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Reblogged:Jawboning Won't Fix This

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Over at In the Pipeline, Pharma blogger Derek Lowe has a short post about Marathon Pharmaceuticals, the latest company to get money -- as opposed to earning it -- thanks to the perverse incentives of the regulatory state:

[W]hat's not to like? Well, this drug has been around since the early 1990s. Marathon most certainly did not invent it. Nor did they think of applying it to [Duchenne Muscular Dystrophy] patients -- the biggest clinical trial of the drug for that indication was done over twenty years ago, by someone else. DMD patients in the US were already taking the (unapproved) drug by importing it from Canada. Marathon just dug through the data again and ran a trial in 29 patients themselves, from what I can see. I should note that this is not any sort of cure, nor does it address the underlying pathology of the disease. The steroid treatment makes muscle strength in DMD patients stronger -- barely. But even for that benefit, US patients will now have to get it from Marathon at something like 50 to 100 times the former price. This is exactly the same business plan as Catalyst Pharmaceuticals and several others, and the only reason that it's viable is because perverse incentives by the FDA make it completely legal. [emphasis added, links omitted]
So the same agency that routinely keeps desperate patients from trying new treatments for their diseases also makes it easy for companies to charge gouging prices for old drugs of dubious value that had been on the market for a reasonable price. Lowe shares a belief held by many that some regulation is necessary, but I differ from him there: Increased consumer vigilance, aided by watchdog organizations like the Consumers Union or UL could perform the legitimate activities of the FDA.

That said, I find this tale ironic, given that I have also heard that Donald Trump wants to jawbone drug companies into offering medicine at lower prices. First, the solution to the economic distortions caused by government control is less of it, not more. Second, it behoves any potential reformer to consider how elsethe government is ruining the drug market, be it through the FDA or other agencies that abuse government power. Finally, notice that "capitalism" is once again implicitly getting the blame for a government-created problem, first of all from the President himself, in the form of his immediate scapegoating/threatening of the companies.

-- CAV

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