5 ms·

My grandmother was killed by an FDA approved drug, so my experience is that sometimes the current system is not conservative enough. What's worse, the company

My grandmother was killed by an FDA approved drug, so my experience is that sometimes the current system is not conservative enough. What's worse, the company reportedly knew about the danger of the drug, and didn't tell anyone. Eventually the drug was removed from the market, but not before hurting thousands of people. This particular story is about Baycol (1), but perhaps, while reading this, you may have been thinking about another similar story. It's happened many times. If "medical conservatives" can help prevent this from happening even one time, they are creating something of value. I think it's ridiculous to claim, as GP did, that protecting people from harm does not "generate anything of actual value". 1: https://www.nytimes.com/2003/02/22/business/papers-indicate-that-bayer-knew-of-dangers-of-its-cholesterol-drug.html https://www.nytimes.com/2003/02/22/business/papers-indicate-...

DoreenMichele 7y ago
I'm very sorry for your loss.
- leereeves 7y ago
  Thank you.
roenxi 7y ago
The medical system is always going to be an ongoing series of tragedies. People are going to die stupidly in the medical system because it is run by humans who make mistakes. The human body is not a controlled and repeatable environment like an aircraft; it is a mess, a lot of the parts look accidental and it is a miracle it works on a good day. "A mistake was made so we must adjust the system to stop that happening" isn't a workable philosophy in this specific instance. There is no scenario where mistakes don't happen. A strategy that attempts to achieve the impossible is not a good idea. Tradeoffs will be made that are bad. I can acknowledge that your story is horrible and unfair; but if that thinking takes hold in medicine (which realistically it probably already has) then people will suffer for no reason in a predictable way. It is better that at least people suffering is a surprise or at least somewhat unexpected. Decisions must be made using statistics and risk assessments rather than grasping hopelessly at certainty and happiness. We must tolerate a few bad drugs slipping through.
- leereeves 7y ago
  According to the FDA itself (1), adverse drug reactions (ADRs) "are one of the leading causes of morbidity and mortality in health care" and may be the fourth leading cause of death. We need people willing to speak up and be skeptical. And whatever small reward they may obtain by doing so is trivial in comparison to the billions that pharma and their sponsored scientists stand to gain by unjustified cheerleading. It's laughable to question the motives and incentives of skeptics like Prasad while ignoring the immeasurably greater perverse incentives in favor of approving drugs too quickly. I can understand the desire, the hope, that a new drug might be the miracle we've been waiting for. But precisely because we so desperately want new drugs to be helpful, it's crucial to remain rational and evaluate new drugs based on what they actually do, not based on our hopes or on the claims made by pharma companies. 1: https://www.fda.gov/drugs/drug-interactions-labeling/preventable-adverse-drug-reactions-focus-drug-interactions https://www.fda.gov/drugs/drug-interactions-labeling/prevent...
  - roenxi 7y ago
    But the statistic you cite might just as likely be evidence that the system is working very well. If the drugs being approved are 99.999% perfectly efficacious and 0.001% deadly then nearly all the deaths would be attributable to when the drugs fail. We aren't going to do better than that. The better the system works and the more effective the medicines, the more deaths will be attributed mainly to adverse drug reactions. That is why we must tolerate them. We can't work towards a system where nobody dies in hospitals; but we can work to one where the leading cause of death is failure of medical care as opposed to natural causes. The better our healthcare gets, the more likely the leading cause of death will be "nurse didn't follow the checklist", "the machine broke" or "the drugs made their body go haywire" and similar. Something has to be the leading cause of death. As we become gods unto our own bodies that cause will be human factors and mistakes.
    - leereeves 7y ago
      In that hypothetical world, life expectancy would be rising. In fact, it is falling.
ZeroGravitas 7y ago
I didn't think the were saying that this function of balancing risk was unnecessary, just that it's already being done as part of the process. It's like if you proposed an open source project for some purpose and someone loudly announced to the non-technical stakeholders that they'd found a list of 1,000 problems with it on the internet. Yes, that's the bugtracker. A bugtracker has value. Someone publicizing it to people who don't understand what it is for their own self-promotion can have negative value and undermine the whole process.
- leereeves 7y ago
  If that project was the control software for an airplane, and thousands of people were going to risk their lives on that plane, I think we'd appreciate someone saying: "wait, there are still hundreds of potentially fatal bugs in the firmware. Let's fix those bugs and do some more testing before we trust our lives to the system." Even if there was a risk to remaining where we are (as in medicine), and the plane was our only hope, it would still be wise to know about the risks and make an informed decision. Perhaps, in theory, the system balances the risks, as you said. But in reality people often cheat, take shortcuts, make mistakes, or believe what they want to believe. We will probably always need the contrarians and skeptics to balance out the overly optimistic and the plainly dishonest.
Gatsky 7y ago
I'm sorry, that's a terrible story. I am not a fan of Prasad. I find him querulous and condescending, but the main reason is that I have seen him give talks, rant on his podcast and tweet about clinical trials in a way that is designed for maximum volume, sacrificing nuance and accuracy. He also has zero tolerance for challenges to his views (that he would write such an article in the OP is another sign of this). As I said, this gives the appearance of being a useful activity, but in my opinion has zero material impact on medical care or policy. He is not merely a skeptic, since skeptics do not need to write articles describing why they are not only important, but somehow more important than people actually doing research. A good example of someone that retains healthy skepticism, writes about it in the literature, advocates for patients but still actually does research and tries to improve the way clinical trials are done is Ian Tannock [1]. [1] https://dailynews.ascopubs.org/do/10.1200/ADN.19.190328/full/ https://dailynews.ascopubs.org/do/10.1200/ADN.19.190328/full...

DoreenMichele 7y ago

I'm very sorry for your loss.

leereeves 7y ago
Thank you.

roenxi 7y ago

The medical system is always going to be an ongoing series of tragedies. People are going to die stupidly in the medical system because it is run by humans who make mistakes. The human body is not a controlled and repeatable environment like an aircraft; it is a mess, a lot of the parts look accidental and it is a miracle it works on a good day. "A mistake was made so we must adjust the system to stop that happening" isn't a workable philosophy in this specific instance. There is no scenario where mistakes don't happen. A strategy that attempts to achieve the impossible is not a good idea. Tradeoffs will be made that are bad. I can acknowledge that your story is horrible and unfair; but if that thinking takes hold in medicine (which realistically it probably already has) then people will suffer for no reason in a predictable way. It is better that at least people suffering is a surprise or at least somewhat unexpected. Decisions must be made using statistics and risk assessments rather than grasping hopelessly at certainty and happiness. We must tolerate a few bad drugs slipping through.

leereeves 7y ago
According to the FDA itself (1), adverse drug reactions (ADRs) "are one of the leading causes of morbidity and mortality in health care" and may be the fourth leading cause of death. We need people willing to speak up and be skeptical. And whatever small reward they may obtain by doing so is trivial in comparison to the billions that pharma and their sponsored scientists stand to gain by unjustified cheerleading. It's laughable to question the motives and incentives of skeptics like Prasad while ignoring the immeasurably greater perverse incentives in favor of approving drugs too quickly. I can understand the desire, the hope, that a new drug might be the miracle we've been waiting for. But precisely because we so desperately want new drugs to be helpful, it's crucial to remain rational and evaluate new drugs based on what they actually do, not based on our hopes or on the claims made by pharma companies. 1: https://www.fda.gov/drugs/drug-interactions-labeling/preventable-adverse-drug-reactions-focus-drug-interactions https://www.fda.gov/drugs/drug-interactions-labeling/prevent...
- roenxi 7y ago
  But the statistic you cite might just as likely be evidence that the system is working very well. If the drugs being approved are 99.999% perfectly efficacious and 0.001% deadly then nearly all the deaths would be attributable to when the drugs fail. We aren't going to do better than that. The better the system works and the more effective the medicines, the more deaths will be attributed mainly to adverse drug reactions. That is why we must tolerate them. We can't work towards a system where nobody dies in hospitals; but we can work to one where the leading cause of death is failure of medical care as opposed to natural causes. The better our healthcare gets, the more likely the leading cause of death will be "nurse didn't follow the checklist", "the machine broke" or "the drugs made their body go haywire" and similar. Something has to be the leading cause of death. As we become gods unto our own bodies that cause will be human factors and mistakes.
  - leereeves 7y ago
    In that hypothetical world, life expectancy would be rising. In fact, it is falling.

ZeroGravitas 7y ago

I didn't think the were saying that this function of balancing risk was unnecessary, just that it's already being done as part of the process. It's like if you proposed an open source project for some purpose and someone loudly announced to the non-technical stakeholders that they'd found a list of 1,000 problems with it on the internet. Yes, that's the bugtracker. A bugtracker has value. Someone publicizing it to people who don't understand what it is for their own self-promotion can have negative value and undermine the whole process.

leereeves 7y ago
If that project was the control software for an airplane, and thousands of people were going to risk their lives on that plane, I think we'd appreciate someone saying: "wait, there are still hundreds of potentially fatal bugs in the firmware. Let's fix those bugs and do some more testing before we trust our lives to the system." Even if there was a risk to remaining where we are (as in medicine), and the plane was our only hope, it would still be wise to know about the risks and make an informed decision. Perhaps, in theory, the system balances the risks, as you said. But in reality people often cheat, take shortcuts, make mistakes, or believe what they want to believe. We will probably always need the contrarians and skeptics to balance out the overly optimistic and the plainly dishonest.

Gatsky 7y ago

I'm sorry, that's a terrible story. I am not a fan of Prasad. I find him querulous and condescending, but the main reason is that I have seen him give talks, rant on his podcast and tweet about clinical trials in a way that is designed for maximum volume, sacrificing nuance and accuracy. He also has zero tolerance for challenges to his views (that he would write such an article in the OP is another sign of this). As I said, this gives the appearance of being a useful activity, but in my opinion has zero material impact on medical care or policy. He is not merely a skeptic, since skeptics do not need to write articles describing why they are not only important, but somehow more important than people actually doing research. A good example of someone that retains healthy skepticism, writes about it in the literature, advocates for patients but still actually does research and tries to improve the way clinical trials are done is Ian Tannock [1]. [1] https://dailynews.ascopubs.org/do/10.1200/ADN.19.190328/full/ https://dailynews.ascopubs.org/do/10.1200/ADN.19.190328/full...