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May 6, 2014 | Posted By Kathleen O’Connor, MSW, MBA, MS

The governor of Massachusetts placed an emergency ban on Zohydro ER (Extended Release), a Schedule II controlled substance that is hydrocodone bitartrate in extended-release capsules.  The easily crushed capsules contain 50 milligrams of pure hydrocodone, which is 10 times more that a regular Vicodin. The FDA approved the drug with a few conditions attached last December although FDA’s advisors voted 11-2 against approving the drug due to concerns about addiction. Governor Patrick does not want the drug in his state until Zogenix, the pharmaceutical company that manufactures the drug, develops an abuse-deterrent version of the drug. He believes that adequate measures are not in place to safeguard against the potential for diversion, overdose and misuse. He was not alone in his concerns.  State attorneys general urged the FDA to reconsider and Congress called a hearing and a bill was introduced by West Virginia Senator Joe Manchin to force the FDA withdraw the drug. 

Zohydro supporters view it as a very important drug to treat chronic pain in fewer doses than hydrocodone therapies that are shorter acting and contain acetaminophen.  The battle began when “Zohydro ER was approved by the FDA after an exhaustive 18-month review of the clinical trial data.  The product’s release requires post-marketing studies as part of a Risk Evaluation and Mitigation Strategy (REMS) to assess serious risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death associated with long term use beyond 12 weeks.”   Though Zohydro is the first drug to undergo these studies, other extended release (ER) and long acting (LA) opioid analgesics will also be studied in this manner. Practioners are recommended to limit the use of Zohydro to patients whom alternative treatment options such as non-opioid analgesics or immediate-release opioids are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain.    

The executive order by Governor Patrick could be thought of as one that ignores the science and data about a new drug that does not have the damaging acetaminophen component, and one that places politics before patients. The other position is that the governor faces a public health crisis because of the extent of painkiller addiction in his state. He is just trying to regulate the drugs coming into the market Massachusetts – especially ones that are very strong, crushable and can be inhaled and injected to provide an instant and possibly lethal high. In a letter to the FDA Commissioner Dr. Margaret Hamburg by a coalition of more than 40 healthcare, consumer and addiction treatment groups the statement “In the midst of a severe drug epidemic fueled by over-prescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid.”  The FDA, as a federal government agency, may pre-empt the governor’s state’s action.  On April 16, of this year the U. S. District Court Judge Rya Zobel issued a preliminary injunction after Zogenix argued that the ban was unconstitutional.  Governor Patrick said the ruling places commercial interests above the public’s health. Judge Zobel stated that Patrick’s ban was “undermining the FDA’s ability to make drugs available to promote and protect the public health.” Patrick said the ban could be lifted if the drug was created in a non-crushable form – but that would mean Zogenix would need to return to the FDA for approval for a drug different from the one the FDA has already deemed safe. 

The state’s concerns can’t trump the legitimate use of the drug. “Although the ban may prevent someone from misusing the drug, the ban prevents all in need of its special attributes from receiving the pain relief Zohydro ER offers.”  Judge Zobel wrote. 

The volatility of the sectors involved in most aspects of opiate regulation from prescribing, distribution, and use are divided into distinct camps.  There are those who believe it is their moral duty to absolutely limit access to opiates, and there are those who absolutely believe that pain medication must be manufactured, provided by practitioners and made available to patients to offer pain relief. Both camps have strong Kantian-guided beliefs in their own morals and views and act accordingly.  The struggle will continue as conflicting views dominate and play out in the FDA, state governments, the DEA, state professional boards, practitioners and patient advocates.

A drug that can provide welcomed relief for so many people and allows them to function beyond their pain and improve their quality of life, is also viewed as the unwanted evil and feared by so many for its abuse potential. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.
2 comments | Topics: Drug Safety, FDA

Comments

Michael Schubert

Michael Schubert wrote on 05/11/14 11:04 AM

Another sensationalistic article, not expected from an educational institute. How about actually looking into hydrocodone, and why was it never developed as an injectable medication? Read below, then maybe do your own research.

Per US PHARMACIST, "Hydrocodone is only available in combination with non-opioids. Compared with codeine, it provides significantly more pain relief and a longer duration of action. Hydrocodone is a prodrug metabolized by CYP2D6, with analgesic effects dependent on its active metabolite hydromorphone." Hydrocodone needs to pass through the liver to create the active metabolite, injecting or snorting does not create a "rush" because the active metabolite has not been created yet. Other drugs such as Vyvanse use this method to PREVENT abuse. Ever wonder why legitimate medical injectable hydrocodone has never been on the market? Because it needs to pass through the liver first. An addict injecting hydrocodone would still get high, but no "rush" like from injecting morphine, oxycodone or oxymorphone. Hydrocodone is water-soluble and passes through the blood-brain barrier slower. At 80% oral bioavailability, injecting or insuffilating hydrocodone is pointless, except on a full stomach. In comparison, Morphine is between 20-40% bio available orally, that's why addicts inject morphine and others because it's MUCH stronger and NOT WATER SOLUBLE.

Sources: http://www.uspharmacist.com/continuing_education/ceviewtest/lessonid/105473/
Michael Schubert

Michael Schubert wrote on 05/11/14 11:43 AM

Also, look into the source of this negative campaign. The CEO of Zogenix says they know of 2 separate groups that want Zogenix obliterated for different reasons on their quarterly conference call. Basically, these 2 groups are guilty of criminal conspiracy. If the CEO stated this on a conference call, then the authorities are definitely looking in to this. The CEO stated that after Zohydro was approved, they were approached by a company that wanted Zohydro. When Zogenix did not want to sell, the negative, libelous campaign started. Another group started a separate attack. Here's the most popular theory, and we won't know for sure until after the criminal investigation is finished.... In the mid-2000s, the FDA wanted acetaminophen removed from combination medications like Vicodin. However, no single-entity hydrocodone medication was available, so the FDA urged drug companies to develop single-entity hydrocodone. All this information is easily found on the internet. Several drug companies began the extremely costly process of development, and Zogenix was the first to receive FDA approval. With that approval came 3 YEAR EXCLUSIVITY under Hatch-Waxman Act, which means no other drug company could introduce their product for a minimum of 3 years, most likely longer since Zogenix will switch to an abuse deterrent product and have their patent extended. Drug companies realized this, and approached Zogenix to buy their product. When they did not want to sell for what was offered, they realized the ONLY way their product could be launched is is Zohydro was removed. Enter smear campaign. A well-funded and politically connected drug company began a coordinated, pre-planned attack on Zohydro and Zogenix. Why would hydrocodone, a relatively weak opiate compared to others (click link in my other post to read about opiates) be singled out and attacked so heavily when generic oxymorphone (also not abuse deterrent at all!) is 6x more potent, much much cheaper, and highly abused all over the US? Fentanyl, an extremely strong prescription opiate is added to heroin, no mention of that. Roxicodone 30mg immediate release (no abuse deterrent either!) took OxyContins place as the most heavily abused medicine in the US, and they went after hydrocodone?!?! Since the amount of pain patients remain the same over the years, adding a new medicine won't create more patients, per the FDA the new med will just take market share away from other products. Mylan Pharmaceuticals in West Virginia markets several opiates including Morphine Sulphate Extended Release 200mg (no abuse deterrents!) and their number one product in sales, Hydrocodone/APAP. Mylan would stand to lose hundreds of millions of dollars in market share to Zohydro. Mylan's CEO, Heather Bresch, has connections however. Her father is Senator Manchin. Mylan was also Manchin's #2 campaign contributor. So begins Manchin's "Crusade Against Zohydro". Did Sen Manchin try and do anything about other non-abuse deterrent opiates, most are much more potent, like Mylan's Morphine Sulphate ER 200mg. TWO HUNDRED MILLIGRAMS. Any mention of Mylan's Oxycodone (non-abuse deterrent), Mylan's Fentanyl (non-abuse deterrent also), or any other of Mylan's opiates? Nope, just Zohydro. Sen Manchin also changed his mind about rescheduling hydrocodone/APAP to Schedule II from Schedule III, probably once he found out it was Mylan's #1 product and the much more stringent restrictions of Schedule II would hurt sales. It is so blatantly obvious, I have no idea how anyone with internet access could possibly support his agenda. The other party trying to remove Zohydro is also getting sloppy. Recently, 2 senators wrote a letter to the FDA urging them to speed up the approval of the recently submitted hydrocodone application from Purdue for "public safety concerns"..... 2 days before Purdue actually submitted the application!!! Pay to play any??? This has gotten so outlandish, but the media keeps recycling the same misinformation. It's unfortunate that most of the authors of these articles in the media are journalists fresh out of college. They were probably so excited to be picked to write the story, but little did they know that they were being sacrificed. No reputable journalist would dare make outlandish statements like "heroin in a capsule" and libel themselves, so the parties behind this assault preyed on young inexperienced journalists to write these articles. Research all this yourself.

Link to Zogenix conference call transcript:
http://seekingalpha.com/article/2205273-zogenix-zgnx-ceo-roger-hawley-on-q1-2014-results-earnings-call-transcript

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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