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I personally hope this shows (some) irrelevance of FDA bureaucracy...if they weren't need in the worst of times, why are they needed in the best of times? Let

I personally hope this shows (some) irrelevance of FDA bureaucracy...if they weren't need in the worst of times, why are they needed in the best of times? Let entrepreneurs, doctors, and patients decide their individual risk level. I would rather have more options than less. Edit: as an alternative to any knee jerk critism (I said "some"), why can't states handle this and the best emerge? I'm a big proponent of localism.

rantwasp 6y ago
i think that in this case it's a risk trade-off. you don't want to have to make these kind of decisions daily
- jngreenlee 6y ago
  I think my doctor and I can make those choices best from a wide spectrum of solutions, not only those lobbyied for by Giliad.
  - Reelin 6y ago
    It's worth mentioning that MDs and pharmacists in the US both have approximately 4 years of schooling (among other things) in addition to their bachelors.
  - mardifoufs 6y ago
    Okay, so the lobbying will move to doctors. And while FDA lobbying is public, good luck guessing who gave a kick back to your doc. A single regulatory body is easier to monitor than a hundred of thousands of them. Doctors getting kickbacks is already a thing so I can't imagine how it wouldn't get worst if they had the power to prescribe anything they want, not just FDA approved meds
monksy 6y ago
Because that is a HUGE risk involved. You can't turn back time and undo damage or bring someone back to life.
maxerickson 6y ago
"Stodgy gatekeeper" and "nothing" are not the only regulatory regimes available. Like you could have looser requirements to enter the market and then penalize/ban companies/people that make bad/unsafe tests. (yes, I'm proposing that people involved in marketing useless medical tests be banned from doing it a second time. Might be hard to structure it, but the goal is clear enough).
- jngreenlee 6y ago
  I would like this, especially for tests (I understand being more restrictive for treatment but still disagree with the winner take all corpratism that results under current regime)
  - ineedasername 6y ago
    I don't see all that much "winner take all" in the medical industry. There are multiple competitors for many/most products, evidenced in this situation by many companies racing to develop & compete against each other for better testing. A few weeks ago there were news stories about rapid testing w/ 1 day turn around. Now we're down to fractions of an hour.
hprotagonist 6y ago
"Right To Try" is a return to legal snake oil. Hell no, get it out of here. https://blogs.sciencemag.org/pipeline/archives/2018/06/21/welcome-to-right-to-try https://blogs.sciencemag.org/pipeline/archives/2018/06/21/we... And let’s see if my nastier, more cynical Derek-Against-Humanity prediction comes true: that the next wave will not be just people who have seized on this plan opportunistically, but who have targeted it right from the start. Who will pick out terrible diseases for which there are no therapies at all, the better to insure a supply of completely desperate patients and families, and provide them with utterly useless therapies at stiff, stiff prices. Utterly harmless therapies, though – don’t want to get sued while you’re raking in the bucks. I’m talking polysaccharide therapy for pancreatic cancer, antioxidant phytonutrients for Alzheimer’s: in other words, corn starch and grape juice. What the hell. The customers are going to die, anyway. Why should they die with their money as well?
- jMyles 6y ago
  > "Right To Try" is a return to legal snake oil. Is that really so bad in 2020, when we have access to the information we actually need to learn about snake oil?
  - mardifoufs 6y ago
    Yes? Access to information does not mean access to good information. and even access to good information does not mean that people will not chose to believe debunked claims. We already have that now, but at least we can regulate what kind of claims are made and what kind of evidence is needed to make them. I'm usually all for individual responsibility, but health is one of the rare things where you can't just rely on people being rational. It is very difficult to expect rational decision making based on evidence when it comes to a dying cancer patient desperate to find a cure. And it's very easy to see people profit from that.
  - hcknwscommenter 6y ago
    Under your scenario you will be targeted by extremely sophisticated psy-ops (think cambridge analytica *1000) to convince you that the super-snake-oil 2xt is the absolute best cure for your disease. Don't let the gov't tell you any different. Just look at this incredibly misleading data.
Reelin 6y ago
Woah. Hold up. I will repeatedly and loudly criticize the US government response to COVID-19 so far as inept, particularly the FDA in the early days. Brittle laws combined with their failure to move quickly hamstrung our chance at containment. Under normal circumstances though, health and safety oriented regulatory bodies such as the FDA play an absolutely essential role in protecting us from bad actors. The only reason I have confidence when purchasing medications of any sort is because of them. They also protect our food supply from all sorts of misguided and dangerous production practices. Even in an emergency situation, they have an essential role to play in preventing bad actors from popping up left and right peddling snake oil. There certainly needed to be more flexibility and speed in responding to the current crisis, and I'd argue that states ought to have _significantly_ more autonomy in a number of areas, but that's a far cry from calling them irrelevant. (As an aside, I was disappointed that none of the states defied the federal government in this instance. I had hoped for a state-level authorization for established medical labs to develop in house tests, and a subsequent court case challenging federal law on the matter. As far as I understand, the FDA only derives its authority from the frequently abused interstate commerce clause.)
- jngreenlee 6y ago
  I think you reacted too strongly, IMO. I only said some. People and their doctors are the MOST concerned with their lives...not you, not politicians, and not FDA staffers. If I want to treat my (illegal war) PTSD, depression or anxiety with novel treatments like 2CB, LSD, or MDMA, that is my choice. It immoral to restrict my supply with the barrel of a gun.
  - Reelin 6y ago
    I completely agree - I had (mis)interpreted what you previously wrote to mean throwing them out entirely. I just can't stress enough that despite all their issues, the FDA still plays an absolutely essential role in keeping our society functioning.
  - Hello71 6y ago
    the fda doesn't regulate any of those drugs, that's the dea.
jMyles 6y ago
The same is true of so many of the things that are suddenly deemed unnecessary in this time of crisis. Let's be judicious about which gatekeepers and rent seekers we choose to bring back online.
nexuist 6y ago
>why can't states handle this and the best emerge? Is it fair to die in State X because it had more inept leaders than State Y? This isn't about long term economic or social policy, this is about an exponentially growing pandemic that doesn't respect borders.
- tathougies 6y ago
  It's as fair as dying in Germany because France had inept leaders (for example, not saying either of those countries have inept or incompetent leadership). American states are way more autonomous than the regions of most countries. The populace elects the leaders they get.
  - ineedasername 6y ago
    It's as fair as dying in Germany because France had inept leaders Yes, which is to say it isn't fair. You're example argues for higher level oversight and uniformity of regulation, say at the EU level, not even more balkanization of them.
xiphias2 6y ago
The oath ,,First do no harm'' is there for a reason: sadly for most new therapies, the alternative of using the old therapy is better in 99% of the cases. The FDA is there to make sure that companies find the remaining 1%. The big difference here is that the speed of finding the right drug can make or break trillions of dollars and thousands of lives, so it's critical for the FDA to focus on the COVID-19 illness.
jancsika 6y ago
> Let entrepreneurs, doctors, and patients decide their individual risk level. Try starting with something less dangerous first like rolling your own ciphers for use in end-to-end encryption.
ineedasername 6y ago
I don't think that fracturing the regulations & approval processes into 50 different jurisdictions would be all that helpful. It would in fact greatly inhibit companies that do business in multiple states. Which set of rules do they follow? Lawsuits would abound whenever there's an issue and the rules of any jurisdiction they might operate within could be contrived to apply to the situation. And consider the current circumstances: Yes, things are relaxed in an emergency. How would that be any different? State-level, or any level of oversight, would also be relaxed in an emergency. All that shows is that sensitivity to risk changes (decreases) when there is a crisis. It doesn't invalidate the greater level of care taken when there is the time to take it. Also, no matter what level you impose oversight & regulation, patients will not be in a position to determine their desired level of risk. If it happens at the state level, there can still be plenty of people who would like a different risk threshold: They won't get it though. Finally, it ignores the fact that what might be in the best interest of a more local jurisdiction (say, it costs less money) it might be very much against the best interests of others. A jurisdiction that decides it's comfortable with higher risk does not exist in a vacuum: It's comfort with higher risk would also bleed over into neighboring areas. Far better to have a uniform set of guidelines and make exceptions on a case by case basis in emergencies, rather than make everything an exception, which would make coordination & consistency during a crisis a complete nightmare.

rantwasp 6y ago

i think that in this case it's a risk trade-off. you don't want to have to make these kind of decisions daily

jngreenlee 6y ago
I think my doctor and I can make those choices best from a wide spectrum of solutions, not only those lobbyied for by Giliad.
- Reelin 6y ago
  It's worth mentioning that MDs and pharmacists in the US both have approximately 4 years of schooling (among other things) in addition to their bachelors.
- mardifoufs 6y ago
  Okay, so the lobbying will move to doctors. And while FDA lobbying is public, good luck guessing who gave a kick back to your doc. A single regulatory body is easier to monitor than a hundred of thousands of them. Doctors getting kickbacks is already a thing so I can't imagine how it wouldn't get worst if they had the power to prescribe anything they want, not just FDA approved meds

monksy 6y ago

Because that is a HUGE risk involved. You can't turn back time and undo damage or bring someone back to life.

maxerickson 6y ago

"Stodgy gatekeeper" and "nothing" are not the only regulatory regimes available. Like you could have looser requirements to enter the market and then penalize/ban companies/people that make bad/unsafe tests. (yes, I'm proposing that people involved in marketing useless medical tests be banned from doing it a second time. Might be hard to structure it, but the goal is clear enough).

jngreenlee 6y ago
I would like this, especially for tests (I understand being more restrictive for treatment but still disagree with the winner take all corpratism that results under current regime)
- ineedasername 6y ago
  I don't see all that much "winner take all" in the medical industry. There are multiple competitors for many/most products, evidenced in this situation by many companies racing to develop & compete against each other for better testing. A few weeks ago there were news stories about rapid testing w/ 1 day turn around. Now we're down to fractions of an hour.

hprotagonist 6y ago

"Right To Try" is a return to legal snake oil. Hell no, get it out of here. https://blogs.sciencemag.org/pipeline/archives/2018/06/21/welcome-to-right-to-try https://blogs.sciencemag.org/pipeline/archives/2018/06/21/we... And let’s see if my nastier, more cynical Derek-Against-Humanity prediction comes true: that the next wave will not be just people who have seized on this plan opportunistically, but who have targeted it right from the start. Who will pick out terrible diseases for which there are no therapies at all, the better to insure a supply of completely desperate patients and families, and provide them with utterly useless therapies at stiff, stiff prices. Utterly harmless therapies, though – don’t want to get sued while you’re raking in the bucks. I’m talking polysaccharide therapy for pancreatic cancer, antioxidant phytonutrients for Alzheimer’s: in other words, corn starch and grape juice. What the hell. The customers are going to die, anyway. Why should they die with their money as well?

jMyles 6y ago
> "Right To Try" is a return to legal snake oil. Is that really so bad in 2020, when we have access to the information we actually need to learn about snake oil?
- mardifoufs 6y ago
  Yes? Access to information does not mean access to good information. and even access to good information does not mean that people will not chose to believe debunked claims. We already have that now, but at least we can regulate what kind of claims are made and what kind of evidence is needed to make them. I'm usually all for individual responsibility, but health is one of the rare things where you can't just rely on people being rational. It is very difficult to expect rational decision making based on evidence when it comes to a dying cancer patient desperate to find a cure. And it's very easy to see people profit from that.
- hcknwscommenter 6y ago
  Under your scenario you will be targeted by extremely sophisticated psy-ops (think cambridge analytica *1000) to convince you that the super-snake-oil 2xt is the absolute best cure for your disease. Don't let the gov't tell you any different. Just look at this incredibly misleading data.

Reelin 6y ago

Woah. Hold up. I will repeatedly and loudly criticize the US government response to COVID-19 so far as inept, particularly the FDA in the early days. Brittle laws combined with their failure to move quickly hamstrung our chance at containment. Under normal circumstances though, health and safety oriented regulatory bodies such as the FDA play an absolutely essential role in protecting us from bad actors. The only reason I have confidence when purchasing medications of any sort is because of them. They also protect our food supply from all sorts of misguided and dangerous production practices. Even in an emergency situation, they have an essential role to play in preventing bad actors from popping up left and right peddling snake oil. There certainly needed to be more flexibility and speed in responding to the current crisis, and I'd argue that states ought to have _significantly_ more autonomy in a number of areas, but that's a far cry from calling them irrelevant. (As an aside, I was disappointed that none of the states defied the federal government in this instance. I had hoped for a state-level authorization for established medical labs to develop in house tests, and a subsequent court case challenging federal law on the matter. As far as I understand, the FDA only derives its authority from the frequently abused interstate commerce clause.)

jngreenlee 6y ago
I think you reacted too strongly, IMO. I only said some. People and their doctors are the MOST concerned with their lives...not you, not politicians, and not FDA staffers. If I want to treat my (illegal war) PTSD, depression or anxiety with novel treatments like 2CB, LSD, or MDMA, that is my choice. It immoral to restrict my supply with the barrel of a gun.
- Reelin 6y ago
  I completely agree - I had (mis)interpreted what you previously wrote to mean throwing them out entirely. I just can't stress enough that despite all their issues, the FDA still plays an absolutely essential role in keeping our society functioning.
- Hello71 6y ago
  the fda doesn't regulate any of those drugs, that's the dea.

jMyles 6y ago

The same is true of so many of the things that are suddenly deemed unnecessary in this time of crisis. Let's be judicious about which gatekeepers and rent seekers we choose to bring back online.

nexuist 6y ago

>why can't states handle this and the best emerge? Is it fair to die in State X because it had more inept leaders than State Y? This isn't about long term economic or social policy, this is about an exponentially growing pandemic that doesn't respect borders.

tathougies 6y ago
It's as fair as dying in Germany because France had inept leaders (for example, not saying either of those countries have inept or incompetent leadership). American states are way more autonomous than the regions of most countries. The populace elects the leaders they get.
- ineedasername 6y ago
  It's as fair as dying in Germany because France had inept leaders Yes, which is to say it isn't fair. You're example argues for higher level oversight and uniformity of regulation, say at the EU level, not even more balkanization of them.

xiphias2 6y ago

The oath ,,First do no harm'' is there for a reason: sadly for most new therapies, the alternative of using the old therapy is better in 99% of the cases. The FDA is there to make sure that companies find the remaining 1%. The big difference here is that the speed of finding the right drug can make or break trillions of dollars and thousands of lives, so it's critical for the FDA to focus on the COVID-19 illness.

jancsika 6y ago

> Let entrepreneurs, doctors, and patients decide their individual risk level. Try starting with something less dangerous first like rolling your own ciphers for use in end-to-end encryption.

ineedasername 6y ago

I don't think that fracturing the regulations & approval processes into 50 different jurisdictions would be all that helpful. It would in fact greatly inhibit companies that do business in multiple states. Which set of rules do they follow? Lawsuits would abound whenever there's an issue and the rules of any jurisdiction they might operate within could be contrived to apply to the situation. And consider the current circumstances: Yes, things are relaxed in an emergency. How would that be any different? State-level, or any level of oversight, would also be relaxed in an emergency. All that shows is that sensitivity to risk changes (decreases) when there is a crisis. It doesn't invalidate the greater level of care taken when there is the time to take it. Also, no matter what level you impose oversight & regulation, patients will not be in a position to determine their desired level of risk. If it happens at the state level, there can still be plenty of people who would like a different risk threshold: They won't get it though. Finally, it ignores the fact that what might be in the best interest of a more local jurisdiction (say, it costs less money) it might be very much against the best interests of others. A jurisdiction that decides it's comfortable with higher risk does not exist in a vacuum: It's comfort with higher risk would also bleed over into neighboring areas. Far better to have a uniform set of guidelines and make exceptions on a case by case basis in emergencies, rather than make everything an exception, which would make coordination & consistency during a crisis a complete nightmare.