Articles

Author Archive

Legislative Alchemy: Michigan House Bill 4531 gives naturopaths a broad scope of practice

Legislative Alchemy

Legislative Alchemy

Michigan House Bill 4531, if passed, would give naturopaths one of the broadest scopes of practice in the U.S., essentially equaling that of a family practice MD or DO. The bill made it through all the necessary House committees and is now before the House for an initial vote determining whether it will proceed further in that body. If it passes there, it will move to the Senate and its committee process.

Most naturopathic licensing bills fail, even in those states where attempts are made year after year. Michigan is no exception. Both David Gorski (a Michigan resident) and I discussed the previous licensing attempts there. In the two states where naturopathic licensing or registration has succeeded in the last few years, they have been able to get only a much more limited scope of practice than the full primary care scope they desire. For example, in Colorado, there are severe limitations on naturopaths’ seeing pediatric patients. They must disclose they are not physicians, recommend to parents that their children have a relationship with a licensed pediatric practitioner, and give parents the CDC-recommended vaccination schedule. All this is to thwart their efforts to talk parents out of vaccinating their children by giving them “balanced” information that is actually full of anti-vaccination dog whistles.

In Maryland, where naturopaths are regulated by the Maryland Board of Physicians, they cannot call themselves physicians or claim to practice primary care. They 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 allowed by law. They cannot deviate from what is termed “safe care of patients” whether or not actual injury to a patient is established.

If passed, HB 4531 would be a radical departure from that trend. This newfound success in moving the ball forward may be due to an influx of funds from Emerson Ecologics, a company that sells dietary supplements and homeopathic remedies to naturopaths for resale to their patients. The company also sells the sort of dubious diagnostic tests used by naturopaths in their practice. For example, they offer a test for “adrenal stress” (to discover, not just “adrenal fatigue,” but actual “exhaustion”) and a saliva test for hormone levels as an indicator of the need for “bio-identical hormones.” (Neither the test nor “bio-identical hormones,” which is actually a marketing, and not medical term, are recommended in evidence-based medical practice.) In March, Emerson Ecologics announced a “grant” to the Michigan Association of Naturopathic Physicians (MANP) of $10,000 to support the effort to obtain full licensure for naturopathic doctors in Michigan.
(more…)

Posted in: Legal, Naturopathy, Politics and Regulation

Leave a Comment (0) →

What (if anything) does “natural” mean?

"When I use a word," said Humpty Dumpty said in a rather scornful tone, "it means just what I choose it to mean -- neither more, nor less." Lewis Carroll, "Through the Looking Glass"

“When I use a word,” said Humpty Dumpty in a rather scornful tone, “it means just what I choose it to mean — neither more, nor less.”
Lewis Carroll, “Through the Looking Glass”

What does the term “natural” mean on a label? Does it mean anything? Should it mean anything? Good questions. And complicated ones, judging from the list of questions the FDA needs your help in answering.

The FDA has resisted defining “natural” in food product labeling, including whether foods that are genetically engineered, or contain genetically engineered ingredients, can use the term. Back in 1991, the agency set out to issue regulations but abandoned the effort and has since held to an informal policy that “natural” means

nothing artificial or synthetic (including color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food.

The only official legal requirement for using the description “natural” on a food label is that it not be misleading or false, which is forbidden by the Food, Drug & Cosmetics Act of 1938. In that appetite-suppressing way of statutory language, “food” is defined by the Act as

articles used for food or drink for man or other animals, chewing gum, and articles for used for components of any such article.

For regulatory purposes, dietary supplements are also considered foods in most cases. (more…)

Posted in: Genetically modified organisms (GMOs), Legal, Nutrition, Politics and Regulation

Leave a Comment (0) →

Academic Consortium plan: force medical residents to practice integrative medicine

The Integrative Medicine Wheel

The Integrative Medicine Wheel

“Integrative medicine” (IM) is an ideological movement within medicine driven in large part by those whose livelihoods depend on its continued existence. This includes both those with positions in academic medicine and individual practitioners who use the IM brand to attract patients.

Despite IM and its antecedents (alternative, complementary, alternative and complementary, complementary and integrative) having been around for about a quarter century, we still do not have a working definition of integrative medicine or have any idea whether it positively affects patient outcomes. And, despite the lip service given to IM being evidence-based, or “evidence-informed” or incorporating “appropriate” services into conventional medicine, there does not seem to be any standard for determining which modalities are appropriate for inclusion. We can infer, however, that evidence of effectiveness is not a criterion, as reiki, cranial sacral “therapy”, and homeopathy are standard fare.

In fact, the prospect for actually improving patient outcomes by importing CAM treatments (such as acupuncture) into medical practice would seem to be decreasing over time, as more and more fail to hold up under the scrutiny of well-designed and conducted clinical trials. Perhaps the dearth of evidence for “alternative” treatments is the impetus behind the importation of conventional modalities, such as nutrition and exercise, into the IM fold, treatments that were never viewed as CAM when the whole enterprise started. It has also led to special pleading demanding that research standards be loosened, most recently by the NCCIH, its director’s promise to ensure “rigorous science” notwithstanding.

There is no standard delivery model for integrative medicine or, importantly, an agreed-upon role for the various practitioners who bring the “integrative” to integrative medicine, such as chiropractors, naturopaths and acupuncturists. For example, should they be allowed to practice independently or should the medical doctor have final say on patient care? And, if they differ in their proposed diagnoses and treatments, how are those issues to be resolved? (more…)

Posted in: Acupuncture, Chiropractic, Ethics, Medical Academia, Medical Ethics, Naturopathy

Leave a Comment (0) →

Regulating CAM Aussie Style

640px-Flag_of_Australia.svg
CAM proponents view National Health Interview Surveys recording the supposed popularity of CAM, an amorphous conflation of anything from conventional medical advice to mythical methods, as an invitation to unleash even more unproven remedies on the public. My interpretation is quite different. I see the same figures as proof that we are doing too little to protect the public from pseudoscience.

In fact, state and federal governments are acting as handmaidens to the CAM industry by legalizing practices and products that have insufficient proof of safety and efficacy and, in some cases, are so scientifically implausible that they can never meet that standard. The federal government keeps “integrative” medicine centers at major academic institutions and private foundations afloat with taxpayer money by funding research that has failed to improve public health or the treatment of disease, despite seemingly endless trials, because “more research is needed”.

As we shall see, Australia has a more effective regulatory system for dealing with CAM. And the advocacy group Friends of Science in Medicine (FSM), an organization with goals similar to our own Society for Science-Based Medicine, is keeping the government on its toes, investigating violations of the law on its own and reporting them. We in the US could learn something from their two recent successful campaigns attacking misleading health claims. (more…)

Posted in: Chiropractic, Diagnostic tests & procedures, Guidelines, Legal, Naturopathy, Politics and Regulation

Leave a Comment (0) →

American Journal of Public Health article touts “potential public health benefits” of homeopathy

Homeopathy: It's just water.

Homeopathy: It’s just water.

An article in the April, 2016 issue of the American Journal of Public Health caught my eye: “Homeopathy Use by US Adults: Results of a National Survey.” I was pleased to see that homeopathy use is actually quite low. The 2012 National Health Survey found that only 2.1% of U.S. adults used homeopathy in the last 12 months, although that was a 15% increase over 2007. Users were mostly young, white, well-educated women, the typical CAM consumer.

Even fewer saw a homeopathic practitioner (only 19% of all users), although those who did perceived a greater benefit from homeopathic remedies. This difference, speculate the authors, could be due to several factors, one of which is

a more individualized and effective homeopathic prescription by the provider.

What? Are the authors suggesting that the series of off-the-wall questions asked by homeopaths leads to a prescription of an “effective” homeopathic remedy?

They certainly seem to be. Who are these authors, anyway?

They are Michelle L. Dossett, MD, PhD, MPH, Roger B. Davis, ScD, Ted J. Kaptchuk, and Gloria Y. Yeh, MD, MPH. All are, or were, with the Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center. All are also connected with Harvard and work, in various ways, in “integrative medicine” research. The article was funded, in part, by the National Center for Complementary and Integrative Health, and in part by Harvard. (more…)

Posted in: Clinical Trials, Homeopathy, Medical Academia, Public Health, Vaccines

Leave a Comment (0) →

Patient Beware: Off-label drug promotion by pharmaceutical companies

In truth, physicians are rarely this happy to see a drug rep.

In truth, physicians are rarely this happy to see a drug rep.

Pharmaceutical companies and their sales reps can distribute information, such as medical journal articles, about unapproved (“off-label“) uses of their drugs as long as they adhere to FDA guidelines. However, the FDA takes the position that this information must be distributed separately from information that is “promotional in nature,” i.e., for marketing purposes, a position that is now open to question.

Off-label promotion of a drug for a use that has not been approved by the FDA is, in the FDA’s view, a violation of the federal Food, Drug & Cosmetic Act (FDC Act). It is subject to criminal prosecution, because promoting a drug for new, unapproved uses is evidence of an intent that the drug be used before it has gone through the extensive process of clinical trials and a review of the evidence of safety and efficacy by a panel of experts, as required by law before a drug can be marketed. Thus, off-label promotion is seen as an end-run around the approval process that perverts the purpose of the FDC Act, which is to protect the public from ineffective and unsafe drugs.

Studies show that personal sales visits to physicians by pharmaceutical reps (called “detailing”) drives prescriptions in favor of the drugs being promoted. This is true even though physicians’ view of detailing ranges from neutral to highly negative, a “necessary evil,” and physicians are aware of potential conflicts of interest these visits precipitate.

While there are restrictions on off-label promotion, off-label prescribing by a physician is not illegal. Physician practice is regulated by the states and not within the jurisdiction of the FDA. In fact, off-label prescribing is considered both ethical and within the standard of care in appropriate circumstances. (I am currently taking a drug for an off-label use, and was informed of this, plus the risks and benefits, by my physician prior to his prescribing it.) It is also common, according to an article by law professors Ryan Abbot and Ian Ayers in the Duke Law Journal, which is well worth reading:

for the 3 leading drugs in each of the 15 leading drug classes, off-label use accounts for approximately 21% of prescriptions. Moreover, off-label uses may be the norm in some areas of practice, such as oncology, pain management, and palliative care, and in some patient populations, such as children, the elderly, and the severely ill. For example, about 80 percent of all drug prescriptions for children are off-label, and between 80 and 90 percent of all drug prescriptions for rare diseases are off-label. [Footnotes omitted.]

(more…)

Posted in: Clinical Trials, Ethics, Legal, Pharmaceuticals, Politics and Regulation

Leave a Comment (0) →

Pseudoscience sneaks into Ohio guidelines for non-drug pain treatment

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.

Ohio recently issued Acute Pain Prescribing Guidelines as part of an effort to reduce the epidemic of opioid abuse and death from overdose. They were drafted under the auspices of the Governor’s Cabinet Opiate Action Team (GCOAT), assisted by medical organizations and other groups.

The guidelines include recommendations for non-pharmacologic treatment, a typical feature of pain treatment guidelines and a worthy effort to avoid prescribing opioids for pain. Unfortunately, the guidelines include treatments that are not evidence based and potentially harmful. We’ll return to that issue shortly.

But first, a brief look at the extent of the opioid problem. According to the CDC, opioids are used to treat moderate-to-severe pain and are often prescribed following surgery, injury, or for painful health conditions, like cancer. In the past few years, there has been a dramatic increase in the acceptance and use of prescription opioids for the treatment of chronic, non-cancer pain, such as back pain or osteoarthritis. From 1999 to 2013, opioid prescription and sales in the U.S. have nearly quadrupled, and overdose deaths have quadrupled right along with them. (more…)

Posted in: Acupuncture, Chiropractic, Guidelines, Pharmaceuticals, Politics and Regulation

Leave a Comment (0) →

Docs v. Glocks: government regulation of physician speech

Glock 19 pistolA few years ago, an Ocala, Florida, pediatrician, as part of a routine visit, asked a patient’s mother whether she kept firearms in the home. She refused to answer, feeling the question constituted an invasion of her right to privacy. The pediatrician then terminated the relationship and told the mother she had 30 days to find a new doctor for her child. In another incident, a mother reported she was separated from her children while medical staff asked them whether their mother owned firearms. And, according to a Florida legislator, he was told to remove firearms from the home during an appointment with his daughter’s pediatrician.

Complaints to Florida legislators about these and similar incidents prompted the introduction of a bill that would have, among other things, criminalized any

verbal or written inquiry by a . . . physician, nurse, or other medical staff person regarding the ownership of a firearm by a patient or the family of a patient or the presence of a firearm in a private home . . .

As finally passed by the legislature and signed by Governor Rick Scott, the 2011 Firearm Owners Privacy Act subjects physicians to disciplinary action for making “verbal or written inquiry” into a patient’s firearm ownership when the physician does not “in good faith believe” such inquiries are “relevant to the patient’s medical care or safety of others.” The Act included amendments to the Florida Patient’s Bill of Rights and Responsibilities, adding similar provisions. (The Act also applies to health care facilities, but here we will discuss only its effect on physicians and their patients.) Physicians may not enter any information regarding firearm ownership into the patient’s medical record if they know this information is not “relevant to the patient’s medical care or safety, or the safety of others.” They may not “discriminate” against a patient “based solely on the patient’s Second Amendment right to own firearms or ammunition.” Finally, physicians must refrain from “unnecessarily harassing” a patient regarding firearm ownership during an examination. (more…)

Posted in: Ethics, Legal, Politics and Regulation, Public Health

Leave a Comment (0) →

Legislative Alchemy 2015: Another losing season for CAM practitioners

legislative-alchemy-image
One of the main, but perhaps underappreciated, reasons quackery thrives in the United States is that the states legalize it by licensing practitioners of pseudoscience as health care providers. These practitioners are placed under the regulatory jurisdiction of, well, themselves. I call the whole deplorable process Legislative Alchemy, and you can see all posts on the topic here. It gives practitioners an underserved imprimatur of state authority and leaves public protection from harmful practices to the oversight of those who are themselves engaging in the very same conduct. Each year, dozens of bills are brought before the state legislatures to establish initial licensure or, once that goal is achieved, scope of practice expansion.

Most attempts fail, but CAM practitioners are a dogged bunch, and they will come back each year until they get what they want. It took chiropractors about 60 years to become licensed in all 50 states. Acupuncturists are almost there. Naturopaths lag far behind, but are slowly gaining ground each year, even if it is only via practice expansion in states where they are already licensed. 2015 was a losing season for all, but not without advancement toward larger goals.

(more…)

Posted in: Acupuncture, Chiropractic, Diagnostic tests & procedures, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation

Leave a Comment (0) →
Page 2 of 15 12345...»