Friday, October 19, 2012

Informed Consent: The Best Way to Promote Evidence-based Practice?

Yesterday, I was one of three experts participating in a new Huffington Post initiative called HuffPost Live. This one was on medications for SUDs, and it can be viewed here. What caught the attention of the producer of HuffPost Live was the Salon.com article, which was picked up from TheFix.com (thanks again to Sacha Scoblic, the author of the article.) 

It was an interesting interchange. I got pretty incensed when one of the "experts," Justin Hewitt, who runs a sober living facility in Los Angeles, said that the evidence about the effectiveness of maintenance treatment for opioid addiction was mixed, that there was evidence on both sides. I don't think I handled it especially well from a communications standpoint, since the moderator then ignored me and went on to ask about his personal "story" about recovery from addiction. I also re-learned that talking about studies seems to put people to sleep, but anecdotes carry real power (see: election, Presidential.) I think I redeemed myself at the end, adopting a more measured tone, and I was able to get the point across that most people with addiction eventually get well, a positive note that the moderater ended the program with.

But I no longer have any patience with treatment professionals who ignore the overwhelming evidence that abstinence based approaches simply do not work for most people with opioid addiction, or worse, distort the evidence. People are dying because of this every day. We lament the fact that deaths from opioid overdoses are up, and then we fail to provide easy and cheap access to live-saving treatment with Suboxone or methadone. Patients and families (and insurance companies, that is, us) spend hundreds of thousands of dollars repeatedly going through 12-step rehab, only to relapse within weeks or months after program completion. And people are dying because of this. In one study in the UK, the death rate among people discharged from methadone programs shot up as high as 8 fold in the following months. 

The program also reinforced an evolving belief of mine, that the best way to advance evidence-based treatment of addiction is to focus on the professional duty to provide full informed consent, something lacking in most treatment facilities. Addiction treatment providers are not held to the same ethical standards of other health care professionals. Justice Cordozo, in a frequently cited landmark court case, Schloendorff v. Society of New York Hospital (1914), stated that "Every human being of adult years and sound mind has the right to determine what shall be done with his own body..." Using that principle as a basis, the current obligation for providing informed consent was established by the D.C. Court of Appeals in another landmark case, Canterbury v Spence (1972). Prior to Canterbury v Spence, the standard had been physician-oriented, based on what the local standard of practice was for informing patients. This led to the common practice of failing to disclose a diagnosis of cancer to a patient, while often informing a spouse, because the physician decided it was in the patient's best interests not to know. In Canterbury v Spence, the court established the principle that a physician's obligation was to give the patient information about a proposed medical treatment, based on what a reasonable person would want to know, in order to make a fully informed decision. They also found that the "the patient's right of self-decision shapes the boundaries of the duty to reveal." Subsequent rulings in other jurisdictions have refined this to find that failure to inform the patient about risks, benefits and alternative treatments violated ethics and law even if the treatment provided was not done negligently. That is, providing competent treatment that the patient may have rejected had they been fully informed was also wrong and potential cause of action. 

So, if someone is seeking treatment for addiction, and meets a professional like Mr. Hewitt, she will be be getting a distorted and factually incorrect account of what the evidence shows, and what the relative risks and benefits of different treatments are. She will typically be told that whatever the treatment the facility provides is the most effective treatment available, and often will be instructed to discontinue more effective treatments, especially medication. That is not the basis for an informed decision, and in my view, this lack of informed consent is unethical, negligent and inexcusable. 

State agencies and the federal government are complicit in keeping the truth from the public. Out of misplaced fear of offending programs, staff and many recovering people who "do not believe in" certain evidence-based treatments, state licensing agencies allow addiction programs to offer virtually anything without regard for its basis. Some programs provide "nutritional therapy," others treat addiction with religion (not spirituality as is the case in 12-Step treatment programs, but actual specific religious practices,) while others use "equine therapy," "golf therapy," hypnosis and acupuncture. I would bet that fewer than 10% of programs or addiction therapists provide true informed consent. The Substance Abuse and Mental Health Services Administration (SAMHSA) and the National Institute on Drug Abuse (NIDA) soft-pedal their recommendations, which are supposed to be evidence-based, for the same reason. For example, their publications often say things like "Medications may also become an essential component of an ongoing treatment plan, enabling opioid-addicted persons to regain control of their health and their lives." (NIDA Topics in Brief: Medication-Assisted Treatment for Opioid Addiction, 2012; emphasis mine.) Even the term "Medication-Assisted Treatment" is designed so as not to offend the ideologues who hate the idea that "working the program" might not be enough. The term suggests that the primary treatment is counseling, but in the treatment of opioid addiction, counseling is adjunctive to the primary treatment. We don't call using insulin for diabetes medication-assisted treatment, even though counseling and behavior change are as essential to proper diabetes management as they are in addiction treatment. A correct statement is this: "The only treatment proven effective for treating established opioid addiction is maintenance on a medication such as Suboxone or methadone, often with adjunctive counseling. Studies show that maintenance treatment reduces illness, mortality and crime, and is highly cost-effective. Therefore, it is the first-line treatment and the treatment of choice. There is no evidence of effectiveness for abstinence-based treatment." 

Adults who are fully informed can make whatever decision they wish. If they want to go to a shaman, homeopath, naturopath, chiropractor, herbalist, spiritual healer or Reiki master for treatment of a medical condition, that's their business. But people who are deprived of access to unbiased information concerning the effectiveness, risk, benefits, and alternatives to treatments provided by a licensed professional or treatment program cannot make an informed decision. I'm waiting for the wrongful death lawsuit by a family whose loved-one died because he was not informed of the effectiveness of maintenance treatment of opioid addiction. The program will lose in court. Unfortunately, that may be what it takes to change the behavior of the addiction treatment industry. 

7 comments:

  1. There is reference made in this otherwise-accurate article that the 12-Step approach is spiritual, not religious. This is, of course, the claim of many advocates of this approach and reflects a decision of the founders to de-emphasize the word "religious" and assert "spiritual" instead. This fiction, however, has been exposed by 6 US Circuit Court decisions and 3 State Supreme Court decisions which concur that the program is "pervasively religious". Any unbiased reading the Twelve Steps and the Big Book would likely reach that conclusion, as well. There is nothing wrong with using a religious-based approach to a problem, per se, but one should preferably not be evasive about it so that the vulnerable people who are referred or coerced into it should be well-aware of what they are getting into and, hopefully, given alternative options if they object to the idea of religious indoctrination as part of their treatment plan.

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    1. Yes, asking God to remove your character defects is a specific religious practice, not a spiritual one. How ironic that the author failed to mention SMART Recovery which is based on a much sounder theoretical footing than "turn(ing) our will and our lives over to the care of God." People go through state-of-the-art evidence-based care after an MI only to relapse at the fast food window on the way home from the hospital, cramming so much salt and sugar into their bodies that they suffer further adverse consequences from their behavior. Do we blame the surgeon for their choices? Let's remember that those who relapse after SUD treatment are also making a choice to do something that is bad for themselves and goes against everything they (should have) learned in treatment. I agree that addiction treatment is not taking full advantage of science and that informed consent should also address the many risks associated with MAT. How about the MAT patient who is going to jail for repeatedly violating the court's order to abstain from alcohol while taking 175 mg of methadone and 80 mg of Xanax daily? That will be a nasty detox by the 5th or 6th day. Those are the people I work with and they are not good advertising for MAT. People like her are a good reason to continue to debate MAT. Thanks for the references to the court cases. This article makes some good points.

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  2. Great points, Dr W. It absolutely blows me away that we are still debating this topic. It is taking way too long to break the stigma of M-ATs and embrace the associated science. I often say that I feel fortunate to be an opiate addict in recovery, because of the scientific advances in medication for my DOC. Along those lines, how close are we to the introduction of pharmacological tools for cocaine addiction?
    Another author at thefix.com, Maia Szalavitz, wrote a great article on the subject of Methadone and buprenorphine, arguing against some of the more recent critics. It's a good read. I recently passed it along to some counselors at the methadone clinics, because I was getting asked questions like, "If someone is on Methadone, are they fit for graduate school? Should they tell their instructors?" (!?!?) To which I replied, "Would you tell your boss if you were on antidepressants? Here is the article:
    http://www.thefix.com/content/russell-brand-misguided-crusade-against-methadone-maintenance00228?page=all

    Thanks

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    1. my hat goes off to you sir. As a patient and a professionals have been making the same or worse observations not only from treatment facilities but from most social service organization. From homeless shelter to job service workforce system. Who believe they have the right to all kinds of patients information and they have the right to serve the patient the way they want to without asking the patients what they want. I am appalled and sometimes even disgusted with social service organization with no ethics in mind. Whose treatment is it anyway???. By the way I have a blog name "the Worst Treatment I ever had: crisis in substance used disorder treatment. I have been looking to who to link with. You are in my list, YOU HAVE BEEN BOOK MARKED>

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    2. After over thirty years of talking about evidence based treatment most facilities still do not have an iota of an idea of how to implement it.

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  3. Would informed consent for opioid addiction treatment include telling patients what kind of treatment opioid addicted health professionals receive and the kind of outcomes they enjoy?

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    1. Additionandrecoverynews:
      It is in each of the Code of Ethical behavior of each profession from psychology to social workers etc. The patient should be informed, not only that. The patient should be informed whether the procedure that they are going to receive is all ready establish and ordinary or whether the methodology is under experimental bases. So the patient should know whether he has a choice. But as you might have notice, most treatment facilities claim that their is no choice. The twelve steps is the only effective treatment for alcoholism and drug addiction. Which as we all know it is not true at all.

      It still irks me that the ACLU has not yet picked up a case where Miami-Dade County Office of Rehabilitation Services continue to use the 12Steps program exclusively. As their only source of treatment. In violation of the 1st Amendment of the Constitution. A government agency using public funds to promote religious indoctrination as if it was treatment. While the 12Step is not supported by scientific research.
      There is not one iota of evidence that is either effective and much less safe. In the past few years some promoters of the 12Steps have attempted to do research to confirm that the 12Steps are indeed effective. Imagen that!!, not one study has been produce by this group of individuals to "refute" whether the 12Step works at all. After all, one of the definitions of science is to "bend yourselves backwards trying to prove you most beloved hypothesis false". Thus assuring more accuracy. You do not have to be a rocket scientist to do clinical work, but you do have to be and honest and ethical scientist.

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