First and Only FDA-Approved (Buccal Formulation) of Buprenorphine and Naloxone to compete in the $1.7 Billion and Growing U.S. Opioid Dependence Market.
A recent press release for Bunavail says it all: First and Only FDA-Approved (Buccal Formulation) of Buprenorphine and Naloxone to compete in the $1.7 Billion and Growing U.S. Opioid Dependence Market. Heroin and prescription opiate addiction are massive, under-treated and under-reported conditions in the United States. According to 2013 estimates, there are over 669,000 opiate addicts in the U.S. Big Pharma enthusiastically went after the market in 2002 when the first buprenorphine/naloxone combination (Suboxone, from Reckitt-Benckiser Pharmaceuticals-RBP) received FDA approval. So it’s not that surprising that a press release refers to opiate addiction as a high competition market for pharmaceutical companies.
With such large numbers of people abusing opiates for non-medical purposes, there has been a decrease in availability of opiates to this population. As this has occurred, there is a growing shift to Heroin use. In the U.S., accurate data is hard to come by, yet the WHO estimates the number of opiate addicts increased 300% between 1999 and 2010, and death rates for poisoning involving opioid analgesics more than tripled between 2000 and 2010. In 2014 the skyrocketing number of 911 calls and overdoses related to heroin and prescription drugs are overwhelming communities which have not been touched before, and the problem is not going away.
According to RBP’s 2013 annual report, Suboxone had sales of $1.2 billion and is ranked at #39 of the top 100 drugs prescribed in the U.S., placing it above Viagra, Adderall and (generic) hydrocodone. So obviously, buprenorphine treatment has found a very secure place as the outpatient opiate replacement treatment under a “harm reduction” model. The problem which is increasing in America is that doctors know how to get patients on Suboxone, but no one knows how to get them off it.
Almost 95% of what is written will say that this is the miracle drug for addicts, and should be used for replacement therapy. We can recognize that violent crime has decreased greatly and that HIV/Hepatitis C infections have decreased since this has become an opiate-maintenance drug. We know that people in the throes of addiction who were robbing, stealing, and losing their employment, friends, and family are often able to rebuild their lives through Suboxone maintenance.
However not all patients experience these kinds of benefits, and many begin to experience unwanted side effects from the long-term use. Many patients say they feel dead to the world and without feelings. They also began exhibiting elevated cortisol levels, thyroid problems, low testosterone, hair loss, decreased libido, and immune function problems which could be from long term use. Many patients report a complete lack of feelings and anhedonia (the inability to experience pleasure from activities usually found enjoyable). Many also experience a poor response to stress when they do not take enough Suboxone. Finally, many loved ones report that they feel like they are living with a stranger, although a stranger whose life is more manageable than before.
This would naturally prompt many to desire a detox from the chronic use of Suboxone. Many realize that they are being prescribed Suboxone and are not being given addiction treatment; simply put, they are trading one drug for another without any psychic change being encouraged. This “stabilization” with Suboxone without addiction treatment being given is just a giant Band-Aid, and this will inevitably lead to major problems down the road. Regardless of the reason one has for ending replacement therapy, making the choice presents a whole new set of challenges.
It is a discouraging fact that there exists little or no information or any studies from the medical community about the long-term effects of being on Suboxone, or how to get a patient safely off it. It is also disappointing to see the many blogs about Suboxone and see that a lot of people are suffering and attempting to get off Suboxone—people turning to blogs to find unprofessional guidance. To get a sense of the problem, type the words “get off Suboxone” into search engines, and you’ll find over 900,000 results. If you ask your Suboxone prescriber how to achieve a Suboxone-free life, you may find him/her woefully lacking in experience or a plan for tapering. Many physicians continue to murmur the mantra of RBP that a majority (95%) of patients who go off the remedy will return to active addiction. The overall statistics on recovery from addiction reflects this same figure. The fact is that a high percentage of people who try to get clean fail. Some fail many times before achieving freedom, and some die. Confusing the rhetoric of a pharmaceutical company with studies on the outcomes of addiction treatment is a mistake.
This perception is changing. The least disruptive way to achieve a Suboxone-free life is to cut down the amount used very slowly week by week until titration is complete. This scenario is complicated by two important facts: the lowest strength Suboxone is 2mg (“Jumping” from a 2mg dose can be a drawn out and debilitating process); RBP warns against cutting Suboxone strips into smaller amounts, and maintains that the medication is not equally distributed in the preparation. A successful taper requires adopting a combination of daily cardio exercise and mindful nutrition to repair and rebuild body and brain. For most, a spiritual program is central.
You may be wondering what my background and credentials are that qualify me to be discussing this topic. I am board-certified in Internal Medicine and have board certification in Addiction Medicine. In addition, I am a recovering addict myself and feel that this gives me a special perspective on these topics. I am able to empathize with patients and understand the unpleasantness of detoxification because I have undergone the process myself.
I do feel that Suboxone is a very powerful detox tool and helped me to get detoxed off my own addiction. At the time, I begged physicians to let me stay on it, but they told me that I could live without narcotics if I was willing to work a program of recovery. I was also informed that if I took it too long I would have a very hard time coming off Suboxone, and that little is known about the effects of taking it for a prolonged period. Furthermore, it was explained to me that if I wanted to practice medicine again I had to be off all narcotics, reminding me that Suboxone is a very potent narcotic. I was told that doctors who agree to dedicate themselves to a twelve-step program, go to a weekly support group for doctors, and agree to urine monitoring have over a 90% success rate at the five-year mark in Louisiana. It became obvious that the disease of addiction does not discriminate and that the procedure for doctors is the same as for everyone else.
If you are having some of the physical, emotional, or spiritual side effects from buprenorphine that I talk about here, then it may be time to look at other options. My hope is that this discussion will help anyone on Suboxone to become more knowledgeable by my sharing of clinical and personal experiences. I absolutely do not recommend that anyone attempt to detox off Suboxone or Subutex without the help of medical professionals. Should you or a loved one who has become dependent on Suboxone or Subutex want to break free from the chains of addiction, there IS a way through Palmetto Addiction Recovery Center. As you may know, fear is caused by a lack of knowledge—wisdom gives us the power to act.