The makers of Suboxone have the Bay State on a leash

For more than a year now, our partners at the Boston Institute for Nonprofit Journalism have been working with local filmmaker Johnny Hickey (Oxy Morons, The Habit) and his company, Moodswing Productions, on a project called Film Intervening Getting High Team. Developed to provide opportunities for aspiring media makers who are in recovery or who have family members struggling with addiction to participate in front of and behind the camera, F.I.G.H.T. aims to push the envelope for how the opioid crisis is covered in Greater Boston. Unlike the impersonal outsider approach taken by more mainstream outlets, the segments are intended to both educate and build awareness around topics that the larger media has yet to notice.

The Dig will be running print and online versions of the videos produced by F.I.G.H.T. It’s fitting, since we first covered Hickey back in 2005. Our reporting on the OxyContin epidemic in his native Charlestown was groundbreaking in retrospect, as other media in New England barely noticed the problem until the end of the aughts, while journalists at major nationals like Time dragged their feet until 2015, a full 10 years after we first visited the issue in these pages. Some of the features we publish in written form will include stories told by recovering addicts, as well as critical explainers about things like how Suboxone works. For this installment, F.I.G.H.T. and BINJ dug deep into the legislative and lobbying efforts that got us here.

The research presented herein ultimately zooms in on the Commonwealth, but much of what we found can be said about any place in the United States or elsewhere that has been ravaged by all and any variations of synthetic opiates and painkillers.

You might say this leg of the story about how opioid abuse ravaged America begins in 2000, when the Drug Addiction Treatment Act was passed by Congress. Aggressively influenced by the pharmaceutical lobby, DATA was a significant game changer and boon for the makers of so-called treatment drugs, allowing physicians to prescribe meds for opioid-related treatments in settings that aren’t registered with the Drug Enforcement Administration as narcotic treatment programs. Basically, the measure removed a lot of the red tape around drugs like Suboxone. Under DATA, a doctor who wants to prescribe buprenorphine simply has to:

• Complete an 8-hour education course.
• Hold subspecialty board certification in addiction psychiatry or addiction medicine.
• Have participated as an investigator in a clinical trial leading to the approval of a narcotic for maintenance or detoxification treatment.
• Have other training or experience that the state medical licensing board considers adequate.
• Or have completed other training or experience that the Department of Health and Human Services believes to be sufficient.

TWISTING DATA

Some businesses may be smitten with a major opportunity that allows for so many more sales in new settings. But not drug companies, which were just getting started in late 2002 when buprenorphine, the first and only drug eligible for use under the DATA Waiver program, was approved by the FDA for use in the treatment of opioid dependence. As Suboxone (a drug with buprenorphine) was introduced to the United States market in 2003, lobbyists hired by its maker, Reckitt Benckiser Pharmaceuticals, were already fighting the restrictions written into DATA. Along with other powerful stakeholders and lobbyists, the National Alliance of Advocates for Buprenorphine Treatment argued:

DATA, void of any supporting science, caps the number of addicted patients a physician can treat at any one time to 30 through the first year following certification [even though no] other medications have such restrictions, including the prescription drugs people get addicted to and die from.

Big pharma got what it wanted. Under DATA the way it was initially written, physicians could only prescribe buprenorphine to up to 10 patients. Soon after, the Substance Abuse and Mental Health Services Administration (SAMHSA) introduced a waiver for up to 30 patients, followed by another that allows up to 100 patients. (As of 2016, after prescribing to up to 100 people for a year, physicians can then apply to increase their limit to 275 patients.)

In March 2006, the US Department of Health and Human Services and SAMHSA released a “Report On the Physician Waiver Program Established by the Drug Addiction Treatment Act of 2000.” Under a section titled “Public Health Consequences,” researchers reported that “the 3-year national evaluation indicated evidence of little diversion or abuse in the beginning years of buprenorphine dissemination.” Years later, Suboxone would become far more controversial; among other findings, according to a 2013 New York Times survey of research up to that point, “Suboxone and Subutex were considered the “primary suspect” in 690 deaths—420 in the United States—reported to the F.D.A.” in the first decade of the drug being sold. But for the first five years after it was introduced, the government basically ruled that Suboxone was harmless, effectively allowing the flood gates to open up.

FOLLOW THE MONEY

Toward the end of the 2000s, Reckitt Benckiser started lobbying in Mass:

• It started slowly in the Commonwealth, spending less than $30,000 in 2008.
• The following year, Reckitt ramped it up to $48,000, specifically hiring lobbyists to work on “legislation … including issues related to substance abuse.”
• By 2011, the company was spending more than $50,000 and was specifically having lobbying done on behalf of “Issues regarding policy coverage for Suboxone Sublingual Film and overall Substance Abuse Treatment strategy.”
• In 2012, Reckitt registered to lobby with an “Interest in contracting with the state for Suboxone Sublingual Film.” It didn’t spend any money on the effort, but the line of interest was a sign of things to come, a push from every angle.
• By 2014, it was a full-court press, with Suboxone lobbyists pushing more than 10 bills on Beacon Hill, many of which aimed to expand access, including An Act Relative to Oxycontin and Other Schedule II Controlled Substances; An Act Reducing Prescription Drug Abuse; An Act to Provide Addiction/Sobriety Solutions Through Increased Substance Treatment; An Act to Establish a Reporting System for Drug Overdoses; An Act Regulating the Use of Buprenorphine in Opioid Dependence Treatment; An Act Regulating the Use of Buprenorphine in Opioid Dependence Treatment; and An Act Ensuring Parity for Mental Health and Substance Abuse Treatment.

Reckitt kept lobbying year after year, and it kept getting results, all despite warnings from early on that Americans were amid another potential OxyContin-sized problem. In 2011, research showed that emergency room visits for the nonmedical use of drugs like Suboxone were nearly five times what they were in 2006.

Despite such research, in 2016 Congress passed the Comprehensive Addiction and Recovery Act , which further expanded access to opioid treatment meds. Since that maneuver, nurse practitioners and physician assistants can prescribe drugs like Suboxone. With just 24 hours of training, they can treat dozens of patients.

Meanwhile, as far back as 2012, the US Federal Trade Commission was investigating Reckitt, which in 2014 turned its Suboxone manufacturing arm into a separate company called Indivior. In 2016, more than 35 states, including Massachusetts, sued the company for “unlawfully delaying and impeding competition from generic versions of Suboxone tablets, resulting in ongoing overpayments by consumers,” among other things. Last year, the Department of Justice (DOJ) joined lawsuits against the company, charging that it improperly marketed Suboxone.

None of which has seemed to matter in the Commonwealth, as Indivior picked up the lobbying ball from its predecessor. Between 2008 and 2018, the makers of Suboxone spent nearly $400,000 lobbying Mass lawmakers, and the company currently has influencers working on Beacon Hill advocating for bills related to “Any and all matters pertaining to Indivior including medication-assisted treatment,” as well as to “the taxation of the sale of active opioids.”

Check out digboston.com, binjonline.org, and fightopiates.org for videos and more information on F.I.G.H.T.