The Maine Board of Medical Licensure has 5 matters before it in my case. Here are the first 3:
The first 2 are complaints from private citizens, who claimed that I spread misinformation on the internet. Neither complainant knows me or is a patient. Neither complaint has anything to do with medical care. Each says the complaint was initiated after they watched me in a video. One said the information I was disseminatiog was a “danger to the public.”
The third complaint is from a midwife who complained that I gave a pregnant patient hydroxychloroquine for acute COVID without asking her, when she could have given the patient monoclonal antibodies instead.
My response is that hydroxychloroquine is approved in pregnancy and is a safe, licensed drug. Monoclonal antibodies are an experimental biologic product that have not been approved in pregnancy; in fact, the pregnancy risks have not even been studied. The midwife apparently did not know this about the product she is prescribing in pregnancy.
Unapproved drugs have no label. For a legal description of what is known about them, one must read a fact sheet. For example, here is what the FDA-approved Fact Sheet for sotrovimab, the only commonly used monoclonal said to be effective against omicron, says about its risk in pregnancy:
There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage,
or adverse maternal or fetal outcome. Sotrovimab should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.
Nonclinical reproductive toxicity studies have not been conducted with sotrovimab. In a crossreactive binding assay using a protein array enriched for human embryofetal proteins, no offtarget binding was detected for sotrovimab. Since sotrovimab is a recombinant human
immunoglobulin G (IgG) containing the LS modification in the Fc domain, it has the potential
for placental transfer from the mother to the developing fetus. The potential treatment benefit or
risk of placental transfer of sotrovimab to the developing fetus is not known.
The estimated background risk of major birth defects and miscarriage for the indicated
population is unknown.“
On the other hand, the label for hydroxychloroquine says the following about use in pregnancy:
Teratogenic Effects: Human pregnancies resulting in live births have been reported in the literature and no increase in the rate of birth defects has been demonstrated. Embryonic deaths and malformations of anophthalmia and microphthalmia in the offspring have been reported when pregnant rats received large doses of chloroquine.”
What does CDC say about hydroxychloroquine in pregnancy?
“Hydroxychloroquine can be prescribed to adults
and children of all ages. It can also be safely taken by
pregnant women and nursing mothers.”
Do you think perhaps the Medical Board and the complaining midwife bothered to check this information? I think not.