By Alex McKendry
As evidence continues to accumulate of the failings of abstinence- and rehab-based treatment for individuals who suffer from opioid addiction, the US is increasingly moving towards an adoption of the more progressive and globally accepted practice of Medically-Assisted Treatment (MAT).
As opposed to sending patients through the antiquated detox and 12-Step mill, MAT prescribes an opiate substitute which stabilizes and medicates the patient’s addiction. This in turn allows them to confront their addiction with a clear mind through modern, evidence-based therapy. No stigma, no jumping through hoops.
Or, that’s how it should work in theory. But since this is America, the devil is in the policy details.
Buprenorphine, one of the very few FDA-approved medications which are now used to treat opioid addiction, is a take-home medication. This medication differs from the more commonly prescribed methadone, which requires the patient to travel to a methadone clinic in order to receive their daily dose. The idea is that the potential convenience of buprenorphine is balanced out by its lower potency.
Unlike methadone, buprenorphine is only a partial agonist opioid. This means that it latches onto opioid receptors in the brain as it activates them, and after a certain dosage, the receptors are blocked from activation either by an additional dosage or by other substances such as heroin or methadone. This makes buprenorphine very difficult to abuse, and it is practically impossible for a patient to overdose on it.
This makes it an ideal treatment choice for patients with low opioid tolerance, for those who wish to minimize their physical dependency on a medication throughout their treatment, or those who find traveling to a clinic every day a prohibitive inconvenience.
Logically, it should be at least as easy to obtain buprenorphine as more controversial drugs such as Oxycontin, Vicodin, or Percocet. However, this is not the case.
Enter the FDA
In reality, only 32,000 doctors nationwide are even licensed to prescribe buprenorphine, and each doctor is limited to prescribing a maximum of 30 patients in the first year, followed by 100 in the following years. In order to obtain this license, doctors are required to take an eight hour training course, and few of these licensed doctors actually choose to prescribe it at all.
Compare this to the availability of Oxycontin or similar medications, for which more than 900,000 doctors can write prescriptions. (Note that these are medications to which at least 2 million Americans have developed serious addictions.)
As Dr. Andrew Kolodny, senior scientist at The Heller School for Social Policy and Management at Brandeis University, explains: “The drugs that can cause this problem don’t have limits, some of which would be reasonable. And we have, I believe, excessive barriers to a safer drug that may be one of the only ways to get out of this mess.”
The FDA created the license requirement for buprenorphine prescription in order to bypass the 1914 federal narcotics law, which is also responsible for the regulations placed upon methadone distribution. Without this new license law, buprenorphine distribution would have also been limited to clinics. On the other hand, the excessive barriers on prescriptions which have been put into practice as a result of this are completely unwarranted.
One possibility is that these barriers were put into place by the FDA out of fear of introducing another opioid into the illegal drug market. These concerns are relatively benign, however, since the street appeal of the drug is severely mitigated by the low level of euphoria produced by the medication, and the chemical ceiling which prevents the effectiveness of high dosages. Ironically, the low availability created by these regulations have ensured that buprenorphine is far more expensive on the street than even heroin, as those who cannot get prescriptions are forced to buy it in whatever way possible.
Most likely, the excessive amount of caution displayed towards buprenorphine by physicians as well as the stagnant policies of the FDA are the result of a shared fear. That is, that there is a chance of repeating the absolute, unmitigated disaster that was Oxycontin.
Some quick history: Heroin, the most potent of all opiates, was created as an alternative to morphine, a widely prescribed painkiller which itself was adapted from opium. At one point, even opium was sold as a cure for alcoholism.
Oxycontin is only the most recent chapter in a long history of pharmaceutical companies modifying and repackaging opiates to be sold and prescribed to the American public.
For evidence of the way in which the regulation of prescription medications by physicians can be completely derailed by pharmaceutical marketing and greed, one needs not look any farther than Purdue Pharmaceutical and their singularly aggressive push for widespread adoption of their newly manufactured painkiller.
According to a report by The National Center for Biotechnology Information on the marketing of Oxycontin, Purdue’s aggressive marketing involved a bonus system which awarded each of its massive 671-man sales representative teams an average of about 70k a year in extra income. This was meant to encourage them to repeatedly visit doctors who were known to distribute a high number of opioid prescriptions.
Their sales force would arrive armed with an expansive information campaign aimed towards physicians, as well as free, branded gifts such as hats, toys, and even promotional music CDs (rest assured, I have searched the internet for these in vain). They even offered a “patient starter coupon program for OxyContin that provided patients with a free limited-time prescription for a 7- to 30-day supply.” By 2001, 34,000 of these coupons had been redeemed.
Around that time is when the knowledge that Oxycontin could be easily abused by crushing up the normally slow-release medication and ingesting it nasally or orally became widespread.
In addition, over the past decade and a half, opioid addiction in America has skyrocketed.
It isn’t much of a stretch to say that pharmaceutical greed is largely to blame for the huge spike in opioid usage over the past decade. And yet the drugs meant to treat opioid addiction either require doctors to take eight hour training courses or for patients to travel out of their way on a daily basis, to clinics where they are often subject to police harassment!
The bottom line is that opioid medications are being regulated in a way which is not dictated by the best interest of patients, but rather by factors such as potential profits, addiction stigma and unfounded concern over promoting illegal drug trading. This is the type of mindset that stops a no-brainer such as buprenorphine from becoming widely distributed, while Oxycontin has been dumped into the hands of adults and children who were uneducated, and often misinformed, about the risks involved.
What is needed is a more open-minded FDA less bound by fear, status quo, and the principles of the war on drugs. We need reasonable, well-balanced regulation of all available opioid medications, regulation which ensures availability where needed, which respects patients’ autonomy and priorities, and presents clear, honest information about the nature and recommended uses of each substance.
Perhaps at some point we’ll be living in a country where the decriminalization of drugs will allow for adequate research into some of the Schedule I substances which could truly radicalize the treatment of opioid addiction, or a country where there is a widespread system of community therapy that isn’t 12-Step-based.
Barring those things, an essential medication should at least be as attainable as one of the greatest contributors to the very problem which is meant to be medicated.
It shouldn’t take a physician to figure that out.