Regular readers of this blog know that I am a big fan of buprenorphine treatment of opiate dependence. I used to spend hours arguing with people over whether or not buprenorphine represents “a drug for a drug”, before eventually deciding that those who must be talked into buprenorphine treatment are poor candidates for buprenorphine treatment. I am now less motivated to engage in such discussions, but for those who are interested, my arguments are scattered throughout the archives of the medhelp.org addiction board, the commentary section of my YouTube videos, and in earlier posts to this blog.
The motivation for this current post stems from two recent incidents. The first was the reaction of a group of physicians at a dinner several nights ago, when I was speaking about a different medication. When I mentioned “Suboxone” I heard hissing and other negative reactions from the assembled group of doctors and nurse prescribers. I am the medical director of a residential AODA treatment center that does not use buprenorphine, so I am familiar with the attitudes of non-prescribing counselors– which tend to run against the use of buprenorphine. But the people at this particular dinner were not addiction counselors, but instead were general practitioners from central Wisconsin. After hearing the negative reaction to mention of Suboxone, I deviated from the topic of my lecture to address their reaction. But I soon realized that their opinions were as fixed as those that I ran up against during the arguments described in the first paragraph above. Despite my certainty that buprenorphine has saved thousands of lives, these practitioners see the medication as ‘villain’ rather than ‘hero.’ The assembled physicians see Suboxone as just one more drug of choice for opiate addicts. More disturbing, they see docs who prescribe Suboxone on a par with physicians who overprescribe opiate agonists.
The second incident that motivated this post was the publication of an excellent group of articles in the Milwaukee Journal Sentinel about the epidemic of opiate dependence in Milwaukee County. The article included statistics on the number of deaths by overdose, the vast majority consisting of respiratory arrest caused by opiates. The numbers included deaths from Suboxone taken in combination with other respiratory depressants by people who lacked significant tolerance to opiates. One of the most striking images from the series was a graphic with the deaths color-coded by year, by age of the deceased, and by type of drug. I am well aware of the epidemic of heroin and oxycodone addiction in my part of the country, but I was shocked at the sheer number and ubiquitous nature of deaths by overdose over the past six years.
I am grateful for the availability of buprenorphine in the form of Suboxone, but I wonder how different the current situation might be had a different pharmaceutical company been involved in the U.S. introduction of buprenorphine for the treatment of opiate dependence. Reckitt-Benckiser is a consumer-goods company based in the UK. When Suboxone received FDA approval in 2003, the pharmaceutical wing of the company did not exist in any meaningful form. From the vantage of a Reckitt-Benckiser stockholder, the company did well. They grew their international pharmaceutical division at an amazing pace thanks to the growth of their one product. But when I take a broad look at the current state of affairs, I wonder where we would be if Reckitt-Benckiser had made the decision to team up with one of the bigger players in the pharmaceutical industry. Doing so would have cost them a portion of their profit from Suboxone. But had a company the size of Pfizer, for example, set their sales force on a mission to market Suboxone, I doubt we would have the now-recognized problems with diversion and low physician acceptance. I am also confident that there would have been far fewer deaths by overdose of opiates over the past six years.
I am old enough to have experienced a number of launches of innovative medications, and I have always been one to quickly adopt the newest approaches and medications. But my early use of Suboxone for treating opiate addiction was a unique experience in many ways. I cannot think of any other medication that was (and still is!) as poorly understood by other physicians. I blame some of the lack of knowledge about Suboxone on the stigma of mental health and addiction, but many psychiatric medications with far more complex mechanisms of action—e.g. atypical antipsychotics—have been introduced without the ignorance that is associated with Suboxone. Even in 2007, four years after the release of Suboxone, the vast majority of physicians had not heard of the medication. Doctors have the bad habit of blaming unknown medications for unusual symptoms, so patients often called me after visiting ER’s or after doctor’s appointments where they were told that their symptoms were ‘from the Suboxone.’ One patient returned to the ER after I called the staff and persuaded them to take a second look, explaining that Suboxone does not generally cause fever or chest pain. On his second visit they did a chest x-ray that showed his pneumonia and pleural effusion. I continue to see examples of the same phenomenon today. The ignorance is not confined to emergency care– I frequently receive e-mails from new mothers with horror stories describing bizarre statements by neonatologists, OB nurses, and obstetricians.
A more common problem is described in the following e-mail:
I need help to figure out what’s wrong with me and what to ask my doctor to do about it. I’ve just been through knee surgery to replace my ACL. It was pretty painful but the pain is a bit better now. I’ve been on 16mg Sub for at least five years, although I recently tapered it to 8mgs. This past month I was down to maybe 4mgs/day when I found out my surgery was scheduled. Since I wanted my pain meds to work I immediately cut down even more and called my doc to see if he would give me some pain meds, because the surgeon refused to help me on the grounds that I was on Suboxone and he doesn’t understand it. Unfortunately my doc was out of town. Nobody would help me, everyone said *my* doc was the only one who could, and sorry he’s gone but oh well. This meant i had to get horribly sick the week of my surgery.
I got to see my doc the day before surgery, and he gave me some Norco which helped the w/d symptoms. Then after surgery I had Norco every four hours. Unfortunately after my release the surgeon AGAIN didn’t want anything to do with me. He wrote a script for Norco and told me I’d have to see my own doctor for anything else. The Norco was barely keeping me out of w/d’s, never mind helping my pain. I was waking up every morning with my nose running, sneezing, and my legs dancing. I got hold of my doc and he prescribed me Percocet, on the theory that those last longer. I’m permitted 1 or 2 of them every six hours, to a maximum of 6 per day. This seems to be utterly inadequate but I don’t know why my doctor would prescribe me something utterly inadequate unless he doesn’t think it’s inadequate.
Please, I need some solid experienced information so I can talk to my doctor. I am NOT trying to get a buzz here. All I asked of everyone prior to my surgery was “please treat me fairly given my tolerance level”. I wonder if my doc thinks that he is treating me fairly. But I’m clearly not getting sufficient dosage of opiate, and I don’t know how to present my case, especially over the telephone and via an intermediary nurse. (As yet, he won’t talk to me in person.) If I have to re-induct on the Suboxone and just deal with the pain then I’ll need some medicine to keep me asleep and not dancing until I’m sick enough, but I’m running scared asking for anything at all because everyone is treating me like a junkie.
Because of my blog, I receive messages like this one almost every day. Most doctors have no idea what Suboxone is used for, and how the medication affects the use of other pain medications. Patients are paying for that lack of knowledge with unnecessary pain and hardship. Of course, they are just addicts, right? (Readers should know my sarcasm by now!).
What should have happened?
To describe what could have happened I will use the example of another medication, Vyvanse, which is owned by a different British company called Shire pharmaceuticals. Vyvanse is a clear advance in ADD treatment. Amphetamine was bound to lysine to create an inactive molecule, and the amphetamine is released at a measured pace after Vyvanse is absorbed into the circulation. Shire is a relatively small company, so they paired with the much larger company, GSK, to get the word out about Vyvanse. The result is that thousands of GSK representatives have provided information about Vyvanse to physicians, pharmacies, and hospitals. Had Reckitt-Benckiser done something similar, doctors everywhere would at minimum know the basics about buprenorphine. And more, the treatment of addiction may have been brought into the mainstream where it belongs.
Reckitt-Benckiser eventually came out with a program called ‘Here to Help’ in order to provide education and by their description to improve compliance in addicts taking Suboxone. I was disappointed that the program began a number of years after Suboxone was released, not until the eve of the launch of a generic form of the medication. The timing left the impression that the program was more about maintaining brand loyalty than concern for addicts. The program pales in comparison to the education and outreach provided by major US pharmaceutical companies when they release a new medication. There are comments about the ‘Here to Help’ program associated with an earlier post on this blog, and I have received a number of similarly negative e-mails, including one just today that included these comments:
This “Here to Help” thing is really not very good. I actually signed up as a patient, and the girl was clueless. Every single issue I wanted to talk about, she told me to “Talk to your physician”.
There are other complaints about the manufacturer of Suboxone even by addicts who appreciate the medication. They resent the fact that so few non-addiction doctors have any knowledge about the medication. Many have fallen victim to what is described in the first e-mail above, and have suffered painful postoperative recoveries. There are complaints about the cost of the medication, once a pricey four dollars per pill and now up to twice that amount. The patient assistance program offered by Reckitt-Benckiser limits support to only 2-4 patients per practice, a limit that is not present for any other medication that I prescribe for psychiatric patients. Many addict-patients have experienced poor treatment practices as a result of insufficient education for physician prescribers. Buprenorphine should be taken once per day in a dose range of 8-16 mg, but I have had new patients whose prior doctors prescribed much larger doses at much more frequent intervals. In my experience frequent dosing of buprenorphine is much less effective at extinguishing the psychological component of addiction. Instead of eliminating the relationship between ‘feelings’ and ‘using, such patients remain fixated on how they feel and take small doses of buprenorphine multiple times per day in response to imaginary withdrawal symptoms. Their physicians should have been taught about the value of less-frequent dosing by people who understand addiction. I was, by the way, a Reckitt-Benckiser/Suboxone ‘Treatment Advocate’ for several years. My experiences as an opiate addict for 16 years, my PhD in neurochemistry, my 3+ months of residential treatment and 6 years of formal aftercare, the hundreds of AA and NA meetings I have attended, the eight years I spent working in pain clinics as an anesthesiologist, my psychiatric training, my experience treating over 450 patients using buprenorphine, and four years as medical director of a large residential treatment center have all contributed to some level of insight into addiction and addiction treatment. I called and wrote to R-B multiple times asking that they use me to educate other physicians. I was called upon to do so three times in four years. As a comparison, I have been asked to educate groups of prescribers about Vyvanse over ten times in the last month or two alone. Can you imagine the knowledge-state about buprenorphine had similar efforts been made by Reckitt-Benckiser over the past 6 years?!
I have blogged about my frustration trying to find an application for an educational grant from Reckitt-Benckiser that would allow me to apply for funding to expand my educational efforts on the internet. To compare, a visit to the Mallinckrodt Pharmaceuticals website quickly leads to the application for funding educational programs. There are, in fact, several significant web-based educational programs related to the prevention and treatment of addiction supported by unrestricted educational grants from Mallinckrodt, who manufactures methadone among its products. There is a similar online application for grant support on at least every pharmaceutical company that I visited this evening as I prepared to write this post. I have not found such an application for Reckitt-Benckiser. I even spent four years calling, writing, and e-mailing different branches of the company in search of an application for such support. My hopes were raised on two occasions when I was visited by regional sales directors and promised that information about grants would be provided. But after the visits nothing happened, and when I called in an attempt to follow up, I was back to square one, talking to people who claimed to have never heard about my prior contact with the company.
Does this all sound like ‘sour grapes’ over a snub by Reckitt-Benckiser? Perhaps it is, to some extent. I am, after all, only human. But I am not only resentful. I spend a great deal of time reading and responding to e-mails from addicts, parents of addicts, spouses of addicts, and friends of addicts, and I am acutely aware of the suffering caused by opiate dependence. I’ve spoken to many people who were close to addicts who lost their lives to opiate dependence, and I have at least some sense of the suffering that they go through. And I have no doubt much of this suffering could—and should– have been avoided.
I fear that the actions of Reckitt-Benckiser, specifically their close-fisted release of a life-saving medication, have permanently endangered the successful use of buprenorphine for the treatment of opiate dependence. Once doctors start hissing, it becomes extremely difficult to create positive impressions of a medication or of a practice technique. I will, for what it is worth, continue with my own small efforts. And I hope that Reckitt-Benckiser will observe one of the principles that we teach addicts in recovery: Ask for help when help is needed.
How ironic if the success of a medication with the potential for a profoundly positive impact on addiction fell victim to addictive thinking by its own manufacturer!?!