The failures of the CDC and FDA endangers us all

QUICK READ: The US Centers for Disease Control and Prevention has removed from its website guidelines for doctors on how to prescribe two antimalarial drugs that President Donald Trump has touted as potential treatments for the novel coronavirus. The CDC and FDA are gambling with our lives and it has to stop.

President Donald Trump has repeatedly touted the potential benefits of hydroxychloroquine, which has been approved by the Food and Drug Administration to treat malaria, lupus and other autoimmune ailments but hasn’t yet been proven effective and safe in treating the coronavirus.

 The president’s reassurance is raising concerns among experts about the dangers the drug poses to some.

 Dr. Michael Ackerman, a genetic cardiologist who is director of the Mayo Clinic’s Windland Smith Rice Genetic Heart Rhythm Clinic, took the unusual step in late March of issuing guidance for physicians.

“What disturbed me the most was when I was seeing not political officials say these medications are safe but seeing on the news cardiologists and infectious disease specialists say” hydroxychloroquine “is completely safe without even mentioning this rare side effect,” Ackerman said in an interview.

“That’s inexcusable,” he added.

In fact, a recent study showed that up to 11 percent of coronavirus patients on hydroxychloroquine and azithromycin are in the so-called “red zone” for potential cardiac side effects.

“This particular medicine is probably the only medication I know of that has become a Republican or a Democrat medication. That’s just crazy.”

Hydroxychloroquine and chloroquine have not been approved by the US Food and Drug Administration to treat coronavirus. Nevertheless, on Saturday the FDA issued an emergency use authorization to distribute the two drugs from the national stockpile to treat patients hospitalized with COVID-19.

Some experts, including Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, have warned the administration that the drug is unproven and that there are dangers in promoting it before data backs up its efficacy. There was a heated disagreement in the White House over the weekend about the effectiveness of the unproven drugs.

Two weeks ago, French doctors published a provocative observation in a microbiology journal. In the absence of a known treatment for COVID-19, the doctors had taken to experimentation with a potent drug known as hydroxychloroquine. Anthony Fauci is not among the impressed. The day the study came out, Fauci, the leading infectious-disease expert advising the White House’s coronavirus task force, downplayed the findings as “anecdotal.” The report was not a randomized clinical trial—one in which many people are followed to see how their health fares, not simply whether a virus is detectable.

The president of the United States has become the world’s most prominent peddler of medical misinformation.

While some very early evidence has shown that hydroxychloroquine may influence the course of COVID-19, Trump is overriding his top medical adviser and minimizing serious risks by encouraging Americans to try the drug right now. This brazen dispensation of medical advice from the president is dangerous in ways beyond the potential harm of the drug itself.

Based on the limited evidence so far, giving hydroxychloroquine to people could very well be—as with most drugs that modulate the immune system—of some benefit in some circumstances. Some people will be made sicker by it, depending on underlying physiology, other medications they’re taking, timing, and dosing. Identifying who stands to benefit and why requires data, and several randomized controlled studies of hydroxychloroquine are underway.

In the U.S., Fauci continues to hold the same line as the rest of the medical community—cautious optimism, with a close eye on the many ongoing clinical trials. Trump, meanwhile, escalates as a peddler.

CDC Fails

The Centers for Disease Control and Prevention is not providing nationwide data about covid-19’s impact on African Americans, Latinos or other racial and ethnic groups.

 The CDC customarily reports such data, but it has not done so with covid-19. Many states and counties are also not publishing the information. As of Tuesday, the CDC had not responded to inquiries about whether it has the demographic data and isn’t releasing it, or simply isn’t tracking the information.

The early data suggest that the COVID-19 pandemic is hitting black communities particularly hard. As of Monday, African Americans made up 27 percent of the population in Milwaukee County, Wis., but 70 percent of its COVID-19 deaths. In Chicago: 30 percent of the population but 69 percent of deaths. And in Louisiana, the disparity is 32 percent and 70 percent. A similar divide can be seen in Michigan, where African Americans make up 14 percent of the population and, as of last Friday, accounted for 40 percent of COVID-19 deaths.

The FDA and CDC seem to be afraid if Trump’s wrath. They are failing us all and it’s just another example of why Trump has to go.