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Robert Yoho, MD's avatar

I went through some of this plus a lot of civil litigation. Great comments. I would add: never respond to legal challenges by yourself. Whoever is on the other end will see you as a soft target. Always use a lawyer. That said, you need to craft your responses and the rest of your defense. It's your problem and you are overwhelmingly likely to be the smartest guy in the room. Average lawyer IQ is 115, for MDs, 125, nearly a standard deviation higher. If you don't understand what they say, it's their fault, not yours. They are working you.

Your lawyer is but a counselor. You are the only one who understands the entire situation: your plans, finances, insurance costs, reputation, etc. etc. Take charge but take advice from them as you would a radiologist.

If you find an attorney who is competent and cares, PAY them. Never be late. For all the others, have a low threshold for firing them. Any excuse will do. They may hit you with a big bill as retribution on the way out. You can often ignore this. You may have to write a threatening letter. They usually are ignoring your wishes, missed a deadline, or made some other mistake. Be creative.

Again, if you find someone with your own professionalism, hold them tight. The majority have little "patient first" ethical structure and the most kindly description of their species is opportunistic. If you smell someone taking advantage of you, they are. Draw limits and look around. No one is irreplaceable.

The last thing is that you will have to do all the work. Make the briefs, do the research, and cooperate by training your lawyers about the issues and sometimes the law. Expect this.

There are occasional situations where you have to hire a co counsel to watch the first one. I'm mentioning this not because it's common, but so you can have it in your databank.

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Martha's avatar

Meryl. I think this is important for every doctor challenging any medical board on these issues. Look up the "Hesinki Declaration" of the World Medical Association. Note that AMA is a member organization of the World Medical Association. The original ethics statement by the World Medical Association was adopted in 1964, it was revised and each time approved by the member organizations in each updating. Now the most recent approved version is 2013 which has precedence over all the other prior versions. In the 1964 version it says this: "In the treatment of the sick person, the doctor must be free to use a new therapeutic measure, if in his judgment it offers hope of saving life, reestablishing health, or alleviating suffering."

Thus, when the NIH published their first guidance on Covid for practicing physicians, they said something like (paraphrased) "We recommend no treatment because the research has not been done, and we have no earthly idea what would help or hurt, so therefore, don't do anything unless they turn blue from no oxygen, and then go ahead and admit to hospital and put them on a ventilator. If you want to prescribe meds, get them into a clinical trial and let them be a guinea pig for pharma, or lab rat, if you will." I know it was not exactly that, but when I read it the first time, I was horrified, and I thought - there is no one with any ethics at all, for them to have said that - don't treat. They are so totally enamored of clinical trials, they can't treat without a randomized placebo controlled clinical trial they can't treat patients who are in danger of dying because "we don't know." I would say, the WMA guidelines, which speak of treating if there is HOPE of saving a life or HOPE of alleviating suffering, to give it a try. A far cry from what NIH said. And this is even worse in that, back when it was SARS a few years back, Fauci at the time recommended HCQ for SARS, so now it is a different corona virus and he has no clue what could possibly work? And with Ivermectin, and HCQ both, there were enough positive trials early on and data from many countries to give "hope." Hope of saving lives. The most recent iteration of the WMA ethics statement was very similar.

It does mention if possible to get "consent" from the patient or their guardian, though it does not say it must be signed consent. I always do very careful, detailed patient education with every med I prescribe, and Ivermectin is known to be very safe, and none of my paitents have died, but I don't know why "informed consent" necessarily would have be written to count with outpatients, considering that if they buy it and put in their mouth, seems to me that is implied consent. Also, I do not see this as "experimental" at all even though some of these meds have their detractors, as well as fraudulent research having been created as proof against their use. If you look at documents from the FDA from the past, and also the FDA website from not so long ago, you will see that the FDA clearly admits that their mandate from Congress is only to regulate new drugs coming to market, and they do regulate what drugs can come to market, and they regulate what indications the meds can be MARKETED for - they regulate the drug companies. They have ZERO authority to regulate physicians, ZERO authority to regulate regulate what we prescribe and when and to whom and for what. None. They admitted this in, I think, a 1982 newsletter, the FDA Bulletin. They particularly said that off-label prescribing was legal and ethical and often beneficial to the patient. I am aware just for example that when Lamictal was in trials for being approved for epilepsy, it was observed that Lamcital (lamotrigine) also seemed to help people with Bipolar Disorder. Because at the time, there were not very many options for treating Bipolar, psychiatrists started using it rather often, even while some small studies weere done, then clinical trials were undertaken. This fits with the WMA ethics in that there definitely was "hope" of alleviating suffering even though it didn't have an FDA indication for Bipolar. Eventually it was approved for Bipolar, and it was somewhat simiarl with Depakote, that it came into use in psychiatry because of need for more meds that would work for more people, and that hope of alleviating suffering. In psychiatry, these meds have been used for decades now, and not always for the narrowly defined diagnosis categories specified by the FDA. They may have studied it for one type of Bipolar, but everyone uses it for other forms of Bipolar or even other psychiatric diagnoses. According to what the FDA has said in the past, there should be no negative connotation about prescribing something that is "unlabeled." Once it is approved, it has to be safe to be approved, and if in your medical judgment you think it will help the patient, you as a physician can do it, and they said we can use it "unlabeled" because there is no specific labeling information for whatever diagnosis we might want to use it for, but "unlabeled" would be preferred rather than saying it is an "unapproved" use. It does NOT require "approval" by FDA for us to use it according to our judgment of what may help our patient. Same thing, if a patient gets a rare cancer, we don't say "So sad, too bad, you die." We find some similar cancer med and use it even if it is an "unlabeled" use. You will find certainly purists among academics who will gnash their teeth at anyone prescribing "off label," but you can also find other studies, besides the FDA's words on this and the WMA documents, to support unlabeled prescribing as normal and a good thing. Here are links to two versions of the WMA ethics statements that I have used in the past:

World Medical Association (1975). Declaration of Helsinki 1975. Retrieved from

https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/doh-oct1975/

World Medical Association (2013). WMA Declaration of Helsinki – Ethical principles for

medical research involving human subjects. Retrieved from https://www.wma.net/policiespost/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-humansubjects

And from the FDA which I found from a document in which I had referenced these:

FDA (2018). Understanding unapproved use of approved drugs "off label." Retrieved from

https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatmentoptions/understanding-unapproved-use-approved-drugs-label (Current as of 02/05/2018).

FDA (1982, April). Use of approved drugs for unlabeled indications. FDA Drug Bulletin 12(1),

4-5. Retrieved from http://circare.org/fda/fdadrugbulletin_041982.pd

One of the nice things about the WMA statements - they would potentially be usable in any country, or most, since most national medical associations are members of the World Medical Association.

On patient autonomy which is really paramount in informed consent these days moreso than in the past - two potentially helpful items and I would say, read carefully and think about them.

Chervanek in particular - it's about OB ultrasound, so you would not immediately think it is pertinent, but it is. It says that the patient may have very different values, beliefs and preferences than the MD, and they may even be idiosyncratic, but still, the physician has some responsibility to help the patient to receive her preferred treatment - I'm paraphrasing here, so read what it actually says, but that seems to me that if we have some evidence that Ivermectin is safe and effective, and the patient wants that instead of some treatment the academics like better - okay, so the dean of the local medical school and everyone on the faculty loves, loves, loves Paxlovid and the Pfizer vax, but your patient for idiosyncratic reasons of her own only wants vitamins, herbs, and Ivermectin - why should she not have her autonomy to make this choice? So these two are good with autonomy -

Chervenak, F.A., & McCullough, L.B. (1989). Ethics in obstetric ultrasound. Journal of

Ultrasound Medicine, 8, 493-497. Retrieved from

https://onlinelibrary.wiley.com/doi/pdf/10.7863/jum.1989.8.9.493

Hall, D.E., Prochazka, A.V., Fink, A.S. (2012). Informed consent for clinical treatment.

Canadian Medical Journal, 184(5): 533–540. Retrieved from

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3307558/

I am sure there are many good articles on patient autonomy, but I do very much like these.

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