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6/15/2015 12:00 AM

There’s little specific to substance use disorders (SUDs) in the “Helping Families in Mental Health Crisis Act of 2015,” a bill from 2013 reintroduced June 4 by Rep. Tim Murphy (R-Pennsylvania) (see ADAW, Dec. 16, 2013). Like its predecessor, the bill seeks to encourage outpatient commitment, which mental health patient advocates oppose, but at the same time funds mental health programs, especially those based in psychiatry and psychology and medications. But there is one item affecting patients with SUDs: a provision that specifically would weaken 42 CFR Part 2, the confidentiality regulation banning the release of information on patients treated for SUDs. The bill wouldn’t change 42 CFR Part 2 itself, but rather make certain information inapplicable to it. And it would be retroactive — people who thought they had been protected by 42 CFR Part 2 would not be protected anymore.

Like its predecessor in 2013, the bill eliminates the Substance Abuse and Mental Health Services Administration (SAMHSA) and adds a bureaucracy within the Department of Health and Human Services at the assistant secretary level.

There’s little specific to substance use disorders (SUDs) in the “Helping Families in Mental Health Crisis Act of 2015,” a bill from 2013 reintroduced June 4 by Rep. Tim Murphy (R-Pennsylvania) (see ADAW, Dec. 16, 2013). Like its predecessor, the bill seeks to encourage outpatient commitment, which mental health patient advocates oppose, but at the same time funds mental health programs, especially those based in psychiatry and psychology and medications. But there is one item affecting patients with SUDs: a provision that specifically would weaken 42 CFR Part 2, the confidentiality regulation banning the release of information on patients treated for SUDs. The bill wouldn’t change 42 CFR Part 2 itself, but rather make certain information inapplicable to it. And it would be retroactive — people who thought they had been protected by 42 CFR Part 2 would not be protected anymore.

Like its predecessor in 2013, the bill eliminates the Substance Abuse and Mental Health Services Administration (SAMHSA) and adds a bureaucracy within the Department of Health and Human Services at the assistant secretary level.

The bill focuses primarily on mental health — except for the provision removing the privacy protections for people in treatment for SUDs, by saying that SUD information doesn’t apply to 42 CFR Part 2 if treatment took place in an integrated health system.

The bill amends section 543(e) of the Public Health Service Act (42 U.S.C. 290dd–2(e)) by inserting that information may be shared “within accountable care organizations described in section 1899 of the Social Security Act (42 U.S.C. 1395jjj), health information exchanges (as defined for purposes of section 3013), health homes (as defined in section 1945(h)(3) of such Act 42 U.S.C. 1396w–4(h)(3)), or other integrated care arrangements (in existence before, on, or after the date of the enactment of this paragraph) involving the interchange of electronic health records (as defined in section 13400 of division A of Public Law 111–5) (42 U.S.C. 17921(5)) containing information described in subsection (a) for purposes of attaining interoperability, improving care coordination, reducing health care costs, and securing or providing patient safety.’’

Retroactivity

Not only does the bill change the meaning of 42 CFR Part 2, but it would change it retroactively for all “integrated care arrangements,” including those “in existence before” the date of enactment. That means that people in treatment decades years ago, who did not consent to the release of their information, might not be protected. It also could discourage anyone in an integrated system from seeking treatment for an SUD.

This is of great concern to H. Westley Clark, M.D., until last fall director of SAMHSA’s Center for Substance Abuse Treatment, which promulgates 42 CFR Part 2.

Clark calls the provision, which makes SUD information inapplicable to 42 CFR Part 2 if it occurred in an integrated health system, an “all-encompassing privacy buster.” The provision “nullifies the understanding that past patients had when they entered treatment, even if that treatment was 20 years ago,” said Clark, now a professor of public health at Santa Clara University in California. “People in recovery will be stripped of their autonomy to decide whether they want to share their past history.”

The argument for the change is that releasing information is “for their own good,” said Clark, adding that he hasn’t seen any studies that indicate that this release of information “for their own good” was warranted. “People with SUDs are an inconvenient afterthought in this bill,” said Clark. They are “given nothing, but forced to give up the most private of rights — personal autonomy.”

Harm to patients

Clark thinks people will deny having a problem with alcohol or drugs, “once it becomes known that anything you say will be held against you.” He may be wrong, he admitted. “But I know that once logic prevails, once the discrimination ensues, higher-functioning users will shy away from admitting the truth,” he said. “The integrated system cannot protect patients’ confidentiality or privacy. And, there is zero discussion about the harm to patients when privacy is breached.”

There are also questions about SUD information and the criminal justice system. HIPAA already allows the criminal justice community access to medical records with minimal justification, said Clark. The non-applicability clause about 42 CFR Part 2 in the bill could “open the floodgates to criminal prosecution.”

The original intent of 42 CFR Part 2 was to keep law enforcement from literally following patients into treatment programs — in particular, opioid treatment programs, which is what happened in New York City.

“I just want people to get treatment that works without fear of retribution,” said Clark.

Sen. Scott “Chris” Murphy (D-Connecticut) is interested in a companion bill. If this happens, the bill from the House side may go further than it did two years ago, before it included the confidentiality change.

5/18/2015 12:00 AM

Jeffrey Lynne, a lawyer based in Florida who represents treatment programs in zoning and other issues, says it’s about time that some drug testing arrangements are being cut back by payers (see ADAW, May 11). Lynne, who is a partner with Weiner, Lynne & Thompson in Delray Beach, said that insurance companies are suing treatment providers to get their money back for excessive and unnecessary testing in “clawback lawsuits.” He tells his clients that if they submit such claims, insurance companies will say it’s insurance fraud.

“You don’t need a clinician to tell you how many times you need to test someone,” Lynne told ADAW. “If you’re coming into my detox, I need to test you once to see what you’re on and how much of it.” For patients who are in residential treatment, under 24-hour supervised care, testing is necessary only if a patient is acting strangely, he said. “But if a patient is under your care 24 hours a day, seven days a week, why would you have any reason to test them?” he asked.

(This is the second of a two-part series on drug testing and treatment centers.)

Jeffrey Lynne, a lawyer based in Florida who represents treatment programs in zoning and other issues, says it’s about time that some drug testing arrangements are being cut back by payers (see ADAW, May 11). Lynne, who is a partner with Weiner, Lynne & Thompson in Delray Beach, said that insurance companies are suing treatment providers to get their money back for excessive and unnecessary testing in “clawback lawsuits.” He tells his clients that if they submit such claims, insurance companies will say it’s insurance fraud.

“You don’t need a clinician to tell you how many times you need to test someone,” Lynne told ADAW. “If you’re coming into my detox, I need to test you once to see what you’re on and how much of it.” For patients who are in residential treatment, under 24-hour supervised care, testing is necessary only if a patient is acting strangely, he said. “But if a patient is under your care 24 hours a day, seven days a week, why would you have any reason to test them?” he asked.

On the other hand, outpatient programs, as well as sober living residences, are doing the testing. Many sober living residences require patients to be tested once a day in order to live there — and if patients test positive, they’re kicked out.

Treatment centers and sober homes want to have their own lab so they can send their patients to it and get the money. For Medicaid and Medicare, this is a violation of anti-kickback law, but there is no such law that applies to private payers that are out-of-network (not contracted).

Desktop analyzers and more

The lure of the testing income was so great, Lynne related, that it first led programs to buy desktop analyzers so they could satisfy insurance company requirements for accuracy. Then, when they learned that a lab would have to perform the quantitative confirmatory test, they had to lease the costly machine that could do the confirmatory testing. Centers “shared” the machine. Other companies wandered into the market saying they were turnkey and would do everything for the center — but wanted a cut of whatever got billed and collected.

Billing companies were driving this trend, said Lynne. “Some billing companies say not only do you need to do the desktop analyzer but also the confirming test. And apparently you can bill one hundred dollars a panel at 15 substances per test per patient,” he said. “If I have a sober house with eight residents, and I can bill fifteen hundred dollars a day for each, you do the math.”

Unfair competition for labs

James Fratantonio, Pharm.D., manager of applied clinical research and education for Dominion Diagnostics, a lab based in Rhode Island that was recommended as a source by Marvin Ventrell, the executive director of the National Association of Addiction Treatment Programs (NAATP), said that labs performing clinical tests on patients need to be approved by CLIA and the College of American Pathologists, and must be audited. “You can’t just rent out machinery,” he said. “You need a lab director, you are regulated, your lab director needs a Ph.D. or an M.D.”

Fratantonio is concerned about the desktop analyzers with unregulated operations. “I do think this is going on, and I do not think that the competition out there is fair,” he told ADAW.

Drug testing is a clinical tool, which means it should be individualized to the patient, said Fratantonio. It would make sense to test a patient who was admitted for a cocaine use disorder for cocaine, but if the patient comes in showing symptoms of sedation, it would be good to test for benzodiazepines and opioids as well.

There are also esoteric drugs — and drugs that contain substances that are entirely unknown, such as “Spice” or “bath salts” — which won’t necessarily show up in standard tests, he said. “Nobody knows what’s in them,” he said. There are tests that can be run, but these are more costly. And they’re not likely to be done by anybody but a reference lab like Dominion Diagnostics.

It’s also important to test for therapeutic medications, to make sure the patient is taking them and not diverting them. This is true for buprenorphine, methadone, and opioids prescribed for pain as well. While there is no evidence to correlate urine drug levels with therapeutic range, “we can make judgment calls based on pharmacokinetic principles,” he said.

The value of testing

Sean Murphy, M.D., medical director of the Harmony Foundation (where the NAATP’s Ventrell is business manager), mainly uses testing for new admissions. Murphy has been providing treatment in residential detoxification programs for about 25 years — 14 in Colorado and, before that, 11 in California. “The technology has changed a lot over this time,” he said. “Ten years ago we sent everything to Texas, and the results were good, but it was a very slow turnaround time.” It took a week to get results back, so the testing just “wasn’t that useful,” said Murphy. “It did give a clear picture of their overall drug use pattern,” he said, noting that it clarified for a counselor what patients were really using. “The history the patient gives isn’t completely reliable — if you ask a diabetic what they’re eating, you’re not going to get the right answer.”

Now, Murphy uses Dominion Diagnostics, and the turnaround time is less than 24 hours — even though this time the samples go from Colorado to Rhode Island. The test results “help me treating people for their withdrawal,” he said. “With the narcotic explosion, there are so many types of drugs, with people using this and that — they can’t even remember what they’re using,” he said. “Someone may mainly use oxycodone, but took a couple Suboxone, chewed a fentanyl patch — they just don’t remember.”

Drug tests can also help Murphy’s patients who come in with alcohol or benzodiazepine dependence. Because withdrawal from these two substances can cause seizures, knowing what the patient was taking can inform Murphy’s treatment and help prevent seizures, he said.

Most of the testing Murphy does is for new admissions. As for ongoing testing, he only does it on a random basis, as a deterrent, due to costs, he said. The kind of random testing he does is more similar to workplace rather than clinical testing — two patients’ names a week are drawn at random for testing, saving money in testing costs. However, the down side is that because the patients are chosen at random, these aren’t really clinical tests, and Murphy doesn’t bill either the insurance company or the patient for them. It didn’t seem fair, said Murphy, to give a patient a bill for $300 because he or she was randomly selected to be tested. “We don’t want to pass the cost on to someone, and the insurance companies won’t pay for it,” he said. “But we can’t spend $25,000 a year on this anymore.”

There is really no good option other than a clinical lab, however. “Part of the problem is that the dipstick testing is not very reliable,” said Murphy. “We’ve been through six brands — and they all have a 50-percent error rate.” Murphy gives every new patient a dipstick test, to see if it confirms the patient history. Then, he sends the sample to the lab.

Laboratory testing is expensive, said Murphy. “We’re still searching for some other alternatives, for some lower-cost testing,” he said. “But it might be slower; we might have to give up a little accuracy.”

The Harmony Foundation doesn’t contract with any insurance companies, so there is no specific assigned lab that pays for each patient’s tests. The struggles reflect the considerations of a physician who is trying to give the best clinical care to his patients — and that, says Lynne, should be the only purpose of drug testing. “People need to know that urinalysis testing should not be viewed as a source of revenue,” said Lynne. “It should not be part of the business plan.”

Fratantonio’s final advice to treatment centers looking at urine drug testing as a profit center: “If you think that something is too good to be true — it is.”

Bottom Line…

Drug tests should enhance a patient’s care, not a center’s profit.

3/23/2015 12:00 AM

The federal Centers for Disease Control and Prevention (CDC) has requested funding to bolster state prescription drug monitoring programs (PDMPs) by linking them to electronic health records (EHRs) and linking both to law enforcement. The purpose is “to improve clinical decision-making and to inform implementation of insurance innovations and evaluation of state-level policies,” according to the Congressional Justification (CJ) (the narrative supporting an agency’s budget request). “In addition, the increased investment will support rigorous monitoring and evaluation, and improvements in data quality, with an emphasis on delivering real-time mortality surveillance,” the CJ says. “CDC also will scale up activities to improve patient safety by bringing together health systems and health departments to develop and track pain management and opioid prescribing quality measures in states with the highest prescribing rates.”

The federal Centers for Disease Control and Prevention (CDC) has requested funding to bolster state prescription drug monitoring programs (PDMPs) by linking them to electronic health records (EHRs) and linking both to law enforcement. The purpose is “to improve clinical decision-making and to inform implementation of insurance innovations and evaluation of state-level policies,” according to the Congressional Justification (CJ) (the narrative supporting an agency’s budget request). “In addition, the increased investment will support rigorous monitoring and evaluation, and improvements in data quality, with an emphasis on delivering real-time mortality surveillance,” the CJ says. “CDC also will scale up activities to improve patient safety by bringing together health systems and health departments to develop and track pain management and opioid prescribing quality measures in states with the highest prescribing rates.”

The CDC will also join with the Department of Justice, according to the CJ, for the purposes of making PDMPs more widely used “for clinical decision-making.”

By linking insurance strategies to PDMPs, there is a risk of “creating a much larger field of information to be mined by law enforcement, insurers and others,” said H. Westley Clark, M.D., former director of the Center for Substance Abuse Treatment at the Substance Abuse and Mental Health Services Administration (SAMHSA), in an email to ADAW. “The objective,” he said, “is to link PDMP data to health outcome data, and to trigger alerts within the PDMP system to identify high-risk patients.”

The databases of physicians writing prescriptions for opioids and pharmacists filling them will be a “gold mine” for law enforcement, said Clark, who is a lawyer. Of particular concern are patients in treatment with methadone in opioid treatment programs (OTPs), which do not currently have to input data into PDMPs thanks to a “Dear Colleague Letter” written by Clark when he was at CSAT (see ADAW, Oct. 24, 2011). “How can these data not be of interest to federal and state law enforcement? Even if the PDMP data are hearsay, the investigations launched as a result of PDMP data will be enough to discourage physicians to prescribe for pain and for OTPs to question the utility of participating in PDMPs,” Clark said.

Creating confidential informants

Clark added that law enforcement can also use information from PDMPs and electronic health records to create confidential informants against physicians and pharmacists — people who were illegally selling their prescriptions, and cut a deal with law enforcement to ensnare the prescribers and dispensers. “Some would see this as a good thing,” he said. “But others would wonder if further converting the medical record into a chess piece on a criminal justice game board is a wise thing to do.”

Through PDMP data, law enforcement can also elicit affidavits from prescribers and pharmacists, said Clark. “They can use those affidavits to pressure patients to identify buyers and sellers of their drugs,” he said. “Deals will be made, and the consequences may not be pretty.”

The CDC is asking Congress for funds so that states will “demonstrate collaboration with a variety of state entities, including law enforcement,” according to the CJ. Clark is very concerned about this, because it “pulls law enforcement deeper into the realm of health care delivery.”

If SAMHSA decides to require OTPs to input patient data into the PDMP, that is tantamount to opening up the OTPs to law enforcement. At that point, as Clark put it, there will be a “whole new ball game.”

Response from CDC, ASAM

The CDC press office declined to make a subject-matter expert available for an interview to respond to our questions. By email, we asked the CDC why it, as a health agency, is encouraging the use of health records as tool of criminal prosecution. The response came by email from Brittany Behm: “Collaborations are a vital part of building an effective program to prevent prescription drug overdoses. No single player can address all the levers that impact drug overdose prevention, and success in this work is not possible without effective collaboration with key stakeholders. This includes coordination and cooperation between public health, law enforcement, substance abuse services authorities, and other sectors to advance prevention and protect those at risk for opioid misuse, abuse, and overdose.” The “public health approach” to preventing drug overdose death by the CDC has three parts, she said: (1) improving data quality and surveillance to monitor and respond to the epidemic, (2) supporting states in their efforts to implement effective solutions and interventions and (3) equipping health care providers with the data and tools needed to improve the safety of their patients.

Finally, we asked if there is concern that curbing access to prescription opioids could have the effect of increasing heroin use, as people with addiction find their supply cut off or too expensive. “There is no evidence that PDMPs lead to heroin use,” Behm said.

We also asked Stuart Gitlow, M.D., president of the American Society of Addiction Medicine (ASAM), to comment on the CDC’s proposed expansion of PDMPs. “ASAM supports PDMPs as a methodology of reducing the potential of diversion and misuse,” he told ADAW in an email. “We do not, however, support the intersection of medical and law enforcement information and therefore are extremely uncomfortable with the concept of law enforcement having access to PDMPs. From there, it would be a short step to law enforcement having access to medical records to determine if patients are utilizing illicit substances, thus placing a damper on patients and physicians having open and private conversations. Even without such access, information in law enforcement’s hands as to the medications prescribed to patients provides likely diagnostic information to law enforcement, a likely driver toward patients preferring to obtain even appropriate prescriptions through illicit means.”

For the CDC CJ, go to http://www.cdc.gov/fmo/topic/Budget%20Information/appropriations_budget_form_pdf/FY2016_CDC_CJ_FINAL.pdf.

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
    Editor

    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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