So You Thought You Could Get Off Suboxone?
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Maybe the headline in the 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.
$1.7 billion and growing, they got that part right. Heroin and prescription opiate addiction are massive, under treated and under reported conditions in the U.S. By 2013 estimates there are over 669,000 opiate addicts in the United States. It's jarring to see a press release referring to opiate addiction as a high competition market for pharmaceutical companies. That, however, is the case, and the heart of the issue when it comes to understanding why Big Pharma enthusiastically went after the market in 2002. That's when the first buprenorphine/naloxone combination (Suboxone, from Reckitt-Benckiser Pharmaceuticals) received FDA approval.
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During the time before Reckitt-Benckiser Pharmaceuticals received the green light to bring Suboxone to market, the company was one busy bee. They lobbied congress to create the Drug Addiction Treatment Act of 2002 (DATA) and worked with the National Institute on Drug Abuse (NIDA) and FDA to lay the groundwork for the successful introduction of their product into a needy marketplace. DATA's passing created a waiver for physicians with specific certification to provide schedule III, IV or V narcotics for detox and ongoing treatment. Buprenorphine (the powerhouse ingredient in Suboxone) was developed back in 1969 by Reckitt & Coleman (now known as RBP). They were attempting to develop an opiate derivative, harnessing pain-killing properties and sidestepping its potential for addiction. This required ten years and millions of dollars to cultivate the formula and an additional 13 years to bring Suboxone to market.
The emergence of the most recent opiate derivative can be framed in a historic context. Since the synthesis of opium in 3400 BC, mankind has danced with the devil, attempting to utilize the drug's benefits and avoid getting burned. Morphine was created in 1817, codeine in 1832, and in 1874, heroin. For a time each of these compounds was thought to be a less addicting substance. By 1914 heroin became available only by prescription, and in 1924 was classified as an illegal narcotic. The narrative of today's heroin addict moved in tandem with the activities of pharmaceutical companies. Oxycontin came to the US in 1996 and was aggressively marketed as (guess what) a less habituating alternative to morphine. By 2001 it was number one with a bullet, the highest selling narcotic pain reliever. In 2010 the formula was altered making it more difficult to crush, snort or inject. The combination of high street prices for Oxycontin and the lower cost of heroin moved some prescription drug abusers to jump the fence.
Vermont Pulls the Covers on Heroin Addiction
The Governor of Vermont dedicated his entire 2014 State of the State speech to heroin addiction. The syndrome has a chokehold on his state. In the bucolic home of Ben and Jerry's ice cream, maple syrup and same sex marriage, the Governor’s entire narrative goes to opiate dependence? You can be sure the problem has gone mainstream. Heroin addiction has swung from being an inner city to a suburban and rural crisis. The demographic shift from young, poor and brown-skinned to post-collegiate suburban and white continues to shock the media.
Globally there are an estimated 9.2 million heroin users. According to the World Health Organization this is triple the figures from 1985. One of the difficulties in quantifying the scope of opiate addiction is that reporting tends to come from treatment centers and other institutions.
In the United States accurate data is also hard to come by. WHO estimates the number of opiate addicts (including heroin) to be two million. Figures from The National Alliance of Advocates for Buprenorphine Treatment (NAABT) puts that figure at 5.5 million. We don't need charts, graphs and annual reports to tell us that opiate addiction is a disaster. Communities around the country once naive to the consequences of active addiction have been thrust into the squall. The Center For Disease Control (CDC) reports opioid analgesic consumption 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 traumatizing communities they never touched before, and the problem is not going away.
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The Scope of the Buprenorphine Market
According to RBP's 2013 annual report, Suboxone had sales of $1.2 billion. It is ranked at #39 of the top 100 drugs prescribed in the U.S., placing it above Viagra, Adderall and (generic) hydrocodone. To give this sum context, Suboxone revenue is three times that of Super Bowl advertiser/provocateur Go Daddy, and dwarfs brands including Urban Outfitters and Ameritrade. In the U.S. more revenue was generated by Suboxone sales than the entire digital music download business. Other companies have arrived or plan to enter the market including Orexo (Zubsolv) and BioDelivery Sciences (Bunavail).
Getting Off Suboxone
RBP created and dominates the buprenorphine/naloxone market. Some patients who have been prescribed the drug decide they want to discontinue it. The reasons vary, ranging from financial pressures arising out of the cost of doctor visits and medication to side effects, potential future side effects and finally, the patient who wants to be 100% drug free.
Regardless of the reason one has for ending replacement therapy, making the choice presents a whole new set of challenges. Suboxone is a hard drug to kick. The medication's long half-life combined with its tight adhesion to opiate receptors makes tapering particularly difficult. From anecdotal reports, 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 facts:
- The lowest strength Suboxone comes in is 2 mg. (”Jumping” from a 2 mg dose can be a drawn out and debilitating process that takes months to recover from);
- RBP warns against cutting Suboxone strips into smaller amounts, and maintains that the medication is not equally distributed in the preparation.
If you ask the doctor who has been prescribing you the drug for months or years, you may find him/her woefully lacking in experience or a plan for tapering. Some 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 reflect 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 outcome of addiction treatment is a mistake.
This perception is changing. Four doctors I spoke to while researching this article told me they have successfully tapered patients formerly on replacement therapy. A successful taper requires adopting a combination of daily cardio exercise and mindful nutrition to repair and rebuild body and brain. For some a spiritual program is central.
While there are lower strength formulations of buprenorphine on the market (that would make tapering a more simple and accurate process) they are created for pain management and are illegal to prescribe to recovering addicts. Physicians routinely prescribe medications for "off label" use, but there are many laws directed towards prescribers of buprenorphine and they have serious repercussions. A doctor could lose his/her license for prescribing a Butrans patch to help taper a patient off of Suboxone.
Getting certified to prescribe buprenorphine is remarkably easy. It requires completion of one eight hour online course. The amount of time in the course agenda dedicated to taking patients off off the drug is nil. No doctor I spoke with recalled the topic of withdrawal from Suboxone being mentioned during the certification process.
Many doctors have found that prescribing Suboxone is akin to installing an ATM in their waiting rooms. It’s the perfect storm. Patients are desperate when they come in, willing to pay significant sums of cash for services, and rarely shop around for the perfect fit between patient and practitioner. In many cities there is a waiting list to get in to see a doctor able to prescribe. No background in addiction medicine is required to take the course. This creates a wide berth for physicians who may be opportunists to cash in on the vast and growing population of opiate addicts frantic for a solution.
Wrestling with Big Pharma
The difficulty of compelling a pharmaceutical company to take suggestions from the public is directly related to the power Big Pharma wields in the United States. Pharmaceutical companies spent almost three billion dollars lobbying the U.S. Government in the last five years. Pharma is the largest of all 121 lobbying entities and donated over $90 million dollars to federal candidates and political parties.
Advocates for an exit strategy from Suboxone have the weight and effect of a single fly in the chardonnay of Big Pharma. There are some lobbying groups working on issues of addiction treatment, and the numbers of these groups are growing. New York, Florida and Pennsylvania have advocacy groups, but their efforts tend to be focused on broader stroke issues. With an entire health care system in transition, obtaining any treatment for addicts is the fight these groups are concentrated on.
Big Pharma's Inconvenient Truth
Pharmaceutical companies gross massive annual earnings; a whopping $950 billion dollars globally. It is an industry of Goliath momentum and political reach. Relying upon recipients of lobbying influence to look their gift horse in the mouth? In the battle of ethics and commerce, conscience rarely rears its inconvenient head. Like Jesse from Breaking Bad, we might ask “What about science, bitches"? Where are the impartial and sovereign scientists? The reality of scientific investigation means taking marching orders from drug companies. For more on this topic read Jacky Law’s examination in her book, Big Pharma - Exposing The Global Healthcare Agenda.
Knee Deep in the Muck
With these facts in mind, I reached out to RBP, Orexo, and BioScience Delivery International. My outreach to RBP is particularly pertinent, since they are both the creator of Suboxone and the market leader. It’s key to understand that the first company to bring a pharmaceutical product to market jumps through extra hoops in order to obtain first entrant advantage. The company had to work closely with the FDA and NIH to first prove that there was a need for the drug. They also worked together to establish dosage protocol, and in the case of Suboxone, on establishment of a certification program so that physicians could legally prescribe the drug (using a narcotic to treat narcotic addicts was against the law until DATA was created in 2002). The intimate relationship between RBP, the NIH, NIDA and the FDA raised a red flag in my mind.
The initial safety and dosage protocol studies created to bring Suboxone to market have not been revisited since 2002. Since the drug has been in the market for 12 years, it seems prudent to have a look at how people on long-term maintenance are faring.
There are no FDA regulations requiring re-evaluation of a drug and its side effects over time. In the past new studies were prompted by negative outcomes not identified during clinical trials. Post-marketing investigation uses a number of methods to check on the safety of drugs: reporting databases, prescription monitoring, electronic health records, patient registries, and linking records between databases. In the U.S. post-marketing surveillance is overseen by the FDA through MedWatch where doctors or the public can report adverse reactions to drugs.
You Can Check Out Anytime You Like But You Can Never Ever Leave
People who have taken Suboxone over time have begun asking questions that Big Pharma finds troubling. Incidences of adrenal imbalances, hair and tooth loss as well as a myriad of psychological issues ranging from dissociative disorders to anxiety have long been denied by the manufacturers of buprenorphine/naloxone medications.
Interestingly, the NAABT (National Alliance of Advocates for Buprenorphine Treatementt) has quietly begun posting questionnaires on their website forums about exactly these maladies. The relationship between NAABT and RBP goes back to well, the introduction of the drug onto the market by RBP. The website was launched with generous and anonymous donations some of which certainly came from RBP’s coffers. While the organization now counts Orexo and BioDelivery Sciences as partners in their mission, for many years it was only RBP.
In 2014 both physicians and patients find themselves in a bureaucratic catch-22 with Suboxone. Some recovering addicts are desperate to get off the medication, and sorely in need of assistance. To get a sense of the scope of the problem type the words “get off Suboxone” into search engines, and you’ll find over 900,000 results.
RBP has gone on since 2002 and obtained FDA approval for two higher strength dosages for the drug. Some patients are pleading for lower strengths to help them titrate off the medication, and this is something no one wants to deal with or talk about.
If you have any doubt about the power and reach of Big Pharma when it comes to Suboxone, you might be interested in the tale of Dr. Steven Scanlan. A Florida addiction specialist who runs the Palm Beach Outpatient Detox, Scanlan was asked to write his opinion on Suboxone maintenance in a 2010 article for a professional journal. It was described to him as a debate, where he took the “con” side. At that time he felt that maintenance on Suboxone was not a good idea, period. The response to this one article was staggering. He received over 2,000 vitriolic e-mails after his personal address was mistakenly (?) printed with the article. The other doctor (who was pro-maintenance) did not have his personal information revealed. Dr. Scanlan told me that in addition to receiving numerous death threats, he was falsely accused of nefarious actions, from violence towards his wife to abusing a young male patient in his care. He was tormented in hundreds of posts on websites and forums. The fallout from the position he took was so overwhelming that he prefers to keep a low profile these days. Scanlan does take on patients who want to get off Suboxone. He takes a maximum of five at any one time, and places strict conditions and terms around being a patient in the program. He has written an article detailing the experiences he has had with patients whom he has tapered off the drug. Before dedicating part of his practice to helping patients get off Suboxone he found that the lengthy withdrawal process associated with it led many patients to give up trying. He is working to change that.
I am not a conspiracy theorist by nature. I find obsessing on the infinite layers of potential actions and counter actions of institutions, governments and countries to be contrary to my mental health. In the case of Suboxone however, I have a lot of questions.
In particular, I want to know about RBP’s incestuous relationship with the NAABT, the development of FDA/NIDA guidelines, and the lack of any studies undertaken by RBP since the drug was approved in 2002. It’s a cozy and profitable world that’s been created, and rocking the boat is not on anyone’s agenda.
With these thoughts in mind I made inquiries with RBP, Orexo and BioDelivery Sciences International. My queries were as follows:
1) Is any company studying the long-term effects of Suboxone use?
2) Will any company debut lower dosages of buprenorphine/naloxone to help patients with the taper process?
3) Do pharmaceutical companies have an agenda to keep patients on buprenorphine/naloxone indefinitely?
Responses from Pharmaceutical Companies
As far as answers went, some common themes emerged from BSDI and Orexo:
Studies of Long Term Treatment with buprenorphine/naloxone:
RBP chose not to answer this question, which I can only presume means they are not studying long term use, or do not intend to reveal any perspective on the topic. To be fair, Orexo and BioSciences Delivery International have been in the market for under one year and do not have any data on their own products to study.
Regarding lower strength dosages of buprenophine/naloxone:
“Formula strengths (of buprenorphine/naloxone combinations) are based on FDA, NIDA and NIH guidelines (established with help from RBP ) They are bound by the doses studied and approved by FDA. Creation of product lower than 1.4 or 2 mg have to be supported by clinical studies and a subsequent regulatory filing. BDSI (BioDelivery Science Industries) is studying buprenorphine at lower doses now for the treatment of chronic pain, where we believe there is also a very high unmet need. Many patients with dependence also suffer from chronic pain. Often, it’s the reason for their dependence.”
“We recognize that there is little medical data for patients trying to discontinue buprenorphine therapy. We have recently launched a buprenorphine product approved for the same use (addiction), but we are a relatively new company and our product has only been available for about 10 months."
"We agree with your assessment on the lack of data, lower strength products, and investment in additional clinical studies by the manufacturers who have had a product approved for some time".
"We are currently evaluating the development of lower dose of our product to submit for FDA approval, but, at this time, we do not have a timetable for additional strengths of our product."
How do you frame theories that pharmaceutical companies have a vested interest in keeping patients on buprenorphine treatment indefinitely?
“Our interest is solely in what’s in the best interest of the patient and what is demonstrated in the medical literature. The length of treatment is an individual decision between the physician and patient. Opioid dependence is a chronic medical condition. Like many chronic conditions, there isn’t a lot of evidence to support the most appropriate length of treatment, and often it is individualized to the patient. In the case of opioid dependence, I’m not certain there is fixed treatment duration suitable for all.”
“We appreciate hearing the perspective of patients who are actually dealing with these issues and your (questions) match what we’ve heard from both patients and physicians. Orexo is a young company and, when we started, we were taken aback by the lack of investment in clinical studies to assist patients in recovery by the companies who have had a buprenorphine product on the market for a number of years".
"We do recognize this as an issue and are looking at both additional strengths of our product and clinical studies that could provide a roadmap for tapering off of the medication."
"Please be assured that your voice was heard and shared with the leadership, including the President, of Orexo. We are actively trying to develop a lower strength and are in discussions with the FDA on how best to do that."
And now for the voice of experience, market savvy and $1.3 billion dollars in the bank, Reckitt Benckiser speaks:
Has RBP written a protocol for titration off of the medication SUBOXONE® Film or SUBUTEX® (buprenorphine HCl) Sublingual Tablet? If not, why?
"No. Reckitt Benckiser Pharmaceuticals Inc. believes there is no “one-size-fits-all” approach to opioid dependence treatment, and the company is not aware of an established guideline or protocol for titration. The decision to discontinue therapy with SUBOXONE® Film after a period of maintenance should be made as part of a comprehensive treatment plan. Patients seeking to discontinue treatment for opioid dependence should be advised to work closely with their healthcare provider on a tapering schedule and should be apprised of the potential to relapse to illicit drug use associated with discontinuation of opioid agonist/partial agonist medication-assisted treatment."
Does RBP have the ability to request changes in the protocol around use of the drug e.g., adding an enhanced segment on tapering to the curriculum physicians have to complete to be able to prescribe the medication?
"The Substance Abuse and Mental Health Services Administration oversees the curriculum healthcare professionals must complete in order to prescribe the medication. In order to be certified under DATA 2000, prescription use of SUBOXONE® Film in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription."
"Reckitt Benckiser Pharmaceuticals Inc. also has proactive and open communication with DATA-waived healthcare professionals to educate them about SUBOXONE® Film as well as their role in minimizing potential abuse, misuse and diversion."
What would it take to influence your firm to bring a lower strength buprenorphine product (for treatment of opiate addiction) to the US market?
This is the topic RBP is not interested in. I did get off the record comments from a different company saying that they were not aware of data or studies that could support a lower dose. I was told that lower dosage protocols would require studies and an FDA filing/review. This will take a number of years.
One company representative (not RBP) told me that they are investing in a lower dose program for the treatment of chronic pain, and that their desire is to bring to market a product with a lower propensity for abuse and addiction.
The information gathered was helpful in understanding the power of RBP, who I began to refer to as "The Kaiser" to remember the correct pronunciation of the company name. The tag sure has a ring to it.
When you research Big Pharma you come away with one principal insight. Innovation is driven by competitive advantage, being the first provider in a new market. Once the initial patent on a drug expires and generics fill the channel, new formulations need to be developed in order to hit revenue goals. In the case of Suboxone those formulas all point one way, towards more potent and easier to absorb preparations.
The criticism is not of basic economic market theory. It speaks to the fact that time and again pharmaceutical companies have been slow to respond to anecdotal reports from patients of complications from a drug. From Thalidomide to Vioxx there are hundreds of examples of drugs that were aggressively marketed and touted as safe that ended up being banned. Unfortunately this occurs only after dire consequences and perhaps more pointedly, expensive litigation.
The following is clear to me:
- RBP refuses to study the long term effects of buprenorphine maintenance;
- The company reflects an intolerance for the faction of buprenorphine patients who decide they want to discontinue replacement therapy;
- There is a dearth of information about Suboxone titration from Suboxone doctors making significant profit prescribing it;
- The lack of medical studies/recommendations on tapering has created Internet "experts" and websites posting unreliable information.
The surge of heroin and prescription opiate addiction ensures that the companies who manufacture and distribute buprenorphine based products will have a burgeoning market of patients to buy their products for many years to come.
If you, or someone you know is on a program of buprenorphine/naloxone maintenance and wants to discontinue, it can be done. We are not victims. On some level we have volunteered for this. We have to advocate for ourselves. As addicts we are extraordinarily crafty and resourceful in getting what we want. If we want to be free of Suboxone we can do it. Unfortunately, for the most part we will be going it alone.
Resources/Links for Information on Tapering off Buprenorphine
Dawn Roberts is a writer and music business survivor. She lives in the Catskill Mountains in the Hudson Valley with two dogs, a cat and a recording engineer.