Reckitt Benckiser Citizen Petition for Suboxone: DENIED

Posted 2/23/2013
For those who missed my explanation, I’m adding these old posts to reconstruct the archive.  The site’s database was damaged by something, somehow… New posts coming soon.
Find a copy of the response here, or at this url:www.suboxonetalkzone.com/cpresponse.pdf

Suboxone Withdrawal in Newborns

One of the top search terms for Suboxone relates to pregnancy, and fear that the baby will experience withdrawal; official name ‘neonatal abstinence syndrome.’ I wrote this post a couple years ago, and I think it is worth reposting. Since the first time around, several studies have shown that withdrawal symptoms occur in about half of babies born to mothers on buprenorphine. The symptoms, when they do occur, tend to be milder than the symptoms in babies born to mothers on methadone or other opioid agonists.
Headlines grasp for attention with words like ‘addicted babies.’ Realize that there are many differences between physiological dependence and addiction to substances. For example, people who take Effexor are dependent– and will have significant discontinuation-emergent side effects– but they are not ‘addicted’, which consists of a mental obsession for a substance. The same is true of beta-blockers, in that discontinuation results in rebound hypertension, but there is no craving for propranolol when it is stopped abruptly.
We have no idea of the ‘cravings’ experienced by a newborn, but I cannot imagine a newborn having the cortical connections required to experience anything akin to the ‘cravings’ experienced by opiate addicts, which consist of memories of using and positive reinforcement of behavior—things that are NOT part of the experience ‘in utero’.
It is also important to realize that the withdrawal experienced by addicts consists of little actual ‘pain’ (I’ve been there—I know). Addicts talk about this subject often, as in ‘why do we hate withdrawal so much?’ It is not physical pain, but rather the discomfort of involuntary movements of the limbs, depression, and very severe shame and guilt. The normal newborn already has such involuntary movements as the result of incomplete myelination of spinal nerve tracts and immature basal ganglia and cerebellar function in the brain. And the worst part of withdrawal—the shame and guilt and hopelessness—are not experienced in the same degree in a baby who has no understanding of the stigma of addiction!
Finally, if we look at the ‘misery’ experienced by a newborn, we should compare it to the misery experienced by being a newborn in general. I doubt it feels good to have one’s head squeezed so hard that it changes shape—yet nobody gets real excited about THAT discomfort—at least not from the baby’s perspective! I also doubt it feels good to have one’s head squeezed by a pair of forceps, and then be pulled by the head through the birth canal! Many hospitals still do circumcisions without local, instead just tying down the limbs and cutting. Babies having surgery for pyloric stenosis are often intubated ‘awake’, as the standard of care– which anyone who understands intubation knows is not a pleasant experience. And up until a couple decades ago—i.e. the 1980s (!), babies had surgery on the heart, including splitting open the sternum or breaking ribs, with a paralytic agent only, as the belief was that a baby with a heart defect wouldn’t tolerate narcotics or anesthetic. I don’t like making a baby experience the heightened autonomic activity that can be associated with abstinence syndrome, but compared to other elements of the birth experience, I know which I would choose!
My points are twofold, and are not intended to encourage more births of physiogically-dependent babies. But everyone in the field should be aware of the very clear difference between physiological dependence and addiction, as the difference is a basic principle that is not a matter of opinion—but rather the need to get one’s definitions right. Second, the cycle of addiction and shame has been well established, and there is already plenty of shame inside of most addicted mothers. If there are ten babies screaming loudly, only the whimper from the ‘addict baby’ elicits the ‘tsk tsk’ of the nurses and breast feeding consultants. My first child was born to a healthy mom years before my own opiate dependence, and he never took to breast feeding; he his mother been an addict, his trouble surely would have been blamed on ‘addiction’ or ‘withdrawal’. Unfortunately even medical people see what they want to see—and sometimes that view needs to be checked for bias due to undeserved stigma—for EVERYONE’S good, baby included.
Addendum: Another of my posts, including a response to a mother’s comments and several references, can be found here.

Size Matters?

I’ve received several complaints from patients and readers about one of the current buprenorphine formulations. The primary complaint is that the tablet is ‘not ‘working as well as the other formulations;’ that it seems to wear off earlier, or that people feel compelled to take more than what is prescribed.

buprenorphine formulations
Buprenorphine 8 mg tabs

My understanding, admittedly based only on what people have told me, is that there are three current formulations of buprenorphine. The brand form, Subutex, comes as a relatively-large, flat-oval tablet, white or off-white in color. The Roxanne version is a round white tablet, with a diameter of about 0.5 inch. The tablet people have complained about is from Teva, and is smaller; about the size of a tic-tac.
In general, I think that generics are as good as brand name medications. I have never come across a reliable instance, in my practice, of generics being less potent or less active. I recognize that particularly for psychiatric medications, the placebo effect accounts for significant portions of the actions of medications—so if a person BELIEVES that generic fluoxetine is less likely to work, it IS less likely to work. But take away the placebo issue, and a molecule of fluoxetine is a molecule of fluoxetine—regardless of where it comes from.
That said, I realize that the delivery of molecules can be affected by the design of capsules and tablets. I remember a study, years ago, that showed that many of the vitamins sold in the US passed through the intestinal system without even dissolving, let alone getting into the bloodstream. If the active substance is encased inside insoluble resin, there is little to be gained from taking it.
The delivery issue is less of a concern with a medication that is delivered through the oral mucosa, as with buprenorphine. There are several factors that affect absorption of buprenorphine; the concentration of buprenorphine in saliva, the amount of surface area that buprenorphine is allowed to pass through, and the time allowed for that passage to occur. If the smaller tablet dissolves more slowly, molecules of buprenorphine may have less actual contact-time with oral mucosa, thereby reducing absorption.
On the other hand, I am well aware of the psychological reward that people describe from taking buprenorphine or buprenorphine-naloxone, even in the absence of any subjective sensation. The fear of withdrawal is relieved by taking buprenorphine—making the dosing experience ‘rewarding.’ It may be that the smaller tablet provides less reward, as the small size engenders less confidence in those unfelt ‘effects.’
In any case, I invite readers to share their experiences, just in case those who have already written are truly onto something. Please leave comments below—and thanks for sharing!

Relapse in an Era of Buprenorphine

A recent experience with a patient helped me realize some of the dramatic differences in the treatment of opioid dependence, in an era of buprenorphine.
I drug-test patients who are treated with buprenorphine or Suboxone. The point of testing is not to catch someone messing up, but rather to determine when a person is in trouble. It would be great if we could simply rely on the word of our patients, but once a person is using opioids, his/her own ability to know what is true falls apart. All of us who treat addiction have heard patients rationalize relapse as something they ‘had to do’ for one reason or another, for example. The effects of active using on insight are why I like the use of ‘DENIAL’ as a mnemonic for ‘Don’t Even Notice I Am Lying.’
The effects of relapse on telling the truth are part of the profound impact of using on a person’s insight. Insight disappears very quickly during active using, as the mind abandons the broad view and becomes focused on one goal. Before buprenorphine, drug testing was in some ways more, and other ways less important. It was more important because after relapse, the person was immediately thrown back into the world of desperate scrambling, where risks for consequences are high. On the other hand, testing was less important—or maybe necessary– because experienced addictionologists (and spouses) could see the effects of using, including the loss of insight, in the active addict’s eyes.
I was one of those people who experienced that rapid loss of insight after my relapse, back in 2000. For years I had attended AA and NA; hundreds if not thousands of meetings over seven years. I remember comforting myself that ‘if I ever get off track, at least I now know where the door is to get back.’ I didn’t realize that at the instant one relapses, that door becomes nowhere to be found.
In retrospect, I don’t know if the door actually disappeared. I suspect that with the right attitude, that same door would have opened for me. But the honesty and humility that I needed, in order to ask for help in finding and passing through the door, were suddenly replaced by the need for secrets—secrets about everything. As soon as I relapsed, nobody could be trusted. Nobody would understand me. I was on my own.
Contrast that with the experiences of patients on buprenorphine who relapse with opioid agonists. As I compare their experiences to mine, I realize that I am using the experiences of a couple people to make broad generalizations. But I have seen a number of examples that support these generalizations, that have consistently followed the paths that I’m about to describe.
One patient—call him ‘Paul’—told me about his relapse before I even mentioned that I would be asking for a urine test. In fact, he was eager to tell me about his experience, as if he looked forward to getting it off his conscience. “I have to tell you that I really screwed up last week,” he said. When I asked him what happened, he said that a friend who he hadn’t seen for several months came through town and stopped by his house. With little warning, his friend pulled out a bag of heroin and a couple clean needles, tossed them on the table, and said ‘let’s fire up.’
After shooting the heroin, Paul immediately felt disappointed in himself. Unlike in the old days, he felt nothing from the heroin. While his old friend nodded off next to him, Paul wondered what the heck happened—and immediately wanted to talk to me about the situation.
His desire to talk is an amazing thing—and worth noting. Without buprenorphine, a person who relapses is not generally eager to speak to his/her sponsor, let alone counselor or physician. In those cases, the mind reels from an avalanche of shame, and the need to keep secrets—even from one’s own awareness—becomes paramount.
There are many buprenorphine programs that would discharge a person for one relapse—and in such cases, I would not expect the same type of honesty from patients. I don’t get the logic of those programs, and I become angry when I think about them. As I’ve said before, if a person relapses, that person NEEDS help—not abandonment! I believe that the proper approach to treating addiction can be found in almost all cases simply by considering opioid dependence to be another chronic illness. And if someone with heart disease overexerts himself and comes in with chest pain, we don’t boot him from treatment!
Paul made an appointment to talk about his experience. He explained how he felt when his old buddy contacted him, and we discussed ways to avoid meeting up with ‘old friends’ in the future. He discussed the urge to escape when he saw the paraphernalia—to escape from life’s responsibilities—and we talked about how difficult it can be to simply tolerate life sometimes, and the powerful effects of triggers and cues. Most interesting to me, as a psychodynamic psychiatrist, he talked about a complicated set of thoughts and feelings that came up when he saw the drugs—questions about who he was, about shame, about the heavy load that comes with doing the right thing, and about the pressure of not letting people down. Those are all big issues, I said as I agreed with him. How much easier, at least for a few moments, to just be ‘nothing’—to have no expectations about one’s self!
We talked about the challenge of being ‘someone’– of being proud of one’s self. It feels good to do the right thing– but it may also feel bad. Am I letting my old friends down, if I do better? I suggested that he might watch the old movie, Ordinary People, where a younger brother struggles after surviving an accident that claimed the life of his brother.
Before buprenorphine, people struggled with opioid dependence largely on their own. Yes, we had twelve step groups—and still do—but twelve step groups place the responsibility to get one’s act together squarely on the back of the using addict. Many people in AA or NA will say that “AA is a selfish program.” It has to be. When one relapses, one is left with his own distorted insight, accumulating consequences until, hopefully, he finds his way back to the pathway established by the simple program of the steps.
On buprenorphine, relapse doesn’t necessarily cause instant loss of insight. I don’t mean to minimize relapse, as bad things can always happen. For example, I have had patients stuck in a pattern of chronic relapse that was difficult to straighten out, even though there was little or no psychic effect from the drug being abused. But from an optimistic standpoint, relapse on buprenorphine stimulates a deeper investigation into what is missing from the person’s life, and a renewed effort to gain what is missing.
This assumes, of course, that the person is not simply tossed from treatment for the relapse. In that case, other people are left trying to figure out what happened—when the obituary appears a few months later.

The Buprenorphine Ceiling Effect

This post is from a couple years ago; I think it is important for people to have a basic understanding of how buprenorphine removes opioid cravings, so I’m republishing the post.
Note that naloxone has NOTHING to do with the effects of Suboxone.
In this video I explain why the ceiling effect is so important to the effects of buprenorphine for treating opiate dependence.