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So You Thought You Could Get Off Suboxone?

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By Dawn Roberts

09/04/14

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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:

BDSI

“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.”

Orexo

“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?

BDSI

“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.”

Orexo

“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.

Final Thoughts

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

http://www.pbod.org/detoxing-suboxone-fear-caused-lack-knowledge/

http://suboxonetaper.com/tips-advice-to-ease-wds/

http://www.suboxforum.com/stopping-suboxone.html

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.

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