Leading Opioid-Addiction Treatment Drug Is Itself a Problem
Within a few hours on a late summer day this year, 27 people in the West Virginia town of Huntington were rushed to the emergency room because of heroin, fentanyl, and other opioid overdoses. The problem is a growing one: In 2014 more than 47,000 Americans died from opioid and other drug overdoses and 2.6 million Americans suffer opioid addiction. This costs the nation about $78.5 billion in health care costs, and drug overdoses have claimed eight times as many U.S. lives between 2000 and 2014 as in the Vietnam War—a half million. Last month, the Surgeon General issued a landmark report on “Facing Addiction in America,“ noting that only 1 in 10 of the 20.8 million Americans with a substance-abuse disorder gets treatment.
While the lack of treatment is an enormous problem, one of the leading drug therapies to address opioid addiction—Suboxone—is itself a troubling tale. It involves a little known, highly profitable pharmaceutical maker who, in September, was hit with a massive antitrust suit by more than 35 state attorneys-generals and tied to morphing the treatment drug into a contraband substance itself.
Medicaid, contraband, crime, and the prison system; The story draws together many of the themes of a tattered America—alleged corporate wrongdoing, out-of-control health-care costs, opioids and declining life expectancy, economic inequality, federal regulators, and mass incarceration. This is enough to get policy wonks and screenwriters alike salivating.
Long hidden behind walls of class and shame, the opioid epidemic burst into public consciousness big time last year, with a much-cited National Academy of Sciences study by Princeton economists Anne Case and Angus Deaton showing rising mortality among middle-aged, less-educated whites. During the presidential primary in New Hampshire, the state with the third-highest addiction rate, politicians from both parties bent over backwards to talk about the epidemic and its personal effects, and Congress jumped to vote nearly unanimously for a bill to fight opioid addiction—which many consider weak and underfunded—that President Obama signed in July.
Since President Nixon declared “war on drugs” 45 years ago, the warriors have faced off against violent urban drug dealers, largely preying on the African American community, and even more violent foreign narcotics gangs and traffickers, with domestic education and treatment programs achieving limited success. Presidents Reagan and Clinton reacted with draconian laws that increased the number of nonviolent drug offenders behind bars from 50,000 in 1980 to more than 400,000 in 1997.
After pouring billions of dollars into fighting Latin American and other drug cartels and locking up marijuana as well as hard-drug users by the hundreds of thousands during the last few decades, the battlefront and tactics have shifted. Most opioid addicts are white and a major thrust of combatting the epidemic is now about medications to treat those addicted to prescription opioids like OxyContin and Vicodin and extremely potent drugs like fentanyl. Heroin use and addiction has risen more rapidly among whites than other racial of ethnic groups during the last decade, and rates of heroin overdose deaths are significantly higher among whites than African Americans, Hispanics, or Asian Americans.
Leaving aside the racial—indeed, racist—implications of this intense new focus on white addicts, the leading approaches now emphasize pharmacological and psychosocial treatment. The “social” component of this, of course, entails the enormous task of bringing decent education, jobs, wages, overall living conditions, and just plain hope to an addicted population largely composed of members of the nation’s huge low-wage, nonworking, and less-than-college-educated underclass.
However, it is in the treatment of opioid addicts where things get strange. Although drugs like methadone to wean addicts off heroin and other opioids were introduced in the 1960s, and counseling and other social services are essential, a second type of drug—buprenorphine, combined with naloxone and marketed as Suboxone—was approved by the Food and Drug Administration (FDA) in 2002 to reduce cravings and withdrawal symptoms.
More profitable than Viagra, the pill brings in more than $1.5 billion a year for its British manufacturer, Reckitt Benckiser (oddly enough, also the maker of Lysol and Mucinex). Including huge sums from Medicaid, which spent $857 million in taxpayer money over three years. More than a million Americans are treated with the drug, a number that could double under a new expanded-treatment rule issued by the Substance Abuse and Mental Health Services Administration in July.
Having cornered 85 percent of the sadly lucrative market for treating opioid addiction, Benckiser embarked on a series of hardball actions when Suboxone’s patent expired in 2009 that seem targeted towards profit rather than patient.
Hardly ready to give up its goldmine, the company promptly spun off a new firm called Invidior and partnered with another firm, MonoSol RX, to develop, patent, and sell a new version of buprenorphine dispensed as a dissolvable film and approved by the FDA in 2010. This so-called “product hopping” went hand in hand with aggressive efforts to fight FDA approval of generic buprenorphine and shameless arguments that its original product was dangerous. Invidior also filed suit against generic maker, Mylan.
The FDA sensibly rejected the company’s rather bizarre argument that its own product was hazardous—one belied by Invidior’s increased marketing of the tablets in Europe and China. In 2013, the Federal Trade Commission opened an investigation and the Department of Justice launched a criminal probe. The FDA subsequently approved generics and three other forms of buprenorphine—Zubsolv, Bunavail, and Probuphine—and the generic makers gained a sliver of market share. However, Suboxone maintained its overwhelming dominance, in part because it is regularly in a top spot on states’ Medicaid preferred drug lists (PDL), which enables providers to prescribe without prior authorization. With the Medicaid’s imprimatur, private insurers tend to follow.
In late September, the war further escalated, as attorneys-general from 35 states and the District of Columbia filed a legal complaint alleging that Invidior had “employed an unlawful, multi-pronged scheme designed to prevent or delay less expensive generic versions of of Suboxone from entering the market to preserve their monopoly profits.” The scathing lawsuit called Benckiser’s actions “deceptive and unconscionable,” forcing those suffering from addiction, as well as taxpayers, to pay much more than necessary for the drug. Using the oldest PR tick in the books, within days, the company announced a paltry grant to help families of addicts.
"When prescription drug companies unlawfully manipulate the marketplace to maximize profits, they put lives at risk and drive up the cost of healthcare for everyone. Indivior and MonosolRX flagrantly violated the law, deceiving doctors and patients and shutting down generic competition in order to rake in profits," Californian Senator Kamala D. Harris said.
In a brief statement on its website, Invidior said: "The company intends to continue to vigorously defend its position."
While the makers of Suboxone and addiction treatment drugs fight for their profitable niche market, pharmaceutical companies that produce popular opiate painkillers like OxyContin, Vicodin, and Percocet defend their own turf. Given the rising prevalence of pain in America, it’s no wonder that doctors wrote 227 million prescriptions for opioid painkillers in 2015, yielding billions in annual revenues. Their manufacturers have spent more than $800 million on lobbying and campaign contributions to fight efforts to limit opioids during the last decade.
The introduction of Suboxone film has had another grim side effect. Because the sheets are small and easily cut and hidden, drugs sold at cash-only clinics have become a hot black-market item. About one-tenth of the 13,000 physicians authorized to prescribed buprenorphine have been cited for offenses like over-prescribing the drug, and police report increasing numbers of seizures of illegally sold Suboxone. Thus, the “war on drugs,” in effect, has created a new illegal drug with which to do battle.
Easily smuggled into prisons, the film has become known as “prison heroin.” Suboxone is "one of the biggest contraband items we now have coming into the local facilities," according to Sharon Tyler, a program manager with the Baltimore County Department of Corrections. Strips of film are sold in prisons for a huge profit, which are often used to buy heroin, which is less expensive. Meanwhile, supervised treatment of addicts is largely absent from prisons.
As a result, with strong interagency support from its Departments of Public Safety and Corrections and Health and Mental Hygiene, Maryland became the first state to take action to address the proliferation of Suboxone in prisons. Arguing that smuggled sheets of the drug endangered both inmates and correctional staff, the state demoted Suboxone to “nonpreferred” status for Medicaid coverage of opioid treatment, making Zubsolv its preferred drug.
Maryland’s action has drawn criticism from some doctors and patients, but as Dr. Stuart Gitlow, past president of the American Society of Addiction Medicine’s board of directors told the Baltimore Sun: “"Is this rocking the boat? No question. If I were a clinician and was told you must switch all your patients, I'd say, 'Hell, no.' That's a totally reasonable response. But if it's cheaper and bioequivalent, then as a society, we have to make that choice.”
Other states are considering similar actions to move other opioid-treatment drugs onto their PDLs. Alternatives drugs like Zubsolv, Bunavail, and generics are on a number of states’ non-preferred lists, Yet, since Suboxone film has become a major law-enforcement problem in and out of prisons, and Zubsolv is considered to be a more efficient drug, changing state Medicaid formularies would seem to be an obvious choice for health-care policymakers, providers, and patients.
The goal should be to solve the suffering of millions resulting from opioid addiction most effectively, at the least expense, and without the potential for abuse. Broadening the options beyond Suboxone not only can accomplish this but also can bring a freer market in which treatment drugs compete more fairly on quality and price.