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Billed as an effort to combat the opioid crisis, a new Florida law requires physicians and other healthcare practitioners to endorse pseudoscience and give patients misleading information about non-opioid alternatives for the treatment of pain. It is yet another attempt at co-opting the opioid epidemic to boost so-called complementary/alternative/integrative medicine at the expense of science-based medicine.

The law imposes several requirements before a healthcare practitioner (except a pharmacist) can prescribe, order, dispense or administer a Schedule II opioid drug for pain treatment. Before we get to those requirements, it’s worth noting the first version the bill was entirely different. As originally introduced, House Bill 451 would have required the Department of Health to create a “non-opioid directive form” which patients could sign, indicating their desire not to be prescribed or administered an opioid. Any physician treating the patient could be disciplined for failing to comply with the directive. (According to one legislative analysis, similar laws have passed in several states.) The Florida Medical Association (FMA) objected and worked with the bill’s sponsor to completely revise the bill. While their concerns about disciplinary action are understandable, the version that passed is, in my view, a worse result for evidence-based medicine and good patient care.

This new law adds to the already substantial statutory and regulatory control of controlled substance prescribing in Florida. However, unlike the rest of Florida’s statute to which the new requirements were added [as Sec. 456.44(7)], it does not exempt cancer pain, terminal conditions, palliative care or certain traumatic injuries.

As of July 1, 2019, before prescribing, ordering, dispensing, or administering a Schedule II opioid drug for the treatment of pain, a physician or other healthcare provider must (except in the provision of emergency care):

Inform the patient of non-opioid alternatives for pain treatment, which may include, non-opioid drugs, interventional procedures, acupuncture, chiropractic treatments, massage therapy, physical therapy, occupational therapy, or any other appropriate therapy as determined by the health care practitioner. Discuss the advantages and disadvantages of non-opioid alternatives. Provide the patient with an educational pamphlet published by the Department of Health. Document the non-opioid alternatives considered in the patient’s record.

Interestingly, as originally drafted, this new version did not mention chiropractic, acupuncture, or massage therapy. They were added later, a legislative staff analysis citing two documents in support of their inclusion. One, the CDC’s “Nonopioid Treatments for Chronic Pain“, does not actually mention any of these treatments. The second, The Joint Commission’s “Non-pharmacologic and non-opioid solutions for pain management”, relies on the recommendations of the American College of Physicians for acupuncture and massage therapy for acute and chronic low back pain, all based on low quality evidence. The Joint Commission also recommends spinal manipulative therapy, based on one systematic review and meta-analysis and one Cochrane Review, neither of which was exactly a ringing endorsement. “Chiropractic treatments” are not mentioned and, of course, chiropractors are not the exclusive providers of spinal manipulation.

In any event, physicians need not discuss options that are inappropriate for the patient, either because they just don’t apply to the patient’s condition or they are not evidence-based. Unfortunately, the same discretion is not available to physicians in complying with the rest of the law.

The Department of Health (DOH) was directed to create a pamphlet on its website “regarding the nonopioid alternatives for the treatment of pain”, including, at a minimum, information on available non-opioid treatments and the advantages and disadvantages of using them. The physician must provide patients with this pamphlet before prescribing/ordering/administering opioids. The law is unclear on whether the patient has to be given the pamphlet at each administration, resulting in multiple pamphlets being handed to, for example, the same hospital patient prescribed a Schedule II opioid every 6 hours post-surgery. (The FMA has requested guidance from the Florida Board of Medicine on the issue.)

The content of the DOH’s pamphlet is unobjectionable in many respects. It urges patients to work with their healthcare providers in deciding on the best course of treatment for pain and talk about the advantages and disadvantages of all options. It warns that some options may not be covered by insurance and may be ineffective for severe pain. It lists cold and heat, exercise, OTC meds, physical and occupational therapy, and behavioral interventions, among others, as treatment options. Unfortunately, the pamphlet’s recommendations also includes chiropractic, acupuncture, and massage therapy.

I’ll leave to others a discussion of whether physicians and other prescribers need to be second-guessed by legislators in their attempt at what one critic has described as “opiophobia”. My particular problem with the new law is that, by mandating the distribution of this pamphlet, healthcare providers are forced to essentially endorse treatments with, at best, questionable evidence of safety and effectiveness. At worst, they are forced to endorse pseudoscience administered by Florida-licensed healthcare providers whose practices will subject patients to quack remedies. Ironically, the authority to treat patients with pseudoscience was bestowed on these licensed providers by the very Legislature that is so keen to protect patients from evidence-based practitioners. That is not to say that physicians and others have not overprescribed opioids or that some corrective action is unnecessary. But pseudoscience is not the solution; it is, in fact, a problem the Legislature itself created and is doing nothing to stop.

Chiropractic, acupuncture, and massage

With that, we’ll turn to a discussion of the three problematic recommendations.

From the DOH pamphlet:

Chiropractic: Chiropractic physicians practice a hands-on approach to treat pain including manual, mechanical, electrical and natural methods, and nutrition guidance. Can help with pain management and improve general health. Aching or soreness in the spinal joints or muscles sometimes happens—usually within the first few hours after treatment.

But here’s how Florida law defines the “practice of chiropractic”:

a noncombative principle and practice consisting of the science, philosophy, and art of the adjustment, manipulation, and treatment of the human body in which vertebral subluxations and other malpositioned articulations and structures that are interfering with the normal generation, transmission, and expression of nerve impulse between the brain, organs, and tissue cells of the body, thereby causing disease, are adjusted, manipulated, or treated, thus restoring the normal flow of nerve impulse which produces normal function and consequent health by chiropractic physicians using specific chiropractic adjustment or manipulation techniques . . .

This is nonsense, of course; pseudoscientific gobbledygook, invented by an uneducated “magnetic healer” in the late 19th century and dutifully incorporated into Florida law by the Legislature. There is no such thing as the chiropractic “subluxation”. Consequently, it cannot interfere with “nerve impulse” or “cause disease”, nor can it be “adjusted” to “restore normal flow of nerve impulse” and “consequent health.”

Some chiropractors, such as now-retired Florida D.C. Sam Homola (a guest contributor here at SBM ) do limit themselves to evidence-based treatment of musculoskeletal conditions with spinal manipulation. On Chirobase, Dr. Homola gives advice on how to locate a good chiropractor, but also admits “it’s not easy to find a good, properly-limited chiropractor” and warns that

“Straight” chiropractors use only spinal adjustments to treat the gamut of human illness. They are dedicated to locating and correcting (imaginary) vertebral “subluxations,” which they find in everyone’s spine. “Mixer” chiropractors offer manipulation with other methods, including such bogus methods as homeopathy, megavitamins, colon irrigation, and acupuncture. Both types might attempt to treat organic ailments—one using only spinal adjustments and the other using spinal manipulation along with vitamins, etc. Both might recommend “maintenance therapy” to prevent the development of “subluxations.”

“Chiropractic”, an ambiguous term that encompasses the entire spectrum described by Dr. Homola (for an overview, see here and here), has been the subject of numerous posts here on SBM describing, among other things, their many unsubstantiated claims in preventing or treating diseases and conditions such as ADHD, bedwetting, ear infections, colic, SIDS, concussions, reflux, autism, Alzheimer’s, Tourette’s, cancer, asthma and allergies, as well as the dangers of chiropractic treatment, including stroke, the use of unvalidated diagnostic testing, and opposition to vaccination. We have also discussed their aggressive efforts to promote themselves as primary care physicians, even to the point of creating the ersatz “specialty” of “chiropractic internist”.

Unfortunately, the physician who is forced by law to provide his or her patient with the incomplete and misleadingly benign description of chiropractic will appear to have endorsed chiropractic practices unless they take the time out of an already burdened schedule to disclaim the pamphlet’s contents. Whether the state can constitutionally mandate a physician to communicate information he or she feels is not truthful is a question we’ll return to in a moment.

Again, from the DOH pamphlet:

Acupuncture: Acupuncturists insert thin needles into the body to stimulate specific points to relieve pain and promote healing. Can help ease some types of chronic pain: low-back, neck and knee pain, and osteoarthritis pain. Can reduce the frequency of tension headaches. Bleeding, bruising and soreness may occur at insertion sites.

Where to begin? First, “acupuncture” is an imprecise term. What kind of “acupuncture”? By the reckoning of (sadly) former SBM blogger Dr. Mark Crislip there are

over 30 different types of acupuncture with many different modes of operation and fantasy explanations for their claimed effectiveness.

Second, the traditional Chinese medicine concepts on which acupuncture is based are pseudoscience. There are no meridians, no “qi” and “specific points”, i.e., “acupuncture points”, do not exist. Third, the evidence simply does not support the conclusion that acupuncture “can ease some types of chronic pain.” In fact,

Acupuncture is a theatrical placebo.

Specifically, there is insufficient evidence to unqualifiedly recommend acupuncture’s effectiveness for low-back, neck (also here), knee pain, osteoarthritis pain (also here), and tension-type headaches, especially when prior probability is considered.

Fourth, the side effects of acupuncture are not limited to “bleeding, bruising and soreness” as this overview of systematic reviews (available at the time DOH composed the pamphlet) concludes:

Minor and serious AEs [adverse events] can occur during the use of acupuncture and related modalities, contrary to the common impression that acupuncture is harmless. Serious AEs are rare, but need significant attention as mortality can be associated with them.

There are three provider choices for acupuncture treatments in Florida: a licensed acupuncturist, a physician providing “medical acupuncture”, and chiropractors, who can be eliminated from consideration based on our previous discussion.

The licensed acupuncturist’s scope of practice in Florida should give any healthcare practitioner pause:

“Acupuncture” means a form of primary health care, based on traditional Chinese medical concepts and modern oriental medical techniques, that employs acupuncture diagnosis and treatment, as well as adjunctive therapies and diagnostic techniques, for the promotion, maintenance, and restoration of health and the prevention of disease. Acupuncture shall include, but not be limited to, the insertion of acupuncture needles and the application of moxibustion to specific areas of the human body and the use of electroacupuncture, Qi Gong, oriental massage, herbal therapy, dietary guidelines, and other adjunctive therapies, as defined by board rule. [Emphasis and link added.]

Acupuncturists can also practice “Oriental medicine”, defined by Florida law as:

the use of acupuncture, electroacupuncture, Qi Gong, oriental massage, herbal therapy, dietary guidelines, and other adjunctive therapies.

The Florida Board of Acupuncture, through rulemaking, has expansively interpreted the scope of practice to include, among other diagnostic methods and treatments: auricular, hand, nose, face, foot and/or scalp acupuncture, moxibustion, cupping, [unspecified] thermal methods, magnets, gua-sha scraping techniques, reflexology, tongue diagnosis, five element correspondence, German electro acupuncture, Kirlian photography, and homeopathic remedies.

Query whether one would want to put one’s patient in the hands of someone who can employ, without limitation as to disease or condition, such a vast array of pseudoscience and quackery. Further caution may be warranted when one is made aware that acupuncturists graduate from acupuncture and Oriental medicine schools that do not require a college degree, an admissions test, or a minimum GPA for admission.

“Medical acupuncture” is, according to the American Academy of Medical Acupuncture, practiced solely by MDs and DOs, who choose treatments “based on traditional principles such as encouraging the flow of qi”, or “modern concepts such as recruiting neuroanatomical activities in segmental distributions, or a combination of these two principles.”

I have no idea what “recruiting neuroanatomical activities in segmental distributions” means. The “traditional principles” are based on pseudoscience, which undermines any notion that “medical acupuncture” is evidence-based. And, in fact, it took only a few minutes on the internet to find evidence contradicting the Academy’s claims of acupuncture’s effectiveness for a number of conditions, including insomnia, asthma, arthritis (also here and here), IBS, dysmenorrhea and pelvic pain, abdominal distension/flatulence, and persistent hiccups.

Finally, briefly,

Massage therapy: Massage therapists manually manipulate muscle, connective tissue, tendons and ligaments. Can relieve pain by relaxing painful muscles, tendons and joints. Can relieve stress and anxiety—possibly slowing pain messages to and from the brain. At certain points during a massage, there may be some discomfort— especially during deep tissue massage.

Like acupuncture, massage therapy is a non-specific term and the evidence for effectiveness of massage for pain is actually quite limited. (See also here.)

However one feels about massage therapy, health care practitioners forced to hand out the DOH pamphlet should be aware that, in addition to traditional massage, massage therapists push a number of unproven and frankly fantastical treatments like reflexology, pranic healing, cranial-sacral therapy, zero balancing, reiki, and polarity therapy, making claims of effectiveness that go beyond relief from musculoskeletal pain.

Constitutional?

While an extended legal analysis is beyond the scope of this post, I question the constitutionality of the new law in that it essentially forces physicians to endorse medical advice with which they may disagree, either on grounds of the lack of evidence for its safety and efficacy, or on the grounds that a particular type of health care providers’ practice is so infused with pseudoscience that it would be irresponsible to recommend it, whether or not there is evidence of safety and efficacy of any particular treatment.

For example, on Tuesday, a federal judge blocked North Dakota from enforcing a new law requiring physicians to inform patients it may be possible to reverse a drug-induced abortion. The judge ruled that the requirement violated the doctors’ First Amendment protections against compelled speech. Noting that the American College of Obstetricians and Gynecologists had rejected the law’s claims about “reversal” treatments as unsupported by evidence, the judge stated

State legislatures should not be mandating unproven medical treatments, or requiring physicians to provide patients with misleading and inaccurate information.

(You can find further discussion of the First Amendment and compelled speech by a constitutional law scholar here.)

The State of Florida has gotten in trouble with this sort of thing before when it tried to interfere with physicians’ discussions of gun safety with patients. (Covered here prior to the most recent decision by the 11th Circuit en banc, which overturned previous decisions upholding the law.) Physicians and their fellow healthcare providers who oppose being forced to give their patients ill-conceived state-mandated medical advice should bring the issue up with their professional associations and regulatory boards.