Last week’s opioids hearing by the House Energy and Commerce Committee had some important testimony by top federal officials. Technically, the hearing, lasting more than five hours, was a status update on the implementation of Comprehensive Addiction and Recovery Act (CARA) and 21st Century Cures Act funding. But it was, as always, an opportunity for education of lawmakers.
Below are some highlights.
Scott Gottlieb, M.D., commissioner of the Food and Drug Administration (FDA), gave a loud and clear endorsement of methadone and buprenorphine, specifically. In his prepared statement, which he read, he said: “A common question that arises with treatment is the proper duration of medication therapy. Clinical evidence shows that people may need treatment with medications for long periods of time to achieve a sustained recovery. Some may even need a lifetime of treatment. Recognizing this, the FDA is revising the labels of these medical products to reflect this fact. Now I know this may make some people uncomfortable. That’s why the third step I’m announcing today is that FDA will join efforts to break the stigma associated with medications used for addiction treatment. This means taking a more active role in speaking out about the proper use of these drugs. It’s part of our existing public health mandate to promote the appropriate use of medicine. Misunderstanding around the profile of these products enables stigma to attach to their use. This stigma serves to keep many Americans who are seeking a life of sobriety from reaching their goal. In this case, in the setting of a public health crisis, we need to take a more active role in challenging these conventions around medical therapy. The stigma reflects a view some have: that a patient is still suffering from addiction even when they’re in full recovery, just because they require medication to treat their illness. This attitude reveals a flawed interpretation of science. It stems from a key misunderstanding many of us have of the difference between a physical dependence and an addiction. Because of the biology of the human body, everyone who uses opioids for any length of time develops a physical dependence — meaning there are withdrawal symptoms after the use stops. Even a cancer patient requiring long-term treatment for the adequate treatment of metastatic pain develops a physical dependence to the opioid medication. That’s very different than being addicted. Addiction requires the continued use of opioids despite harmful consequences. Addiction involves a psychological craving above and beyond a physical dependence. Someone who neglects his family, has trouble holding a job or commits crimes to obtain opioids has an addiction. But someone who is physically dependent on opioids as a result of the treatment of pain but who is not craving more or harming themselves or others is not addicted. The same principle applies to medications used to treat opioid addiction. Someone who requires long-term treatment for opioid addiction with medications — including those that cause a physical dependence — is not addicted to those medications. Here’s the bottom line: We should not consider people who hold jobs, re-engage with their families and regain control over their lives through treatment that uses medications to be addicted. Rather, we should consider them to be role models in the fight against the opioid epidemic.”
Elinore McCance-Katz, M.D., assistant secretary for mental health and substance use at the Substance Abuse and Mental Health Services Administration (SAMHSA), explained — several times — that the Department of Health and Human Services (HHS) only regulates opioid treatment programs (OTPs) and buprenorphine providers. Rep. Mimi Walters (R-California) asked who licenses other facilities. “The states do, and some aren’t even licensed,” responded McCance-Katz. “Why aren’t all facilities licensed?” asked Walters, to which McCance-Katz said states should consider doing this. Asked specifically about sober homes, McCance-Katz explained that states, not SAMHSA, have purview over these. “States would need to require licensing and states would need to charge a licensing fee,” she said. She added that all of the facilities on SAMHSA’s treatment locator system are approved by the SSAs in the respective states. “We are making a bigger effort to put families in contact with our treatment locator system,” said McCance-Katz.
And 42 CFR Part 2, the confidentiality regulations requiring the SUD treatment provider to get written consent from a patient prior to releasing information about him or her, looks as if it is going to be weakened after all. “I will tell you that this is something that the Trump administration has been looking at since before I got here. We will be coming out with some changes,” said McCance-Katz in response to a question about the rule by Susan Brooks (R-Indiana).
Rep. David B. McKinley (R-West Virginia) pressed McCance-Katz on why SAMHSA hadn’t given more funding to his state. “West Virginia is at the epicenter of this crisis. We are experiencing the highest rate of opioid deaths in the nation. Yet when West Virginia applied for the grant to help babies with opioid dependency, they were denied,” he said. “When HHS released an additional $144 million in funding, we received none of it. As ground zero for this public health crisis, it is time West Virginia received the funding it deserves.”
McKinley’s press office told us the grants he was referring to were CARA-funded grants, one for the State Pilot Grant for Treatment of Pregnant and Post-Partum Women (for treating babies) and one for first responders to treat opioid ODs. The state’s health department wrote both grants. A SAMHSA official confirmed that other applications for these grants were scored higher than West Virginia’s, and that applications were funded based on the highest score after a peer review process.
West Virginia was awarded $5,881,983 in April 2017 through the State Targeted Response to the Opioid Crisis Grants, which are administered by SAMHSA.
In addition, West Virginia’s Substance Abuse Prevention and Treatment block grant award, also administered by SAMHSA, is more than $8.4 million a year.
Rep. Gus Bilirakis (R-Florida) sounded a warning note about medication-assisted treatment, citing pop-up buprenorphine providers who are not following Drug Enforcement Administration (DEA) or other rules. He asked McCance-Katz what SAMHSA is doing to make sure “rogue actors” are not doing the wrong thing, such as masquerading as pain clinics while selling addictive medications. Again, she noted that SAMHSA certifies practitioners who provide office-based treatment of opioid use disorder with buprenorphine. “We regulate and manage that,” she said. “However, we do not have any jurisdiction over these other types of providers within the states. We try to inform the states.”
On the DEA side, there were calls by legislators for hearing was dominated by badgering of Neil Doherty, deputy assistant administrator, of the DEA’s Office of Diversion Control, to disclose what companies shipped prescription opioids to several small pharmacies in West Virginia, something the committee has been requesting for months. Doherty, for his part, explained that there is a fundamental shift from abuse of prescription opioids to illicitly produced fentanyl, sold as heroin or mixed with heroin, or pressed into pill form and sold as counterfeit prescription pain pills.
Anne Schuchat, M.D., principal deputy director for the Centers for Disease Control and Prevention, said that OD deaths “are the tip of the iceberg.” For every person who dies, more than 600 are addicted, she said.
Nora Volkow, M.D., director of the National Institute on Drug Abuse, said her agency is working on nonopioid pain treatments; new formulations of existing medications, such as weekly and monthly buprenorphine formulations “to facilitate compliance and treatment in hard-to-reach areas”; research into the neurobiology of addiction, including into vaccines; and expansion of services and implementation research.
At the end of the meeting, it was clear that Congress is frustrated by the continuous epidemic and death rate. Left dangling as possibilities were an extension of the Cures Act funding, which Rep. Frank Pallone (D-New Jersey) called only a “down payment,” saying that more is needed, and a possible second iteration of CARA. While all of the committee members suggested resources were needed, many had voted repeatedly to undercut health insurance and Medicaid.
The House Energy and Commerce Committee hearing on opioids was an opportunity for education of Congress on key issues.