By guest-blogger Jay Udani, M.D., C.P.I.
CEO, Medicus Research LLC
Assistant Clinical Professor, UCLA School of Medicine
Medical Director, Northridge Hospital Integrative Medicine Program
The relationship between doctors (allopathic physicians) and dietary supplements has become more intimate over time. During their initial introduction, doctors simply chose to ignore dietary supplements—denial is a common defense mechanism used by physicians, and it has worked so well for managed care, HMOs, Independent Practice Associations (IPAs), Medicare cuts, and now medical tourism, that it was a logical choice for dietary supplements as well.
Like the rest of these realities, dietary supplements didn’t just go away, so doctors began to dismiss them as nonsense. This was easy to do, as the marketing companies who sold dietary supplements didn’t know how to speak the language of physicians. The only communication that the doctors had with these products was in the general marketplace where the dietary supplements were promoted with testimonials, infomercials, advertorials, and hype. “Clinically tested” or “Clinically proven” meant a rat study in Siberia. Naturally the doctors felt that they had the moral high ground when they told their patients that these products are “snake oil”. They had not been given data to evaluate that was in a format familiar to them, i.e. the Randomized, Double-Blind, Placebo Controlled Study published in a peer-reviewed medical journal which was indexed on Medline. One thousand years of traditional use means nothing to a physician if he cannot find that information on Medline.
Over the last decade, several things have changed which have contributed to warming of the relationship between doctors and dietary supplements. While they may not be married, they are at least dating and exploring the relationship. What is the current and future nature of the relationship and what are the factors that have led to this change?
Recently, physicians have become much more likely to recommend dietary supplements to their patients. In the opinion of the author, there are several reasons for this shift. The first is the changing demographics of practicing physicians. A physician today is more likely to be younger, female, and of an Asian or Hispanic background. The relevance of their ethnic background is that these cultures have a history of traditional use of herbal medicine and therefore the physician is likely to have been exposed to these products while growing up. Also, female physicians are more likely to recommend, inquire about, and personally take dietary supplements than their male counterparts (HCPIS, 2007). Personal experience with dietary supplements is critical as physicians are also consumers and are influenced outside of their professional environment by the same marketing messages as everyone else.
There is also a new strain in the relationship between doctors and the pharmaceutical industry. The recent safety concerns stemming from the withdrawal of several medications from the market has put physicians on edge. There are more and more restrictions regarding the role of the pharmaceutical sales representative, and the explosion in direct-to-consumer advertising has put an unwelcome new participant in the middle of the doctor-patient relationship. All of this serves to make the physician more wary and more open to alternatives.
The role of insurance companies and managed care has turned the doctor-patient relationship into a consumer-vendor relationship, with neither side able to count on a long term bond. The disintegration of this relationship coupled with a significant financial struggle to fill prescriptions has resulted in a new form of non-compliance. Up to 40% of all patients have failed to fill a prescription or have cut their prescription pills in half for financial reasons (SOURCE: USA Today/Kaiser Family Foundation/Harvard School of Public Health: The Public On Prescription Drugs and Pharmaceutical Companies (conducted Jan. 3-23, 2008)). Many of these patients end up purchasing over-the-counter alternatives to these prescriptions, including dietary supplements.
Add to this non-compliance the arrival of the internet printout-armed patient, and significant reductions in physician reimbursement (as of the writing of this article, the senate has failed to block a 10% cut in Medicare reimbursement), physicians have begun to not only tolerate, but recommend and even sell supplements in their offices as they look for alternative sources of income.
So who are these physicians and what are they recommending? They vary from specialty to specialty and across practice setting (solo, small group, large HMO, etc), so we will provide some generalizations based on observation and informal surveys. These data are not based on formal survey results.
Obstetrics and Gynecology – were found in the HCP study to be the most likely to recommend supplements, but this appears to be an artifact of the near universal recommendation of pre-natal vitamins to all women who are of child-bearing age.
Integrative Medicine / Alternative Medicine Physicians – These physicians are self-defined, as there is not a formal board certified specialty requirement. However they are usually primary care physicians (internal medicine, family practice) who use dietary supplements for almost every therapeutic area in their practice.
Family Practice / Internal Medicine – These are the general adult physicians and use dietary supplements for general wellness (multivitamin), heart health (omega 3 fatty acids, fiber), and chronic conditions which require continual medication usage and adjustment (hypertension, diabetes, arthritis, etc.).
Orthopedic Surgery – Despite the results of the GAIT trial, orthopedic surgeons recommend (or at least tolerate) glucosamine and chondroitin combinations.
Dermatologists / Medi-Spa Physicians – These physicians recommend and often sell a host of cosmeceuticals which often contain anti-oxidants and other supplements and herbs to promote skin health.
Cosmetic Surgeons – In Beverly Hills, these physicians routinely use arnica to reduce post-operative swelling and bruising in order to improve post-operative recovery from cosmetic surgery procedures.
Urologists – Urologists will tolerate the use of saw palmetto and other prostate health herbs, but recent studies questioning the safety of selenium in this population have led to increased caution.
Anti-Aging Physicians – use anti-oxidants, hormones, and phytohormones including DHEA and phyto-estrogens.
Weight Management Physicians – will use dietary supplement stimulants, fat and carbohydrate blockers, and meal replacements with vitamins and minerals.
Ophthalmologists – will use bilberry and high-dose antioxidants for eye health.
Oncologists – will tolerate the use of dietary supplements for the reduction of side effects from chemotherapy (such as ginger for nausea) and radiation so long as these products do not interfere with the mechanism of action of these treatments.
Detailed information on these specialists, including the percentage of those who recommend vs. sell dietary supplements in their practice will require further study.
Physicians seem to be comfortable with products sold by pharmaceutical companies (Abbott, Allergan, etc) and even with pharmaceutical products which were derived from dietary supplements (Lovaza, which is omega-3 fatty acids from fish oil). After these companies, physicians seem most comfortable with products which are sold as “physician only,” since this seems to lend the products an aura of increased authenticity. Lastly, physicians are wary of the bewildering array of mass market brands and products which seem impossible to distinguish from one another.
What are physicians looking for? Safety, first and foremost. Above all else, “do no harm”. They want evidence that the ingredient and product is safe. Different specialties have different levels of need here. In oncology, the primary concern is that the product does not interfere with the prescribed treatment (chemo, radiation, surgery). Whatever else it may do is a bonus. Orthopedic surgeons are concerned only when there is an upcoming surgery to make sure the supplements don’t cause surgical complications. Internists are watching for drug-herb and herb-drug interactions, especially supplements and herbs that impact the cytochrome p450 system. Recent meta-analyses touting the dangers of vitamin supplementation have indicated that consumption of these vitamins may have significant untoward effects including death. These analyses are not without their methodological flaws, a discussion which is beyond the scope of this article, but suffice it to say that physicians reading mainstream journals will be more likely to believe this information than the small efficacy studies which are published in defense of these vitamins.
Once assured of safety, physicians look for efficacy. There will never be a randomized, double-blind, placebo-controlled study with 10,000 patients followed for 5 years each, but physicians are beginning to understand that. The baseline for discussion is a randomized, placebo controlled study. The sample size is secondary, although they are unlikely to be all that impressed with a 10 person pilot study. They understand (and so should those who fund these studies) that a pilot study is just that, a pilot to test a hypothesis. If the product works as expected, the physician will be looking for the larger follow-up study to confirm the pilot. The physician looks for statistical significance (with a p value less than 0.05), but is also looking for clinically significant results. In other words, a product that achieves a statistically significant reduction in cholesterol but a total reduction of only 5 points will be meaningless, because a 5 point reduction in cholesterol will not impact the likelihood of any of the bad outcomes such as heart attack or stroke. Finally the physician is going to look at who performed the study. When the study is performed outside of the United States, rightfully or not, extra scrutiny will be paid to the results and the patient population. This is the concept of generalizability: Can a study in a rural Chinese population be applied to an inner city urban population in the United States? The answer is unknown, but the physician is trained to be skeptical of such results. The physician is also likely to apply extra scrutiny when the authors of the study are employees of the sponsoring company. Finally, when touting efficacy, if you have a good study, please stick to the results of the study. Nothing is a bigger turnoff to a physician when the salesperson starts talking about “testimonials” such as “I know my aunt Mildred reduced her cholesterol by 100 points on this product.” All that does is cheapen the value of the study efficacy results and turn off the physician who now has to doubt the study veracity because the testimonials have been given equal weight.
The future of the relationship between dietary supplements and physicians is bright. All of the demographic and economic reasons that have driven these two together are only going to continue. The opportunity is for the dietary supplement industry to support quality clinical trials with reputable researchers, report that data in Medline-indexed medical journals, and sponsor continuing medical education for physicians to educate them on the results. Physicians still have a significant role to play in the healthcare decisions of Americans, and by providing them the information they need in the format that they require, physicians will increasingly educate their patients on the benefits of well designed, well manufactured, and well tested dietary supplements.