y company, Alkermes, has been at work since the late 1990s developing and bringing to patients a medicine that helps them fight addiction to opioids. As we set out on that path, CEOs of larger companies urged me to reconsider that decision. They pointed out that addiction is a difficult disease with challenging patients, a fragmented treatment system, and plenty of stigma. We went ahead anyway, convinced in the power of our science and the compelling medical need.
Since that time, we have learned the hard way that there are significant impediments to getting people the treatment they need; that strong opinions — often unsupported by data — can dominate the public discourse on addiction; and that shifting from anecdote-based to evidence-based treatment is an extremely difficult endeavor.
Addiction, once seen largely as a failure of will, is now understood to be a hijacking of brain chemistry. With this change in thinking has come a related change in how best to treat addiction, moving from detox and 12 step programs to medication-assisted therapy.
Medications have been used for more than 50 years to help people break opioid addictions. Medication-assisted therapy is now recognized by the World Health Organization and the Department of Health and Human Services as the most effective method for treating opioid addiction. Yet an estimated 90 percent of people suffering from this substance use disorder do not receive any treatment at all. Even though Congress passed legislation more than a year ago to expand access to all approved medications for opioid addiction, the federal government has been slow to implement this mandate.
Distinct from other areas of medicine, policymakers have played central roles in establishing and regulating how addiction is treated. Dozens of state and federal laws have been passed in order to ensure appropriate access to opioid medications while at the same time attempting to reduce their risk for diversion and abuse.
In the early 1970s, an extensive regulatory framework for the use of methadone was developed by the federal government, culminating with the Narcotic Addict Treatment Act of 1974. With the passage of the Drug Addiction Treatment Act of 2000 and the subsequent approval of buprenorphine (Subutex and Suboxone), the U.S. government further expanded the treatment system to make it possible for qualified physicians to treat opioid dependency with buprenorphine in various settings outside of the traditional methadone clinic.
Long before anyone could see the gathering storm that would become today’s opioid epidemic, the National Institute on Drug Abuse was seeking another new treatment strategy. In the late 1970s, NIDA issued a call for the development of a long-acting opioid antagonist — a medicine to block opioid receptors in the brain — and identified naltrexone as the most promising agent for consideration.
In the late 1990s, Alkermes was breaking new ground in the science and manufacturing of long-acting medications for schizophrenia. Our success prompted us to take on the challenge of developing a long-acting version of naltrexone.
While daily medications such as methadone and buprenorphine work, a once-a-month injection could remove the decision that people with addictions must make every day — to take a medication to block the effects of opioids and help stay sober, or to revert to abusing illicit opioids or alcohol. Choosing the latter isn’t a failure of will, but rather shows the extraordinary effects of a disease that subverts brain chemistry.
In 2006, our efforts succeeded with the FDA approval of our once-monthly medication, Vivitrol (naltrexone for extended-release injectable suspension) for the treatment of alcohol dependence. As we began to see the alarming surge in opioid overdose deaths driven by the increasing abuse of prescription opioids, we expanded our clinical research and, in 2010, Vivitrol was approved for the prevention of relapse to opioid dependence after opioid detoxification.
Little did we know at the time that the hard work that went into creating Vivitrol, conducting the clinical trials for it, and gaining FDA approval would turn out to be an easy part of bringing this medicine to patients in need. Introducing Vivitrol into a primitive treatment system for opioid addiction that remains largely wedded to the same approaches employed since before the epidemic began has turned out to be harder than we expected.
More than 30,000 Americans died from opioid overdoses last year. As the crisis escalates, our country needs more paths to recovery, not fewer. I know firsthand the stories of patients whose lives have been saved by methadone, buprenorphine, and Vivitrol. The question is not which of these drugs is better. Scientific data, including the recent publication in the Lancet and JAMA Psychiatry of two head-to-head studies of Vivitrol and buprenorphine, show that they all work.
The real question is this: Which one is right for me or my loved one at this moment and can I get timely access to it? Just as there is great diversity among individuals struggling with opioid dependence, so too are there differences among the FDA-approved medications for it. Available FDA-approved treatments for opioid dependence, consisting of agonists, partial agonists (including the recent approval of a long-acting version of buprenorphine), and antagonists, are “diametrically opposite” in domains ranging from pharmacology to treatment philosophy. Stated another way, the FDA-approved therapies represent different approaches that support individuals’ desired recovery goals in different ways.
Surprisingly, the treatment that a patient with an opioid addiction receives largely depends on which doctor’s door he or she walks through, regardless of the patient’s unique needs. Some doctors offer only detox and group therapy, without medication. Others offer just one FDA-approved treatment. The opioid addiction treatment system must change if we are to realize the promise of patient-centered care — care customized to the needs of the patient regardless of the treatment setting in which the patient is seen.
The Comprehensive Addiction and Recovery Act supports this treatment philosophy. Enacted into law last year, it requires office-based providers of opioid addiction therapy to be able to offer their patients all FDA-approved medications, either directly or by referral. It also requires these providers to complete training on all approved medication options, detoxification, relapse prevention, and overdose reversal. While this act is the law of the land, it has not yet been implemented across the country. The Substance Abuse and Mental Health Services Administration needs to issue a proposed rule directing the medical organizations named in CARA to update their training curriculums to be fully compliant with the law. Similarly, training for those who are already in practice needs to be brought into compliance with the law.
Models of success exist in pockets across the country. Innovative public health and criminal justice systems have introduced programs focused on new ways to prevent and treat opioid addiction and are improving the standard of care. Drug courts in Ohio and other states across the country, for example, are partnering with medical providers to break the repetitive cycle of incarceration. These comprehensive programs include medication-assisted treatment that offers all three FDA-approved medicines, along with counseling and assistance with housing and employment. These programs should be built on and expanded across the country.
There are plenty of other good ideas. What’s needed is to bring together a wide range of patients, clinicians, academics, and representatives from industry and government to identify and sort through them.
It is time for all hands on deck. The opioid epidemic is much bigger than any single medicine, company, group of physicians, or piece of legislation. It is about integrating knowledge, data, and expertise to develop comprehensive solutions designed to help the millions of people — our children, spouses, siblings, parents, friends, neighbors, co-workers, and others — who are battling this debilitating disease.
Richard F. Pops has been the CEO of Alkermes since 1991.