When Politicians Play Doctor

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When politicians play doctor: patients lose, but politicians still win.

The political and media assault on an important new pain medication, Zohydro ER, continued this week. New actions by state officials have provided further proof that our elected leaders would rather grab headlines than help their pain-suffering constituents – another needlessly sad episode of “When Politicians Play Doctor.”

This week, Vermont Governor Peter Schumin issued an executive order creating barriers for medical professionals to prescribe Zohydro ER in his state. His action stopped short of attempting to ban Zohydro ER, which was the tactic adopted by his fellow New Englander, Governor Deval Patrick of Massachusetts, who declared that Zohydro ER could not be sold in his state.

Despite the FDA approval of Zohydro ER, and the steadfast defense of the medication in light of a proven patient need, these Governors decided they know more than scientists and professionals at FDA. With the stroke of a pen, they threatened the promise of a unique, new pain medication developed specifically for a subset of people who suffer from chronic pain, but who cannot take other hydrocodone medications containing acetaminophen.

The makers of Zohydro ER, Zogenix, fought back this week, filing a lawsuit in Massachusetts to overturn Governor Patrick’s executive order. After hearing the case, the Federal judge indicated she would likely grant Zogenix a temporary injunction against the ban. She stated the Governor had no jurisdiction to undercut the FDA. She scolded the state for not even consulting the company before banning it from Bay State pharmacies.

If Zogenix ER successfully gets the Massachusetts order overturned in Federal court, hopefully other state governors, state attorneys general and legislators will hopefully think twice before playing doctor.

These knee-jerk attempts to undermine the FDA are ostensibly grounded in a deep concern about heroin addiction and misuse of prescription opioid drugs. There is no question that illegal use and diversion of prescription medications is a major public health issue. These governors are right to make it a national and state priority.

But while their motivation, in most cases, may be well-intentioned, their policy “solution” in this instance is totally misguided. More pointedly, these politicians ignore the needs of thousands of their own constituents – people suffering every day from serious, chronic, debilitating pain.

Jeff ZORRO

And for some politicians, the true motivation underpinning their proposed actions is in question. One of the most outspoken critics of Zohydro ER is Senator Joe Manchin, Democrat from West Virginia. Senator Manchin has drafted a bill to outlaw Zohydro ER, once again citing the “national epidemic” of opioid abuse, particularly in his own state. But a closer look at Senator Manchin’s connections and contributors leads me to think his motives may be more self-serving.

While the Senator rails against hydrocodone, it turns out one of the largest hydrocodone manufacturing centers is in his own state, in Morgantown. That plant is owned by Mylan Laboratories, a leading manufacturer of hydrocodone, oxycodone and morphine products. And who is the CEO of Mylan? Heather Bresch, Senator Manchin’s own daughter!

Beyond the obvious hypocrisy of Senator Manchin’s opposition to Zohydro ER, there is more troubling evidence of a potential conflict of interest. As Zohydro ER enters the market, and is prescribed more regularly to suffering patients who cannot take acetaminophen, it will take away market share from Mylan’s own hydrocodone products. According to Open Secrets, Mylan is one of the largest contributors to Senator Manchin’s campaigns.

I’m a clinician, not a politician. I wouldn’t dream of playing politics with my own patients’ health. But even I can see troubling signs in the Senator’s political crusade against Zohydro ER. For all the attention the news media has given to Zohydro ER, they should spend a little extra effort on exposing what – and who – is behind a coordinated campaign against an important medication option for people with chronic pain.

As always, comments are encouraged and welcome!

31 thoughts on “When Politicians Play Doctor

  1. If politicians would only be so hard on illicit drug dealers we may stand a chance of wiping out heroin laced with fentanyl being sold in the streets. Punish drug dealers and street drug users not patients. Or make heroin legal, clean it up, put dealers out of business, open drug use centers with needle exchanges and place it between a morgue and hospital. See how that goes, but please leave chronic pain patients alone.

  2. If we could only hold politicians accountable for passing legislation and supporting laws that have negative effects on the people they are supposed to be representing. Being a veteran it bothers me to see government overreach with nowhere to turn for help. The government has been out of touch with the American people for years and I am always amazed that no one can see the problems we have with big government and small minds..

  3. Thank you for another great post. As a disabled patient with chronic pain I hate the discrimination and begging for relief. I appreciate your understanding and the Information provided. Tennessee is targeting the doctors and pharmacies that use narcotics with no regard to the patient. One important fact is that the medication politics are trying to deny are the ones that keep me walking.

  4. If I was a mean spirited person I would wish that these politicians could feel my pain for one day. Because I k ow it would put a stop to this sort of thing. But I would not wish the pain of arachnoiditis on another human being. Thanks paindr for fighting for us.

  5. Could not the problem be solved by a state using its controlled substances act to “up scheule” hydrocodone products without acetaminophen or aspirin in them to Schedule I of the act. that would make them illegal in that state.

      1. Dr. Fudin I wonder if we could pass a piece of legislation of our own that would hold politicians liable in some way for intruding into our lives. Being a veteran it really bothers me to see elected officials with complete disregard to our freedom and continue to force their will upon us for the sake of a headline.

  6. Awesome article Dr. Fudin, as usual. Thanks for standing up against the politicians. Now, if we could find way to call off the DEA we would be in much better shape. I wish there was way…
    Sadly, nothing is better here in Florida.
    We appreciate you very much for supporting us .

  7. Dr Fudin,
    First off, thank you for your article.
    Secondly, (in regard to Senator Manchin) why don’t you notify the senate ethics committee and other organizations/media outlets about this connection? I have known about this connection for a long time now, however no one in the media is reporting the story despite my efforts and the efforts of others.
    If a doctor were to notify some of these outlets maybe they would listen and expose Senator Manchin. The senate ethics committee website says this under > conflict of interest > basic principles
    Legislative Action

    “A Member, officer, or employee may not use his or her official position to introduce or pass legislation, when the principal purpose is to further the official’s or an immediate family member’s financial interests, or the financial interests of a limited class to which such individuals belong.”

    Now, doesn’t it seem that Senator Manchin has shown a clear conflict of interest with his family member working for the competition that stands to lose market share to Zohydro ER?

    Thank you for your article, we need more brave people like yourself with a format to speak and be heard to shout from the rooftops about this!

      1. Dr Fudin, did u by chance make any headway with not so ethical, senator joe manchin! This article put tgecmussing pieces of the puzzle together 4 me! I just knew fragments now it’s complete!

  8. Hello Dr Fudin and readers. Dr Fudin, applaud your support for those like myself that struggle with Chronic Pain (Chronic Hell). How easily 100 million Americans that had no choice when forced to live with chronic pain were overlooked by one politician’s shameless attempt to secure market share for his #2 campaign contributor. Almost as insulting is this Senator must truly believe that the American public is too stupid to connect the blatantly obvious dots. Unfortunately, other politicians read about Sen Manchin’s crusade against “the most potent killer drug ever” and saw it as a slam dunk to get such a evil potent drug removed…….until the facts got in the way. For many like myself, this medicine could be the difference between a good day and a bad day. That might not seem very important to most, but a good day for myself and other sufferers might mean the excruciating pain episodes only lasted half as long as usual and the background pain was tolerable enough to do something most take for granted. And the bad days…. no point in depressing anybody, but what you are imagining now is probably an accurate description. The most shocking part of this whole situation is that while Sen Manchin is crusading against a non abuse deterrent hydrocodone, he has no problem whatsoever with Mylan’s Morphine Sulphate Extended Release 200mg (without abuse-deterrents) or Mylan’s fentanyl patches. Ban beer but leave Bacardi 151 and moonshine on the market?!?! I know that’s an inappropriate comparison, especially coming from someone who believes very passionately that these medicines should remain accessible to all patients in need, but that is an easily understood metaphor for potency. Thank you sir for your bravery, exposing the truth took a whole lot of guts. Most importantly, I feel like I can speak for every single one of the silent 100 million when I say thank you for your support.

  9. Thanks for another great post, Dr. Fudin!

    How disgusting to learn of Senator Joe Manchin’s deceit and greed. Even more disturbing is that my own MA Governor Duval Patrick could care so little about the patients who could significantly benefit from Zohydro ER. As the one year anniversary of the Boston Marathon bombing approaches, I wonder if he realizes that some of the very survivors that he has sworn to help and support, could be some of the same patients being denied access to this medication.

    Can he not see the connection between those survivors who were mangled, and left with devastating permanent injuries and the type of non-cancer chronic pain patients that require longterm opioid therapy? I have often wondered how long it would be before we started hearing stories about our city’s bravest, most courageous, and most public victims of debilitating pain being denied access to opioids. I figured it might take a year or so before hearing that some of them were caught up in this CRISIS that is hurting patients with pain. Perhaps this is just the beginning of that. Clearly THEY aren’t malingering, faking, and feigning pain.

    SHAME on Governor Duval Patrick for putting politics ahead of the needs of the thousands of patients who live with debilitating, painful, medical conditions in Massachusetts. Whether that pain comes from a cowardly terrorist attack on a major city, an inherited genetic condition, an accident, or some other health crisis… What kind of world are we creating , when our disabled and vulnerable citizens are left to suffer in favor of ignorance, financial gain, and grandstanding?

    I am not belittling the devastating effects of addiction, overdose, and death. However….perhaps if we start treating addiction as a medical condition instead of a moral or law enforcement issue, and start treating debilitating chronic pain as a medical condition, instead of a psychological weekness or character flaw… We can start making some progress. It seems that ONE way to do that would be to keep politics out of medicine.

  10. It just goes to show that big pharm money will get are elected officials and media to say anything. SHAME ON ALL OF THEM

  11. Bravo, Dr. Fudin! And thank God for physicians like you and Dr. Murphy, who have the courage and the commitment to stand up for what is best for patients in this politicized and potentially dangerous environment. If politicians would stay out of medicine and education, and concentrate on what they were elected to achieve, the rest of us could do our jobs.

    1. Thank you Dr. James. It’s great to see someone weigh in with your background and perspective in administrative education and the social sciences! Stay tuned – there’s lots more to come.

  12. The reason Zohydro ER was made, is to have a hydrocodone product available without Acetaminophen. I don’t think abuse deterrent technology is needed in this medication for now and it would do more harm for politicians having a say so in what medications are sold in their state. After all wasn’t it Massachusetts… home of the New England Compounding Center killing 60 odd people from contaminated product by state lack of oversight ,,,we cant ask them if they would benefit from Zohydro ER but could ask the 700 odd people still suffering from contaminated product that was injected into their spine and they ended up with fungal meningitis if Zohydro ER might be of some help.

    1. Being a retired physician with a cauda equina injury and disability with pain, I find it , almost, impossible to get compassionate, adequate care for my post traumatic pain. The politics of medicine lost me my practice and now denies me the quality of life that I should have. Something has to change. People in chronic pain from an incurable disease, should get adequate medication. But, doctors are afraid of losing their practices after the DEA comes in, takes all of their patient records and put all of the doctors assets in their control. It is a no win situation. So, it is an easy choice…do what we say or lose your practice, your love…your medical practice, and ignore the people that need compassionate care. It is like they are saying “we don’t want you to practice cutting edge medicine”! When will the
      “authorities” admit they are not as well prepared to take care of the patients than their personal doctors.

  13. Nice blog, Jeff. However, I disagree with you on one point. People like us should and do play politics in our efforts at patient advocacy. Jim Giordano’s and I have posited that the righteous pain doctor is not only the patient’s therapeutic agent, but his/her MORAL agent as well. Whatever it takes. Even playing politics.

    1. 🙂 Okay michael, I can’t disagree with you there. Let me clarify; “I wouldn’t dream of playing politics with my own patients’ health.” Essentially, I wouldn’t place myself in a position whereby a governmental action could either place me in jail, harm patients, or be construed as seditious. Other than that, yes, we all go to bat for our patients to “lobby” or “politic” for better care, coverage for various interventions, tests, medications, etc. Bottom line, I can’t disagree with you but the politics outlined herein are far removed from any sort of activity I’d expect from a clinician.

  14. Excellent post, Jeff — love the ‘Dr. Uncle Sam’ graphic. Certainly, these are confusing times. The FDA approves drugs for marketing on the basis of their demonstrated clinical efficacy and relative safety profile (if prescribed and used as directed). Yet, they also appear to be concerned with misuse; hence, the ER/LA-opioid REMS mandates. It seems that the FDA could have drawn a ‘line in the sand’ so to speak, demanding that, going forward, all newly-approved opioid formulations must have abuse-deterrent features of some sort. One must also wonder why the manufacturer of Zohydro did not ‘go the extra mile’ and incorporate such features into their new product. Not that abuse-deterrent features are foolproof, since the fools who would abuse opioids can be so desperately clever; but, that’s a separate issue.

    1. Zogenix is working on an extended release abuse deterrent version, but until it is approved, this medication the current available product can be an excellent and viable choice for those it is intended for. As pointed out in the link below, a majority of opioid overdoses involve acetaminophen poisoning. Why would we wait, especially when according to the FDA tamper proofing technology is not flawless? Responsible patients should not be penalized for those who abuse, misuse and divert. If I have a choice, I choose to spare my liver. Helping patients with chronic pain should be the first order. I applaud Dr. Fudin for his candor and willingness to shed light on perhaps the most disturbing issue facing medicine-political interference.. See http://ir.zogenix.com/phoenix.zhtml?c=220862&p=irol-newsArticle&cat=news&id=1917939 for the facts.

      1. Yes it’s scary, however what is even scarier is the further corruption that continues that we hv very little control over rather than to expose these ppl! I’m all for exposing this corruption!

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