FLCCC Doctors: “We treat patients, not p-values.”
JAMA has done it again.
“It” is the February 18, 2022 publication of a study on ivermectin with a conclusion that inexplicably departs from the study’s own data. Even worse, the Malaysian I-TECH Randomized Clinical Trial and JAMA itself dismiss the totality of peer-reviewed, published evidence (and a number of summary meta-analyses) showing repeatedly shorter times to clinical recovery, fewer hospitalizations, and far less death when COVID patients are treated with ivermectin.
“This study was clearly designed to fail. The authors selected out patients with mild or moderate disease who were at low risk of having a major event. Consequently it was grossly underpowered for any meaningful patient-centered outcome,” said Dr. Paul Marik, FLCCC Chairman Chief Scientific Officer.
The authors of the study reported that “ivermectin treatment during early illness did not prevent progression to severe disease. The study findings do not support the use of ivermectin for patients with COVID-19.”
But Dr. Pierre Kory, FLCCC president and Chief Medical Officer, says that is flat out wrong and highly misleading.
“In the study’s control group, two and a half times more patients had to be placed on mechanical ventilation —and there were three times more deaths in the control group. This shows that ivermectin causes a 75% risk reduction in death and further strengthens metadata of Ivermectin’s large mortality benefits in severe COVID.”
Dr. Keith Berkowitz, FLCCC co-founder, noted that the study’s strongest p-value (the measure of statistical significance) was for the 28-day hospital mortality. “Overall, this study was too limited and small to even be randomized. Still, the results trended in favor of ivermectin,” said Berkowitz.
An important note about the study:
It’s important to recognize here that the study participants had been experiencing symptoms for FIVE days by the time they were enrolled in the study. This is an important point to consider, given the primary outcome of the study was “the proportion of patients who progressed to severe disease.” As those of you who have been following the FLCCC know, early treatment (within the first ONE OR TWO DAYS of symptom onset) is critical to slow virus replication and impeded progression to severe disease.
So the authors of the study reported that ivermectin was not helpful in preventing progression to severe disease—among study patients who had been started too late in their disease at the start. Nevertheless, the authors concluded that IVM was not helpful in the treatment of COVID.
But wait a second.
What happened to the patients when they did progress to severe disease? What did the study find out about its secondary outcomes, which included rates of mechanical ventilation, intensive care unit admission, 28-day in-hospital mortality, and adverse events? Let’s take a look:
“It is clear that a massive study would have been far better to determine greater statistical significance,” continued Dr. Marik. “But to be honest, this study is in line with the major medical journals which will only publish negative studies on ivermectin and hydroxychloroquine. They simply will not publish any of the dozens of positive studies that have emerged. This constitutes enormous, deliberate publication bias, which is immensely injurious to scientific truth—and to patients throughout the world.”
The first tweet should say RR (relative risk) rather than HR (hazard ratio).