Infectious-disease expert: 'American medicine has gone nuts'

President Donald J. Trump delivers remarks during a coronavirus (COVID-19) update briefing Monday, March 30, 2020, in the Rose Garden at the White House. (Official White House photo by Tia Dufour)

Dr. Stephen M. Smith is the widely respected infectious-disease specialist who briefed President Trump last month at the White House on the promise of the anti-malarial drug hydroxychloroquine as a treatment for COVID-19, calling it a "game changer."

His contribution to the president's highly controversial enthusiasm for the drug was recounted in a Washington Post story reporting that immediately after Smith gave a detailed presentation at the White House on April 3, Trump ordered the delivery of mass doses to coronavirus hot spots such as New York City and New Orleans.

Dr. Stephen M. Smith in an interview with Fox News (screenshot)

The Post opined that Trump's "swift embrace" of hydroxychloroquine "illustrates the degree to which the president prioritizes anecdote and feeling over science and fact."

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But that is precisely how Smith – a graduate of the Yale University School of Medicine and a former research scientist at the National Institute of Allergy and Infectious Diseases under Dr. Anthony Fauci – sees many of his colleagues reacting to a drug he argues has been shown in studies worldwide and in his own practice to be a safe and effective treatment for COVID-19.

"I don't have words to describe how frustrating this is," he said in a phone interview Wednesday morning with WND.

"There's just a craziness out there, and I don't know how to correct it," Smith said. "The truth doesn't matter any more."

Smith said the disconnect between the data and the statements of scientists who have access to that data is "unbelievably frustrating."

"American medicine has gone nuts," he said. "It's one thing for the press to go nuts, but doctors have done that. The Journal of American Medicine has done that."

'It's a complete joke'

Trump caused an uproar Monday afternoon when he revealed to reporters he had been taking hydroxychloroquine every day for the past couple of weeks as a preventative measure against the coronavirus. Immediately after the news conference, visibly angry Fox News anchor Neil Cavuto warned viewers that people will die if they follow Trump's lead, pointing to a University of Virginia study of veterans.

Smith told WND he wasn't aware of Cavuto's rebuke but already is on record calling the UVA study – which concluded COVID patients who took hydroxychloroquine were more likely to die – a "sham."

"I've never seen an efficacy trial of any drug where they didn't list the dose or the days of therapy," he told WND. "It's a complete joke."

At a White House Cabinet meeting Tuesday open to reporters, Veterans Affairs Secretary Robert Wilkie critized the study, noting the researchers "took VA numbers and they did not clinically review them" and ignored the fact that many of the patients were near death with "various comorbidities."  Last week, two physicians in Congress challenged ousted HHS official Dr. Rick Bright during a hearing for his resistance to hydroxychloroquine, citing the many doctors reporting its success with "lives on the line."

Smith said the "consistency of approach to analyzing data is gone," and he finds it difficult to engage with colleagues on the subject of hydroxychloroquine and COVID-19.

"Either I've gone nuts or they have, but we can't both be sane," said Smith, the director of the Smith Center for Infectious Diseases and Urban Health in East Orange, New Jersey.

"The only thing I've heard that is even near an argument is 'just because.'"

Smith, who he has been taking hydroxychloroquine as a prophylatic since early March, before he began treating COVID patients, said he has no financial gain in hydroxychloroqine.

"To me, I just want to know the truth," he said. "The truth in medicine will come out eventually."

In early April, a poll of 6,200 physicians in 30 countries found hydroxychloroquine to be the best drug available to treat COVID-19.

At the same time, Smith declared he had seen remarkable success in his treatment of 72 seriously ill COVID-19 patients with hydroxchloroquine and the common antibiotic azithromycin, or Z-pack.

"I think this is the beginning of the end of the pandemic," he said in an April 1 interview with Fox News' Laura Ingraham. "I'm very serious."

"It's a game-changer. An absolute game-changer."

But resistance has only intensified to the drug, which has been used to treat malaria since 1955 and is commonly used for lupus and rheumatoid arthritis patients.

Not the first time

Ironically, in this season of enhanced handwashing, there are echoes of that resistance in the story of the pioneer of hand disinfection in medicine, Dr. Ignaz Semmelwies.

Dr. Ignaz Semmelweis

In 1847, not long before the germ theory discoveries of Louis Pasteur and Joseph Lister, the Hungarian physician-scientist cited published reports that handwashing reduced mortality in obstetrical clinics to below 1%. But his proposal to require doctors at Vienna General Hospital to wash their hands was met with mockery and disdain. His views conflicted with the established scientific and medical consensus of the time.

"This is what is going on now," Smith told WND.

The FDA, for one, is contradicting itself, he said. The agency officially "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 in the 400 clinical trials on hydroxychloroquine the FDA has approved, not one requires EKG monitoring, Smith points out.

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

The FDA, he said, has decades of randomized, double-blind studies on hydroxychloroquine for the treatment of lupus and rheumatoid arthrititis.

"Every one of them has higher doses than anyone is giving for COVID therapy," he said, with some giving more than 1,000 milligrams trials a day.

"None of them require EKG monitoring. None of them talk about increased death," he said. "It's a canard."

The Journal of the American Medical Assocation, JAMA, published an editorial warning that hydroxchloroquine is "toxic," without any citation, he noted.

But the same journal published a peer-reviewed study touting the drug as a safe treatment for pancreatic cancer at 1,200 milligrams per day. That's twice the amount Smith gives to his COVID-19 patients.

"Which JAMA are we supposed to believe, the editorial that is uncited or the one that publishes on data from a patient population?" Smith asked.

The saga of the ostracized 19th century physician-scientist, Semmelweis, did not end well personally, although he was later vindicated by Pasteur.

In 1865, Semmelweis was committed to an asylum by a colleague after it was believed he had suffered a nervous breakdown. Just 14 days later, he died in the institution at age 47 after being beaten by guards.

Fauci's father figures

Smith has known Fauci, President Trump's top coronavirus health adviser, for decades, both as an employee of NIAID and through a family relationship.

Smith's father, the renowned infectious disease specialist Dr. Leon Smith, was a close colleague of Fauci's mentor, Dr. Sheldon Wolff.

Wolff joined the National Institute of Allergy and Infectious Diseases in 1960 and eventually became its director.

Director of the National Institute of Allergy and Infectious Diseases Dr. Anthony S. Fauci at a coronavirus briefing April 22, 2020. (Official White House photo by Shealah Craighead)

"Wolff was a father figure, as was my father, to Fauci," said Smith.

The elder Smith, along with Fauci, gave the eulogy for Wolff when he died in 1994.

Smith, emphasizing he has a lot of respect for Fauci, takes issue with the NIAID director's publicly stated insistence that the efficacy of hydroxychloroquine and azithromycin in the treatment of COVID-19 is merely "anecdotal."

Anecdotal means without controls, Smith argued, but there are many studies with controls indicating COVID-19 patients taking hydroxychloroquine didn't get well merely because they were going to get well anyway, with or without treatment.

In fact, he pointed out, Fauci's "claim to fame" is a study that provided the basis for a therapy to treat an autoimmune disease called Wegener's granulomatosis.

Fauci's study examined only 17 patients and had no controls, observing patients who did not take the drug and relying only on historical controls.

"By defintion that is anecdotal," Smith said, noting that doesn't mean it's incorrect.

"We use anecdotal data all the time," he explained.

Smith also pointed out that there have been no randomized-controlled trials for treatment of syphilis.

Nevertheless, the Centers for Disease Control and Prevention puts out the same antibiotic regimens every few years for the disease.

Decisions in medicine often are made without perfect data, he explained, but the data that hydroxychloroquine is effective in the treatment of COVID-19 is overwhelming.

Addressing conflicting studies, he argued it's much easier to show that a drug does not work when it's not a randomized trial, particularly because of "selection bias."

Smith noted there's bias, for example, when doctors decide to give some patients the drugs as opposed to others.

Because doctors are human beings, they tend to give the drugs to the sicker patients.

Apples to oranges

Smith also argued it's difficult to compare hydroxchloroquine-COVID-19 studies because of the wide variance in dosage.

And, with the exception of an oft-cited French study that has shown it to be effective, the studies do not combine hydroxychloroquine with azithromycin, which is the regimen he has been using to great effect.

"We're not comparing apples to apples, but apples to oranges and grapefruits," he said.

The French study, published March 20, tested a total of 36 people with COVID-19.

Over 10 days, 16 were given nothing and 14 were given 600 milligrams of hydroxychlorquine daily. The last six, the sickest of the group, received azthromycin plus the 600 miligrams of hydroxychloroqine.

Of the six, all were "virologically cleared" of COVID-19 by day five, Smith said.

In the group receiving only hydroxychloroquine, eight of the 14 were cleared of the virus by day five. Of the 16 who received nothing, only two were cleared.

"Those were controls," he said. "Actually, the bias was against those results, because the sicker patients were in the azithromycin group."

Significantly, he said, the clearance of the virus within five days is consistent with what he and many other physicians have seen.

A newer French study, one with an arm of 80 and another with 1,000 people receiving the same hydroxychloroquine-azithormycin regimen, found 90% got better.

Smith said that after the March study from France, he began administering the hydroxychloroquine-azithromycin protocol to his patients.

"When I saw the virologic results, I wanted to give my patients the best chance," he said, explaining that those who clear the virus quicker get better quicker.

But he noted the French study did not specifically address the reported side effect of heart arrthymia, concluding only that the drug was found to be safe.

"So I measured EKGs in every patient, every day and recruited a physiologist to examine the records," Smith said.

"Much to my surprise, even with high-risk patients and those who were taking a third drug, we didn't see it," he said.

"I was not expecting that. I was checking to see who I should stop the drug on."

Smith said he will soon publish data showing that people with a baseline normal EKG can take the drug safely.

"I was stunned by that," he said of the result.