The doctor-patient relationship is deemed legally immune to demands for information from agents of the State. That immunity is considered so important that it extends beyond the death of either party. It covers diagnoses, the results of lab tests, decisions to treat or not to treat, and details of both treatment and results. And like many other relationships once considered utterly private, it’s under attack:
Doctors are speaking out against a new law that arguably paves the way for the FDA to prohibit treatments for purposes it hasn’t expressly authorized, going far beyond highly politicized subjects such as treating COVID-19 with ivermectin.
The authority to ban off-label uses was buried on page 3,542 of the 4,155-page omnibus appropriations bill signed into law at year’s end, though it’s specifically applied to “banned devices.”
The FDA requested this “very unprecedented” update after a string of court losses, Endpoints News senior editor Zachary Brennan told WBUR earlier this month, while cautioning that it’s not clear whether the agency could broadly interpret “devices” to cover drug treatments.
Apparently the “experts” in our federal government are smarting after the string of losses and rebuffs they’ve suffered over COVID-19, chloroquine, and ivermectin. They don’t want to be shown up again; it’s bad for their reputation. But any such ban would be unenforceable as long as the doctor-patient confidentiality rule stands strong. So what’s the point of this?
Under 5th Circuit precedent, which recognizes off-label use as the “standard of care” in many medical contexts, federalism constraints prevent the agency from even “advis[ing] whether or for what purpose a doctor should prescribe” an approved drug, they said. The doctors’ lawyers didn’t respond to Just the News queries on how the revision could affect their litigation.
Hm. A federal attempt to muddy the waters in a lawsuit highly likely to be won by the plaintiffs? Interesting.
Applied to existing law, the revisions grant the secretary of health and human services authority to initiate a regulatory proceeding for an already approved “device intended for human use” to ban intended uses that present “substantial deception or an unreasonable and substantial risk of illness or injury.”
Just the News confirmed this legislative construction with Joel Zinberg, associate clinical professor of surgery at the Icahn School of Medicine and former Columbia law lecturer, who was apparently the first to widely publicize the omnibus provision in a Wall Street Journal op-ed accusing the FDA of “unwarranted intrusion into the physician-patient relationship.”
“Since the new provision lets the FDA skirt the ban on interfering with the practice of medicine by banning devices for particular uses, the agency will likely claim this as a precedent allowing it to ban off-label uses of drugs as well,” Zinberg wrote in the op-ed.
Even more interesting. And it would have exceedingly wide effects on current medical practice:
“Damn — 3/4 of the stuff we use Is off label,” University of Kentucky medical professor Lisbeth Selby wrote. “This is a ploy to get more money for drug companies.”
“Potentially catastrophic for use of antibiotics,” said Livermore, former director of antibiotic resistance monitoring at Public Health England. Restricting their use to “indication only” would “deny useful treatments to patients with highly resistant bacteria simply because these drugs never had an appropriate trial in the setting,” such as tigecycline for hospital pneumonia, he told Just the News.
Selby provided Just the News an exhaustive list of the off-label treatments she uses regularly in her gastroenterology practice at the Lexington Veterans Affairs Medical Center, with asterisks on “those used daily.”
There’s a whole education here. But it stands to reason: many drugs are brought to market because of their success in clinical trials at combating a single, well defined ailment. That such a drug should reveal effectiveness against other illnesses becomes more likely the longer it’s in use – which means after the patent on it has expired. There go the larger profits the manufacturer could have made for those “off-label” uses.
Will these revisions become law? Unclear. But to have some light shed on the monetary incentives behind the attempt is clearly of value.
Full disclosure: I take several drugs for “off-label” reasons…and they’ve done good things for me. Suffice it to say that my quality of life would be substantially degraded were I denied the use of those medicines. We shall see.