$1.4 Billion Suboxone Payout Raises Questions about Clinics Delivering the Drug

By Jan Eastgate
President, CCHR International
Mental Health Industry Watchdog
July 29, 2019

A pharmaceutical company’s recent $1.4 billion settlement with the Department of Justice (DOJ) over probes into its addiction treatment drug, Suboxone Film (buprenorphine and naloxone), raises concerns about psychiatric drug treatments offered as solutions to the opioid crisis.[1] Buprenorphine, one of the active ingredients in Suboxone, is a synthetic opioid that is potentially addictive.[2] The DOJ alleged the drug was marketed as safer and less susceptible to diversion and abuse than similar drugs containing buprenorphine.[3]

Suboxone Clinics have sprung up across the U.S., including within a major behavioral hospital chain, Acadia Healthcare, that owns more than 100 Suboxone and methadone clinics.[4]

While the country suffers from the opioid crisis, huge profits and serious dangers come from the treatment of addiction to them. The Food and Drug Administration (FDA), which approved Suboxone in 2002, warns that people taking buprenorphine have suffered serious breathing problems and death—especially when taking buprenorphine by injection, and in combination with benzodiazepines or other central nervous system depressants.[5]

According to Steven R. Scanlan, board-certified in addiction medicine, Suboxone is estimated to be 25 to 40 times more potent than morphine.[6]

Between 2009 and 2011, buprenorphine was associated with at least 33 deaths.[7] A New York Times investigation in 2013 also found adverse drug reactions reported to the FDA showed buprenorphine was a “primary suspect” in 420 deaths since it reached the market in 2003.[8]

A Suboxone Strip is a sublingual film, which is placed on the tongue to dissolve within about a minute. If enough of the strips are placed under the tongue and dissolved, it can result in a high. Those with Suboxone addiction and seeking a high tend to dissolve Suboxone strips into water to inject into themselves.[9]

Other adverse effects of Suboxone Film include: respiratory problems, with a higher risk of death and coma if it is taken with other medicines, such as benzodiazepines; dependency or abuse, liver problems, decrease in blood pressure and opioid withdrawal. The latter includes symptoms which can include: shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting, and muscle aches.  Long-term (chronic) use of opioids, including Suboxone, may cause fertility problems in males and females.[10]

The other active ingredient in Suboxone is naloxone that works only if a person has opioids in the body. Its adverse effects include agitation, high or low blood pressure, cardiac arrhythmias, shortness of breath, pulmonary edema, abnormal brain damage, seizures, coma and death. [11] Use of naloxone may also cause symptoms of opioid withdrawal.[12]

U.S. sales of Sublingual Film were approximately $1.87 billion for the 12 months ending December 31, 2018, according to IQVIA.[13]

Opioid dependence is a significant and growing problem. For nearly a century, federal regulations made it illegal for psychiatrists and physicians to pharmacologically manage this condition in an office-based setting using opioids. But the passage of the Drug Addiction Treatment Act of 2000 changed that making it possible for all physicians to prescribe buprenorphine to patients in such a setting.[14]

Doctors must notify the Secretary of Health and Human Services (HHS) of their intent to prescribe it and are assigned a unique identification number that must be included on every prescription. [15]  A physician has a limitation of 275 patients to whom they can prescribe Suboxone.[16]

“Addiction Psychiatry”—Raking in the Profits

It became a lucrative business for the mental health industry, starting with opioids themselves. According to a study published in the Journal of the American Board of Family Medicine in 2017, adults with a “mental illness” receive more than 50 percent of the 115 million opioid prescriptions in the U.S. annually.  Researchers asserted that nearly 19 percent of Americans with a mental health disorder use prescription opioids, while the same is true for only 5 percent of those without a mental health condition.[17]

The American Psychiatric Association’s (APA) Diagnostic & Statistical Manual of Mental Disorders (DSM) lists about twelve disorders associated with opioid use and abuse, for which psychiatrists can bill insurance.[18]

Evelyn Pringle and Martha Rosenberg writing in Alternet asked why addiction treatment companies are so lucrative, with profit margins of over 20 percent. They wrote that this is “largely because of the booming specialty of addiction psychiatry, which has exploded and muscled its way into standard rehabilitation and monetized it.”[19]

Addiction psychiatry involves substituting one drug with another or a combination of two. The problem with this model, Pringle and Rosenberg pointed out, is that “the substance abuser never recovers, but simply stays hooked on another or multiple drugs, while Big Pharma cashes in.”[20]

Inve$ting in Addiction Psychiatry

NPR also reported that “Every crisis presents an opportunity, as the saying goes. And when it comes to opioid addiction, investors and businesses are seeing a big opportunity in addiction treatment…gobbled up by private equity companies and publicly-traded chains….”[21]

But with investors pouring money into addiction treatment, this has raised quality concerns, according to Modern Healthcare. “Addiction treatment has been a very hot sector,” said Jordan Lampos, a director with Duff & Phelps, a global corporate finance firm. “A lot of investors want to capitalize on the macro tail winds.”[22]

Enter opioid maintenance and addiction treatment drugs like Suboxone.[23]  Psychiatrist Stefan P. Kruszewski at the Center for Drug Safety and Effectiveness, Department of Mental Health, at Bloomberg School of Public Health and John Hopkins University Medical School, pointed out: “Opioid maintenance drugs cause their own dependence and serious withdrawal states and other drugs used to treat alcoholism may blur the baseline mental status and delay recovery.” [24]

Between 2006 and 2016, private equity firms invested more than $2.2 billion in substance abuse treatment companies. The private equity firm Bain Capital paid $270 million for CRC Health in 2006 only to sell it for $1.18 billion to Acadia Healthcare Company Inc. in 2014.[25]

The National Institute of Drug Abuse (NIDA) estimates the total costs of prescription opioid use “disorders” and overdoses in the U.S. was $78 billion in 2013. Of that, 3.6 percent, or about $2.8 billion, was for treatment.[26]

For more than five years CCHR has investigated the use of Suboxone and other opioid addiction treatment drugs in for-profit psychiatric hospitals, including Acadia Healthcare, which owns 127 methadone and Suboxone drug rehab facilities in about 26 states, most in Pennsylvania, Wisconsin, Massachusetts, California and Oregon.[27] Universal Health Services (UHS), which has 30 of its behavioral facilities under DOJ investigation for potential billing fraud, also has outpatient Suboxone programs.  Both chains could profit from long-term patients, dependent either on opioids or Suboxone.[28]

Medicare, Medicaid and Veterans Administration paid 27% of all Suboxone Tablet and Subutex Tablet (sublingual tablet buprenorphine) prescribed while private health care benefit programs paid 55%.[29]

A Suboxone clinic can charge $200 to $300 per month, per patient, for a 5-to-10 minute checkup to renew a Suboxone prescription.[30] According to Dr. Scanlan, “the lucrative nature of Suboxone on a maintenance basis creates a disincentive to tapering the drug and its income-generating potential.” [31]

According to NIDA:

• methadone treatment, including psychosocial and support services (assumes daily visits) could cost $6,552.00 per year

• buprenorphine treatment costs $5,980.00 per year

• naltrexone costs $14,112.00 per year.[32]

Furthermore, as Suboxone has a potential for addiction, Dr. Scanlan, warns “A detox from Suboxone dependence costs $5,000 because it takes four to five months, incorporating about 10 different medications to detox the patient successfully. The success rate for detox from Suboxone is much lower than that for detox from other opiates because patients tend to give up hope during the lengthy withdrawal process.”[33]

In a sample of 12 psychiatrists CCHR identified as affiliated with Acadia behavioral facilities in nine states, seven were top state prescribers of psychotropic drugs, including two being among the top 20 prescribers of Suboxone.[34]

In May 2019, U.S. Attorney announced that Acadia, acting through its subsidiary, CRC Health, would pay $17 million in a Healthcare Fraud Settlement over its billing Medicaid for fraudulent laboratory tests related to its drug treatment programs in West Virginia, including the administration of methadone and the prescribing of Suboxone and Subutex. [35] CRC Health was accused of collecting blood and urine samples at drug treatment centers in a number of West Virginia towns, which it then sent for screening to San Diego Reference Laboratory. CRC allegedly billed Acadia, and Acadia paid the San Diego lab, while at the same time billing West Virginia’s Medicaid program, with the latter company receiving more than $8 million from Medicaid. The problem is that Medicaid paid the facilities a much higher amount for the tests than the lab had charged for the analysis. The settlement is about double the payment that Acadia received from Medicaid, according to Healthcare Finance.[36]

In the Federal Suboxone case, prosecutors charged that Reckitt Benckiser Pharmaceuticals Inc (RB Group) and Indivior (known as Reckitt Benckiser before it became a standalone company in 2014) allegedly marketed Suboxone Film to medical professionals as less addictive and safer than other drugs containing buprenorphine.  RB Group settled its case, while Indivior’s case is expected to go to trial in 2020.[37]

The prosecutors allege Indivior:

• Developed marketing plans that included claims that Suboxone Film was a “more responsible medication from a public health perspective,” “less divertable/abuseable formulation” and had a “lower risk of child exposure.” Yet, allegedly, the company “knew that Suboxone Film had attributes that potentially could make it more dangerous to children; dissolved more rapidly, leaving less time to remove it from a child’s mouth before absorption; had potentially higher bioavailability [absorption] at certain doses,” among other risks.[38]

• Announced it would discontinue its tablet form of Suboxone “based on supposed ‘concerns regarding pediatric exposure’ to tablets, despite Indivior executives’ knowledge that the primary reason for the discontinuance was to delay the FDA’s approval of generic tablet forms of the drug,” according to the DOJ statement.[39]

• “Illegally obtained billions of dollars in revenue” in this way.[40]

• On or about June 9, 2009, Indivior’s medical director told fellow Indivior medical personnel, “We need to develop a story about childhood exposures to set the stage for switching patients to” Suboxone Film.

• Yet they knew that the dangers to children included that it stuck and could not easily be spit out if accidentally taken by a child; was formulated to taste better, potentially reducing the likelihood that a child would seek to remove it; and could not easily be re-secured in its original packaging, which, unlike a bottle with a child-resistant cap, was not designed to be re-closed.

• Sought to further boost its profits from Suboxone Film by establishing a telephone program for patients to call to be connected with doctors it knew were prescribing opioids in a “careless and clinically unwarranted manner.” Company executives, managers, and personnel knew that Suboxone Film’s thin form potentially could make it easier to conceal, and thus more susceptible to smuggling than tablets; its individual packaging could make it more portable, including for reselling and sharing; and the serial numbers on the pouches were not electronically tracked and not shown to deter diversion. [41]

Indivior has denied the charges. [42]

In 2014, a study published in Pediatrics covered data from 2007 to 2011 and showed children accidentally swallowing relatives’ prescriptions of buprenorphine had died. The study found that the drug was most commonly implicated in emergency hospitalizations of children aged six and younger. For every 100,000 patients prescribed buprenorphine, 200 young children were hospitalized for taking it. Almost 800 youngsters a year were hospitalized after swallowing buprenorphine, the study found.[43]

Reckitt Benckiser denied wrongdoing asserting the $1.4 billion settlement deal “avoids the costs, uncertainty and distraction associated with continued investigations, litigation and the potential for an indictment.”[44]

Psychiatrists’ Hand in the Opioid Crisis

Psychiatrists have played an integral role in the opioid crisis.

OxyContin maker Purdue Pharma was started by three psychiatrists, all brothers. The eldest, Arthur Sackler died before Oxycontin was developed. Raymond (died 2017[45]) and Mortimer (died 2010[46]) bought Arthur’s share in Purdue from his estate for $22.4 million after he died in 1987. OxyContin became the driving power that has made their heirs many billions. All three had worked at Creedmoor psychiatric hospital in Queens, New York and coauthored more than 100 studies on the still unproven “biochemical roots” of mental illness. [47]

Concurrent with his psychiatric work, Arthur Sackler had made his name in pharmaceutical advertising, including for the benzodiazepine Valium—a drug that can be addictive within 14 days of taking it—leading to $100 million in sale in the 1960s. He was compensated by the number of pills sold and became one of the first inductees into the Medical Advertising Hall of Fame.[48]

• In 2007, Purdue paid $600 million to settle a case with the Justice Department over its marketing claims about Oxycontin and three executives, who weren’t family members, pleaded guilty to criminal misbranding, when they misled the public about Oxycontin’s addictiveness between 1995 and 2001. Purdue signed a five-year corporate-integrity agreement with the U.S. government. In 2013, the U.S. said Purdue had met the agreement’s requirements.[49]

• In a 2015 deposition, it was revealed that licensed physician and surgeon, Dr. Richard Sackler, son of Raymond Sackler, a former Purdue president (1999-2003) and co-chairman of Purdue’s board, knew as early as 1997 that OxyContin was much stronger than morphine.[50]

• In March 2019, Purdue agreed to pay the state of Oklahoma $270 million rather than face trial on charges of misleading marketing practices and misrepresentation regarding Oxycontin, according to company and state press releases.[51]

• In May 2019, New Jersey Attorney General Gurbir S. Grewal announced that the State had filed a lawsuit against eight members of Purdue Pharma’s founding Sackler family, alleging that their opioid marketing and sales strategy fomented the opioid crisis that continues to claim lives in New Jersey and across the nation. “Our communities are still reeling from the epidemic of addiction and overdose deaths caused by their misconduct,” Grewal stated. The suit also alleges that Purdue failed to disclose it had no studies to support most of its promotional claims—for example, that opioids were not very addictive, that addiction risks were easily managed, opioids continued to be effective when used for treatment periods lasting many months and years, and that long-term opioid usage improved patients’ daily function and quality of life. In the AG’s complaint, it is also alleged that in 2011, defendant Dr. Richard Sackler – who served as Co-Chairman of Purdue’s Board of Directors at the time – demanded to spend a week in the field with Purdue’s sales representatives.[52]

What we are seeing is a greedy pharmaceutical industry making sales from a drug of addiction and obfuscating the risks. Psychiatrists push for “medication-assisted” addiction treatment, replacing one addictive drug with one to two others and hooking individuals onto the “treatment” for opioid abuse. They redefine addiction as “dependence,” bolster profits with a slew of “disorders” added to their DSM; dilute the serious dangers of the treatments and redefine adverse drug-induced effects as yet more “mental disorders,” for which they can bill insurance companies.  We now have an industry completely out of control that’s creating or reinforcing legalized drug addiction across the country.  And for-profit behavioral hospital chains cashing on a created crisis.

References:

[1] “U.S. Reaches $1.4 Billion Opioid-Drug Settlement With U.K.’s Reckitt,” Wall Street Journal, 11 July 2019, https://www.wsj.com/articles/reckitt-to-pay-1-4-billion-to-settle-u-s-opioid-addiction-drug-probes-11562831584; http://www.drugfree.com/drug-guide/suboxone-abuse-symptoms-signs-and-addiction-treatment/is-suboxone-an-opiate/; https://www.prnewswire.com/news-releases/watchdog-warns-about-replacing-opioid-epidemic-with-a-psychotropic-one-300525829.html

[2] https://www.dualdiagnosis.org/suboxone-abuse/how-long-does-it-take-to-get-addicted-to-buprenorphine/

[3] https://www.justice.gov/opa/press-release/file/1153066/download

[4] https://delrayaddictionmedicine.com/florida-drug-rehab/

[5] https://www.cchrint.org/2016/04/14/state-investigations-expand-into-psychiatric-hospital-patient-deaths-safety-violations/ citing: “Treatment with SUBOXONE Film: Understanding the benefits,” Suboxone.com, http://suboxone.com/patients/about_suboxone/Default.aspx?gclid=COKk7ey79rYCFceDQgodWioA7w.

[6] Steven R. Scanlan, MD, “Suboxone: concerns behind the miracle,” Addiction Professional website, 1 Nov. 2010, https://www.addictionpro.com/article/suboxone-concerns-behind-miracle

[7] https://www.cchrint.org/2016/04/14/state-investigations-expand-into-psychiatric-hospital-patient-deaths-safety-violations/ citing: “Suboxone® Sales Estimated to Reach $1.4 Billion – More Than Viagra® or Adderall ®,” A Weekly FAX from the Center for Substance Abuse Research, Vol. 21, Issue 49, 10 Dec. 2012, http://www.cesar.umd.edu/cesar/cesarfax/vol21/21-49.pdf.

[8] Deborah Sontag, “Addiction Treatment With a Dark Side,” The New York Times, 16 Nov. 2013, http://www.nytimes.com/2013/11/17/health/in-demand-in-clinics-and-on-the-street-bupe-can-be-savior-or-menace.html?_r=0

[9] https://www.therecoveryvillage.com/suboxone-addiction/#gref

[10] https://www.suboxone.com/medical-treatment/side-effects-adverse-events; https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022410s000lbl.pdf

[11] https://www.rxlist.com/narcan-side-effects-drug-center.htm

[12] https://www.samhsa.gov/medication-assisted-treatment/treatment/naloxone

[13] http://newsroom.mylan.com/2019-02-22-Mylan-Launches-Generic-Suboxone-R-Sublingual-Film-to-Treat-Opioid-Dependence

[14] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2994593/

[15] https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022410s000lbl.pdf

[16] https://www.samhsa.gov/medication-assisted-treatment/buprenorphine-waiver-management/increase-patient-limits

[17] https://khn.org/news/patients-with-mental-disorders-get-half-of-all-opioid-prescriptions/

[18] “Substance/Medication-Induced Mental Disorders,” DSM-5, (APA, 2013), p. 488-549.

[19] https://www.alternet.org/2016/03/how-big-pharma-cashing-addiction-alcohol-and-illicit-drugs/

[20] https://www.alternet.org/2016/03/how-big-pharma-cashing-addiction-alcohol-and-illicit-drugs/

[21] “Investors See Big Opportunities In Opioid Addiction Treatment,” NPR, 10 June 2016, https://www.npr.org/sections/health-shots/2016/06/10/480663056/investors-see-big-opportunities-in-opioid-addiction-treatment

[22] “Investors pour money into addiction treatment, but quality questions remain,” Modern Healthcare, 24 Nov. 2019, https://www.modernhealthcare.com/article/20181124/NEWS/181129978/investors-pour-money-into-addiction-treatment-but-quality-questions-remain

[23] https://www.suboxone.com/hcp/maintenance-phase

[24] https://www.alternet.org/2016/03/how-big-pharma-cashing-addiction-alcohol-and-illicit-drugs/

[25] https://www.alternet.org/2016/03/how-big-pharma-cashing-addiction-alcohol-and-illicit-drugs/

[26] https://www.drugabuse.gov/publications/research-reports/medications-to-treat-opioid-addiction/how-much-does-opioid-treatment-cost

[27] http://www.acadiahealthcare.com/locations?q=&r=100&t%5B27%5D=27#page1

[28] https://www.cchrint.org/2018/01/15/behavioral-health-malpractice-cchr-calls-for-termination-of-medicare-and-medicaid-contracts/ citing Steven R. Scanlan, MD, “Suboxone: concerns behind the miracle,”  Addiction Professional website, 1 Nov. 2010, http://www.addictionpro.com/article/suboxone-concerns-behind-miracle.

[29] https://www.justice.gov/opa/press-release/file/1153066/download

[30] Acadia complaint

[31] https://www.cchrint.org/2018/01/15/behavioral-health-malpractice-cchr-calls-for-termination-of-medicare-and-medicaid-contracts/ citing Steven R. Scanlan, MD, “Suboxone: concerns behind the miracle,”  Addiction Professional website, 1 Nov. 2010, http://www.addictionpro.com/article/suboxone-concerns-behind-miracle.

[32] https://www.drugabuse.gov/publications/research-reports/medications-to-treat-opioid-addiction/how-much-does-opioid-treatment-cost

[33] https://www.cchrint.org/2018/01/15/behavioral-health-malpractice-cchr-calls-for-termination-of-medicare-and-medicaid-contracts/ citing Steven R. Scanlan, MD, “Suboxone: concerns behind the miracle,” Addiction Professional website, 1 Nov. 2010, http://www.addictionpro.com/article/suboxone-concerns-behind-miracle.

[34] https://www.cchrint.org/2016/08/17/cchr-calls-for-legislative-intervention-against-for-profit-psych-facility-planned-for-pennsylvania/

[35] “Pursuant to the settlement agreement, Acadia will pay $17 million to resolve allegations of a United States Attorney Announces $17 Million Healthcare Fraud Settlement,” U.S. Attorney’s Office, Southern District of West Virginia, 6 May 2019, https://www.justice.gov/usao-sdwv/pr/united-states-attorney-announces-17-million-healthcare-fraud-settlement

[36] Jeff Lagasse, “Acadia Healthcare to pay $17 million in settlement of Medicare fraud case,” Healthcare Finance, 8 May 2019, https://www.healthcarefinancenews.com/news/acadia-healthcare-pay-17-million-settlement-medicare-fraud-case

[37] “Suboxone maker Reckitt Benckiser to pay $1.4 billion in largest opioid settlement in US history,” ABC News, 12 July 2019, https://abcnews.go.com/Business/suboxone-maker-reckitt-benckiser-pay-14-billion-largest/story?id=64274260; “U.S. Reaches $1.4 Billion Opioid-Drug Settlement With U.K.’s Reckitt,” Wall Street Journal, 11 July 2019, https://www.wsj.com/articles/reckitt-to-pay-1-4-billion-to-settle-u-s-opioid-addiction-drug-probes-11562831584

[38] https://www.justice.gov/opa/press-release/file/1153066/download

[39] “Suboxone maker Reckitt Benckiser to pay $1.4 billion in largest opioid settlement in US history,” ABC News, 12 July 2019, https://abcnews.go.com/Business/suboxone-maker-reckitt-benckiser-pay-14-billion-largest/story?id=64274260

[40] https://www.justice.gov/opa/press-release/file/1153066/download

[41] https://www.justice.gov/opa/press-release/file/1153066/download

[44] https://www.justice.gov/opa/press-release/file/1153066/download

[43] “Anti-addiction medication poses poisoning risk for kids,” CBS News, 15 Sept. 2014, https://www.cbsnews.com/news/anti-addiction-medication-poses-poisoning-risk-for-kids/

[44] “Reckitt Benckiser Agrees To Pay $1.4 Billion in Opioid Settlement,” NPR, 11 July, 2019, https://www.npr.org/2019/07/11/740856948/reckitt-benckiser-agrees-to-pay-1-4-billion-in-opioid-settlement

[45] https://www.theguardian.com/us-news/2018/feb/13/meet-the-sacklers-the-family-feuding-over-blame-for-the-opioid-crisis

[46] https://www.theguardian.com/us-news/2018/feb/13/meet-the-sacklers-the-family-feuding-over-blame-for-the-opioid-crisis

[47] “The Family Trying to Escape Blame for the Opioid Crisis,” The Atlantic, 10 Apr. 2018, https://www.theatlantic.com/health/archive/2018/04/sacklers-oxycontin-opioids/557525/; http://www.esquire.com/news-politics/a12775932/sackler-family-oxycontin/https://www.newyorker.com/magazine/2017/10/30/the-family-that-built-an-empire-of-pain.

[48] “The Family Trying to Escape Blame for the Opioid Crisis,” The Atlantic, 10 Apr. 2018, https://www.theatlantic.com/health/archive/2018/04/sacklers-oxycontin-opioids/557525/; http://www.esquire.com/news-politics/a12775932/sackler-family-oxycontin/https://www.newyorker.com/magazine/2017/10/30/the-family-that-built-an-empire-of-pain;

[49] “Suboxone maker Reckitt Benckiser to pay $1.4 billion in largest opioid settlement in US history,” ABC News, 12 July 2019, https://abcnews.go.com/Business/suboxone-maker-reckitt-benckiser-pay-14-billion-largest/story?id=64274260; https://www.wsj.com/articles/oxycontin-made-the-sacklers-rich-now-its-tearing-them-apart-11562990475

[50] https://time.com/5520159/purdue-pharma-lawsuits/

[51] https://www.healio.com/family-medicine/addiction/news/online/%7B5e71a141-52f9-4095-90cc-a6437c0ef1ea%7D/first-opioid-lawsuit-settlement-raises-questions-with-dozens-more-cases-waiting

[52] “AG Grewal Sues Eight Sackler Family Members; Alleges Their Greed-Driven Campaign to Boost Purdue Pharma Sales Triggered Opioid Crisis.” Press Release, 30 May 2019, https://www.nj.gov/oag/newsreleases19/pr20190530a.html