Posted on 06/10/2020 7:35:38 AM PDT by SeekAndFind
Science’s COVID-19 reporting is supported by the Pulitzer Center.
Through the fog of alleged misconduct, hope, hype, and politicization that surrounds hydroxychloroquine, the malaria drug touted as a COVID-19 treatment, a scientific picture is now emerging.
Praised by presidents as a potential miracle cure and dismissed by others as a deadly distraction, hydroxychloroquine was spared a seeming death blow last week. On 4 June, after critics challenged the data, The Lancet suddenly retracted a paper that had suggested the drug increased the death rate in COVID-19 patients, a finding that had stopped many clinical trials in their tracks. But now three large studies, two in people exposed to the virus and at risk of infection and the other in severely ill patients, show no benefit from the drug. Coming on top of earlier smaller trials with disappointing findings, the new results mean it’s time to move on, some scientists say, and end most of the trials still in progress.
“It just seems like we are ignoring signal after signal,” says Eric Topol, director of the Scripps Translational Science Institute. U.S. President Donald Trump’s promotion of it led to a scientific “obsession” with hydroxychloroquine despite thin evidence for its promise, he says. “We’d be better off shifting our attention to drugs that might actually work.” Peter Kremsner of the University of Tübingen agrees hydroxychloroquine “certainly isn’t a wonder drug.” The new results left him “wrestling” with the question of whether to proceed with two hydroxychloroquine trials, one in hospitals and the other in patients with milder illness at home.
Hydroxychloroquine and its sister drug chloroquine have been used against malaria and other diseases for decades. The first evidence that they might work against SARS-CoV-2 came from test tube data. Since then, hundreds of trials have been launched around the globe. Scientists are trying the drugs in low doses and high doses; alone or combined with the antibiotic azithromycin, the antiviral compound favipiravir, or other drugs; and in patients with mild or severe disease, health care workers, pregnant women, and people living with HIV.
On 5 June, researchers in the United Kingdom announced the results from the largest trial yet, Recovery, in a press release. In a group of 1542 hospitalized patients treated with hydroxychloroquine, 25.7% had died after 28 days, compared with 23.5% in a group of 3132 patients who had only received standard care. “These data convincingly rule out any meaningful mortality benefit,” wrote the investigators, who ended the study early and promised to publish the full results as soon as possible.
The results are persuading some doctors to stop using the drug for COVID-19. “The Recovery trial, in addition to the signals from other studies we have received so far, are enough to convince me to not offer hydroxychloroquine to hospitalized patients,” Nahid Bhadelia, a physician at Boston Medical Center, wrote in an email. Martin Landray of the University of Oxford, one of Recovery’s principal investigators, agrees: “If you, your spouse, your mother gets admitted to hospital and is offered hydroxychloroquine, don’t take it,” he says.
But some scientists say they want to see the full data before making up their minds. About one in four patients died in both arms of the study, Kremsner notes—a very high rate, suggesting they were gravely ill when treatment started. Nicholas White of Mahidol University in Bangkok, who also studies hydroxychloroquine, agrees the full data need evaluation. “But overall, it’s very unlikely, in my view right now sitting here, that anything’s going to change,” he says.
Another hope for hydroxychloroquine, that it might prevent people exposed to the virus from getting sick, also faded last week when David Boulware of the University of Minnesota, Twin Cities, and colleagues published the results of the largest study to date of this strategy, called postexposure prophylaxis (PEP). The researchers sent either hydroxychloroquine or a placebo by mail to 821 people who had been in close contact with a COVID-19 patient for more than 10 minutes without proper protection. They reported in The New England Journal of Medicine that 12% of the people who took the drug went on to develop COVID-19 symptoms, versus 14% in a placebo group, a difference that was not statistically significant.
A second large PEP trial has come up empty as well, its leader tells Science. Carried out in Barcelona, Spain, that study randomized more than 2300 people exposed to the virus to either hydroxychloroquine or the usual care. There was no significant difference between the number of people in each group who developed COVID-19, says Oriol Mitjà of the Germans Trias i Pujol University Hospital. Mitjà says he has submitted the results for publication.
If you, your spouse, your mother gets admitted to hospital and is offered hydroxychloroquine, don’t take it.
Martin Landray, University of Oxford
The data are important because they come from large randomized trials. So far, most data came from small trials or case series. A meta-analysis of 24 such studies published in the Annals of Internal Medicine concluded there was “insufficient and often conflicting evidence on the benefits and harms of using hydroxychloroquine or chloroquine to treat COVID-19.”
The new findings raise questions about whether to stop other trials. Most are much smaller than Recovery, and thus less powerful; their outcomes are unlikely to change many minds. And continuing the trials may prevent researchers from testing drugs with a better chance of working and robs patients of the chance to try those. Landray says the World Health Organization (WHO) is now likely to end the hydroxychloroquine arm of its large COVID-19 treatment trial, named Solidarity. “I think the decision is pretty obvious,” he says. WHO says it is considering the issue.
There is one exception. Many researchers agree that a good case can be made for continuing to test whether hydroxychloroquine can prevent infection if given to people just in case they get exposed to the virus, for instance on the job at a hospital—a strategy called pre-exposure prophylaxis (PrEP). “You have a much better chance of preventing something with a weak drug than you have of curing a fully established infection,” says White, who runs one of the largest PrEP trials. He notes that doxycycline, an antibiotic, has long been used in malaria prophylaxis. “We would never treat anybody with it, it’s too weak. But it’s a very good prophylactic.”
Landray, however, is on the fence about continuing prophylaxis trials: “I suspect it’s one of these decisions where there isn’t a right or wrong.” It’s an important question, Bhadelia says, because an effective PrEP drug could have a major impact on the pandemic. Hydroxychloroquine, a cheap and widely available drug, is one of the few compounds that could fit the bill.
But the Lancet paper, despite its retraction, will make it more difficult to continue current trials, White laments. Published on 22 May, the study claimed, supposedly based on data from 96,000 patients around the world, that hydroxychloroquine and chloroquine, whether given alone or in combination with another drug, caused a steep increase in deaths. That led many regulatory agencies to ask scientists to halt their trials and make sure they were not harming their patients. Recovery and Solidarity were temporarily halted but resumed after a safety committee took a look at the data.
Many other trials are still on pause. U.K. regulators, for instance, have asked for a raft of additional safeguards, says Joseph Cheriyan, a clinical pharmacologist at Cambridge University Hospital and principal investigator of a PrEP trial in health care workers. That study already excluded patients who take any one of several dozens of drugs, but Cheriyan says regulators have asked for more changes, which will set the trial back weeks. And despite the Lancet retraction, the alarming headlines about the drug’s risks have made it much more difficult to convince people to participate in a trial, White says. “I just think these trials have been really badly damaged and some of them may never restart.”
The problem for scientists is that there’s such a rush to find treatments for the rapidly spreading virus, Mitjà says: “The pressure is immense.” Yet that shouldn’t stop researchers from properly analyzing data and making carefully considered decisions, White says. “We don’t always have to act today,” he says. “Let’s not panic.”
Where’s the zinc?
Just more BS. It was never touted as being the cure, but rather another tool that can be used. We already know it can be an effective tool.
86 the propaganda, “Science”.
Zinc not mentioned anywhere. Might as well just put the pill in your pocket, will work the same without the zinc.
We are so over COVID. The HDQ and zinc work when administered early, they just want to prolong the misery of shutdowns.
I have Ginko Biloba, Zinc and Vitamin D3 stocked in case I get Wuhan Virus and the Democrats withhold hydroxychloroquine from me in my state.
They are going to shut things down again.
Just redraw the lines now. We already have two governments in this country.
There’s money in them thar vaccines!
“You have a much better chance of preventing something with a weak drug than you have of curing a fully established infection,” says White, who runs one of the largest PrEP trials. He notes that doxycycline, an antibiotic, has long been used in malaria prophylaxis. “We would never treat anybody with it, it’s too weak. But it’s a very good prophylactic.”
You have to read three-quarters of the paper to get to the part that we all know. It will NOT cure a seriously ill patient, but it is a very effective PrEP when administered soon after you get infected. All of the protocols published have said that AND all the protocols recommend the cocktail of HCQ + azithromycin + zinc.
These studies ALWAYS ignore the recommended treatment and they rarely, if ever, get called out on that failure. They are either written by ignoramuses or by people who intentionally want it to fail.
It’s like Tamiflu. Tamiflu doesn’t really stop one from getting infected, but it can reduce the infection and its symptoms once infected. You can take it as a prophylactic, but it still doesn’t actually “stop” all cells from getting it. You can always have a small number get infected and keep the rest from getting it, making it seem like you were “immune.”
For that matter, you still get infected when you have a full immune response, but your body already knows how to fight off that invader.
“Praised by president(s?) as a potential miracle cure” is a lie, and nothing further need be read.
“Science’s COVID-19 reporting is supported by the Pulitzer Center.”
The PUTZLIAR Center!? You mean the folks that awarded all the LEFTY Urinalists PUTZLIAR for reporting on FAKE Russian Collusion!?
Except for the fact that when it has been used with zinc and an antibiotic in a timely manner (not waiting until the patient is dying) it works spectacularly well, why should we believe in it? < /sarc >
Well that’s it then. It’s in Science Magazine!
PrEP has gotten a bad name, as the first most of us ever heard of it was when ads started appearing for PrEP drugs to keep homosexuals safe for buggery. Prepping them to survive their risky behavior.
Studies designed to fail. As Dr Zelenko said, (I paraphrase) look at it as hydroxychloroquine as the gun, and the zinc as the bullet (to the virus). No zinc, no bullet. These scientists are morons with empty guns and I have never seen such a worldwide failure of science in my lifetime.
“The researchers sent either hydroxychloroquine or a placebo by mail to 821 people who had been in close contact with a COVID-19 patient for more than 10 minutes without proper protection. They reported in The New England Journal of Medicine that 12% of the people who took the drug went on to develop COVID-19 symptoms, versus 14% in a placebo group, a difference that was not statistically significant.”
We will all “get symptoms” of COVID. Most people think it’s a cold or allergy for a few days.
Big deal.
It really could pose an ethical choice for a doctor who believes HCQ is effective (in concert with zinc and an antibiotic) for his patient but would have to lie to his phamacist who has been prohibited by Blue state government to fill a HCQ prescription for the virus and must question the doctor about its use.
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