Dr. Stephen Smith: FDA's reversal on 'Trump drug' handcuffs physicians

Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, and a member of the White House Coronavirus Task Force, responds to a reporter's question at a coronavirus (COVID-19) update briefing Wednesday, March 25, 2020, in the James S. Brady Press Briefing Room of the White House. (Official White House photo by Tia Dufour)

The Food and Drug Administration has revoked its emergency-use authorization for the common anti-malarial drug touted by President Trump and many physicians around the world as an effective treatment for COVID-19, hydroxychloroquine.

The FDA said on its website Monday that after a review of current research on hydroxychloroquine and its cousin chloroquine, the agency determined the drugs didn't meet the "the statutory criteria" for emergency use authorization.

Doctors can continue to legally prescribe the two drugs off-label, as the emergency-use authorization applied to hospitalized COVID-19 patients and to drugs donated to the Strategic National Stockpile.

But the FDA -- essentially declaring hydroxychloroquine doesn't work and is dangerous -- has tied the hands of doctors who have successfully treated COVID-19 patients by combining the drug with azithromycin and sometimes zinc, said Dr. Stephen M. Smith, an infectious-disease specialist in East Orange, New Jersey, who trained as a researcher under Dr. Anthony Fauci at the National Institutes of Health.

"Physicians will be extremely hesitant to prescribe hydroxychloroquine," Smith told WND on Tuesday.

Smith, who briefed President Trump in April on the safety and effectiveness of hydroxychloroquine, said it would have been better if the FDA never had issued the emergency-use authorization.

The authorization, he explained, relying on a "poorly done" study, recommended a "ridiculously low" dosage of 2,400 milligrams of hydroxychloroquine over five days. Meanwhile, the FDA recommends 2,000 milligrams of hydroxychloroquine for malaria in 48 hours.

Then, the FDA said the dose that would be required in order to produce any effect against COVID-19 would likely be toxic, without specifying what that dose would be, he pointed out.

"What doctor now wants to fight for this drug?" Smith asked.

FDA chief scientist Denise Hinton said in a letter to Gary Disbrow of the Biomedical Advanced Research and Development Authority (BARDA) on Monday that the FDA "has concluded that, based on this new information and other information discussed in the attached memorandum, it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks."

The FDA said hydroxychloroquine and chloroquine have been tied to serious cardiac events and other side effects among COVID-19 patients.

Long before it withdrew emergency-use authorization, the FDA posted a warning on its website saying it "cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems."

But Smith pointed out in an interview with WND in May that in the approximately 400 clinical trials on hydroxychloroquine the FDA has approved for various diseases, not one requires EKG monitoring.

The drug has been used to treat malaria since 1955 and is commonly used for lupus and rheumatoid arthritis patients.

"People have doubled down on the toxicity of a drug that is not toxic," he said at the time. "They've gone around and told everybody it's killing people. It's not."

On Tuesday, Smith noted clinical trials in India show hydroxychloroquine works in prophylaxis, as a preventative. President Trump, prompting shock and scorn from media, took the drug as a preventative for a time, citing the fact that health-care workers around the world treating COVID-19 patients were doing the same.

But, now, no one in the United States will prescribe it for that purpose, Smith said.

"This is very bad in many ways for American medicine," he said. "The FDA, perhaps unintentionally, perhaps intentionally, weighed in on the use of FDA-approved drugs. That hasn't happened before to my knowledge."

The good news, regarding COVID-19, Smith said, is that the number of cases are declining in what was once the nation's hot zone, the New York City area, where he works, and the greater Northeast.

In May, the World Health Organization temporarily halted studying hydroxychloroquine in response to a widely reported observational study published in the medical journal The Lancet that concluded seriously ill COVID-19 patients who were treated with hydroxychloroquine were more likely to die.

But in an embarrassing turn, the premiere journal was forced to withdraw the study after three of the four authors issued an apology, citing concerns about the quality and veracity of the data.

The Lancet study's fatal flaws were immediately apparent to Smith when the study was released in May. Dr. Marc Siegel, associate professor of medicine at the New York University Langone Medical Center, called The Lancet study a "political hit job."

In another interview with WND in May, Smith expressed his frustration with the politicization of hydroxychloroquine and the disconnect between the scientific data on the drug and the statements of scientists, media and politicians who have access to that data.

CNN, in its report Monday on the FDA's revocation, mentioned the WHO's suspension of its hydroxychloroquine clinical trials with a link to a story about The Lancet study's damning findings.

The network reported the WHO has resumed the trials. But CNN failed to explain in its story Monday that the WHO trials resumed because The Lancet withdrew the deeply flawed study after it had been given so much attention by establishment media.

'Irrational interference'

WND reported Monday the Association of American Physicians and Surgeons has sued the federal government, alleging "irrational interference" with doctors' efforts to prescribe hydroxychloroquine for COVID-19 patients.

The doctors point out that hydroxychloroquine has been approved as safe by the FDA for 65 years. It's "safer than numerous medications that are widely available over-the-counter, including anti-depressants, sleeping pills, bronchodilators, Tylenol, and even aspirin," they said.

AAPS cited Harvey A. Risch, professor of epidemiology at the Yale School of Public Health and Yale School of Medicine, who said five studies, including two controlled clinical trials, have demonstrated significant major outpatient treatment efficacy. He concluded that "these medications need to be widely available and promoted immediately for physicians."

AAPS said that in countries that began using hydroxychloroquine "for prophylaxis and early treatment, death rates soon began to decrease, and the ratio of recoveries to deaths increased dramatically," including Cyprus, Costa Rica, Russia, Monaco, Algeria, Turkey, Israel, Italy, Peru, Honduras, Indonesia, United Arab Emirates, South Africa and Portugal.