3 ms·

If we agree that a conflict-of-interest free system is the goal (and non-negotiable) then an independent entity is essential in a properly-functioning regulator

by justsee 14y ago

If we agree that a conflict-of-interest free system is the goal (and non-negotiable) then an independent entity is essential in a properly-functioning regulatory system. However you appear to have retired undefeated as devil's advocate, as if the questions you put are unanswerable. I would admit that there are more questions and answers that need to be given before we fully implement my HN comment, but that is hardly a refutation of the core idea: that a system free of conflict-of-interest requires independent entities and umpires that are more empowered than the conflicted interests in that system. A recent Forbes opinion piece has its own take on inserting independent entities into the system [0]: What we need is a construct with teeth, an established network of industry-independent researchers (not contractors) equipped to evaluate trial design, statistical power, data analysis, and interpretation, not as regulators but as contributors to final research publications. It would be a sort of Congressional Budget Office for clinical trial results. Admittedly the position outlined in that article does not go as far as a completely independent entity operating all clinical trials for the purposes of regulatory approval, but it's in the right direction. [0] http://www.forbes.com/sites/emilywillingham/2012/11/26/how-can-big-pharma-restore-a-reputation/ http://www.forbes.com/sites/emilywillingham/2012/11/26/how-c...

refurb 14y ago
The issue is not independent entities, it is the unwillingness of the gov't to use the powers it has. For example, Pfizer was found guilty of promoting Bextra off label, a very serious charge from the viewpoint of the FDA and the Justice Department. Punishment includes banning companies from doing business with CMS (who run Medicare and Medicaid). Pfizer entered into an agreement with the Justice Department/HHS where a shell company was allowed to plead guilty and be banned from doing business with Medicare. That's right, a shell company that doesn't actually sell any drugs. http://www.cnn.com/2010/HEALTH/04/02/pfizer.bextra/index.html http://www.cnn.com/2010/HEALTH/04/02/pfizer.bextra/index.htm...
- badgar 14y ago
  What would the short- to medium-term impact on the poor and elderly be if all Pfizer inventories suddenly weren't available? Are you sure it's worth it?
- justsee 14y ago
  Who said the issue was independent entities? That's the solution. The issue is conflicted interests having too much influence. I'd agree the unwillingness of the gov't to use the powers it has is a problem. But that's a separate and equally important issue that others in this thread have flagged, filed under the label 'regulatory capture'. It's not a situation that requires fire and brimstone and outrage. It should just be approached with dispassionate understanding: we have a defective system that is not designed to withstand attacks by self-interested system 'hackers'. The solution is to design a system that neutralises short-term, narrow self-interest.

by justsee 14y ago

refurb 14y ago

The issue is not independent entities, it is the unwillingness of the gov't to use the powers it has. For example, Pfizer was found guilty of promoting Bextra off label, a very serious charge from the viewpoint of the FDA and the Justice Department. Punishment includes banning companies from doing business with CMS (who run Medicare and Medicaid). Pfizer entered into an agreement with the Justice Department/HHS where a shell company was allowed to plead guilty and be banned from doing business with Medicare. That's right, a shell company that doesn't actually sell any drugs. http://www.cnn.com/2010/HEALTH/04/02/pfizer.bextra/index.html http://www.cnn.com/2010/HEALTH/04/02/pfizer.bextra/index.htm...

badgar 14y ago
What would the short- to medium-term impact on the poor and elderly be if all Pfizer inventories suddenly weren't available? Are you sure it's worth it?
justsee 14y ago
Who said the issue was independent entities? That's the solution. The issue is conflicted interests having too much influence. I'd agree the unwillingness of the gov't to use the powers it has is a problem. But that's a separate and equally important issue that others in this thread have flagged, filed under the label 'regulatory capture'. It's not a situation that requires fire and brimstone and outrage. It should just be approached with dispassionate understanding: we have a defective system that is not designed to withstand attacks by self-interested system 'hackers'. The solution is to design a system that neutralises short-term, narrow self-interest.