The Politics Of Ivermectin

This will mark the fourth article in a little over a week on ivermectin on our website, and we are not alone. In over 30 years of clinical practice, with the exception of hydroxychloroquine, I have never seen a drug and its current off-label use garner so much attention. I have never seen a drug have its own physician-driven advocacy, the FLCCC – the Front Line COVID-19 Critical Care Alliance.

What is driving the ivermectin push?

In short, it is the same intent that pushed hydroxychloroquine into the headlines, a place where it does not belong. But before you start writing your comments, I am not speaking about the intent described on the Internet, old-school media and their talking heads, or politicians. I am talking about physicians. 

Put yourself in the position of a critical care physician. An intensive care unit full of patients, few if any, responding to any of the standard means and extremes we deftly employ. The patients changing every few hours, with the new replacing the old, who go to the morgue, not to a med-surg floor. You are helpless, in a place and role where you have never or rarely failed before.  What is it like to suddenly lose your “mojo” with that loss counted in body bags?

You go off-label and out-of-the-therapeutic box. What typically was considered “being a cowboy” takes on grudging respect or at least empathy. 

"People are dying. …We treat patients at the bedside. We don't have the ivory tower syndrome where you tell people what to do though you have no idea what you're doing."

Paul Marik, MD, chief of pulmonary and critical care medicine at Eastern Virginia Medical School [1]

The art and science of medicine

For me, the current fight over ivermectin in the medical community is a skirmish in the more significant tension over medicine; are we scientists, or craft-persons, applying science to our craft. I hasten to add that these polar opposites are a continuum rather than a binary choice, and as a practitioner, science infuses my art. The words of Dr. Marik speak to our art. Dr. Joffe speaks for the scientists among us.  

Clinicians shouldn’t, "be lowering our standards of evidence because we're in a pandemic. … if they believe so strongly in the efficacy of ivermectin, if in fact it is effective, the only way to convince the clinical and scientific community and allow patients all over the world to benefit is to prove the case in such a trial." 

Steven Joffe, MD, MPH, a medical ethicist at the University of Pennsylvania [1]

Going Off-label

Off-label use is how a physician can practice their art, tailoring care to each individual, the ultimate in personalized medicine. Physicians are held accountable for the application of their craft. But when off-label use is scaled to populations, losing its personalization and accountability, especially its accountability, the words of Dr. Wilson may be more applicable. 

"With a new disease, it is totally reasonable to take your best guess at a therapy. …When there is limited information, you go with what you have. What I take issue with here is the authors' implication that that's where the scientific process stops. …Every investigator believes his or her intervention is beneficial but is not sure — that's why they conduct a randomized controlled trial. …Without robust trials, we are left with too many options on the table and no way to know what helps — leading to this 'throw the book at them' approach...”

F. Perry Wilson, MD, MSCE, director of the Clinical and Translational Research Accelerator at Yale University School of Medicine [2]

Within medicine, this is a fight not about evidence-based care but about how much evidence is sufficient when you have little to offer when death or disability is the alternative, and there is a line stretching further than you can see waiting for your response.

This battle within the house of medicine has become more public and transparent. For some, that is a good thing; for others, it is a little bit like watching sausage made, alarming and deeply disturbing. The use of the Internet for the dissemination of medical knowledge remains in its infancy. Certainly, the pandemic has made pre-prints more palatable to many physicians looking at sources of information beyond peer-reviewed journals. 

But many clinicians are not ready and find it jarring to get medical information and guidance from blogs, sound bites, anecdotal reports, or Senate hearing – all communication channels being used. We are used to learning from journals and conferences where the media is not as hot or urgent. Peer review removes the urgency, and it softens some of the rougher edges, pulling back misplaced words like this statement by Pierre Krory, another FLCCC leader.

“These data show that ivermectin is effectively a “miracle drug” against COVID-19.”

Statement of Pierre Krory, MD to the Senate

The medium does affect the message, especially in medicine, where actions have real consequences making us more deliberate and seeking greater assurances. My reading of the data is more in line with the NIH,

“there are insufficient data . . . to recommend either for or against the use of ivermectin for the treatment of COVID-19,” and calls for “adequately powered, well-designed, and well-conducted clinical trials.”

But I am no longer on the front line, and my responsibilities are changed. I will leave the last word to Dr. Marik:

"This is not a political issue and it should never be. …We are driven by the science and the data, not by politics or anything else. …It angers me, when I hear that it's a conspiracy, that this virus doesn't exist, that there aren't that many deaths. You have to come to the ICU and see that people are dying to realize this is no hoax, this is real." Paul Marik, MD [1]

[1] https://www.medpagetoday.com/infectiousdisease/covid19/90552

[2] https://www.medscape.com/viewarticle/942995#vp_3