In a July 2019 interview, two faculty of Boston University proposed that the opioid drug buprenorphine start being distributed without a prescription, with only a pharmacist’s approval. Currently, buprenorphine is one of the three drugs used in medication-assisted treatment of opioid addiction.

Who is featured in this interview? 

• Payel Roy, MD, is the Clinical Director of the Addiction Medicine Consult Service. 
• Michael Stein is an MD and chair of Health, Law, Policy & Management. 

You can read their interview here. 

Easier access means that anyone currently struggling with opioid addiction could obtain this drug whenever they chose. Stein encourages this liberalization of buprenorphine distributing, saying it could be life-saving. He said: 

When every dose of heroin or fentanyl could kill you, having immediate access to buprenorphine at a pharmacy—morning or evening—could be lifesaving. Most heroin and fentanyl and prescription pill users use multiple times every day, whereas buprenorphine is long-lasting, requiring a single dose daily, limiting exposure to potentially lethal illicit opioids. To me, this upside and the possibility of reducing overdose deaths mitigate my real concerns about this new idea. 

What’s the Problem?

Stein’s point is valid. Buprenorphine is a less intoxicating drug. A person who could find fentanyl in their next pill or bag of heroin bought off the street is safer getting prescription buprenorphine. 

So where’s the problem? Here’s some possible faulty points in their arguments. 

1. Roy relies on “stigma” as a reason buprenorphine is not more readily available. Stigma is, of course, more or less a dirty word. By invoking this term in her interview, she could be simply be trying to shame anyone who disagrees with her.
2. Roy also states that a practitioner who wants to treat addiction with this drug must get a waiver from the Drug Enforcement Administration before doing so. She says that this requirement “can bias many well-meaning clinicians into thinking that prescribing buprenorphine is too complicated or advanced for their practice.” The only requirement by the DEA is completion of an eight-hour online course. Any person who completed medical school should be able to face an eight-hour online course.
3. Roy then adds that those who are addicted could start on treatment right away, without waiting for an appointment with a doctor. Well, there is value in that. A person wishing to leave addiction behind might have a delay before they can find a practitioner to accept them. But in this case, we are encouraging completely uneducated people to make life-or-death medical decisions on their own. Buprenorphine is addictive and can cause overdoses. It is frequently sold on the illicit market. Do we want to take this out of the control of a medical doctor and give it to a pharmacist who is not set up to privately interview patients, take full medical histories and maintain patient records?

Cui Bono?

Who’s currently making buprenorphine? In other words, who might profit from this interview with Boston University addiction experts Payel Roy and Michael Stein?

• Sublocade: Extended release buprenorphine injection: Made by Invidior.
• Suboxone (buprenorphine/naloxone) film and pill: Made by Invidior

Generic forms of Suboxone are made by Alvogen Pine Brook, Dr. Reddy’s Lab SA, Milan Technologies, Actavis, Alken and several other labs. 

Regarding Invidior, there’s this from the U.S. Justice Department:

Until December 2014, RB Group’s wholly owned subsidiary, Indivior Inc. (then known as Reckitt Benckiser Pharmaceuticals Inc.) marketed and sold Suboxone throughout the United States. In December 2014, RB Group spun off Indivior Inc., and the two companies are no longer affiliated. On April 9, a federal grand jury sitting in Abingdon, Virginia, indicted Indivior for allegedly engaging in an illicit nationwide scheme to increase prescriptions of Suboxone. 

This case was resolved in 2019 with a $1.4 billion dollar settlement by Reckitt Benckiser Pharmaceuticals. 

Trusting an argument that encourages the liberalization of buprenorphine distribution when the profits could lead directly back to Invidior seems like a very dangerous move. 

Next, Tracing Back to Purdue Pharma

Buprenorphine is also made by Rhodes Pharma, a wholly owned subsidiary of Purdue Pharma.

We should never forget the tactics used by Purdue Pharma to soften the field to accept the idea that opioids should be prescribed for long-term use. 

According to Congressional testimony:

• Purdue promoted false narratives about their products to steer patients away from safer alternatives 
• Purdue Pharma created false advertising documents to provide doctors and patients illustrating that time-released OxyContin was less addictive than other immediate-release alternatives
• They sought out doctors who were more likely to prescribe opioids and encouraged them to prescribe OxyContin because it was safe
• They ignored and worked around safeguards intended to reduce prescription opioid misuse
• Purdue made false claims about the OxyContin’s benefit to elderly patients, and even provided doctors with staged photographs featuring fake patients
• In 2007, Purdue pleaded guilty in Federal court to falsely promoting OxyContin as, quote, less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medications.

In the book Empire of Pain: The Secret History of the Sackler Dynasty, Patrick Radden Keefe describes some of the early steps Purdue Pharma took to popularize OxyContin:

The sales team had what the company described as “non-branded” literature material generated by ostensibly independent groups, which had actually been produced or funded by Purdue… The marketing of OxyContin relied on an empirical circularity: the company convinced doctors of the drug’s safety with literature that had been produced by doctors who were paid, or funded, by the company.

Are We Seeing the Same Tactics Again?

The interview with Roy and Stein sounds plausible. It sounds caring. It sounds like they want to reduce deaths. All it would take is making buprenorphine available over the counter. 

But everything Purdue did on behalf of OxyContin sounded good at the time they did it. It sounded logical. They hired the best people to phrase their marketing messages so they sounded caring and rational. Doctors who wanted to help people bought into their false tactics. 

Many people saw this catastrophe coming for years before anything could be done about it. For the years leading up to their 2007 guilty plea, federal investigators did their best to shine the light on their misdeeds. Many people are contributing to the current effort to hold them accountable. We must not walk down the same road again.

If there is a similar tactic being used again on behalf of buprenorphine, we must be watchful, cautious and insistent on high ethical standards. And that includes not accepting spurious arguments in favor of easing restrictions on a drug that is currently abused, sold on the illicit market and is addictive.