Many CAM and integrative doctors recommend and/or sell all kinds of nutritional and herbal products to their patients. There is a supplement manufacturer sub-industry which only sells to physicians and other health care professionals, for resale to patients. And most of the top tier, high profile docs have their own private label supplement brands. That’s a fact. But is it legal and ethical to do so?
Legal is a matter of state law. But for better, (but mostly) for worse, ethical is largely determined by those noble, public-spirited and never ethically-challenged folks at the AMA (American Medical Association for those living under a rock). They’re not completely controlled by Pharma; just ask them and they will tell you. And they’re not trying to stop cheaper non-patentable interventions like nutritional supplements and herbs, all at Pharma’s behest. Their thought leaders do not receive tens, hundreds of thousands, or millions of dollars from Pharma for research, public relations and advocacy. Just ask them and they will tell you.
And their “ethical guidelines” reflect an open-minded attitude serving the best interests of the patients. Ok, you get the point.
So is it AMA “ethical” for physicians to sell nutritional and herbal products? Technically yes, but practically, not so much:
Here’s the latest iteration of the AMA “ethical” rule on the sale of health related products. (Sorry, it’s longish)
9.6.4 Sale of Health-Related Products The sale of health-related products by physicians can offer convenience for patients, but can also pose ethical challenges. “Health-related products” are any products other than prescription items that, according to the manufacturer or distributor, benefit health. “Selling” refers to dispensing items from the physician’s office or website in exchange for money or endorsing a product that the patient may order or purchase elsewhere that results in remuneration for the physician. Physician sale of health-related products raises ethical concerns about financial conflict of interest, risks placing undue pressure on the patient, threatens to erode patient trust, undermine the primary obligation of physicians to serve the interests of their patients before their own, and demean the profession of medicine. Physicians who choose to sell health-related products from their offices or through their office website or other online venues have ethical obligations to:
(a) Offer only products whose claims of benefit are based on peer-reviewed literature or other sources of scientific review of efficacy that are unbiased, sound, systematic, and reliable. Physicians should not offer products whose claims to benefit lack scientific validity.
(b) Address conflict of interest and possible exploitation of patients by: (i) fully disclosing the nature of their financial interest in the sale of the product(s), either in person or through written notification, and informing patients of the availability of the product or other equivalent products elsewhere; (ii) limiting sales to products that serve immediate and pressing needs of their patients (e.g., to avoid requiring a patient on crutches to travel to a local pharmacy to purchase the product). Distributing products free of charge or at cost makes products readily available and helps to eliminate the elements of personal gain and financial conflict of interest that may interfere, or appear to interfere with the physician’s independent medical judgment.
(c) Provide information about the risks, benefits, and limits of scientific knowledge regarding the products in language that is understandable to patients.
(d) Avoid exclusive distributorship arrangements that make the products available only through physician offices. Physicians should encourage manufacturers to make products widely accessible to patients.
So what does this gobbledygook mean? Well, it means that you CAM docs have a problem.
First, virtually no supplements or herbal remedies have the kind of scientific support set out in subparagraph (a). There are only a few supplements for which the FDA have approved health claims, like folic acid for pregnant mothers, and such. I also suspect that the peer-reviewed literature the rule refers to means mainstream journals to the AMA. My guess is that this AMA subsection could be used to render “unethical” the recommendation of the products routinely recommended and sold by physicians.
But there are bigger problems.
Subsection (b) seems to suggest you have to either give away the products, or sell them at cost in order to avoid the conflict of interest or appearance of the conflict. Moreover, you’re only supposed to give away or sell at cost enough product to meet the patient’s immediate needs, or until they can get the product from a less conflict-ridden source.
This is idiotic. By the logic of this provision, if you go to a surgeon for a surgical consult, it would be unethical for the surgeon to actually perform the surgery rather than just recommend it, because he has a financial interest in performing the operation.
But not to worry, under the rule, the surgeon can lessen the conflict by either 1. Operating for free, or 2. Charging his actual cost, rather than the high fees the surgeon normally charges. To further lessen the conflict, he should only do a temporary surgery, just fix the problem enough to allow the patient to go to another surgeon who has no financial conflict of interest arising from the first surgeon’s surgery recommendation. The same would apply to an interventional cardiologist recommending a stent, angiogram/angioplasty or to any other physician who both makes recommendations and provides a procedure or therapy to effectuate or implement the recommendation.
To generalize, there is the same conflict of interest for any professional who both consults and does something. By the logic of the AMA rule, a lawyer cannot both recommend suing and actually suing (unless he sues for free or at cost). Nor could a lawyer prepare a trust, or do anything the lawyer recommends, because implementing the recommendation means that the lawyer makes extra money for the doing, which under the logic of the AMA rule irreparably taints the lawyer’s judgement (unless the service is done for free or at cost, and is only a temporary fix until a conflict-free professional is retained).
The AMA world view embodied in this rule reminds me of the commercial for a personal identity protection company. You know these commercials: There’s a patient with his mouth open in a dentist’s chair, and a guy with a white coat looking in the patient’s mouth who says “you have one of the worst cavities I’ve ever seen.” The patient says. “OK doc, fix it.” And the guy in the white coat says “Oh, I’m not a dentist; I don’t fix teeth, I’m just a dental monitor.”
In the AMA la-la ethical world, the guy tells the patient “Yes I am a dentist and I’d like to fix your tooth, but I have a conflict because I’m going to make extra money doing what I said should be done. So, we’re done here and you have to see another dentist who will actually fix your cavity”
Is this really how we want physicians who have a service or product to act? Have them become health care monitors, and have another class who are health care problem fixers?
Let’s not leave AMA ethical la la land yet: At the new dentist’s office, the dentist looks over the films, examines the patient, and concurs with the recommendation, thereby creating a chargeable evaluation and management fee. Doesn’t the new dentist also have a conflict? He’s got his examination fee, and he’ll get extra money for fixing the cavity. This can get ridiculous!
Let’s face it, we rely on professional to give their opinions and implement a solution within the professional’s expertise. This happens zillions of times a day, all over the world. To single out physicians who use and sell the kind of products used by millions of people is just nuts.
This rule obviously hasn’t been used to stop surgeons, cardiologists or dentists from doing the thing they were trained to do. But what about a CAM physician who uses herbals or nutraceuticals as primary therapy? Can they do that, or are they caught in the same AMA ethical net?
But before we get to that, here is another question:
Does this AMA ethical rule matter?
Short answer: yes
Alittle longer answer: it matters because some state medical board laws have specifically incorporated the AMA ethical rules into their standards of professional conduct, such that a violation of an AMA ethical rule is a violation of the state’s medical board law. Even in the absence of express incorporation, states can and do go after physicians for ethical violations of all sorts (just ask docs like Burzynski about that).
Why is any of this relevant or important to CAM docs?
There’s a new case against a doc (it’s my case, and not in California or Texas where I maintain offices, but I don’t want to give the details just yet) which raises the very issue of whether it is unethical and a state board law violation to use and sell herbal and nutritional interventions as primary therapy. What makes the case more interesting is that the therapy is only available from physicians, and only physicians who have gone through the company’s training about how to use the products. (Many of you CAM docs probably know the product line I’m referring to.)
How can the AMA possibly view this kind of thing as the “sale of health a related product?” Well maybe it doesn’t, but initially at least, the state medical board seems to think it is the sale of a “health related product” and is going after the doctor for do so.
Here’s where it gets interesting with the AMA ethical rules: The second opinion after the sale of health related products is the following ethical precept:
9.6.6 Prescribing & Dispensing Drugs & Devices In keeping with physicians’ ethical responsibility to hold the patient’s interests as paramount, in their role as prescribers and dispensers of drugs and devices, physicians should:
(a) Prescribe drugs, devices, and other treatments based solely on medical considerations, patient need, and reasonable expectations of effectiveness for the particular patient.
(b) Dispense drugs in their office practices only if such dispensing primarily benefits the patient. (c) Avoid direct or indirect influence of financial interests on prescribing decisions by: (i) declining any kind of payment or compensation from a drug company or device manufacturer for prescribing its products, including offers of indemnification; (ii) respecting the patient’s freedom to choose where to fill prescriptions. In general, physicians should not refer patients to a pharmacy the physician owns or operates. AMA Principles of Medical Ethics: II,III,IV,V.
Does this section apply to a doctor prescribing and selling a product used as primary therapy if the product is only available from the health care provider and only from one who is trained by the manufacturer? It seems to.
Although the heading only refers to “drugs” and “devices”, the actual rule specifically mentions “drugs, devices, and other treatments.”
A prescription is just a written order issued by a healthcare provider containing the provider’s recommendation for a product, such as a drug, device, or other treatment, or in some cases a recommendation of behavior (like bedrest). So a written order by a physician to take an herb or nutritional supplement in order to cure or mitigate a disease is a prescription and such products are prescribed. (And in case you are concerned, the fact that a physician prescribes an herb or supplement for the treatment of a disease doesn’t turn the product into a drug, because it’s the manufacturer’s intent that governs not the prescribing practices of healthcare providers, under FDA law.)
Admittedly, the language in (b) mentions a pharmacy, but not all prescribed things are found in pharmacies. Take the aforementioned bedrest for example. And we’re stipulating that the prescribed products can only be obtained through the doctor, and is not available directly to the consumer.
So does this AMA rule 9.6.6 sanction a physician prescribing an herbal remedy or supplement for the treatment or mitigation of the disease or medical condition?
I looked at the literature and haven’t seen any cases on this yet. I think it does, and the case I’m working on will provide what may be the first legal ruling on the issue.
As a backup, it seems to me that even if both AMA ethical rules could apply, I don’t see how a medical board can sanction a physician for a violation of an ethical rule where the physician’s actions are ethical under another ethical rule, or arguably so. It seems to me that a board must first make this determination, publish it and put the licensees on notice, which my research indicates has not yet been done in this state at least.
So although I think I am right, as of right now, there doesn’t appear to be a definitive answer to the question as to whether a CAM physician can prescribe and sell an herbal remedy or nutritional supplement or supplement regime as primary therapy for the treatment or mitigation of a disease, at least in a state which has specifically incorporated the AMA ethical rules.
But give me six months or so and I’ll give you the answer; hopefully the one you’re looking for.
In the meantime, and to make that happen, any academics out there with some ethics background care to opine and help make it happen? I’ll be waiting to hear from you.
Rick Jaffe, Esq.