Donald Trump, FDA, Christopher Roland discussed on The Daily Dive


On the weekend edition. I'll be bringing some of the best stories from the week. This week. The CEOs of nine drug companies that are developing Corona virus vaccines all signed on to a pledge not to seek regulatory approval until the shots have been shown to work in late stage clinical trials. This is all an attempt to calm fears that a vaccine maybe prove too soon. For political reasons. Many Americans are skeptical about taking a vaccine. If it seems the development and authorizations were rushed. For more on this will speak to Christopher Roland. He's the business of health care reporter at The Washington Post. Stakes couldn't be higher, obviously and what we've seen, Unfortunately from this administration since the pandemic began, is a number of overhyped And rushed through decisions through the FDA and through other political statements that have had the effect of kind of undermining the public's faith and exactly what the FDA is going to approve. The biggest example is the Hydroxide cork when debacle which the FDA gave a emergency youth authorization to it, you know, at the behest of Trump in the White House, really with very little to zero hard evidence that it would have any effect of the treatment for Corona virus for covert 19. And when some more hard studies were done for hydroxide Cork win By June, it became apparent that the drug had no benefit and, in fact posed dangers of dangerous heart arrhythmias. The FDA had to rescind it see us, which was a big black eye for the agency and kind of set the tone for the relationship between the White House and the FDA. And so you've seen Trump expressing frequent displeasure with the pace of FDA deliberations. And then what? You've also seen Wass. Just recently, two weeks ago, Trump totally over hyping the A for convalescent plasma for treatment of Corona virus and then his own FDA commissioner Stephen Han. Completely botching the rollout of the statistics and totally exaggerating what the effect of convalescent plasma is What the benefit is. It's actually of somewhat potentially some use. But there have been good randomized clinical trials that even show what it does. That's the backdrop to today's announcement by the drug companies where they are want to rush in and here and so the vaccine is a much bigger deal. Obviously then hydroxy cork, winter convalescent plasma. And if people don't have faith in the vaccine in the safety and efficacy of the vaccine, and not enough people signed up to take and accept that it's goingto inoculate them from Corona virus. It won't stand the pandemic. I mean, you need at least 50 to 70% of people taking it to build herd immunity is going to be a couple of year endeavor and rush something into the marketplace. Without having it appropriately tested is a really dangerous course. And so that's why you're seeing these drug companies. You know, it's sort of tacit or implicit criticism of Trump's path here. So they are, you know, boldly saying what would normally not be bold at all? Don't worry, folks. We've got you The headline for their statement, said Bio farmer leaders unite to stand with science school Right there sounds pretty. That's a sort of an unsubtle dig. I think Trump the political environment. A lot of the top vaccine makers that Aaron content and right now they're in stage. Three trials and others have signed on to this list. A few of those if you could, please, so the ones that are in the most advanced stages, there's three that are in phase three trials. AstraZeneca Visor and Madonna. Each of these is not a traditional vaccine. You know you have what's called deactivated virus and then use the deactivated virus in some sort of growth. You grow it in like egg whites or egg yolks, and it's a very painstaking in long process. With these genetic based vaccines, you can rush him through the manufacturing and development process much more quickly. And so that's what they've done. So that's why those three manufacturers are ahead of the game ahead of the pack and our manufacturing large volumes of vaccine in the event. That they do prove safe and effective through massive stage three clinical trials, clinical trials vaccine take about 30,000 people, and that's an important distinction that these vaccines are made a different way because we don't have a vaccine that has been made in the way that they're going about it, so they really do need to do all the due diligence in these late stage clinical trials to make sure it's safe and effective. That's a great point, really these air novel technologies so they do show in early stages. They've shown clinical effectiveness, and they've shown decent safety profiles. And so it's encouraging. But until you have the really large scale population scale clinical trials that were you, Khun See that it's actually preventing people from getting infection. Out in a community. We really won't know how everything is you got to figure out how long it's going to work that will take even longer you'll see is a une way before we know exactly whether or not the effect of the vaccine will last one year, two years, five years. So no one will really know that for quite some time as well, and those of the concerns, even with the emergency use authorization that could be done a lot sooner, and that's kind of the thinking. That is what will happen. But as you mentioned earlier, they want to be sure that this works in a safe and effective so that the public isn't wary of us, and the public wants to take these. So, for now, nine different drug companies pledging to go through all this late stage clinical trials, make sure everything is up to par before they prove anything. So at least some good news on that front. Right there. Christopher Roland, Business of Healthcare Reporter for the Washington Post. Thank you very much for joining us. Oh, thanks for having me on as businesses and schools are trying to reopen one of the keys to preventing Koven 19 indoors is proper ventilation. L. Scientists have started to issue recommendations to schools and businesses that want to reopen on how often indoor air needs to be recycled, as well as fans, filters and other equipment that needs to be replaced. For schools think open windows with fans. Air purifiers enough created eight back systems. For.

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