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Dog days of summer. Dog years of oncology?
As the heat and humidity fully roll in to announce we’re deep into summer, I don’t really have any opinions. Y’know, except that the first half of spring and most of the season of fall are the only two times in the year I feel really comfy.
However, the fact I’m light on opinions right now related to pharma, biotech and life sciences doesn’t mean I have nothing to share. Got something in my inbox from some folks at MIT that piqued my interest, so let’s let it shine here.
According to a study newly published and co-authored by MIT economists, pharmaceutical firms “underinvest” in long-term research to develop new cancer-fighting drugs due to the greater time and cost required to conduct such research.
I know, I know...you’re thinking: All those hundreds of millions—billions even—of R&D dollars and trying to get approval if you make it past clinical trials, and there’s underinvestment?
Here’s the thing, according to the MIT economists: specifically, drugs to treat late-stage cancers are less costly to develop than drugs for earlier-stage cancers, partly because the late-stage drugs extend people’s lives for shorter durations of time. This means that the clinical trials for such drugs get wrapped up more quickly, too, as well as provide drug manufacturers more time to control patented drugs in the marketplace.
“There is a pattern where we get more investment in drugs that take a short time to complete, and less investment in drugs that take a longer time to complete,” says MIT economist Heidi Williams, co-author of a new paper in the American Economic Review that details the findings of the study. She is the Class of 1957 Career Development Assistant Professor in MIT’s Department of Economics, and her co-authors are Eric Budish, an economist at the University of Chicago’s Booth School of Business, and Benjamin Roin, an assistant professor at the MIT Sloan School of Management.
The social cost is significant, the researchers say, estimating that the lack of investment in longer-term drugs resulted in a loss of 890,000 life-years among people diagnosed with cancer in the year 2003 alone. The paper also suggests three policy adjustments that might produce more long-term research on anticancer drugs.
The finding “doesn’t mean that the private firms are doing anything wrong,” Williams adds, given the incentives they face. However, she observes, “The public sector is more willing to invest in these long-term projects than is the private sector,” suggesting that new policies could produce more types of drugs for patients.
By examining the historical data, Budish, Roin and Williams found that in some cases where surrogate endpoints are allowed in cancer research clinical trials—including many types of leukemias—there were relatively more trials and money poured into research, other things being equal.
“When you have good surrogate endpoints, you see a dramatic increase in R&D investment, which means lives saved,” Roin says.
All well and good, but they did say there were three possible solutions, right? What are they?
The first, they say, coming off the point just made, is the continued use of surrogate endpoints—or at least, initially, more research to find out if wider use of surrogate endpoints for additional cancers is valid.
A second possible policy change is more public funding of research and development for anticancer drugs, since such funding is free of short-term, private-sector shareholder pressure to produce returns. There are only six cancer drugs in existence that are preventative in nature — and all six have been developed because of public funding, or relied on surrogate endpoints.
These first two points are related, Williams emphasizes, noting, “No individual private firm wants to come in and provide all of the evidence that you need to validate a surrogate endpoint, because once one is validated, that’s going to be used by all of the firms on the market.”
A third potential new policy, suggest the researchers, would be changing the terms of drug patents, which typically run from the time of patent filing, to run from the time when the drug hits the market. That said, the FDA can currently grant exemptions that lengthen drug patents to account for the time R&D takes.
The researchers admit they aren’t trying to be medical or healthcare professionals—they aren’t life scientists and they know it. And, similarly, I’m not an economist. But it sounds to me like they have some good places to start, and the sooner we get started on better ways of carrying out cancer research, the sooner we can get to a plethora of cures and maybe stop hearing the conspiracy theories about how Big Pharma is hiding the cure for cancer.