13 ms·

I used to be in the academic side of the so-called industry and I can tell you that most drugs fail because of horrendously bad decisions and hypotheses. Most c

I used to be in the academic side of the so-called industry and I can tell you that most drugs fail because of horrendously bad decisions and hypotheses. Most companies make decisions on what drugs to take to trial on stupidly misleading preclinical data and have been graciously rewarded for their mistakes with no consequences.

refurb 3y ago
There is no "academic side" of the pharmaceutical industry. There is just academia. And the goal of academia (publishing) are very different than the industry (identifying a new drug).
- hcknwscommenter 3y ago
  Agree. I don't think there is any signal from the "academic side" of this discussion. All of the detailed relevant information is very proprietary. I know multiple large players in the industry that share huge amounts of data with academics regularly, but not that data. Decision makers are informed by internal experts with just as many bona fides (and more) than academic peers. Having been in both worlds, and admittedly in my opinion only, academics do well to move their technical fields forward into new and exciting and useful science medicine and economics but do little (well nothing really) in delving into or even accessing the actual data that directly informs clinical trial decisions. That said, I can totally understand why Pharma clinical trial decisions are baffling to academics. E.g., why did aduhelm go forward to (conditional) market approval? That one is baffling to me, but I don't have the data:) [edit] I'm going to add something here. The grandparent refers to "stupidly misleading pre-clinical data." Pre-clinical data informs very inexpensive (relatively) Phase I studies. And there is a ton of it. You might have potentially misleading pre-clinical data that suggests the possibility of an entirely new therapeutic mechanism of action for a huge unmet need coupled with massive amounts of pre-clinical data that demonstrates a near certainty that the intervention will be safe. That's the entire point of moving forward to a Phase I or Ib (or maybe even II) study. The 1000x-10,000x more expensive phase 3's are not relying on pre-clinical studies.
  - ramraj07 3y ago
    Then what are the phase 3s relying on? Why is it so hard for such a bunch of supposedly smart people to figure out why their expensive trials are not successful often? Here’s a simple answer: it doesn’t actually matter to the individuals. They still get paid. I’m from the academic side in the sense have talked to many folks who quit industry to start jobs and come from a lab that did get a drug into the market eventually. I might not know this “secret data” you speak of but given the results are crap, I think they speak for themselves anyway.
    - refurb 3y ago
      > Here’s a simple answer: it doesn’t actually matter to the individuals. They still get paid. I'm wondering how much you're actually involved in research to make a statement like that. Scientists at these companies are likely out of a job if the trials aren't successful (especially for start-ups that have one shot). The answer is - when you're developing a brand new molecule, often for a recently discovered pathway, in a biological organism that is so complex we barely understand it, failure shouldn't be surprising.
      - sudosysgen 3y ago
        Most startups that aim to market a drug don't work like that. The majority just buy the rights to a molecule from academic research, perhaps the founder's research. Before any trials, they have to raise a lot of money, more than enough to pay the founders, so even if the trials fail, the people that make the decisions still get paid. The large drug companies don't develop many new drugs anymore, and they don't fire their scientists when a trial fails. The people that make the decision on whether or not to move to clinical trials from preclinical data are not necessarily scientists either and they certainly will not be fired. Their decision on whether or not to proceed with trials is far more complicated than for an academic or an early startup such that it can make sense for a large pharma company to attempt a trial even if it is unlikely to work if the expected payoff is sufficient. They will definitely still get paid.
        3y ago
- sudosysgen 3y ago
  Academia identified over 30% of approved drugs in the past 10 years, and that share is growing. There is a ton of incentive for academics to identify new drugs.
nairboon 3y ago
>Most companies make decisions on what drugs to take to trial on stupidly misleading preclinical data and have been graciously rewarded for their mistakes with no consequences. Could you elaborate on this? Are you saying that some groups/people in those companies "ignore" the honest interpretation of their preclinical data and run phase I studies just so that they have something to run?

refurb 3y ago

There is no "academic side" of the pharmaceutical industry. There is just academia. And the goal of academia (publishing) are very different than the industry (identifying a new drug).

hcknwscommenter 3y ago
Agree. I don't think there is any signal from the "academic side" of this discussion. All of the detailed relevant information is very proprietary. I know multiple large players in the industry that share huge amounts of data with academics regularly, but not that data. Decision makers are informed by internal experts with just as many bona fides (and more) than academic peers. Having been in both worlds, and admittedly in my opinion only, academics do well to move their technical fields forward into new and exciting and useful science medicine and economics but do little (well nothing really) in delving into or even accessing the actual data that directly informs clinical trial decisions. That said, I can totally understand why Pharma clinical trial decisions are baffling to academics. E.g., why did aduhelm go forward to (conditional) market approval? That one is baffling to me, but I don't have the data:) [edit] I'm going to add something here. The grandparent refers to "stupidly misleading pre-clinical data." Pre-clinical data informs very inexpensive (relatively) Phase I studies. And there is a ton of it. You might have potentially misleading pre-clinical data that suggests the possibility of an entirely new therapeutic mechanism of action for a huge unmet need coupled with massive amounts of pre-clinical data that demonstrates a near certainty that the intervention will be safe. That's the entire point of moving forward to a Phase I or Ib (or maybe even II) study. The 1000x-10,000x more expensive phase 3's are not relying on pre-clinical studies.
- ramraj07 3y ago
  Then what are the phase 3s relying on? Why is it so hard for such a bunch of supposedly smart people to figure out why their expensive trials are not successful often? Here’s a simple answer: it doesn’t actually matter to the individuals. They still get paid. I’m from the academic side in the sense have talked to many folks who quit industry to start jobs and come from a lab that did get a drug into the market eventually. I might not know this “secret data” you speak of but given the results are crap, I think they speak for themselves anyway.
  - refurb 3y ago
    > Here’s a simple answer: it doesn’t actually matter to the individuals. They still get paid. I'm wondering how much you're actually involved in research to make a statement like that. Scientists at these companies are likely out of a job if the trials aren't successful (especially for start-ups that have one shot). The answer is - when you're developing a brand new molecule, often for a recently discovered pathway, in a biological organism that is so complex we barely understand it, failure shouldn't be surprising.
    - sudosysgen 3y ago
      Most startups that aim to market a drug don't work like that. The majority just buy the rights to a molecule from academic research, perhaps the founder's research. Before any trials, they have to raise a lot of money, more than enough to pay the founders, so even if the trials fail, the people that make the decisions still get paid. The large drug companies don't develop many new drugs anymore, and they don't fire their scientists when a trial fails. The people that make the decision on whether or not to move to clinical trials from preclinical data are not necessarily scientists either and they certainly will not be fired. Their decision on whether or not to proceed with trials is far more complicated than for an academic or an early startup such that it can make sense for a large pharma company to attempt a trial even if it is unlikely to work if the expected payoff is sufficient. They will definitely still get paid.
      - 3y ago
sudosysgen 3y ago
Academia identified over 30% of approved drugs in the past 10 years, and that share is growing. There is a ton of incentive for academics to identify new drugs.

nairboon 3y ago

>Most companies make decisions on what drugs to take to trial on stupidly misleading preclinical data and have been graciously rewarded for their mistakes with no consequences. Could you elaborate on this? Are you saying that some groups/people in those companies "ignore" the honest interpretation of their preclinical data and run phase I studies just so that they have something to run?