One of the concepts of innovation that Husick doesn't get into (see earlier posting) is where innovation comes from. It seems to be both a top down (science/inventor-driven) and a bottom up (user-driven) approach. A recent article in Forbes -- Patient Power -- describes these two models might interact as patient groups, like the Cystic Fibrosis Foundation (CFF) are changing biomedical research:
Inspired by the CFF's success, patient groups with an entrepreneurial bent have become the drug industry's new power brokers. Medicines for blood and bone cancers have reached the market faster because of their efforts. A hundred more patient-group-backed drugs, one-twentieth of all the medicines in development, are in human clinical trials for Parkinson's, diabetes, muscular dystrophy and a litany of cancers. These patient power brokers will give drug companies $90 million this year, 13 times as much as in 2000, according to Thomson CenterWatch, a research firm that analyzes clinical trials. The Leukemia & Lymphoma Society has 50 drugs in development, including 11 in clinical trials. The Multiple Myeloma Research Foundation is working with 30 drugs, up from none in 2000, and just recruited a cancer-drug executive from Bayer to help run its effort. The Juvenile Diabetes Research Foundation is testing 18 drugs with biotech companies.
Patient power brokers assemble teams of academic scientists to help identify the best medicines to fund. They pay for the invention of new drugs and for clinical trials of medicines making their way to the market. They grease the skids for clinical trials, too, by assembling networks of doctors and patients who want to participate. By becoming a one-stop source for expertise and research about their disease, these patient groups can use as little as a few million dollars in funding to shift the priorities of the drug industry.
The patient groups are filling a void in drug research created by the industry's legitimate fear of failure. Biotech executives dread what they call "the valley of death," the period of time between a drug's conception in a lab and its first clinical trial. For every 10,000 would-be medicines chemists create, only one makes it to market. But if a drug has already been through enough tests in cell cultures and lab animals to justify starting clinical trials, the odds of success have risen to one in nine. Put the substance through early clinical trials with a few dozen patients, and the odds jump to one in six. At some point a drug for even the most uncommon disease becomes every bit as appealing to drug companies as an untested potential heart treatment or impotence pill.
Another version is Michael J. Fox Foundation. As a story in the New York Times (Taking Science Personally) relates:
What makes the story of the Michael J. Fox Foundation different — nay, what makes it important — is that it doesn’t just dole out money to scientists and hope for the best. It has used its money to take control of Parkinson’s research like few other foundations have ever done. In the process of trying to solve the mysteries of Parkinson’s, it has upended the way scientific research is done, and the way academics interact with pharmaceutical and biotech companies, at least in its little corner of the world. It demands accountability and information sharing that is almost unheard of in the broad scientific community. And it has managed to become, in its short seven-year life, the most credible voice on Parkinson’s research in the world.
The story goes on to explain the why the model is different:
What is wrong with N.I.H. funding? To most people, it is a model that makes perfect sense — in part because it is what we are used to. The government accepts grant applications from scientists, and then metes out money to a handful of those with ideas that it deems most promising.
But from the point of view of a disease foundation desperate to find a cure, everything is wrong with it. The government grants tend to go to low-risk projects, so the kind of science that leads to big breakthroughs tends to go underfinanced. The N.I.H. pays for areas of science that are high profile or have a large constituency. It has no connection to industry research, so it is largely through happenstance that government-financed research turns into medicine that helps make us better. And once the money is channeled, that’s pretty much the end of it: there is no follow-up.
In other words, there are two failures here: the failure to think big and outside the box and the failure to think practical. In part, this reminds me of the reason why DARPA was set up -- to handle both types of failures simultaneously.
Interesting models. I think we certainly want to continue the NIH model. That funding provides for the basic research. But we also want alternative approaches. After all, we don't want the initials N.I.H. in this case to stand for "not invented here."
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