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> I don’t understand this point, though I’ve heard it before. If the original patents expire, the original drugs can be manufactured as generics right? If the n
by skohan 7y ago
> I don’t understand this point, though I’ve heard it before. If the original patents expire, the original drugs can be manufactured as generics right? If the new patents provide no new benefit, don’t use them?
So it's because of a loophole created in the Hatch-Waxman act, which basically stipulates that if a drug company creates a "new chemical version" of a name-brand drug, then it's possible to extend the patent for 5 years and block the FDA approval of any generics. [0]
[0]: https://www.upcounsel.com/how-long-does-a-drug-patent-last https://www.upcounsel.com/how-long-does-a-drug-patent-last
> Projects I’ve seen suggests that technology development carried out in an academic context often requires significant refinement (or complete reworking tbh) when being brought to market. So, it’s not clear to me how well the model you suggest would work.
So the problem, as I see it, is that the people who profit from the production and sale of drugs also have an essential monopoly over the talent pool which is capable of developing new drugs. As a result, the incentive is for them to direct their R&D resources in ways which maximize profitability rather than maximize health outcomes.
In such a system as I have described, there would still be room for drug companies to do the work of producing drugs, but the incentives for the R&D process could be aligned with the general population rather than drug company shareholders. The current system represents something of a conflict of interest.
- refurb 7y agoI think you mean new chemical entity (NCE). That’s not a small tweak, that’s an entirely new drug. And the older drug can still be sold by genetics companies.
- skohan 7y agoThe point is not the level of effort that it takes to create the drug, the problem is they are allocating resources to research drugs to treat already-served ailments due to the profit motive rather than trying to find solutions for conditions which are not yet adequately treated.
- refurb 7y agoWhat does adequately treated mean? It may come as a surprise, but most pharmaceutical advances come as incremental changes. I can't find it, but there was an interesting chart showing life expectancy of colon cancer over time. Each of the new advances only added 2-3 months of life. However, after a decade, life expectancy had grown by almost 5 years. So my comment for you is that they wouldn't be putting R&D money into something unless there was enough demand for it.
- skohan 7y agoSo for instance, take a look at this study on the cost/benefit evaluation of patent extensions in the pharma industry: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3672218/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3672218/ What they found is that the strategies used by drug companies to "evergreen" their patented drugs resulted in massive unnecessary expenditures with negligible differences in outcomes.
- refurb 7y agoYeah, but that article suggests the problem lies with the hospital, not the drug company. The hospital is choosing to use these marginally better drugs over the cheaper generics. And I take issue with their claim that pregabalin is an evergreen strategy for gabapentin. Those are two very different drugs.