The FDA has the authority to review medical devices, including lab-developed tests. However, to date FDA has not used this authority to regulate LDTs, allowing the devices to flow freely onto the market without premarket approval.
As the saying goes, “Another day, another dollar.” That’s how people shilling for shady Covid-19 cures must view the pandemic. One day it’s ivermectin, the next it’s hydroxychloroquine or colloidal silver.
It’s not as if the U.S. monkeypox response has been ideal, but we actually began with a head start. Unlike in the early days of COVID-19, viable vaccines were available for monkeypox in the form of smallpox vaccines.
Remember hydroxychloroquine? Yes, there were anecdotes and observational studies, but, no, it flunked the gold standard for evidence, randomized controlled trials. Ditto with ivermectin.
Now the man named “the most influential spreader of coronavirus misinformation online” is promoting another candidate for magic bullet: vitamin D.
It’s no surprise that in this confusing environment, with millions of patients desperate for help, some companies have taken advantage of how loosely dietary supplement claims are regulated to sell unproven long COVID treatments.
