Legitimately prescribed drugs can be stolen from a medicine cabinet a few at a time, usually without notice. From the Iowa Governor's Office of Drug Control Policy.

Legitimately prescribed drugs can be stolen from a medicine cabinet a few at a time, usually without notice. From the Iowa Governor’s Office of Drug Control Policy.

Opioids are widely available as prescription drugs for pain: hydrocodone (e.g., Vicodin), oxycodone (e.g., OxyContin, Percocet), morphine (e.g., Kadian, Avinza), and codeine. Heroin, which has no medically approved use, is also an opioid. Unfortunately, opioids are also widely abused.

How enticing it is to imagine a magic bullet for opioid drug addiction. Addiction causes huge social problems. Yet it is hard to treat and suffers from a stigma that does not attach to other chronic diseases, like diabetes. Drugs like naltrexone, methadone and buprenorphine, as well as behavioral therapies, are common opioid addiction treatments, although the relapse rate for addiction treatment is high.

One of the barriers to treatment is the addict’s fear of the side effects of withdrawal, which can be extremely uncomfortable, including nausea, cramping and vomiting. It is no wonder, then, that the opioid addict and his family would be drawn to a detoxification procedure advertised as both rapid, to speed up the initiation of relapse-prevention therapy, and relatively painless: anesthesia-assisted rapid opioid detox (AAROD), sometimes called ultra-rapid detox, or even just plain rapid detox, although the latter also refers to detox under lighter sedation.

Several clinics in the U.S. offer AAROD, claiming it is safe and effective. A more sober analysis by responsible medical authorities doesn’t agree. In fact, AAROD can be extremely dangerous and appears to be universally rejected by experts who actually waited to see what they evidence would say before coming to a decision.

The overwhelming evidence against AAROD

Concerns about the procedure were published in the medical literature as early as 1997. As reported in JAMA, clinics were advertising AAROD as virtually painless opiate detoxification achieved in hours rather than days or weeks, even though

many addiction experts say that until claims of superior relapse rates for the ultrarapid detoxification methods are proven and concerns about the potential risks are allayed, the procedure should be considered experimental.

A Cochrane Review, in 2001, concluded that managing withdrawal by administration of opioid antagonists under anesthesia should be regarded as “experimental with both risks and benefits remaining uncertain.”

The California Society of Addiction Medicine was asked by an insurance company to evaluate AAROD. (Their report is undated, but appears to have been issued between 2001 and 2006). Their conclusion:

Until its safety and efficacy have been proven, and the procedure has been standardized, AAROD should only be used under research conditions . . . Two components of this procedure, precipitated withdrawal and anesthesia, are known to have risks that are not present in the more commonly used detoxification and withdrawal treatments. Any benefits of the procedure have not yet been shown to be worth these added risks.

“Precipitated withdrawal” refers to reports from clinicians that patients doing well in drug treatment had been targeted by AAROD clinics. They went through the procedure, lured by the idea that they could go to sleep and “wake up clean,” yet subsequently relapsed.

Based on the available evidence, the American Society of Addiction Medicine issued a policy statement in 2005, finding AAROD “not supportable until a clearly positive risk-benefit relationship can be demonstrated.” (Oddly, the procedure was approved, under certain conditions, by the ASAM as late as 2000, according to a Los Angeles Times story, even though it had not been adequately studied at that point.)

In 2006, two reports were published in the medical literature that should have sealed AAROD’s fate. A Cochrane Review updated previous Reviews (2001 and 2002). This time it said, flat out, that

Given that the adverse events are potentially life-threatening, the value of antagonist-induced withdrawal under heavy sedation or anaesthesia is not supported. The high cost of anaesthesia-based approaches, both in monetary terms and use of scarce intensive care resources, suggest that this form of treatment should not be pursued.

Researchers at Columbia University Medical Center’s Clinical Research Center conducted a randomized clinical trial (blinding wasn’t possible), funded by the National Institute of Drug Abuse (NIDA), comparing AAROD for heroin detox with traditional detox approaches. The researchers concluded, as reported in JAMA, that AAROD patients suffer withdrawal symptoms as severe as those of patients treated with traditional methods. Post-detox treatment outcomes were no better for AAROD.

Three patients receiving AAROD suffered serious adverse events related preexisting medical conditions the patients failed to disclose to researchers. This gave rise to a concern that AAROD patients would conceal medical conditions that might disqualify them for treatment due to the allure of painless, yet effective, detox.

After the study was released, Dr. Ivan Montoya of NIDA’s Division of Pharmacotherapies and Medical Consequences of Drug Abuse, concluded:

We now have several rigorous studies indicating that anesthesia-assisted detox— a costly and risky approach—offers no advantage over other methods.

Even if you weren’t convinced in 2006, warnings about AAROD continued to pile on. The U.K.’s National Institute for Healthcare and Excellence 2007 Guidelines warned against AAROD as well. Yet another Cochrane Review, in 2010, reached the same conclusion as in 2006.

Based on a serious adverse event rate of 9.3% at one New York City clinic offering AAROD, in 2012, the New York State Department of Health, the New York Office of Alcoholism and Substance Abuse Services, and New York City Department of Health and Mental Hygiene jointly issued a Health Alert informing New York health-care providers of AAROD-associated serious adverse events and recommending that they avoid use of AAROD in favor of evidence-based options for opioid dependence treatment. All adverse events required hospitalization and there were two deaths. There is no standardized AAROD procedure, but that used by the clinic was consistent with AAROD offered at other clinics: general anesthesia with intubation continued for a median duration of 8.3 hours, and the median time for administration of the opioid antagonist was 3.9 hours.

This, in turn, resulted in a CDC Morbidity and Mortality Weekly Report (September 27, 2013) warning that AAROD should be avoided.

So, as early as 1997 there were concerns in the medical literature. By 2006, the evidence was clear that AAROD carried serious risks and offered no benefit over other methods. As of 2015, the jury is in: don’t use AAROD. In fact, it is hard to imagine who else might be left to come out against it.

Evidence v. money

But never let the evidence get in the way of making money. Several clinics around the country still offer it.

For example, Houston Rapid Detox, in Texas, administers naltrexone while the patient is under anesthesia lasting 4-6 hours. The results? According to their website:

Once patients wake up, they are no longer physically dependent on opiates and they are unaware of the withdrawal that occurred during the procedure.

Although the website mentions complications at “other” clinics, they say this was due to improper procedure. While they say that “thousands” have benefitted, no research is cited in support of their claims for the safety and efficacy of their services. They even claim that traditional drug addiction treatment is itself unscientific and that they are among the few who understand addiction’s true nature. Again, they offer no research to support their allegedly novel theories. The website, as far as I can tell, doesn’t even say who is on the medical staff.

Midwest Rapid Opiate Detoxification Specialists, in Illinois (there is an affiliated center in Dallas as well), makes similar claims of safety and efficacy, without citing any supporting evidence. (Testimonials , yes; evidence, no.) It is as if the information discussed above doesn’t exist.

Anesthesia Assisted Rapid Opiate Detoxification (AAROD) is a safe and effective method to rapidly detoxify the body at the receptor level of active opiates. AAROD detoxifies the body of active opiates in 6 hours or less under the medical care of an anesthesiologist and skilled nurses. The AAROD procedure is safely conducted in a clinically equipped medical/surgical area by staff trained and experienced in the AAROD procedure.

This claim – that offering AAROD in a properly staffed and equipped facility is safe – is common among AAROD clinics. It may be true that it is safer, but that doesn’t mean it is safe and doesn’t address effectiveness. The 2006 JAMA study employed AAROD in a “safe” facility, but it made no difference in the study’s recommendations.

Interestingly, Midwest claims that:

Our ASAM (American Society of Addiction Medicine) trained physicians are directly involved in the individual care of each patient.

They either don’t realize, or don’t want to admit, that ASAM’s own policy statement advises against the use of AAROD.

A Beverly Hills rapid detox facility uses the “Waismann Method,” which is

a pioneering opiate treatment based on a safe and proven protocol that utilizes the most advanced medical techniques available.

Again, no research is cited. I did find Dr. Waismann, who has treatment centers in Israel and Switzerland, and his claims that his

ANR Method (Accelerated Neuroregulation) reverses both the opiate dependency and its symptoms. ANR reverses dependency on Heroin, Methadone, Suboxone, Subutex, and prescription opiate medications using an effective, safe, and humane treatment.

I cannot find anything in PubMed about him or his treatment and he doesn’t help me out by citing any research.

My state, Florida, has, or maybe had, an AAROD clinic as well. In fact, it was through an article about Dr. Rick Sponaugle, of Florida Detox and Wellness in the Cleveland Plain Dealer that I first heard of AAROD. Unlike the Plain Dealer’s more thorough article, Dr. Spanaugle was the subject of some credulous media coverage, including a story by Anderson Cooper (sadly, featuring Dr. Sanjay Gupta’s report, which was less than satisfactory, though Dr. Gupta has somewhat redeemed himself since). Dr. Phil actually sent patients to Florida Detox. (The Plain Dealer story contains links, if you can bear it.) The clinic still offers detox, although it is not clear if he is still offering this particular procedure.

Dr. Sponaugle does, however, claim that he successfully treated Cleveland Browns’ player Bernie Kosar’s brain trauma, a service he is now offering to others, as well as treatments for “chronic Lyme disease” and “mold toxicity,” if you get my drift.

If you Google “rapid detox” you’ll find other treatment centers, but we’ll leave it at that.

Why is this even legal?

The question of whether AAROD is safe and effective is settled: it isn’t. Yet, physicians continue to offer it. How can they do this?

Part of the problem, perhaps a large part, is the way we regulate medical practice in the U.S. Each state issues medical licenses under its own terms, which vary from state to state. Generally, once a license is issued, the medical doctor doesn’t have to stop using a diagnostic procedure or treatment until the state board of medicine makes him. And for the medical board to act, someone must file a complaint against the physician. No complaint, no action against the physician’s license. A malpractice suit might result in a monetary judgment, but it won’t cause the medical board to act unless a complaint is filed, although physicians must generally report malpractice settlements or awards over a certain amount, as well as other disciplinary actions, to the board.

There is always the possibility of a ruling that results in a fine, the requirement of additional education, temporary suspension, or other sanctions that fall short of losing a license. (Two rapid detox doctors were suspended in New Jersey. One of them was also suspended in Pennsylvania and had his DEA registration revoked. He is now back in addiction medicine practice.)

Even falling below the medical standard of care isn’t always a cause for discipline. Some states have “healthcare freedom” laws that provide physicians with wiggle room when they want to offer unconventional treatments.

The current system allows physicians to engage in unproven, and sometimes dangerous, practices for too long. There needs to be a way to stop the problem before it starts. I’m not sure what that system would look like, but if you have any suggestions, please post them in the comments.

 

 

Posted by Jann Bellamy

Jann J. Bellamy is a Florida attorney and lives in Tallahassee. She is one of the founders and Board members of the Society for Science-Based Medicine (SfSBM) dedicated to providing accurate information about CAM and advocating for state and federal laws that incorporate a science-based standard for all health care practitioners. She tracks state and federal bills that would allow pseudoscience in health care for the SfSBM website.  Her posts are archived here.    

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