Summary/Abstract

Big Pharma builds body shop next to race track. Alkermes, is the maker of Zohydro a highly addictive opioid pain management medication and Vivitrol, an opioid addiction and alcoholism treatment medication. Alkermes appears to have close ties to experts in the field of substance abuse treatment and is a financial contributor to the American Society of Addiction Medicine.as well as a frequent sponsor for many addiction treatment conferences. So, we have a pharmaceutical company that makes a highly addictive opioid drug as well as a drug for opioid addiction treatment making financial contributions to addiction treatment industry associations comprised of alleged substance abuse experts. As the old saying goes, there appears to be something rotten in Denmark. Have we lost our moral compass?

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“One has to wonder how many more pain patients have to be harmed, how many more people have to become addicted, how many more lives will have to be lost,” he said, “before the F.D.A. finally begins to exercise its authority and responsibility to prohibit drug companies from marketing opioids as if they have been proven safe and effective for long-term use.”

Andrew Kolodny, MD -  Chief Medical Officer of Phoenix House

Big Pharma Builds Body Shop Next to Race Track.

Alkermes, is the maker of Zohydro ER which is a potent, highly addictive schedule II opioid used for moderate to severe pain management and Vivitrol, an opioid addiction and alcoholism treatment medication. It is scheduled to be available in March of 2014. The primary ingredient in Zohydro ER is hydrocodone which currently is available to the public under the brand names of Vicodin, Vicodin ES, Vicodin HP, Anexsia, Lortab, Lorcet, Lorcet Plus, Norco, and Zydone. It is the most highly prescribed opioid in the US with over 131 million prescriptions written annually. These current forms of hydrocodone contain diluents just as the oxycodone formulations did prior to the development of Oxycontin ER.

This is déjà vu all over again. These guys have taken this business model one step further than their predecessors at Purdue Pharma. This business model is similar to MRP but I am renaming it to Addiction Requirement Planning. Opioid Addiction is "a chronic, often relapsing brain disease" according to the American Society of Addiction Medicine. So as logic might suggest, the cycle would include two primary input cohorts: the individual with no prior addiction history and the individual with a previous or current substance use problem. The next step in the cycle is continued use for the first cohort and use and abuse with the second cohort. Next step is dependency and subsequent treatment with (you guessed it) Vivitrol and then potentially relapse. The cycle repeats. In some financial circles this is referred to as an annuity.  Should the cycle be interrupted by incarceration, the prison industrial complex then profits. Mortality  is merely collateral damage and actually good marketing material for the addict who forever is seeking the more potent product. As with Purdue Pharma, future law suits will be written off and classified as the cost of doing business. 

Purdue Pharma was the first pharmaceutical company/cartel that ingeniously developed an addiction business model by eliminating the diluents (acetamophin - Percocet;  aspirin, caffeine - Percodan) in traditional oxycodone products and initially developing an extended release compound that was manufactured in high dosage forms that could be administered intravenously. A junkies dream was born and Purdue Pharma's multi-billion dollar pharmacological nightmare, Oxycontin, aka Hillbilly Heroin, became a household word synonymous with addiction. treatment admissions, emergency room visits and overdose mortalities skyrocketed nationwide. From the initial point when medical and law enforcement personnel identified its high addiction potential, it took over eight years to modify the drugs delivery system to preclude intravenous administration and lower its abuse potential.

Zogenix, the licensed distributer, aka dealer, for Alkermes, has announced it is pursuing the Development of Abuse Deterrent Formulations of Zohydro(TM) ER with Altus Formulation a Canadian pharmaceutical firm. A press release on 11/1/2013 included the following disclaimer regarding forward looking statements. Please note that these are foward looking statements which means that this drug may come to market prior to any modification in its formulatiion as did oxycontin ER.

Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding: the potential to develop abuse deterrent formulations of Zohydro ER with Altus and the potential exercise of the licensing option by Zogenix under the D&O Agreement. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: risks and uncertainties associated with the development and regulatory approval of an abuse deterrent formulation and Zogenix's reliance on Altus and its drug delivery platform in such development efforts.

Perhaps, the most problematic aspect of this is that once again capitalism trumps ethics. signaling that that the new formula for defining what constitutes acceptable ethical and moral practices in commerce is determined by a single financial equation - acceptable = revenues > liabilities. The value of human life and human suffering have now mutated into a mere accrued liability.  

Alkermes appears to have close ties to experts in the field of addiction treatment, and is a financial contributor to the American Society of Addiction Medicine and a frequent sponsor for many addiction treatment conferences. So, we have a pharmaceutical company that makes both a highly addictive drug and also a drug for addiction to their product. Is that a Fox in the chicken house? 

I find it morally repugnant that the addiction industry leaders and the FDA will knowingly partner with a pharmaceutical firm that is premeditatively launching a product that potentially will claim thousands of lives. However, this is characterictic of todays American Corporate Society and the Temple of the Almighty Dollar. This is Sociopathic Capitalism at its zenith. Great society? Sadly no more. Looking for a bronze moral compass, try Ebay.

Further reading on the topic. See Video at bottom

Attorneys General Ask FDA to Rethink Zohydro ER Approval

Susan Jeffrey | MedScape | December 12, 2013

The attorneys general of 29 states and territories have sent a letter to the US Food and Drug Administration (FDA) asking that the agency consider reversal of its recent approval of a single-entity extended-release hydrocodone product (Zohydro ER, Zogenix Inc).

The letter is addressed to Margaret Hamburg, MD, FDA Commissioner of Food and Drugs.

"We believe your approval of Zohydro ER has the potential to exacerbate our nation's prescription drug abuse epidemic because this drug will be the first hydrocodone-only opioid narcotic that is reportedly 5 to 10 times more potent than traditional hydrocodone products, and it has no abuse-deterrent properties," the attorneys general write.

"We hope that the FDA either reconsiders its approval of Zohydro ER, or sets a rigorous timeline for Zohydro ER to be reformulated to be abuse-deterrent while working with other federal agencies on how Zohydro ER can be marketed and prescribed," they conclude. "Law enforcement officers, public health workers, and substance abuse treatment providers are just now beginning to stem the tide of prescription drug addiction. We do not want to see their dedicated work undone."

Asked for comment, the FDA press office told Medscape Medical News that the agency is reviewing the letter and plans to respond directly to the attorneys general.

On November 1, Zogenix announced a new collaboration with Altus Formulation Inc to develop an abuse-deterrent formulation of Zohydro ER.

A "Vicious Cycle"

Zohydro ER was approved in October "for the management of pain severe enough to require daily around-the-clock long-term treatment and for which alternative options are inadequate," the FDA said in a statement at that time.

"Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids," the FDA statement said. "Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA [extended-release/long-acting] opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain."

The decision to approve the product had many puzzled, both because the FDA's decision went against the recommendation of the agency's advisory panel and because of its proximity to another decision, to reschedule all other combination hydrocodone formulations, including the hydrocodone-acetaminophen combo Vicodin, from Schedule III to Schedule II, increasing security measures associated with its use in an effort to reduce misuse.

"By early December, FDA plans to submit our formal recommendation package to HHS [US Department of Health and Human Services] to reclassify hydrocodone combination products into Schedule II," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statementposted on the FDA Web site October 24.

The approval of Zohydro ER was "more shocking to me than this announcement," Edward Michna, MD, member of the American Pain Society, told Medscape Medical News at that time. That these 2 events happened back-to-back is "kind of odd," added Dr. Michna, who is director of the Pain Trials Center at Brigham and Women's Hospital and assistant professor at Harvard Medical School, both in Boston, Massachusetts.

"Zohydro is another drug that doesn't have abuse-deterrent technology; so you have another opioid in high dose that is going to be released [in the midst] of pressure on drug companies to develop abuse-deterrent drugs," Dr. Michna noted.

Signing the letter addressed to the FDA are attorneys general from Alaska, Arizona, Arkansas, Connecticut, Delaware, Florida, Georgia, Guam, Hawaii, Illinois, Indiana, Iowa, Kentucky, Maine, Maryland, Massachusetts, Michigan, Mississippi, Nevada, New Hampshire, North Carolina, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, and Washington.

What they don't want, they write, is "a repeat of the recent past, when potent prescription painkilling drugs entered the market without abuse-deterrent qualities and without clear guidance on how they were to be prescribed. This created an environment whereby our nation witnessed a vicious cycle of overzealous pharmaceutical sales, doctors over-prescribing the narcotics, and patients tampering with these drugs, ultimately resulting in a nationwide prescription drug epidemic claiming thousands of lives."