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11/13/2017 12:00 AM

When Elinore McCance-Katz, M.D., assistant secretary for mental health and substance use at the Department of Health and Human Services (HHS), told the House Energy and Commerce Committee that changes were coming for 42 CFR Part 2, the regulation governing confidentiality of substance use disorder treatment records (see ADAW, Oct. 30), she was referring to the Supplemental Notice of Proposed Rulemaking (SNPRM). The SNPRM was published in the Jan. 18 Federal Register, along with the final rule on 42 CFR Part 2 issued by HHS under President Obama Jan. 18 (see ADAW, Jan. 23).

When Elinore McCance-Katz, M.D., assistant secretary for mental health and substance use at the Department of Health and Human Services (HHS), told the House Energy and Commerce Committee that changes were coming for 42 CFR Part 2, the regulation governing confidentiality of substance use disorder (SUD) treatment records (see ADAW, Oct. 30), she was referring to the Supplemental Notice of Proposed Rulemaking (SNPRM). The SNPRM was published in the Jan. 18 Federal Register, along with the final rule on 42 CFR Part 2 issued by HHS under President Obama Jan. 18 (see ADAW, Jan. 23).

Under 42 CFR Part 2, individual consent in writing is required before an SUD treatment provider receiving any federal funds can release information about a patient. The final rule kept the essential protections of consent. The SNPRM, however, creates an abbreviated alternative statement for the notice to accompany disclosure, and opens up disclosure to anyone involved in the vague term of “health care operations.”

Nobody is sure exactly what the supplemental rule will say. “It could fundamentally change how Part 2 operates,” said Paul N. Samuels, director and president of the Legal Action Center, in an interview last week.

The Legal Action Center has been at the forefront of 42 CFR Part 2 advocacy since before the rule was first promulgated in 1975. This summer, the Legal Action Center formed a coalition to protect patient privacy after the Partnership to Amend 42 CFR Part 2 was formed — a partnership that includes the American Society of Addiction Medicine (ASAM) and the Hazelden-Betty Ford Foundation (see ADAW, Aug. 7).

The Substance Abuse and Mental Health Services Administration (SAMHSA) said throughout the final rule issued last January that it would release subregulatory guidance. “We think it would be helpful for that guidance to be released,” said Karla Lopez, senior staff attorney with the Legal Action Center. “As far as we know, they’re still planning to do that,” she told ADAW.

And in fact, 42 CFR Part 2 has a very limited scope — providers who put themselves forward as treating SUDs. It does not apply, for example, to emergency department personnel who treat someone for an overdose; one myth is that these personnel are not allowed to disclose information about the patient to family members.

“We at the Legal Action Center are talking to whoever we can to find out what the specific concerns are that people have,” said Samuels. “We have worked closely with treatment providers on these issues for decades, and from our experience with them, treatment providers have routinely told us that obtaining consent at admission is not only possible, but to our understanding, it’s standard.”

There is so much confusion and misinformation that clarification is constantly needed. While the Association for Behavioral Health and Wellness, the organization leading the Partnership to Amend 42 CFR Part 2, calls the 42 CFR Part 2 rule “antiquated” and wants it to revert to the Health Insurance Portability and Accountability Act (HIPAA), the main concern seems to be with the technology (paper vs. digital). Unfortunately, stigma is as pervasive now as ever, and there is nothing antiquated about a patient not wanting his or her SUD treatment records made public.

And the Legal Action Center supports the need for integrated care. “We support whatever mechanisms can facilitate communication, as long as the core protections of Part 2 remain,” said Samuels. “We are very worried that reducing or removing Part 2 protection will scare many people away from entering the lifesaving treatment they need,” he told ADAW.

‘Inconvenience’ to EHRs

Opposition to 42 CFR Part 2 seems to be focused around electronic health records (EHRs). For more than 25 years, there were no complaints against the regulation, but in 2010, the EHR industry began to recognize that consents in writing could not easily fit into their systems. Since then, 42 CFR Part 2 has been under siege, with various arguments being used, including a call by some ASAM representatives to know about what patients are taking methadone. The American Association for the Treatment of Opioid Dependence and patient advocates have been the staunchest supporters of 42 CFR Part 2.

H. Westley Clark, M.D., who was responsible for the interpretation of 42 CFR Part 2 as director of the Center for Substance Abuse Treatment at SAMHSA, thinks the opioid epidemic is being used “as cover for business interests.” Clark, who is now Dean’s Executive Professor of Public Health at Santa Clara University, frequently describes 42 CFR Part 2 as an “inconvenience” to businesses like EHR vendors. “With regard to 42 CFR Part 2, only anecdote and passion are offered as justification for eviscerating fundamental interests of those who come seeking assistance from those with established interests,” he told ADAW last week. “Software vendors, the health care industry and professional associations know that the evidence for sweeping away the protections of 42 CFR Part 2 is scant,” he said. “The demand to include the boundless exception to 42 CFR Part 2 found in the health care operations rubric is evidence of the lack of respect for those with substance use disorders and the disregard for patient welfare and public safety.”

How will a clinician respond when a patient asks “Is my treatment confidential?” is an important question no one is asking, said Clark. “Those in the know will artfully say, ‘Yes, to the fullest extent of the law,’ capitalizing on an insincere twist and knowledge of, and the unwillingness to explain, the unlimited possibilities that the rubric ‘health care operations’ offers,” he said. “We may have to wait until people are harmed by social exclusion, whisper and rumor. Worse yet, we may have to wait to see how many people truly value their privacy by refusing treatment rather than expose themselves to the vagaries of the health care operations exception. This, the middle of an opioid epidemic, when treatment should be welcoming, not discouraging.”

The President’s Commission on Combating Drug Addiction and the Opioid Crisis (see ADAW, Nov. 6) also wants to move in the direction of opening up 42 CFR Part 2, Clark noted. “In addition, the hunt is on for those on methadone,” he said. However, many OTPs are “off the grid,” in terms of EHRs, he said.

“We remain very concerned that many of the electronic health networks do not seem to be compliant with Part 2,” said Samuels. “The law requires that Part 2 be followed, and technology should follow the law,” he said. “We need to protect patient confidentiality.”

The Overdose Prevention and Patient Safety Act (H.R. 3545) would specifically align 42 CFR Part 2 with HIPAA, by allowing sharing of SUD records. The original sponsor, Rep. Tim Murphy (R-Pennsylvania), is no longer in office after a scandal (see ADAW, October 23). The lead Democrat sponsor is Rep. Earl Blumenauer (D-Oregon).

SAMHSA expects to release the supplemental final rule in early winter, ADAW has learned.

11/6/2017 12:00 AM

Men make up 70 to 80 percent of the population in substance use treatment programs, but women represent about 70 to 80 percent of the group providing the services in these programs. That does not by definition constitute a problem, but it does help call attention to what has been a historical challenge in meeting the needs of the majority of addiction treatment patients.

Men make up 70 to 80 percent of the population in substance use treatment programs, but women represent about 70 to 80 percent of the group providing the services in these programs. That does not by definition constitute a problem, but it does help call attention to what has been a historical challenge in meeting the needs of the majority of addiction treatment patients.

In recent years, the gender-specific needs of male patients have received growing attention, with guidance modeled largely after the greater volume of research around gender-sensitive treatment for women. But while this has led to a growth in men’s treatment groups as well as male-only treatment and recovery programs, a leading speaker and author in men’s relationships says the vast majority of programs don’t take the deep dive needed to understand how beliefs about masculinity affect recovery outcomes.

“A lot of men’s programs unintentionally reinforce traditional masculinity that is counterproductive to long-term recovery,” Dan Griffin, co-creator of the Helping Men Recover curriculum that integrates theories of addiction, trauma and male psychosocial development, told ADAW. “There is not enough inquiry on masculinity and the internalized beliefs about masculinity. There needs to be a focus on ‘How are my ideas about being a man affecting my recovery and my relationships?’”

While Griffin says men’s treatment issues increasingly are being discussed at professional conferences, he still sees the same absence of raised hands in his audiences when he asks how many attendees received training in these topics in graduate school or as part of their professional credentialing requirements. There simply has been no systemic look at these issues at the training level, he says.

At Metropolitan State College of Denver, a faculty member in the Integrative Healthcare program will begin offering a one-credit course on men and recovery next semester. At the outset, this will be only an elective course for students in the school’s addiction studies program. When he has presented on the topic of masculinity as it relates to addictions, even before a group of male treatment professionals, “It seems that the men were hearing this for the first time,” Steven Rissman told ADAW. “That was surprising to me.”

Meeting men’s needs

Griffin, who last week in Huntington Beach, California, presented a free workshop on Helping Men Recover in an event sponsored by the Coastal Recovery, offers several potential measures for determining whether a treatment program is male-focused in name only or genuinely in practice. A strict count of male versus female clinical staff is not particularly telling, he says, but if there are no men on a program’s staff, that should raise a red flag.

His assessment of programs also seeks information about the type and extent of training staff members have received, and how far into the organization that has reached. “Some programs will have one counselor who is deemed as being the guy who ‘gets it,’” Griffin said. “But the techs in that center haven’t been trained. Young guys in recovery can undermine what the rest of the program is doing.”

A significant component of a program’s work with men, Griffin says, involves how staff responds when a man in treatment reacts with anger (or, in the pejorative way of characterizing this, “acts out”). It is important for programs to accept that men affected by unaddressed trauma will externalize in responses of rage. “If a program uses power and control to shut the door on that, without using a trauma-informed lens, that reinforces negative aspects of masculinity,” Griffin said.

This has been an area of transformation at the Jaywalker Lodge treatment and recovery program for young men in Colorado, explained founder Bob Ferguson. He told ADAW that in the time current CEO Dirk Eldredge (who has a background in intervention) has led the organization, atypical discharges from the program have dropped by more than 50 percent. The reason: “He has reoriented the team toward a clinical intervention, not a punitive one,” Ferguson said of the CEO.

The roots of this issue, says Metropolitan State’s Rissman, can be found in how boys are raised in society. From an early age, boys learn that the definition of being male means not talking about feelings, and not revealing. “The boy code for everything is ‘Just fine,’” Rissman said.

“Then we’re puzzled about why, when we get to a certain age, there’s no place to go with any of this,” he said. “We gave men anger as their only outlet, and then we took that away because we recognized that other people were hurt.”

In treatment settings, the temptation becomes one of controlling men’s behavior rather than giving voice to it, Rissman said. “In group, when a man can’t communicate, we punish,” he said.

Rissman points the finger in part toward clinical professionals who haven’t processed their own trauma and their own beliefs about gender. He compares this to what happens in the general health setting, where a man will tend not to reveal something important to his doctor.

“Of course he won’t, because the doctor is not able to invite it,” he said. “He has his own hang-ups about being able to reveal.”

Equal opportunity

While Jaywalker Lodge serves men only, Eldredge says its clinical staff is around two-thirds female (total staffing is split about evenly, as many Jaywalker alumni work in nonclinical roles in the organization). The organization believes women and men can be equally successful in working with men in treatment and recovery settings.

Griffin has found, in fact, that perhaps the most effective structure in men’s group therapy involves having one man and one woman as co-facilitators of a group. “Their interaction models healthy interactions between the genders,” he said. Men and women working together in professional settings can help erase misconceptions that the genders often bring to the table.

Ferguson outlines three guiding principles he says have helped Jaywalker Lodge in its work with men over the past 15 years:

  • “Men are much more afraid of becoming invisible and insignificant in their recovery than they are to die in their addiction,” he said. Therefore, programs need to emphasize all the good things that can come in recovery, rather than use scare tactics about relapse that ultimately don’t work, he said.
  • Men’s ability to form intimate relationships with other men is a greater predictor of positive recovery outcomes than their ability to form a therapeutic alliance with a counselor while in treatment. In hiring staff, therefore, Jaywalker looks for individuals who can help facilitate bonds among the men in the program.
  • “Men engage at a different level in community than they do in containment,” Ferguson said. Therefore, Jaywalker emphasizes the importance of getting out of a traditional therapeutic setting and encouraging men’s involvement in community work and adventure activities. He and Eldredge added that art and music therapy have become an important element in Jaywalker’s programming, which maintains a 12-Step foundation. “Those haven’t historically been areas of focus in men’s treatment,” Ferguson said.

Bottom Line…

Having a men’s group, or even being a program that treats only men, doesn’t guarantee that a program is being sensitive to the core issues that most affect treatment outcomes for men.

10/30/2017 12:00 AM

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 and 21st Century Cures Act funding. But it was, as always, an opportunity for education of lawmakers.

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.”

Other highlights

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.

Bottom Line…

The House Energy and Commerce Committee hearing on opioids was an opportunity for education of Congress on key issues.

In Case You Haven’t Heard
10/10/2016 12:00 AM

The Office of National Drug Control Policy (ONDCP) is asking everybody to change their language when talking about addiction. Actually, they prefer substance use disorder. They also say to stay away from words like “dirty,” “abuse” and “dependence.” All good. After all, even the Diagnostic and Statistical Manual of Mental Disorders no longer uses “abuse” or “dependence” (to describe a pathology), and only the worst kinds of people use the word “dirty” to describe a urine test that is positive for drugs. The ONDCP is even asking for comments on this, in what must be the most frustrating time of the year for substance use disorder treatment advocates who have been trying to pry pennies from Congress for the worst opioid epidemic the country has ever seen. If you want to comment, here’s the draft: We would like to put in a plug for a change that has been due for some time: “medication-assisted treatment.” What does that even mean? In the field of substance use disorders, we have medications approved for alcohol use disorders (acamprosate, naltrexone) and for opioid use disorders (methadone, buprenorphine, naltrexone). The ONDCP and, increasingly, Congress use “medication-assisted treatment” to mean treatment for opioid use disorders. There’s a huge difference between methadone, which is only dispensed in opioid treatment programs; buprenorphine, which, like methadone, is an agonist (or partial); and naltrexone, which most of the time means the patented extended-release version: Vivitrol. Now “MAT” is in the lexicon — of legislation and regulation — and nobody knows what it means. So can we stop using the phrase “medication-assisted treatment” and just call it medication?

In Case You Haven’t Heard
10/3/2016 12:00 AM

As syringe programs, safe-injecting facilities and harm reduction in general enter the mainstream, what does “harm reduction” even mean anymore? Does it still mean encouraging drug users to get treatment? We asked the policy director of the Harm Reduction Coalition these questions. He is concerned about drug users being left behind as the field gets more mainstream. “Harm reduction has always been grounded in reaching and engaging people who use drugs to support their health needs, including overdose and HIV risk but also substance use itself,” Daniel Raymond told ADAW last week. “So I hope that we’re moving towards building deeper relationships with the treatment and recovery communities so that we can support each other and create a stronger continuum of care.” Raymond also wants to see “more engagement with health care, housing and criminal justice/re-entry,” he said. “Harm reduction philosophy and strategies have a lot to offer and share with these sectors. More broadly, we’re looking at addressing the broader structural issues like stigma, trauma, homelessness and mass incarceration that intersect with substance use and multiply vulnerability and harm.” For more on Raymond’s concerns about mainstreaming the harm reduction agenda, see his piece on the Midwest Harm Reduction Institute’s annual conference, published last week:

From the Field
9/19/2016 12:00 AM

Opioid addiction is a disorder of brain structure and function. It is an illness. And the most effective treatment for this illness is medication. And as with any illness, the medication that should be used is the one that proves most effective for that patient. And yet, there are those that argue we should limit the medications we use to fight this epidemic of opioid addiction and death.

We’re dying out there. Look at the number of overdoses that have occurred in the last month to heroin and to fentanyl- or carfentanyl-laced heroin. If something, anything, can be used to save lives, then please, let’s put ideology aside and let’s do that. When used as a medication, prescribed by a physician, diacetylmorphine — prescription heroin — stabilizes brain function and allows the person to become well, stay well and, most importantly, stay alive. And this treatment is for those that are refractory to the other medications used to treat this medical condition. Methadone and buprenorphine don’t work for them. So, because those treatments failed, should we just discard the people?

According to the NAOMI study, the countries that have established heroin treatment programs — Switzerland, the Netherlands, the United Kingdom, Germany, Spain, Denmark, Belgium, Canada and Luxembourg — have all reported positive results for those individuals who are refractory to methadone and buprenorphine treatment.

It sounds radical, the provision of heroin to those addicted to heroin. But do understand, a drug is just a drug. It just does what it does. This controversy over using heroin as a treatment to control opioid addiction — it’s not about the data. It’s not about the research. It’s about stigma, ideology and people protecting their turf.

In a previous ADAW issue, Robert Lubran, then with the Substance Abuse and Mental Health Services Administration, stated, “It’s not difficult to find individuals who will prefer access to heroin over methadone maintenance treatment” (see ADAW, Aug. 31, 2009). He seems to believe this is a bad thing. I do not. If we can get more people into treatment, if heroin treatment will do that, how many lives can we save? And every life is someone’s son, it is someone’s daughter, and we would not only be saving them but also their mothers and fathers from the devastating loss of their child. We should be doing everything we can to keep them alive. And, yes, that includes treatment with diacetylmorphine.

The NAOMI studies show that, for those refractory to methadone or buprenorphine, heroin-assisted treatment is effective, with retention rates of about 88 percent. But there seems to be a problem. The acceptance of this form of treatment is opposed by some in the treatment field.

This is not a game. This is not a “my treatment is better than your treatment” contest. This is about saving lives. Heroin can produce addiction, or it can be used to stabilize (with medication) an addiction. It is how we use it that determines its effects. In this epidemic, we have an obligation to do everything we can to save lives. If the use of heroin-assisted treatment will do that, and the data show that it will, then please, put the ideologies aside, put the financial interests aside, push back on the stigma and let’s do everything we can to reduce the harm of this epidemic to those who suffer from this disorder of brain structure and function we call opioid addiction. Because every death, every loss, is someone’s son or daughter, and their lives are precious too.


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  • Meet the Editor

    Alison Knopf

    Alison Knopf is a professional journalist who began covering the addiction field in 1984 as founding editor of Substance Abuse Report. She has been the editor of Alcoholism & Drug Abuse Weekly since 2005.
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