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The Politics of Hydroxychloroquine – The Wall Street Journal

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Joe Biden and Donald Trump.



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jim bourg/Reuters; Patrick Semansky/Associated Press

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 But on June 15 the agency rescinded the authorization.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 effects,” 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 effects 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 didn’t release its raw data, so it’s impossible to know whether the drug may have helped a subset of patients, such as those treated at an earlier stage of the disease or with elevated biomarkers of inflammation. 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 efficacy 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 effects 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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U.S., UK, Germany clash with China at U.N. over Xinjiang

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The United States, Germany and Britain clashed with China at the United Nations on Wednesday over the treatment of Uyghur Muslims in Xinjiang, angering Beijing by hosting a virtual event that China had lobbied U.N. member states to stay away from.

“We will keep standing up and speaking out until China’s government stops its crimes against humanity and the genocide of Uyghurs and other minorities in Xinjiang,” U.S. Ambassador to the U.N. Linda Thomas-Greenfield told the event, which organizers said was attended by about 50 countries.

Western states and rights groups accuse Xinjiang authorities of detaining and torturing Uyghurs and other minorities in camps. Beijing denies the accusations and describes the camps as vocational training facilities to combat religious extremism.

“In Xinjiang, people are being tortured. Women are being forcibly sterilized,” Thomas-Greenfield said.

Amnesty International secretary general Agnes Callamard told the event there were an estimated 1 million Uyghurs and predominantly Muslim ethnic minorities arbitrarily detained.

In a note to U.N. member states last week, China’s U.N. mission rejected the accusations as “lies and false allegations” and accused the organizers of being “obsessed with provoking confrontation with China.”

While China urged countries “NOT to participate in this anti-China event,” a Chinese diplomat addressed the event.

“China has nothing to hide on Xinjiang. Xinjiang is always open,” said Chinese diplomat Guo Jiakun. “We welcome everyone to visit Xinjiang, but we oppose any kind of investigation based on lies and with the presumption of guilt.”

The event was organized by Germany, the United States and Britain and co-sponsored by Canada, Australia, New Zealand and several other European nations. Germany’s U.N. Ambassador Christoph Heusgen said countries who sponsored the event faced “massive Chinese threats,” but did not elaborate.

British U.N. Ambassador Barbara Woodward described the situation in Xinjiang as “one of the worst human rights crises of our time,” adding: “The evidence … points to a program of repression of specific ethnic groups.”

She called for China to allow “immediate, meaningful and unfettered access” to U.N. human rights chief Michelle Bachelet.

Human Rights Watch executive director Kenneth Roth called out Bachelet for not joining the event.

“I’m sure she’s busy. You know we all are. But I have a similar global mandate to defend human rights and I couldn’t think of anything more important to do than to join you here today,” Roth told the event.

Ravina Shamdasani, deputy spokesperson for the U.N. Human Rights office, said Bachelet – who has expressed serious concerns about the human rights situation in Xinjiang and is seeking access – was unable to participate.

“The High Commissioner continues to engage with the Chinese authorities on the modalities for such a visit,” she said, adding that Bachelet’s office “continues to gather and analyze relevant information and follow the situation closely.”

(Reporting by Michelle NicholsEditing by Chizu Nomiyama, Alison Williams and Elaine Hardcastle)

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Ex-finance minister breached ethics rules in charity dealings

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Former Canadian Finance Minister Bill Morneau breached conflict-of-interest rules by not recusing himself when the government awarded a contract to a charity he had close ties to, independent ethics commissioner Mario Dion said on Thursday.

In a parallel probe, Prime Minister Justin Trudeau was cleared of having broken any ethics rules when WE Charity was tapped to run a C$900 million ($740.9 million) program to help students find work during the COVID-19 pandemic last year.

The charity later walked away from the contract.

Trudeau and Morneau both apologized last year for not recusing themselves during Cabinet discussions involving WE.

Trudeau’s wife, brother and mother had been paid to speak at WE Charity events in previous years, but Dion said this appearance of a conflict of interest was not “real”.

Morneau, on the other hand, was a friend of Craig Kielburger, one of the charity’s founders, Dion said. The charity had “unfettered access” to the minister’s office that “amounted to preferential treatment”, a statement said.

No fines or penalties were levied.

Morneau said on Twitter he should have recused himself. Trudeau said in a statement issued by his office that the decision “confirms what I have been saying from the beginning” that there was no conflict of interest.

Ahead of a possible federal election later this year, the opposition could use the ruling to underscore the government’s uneven track record on ethics. Trudeau has been twice been found in breach of ethics rules in the past.

In August 2019, he was found to have broken rules by trying to influence a corporate legal case, and in December 2017, the previous ethics commissioner said Trudeau had acted wrongly by accepting a vacation on the Aga Khan’s private island.

In a statement, opposition Conservative Party leader Erin O’Toole said: “To clean up Ottawa, Conservatives will impose higher penalties for individuals who break the Conflict of Interest Act and shine a light on Liberal cover-ups and scandals, ending them once and for all.”

The controversy over Morneau’s ties to the charity was a factor in his resignation in August last year, when he also left his parliamentary seat, saying he would not run again. Chrystia Freeland was named to take over for him a day later.

($1 = 1.2147 Canadian dollars)

(Reporting by Steve Scherer; Editing by Frances Kerry and Jan Harvey)

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EU prepares new round of Belarus sanctions from June

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The European Union is readying a fourth round of sanctions against senior Belarus officials in response to last year’s contested presidential election and could target as many as 50 people from June, four diplomats said.

Along with the United States, Britain and Canada, the EU has already imposed asset freezes and travel bans on almost 90 officials, including President Alexander Lukashenko, following an August election which opponents and the West say was rigged.

Despite a months-long crackdown on pro-democracy protesters by Lukashenko, the EU’s response has been narrower than during a previous period of sanctions between 2004 and 2015, when more than 200 people were blacklisted.

The crisis has pushed 66-year-old Lukashenko back towards traditional ally Russia, which along with Ukraine and NATO member states Latvia, Lithuania and Poland, borders Belarus.

Some Western diplomats say Moscow regards Belarus as a buffer zone against NATO and has propped up Lukashenko with loans and an offer of military support.

Poland and Lithuania, where opposition leader Sviatlana Tsikhanouskaya fled to after the election she says she won, have led the push for more sanctions amid frustration that the measures imposed so far have had little effect.

EU foreign ministers discussed Belarus on Monday and diplomats said many more of the bloc’s 27 members now supported further sanctions, but that Brussels needed to gather sufficient evidence to provide legally solid listings.

“We are working on the next sanctions package, which I hope will be adopted in the coming weeks,” said EU foreign policy chief Josep Borrell, who chaired the meeting.

The EU has sought to promote democracy and develop a market economy in Belarus, but, along with the United States, alleges that Lukashenko has remained in power by holding fraudulent elections, jailing opponents and muzzling the media.

Lukashenko, who along with Russia says the West is meddling in Belarus’ internal affairs, has sought to deflect the condemnation by imposing countersanctions on the EU and banning some EU officials from entering the country.

“The fourth package (of sanctions) is likely to come in groups (of individuals), but it will be a sizeable package,” one EU diplomat told Reuters.

More details were not immediately available.

 

(Reporting by Robin Emmott in Brussels, additional reporting by Sabine Siebold in Berlin, editing by Alexander Smith)

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