With COVID-19 surging, Trump wants science to move far faster. It can’t.

[C C]

https://www.statnews.com/2020/03/19/with...r-it-cant/

EXCERPT: For about 20 minutes on Thursday, President Trump undermined six decades of dogma on the development of safe and effective drugs. Trump, addressing a nation under shelter and quarantine from the coronavirus pandemic, said a new drug for Covid-19, yet to be proved safe and effective, was now “approved or very close to approved.” Another, also not approved for coronavirus, would be “available almost immediately,” in part because using it is “not going to kill anybody.”

Then, minutes later, the commissioner of the Food and Drug Administration, Stephen Hahn, took the dais in the White House briefing room and delicately walked back each one of Trump’s statements. Nothing about the FDA’s deliberate process had changed, and no miracle medicine was a pen stroke away from solving the crisis. Pharma stocks that had surged fell back again.

The president’s remarks ran afoul of nearly every established FDA norm ... for instance, and avoiding promises, let alone those that can’t be kept. But they were also a sign of his long-running impatience with the realities of drug development [...] “Trump entered the White House fuming at bureaucrats ... in particular trying to bring down the FDA,” said Arthur Caplan ... “That’s pure ideology, and it turns out that ideology is barren and impotent in the face of a pandemic.”

In many ways Trump’s science policy has been defined by his disdain for red tape at the FDA. [...] The coronavirus pandemic has rekindled Trump’s eagerness to expedite the development of new medicines. But in this case the process of developing new therapies is already moving at an unprecedented pace. ... “The FDA has been a global leader in medical product development,” said Jeff Allen, president and CEO of Friends of Cancer Research. “There’s nothing to suggest that they are standing in the way of the important development and access to these therapies.”

Still, the bracing pace may not be enough for Trump. [...] Most FDA watchers can recite by heart the history of how the agency was granted the ability to review drugs for safety and efficacy in the first place. It wasn’t until a so-called “elixir” that was being promoted to cure sore throats killed over 100 people that Congress acted in 1938 to give the FDA the ability to regulate drugs for safety. Decades later, in the 1960s, a drug promoted to help with morning sickness led to thousands of babies born with lifelong birth defects. The crisis prompted Congress to again boost the FDA’s power. Among those changes were some requiring the FDA to not just consider safety, but also efficacy, when approving drugs.

Those are responsibilities that the FDA still holds dear. “Let me make one thing clear: FDA’s responsibility to the American people is to ensure that products are safe and effective. And we are continuing to do that,” Hahn said Thursday. (MORE - details)

EDIT: Videos added

https://www.youtube-nocookie.com/embed/JKC8gu7UsVo

https://www.youtube-nocookie.com/embed/WVlTpIAK1CU

[Syne]

The truth is actually somewhere inbetween. Regulation does stifle the development of new drugs, even expedited ones, and Trump is not a specialist who knows exactly how long these things may take. The presidents job is to project calmness and surety, not know every single detail.

[Yazata]

It's better to actually watch the daily coronavirus briefings than to receive the message filtered through a politicized media seemingly intent on setting the President and his CDC, NIH and FDA medical advisers against each other to the President's detriment. In real life, Dr. Fauchi explained at some length that there was no real difference between them.

EXCERPT: For about 20 minutes on Thursday, President Trump undermined six decades of dogma on the development of safe and effective drugs.

Except he didn't do anything of the kind.

Trump, addressing a nation under shelter and quarantine from the coronavirus pandemic, said a new drug for Covid-19, yet to be proved safe and effective, was now “approved or very close to approved.” Another, also not approved for coronavirus, would be “available almost immediately,” in part because using it is “not going to kill anybody.”

It sounded to me like three drugs were discussed. Chloroquine, hydroxychloroquine and remdesvir. The first two are long established and widely prescribed anti-malarial drugs, considered reasonably safe and already in the prescription formulary for decades. Their side effects are well-known. Hence, prescribing them for coronavirus isn't likely to reveal an unknown side effect that is likely to kill anyone.

While neither of these two drugs has been "proven" effective for coronavirus by the standards of the FDA, there is a lot of anecdotal evidence from China and other places where desperate last-chance cases near death were given these drugs and immediately started to recover. I believe that they have been tried in Europe too.

So, these drugs have been approved for what's termed "compassionate use", where doctors can use them for off-label uses (like coronavirus) without waiting for a year or more as the FDA performs all kinds of studies before approving them for coronavirus use. 

Then, minutes later, the commissioner of the Food and Drug Administration, Stephen Hahn, took the dais in the White House briefing room and delicately walked back each one of Trump’s statements. Nothing about the FDA’s deliberate process had changed, and no miracle medicine was a pen stroke away from solving the crisis. Pharma stocks that had surged fell back again.

Well, it's true that chloroquine and hydroxychloroquine have not been "proven" effective for coronavirus. The FDA feels that it needs to perform those studies. As Dr. Fauchi explained, science needs data. So the 'compassionate use' authorization asks that doctors report the results of prescribing the drugs back to the FDA so that the results can go into the database. All while the double-blind studies are also taking place, studies that will take a year or more to complete.

The president’s remarks ran afoul of nearly every established FDA norm ... for instance, and avoiding promises, let alone those that can’t be kept.

Except that the President didn't promise anything. He said that these drugs might help and might not. (Dr. Fauchi said exactly the same thing.) President Trump did say that he had a good feeling about them, based on their impressive performance reported in China. (Which of course isn't a formal "study" and is just anecdotal.) Having said that, he also said that there's also a possibility that they might not work. But given the unprecedented emergency situation and the prospect of large-scale loss of life, he's requested that the FDA approve them for "compassionate use", so that doctors can prescribe them in desperate cases on the chance that they will help.

Just imagine what people would say if a year from now these drugs are indeed ultimately "proven" effective for coronavirus, but they were withheld from patients in a bureaucratic tangle while hundreds of thousands of people died. Imagine the screaming and the calls for Trump's head. The guy can't win. The media will attack anything he does. (Why they do that, I have no idea. It just looks like insane hatred to me.) They think that they have him coming and going on this one.

Anthony Fauchi put it best when, replying to reporters who were trying to push the assertions in the OP, he said that there was no disagreement between him and the President. It's just that the President chose to emphasize the potential of these drugs, while the food and drug establishment wanted to emphasize the need for more data and formal studies. There's no fundamental contradiction, just a difference in emphasis, neither of which is necessarily wrong.

[Magical Realist]

The guy can't win. The media will attack anything he does. (Why they do that, I have no idea. It just looks like insane hatred to me.)

It's because Trump is stupid AND ignorant and a known bullshitter and a pusher of conspiracy theories, making up shit even when he doesn't have to. The media is used to Trump being like this, having him on record, while we tend to forget it and wake up everyday with new expectations. It's gotten to the point that I mute my TV every time he starts speaking because I don't want to hear his lies. I'm so tired of it. I remember when the president was someone you could trust to have a handle on a situation and who spoke the truth. Not anymore. He is the last person on earth I would rely on for anything like factual information.

Trump's misinformation about the coronavirus:

https://www.vox.com/policy-and-politics/...oronavirus

[Syne]

^^^Cue the "insane hatred"...of course, fueled by Vox.

[Magical Realist]

That poor man, having to stand up there with the bullshitter in chief...

https://www.youtube.com/watch?feature=sh...pp=desktop

[Yazata]

Watch the video starting at 3:40, where FDA commissioner Hahn basically says the exact same things I wrote in my first post.

I don't think that it's helpful for the hugely-politicized media to try to create fanciful divisions and antagonisms where they don't really exist, in a time of national crisis when everyone needs to be pulling together in the common interest.

EDIT: Videos added

https://www.youtube-nocookie.com/embed/WVlTpIAK1CU

[Zinjanthropos]

I don't follow politics and if the Americans elected an idiot then it's their problem. Still I can't help but see Trump on tv once in awhile. I figure he's smarter than any of the plugs who are trying to get him out of office.

I've invested in drug companies in the past and I can tell you for a fact that the FDA approval process takes years for most everything new, from drugs, devices & procedures, primarily to avoid liability because there's always people who have an adverse affect or die. Covering the bases. But there is a fly in the ointment.

Do I think it could be speeded up? Absolutely. Big Pharma has clout and it seems to me that they have some control over how fast new drugs get to approval. If they can bleed a company dry or use political influence they will, before even thinking of partnering, assisting or buying a company that has something better than them. I have seen this countless times on the investment market and that is why pharmaceutical stocks are the most volatile on the stock exchange. So if gov't can push Big Pharma aside during a national crisis then do it and worry about who gets the credit later. It's pharmaceutical triage.... people will still die but you hope the numbers are fewer. Kind of like dropping an A-bomb to avoid excess casualties, it's war.

[C C]

That poor man, having to stand up there with the bullshitter in chief...

https://www.youtube.com/watch?feature=sh...pp=desktop

Context for international readers (as this might be getting confusing): The day after (Friday) with Anthony Fauci (member of the White House Coronavirus Task Force, appointed by Trump) being the guy in the hot seat there. Thursday it was Stephen Hahn, nominated by Trump to be commissioner of the FDA (later approved by the senate).

https://www.usnews.com/news/health-news/...roven-drug

"Rather than fighting with Trump, he [Fauci] stepped up to the podium Friday to say he’s not ruling the drug out, but that it must be studied before making any promises."

---

[...] Do I think it could be speeded up? Absolutely. Big Pharma has clout and it seems to me that they have some control over how fast new drugs get to approval. If they can bleed a company dry or use political influence they will, before even thinking of partnering, assisting or buying a company that has something better than them. I have seen this countless times on the investment market and that is why pharmaceutical stocks are the most volatile on the stock exchange. So if gov't can push Big Pharma aside during a national crisis then do it and worry about who gets the credit later. It's pharmaceutical triage.... people will still die but you hope the numbers are fewer. Kind of like dropping an A-bomb to avoid excess casualties, it's war.

Yeah, they've got clout alright. The FDA has allowed fraudulent research to slip by. So the irony is that FDA approval doesn't guarantee the drugs are safe, after all those years of testing and millions spent. Big Pharma even funds reviews of new drugs, a tail wagging the dog situation.

https://www.pbs.org/newshour/health/fda-...-they-work

Essentially, regardless of which side, this is much ado about either protecting or bypassing appearances rather than the USA literally having a secure guardian of drug safety.

[Zinjanthropos]

Yeah, they've got clout alright. The FDA has allowed fraudulent research to slip by. So the irony is that FDA approval doesn't guarantee the drugs are safe, after all those years of testing and millions spent. Big Pharma even funds reviews of new drugs, a tail wagging the dog situation. 

Most companies, even foreign, use FDA as their benchmark for approval. Fact is other countries have their own testing agencies and can approve drugs the FDA does not. It's just that you won't be able to use them legally in USA. It's why people travel to other countries for treatments. Right now I think every country with an approval position should be making every effort through their own agencies to get something on the table. Might speed things up.