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Bloomberg Praises “Uninterpretable” Gilead Study While Bashing Trump “Miracle Drug” Hydroxychloroquine

Courtesy of ZeroHedge View original post here.

With a vaccine still a year to 18 months away, and various treatments for COVID-19 in early-stage testing (in New York City, some patients are being given Trump-approved hydroxycloroquine, a medication typically used to treat lupus and malaria), it’s still unclear when exactly the world can expect a broadly effective treatment to liberate humanity from its fear of potentially lethal infection.

Much, including the virus’s exact mortality rate on a global scale, remains undetermined when it comes to the coronavirus. Most research comes with an asterisk next to it noting that it is ‘preliminary’ or has not been ‘peer-reviewed’. We are all learning about this new virus as we go, and yet, as deaths continue to accelerate in the US and the UK, some readers are desperate for good news about the treatment options, even if there isn’t really any good news to share.

But doesn’t mean the press can’t utilize certain tricks of the trade to try and amplify the apparent importance of what are, in reality, relatively minor developments.

That’s what Bloomberg did on Saturday in a story about the race for a vaccine, and another quoting findings from a ‘preliminary’ study that has little to no actual merit.

The lead scientist on a team working to develop a vaccine in the UK told the British press that her team might have a vaccine ready by September, roughly a 6 months to a year faster than initially believed.

Professor of Vaccinology at Oxford University Sarah Gilbert said Saturday that she is “80% confident” the vaccine would work, and could be ready by September, even as many other experts have warned the process could take 18 months.

In the case of the Oxford team, however, “it’s not just a hunch, and as every week goes by we have more data to look at,” Gilbert told the London newspaper.

Oh, it’s not just a hunch? Well then, that’s great. We’ll just take your word for it.

In a different report, Bloomberg heralded that a Gilead preliminary study carried out in North America had shown promise for its remdesivir antiviral, a broad-spectrum anti-viral shown to be effective against other coronaviruses, and has been heralded by the press as one of the most highly anticipated treatments for coronavirus.

A study involving 56 patients (minus 7 whose data were excluded from the results for one reason or another) found that 68% saw their condition improve on the drug.

The report published in the New England Journal of Medicine tracked 53 people in the U.S., Europe and Canada who needed respiratory support, with about half receiving mechanical ventilation and four on a heart-lung by-pass machine. Eight additional patients were left out of the analysis: one due to a dosing error and seven because no information was available on how they fared.

All received remdesivir for up to 10 days on a compassionate use basis, a program that allows people to use unapproved medicines when no other treatment options are available. Over 18 days, 68% of the patients improved, with 17 of the 30 patients on mechanical ventilation being able to get off the breathing device. Almost half of the patients studied were ultimately discharged, while 13% died. Mortality was highest among those who were on a ventilator, with 18% of them dying.

But how promising is this study, really? Is it that far removed from the small studies of hydroxychloroquine and chloroquine carried out in France and China, which showed that drug to be modestly effective with little harm to the patient (unless they drink the fish-tank cleaner). One researcher even admits that the study isn’t enough to draw any kind of definitive conclusion, and BBG even let it slip that Gilead even helped interpret the study’s results.

“We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful,” said lead author Jonathan Grein, director of hospital epidemiology at Cedars-Sinai Medical Center in Los Angeles, in a statement from Gilead. The Foster City, California-based company provided the medication and also helped analyze the results.

And in the very next paragraph, BBG criticizes hydroxychloroquine and the “tiny French study” whose methodology “has been heavily criticized” by many experts.

As one “skeptic” who read the study reportedly said, the data from the paper are “almost uninterpretable.”

“The data from this paper are almost uninterpretable,” Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said in an emailed statement. “There is some evidence suggesting efficacy, but we simply do not know what would have happened to these patients had they not been given the drug.”

Aside from simply determining whether the medication “works” or not, these comprehensive studies are supposed to shed some light on how to use the medication in the most safe and effective way, like when is the best time to start the course – in terms of the disease’s progression.

“In studying remdesivir, the question is not just whether it is safe and effective against Covid-19, but in which patients it shows activity, how long should they receive treatment and at what stage of their disease would treatment be most beneficial,” said Daniel O’Day, Gilead’s chairman and chief executive officer. “Many answers are needed, which is why we need multiple types of studies involving many types of patients.”

Some of these answers will emerge in the coming weeks with the release of initial data from the various clinical trials, O’Day said Friday in an open letter sent via email.

This might be a typo or a mistake, but after reporting that researchers were able to ramp up research on remdesivir so quickly because it had recently been studied for efficacy against ebola (it was determined to be safe but ineffective). However, BBG claims that 1 in 4 patients suffered serious side effects like organ malfunction or acute kidney damage.

About one in four patients on the medicine experienced severe side effects, including multiple-organ dysfunction syndrome, septic shock, acute kidney injury and low blood pressure. Another 23% showed signs of liver damage on laboratory tests. Four patients had to stop receiving infusions of the drug entirely.

Remdesivir was considered to be the most promising therapeutic candidate based on its broad antiviral spectrum, and existing data based on human and animal studies, a World Health Organization panel said in January. The medication was developed initially for Ebola and studied in patients in Eastern Congo.

If it works well, one issue will be whether there is enough of a supply of the drug, especially if the epidemic is still raging. Gilead has been working all-out to bolster supply of the hard-to-make medicine. It said earlier this month that it hopes to to have 500,000 treatment courses by October, and more than 1 million by year-end. Production time has also been accelerated to six months from one year.

In what world is that a “safe” standard?


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