There have been a number of events over the past couple weeks that have been ‘game changers’ in the efforts by Reckitt Benckiser to hang onto their profitable treatment for opioid dependence, Suboxone. Reckitt Benckiser (RB) had asked the FDA to deny any future generic drugs based on Suboxone tabs because of deaths of several chldren, who might have confused the tabs for candy.
The FDA gave RB’s comments some thought and then discarded them, even stating that the efforts by RB might have been unlawful anticompetetive marketing. The FDA wrote that they were referring their concerns about unlawful marketing to the FTC.
The FDA went on to approve two generic versions of Suboxone, or more properly, buprenorphine/naloxone tablets. It will be interesting to see whether insurers and medicaid agencies go back to covering tabs (generic tabs), or whether they will continue to waste money on the heavily-marketed Suboxone’film.’
Just in case that isn’t enough drama for one week, the FDA announced that they will be holding hearings to determine whether to approve a buprenorphine implant called Probuphine.. I’d love to share details about the product, but at this point I don’t have further information. The manufacturers of Probuphine are hoping that the medication will be used to treat opioid dependence. On the surface, a number of advantages are apparent about such a product; one would expect a lower risk of diversion, for example, and better compliance.
NOT mentioned at this point, is whether the implant could help people who would like to discontinue Suboxone. Many patients on Suboxone become resentful of the medication at some point, wishing they could be completely free from opioids. I’m not a big proponent of such an idea, as I’ve witnessed far too much death and misery from relapse by people who stopped Suboxone. But I could see how an implant would offer advantages for those people, depending on the release pattern of the medication. For example, if the medication wears off slowly in the lower dose range, it may serve as a useful tapering device. Such use would likely be off-label, and might even be illegal, depending on the wording …
I subscribe to Google news alerts for the phrase ‘overdose deaths.’ Google Alerts are a great way to follow any topic; subscribers receive headlines from newspapers and web sites for certain keywords from around the world. One thing that has become clear from my subscription is that there is no shortage of stories about deaths from opioids! Every day I see one article after the next, as news reporters notice the loss of more and more of their communities’ young people.
Along with the reports of overdoses are stories about doctors who are increasingly being prosecuted for the deaths of their patients. In an earlier post I described the case of Dr. Schneider and his wife, a nurse, who were tied to a number of overdose deaths in Kansas. That case stood out by the sheer number of deaths; the State charged the couple with the deaths of 56 patients. Cases involving fewer patients have become relatively common. The latest case that I’ve read about is a doctor in Iowa, who is accused of causing or contributing to the deaths of 8 people.
I try to present both sides of the argument when I write about this topic. I have been faced with the difficult decision over whether or not to prescribe narcotics many times, and I understand a doctor’s dilemma. The doctor sees a person who is in pain, and knows that there is a pill that will reduce that pain. But the doctor also knows, or SHOULD know, that initiating a prescription for narcotic pain medication always has unintended consequences, no matter how good the intentions of both doctor and patient.
In the Iowa case, the dilemma over narcotic-prescribing is very clear. The prosecution states that the doctor prescribed pain medication to drug addicts. On the surface, that sounds bad, right? One gets the mental picture of dirty, lazy people, dissolving tablets in a spoon, over a candle, and then injecting the mixture. But reality is much more complicated. Patients with histories of opioid dependence do not always have track marks. And even …
Please review my prior post, as my comments will refer to an email in that post.
There are many directions that we could take as we review that message. My overall impression, as I read the letter, was of a person struggling to accept the reality of his condition. Over and over, the person repeated the same behavior, starting Suboxone, stopping, and thinking this time will be different.
One thing I’ve learned as a psychiatrist, more than anything, is that change is difficult, and rare. The writer ends with the thought that maybe this time will REALLY be different. I have no idea if it will be, and for his sake, I hope it is… but unfortunately, the odds are that history will repeat itself.
I often receive emails from patients on buprenorphine (or Suboxone) who are preparing for surgery or other painful medical procedures. Ideally in such cases, the surgeon would have a discussion with the person prescribing buprenorphine, in order to coordinate the plan for treating postoperative pain.
In practice such discussions don’t seem to take place, leaving patients to scramble for effective pain control after surgery– when it is too late to take the steps necessary for a smooth perioperative course.
I am familiar with an NIH article that describes pain control in people who take buprenorphine. I’ve also prepared a handbook that describes the issues that must be considered in such patients; the handbook can be found easily-enough by searching for the User’s Guide to Suboxone.
Even with those descriptions ‘out there,’ I’ll get requests for a short, ‘just-the-facts’ note that patients can give to their surgeons. I realize that unfortunately, the average surgeon will not sit down for an in-depth discussion of post-op pain control, so I have prepared a few paragraphs that lay out the issues. People on buprenorphine who are having surgery are welcome to copy the paragraphs below and give them to their surgeons, in order to facilitate discussion.
I have been struggling with Part II, primarily because there are no easy answers to the situation. I realize that I could easily criticize whichever path a doctor suggests for our imaginary patient.
As an aside, I believe that a major reason for the lack of sufficient prescribers of buprenorphine in some parts of the country is the ‘damned if I do, or damned if I don’t’ scenario. All docs are aware of the current epidemic of opioid overdose deaths, and I think most doctors assume that tighter regulations on opioids are appropriate, and are just around the corner.
Some addiction physicians and some pain physicians, particularly those who prescribe opioids, fear being grouped by the media, DEA, or a licensing board as part of the problem, rather than as part of the solution. I recently read of a doctor charged with manslaughter for being one of several prescribers for a person who died from opioid overdose. He prescribed meperidine—an outdated and toxic medication—which likely contributed to the charges, but the story creates a chilling atmosphere, regardless.
Suboxone and buprenorphine are much safer medications, but when the target population consists of people with addictions to opioids, there will always be some people who use the medication inappropriately— some with disastrous results.
Hi, you probably answer this quite a bit. I’ve been depressed for as long as i can remember.
Ive been on the ssris, snris, amphetamines and methylphenadate but none of these have worked as well as opiates. (Certainly short term,I don’t take for long periods of time). But have you ever used suboxone or oxymorphone for depression?
Depression is probably a broad term, for what may be multiple conditions. For example, some people become depressed almost as if it is part of their nature— they will get episodes of depression even when everything in life is going well, in spite of good marriages, healthy children and an absence of significant baggage from the past– at least baggage that is visible.
Other people will present with depression that has developed after a series of blows to their sense of self or self-worth— after a health scare, job loss, divorce, death of a child, or perhaps from carrying around guilt or shame from abuse that occurred during their childhood.
Does it matter whether the depression is more like the first or the second category? I think so, but I have no proof that my perception is accurate. I will see different responses to medications by people with different types of depression, but I’m always challenging that perception, realizing how easy it is to be ‘fooled by randomness’, to copy a phrase from a book title.
In my experience, the second person is more likely to bounce back, providing the negative onslaught eventually stops. But the people in the first group are more difficult to treat, especially if the depression becomes part of how a person defines him or herself— as it is very difficult to change self-perception.
I presented the paper below at the ASAM annual meeting in Atlanta a few weeks ago. Understand that my findings are very preliminary, and should be attempted only by physicians with exceptional understanding of the risks of opioid treatments, under close monitoring.
The findings suggest a method to yield long-term, even permanent analgesia, at less risk than from agonists alone.
I’ve written about the Pain Relief Network in prior posts — one side of the battle between those trying to limit access to schedule II opioids (led by PROP, or Physicians for Responsible Opioid Prescribing), and until recently, the Pain Relief Network, or PRN.
If you haven’t read my earlier posts on the subject, I encourage you to do so; the final chapter, including the death of PRN’s founder in a plane crash, had all of the drama of a made-for-TV movie. PRN suffered a number of consecutive blows, including the founder’s death, the loss of a major case against a ‘pill-pushing’ doctor, and investigations into PRN’s finances by the prosecutors of the doctor’s case.
PRN did things that angered too many people, including placing a billboard for jurors to see on the way to the doctor’s case; a deliberate ‘spit in the eye’ of the judge and prosecutors in the case. At some point, I think PRN went too far, and discovered that they didn’t have quite as much power as they thought. PRN no longer exists.
I appreciate the feedback to my last post. I had no doubt that the thoughts expressed in the original letter would ring such a chord, as I hear similar comments on a daily basis. For people new to my blog this week, please review the letter in last week’s post, as that is where I’m starting today.
I had the same ‘love at first site’ reaction to opioids described by many people who become addicted. My addiction began with a relatively weak opioid — codeine —but I still remember lying in bed as the effects of the substance drifted over me, easing the life-long depression that I had long accepted as ‘just how things are.’
I should make clear at this point that I do not mean to recommend that depressed people take opioids. Unfortunately, every bit of relief that I found from opioids had to be paid back, in the form of sadness, loss, and despair. There is some possibility that medicine will find a way to tap into the powerful mood effects of opioids at some point, but we are NOT there now.
For people who are thinking ‘I’m smart—I’ll find a way to tame the beast,’ I can only plead that you look beyond that feeling of uniqueness. I was a pretty smart guy too. But a PhD in neurochemistry, honors in medicine, and board certification in anesthesiology offered no protection against addiction. If anything, that advanced knowledge made me more difficult to treat.
Thank you for your comments about my post about treating chronic pain with opioids. I was in the middle of adding a response to one of the comments this morning, when I decided to elevate my response to a post of its own. Starting a new post might, I hope, keep the discussion going… and besides, I was struggling to find a stopping point!
Here are highlights from the comment I was responding to this morning:
My aunt can attend family functions and be active in her children’s lives WITH the medication. Before she was put on methadone she couldn’t function at all and just lied in bed wanting to commit suicide… I definitely don’t think function is improved by withholding pain medication… I have experienced pain and… I know that when I’m in pain I don’t function well but if I take something for that pain I do. I had a bad headache earlier today and all I wanted to do was to lie on the couch… I think it would be extremely cruel for a doctor to not give me medication that would relieve that pain… Isn’t it as much worth to give opiates to pain patients to save their lives as it is to give them to addicts to save theirs?
One thing I’ve noticed, as a 50-something doc, is that it is one thing to talk about pain, and something else to experience pain. I’ve had thoughts on occasion that the injury I’m suffering at a given time is there, in part, to remind me of what it is like for my patients–who generally are much worse off.