This seems like a good way to deal with the types of problems Woodcock and others identified with this Medicines Trials pipeline. In fact, this week the Food and Drug Administration in Woodcock released a giant batch of the new The guidelines To create one more of these main protocol experiments.
But none of that solves an equally pressing problem: time. It would be difficult for any of these studies to find Covid patients to enroll. “The nature of the epidemic is that it will have peaks and troughs at different times and places in the world.” “At the moment, you wouldn’t be surprised by our biggest recruiters in India,” says Gordon of RimapCap. “Now, they are not well prepared for research as they are in The United Kingdom and the United States, so their recruits are considerably less than in the United Kingdom, although their cases are greater. “
Vaccines will not eliminate Covid-19 completely. In the countries where they are available, some people refuse to take it; Some countries cannot afford it. So good Covid medicines are still important. However, these trials appear a little late. “The concept is awesome.” David Bulwer, an infectious disease physician and researcher at the University of Minnesota Medical School who has been involved in Activ-6 and some other Covid trials, says the concept a year ago could have been better. Don’t consider the delay in science, he says, but for politics .
Woodcock was at the FDA last year and worked on treatments as part of the Trump administration’s Warp Speed operation. This program helped produce the vaccines that are now weathering the epidemic, but the urgency of treatments was less urgent. “Obviously, the previous administration wasn’t really interested in the research, because all of this was going to be gone by last Easter,” says Bulwer, as he reads Baseless optimism In the early days of the epidemic. “It really all happened after January 20, 2021.”
Where politics is an obstacle, so is money. (As Carl Zimmer Wrote at New York timesBy January this year, the US government had spent about $ 18 billion on research and development of vaccines and nearly $ 8 billion on treatments.) One of the types of early successes was in the search for Covid drugs RemsiverIt is a shiny antivirus manufactured by the pharmaceutical company Gilead; United State a study Done with the help of the company and materials that were found in April of 2020 to reduce the length of time people had symptoms; later studies Including Symbiosis I found no effect on staying.
But non-patent medicines don’t make the same money for drug companies, so they don’t get the same payout as the companies. The study of inexpensive and reused drugs usually requires government funding. “A lot of these drugs are generic. Why haven’t these things been pushed forward? Because there is no patent, and therefore no profit motive for a pharmaceutical company. No pharmaceutical company says,” We’re going to give you $ 10 million to look at this, “says Bulwer. So the government has to do it, and the government has to do it. The good news is that these drugs are available in low- and middle-income countries, or at the end of the street in Walgreens. It’s not “We invented some new drugs that we don’t actually have, but after six. Months from now we will have enough to treat 10,000 people and it will cost 10,000 dollars a dose. “
Which leads to the other, larger insight that Woodcock hopes to prevent the clutter of small experiments in next one Pandemic – more economical and more efficient major protocols for testing more than one drug at a time. “What was really interesting about this epidemic, if you look at all the results of the treatments, especially for immunity modifiers, is that there are currently still a lot of contradictions about which regimen to use, and we have conflicting trial results,” Woodcock says. “What this usually means is that there were small therapeutic effects and the trials were not sufficiently supported to give a definitive answer.” Large, multi-pronged major protocol studies aim to bridge the gap between major pharmaceutical companies that are conducting large and expensive trials of large, expensive drugs and those of small idiosyncrasies that do not produce enough new knowledge. During the pandemic, there have not been enough of those government-funded, ambitious, and centrist studies – a flaw in the system that costs lives.
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