narcotic than traditional hydrocodone products such as Vicodin. Yes you read that correctly "heroin-like" narcotic. Do I have your attention yet Attorneys General and U.S. Senate?

Why does the FDA cite their reason for approving Zohydro ER being it is the first extended-release formulation hydrocodone therapy without acetaminophen (Tylenol)? Is the FDA more concerned about acetaminophen over long periods of time causing liver injury than concerned with a heroin-like prescribed opioid with the potential of killing and addicting in the tens of thousands? Keep reading Attorneys General and U.S. Senate. It gets better and if you are groping for a word here -- consider the word "corruption".

How could the FDA approve Zohydro ER when there is no abuse deterrent built into the drug and when it is crushed chewed or mixed with alcohol -- there is an instant kick? Didn't the FDA violate their own directive that opioids would only be approved by them if there were a built-in abuse preventative in the drug? Anyone question why the FDA feels Zohydro ER should get a free ride and have the built-in abuse preventative added to the drug in the future? How many deaths will be attributable to the FDA catering to the maker of Zohydro ER instead of to the lives of the American people? Keep reading Attorneys General and U.S. Senate -- it gets uglier.

Dr. Bob Rappaport, FDA

Bob Rappaport, MD and Director of Anesthesia, Analgesia and Addiction Products at the FDA was quoted as saying the FDA did not want to be seen as "punishing this company (Zogenix) and this drug (Zohydro ER) because of the sins of other companies and their product." Sins of other companies, Dr. Rappaport? Your agency approved these "sins" and now you recklessly approved "heroin in a capsule" -- but thank goodness it doesn't contain acetaminophen because that could cause liver damage.

Dr. Srinivas Nalamachu

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. Also, a significant proportion of patients on existing forms of immediate-release hydrocodone-acetaminophen combination treatments have liver disease or risk factors, and the availability of an acetaminophen-free formulation encompassing a range of hydrocodone doses is an important therapeutic option for these patients," said Dr. Srinivas Nalamachu, M.D., a pain specialist at the International Clinical Research Institute, Overland Park, Kansas and investigator in the clinical trials of Zohydro ER

More on the very interesting Dr. Nalamachu next week.

Since Zogenix will be unleashed on the American people in 2 weeks, in a very cavalier effort, Zogenix established what they called an "External Safe-Use Board. Here's where things become more interesting -- the players involved on this Board and who they are associated with. They are considered experts to provide independent oversight and recommendations -- but what are their affiliations to the FDA and the lucrative pharmaceutical industry? These affiliations will be outlined next in my series on Zohydro ER before its launch in two weeks.

Zohydro TM External Safe-Use Board 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 (with a resume that will raise the eyebrows of every Attorney General in the country as well as the U.S. Senate).

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's resume should raise the hairs on the neck of every Attorney General in the country and the U.S. Senate).

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.

In the countdown to Zohydro ER (heroin in a capsule) and the blood on the hands of the FDA for approving this opioid, my next article before the launch of Zohydro ER will be focusing on the word "corruption" and hopefully Attorneys General and the U.S. Senate will agree with my focus. Tens of thousands of lives hang in the balance as the clock ticks away to "heroin in a capsule" compliments of the FDA in two weeks.

LP - Even when I step into your "heaven zone" from my "hell zone" you are understanding and bring me such love and peace.

Marianne Skolek



Comments Leave a comment on this story.

All comments and messages are approved by people and self promotional links or unacceptable comments are denied.

Karen Brasher February 24, 2014 12:16 pm (Pacific time)

Does Seboxone ring a bell. The drug prescribed to help addicts get off opiods. Well now it is abused and being sold on the streets. What are you The FDA doing? There is a epidemic in our country and legalizing more and more drugs is not the solution. There is such a stigma that if it can be prescribed it can be better managed. Really? There are doctors out there now that abuse their right to prescribe pain medication and now lets add one more drug to their prescription options. God help this country. We are loosing our children, children loosing their parents to these so called legal drugs. It is all about the mighty dollar.

Traci Spain February 24, 2014 7:45 am (Pacific time)

I don't even know what to say except that these drugs are dangerous whether someone has a history of addiction or not. Please educate yourselves. This drug will kill many.

Anonymous February 23, 2014 11:32 pm (Pacific time)

The warnings for this drug are enough to scare anyone away from it. Yes, as usual, follow the money. Too much death from overdoses - too many caskets. Once people become addicted...then what? Ineffective and outdated treatments, jails/prisons, or death. More pill mills and more profits for doctors, too. No abuse deterrent built in. Do not trust big pharma.

Pamela Kirgin February 23, 2014 8:32 pm (Pacific time)

In this time of an addiction epidemic parents are losing their children, children are losing their parents,our families are forever changed. So we count dead kids ad you they count their money....SHAMEFUL

Patti David February 23, 2014 8:10 pm (Pacific time)

what the hell are we doing here, you know the deadly drug overdose epidemic that is killing our children to the tune of one every 19 minutes we are fighting to gain control over, who the hell is making these horrific decisions that will only bring more death and pain and agony for families. I am appalled and disgusted, have you no shame, no conscience, no compassion for humanity anymore, is greed really what we have become all about??? God HELP us and destroy these who are killing our children, your children!!!

Joanna Cain February 23, 2014 7:23 pm (Pacific time)

While I understand that some people have a need for chronic-pain medicine that does not contain acetaminophen, what about the need to protect people from addiction? You ask why the FDA would go against their own advisory committee? Follow the money!

Dody Pinkerton February 23, 2014 7:05 pm (Pacific time)

We are fighting an epidemic and now you want to add to the list of what's killing our children. This is outrageous. It's all about the almighty dollar. Are all the addictions and death worth it.

Mary Beth Murtha February 23, 2014 5:19 pm (Pacific time)

The FDA is breaking it's own rules approving this drug with no abuse deterrent built in. I have compassion for those who struggle with chronic pain, I have a chronic illness myself but this kind of opioid is not the answer.

Cindy Koumoutzis February 23, 2014 3:55 pm (Pacific time)

It sounds like a fentanyl/heroin outbreak made legal in my opinion. And the left hand feeding the right. Vivitrol to fix what Zohydro creates. Money from both sides.

Duana Wilkins, Executive Director of February 23, 2014 3:20 pm (Pacific time)

I am so concerned about this. We must get involved and have our voices heard! We are consumers and we can refuse to buy and/or use this drug if it is not removed from the market.

Lauri February 23, 2014 3:16 pm (Pacific time)

We don't need another pill that delivers death! Enough already!!! All you people who claim that you suffer from chronic pain... do you realize that chronic pain is one of the side effects (a withdrawal symptom) from pain killer addiction? How about trying something different, like physical therapy? I too suffer from fibromyalgia, nerve damage, and degenerative disc disease in my back and neck which cause horrible pain. Try some physical therapy, moist heat, regular aerobic exercise, relaxation, and stress reduction to help you self-manage your symptoms. Not everything needs to be treated with an addictive pain killer!

What a pain February 21, 2014 3:24 pm (Pacific time)

You need to spend a week or more experiencing what it is like to suffer from severe chronic pain and be told that the drugs that will help you function on a daily basis are no longer available!

Don't Punish Me February 21, 2014 3:20 pm (Pacific time)

It is true that big pharma has profited at the expense of human life, but it is also true that there are many people that live every day with very severe chronic pain. Companies that have marketed products that people are abusing need to be made responsible, but chronic pain patients should not suffer. If the company marketing Zohydro ER does not market the drug responsibly, then they should be held liable. However, if they put programs in place that monitor and fight the abuse of their drug, then they should be applauded. Let's keep things in perspective people!

Chris February 18, 2014 9:35 pm (Pacific time)

It is unfortunate that you lost a daughter to an OxyContin overdose... but please don't treat the American public like little children. Nobody is putting a gun to our and forcing these pills down our throats. As someone who suffers from chronic pain (and doesn't abuse drugs), this drug will be very beneficial to my life. Please don't get in my way of purchasing something that will benefit me... or the freedom of Americans to make their own choice.

Stan Timmons February 18, 2014 3:13 pm (Pacific time)

I can't see where Ed ( the comment below) insulted your staff in his comment. There is no way Zohydro ER is as harmful to the public as your attempt at journalism is to readers seeking unbiased reporting. This is a hatchet job , and poor one at that.

"You are beyond an idiot" - are you just trying to be funny Stan?  You don't see what?  This article is powerful and frankly it is causing a little storm today, I'm not surprised by the reaction from the industry, trust me.  This is the truth, call it what you will.

Disappointed February 18, 2014 2:59 pm (Pacific time)

The writer of this story has an agenda, this is not unbiased journalism and Zohydro ER is not "herion in a pill" . Sorry that you lost a daughter to an OxyContin overdose, but that is not the drug company's fault. Everyone one knows the dangers associated with narcotics, no matter how the drugs were marketed, educated people have known that opiates are addictive since Galen used them to treat Roman gladiators. You sound like a pissed of PTA member who child didn't make the cheer leader squad.

Anonymous February 18, 2014 2:57 pm (Pacific time)

I completely support this article, the writer is accurate, there are endless drugs already on the market, this is dirty blood money that big pharma expects to gain.

ed rylant February 18, 2014 6:36 am (Pacific time)

You are beyond an idiot who seems to be presenting a story from the side you want to present. Why don't don't you try taking the side of those in chronic pain and see what they have to say, or is that too far outside what you wanted to portray here.

"Beyond an idiot" is abusive and unacceptable.  So you have to have a new drug to manage pain do you?  Listen, nobody is against reasonable pain treatment, this is about drug company profiteers and people in official capacity lying and death, more death... you're still alive, many people are not due to the actions of these drug companies.  Don't insult our staff in comments.  

Why did the FDA approve Zohydro ER February 18, 2014 6:04 am (Pacific time)

When bad decisions result in such harm to the public shouldn't 't there be accountability? Or is this another powerful govt agency above the law and out of control. They should recall oxycodone or maybe 16,000 deaths in one year and the fact that once addicted leads to heroine maybe is not a good enough reason. We should petition to replace the current FDA

Law February 18, 2014 3:46 am (Pacific time)

Who ever wrote this pessimist, these are false accusations and this is defamation of this business.

The writer of this article lost a daughter to an Oxycontin related respiratory failure and spent years raising her grandson as a result.  Her family is among those who convicted Purdue Pharma for marketing OxyContin as both "non lethal" and "non addictive".  These drug companies are foul in their practice and factual news is not defamation. 

Patty February 17, 2014 5:34 pm (Pacific time)

Good exposure to the eminent death toll that will rise as this pill rolls out to the public. Look forward to your next article. This is the definitive insanity .

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