Wednesday, April 8, 2020

'What do you have to lose' Trump touts an unproven drug, Part 1

Let me be real clear. I am not a medical doctor. Neither am I a medical researcher investigating viruses and pandemics. (I am just a cognitive scientist with a Ph. D. in Psychology.) So forgive my naivety, please, as I ask a simple question.

Hydroxychloroquine is a drug that treats and prevents malaria. It’s target is a protozoan parasite that is transmitted by mosquitoes. Azithromycin (known to many as “Z-Pak,”) is an antibiotic that kills bacteria. So why would I, or anyone else, on the surface of it, think to use either drug, as either a prophylactic or treatment f0r COVID–19, the disorder due to the coronavirus?

[Disclosure: Hydroxychloroquine is used to treat rheumatoid arthritis and lupus.]

“What do you have to lose?” Trump asked Saturday at the White House when pressed by reporters about hydroxychloroquine’s effectiveness. And while he’s suggested that patients consult with their physicians about the treatment, he’s also said the drug can “help them, but it’s not going to hurt them.”

He’s wrong on both counts. Whether it helps needs to be confirmed with randomized clinical trials. And it can hurt according to a Mayo Clinic cardiologist: ‘Inexcusable’ to ignore hydroxychloroquine side effects. While safe for most, the drug carries serious side effects for some, including sudden cardiac arrest.

For example:

After observing the debate over hydroxychloroquine on TV news and in social media, 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.

While hydroxychloroquine is likely to be safe for 90 percent of the population, Ackerman said, it could pose serious and potentially lethal risks to a small number of those susceptible to heart conditions, especially those with other chronic medical problems already on multiple medications.

In fact, a small 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.

So why DOES Trump (aka Dr. Fauxi) tout this drug?

The answer will take two posts. This is the first.

James Hamblin, writing in The Atlantic, asks Why Does the President Keep Pushing a Malaria Drug?. What is actually known about hydroxychloroquine, the medication that Trump is fixated on recommending for COVID–19.

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. For decades, the drug has been used to treat malaria—which is caused by a parasite, not a virus. In six patients with COVID–19, the doctors combined hydroxychloroquine with azithromycin (known to many as “Z-Pak,” an antibiotic that kills bacteria, not viruses) and reported that after six days of this regimen, all six people tested negative for the virus.

The lack of a control condition precludes causal inference. For example, the patients might have gotten well on their own. Moreover, the inference by Trump and his sickophants left out critical information.

… According to the study itself, three other patients who received hydroxychloroquine were too sick to be tested for the virus by day six (they were intubated in the ICU). Another had a bad reaction to the drug and stopped taking it. Another was not tested because, by day six, he had died.

Nonetheless, the day after Raoult’s study was published, Donald Trump tweeted about it: “HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine.” …

Dr. Fauxi asks “What do you have to lose?” The answer is clinging to false hope created by crappy science and embraced by a very ignorant man.

What else us known about Trump’s drug deal?

The NY Times reported:

The professional organization that published a positive French study cited by Mr. Trump’s allies changed its mind in recent days. The International Society of Antimicrobial Chemotherapy said, “The article does not meet the society’s expected standard.” Some hospitals in Sweden stopped providing hydroxychloroquine to treat the coronavirus after reports of adverse side effects, according to Swedish news media.

… The University of Michigan Medical School advises its doctors that “the current body of literature and local experience does not support the routine use of any specific treatment regimen, including hydroxychloroquine, for patients with confirmed COVID–19 infection.”

Conclusions like these draw on the fact that the body of evidence remains small, and the results are mixed. A randomized trial of 30 patients with COVID–19 in Shanghai found no difference in detectable virus at day seven, with or without hydroxychloroquine. Another recent study suggested that the drug may help with COVID–19 symptoms, including coughing and fever, but it included only 62 people with mild cases of the disease, and excluded anyone with conditions that could be exacerbated by hydroxychloroquine. …

In his capricious responses to this pandemic, Trump has given little indication that he respects, or even comprehends, the reasons for the scientific process. Hydroxychloroquine could end up as part of the treatment approach that one day saves lives. Outside of a proper testing process and clear messaging, it could cost lives. Addressing a world in a collective state of despair, Trump offers exaggerated hope and endangers people as he rambles.

On Saturday, Trump suggested research exists that shows people with lupus don’t get the coronavirus, implying that their use of hydroxychloroquine protects them. “There’s a rumor out there that because it takes care of lupus very effectively, as I understand it, and it’s a, you know, a drug that’s used for lupus,” he said, “so there’s a study out there that says people that have lupus haven’t been catching this virus. Maybe it’s true; maybe it’s not.”

There is no such study.

Jonathon Chait, writing in the NY Magazine’s Intelligencer, explains Why Trump Is Overruling Scientists to Pursue His Pet Coronavirus Drug.

Trofim Lysenko was a Soviet biologist who gained the favor of Joseph Stalin by promoting pseudoscientific theories that purported to apply Marxist-Leninist theory to biology. Lysenko’s insight was to dismiss the burgeoning field of genetics as a capitalist lie, and to posit a socialist alternative theory of biology that refused to accept that plants were bound by any such thing as “genes.” Orange trees would flourish in Siberia, he promised Stalin. Catering both to the regime’s state ideology and its yearning for prosperity — he promised his methods would yield orange trees in Siberia — Lysenko established his crackpot theories as official Soviet science, and purged scientists who refused to endorse them. Stalin directed Soviet farmers to follow Lysenko’s bizarre theories, contributing to mass starvation.

There are eerie echoes of Lysenkoism in President Trump’s obsession with promoting hydroxychloroquine, a medication used to treat malaria, as a cure for the coronavirus. The parallel is not exact: Hydroxychloroquine has shown some anecdotal promise as a coronavirus therapy. It might emerge as a treatment, and conceivably even the major treatment, for the coronavirus. What gives Trump’s hydroxychloroquine obsessions its creepy Lysenkoist tinge is that the fervor is altogether disconnected from science.

Public-health officials are … skeptical. Evidence to date can be summarized as “limited and inconclusive.” Trump’s former FDA commissioner Scott Gottlieb wrote a Wall Street Journal column urging the rapid development of coronavirus treatments, citing several promising examples, but conspicuously omitting the president’s favorite example. On Twitter, Gottlieb cautioned that hydroxychloroquine is not the wonder treatment Trump believes it to be: “If the [hydroxychloroquine] drug combo is working its effect is probably subtle enough that only rigorous and large scale trials will tease it out.” Dr. Anthony Fauci, the White House’s top scientist, has sounded cautionary notes. “The data are really just at best suggestive,” he says. “There have been cases that show there may be an effect and there are others to show there’s no effect.”

The skeptics’ argument is not that hydroxychloroquine is certain to fail, but that clinical tests, not presidential hunches, will be needed to determine the most effective treatments. Trump appears to lack the patience to wait for this process, even one hurried along by the universal rush to treat the global pandemic.

… developing effective treatments may be the most important determinant of how quickly American life can regain some semblance of normal functioning. Deploying a vaccine will take at least a year — until then, only treatment can permit people to reenter public spaces without overcrowding intensive care units. That race to produce such vital medicine is being diverted by the president’s insistence on disregarding the scientific method for his own hunches.

What it augurs more broadly about Trump’s disdain for public-health expertise is even darker. Over the last two days, Trump has visibly balked at social-distancing guidelines and renewed his impatience to reopen the economy soon. His demand to produce a silver-bullet wonder drug right away seems both to grow out of his dissatisfaction with public-health authorities and is feeding into his skepticism of them. Lysenko’s pseudoscience killed millions of people. How many Americans will perish from Trump’s?

Dr. Fauxi asks “What do you have to lose?”

Medical research answers: “Your lives.”

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