Leigh Page
June 12, 2013

Treatments That Are Still Controversial

Physicians are deeply divided over the efficacy of complementary or alternative medicine (CAM). Many believe that such treatments have a place within everyday medical treatment; others feel that prescribing or condoning them is not responsible medicine.

Whatever their own belief, doctors are regularly faced with patients who are using or who ask for complementary or alternative treatments, and the physician needs to decide how to respond.

To figure out what to do, you first have to understand what CAM is. If you’re not quite sure, you’re not alone.

“Defining CAM is difficult, because the field is very broad and constantly changing,” states the National Center for Complementary and Alternative Medicine (NCCAM),[1] which is part of the National Institutes of Health. “NCCAM defines CAM as a group of diverse medical and health care systems, practices, and products that are not generally considered part of conventional (allopathic) medicine.”

“Complementary medicine” refers the use of such therapies as acupuncture in conjunction with conventional therapies — in this instance, pain.[1] Most CAM use by US physicians is of the complementary variety. “Alternative medicine” refers to the use of CAM in place of conventional medicine.

Consider the views of 2 physicians on opposite sides of the CAM debate: Aditi Nerurkar, MD, Assistant Medical Director at the Cheng and Tsui Center for Integrative Care at Beth Israel Deaconess Medical Center in Boston, and David H. Gorski, MD, PhD, Associate Professor of Surgery at Wayne State University in Detroit. Nerurkar is a supporter of CAM; Gorski is a skeptic.

But Nerurkar and Gorski have something in common. Both are very careful about what they tell patients about this sweeping field, which includes many unrelated therapies — from chiropractic, to naturopathy, acupuncture, yoga, and massage, not to mention a vast array of vitamins and herbal supplements — that are still largely untested in scientific studies.

Both physicians choose their words carefully when discussing CAM because they face a rather thin line between what is medically acceptable, even if unorthodox, and what is not. If you exaggerate claims, you may be sued for malpractice or hauled before your medical board. But if you come down hard on CAM, you’ll alienate patients who are tenacious believers.

At Beth Israel Deaconess, for instance, Nerurkar uses CAM techniques, such as yoga and meditation, in conjunction with standard drugs and procedures in internal medicine. That combination is now being called “integrative medicine.” But Nerurkar has good reason for keeping her enthusiasm for CAM in check. “Some of these treatments have evidence supporting them, and some don’t yet,” she admits. Nerurkar acknowledges there are still many gaps in knowledge of mind/body treatments, and they will have to be filled in with further studies, but she strongly believes those future studies will show effectiveness.

Gorski, a breast cancer specialist, flat-out calls CAM techniques quackery. He says yoga is nothing more than a stretching exercise, but “yoga sounds way more cool than stretching.” But he tones down his anti-CAM rhetoric when discussing treatments with patients. “I try to be as nonjudgmental as possible,” he says. Gorski believes that stretching is helpful for many breast cancer patients, and because yoga involves stretching, it may be helpful.

A physician’s stance on CAM can affect patient safety. Take the wide and confusing field of supplements, which account for the majority of CAM use. According to a recent article in JAMA Internal Medicine, 51% of all US Food and Drug Administration (FDA) Class I recalls from 2004-2012 involved supplements; the worst offenders were preparations for sexual enhancement, bodybuilding, and weight loss.[2]

One problem with supplements is the potential for serious interactions with prescription medications. Such adverse events may even involve seemingly harmless herbal preparations, such as ginkgo biloba, saw palmetto, and ginseng. The Natural Medicines Comprehensive Database, which is said to offer “the most comprehensive listing of brand-name product ingredients available,” has identified more than 1600 potential interactions between natural products and conventional drugs.[3]

Still, despite the potential safety risks, doctors dealing with patients’ use of supplements tend to be what Gorski terms “shruggies”: They just shrug off the fact that their patients are using CAM therapies and don’t bother to research them. “They know it’s BS,” he says, “but they don’t want to do anything about it.”

Ethical Complications for Doctors

CAM became complicated for doctors in the 1980s, when the American Medical Association (AMA) was forced to abandon a simple rule: The medical profession should have nothing to do with alternative medicine. For 30 years, Section 3 of the AMA principles of medical ethics stated, “A physician should practice a method of healing founded on a scientific basis; and he should not voluntarily associate professionally with anyone who violates this principle.”[4]

The AMA expunged this principle after it was sued for antitrust violations by chiropractor Chester A. Wilk in 1976. The AMA litigated for 14 years and ultimately lost the case. Four years later, Congress passed the Dietary Supplement Health and Education Act (DSHEA) of 1994, which put supplements in a different category from food or drugs.[5]

Under DSHEA, supplements still have to meet their advertising claims and manufacturing standards, but they do not have to meet the premarket efficacy and safety standards that all pharmaceuticals must comply with. During this period, CAM use rose sharply, and by 2007, nearly 40% of all adult Americans were using some form of CAM.[6]

This leaves doctors in the uncomfortable position of balancing a patient’s wishes to use CAM treatments with what the physician feels is the patient’s best interests — 2 goals that can conflict.

But do doctors have much sway when patients are set on using a CAM treatment? Many observers think Steve Jobs, the Apple CEO who died in 2011 of pancreatic cancer at age 56 years, shortened his life when he delayed surgery and chemotherapy for 9 months to focus on acupuncture, fruit juice therapy, and spiritual consultations.[7] “It’s not certain whether the delay affected [Jobs],” Gorski says, “but you don’t know for sure, and what he did certainly didn’t help him.” The bottom line, however, is that this famously strong-willed executive would not be dissuaded from his unorthodox approach.

Making CAM Use as Safe as Possible

Family physician Terrence E. Steyer, MD, Chairman of the Department of Clinical Sciences at the University of Georgia, says monitoring patients’ use of CAM is not so hard. It involves bringing up the topic with them, researching treatments, and being willing to go with their choices. “You need to keep your priorities in mind,” he says. “First, do no harm, and then look for evidence that backs up the claims.”

Steyer recommends asking every patient about CAM use during routine history-taking. Patients often don’t volunteer this information because they expect physician push-back, so it is important to not sound judgmental, he says. Rather than mentioning CAM by name, he suggests asking patients, “Are you doing anything else for this condition?” Once the therapy is known, check for possible risks with the FDA’s list of tainted supplements, posted on the agency’s Website.[8]

Steyer also recommends verifying the licensure and checking the record of your patient’s alternative-care provider with his or her board. Whereas chiropractors, massage therapists, and acupuncturists have to be licensed in most states, oversight is spottier for other practitioners. He recommends contacting CAM providers to learn about their therapies. A CAM provider may instruct patients to tell their regular physicians about CAM use and may even refer patients to a conventional physician who is a CAM-friendly doctor.

Learning about the efficacy of CAM treatments is challenging; there aren’t that many scientific studies on CAM. NCCAM and the National Cancer Institute’s Office of Complementary and Alternative Medicine fund some studies of CAM therapies and list their findings.[9] Findings are also reported by Science-Based Medicine, run by skeptics of CAM; Gorski is Managing Editor.

“There are no amazing results yet,” Steyer says of the research done to date, but he expects more encouraging findings in the future. If no efficacy can be found, he counsels against trying to get patients to stop using a treatment, provided there is no evidence of harm. “The placebo effect of a supplement is huge,” he says. “A lot of people think it is making them feel better.”

An Invitation to a Malpractice Suit?

Are doctors legally required to discuss CAM treatments with patients? The jury is still out on that.

Attorneys who have dealt with lawsuits involving CAM have differing opinions. Ericka L. Adler, JD, a partner in the Chicago law firm of Kamensky Rubinstein Hochman & Delott, which handles healthcare cases, says that doctors can tell patients, “I’m not familiar with these other types of products,” and leave it at that.

Others feel that the law of informed consent requires physicians to discuss CAM treatment options. “The information about potential risks, including frequent, nonserious adverse effects as well as serious complications, is crucial for patients to know. Failure to disclose availability of benefits and risks of CAM treatments could give rise to malpractice claims,” according to Edzard Ernst, MD, and Michael Cohen, JD.[10]

Some patients may ask for a prescription or a referral to a CAM provider to help get insurance coverage. Although almost all CAM treatments are paid out of pocket, in some exceptions, health insurers may approve coverage if it meets their medical necessity criteria.

State medical boards also have a say on physician referrals to CAM providers. Find out your own state board’s regulations. Generally, state boards tend to follow guidelines approved by the Federation of State Medical Boards, which state that physicians must discuss available treatments with the patient, thoroughly examine the patient, have a basic understanding of the therapy, refer to a state-regulated therapist, and monitor the treatment.[11]

Some physicians sell nutritional supplements in their offices, which can be a valuable source of income. But the AMA considers such sales a conflict of interest.[12] Such sales are illegal in some states, whereas other states require doctors to disclose their interests in the product or limit their profits.

Nerurkar predicts that as physicians become more aware of alternative therapies, they will become more tolerant. In 2011, she led a study that found that nearly 1 in 30 Americans (2.9% of survey respondents), representing 6.36 million Americans, reported using “mind/body therapies” (MBTs) in the prior 12 months because their provider recommended that they do so (compared with 15.5% who self-referred for such therapies). Deep-breathing exercises were the most commonly used provider-recommended MBT (84.4%), followed by meditation (49.3%), yoga (22.6%), progressive muscle relaxation (19.9%), and guided imagery (13.9%); similar trends were seen in the self-referred MBT group. (The total percentage exceeded 100% because some respondents used more than 1 MBT modality.)[13]

“We didn’t expect to see provider referral rates that were quite so high,” she observes. “It makes us wonder whether referring patients for these therapies earlier in the treatment process could lead to less use of the healthcare system, and possibly better outcomes.”

Story Source

References

1. National Center for Complementary and Alternative Medicine. Complementary, alternative, or integrative health: what’s in a name? May 2013. http://nccam.nih.gov/health/whatiscam Accessed May 23, 2013.
2. Harel Z, Harel S, Wald R, Mamdani M, Bell CM. The frequency and characteristics of dietary supplement recalls in the United States. JAMA Intern Med. 2013;173:929-930.
3. Natural Medicines Comprehensive Database. Over 1600 potential interactions between natural products and conventional drugs identified by research group; 25% rated as severe. May 18, 2007.http://naturaldatabase.therapeuticresearch.com/PressReleases.aspx?s=ND&cs=&page=PressReleases&xsl=PressRelease&ID=20070515-Ix&ReturnLink=s%3DND%26Archive%3DFalseAccessed June 1, 2013.
4. Judicial Council, American Medical Association. Principles of medical ethics. June 7, 1958. http://www.ama-assn.org/resources/doc/ethics/1957_principles.pdf Accessed May 26, 2013.
5. US Court of Appeals 7th Circuit. Wilk v. American Medical Association. 1990. http://openjurist.org/895/f2d/352/wilk-dc-dc-dc-dc-v-american-medical-association-a-wilk-dc-w-dc-b-dc-b-dc Accessed May 29, 2013.
6. National Center for Complementary and Alternative Medicine. National Health Interview Survey. December 2008.ftp://ftp.cdc.gov/pub/Health_Statistics/NCHS/Dataset_Documentation/NHIS/2007/althealt_freq.pdf Accessed June 1, 2013.
7. Cartwright MM. Alternative medicine & the death of Steve Jobs. Psychology Today. October 21, 2011.http://www.psychologytoday.com/blog/food-thought/201110/alternative-medicine-the-death-steve-jobs Accessed May 20, 2013.
8. US Food and Drug Administration. Tainted supplements CDER.http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder Accessed May 22, 2013.
9. National Center for Complementary and Alternative Medicine. Health topics A to Z.http://nccam.nih.gov/health/atoz.htm Accessed May 30, 2013.
10. Ernst E, Cohen M. Informed consent in complementary and alternative medicine. Arch Intern Med. 2001;161:2288-2292. Abstract
11. Federation of State Medical Boards. Model guidelines for the use of complementary and alternative therapies in medical practice. April 2002. http://www.fsmb.org/pdf/2002_grpol_Complementary_Alternative_Therapies.pdfAccessed May 23, 2013.
12. American Medical Association. Opinion 8.063 — sale of health-related products from physicians’ offices. December 1999. http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion8063.pageAccessed May 23, 2013.
13. Nerurkar A, Yeh G, Davis RB, Birdee G, Phillips RS. When conventional medical providers recommend unconventional medicine: results of a national study. Arch Intern Med. 2011;171:862-886.http://archinte.jamanetwork.com/article.aspx?articleid=487037 Accessed May 23, 2013.