4 ms·

> BrainStorm CEO Chaim Lebovits told Bloomberg he’s considering charging $300,000 for each NurOwn treatment The problem isn’t that they get to try an unproven

by xevb3k 8y ago

> BrainStorm CEO Chaim Lebovits told Bloomberg he’s considering charging $300,000 for each NurOwn treatment The problem isn’t that they get to try an unproven treatment to see if it works. The problem is that they get to charge desperate people huge amounts of money for it. Do it for free, as a way to validate a drug and advance research and this wouldn’t be a problem (or at least it’d be a completely different problem).

DennisP 8y ago
I don't disagree; a better middle ground might be cost plus some reasonable percentage for unapproved treatments.
- filoeleven 8y ago
  Isn’t that akin to making people pay to participate in a study? Shouldn’t their payment consist of all the information a company receives from essentially testing their new treatment on a human?
  - danielnesbitt 8y ago
    They are not participating in the study though, at least not the regulated portion of the trial. The rule prevents negative outcomes for risky non-qualified patients from harming the trial, but the converse is also true. Positive outcomes for patients outside the regulated trial will not help gain approval at Phase II or Phase III. On a board like hn, there's a tendency to look at all data as useful data, but this isn't true in the case of a clinical trial. On further thinking, I'm not even sure what happens in the case of a patient receiving a pre-approval drug outside of the trial. Handling their data would likely need to meet the same standards required in trial (consent tracking, electronic signatures, etc) without any of the machinery of the trial to help. It could well be the case that nothing is collected if the cost to keep it and use it are too high.
    - mbreese 8y ago
      On further thinking, I'm not even sure what happens in the case of a patient receiving a pre-approval drug outside of the trial. Handling their data would likely need to meet the same standards required in trial (consent tracking, electronic signatures, etc) without any of the machinery of the trial to help. It could well be the case that nothing is collected if the cost to keep it and use it are too high. IIRC, some of this was handled by FDA (or could have been), if they were part of the process by granting an unapproved treatment waiver. This way some amount of 'informal' data could be collected and used to guide others, even if the treatment was outside of a formal trial. Now, without FDA having a role, I fear that none of this data will be captured (or at least not in a useable form).
  - deleted 8y ago
    [deleted]
WC3w6pXxgGd 8y ago
> Do it for free You're aware creating products costs money, right?
- sdoering 8y ago
  You are aware that you want people to pay for the 'right' to be guinea pigs? Your argument sadly does not add much to the discussion. If we were debating whether to allow people to take these unapproved pills or not you would be right. But we are talking about allowing companies to market and charge for totally untested and unapproved (stated) cures. If these companies would need to test their treatments to prove that they are really working, why then should people not only bear the risk of (till then unknown) side effects, but also pay hefty sums for that "right"?

by xevb3k 8y ago

DennisP 8y ago

I don't disagree; a better middle ground might be cost plus some reasonable percentage for unapproved treatments.

filoeleven 8y ago
Isn’t that akin to making people pay to participate in a study? Shouldn’t their payment consist of all the information a company receives from essentially testing their new treatment on a human?
- danielnesbitt 8y ago
  They are not participating in the study though, at least not the regulated portion of the trial. The rule prevents negative outcomes for risky non-qualified patients from harming the trial, but the converse is also true. Positive outcomes for patients outside the regulated trial will not help gain approval at Phase II or Phase III. On a board like hn, there's a tendency to look at all data as useful data, but this isn't true in the case of a clinical trial. On further thinking, I'm not even sure what happens in the case of a patient receiving a pre-approval drug outside of the trial. Handling their data would likely need to meet the same standards required in trial (consent tracking, electronic signatures, etc) without any of the machinery of the trial to help. It could well be the case that nothing is collected if the cost to keep it and use it are too high.
  - mbreese 8y ago
    On further thinking, I'm not even sure what happens in the case of a patient receiving a pre-approval drug outside of the trial. Handling their data would likely need to meet the same standards required in trial (consent tracking, electronic signatures, etc) without any of the machinery of the trial to help. It could well be the case that nothing is collected if the cost to keep it and use it are too high. IIRC, some of this was handled by FDA (or could have been), if they were part of the process by granting an unapproved treatment waiver. This way some amount of 'informal' data could be collected and used to guide others, even if the treatment was outside of a formal trial. Now, without FDA having a role, I fear that none of this data will be captured (or at least not in a useable form).
- deleted 8y ago
  [deleted]

WC3w6pXxgGd 8y ago

> Do it for free You're aware creating products costs money, right?

sdoering 8y ago
You are aware that you want people to pay for the 'right' to be guinea pigs? Your argument sadly does not add much to the discussion. If we were debating whether to allow people to take these unapproved pills or not you would be right. But we are talking about allowing companies to market and charge for totally untested and unapproved (stated) cures. If these companies would need to test their treatments to prove that they are really working, why then should people not only bear the risk of (till then unknown) side effects, but also pay hefty sums for that "right"?