those australian students and their daraprim...
Posted by
x (aka dmuck)
Dec 2 '16, 06:37
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"OK, enough people have emailed me the press coverage of the students in Sydney making daraprim, which is the drug that Martin Shkreli’s former firm has famously jacked up the price of. From what I can see, a lot of the news stories on this are missing the point.
Daraprim is not hard to make in the lab. A lot of pharmaceuticals are not hard to make in the lab. The Sydney students have not achieved some sort of breakthrough workaround – they’re following perfectly reasonable organic synthesis procedures. Any competent organic chemist should be able to go over to their hood and do the same thing, and the Sydney professors involved know this, of course, as well as anyone. The people who don’t know this are the news reporters. So when the Sydney Morning Herald says that the students have “taken down” Martin Shkreli, the newspaper is spouting nonsense. This was a perfectly reasonable organic chemistry teaching exercise that’s being completely overblown in the headlines.
Here are the other things that the news stories are missing:
1. The price of a drug does not depend on the price of its ingredients, or the cost of its synthesis. We try to get that cost down as low as possible, of course, because why waste money, but it’s not the determining factor for small molecule drugs. This shouldn’t be a surprise: different models of cars (for example), at different prices, get their steel and aluminum from the same places, and contain comparable amounts of each. If you want to know what the price of a drug really does depend on, read Jack Scannell.
2. Daraprim’s ridiculous price is completely a regulatory failure. Well, that and a failure of human nature, which allows the manufacturer to exploit the regulatory failure, but you know what I mean. The company is exploiting a loophole in the regulation of generic drugs that allows it to set the price wherever it wants to, and as soon as the FDA gets off its rear about the way it handles generic drug applications and approvals, the problem will start to go away. Until it does that, the problem never will. FDA regulations are completely the reason that this situation is feasible in the first place. Don’t get me wrong; the agency has a very tough job, and gets hammered from every direction as they do it, but that’s the situation here. We should also not ignore the role of whatever insurance companies that are actually meeting the insanely jacked-up asked-for price.
3. Daraprim is not some cutting-edge wonder drug. As mentioned, it’s a generic medication. It’s been around since the 1950s; it should be basically a cheap commodity by this point. And it used to be. The reason that has changed is because of the regulatory loophole stuff mentioned in the links above.
4. You cannot make daraprim in a school lab and sell it. This should go without saying, but from the tone of some of the news stories, I wonder. Again, this is because of regulatory considerations, but these I agree with and think that they’re good ideas. If you want to manufacture a drug that people are going to put in their mouths and swallow, you have to do it under all sorts of scrutiny (Good Manufacturing Practices), and you have to formulate and package it in an appropriate (and safe) manner, and if it’s a generic drug, you have to show that what you’re making is equivalent to the other brands of the same drug that are already on the market. A university lab is not a GMP production facility, and neither is my own fume hood. Thank goodness.
OK, then. Enough with the amazing Shkreli-busting headlines. All these are doing is confusing people about where drugs come from and how daraprim’s outrageous cost increase has actually happened. The general public – and many of its elected representatives – are already confused enough about these issues. No need to make things even worse."
- linky (blogs.sciencemag.org)
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