Legislators in several states have introduced bills, some of which have passed, protecting physicians who prescribe unproven COVID-19 prophylaxes and treatments (like hydroxychloroquine and ivermectin) from discipline by state medical boards. Other bills hamstring efforts to prevent the spread of medical misinformation.

Such proposals, typically sponsored by Republicans and supported in Republican-led statehouses, substitute the judgment of legislators, who often have no science background, for that of medical peers, and relieve physicians of the burden of adhering to a standard of care. As noted bioethicist Arthur Caplan told a reporter, this type of legislation is “purely ideology masquerading as medicine”.

Today we’ll take a look (in no particular order) at some of these efforts to sacrifice good patient care on the altar of political expediency as well as welcome pushback from the medical profession.

One bill has already become law in Tennessee where, as I explained in a previous post,

the legislature bull[ied] the state medical board into rescinding its COVID anti-misinformation policy and [threw] huge bureaucratic obstacles in the board’s way before it can discipline physicians who use unproven COVID treatments, including downright quackery.

By way of background, as noted in that post:

In July [2021], the FSMB [Federation of State Medical Boards] issued a statement reminding physicians who spread COVID misinformation that they risk disciplinary action. Since then, according to the FSMB, at least 15 boards published statements about false or misleading information and at least 12 boards have taken disciplinary action against a licensee. The FSMB is currently developing guidelines for medical boards to help address the spread of disinformation.

Although the statement did not address the use of unproven therapies, this crackdown sent physicians, under threat from being held to the standard of care, running to their friends in state government for protection from medical boards doing their job.

Like Tennessee, North Dakota has already taken action. A new law protects from discipline physicians, nurse practitioners, and pharmacists who prescribe, dispense, or administer ivermectin, although a regulatory board can still take action on another basis, such as inappropriate documentation, substandard care, or “any basis that would in the board’s determination harm the patient”.

This is somewhat of an improvement over the original bill, which would have shielded the prescription of any drug off-label for the treatment of COVID-19, as well as

distributing documented medical information, providing information regarding the licensee’s professional experience or observations, or speaking against a public official.

Which would be a cover for, say, distributing information “documented” in sketchy source material or relying on “professional experience” that flies in the face of evidence-based medicine.

The legislation was opposed by hospital, medical, and pharmacy groups, to no avail.

In a sign of just how far down the rabbit hole some legislators have gone, one of the bill’s sponsors, Rep. Bill Tveit,

responded to data showing that unvaccinated people die at a higher rate with his own data: screenshots of a self-reported article from doctor Stella Immanuel, who in October 2021 claimed she and her team treated more than 7,000 patients, of which “only eight precious souls,” who she wrote had advanced stages of COVID, died. Immanuel, who was briefly boosted by Donald Trump when he was president, has also contended that the US government is at least partially run by reptiles.

Fortunately, despite rowdy constituents who appeared at a committee hearing to support the bill, Virginia rejected a similar effort. The state legislature recently voted down a proposal that would have protected doctors and pharmacists who prescribed or dispensed ivermectin and other off-label COVID-19 treatments.

In a particularly ham-fisted attempt, a Colorado bill was introduced last year that would shield physicians, nurse practitioners, and pharmacists who prescribe or dispense any FDA-approved drug off-label for the treatment of COVID-19, specifically including hydroxychloroquine and ivermectin, as long as the patient gives “informed consent”. Not only could providers not be disciplined for prescribing, no matter their degree of negligence or the harm caused, regulators were forbidden from even initiating an investigation of such conduct. Happily, the bill failed.

A bill introduced in Pennsylvania, and now before the House Health Committee, would prohibit regulatory boards from taking disciplinary action against physicians (as well as other providers) for prescribing, with the patient’s “informed consent”, or dispensing, any therapeutic drug

for off-label use to the patient for prophylaxis or for at-home, early-stage outpatient or hospital inpatient treatment of coronavirus infections [not just COVID-19] causing respiratory syndrome-related illnesses . . . absent a showing of recklessness or gross negligence.

As originally filed, there were no circumstances under which a physician could be held responsible for inappropriate prescribing. It was only in the amended bill that recklessness or gross negligence was added to allow disciplinary action. Legally, this replaces the usual negligence standard (that is, falling below the standard of care, or what a reasonable physician would do in similar circumstances) with a very high bar. Although state law can vary, recklessness generally requires a showing that the physician was “so careless that it is considered an extreme departure from the care that a reasonable [physician] would exercise in similar circumstances”. Gross negligence “demonstrates reckless disregard for the safety or lives of others, which is so great it appears to be a conscious violation of other people’s rights to safety”.

In Wisconsin, a group of legislators recently unveiled a set of so-called “medical freedom” bills that prohibit hospitals and other health care entities and credentialing agencies (such as the state medical board) from taking action against a health care provider

for ordering an innovative or novel therapy based on his or her assessment of the patient and any available clinical data supporting the innovative or novel therapy.

The bills are startling in their breadth. They would apply to the entire range of licensed health care providers in Wisconsin including, in addition to physicians and nurses, chiropractors and massage therapists. “Innovative or novel therapy” is undefined and is not limited to drugs. Protection from disciplinary or other adverse action is not confined to treatment of COVID-19 and presumably applies to any disease or condition.

Of course, “any available clinical data” would allow the provider to cherry-pick the data to support his choice of therapies. This is evidenced by the legislators’ citation to a dodgy website, the anonymous “c19early.com”, for treatments they claim are “demonstrating clear signals of efficacy and robust safety profiles”. This includes the decidedly inefficacious ivermectin, the drug of choice among the conspiracy-minded, such as the legislators themselves, who say that

[m]any continue to speculate as to the exact reasons why the efforts of these health care professionals have been actively suppressed by those who have assumed the responsibility of dictating the response to the COVID-19 pandemic.

In another demonstration of utter cluelessness, the bills’ proponents depict the Front Line COVID-19 Critical Care Alliance [FLCCC] as

health care professionals with first-hand experience treating COVID-19 patients through each phase of the disease [who] worked tirelessly to identify and utilize early treatment options . . .

FLCCC has made several appearances here on SBM, and not in a good way. As Dr. David Gorski details, the “brave maverick doctors” of FLCCC have concocted COVID-19 protocols using ivermectin, vitamins, melatonin, zinc, mouthwash and other nostrums, but

[n]one of these protocols has anything resembling solid evidence from randomized clinical trials to support it.

A third “medical freedom” bill would prohibit pharmacists from refusing to dispense a prescribed drug unless there is an “absolute contradiction” to the patient’s taking the drug. This amends current law, which allows a pharmacist to refuse a prescription if there is simply a “contradiction”. “Absolute contradiction” means that the drug is

not safe to be used as prescribed under any circumstance because of the severe or potentially life-threatening risks involved.

This is necessary, according to the bill’s sponsors, because, citing hydroxychloroquine and ivermectin as examples,

big government, corporate media, and big pharma have waged a war of intimidation on pharmacists who distribute medicines in the treatment or prevention of COVID-19.

Fortunately, the medical profession and hospitals are pushing back. According to the Wisconsin Hospital Association:

This legislation removes the most fundamental tool hospitals use to ensure safe patient care through medical staff governance and privileging. This legislation circumvents an existing evidence-based process medical staff within a hospital use to maximize the health and safety of the patients and communities they serve.

And, from the Wisconsin Medical Society:

[W]e believe these bills are not necessary. Further, the bills appear to undermine some basic safeguards now in place that help prevent care that might fall below minimal accepted standards.

A bill has been introduced in Indiana that permits physicians and nurse practitioners to create “standing orders” allowing pharmacists to dispense ivermectin without a prescription. Per the bill, ivermectin thus dispensed is, ipso facto,

considered to be issued for a legitimate medical purpose in the usual course of professional practice.

The standing order must “specify a mechanism to document the screening performed with the patient” and the dose dispensed in the patient’s medical record, as well as a “plan for evaluating and treating adverse events”.

The pharmacist must give the person receiving ivermectin under a standing order “a standardized information sheet” that has to include “the importance of follow-up care and health care referral information” but cannot discourage the recipient from using ivermectin for the treatment of COVID-19. Physicians and nurse practitioners cannot be disciplined if the pharmacist fails to follow a standing order and pharmacists cannot be disciplined if there is a defect in the standing order.

Frankly, I am not sure how all this would work. How would the pharmacist verify that the standing order is legitimate? (I’m assuming here that the patient keeps the standing order until he wants to use it?) Does giving the patient accurate information about ivermectin, such as the overwhelming consensus that it is ineffective and its risks, constitute “discouraging” the patient from using it? Can pharmacists refuse to participate? (I assume, for one thing, that screening and other procedures will take time the busy pharmacist may not have to spend on this sort of thing.) Who is to execute this “plan” for adverse events?

In any event, this bill is identical in language to one introduced in New Hampshire, which may mean there is some as-yet-unidentified group pushing it. Fortunately, according to a local news report, multiple medical experts testified against this bill in a recent committee hearing. Also encouraging is the news that a “fact-based” coalition made up of “more than 50 business leaders, healthcare institutions and advocacy groups” has been formed in New Hampshire to educate legislators and the public about COVID-related issues.

Finally, my state of Florida, is not about to be left behind in this race to the bottom. Companion House and Senate bills would allow the medical and other health care practitioner regulatory boards to discipline health care providers for misinformation (called “free speech” in the bill) posted on social media only if the board can prove “beyond a reasonable doubt” (the evidentiary standard required for conviction in criminal cases) that the “free speech” “led to the direct physical harm” of an actual patient of the practitioner.

This is, in effect, an impossible standard to meet. Nevertheless, boards could be fined up to $1.5 million (a figure apparently pulled from nowhere) each time they try to discipline a practitioner for “free speech” but fail to prove their case beyond a reasonable doubt.

I’m sure it was merely a coincidence, but the House bill was filed just as we were learning that a Florida physician had lodged a complaint with the medical board against our infamous Surgeon General, Dr. Joseph Ladapo, for spreading false information. To no one’s surprise, the complaint that was promptly dismissed, no threat of a $1.5 million penalty required.

Author

  • Jann J. Bellamy is a Florida attorney and lives in Tallahassee. She is one of the founders and Board members of the Society for Science-Based Medicine (SfSBM) dedicated to providing accurate information about CAM and advocating for state and federal laws that incorporate a science-based standard for all health care practitioners. She tracks state and federal bills that would allow pseudoscience in health care for the SfSBM website.  Her posts are archived here.    

Posted by Jann Bellamy

Jann J. Bellamy is a Florida attorney and lives in Tallahassee. She is one of the founders and Board members of the Society for Science-Based Medicine (SfSBM) dedicated to providing accurate information about CAM and advocating for state and federal laws that incorporate a science-based standard for all health care practitioners. She tracks state and federal bills that would allow pseudoscience in health care for the SfSBM website.  Her posts are archived here.