LA Times, APRIL 1, 2020, 5 AM

By MICHAEL HILTZIK BUSINESS COLUMNIST

https://www.latimes.com/business/story/2020-04-01/trump-chloroquine-coronavirus-bad-science-hiltzik-column

Jennifer Herrera is down to her last 15 days of a drug she needs to control her inflammatory arthritis. Her pharmacy is out of stock and has no idea when its next shipment will come in.

Her misfortune is that she’s dependent on a version of chloroquine, a drug touted by President Trump and others as a treatment for COVID-19, the disease caused by the novel coronavirus. Pharmacists have been telling patients with arthritis and lupus, an autoimmune condition treated with the drug, that retail supplies are short, if not currently nonexistent. On Tuesday, the Food and Drug Administration placed two formulations of the drug on its list of drug shortages.

‘It’s like the toilet paper shortage. But this is a medication.’

ARTHRITIS SUFFERER JENNIFER HERRERA, ON HER INABILITY TO OBTAIN CHLOROQUINE

Reports of the federal stockpiling raised the hackles of the Lupus Foundation and Arthritis Foundation, which have asked Vice President Mike Pence in a joint letter to ensure that their patients aren’t deprived of the medication.

Meanwhile, doctors have been reported to be writing prescriptions for chloroquine for themselves and their families, and prescribing it as an off-label treatment — that is, unapproved by the Food and Drug Administration for the purpose, but legal for doctors to prescribe — for patients facing COVID-19.

“It’s like the toilet paper shortage,” Herrera, 72, told me. “But this is a medication.”

Sanofi, the lead manufacturer of Plaquenil, the hydroxychloroquine formulation Herrera takes, says it doesn’t anticipate shortages of the drug due to COVID-19. Novartis, which makes a generic version of hydroxychloroquine, is donating 30 million doses of its drug to the federal government for stockpiling as a COVID-19 treatment. The company says, however, that it “continues to fill orders at historical levels for existing customers to ensure supply for patients that are most in need.”

Several states have tried to put a leash on diversions of chloroquine preparations. Michigan health officials, for instance, have threatened doctors with “administrative action” for prescribing or stockpiling chloroquine-based medications for themselves or family members without a “legitimate medical purpose.” The state has also advised pharmacists to refuse to fill such prescriptions under those circumstances.

There are scientific grounds for examining chloroquine and hydroxychloroquine as possible treatments for COVID-19; dozens of clinical trials have been announced. Infectious disease experts consider the drugs to be promising, but there’s a lot more they’d like to know before certifying them for clinical use.

One trial underway at the University of Minnesota aims to recruit 3,000 subjects from among healthcare workers and their household members who have been exposed to infected persons or are showing symptoms or been diagnosed with the disease. Half the subjects will be given chloroquine. Preliminary results may be available by April 21.

Yet generally, the hype has run so far ahead of scientific knowledge that red lights should be flashing and danger sirens sounding.

“We need to be really careful about not jumping the gun here,” Annie Luetkemeyer, an infectious disease expert at UC San Francisco, said 

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in a March 24 video discussion in which she spoke of the need for more study. “We don’t have the data that we need to say that these drugs are effective for treatment or for prevention of the disease.” She warned that it is “premature…to be giving either of these medications widely to people” without knowing more about their efficacy or possible hazards.

Chloroquine is dangerous when not taken under a doctor’s rigorous supervision, and its shortage can cause life-threatening consequences for lupus patients and serious health effects for rheumatoid or inflammatory arthritis patients.

The bottom line is that evidence for chloroquine’s effectiveness in COVID-19 is unsubstantiated. It derives heavily from the work of a controversial French expert in infectious diseases, Didier Raoult, whose studies on the topic have been criticized as inconclusive, but who has been enthusiastically promoting chloroquine as the nearest thing to a miracle drug.

Google searches for “chloroquine” and “hydroxychloroquine” soared after Trump talked them up as COVID-19 treatments. (Annals of Internal Medicine)

The craze has been pumped up, moreover, by figures who have a large public platform, including Trump and Dr. Mehmet Oz. Trump promoted Raoult’s claims about a drug cocktail containing chloroquine and the antibiotic azithromycin at a public briefing March 20 and tweeted about the drugs on March 21: “HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine.”

Dr. Oz, a prominent heart surgeon whose television show is a platform for 

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