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8/4/2014 12:00 AM

When The New York Times on July 27 announced that its editorial board endorsed marijuana legalization, the pro-marijuana lobby immediately responded with glee. Although Andrew Rosenthal of the Times wrote that the endorsement was based on meeting with medical experts and others, he did not respond to a request from ADAW about who those medical experts were. The federal Office of National Drug Control Policy and the National Institute on Drug Abuse are opposed to legalization, with recent surveys clearly suggesting that underage increases in daily marijuana use are connected to a perception that marijuana is not harmful, due in part to medical marijuana and, more recently, to legalization in Colorado.

When The New York Times on July 27 announced that its editorial board endorsed marijuana legalization, the pro-marijuana lobby immediately responded with glee. Although Andrew Rosenthal of the Times wrote that the endorsement was based on meeting with medical experts and others, he did not respond to a request from ADAW about who those medical experts were. The federal Office of National Drug Control Policy (ONDCP) and the National Institute on Drug Abuse are opposed to legalization, with recent surveys clearly suggesting that underage increases in daily marijuana use are connected to a perception that marijuana is not harmful, due in part to medical marijuana and, more recently, to legalization in Colorado.

The Times, like many other proponents of legalization, singles out the harms inflicted on blacks who are arrested and incarcerated due only to marijuana possession charges. The ONDCP had a response to this on July 28: “We agree that the criminal justice system is in need of reform and that disproportionality exists throughout the system. However, marijuana legalization is not the silver bullet solution to the issue.”

What the Times didn’t discuss was “a cascade of public health problems associated with the increased availability of marijuana,” according to the ONDCP. “While law enforcement will always play an important role in combating violent crime associated with the drug trade, the Obama Administration approaches substance use as a public health issue, not merely a criminal justice problem.” Among the health problems mentioned by the ONDCP are marijuana use impairs the development of the brain, resulting in cognitive problems; 25 to 50 percent of daily users of marijuana are addicted; and marijuana impairs coordination and is a threat to roadway safety.

The valid concerns about the racism in the criminal justice system do not mean that marijuana should be legal, the ONDCP wrote. Alcohol and tobacco, because they are legal, already cause “much higher social costs than the revenue they generate” from taxes.

Experts not consulted

ADAW has learned that the medical experts consulted by the Times did not include the American Society of Addiction Medicine (ASAM), the physicians who specialize in treating addiction. “I don’t know that they spoke to any medical experts at all,” Stuart Gitlow, M.D., ASAM president, told ADAW. “I had no inkling of the editorial until the day it ran.”

The American Medical Association and the American Psychiatric Association also oppose legalization.

Project SAM, headed by Kevin Sabet, Ph.D., and Patrick Kennedy, the former congressman, asked to speak with the Times six months ago and was rejected, Sabet told ADAW, adding that he was “surprised” by the editorial board policy. “A paper like the Times that has expressed its support for greater health coverage, expanded education and raising awareness about the mental health crisis in this country should have been able to easily see how legalization runs counter to all of those things,” he continued. “We know this decision was made with very little research,” Sabet said, adding that “none of the major scientific groups were consulted.” Even a meeting with the White House drug policy people attracted only one editor, said Sabet. “These guys did not do their homework, and I think the overwhelming criticism they received from the scientific community already shows that,” he said.

But Sabet said the medical field needs to be more vocal. “If anything, this is a wake-up call to our field,” states a July 27 response from Project SAM to the Times announcement. “We need to be able to discuss opposition to legalization with the science. But we cannot stay silent any longer.”

Gitlow, an advisor to SAM, said in that statement: “Contrary to positions taken by the American Medical Association, American Society of Addiction Medicine, and the American Psychiatric Association, the public is getting the message — from the media and our lawmakers — that marijuana use comes with few negative consequences. It is time we all set the record straight.”

Also see “Marijuana: The new alcohol? Voices from the legalization debate” in ADAW, January 13.

To read the ONDCP’s entire response to the Times editorial, go to http://www.whitehouse.gov/blog/2014/07/28/response-new-york-times-editorial-marijuana-legalization.

7/28/2014 12:00 AM

Sovaldi, approved by the Food and Drug Administration (FDA) last year for the treatment of chronic hepatitis C (HCV), has a success rate better than 90 percent, and is ideal for use in opioid treatment programs (OTPs), yet payers are balking at covering it for patients who have a history of a substance use disorder (SUD), ADAW has learned. This is despite any labeling that indicates it is not safe for these patients; in fact, in trials it was given concomitantly with methadone with patients in OTPs, and the FDA states it can be given concomitantly with methadone, with no dose adjustments.

Sovaldi (sofosbuvir) is the first oral medication for HCV that doesn’t require interferon, an injected medication that has, for many patients, intolerable side effects, including nausea, fatigue and depression. Also last year, the FDA approved another oral medication for HCV: Olysio (simeprevir).

Sovaldi, approved by the Food and Drug Administration (FDA) last year for the treatment of chronic hepatitis C (HCV), has a success rate better than 90 percent, and is ideal for use in opioid treatment programs (OTPs), yet payers are balking at covering it for patients who have a history of a substance use disorder (SUD), ADAW has learned. This is despite any labeling that indicates it is not safe for these patients; in fact, in trials it was given concomitantly with methadone with patients in OTPs, and the FDA states it can be given concomitantly with methadone, with no dose adjustments.

Sovaldi (sofosbuvir) is the first oral medication for HCV that doesn’t require interferon, an injected medication that has, for many patients, intolerable side effects, including nausea, fatigue and depression. Also last year, the FDA approved another oral medication for HCV: Olysio (simeprevir).

The problems with these medications are that they are costly: more than $60,000 for Olysio and more than $80,000 for Sovaldi. Treatment takes 12 to 24 weeks.

Still, the morbidity and mortality associated with HCV, which can lead to cirrhosis, liver failure and death, call for the use of these medications, especially in OTPs, said Elinore McCance-Katz, M.D., chief medical officer for the Substance Abuse and Mental Health Services Administration (SAMHSA), which regulates OTPs.

“I’ve been waiting for these drugs for a long time,” McCance-Katz, whose background is in infectious diseases, told ADAW last week. “This is an area that’s very near and dear to my heart.” Noting that people die from liver disease that is induced by HCV, she said that the first “Dear Colleague” letter she wrote to OTPs was about the need for testing for HCV. She just reissued that letter because the disease “is so important in terms of morbidity and mortality.”

OTPs are uniquely able to provide HCV testing and treatment because they are already required to oversee medical care, she said. “Patients must have a physical exam, be seen by a doctor, and the OTP must make sure that patients get all the care that they need,” she said.

Testing and treatment

It’s not enough to simply do an antibody test for HCV; programs also need to test for viral load, said McCance-Katz. “Not everybody who shows a positive for ever being infected is still infected,” she said. And then, it’s essential to treat the HCV, if the infection is there, she said. “It’s unfair to patients to tell them they are infected with HCV if there isn’t anything that’s being done on it,” she said.

If patients have a viral load, they need to be referred to medical care, said McCance-Katz, adding that the care doesn’t necessarily need to be provided in the OTP. “Another physician could do the workup,” she said, adding, “not everybody with a viral load is going to be treated, because they may not be at a point where that is clinically indicated.”

Hepatitis C is generally transmitted parenterally — via injection with infected needles, or a blood transfusion before 1992, when the supply was tested.

The FDA requires testing medications with methadone, and that was done for Sovaldi — another reason that OTP patients are uniquely suited to this medication, said McCance-Katz. There are no contraindications to giving both medications, and no dose adjustments are required.

Welcome from OTPs

OTPs are on the one hand delighted that they can offer this medication to their patients, but on the other hand cynical about whether payers will pay for it. “Over the next 10 to 20 years we can expect increased morbidity in terms of cirrhosis and liver cancer,” said Alain H. Litwin, M.D., who helped develop the HCV screening and treatment programs at the Albert Einstein College of Medicine in New York City. “But this can be avoided with treatment.” The Einstein OTP has treated 500 patients for HCV over the years, and Litwin is thrilled that Sovaldi is now available to these patients. “The time is now,” he said. “There’s always been excuses to wait — treatments aren’t effective, the OTP population is too complicated, there are too many competing priorities.” But now, with one pill a day, a 95 percent cure rate and very few side effects, there is no reason to back off treatment for what is a leading cause of death in OTP patients, he said.

Einstein has been treating patients with interferon, with injections given on site twice a week. Side effects are problematic. But the switch to Sovaldi is likely to be constrained by payers, he said.

OHSU-Medicaid report

In particular, Litwin cited a report issued in May by the Center for Evidence-Based Policy at Oregon Health and Science University (OHSU), supported by state Medicaid directors, that seeks to deter payments for Sovaldi, discrediting the trials and taking issue with the practice guidelines issued by the American Association for the Study of Liver Disease, which support the use of Sovaldi. The report singles out drug users as a group that should not be given the medication, saying that “patients with alcohol or drug use within the past year” should be excluded from treatment.

“Now we have this great treatment, but let’s restrict it to people who are not actively using drugs — that is contrary to everything society should stand for,” said Litwin. “It’s unjust.” In New York state, 65 percent of OTP patients have chronic HCV, he said. “Other than addiction, hepatitis C is the leading chronic illness,” said Litwin. Einstein’s model of care is group treatment — a shared medical visit in which everyone gets their medication. Now, with genotypes 2 and 3 of HCV, interferon-free is the best treatment, he said. The OTP could easily observe administration of the oral medication. About 30 percent of the OTP’s patients have those genotypes and are getting Sovaldi, said Litwin. For genotype 3, Sovaldi must be taken for 24 weeks, at a cost of $168,000, said Litwin. “At some point, this does not become cost-effective,” he said. “Everyone needs to contribute to this equation.”

Hours on pre-authorization

At CODAC Behavioral Health Care based in Providence, Rhode Island, the OTP is spending hours on getting documentation together to get Sovaldi for HCV patients. At one point, 85 percent of patients were infected with HCV; that is now down to 50 percent, largely as a result of the recent expansion of patients from 700 three years ago to 1,400 now. The newer patients are “more savvy in terms of taking care of their health, and not sharing needles,” said Diane Plante, CODAC nurse manager. “We do rapid HCV testing, and all patients who come back positive are sent to another clinic for viral load testing,” said Plante. Depending on the genotype, patients get Sovaldi or Olysio; no patients get interferon due to the significant side effects, she said.

Clinically, everything is going well. But the problem is getting paid, said Plante. “We’ve prescribed and we’re still muddling through the prior authorization process,” she said. A nurse and an aide spend several hours per patient documenting the need for these medications, with private insurance companies and Medicaid alike, she said.

“The insurance companies aren’t responsive when it comes to the request to use these new medications,” said Michael Rizzi, CODAC president and CEO. “They want us to use old protocol first, which is throwing good money down the tube.” The patient experience of using interferon “causes as much frustration as the disease” of HCV, he said.

Rizzi noted that $84,000, the cost of 12 weeks on Sovaldi, is much less than one acute hospitalization of a week in the ICU. “They’re going to pay for it one way or another,” he said of insurance companies and HCV treatment. He also thinks that patients in OTPs are being discriminated against if insurance companies think that everyone who is in recovery is a bad risk for reinfection.

“They wouldn’t say to a guy who needed another bypass that he couldn’t get it because he didn’t change his diet,” said Rizzi.

One concern is “warehousing” — that patients will be stuck using interferon until there are less expensive versions of Sovaldi on the market.

Medical discrimination

The National Association of Medicaid Directors (NAMD) circulated the OHSU report to state Medicaid directors, saying that the high cost of the medication “requires careful consideration of how to responsibly decide how to best use this new treatment option,” especially considering that there are 3 million people with HCV. “Nobody is demonizing drug users and saying that they shouldn’t be treated/cured,” said Matt Salo, NAMD executive director, in an email to ADAW. “But the practical implications of administering a 12-week course of treatment that can cost between $84–140K need to at least take into consideration a variety of factors,” he said. “Those factors may well include current drug use, in part because it may make adherence/compliance more difficult, but also because of the potential repercussions of successfully curing an individual only to have the risk of reinfection.”

We asked if he had any evidence that OTP patients or drug users are more likely to have a reinfection of HCV or be less compliant with medication. “I’m not sure that I have evidence on any of those things, per se,” he said, but he pointed out that isn’t NAMD’s role. “But we have heard (in a few states) that they’ve already spent more on Sovaldi in the first quarter of 2014 than they did for liver transplants in all of 2012 and 2013 combined.”

“NAMD has no opinion on whether or not any individual or group of individuals should or shouldn’t get treatment for anything,” said Salo. “We do stand behind the ability of states (who have to make difficult decisions about this and many other things every day) to make those types of decisions, however.”

Valerie King, spokeswoman for the OHSU project, said that the published studies on Sovaldi “all excluded subjects with active substance misuse,” and that is why the report concluded that these patients should not get the medication. She noted that there is no published research about using Sovaldi with naltrexone or buprenorphine.

Gilead responds

The maker of Sovaldi, Foster City, Calif.–based Gilead Sciences, “disputes and strongly disagrees with the conclusions of the OHSU report, commissioned by the National Association of Medicaid Directors (NAMD), regarding the use of sofosbuvir for chronic hepatitis C,” according to a spokeswoman for the company. “The report runs counter to the conclusions of regulatory authorities and expert professional groups that have licensed and endorsed sofosbuvir based on a well-designed and well-conducted clinical program demonstrating its ability to consistently deliver cure rates of over 90 percent.”

Sovaldi has been studied in subjects who were taking methadone, and the success rates were comparable to overall outcomes, according to Gilead. Methadone use was permitted in clinical trials, after the potential for drug interaction between Sovaldi and methadone was assessed in Phase I and it was found that the medications did not affect each other in terms of levels.

Concerns with alcohol

Because alcohol accelerates the damage caused by HCV and leads to the more rapid development of cirrhosis, clinicians caution HCV patients to abstain from alcohol, the spokeswoman said. However, based on the Sovaldi label, alcohol or other drug use is not a contraindication, she said.

In the trials, HCV patients were counseled to discontinue alcohol use, the spokeswoman said. “Patients who were actively abusing alcohol were excluded from the clinical trials,” she said. “However, a history of alcohol abuse or ongoing alcohol use was not exclusionary; approximately 5–10 percent of patients in the Phase 3 studies self-reported this medical history, and there was no significant difference in [success] rates among these groups.”

Stigma

But OTPs are still concerned about patients not being able to afford the medication, especially if they pick up on the OHSU language.

For example, the Virginia Medicaid formulary states that patients “must be evaluated for current history of substance abuse and alcohol with validated screening instruments” in order to get Sovaldi. “The prescriber can submit clinical rationale for treatment continuation, for positive tests that are false positives and not thought to be due to a relapse in alcohol or substance abuse,” according to the formulary.

New York has a generous Medicaid benefit, but some states don’t even pay for OTP treatment, much less HCV treatment. “That’s the tragedy of our system,” said Litwin. “These people are going to die, and society is okay with that.”

“That’s part of the stigma, isn’t it?” said McCance-Katz. “People who receive treatment in methadone programs are not relapsing,” she said. “There’s no reason to discriminate against them.” But even if there were a relapse, that doesn’t mean the patient shouldn’t be treated for HCV, she said.

McCance-Katz added that patients in methadone treatment are being diligently monitored and therefore would be better candidates than other patients for Sovaldi. “If you are not in an OTP, they’re probably not even going to be monitoring, not even doing drug screens,” she said.

“This is something that’s killing our people,” said McCance-Katz. “I think OTPs are well-positioned to provide and to help to provide this care, and our patients deserve to have all of their issues that they bring to treatment addressed.”

Gilead has established a patient assistance program to help patients with high copays or without insurance.

For the OHSU report, go to http://www.ohsu.edu/xd/research/centers-institutes/evidence-based-policy-center/med/upload/Sofosbuvir_for_HepatitisC_FINALDRAFT_6_12_2014.pdf.

Bottom Line…

An oral drug with few side effects and a 90-percent cure rate is now available to treat hepatitis C, which is prevalent in OTP patients, who are ideally suited for this medication. The hitch: It’s too expensive.

6/23/2014 12:00 AM

It was an unusual meeting — a top legislator and a group of experts and officials sat around a horseshoe table for almost four hours on June 18 discussing possible regulatory changes to the Drug Addiction Treatment Act of 2000 (DATA 2000). The meeting, which was livestreamed, gave a glimpse into how a key lawmaker gets educated about a topic, while at the same time setting the course for change.

Sen. Carl Levin (D-Michigan) convened the forum along with Sen. Orrin Hatch (R-Utah). Both congressmen had also spearheaded the two laws allowing buprenorphine to be prescribed: DATA 2000, which limits physicians to 30 buprenorphine patients, and the 2006 amendment, which allows physicians to treat up to 100 patients after the first year of treating 30. The group was preselected to be in favor of buprenorphine expansion, with the exception of federal officials, who outlined pros and cons.

It was an unusual meeting — a top legislator and a group of experts and officials sat around a horseshoe table for almost four hours on June 18 discussing possible regulatory changes to the Drug Addiction Treatment Act of 2000 (DATA 2000). The meeting, which was livestreamed, gave a glimpse into how a key lawmaker gets educated about a topic, while at the same time setting the course for change.

Sen. Carl Levin (D-Michigan) convened the forum along with Sen. Orrin Hatch (R-Utah). Both congressmen had also spearheaded the two laws allowing buprenorphine to be prescribed: DATA 2000, which limits physicians to 30 buprenorphine patients, and the 2006 amendment, which allows physicians to treat up to 100 patients after the first year of treating 30. The group was preselected to be in favor of buprenorphine expansion, with the exception of federal officials, who outlined pros and cons and focused on diversion and other consequences caused by lack of adequate care, including drug tests and counseling, for patients.

Senator Levin opened the meeting by saying there were too few doctors certified to prescribe buprenorphine and stressed that the current opioid addiction problem makes it important to remove as many barriers to treatment as possible.

The forum was only about buprenorphine, and the witnesses had been told to prepare their opening remarks accordingly. The participants included Michael Botticelli, acting director of the White House Office of National Drug Control Policy (ONDCP); Nora Volkow, M.D., director of the National Institute on Drug Abuse; H. Westley Clark, M.D., director of the Center for Substance Abuse Treatment at the Substance Abuse and Mental Health Services Administration (SAMHSA); Elinore McCance-Katz, M.D., chief medical officer of SAMHSA; Colleen LaBelle, program director with the office-based opioid treatment with buprenorphine program at Boston University Medical Center; Andrew Kolodny, medical director of the Phoenix House Foundation and president of Physicians for Responsible Opioid Prescribing; John Kitzmiller, M.D., a certified buprenorphine prescriber from Senator Levin’s home state of Michigan; and R. Corey Waller, M.D., a buprenorphine prescriber and founder of the Center for Integrative Medicine at Spectrum Health in Grand Rapids, Michigan, who was also representing the American Society of Addiction Medicine (ASAM). There were also buprenorphine patients who spoke.

After the prepared remarks, Senator Levin and the participants engaged in a colloquy that revealed some of the forces behind buprenorphine expansion, and the concerns about what will happen if in fact the “floodgates are opened,” as Botticelli put it.

Waivered physicians

Under the Harrison Narcotics Act of 1914, physicians are not allowed to prescribe narcotics to treat addiction, which is why opioid treatment programs (OTPs) — methadone is an opioid agonist — are so tightly regulated, allowing only dispensing and only under strict federal and state regulations. The 1914 law is also why DATA 2000 was needed, to allow buprenorphine — also an agonist — to be used in the treatment of opioid addiction. Under DATA 2000, physicians must receive eight hours of training to be “waivered” from the Harrison Narcotics Act, which is enforced by the Drug Enforcement Administration (DEA), and then they can prescribe Schedule III, IV or V controlled substances to treat addiction. Buprenorphine is Schedule III and is only indicated for addiction in this country. Methadone is Schedule II but can be prescribed for pain by any physician with a DEA license.

One theme that emerged was that there are barriers to treating buprenorphine even among the physicians who have been waivered. McCance-Katz said that the main barrier is a “lack of implementation tools.” After meeting with the Health Resources and Services Administration (HRSA) and the ONDCP, SAMHSA concluded that physicians need to understand the induction process better, need training for office staff on how to work with patients with addiction, and need more detailed information on documentation and billing for buprenorphine treatment.

“Only a small number of physicians are electing to use medication-assisted treatment,” said Botticelli. There are more than 25,000 waivered physicians, of whom about 2,500 are allowed to treat up to 100. But most of the 20,000 aren’t treating anybody.

SAMHSA’s role

Prior to DATA 2000, the only treatment for opioid addiction was in methadone programs and the only office-based treatment was with naltrexone, said Clark. DATA 2000 made it possible for patients to get treatment “in the privacy of a physician’s office,” and SAMHSA certifies the physicians who prescribe it, as well as certifying OTPs. The Department of Health and Human Services (HHS) “is considering the need for changing the cap,” said Clark, noting that the lack of physician access in underserved areas is a problem.

What is needed, more than the lifting of the cap, is more physicians to prescribe buprenorphine, said Clark, noting that there are already 20,000 doctors who could treat up to 100, but who aren’t — they are sticking with the 30, and most of them aren’t even treating one patient.

Another theme was that of changing times, with some witnesses suggesting that the new treatment population for opioid addiction is people who got into trouble with prescription pain medication and who are better candidates for office-based treatment than for OTPs. “Before DATA 2000, people suffering from opioid addiction were disproportionately African American and Latino, from poor districts,” said Kolodny. “Nobody paid attention to them.” Now, however, he said many people get addicted to opioids by being overprescribed pain medication, and progress to injecting heroin.

Problems with expansion

Because the forum was geared toward the topic of expanding buprenorphine treatment, and the witnesses had been told to be prepared to discuss the barriers to such expansion, Senator Levin didn’t seek out comments about the problems with buprenorphine expansion, and in fact his questions and comments were all geared toward removing the barriers. But after Botticelli, Clark and Volkow explained some of the problems with unmitigated expansion, he pulled back slightly, concluding that should be undertaken but “with caution.”

In OTPs, one physician can be responsible for up to 300 patients. Senator Levin asked why the cap couldn’t be similar for buprenorphine.

At this point, Clark stepped in, reminding Senator Levin that in the process of passing DATA 2000, lawmakers were concerned about creating pill mills. “We are dealing with the issue of addiction, not simply a medication,” he said. “The risk of diversion, or of comorbidity with benzodiazepines, could go up,” he said. “While the system has tolerated the modest diversion that has occurred because of access issues, once that lack of access disappears and diversion goes up, then you have the backlash.”

LaBelle said that there are serious problems with getting rid of limits. Physicians with a lot of patients may become pill mills, and then get shut down, so there are hundreds of patients whose source of medication is cut off. “We have many places we can send patients so they don’t go into withdrawal,” said LaBelle.

“The concept of backlash by opening up the floodgates is not theoretical,” said Botticelli. “As buprenorphine expands, there’s been a backlash, even with the 100-patient limit,” he said, noting that even now states are imposing restrictions on buprenorphine.

Senator Levin, who seemed to equate OTPs with buprenorphine despite there being a strict regulatory system for OTPs, asked if there was a backlash against methadone too, and Botticelli said there isn’t because it’s already “so heavily regulated.” But the physicians prescribing buprenorphine have no such regulations, and may indeed only be handing out prescriptions. “What is the physician support?” asked Botticelli. “Are they doing urine testing, are they doing pill counts, are they ensuring patients are getting access to other behavioral therapies?”

Lack of access

Volkow said that 95 percent of buprenorphine diversion is due to lack of access to the medication — that people are buying it on the street to forestall withdrawal. Whether the same could be said for other opioids bought on the street is unclear. The implication is that if these users could have access to buprenorphine, the diversion wouldn’t happen. Only 5 percent is due to patients seeking euphoria.

Diversion of buprenorphine isn’t being used recreationally by people who are opioid-naïve, said Kolodny, who thinks buprenorphine should be more available.

But when Kolodny said that it’s difficult to overdose on buprenorphine, Volkow stepped in to correct him. The situation in Europe, where buprenorphine is used for pain, has proven that buprenorphine combined with benzodiazepines does result in overdoses, she said. Then, Senator Levin asked why buprenorphine can’t be used for pain, and Volkow described another way in which buprenorphine can cause overdose — it’s so slow-acting that when the pain doesn’t go away after the first pill, the patient may take another, and another. “The dose accumulates and it can result in overdose,” she said.

Other issues

The use of nurse practitioners (NPs) to increase buprenorphine prescribers was also discussed. Senator Levin asked if it made sense that nurse practitioners can prescribe opioids for pain but can’t prescribe buprenorphine for addiction. “No, it does not make sense,” said Kolodny. McCance-Katz noted that NPs can’t prescribe buprenorphine but can perform other addiction treatment functions.

The DEA works in conjunction with SAMHSA on certifying physicians, but Kolodny wants to eliminate the DEA visit to buprenorphine doctors, which he says discourages new physicians from signing up.

Waller said that his addiction patients are “treated terribly” in the general medical system, and he thinks that this shows the stigma and discrimination among physicians that is another barrier.

In fact, the physicians who treat 100 seem to be the ones who focus on addiction — which was not necessarily the way the system was set up. “So at 30 you’re not an addiction doctor but at 100 you are?” asked Senator Levin.

Patients prefer to go to the 100-cap physicians, because these are the doctors most enlightened about addiction. Asked how patients know whether a physician has 100 instead of 30 patients, Waller said that “it’s the word on the street.” Because buprenorphine combined with naloxone can’t be started until the patient is in withdrawal, induction is something that physicians familiar with addiction are more comfortable handling.

He noted that he stays in the high 90s in terms of patients but has primary care physicians that he hands stable patients over to so he can keep taking new patients.

Regulatory fix

Senator Levin asked whether there was authority to increase the patient limit, so that he and Senator Hatch did not have to go the legislative route. “We believe the secretary [of HHS] through regulatory exercise may be able to increase the limit,” said Clark, telling Senator Levin that “we are briefing her as we speak, and we will let you know.”

Waller said that ASAM would take on Senator Levin’s questions about what the hurdles are in insurance to buprenorphine.

Training

Senator Levin also asked whether it was possible for the SAMHSA website to indicate what physicians are prescribing buprenorphine, or who have openings available for patients. But McCance-Katz said physicians don’t want their names published — they don’t want to deal with the annoyance of phone calls.

“We would need staff and funds for that because the list would need to be maintained,” added Clark.

There was also a discussion about training not being more available, with Kolodny complaining that any doctor who wants to get trained should be able to get it for free. In fact, SAMHSA offers free training through its Physician Clinical Support System (PCSS), and two of the groups named in DATA 2000 don’t charge for training. The other groups, including ASAM, do charge, however, and Clark said that in at least one case, the revenue from these trainings is significant. Physicians must belong to the medical society that is providing the training.

Still, training is only $200. “That’s an impediment?” asked Senator Levin, incredulously. “A lot of doctors won’t do it,” said Kolodny. McCance-Katz noted that SAMHSA gets no money from the trainings, but that groups that provide them under DATA 2000 can charge if they want.

Clark said the problem is not the cost of the training, it’s the fact that doctors aren’t interested in treating addiction. “The issue is whether I want to be bothered with the patients,” he said. They don’t mind paying for the junkets they go to for Continuing Medical Education (CME), he said. Physicians have “no problem paying to take the family to an event for CMEs and spend the afternoon on the golf course,” he said. “But if I don’t want to be bothered with the patients, then two hundred dollars for eight hours of training is prohibitive.”

Kolodny criticized President Obama for not speaking about the issue of opioid deaths, and Senator Levin said the issue was a good one for Mrs. Obama to take on.

Stay tuned.

For the forum, which is now on YouTube, go to https://www.youtube.com/watch?v=dXpFFwC-nZQ.

From the Field
6/30/2014 12:00 AM

Marijuana is a potent drug. My personal experiences with marijuana — occasional recreational use during graduate school — were relatively benign. A few times I had experiences I found distinctly unpleasant. Usually I found that marijuana made me feel slow, heavy, dull and sedate. And because I am a person who is predisposed to the seduction of altered states, I generally enjoyed those feelings. But I found that mixing alcohol and marijuana tended to make those unpleasant experiences more likely. And because I greatly preferred the effects produced by alcohol to those produced by marijuana — and because I was uncomfortable with the illegality of marijuana — I almost always forsook smoking for drinking.

In sobriety, I have had the opportunity to see a very different side of marijuana from the privileged, private-university world I inhabited when I indulged. In the rooms of Alcoholics Anonymous, it is very common that the stories I hear involve both drugs and alcohol. While I consider myself to be fairly exclusively an alcoholic and not a drug addict, I have no illusions about the nature of my disease: I enjoy treating discomfort with mind-altering substances. Though alcohol is my preference, I have also used marijuana and benzodiazepines. That’s not uncommon at all, nor is using cocaine, heroin, methamphetamine, or any number of prescription drugs.

The effects of chronic marijuana use that I have seen are not particularly dissimilar in their manifestations from the effects of chronic alcohol use. Not in terms of how they affect a person’s body, perhaps, but in terms of how they affect a person’s life — increasing isolation from mainstream society, ruptures in relationships and families, unemployment, legal consequences, despair, suffering and misery — problems that are routinely relieved when the abuser commits to abstinence and a program of recovery.

I also see what we in AA call “The Marijuana Maintenance Program.” Many of us come to realize that we have a problem with alcohol and need to stop imbibing. But we are unwilling or unable to face the things in ourselves that are necessary to face in order to recover. And so we turn to a drug that we believe is less harmful, or more manageable. This is no different from deciding that liquor is too dangerous so we try to switch to beer. There is occasionally a brief period of respite, but our addiction will not remit until we abandon all of our artificial anesthesias and examine the underlying causes of our affliction.

As a member of Alcoholics Anonymous — I do not, of course, speak for that organization — I take no position on the legalization of marijuana for recreational use. As a scientist, I do believe that the medical value of the cannabis plant should be studied as we study any other plant and given appropriate opportunities to relieve human morbidity and suffering as is possible. Simply because some people abuse it, we should not discard it as a source of medicines. And there is significant evidence that medicines derived from marijuana, or marijuana itself, may be beneficial for a variety of conditions. A recent article in the British Medical Journal (Farrell M et al., Should doctors prescribe cannabinoids? BMJ 2014;348:g2737) neatly capsulizes the evidence and counter-evidence for marijuana as a medical intervention for a variety of conditions.

Medical marijuana is, of course, also obviously a capillary-action attempt to open the door to recreational marijuana, and it has been successful in Washington and Colorado. The joke I’ve heard over and over again from such advocates is “I need medical marijuana because I get depressed when I run out of pot.” From the pragmatic perspective of someone who is primarily interested in addicts and alcoholics having a path to recovery, and the opportunity to reclaim lost lives, I am not certain that whether marijuana, or even alcohol, is legal or not matters much to me. Humans will use and abuse mind-altering substances. Some will become dependent. Of those, a few will seek recovery.

There are enormous societal investments and consequences associated with the control and enforcement of marijuana as a banned substance, and it may be worth investigating whether legalization would have a net positive or net negative impact on things like crime, poverty and social disparities. I don’t pretend to know the answer. What I know is that marijuana abuse and dependence are real and troublesome problems, but recovery from them is entirely feasible. I have seen it countless times.

From the field
12/20/2012 12:00 AM
Advocates call for mental health treatment, gun control in wake of tragedy in Newtown.

(Editor’s note: On December 14, 20 elementary school students and six school teachers and administrators were shot and killed by a troubled young man, Adam Lanza, who also killed his mother and himself.)

Now is the time for the substance use and mental health community to act together to help end the violence and self-mutilation we as a nation encourage. The victims, their families and all of our children and communities must be comforted. Substance use and mental health clinicians are often at the forefront helping in the aftermath of these too frequent massacres.

We can resolve to change this social environment of destruction. Below is a letter from the behavioral health community to President Obama, congressional leadership, members of Congress and state government officials. Will you sign on? Will you send this or your own letter to your member of Congress, governor or state legislator? Will you help recruit others — people in recovery, families caring for a loved one struggling with substance use or mental illness, counselors and leaders of behavioral health programs — to send letters and call their congressional delegations, governors and state legislators?

As people touched by the tragedies in Connecticut, Arizona, Colorado and too many other communities, as people who are touched by the destruction of untreated alcohol, drug and mental health problems, we must act together to end these killings.

We must all be part of the solution — by showing the faces, voices and resolve of people affected by mental illness and addiction to end this violence and repair our communities. Mental health and substance use are not the causes of the violence, but we can help with solutions.

Dear Mr. President, Mr. Speaker and Members of Congress:

As people who have direct, lived experience with mental illness and addiction, as family members caring for our loved ones with these illnesses, as counselors and healthcare workers and as leaders of behavioral health programs, we all call on you, the leaders of our nation, to begin with us a road to recovery from these tragedies. We grieve for the innocents murdered in Newtown. These are our children, our neighbors, our families, our friends. There can be no greater tragedy in a society than losing its young, its own future, so needlessly and so senselessly. Such actions strike at the very heart of who we are and who we hope to become.

So we must grieve. We grieve for the families who lost their children, for the families of their teachers who were killed, for the entire Newtown community and for America itself. Yet, we owe them all much, much more than just our tears. They also deserve our action to identify and implement solutions.

To begin our recovery, we recommend that you provide federal assistance to:

  • Immediately double the capacity of public mental health and substance abuse programs. Funding for community mental health and substance use treatment services has been cut dramatically. As a result, only a third of those with moderate mental illness and two-thirds of those with severe illness ever receive any care. Families simply cannot get badly needed care. The Affordable Care Act must be implemented fully, and mental health and substance use care must be fully integrated into good medical care.
  • Immediately implement school- and community-based programs to promote mental health, to prevent mental illness and substance abuse and to provide early interventions for those exhibiting these conditions. Prevention and early intervention strategies can strengthen children’s mental health and resiliency, prevent or lessen the burden of illness and help them and their families to recover from trauma. Further, teachers must be taught how to identify troubled children and to guide them into effective supports before these children get into trouble.
  • Immediately begin teaching students at all levels to recognize the signs of mental illness and addiction, and to seek help when needed. Few young people get even a single hour of education about mental illness or addiction, its signs or its treatment. We can’t expect people to step forward or to seek help for a family member when we don’t even provide them the rudimentary tools to do so. We must begin to do so.
  • Immediately ban assault rifles and large-capacity clips. Possession of these weapons is a fundamental public health problem. They are designed for the battlefield, not our closets. They are used to kill people senselessly and needlessly. In Newtown, an assault weapon was used to kill 20 young children just starting their lives and six of their heroic teachers. Enough!

Yes, we must grieve for the innocents, just as we grieved recently for those lost in Tucson, Aurora and Portland. But this time, our grieving must have a direction and purpose to galvanize action. As people who know firsthand the tragedies of mental illness and addiction, and the triumphs that are possible, we all call on you to take immediate action.

Our nation expects nothing less of all of us.

From the Field
10/1/2012 12:00 AM

We have seen a recent uptick in one-sided reporting by media outlets that are either misinformed about the successes and difficult challenges of the treatment field, have no interest in balanced reporting on these important issues or are using old and outdated information. CRC Health Group, in particular, the nation’s largest provider of behavioral health and addiction treatment services, has been the subject of a disproportionate number of these reports. And while this increased attention on addiction and treatment would be welcome if it were to raise awareness about this devastating disease, the unfortunate reality is that these media inquiries are spurred by our nation’s upcoming presidential election, CRC’s exaggerated connection with one of the candidates and the continued stigmatization of addicts and treatment.

We have seen a recent uptick in one-sided reporting by media outlets that are either misinformed about the successes and difficult challenges of the treatment field, have no interest in balanced reporting on these important issues or are using old and outdated information. CRC Health Group, in particular, the nation’s largest provider of behavioral health and addiction treatment services, has been the subject of a disproportionate number of these reports. And while this increased focus on addiction and treatment would be welcome if it were to raise awareness about this devastating disease, the unfortunate reality is that these media inquiries are spurred by our nation’s upcoming presidential election, an exaggeration of CRC’s connection with one of the candidates and the continued stigmatization of addicts and treatment.

Some recent media articles have attempted to politicize what CRC does and have accused CRC of “putting profits ahead of patients.” This is just not true. The truth is, having for-profit, investor-owned treatment centers is a positive thing for our country. Unlike many nonprofits or single-owned facilities, we have the geographic breadth and financial stability that enable us to continue to provide these necessary services, even in challenging economic times. As a result of our structure and access to capital, our programs are more insulated from state and local budget cuts or economic downturns. Our structure also allows us to invest significant dollars on patient quality, even when the general economic environment is stagnant.

Some journalists have chosen to focus on anecdotal — and dated — reports of incidents in our facilities and falsely extrapolate to a conclusion of declining quality. But the reality is that the addiction treatment field is increasingly dealing with more medically complex and highly compromised patients. While very unfortunate, incidents do happen within this field of healthcare, one that treats a population of people who are at the ends of their ropes, in the depths of their despair: troubled teens, patients with alcohol and drug abuse addiction, co-occurring mental health and drug and alcohol issues, sometimes suicidal, most in denial, and many untruthful to themselves, their families and us about preexisting medical and mental health conditions.

Some media have chosen to focus their criticism on incidents that occur outside of our facilities, when patients, under the supervision of doctors, take their methadone or buprenorphine home for administration of doses, despite the safeguards that we put in place such as lockboxes and patient accountability checks and contracts. Our mission is to help these individuals, but sadly, we cannot report 100 percent success. No treatment provider can.

The media often fails to mention that the overwhelming number of patients do experience significant success. Journalists rarely interview any of the number of referrals provided by CRC who have positive experiences. Instead, the articles rely extensively on “survivor” organizations that criticize youth treatment or drug and alcohol programs across the board, critics with no firsthand knowledge of the events they purport to describe, and the selective republication of erroneous information from earlier media articles.

It is a fact that treatment organizations are prohibited by law from discussing specific cases or patient care, while other sources and family members making allegations have no such restraints. The occasional article that does mention such privacy regulations does so in a way that implies that treatment providers hide behind this language so as not to have to publicly discuss patient incidents. In actuality, these regulations are to protect our clients, every individual who enters our doors to get the treatment they so desperately need, who can take some comfort in this time of great distress knowing that their confidentiality is assured and trusting that it will never be revoked.

Several journalists who have written about CRC and treatment began their reporting with biased perspectives, specifically soliciting only critics of treatment programs to be sources.

CRC treats 30,000 people every day, yet this is just the tip of the iceberg when considering this nation’s treatment gap of people who need but do not receive treatment is over 20 million. We need more, not fewer, treatment options. When the media criticizes one provider because that sells newspapers or increases web hits, ignoring all of the positive aspects of treatment and lambasting our outcomes research, they are perpetuating the stigmatization, condemnation and discrimination of the entire treatment industry, with likely ramifications on millions of lives.

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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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