One of the great pleasures of being on a college campus is to observe the regular doses of hypocrisy, inconsistency and message massaging that takes place. It sort of feels like working in Disney Land. In today’s installment we learn some good news about a new medical device that was developed here at the U of R:
A University of Rochester Medical Center startup company that developed an imaging system to detect breast cancer, announced that it has obtained a key approval from the European Union signaling that it is in compliance with legislation and medical device regulation. This will allow the system to be marketed and sold throughout the EU.
Which would be good news of course. But this news raises three issues:
- We have developed a breast cancer screening test here in Rochester, yet it is still not legal to use it here in Rochester and the United States? The Euro version of the FDA, as I understand it, is way ahead of the curve in the permitting of medical devices. I don’t know how they compare on allowing the use of experimental drugs, but they clearly cannot be worse than the US FDA. Tucked down in the piece is the comment that it is still waiting for regulatory approval in the US.
- I understand why the regulators are holding this up — because the device pushes out radiation and the FDA wishes to make sure this is safe exposure. I’d love to have seen an article written that asks women, particularly those with a family history of breast cancer, whether they’d like to have the option themselves to endure this extra radiation risk for the chance to have a better diagnostic test – so long as they were fully informed of the risk?
- University technology transfer policies are typically money losers. My adviser and I wrote a paper some years ago based on survey evidence from the top research universities finding that the ROI on this sort of thing is very low and often negative. It is easy to demonstrate in a newsletter the successes, but it would be phenomenally interesting to see the full record.
- Do the socialists, particularly in the public health side of things, on campus get cognitive dissonance when they read stories like this? After all, the device is produced privately, the U of R licensed it to the private company, the U of R keeps a small equity stake in the success of the company, etc. Don’t they believe that all public dollars spent on medical R&D should end up right back in the public domain? Where are the student protesters demanding that the U of R divest themselves of this equity slice and where are they demanding that the patents and license get placed freely into the public domain?
- And then of course is the necessary celebratory role for the glories of wise and good government in making this happen: “
U.S. Representative Louise M. Slaughter (D-Fairport) supported the company’s efforts in 2008 by securing approximately $3 million from the DOD to fund ongoing research and development. Slaughter’s commitment to early detection of breast cancer as well as the opportunity for economic growth in Rochester were key reasons for her support of the Koning project.
Maybe her commitment to early detection of breast cancer is sincere – sincere enough to pressure the FDA to ease off on the approval of medical devices that American Women might hope one day to have access to. And as far as economic growth in Rochester, I look forward to the follow up article showing how much economic growth in Duluth she is responsible for killing because there are $3 million fewer investment dollars there. And I am sure the political allocation of capital does a far better job at determining where the “next big thing” is than if it were done privately. More to say, but time to get to work.