[ZenoArrow]

http://www.politifact.com/punditfact/statements/2015/sep/24/...

"Daraprim is used to treat a parasitic infection known as toxoplasmosis, which the Centers for Disease Control and Prevention considers a leading cause of death attributed to food-borne illnesses. The Toxoplasma parasite can be transmitted through contaminated food, water, and kitchen utensils as well as contact with infected cat feces. While 60 million Americans carry the parasite with no symptoms, it can become deadly for those with weakened immune systems."

""Turing has not got a single clinical trial underway. Shkreli’s not testing new drugs of any kind for toxoplasmosis. He's got nothing registered," Attaran said. "No one needs a new drug for toxoplasmosis anyways. It works so well bloody well.""

[MichaelGG]

It's only 2000 users in the US. Which is why no one bothers to make it, except Turing.

It's easy enough to make, but the FDA changes to older drugs' approval creates perfect conditions for such abuse. Zero other companies have stepped up and got approval yet.

Doesn't it take a while to get to clinical trials?

[ZenoArrow]

The volume of patients is irrelevant, the FDA could easily open up the market to competition by bringing in suppliers that were approved by other nations with similar medical standards. They could even compare the statistics regarding complications arising from the drug, it's not exactly like there would be a shortage of applicable data. Why they choose not to do so is beyond me, perhaps other drug companies would fight back against such a move, even if it was only limited to generics.

On a side note, regarding those 2000, there's evidence that toxoplasmosis is under treated in the US, particularly with regards to pregnant women.

https://med.stanford.edu/news/all-news/2011/10/u-s-not-takin...