Browsed by
Category: supplements

Happy New Year! Last year review, and what’s coming this year/ ACCME/Cali. Vaccine /Homeopathy/Supplements/Antitrust/Obamacare

Happy New Year! Last year review, and what’s coming this year/ ACCME/Cali. Vaccine /Homeopathy/Supplements/Antitrust/Obamacare

As we start the New Year, let’s look back and forward:

CAM’s ACCME problem

The biggest challenge facing the CAM community in the coming years is that CAM organizations are under direct attack by ACCME, the main CME accrediting agency. In the last year or two, the ACCME have initiated a process to revoke several CAM organization’s CME credit provider status.

See my post:

http://rickjaffeesq.com/2017/04/04/bad-day-cam-patients-first-cam-group-caves-accmes-extortionre-education/

If ACCME succeeds, the result would be devastating to these groups because they are financially dependent on their annual conferences. CAM physicians travel to these conferences in no small part to satisfy their annual CME requirements. Removing CME accreditations would likely dramatically reduce attendance, which would put these organizations in deep financial jeopardy. The conferences are where the CAM docs learn about the latest CAM therapies, so it’s all bad, if the CAM groups lose their course accreditation status.

There are now a handful of CAM organization that are in the process of having their CME accreditation status “reviewed.” I think revocation of ACCME CME status is the intended and likely result of ACCME’s review process of these organizations. Most of these groups are keeping this problem quiet, because they understandably fear that disclosure might jeopardize membership and future conference attendance.

What there hasn’t been yet or even seriously discussed is an all-CAM response and mobilization to deal with the problem. And I think that’s a shame and short-sighted.

Reminds me of a joke: A guy jumps off a hundred story building. As he passes the 50th floor, someone asks him “How you doing.” He responds “So far, so good.”

I have to believe there is a smoking gun out there. The ACCME has seven members, one of which is CAM’s biggest institutional adversary/detractor, the Federation of State Medical Boards.

Because there are so many CAM groups that have come under review/attack in such a short period of time, I have to believe that it’s not chance; its a concerted effort, or a conspiracy if you will, to eliminate CAM organizations which will make the dissemination of CAM information much more difficult.

Hey Santa Claus, I know I’m alittle late (or early), but what I want for Christmas is that smoking gun from the Federation to the other ACCME members laying out the illegal conspiracy to revoke the ACCME certification of all CAM groups. That would be a gift that would keep on giving and I think could result in the end of the attack.

Are you listening Santa?

The California vaccine concerned folks

For better and worse, not a lot happened in California vaccine concerned world.
You didn’t need a crystal ball to predict that every lawsuits challenging SB 277 would be dismissed, and that’s exactly what happened. And the same result awaits any new lawsuits which are direct attacks on the law (which removed the personal belief exemption).

The law’s primary legislative sponsor, Dr. Richard Pan, tried some other legislative tricks to eventually force all parents to vaccinate their kids, but nothing has gotten close so far. The vaccine concerned have to remain vigilant because there’s surely more coming from this guy and his vaccine happy posse.

There’s some talk about a SB 277 repeal bill. Obviously that won’t happen next year, but there are benefits to keeping the issue alive in the California legislature. So go for it, I say.

The Biggest surprise

I had thought that 2017 would bring a spate of new board actions against Cali docs who have written medical exemptions, since according to conventional medical authorities, there’s no such thing as a valid exemption from all vaccines throughout childhood. But apart from the Bob Sears case, (and maybe one other), I haven’t seen the California Medical Board go after the many docs who are writing these exemptions. It might because the board requires a complaint from someone to initiate an investigation, and there just aren’t any complaints yet.

What’s going to happen in 2018 for the vaccine concerned?

This year we should get a ruling in Bob Sears’s case and that ruling will tell the community and its docs who are writing the exemptions whether it’s safe to continue to do so. So keep your fingers crossed and stay tuned!

The Green Pharmaceutical homeopathy case

Homeopathy is under attack in California.

See my most recent post on it:

http://rickjaffeesq.com/2017/12/12/update-green-pharmaceuticals-homeopathy-caseyou-can/

The plaintiffs did file a response to Green’s request to the California Supreme Court to review the appellate court’s decision which overturned the bench trial judge’s defense verdict. Green’s lawyers have submitted a reply, and several groups and at least one private attorney (me) filed amicus letters. We should know this month whether the Cali. Supremes will take the case. I hope they do.

Can physicians sell supplements?

Last year, I handled a case in New Mexico involving a physician’s sale of supplements. The AMA considers it unethical for physicians to sell supplements.

Who Cares? The eight or so states that incorporate the AMA ethical precepts into their standard of care laws.

New Mexico went after a physician for selling a therapeutic herbal remedy (Byron White formulas) to a patient, a practice violation based on the AMA precepts. We said it wasn’t.

I didn’t change or clarify the law, but I did get the case against the doc dismissed, (which was my job), and I had some help from star and energy powerhouse Shirley MacLaine.

See my post:

http://rickjaffeesq.com/2017/07/05/new-mexico-integ…danger-work-done/

Thanks again Shirley!

Can a CAM physician sue a medical board for antitrust violation for bringing a board case?

My view is that it’s almost impossible to win such a case.
See my post at:
http://rickjaffeesq.com/2017/04/14/want-sue-medical-board-antitrust-violations-restraining-trade-prosecuting-practicing-kind-medicine/

Nothing has happened since the post to change my mind. Every doc who has tried has had his/her case dismissed. I don’t see anything changing in the next year on that score. Are there possible benefits to bringing this kind of case and getting thrown out of court? It depends on who you ask.

Obamacare

I end with Obamacare because its demise continues to be predicted, but from the CAM business perspective, Obamacare is basically irrelevant. Let’s face it, CAM by definition is unaccepted by the mainstream which in insurance-speak means it is experimental and makes it not insurance reimbursable (at least if the therapies and procedures are properly coded). CAM practice is a cash-based business model. So I don’t see the recent or future efforts to cripple Obamacare as having a direct adverse impact on CAM practitioners. In addition, the large majority of Americans receive their health insurance through their employers or various associations, and those folks will not be directly impacted by whatever the Republicans do to further cripple Obamacare.

Indirectly however, as more people are forced out of insurance, they will either not get the care, or get the care and not pay for it. This will raise the cost of healthcare and health insurance for others. Higher costs for healthcare and healthcare insurance which will result in people having less income for discretionary, non-insurance reimbursable CAM healthcare. So as Obamacare becomes increasingly crippled, in the mid-term, there could be some financial downside experienced by CAM businesses. (I’m not going to go into the morality or efficiency of what’s going on as I’ve already addressed those issues in prior posts dealing with what’s wrong with the American healthcare system.
See my post at:
http://rickjaffeesq.com/2016/09/24/whats-wrong-u-s-healthcare-system-take-fix/

That’s about all for now. Looking forward to the New Year’s challenges.
To paraphrase George C. Scott in Patton as he overlooks the aftermath of a brutal battle: God help me, I love this stuff.

Happy New Year!

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com
www.rickjaffe.com

New Mexico Integrative Practitioners Dodge a Bullet (with Shirley MacLaine’s help) but there’s still danger and work to be done

New Mexico Integrative Practitioners Dodge a Bullet (with Shirley MacLaine’s help) but there’s still danger and work to be done

(Dinner with Shirley MacLaine, Pamela Costello, M.D., and Bill Wolfe, D.D.S.)

Awhile back I reported that the New Mexico Medical Board was going after a prominent integrative medical practitioner because she was prescribing and selling herbal protocols as primary therapy for the treatment of various environmentally caused neurological conditions, supposedly in violation of the AMA ethical guidelines.

See http://rickjaffeesq.com/2017/03/22/can-cam-docs-legally-prescribe-and-sell-herbals-and-nutritional-supplements-as-therapy-without-bad-things-happening-prescribe-yes-sell-well-see/

New Mexico is one of a handful of states that incorporates the AMA’s ethical guidelines as rules of practice, the violation of which are disciplinable offenses. Ironically, the AMA never intended its ethical precepts to be used as practice guidelines to discipline doctors. How do I know this? Easy, after each general ethical precept, the AMA places the following cautionary language: “The Opinions in this chapter are offered as ethics guidance for physicians and are not intended to establish standards of clinical practice or rules of law.” So why have some states like New Mexico decided to disregard the very limitations placed on these precepts by the AMA? Good question.

Ethical precept 9.6.4 puts severe restrictions on the sale and even the use of nutritional supplements. (I won’t repeat my detailed discussion of this section in my prior post http://rickjaffeesq.com/2017/03/22/can-cam-docs-legally-prescribe-and-sell-herbals-and-nutritional-supplements-as-therapy-without-bad-things-happening-prescribe-yes-sell-well-see/.)

The effect of the rule is to make it basically AMA unethical and New Mexico disciplinable for a physician to sell supplements out of his/her office or via a web site. Previously, when the New Mexico Medical Board found out about a physician’s sale of supplements via a Board complaint, the doc has been forced to stop, which apparently prompted a few to quit the state.

I got involved after the case was presented to a panel of the Board to see if there was a violation. Based on the AMA “guideline,” the panel gave the doctor the same ultimatum as it had to other docs: stop selling supplements or face formal charges. That didn’t make sense to me for a few reasons, not the least of which was that she wasn’t just selling supplements for general health or immune purposes. Rather, she was using natural remedies as primary therapy, which because of training requirement set by the manufacturer, the products were only sold to company trained practitioners for dispensing to their patients.

The AMA seems to cover this type of practice in precept 9.6.6 which allows the sale of drugs, devices and “other treatments.” That seemed like a better fit and it didn’t have all the anti-supplement nonsense contained in 9.6.4. So after I came into the case, we asked the prosecutor to re-present the case to the board panel. Because the Board’s statute of limitation to file the case was fast approaching we suggested we would be agreeable to waive the limitation period in the hopes he would ask the panel to change its mind based on this new information.

And then a funny thing happened…. Actually, nothing happened. We didn’t hear back from the prosecutor for over a month. We had expected to receive a formal waiver of the statute of limitations, to be signed by the doctor, and we would have advised her to sign it. The proposed settlement had contained such a waiver, and we expected to get a proposed written waiver. But we never got it. Instead, over a month later, we got basically the same settlement agreement with the same prohibition against the sale of supplements, and the same waiver of the statute of limitations as in the original settlement proposal, but this second settlement proposal was over a month after the statute of limitations had expired. Hmmm.

I decided to take another run at the prosecutor to change his mind about the case. I gave him case studies showing the miraculous results achieved by the doctor on non-functioning patients who tried and failed many conventional modalities. We also showed him that almost all New Mexico integrative practitioners were selling supplements for general health, in direct violation of the AMA rules. I even showed him that the University of New Mexico’s Integrative Medicine Clinic was selling supplements to patients, and the University was teaching medical students about the use of herbal remedies.

This case against the doctor arose because her office staff did not timely respond to the patient’s request for medical records. So I had the doctor take a medical records keeping course (which the board requested in the two settlement proposals) and offered that she would accept responsibility for the oversight, as a full settlement of the case.

But the prosecutor was a tough guy and insisted that she comply with the AMA supplement guideline, the way the other doctors faced with board action had done. As incentive (read threat), after he sent the first settlement proposal, he said that if she didn’t take the deal, he’d go after her license. When he finally filed the case, he made good on his threat by throwing in a charge of incompetence for using herbal remedies, which could result in license revocation.

Despite all my efforts at persuasion, I couldn’t get him to back-off. I started to think about an appropriate time to file a motion to dismiss based on his failure to timely file the case. Filing the motion wouldn’t make dealing with him or the Board any easier. But frankly, I was tired of all his crap about supplements and how he was going to take out my client for being a supplement distributor.

Maybe I was waiting for a sign, and I got it. On a routine email exchange on a Monday, he announced that he was leaving the board on Friday and going into private practice. That was good enough for me. The following Monday I filed a short motion to dismiss based on the fact that the complaint (called a “Notice of Contemplated Action” in New Mexico) was filed more than two years after the Board had notice of the patient complaint, which makes the case dismissible under New Mexico law. I’d let the new prosecutor figure out how to deal with the fact that his predecessor never presented us with a written waiver of the statute of limitations even though we offered to enter into such an agreement.
Turns out the Board didn’t have a replacement for him, so he ended up responding to our motion. Awkward! I didn’t think much of his responding papers.

The motion was to be heard by the full Board. I figured they wouldn’t be too fond of me or my client for trying to dismiss a case on a technicality, based on its mission to protect the public and considering the fact I did offer to enter into a waiver of the statute of limitations. I also didn’t think I had much of a chance to have the Board make a public finding that its own prosecutor screwed the pooch. Hmm. What to do?

I have a saying or rule which I try to follow. You have to give a board/judge the will and the way to rule for you. But even though my motion was legally correct, I had given the Board neither. After more thought, I figured it out. I filed another motion to dismiss in the interests of justice, and argued that the supplement issue was a matter of great public interest that was better addressed in a rule-making rather than a disciplinary process, in part because all integrative practitioners, including the University of New Mexico’s own clinic were already selling supplements. I also showed the Board the doctor’s truly impressive case studies. My goal was to go to the hearing and immediately pivot to the interest of justice motion, so as not to have to deal with the unpleasantness of the Board’s own prosecutor’s screw-up. It was a good plan, but it was not to be.

Things got really interesting right before the hearing. The prosecutor recused himself from the case because he was going to have to be a witness explaining why he didn’t obtain a written wavier of the statute of limitations from the doctor. (The irony was that Mr. Tough prosecutor charged the doctor with incompetence, and yet he was the one going before the Board testifying about his conduct and competence. Who says the universe doesn’t have a sense of humor and karma.)

The other super interesting thing was that one of the patients whom the doctor was dramatically helping is Shirley MacLaine. She lives part-time in New Mexico. As luck would have it, she was going to be in town on the day of the hearing. I insisted that the doctor contact her and try to have Shirley come to the hearing. It was going to be a very tough day with personal attacks directed my way, so some star power wouldn’t hurt. More metaphysically, based on her life and books, she seemed to be a very powerful force, (as in “the force is strong with that one”), and I really needed all the help on that front/dimension I could get.

We all showed-up at the hearing. My plan to pivot to the interest of justice motion failed. The Board insisted of focusing on the statute of limitations motion, despite my repeated efforts to talk about how the public would be better served by the Board considering the supplement issue in a rulemaking capacity and to dismiss the case to allow that process to take place.

As expected, as I argued that the prosecutor missed the deadline under the law, he as a witness and some of the Board members went after me, questioning my professionalism honesty and integrity. But zealous advocacy is the job, and taking some incoming is sometimes a part of it.

We went at it for over an hour and a half. The former prosecutor testified in effect that I was a sleaze ball, and me arguing that he didn’t do the one thing he had to do, get a written waiver, while imploring the Board we should really be talking about creating a public forum for input on the supplement issue.

For over an hour I got nowhere, or so it seemed, but then one Board member asked me a question which suggested that the former prosecutor should have gotten a written waiver, and I ran with it. Then the chairman of the Board asked me how important a right it was for someone to have statute of limitation protection, and how would that right best be protected. Terrific question! From then it was all downhill. Some of the other members starting asking similar questions, then the Board said they heard enough and excused us to go into executive session.

We waited almost half an hour. In the lobby, some board employees came out from their offices to meet Shirley. She was gracious and engaging. We both chatted-up the new prosecutor, whom I’d be dealing with if the Board denied our motion. Shirley was apparently fascinated by the proceeding. She had never been to a board hearing or seen the kind of legal back and forth. She told the prosecutor she was going to do a feature film about the case, and asked the prosecutor – a fit and attractive woman of Hispanic decent, who she wanted to play her in the movie. They prosecutor loved it. They had a lengthy discussion about different actresses and they decided that Jennifer Lopez would be offered the part. We had a great time waiting, laughing so loud at times that the Board members inside must have wondered what was going on.

Finally, we were called back into the room. The chairman announced that they were going to vote on two motions. Ok, I had only argued one, but I had put in strong papers on my interest of justice motion. The first motion was the limitations motion. One-by-one they voted. We lost that vote by a wide margin.

Then the chairman called a vote on a motion to terminate the proceedings against the doctor. No interests of justice, no nothing, just a motion to end the case. We won that motion by a wide margin. And so the case against the doctor ended. It took a while for it to sink in. We thanked the board profusely.

You know the saying “when you make the sale, sit down.” Well I don’t subscribe to it. I wasn’t done. I told the Board members that I hoped they would consider the physician sale of supplements issue because integrative physicians and the people of New Mexico deserved to have input. In response, the Board chairman told us that the Board had decided to address the issue at an upcoming meeting, and, he invited me to return and make a presentation to the Board. I immediately accepted.

Finally, I told the Board members that I was giving them all homework. They had to decide who they wanted to play them in the movie. Everyone got a good laugh, and I’m sure they left the meeting amused and had a good story to tell their families.

I’m hoping to enlist some of the American College of Nutrition luminaries and other of my high-profile integrative physician friends to take a trip to Santa Fe and help make the case for rescinding that idiotic AMA “guideline.”
Any takers?

And finally, the one burning question which I’m sure is on everyone’s mind:
Who’s going to play me? George, Brad or Ben.

Happy Independence Day to you Dr. Pamela Costello, holistic neurologist extraordinaire, and thank you Shirley MacLaine.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Can CAM Docs Legally Prescribe and Sell Herbals and Nutritional Supplements as Therapy without Bad Things Happening? Prescribe, YES. Sell? WE’LL SEE

Can CAM Docs Legally Prescribe and Sell Herbals and Nutritional Supplements as Therapy without Bad Things Happening? Prescribe, YES. Sell? WE’LL SEE


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.
rickjaffeesquire@gmail.com

Then again, maybe the glass is still less than half full, and water might start leaking out

Then again, maybe the glass is still less than half full, and water might start leaking out

 

Well I tried to transform myself into a half-full kind of a guy by talking about how much access we have to dietary supplements here in the U.S. compared to the rest of the world. But my new found optimism was short-lived:

The FDA just released its revised draft guidelines on New Dietary Ingredients which will have a profoundly negative effect on access to supplements, and not necessarily just new dietary supplements, as my friends at the Alliance for Natural Health have so cogently explained below. Kudos to Gretchen and the rest of the group for such a trenchant analysis.

Time now for a ground-swell of opposition to send the FDA back to the drawing board and come back with guidelines that respect the public’s right to access to dietary supplements which we’re supposed to have under the 1994 dietary supplement act.  Onwards!

 

FDA: Massive Attack on Supplements

 

My Doom and Gloom at IAACN Jacksonville

My Doom and Gloom at IAACN Jacksonville

rajccn2016

it’s just the power point, so it might not be as depressing/scary as the talk.

 

A glass half empty guy sees it’s really mostly full

A glass half empty guy sees it’s really mostly full

I just gave alittle talk at the Certified Clinical Nutritionist Conference in Jacksonville, Florida. Up until  the last few years, I had been attending their annual conferences for the better part of twenty years, usually giving a talk about what’s going on in the CAM field (complementary and alternative medicine, now called integrative medicine).

As I look back at all those speeches, and others I have given to other CAM groups, it struck me that most of the content of these speeches was about how practitioners and companies can or did get into trouble with the feds or state regulatory authorities, and bringing forth the many examples of the unfortunate victims. In a word, doom and gloom. But in my defense, I spend most of my waking hours dealing with practitioners and companies who are attacked by the government or concerned that they will be, which causes a certain amount of regulatory paranoia. Consistent with my jaded, glass is half empty, view from the trenches perspective, that’s what I talked about in Jacksonville, witness the title of my talk, “(not so) Fun 2016 CAM Facts.”  It was all about who’s being targeted by the regulators and what they’re being targeted for. I may have buried the lead in my talk because it was only as an afterthought that I mentioned that most nutritionists wouldn’t be affected by the recent spate of regulatory action, but that just shows you how perspective influences things.

Because I hadn’t been there for a couple years, and perhaps because the past insane litigation docket has become more manageable, at the conference, I had the space to really listen to some of the lectures and talk to some of the speakers and vendors. Some of what I heard was pretty exciting and probably revolutionary. Of course, the Microbiome was a hot topic (as it’s been for a couple years now) and the therapeutic implications are huge for a wide variety of disease including and especially autism and age related cognitive conditions.

One of the new big things for me was Nitric Oxide. Like many exercise fanatics, I’ve tried L-Arginine pre- work-outs but, I do it mostly on faith because I never really felt any benefit. But after listening to Nathan Bryan’s lecture and reading his book “The Nitric Oxide (NO) Solution,” I have an understanding of why L-Arginine isn’t doing it for me. More importantly, I’ve come away with some dietary and supplement alternative solutions, and a simple test to monitor results. I can’t wait to hit the gym and test it out. I’m thinking that this new NO approach is going be very huge in the near future.

Collagen is something else I’ve tried in the past but I didn’t stick with it. After hearing a lecture about it, I’m going to try again. After walking the exhibit floor with one of my nutrition buddies (thanks Sunny), I’ve made some supplement vendor changes and added a few new things (I’m also a supplement fanatic which I got from my health-nut father and my 30 years in the CAM field.)

In walking the Exhibit Hall, listening and asking questions to try to figure it out, I recalled a snippet of this guy Bryan’s lecture, something about that in his travel in Dubai or some other Arab country the docs were demanding literature support for his NO theory because as he said, supplements were mostly prescribed by medical docs, and there had to be adequate literature support because they were prescriptions.  Then I recalled all the past angst with Codex and what’s going on in the rest of the world.  Despite all the past concern, it’s still not here (and in my view, Codex isn’t coming here anytime soon, perhaps in part due to Scott Tipps who basically lives at Codex and hold their feet to the fire).

I then looked around and saw some of the same non MD nutritionist folks I’ve seeing for a couple decades, and it hit me. Wow. I’m a lucky guy. I can walk around talk to all these knowledgeable people and buy stuff that has or might have a profoundly beneficial effect on my health and wellbeing. And that there’s not too many places in the world where I could do that.  Sure the supplement companies are sort of muzzled, and legally, their free speech is impaired, but the information is out there, on line, at conferences for MD and non-MD practitioners, and to laymen at the big health expos.  More importantly, it’s all available to anyone who wants to try it.  And that freedom and control over one’s body is pretty special, if not unique in this world.

So thank you Keith, Radhia, Sunny, Marty, Theresa, Seth, and Nathan (great lecture and wonderful book), Luke, Lisa and Debra, and the rest of you guys for helping me look beyond the trenches and see how many good and exciting things there are going on in the nutrition and health field, and reminding me of how interesting and fun the ride has been for me.

Best

Rick Jaffe