IS GOVERNMENT “IN THE WAY”?
by Sharon Rondeau
(Apr. 3, 2020) — On Thursday’s “Hannity,” Dr. Mehmet Oz, a cardiac surgeon and radio host who has been following closely developments in emerging coronavirus therapies, reported that the governors of Michigan and Nevada have rescinded executive directives issued last week forbidding physicians from prescribing hydroxychloroquine sulphate and chloroquine phosphate for “off-label” use in coronavirus patients who are not hospitalized.
The FDA has approved the two medications for the treatment of the auto-immune disease lupus, for malaria and rheumatoid arthritis. According to Oz, the drugs are reasonably safe and show promise in the treatment of the novel coronavirus, or COVID-19, based on a “small” French study conducted by Dr. Didier Raoult and other physicians’ reported results.
On March 24, Gov. Steve Sisolak (D-NV) and Gov. Gretchen Whitmer (D-MI) each issued executive orders based on the respective recommendations of their state public-health entities to limit the prescription of the two medications to hospitalized patients only for COVID-19, thereby precluding “off-label” use on an outpatient basis. Whitmer’s directive was based on the Michigan Department of Licensing and Regulatory Affairs’ letter to “Licensed Prescribers and Dispensers” claiming that “The Department of Licensing and Regulatory Affairs has received multiple allegations of Michigan physicians inappropriately prescribing hydroxychloroquine or chloroquine to themselves, family, friends, and/or coworkers without a legitimate medical purpose.”
“Prescribing hydroxychloroquine or chloroquine without further proof of efficacy for treating COVID-19 or with the intent to stockpile the drug may create a shortage for patients with lupus, rheumatoid arthritis, or other ailments for which chloroquine and hydroxychloroquine are proven treatments. Reports of this conduct will be evaluated and may be further investigated for administrative action,” the Department further wrote.
Michigan, particularly Detroit, has been heavily-impacted by the coronavirus.
On the evening of March 23, New York Gov. Andrew Cuomo (D) wrote in Executive Order #202.10 that “No pharmacist shall dispense hydroxychloroquine or chloroquine except when written as prescribed for an FDA-approved indication; or as part of a state approved clinical trial related to COVID-19 for a patient who has tested positive for COVID-19, with such test result documented as part of the prescription. No other experimental or prophylactic use shall be permitted, and any permitted prescription is limited to one fourteen day prescription with no refills,” an order which has not been rescinded.
At the same time, an FDA-approved clinical trial of the two medications, possibly in tandem with azithromycin, began in New York City with 1,100 patients, the results of which President Trump said on Monday could be available soon. New York State, and the city in particular, have the highest number of coronavirus cases and deaths in the country.
On Sunday evening, RADM Denise M. Hinton, Chief Scientist of the Food and Drug Administration (FDA), announced an Emergency Use Authorization (EUA) for both drugs “for the treatment of 2019 coronavirus disease (COVID-19) when administered by a healthcare provider (HCP)1 pursuant to a valid prescription of a licensed practitioner.”
“The authorized chloroquine phosphate and hydroxychloroquine sulfate are limited to product supplied from the Strategic National Stockpile (SNS) to public health authorities,” the letter continued.
On page 8, Hinton wrote, “I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective for the treatment of COVID-19, when used consistently with the Scope of Authorization of this letter (Section II), pursuant to Section 564(c)(2)(A) of the Act.”
On Tuesday, Bridge Magazine reported that Whitmer’s “supply concerns appear to be fading after drug maker Sandoz donated 30 million doses of hydroxychloroquine sulfate to the federal government’s Strategic National Stockpile and Bayer Pharmaceutical donated another 1 million doses of chloroquine phosphate.”
On Thursday, the Detroit Metro Times reported that “After being accused of ‘banning’ the use of a potential coronavirus drug, Michigan is now leading the nation’s largest study on whether hydroxychloroquine can be used to treat COVID-19.” Whitmer now sees “great potential” in the use of the drugs for coronavirus, the outlet said, and “Detroit is now leading the nation’s first large-scale study.”
The same day, The Washington Times reported that a poll encompassing 6,000 physicians from around the world identified hydroxychloroquine as “the most highly rated treatment for the novel coronavirus,” a report Oz cited to Hannity.
As of Thursday night, The Post & Email was unable to verify through public reporting that Sisolak rescinded his March 24 order as to the two medications and therefore contacted his spokesperson, Meghin Delaney, for comment. Any response from Delaney will be included in an update to this article.
During the interview, Hannity asked Oz, “Why? Why are we pushing people into the hospital to use a medicine that is, according to you…fairly safe and seemingly effective, both anecdotally and you told us about the study last night, the clinical study?”
Oz responded that a small “randomized trial” conducted in China showed that the regimen “significantly improved results with reduction of fevers, reduction of the cough, improvement of CT scans showing less pneumonia — significant. Statistically, less than one in 100 chance in two of those cases there could just be random.” He said that while a “large trial” is necessary, “I think most clinicians are getting comfortable with this.”
Oz added that he interviewed former Kansas Gov. Jeff Colyer, a physician who has returned to practicing medicine since leaving office and who Oz said is “using it legitimately” and “is very happy with the results.”
Some results have been “mixed,” Oz conceded.
In former New York City Mayor Rudy Giuliani’s “Common Sense” podcast, Giuliani interviewed a prominent 73-year-old Florida rabbi who was recently hospitalized for nine days with COVID-19 and treated with the combination of hydroxychloroquine and azithromycin. Rabbi
“I’ve been calling around to different countries,” Oz told Hannity, and said that Turkey has “mandated” the use of hydroxychloroquine early in the virus’s progression. “In China, it’s in their formulary,” he said.
Last month, the French government announced that it would conduct a larger clinical trial of hydroxychloroquine on coronavirus than Raoult’s.
“…I don’t want to have government getting in the way of physicians prescribing medications that they think their patients benefit from. The FDA, God bless them, has expedited, and made it comfortable for doctors to prescribe this off-label…I do think Governor Cuomo is going to pull back with what he thinks about the trials…” at which point Hannity, a New York resident, interjected, “When? When? Now’s the time! Lift the ban; lift it! You’re the only state; lift the ban!”
Oz did not respond to Hannity’s exclamations, after which Hannity said, “You bring us all this information; you tell us all these countries; you’re talking all these doctors around the world, all these patients you’re putting on your show in the afternoon. Alright. Dr. Oz, you’re the best.”
On Friday morning’s edition of “Fox & Friends,” NIAID Director Dr. Anthony Fauci was more skeptical of the efficacy of hydroxychloroquine for COVID-19, stressing the need for traditional clinical trials and more evidence in order for accurate conclusions to be drawn.
Oz has previously urged Cuomo to “reverse the order” on Hannity’s show. As of this writing, The Post & Email has found no evidence that Cuomo has acted on Oz’s recommendation but contacted the governor’s press office to ask the question.
On March 26, Cuomo’s website reported that it received “70,000 Doses of Hydroxychloroquine, 10,000 doses of Zithromax and 750,000 Doses of Chloroquine to Implement Drug Trials.” On March 28, Cuomo announced that Amneal Pharmaceuticals donated 20,000 additional bottles of hydroxychloroquine to New York State.