Important Meeting In Tennessee!

Educated and informed people have an opportunity to make an impact on the life expectancies of opioid addicts in Eastern Tennessee!

The Tennessee Health Services and Development Agency is holding a fact-finding public hearing, regarding the certificate of need application for a methadone treatment facility, proposed to be located in Johnson City, Tennessee.

This meeting will be held on May 28th, 5pm, in the Jones Meeting Center, Johnson City Public Library, on 100 West Millard Street in Johnson City, Tennessee.

There’s a desperate need for medication-assisted treatment of opioid addiction in that part of Tennessee. Opioid addicts can get treatment in office-based Suboxone practices now, but as discussed in previous entries on this blog, this can be an expensive treatment. Many addicts don’t have insurance to pay for this treatment, which is then out of financial reach. For other addicts, buprenorphine, being a partial opioid, isn’t strong enough. Methadone can work beautifully for patients who don’t do well on buprenorphine (known to most as Suboxone or Subutex). However, there are no methadone treatment programs in Eastern Tennessee, so a clinic in that area is desperately needed. The nearest in-state clinic is in Knoxville.

People who know methadone works and saves lives need to go to this meeting to be heard. I suspect there will be people there who know next to nothing about methadone who are nonetheless opposed to a clinic. We’ve all met them: people adamantly opposed to methadone even though their brains are uncomplicated with any actual knowledge of methadone. And there will the NIMBYs, the not-in-my-backyard people.

Citizens who know there are scientific studies showing that methadone is an evidence-based treatment shown to save lives need to go and be heard. Tell other people at the meeting about the forty years’ of studies consistently showing that methadone maintenance reduces overdose death rates, improves overall physical and mental health, increases rates of employment, reduces the risk of suicide, dramatically reduces criminal activities of opioid addicts (by a whopping 91%), and reduces the rates of new cases of HIV.

It’s hard to imagine the certificate of need could be denied, but remember attempts to locate a methadone treatment center in Eastern Tennessee have tried – and failed – ten times before. Let’s hope science and reason can win over ignorance and prejudice.

If, like me, you can’t make the meeting, please send a letter to:

Tennessee Health Services and Development Agency
Melanie M. Hill, Executive Director
Frost Building, 3rd floor
161 Rosa Parks Boulevard
Nashville, TN 37243

The State of Denial (Tennessee) gets Another Chance

If you read my blog, you know Tennessee is a frequent target of my ire. I’ve been aghast and distressed at Tennessee’s refusal to allow an opioid treatment program to open in the Eastern part of that state. Hopefully, that’s about to change.

Now a new opioid treatment program has applied for a certificate of need with Tennessee’s Department of Mental Health and Substance Abuse Services, asking for permission to locate a methadone clinic in Eastern Tennessee. Sources say this is the eleventh attempt to locate an opioid treatment program that prescribes methadone in that part of Tennessee. In 2002, approval was given but then withdrawn due to a technicality.

Even if the certificate of need is approved, this company faces stiff opposition from the modern-day equivalent of villagers with pitchforks, demanding that no treatment center be located near them. This is the ugly face of modern day NIMBYism, and it violates the American with Disabilities Act, a topic of a past blog. (See November 14, 2012) It’s illegal, and past federal court rulings have sent a clear message to towns that violated the ADA in this way, with high six-figure fines.

I’m surprised anyone wants to put a new clinic in Tennessee, given its recently passed anti-evidence-based regulations on methadone clinics, but I’m pleased. Eastern Tennessee probably has more untreated opioids addicts per acre than anywhere else in the nation. Tennessee has the 13th highest opioid overdose deaths per capita, compared to all other states, and is ranked number two in the kilogram of opioids prescribed per capita. [1]

Yet it has only a small number of opioid treatment programs. The nearest methadone clinic to Eastern Tennessee is located in Knoxville, and in bordering states. These states treat the opioid addicts Tennessee is neglecting. The certificate of need submitted by the petitioning opioid treatment program says that around one thousand opioid addicts are now traveling one or two hundred miles round trip each day for treatment. You know there are thousands more getting no treatment at all.

The state will make a decision about the certificate of need request this summer. Of course, any educated interpretation of data would conclude that the certificate of need should be approved forthwith. As I said, you can’t throw a rock in Eastern Tennessee without hitting an opioid addict. But so many people don’t know anything about the benefits of methadone.

Lack of knowledge about methadone does not prevent people in positions of authority from taking a strong stance against it. For example, this is a quote in the Johnson City Press from Roger Nave, committee chairman of the public safety committee of the county where Johnson City is located: “We have top-class medical facilities in this area to deal with any problem that our citizens have. The addicts do need help and support, but methadone is not the answer to their problems.”

Does Mr. Nave actually know any facts about methadone?? Does Mr. Nave know that the treatment of opioid addiction with methadone is one of the most strongly evidence-based medical treatments in all of medicine? Does he know that we have over forty years’ of studies that show the treatment of opioid addiction with methadone reduces overdose death rates and suicide rates? Does he know it improves employment rates and dramatically reduces crime rates? Does he know addicts treated with methadone have better physical and mental health? Does he know that for each dollar spent on methadone treatment, taxpayers save four dollars, mostly in reduced incarceration costs? Does he know that methadone treatment of opioid addiction significantly reduces the incidence of HIV in intravenous opioid addicts? [2,3,4]

Eastern Tennessee now has Suboxone providers, and these doctors have likely saved hundreds of lives. Buprenorphine is a great medication, and I prefer prescribing it rather than methadone because of its better safety record. It works on the same principle as methadone: both are long-acting opioids that can be dosed once daily to keep opioid addicts from having withdrawal or craving, thus freeing them to focus on changing their lives.

But buprenorphine is not strong enough for all opioid addicts. It doesn’t work for all opioid addicts. In fact, no treatment works for all opioid addicts, even medication-assisted treatment with buprenorphine and methadone. Some are too sick for these medications, and some aren’t sick enough.

Suboxone programs are too expensive for many addicts. Yesterday I called three programs in Tennessee to get an idea of their prices. A month’s worth of treatment is around $400, including doctors’ visits, group and individual counseling, and drug tests. The medication is not included in this cost, and can cost an additional $240 to $900 per month, depending on the dose of medication. Opioid addicts without health insurance can’t afford that kind of treatment. Methadone programs usually cost $9-$11 per day, and addicts can pay as they go.

At least one big Suboxone program in Johnson City doesn’t do maintenance treatment, but only a few months of detox, despite more studies showing greater benefit with longer treatment. Some addicts are forced to come off Suboxone before they are ready, a recipe for relapse.

Suboxone is a valuable option for opioid addicts, but let’s make all forms of evidence-based treatment available for opioid addicts. Why not let addiction specialist doctors decide which treatment is appropriate, rather than government officials without any medical training?

With so many untreated opioid addicts in Eastern Tennessee, all forms of evidence-based treatments need to be available. At present, health officials in Tennessee push patients into medication –free treatments. These can work, if patients are given long enough treatment and if they can afford it. In my experience, inpatient programs in Eastern Tennessee seem to keep patients for two or three weeks, instead of two or three months. This is understandable, since Medicaid isn’t known for generous reimbursement, and private insurance rarely pays for longer treatments. Patients with no insurance at all are often asked to bring money up front to pay for treatment. Asking an addict to bring a few thousand dollars with them to start inpatient treatment doesn’t work, for obvious reasons. Even treated patients are sent back home to the same living situation, and relapse quickly. Using inpatient detox alone for five to seven days has always given relapse rates of 92%, with most relapsing within the first week.

Tennessee state officials have a chance to save lives, if only they can put aside their personal biases and look at the science supporting medication-assisted treatments. It’s the right thing to do. It’s a bargain, too. Patients are mostly self-pay, so it doesn’t cost taxpayers anything. Even from a purely economic view, methadone treatment would save taxpayers money.

If you support medical treatment of opioid addiction with evidence-based therapies, please write to the state and let them know. If you are an addict who has been helped by methadone, send a letter to the below address. If you are a family member who has seen the benefits of methadone treatment in your loved one, tell the people in government. This is the time to act. Don’t let this opportunity to slip by. Send your letter to:

Tennessee Health Services and Development Agency
Melanie M. Hill, Executive Director
Frost Building, 3rd Floor
161 Rosa L. Parks Boulevard
Nashville, TN 37243

1.http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6043a4.htm?s_cid=mm6043a4_w
2.http://international.drugabuse.gov/sites/default/files/pdf/methadoneresearchwebguide.pdf
3.California Department of Drug and Alcohol Programs, 2004, California drug and alcohol treatment assessment (CALDATA) California Department of Alcohol and Drug Programs. California Drug and Alcohol Treatment Assessment (CALDATA), 1991-1993 [Computer File]. ICPSR02295-v2. Ann Arbor, MI: Inter-university Consortium for Political and Social Research [distributor], 2008-10-07. doi:10.3886/ICPSR02295
4.http://www.asam.org/docs/publicy-policy-statements/1methadone-rev-10-061.pdf?sfvrsn=0#search=”methadone

Good News for Opioid Addicts: Reckitt’s Requests Rejected by the FDA

This week’s issue of Alcohol and Drug Abuse Weekly ran a front page article about the FDA’s recent ruling on Reckitt Benckiser’s requests. Reckitt, the manufacturer of buprenorphine (Suboxone and Subutex), had submitted a Citizen’s Petition to the FDA, asking them to refuse to approve any form of buprenorphine that didn’t have additional child-resistant safety measures.

Last year, Reckitt said they were taking the tablet form off the market because of increased risk for pediatric exposure with tablets as compared to the newer film form of Suboxone. Cynics (like me) said this was an attempt to hide profit motives behind claims of concern for children. The film is still under patent, while the patent for the tablet form had already expired. This Citizen’s Petition was felt by some (like me) to be an additional smokescreen, invented to prevent the release of a generic competitor.

In their ruling at the end of February of this year, the FDA said the scientific and regulatory concerns raised by Reckitt’s petition weren’t valid. They said there was no proof of Reckitt’s claim that the unit-dose packaging of the film reduced pediatric exposures. The FDA noted that the new REMS (Risk Evaluation and Mitigation Strategy), put in place for buprenorphine and other opioids, could have caused the decline in pediatric exposures. The FDA has also made efforts to educate physicians about overdose potential in children. The FDA also pointed out that many drugs dangerous to children are packaged in bottles, rather than unit –dose packaging. Also, the FDA pointed out that Reckitt received the pediatric overdose information two years before they announced they would voluntarily stop making the tablets due to pediatric overdose concern. This delay undermined their claim of making the change for patient safety.

The FDA criticized Reckitt for making these safety claims, yet still selling the tablets. In fact, the FDA has asked the Federal Trade Commission, the FTC, to investigate the United Kingdom-based Reckitt-Benckiser for possible anticompetitive business practices.

I admired Reckitt Benckiser when they first released Suboxone. At last, a drug company was willing to take a chance on manufacturing a medication to treat addiction. Since drug addicts often don’t have insurance or money, this is not usually a lucrative market. They took a financial risk. They funded, or helped to fund, many of the training programs doctors needed to get licensed to prescribe Suboxone. Reckitt provided free treatment for a few indigent patients per doctor with their Here to Help program. They provided telephone support to addicts entering Suboxone treatment, at no cost, though few addicts used this benefit.

But over the last few years, Reckitt Benckiser has lost credibility with me. I feel they’ve become heavy-handed, and have pressured doctors to prescribe only the films, saying it’s less likely to be sold on the black market and less likely to be misused than the tablets. That may be true, but some patients don’t like the film, and would leave treatment if it’s the only available medication. And many addicts have written in to this blog, claiming to be able to dilute and inject the films more easily than the tablets. At the same time, the prices of the Suboxone tablets skyrocketed, in an attempt to force patients to switch to films. Reckitt of course also discouraged doctors from prescribing the less expensive generic monoproduct buprenorphine, which costs less than half of the name brand manufactured by Reckitt.

Then there was that whole pediatric overdose issue. After that, my opinion of Reckitt fell. They lost credibility with me.

The two drug companies that make the generic form of Suboxone say their tablets should be available in pharmacies within a month. Actavis, based in New Jersey, is the third largest manufacturer of generic medications. The other manufacturer, Amnel Pharmaceutical, is also based in New Jersey and is the 7th largest generic manufacturer. Amnel’s press release describes their tablet as being cheaper than Suboxone, with a “pleasant orange flavor.”

I can’t wait to see how much these generics will cost. I’d expect them to be a little more expensive than the generic monoproduct buprenorphine. In my area, that generic sells for around three to four dollars per pill, less than half what the name brand Suboxone costs now.

The release of these two generics will likely mean more patients will be able to afford addiction treatment. The more affordable treatment becomes, the more patients will take advantage of help for their addiction.

Huzzah for the FDA! This was a good decision.

Medical Care in Opioid Treatment Programs: Red Tape

At recent meetings of OTP medical directors in my state, we’ve had renewed discussions about how to provide primary care and psychiatric care to program patients.

Opioid treatment centers that are able to offer a wider array of services than just dosing with methadone show better patient retention in treatment and better patient outcomes. This means that the more services that are added, like psychiatric care, primary medical care, help with employment, and family counseling services, patients in those programs have better outcomes than patients in programs that offer only medication and individual counseling. This shouldn’t be a surprise; it makes sense to me. (1)

The problem is, of course, these extra services cost more to the treatment program. If you want to offer psychiatric services, a psychiatrist must be hired, usually on a contract basis, to be available during dosing hours. If the program’s medical director is a psychiatrist, that doctor has to be paid for the extra time it takes to provide the extra care. More commonly, patients are referred to other places for low-cost psychiatric help.

It’s the same with medical care. In order to offer any level of primary care, you have to hire a doctor, unless patients are asked to pay extra for this. Most patients can barely afford basic treatment, so extra expenses can’t be obtained.

At both of the programs where I work, I used to offer some level of primary and psychiatric care. I used to try to treat uncomplicated mental illness like depression and anxiety disorders, and non-chronic, low-intensity primary care illnesses. Of course I referred patients who needed ongoing medical or psychiatric care, but was able to provide them some level of care until they got an appointment, or were able to afford an appointment. I already knew their history of addiction and didn’t prescribe anything that would interact with methadone or buprenorphine, of course. It didn’t cost the patient anything to see me for these extra services, so it saved patients money. I saw six or seven such patients each time I worked at the clinic, and they didn’t necessarily need any appointment. It seems like a good thing all around.

But then came time for us to have our first CARF survey in one program.

Treatment centers want to be certified by the Commission of the Accreditation of Rehabilitation Facilities (CARF). CARF personnel are invited to facilities for a voluntary inspection. These OTPs hope to be given a sort of seal of approval by this agency. The CARF agency inspects mental health, substance abuse treatment, and physical rehabilitation facilities, as well as youth and family service facilities. Accreditation is important because it demonstrates the facility is providing good care.

Our CARF survey went fair in most regards. We got a one-year accreditation, and the CARF surveyors had good things to say about our clinic regarding our dedication to our mission to help our patients. They said great things about the staff enthusiasm and outlook. But they did not like how I was providing primary physical and mental healthcare. The CARF people supported the idea of providing primary care to patients, but they had many recommendations about how to do it. They wanted implementation of a few policies and procedures. This is what they recommended, verbatim:

F.2.a.(1) through F.2.b.(16)
It is recommended that ongoing documented training and education on medications be provided to the person served, family members, individuals identified by the person served, the team, and service providers. This ongoing training should include how the medication works; risks associated with each medicine; the intended benefits as related to the behavior or symptom targeted by the medication; side effects, contraindications, and potential implications between medications and diet/exercise; risks associated with pregnancy; the importance of taking medications as prescribed, including, when applicable, the identification of potential obstacles to adherence; the need for laboratory monitoring; the rationale for each medication; early signs of relapse related to medication efficacy; signs of nonadherence to medication prescriptions, including alcohol, tobacco, caffeine, illicit drugs, and alternative medications; instructions on self-administration, when applicable; wellness management and recovery planning; and the availability of financial supports and resources to assist the persons served with handling the cost associated with medications.

F.a.(1) through F.4.c.(3)
It is recommended that, when medications are prescribed for or provided to a person served (including those self-administered medications), an up-to-date individual record of all medications, including nonprescription and non-psychoactive medications, include the name of the medication; the dosage; the frequency; instructions for use, including the method/route of administration; and the prescribing professional. The program should provide ready access to the telephone number of a poison control center to the program personnel and the person served. Written procedures that address how the medication will be integrated into the overall plan of the person served should be available. There should be a process for identifying, responding to, documenting, and reporting medication reactions and actions to be followed in case of emergencies related to the use of medication.

F.5.a.through F.5.n.
It is recommended that, as the organization prescribes medications, it implement written procedures that include compliance with all applicable local, state or provincial and federal laws and regulations pertaining to medications and controlled substances, including on-site pharmacy services and dispensing. Written procedures should include the active involvement of the persons served, when able, or their parents or guardians, when appropriate, in making decisions related to the use of medications; the availability of a physician, pharmacist, or qualified professional licensed to prescribe for consultation 24 hours a day, 7 days a week; documentation and reporting of observed and/or reported medication reactions and medication errors; and a review of past medication use, including effectiveness, side effects, and allergies or adverse reactions. Written procedures should include the identification of alcohol, tobacco, and other drug use; use of over-the-counter medications; use of medications by women of childbearing age; use of medications during pregnancy; special dietary needs and restrictions associated with medication use; necessary laboratory studies, tests, or other procedures, when applicable; documented assessment of abnormal involuntary movements at the initiation of treatment and every six months thereafter for persons served receiving typical antipsychotic medications; when possible, coordination with the physician(s) providing primary care needs; and review of medication use activities, including medication errors and drug reactions, as part of the quality monitoring and improvement system.

F.6.a. through F.6.f.
If the organization provides prescribing of medications, it is recommended that it implement written procedures that include screening for common medical co-morbidities using evidence- or consensus-based protocols; evaluation of co-existing medical conditions for potential medications impact; identifying potential drug interactions, including the use of over the counter or homeopathic supplements; documentation or confirmation of informed consent for each medication prescribed, when possible; continuing a prescribed medication if a generic medication is not available; and continuity of medication use, when identified as a need in a transition plan for a person served.

F.7.a.through F.7.b.(2)
It is recommended that, as an organization that provides prescribing of medications, it demonstrate, to the extent possible, the use of treatment guidelines and protocols to promote state-of-the-art prescribing and ensure the safety of the person served. It is also recommended that a program of medication utilization evaluation include measures of effectiveness and satisfaction of the person served.

F.8.a. through F.8.e.(2)
As an organization that provides prescribing of medications, a documented peer review should be conducted at least annually on a representative sample of records of persons for whom prescriptions were provided in order to assess the appropriateness of each medication as determined by the needs and preferences of each person served and the efficacy of the medication. It should be used to determine if the presence of side effects, unusual effects, and contraindications were identified and addressed and if necessary tests were conducted and used to identify the use of multiple simultaneous medications and medication interactions.

F.9.a. through F.9.c.
It is recommended that information collected from the peer review process be reported to applicable staff, used to improve the quality of the services provided, and incorporated into the organization’s performance improvement system.

Huh?
I was overwhelmed. I’m a relatively intelligent person, but I’m still fuzzy on exactly what they mean. Here are some of my concerns:
-I already record a full history and physical on each patient, and have a record of all medications each patient takes. But apparently the way I’m doing this isn’t adequate, and I’m left to wonder what the specifics of their recommendations would look like.
-Get a signed informed consent in order for me to write a prescription? This is not generally done in primary care. Maybe if I were administering chemotherapy…but I was prescribing things like penicillin for an infected tooth. I’m not sure what the justification for this is in a methadone clinic population.
-Apparently I need to give each patient a written summary of all side effects of a prescribed medication. I don’t do this in primary care, because the pharmacy does all of that. Each time a prescription is filled, they give a long sheet of possible side effects. What’s the rationale for redundancy?

When faced with the task of complying with all of these recommendations, the owners of this clinic said forget it. They told me to prescribe only the methadone and buprenorphine, and when I saw other medical problems, provide a referral to doctors in the community. That way, the opioid treatment center won’t be penalized by CARF for not implementing…well, the byzantine recommendations above. I still don’t know exactly what CARF meant. Maybe I should say I don’t know what their recommendations would look like in real life.

Not providing any primary care took pressure off of me, but our patients were left with less medical care than they already have, which is little. It’s really hard to “coordinate care” for patients who have no insurance and no money. Yes, I know there are free clinics available in many areas, but they only provide a limited amount of care and follow-up. And specialty care is unattainable.

At our next CARF survey a year later, our program got good marks from CARF, and a three-year accreditation, instead of only one year. Without requirements around primary care to meet, it was simple.

CARF does a needed service, but in many matters I think it’s important to pull back to see the whole picture. Plus, drop the jargon and use words that make sense, please. It’s similar to the paperwork requirements for Medicaid – most of this paperwork is probably needed in some form or fashion, but I’ve seen the repetition. Leave counselors time to counsel.

Regulations are important. But don’t make the regulations so obscure and onerous that most clinics stop providing any extra care because of the difficulty meeting these requirements.

I’d love to see my state’s methadone authority work with the CARF organization. Maybe together they could issue new guidelines for primary care in opioid treatment programs that make sense. Then programs may be more likely to offer extra services.

(1) McLellan AT, Arndt IO, Metzger DS, Woody GE, O’Brien CP. The effects of psychosocial services in substance abuse treatment. JAMA 1993;269(15):1953-59

FDA Favors More Restrictions on Hydrocodone

Last week, a panel of experts at the Food and Drug Administration voted in favor of new regulations on prescription pain pills containing hydrocodone. Hydrocodone is the active ingredient in name brand opioid pain relievers like Vicodin and Lortab, which contain mixtures of hydrocodone and acetaminophen. These preparations of hydrocodone are presently Schedule III controlled substances.

Any potentially addicting drug is given a Schedule designation from I through V. Schedule I reserved for drugs with little medical use and very high abuse potential, Schedule II for medications with medical uses but high addicting potential, and so on, down to level V, reserved for medications with slight risk for addiction but with medical uses.

At present, regulations for Schedule II medications like Opana and methadone are more stringent than for Schedule III medications like Vicodin and Lortab. Schedule III medications can be written with refills if the physician decides this is necessary and prudent. Schedule III medications can be called in by telephone, while Schedule II can’t be called in by a physician or anyone else, and even the written prescriptions can’t be refilled. A new prescription must be written by the doctor if a Schedule II pain medication is to be continued.

The New York Times article didn’t explain whether the FDA aims to recommend a change in the schedule designation of hydrocodone, or if new regulations will be put in place in some other way. This matters a great deal, since in some states, only physicians can write for Schedule II medications, and nurse practitioners and physician assistants can’t prescribe them at all.

Any reader of my blog knows I’m in favor of more cautious prescribing of opioids by all providers, because loose prescribing habits are one causative factor in our present epidemic mess of opioid addiction. However, we can over-react to the crisis, to the point of making it unreasonably difficult for patients with acute pain to get reasonable care.

In states where physician extenders like nurse practitioners and physician assistants aren’t allowed to prescribe Schedule II medications, the outcome could be dire. Some communities rely on these providers because there are few physicians in the area. This new decision could make it very difficult to get appropriate pain medication for even short-term use in rural areas with few physicians.

There are dozens of medical situations when it’s handy to be able to call in a refill of hydrocodone when pain extends longer than expected. If refills can’t be called in, doctors and dentists may actually decide to prescribe more pills at a time, knowing they won’t have the luxury of calling in a few more pills.

The New York Times article mentioned nursing home patients as one group who could be adversely affected by the new recommended changes. Many are frail, and unable to travel back and forth to a doctor’s office to get a new prescription each time one is needed for a chronic pain condition. In some areas, doctors come to see the patients at the nursing home facility, though not in all facilities. Home-bound patients with chronic pain would be required to travel to doctors’ offices.

Hydrocodone is the number-one prescribed opioid in our country, and certainly many pain pill addicts have used it illicitly. But by the time addicts come to me for treatment, it’s rare for hydrocodone to be only opioid being abused. Most of the addicts I admit to treatment say they may have started with hydrocodone, but switched to more powerful opioids at some point in their addiction. Perhaps hydrocodone is more of a “gateway” opioid for these addicts.

Restricting access to hydrocodone will likely reduce addiction, because studies do show that decreased access to drugs (including alcohol) decreases the number of people who become addicted. But let’s not overlook the hardships over-regulation may cause to patients with acute pain.

It will be interesting to see what happens if/when these new recommendations take effect.

Kafkaesque

Quackery

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Once again, Tennessee’s Department of Mental Health and Substance Abuse Services has managed to bitch slap science in the face.

Yesterday I asked a knowledgeable friend what he knew about Tennessee’s final version of the Opioid Treatment Program regulations, and he sent me a file containing the final revisions. The document also records commentary and objections of various stakeholders (trendy term for, “the people who are really affected”). I read this material late last night, and went to bed feeling depressed and defeated.

This morning, I reflected on the progress of science. Particularly in the field of medicine, we’ve made great strides, largely after the advent of the scientific method of clinical trials. Before we knew how to test different treatment methods in clinical trials, medical treatment of illness in the U.S. depended on the individual doctor’s anecdotal experiences with patients, and traditional healing methods. When asked why they used leeches and bloodletting, the doctor would say “Because that’s the way we’ve always done it.” Doctors did the best they could with limited scientific data.

In the early part of the twentieth century, European scientists and research doctors began using scientific methods to determine which treatments really worked. These methods included the use of randomized trials comparing one treatment to another, and the use of statistics to analyze results. As a result, medical knowledge and practice advanced rapidly in Europe, and the U.S. medical establishment lagged far behind. U.S. medical schools and the doctors they produced began to have terrible reputations worldwide.

Appalled at the poor quality of care provided by many practicing physicians in the U.S., the Carnegie Foundation asked a group of scientists to investigate what should be recommended to bring the U.S. up to date with the rest of the world. The result of this mission was contained in the “Flexner Report,” written by Dr. Abraham Flexner.

The Flexner report was a great document. It outlined in great detail the failings of U.S. medical schools and medical establishment. At that time, 1910, many schools were for-profit affairs owned by a few physicians more interested in collecting tuition than teaching accurate material. Much of what young doctors were taught was outdated and inaccurate. The Flexner Report stated what doctors at the few good medical schools already knew: many poorly trained doctors throughout the U.S. offered so-called cures with little or no evidence to support their treatments. Citizens were not getting scientifically-based treatments then available in other parts of the world.

As a result of this report, many deficient medical education programs were shut down. Flexner recommended that only medical schools whose teachings adhered to the accepted scientific method should be allowed to remain open. Because of the Flexner report and the actions taken based on its findings, scientific method eliminated the quackery that was popular in the U.S. in the early 1900’s. The United States followed the recommendations of the Flexner Report, and now U. S. medical care and research meets or exceeds standards in other countries.

But in Tennessee, the leeches are back.

From four decades worth of research into the treatment of opioid addiction with methadone, we know what works and what doesn’t work. We have a coherent, evidence-based body of knowledge surrounding best practices for the treatment of opioid addiction with methadone. Numerous agencies have produced documents containing evidence supporting the use of methadone maintenance in the treatment for opioid addiction: National Institutes of Health, Center for Disease Control and Prevention, Institute of Medicine, National Institute of Drug Abuse, Center for Substance Abuse Treatment, and Substance Abuse and Mental Health Services Agency.

Great summaries of this data are easily available in several places: NIDA’s wonderful website at http://international.drugabuse.gov has all the answers to most questions, and references (studies done with scientific method) to support the data. SAMHSA published – for free to anyone who wishes a copy – the Treatment Improvement Protocol 43, often called “TIP 43” for short. To point out the obvious, treatment of a medical illness shouldn’t be decided by how one “feels.” about the treatment. It should – of course – be based on the best science. In response to many of the odd regulations proposed by Tennessee’s Department of Mental Health, many respectable organizations weighed in with their concerns. Usually, they cited data to back up what they claimed was the current, state-of-the-art practices for methadone maintenance treatment of opioid addiction. Groups included not only the present treatment programs currently operating in Tennessee, but also the American Association for the Treatment of Opioid Dependence (AATOD), the National Alliance for Medication-Assisted Recovery (NAMA),

To be fair, the state did acknowledge and change some of their rules on minor things. But when confronted with data that proves their regulations are not best practice, the Tennessee Department of Mental Health basically said, “We disagree.” In other words, “We don’t need no stinkin’ science to tell us how to do things! We know what’s best!”

I can’t stand to go into detail about all the ways in which Tennessee goes back into the dark ages, but here are a few of the most imprudent regulations:

• Before being allowed into methadone treatment, a new patient must have two years of physical dependence, unless they’ve had a failed abstinence-based treatment attempt and one year of physical opioid dependency.

My beef with this is: we know patients on waiting lists for methadone die at eight times the rate of patients enrolled in methadone treatment. Is Tennessee just hoping addicts will die off ? Also, has Doug Varney (head of the state methadone authority in Tennessee) ever tried getting an opioid addict with no money and no insurance into an abstinence-based Tennessee treatment program lately?

• The state methadone authority needs to be notified of patients going to doses higher than 100mg
• No patient can go over 120mg unless first given permission by the state methadoneauthority.

OK, so a non-physician is going to make a medical decision? That sounds like practicing medicine without a license to me…isn’t that a felony? Maybe it’s only a misdemeanor in Tennessee. Seriously, what qualifies a state administrator to make any decisions about the dose of any medication? They have no way to talk to the patient, no way to examine them to get clinical information. Does a pharmacist working as the head of the state’s mental health administration have the experience or knowledge, let alone the authority, to decide the doses appropriate for patients?

Even putting aside the suffering this inane rule will bring to patients, what about the legal implications for the person making these decisions at a state level? What non-doctor would be foolish enough to go on record denying a dose of medication that a doctor thought necessary? It seems like a situation ripe for a lawsuit. Consider the following scenario: patient needs dose increase because she is still having significant withdrawal. Doctor at OTP examines her, makes the clinical decision that she needs a higher dose of methadone. State office worker denies permission for the dose increase. Patient leaves treatment, frustrated that she’s still in opioid withdrawal and can’t become stable. A few weeks later, she dies from a fatal illicit opioid overdose.

Usually I eschew lawyers, since they can complicate a one-car funeral procession, but wouldn’t this be a winnable legal case for the family? But for the interference of the state office worker, the patient may not have dropped out of treatment and died from untreated opioid addiction. And what if the office worker approved the increased dose, and the patient died from a methadone overdose? Is the state, since they approved the increased dose, at risk for any bad outcome that results from the dose increase?

• With one positive urine drug screen, patients get no take homes for 30 days, and have to do mandatory weekly counseling.

I like the idea of more counseling, but weekly may be difficult for working patients, and we do want them to be able to keep their jobs, right? That is one goal of recovery, right? Besides, removing take homes after only one positive is simply punitive unless there’s imminent danger of overdose.

• With the fourth consecutive positive urine drug screen within six months, more intense counseling is mandated. Intensive outpatient and residential treatment are listed as options. And if the patient refuses these options, he will be terminated from the opioid treatment program.

I can barely stand to list all the reasons this is a miserable decision. First of all, have you ever tried to get a patient on methadone into a Tennessee Intensive Outpatient Program or residential program? All the ones I’ve dealt with say they must be off methadone before entering, so this is all very Kafkaesque.

In fact, Tennessee’s state methadone authority is Kafkaesque (“Instances in which people are overpowered by bureaucracies, often in a surreal, nightmarish milieu which evokes feelings of senselessness, disorientation, and helplessness.”) [1]

As I said, I’m depressed by the thought of how thoroughly Tennessee’s ignorance has managed – yet again- to bitch slap science in the face.

I think I’ll go back to bad.

1. Wikipedia, 10/17/2012   http://en.wikipedia.org/wiki/Franz_Kafka

The Drug Czar Praises Project Lazarus

On Wednesday, August 22, the Drug Czar came to town.

Mr. Gil Kerlikowske, the director of the ONDCP (Office of National Drug Control Policy) gave the keynote speech at the Project Lazarus Symposium held in Wilkesboro, NC.

Being a drug czar isn’t as much fun as it sounds like it might be. It means Mr. Kerlikowske works hard helping to create the drug control strategy for the nation. His agency advises the president regarding drug-control issues, and sets the tone for the nation’s approach to drug addiction and treatment. For more information see my blog of April 20^th, 2011. At the Project Lazarus Symposium in Wilkesboro, Mr. Kerlikowske gave the keynote speech and elaborated on these topics.

The Drug Czar came to Wilkesboro because of the impressive program Project Lazarus. Project Lazarus is a grass-root, non-profit organization established in 2008 in response to the very high rates of opioid overdose deaths in Wilkes County. That county had one of the highest drug overdose death rates in the entire nation, but over the last four years, those rates have dropped dramatically. For more data about these rates and about Project Lazarus, go to their website at:  http://projectlazarus.org

The ONDCP has placed more emphasis on prevention and treatment, acknowledging that law enforcement efforts alone won’t fix our nations’ problems. During his keynote address, Mr. Kerlikowske praised Project Lazarus and said it should be used as a model for communities in other states facing the same problem of overdose deaths.

Project Lazarus’ founder and CEO, Fred Brason, gave an overview of the components of the program and most recent data. Then Mr. Kerlikowske spoke for about twenty minutes, explaining the ONDCP’s vision for drug control policy. Then came a roundtable discussion where parties from various agencies and organizations explained their role with the project.

I was invited to the roundtable because I am the medical director at Mountain Health Solutions, an opioid treatment program in North Wilkesboro that prescribes both buprenorphine and methadone to treat patients with opioid addiction. This OTP is now owned by CRC Health, but was started by Dr. Elizabeth Stanton nearly three years ago, in response to the need for medication- assisted treatment in Wilkes County. At first, her program prescribed only buprenorphine, but later she saw the need for methadone for those patients for whom buprenorphine didn’t work.

I started working there relatively recently. I’ve been amazed at the number of patients presenting for treatment for pain pill addiction, nearly all of whom live in this relatively small community. At present we have more than three hundred and fifty patients enrolled in treatment.

As part of Project Lazarus, all of our patients receive a prescription for (free) naloxone kit to prevent opioid overdose deaths. I was invited to the Project Lazarus Symposium because in my blog on March 28^th, 2012, I described how a patient of our OTP clinic saved a relative’s life by using one of the kits.

At the roundtable, I said a few words about the effectiveness of medication-assisted treatment using buprenorphine and methadone, and then made a few comments about the overdose death that was prevented with the naloxone kit.

Next, during the roundtable discussion, representatives from many different organizations and locations across North Carolina described the role Project Lazarus plays in their missions. Representatives from such disparate populations as the Cherokee Nation and the military at Ft. Bragg described how they used Project Lazarus’ programs to keep patients safer. Several epidemiologists gave information about the lowered overdose death rates in Wilkes County. A local doctor explained how doctors have revised their prescribing of opioids in the Emergency Department. We also heard from several people connected with the Harm Reduction Coalition, and from the county’s sheriff.

Representatives from state organizations such as the Governor’s Institute on Substance Abuse, the North Carolina Medical Board, the NC Department of Health and Human Services, and the NC Division of Public Health, Injury and Prevention all explained how they worked with Project Lazarus. For example, a portion of Project Lazarus’ activity has been to encourage physicians to sign up for – and use – our states’ prescription monitoring program.

We heard about the Chronic Pain Initiative, a program developed with the help of Project Lazarus, which helps educate physicians about the best practices of opioid prescribing. Initially meant for Medicaid patients, the Chronic Pain Initiative is now available to help all patients.

This initiative helps reduce overdose deaths by providing physicians with, among other things, a toolkit for healthcare providers. It gives them everything from evidence-based information about safe opioid prescribing to a form that can be filled out to gain access to the NC CSRS. It contains worksheets, flow sheets, and addiction screening tools. It contains everything a doctor could want to keep patients on opioids as safe as is possible, while still making opioids available for patients who need them.

I’ve blogged about this program in the past. I knew there was more to Project Lazarus than distribution of naloxone rescue kits, but I didn’t know the full extent of the Projects activities in the state. At Wednesday’s program, I was impressed as professionals from organizations across the state explained how Project Lazarus helps them prevent, intervene, and treat opioid addiction, and reduce overdose deaths.

I was inspired with the depth of knowledge and commitment of all of these people, and by their collaborative spirit. People in all strata of the community cared enough about overdose deaths that they were trying to fix the problem before more lives are lost. These groups were cooperating, which is essential. Both Gil Kerlikowske and Fred Brason took pains to emphasize the importance of working together and not against each other.

In other words, naloxone kits aren’t enough to fix the epidemic of opioid overdose drug deaths. Law enforcement can’t arrest our way out of this problem. Prescription monitoring programs aren’t enough to stop all drug diversion. It takes the sustained efforts of people different segments of the community, working together, to get results. No one intervention is enough. That was the bottom line message I got from the Project Lazarus Symposium and the Drug Czar.

Finding a Better Way to Treat Addiction

In my previous blog, I mentioned a great new resource that CASA has published about the condition of addiction treatment in this country. The book, “Addiction Treatment: Closing the Gap between Science and Practice,” is available for free as a download at http://casacolumbia.org

I’ve been reading this document in detail, finding facts that support what I see in the real world of treatment. In the U.S., our approach toward funding of addiction treatment is exactly backwards. We spend a relatively small amount on prevention and treatment of the actual disease of addiction, but billions on the constellation of medical issues caused by addiction.

Most addiction-related medical expenses are paid for from public funds. In fact, over ten percent of all federal, state, and local government dollars are spent on risky substance use and addiction problems. Sadly, over 95% of this money is spent on the consequences of drug use and abuse. Only 2% is spent on treatment or prevention.

Untreated addiction costs mightily. People with untreated addiction incur more health care costs than nearly any other group. An estimated one third of all costs from inpatient medical treatment are related to substance abuse and addiction. Untreated addicts (I include alcohol addicts with drug addicts) go to the hospital more often, are admitted for longer than people without addiction, and require more expensive heath care than hospitalized non-addicts. The complications these people suffer could be from underlying poor physical health and lack of regular preventive healthcare, but most of the cost is incurred treating the medical problems directly caused by addiction and risky substance use.

That data is consistent with my experiences when I worked in primary care. I always felt like I was slapping Band-Aids on gaping wounds when I treated people with alcohol or other drug addictions. I never felt like I was treating the real problem, and I wasn’t, as this report so eloquently indicates. My practice had a handful of “frequent fliers” who came to the ER several times per month with the same addition- related illnesses, over and over. I admitted one patient to the hospital at least twenty times over four years for the treatment of alcoholic gastritis. Each hospital visit lasted four or five days until he was well enough to go home and drink again. Another patient was admitted about every two months after he got pancreatitis from another bout of binge drinking. This went on for years.

This was in the early 1990’s, in my former life as a doctor of Internal Medicine. I didn’t know what to do with these people. They frustrated me. Maybe I told these patients to go to Alcoholics Anonymous, and probably I asked the social worker to arrange inpatient treatment if possible. But I didn’t have the knowledge or tools to really help these people, and instead only did what I was trained to do: treat the medical problems caused by addiction.

In my Internal Medicine residency, I admitted many patients to the hospital for endocarditis (infected heart valve) contracted from IV heroin use. Each time, this required six month of intravenous antibiotics. Back then we kept such patients in the hospital the whole time. You can imagine the cost of a six week hospital stay, not that these addicts had any money to pay. Just a fraction of that amount could have paid for treatment at a methadone clinic, the most effective way to treat heroin addiction, and prevent dozens of medical problems. But I never referred them to the methadone clinic available in that city. I didn’t know anything about methadone or the medical-assisted treatment of opioid addiction, and apparently my attending physicians, responsible for my training, didn’t know about it either. It was a shame, because in those years, the late 1980’s, we were making new diagnoses of HIV almost daily among IV drug users. Since then, a study showed a patient using IV heroin drops his risk of contracting HIV by more than threefold if he enrolls in a methadone clinic.

Family members of people with untreated addiction have higher health costs, too. Families of people with addiction have 30% higher health care costs than families with no addicted member. I presume that’s from the stress of living and dealing with a loved one in active addiction. Often family members are so caught up in trying to control the chaos caused by active addiction that they don’t take time for routine health visits.

The costs of untreated addiction aren’t only financial. Addiction and risky drug use are the leading causes of preventable deaths in the U.S. Around 2.9 million people died in 2009, and well over a half million of these deaths were attributable to tobacco, alcohol, and other drugs. Overdose deaths alone have increased five-fold since 1990.

We know addiction is a chronic disease, yet we spend far less on it than other chronic diseases.

For example, the CASA report says that in the U.S., around 26 million people have diabetes, and we spend nearly 44 billion dollars per year to treat these patients. Similarly, just over 19 million have cancer, and we spend over 87 billion for treatment of that disease. In the U.S., 27 million people have heart disease, and we spend 107 billion dollars on treatment.

But when it comes to addiction, we spend only 28 billion to treat the estimated 40.3 million people with addiction, including nicotine. Most of the money we do spend is paid by public insurance. For other chronic diseases, about 56% of medical expenses are covered by private payers, meaning private insurance or self-pay. But for addiction treatment, only 21% of expenses are paid from private insurance or self-pay. This suggests that private insurance companies aren’t adequately covering the expense of addiction treatment. Indeed, patients being treated with private insurance for addiction are three to six times less likely to get specialty addiction treatment than those with public insurance such as Medicaid or Medicare.

In the U.S., we don’t treat addiction as the public health problem that it is. Some people still don’t believe it’s an illness but rather a moral failing. Doctors aren’t educated about addiction is medical school or residencies, and we often have an attitude of therapeutic nihilism, feeling that addiction treatment doesn’t work and it’s hopeless to try.

Families and medical professionals often expect addiction to behave like an acute illness. We may mistakenly think addiction should be resolved with a single treatment episode. If that episode fails, it means treatment is worthless. Families want to put their addicted loved one into a 28-day treatment program and expect them to be fixed forever when they get out. They’re disappointed and angry if their loved one relapses.

This reminds me of an elderly man I treated for high blood pressure many years ago. I gave him a month’s prescription of blood pressure medication, and when he came back, his blood pressure was good. I was pleased, and I wanted to keep him on the medication. He was angry. He said he was going to find another doctor. He thought the one prescription should have cured his high blood pressure so that he would never have to take pills again, and was disappointed with my treatment.

If we keep our same attitude toward addiction treatment, we are doomed to be as disappointed as my patient with high blood pressure. Addiction behaves like a chronic disease, with period of remission and episodes of relapse.

We have a lot of work to do. As this CASA publication shows, we have to change public attitudes with scientific information and do a much better job of training physicians and other health care providers. We should pay for evidence-based, high-quality addiction treatment, rather than spend billions on the medical problems caused by addiction as we are now doing.

Tennessee’s Vision for Mental Health

“Prejudice is a great time saver. You can form opinions without having to get the facts.”   E. B. White

You’d think I’d get tired of bashing Tennessee’s Department of Mental Health, but nope, not yet. That agency is like popcorn stuck between my teeth. It’s so annoying.

Mr. Doug Varney, the new leader of Tennessee’s Department of Mental Health, has a negative opinion of medication-assisted therapies, as I’ve discussed in prior blog entries.

Among his misconceptions, he’ made some curious statements about the for-profit status of opioid treatment programs seeking to open programs to treat Tennessee’s mass of opioid addicts.

According to the Kingsport Times-News, Mr. Varney said, “All the financial incentives are for them to keep people maintained on methadone as opposed to being drug-free,” he said. “I have a problem when I read the applications and one of the goals of the program that measures their outcome is that the person will still be coming to the clinic two years later. There’s no detox there.”  (1)

Yet as reviewed in my previous blog entry, the American Society of Addiction Medicine’s position paper on the use of methadone to treat addiction says quite the opposite, recommending …“Discontinuation of methadone maintenance should be attempted only when strongly desired by the rehabilitated patient…” and “Arbitrary caps on the number of patients who can be treated by a physician, the dosage of medication which is allowed, or the duration of treatment with methadone are not supported by medical evidence and should not be imposed by law, regulation, or health insurance practices.” (2)

ASAM is made up of physicians who specialize in treating addiction. They are the most knowledgeable doctors in the nation about addiction and treatment. For all other diseases, this would qualify them to set treatment standards.

Not in Tennessee.

In Tennessee, Mr. Varney’s personal opinions override evidence-based medical treatment. It’s a triumph of ideology over medicine, and it adversely affects opioid addicts all across Tennessee. This is something that would not be tolerated in any other field of medical care.

It sounds like Mr. Varney thinks addiction treatment facilities should be non-profit, to remove the financial motive for treatment. If so, I don’t necessarily disagree with him, but it would be an unusual position for an appointed public official to take in Tennessee, a state with a Republican governor.

Right now, medical care is a business in the U.S. I’m not particularly happy about that, and have my own opinions, but that’s the current state of affairs in this country. There’s no reason why the treatment of addiction is any different than the treatment of any other disease. For-profit companies own hospitals, doctors’ offices, x-ray facilities, nursing homes, and so on. Therefore Mr. Varney’s protestations about for-profit facilities make no sense given the realities of medical care in the U.S. today.

Besides, I’ve personally worked for one non-profit opioid treatment center, and four for-profit opioid treatment centers. The non-profit clinic didn’t give the best care of the five. At least two of the for-profit clinics gave better care, so I don’t think it necessarily helps the patients to go to a non-profit opioid treatment program, unless they have some sort of government funding. And then the care may be more affordable, not necessarily better.

Mr. Varney should be grateful for any opioid treatment program, non-profit or for-profit, willing to open a facility in his state. I can only imagine how difficult it is for the existing opioid treatment programs in that state, subjected to regulations that fly in the face of good patient care. Not to mention that every dollar these self-pay patients spend on medication-assisted treatment would save Tennessee taxpayers a minimum of $4 in expenditures, mostly in reduced incarceration expenses and reduced healthcare costs. (3)

1. http://www.mapinc.org/drugnews/v04/n1408/a02.html
2. http://www.asam.org/docs/publicy-policy-statements/1methadone-rev-10-061.pdf?sfvrsn=0#search=”methadone“
3. California Department of Drug and Alcohol Programs, 2004, California drug and alcohol treatment assessment (CALDATA) California Department of Alcohol and Drug Programs. California Drug and Alcohol Treatment Assessment (CALDATA), 1991-1993 [Computer File]. ICPSR02295-v2. Ann Arbor, MI: Inter-university Consortium for Political and Social Research [distributor], 2008-10-07. doi:10.3886/ICPSR02295

In Utah, Pain Medicine Specialists have the Highest Death-to-Prescription Rates

Of all fifty states in the U.S., Utah has the fourth highest opioid overdose death rate. In a study presented at this year’s American Academy of Pain Medicine conference, one researcher compared data from Utah’s prescription monitoring program with information regarding prescription opioid deaths in that state. She did this to discover which physician specialties have the highest death-to-opioid prescription rates. (1)

The results were somewhat surprising. Though pain medicine specialists wrote only 1% of all opioids prescribed in the state, their patients accounted for 3% of the state’s overdose deaths. Family practice physicians prescribed the highest amounts of opioids in Utah, but had half the death rates of pain medicine specialists. Other specialties with high death-to-prescription rates were anesthesiologists, physiatrists (physical medicine and rehabilitation doctors), and physician extenders (nurse practitioners and physicians’ assistants).

Specialties with the lowest risk were internal medicine doctors, orthopedic surgeons, emergency room doctors, and dentists.

Of course, pain medicine specialists correctly responded to this data by reminding us that association doesn’t prove causation. The pain medicine specialists say they care for the most complicated of patients, referred when primary care physicians feel they need expert help.

This is an important point. You have to look at the population being treated.

I’m reminded of a similar example in my region. A few years ago, a local suburban community hospital claimed that patients admitted to their hospital had the lowest complication rates of any hospital in the area. They were correct, but it was because they referred very sick patients to a nearby urban tertiary care hospital. That hospital, caring for the sickest of the sick, had a high complication rate for their inpatients. In other words, the data was accurate but still misleading, due to the marked differences in the patient population treated by each hospital.

In the same way, pain medicine experts aren’t likely to be caring for uncomplicated, easily treated patients. The tough, complicated cases will be referred to them from primary care doctors.

Pain medicine specialists also point out that dentists and primary care doctors may be prescribing for many patients with acute, short-term pain. This type of patient is likely at less risk than patients with chronic pain from serious illnesses. The amount and strength of opioids that dentists and primary care doctors prescribe is likely to be lower than the amount and strength of opioids prescribed by pain specialists. And we know that the higher the dose of opioids prescribed, the more likely the patient is to suffer an overdose death.

The author of the study acknowledged the difficulty in interpreting the data, but also said she felt this information indicated a need for education for all the state’s physicians. Adding support for her recommendation is a report released last fall that describes the results of a survey of pain medicine specialists. (2) Only 70% of these specialists answered questions correctly about opioid abuse and the FDA’s new Risk Evaluation and Mitigation Strategies. Thirteen percent say they don’t assess their pain patients for risk of opioid misuse, which is now the recommended standard of care for all patients receiving long-term opioid prescriptions.

Getting back to the Utah study: It’s important to note that even in this state with a high overdose death rate, only .475% of all opioid prescriptions were associated with fatalities

1.Drug and Alcohol Dependence News, Feb. 28, 2012, citing Porucznik C, et al, “Physician specialty and opioid prescribing in the Utah controlled substance database 2005-2009 AAPM; Abstract 201.

2. http://www.medscape.com/viewarticle/749713