9 ms·

The FDA's perpetual process machine

125 points by jseliger 6y ago

causality0 6y ago
The sorry state of the FDA and drug development and deployment as a whole is in my opinion due to a preponderance of two types of people: Type A will happily bankrupt their customers while giving them heart failure in order to reduce allergy symptoms by 10%, and Type B would rather let ten thousand people die in unmedicated screaming agony than have a drug show up in a news story saying it killed three of them, regardless of how many hundreds of lives it saved.
- jschwartzi 6y ago
  The FDA is largely composed of Type B people. They are very risk averse and will often delay a new technology simply because there might be unknown risks. There are technologies widely used in European ventilators such as automatic alarm control or adaptive alarm limits which the FDA views as unsafe based on their fear that the alarm system might fail somehow. It doesn’t surprise me that they tried to slow the approval process down. Anyone that believes the FDAs mandate is to foster progress is severely misinformed. Their actual mandate as I understand it is specifically to protect the public from injury by making progress really slow and making sure there are enough barriers to prevent someone selling a product which makes patients worse off than competitors. In this case they probably caused a lot more damage than they prevented.
  - jokowueu 6y ago
    There were some great drugs that were blocked because it raised blood pressure slightly :/
    - refurb 6y ago
      Higher blood pressure is linked to increased mortality. It's not like they are blocking the drug for fun.
      - deleted 6y ago
        [deleted]
      - cyphar 6y ago
        Especially in a country where 2/3rds of the adult population are overweight or obese and likely already have elevated blood pressure.
      - jokowueu 6y ago
        It depends what ur treating . For some disease an increase in blood pressure is nothing ,taking BP meds fixes this issue
      - amanaplanacanal 6y ago
        You really need to look at all cause mortality. You can’t just say A is associated with B, therefore we should keep A low. We make that mistake all the time as far as I can tell.
        refurb 6y ago
        My understanding is that connection has already been made through several robust trials. There may be drugs that raise blood pressure, but not mortality, but so far we haven’t actual data on one of them.
  - hanniabu 6y ago
    > They are very risk averse and will often delay a new technology simply because there might be unknown risks. I think this is smart simply because of how difficult it is to undo something that's been approved. You have people coming forward with side effects and the company simply shrugging their shoulders and saying there's no way you can prove that it's from this vs something else.
    - refurb 6y ago
      the company simply shrugging their shoulders and saying there's no way you can prove that it's from this vs something else That's not how it works. It doesn't matter if the company "shrugs their shoulders", if the FDA wants to pull the drug, it gets pulled. The FDA has a requirement that all adverse events reported to a company must be reported to the FDA (massive fines if you don't). The FDA will then take that data and do their own analysis. Yes, they will work with the company to discuss the data and it's implications, but have zero qualms with yanking a drug if the company thinks it's still safe. When we were negotiating our label with the FDA, we asked for a wording change because we thought the current wording was confusing. FDA came back with "we don't agree". So we added more explanation and they came back with "we're not changing it". We just accepted it as it was just delaying launch and it was clear we werne't going to get our way.
  - refurb 6y ago
    I work with the FDA as a part of my job and I disagree they are overly risk adverse. When we previewed our development plan with the FDA, they actually asked us "can't you move faster?". When a safety signal showed up, they were more than willing to work with us to develop a protocol to reduce the risk while still providing patients with drugs. I don't disagree that the FDA is very concerned about safety, but in situations where there is a very strong need, the FDA is willing to move quickly and accept a level of risk.
    - gwern 6y ago
      It's nice that they offered to slightly tweak the protocol for you. How very generous and magnanimous of them. On the other hand: coronavirus.
      - refurb 6y ago
        I honestly don't think it's fair to crap all over the FDA for Covid. One day we read that people become immune, the next day they lose it. One day hydroxychloroquine works, then next day it doesn't. It's hard enough managing drug approvals when you have all the data and plenty of time.
  - newyankee 6y ago
    The big question is whether any other country has processes and a market that is leading to faster drug discovery, development and launch ? If yes, that may help and in the current circumstances there is only 1 country big and powerful enough that i can think of, China.
  - pinkfoot 6y ago
    How would you classify Frances Kesley who prevented thalidomide from being sold in the USA. And how would you rank the German authorities who allowed it to be sold over the counter?
- BurningFrog 6y ago
  Those types of people exist in all countries. Yet the FDA is uniquely American. A different agency working under different incentives could produce much different, and hopefully better outcomes.
  - Symmetry 6y ago
    I think the Europeans Medicine Agency is a model for making sensible tradeoffs here, at least compared to the FDA. I sort of with the US could just outsource drug approval to them.
    - seehafer 6y ago
      EMA and FDA make different tradeoffs. They’re not necessarily easier. But I agree with you in part, I wish we had more harmonization or at least regulatory overlap — approved in EU you can sell in US, and vice versa, for instance.
    - refurb 6y ago
      The EMA is? The EMA typically takes longer on average to approve a drug than the FDA.[1] And if you want to look up an EU scandal, check out the Servier and Mediator. Hundreds of deaths reports and it took France almost 20 years to pull it off the market.[2] [1]https://news.yale.edu/2017/04/05/fda-approves-drugs-more-quickly-peer-agency-europe https://news.yale.edu/2017/04/05/fda-approves-drugs-more-qui... [2]https://www.fiercepharma.com/pharma/servier-faces-courtroom-long-running-mediator-death-investigation#:~:text=Servier%20is%20among%2011%20institutions,other%20countries%20stopped%20selling%20it https://www.fiercepharma.com/pharma/servier-faces-courtroom-....
      - Symmetry 6y ago
        Sure but I'm thinking of different metrics here.Europe has a variety of competing EpiPen equivalents so no price gouging. They had beta-blockers approved a decade before they were available in the US, with a small risk of liver failure for that first drug true, but many, many more lives were saved than lost. They had sunscreen that stopped UV A a decade before the US because the FDA's test only looked at skin burning so it took a long time to get the framework in place to examine sunscreens that block both. And yes you do have failures like Mediator or Thalidomide but on net I'd rather have their system.
- bsder 6y ago
  > Type B would rather let ten thousand people die in unmedicated screaming agony than have a drug show up in a news story saying it killed three of them, regardless of how many hundreds of lives it saved. Who gets to set those numbers and by what process? And, probably more importantly, who gets the indemnification liability for the ones who die? If you don't have good, solid answers for those questions, you don't get to bitch about the FDA. This isn't theoretical. It's playing itself out in the Type-1 Diabetes arena right now. Nobody wants to be holding the liability bag, so progress is glacially slow.
  - causality0 6y ago
    Informed consent. If you have the probability numbers let people decide if they want to risk it. Make them as well as their next of kin sign ironclad contracts releasing the hospital and manufacturer from any and all liability.
    - bsder 6y ago
      1) Good luck with getting informed consent from every patient on all the myriad drugs and treatments that the FDA approves in a year. The bureaucracy that ensures that will make the FDA look like a fleet-footed fox. 2) Informed consent only holds until someone's child dies. Then you're in court no matter how good your contract is. 3) Who defines the informed consent boundaries? It's turtles all the way down. All you did was push the complexity around--you didn't get rid of it. The FDA is where ethics and economics intersect. The problems don't have easy, magical answers.
    - refurb 6y ago
      That would never work. People sign disclaimers all the time and still sue.
- wwweston 6y ago
  Type C reduces people to the caricatures demonstrated in Type A and Type B? Not that it's impossible that either type exists, but we know that plenty of drugs make it through the system and are regularly prescribed that nevertheless have non-trivial risks, so the idea that the FDA is only evaluating the downsides seems pretty limited in its explaining power. And as posters frequenting HN should know, systems are hard. Good systems over a domain of any complexity aren't trivial even when incentives are aligned. Economic and political incentives in medical domains aren't always well-aligned. I'm sure the FDA and industrial incentives could both be improved, but I think it's going to take sharper and more detailed insights than imagining a personality binary.
  - causality0 6y ago
    I said there is a preponderance of those two types, not that everyone involved falls into one of them.
seehafer 6y ago
There are number of conflated regulatory problems in this piece: 1) FDA needs to move its data ingestion into the 21st century (note: large industry can be as resistant to changing current process as bureaucracy). In no rational universe should we have to mail data in 2020 2) In vitro diagnostic regulation is a mess and needs to be revamped top to bottom. Either exempt all Lab Developed Tests, rewrite the law to make them all subject to oversight, or come up with a 3rd path. 3) Emergency Use Authorization needs to be rethought with the ability for either political leadership or FDA to have broad capability to expand the category of what gets covered
- jazzkingrt 6y ago
  I don't think "conflated" is the right word. Romer doesn't imply that these problems have the same cause, or are even correlated (although I suspect they are). He just lays them out as stark examples of FDA getting in the way of the public interest in this pandemic.
  - seehafer 6y ago
    That's a fair point. I was responding to this idea of all of these being part of a single "process machine".
- protomyth 6y ago
  In no rational universe should we have to mail data in 2020 I remember a study where the lab reports were printed on there own printer. The FedEx employee showed up with a labeled box, put the huge stack in it, and left. I think that daily stack of labs cost somewhere in the five figure range each day.
- joe_the_user 6y ago
  Thing about these problems (and others) is that bottle necks and red tape generally are problems in just about any country. Political leadership in this situation involves noting the regulatory and bureaucratic hurdles to action and using your authority to supersede them when a pressing situation requires it. Someone has to sit down and say "what needs to happen, what's standing in its way? What orders have to be issue to stop this today?" Someone has to say "this priority is more important than anything else at this point", etc. Just as an example, it shouldn't be hard to notice tests are only being mailed and to stop that this case, etc. A crisis always requires political leadership because of both the this bureaucracy and the general confusion created by crisis. Many if not all bureaucracy will act ineffectively by default unless someone forces their hand. Which is to say that the current situation is an abject failure of leadership specifically.
chmaynard 6y ago
Unfortunately, we need to be skeptical about almost every decision and communication from the CDC, FDA, and a number of other federal agencies. The current administration has done a remarkably effective job of bending these agencies to their will and forcing out anyone who doesn't fall in line.
- wonnage 6y ago
  I think this is one of the great side tragedies of the coronavirus. The US generally had a lot of trust in these federal agencies. They've always been susceptible to political interference, as demonstrated now. But it's never (?) gotten to the point it has now, where you simply can't trust the CDC to provide accurate information, or information that every other country has accepted months ago. Will the next administration provide a V-shaped recovery in trust? Or is it just gone forever?
  - bsder 6y ago
    > Will the next administration provide a V-shaped recovery in trust? Or is it just gone forever? The big problem is that in order to fix trust, you will need to purge a lot of the senior bureaucrats who decided that keeping their job was more important than serving the public. If you don't do this, then you have sent the signal that being a political operator is more important than doing your actual job.
    - teddyh 6y ago
      Pournelle's Iron Law of Bureaucracy states that in any bureaucratic organization there will be two kinds of people: First, there will be those who are devoted to the goals of the organization. Examples are dedicated classroom teachers in an educational bureaucracy, many of the engineers and launch technicians and scientists at NASA, even some agricultural scientists and advisors in the former Soviet Union collective farming administration. Secondly, there will be those dedicated to the organization itself. Examples are many of the administrators in the education system, many professors of education, many teachers union officials, much of the NASA headquarters staff, etc. The Iron Law states that in every case the second group will gain and keep control of the organization. It will write the rules, and control promotions within the organization. — https://www.jerrypournelle.com/reports/jerryp/iron.html https://www.jerrypournelle.com/reports/jerryp/iron.html
killjoywashere 6y ago
The main economic function of employees of agencies in DC is the transfer of risk away from the DC housing market, onto the American people. The career employees of the military, as a particularly extreme example, exist to transfer risk away from the DC housing market as far away as possible, which ultimately ends with special forces personnel deployed to hostile territory. Similarly, the main economic function of employees of big tech companies is transferring risk away from the West Coast housing markets, onto their users. In my experience, the only way to handle the government side of this is to "not waste the crisis" and execute under conditions where they will see stopping you as more risky than not stopping you. The only way I know of to manage large corporations is to get the government to create incentives that make it riskier for them to transfer risk onto their customers. That's what financial penalities and anti-trust law are for. The trick is you have to go back to the point about the government: you have to make action less risky for the government actors than non-action.
LatteLazy 6y ago
I find this interesting as the FDA basically fell over themselves to sign off in treatments. They gave chloroquine the ok based on less than nothing and other drugs have been given breakthrough treatment status without trials. I can see an arguement to "try anything" in an emergency. But how did the fda end up being BOTH to lose and too tight with their regulation?
- beagle3 6y ago
  Chloroquine and hyrdorchloroquine have been in use for decades (70 years for chloroquine!) with millions taking them daily and a very well known safety profile. It was already FDA approved, could have been used by any doctor for COVID as an off-label treatment already. Everything about CQ/HCQ has been ridiculously politicized to the point that the facts have become very hard to find. In fact, given the huge number of people taking them for lupus and other diseases (a significant fraction of a percent of the population, having autoimmune disorders and poor health and thus at greater COVID risk), we've basically had a biased but ultra-informative experiemnt already: What percentage of them got covid and what severity, as compared to general population, and compared to other comparable populations (autoimmune that isn't treated by CQ/HCQ)? It's not perfect, but it would have been very informative. CDC has this info. No ethical issues about it.
magwa101 6y ago
Trump appointee, wake up people: https://www.politico.com/news/2020/04/09/cdc-director-robert-redfield-coronavirus-176247 https://www.politico.com/news/2020/04/09/cdc-director-robert...
projektfu 6y ago
I still don’t understand why the FDA was telling labs not to develop their own tests. After publication of the primers, it’s standard work to create an rtPCR. And being a lab developed test it should be out of the jurisdiction of the FDA.
- James_Henry 6y ago
  If I recall correctly, it is due to the declaration of a state of emergency. Usually only a lab would need certification, but the emergency made it necessary for every test to be certified. Don't quote me on this though, I'll try and find a source.

125 points by jseliger 6y ago

The sorry state of the FDA and drug development and deployment as a whole is in my opinion due to a preponderance of two types of people: Type A will happily bankrupt their customers while giving them heart failure in order to reduce allergy symptoms by 10%, and Type B would rather let ten thousand people die in unmedicated screaming agony than have a drug show up in a news story saying it killed three of them, regardless of how many hundreds of lives it saved.

jschwartzi 6y ago
The FDA is largely composed of Type B people. They are very risk averse and will often delay a new technology simply because there might be unknown risks. There are technologies widely used in European ventilators such as automatic alarm control or adaptive alarm limits which the FDA views as unsafe based on their fear that the alarm system might fail somehow. It doesn’t surprise me that they tried to slow the approval process down. Anyone that believes the FDAs mandate is to foster progress is severely misinformed. Their actual mandate as I understand it is specifically to protect the public from injury by making progress really slow and making sure there are enough barriers to prevent someone selling a product which makes patients worse off than competitors. In this case they probably caused a lot more damage than they prevented.
- jokowueu 6y ago
  There were some great drugs that were blocked because it raised blood pressure slightly :/
  - refurb 6y ago
    Higher blood pressure is linked to increased mortality. It's not like they are blocking the drug for fun.
    - deleted 6y ago
      [deleted]
    - cyphar 6y ago
      Especially in a country where 2/3rds of the adult population are overweight or obese and likely already have elevated blood pressure.
    - jokowueu 6y ago
      It depends what ur treating . For some disease an increase in blood pressure is nothing ,taking BP meds fixes this issue
    - amanaplanacanal 6y ago
      You really need to look at all cause mortality. You can’t just say A is associated with B, therefore we should keep A low. We make that mistake all the time as far as I can tell.
      - refurb 6y ago
        My understanding is that connection has already been made through several robust trials. There may be drugs that raise blood pressure, but not mortality, but so far we haven’t actual data on one of them.
- hanniabu 6y ago
  > They are very risk averse and will often delay a new technology simply because there might be unknown risks. I think this is smart simply because of how difficult it is to undo something that's been approved. You have people coming forward with side effects and the company simply shrugging their shoulders and saying there's no way you can prove that it's from this vs something else.
  - refurb 6y ago
    the company simply shrugging their shoulders and saying there's no way you can prove that it's from this vs something else That's not how it works. It doesn't matter if the company "shrugs their shoulders", if the FDA wants to pull the drug, it gets pulled. The FDA has a requirement that all adverse events reported to a company must be reported to the FDA (massive fines if you don't). The FDA will then take that data and do their own analysis. Yes, they will work with the company to discuss the data and it's implications, but have zero qualms with yanking a drug if the company thinks it's still safe. When we were negotiating our label with the FDA, we asked for a wording change because we thought the current wording was confusing. FDA came back with "we don't agree". So we added more explanation and they came back with "we're not changing it". We just accepted it as it was just delaying launch and it was clear we werne't going to get our way.
- refurb 6y ago
  I work with the FDA as a part of my job and I disagree they are overly risk adverse. When we previewed our development plan with the FDA, they actually asked us "can't you move faster?". When a safety signal showed up, they were more than willing to work with us to develop a protocol to reduce the risk while still providing patients with drugs. I don't disagree that the FDA is very concerned about safety, but in situations where there is a very strong need, the FDA is willing to move quickly and accept a level of risk.
  - gwern 6y ago
    It's nice that they offered to slightly tweak the protocol for you. How very generous and magnanimous of them. On the other hand: coronavirus.
    - refurb 6y ago
      I honestly don't think it's fair to crap all over the FDA for Covid. One day we read that people become immune, the next day they lose it. One day hydroxychloroquine works, then next day it doesn't. It's hard enough managing drug approvals when you have all the data and plenty of time.
- newyankee 6y ago
  The big question is whether any other country has processes and a market that is leading to faster drug discovery, development and launch ? If yes, that may help and in the current circumstances there is only 1 country big and powerful enough that i can think of, China.
- pinkfoot 6y ago
  How would you classify Frances Kesley who prevented thalidomide from being sold in the USA. And how would you rank the German authorities who allowed it to be sold over the counter?
BurningFrog 6y ago
Those types of people exist in all countries. Yet the FDA is uniquely American. A different agency working under different incentives could produce much different, and hopefully better outcomes.
- Symmetry 6y ago
  I think the Europeans Medicine Agency is a model for making sensible tradeoffs here, at least compared to the FDA. I sort of with the US could just outsource drug approval to them.
  - seehafer 6y ago
    EMA and FDA make different tradeoffs. They’re not necessarily easier. But I agree with you in part, I wish we had more harmonization or at least regulatory overlap — approved in EU you can sell in US, and vice versa, for instance.
  - refurb 6y ago
    The EMA is? The EMA typically takes longer on average to approve a drug than the FDA.[1] And if you want to look up an EU scandal, check out the Servier and Mediator. Hundreds of deaths reports and it took France almost 20 years to pull it off the market.[2] [1]https://news.yale.edu/2017/04/05/fda-approves-drugs-more-quickly-peer-agency-europe https://news.yale.edu/2017/04/05/fda-approves-drugs-more-qui... [2]https://www.fiercepharma.com/pharma/servier-faces-courtroom-long-running-mediator-death-investigation#:~:text=Servier%20is%20among%2011%20institutions,other%20countries%20stopped%20selling%20it https://www.fiercepharma.com/pharma/servier-faces-courtroom-....
    - Symmetry 6y ago
      Sure but I'm thinking of different metrics here.Europe has a variety of competing EpiPen equivalents so no price gouging. They had beta-blockers approved a decade before they were available in the US, with a small risk of liver failure for that first drug true, but many, many more lives were saved than lost. They had sunscreen that stopped UV A a decade before the US because the FDA's test only looked at skin burning so it took a long time to get the framework in place to examine sunscreens that block both. And yes you do have failures like Mediator or Thalidomide but on net I'd rather have their system.
bsder 6y ago
> Type B would rather let ten thousand people die in unmedicated screaming agony than have a drug show up in a news story saying it killed three of them, regardless of how many hundreds of lives it saved. Who gets to set those numbers and by what process? And, probably more importantly, who gets the indemnification liability for the ones who die? If you don't have good, solid answers for those questions, you don't get to bitch about the FDA. This isn't theoretical. It's playing itself out in the Type-1 Diabetes arena right now. Nobody wants to be holding the liability bag, so progress is glacially slow.
- causality0 6y ago
  Informed consent. If you have the probability numbers let people decide if they want to risk it. Make them as well as their next of kin sign ironclad contracts releasing the hospital and manufacturer from any and all liability.
  - bsder 6y ago
    1) Good luck with getting informed consent from every patient on all the myriad drugs and treatments that the FDA approves in a year. The bureaucracy that ensures that will make the FDA look like a fleet-footed fox. 2) Informed consent only holds until someone's child dies. Then you're in court no matter how good your contract is. 3) Who defines the informed consent boundaries? It's turtles all the way down. All you did was push the complexity around--you didn't get rid of it. The FDA is where ethics and economics intersect. The problems don't have easy, magical answers.
  - refurb 6y ago
    That would never work. People sign disclaimers all the time and still sue.
wwweston 6y ago
Type C reduces people to the caricatures demonstrated in Type A and Type B? Not that it's impossible that either type exists, but we know that plenty of drugs make it through the system and are regularly prescribed that nevertheless have non-trivial risks, so the idea that the FDA is only evaluating the downsides seems pretty limited in its explaining power. And as posters frequenting HN should know, systems are hard. Good systems over a domain of any complexity aren't trivial even when incentives are aligned. Economic and political incentives in medical domains aren't always well-aligned. I'm sure the FDA and industrial incentives could both be improved, but I think it's going to take sharper and more detailed insights than imagining a personality binary.
- causality0 6y ago
  I said there is a preponderance of those two types, not that everyone involved falls into one of them.

seehafer 6y ago

There are number of conflated regulatory problems in this piece: 1) FDA needs to move its data ingestion into the 21st century (note: large industry can be as resistant to changing current process as bureaucracy). In no rational universe should we have to mail data in 2020 2) In vitro diagnostic regulation is a mess and needs to be revamped top to bottom. Either exempt all Lab Developed Tests, rewrite the law to make them all subject to oversight, or come up with a 3rd path. 3) Emergency Use Authorization needs to be rethought with the ability for either political leadership or FDA to have broad capability to expand the category of what gets covered

jazzkingrt 6y ago
I don't think "conflated" is the right word. Romer doesn't imply that these problems have the same cause, or are even correlated (although I suspect they are). He just lays them out as stark examples of FDA getting in the way of the public interest in this pandemic.
- seehafer 6y ago
  That's a fair point. I was responding to this idea of all of these being part of a single "process machine".
protomyth 6y ago
In no rational universe should we have to mail data in 2020 I remember a study where the lab reports were printed on there own printer. The FedEx employee showed up with a labeled box, put the huge stack in it, and left. I think that daily stack of labs cost somewhere in the five figure range each day.
joe_the_user 6y ago
Thing about these problems (and others) is that bottle necks and red tape generally are problems in just about any country. Political leadership in this situation involves noting the regulatory and bureaucratic hurdles to action and using your authority to supersede them when a pressing situation requires it. Someone has to sit down and say "what needs to happen, what's standing in its way? What orders have to be issue to stop this today?" Someone has to say "this priority is more important than anything else at this point", etc. Just as an example, it shouldn't be hard to notice tests are only being mailed and to stop that this case, etc. A crisis always requires political leadership because of both the this bureaucracy and the general confusion created by crisis. Many if not all bureaucracy will act ineffectively by default unless someone forces their hand. Which is to say that the current situation is an abject failure of leadership specifically.

chmaynard 6y ago

Unfortunately, we need to be skeptical about almost every decision and communication from the CDC, FDA, and a number of other federal agencies. The current administration has done a remarkably effective job of bending these agencies to their will and forcing out anyone who doesn't fall in line.

wonnage 6y ago
I think this is one of the great side tragedies of the coronavirus. The US generally had a lot of trust in these federal agencies. They've always been susceptible to political interference, as demonstrated now. But it's never (?) gotten to the point it has now, where you simply can't trust the CDC to provide accurate information, or information that every other country has accepted months ago. Will the next administration provide a V-shaped recovery in trust? Or is it just gone forever?
- bsder 6y ago
  > Will the next administration provide a V-shaped recovery in trust? Or is it just gone forever? The big problem is that in order to fix trust, you will need to purge a lot of the senior bureaucrats who decided that keeping their job was more important than serving the public. If you don't do this, then you have sent the signal that being a political operator is more important than doing your actual job.
  - teddyh 6y ago
    Pournelle's Iron Law of Bureaucracy states that in any bureaucratic organization there will be two kinds of people: First, there will be those who are devoted to the goals of the organization. Examples are dedicated classroom teachers in an educational bureaucracy, many of the engineers and launch technicians and scientists at NASA, even some agricultural scientists and advisors in the former Soviet Union collective farming administration. Secondly, there will be those dedicated to the organization itself. Examples are many of the administrators in the education system, many professors of education, many teachers union officials, much of the NASA headquarters staff, etc. The Iron Law states that in every case the second group will gain and keep control of the organization. It will write the rules, and control promotions within the organization. — https://www.jerrypournelle.com/reports/jerryp/iron.html https://www.jerrypournelle.com/reports/jerryp/iron.html

killjoywashere 6y ago

The main economic function of employees of agencies in DC is the transfer of risk away from the DC housing market, onto the American people. The career employees of the military, as a particularly extreme example, exist to transfer risk away from the DC housing market as far away as possible, which ultimately ends with special forces personnel deployed to hostile territory. Similarly, the main economic function of employees of big tech companies is transferring risk away from the West Coast housing markets, onto their users. In my experience, the only way to handle the government side of this is to "not waste the crisis" and execute under conditions where they will see stopping you as more risky than not stopping you. The only way I know of to manage large corporations is to get the government to create incentives that make it riskier for them to transfer risk onto their customers. That's what financial penalities and anti-trust law are for. The trick is you have to go back to the point about the government: you have to make action less risky for the government actors than non-action.

LatteLazy 6y ago

I find this interesting as the FDA basically fell over themselves to sign off in treatments. They gave chloroquine the ok based on less than nothing and other drugs have been given breakthrough treatment status without trials. I can see an arguement to "try anything" in an emergency. But how did the fda end up being BOTH to lose and too tight with their regulation?

beagle3 6y ago
Chloroquine and hyrdorchloroquine have been in use for decades (70 years for chloroquine!) with millions taking them daily and a very well known safety profile. It was already FDA approved, could have been used by any doctor for COVID as an off-label treatment already. Everything about CQ/HCQ has been ridiculously politicized to the point that the facts have become very hard to find. In fact, given the huge number of people taking them for lupus and other diseases (a significant fraction of a percent of the population, having autoimmune disorders and poor health and thus at greater COVID risk), we've basically had a biased but ultra-informative experiemnt already: What percentage of them got covid and what severity, as compared to general population, and compared to other comparable populations (autoimmune that isn't treated by CQ/HCQ)? It's not perfect, but it would have been very informative. CDC has this info. No ethical issues about it.

magwa101 6y ago

Trump appointee, wake up people: https://www.politico.com/news/2020/04/09/cdc-director-robert-redfield-coronavirus-176247 https://www.politico.com/news/2020/04/09/cdc-director-robert...

projektfu 6y ago

I still don’t understand why the FDA was telling labs not to develop their own tests. After publication of the primers, it’s standard work to create an rtPCR. And being a lab developed test it should be out of the jurisdiction of the FDA.

James_Henry 6y ago
If I recall correctly, it is due to the declaration of a state of emergency. Usually only a lab would need certification, but the emergency made it necessary for every test to be certified. Don't quote me on this though, I'll try and find a source.