Legal Issues Regarding Unlicensed Health Care Practices and Nutritional Supplements

  • Bruce W. McIntyre
  • Alexandra O. Binek
  • Stephanie S. DelPonte
  • and Eric Greenberg
  • Journal of Medical Regulation
  • September 2009,
  • 95
  • (3)
  • 9-15;
  • DOI: https://doi.org/10.30770/2572-1852-95.3.9

ABSTRACT

Complementary and Alternative Medicine (CAM) has increasingly become a popular option for many Americans. A 2007 study showed that a majority of Americans used at least one form of CAM during that year. In response, many states opted to license practices that had previously been unlicensed, such as acupuncture, massage therapy and naturopathy. In addition, some states passed legislation to regulate and discipline unlicensed CAM practitioners. Minnesota spearheaded these efforts in 1999 by passing a law that set guidelines and standards for unlicensed health care practitioners, while protecting the public's right to choose to use CAM. California, Rhode Island, Louisiana, New Mexico and Puerto Rico all followed with similar legislation.

The federal government's attempts at regulation of CAM have been varied. In 1994, Congress passed the Dietary Supplemental Health and Education Act (DSHEA) as a result of intense lobbying by health food manufacturers and the public. While it limited the claims manufacturers could make on labels, the law also severely curtailed the FDA's ability to regulate nutritional and dietary supplements. Partially due to the adverse effects of DSHEA, President Bush signed the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA) into law on Dec. 22, 2006.

INTRODUCTION

Many Americans have increasingly turned to the field of Complementary and Alternative Medicine (CAM). This field, unlike conventional medicine, is largely unregulated and uses techniques and treatments that are not typically used in U.S. medical schools or hospitals. However, five states and one territory, Minnesota, California, Rhode Island, Louisiana, New Mexico and Puerto Rico recently passed legislation that attempts to regulate unlicensed health care. The laws passed not only protect consumers' choice to use CAM, but also outline standards and rules applicable to unlicensed health care practitioners. In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA). The result of DSHEA was an environment in which nutritional and dietary supplements became widely available to the public and, as a result, the supplement industry flourished. This act also led to decreased public protection by the U.S. Food and Drug Administration. The act impaired the FDA's ability to regulate supplements because it allowed the manufacturers to determine the safety of the supplement before it is marketed. The FDA became responsible for taking action against an unsafe supplement only after it is on the market. The FDA's post-marketing responsibilities include safety (voluntary adverse event reporting) and labeling. The Federal Trade Commission regulates dietary supplement advertising. Consequently, in 2006, the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA) was passed into law. This law specifically addressed the serious adverse-event reporting requirements for nonprescription drugs and dietary supplements.

STATE RESPONSES TO UNLICENSED HEALTH CARE

The use of CAM is widespread throughout the United States. In 1990 there were approximately 425 million visits to practitioners of CAM.1 Since then the number of people using some form of CAM has steadily continued to increase. The revenue from professional services for alternative medicine totaled $22.6 billion in 1990 and increased to $32.7 billion in 1997, three years after DSHEA was enacted.2 Furthermore, between 1990 and 1997, the annual visits to primary care physicians in the United States remained steady at approximately 385 million. However, visits to CAM practitioners totaled approximately 427 million in 1990 and rose to more than 629 million in 1997.2 In addition, a large number of Americans also use supplements. In one study, sales of nutritional supplements in 1994 totaled $8.8 billion; and in 2000 that amount nearly doubled to $15.7 billion.3 The sale of supplements continued to escalate, and totaled $18.8 billion in 2003.4

According to a study by the National Center for Complementary and Alternative Medicine, through the U.S. Department of Health and Human Services, about 38.3 percent of adults used some form of CAM one or more times in 2007.5 In the study, CAM was defined as including alternative medical systems, such as acupuncture and naturopathy; biologically based therapies, such as folk medicine and diet-based therapies; manipulative body-based therapies, such as chiropractic care and massage; and mind-body therapies, such as meditation and hypnosis. The research found that though CAM usage was fairly evenly spread among the demographic groups, “CAM use was more prevalent among women, adults aged 30–69, adults with higher levels of education, adults who were not poor, adults living in the West, former smokers, and adults who were hospitalized in the last year.”5 Furthermore, the use of CAM was more prevalent when the cost of conventional care was an issue, though many people who used CAM did so in addition to conventional care. These statistics are very similar to results found in a 2002 study by the National Center for Complementary and Alternative Medicine, showing that the use of CAM has remained fairly consistent.5 Although the study included both licensed and unlicensed forms of CAM, the information is still relevant to show the rising popularity of unlicensed health care.

Some states have responded to CAM's popularity by passing laws to regulate unlicensed health care in order to protect the public. Prior to 1999, limited legislation existed to regulate unlicensed health care. Minnesota was one of the first to enact such legislation, passing a law titled Minnesota Freedom of Access to Complementary and Alternative Health Care Practitioners.6 It has since become a “model” act and other states and territories that have adopted similar legislation include California, Rhode Island, Louisiana, New Mexico and Puerto Rico.7–10 In addition, similar legislation has been considered by state legislatures in Arizona, Georgia, Hawaii, Idaho, Illinois, Iowa, Maine, Montana, Nevada, North Carolina, Ohio, Texas, Virginia, Washington and Wisconsin.11–23 However, a few states have taken a different approach by making certain types of CAM illegal. Tennessee and South Carolina, for example, have outlawed the practice of naturopathy, which is commonly defined as an “alternative medical system” where the purpose is “that there is a healing power in the body that establishes, maintains, and restores health.”5 Tennessee law states that the practice of naturopathy is a Class B misdemeanor, and in South Carolina, one could be fined or imprisoned for up to one year.24

A combination of public health concerns about the use of CAM and the activities of large corporations, which have targeted the public for monetary gain, have led to legal actions. An example is the Mannatech case. Mannatech, a company that produces and sells supplements, made claims that its products had proven health benefits. Manntech is invested in the field of glycobiology, which is the study of “glycan structure, metabolism, and function by developing and applying rigorous scientific tools and standards.”25 One type of glyconutrient that the company was marketing claimed to “cure, mitigate, treat or prevent disease.”25 However, Samuel Caster, one of the founders of Mannatech, acknowledged in evidence presented to the District Court of Travis County, Texas, “that the products do not cure any diseases.”26 In the petition, the Attorney General of Texas cited the Texas Food, Drug and Cosmetic Act, which states that “claims cannot be made that dietary supplements are intended to cure, mitigate, treat or prevent disease.”26 Mannatech settled the lawsuit for $11.25 million.27

Aside from large companies targeting the general public with outlandish promises, Rhode Island has two important cases in which legal action was taken against two unlicensed health care practitioners. Prior to Rhode Island passing its unlicensed health care law, certain naturopathic practitioners sought legislation that would license them and grant their industry legitimacy. However, there were other naturopathic practitioners who were strongly opposed to this and preferred to stay unlicensed and unregulated. A committee was commissioned to consider testimony from both sides and resolve the matter. An issue that was subsequently raised was public safety, as the training of naturopaths was found to be inconsistent and informal. However, health officials had few resources to regulate these unlicensed health care practices. Rhode Island opted for a compromise and the legislature passed the Unlicensed Health Care Practices Act. The Act regulates certain CAM practices through the Department of Health, but does not offer licensure. Representative Arthur Corvese, who helped guide legislation through the enactment process in Rhode Island, said: “The state has a responsibility to protect the safety of its citizens. With the rise in popularity of alternative medical therapies, this legislation is a necessary first step towards achieving that protection.”28

The Rhode Island Unlicensed Health Care Practices Act was enacted in 2003 and not only established guidelines and standards for unlicensed health care practitioners, but also protected the public's right to choose to use CAM. Rhode Island's Unlicensed Health Care Practices Act, RIGL §23–74, includes, “but is not limited to, (i) acupressure; (ii) Alexander technique; (iii) aroma therapy; (iv) ayurveda; (v) cranial sacral therapy; (vi) crystal therapy; (vii) detoxification practices and therapies; (viii) energetic healing; (ix) rolfing; (x) Gerson therapy and colostrum therapy; (xi) therapeutic touch; (xii) herbology or herbalism; (xiii) polarity therapy; (xiv) homeopathy; (xv) nondiagnostic iridology; (xvi) body work; (xvii) reiki; (xviii) mind-body healing practices; (ixx) naturopathy; and (xx) Qi Gong energy healing ... Unlicensed health care practices do not include surgery, x-ray radiation, prescribing, administering or dispensing legend drugs or controlled substances, practices that invade the human body by puncture of the skin, setting fractures ... [and] the manipulation ... of joints or the spine.”9 Unlicensed health care practitioners may not provide a medical diagnosis or advise clients to disregard or discontinue the medical treatment of their primary care doctor.9

Furthermore, this law provides that clients of these unlicensed health care practitioners must be presented with a patient's bill of rights that must also be posted in the practitioner's office. A patient is entitled to know, “the degrees, training, experience, or other qualifications of the practitioner regarding the unlicensed health care being provided.” The notice must include “the following statement in bold print: The state of Rhode Island has not adopted any educational and training standards for unlicensed health care practitioners. This statement of credentials is for information purposes only; … a brief summary, in plain language, of the theoretical approach used by the practitioner in providing services to clients; … notice that the client has a right to complete and current information concerning the practitioner's assessment and recommended service that is to be provided, including the expected duration of the service to be provided.”9

The Unlicensed Health Care Act in Rhode Island has been used to protect the public in two important cases. In both cases the health of the public was at risk due to the false claims that were procured. In the first case, the Rhode Island Department of Health and the Board of Medical Licensure and Discipline (BMLD) investigated John Curran's practices and contacted the Food and Drug Administration's Office of Criminal Investigations (FDAOCI). The BMLD worked with the FDA-OCI, Internal Revenue Service, Office of the U.S. Postal Inspector, and U.S. Attorney for the District of Rhode Island in a joint state and federal investigation in the matter of John Curran.

John Curran, a self-proclaimed naturopath and medical doctor, used certain CAM diagnosis and treatments in order to bilk money out of his patients.29 John Curran posed as a medical doctor to gain his patients' trust. He had fake diplomas and certificates on his office walls from multiple prestigious medical schools, such as Harvard University, Brown University and Duke University, as well as a diploma from St. Luke School of Medicine, an unaccredited medical school that he never attended.30 Curran also referred to himself as an M.D. and a Ph.D., using those titles on his nametag, office door, business cards, prescription pads, and pamphlets – though he had never earned either title.30

When patients came to see Curran he would first perform a $950 full-body exam. Parts of this exam included such techniques as live blood analysis, which state health regulators and federal authorities had previously told him he was not permitted to perform. He used these “test results” to inform his patients that they had some form of disease or abnormality of the blood, including parasites and “pre-cancer.”29 Curran told the majority of his patients that they had “live parasites, double-headed parasites, worms, holes, big eggs, green-tinted cells, red crystals, dying cells, dormant cells, severely reduced blood cells, and/or no white blood cells.”29 He also purported to diagnose deficient body functions or immune systems, fungus of the liver, defective lungs and kidneys, or organs in distress.”29 An expert witness in the federal court trial testified that the presence of parasites in the blood is extremely rare and Curran's diagnosis of such parasites in two thirds of his patients is statistically impossible. Occasionally he would also tell his patients that they had life-threatening diseases such as cancer.29

After frightening his patients with these diagnoses, Curran would prescribe “medically frivolous remedies designed for defendant's financial benefit rather than his clients' wellbeing.” 29 He would prescribe such remedies as the “green drink,” which was a commercially produced liquid that he told his patients he invented and made, and “specially energized water,” which was distilled water he ran through a blender.29 Curran would then charge his patients exorbitantly high prices for these products.29

The director of Health deemed John Curran's practices to be an immediate threat to the public health and issued a compliance order suspending his right to practice unlicensed health care. An administrative hearing was conducted in which John Curran was called as an adverse witness. After approximately two hours of testimony, which included the time, place, manner and methods in which he procured his phony credentials, he consented to the terms of the immediate compliance order that stopped his practices. The case then moved to federal court, where he was charged with money laundering and wire fraud.29

The court used Curran's own records of patient purchases and calculated that between 2003–2004 Curran treated 340 patients for a profit of approximately $1.4 million in fees for his “services.” The U.S. Court of Appeals for the First Circuit held that RIGL §23-74-1(a) prohibited Curran from “holding himself out as a licensed physician and from diagnosing disease or treating it.”29 The U.S. District Court for the District of Rhode Island convicted Curran on multiple counts of wire fraud and money laundering, saying that “Curran was a menace who took advantage of [the patients'] worst fears and preyed on them for reasons of greed as he undertook a scam of the worst kind.”29 Curran was sentenced to 150 months in prison as well as having to pay restitution fees totaling $1,425,061.62.29

In another case, Dr. Long V. Mai, a licensed acupuncturist, was concurrently practicing herbology and selling herbs, which is an unlicensed health care practice in Rhode Island. 9 Rhode Island bestows the honorary title of Doctor to licensed acupuncturists even though few, if any, have matriculated through a doctoral level training program. Dr. Mai had advertised in Vietnamese newspapers presenting not only a Rhode Island Department of Health license for acupuncture but also giving the impression that he could treat more serious diseases, such as cancer. In this case, there were multiple incidents where patients were charged thousands of dollars for supplements along with visits to the practitioner's office in order to treat diseases such as liver cancer and paralysis.31

Dr. Tierney Tully, an expert witness and a doctor of acupuncture and Oriental medicine, testified about the proper method of diagnosis, including a four-step method. It was clear in the testimony from two of Dr. Mai's former patients that Dr. Mai did not complete all of the steps.31 Furthermore, in regards to curing diseases, specifically liver cancer, Dr. Tully testified that “Acupuncture and Oriental Medicine do not make any claims to cure this disease [liver cancer].”31 Another acupuncturist, Dr. Ming Li, also concluded that “with respect to a patient with liver cancer, an acupuncturist would provide support treatment to the person but would not attempt to cure the underlying disease.”31

The final decision by Justice Thompson in the Superior Court of Rhode Island agreed with the Rhode Island Department of Health and with the permanent revocation of Dr. Mai's license. The false advertising that was used by Dr. Mai was deemed unethical and false. He claimed that he could cure diseases but, after charging patients for many expensive treatments and/or visits, he was never able to do so. The Superior Court upheld the revocation of his license to practice acupuncture and engage in herbology and the sale of nutritional supplements. The court ruled that unlicensed health care practitioners can “educate and explain the uses of those products; however, education and explanation could not extend to medical diagnosis or treatment.”32

Apart from public health concerns like the cases in Rhode Island, courts in the state of New York have found civil liability in cases dealing with CAM. The case of Charell v. Gonzalez was heard by the New York Supreme Court in 1998. Julianne Charell was suffering from cancer. She refused the treatment recommended by her oncologist and instead opted to receive alternative medical care from Nicholas Gonzalez. Charell sued Gonzalez for malpractice and the jury found Gonzalez civilly liable. The jury awarded Charell more than $4 million in compensatory damages and $150,000 in punitive damages. On appeal, the court overturned the punitive damage award but upheld the $4 million in compensatory damages. The appeal also found that by foregoing conventional medicine and choosing alternative medicine, even without the complete risk information, Charell had assumed some of the risk.33

FEDERAL LEGISLATION FOR NUTRITIONAL AND DIETARY SUPPLEMENTS

In 1994, noting that many Americans regularly consume dietary supplements, Congress passed the DSHEA.34 The Act praised the healthful benefits of nutritional and dietary supplements while also stating that “safety problems with the supplements are relatively rare.”34 The Act further stated that “the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers.”34 Thus, the overall purpose of the Act was to protect the consumer's right of access to dietary supplements while limiting FDA's ability to regulate. In one regard DSHEA accomplished precisely what it set out to do: The deregulated environment that followed permitted the nutritional supplement market to expand rapidly and provided wide access to consumers. In particular, unlicensed health care providers could now suggest and sell more nutritional supplements to patients, at great profit, to complement their alternative health care practices.

Unfortunately, DSHEA also had negative consequences. First, manufacturers were no longer required to submit to testing prior to marketing their product. DSHEA also defined “dietary supplement” broadly. It was defined as “a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (a) a vitamin, (b) a mineral, (c) an herb or other botanical, (d) an amino acid, (e) a dietary supplement used by man to supplement the diet by increasing the total dietary intake or, a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).”34 Due to the broad definition within the law, the producers of dietary supplements did not need to demonstrate prior to marketing a product that it is beneficial or effective.35

This Act also made it harder to ban potentially harmful supplements from the public. The most prevalent example was when the government attempted to ban ephedra. A review in the New England Journal of Medicine by Haller and Benowitz examines the effects of ephedra.36 The conclusion was that, of the symptoms experienced by the 140 participants, 31 percent of the symptoms were deemed “definitely or probably” related to ephedra, another 31 percent “possibly related” to ephedra, and 17 percent were deemed “unrelated.”36 Of the 31 percent of symptoms considered “definitely or probably” related to ephedra, the majority of the complaints were related to cardiovascular symptoms that included hypertension and even cardiac arrest.36 Even with a review that showed that there were harmful effects from this substance, the FDA's powers were limited and, although ephedra was ultimately banned by the federal government, it was difficult to get this substance off the market.

Similar to ephedra, the Chinese herb Aristolochia fangchi or A. fangchi had been banned in many European countries. 37 In Europe, this substance had been used for weight loss, but was thought to cause severe kidney damage in some patients.38 Further research published in the New England Journal of Medicine showed the link between this same Chinese herb and cancer, specifically urothelial carcinoma.39 Under DSHEA, however, this supplement was not tested before it was made widely available in the United States and was only under investigation after several people who used the supplement filed complaints.40 Even after complaints were made and the FDA issued a warning, the substance was still sold on the Internet worldwide.40

Due somewhat to the difficulty of banning ephedra, Congress enacted the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA) in 2006. This Act requires manufacturers to report “serious adverse effects” of supplements to consumers.41 Serious adverse effects are defined by the DSNDCPA as: “(A) i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; or (v) a congenital anomaly or birth defect; or (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph A.”41 Thus, where previously manufacturers of supplements were under no obligation to furnish such information, under DSNDCPA they are required to do so.41

Prior to the enactment of DSNDCPA, Pharmavite LLC, the company that makes Nature Made Vitamins, praised the proposed bill by stating it would “validate the dietary supplement industry's strong safety record.”42 The president of the Consumer Healthcare Products Association, Linda Suydam, noted that “this legislation… will ensure the FDA has the tools it needs to fulfill its public health mission to more aggressively monitor the medicines and nutritional supplements it regulates.”43

The DSNDCPA was put to use by the FDA against Matrixx Initiatives, Inc., and its Zicam nasal products. Matrix Initiatives discovered the possible side effect of loss of smell and taste from more than 800 reports. Under the DSNDCPA, Matrixx Initiatives had a legal obligation to report the possible side effect to the FDA once the company had become aware of it, which they failed to do. After learning about these long-lasting and possibly permanent side effects, Matrixx Initiatives also was required to file a new drug application listing the side effects, which the company also neglected to do. The FDA advised consumers against using Zicam nasal products on June 13, 2009, because of possible side effects involving loss of smell and taste in some consumers. Three days later, the FDA issued a warning letter to Matrixx Initiatives stating that Zicam created a serious risk to consumers. Matrixx Initiatives has since recalled its Zicam nasal products.44

CONCLUSION

With the rise in popularity of CAM, some companies and individuals have attempted to take advantage of medically compromised patients in order to profit through false claims. By using laws such as the Unlicensed Health Care Practices Act in Rhode Island, state health regulators have been able to protect the public from false health claims and criminal behavior. Since Minnesota began this effort in 1999, the few states that have enacted such legislation now have tools to protect the public and provide access to CAM in a safer, regulated environment.

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In this Issue

Journal of Medical Regulation

Vol. 95, Issue 3

1 Sep 2009

Table of Contents Index by author

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