The Politics of Hydroxychloroquine. The FDA has suspended a permit for its use. Let doctors decide/ WSJ

Below is a Wall Street Journal article I am reposting in full–Nass


https://www.wsj.com/articles/the-politics-of-hydroxychloroquine-11594831408


OPINION | COMMENTARY

The Politics of Hydroxychloroquine

Trump touted it, so Biden denounces it. The FDA has suspended a permit for its use. Let doctors decide.



By Allysia Finley
July 15, 2020 12:43 pm ET


Hubert Humphrey began his career as a pharmacist before going into politics. Today’s
politicians sometimes seem to have the opposite aspiration. President Trump “pushes
dangerous, disproven drugs,” Joe Biden declares in his “
Plan to Beat Covid-19.” “Our
country is now stuck with a massive stockpile of hydroxychloroquine, a drug Trump
repeatedly hailed.”



Neither man has any expertise in pharmacology, and Mr. Trump did get out over his skis
in promoting the malaria treatment, also known as HCQ, for the novel coronavirus. But
since every Trump action prompts a reaction, his political and media opponents launched
a campaign to discredit the drug. This politicized environment has produced dubious
science and erratic policy.

The Food and Drug Administration issued an emergency use authorization on March 28,
allowing hospitals to treat Covid-19 patients outside clinical trials using HCQ donated by
manufacturers to the national stockpile. But on June 15 the agency
rescinded the
authorization. “In light of ongoing serious cardiac adverse events and other potential
serious side e
ffects,” the FDA announced, “the known and potential benefits of . . .
hydroxychloroquine no longer outweigh the known and potential risks for the authorized
use.”

But the scientific basis for the revocation now appears faulty. Most studies didn’t adjust
results for confounding variables such as disease severity, drug dosage or when patients

started treatment. Two new peer-reviewed
studies find that HCQ can significantly reduce
mortality in hospitalized patients. With hospital
beds filling up across the American South and
West and a limited supply of
Gilead Sciences
antiviral remdesivir, the FDA should reinstate its
emergency-use authorization for HCQ.

HCQ has been safely used for decades to treat
patients with lupus and rheumatoid arthritis,
both inflammatory autoimmune conditions. The
drug has also been found to interfere with the

novel coronavirus’s replication in vitro, and studies this spring from France, Brazil and
China showed the drug might help moderately ill patients.



HCQ also has side effects. It can cause cardiac arrhythmias, a particular risk for severely
ill Covid-19 patients because the virus can damage heart tissue. But the FDA emergency
authorization warned about this and required doctors to monitor patients closely and
report adverse side e
ffects to the agency.



In late May, the Lancet published a large-scale international study that claimed
hospitalized Covid-19 patients treated with HCQ were 30% more likely to die. But the
medical journal retracted the study on June 4 after more than 120 scientists pointed out
significant flaws in the data and methodology. The source of the raw data refused to share
it with independent reviewers.



Nonetheless, the anti-Trump media claimed vindication later that day when the New
England Journal of Medicine
published a randomized trial that concluded HCQ didn’t
prevent illness in people who had been exposed to the virus. The study’s raw data showed
that people who took HCQ within two days of exposure were 38% less likely to develop
symptoms. But a third of subjects in the trial took the drug four days after exposure,
which obscured its benefits. Since the average viral incubation period is five days, starting
the drug four days after exposure is unlikely to do much good.



On June 5, University of Oxford researchers reported that a midpoint review of their HCQ
trial had found no clinical benefit. “This result should change medical practice
worldwide,” Oxford epidemiologist Martin Landray declared in a press release. It usually
pays to be skeptical of such sweeping claims based on a single study.



The Oxford team released a preprint study with more data from its trial on Wednesday.
Patients were treated on average nine days after their symptom onset, which may have
been too late to improve clinical outcomes. The trial’s protocol also called for dosages two
to three times as high as those recommended by the FDA’s emergency use authorization.



In revoking the authorization 10 days later, the FDA cited the New England Journal and
Oxford work as well as a British Medical Journal
study from China that purportedly found
no benefit from the drug. Yet
an April draft of the last study concluded that HCQ
accelerated “the alleviation of clinical symptoms, possibly through anti-inflammatory
properties” and “might prevent disease progression, particularly in patients at higher
risk.”



The draft also noted that after adjusting for the confounding effects of other antivirals
used to treat patients, “the e
fficacy of HCQ on the alleviation of symptoms was more
evident.” This analysis of HCQ’s benefits was scrubbed from the published version
because some editors and reviewers quibbled that it wasn’t called for in the trial protocol.



The first of the new studies showing benefits from HCQ appeared in the Journal of
General Internal Medicine on June 30. It found patients treated with the drug at New
York’s Mount Sinai Health System hospitals were 47% less likely to die after adjusting for
confounding variables such as underlying health conditions and disease severity. Notably,
Mount Sinai’s
treatment protocol called for lower dosages than in the Oxford trial, and
patients on average were treated within one day of hospitalization.



The second, published July 1 in the International Journal of Infectious Diseases, found
that patients treated with HCQ at Henry Ford Health System hospitals in Detroit were 50%
to 66% less likely to die after adjusting for confounding variables including other
treatments. Nearly all patients began treatment within two days of admission, received
dosages that hewed closely to FDA guidelines, and were continuously monitored for
cardiac arrhythmias.



“Our patient population received aggressive early medical intervention, and were less
prone to development of myocarditis, and cardiac inflammation commonly seen in later
stages of COVID-19 disease,” the Henry Ford doctors noted.



This shouldn’t be surprising. An FDA safety review published July 1 reported only five
adverse side e
ffects from HCQ through the emergency use authorization among tens of
millions of doses
that were distributed to hospitals. This suggests that the drug isn’t
harmful to the vast majority of patients who are treated according to FDA guidelines.



With hundreds of Covid-infected Americans still dying each day, the agency should let
physicians decide whether to treat patients with HCQ based on their experience and
scientific evidence. Leave politics out of it.



Ms. Finley is a member of the Journal’s editorial board.

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