Drug Testing That Could Really Produce Covid Treatments

This feels like a good way to deal with the types of problems Woodcock and others identified with the drug processing pipeline. In fact, the FDA in Woodcock this week released a giant batch again guidelines to create more of these master protocol processes.

But none of this solves such an urgent problem: time. It will be difficult for any of these studies to find Covid patients to enroll. “The nature of a pandemic is that it will peak at different times and places in the world. Now our biggest recruiters, don’t be surprised, are in India, ”says Gordon of Remap-Cap.“ Now, they’re not as suited to research as the UK and the US, so their number of recruits are much less than those we recruit in the UK, although their number of cases is higher ”.

Vaccines will never completely eliminate Covid-19. In countries where they are available, some people refuse to take them; some countries cannot afford them. So a good Covid drug is always important. But even so, these processes feel a little late. “The concept is beautiful. The concept a year ago would have been even better, “says David Boulware, an infectious disease physician and researcher at the University of Minnesota Medical School who is involved with Activ-6 and some other Covid trials. Don’t add the delay until science, he says, but politics.

Woodcock was in the FDA last year and has been working on therapeutics as part of Operation Trump’s Warp Speed ​​Operation. This program helped produce the vaccines that are now battling the pandemic, but the urgency for therapies was less … urgent. “Obviously the previous administration wasn’t really interested in the research, because everything was going up from last Easter,” Boulware says, then changing President Trump. unfounded optimism in the early days of the pandemic. “Then really everything happened after January 20, 2021.”

Wherever politics is an obstacle, so is money. (Like Carl Zimmer he wrote in In the New York Times, as of last January the U.S. government had spent about $ 18 billion on vaccine research and development and about $ 8 billion in therapeutics.) As always, however, pharma money is doing a lot to clear the course of a drug. One of the first success stories in the Covid drug hunt was put off, a brilliant antiviral made by the pharmaceutical company Gilead; an SU study carried out with the help of the company and the materials found in April 2020 which decreased the length of time people had symptoms; after studies including Solidarity it found no impact on survival

But out-of-patent drugs don’t make pharmaceutical companies the same money, so they don’t get the same business boost. Studying medicines cheaply, restlessly, usually requires government funding. “A lot of these are generic drugs. So why aren’t they being pushed forward? Because there’s no patent, and so there’s nothing profitable for a pharmaceutical company. There’s not a drug company that says that.” “We’re going to give you $ 10 million to look at it,” Boulware says. “So the government has to do it, and the government has to want to do it. The good news is that these are drugs available in low- and low-income countries, or on the road to Walgreens. It’s not “We invented a new drug that we don’t have, but in six months from now we’ll have enough to treat 10,000 people and it will cost $ 10,000 a dose.”

Which leads to the other, bigger vision that Woodcock hopes to prevent the chaos of small trials in the after pandemic — more economical and more effective master protocols for trying more than one drug at a time. “What was interesting about this pandemic, if you look at all the results for therapeutics, especially for immunomodulators, is that there is always a lot going on and on about which regimen should be used, and we have contrasting trial results,” he said. says Woodcock. “What it usually means is, there have been small treatment effects and the processes have not been adequately fed to give a definitive answer.” Large multi-arm, master-protocol studies are intended to bridge the gap between large drug companies handling large and expensive trials on large and expensive drugs and small, idiosyncratic ones that do not produce enough new knowledge. During the pandemic, there were not enough of these ambitious government-funded studies, a defect in the system that cost lives.

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