A group of high school students in Sydney, Australia are enjoying a moment of fame after announcing they could synthesize Daraprim – the antiparasitic drug that went from $13.50 to $750 a pill last year thanks to infamous Martin Shkreli, ex-CEO of Turing Drugs.
According to the headlines, the children “appear” and “school” Martin Shkreli with their basic chemistry. Forbes even went a violent route by saying that the high school students are “punching Martin Shkreli in the face, figuratively” with their scientific knowledge. On Twitterthere even seemed to be genuine question as to whether the children could actually compete with Daraprim in the marketplace.
Shkreli – who is always present on social media – simply replied: “… no.” And whether we like it or not, he’s absolutely right.
This pioneering chemistry project does not embarrass Shkreli in any way. It’s not a new way of making cheap Daraprim and unfortunately doesn’t make any difference. In fact, it’s almost absurd to think that the reason Shkreli could relentlessly raise the price of a life-saving drug is because rival drug companies simply don’t have the chemistry to make their own low-cost Daraprim.
In the words of Derek Lowe, a chemist and pharmaceutical blogger at Science:
Daraprim is not difficult to make in the lab. Many medicines are not difficult to make in the laboratory. The Sydney students have not achieved a breakthrough solution – they follow perfectly reasonable organic synthesis procedures. Any competent organic chemist should be able to go up to their hood and do the same, and of course the Sydney professors involved know this as well as anyone.
On the surface, this may seem like yet another case of bad science reporting misrepresenting what the kids actually did – which, to be clear, is a fine chemistry project (it’s just not a breakthrough). This rotten reporting is actually even worse, because it obscures what the real problem is with US drug pricing: regulatory gimmicks and greed. The problem was never chemistry.
In recent years, the pharmaceutical industry’s Turings, Valeants, and Mylans have found several creative ways to play the market and drive up drug prices. In Shkreli’s case, he bought the marketing rights to Daraprim, a decades-old, off-patent drug used in a small patient population, creating a controlled distribution system where he could drive up the price.
Created in the early 1950s, Daraprim treats parasitic infections, namely malaria and toxoplasmosis, that can be spread by cats. Daraprim is most commonly used in the US for the latter, which usually develops as a secondary infection in HIV/AIDS patients, but can also be a problem for pregnant women and babies.
This stale, unglamorous drug is ideal for price gouging, which Shkreli knew when he bought it as CEO and founder of Turing Pharmaceuticals (he later left the company after being indicted for fraud). With so few patients taking Daraprim, there is a small market. So even though the patent has expired and a competitor has the ability to make a generic drug, there wasn’t much interest in doing so before Shkreli hit the market.
Exploiting that lack of competition, Shkreli established a powerful, controlled distribution system. This is a legally controversial ploy in which pharmaceutical companies use restricted access systems and security protocols to thwart potential competitors.
Restricted access distribution systems may be part of safety protocol requirements established with the Food and Drug Administration to ensure that a drug is distributed and used safely, under controlled conditions, and by the appropriate professionals. But it can also happen that other pharmaceutical companies get their hands on samples of the drugs. Without those samples, companies cannot perform the tests required by the FDA that prove their generic drug is the same as the brand name drug.
Currently, Daraprim is distributed only through Turing direct (for inpatients) or through Walgreens Specialty Pharmacy (for outpatients).
If a company wanted to make a generic version of Daraprim, and that company could get their hands on a sample of the drug, they could make it as easily and cheaply as those high school kids. But unlike those kids, that pharmaceutical company would presumably produce on a commercial scale — not on a table — under the proper safety and regulatory conditions necessary for drug production.