Editor’s note: The following commentary received 170 comments stating the opinion piece was not “fact-based,”and “irresponsible,”and “written to score political points.” For the record, the order states, “these are drugs that have not been proven scientifically or medically to treat COVID-19,” and “a pharmacists shall not fill a prescription if the pharmacist believes the prescription will be used for other than legitimate medical purposes,” and “it is also important to be mindful that licensed health professionals are required to report inappropriate prescribing practices.”
The coronavirus is unquestionably a significant threat to the health and safety of people throughout the world. The infection’s worldwide death toll is more than 23,000 and counting, with 1,163 in the United States.
There is a silver lining, however, in the numbers of people who are recovering from COVID-19 – more than 122,000 at this writing. Even great hope lies in a promising new treatment using a combination of old drugs: Plaquenil (hydroxychloroquine) and a Z-Pak (azithromycin).
These well-known drugs have very favorable safety profiles. Several small studies have shown significant reduction in viral loads and symptom improvement when combining these medications in COVID-19 patients. Though these studies are small and do not prove efficacy, the results were so promising that the authors of the most famous study concluded: “We, therefore recommend that COVID-19 patients be treated with hydoxycholoroquine and azithromycin to cure their infection and to limit the transmission of the virus to other people in order to curb the spread of COVID-19 in the world.”
Based on these and other results, physicians and governments around the world are now using these medications to claimed great effect. Even in the state of Michigan, where there have now been 60 deaths, prominent health care systems such as the Henry Ford Hospital and the University of Michigan have added hydroxychloroquine to their treatment protocols for hospitalized patients with COVID-19.
By doing so, physicians are using these medications “off-label,” that is, without the costly and time-consuming process of Food and Drug Administration (FDA) approval. The federal agency’s approval process performs the good task of helping to ensure medications safely do what they claim to do. Lack of FDA approval, however, does not mean lack of efficacy. It means lack of governmental confirmation of efficacy.
“Off-label” use of medications is legal and common. It may even account for as many as one in five prescriptions in the United States. This practice is even accepted by the FDA. Furthermore, given the severity of the COVID-19 pandemic and the promise of these medications the FDA has avoided condemning the “off-label” use of hydroxychloroquine for COVID-19.
But if you live in Michigan, and you or a love one is infected with this potentially lethal disease, you’re out of luck.
Gov. Gretchen Whitmer’s Department of Licensing and Regulatory Affairs literally threatened all doctors and pharmacists in the state who prescribe or dispense hydroxychloroquine to treat COVID-19.
The agency’s March 24 letter warns physicians and pharmacists of professional consequences for the prescribing of hydroxychloroquine (and chloroquine). Beyond the rational recommendation against hoarding as production of this medication needs to be ramped up, the letter deviates into open threats of “administrative action” against the licenses of doctors that prescribe hydroxychloroquine.
The letter also instructs pharmacists to ignore physician orders for this medication. Due to the debate over a pharmacist’s refusal right to fill medications that go against their religious beliefs, this could place pharmacists in the unprecedented position of being told that they must fill prescriptions that violate their “conscience (religious belief)” but must not fill prescriptions to great COVID-19.
Worse, the letter indicates healthcare providers are “required to report” their fellow physicians who are prescribing these medications. This draconian measure carries ominous Gestapo-like overtones of neighbor reporting neighbor to “authorities.”
During a time of crisis, in which physicians continue to see patients despite not having enough protective gear, this threatening, authoritarian stance from a governor is counter-productive at best.
What makes this directive more of a head-scratcher is that the same day the state issued its threatening nastygram to Michigan’s health care providers, Whitmer’s counterpart in New York started clinical trials of the very same drugs.
With his state now the nation’s pandemic epicenter, and with the blessing and help of the President and FDA, New York Gov.Andrew Cuomo brought in 70,000 doses of hydroxychloroquine, 10,000 doses of Zithromax and 750,000 doses of chloroquine.
The implications of Gov. Whitmer and her administration’s knee-jerk scare tactics should terrify all Michiganders. Not only is our state’s top leader threatening the selfless healthcare workers who are on the frontline trying to save lives, but she’s denying possible life-saving medications to actual COVID-19 victims.
Kathy Hoekstra (#@khoekstra) writes from Michigan. An earlier version of this article was published in The Detroit News, March 26. Reprinted with permission.
Kathy Hoekstra is the Regulatory Policy Reporter for Watchdog.org, writing about national and state regulatory issues.
