Massachusetts Ban on Zohydro a Slippery Slope

Massachusetts Ban on Zohydro a Slippery Slope

(Editor’s note: John Burke is president of National Association of Drug Diversion Investigators and Pharmaceutical Diversion Education Inc., which provide educational and consulting services on prescription drug abuse issues to law enforcement, health professionals, and the pharmaceutical industry.

Mr. Burke also serves on the Safe Use External Advisory Board for Zogenix, the maker of Zohydro, for which he receives compensation.)

John Burke

John Burke

Recently, the state of Massachusetts governor declared through an emergency order that single entity hydrocodone products could not be sold in his state. This eliminated Zohydro and any specialty compounding of the drug for patients. This of course is long after the FDA approved the extended release analgesic as a Schedule II controlled substance.

A few days before, an Ohio legislator introduced a statute to change the drug to a Schedule I in my home state, a category that means “no medical use”.  All of this was done without a single dose of Zohydro being sold or diverted!

This is an incredibly slippery slope when government decides that they will ignore the FDA, a body that has been appointed to decide what medications are safe, effective, and have value to an identified group of patients.

With the abuse of opioid medications in the 15%-20% range, 80-85% of legitimate patients are denied this choice in these states. Why not eliminate hydrocodone sales altogether, and while they are at it, remove oxycodone 30mg tablets that are being abused nationwide in part as a fallout from the reformulation of OxyContin?

Of course all of this is absurd in my opinion, and you have to wonder who, if any, healthcare professionals were consulted before moving forward with these actions. Scare tactics and the “sky is falling” type rhetoric helped to drive these decisions. In addition, news reports of the endless junkies this new drug will cause are simply unfounded.

More likely, from my experience, those that will end up abusing Zohydro are those that are already addicted to an opiate or abusing it. Other hydrocodone, oxycodone, oxymorphone, hydromorphone, morphine or heroin addicts would be the most likely abusers of an extended release hydrocodone single entity drug.

However, if you listen to some critics, this drug will bring addicts out of the woodwork!

Apparently we have a whole host of “would be” opiate addicts that have been waiting for the day an extended release, single entity hydrocodone hits the market so that they can start their life of misery and ultimate death. If you believe that, I have a very long bridge in Brooklyn to sell you!

I don’t believe anyone thinks the FDA is perfect. However, they are the federal body that determines the safety and efficacy of drugs in our country, and by and large does a good job.  I don’t want politicians deciding that a drug the FDA approved for pain patients (or any patients) is too dangerous to distribute to the public, especially when it was launched less than a month ago and no diversion has yet been reported.

The FDA continues to stand strong that marijuana is not for legal consumption (with the exception of prescription Marinol, aka dronabinol), regardless of the actions by several states to either make it a legitimate medicine or allow recreational use. Although I certainly don’t oppose the FDA approved use of THC products that are deemed effective for medicinal use, I would like to see the current U.S. Attorney enforce the laws on the sale and possession of marijuana.

If the FDA would decide to approve marijuana in any of its abuseable forms and declare it a legitimate pharmaceutical, then it should be dispensed only out of legitimate pharmacies by a registered pharmacist. Somehow marijuana legalization entities are not excited about that prospect.

The bottom line is that the primary focus of health professionals and law enforcement should be the protection of legitimate patients and their access to bona fide pain medications. Every time a prescriber or dispenser of pharmaceuticals is deceived by a drug-seeker, it can potentially have a negative impact on the legitimate patient.

Therefore, I continue to propose an aggressive pursuit of those involved in pharmaceutical diversion while the prescribers for legitimate pain patients are given all of the legal tools in their toolbox to address the issues of pain. Taking that option away from prescribers will not reduce the number of addicts in this country, but it may negatively impact pain patients.

(Mr. Burke’s column was originally published in paindr.com)

There are 20 comments for this article
  1. Bill Chaffee at 8:20 pm

    I read that the three most ototoxic OTC drugs are aspirin, ibuprofen and acetaminophen, with acetaminophen being the worst. It used to be thought that hydrocodone is ototoxic, however now that is questioned. When one drug is always combined with another it makes it difficult ascertain which harmful effects are caused by that drug. Ototoxins are substances that damage hearing.
    I have the feeling that the FDA will eventually revoke approval of acetaminophen.

  2. Bill Chaffee at 4:58 am

    Thank you for the support Margo. I wish there wasn’t so much geographic separation.

  3. Bill Chaffee at 8:38 pm

    I have some misgivings about my own porposal, which is why I call it “less of a slippery slope”. However it bothers me that research into combining an opioid with very low doses of an antagonist is underfunded.
    I live in California, which has the intractable pain act of 1990 and the pain patients bill of rights of 1997. However these two laws are often ignored.

  4. Bill Chaffee at 9:10 am

    If there is public health emergency in MA then instead of banning Zohydro, why not add one part per billion (ppb) of naltrexone to the water supply (subject to voter approval)? Many jurisdictions already add 700 ppb of fluoride to their water. That is the equivalent of dissolving a 50 mg. naltrexone pill in a 50,000 liter swimming pool. If the proposal was actually enacted then there would be a large enough sample for statistical analysis. I think that the idea is less of a slippery slope then banning a product for a competitor. It might even be beneficial to the health of some people.

  5. sam at 11:13 pm

    >>Consider the hypocrisy. Cigarettes are considered more addicting than Heroin and kill a ton more people than any opiate medication. What is the benefit to society? What medical benefits do they have? Why aren’t they banned. If it is a matter of dose or delivery system, then why isn’t hard liquor banned and only beer and wine available. Where is the potential medical benefit to people suffering daily in pain that would send 99% of most people and yes politicians to the Emergency Room for relief. NONE! Yet at the end of the day they settle down with a stiff drink and relax knowing that they took away another tool that doctors need to treat patients that may not tolerate other pain medicines. The benefit of !2 hour dosing is stable, controlled blood levels of drug which actually cuts down on the spike in the blood with short acting 4 hour dosing. Therefore, much less euphoria and the pill popping pain roller coaster ride. I personally prefer to sleep longer than 4 hours. If my medicine only lasts that long then I am going to wake up in pain. Chasing pain takes much more medicine than keeping it under control. Is it easier to control a fire on a match or a forest fire. The logic has been put away. The science is not mentioned. The clinical benefits are not discussed. Only what might happen if it is used inappropriately. With that logic, then lets ban cars. Some people will drive too fast and recklessly. When actual intelligent decision making is used, it is easy to see that the only thing that needs to be banned is the people that made this decision. I don’t go to the Dog Catcher for my medical treatment. You wouldn’t go to your local politician for a routine physical. Then why is it that unqualified people are allowed to make medical decisions that can adversely affect an untold number of people. One thing is for sure, no one can benefit from all of the research and science that went into designing and studying this drug. What has been banned is adequate pain control for who knows how many people. To me it seems rather cruel and quite unusual.

  6. Margo at 5:47 pm

    Dear Bill,
    I have suffered the same way. Where is the compassion? Just wanted you to know you’re in my thoughts and your strength is an inspiration. Maybe one day we won’t have to fight and can try to heal.

  7. Bill Chaffee at 1:22 pm

    When I was in a nursing hospital I was given two 5/500 mg. Vicodin tablets every six hours. When I complained of pain before the end of the six hour period I was given two 500mg. Tylenol tables in between the Vicodin doses. It didn’t seem to help. I would have been blamed if I had developed liver failure because I have cerebral palsy which was misdiagnosed as a psychological problem.

  8. Bill Chaffee at 3:20 am

    Some research indicates that combining microgram amounts of naltrexone with an opioid can reduce the physical dependence and other side effects of an opioid without reducing pain relief (see ultra low dose naltrexone). Unfortunately most doctors aren’t aware of it.

    One milligram of naltrexone can cause withdrawals if you’re dependent.
    Naltrexone pills on the market have thousands of times too high of a dosage for this purpose.

  9. Dave at 10:45 am

    Shiyu- The FDa is supposed to consist of officials who are our “betters” that is how our Republican form of government is justified-Otherwise we would have a democratic form of government. Nonetheless, Our Framers- such as Madison knew that not only were people not Angels- but government officials- our betters also sometimes became tyrannical- hence 3 branches of government -instead of one monolithic branch of government. “Ambition must meet ambition” is why there are three branches. And so members of Congress -and the courts have the right to serve as a check and balance on the tyranny of government agencies like the fda. I had nothing to do with the GAO reports revealing what I believe to be serious moral gaps and gaps in technical skills at the FDA. Also keep in mind Dr. Hamburg and fda staff is not required to undergo any debiasing process or have any special reasoning skills. Biases are very common in doctors. And I agree with you Legislators are biased too- that is why democracy is the best check and balance on our Republican government. It is up to people like you an me- the 4th branch of government to see our government serves us- just as our Framers realized they needed to have a revolution against a tyrannical British Government. I am not proposing a revolution- I only propose is that pain care has been hijacked by government and special interests- and that people in pain would serve themselves better if they became politically active and petition the government to be heard fully.

    With regard to FDA responding to peoples concerns about zohydro- I wrote twice to Dr Throckmorton and Dr Hamburg- without response. Responding to someone does not mean you heard and considered their concern with respect. And with regard to hearing the fda- the fact that they were found to lack the ability to interpret research by the GAO and the fact that Dr. Collins of NIH saying recently that efforts at ensuring reproducibility of research is “hobbled” and that he said the DHHS didn’t have the power alone to fix such-is another clear indication that both the research the fda reviews and their ability to interpret that research is inadequate. 50% of research is so poorly conducted that it goes unpublished-and this is a violation of what scientific research is all about. It is well known that drug companies suffer from the innovation gap in pain care-and are on a campaign to see that they can continue to hawk suboptimal treatments like opioids for conditions that has yet to be supported by the evidence pyramid.
    If condemnation without investigation is the height of ignorance so is faith in science without investigation.
    You have the right as does Mr. Burke to believe that experts should decide for you what access people have to pain care. But it is clear to me and others that leaving it up to experts and government has lead to the sorry state of affairs in pain care. And I have a news flash for you- its an easy bet that pain care will only be getting worse in the next coming years- due to societal nescience and the ambitions of government and greedy experts in the health care industry.

  10. Dawn Nulph at 8:18 am

    I struggle everyday of my life with chronic pain..
    Drug dealers have caused such a huge impact on
    My Life..Now pharmacies give us a hard time..Politicians are stepping in to stop a new pain pill that may help thousounds. If this continuous you will begin to see suicide in a big number..We never asked for this pain..Its not our fault that the drug dealers continue to make huge profits off something chronic pain suffers Dealers need just to get walking, and moving around so we can work..We have families and bills just as normal people….Taking something that was made for chronically ill patients and fully approved and the governor turns around and makes it illegal in the state..See how Drug Dealers stay in business!!!Between the pharmacies run around and politicians taking away something they can help more people be able to work instead of disability you will see a slow rise in suicide..For one day governor
    take my pain..Work in this pain..Run kids around to sports games,run home and cook dinner..Help with homework…You would not make it 2 hours in my shoes…Shame on you Mr Governor..

  11. Pharmacist steve at 8:07 am

    Color me skeptical.. if you notice that Cmdr Burke’s two association have one thing in common DIVERSION in their names.. go and read some of his monthly posts in PHARMACY TIMES
    http://www.pharmacytimes.com/search?get1=search&keywordTerm=burke
    IMO.. his whole existence is about those who will divert control drugs.. that is what law enforcement is all about.. always has been always will be..That is Cmdr Burke’s background.

    Yes, he chooses his words carefully.. depending on the audience that they are directed to..

    Read the “about” page on his non-profit organization’s page
    http://www.naddi.org/aws/NADDI/pt/sp/about_us
    I did not see one word about chronic pain, the proper use of controlled drugs or anything other than DIVERSION !

    But judge for yourself..

  12. Shiyu at 9:59 pm

    dave, Officials of FDA are human beings like us. I have no surprise to know that lots of corruptions and pay to play schemes could happen in FDA. HOWEVER, same thing could happen to politicians, too. Everything needs justification and investigation before action.

    Patrick’s epidemic makes no sense, because it’s a new drug and the quota for Zohydro ER is less than one percent of the total allotted hydrocodone product that will be manufactured in the U.S. this year.

    FDA actually responded millions of times about the approval of Zohydro. In those statement, FDA explains why it is approved, how its benefits outweight the risks and what the guidance is in FDA for those opioids. Ignoring statements from FDA and seeking to revoke FDA’s decision is indeed a slippery slope.

    If the politicians do care their people and want to solve the abuse issue, they should work together with FDA to draft a comprehensive solution as suggested by FDA, instead of simply ban a new drug from a particular manufacturer.

  13. dave at 8:00 pm

    Shiyu- The FDA consists of unelected officials- claiming expertise and claiming to serve the public good.Their expertise was challenged in a GAO reports- 13 702, 07 54, 13 560, and 14 163Sp- to name a few. A few years ago a report which found many of their staff was untrained in interpreting research results. The FDA waited 543 days before taking action against a compounders whose pain medication lead to several people in pain becoming ill. Last year the FDA was caught in a pay to play scheme with pain specialists and pharmaceutical companies- the pharmaceutical companies weren’t supposed to be their- but the FDA continued the meeting nonethless- One Senator indicated he was considering an official investigation of the FDA. Several studies have shown the FDA slow to approve of medical devices and biased towards medications.
    The FDA has a poor record of postmarketing surveillance of medications and also fails to ensure that drug manufacturers do drug drug interaction testing. And drug drug interactions are very common and lead to many thousands of hospitalizations every year.
    Government by experts leads to government for experts. The FDA serves pharmaceutical companies- the comments recently made here about fibromyalgia are further proof that the FDA is too far removed from the public good.
    As members of Congress have oversight over the FDA and Senator Schumer and other have raised objections over Zohydro- they have the right to overturn the FDA’s decisions or launch an investigation.
    Mr. Burke was very careful in not stating the obvious regarding government control over the drug approval process- I’m sure he is well paid to use words in very careful ways. Moreover, I am unaware of any effort he or his organization has made to enforce the prohibition against cruel and degrading treatment in pain care-though he claims to protect “legitimate patients” access to pain care. Let us see some proof Mr Burke- or should we just take it on faith from the experts.

  14. Margo at 7:03 pm

    Just moved to MA. Can’t get treatment. Isn’t this the medical epicenter of the world? I would rather die than live in this pain. Let those making these decisions try living one day in pain. Thank you for the article & please keep this issue out there! To those who suffer my thoughts are with you

  15. concerned at 5:05 pm

    Thanks National Pain for publishing this article. It’s time legitimate patient need is defended with the true facts. Though I sympathize with addiction concerns, pain is a serious issue for millions of people on a daily basis and many struggle with the will to live because of chronic pain and how it impacts their lives. So much misinformation only hurts legitimate patients. Responsible patients should never be penalized for the inappropriate actions of those who abuse, divert or misuse medicine. It’s a sad time to see how people in pain are being pushed aside by political agendas. Politics or addiction fears should not supersede real patient need for this acetaminophen free pain med.

  16. Shiyu Song at 4:21 pm

    Democracy is not the answer for everything. Democracy could kill people and it’s called “Tyranny of the majority”. Democracy could cause considerable damage to minority rights (the chronic pain patients in this article). I agree with this article that “this is an incredibly slippery slope when government decides that they will ignore the FDA, a body that has been appointed to decide what medications are safe, effective, and have value to an identified group of patients”. Politicians don’t have enough knowledge to make valuable, balanced and scientific judgement on medicines. Let FDA do it!!

  17. Cliff at 3:56 pm

    MONEY is the motive.Conflict of interest? Senator Joe Manchin (WV) is leading the terror attack against Zohydro. The link between Mylan pharmaceuticals, Manchin’s daughter Heather Bresch (who happens to be CEO) and direct competitor to Zogenix’s Zohydro, smells of impropriety. Manchin pretends to care for the people of WV. Mylan produces more than one opiate painkiller, Hydrocodone w/apap and extended release Morphine pills, both devoid of abuse deterrent technology.

  18. dave at 3:07 pm

    This issue represents the breakdown of the democratic process in pain care. The fad and federal government should develop a better process where all stakeholders can work together to reach decisions on this. The fact that members of Confess and most state attorney general’s are opposed to hydro is further evidence that fad decisions are not safe for democracy. Furthermore the fad was recently caught in a pay to play scheme over opioid with pain specialists and pharmaceutical companies. Let us call for restoring democracy and integrity in pain care.

  19. Robin at 1:06 pm

    Thank you! You need to say this on national news…of course I prefer Fox…trust them not to spin for someone’s agenda.

  20. Mike Fogarty at 12:42 pm

    I agree John. I’ve never understood this hysteria about extended release opioids. Most of them contain exactly TWO doses of medication and nothing anyone does to them will get more than that out of them. If absolutely foolproof tamper resistance is built in to them, nothing prevents someone from taking two of them for the same effect only twice as long. In the mean time those of us who require them for chronic pain have to put up with increasing amounts of crap added to our medications. I understand my Oxycontin now contains Propylene Glycol among other things.