Zohydro, Zobel, Zogenix, Zealots, and Zoro
In the state famous for rebuking taxation without representation, a Massachusetts court on Tuesday (4/15) struck a blow against another overreach of power by government – this time by Gov. Deval Patrick. In doing so, a U.S. District Judge ruled the governor had overstepped his authority in banning a FDA-approved prescription medication (in this instance Zohydro ER) for people in debilitating chronic pain.
Watching Governor Deval Patrick be so human, warm and even add some humor at an otherwise somber tribute to the Boston Marathon victims and survivors, it was difficult to reconcile that persona with the one who would attempt to restrict access to a pain medication that might otherwise alleviate suffering. Indeed, it got me to thinking – how many of the survivors were treated with hydrocodone after the blast ripped their flesh and tore their limbs for the treatment of their acute pain? How many are still benefitting from short acting hydrocodone having transitioned to chronic pain? (although they might live from dose to dose, withdrawing or suffering in between doses I imagine) Or how many might benefit from a switch to Zohydro ER to smooth all that out, allow them to sleep, to function, to engage in the rigorous physical therapy and rehab they still need to do? Governor Patrick would deprive THEM of this access?
Make no mistake about it: this country finds itself in a war over the legitimate rights of people with chronic pain to have access to all approved medications that can help them achieve some measure of quality of life and dignity. In various states, patients are plagued with the monthly pharmacy crawl wondering about needlessly as nomads in the desert seeking out a single pharmacy to fill their prescriptions as seen on previous blogs, Dancing to the Pharmacy Crawl for Opioids and Kentucky’s Pharmacy Crawl. Word of Tuesday’s victory – albeit only a preliminary injunction against the governor’s proposed ban of Zohydro ER – will spread throughout the country like locusts and into the halls of Congress in Washington DC.
The only question remaining for other state governors and attorneys general and some members of Congress who want to follow Gov. Patrick’s efforts on Zohydro ER is whether their stated interest and battle plan to protect citizens from abusing powerful drugs and allowing opioid pestilence to trump the facts on how best to achieve their outcome. In fact, increased heroin use among Massachusetts constituents does not justify the action by Gov. Patrick. Commensurate with the season, patients enslaved to persistent pain might otherwise need to flee their homes in a hurry before the plague of heroin abuse has time to rise to the next level.
As I wrote in my “Truth or Dare” blog Monday, the statements that Gov. Patrick and still others have used to vilify Zohydro ER don’t match the facts, all of which can be reviewed on that post, nor does the Boston survivors’ suffering end even with the closure attempted at by the public recognition of the anniversary of their becoming chronic pain patients. It’s easy to be anti-opioid when you dehumanize the sufferers and think of them as drug-seeking slaves or drug-abusing wimps or thugs. Not so easy, when you are talking about denying a medication to a hero. We are a fickle society, defining winners and losers so arbitrarily. The Boston Survivors didn’t choose a life of chronic pain and suffering to ennoble themselves, yet they have been ennobled. Fibromyalgia sufferers and others with chronic pain are no less heroes for facing every day, facing the abuse and indignity that is heaped upon them. They deserve access too. Indeed they deserve a medal for the marathon that they run daily.
If gubernatorial or senatorial offices continue to act as the Angels of Death to downtrodden patients with persistent unrelenting pain that enslaves their lives daily, slaying the innocent by marking their doors for depression, anxiety, and suicidality, I’m afraid we’ll be plagued by far more than opioid pestilence nationwide. Governor, please ennoble all patient nomads…enable them to have the treatment they deserve. Let them go to the pharmacy with dignity. Let them be. Let our people go!
As always, comments are met with enthusiasm!
Wow Dr. Fudin, great post indeed! One can truly sense how passionate you are about advocating for individuals who suffer from chronic pain. I read this blog a couple days ago when it was first posted; however, it took me a while to gather my thoughts as I researched a little bit more about Gov. Deval Patrick as well as reading the comments left by the audience.
Upon reading about Gov. Deval Patrick, I could not help but be impressed by what he has accomplished so far. Coming from such humble beginnings to eventually graduating from Harvard Law School and to now being in such a state of empowerment as the Governor of Massachusetts is very inspiring. Nevertheless, there was nothing stated anywhere about studying medicine in the Governor’s bio. This leads me to question his judgment on trying to ban Zohydro in Massachusetts. If Gov. Patrick lacks any medical expertise, particularly in pain management or addiction medicine, why would he jeopardize his credibility with such a decision? I know for sure that if I were a chronic pain patient and needed Zohydro, I would trust my physician and pharmacist over a government official. Overall, its seems that lack of knowledge and the negative media hype led Gov. Patrick to come the conclusion that banning Zohydro was appropriate. I understand that Gov. Patrick may be trying to protect the public; however, he fails to realize this will do more harm than good and will put up more barriers for chronic pain patients. I am hoping that Gov. Patrick can have some faith in humanity and trust healthcare providers enough so that we can provide for our patients.
I would also like to chime in on some comments made so far. The insights provided by the comments are very intriguing, and thought provoking. It is true that pharmaceutical companies will try to do anything to financially benefit them; whether this be by meddling with the drug’s structure, strength, or even manufacturing a sustained release formulation. In the case for Zohydro however, I feel it will not only benefit the drug company but patients as well. Are there other opiates that can be used other than Zohydro? Yes there are, however one cannot predict how a patient may respond to a certain medication due to the drug’s chemical structure and/or genetics. Is Zohydro subject to abuse? Yes without a doubt, but so are the other opiates like Oxycontin. However, we cannot be certain as to what the abuse liability of Zohydro is compared to other opioids due to the conflicting results produced from various studies. Therefore it is credulous and premature to say that Zohydro is more likely to be abused than most other opiates. All in all, medicine is meant to be practiced by those individuals who have extensively studied it and earned the doctoral degree; it is not meant to be practiced by scared politicians who seek to be viewed as heroes through the eyes of the general population. If someone as well-educated as Gov. Deval can fall prey to the Zohydro media train, I’m afraid the general public at large is in for a train wreck.
Respectfully,
Abhishek Shrivastava
Pharm.D. Candidate 2014
I want to take a moment here and thank everyone for making such thought-provoking comments. I’d like to remind everyone that this blog has been created to encourage dialogue among professional peers, patients, lawmakers, regulatory personnel, or anyone else who wants to participate.
I am always especially delighted to see opposing views and discussion back and forth on those views. I was particularly enamored by Dr. Elliot Krane’s comments and although we disagree on some of the approach, neither of us is so hardheaded that we can’t embrace the other’s opinion or at least consider opposing views and the horrors that come with drawing a line in the sand or parting of the sea. It is important to hear what everyone has to say. Dr. Krane speaks of a “middle ground” – I believe the only way to reach that middle ground is to hear from scholars and pain victims with varying opinions. That is why I do this.
To set the record straight, I often take a hardline approach to various topics because that’s what encourages discussion. But, as stated at the end of this blog (in red), “As always, comments are met with enthusiasm!”. That includes all comments. I am not so pretentious that I expect the entire world to line up behind my opinion. What I do hope is for a thoughtful forum that enables real people to tell their side and offer their opinions.
I am reminded of an important quote by Claude Lévi-Strauss
“The scientist is not a person who gives the right answers, she’s the one who asks the right questions.”
Please encourage your colleagues, groups, and friends to participate. And please accept my best wishes for a wonderful spring, safe holidays, and painless days ahead.
I agree with everyone here that this medicine Zohydro is needed and isn’t any more dangerous than any of the others. People like this MA governor is who is causing all these problems for chronic pain patients is why the situation is not getting better in this country! I also have to wonder if it’s going to take 40 more years before legitimate pain patients will be treated properly for pain again. I still continue to get emails everyday from patients begging me to help them. They still can’t get their pain medicines filled for several DAYS after they are due to be refilled in here in FL. After their 30 day mark! People are crying in pain in their emails because they are experiencing withdraw and suffering increased severe pain from going so long before being able to find their medications. Now with the new Zohydro becoming available, many of them will never even have the chance to try the med, not in FL. Because of the limited medicines available here, patients are having to take a pain medicine that doesn’t help their pain as it should because it’s the only thing the pharmacy has on hand. Not what their doctors prescribed. They have to return to the doctor and tell them what the pharmacy is willing to fill. How is this a choice? How is this good pain management? It’s so screwed UP!
When is this going to stop? When will our Congress realize there is a major problem and call off the DEA? I wanted to try another state capitol rally to show nothing has changed and create more awareness but that got shot down because a pharmacist on my group was saying that reaching out to legislators wouldn’t work. That everyone needed to complain to the BOP in their states. We’ve done all that many times with no results. Sadly, that killed the morale of these people. Patients who are suffering have No hope of the future ever getting better for them.
I think having another time released med was really good for patients so they would more choices, but most likely it will not available for anyone to try it because of all the negative publicity popping up on TV and in web news.
I really hope that someone can get through to the government soon, that thousands of people are suffering! Something needs to change. So many patients are undertreated now. Doses have been cut so severely for long term patients that they can’t get out bed anymore much less have any kind of life.
I’m glad Dr Fudin keeps bringing more awareness to his blog. Hopefully it’s being read by the FDA or someone who can help and change all this.
Thank you Dr. Jeff
@Donna, I would have that state capitol rally! So, there is one pharmacist in your group who doesn’t agree with the approach… so what?! S/he can opt out. Writing to the BOP does not make anywhere near as much sense as going directly to your elected officials. I know, I’ve been doing it for 30 yrs and have close relationships with several lawmakers in my state (IL.)
The only way to get a handle on opioids making it to the streets includes shutting down irresponsible prescribers, control diversion, while maintaining access to those who need these medications for their intended purpose. The reason Zohydro is needed is Hydrocodone is intended for those that have drug allergies and cant take other opioid medications. The time released purpose is dosing only twice a day instead of six to eight times a day, not to mention excluding the acetaminophen .
I don’t know why this Zohydro medication has everyone on edge ,media hype has blown this thing so far out of proportion its ridiculous. A few years from now we will look back on this and think why did everyone freak out over such a minute thing. By then people who need Zohydro will have it and all will be well. So stop this nonsense about something a lot of people know nothing about. Your upsetting yourself for no good reason.
Geeeze, Dr. Krane, it was just an anology by Dr. Fudin. NO need to jump ole Dr. Jeff here for using something like this………Dr. Fudin has fought for we brave few, “MANY”, who go day to day with something that is kicking the every living crap out of our daily existence. God love the folks from Mass. the ones who were in the way of those terrorist bombers. I pray they get what they need…..As for me, i just got done fighting a three week battle with the ever present, and ever “in your face”, Walgreens. With the help of a warehouse that I used to get my meds from, and my Doc and his wonderful staff, we staved off a punch in the mouth from the big “W”. lol……what a fight. The folks that talk down to you from the Walgreens answering service at the mail order house……..And, they use a little catch phrase from a “90s” move…..”Demolition Man”. lolol…….At the end of every conversation they say, “And, please, Mr. Neeland, BE WELL”…….I couldn’t help but ask some of these young folk,,,,,”Do you know where the phrase “Be Well” comes from in “MY TALK?” They of course said, “NO”. I said, “It’s from a movie when the cops, Warden Smithers from the prison would end a conversation by saying, BE WELL”. It was all wasted on them anyway, hahaha. Hell, none of them had seen the movie……..BUT, when dealing with Walgreens, stand your ground, have your guns loaded, and prepared for being told, “We are right and you are wrong.” Well, not this TIME!!!!!!! Thanks Dr. Jeff for another great blog,,,,,,,,,,,,,,,,,,,Herb “doc” Neeland
Jeff,
You make good points, but I think the use of such hyperbole in your language does not serve our purpose. This is not “Biblical” struggle, it is not “a war,” etc., etc., etc. God will not bring seven plagues down upon those with whom you disagree (though the Passover metaphor is timely). In a war there is a victor and a vanquished and a lot of unintended casualty. In this there is a reasonable middle ground and everyone can win a little.
Language such as this is polarizing, it both puts you on one end of a spectrum and alienates those opposed to your point of view, who also may see this struggle in similar terms. It does not further a reasonable dialogue or promote compromise. Rather, it draws lines.
Biblical struggles are very bad. The reason that there is such a poor prognosis for peace in the Middle East is that the two sides see this as a religious struggle, The Israeli right wing will never cede Judea and Samaria, which were deeded to them by God, and the Arabs/Palestinian right wing quote the Quran and its tenet that land lived upon by a Muslim is forever Muslim. There is no middle ground in a Biblical struggle.
As for the middle ground, I am reminded that the drug companies are not our saviors; they are mercenary corporations trying to extract the most money possible in a dysfunctional system. Their drug development is simply that, it is not motivated by altruism but by business development. They repackage an old molecule in a new form, using long acting chemistry that can be reproduced in a high school laboratory, and then sell the drug for obscene prices as if it were manna from heaven (see how I perpetuate this allegory?). On the other side are politicians who will do almost anything to get a vote from the rabble, and fact checking is not their strong suit. There are many, many more votes in the rabid anti-narcotic opiophobic population than there are in those in chronic pain, the calculation is simple. Neither of these positions needs to be intransigent, like the ground upon which the orthodox rabbis and mullahs stand. The middle ground is wide open and I would love to hear a reasonable discourse that includes acknowledgment of the need to shut down irresponsible or inept prescribers, control diversion, while maintaining access to those who need the drug, as well as the acknowledgment that other drugs may in fact be just as good (see this month’s article in Pain on Zohydro).
Just my opinion.
Elliot Krane, MD
Stanford Children’s Health
Stanford University
Thanks for your contribution Dr Krane. While I agree with the overall direction of your statement, especially the need for a middle ground, I believe it is a bit naïve to believe that the DEA is not conducting this campaign of fear and rhetoric as a war. This is what the DEA does, its how they operate AND how they view drug users of any type, as the enemy. So naturally what stuck out to me stuck out to me was your thoughts on war and unintended casualties. These are sometimes known as collateral damage.
While doctors and relatives empathize with patients in chronic pain, who for many pain is just one of a multitude of symptoms battled daily, the DEA sees them and ANY daily users of evil narcotics as addicts.
Doctors can point out the difference between a patient, who benefits from the use of opioids and despite tolerance and dependence, becomes more involved in LIFE; and an addict. They can point to addicts, who in addition to tolerance and dependence, have a psychological obsession and compulsion to use opioids despite a deterioration in their quality of their life and put drug use ahead of everything including their families and jobs. But to the DEA, no distinction is made, all who NEED NARCOTICS, for whatever reason, are ADDICTS, its easier that way. Even those w/ debilitating illness are not exempt from this label. The irony to this is that many w/ non-cancer pain (somehow seen as less noble) may live on for decades wishing they could have an end all battle win or lose to something like cancer rather than a sustained misery that lingers and lingers with no cure or medicine that is proven to induce remission. Don’t believe it? Read a few patient support message boards, these folks are barely hanging on w/out much hope or help and when they reach out they are treated with contempt and suspicion. How can this be anything but depressing. Only then the depression is turned around and used against the patient as ‘its all in your head’ because they are depressed and have anxiety. Whom among us who have endured pain, surgeries, infections, nausea, fatigue, etc, etc day after day wouldn’t be anxious and depressed? Symptom management is the best some of us can expect while hoping for the day one may miraculously enter into a period of remission.
You see, I don’t believe pain patients were/are unintended casualties or collateral damage at all.
I believe that the DEA knew full well that a great number of patients would be sacrificed. It boils down to simple mathematics really. Cutting supplies w/out regard to the fact that pain was already under-treated, even as more and more meds landed in the wrong hands could only lead to one result; an even more desperate situation for those in debilitating pain. Why else is a law enforcement agency entrusted to set the limitations it does on the deliveries of each narcotic? Note the use of the word narcotics.
Narcotics and addicts are what we are dealing with now. One rarely sees the term opioid pain medicine used anymore in the media or in the politicians diatribes. Even pain clinic is a dirty word, now a code word for a pill mill despite the closing of most of the latter. Ask a citizen on the street how he feels if a pain clinic opened up in his neighborhood. One would think they had misheard you and thought what was said was a crack house or brothel.
If only one side of the story is covered it is easy to blur the lines between compliant patient and dope fiend. Us and them. Propaganda for war, nothing else. In todays climate of sophisticated and brutally effective propaganda, the likes of Hughes and Riefenstahl would be in an unemployment line looking for work.
The sad part of this whole debacle is that I believe this middle road you advocate for was mapped out and paved. Given an adequate amount of time and it could have easily been a great recipe for success. REMS were put in place. Rx monitoring programs developed. Tamper resistant meds rolled out. Rules and laws implemented to put the operation of pain clinics into the right hands and taken out of those from criminal elements. On site cash for drugs operations shut down, etc, etc. Add to these the already present and humiliating pill counts, drug tests, and opiate contracts and one has a protected supply of medication FOR legitimate patients and protected FROM the hands of unscrupulous doctors and addicts.
Instead we are faced w/ hit or miss at most pharmacies which makes a legitimate Rx into a lottery ticket. A retirement of the word titration, replaced with a stance of ‘be happy you are getting anything’ as it could be much worse. Non pharmaceutical procedures either unaffordable, not covered by insurance, or risky ones ‘offered’ to patients in order for them to receive a prescription. At this rate, one can only envision chronic pain patients soon competing for limited spots in methadone clinics w/ addicts for some form of treatment, ironically ACCEPTING the label of ADDICT in order to procure some form of respite from their daily agony. Seems like war from this end and a very uneven one at that.
Just one dog-tired coonhound’s opinion though.
Wow, another great post. Finally someone who understands it’s the patients of chronic pain that really matter. Thank you Dr. Fudin for your willingness to speak out for those who may be too weak to do so.
I like the analogy drawn to passover. I might add “If only a preliminary injunction against the governor’s proposed ban of Zohydro ER was in place, but Blue Cross/Blue Shield of Massachusetts limited you to a 15 day lifetime supply… Dayenu!?!? ….
Let’s hope we don’t end up wandering in the dessert for 40 years due to the behavior of a few,
Great point, Paul. The zealots cannot function without the complicity of the insurance industry. Definitely, “Dayenu”! Fortunately, our 40 years of wandering in the desert due to the greed of the insurance industry are approaching an end. Hopefully, Jeff and I haven’t sinned too much to be let in! 😉