This is almost the final entry (for now) in a series of posts about the pitfalls of regulating physicians who peddle quackery.† In previous entries we’ve seen how quacks have portrayed an illegal and pseudoscientific treatment, intravenous hydrogen peroxide, as legitimate; how a physician who practiced that and other dubious methods eluded definitive regulatory sanctions for years; examples of quacks banding together to form pseudomedical pseudoprofessional organizations (PPOs) and bogus board-certification schemes to establish the appearance of professional legitimacy, for protection from regulatory scrutiny, to garner political clout, to attract funds from interested businesses, to dupe the Accreditation Council for Continuing Medical Education into granting continuing medical education credits (CMEs) for pseudoscientific conferences, and more.
Now we’ll look at several examples of how state medical boards in the U.S. have abdicated their responsibility to protect the public from such practitioners. A few caveats: first, in most cases I can only guess why that has happened. Some of it has probably been due to naiveté, or to political or legal pressures. To some extent it has probably been due to faddism and its close relative, misleading language. Next, the examples given here are by no means exhaustive. Next, a state medical board can only be as effective as the language in the state’s medical practice act allows it to be, and that is determined by legislators (politics), not board members. Finally, state medical boards have not uniformly made the wrong choices regarding quack practices and practitioners.
The Federation of State Medical Boards (FSMB) Succumbs to “Academic CAM” Pressure
Let’s start with the organization that advises all state medical boards. In 2000, after several years of sincere efforts to curb quackery, the FSMB abruptly did an about-face, establishing a “Special Committee for the Study of Unconventional Health Care Practices (Complementary and Alternative Medicine).” Consultants to the committee were Russell Greenfield, an early graduate of Andrew Weil’s “Program in Integrative Medicine” at the University of Arizona, and two more pals of Weil, Kenneth Pelletier and David Eisenberg. This resulted in Model Guidelines for the Use of Complementary and Alternative Therapies in Medical Practice, published in 2002 and subsequently accepted by several state medical boards. I’ve discussed this previously on SBM, but here will add a few comments.
In 2001, Tim Gorski (no relation to our David) who, along with the late John Renner, had advised the FSMB’s now defunct “Special Committee on Questionable and Deceptive Health Care Practices,” sent this email:
As you saw, the committee report issued when John and I were consulting was really quite good. But compare/contrast what will come if E [Eisenberg] and RG [Greenfield] get their way:
1997 report: “committee recognized that the primary responsibility of state medical boards is to protect the public from the incompetent, unprofessional, improper, and unlawful practice of medicine”
E & RG: (looking into my crystal ball!): “recognized that half of all Americans are already visiting CAM practitioners and, in order to protect the public, guidelines need to be established for licensed physicians to co-manage their patients”
Likewise, the 1997 report’s sections entitled “evaluation and investigation,” “education,” and “collaboration” will take on whole new meanings …
Tim had a pretty good crystal ball. Here’s what the 2002 report says:
Because of the increasing interest in and use of complementary and alternative therapies in medical practices (CAM), state medical boards have a responsibility to assure that licensees utilize CAM in a manner consistent with safe and responsible medicine. On behalf of the Federation of State Medical Boards and its continued commitment to assist state medical boards in protecting the public and improving the quality of health care in the United States, the Special Committee for the Study of Unconventional Health Care Practices (Complementary and Alternative Medicine), undertook an initiative in April 2000 to develop model guidelines for state medical boards to use in educating and regulating (1) physicians who use CAM in their practices, and/or (2) those who co-manage patients with licensed or otherwise stateregulated CAM providers.
The 2002 report makes much of the notion that “conventional medicine” and “CAM” ought to be judged according to the same standards and “ethical guidelines”:
This initiative focuses on encouraging the medical community to adopt consistent standards, ensuring the public health and safety by facilitating the proper and effective use of both conventional and CAM treatments, while educating physicians on the adequate safeguards needed to assure these services are provided within the bounds of acceptable professional practice. The Committee believes adoption of guidelines based on this model will protect legitimate medical uses of CAM while avoiding unacceptable risk.
The intention of the Committee is to provide guidelines that are clinically responsible and ethically appropriate. These guidelines are designed to be consistent with what state medical boards generally consider to be within the boundaries of professional practice and accepted standard of care.
That shouldn’t be hard, right? Just do what you’ve always done! That oughtta deal with the other ‘sections’ mentioned by Tim, but the devil, of course, is in the details: the elusive natures of “CAM,” its definition, and its champions. Regarding “evaluation and investigation,” “education,” and “collaboration,” the committee treated them like so many bulls at the mercy of its faena:
CAM is a fluid concept that has been defined differently by various organizations and groups. For the purposes of these guidelines, the Committee has chosen to use the term CAM as defined by the National Institutes of Health (NIH) National Center for Complementary and Alternative Medicine (NCCAM) (see Definitions). The Committee acknowledges that some therapies deemed CAM today may eventually be recognized as conventional, based on evidence over time…
Inasmuch as the (name of board) is obligated under the laws of the state of (name of state) to protect the public’s health, safety and welfare and recognizes that the standards used in evaluating health care practices should be consistent, whether such practices are regarded as conventional or CAM, the Board recognizes that a licensed physician shall not be found guilty of unprofessional conduct for failure to practice medicine in an acceptable manner solely on the basis of utilizing CAM…
CAM refers to a broad range of healing philosophies (schools of thought), approaches and therapies that mainstream Western (conventional) medicine does not commonly use, accept, study, understand, or make available. A few of the many CAM practices include the use of acupuncture, herbs, homeopathy, therapeutic massage, and traditional Oriental medicine to promote well-being or treat health conditions. People use CAM treatments and therapies in a variety of ways. Therapies may be used alone, as an alternative to conventional therapies, or in addition to conventional, mainstream therapies, in what is referred to as a complementary or an integrative approach. Many CAM therapies are called holistic, which generally means they consider the whole person, including physical, mental, emotional and spiritual aspects.
And so, in one fell swoop, the organization that had just finished advising every state medical board to take a stand against questionable and deceptive health care practices issued a breezy “Never Mind.” As long as the practice is not “proven to be ineffective or unsafe through controlled trials or documented evidence or as measured by a risk/benefit assessment,” anything goes!
A few months after Tim Gorski sent his email, by the way, he became the target of a dirty trick played by Rep. Dan Burton (R-IN), “organized quackery’s best friend in Congress.” Dr. Gorski used the opportunity to whip off a rebuttal that is jam-packed with still-useful information for those interested in our government’s role in promoting quackery to its citizens.
(Timothy! Where on earth did you go?)
Language Specific to State Medical Boards: Often Incoherent or Self-Defeating
What follows are a couple of arbitrary examples of how state medical boards attempt to deal with “CAM.”
Illinois
Among the credits in the FSMB’s 2002 report was this:
“Illinois Department of Professional Regulation Medical Disciplinary Board (MDB). Board Policy Statement: Complementary and Alternative Therapies. November 1999″
I can’t find that anywhere on line (perhaps it is obsolete), but thanks to Tim Gorski I have a paper copy. It is a maze of internal and external contradictions. On the one hand:
The various offerings of alternative medicine fall into one of three categories:
1) Invalidated: interventions that are “invalidated” because they have neither a proven nor a scientific basis for any health benefit. Invalidated remedies include any therapy that
a) is implausible on a priori grounds (because its implied mechanisms or putative effects contradict well established laws, principles, or empirical findings in physics, chemistry, or biology):
b) lacks a sufficiently acceptable rationale of its own;
c) has insufficient supporting evidence derived from adequately controlled outcome research; and
d) has failed in well-controlled studies done by impartial evaluations [sic] and has been unable to rule out competing explanations for why it might seem to work in uncontrolled settings.
2) Nonvalidated (plausible but not yet proven): [etc.]
3) Validated (proven to be efficacious).
………………..
The MDB feels physicians and providers should never accede to invalidated treatments. The Board does believe physicians may incorporate nonvalidated treatments if research results are very promising, if the physician believes a particular patient may benefit, if the risk of harm is very low, and if the physician adheres to the conventions that govern the doctrine of informed consent for nonvalidated treatment.
Wow. That could almost have been written by an SBM blogger: homeopathy is clearly out, as are chiropractic, naturopathy, Ayurveda, TCM, and almost all the rest of “CAM” other than biologically-active molecules, right? Prepare to bonk yourself in the forehead, then, as you read the sentence that immediately precedes the one first quoted above:
The State of Illinois recognizes allopathic and chiropractic medicine as the medically dominant health systems.
Or a sentence in the paragraph that immediately precedes the one last quoted:
Abusive criticism of alternative practitioners and threats to their licensure solely because they offer their patients an integrated practice will not be tolerated.
Finally, consider that in Illinois, chiropractors are subject to the same practice act that regulates MDs, and as such may (and do) hold themselves out to the public as “primary care physicians.”
Such contradictions aren’t really surprising, coming from a Medical Practice Act that issues this dire warning:
Where a physician has been found, upon complaint and investigation of the Department, and after hearing, to have performed an abortion procedure in a wilful and wanton manner upon a woman who was not pregnant at the time such abortion procedure was performed, the Department shall automatically revoke the license of such physician to practice medicine in Illinois.
Are you reeling yet? Let’s go next door to…
Missouri
Many SBM readers are aware of “chelation therapy,” a major health fraud in the US for about 40 years. Although its proponents originally thought that disodium EDTA could leech calcium from atherosclerotic plaques, for more than 20 years they’ve claimed that it works by treating “heavy metal toxicity.” This has served them quite well: it provides a rationale for using the treatment not for merely one or two, but for approximately 70 “indications,” and it approximates the formal indication for another EDTA salt, calcium-disodium EDTA. Such sleight-of-hand has duped more than one state medical board, mainly due to the efforts of a PPO discussed 2 weeks ago, the American College for Advancement in Medicine (ACAM). Here is an example (numbered references in the original):
In 2001 the Missouri Code of State Regulations added language about chelation. It begins with a promising statement:
…the board declares the use of ethylinediaminetetracetic acid (EDTA) chelation on a patient is of no medical or osteopathic value except for those uses approved by the Food and Drug Administration (FDA) by federal regulation.[120]
Notwithstanding that preamble:
The board shall not seek disciplinary action against a licensee based solely upon a non-approved use of EDTA chelation if the licensee has the patient sign the Informed Consent for EDTA Chelation Therapy form, included herein….[120]
The consent form warns that chelation “may be harmful” and “has been authoritatively demonstrated to be ineffective in the treatment of vascular diseases,” (emphasis in the original) but also includes these statements:
My physician has explained to me and I fully understand:
(a) that the use of ethylenediaminetetracetic [sic] acid (EDTA) has been approved by the federal Food and Drug Administration (FDA) only for the use of removing heavy metals from the body;
(b) that the FDA has not approved the drug EDTA for treatment of diseases or conditions other than heavy metals poisoning;
…(i) that the Missouri State Board of Registration for the Healing Arts strongly recommends that Missouri citizens not undergo EDTA chelation therapy for the treatment of any human disease, illness, malady, or physical condition other than heavy metals poisoning;
Notwithstanding having read and understood the above, I hereby elect to undergo treatment with EDTA chelation therapy under the protocol recommended by the American College for the Advancement in Medicine (ACAM) [sic].[120]
It seems odd that the Missouri Board would warn citizens to avoid chelation, which it deems dangerous and ineffective, but declines to discipline licensees who push it. The Board appears to have been unaware, when it wrote that rule, that the statements about heavy metals undermine the statements urging citizens to refuse chelation, and are also quite false: The EDTA salt recommended by the ACAM protocol,[33] Na2EDTA, is not approved by the FDA for removing heavy metals. Even the somewhat safer CaEDTA is approved for the removal of only 1 heavy metal (lead), not heavy metals. Because there is nothing in the Missouri rule requiring a proper diagnosis of “heavy metals poisoning,” chelationists can conform to the letter of the law by doing exactly what they’ve been doing for years: prescribing chelation ostensibly to remove heavy metals, no matter what may or may not ail the patient.
Several other state medical boards or practice acts have language addressing unapproved uses of EDTA or chelation.[121] They vary in the extent to which they tolerate or condemn the practice, but most appear to have been misled by the heavy metals gambit. Tennessee is a laudable exception.[122,123]
Recently, the FDA did the job that had eluded state medical boards for years: it withdrew its approval for Na2EDTA, thus making it, for practical purposes, illegal for a physician to prescribe or administer it to a patient. Nevertheless, the problem won’t easily go away: hydrogen peroxide has never been approved for internal administration, and is thus similarly illegal when given intravenously. As we’ve seen, that hasn’t stopped our quack colleagues from doing exactly that.
“Health Freedom” States
Several states now have language in their medical practice acts or board regulations that mimic the FSMB language quoted above. Here’s how a proponent website introduces them:
Health Freedom States
The following states have laws that protect patient access to alternative therapies from licensed physicians:
Alaska | Colorado | Georgia | Indiana | Massachusetts | New York
North Carolina | Ohio | Oklahoma | Oregon | Texas | Washington
The following has law that protects patient access to alternative therapies from all licensed health care professionals:
The following states have regulations that protect patient access to alternative therapies from licensed physicians:
The following states have enacted laws that protect patient access to EDTA Chelation, specifically, from licensed physicians:
Oklahoma | South Dakota | Louisiana
The following states license homeopathic practice for physicians already licensed in any state:
Arizona| Connecticut | Nevada.
Notice that the index doesn’t include variations such as those in Illinois and Missouri. It is also somewhat dated; it is on the website of a PPO, the Foundation for the Advancement of Innovative Medicine (FAIM), that seems to be petering out—possibly because of the death, in 2003, of its founder and former president, diet guru Robert Atkins. A more general resource for laws relating to the selling of implausible medical claims is the Georgetown Law Library “CAM Research Guide.”
Arizona: Pleasure Island for Quacks
For about 25 years, the Arizona Board of Homeopathic Medical Examiners has offered a safe haven for dangerous misfits with MD or DO degrees. It is entirely distinct from the Arizona Medical Board and the Arizona Osteopathic Board, and has even allowed a couple of docs to practice who’d had their licenses revoked by those boards. Notwithstanding the word “homeopathic,” a license granted by the Homeopathy Board confers upon its holder a broad scope of practice, including general medicine, minor surgery, and…quackery: the pertinent Statutes and Rules explicitly or implicitly allow licensees to practice “classical homeopathy,” “complex homeopathy,” “chelation therapy,” “oxidative therapy,” “electro-diagnosis,” “EAV,” “diagnosis and treatment of ailments according to the systematic principles of traditional Asian medicine,” “orthomolecular therapy,” “neuromuscular integration,” “bio-terrain analysis,” “live blood analysis,” “magnetic therapy,” and more. On October 1, 2008, to (ahem) more accurately reflect this broad scope, the name of the board was officially changed to the “Board of Homeopathic and Integrated Medicine Examiners.”
It’s not surprising that scoundrels from other states have found sanctuary in Arizona. In 2005, investigative reporter Robbie Sherwood of the Arizona Republic documented examples of the homeopathy board granting licenses to felons and other physicians who’d been disciplined elsewhere for substandard practices and fraud, among other charges. Interviews with board members made it clear that this was no accident:
Members of the homeopathic board say they have welcomed doctors to Arizona who have been disciplined unfairly in other states and whose skills could benefit patients seeking alternative remedies. Until recently, a Web page operated by the Arizona Homeopathic and Integrative Medical Association urged homeopathic doctors to come to Arizona if they have been “oppressed” by medical boards elsewhere.
“There are doctors that have been enlightened as far as natural cures that have been around for hundreds of years, and their medical boards take them up on charges,” said Dr. Bruce Shelton, former Arizona homeopathic board chairman. “Those doctors are welcomed here to practice integrative medicine.”
Come in Rangoon!
“Natural cures” weren’t the only reasons that such émigrés had been “oppressed by medical boards elsewhere”:
Troubled physicians licensed by the board include Dr. Charles Crosby, who obtained his Arizona homeopathic license in May 2004 despite revealing to the board that he had been ordered to have counseling for a “perceived loss of social inhibition” in his home state of Florida. It later became known that Crosby had been accused of fondling patients and of having a breast fetish. A report on the case in Florida said Crosby had developed “a special technique of manipulating women’s breasts to treat pain in other areas of their body.”
The suspension of Crosby’s license in Florida triggered a inquiry before the Arizona homeopathic board in July. At the meeting, Schwengel, the board president, said he did not find any specific examples that showed Crosby had acted unprofessionally, according to meeting minutes.
The Arizona Republic stories are no longer available online without paying a fee, but at the time were posted by several skeptics’ sites, including that of physical therapist Paul Lee (here and here).
At some point you had to wonder how the Arizona Homeopathy Board had responded to the bad press, which it certainly must have noticed. Its website has minutes of its meetings, and there just had to be references to the articles in the Republic. Well, the meeting of Nov. 15, 2005, which would have been the first to follow the articles’ publication, was cancelled for unstated reasons. The following meeting, on Dec. 6, gave almost no indication that the Board had noticed the criticism. On Jan. 10, 2006, however, the Board offered this discussion:
General discussion: function and duty of Board members
Dr. Schwengel began the discussion by noting that a board member’s duty was to protect the public and license qualified doctors. He explained that the homeopathic physician represented a considerable expansion of medical skills and offered the public greater choice of healthcare. The special training needed to qualify for the homeopathic license is not limited to homeopathic medicine but also encompasses other modalities defined in ARS §32-2901(22) including acupuncture, nutrition, chelation therapy, orthomolecular medicine and osteopathic manipulation.
He indicated that the board provides recourse for the public to file complaints and the Office of the Attorney General serves as the legal advocate to the Board. The confidentiality of patient records is maintained during deliberations and executive sessions offer the board the opportunity to receive legal advice from its legal advocate, their assistant attorney general. He explained that during an executive session the board can not deliberate matters or make personal comments but can only seek legal advice.
In closing Dr. Schwengel noted that the sunset review process is an opportunity to make changes and address procedures that would make it more responsive to the needs of the citizens of Arizona. In as much as an audit of the board has not been performed in twenty years, the board welcomes the audit process and believes the processes examined by the auditors will benefit from the scrutiny and ultimately, the citizens of Arizona will be better served.
At this point, Dr. Schwengel opened the floor to board members.
Mr. Farris commented that in his opinion the public does not fully understand what the roll of the board is. As a public member, his job is to protect the public by applying the laws governing the board to the processes of licensing and complaint reviews. He noted his personal experience in the value of homeopathic medicine through the effectiveness of treatments received by his own family members.
Dr. Rowe thanked the Office of the Attorney General for their assistance to the Board and for providing clarity in their interpretation of the laws governing the board.
Dr. Gordon stated that there was a national crisis relative to the public’s access to affordable healthcare and to choices in the type of care available. The board serves an important roll in regulating alternative healthcare providers.
Once again, please pass the potentized Ipecac. It turns out that there was, subsequently, an audit of the Arizona Homeopathy Board (although you’d be hard-pressed to discover that fact by looking on the Board’s website). The auditors, in spite of being barraged by conflicting opinions that they may not have been capable of evaluating, made some good points, albeit in the understated language common to such efforts. To wit: “The Legislature should consider whether there is a need to continue the Board.”
Alas, it appears to have continued.
Colorado and the Unlawful Practice of Medicine
Some state medical practice acts require medical boards not only to discipline their licensees, but to identify and trigger actions against non-licensees whose activities constitute the unlawful practice of medicine. Colorado is one such state. Three years ago, rational health care activists Linda Rosa and Larry Sarner of Loveland discovered numerous examples of such unlawful practices. They gathered the evidence and presented it to the Board of Medical Examiners, as stipulated by the Colorado Medical Practice Act. Rosemary McCool, the director of the Division of Registrations, responded that “we are not in a position to accept and process your complaints,” citing the following:
. . . you have not included specific patient-care allegations regarding these individuals. In fact, it does not appear that you have personally interacted with these naturopaths and have no direct knowledge of the services that they provide. . . . it appears that your primary objection is to the fact that these individuals provide some type of health-care service.
Ms. Rosa and Mr. Sarner had been corresponding with others interested in the issue, including Dr. Carl Bartecchi at the University of Colorado School of Medicine and yers truly (previously mentioned on SBM here). Needless to say, Ms. McCool’s response rankled, enough to inspire us to write an op-ed piece for the Rocky Mountain News. That piece also now appears to be available only for a price, but thanks again to Paul Lee you can read it here for free. It doesn’t seem to have had any tangible effect, but it sure felt good.
Sometimes this anti-health-fraud stuff feels like bein’ in the Folk Song Army (the part about Franco, that is).
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† The State Regulation Series:
- Pitfalls in Regulating Physicians. Part 1
- Pitfalls in Regulating Physicians. Part 2: The Games Scoundrels Play
- The Pseudomedical Pseudoprofessional Organization (PPO*)
- A New Twist for Autism: A Bogus “Biomedical” Board
- How State Medical Boards Shoot Themselves (and You) in the Foot
- “Integrative Medicine Experts”: Another Barrier to Effective Discipline
- Bogus Diagnostic Tests