Dr. Mehmet Oz, host of The Dr. Oz Show has been criticizing infectious disease expert Dr. Anthony Fauci for calling the data from studies of a drug used to treat coronavirus ‘anecdotal.’
Doctors in France and China have been conducting small, randomized studies of the malaria drug hydroxychloroquine and reporting excellent outcomes for coronavirus patients.
The drug (also known as Plaquenil) is often paired with the antibiotic azithromycin for more effective treatment. President Donald Trump has called the drug a potential “gamechanger” in treating COVID-19 patients.
Dr. Oz said “the word “anecdote” is used a lot — that is an incorrect description of where this medication is now,” during a Monday interview on Fox News’ Fox & Friends.
“There’s no question it’s not proven to be beneficial in the large clinical trials we expect in America, and certainly the FDA and medical societies would desire. But these have been supported with case studies,” said Dr. Oz.
He also spoke by phone with Didier Raoult, the French physician who touted the drug based on his research, on Monday.
“Thousand series of patients — 1,000 patients in a row he’s treated, and he’s not published yet, he’s going to be published over the next two weeks. But he’s got seven people who have died, they were all older and had other co-morbidities, 20 people have gone to the ICU of that trial. Now, it’s not a randomized trial, but that’s not anecdotal,” said Dr. Oz.
He also explained why he opposed Dr. Fauci’s stance: “He’s a pro and I respect him a lot, but a small study that shows statistical significance is a really important observation. If it takes me 30,000 patients to show a difference, is that better than showing a difference in 62 patients? If a small trial demonstrates statistically significant differences, you should respect it. At least pay attention to it.”
Denver family physician Dr. Constantine Tsamasfyros told CBS4 Investigator Brian Maass on Monday he started prescribing the drug for his patients four weeks ago because there was nothing else available.
“If they’re drowning, you either pull them out of the water or at least throw them a rope to come out” said Tsamasfyros. “They all did well. They seemed to reverse their symptoms in a day or two.”
Tsamasfyros has been a primary care doctor in the state for nearly 50 years. He has prescribed a combination of hydroxychloroquine and azithromycin to about a dozen patients over the last few weeks.
“On an outpatient basis there is really nothing to offer our patients,” he said. “Until we have something documented or better this is a fallback and we should not be depriving our patients. You certainly don’t want to deprive a patient that might be drowning in an inflamed lung situation of any kind of help or assistance.” He told CBS4 he advises patients of the potential side effects.
The American Academy of Ophthalmology has reported evidence of retinal damage from hydroxychloroquine in about 1 percent to 2 percent of patients who develop retinal problems during a five-year course of treatment.
Prolonged use can also cause an interrupted heartbeat or a cardiac arrhythmia. The Mayo Clinic issued urgent guidance advising cardiac screenings of all patients who take hydroxychloroquine and chloroquine.
The American Thoracic Society, which specializes in the treatment of respiratory diseases, backed the use of hydroxychloroquine for seriously ill, hospitalized coronavirus patients on Monday.
It issued guidelines for using the anti-malaria drug for patients with pneumonia, advising doctors “to prescribe hydroxychloroquine (or chloroquine) to hospitalized patients with COVID-19 pneumonia if all of the following apply:
a) shared decision-making is possible
b) data can be collected for interim comparisons of patients who received hydroxychloroquine (or chloroquine) versus those who did not
c) the illness is sufficiently severe to warrant investigational therapy, and
d) the drug is not in short supply
The Thoracic Society set its guidelines with input from an international task force comprised of doctors from medical centers that are currently treating COVID-19 patients.
The group concluded that evidence about the efficacy of hydroxychloroquine in the treatment of COVID-19 is “contradictory” but experimenting with the drug during a public health crisis to treat very sick patients could elicit critical data.
“We believe that in urgent situations like a pandemic, we can learn while treating by collecting real-world data,” said Dr. Kevin Wilson, chief of guidelines and documents at the American Thoracic Society.
“There are in vitro studies that suggest that hydroxychloroquine and chloroquine have activity against SARS-CoV-2019, the virus that causes COVID-19,” Wilson said.
He argued that several controlled trials from China and France “all have serious flaws and inconsistent findings. … Thus, the bottom line is, whether hydroxychloroquine and chloroquine confer benefits to patients with COVID-19 are unanswered questions.”