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 Much of what young doctors were taught was outdated and inaccurate.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.”) 
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.
- Wikipedia, 10/17/2012 http://en.wikipedia.org/wiki/Franz_Kafka