Plos Blogs, October 16, 2015. By Atif Kukaswadia, epidemiologist.
When I was 6 or 7, my uncle gave me a book of Aesop’s Fables. I liked their imagery, and the idea of talking animals with anthropomorphized human traits appealed to my child sensibilities. Recent news about Turing Pharmaceuticals raising the price of Duraprim, a potentially life-saving drug, from a paltry $13.50 to an astonishing $750 brought one of these fables vividly back to mind: the story of the Scorpion and the Frog.
A scorpion and a frog meet on the bank of a stream and the scorpion asks the frog to carry him across on its back. The frog asks, “How do I know you won’t sting me?” The scorpion says, “Because if I do, I will die too.” The frog is satisfied, and they set out, but in midstream, the scorpion stings the frog. The frog feels the onset of paralysis and starts to sink, knowing they both will drown, but has just enough time to gasp “Why?” Replies the scorpion: “It’s my nature…”
Now, the metaphor isn’t exactly perfect. For one, the scorpion in this case (drug companies), won’t drown. They’ll make millions, and then be airlifted across the river by a gold-plated chopper and eat caviar at the tops of mountains. But more to the point is why the frog gave a ride to the scorpion in the first place.
The gist of it is that the FDA wanted to make older drugs follow its new approval process. Rather than have the government go through the (expensive) process itself, the agency made a deal with the scorpions: you go through the approval process, and you get the exclusive rights to make and sell it. This was the closest thing to a sure bet that drug companies were going to get – a drug that had been used, has been shown to be pretty safe, with years of data on it. So they jumped on this opportunity.
They then raised the price by 5000%, and all hell broke loose.
I shouldn’t pick on Turing Pharmaceuticals. They just had the misfortune of being the poster child for this. Rodelis Therapeutics and Valeant Pharmaceuticals are two other companies that followed the exact same course of action, raising their drugs by 212% to 2000%.
The fact is that drugs are expensive to make. There are 4 basic phases to drug development, creatively titled Phases 1 through 4. It has been estimated that only between 6-8% of all drugs make it through to Phase 4, which is the point where they start making money (it’s even lower if you consider everything prior to Phase 1).
Until that point, the costs are borne by whoever is doing the research. Those costs need to be paid by someone, and more often than not, that’s drug companies investing into drugs that may or may not pan out.
I want us to step back in time for a second – back to the time of the Salk vaccine. Back in the 1950s, Jonas Salk created a vaccine that was successful at reducing the incidence of polio from 35,000 in 1953 to 5,600 by 1957. As part of the development process, approximately 1.8 million children were given the vaccine; an unprecedented number of people.
The vaccine was incredibly expensive to produce. In order to raise funds to conduct research, collect data, pilot test the drug and ensure it was safe, funds had to be raised. The American people pitched in in droves, providing whatever they could, even as little as ten cents. This lead to the eventual name of the charity: the March of Dimes. As the creator, Salk was famously asked on TV whether he would patent the vaccine or not. He responded with the line: “There is no patent. Could you patent the sun?” Many took this to mean that Salk voluntarily turned down patenting the vaccine out of a sense of benevolence and moral standing. Even if that was his partial or whole motivation, because the people had paid for the vaccine, and because of other, more legal reasons, the vaccine could not have been patented.
Since Salk’s time, there’s been a gradual erosion in science funding. Granting agencies are drying up, budgets have shrunk, and, despite being a fraction of overall government spending, research is still often singled out as an area to cut. The only entities now able to conduct such large trials are corporations and companies. When we cut science funding, allow drug companies to conduct this expensive research, and then sell it for whatever the market will bear, should we really be so shocked and outraged? After all, it’s just their nature – and didn’t we offer them the ride?
Atif Kukaswadia PhD is Senior Epidemiologist at the Institute for Clinical Evaluative Sciences, and a science writer for Public Health Perspectives on the PLOS BLOGS Network. He completed his Masters and PhD in Epidemiology at Queen’s University, where he investigated the measurement of acculturation, and the effects of acculturation on obesity, physical activity and sedentary behaviour, among Canadian youth.