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The ABC news website (an Australian national news service funded by the Australian government) reports on a group of high school students from Sydney Australia who have managed to recreate the active ingredient in Daraprim for a mere $20.
Daraprim has received a lot of coverage recently after Turing Pharmaceuticals who owns the patent, initially raised the price of the drug from $13.50 to $750.00, though they have since stated that the price will be reduced.
From the article:
For $US20, a group of high school students has created 3.7 grams of an active ingredient used in the medicine Daraprim, which would sell in the United States for between $US35,000 and $US110,000.
Pyrimethamine, the active ingredient in Daraprim, treats a parasitic infection in people with weak immune systems such as pregnant women and HIV patients.
In August 2015, the price of Daraprim in the US rose from $US13.50 per tablet to $US750 when Turing Pharmaceuticals, and its controversial then-chief executive Martin Shkreli, acquired the drug's exclusive rights and hiked up the price.
Since then, the 17-year-olds from Sydney Grammar have worked in their school laboratory to create the drug cheaply in order to draw attention to its inflated price overseas, which student Milan Leonard said was "ridiculous".
(Score: 3, Insightful) by jmorris on Thursday December 01 2016, @05:43PM
If the school was interested in educating vs indoctrinating they would now let them experience some reality. Let em try to do the paperwork for FDA approval, the paperwork and extra expense of an FDA approved manufacturing process, the end to end inventory controls and understand WHY a drug that can be made for $20 and (a few man years of donated student labor) costs a lot more to bring to market. Then let them study how few doses are actually needed annually and use that as a teachable moment in economics to realize how few customers have to shoulder all of that government mandated overhead.
The problem is the FDA makes all sorts of elaborate rules that might make some sense when regulating a drug intended for sales in the billions of dollars annually to millions of patients, but then they apply them to drugs that will sell in the low thousands of pills. Because if the FDA approves a drug that has problems they will be embarrassed and somebody could lose a job. BUt if they prevent a drug from ever making it to market the people who will die are unseen and no consequence is felt in the government machinery.
Lets make that concept really clear. Imagine a new drug. It generally takes a decade to get through the FDA now. Imagine this new drug saves a thousand lives per year, not a huge number. If the paperwork could be streamlined to save ONE year we should have to credit a thousand deaths on the FDA pinheads. We don't and they follow the incentives that flow from that decision.
(Score: 0) by Anonymous Coward on Thursday December 01 2016, @06:22PM
I wonder if this ever got fixed, it sounds like most of the paperwork they get is shipped to a warehouse and thrown on a pile:
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf [fda.gov]
(Score: 1, Insightful) by Anonymous Coward on Thursday December 01 2016, @07:22PM
https://soylentnews.org/comments.pl?sid=16766&cid=435560#commentwrap [soylentnews.org]
TL:DR you're mistaking the daraprim situation for a new drug that hasn't already recouped its R&D. Regulation and testing is very important, even still we get some drugs approved that have nasty side effects and sometimes are recalled completely. I'm all for trying to streamline regulation, but you must be careful of trading one risk for another.
(Score: 1) by Tara Li on Thursday December 01 2016, @09:40PM
The problem is that simply reproducing the drug is not sufficient to get FDA approval. A new manufacturer has to get *their* version FDA approved, as well.
(Score: 3, Insightful) by Zz9zZ on Thursday December 01 2016, @10:09PM
Source please that states Shkreli had to pay millions and millions in R&D to get their product out the door.
~Tilting at windmills~
(Score: 1, Troll) by JoeMerchant on Friday December 02 2016, @01:23PM
Australia is closer to China than most people realize... the school is teaching them how to reverse engineer and profit off of the groundbreaking work of others.
It has been a Chinese philosophy for how to deal with the "White Menace from the West" since the first trading ships arrived.
🌻🌻 [google.com]
(Score: 0) by Anonymous Coward on Friday December 02 2016, @02:33PM
Except no it wasn't. The patent had long expired. The gouging company is outrageously profiting due to regulatory capture and a monpoly they were granted, then capitalism kicked in and the drug got a billion times more expensive, because, fuck you.