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Trump’s use of Regeneron treatment creates ‘tough situation’: CEO

President Donald Trump’s use of Regeneron’s experimental coronavirus treatment creates “a very tough situation” for the drugmaker since it hasn’t been cleared for broader use, CEO Dr. Leonard Schleifer told CNBC on Monday.

The president, who announced Friday that he and first lady Melania Trump tested positive for the coronavirus, was given an 8 gram dose of Regeneron’s monoclonal antibody treatment, his doctors said.

The company said it provided the drug to the president in response to a “compassionate use” request from Trump’s doctors, which allows for expanded access to experimental drugs for “immediately life-threatening” illnesses, according to the Food and Drug Administration. It allows patients to access an investigational drug outside of clinical trials in lieu of adequate other treatments.

That means that while the president’s doctors were confident enough of the drug’s benefit to administer it to Trump, the treatment remains unavailable to most Americans.

“We have tried to take a principled approach until there is a broader authorization,” Schleifer told CNBC’s Meg Tirrell on “Squawk Box.” “Asking somebody like the president to go into a clinical trial just wasn’t practical.”

Until the FDA takes a look at all the available data on the benefits and risk of the drug for Covid-19 patients, patients who want to receive the treatment should enroll in a clinical trial, Schleifer said. He added that patients in clinical trials are closely monitored so that researchers can understand how the drug affects the disease, but at least a third of patients will receive a placebo.

“Giving it to [Trump] or to others who might not be able or don’t qualify for clinical trials is the right use of compassionate use. That’s for small numbers of people, for these exceptions,” he said. “We want everybody to be potentially able to benefit. We understand we don’t make that decision. This is a decision the FDA has to make.”

Schleifer added that he thinks the treatment meets “a lot of” the FDA’s standards for an emergency authorization. But he said the company needs to continue to collect data in controlled clinical trials to better understand the treatment. But as trials continue, the virus continues to infect more than 40,000 people every day across the U.S.

“This is all very complicated because it’s real lives at stake” he said. “If it’s my loved one or your loved one, … yes, we want to give this if we can help them. Of course, we want to get definitive evidence, so it’s a tough act to balance.”

Shares of the company were up more than 5% in early trading Monday.

Some analysts have speculated that the use of Regeneron’s antibody cocktail to treat the president is a tacit endorsement of the drug and could signal a swift approval by the FDA. Schleifer, however, tried to assure the public in the CNBC interview that the FDA has its own standards for authorization and the White House does not play a role. 

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Pandemic creates ‘surge’ of flawed research

The Covid-19 pandemic has created a surge in potentially flawed scientific studies as researchers rush to publish results without adequate oversight, a leading medical ethicist said Friday.

Since the novel coronavirus appeared late last year there have been more than 4,000 academic papers relating to the virus, many of which have appeared online without the benefit of a full peer-review process. 

Writing in the Journal of Medical Ethics, Katrina Bramstedt, a professor at the Bond University Faculty of Health Sciences and Medicine, Queensland, warned that rushed or inaccurate research could put lives at risk.

“Patient harm that is significant, permanent and irreversible could result from using faulty research results from pre-prints as well as published papers,” she wrote.

As of the end of July, there were 19 published articles and 14 pre-prints — papers that have not yet been peer reviewed — dealing with Covid-19 that were retracted, withdrawn, or tagged with an “expression of concern”. 

Most of these occurred in Asia, with China alone responsible for 11 retractions or withdrawals.

One of the most high profile retractions was of a paper published in the prestigious Lancet medical journal on the effectiveness of treating Covid-19 patients with the anti-arthritis drug hydroxychloroquine. 

The research, released in May, prompted the World Health Organization to pause its trials of hydroxychloroquine after the results suggested the drug had no positive effects on hospitalised individuals and may in fact increase the likelihood of death. 

The study was withdrawn after a group of experts raised “both methodological and data integrity concerns” about it.

In September The Lancet said it had bolstered its peer-review system to ensure at least one reviewer was an expert on the area of research in question.

Another study — also in The Lancet — on a potential Russian vaccine raised concerns among Western scientists over a lack of safety data.

An open letter signed by more than 30 Europe-based experts last month cast doubt on the Russian findings, pointing towards potentially duplicated data. 

The Lancet has asked the authors in Russia for clarifications.

– Publishing ‘sprint’ –

Bramstedt said that scientists were under increased pressure to get research out in the public sphere as the world races towards effective Covid-19 treatments and vaccines.

“Research normally occurs at the speed of a marathon, but during a pandemic, the pace is more like a sprint,” she wrote. 

She said the pandemic had created a “surge” of manuscripts, something which the fleet of journal reviewers were struggling to keep pace with. 

“No research team is exempt from the pressures and speed at which COVID-19 research is occurring,” said Bramstedt.  

“And this can increase the risk of honest error as well as deliberate misconduct.”

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