Legislative Alchemy
The companion House (HB 402) and Senate (SB 314) bills moved through the General Assembly with lightning speed, suggesting the legislative wheels were well-greased behind the scenes. The lubricant was compromise by all parties: the NDs, the Maryland Board of Physicians, and Med Chi, the state’s medical association. The result seems to be the product of the legislature giving everyone some of what they want, but no one got it all. The baby got split, and that is never good for the baby’s health.
The warhorse parade
The bills originally introduced were obviously drafted by the naturopaths. It gave them their own governing board. They would be able to perform minor office procedures, use colon hydrotherapy, dispense therapeutic devices for barrier contraception, and durable medical equipment. They could administer homeopathic remedies, nutritional “medicine,” vitamins, minerals and so forth via intradermal, subcutaneous and intravenous routes. And they could practice independently, free of any supervision by a physician. Basically, they would be primary care physicians, which is what they claim they are.
Fortunately, all of that is gone in the version that passed. Unfortunately, there is still plenty to be concerned about. We’ll get to those features in a minute.
I listened to recordings of a couple of hours of testimony before two committees, one House, one Senate. (You’re welcome.) But the groundwork for licensing was laid last year, with a report from the Maryland Board of Physicians based on “Practitioner Workgroup” meetings that included representatives from state government and medical, chiropractic, acupuncture, occupational therapy, naturopathic and “chain drug store” (go figure) organizations, a law/lobbying firm (can’t tell who they represented), and Dr. Linda Lee, the Director of the Center for Integrative Medicine at Johns Hopkins. These “stakeholders” decided to try to iron out their differences rather than duke out all the issues in front of the legislature.
During the Workgroup meetings (of which there were only 3) the Maryland Association of Naturopathic Physicians trotted out the usual naturopathic warhorses, such as (with my comments in parentheses):
- NDs are “natural medicine experts” (One cannot claim both to be an “expert” and at the same time ignore the lack of evidence of safety and effectiveness for many of the herbs and dietary supplements they recommend. And the use of homeopathy instantly disqualifies one from claiming “expertise” in anything, even the basic sciences.)
- “Many patients visit NDs who would not otherwise seek healthcare and NDs assist those patients in entering the system.” (As far as I can tell, there is zero evidence for this position.)
- NDs “search for the underlying causes of disease.” (True, to the extent diet and exercise may play a role in disease. False, if the underlying cause is something that doesn’t exist, such as “leaky gut,” “chronic yeast overgrowth,” or “adrenal fatigue.”)
- The pre-med pre-requisites for ND school are the same as applicants for med school. (Except for the small matter that there is no entrance exam for ND school, while med school applicants must take the MCAT.)
- A med school – naturopathic school “Comparative Curricula” chart showing, among other things that students at the University of Wisconsin Medical School have only 67 more hours in “clerkships and allopathic therapeutics” than ND students in the National College of Natural Medicine’s program. (As is typical, NDs completely ignore the 3-7 additional years of training medical residency requires. And we’d all love to see how they define “allopathic therapeutics” or why they combined this with clerkship hours. What’s the rationale there?)
- “Significant data exists and continues to increase” for naturopathic practice. (I’ll let one their own examples speak for itself: “Herbs (ex: ‘tumeric’ or ‘curcumin’ into [sic] PubMed) yields 5780 citations.” Query: what information is missing from this example?)
All in all, the NDs presented themselves to both the Workgroup and the legislative committees as educated and trained to the same standards as MDs and DOs, able to fill an unmet need for “health promotion, wellness, disease prevention, and disease management” which they, to the exclusion of other health care providers, could provide in a safe, evidence-based, and cost-effective manner. Their licensure would, in addition, protect the public from poorly trained naturopaths, with their “on-line degrees.” As far as I can see from their presentation to the Workgroup and at the legislative hearings, the evidence they presented in support of their claims is between none and middling. (There is a 400-plus page “compendium” they put together for the legislature. I am attempting to get a copy.)
The Board of Physicians and Med Chi objected to the proposed scope of practice for NDs but not to licensure itself. Both emphasized groups that naturopaths’ unscientific education and training renders them unqualified to diagnose, order and interpret tests, or do anything else beyond use noninvasive “natural” remedies. The Board was adamant that they did not want anything to do with supervising NDs, and who could blame them? Instead they wanted them under the jurisdiction of their own Board (which is, of course, what the NDs wanted). Another possibility they floated was a newly-created Alternative and Complementary Medicine Board, which would also have jurisdiction over chiropractors and acupuncturists, a non-starter as the chiropractors and acupuncturists weren’t about to give up their autonomous boards. Med Chi wanted NDs firmly in the sights of the physicians board, a no-compromise position necessary for their support. Both the Board and Med Chi also objected to NDs using the term “physician.”
(I did not see any mention of the fact that Section 2607 of the Affordable Care Act would prevent insurers from “discriminating” against licensed naturopaths, although apparently Health and Human Services has told insurers they do not need to include naturopaths in their networks.)
As best I can tell, there was not a single skeptical or patient protection group involved. This left opponents from other professions open to the attack that it was all about turf protection. And that is exactly what happened at subsequent legislative hearings. After the chiropractors and acupuncturists were neutralized with provisions in the bill protecting their turfs, the MDs and DOs were left to defend the citadel with pointed questions about why they were always before the Maryland General Assembly trying to limit other health care professions’ scope of practice.
By the time the legislation was drafted and made it to legislative committee hearings, the big battleground turned out to be scope of practice. And it is here that the legislators split the baby, or rather divided the baby up among the various “stakeholders,” as they like to say.
A few MDs testified or wrote letters in support of licensure (integrative medicine’s collateral damage at work), as did a few patients. One patient’s testimony was particularly telling. She has been diagnosed with smoldering myeloma and her oncologist had suggested a watchful waiting to see how things developed. If the disease progressed further, she would go on a regimen of chemotherapy, which is standard practice.
Although smoldering myeloma has a greater risk of progressing to active multiple myeloma, some patients with smoldering myeloma do not make this transition and smolder for many years. Therefore, the current International Myeloma Working Group recommendation is that smoldering myeloma should be observed off treatment outside the setting of a clinical trial. There is at least one small clinical trial that has suggested better outcomes for early intervention, and larger studies are underway to confirm this finding.
So she went to a “naturopathic oncologist,” who prescribed a regimen of dietary supplements and curcumin, which, she pointed out, is being studied at the MD Anderson Cancer Center. This is true, but for lymphoma. Two trials have been terminated and no results are posted. According to the Natural Medicines Comprehensive Database, curcumin is possibly effective for dyspepsia and osteoarthritis. Apparently, there is some very preliminary research about its use in treating cancer, and the internet chatter is taking that one to the bank. She also ascribed the fact that she had not developed full blown myeloma, and therefore the need for chemotherapy, to her naturopath’s treatment.
To the uninitiated, this might sound impressive, and apparently the NDs thought it so or they wouldn’t have asked her to testify. Yet, what she said was actually troubling: an ND claiming a specialty in oncology prescribed dietary supplements, including curcumin, which has insufficient evidence of safety and effectiveness for cancer and none for smoldering myeloma. And she was attributing lack of progression of her disease to this treatment – was the ND fostering this confusion between correlation and causation?
In fact, each of the patients testifying in favor of licensing attributed improvement to ND treatments (including cranial sacral therapy for a concussion), when in fact the improvement could just have easily been the result of the natural progression of the condition or other treatments the patients were using.
And the results are . . .
The NDs got the scope of practice they wanted in terms of what and who they can treat. This includes:
the prevention, diagnosis, and treatment of human health conditions, injury, and disease . . .
In other words, they can diagnose and treat any patient of any age with any disease or condition. They can order and perform physical and lab exams, including phlebotomy, clinical lab tests, and order and interpret the reports of diagnostic imaging studies.
And here’s the interesting thing: other than the testimony about the time spent in clinical training (or lack thereof) there was no testimony or documentation, at least publicly available, demonstrating that NDs come out of school capable of diagnosing and treating the broad range of disease and conditions presented by a potential patient population, which includes basically everyone who can walk in off the street and present themselves to the ND. This is a point the DOs and MDs addressed and the NDs never really responded to. Virtually all of the ND testimony consisted of emphasis on their supposed ability to collaborate with other health care providers by serving as the experts in CAM, especially dietary supplements. Well, that’s just marvelous if all your patients happen to present with the limited number of diseases and conditions you’ve seen in your training or know how to recognize. And you can say all day that you will refer when necessary. But you can’t refer if you don’t see the problem in the first place.
Treatments will be limited to:
patient education and naturopathic therapies and therapeutic substances recognized by the Council on Naturopathic Medical Education.
Thus, the State of Maryland will default to the CNME to decide what “naturopathic therapies and therapeutic substances” are appropriate. I looked on the CNME website and could not find any information about what substances and therapies they do and do not recognize, nor do I see any evidence that they regard making such a list as part of their duties. In fact, the CNME’s standards for what is taught in ND school (if this is what is meant by being “recognized” by the CNME) is remarkably vague. And the bar for what treatments are recognized must be awfully low, considering the fact that ND schools teach homeopathy, acupuncture, Unani (that is, humoral medicine), Ayurvedic medicine, cranial sacral therapy, and a host of other dubious treatments.
After granting NDs the right to diagnose and treat, legislators turned around and piled on a whole bunch of restrictions and safeguards, some of which the NDs agreed to in order to get their feet in the door. Of course, as we know, the American Association of Naturopathic Physicians is gunning for full primary care physician scope of practice, including prescription privileges, in all 50 states. However, they are amenable to an incremental strategy, getting what they can initially and then returning to the legislature year after year. This strategy is playing out in Colorado right now, where, having gained registration rights just last year, they’ve already managed to get bills filed removing restrictions on their practice, some of which are similar to the ones imposed in Maryland.
Maryland NDs won’t be able to perform minor office procedures or any type of surgery, use transdermal, subcutaneous or IV routes of administration (eliminating their shooting patients up with vitamin and mineral “cocktails”) or colonic irrigation, or prescribe drugs. Nor claim they are “physicians.”
And, best of all, but much to the chagrin of the Board, they will be under the jurisdiction of the Board of Physicians, with a naturopathic advisory committee (2 NDs, 2 MDs or DOs, one consumer).
This advisory committee will be able to
- Evaluate the content of any clinical, practice or residency requirement for licensure;
- Develop and recommend to the Board exam standards for licensure, a code of ethics, and continuing education requirements.
Interestingly, one of the duties of the Board will be to collect licensing fees, which were estimated by legislative staff to be as much as $5,100 biennially, making it, by a factor of about 4, the biggest health care practitioner licensing fee in the state. This is because there are only about 25 NDs in Maryland. Fewer licensees means fewer people to share the administrative costs of regulating them. Of course, Maryland can expect to become a magnet for un- or under- employed NDs. According to their figures, there are about 4,750 licensees in the U.S. While some NDs practice in Canada, that number exceeds the number of graduates from ND schools, apparently by a large factor. According to one person who testified at a legislative hearing, the ND schools are graduating 500 NDs per year, although I couldn’t verify that.
As well, all NDs must have a “collaboration and consultation agreement” with an MD or DO, and attest to the Board that the ND will “refer patients to and consult with physicians and other health care providers.” NDs must also have patients sign a consent form stating that the ND’s practice is limited to the scope of practice identified in the statute. (I have to assume here that the ND must actually tell the patient what that is and not just refer to the section of the state statutes where the scope appears. Let’s hope so.)
NDs are prohibited from using “false, deceptive, or misleading advertising.” These prohibitions are typical in health care practitioner licensing statutes. But, while a naturopathic board might not find it problematic for a naturopath to claim, for example, that “toxins” have invaded a patient’s body and therefore “detoxification” is in order, a Board composed of physicians might take a decidedly different view. NDs can’t do anything that doesn’t meet “generally accepted standards of practice of naturopathic medicine.” One wonders what that might be, considering standardization of treatment doesn’t appear to fit into the naturopathic paradigm and their rejection of evidence-based medicine.
However, in addition, they cannot deviate from what is termed “safe care of patients” whether or not actual injury to a patient is established. This is important, for it gives the Board the opportunity to discipline a naturopath for conduct that may well be within the naturopathic standard but is nevertheless unsafe, and without having to show actual injury. Some possibilities: the prescription of dietary supplements where there is insufficient evidence of safety and effectiveness (especially for children, for whom there is virtually no research on dietary supplements), discouraging vaccination by giving parents misleading information about their safety and efficacy, and using naturopathic treatments without advising patients there are more effective medical treatments, or diagnosing and treating one of their non-existent diseases (e.g., food “sensitivities”). They also can’t offer to treat a disease by “a secret method, treatment or medicine,” or promote the sale of goods or services to a patient “so as to exploit the patient for financial gain.”
The bill creates a workgroup to study the development of a naturopathic formulary and make recommendations regarding a formulary, including the types of drugs, medicines and devices to be included and their routes of delivery. But they can’t actually establish a formulary without the legislature giving the green light.
Some disinfectant sunshine
If the Board takes its responsibilities seriously and wants to put in the time and effort, there are some real possibilities to both inform the public about, and protect the public from, naturopathic practice. Here are a few ideas in keeping with the authority granted them by this legislation:
- Require informed consent, including an accurate (scientifically accurate, not accurate according to “naturopathic principles”) statement of the risks and benefits of any treatment. For example, make them tell patients that homeopathic remedies are water with no evidence of efficacy. Make them accurately state the evidence for any particular dietary supplement. Do not allow them to tell patients they need “detoxification” by falsely stating their bodies are full of “toxins.”
- Do not accept at face value the ND’s version of their education, training and testing (the NPLEX). There is specific authority to look into it and NDs aren’t telling the straight story. (Why believe an ND who represents his education and training as the same as an MD and qualifies him to diagnose all comers?) Look at the CNME’s accreditation requirements and ask for documentary evidence of what they are taught and details of their training. And beef up the standards where you can.
- There is no specific prohibition against their selling dietary supplements, homeopathic remedies, and the like to patients, but there is also nothing to prevent the Board from enacting an ethical rule saying they can’t. After all, not selling drugs to patients is already a well-established ethical principle in medicine.
- Make their continuing education requirements rigorous, and be sure to include the safety and efficacy of vaccination as one of your first required courses.
Finally, I hope Maryland physicians, PAs and nurse practitioners won’t be shy about calling them out on their diagnoses and treatments. Actually, all health care practitioners are required by this legislation to report NDs who are in violation of the statute or the Board’s rules.
The NDs got their licensing statute and most of the scope of practice they wanted. But they did so at the cost of submitting themselves to closer scrutiny (but not actual supervision) via having an MD or DO watching what they are doing. As well, other physicians, PAs, and nurse practitioners will be made aware of how they operate. They had to give up their claim of being PCPs and must tell patients about their limitations. And, if the Board does its job, the public will have an opportunity to examine their education, training, and practice in a way that hasn’t been done before. What comes of this remains to be seen.
