3 ms·

Patents are not perpetually extended, Disney-style. Only copyrights are. Daraprim is not under patent. The issue with Shkreli is purely exploitation of bad FDA

Patents are not perpetually extended, Disney-style. Only copyrights are. Daraprim is not under patent. The issue with Shkreli is purely exploitation of bad FDA rules, not patents. The FDA is the problem here.

HarryHirsch 11y ago
The issue with Shkreli is that he broke the gentlemen's agreement arount low-volume drugs. Derek Lowe talks about it from time to time. The FDA insisting that drugs conform to standards of purity and activity isn't the problem here. When you talk to someone who is working in pill manufacturing you'll learn that it is a complex process. The thing must reliably disintegrate in the digestive tract, the active substance must be distributed evenly, excipients do influence bioavailability - just as with Theranos the standards exist for a reason. The ecosystem around low-volume drugs is strange. Perhaps it would be best for the NIH to open up their own facility, just because of the bad press that Pharma Bro caused for the whole industry.
- yummyfajitas 11y ago
  I'm not disputing the existence of safety/efficacy standards. I'm disputing the implementation. A "gentlemen's agreement" is bound to disintegrate - it's just begging for someone to defect. If regulatory mechanisms allow exploits like this they are clearly broken. Of course it's unlikely the FDA will fix this since their incentives are just as broken. If they prevent millions of people from getting potentially lifesaving drugs they keep their jobs. But if a few photogenic babies die due to a drug that they approved, congressional inquiry incoming!
  - HarryHirsch 11y ago
    Since we are talking orphan drugs that are no longer under patent, they do look like a natural monopoly to me, and there are tools in the economic toolbox to handle these. Regulated utilities show how it's done. There is no need for FDA dissing here. What "photogenic babies" are you even talking about? And who are the "millions of people"? We are talking orphan drugs! Do you have any examples or nothing beyond rhetoric? The biggest problem facing R & D in the phrmaceutical industry is that incentives for investment that the market provides are completely at odds to what is needed on the ground.
    - yummyfajitas 11y ago
      Since you claim these drugs are a natural monopoly, what prevents a competitor from producing them? I'm discussing the fact that the FDA has incentives misaligned with the public good. If they approve X and something bad happens, they get heat from Congress and the media. If they reject something unnecessarily no one cares. The biggest problem facing R & D in the phrmaceutical industry is that incentives for investment that the market provides are completely at odds to what is needed on the ground. Could you explain this claim?
      - HarryHirsch 11y ago
        It's well-known in the trade that there is an upcoming public health crisis because of antibiotic resistance, yet the biggest research efforts go to cancer drugs because that's what provides the highest return on investment. Hell, I am on cancer money, but what we really need is new antibiotics! Also, no one wants to introduce any new class of drug to the market because the research effort is too expensive and the market does not exist. The market in current statins is so much bigger than it was when Merck introduced the first one, and they had to go and verify the target, the mechanism, everything. Merck did all that for every other competitor that wants to bring another statin to market. It really is the financing model that is opposed to the public good. People will admit it freely. And the heat that the FDA gets when something slips past them is incomparably smaller than the heat the pharmco gets. Anyone remember Vioxx and the cardiac side effects? The FDA's incentives are aligned with the public good. There are already drugs for most conditions, and if there is anything that performs outstandingly well in clinical trials there is the fast track. As for the natural monopoly, it's a fact that the number of manufacturers for any given drug is surprisingly small. For orphan drug the market is so small that it's inevitably just one manufacturer. The upfront costs to qualify equivalence are just a contributor.

HarryHirsch 11y ago

The issue with Shkreli is that he broke the gentlemen's agreement arount low-volume drugs. Derek Lowe talks about it from time to time. The FDA insisting that drugs conform to standards of purity and activity isn't the problem here. When you talk to someone who is working in pill manufacturing you'll learn that it is a complex process. The thing must reliably disintegrate in the digestive tract, the active substance must be distributed evenly, excipients do influence bioavailability - just as with Theranos the standards exist for a reason. The ecosystem around low-volume drugs is strange. Perhaps it would be best for the NIH to open up their own facility, just because of the bad press that Pharma Bro caused for the whole industry.

yummyfajitas 11y ago
I'm not disputing the existence of safety/efficacy standards. I'm disputing the implementation. A "gentlemen's agreement" is bound to disintegrate - it's just begging for someone to defect. If regulatory mechanisms allow exploits like this they are clearly broken. Of course it's unlikely the FDA will fix this since their incentives are just as broken. If they prevent millions of people from getting potentially lifesaving drugs they keep their jobs. But if a few photogenic babies die due to a drug that they approved, congressional inquiry incoming!
- HarryHirsch 11y ago
  Since we are talking orphan drugs that are no longer under patent, they do look like a natural monopoly to me, and there are tools in the economic toolbox to handle these. Regulated utilities show how it's done. There is no need for FDA dissing here. What "photogenic babies" are you even talking about? And who are the "millions of people"? We are talking orphan drugs! Do you have any examples or nothing beyond rhetoric? The biggest problem facing R & D in the phrmaceutical industry is that incentives for investment that the market provides are completely at odds to what is needed on the ground.
  - yummyfajitas 11y ago
    Since you claim these drugs are a natural monopoly, what prevents a competitor from producing them? I'm discussing the fact that the FDA has incentives misaligned with the public good. If they approve X and something bad happens, they get heat from Congress and the media. If they reject something unnecessarily no one cares. The biggest problem facing R & D in the phrmaceutical industry is that incentives for investment that the market provides are completely at odds to what is needed on the ground. Could you explain this claim?
    - HarryHirsch 11y ago
      It's well-known in the trade that there is an upcoming public health crisis because of antibiotic resistance, yet the biggest research efforts go to cancer drugs because that's what provides the highest return on investment. Hell, I am on cancer money, but what we really need is new antibiotics! Also, no one wants to introduce any new class of drug to the market because the research effort is too expensive and the market does not exist. The market in current statins is so much bigger than it was when Merck introduced the first one, and they had to go and verify the target, the mechanism, everything. Merck did all that for every other competitor that wants to bring another statin to market. It really is the financing model that is opposed to the public good. People will admit it freely. And the heat that the FDA gets when something slips past them is incomparably smaller than the heat the pharmco gets. Anyone remember Vioxx and the cardiac side effects? The FDA's incentives are aligned with the public good. There are already drugs for most conditions, and if there is anything that performs outstandingly well in clinical trials there is the fast track. As for the natural monopoly, it's a fact that the number of manufacturers for any given drug is surprisingly small. For orphan drug the market is so small that it's inevitably just one manufacturer. The upfront costs to qualify equivalence are just a contributor.