The short story is the sudden retirement, effective October 3, of H. Westley Clark, M.D., who for the past 16 years has been the director of the Center for Substance Abuse Treatment (CSAT) at the Substance Abuse and Mental Health Services Administration (SAMHSA). The longer story is how his departure will affect two policy decisions pending at SAMHSA: lifting the cap on the number of patients who can be treated with buprenorphine and preserving the confidentiality regulations for alcohol and drug abuse treatment, 42 CFR Part 2.

According to a September 30 email from SAMHSA Administrator Pam Hyde, a copy of which was obtained by ADAW, Clark and Hyde met late during the week of September 23. That was the same week of the buprenorphine summit, which was geared toward lifting the cap (see ADAW, September 29). During the discussion, “he let me know then that he was thinking about this decision,” said Hyde. “I was very sorry to hear this, but recognize that each individual’s decision and life trajectory takes its own course and timing comes when it’s right for them.”

“This was Wes’ decision,” said Hyde in the email, which was sent under the subject line “SAMHSA personnel announcement.”

We don’t know what was said between Clark and Hyde. But we do know that he has been on the wrong side, politically speaking, of the debate on 42 CFR Part 2 and on lifting the buprenorphine cap.

42 CFR Part 2

In an August 4, 2010, public meeting on 42 CFR Part 2, Hyde and Clark said 42 CFR Part 2 would not be revised (see ADAW, August 9, 2010). The regulation requires patients to give individualized consent to having their records released. However, last year, Hyde said at a workforce meeting that 42 CFR Part 2 is “getting in our way” (see ADAW, September 23, 2013). Then, there was a “listening session” on 42 CFR Part 2 on June 11 at which Clark was not even present, much less participating, where the door was clearly opened to changing the rule (see ADAW, June 16). SAMHSA told us that his schedule didn’t allow him to be present.

In addition, ADAW has learned that the Department of Health and Human Services (HHS), in a telephone call with federal and state officials and with stakeholders earlier this year, pressed to have methadone patients’ information put into prescription drug monitoring programs (PDMPs). Apparently, the HHS officials weren’t aware of the “Dear Colleague Letter” sent three years ago by Clark to opioid treatment programs (OTPs), advising them not to send patient data to PDMPs (see ADAW, October 24, 2011). The letter advised them to access PDMPs to find out about their patients’ other prescriptions, but said that giving OTP patient information to PDMPs would violate 42 CFR Part 2.

Any effort to require OTP patient data to go to electronic health records and PDMPs would be met with a fight from patient advocates.

CSAT promulgates 42 CFR Part 2 and regulates OTPs.

Buprenorphine cap

At a June 18 forum hosted by Sen. Carl Levin (D-Michigan) on raising the buprenorphine cap — which Levin supports — Clark pointed out, “We are dealing with the issue of addiction, not simply a medication,” and discussed concerns about diversion if the cap is lifted (see ADAW, June 23). This was not a welcome question at the forum, which ultimately led to the introduction of legislation by Sen. Ed Markey (D-Massachusetts) that would allow physicians to treat an unlimited number of patients with buprenorphine (see ADAW, August 11). Finally, there was the buprenorphine summit last month, at which Clark was not present and no discussion about the pros and cons of lifting the cap was allowed — rather, the discussion was about the logistics of how to lift the cap, and Levin himself made a presentation (see ADAW, September 29).

Current law allows physicians to treat only 30 patients with buprenorphine for the first year, and up to 100 patients with additional training. OTP physicians are allowed to have a caseload of 300 patients.

Funding for recovery

Clark has also been a champion for recovery — and patients in opioid treatment programs appreciate him for understanding that they are in recovery. “He always managed to squeeze funding for recovery in, before recovery was even fashionable,” said Walter Ginter, project director of Medication-Assisted Recovery Services in New York. The early days of the Recovery Community Services Program made it possible for the groundswell of support for recovery that now exists. “People forget that this couldn’t have happened without the funding, and there was nobody but Westley Clark getting the money,” Ginter told ADAW. Clark also stood up for patients, “including those in the methadone world,” said Ginter. “He’s going to be a phenomenal loss.”

“Dr. Clark has been an unparalleled voice for patients in medication-assisted recovery throughout his tenure with CSAT,” said Zachary C. Talbott, director of the Tennessee Statewide and Northwestern Georgia chapter of the National Alliance for Medication Assisted Recovery. “We can only hope and pray that his successor will be equally experienced with a background in opioid treatment programs and equally unbiased when looking at the science and evidence base determining what’s effective and what should be priority.”

Recovery researcher Alexandre Laudet, Ph.D., said Clark has “contributed significantly to advancing the recovery-oriented systems of care model both conceptually as well as at the implementation level.” Clark is “a brilliant, dedicated and compassionate individual and I’m sorry to see him leave,” said Laudet.

Stuart Gitlow, M.D., president of the American Society of Addiction Medicine (ASAM), sent us this comment: “I first met Wes Clark in 1995 when he began serving on the ASAM board of directors. In the two decades since, he has always been an inspiration to me personally as well as an outspoken and respected voice within the broad field of addiction medicine. We at ASAM wish him well in his retirement and look forward to many more years of collaboration.”

“Dr. Clark’s departure from SAMHSA represents a giant loss for the federal government and the addiction field,” said Robert I.L. Morrison, executive director of the National Association of State Alcohol and Drug Abuse Directors. “As Director of CSAT, he provided incredible leadership on a range of issues. Further, he performed his duties with unrivaled integrity and commitment. It was great to see Dr. Clark recognized at our most recent Annual Meeting when Mark Stringer, President of our Board of Directors, chose to honor him with the 2014 President’s Award. I hope we can convince him to stay involved in these issues because of his expertise and knowledge.”

The American Association for the Treatment of Opioid Dependence (AATOD), which represents OTPs, gave Clark a “friend of the field” award at its conference last November, noted President Mark Parrino. “That was the first time AATOD recognized a SAMHSA official through such a public honor,” he said. “We gave Dr. Clark the award because of what he did to provide guidance to the field of addiction. We also recognize many of his behind-the-scenes struggles to protect patients and the integrity of the treatment system.”

Carol McDaid, principal with Capitol Decisions, offered the following: “Dr. Clark is a true pioneer in our field in so many ways. He has that rare gift of being a true expert steeped in the science of addiction and its treatments while really getting on a deep level the plight of those in or seeking recovery from addiction. He championed recovery before it was popular to do so, stuck his neck out on new medical innovations to treat addiction and always walked a bright line on being a true public servant. He will be missed at SAMHSA but we won’t let him get too far out of the fray. There’s more work to be done.”

And Paul Samuels, president of the Legal Action Center, said: “We are very sorry to see Westley leave, as he has been a terrific champion of addiction treatment in many aspects, including his understanding of the importance of confidentiality protections for people in substance use disorder treatment.”

Finally, Pam Hyde sent a comment as well: “Dr. H. Westley Clark has announced that he will be retiring from SAMHSA after 16 years of distinguished service with the agency and 33 years of federal service. His career has been marked by a series of extraordinary contributions to science and learning, to service and practice, and to teaching and leading. His passion for the field and his dedication to staying abreast of the latest evidence and emerging issues — domestic and international — are without equal. His commitment to the people who experience addiction and/or mental illness sets a standard to which we all can aspire. SAMHSA will deeply miss his ideas, his vast knowledge, his perspective, and many other attributes. We are profoundly grateful for his service and wish him well in all future endeavors.”

By October 2, SAMHSA had still not announced that Clark would be retiring the next day. There was no indication of who would be replacing him. Observers speculated that it would most likely be someone who would approve changing 42 CFR Part 2 and lifting the buprenorphine cap. And based on the hastiness of his departure, these changes may be taking place fairly soon.

Bottom Line…

H. Westley Clark is hastily retiring from CSAT, leaving the fate of 42 CFR Part 2 and lifting the buprenorphine cap to his still-unnamed successor.