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8/31/2015 12:00 AM

The debate about lifting the patient cap — 30 or 100, depending on training — for buprenorphine is entering its second official year, with one side questioning whether physicians would be able to treat a large volume of patients and the other arguing that once patients are stable, treatment is not time-consuming. In last week’s issue, Mark Parrino, president of the American Association for the Treatment of Opioid Dependence, the trade association representing opioid treatment programs, pointed out that the guidelines for the use of medication-assisted treatment call for the use of best practices (see ADAW, Aug. 24). “If you’re treating 300 to 500 patients, how do you do this?” he asked.

“Very easily,” Stuart Gitlow, M.D., immediate past president of the American Society of Addiction Medicine (ASAM), wrote us. The letter from Gitlow continues below.

“Parrino, who is not a physician, may not realize that a typical outpatient physician can easily handle this volume of patients, and indeed, many more. Let’s look at a less stigmatized situation first: a patient presents for first-time treatment for major depression. Symptoms are significant and the patient is functionally impaired. The intake takes some time and a combination of psychotherapy and pharmacotherapy is initiated. The patient is seen frequently at first, with significant time taken at each visit. As time passes, the patient typically improves. Psychotherapy is discontinued when the patient reaches maximum improvement from that modality. Eventually, as the patient becomes symptom-free, the patient is seen annually for renewal of medication. A typical psychiatrist in long-term private practice has quite literally hundreds of such patients.

“The outpatient addiction model is quite similar. So in my practice, after nearly ten years of prescribing buprenorphine, I have roughly 90 patients who I’ve been seeing for an average of seven years. They are largely symptom-free, functional in all respects, attending twelve-step meetings, demonstrating negative urine drug test results, and no longer in need of any intensive care. I see many of them every 3 to 4 months to renew their medication, just as I do my patients with well-treated schizophrenia, bipolar disorder or anxiety disorder. My total number of patients in my outpatient practice is just under 1000, and since I’ve been in practice for 22 years, the vast majority of these patients are stable and symptom-free. The bulk of my time, however, is spent with the minority: the patients more recently admitted into the practice.

“So when Parrino asks how could one treat 300 to 500 patients, the answer is: very easily. In fact, the number could be significantly higher. Could I, a single private practice physician, handle 300 to 500 NEW patients all at once? Of course not. There aren’t the hours in the day to do that. But that’s not the question. The question is whether a typical practice could accommodate greater than 100 patients taking buprenorphine. We could indeed, so long as we follow a typical course of a private practice, where new patients are gradually added as existing patients require diminishing amounts of treatment intensity. The concept of a limit is foolish; we don’t have a limit with schizophrenia, a disease that arguably requires even more complexity of services over a more extended time period than addiction. Why would we possibly have a limit with addictive disease treatment?”

Legislation has been proposed that would lift or eliminate the cap. SAMHSA has not indicated which way it will go but has provided information to Sylvia Burwell, secretary of the Department of Health and Human Services, on the issue. Stay tuned.

8/24/2015 12:00 AM

The opioid epidemic — prescription and heroin — is persisting as a public health crisis and medications to treat opioid addiction are increasingly supported by public health authorities, so why is the opioid treatment program (OTP) with its methadone maintenance treatment not getting more attention? We talked to Mark Parrino, president of the American Association for the Treatment of Opioid Dependence (AATOD), a membership organization representing OTPs, to gain some insight.

The opioid epidemic — prescription and heroin — is persisting as a public health crisis, and medications to treat opioid addiction are increasingly supported by public health authorities. So why is the opioid treatment program (OTP) with its methadone maintenance treatment not getting more attention? We talked to Mark Parrino, president of the American Association for the Treatment of Opioid Dependence (AATOD), a membership organization representing OTPs, to gain some insight.

Parrino has been involved in the OTP field for decades, first as a clinic owner, and then for more than 30 years as head of the trade organization. Over the past 10 years, as many people became addicted to prescription opioids and then transferred to heroin when the prescription medications became harder to get, OTPs seemed the logical solution, as they had been successfully treating opioid dependence with methadone since the 1950s. Because of the 1914 Harrison Narcotics Act, which makes it illegal to treat opioid addiction with an opioid, OTPs are highly regulated.

However, 15 years ago. the federal Drug Addiction Treatment Act (DATA) made it possible for another opioid medication — buprenorphine — to be used to treat opioid addiction, this time with far less regulation than an OTP. Physicians could be waivered from the Harrison Narcotics Act under DATA 2000 to treat up to 30 patients with buprenorphine, prescribing it from their offices, and then up to 100 patients under DATA 2003. The opioid crisis has led to proposed legislation to lift these caps. Parrino has been a vocal force in Washington, D.C., as the Substance Abuse and Mental Health Services Administration (SAMHSA) considers lifting the cap, among other issues.

In addition to the expansion of access to buprenorphine, two other initiatives have had more support already from the federal government and Congress: expanding access to naloxone, especially to first responders, to reverse opioid overdoses, and discouraging physicians from prescribing opioids by requiring them to use prescription drug monitoring programs.

States

The federal government is moving forward to address the opioid crisis, but the state response is “where the rubber meets the road,” Parrino told ADAW last week. “This isn’t about a philosophical challenge,” he said. “The question is, what exactly are we going to do to respond to this issue?”

Parrino said the most complete model of getting people into treatment is Vermont’s hub-and-spoke model, in which all new patients are assessed at the central spoke, where they are then moved to either office-based treatment (in a spoke) with buprenorphine or methadone treatment in an OTP (a hub). He credited Vermont Governor Peter Shumlin with the vision and support to make the hub-and-spoke program work, noting that what makes the program unique is the clinical coordination.

For example, in Vermont, when someone overdoses on opioids and the first responder rescues the person with the naloxone overdose prevention kit, the first responder brings them to the emergency department, which connects them to a treatment program.

In other states, the atmosphere is completely opposed to methadone — such as in Maine, due to the opposition to the medication by the governor. And in many states, there is no public financial support of OTPs.

Medicare and Medicaid

Reimbursement, even in the age of the Affordable Care Act, is not easy for OTPs. In states that don’t provide any funding, including Medicaid funding, for treatment in an OTP, patients typically have to pay for their own treatment out of their pockets. Currently, Parrino is working with the Centers for Medicare & Medicaid Services (CMS) on making it possible for OTPs to bill Medicare for the treatment of Medicare beneficiaries. CMS is being responsive to concerns, he said.

One example is Maryland, where the OTP bills the regional Medicare office, waits for the claim to be denied and then files the claim with the state to be able to access Substance Abuse Prevention and Treatment block grant funds, said Parrino. Sylvia Burwell, the secretary of the Department of Health and Human Services (HHS), is serious about trying to close the treatment gap, Parrino said.

However, Medicaid is far more complicated than Medicare, because about 19 states have absolutely no Medicaid coverage for treatment in an OTP.

Private sector and self-pay

There are 340,000 patients in OTPs across the country. There should be many more, given the number of people with opioid use disorders. But reimbursement problems limit expansion, said Parrino. In fact, the only reason there has been any expansion at all is investment in the private for-profit sector. “You don’t see a similar sort of increase on the public side,” he said. There may be change in the future, however. For example, there is no Medicaid reimbursement for OTPs in Georgia or Tennessee, but after the AATOD conference last spring OTP representatives met with Cassandra Price, the SSA of Georgia who is also the new president of the National Association of State Alcohol and Drug Abuse Directors, said Parrino. “Now, after years of recalcitrance, they are working to develop a Medicaid reimbursement model,” he said.

Expansion is also difficult because of public opposition to OTPs on the part of people who don’t understand methadone. In North Dakota, OTPs are in the process of expanding, but facing NIMBY (not in my back yard) problems. As soon as program operators want to site the facilities, municipalities develop moratoria against any new OTPs, said Parrino.

HRSA

Parrino views the $100 million in treatment funding going to Federally Qualified Health Centers (FQHCs) from the Health Resources and Services Administration (HRSA) as a more focused approach. The funding, announced July 27 by Burwell, would require that some of the money be used for medications to treat opioid use disorders (see ADAW, Aug. 3, Aug. 10). “My sense is that HHS is truly interested in this,” said Parrino. “This is a way of saying to the FQHCs, ‘We want you in the business of treating opioid addiction.’”

The FQHCs could be licensed as OTPs, which would immediately expand capacity, he noted. Or they could train their physicians to provide buprenorphine in the office-based model. What many in the field are hoping is that the FQHCs will prove the medication, and the specialty addiction treatment providers will provide the counseling. There is some concern that the service delivery model will not include counseling, but only medication. “It depends on how the federal government wants to monitor this,” said Parrino. “To some degree, the department wants to increase treatment capacity.” OTPs provide comprehensive services, as required by SAMHSA.

Buprenorphine cap

This leads to the conflict between OTPs and office-based treatment with buprenorphine, which does not carry the counseling requirement or any other requirements of OTPs. The conflict between OTPs and office-based treatment is particularly germane in the current discussion of lifting the patient cap for buprenorphine, now at 100. How the American Society of Addiction Medicine guidelines for medication-assisted treatment mesh with their own policy recommendations for office-based buprenorphine is a “great question,” said Parrino. “You have 100 pages of guidelines saying that clinicians treating addiction using any of these medications should follow these best practices,” he said. “If you’re treating 300 to 500 patients, how do you do this?”

The current crisis — overdoses and addiction — is causing a “fixation on numbers,” said Parrino. In the midst of that crisis, the principles of treatment no longer seem a priority, he said. Treating large numbers of people, even with substandard care, may seem better than not expanding treatment at all.

“I believe that the rapid expansion of methadone treatment in the ’60s and ’70s is to some extent culpable for the stigma we have now,” he said, noting that the first Treatment Improvement Protocol (TIP) on methadone came out in 1993 — three decades after the treatment was first used.

Parrino stressed that he was not criticizing office-based physicians treating patients with buprenorphine under the DATA 2000 waiver. “Clearly there are a number of DATA 2000 physicians who are very thoughtful about treating their patients,” he said. “But you still don’t know what the level of service delivery is, and you surely don’t have the same regulatory oversight as there is for OTPs.”

In fact, SAMHSA wanted to avoid that level of regulatory oversight when it set the rules for DATA 2000 physicians — which is why they capped the number of patients a single physician could treat. There were concerns about patient care and about diversion. H. Westley Clark, M.D., who was director of SAMHSA’s Center for Substance Abuse Treatment from 1998 until last year, when he left the federal government, was closely aligned with this discussion. Last spring, when he spoke at the American Society of Addiction Medicine annual conference, he may have surprised many people by saying clearly that it was premature to talk about lifting the cap (see ADAW, May 4). “He said unenforceable guidelines are existentialist documents,” recalled Parrino. “He should know.”

Trade association calling for regulations

AATOD itself was founded in 1984, 20 years after methadone was first used in the treatment of opioid dependence. It was called the Northeast Regional Methadone Treatment Coalition, and it didn’t become national until 1991. Within months, Parrino met with SAMHSA about the concept of the first TIP, which in 2005 was revised to be TIP 43. So it was the OTP association itself that reached out for regulation.

A second action, also very unlike a trade association, was when the OTPs supported the transfer from the Food and Drug Administration (FDA) to SAMHSA. “The regulations become the great homogenizers,” said Parrino. “It’s no longer true that the not-for-profits are better than the for-profits, because they’re all going to be on the radar screen of the regulators.”

Regulations came after a report the GAO published 25 years ago; a stinging indictment of the FDA’s handling of OTPs, the report showed that the more effective programs were those with good staff training, therapeutic dosing and staff who aren’t revolving out the clinic.

Good management and good policy are linked, said Parrino. “Whether it’s how many patients you treat or how the patients are treated, all of this is tied together,” he said. “But it requires thought, and I believe now the atmosphere does not lend itself to very careful thought.”

For the 1990 GAO report on methadone maintenance, go to http://www.gao.gov/assets/150/148872.pdf.

Correction

In the above story on opioid treatment programs, we incorrectly cited the source guidelines on medication-assisted treatment. The guidelines will be coming from the American Society of Addiction Medicine, not the Substance Abuse and Mental Health Services Administration. The story has been corrected. We regret the error.

8/17/2015 12:00 AM

A new opioid treatment program is about to open in Georgia, and it’s notable for the fact that one of the two owners is a methadone patient and a nationally known patient advocate. Zac Talbott, along with Keith Jones, will open the program within the next few months, after final inspections have taken place.

A new opioid treatment program (OTP) is about to open in Georgia, and it’s notable for the fact that one of the two owners is a methadone patient and a nationally known patient advocate. Zac Talbott, along with Keith Jones, will open the program within the next few months, after final inspections have taken place.

Talbott had always planned on a career in behavioral health, he told ADAW last week in an interview about his program, and about how the program where he was a patient kicked him out when they found out about it.

Talbott told the owner of the OTP where he had been a monthly patient for a number of years about the plans to open a clinic. “Two weeks later he called me in and discharged me,” said Talbott. “His initial reaction was that patients shouldn’t own clinics, that I wasn’t really in recovery, and that I would have access to all that methadone.” (In fact, Talbott won’t have access: DEA registrants can’t be dependent on opioids.) He was told he had two weeks to find another clinic — Talbott had two weeks of take-homes left — but gave him no referral. “It was no big deal, because I had connections, and I was able to find another clinic,” Talbott said. “But this shows how far we have to go — too many providers still have that foundation of anti-patient stigma.” Since then, the two have talked, and the owner seemed apologetic, but what he did was “highly unethical and potentially illegal,” said Talbott. “I was completely compliant as a patient, and my recovery and my life were potentially put at risk because of I was going to open a clinic?”

Studying social work

Talbott was in a master’s program for clinical social work at the University of Tennessee in Knoxville before he became addicted to opioids and ended up in treatment with methadone. “Once I was stable and in recovery, all the dreams of the pre-addiction Zac started coming back,” he said. He then became a certified medication-assisted treatment (MAT) advocate, and met many people in the OTP field. “I had done consulting work with OTPs, visited numerous OTPs, done patient advocacy and training for staff,” he said. “With my passion for this treatment, not only because it saved my life but because of my travels across the country, seeing that this was an amazing treatment when done properly, it was natural for me ultimately to want to open a clinic.”

Access is particularly difficult in Tennessee — in fact, although Talbott is a lifelong resident of Maryville, his OTP is south of the state line, in Georgia, which is much more hospitable to OTPs. “My dream would be to open an OTP in my town, but it’s really not possible to open an OTP now in Tennessee for many reasons,” he said.

Talbott’s clinic will be a for-profit, self-pay model, like all the OTPs in Tennessee and all but two in Georgia. However, by the end of the year, he hopes to be able to take Medicaid. As for commercial insurance, he will not be taking that at first. “I would love to have a billing person that can do all that as parity starts to really kick in, but we’re just trying to open to bring services to a no-service area first,” he said.

The beginnings of the plan took place at the OTP-G meeting two years ago — the annual meeting of the Georgia chapter of the American Association for the Treatment of Opioid Dependence (AATOD). He met Jones, who is the owner of a company that develops software for OTPs, at that meeting. “He was a supporter of patient advocacy, and we got to talking,” said Talbott. Then at last year’s Georgia meeting, they met up again and discussed the idea of opening up a clinic. “So in casual conversation, we said let’s follow up, and we are now business partners,” said Talbott.

Siting

There are several OTPs in the metropolitan Chattanooga area, which is about an hour from Chatsworth, where Talbott’s OTP is located. So Chattanooga, which itself sits on the state line, didn’t need new OTPs. Chatsworth, however, is in the middle of an area in which there are no OTPs. Georgia already has 62 OTPs, but more are needed, said Talbott. “It made sense for us to go into this underserved area.” he said.

The OTP, called Counseling Solutions, will be able to accommodate up to 300 patients starting out. Talbott anticipates that eventually there will be about 500 patients, based on what he knows about the area and the population.

The process of opening an OTP varies from state to state, but even in Georgia, it’s “very cumbersome and difficult,” said Talbott. Applications must be filled out with the Substance Abuse and Mental Health Services Administration, with the Drug Enforcement Administration, with the accrediting body (in this case, the Joint Commission), with the state, and, in the case of Georgia, with the Board of Pharmacy. “And the problem is, they all want you to have applied with someone else first,” said Talbott. “The DEA won’t even give you a copy of their application until the state gives you one, and the state won’t give you one until the DEA does.” There are standard local business licenses and liability insurance.

There is no specific zoning for OTPs in Georgia. Talbott was fortunate to find a building that was previously a doctor’s office — a freestanding building that is zoned medical. “The other good thing about Georgia is that you don’t have to go through any public hearings or putting it in the paper, like in Tennessee, and getting the community all stirred up,” he said.

Talbott introduced himself to the citizens of Chatsworth, explaining that “we’re an opioid treatment program, we’re mostly going to be doing counseling, and most patients will need some kind of medication,” he said. “People hear ‘methadone clinic’ and they immediately have connotations that are not accurate, so I give the complete truth but don’t use words that shut down their mind,” he said. The OTP will have methadone liquid and diskets, and buprenorphine, from day one, and in the future might also have Vivitrol on an as-needed basis, he said.

Talbott credited Mark Parrino, president of AATOD, for giving him advice throughout the process. “Despite my experience in the field, I’m far from knowing it all,” he said.

“I think Zac is the ideal patient to own a clinic,” said Walter Ginter, project director of M.A.R.S. (Medication-Assisted Recovery Support) in New York City. “He is bright, well-educated and a great advocate.” Ginter’s only concern for Talbott is that now that he is a provider himself, his long-established relationships with other providers can “suddenly turn cold.” Ginter calls this “an interesting kind of stigma, but Zac can handle it.”

As for the treatment Talbott received at the clinic where he was formerly a patient, Ginter, who had known about Talbott’s plans for a long time, said he had advised against going public until the clinic was actually open, for this exact reason. “It really isn’t uncommon for clinic owners to think that patients shouldn’t run treatment even if the clinic owner inherited the clinic and their prior experience was working in a pizza parlor,” he said.

The Georgia Department of Community Health, then the Board of Pharmacy, and then the DEA must come to inspect before the program can open, but “we’re in the home stretch,” said Talbott.

For the OTP’s website, go to www.counselingsolutions.clinic/resources.html.

From the Field
6/15/2015 12:00 AM

Yet when it comes to health policy, there is only one reality: funding. While rhetoric for increasing the amount of attention paid to substance abuse has been at an all-time high, the commitment to funding by Congress has not kept up. Congressional funding for the Substance Abuse and Mental Health Services Administration’s Substance Abuse Prevention and Treatment block grant has not kept up with inflation and, as a result, would need a $450 million increase just to bring its purchasing power back to where it was in 2010. There are no signs on the horizon that this negative trend will change any time soon.

I have spent a career working on the issues of crime and substance abuse, including a time as vice president and chief operating officer of the National Crime Prevention Council. It is undeniable that substance abuse treatment for the incarcerated not only reduces recidivism, but in turn it allows its participants to at least have a chance at a productive life upon release. Based on my time working with states and communities on model state statutes and local ordinances related to drug abuse and gang violence, I can say this unequivocally.

Some members of Congress are to be praised for their efforts in the fight against substance abuse, and their recognition of the importance of treatment within the criminal justice system. In the Senate, Senators Rob Portman (R-Ohio) and Sheldon Whitehouse (D-R.I.) introduced the Comprehensive Addiction and Recovery Act (CARA), in both 2014 and 2015. Rep. Jim Sensenbrenner (R-Wis.) introduced a companion bill to CARA in the House. Senator Ed Markey (D-Mass.) introduced legislation that would expand access to medication-assisted treatment. Rep. Hal Rogers (R-Ky.), chair of the appropriations committee, remains committed to funding programs at the Department of Justice that screen for prescription drug abuse.

Yet when it comes to health policy, there is only one reality: funding. While rhetoric for increasing the amount of attention paid to substance abuse has been at an all-time high, the commitment to funding by Congress has not kept up. Congressional funding for the Substance Abuse and Mental Health Services Administration’s Substance Abuse Prevention and Treatment block grant has not kept up with inflation and, as a result, would need a $450 million increase just to bring its purchasing power back to where it was in 2010. There are no signs on the horizon that this negative trend will change any time soon.

RSAT slashed

Many members of Congress have uttered the phrase, or paraphrased, “We cannot arrest our way out of this problem.” They realize the law-and-order approach is not an effective deterrent to drug use. As a result, there has been much support in the past for the treatment of those in need who end up in the criminal justice system. One such program is the Residential Substance Abuse Treatment (RSAT) program housed by the Bureau of Justice Assistance in the Department of Justice.

According to the Bureau of Justice Assistance, 68 percent of jail inmates report substance abuse dependence prior to incarceration, with 29 percent being under the influence of drugs at the time of the offense and 16 percent committing offenses in order to obtain money for drugs. Of all jail inmates, over two-thirds were found to be dependent on or abusing alcohol or drugs. RSAT exists to help address the issue of substance abuse dependence and the direct link to public safety, crime and victimization by providing comprehensive treatment and services within the institution and in the community after a prisoner is released. RSAT funds are allocated to each state, the District of Columbia and territories based upon the respective prison population in relationship to the total prison population of all states combined.

So now, in 2015, when so many members of Congress are saying one thing, why are they doing another? Unless there is funding for programs that will benefit those in need, the words of support for treatment ring hollow. The appropriations subcommittee for Commerce, Justice, and Science (CJS) is guilty of this very hypocrisy. In their FY 2016 markup, they proposed the RSAT program be zeroed out. In layman’s terms, their recommendation was that funding for the program go from $11 million to nothing.

The CJS subcommittee slashed and burned in other places as well, and many of the programs impacted play a great role in reducing substance abuse or behavior that leads to it. Juvenile Justice programs overall are decimated, with a cut of $68 million below FY 2015 and $155.9 million below the White House request. This includes the proposed elimination of the Community-Based Violence Initiative, the National Forum on Youth Violence, the Local Delinquency Prevention Incentive grant program, the Children of Incarcerated Parents program, and a program targeting girls in the justice system.

Some politicians will recite the same tired lines. They need to prioritize. They hate to cut any programs, but in this fiscal environment, something has to go. What they are saying when they zero out a program such as RSAT is that substance abuse treatment is not a priority, especially among the incarcerated and the underserved. Such an act flies in the face of everything Congress has been telling us for the past year — that opioid abuse is the single greatest threat to our public health. If the members of the CJS subcommittee, led by Rep. John Culberson (R-Texas), truly believed this, the RSAT program would not only be fully funded, it would receive an increase. Rep. John Carter (R-Texas) is a member of the House Addiction, Treatment, and Recovery Caucus, yet he sits on the subcommittee that authored this bill. Also on the subcommittee responsible for this bill is Rep. Steven Palazzo (R-Miss.). In 2012 he joined in the celebration as a residential and workforce training center for children struggling with emotional, mental and substance abuse problems was opened in his district. Now, his committee produces legislation that will do anything but assist those with a substance abuse problem in great need of help.

It’s time for Congress to step up to the plate and fund the programs that will bring us closer to a healthier nation that fights substance abuse with every weapon in its arsenal — including appropriations.

From the Field
4/27/2015 12:00 AM

Opinion on marijuana has changed dramatically in the United States. The public increasingly perceives it as a benign substance, and there is growing interest in its potential medicinal uses. Already almost half of the states have medical marijuana laws, and congressional bills have recently been proposed that would reschedule the drug to reduce hindrances to research and facilitate marijuana’s use as medicine.

Advocates tout marijuana as a miracle drug with a wide range of potential therapeutic uses, while public health voices raise alarms about its dangers if made more widely available. The science justifying either position is often not as robust or clear as its partisans would wish. Marijuana’s impact on lung cancer remains unclear, for instance, but so does its actual range of medicinal benefits. The urgent need for more research is something all sides in the current marijuana debate can agree on. Policy changes around marijuana will need to be informed, as much as possible, by science.

There is solid evidence that the main psychoactive ingredient in marijuana, THC, is effective at controlling nausea and boosting appetite. There is also some preliminary evidence that THC or related cannabinoid compounds such as cannabidiol (CBD) may also have uses in treating autoimmune diseases, inflammation, pain, seizures and psychiatric disorders, including substance use disorders. Despite claims of marijuana’s usefulness in treating post-traumatic stress disorder, supporting data is minimal, and studies have not investigated whether symptoms may worsen after treatment is discontinued.

We do not yet know all the ways chronic treatment with marijuana or marijuana-derived compounds could affect people who are rendered vulnerable either by their illnesses or by their age. We also don’t know how medical marijuana laws will affect other aspects of public health and safety. For example, wider medical marijuana use could potentially impact driver safety, as both laboratory and epidemiological research link recent marijuana use to increased accident risk, likely reflecting marijuana’s disruptive effects on motor coordination and time perception.

Impact on teenagers

Perhaps the biggest public health concern around medical marijuana liberalization and legalization concerns the potential impact on teenagers, who could have greater access to it as a drug of abuse and who may increasingly see marijuana as a “safe, natural” medicine rather than a harmful intoxicant. Although there is still much to learn about marijuana’s impact on the developing brain, the existing science paints a picture of lasting adverse consequences when the drug is used heavily prior to the completion of brain maturation in young adulthood. In teens, marijuana appears to impair cognitive development, may lower IQ and may precipitate psychosis in individuals with a genetic vulnerability.

Most states currently don’t allow medical marijuana for children, but they too are vulnerable. Accidental ingestion of marijuana edibles by children has increased in Colorado since marijuana was decriminalized for medicinal use in 2009. Also potentially concerning is the possibility of increased prenatal exposure if women self-treat with marijuana to control nausea associated with pregnancy. Research suggests prenatal exposure could have adverse consequences for children’s future health and brain development. There is as yet no research on the potential effects of secondhand marijuana smoke on children growing up in households where parents smoke.

Even in conditions for which THC, CBD or other cannabinoid constituents of the marijuana plant prove to be medically beneficial, consumption of the marijuana plant itself or its crude extracts via smoking, vaporizing or eating is unlikely to be the most effective, reliable or safe way for patients to obtain these benefits. Laboratory research is ongoing to better understand how cannabinoids work in the brain and body and hopefully guide development of safe, reliable therapeutic compounds that have a minimum of adverse side effects.

Existing medications

Two THC-based medications, dronabinol and nabilone, are already approved by the Food and Drug Administration to treat nausea caused by chemotherapy and to boost appetite in patients with AIDS wasting syndrome. The United Kingdom, Canada and several European countries have approved a drug called nabiximols (Sativex), containing THC and CBD, as a medication for spasticity caused by multiple sclerosis (MS) and, in Canada, for MS- and cancer-related pain. Despite its success in reducing pain and spasticity, it has not received approval in the United States, and recent evidence has found impairments in cognition in users.

CBD on its own is not psychoactive and it actually mitigates the “high” produced by THC; it has been studied as a potential antipsychotic drug, and ongoing trials are testing its efficacy as an antiseizure agent. Some parents of children with severe forms of pediatric epilepsy have claimed that high-CBD (and low-THC) marijuana extracts control their children’s seizures better than existing medicines. The maker of Sativex has recently created a CBD-based drug called Epidiolex to treat children with these conditions, and is in the process of conducting initial small-scale trials. Evidence so far shows that CBD is only effective in controlling seizures in a small subset of patients.

As public approval for medical marijuana grows, we need to ensure that our policy decisions are science-based and not swayed by the enthusiastic claims made widely in the media or on the Internet. We need to support and encourage increased research on marijuana’s potential benefits and conduct intensified research on the cannabinoid system to inform the development of safe, FDA-approvable drugs. But the existing science on marijuana’s adverse effects on youth demands we also proceed with caution in making policy changes that could result in increased use of or exposure to marijuana by young people.

From the Field
10/27/2014 12:00 AM

Last week, the Harm Reduction Coalition held its conference in Baltimore. Marijuana legalization is not one of its issues, which are mainly access to clean needles and syringes, overdose prevention with naloxone, HIV and hepatitis C, and the rights of drug users. Keynote speaker Michael Botticelli, acting director of the Office of National Drug Control Policy (ONDCP), supports naloxone and medication-assisted treatment. He is a clear harm reduction advocate, but not an advocate of marijuana legalization.

But harm reduction sometimes gets confused with marijuana legalization. I had the privilege of speaking to the “Politics” class at American University in nearby Washington, D.C. on October 20, a few days before the conference was to begin. I was invited to discuss the movement toward drug legalization. I also covered some “harm reduction” assertions as well.

Unfortunately, because the legalization movement is sweeping across America, my counterpoints were very well-received — I say “unfortunately” because we are being overcome by the tidal wave of the movement. Here is some of what I said to Assistant Professor Rick Semiatin’s “Washington Semester” class of juniors and seniors from 200 colleges and universities across the United States.

I’m a “liberal” on most things, but on the drug issue, I know the harm that is done by car crashes, DUIs, date rape and the impact of flooding already overcrowded emergency rooms — and that includes from marijuana, which most “legalizers” claim they want to separate from “harder” drugs. I was the one who wrote then-Congressman Ed Koch’s testimony on his bill in the 1970s to legalize marijuana, and sat with him at the table as he told Congress that drugs are personal and harmless, and that we should stop crowding our prisons. But both Ed and I learned and changed our positions, he as mayor of New York City and me as I learned more and more as spokesman for the House Narcotics Committee and then the White House ONDCP.

I told the students that the election is being overwhelmed by the issue because my own party, the Democrats, don’t want to touch it. They are afraid their candidates will lose a big chunk of the youth and liberal base who support legalization/decriminalization in the legislatures and state referenda. Like laetrile in the 1970s (which was legalized in more than 20 states and was supposed to cure cancer but turned out to be useless apricot pits that simply deferred real and needed treatment), “medical” marijuana is backed up only anecdotally and never is compared to an “n” of other treatment modalities that would be prescribed by doctors. There is truth to former drug czar Barry McCaffrey’s joke that a shot of gin also takes away your pain. Having said that, no one wants to deny a truly sick or dying patient who wants to get high the opportunity to feel better, even if it’s a placebo effect. It’s not the truly “medical” cases anyone wants to stop; it’s what law enforcement tells us are the 90-percent-plus (and as many as 99 percent) nonsick people who also come in to the clinics feigning illness with a makeshift letter just to get drugs.

Harms of marijuana

The evidence on harm in the legalizing states is rolling in. You have to scrounge for the reports, but they say, “youth marijuana use increased by nearly 11 percent since medical marijuana became legal in 2009,” “traffic fatalities involving drivers testing positive for marijuana have increased by 100 percent between 2007 and 2012” and “toxicology reports with positive marijuana results for driving under the influence have increased 16 percent from 2011 to 2013.” In addition, Colorado Public Radio reported, “Denver Emergency Room Doctor Seeing More Patients for Marijuana Edibles.” The United Nations reported, “Marijuana-related Health Problems on Rise in US,” with a 12 percent rise last year in marijuana usage by teens.

But for the most part, the legalization referenda are speeding ahead. The most-cited ones, in Oregon and D.C., show legalization 11 and 20 points up, respectively, with just days before the election, and the legalization advocates say they are counting on “young voter turnout.” Since Democrats count on that demographic as well, you can understand the silence.

Even though Maryland Governor Martin O’Malley told me personally two weeks ago that “I’m concerned about legalization” because of car crashes, emergency room upticks, the horrible message to kids (how legalization disarms parents from the moral high ground on the message), and the like, politicians in the state are silent on the issue.

Of course, the legalizers say the drug war is a “failure.” But the students I addressed did open their eyes when I said that because of the efforts of parents, teachers, coaches and religious and business leaders, and a strong foreign policy (Plan Colombia) and domestic enforcement efforts, drug use has declined almost 50 percent in the last three decades, and cocaine use — the disproportionate driver of crime — is down 70 percent. If any other social problem, such as literacy, hunger or poverty, or health problem, such as cancer, diabetes and heart attacks, improved 50–70 percent, would we call it a failure?

To these quite smart college juniors and seniors, I pointed out that medically assisted treatment — including methadone, buprenorphine and Vivitrol — is in fact harm reduction. It’s valid because people can function, work and pay taxes. But if we’re talking about heroin, cocaine and methamphetamine to addicts, that’s pure nonsense that destroys their lives. If we are talking about marijuana, I still oppose it because it jams hospital emergency rooms with car crashes and treatment centers with patients. Legalization or decriminalization would simply increase availability and use. When I debate the Ethan Nadelmanns of the world on radio or Bill Maher or Crossfire, they invariably say, “That’s true but…” I cut in and say, “You can’t say ‘but’ to more availability and use — that’s the point. Aside from that, Mrs. Lincoln, how was the play?”

I do concede we need to stop prison overcrowding but point out that’s why Attorney General Janet Reno and ONDCP Director McCaffrey supported creating drug courts, for treatment instead of prison for nonviolent drug offenders. There were eight drug courts when we started in 1996. Drug courts rose to 1,000 under Clinton-Reno-McCaffrey, and now are near 3,000.

Science, not politics, should guide U.S. drug policy.

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  • Meet the Editor

    Alison Knopf
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    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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