Abolish the FDA

[acesfull86]

https://reason.com/2021/04/03/abolish-the-fda/


Last year, hashtag activists were ready to #AbolishICE, in part over the deaths of about 20 immigrants in custody in 2020. Protesters called on the government to "defund the police" over more than 1,000 killings by law enforcement during the same period. Those deaths are tragic, and many could have been prevented with better policy. But they pale in comparison to the blood on the hands of the Food and Drug Administration (FDA) over the last 12 months.

Faced with the challenge of COVID-19, the FDA screwed up on nearly every level. When the agency did do something right, it was almost always by making exceptions to its normal policies and procedures.

....

The FDA screwed up in prohibiting researchers from testing affected populations in the early days of 2020, when the virus might have been better contained upon arrival in the United States. It screwed up in refusing to lift requirements for mask manufacturers and by declining to allow good substitutes for masks in short supply. It screwed up by collaborating with the Centers for Disease Control and Prevention (CDC) to protect a monopoly on testing tools that ended in a disastrous shortage. FDA staffers tasked with approving both treatments and vaccines screwed up by delaying meetings and taking days off as Americans were dying in unprecedented numbers of a disease for which the agency had potential solutions. At press time, the AstraZeneca vaccine, which was widely available in many other nations, remained unapproved in the U.S., for reasons that are opaque to Americans desperate to resume normal lives.

But this is nothing new. The FDA started screwing up the COVID crisis long before the first bite of bat soup, by suppressing innovation and experimentation that could have better positioned scientists and researchers to prevent the outbreak from becoming a pandemic.

.....

The FDA is being asked to do an impossible, immoral task—and it is doing it badly. Ordinarily, people tend to discover this one at a time, in moments of personal crisis. A patient with a rare cancer is heartbroken to find out a potential treatment is not approved for use in the United States. A pharmacist who would like to offer a customer suffering from side effects an alternate drug is unable to do so. An entrepreneur who has an idea for a new testing tool gets discouraged when she looks into the approvals she would have to obtain before going to market. People seeking to make decisions about their own bodies that would harm no one else are forbidden from doing so, sometimes literally condemning them to death.

This year, Americans experienced that despair and frustration in unison. As our friends and neighbors sickened and died, the FDA equivocated, procrastinated, and played hot potato with tough decisions, just as it has done with minimal consequences to the agency for decades.

.....

Even now, with three COVID vaccines approved and on the U.S. market, health professionals are unable to pivot to offering a single dose to twice as many people, despite clear evidence that one shot can be highly effective. Why? Because the FDA approval process is not built to handle that kind of change mid-stride. And methods that would have allowed researchers to formally evaluate the efficacy of a single shot were also not allowed pre-release.

The current system is this: The FDA approves new pharmaceuticals as both safe and effective, in most cases after a laborious and expensive process of many years and many millions of dollars. Pharmaceuticals are only approved for certain uses, but physicians are allowed to use them off-label, which immediately undermines the case for the time-consuming efficacy part of the approval. Sometimes, even though drugs have been approved as safe, they are discovered to be harmful after the fact and have to be withdrawn.

....

Whenever a government agency fails in its mission, there are calls for more funding, more authority, more high-quality leadership. But in this case, there is little reason to believe those things will help; the agency's mission was flawed from the beginning.

In its 115 years of existence, the FDA has certainly nabbed quacks and prevented harmful drugs from coming to market. The agency has been dining out for decades on the story of how it refused to approve thalidomide for sale in the United States, for instance. With all due respect to that incredible catch, this is like NASA boasting about Tang and Velcro. It's not that the FDA has never done anything good; it's that it hasn't done enough to justify the costs.

Sometimes the costs are clear, as they have been this year in the struggle to get access to vaccines and treatments, or as they have been to the sufferers of chronic or terminal illnesses for much longer. Other times the stakes are low for any individual patient but add up. Thousands, maybe millions, of men with heart trouble take a low dose of aspirin every day to reduce the risk of myocardial occlusion. But for many years after that connection was established, the FDA prohibited aspirin manufacturers from advertising it. That single, seemingly minor restriction contributed to the deaths of many, many thousands of Americans.

Alternatives to regulation can also be hard to envision. But the role of the state, if it has one at all, is to protect rights and guard against fraud, not to prevent people from making risky choices.



----------------------

It'll never happen, but this would be a much, much-welcomed legacy of COVID...

[acesfull86]

Started badly, not getting better

[zitothebrave]

I feel like many agencies like the FDA, etc. should be nuked every decade or so to get leaner and make regulations to an ever changing environment.

[acesfull86]

Still don’t have cheap, widely available at home testing, yet Europe is flush with these very tests, made by American companies

Thanks FDA!

[nsacpi]

I'm willing to accept abolishment of the FDA if it will lead the pro-covid traitors in our midst to get vaccinated.

[acesfull86]

I'm willing to accept abolishment of the FDA if it will lead the pro-covid traitors in our midst to get vaccinated.

That’s a fantastic deal

[57Brave]

abolish the FDA by the same mechanism we defund the police ?

pretty empty notion though.
The FDA is so woven into our societal DNA

Break up ?
That could be better
Separate the food from the drug.

My guess is you would see that as just adding another government agency
Personally not opposed to separating this early 20th century behemoth

[acesfull86]

https://reason.com/2021/09/23/the-cd...andemic-worse/

^ and while we’re at it…

[cajunrevenge]

I'm willing to accept abolishment of the FDA if it will lead the pro-covid traitors in our midst to get vaccinated.

I would take that deal

[acesfull86]

In late March 2020, after much of the country had shut down, the CDC went so far as to "edit an article that was slated for publication in a science journal, to remove a passage inserted by a Washington State public health official that called for widespread testing at senior assisted-living facilities," Gottlieb writes. Senior living facilities were, of course, among the communities where COVID was most deadly. Yet even there, the agency resisted mass testing. It resisted was because that state official had "encouraged more testing than the CDC was prepared to allow or was able to handle at the time." In an editing comment on the article, according to Gottlieb, a CDC official explicitly cautioned: "I would be careful promoting widespread testing."

This wasn't entirely unprecedented or unexpected. In 2016 and 2017, the CDC had similarly mishandled the development of a Zika test kit. As with COVID-19, the CDC's unwillingness to provide diagnostic tests to commercial labs was at the root of the problem.

Thus, the agency's COVID failure wasn't just foreseeable; it was foreseen. A Government Accountability Office report from 2017 noted that the CDC distributed diagnostic tests for Zika to public health labs but not to other manufacturers. The underlying process was murky at best. "Without a clear and transparent process for distributing CDC diagnostic tests," the report warned, "the agency may not be able to develop the capacity of the commercial sector to meet the needs during an outbreak." Despite the warning, this was exactly how the COVID pandemic played out.


Widespread testing from the early days of the pandemic wouldn't have stopped COVID completely. But it might have enabled a more tailored response, with mitigation measures limited to certain geographic regions and times. Because policymakers and the public were initially blind to the scale of the outbreak, we shut down the entire country instead, to disastrous results. No single organization is more to fault for that early blindness than the CDC.

The CDC continued its run of failures as the pandemic proceeded. It promoted arbitrary guidelines based in shoddy science, like the rule calling for six feet of distance between people interacting indoors, which made it maddeningly difficult to reopen schools in the fall of 2020. The agency didn't update that guideline to three feet until March 2021, despite months of evidence indicating that three feet was safe enough.

So the CDC was not just wrong when it mattered; it was stubborn about its wrongness. It also often refused to explain its decisions, or to provide useful, practical information on which officials and private individuals could base their decisions. And when it did provide information, as Zeynep Tufecki has noted, the info was often confusing, full of vague or impractical advice and conflicting pronouncements.

The root of the problem is the agency's self-conception: It sees itself as the ultimate arbiter of what is true and what to do on all matters of infectious disease. In essence, the CDC believes there is no other authority besides the CDC, so it shuts out private labs from the testing process, insists that its faulty tests actually work pretty well long after problems arise, sticks with overly complicated plans that bog down processes, and resists calls to update its guidance, even when that guidance makes living ordinary life difficult or impossible. In a pandemic, where information is scarce and evolves rapidly—and when hundreds of millions of people have to make decisions right now—the agency's preference for deliberative slowness and absolutist pronouncements would be a problem even if it were largely competent. And as it turns out, the agency isn't that competent at all.


——————-

The failures of these agencies need to be highlighted, talked about, and dealt with.

Their screw ups are orders of magnitude more important than the individual bad decisions of an unvaccinated guy in Alabama yelling about not wanting to wear his mask in the supermarket.

We need a national conversation about these agencies. When called on when we needed them most, they didn’t deliver. We shouldn’t just shrug and move on and let history repeat itself.

[57Brave]

how outside of a Braves message board do you intend on not " just shrug and move on"

otherwise you are shaking your fist at clouds

[acesfull86]

how outside of a Braves message board do you intend on not " just shrug and move on"

otherwise you are shaking your fist at clouds

Getting a conversation going is a start

What do you suggest?

[Oklahomahawk]

Unless we redevelop a love for and desire for THE truth and the ability to see it when it's right before our eyes, we really don't have any hope left as a nation, regarding the FDA or anything else.

[57Brave]

as much as we have on our collective plates right now I am not holding my breath on any bureaucratic shake up of CDC.

regulations are tedious.
a streamlining of FDA is very very complicated

Like I said at first abolishing the FDA is akin to defunding the police

[nsacpi]

Unless we redevelop a love for and desire for THE truth and the ability to see it when it's right before our eyes, we really don't have any hope left as a nation, regarding the FDA or anything else.

We are very much an outlier when it comes to this as a country. And it hurts us in a lot of ways. And seems to be getting worse.

An outlier in the opposite direction is Denmark.

I found this piece about Denmark interesting.

https://www.washingtonpost.com/polit...how-it-did-it/

On Sept. 10, Danish authorities lifted all pandemic restrictions and pronounced that covid-19 is no longer a “critical threat” in the country. Vaccination rates are high — 86 percent of all eligible citizens 12 and older have received at least one shot, and 95 percent of people 50 and older are fully vaccinated.

Denmark’s death toll during the pandemic was only 450 people per million citizens, compared to 1,982 per million in the United States. How did Denmark, and its 5.8 million people, beat the covid-19 pandemic?

As part of Denmark’s largest behavioral covid-19 research project (the HOPE project), we surveyed more than 400,000 individuals in Denmark and seven other countries. Our findings suggest that citizens’ high and stable trust in their health authorities has been a crucial factor in Denmark’s success. This trust, shown in the figure below, encouraged high vaccination rates and the successful implementation of key policies such as mass testing and coronavirus passports.

Research on vaccine hesitancy — including our own — consistently finds that lack of trust in authorities — government officials, local leaders and health experts, for instance — is one of the primary reasons people refuse to get vaccinated against the virus. This is hardly a surprise, given that few of us have more than a vague understanding of how vaccines work, let alone the ability to verify that the coronavirus vaccines will work as vaccine companies claim. This leaves people with a need to trust stakeholders, from scientists testing the vaccine to authorities approving and distributing it.

Over 90 percent of Danes trust the national health authorities, our survey data revealed. By last fall, over 80 percent of the eligible population was willing to get an approved vaccine, compared to less than 50 percent in the United States. While starting with high levels of trust certainly helps, sustaining this trust could be a challenge, especially if authorities may be tempted to promote vaccines that prove less effective or more risky than others. Our research shows that in these situations, transparent communication about all features of vaccines — including the negative ones — is key to sustain trust, even if in the short run it reduces vaccine acceptance.

This finding highlights that trust between citizens and the authorities ideally runs both ways, as authorities need to trust that citizens can weather bad news and still make responsible decisions.

in other words our government should treat citizens like responsible adults...but citizens also need to process information and act like responsible adults...both links of this chain need to be strong

[57Brave]

Unless we redevelop a love for and desire for THE truth and the ability to see it when it's right before our eyes, we really don't have any hope left as a nation, regarding the FDA or anything else.

when have we ever ?
yet ...

[sturg33]

Trump should have actually drained the swamp.

He failed miserably.

The FDA, FBI, CDC, and all the alphabet agencies are total trash

[57Brave]

We are very much an outlier when it comes to this as a country. And it hurts us in a lot of ways. And seems to be getting worse.

An outlier in the opposite direction is Denmark.

I found this piece about Denmark interesting.

https://www.washingtonpost.com/polit...how-it-did-it/

On Sept. 10, Danish authorities lifted all pandemic restrictions and pronounced that covid-19 is no longer a “critical threat” in the country. Vaccination rates are high — 86 percent of all eligible citizens 12 and older have received at least one shot, and 95 percent of people 50 and older are fully vaccinated.

Denmark’s death toll during the pandemic was only 450 people per million citizens, compared to 1,982 per million in the United States. How did Denmark, and its 5.8 million people, beat the covid-19 pandemic?

As part of Denmark’s largest behavioral covid-19 research project (the HOPE project), we surveyed more than 400,000 individuals in Denmark and seven other countries. Our findings suggest that citizens’ high and stable trust in their health authorities has been a crucial factor in Denmark’s success. This trust, shown in the figure below, encouraged high vaccination rates and the successful implementation of key policies such as mass testing and coronavirus passports.

Research on vaccine hesitancy — including our own — consistently finds that lack of trust in authorities — government officials, local leaders and health experts, for instance — is one of the primary reasons people refuse to get vaccinated against the virus. This is hardly a surprise, given that few of us have more than a vague understanding of how vaccines work, let alone the ability to verify that the coronavirus vaccines will work as vaccine companies claim. This leaves people with a need to trust stakeholders, from scientists testing the vaccine to authorities approving and distributing it.

Over 90 percent of Danes trust the national health authorities, our survey data revealed. By last fall, over 80 percent of the eligible population was willing to get an approved vaccine, compared to less than 50 percent in the United States. While starting with high levels of trust certainly helps, sustaining this trust could be a challenge, especially if authorities may be tempted to promote vaccines that prove less effective or more risky than others. Our research shows that in these situations, transparent communication about all features of vaccines — including the negative ones — is key to sustain trust, even if in the short run it reduces vaccine acceptance.

This finding highlights that trust between citizens and the authorities ideally runs both ways, as authorities need to trust that citizens can weather bad news and still make responsible decisions.

in other words our government should treat citizens like responsible adults...but citizens also need to process information and act like responsible adults...both links of this chain need to be strong

socialism ?

that is what we would hear and it would stall right then and there

[57Brave]

Trump should have actually drained the swamp.

He failed miserably.

The FDA, FBI, CDC, and all the alphabet agencies are total trash

you are never right about anything and just clog up conversation
with the same nonsense
Please stop it

[sturg33]

Oh my bad the actual solution is to give them more funding, right?