Ivermectin and Informed Consent

“Any physician that espouses the use of this should be reported to their State Medical Association.”  That is a direct quote from the Chairman of the Department of Internal Medicine at the University of South Florida; his name is Dr. John Sinnott. Dr. Sinnott’s alarming words were quoted in an article by the Tampa Bay Times just last week, talking about Ivermectin and off-label use. In the article, we learn that both Merck and the CDC recommend against using Ivermectin for COVID-19 treatment. 

In Terms of Protecting Yourself...

I know there is some disagreement in the medical community, and I'm not here to take sides or to tell you to stop the use of Ivermectin or to start its use. I know that some of the doctors in my community who follow me believe very strongly in Ivermectin, whereas some, like Dr. Sinnott, very much do not believe in its use for COVID-19. I am here to answer what you need to do about this in terms of protecting yourself so that you're not reported to the Medical Association in your state, and, better yet, how you can protect yourself from any inquiries or phone calls you get from them. 

Just as a reminder, I'm an attorney and founder of Functional Lawyer, and my wife is a Functional Medicine doctor, so I am heavily invested in all of the scuttlebutt that we see on Facebook, all social media platforms, and many other sources. I also know that there's a lot of disagreement about this, so I'm not here to pick sides, politically and/or scientifically. I am not a doctor and don't fully know what Ivermectin does or does not do. That being said, when you see an article like that in my line of work, it's my job to tell you what to do regarding how you can prevent your risk. That really scary quote that was actually the subtitle of the article. Because of this and other surrounding discussions, I have had several conversations this week with doctors who are prescribing Ivermectin and wanting to know how to do it safely and make sure that they are reducing their risk as much as possible. 

The Best Path for You

The number one way to cover yourself is to have an open discussion with your patient(s).  If you've been following me for any length of time, you know that I always say it is all about informed consent. To do a proper informed consent, make sure you use a written memorialization so that the document confirms the conversation that you have with the patient. The document should include all the risks, benefits, and alternatives to Ivermectin, along with a statement that you believe in its efficacy, even with its off-label use. This is probably the best path that you can take for this situation now.   

 Solid, Informed Consent

I know everybody in the Functional Medicine world comes from different political ends of the spectrum and different backgrounds. So, again, I'm not here to tell you what to believe, or what to do, or what to think. But, if you want to engage in prescribing or recommending Ivermectin to patients, this is what I recommend for you. Get a solid, informed consent; not one that you found on the internet, not one that you found 10 years ago when you first got into alternative medicine - - get a solid, current one. If you don't have it, we have it at Functional Lawyer and you can edit it to make sure that the informed consent covers the risks of using this drug, particularly the risks of using it for its unintended purpose, along with the alternatives to it. As for the benefits, the CDC and Merck say that there are no benefits to treating COVID-19 with Ivermectin. You should definitely tell the patients this, so that there's no coercion or anything like that; you should tell them that the drug is not intended for COVID-19, and in fact the CDC and Merck have said it's not supposed to be used for COVID-19. That being said, if you can point to studies that you know of or any kind of evidence that back up your decision, do that and explain the benefits that the study discusses regarding Ivermectin.  Be sure to use good, peer-reviewed studies and academic papers. Obviously get your support from good sources so that you will be able to confidently point to those and explain to the patient how Ivermectin is working and showing good results.

Full Disclosure

Keep in mind that you better tell them that not only does the CDC say NO, Merck also says NO, and the Chairman of Internal Medicine at the University of South Florida's medical school, who is an epidemiologist, also says NO. Again, I'm not here to slant anything, either way, but if you're going to do this, you need to let your patients know all of this information. 

 Alternatives

Be prepared to talk about the risks, benefits, and the alternatives. There are many alternatives, such as getting a vaccine. Some are also getting the Regeneron, which is another a lightning rod issue. You may see another alternative as not getting the vaccine but continuing to wear a mask while we still rage in this pandemic. Just know and state that there are other alternatives to using this off-label drug. 

 Reduce the Risk

Looking back at the quote: “Any physician who espouses this should be reported to their State Medical Association”... This is an alarming but good reminder that Functional Medicine, although growing and becoming more popular by the day, is still very much not the mainstream. It is still very much a minority, especially for conventional doctors, including those in academia as well. As I always remind you, you ought to be taking steps to reduce any kind of risk that you have. In this case, getting the informed consent is giving you greater protection. Your patient should be made aware that Merck the CDC don't approve of Ivermectin for COVID-19 treatments. Even if you point to the benefits, they need to know that there are still critics and that there are also alternatives. After pointing to these facts, you can then say that you believe in its efficacy as their doctor and proceed to recommend this treatment. You should eliminate most of the risk that you are incurring with that. 

Of course there are no guarantees in life, but you will at least be able to go to bed and sleep soundly, more secure in the fact that you're having people come into this with their eyes wide open. This is crucial particularly in today's age, where people get their information from a vast variety of places. It could be from peer-reviewed studies, or from mainstream news sites, or from some random corners of the internet.  On both the right and the left, misinformation runs rampant, so you need to do your duty as a person of medical licensure and make sure that you're giving people accurate information. 

 A Document for You

Cover yourself with a proper informed consent, which, again you can get here at Functional Lawyer. I also have a video that teaches you how to edit for your situation as well, and you can always reach out to me with any questions. (Click here for the informed consent from Functional Lawyer.)

In the meantime, be careful out there! This is a lightning rod, a contentious and polarizing issue. Make sure you're covering yourself, covering your risks, and protecting your assets.  Nobody wants a Medical Board review! They can be quite scary! A review can take a serious emotional toll, time toll, and financial toll. Right now, the best way to prevent that or make that go smoother is to use a proper informed consent process. 

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