Sunday July 5, 2015
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First in a Series: Why did the FDA approve Zohydro ER?Marianne Skolek Salem-News.com
Countdown to thousands of deaths and addictions with blood on the hands of the FDA!
(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.
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.
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 https://twitter.com/
Investigative Reporter for Salem-News.com covering OxyContin and prescription drug epidemic in the U.S. and Canada