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Sunday, September 14, 2014
So You Thought You Could Get Off Suboxone?
Why is there no official medical protocol to detox addicts off of Suboxone? The Fix goes to the pharmaceutical companies for answers.
By Dawn Roberts
Maybe the headline in the press release for Bunavailsays 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. By2013 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.
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.
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 thelargest 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 dollarsglobally. 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.