Since the passage of the Affordable Care Act in 2010, healthcare has become a lot less affordable, and Washington has now essentially admitted defeat in trying to fix it. But we are fighting the wrong battle. A large part of healthcare costs arises from the terminal diseases which we have failed to cure. Curing cancer, Alzheimer's and cardiovascular disease will save millions of lives every year and dramatically reduce healthcare costs. Unfortunately the medical R&D system we rely on to do that was never designed to accomplish the task. And this should be the real target for reducing healthcare costs. The National Institutes of Health, where I spent 12 years, and the universities it funds are pumping out exciting science, but that is not enough to tackle a mission like eradicating a terminal disease. The cure quest must be managed and coordinated by proven leaders driving multiple near- and long-term potential cure strategies, something most scientists are not trained to do. In other words, the NIH-led academic research enterprise is not designed to deal with the urgency required for curing terminal diseases. And of course, cures are not mentioned in the NIH mission statement. A development-oriented facility is required to supplement the current NIH by taking over its terminal disease cure development efforts and planting it in a business setting like the one that got us to the Moon 50 years ago. This new entity would consist of four divisions, one each for cancer, degenerative disease and cardiovascular disease and a fourth for the terminal disease regulatory function. It could be designated, the Terminal Disease Administration and it would implement the strategy and direct drug development activities of both the TDA applied research staff as well as industry partners which would pay for such services if they opted to do so. The TDA would focus on applied research, with greatly expanded clinical trial capabilities and focus on multiple approaches to the terminal diseases guided by a pragmatic strategy to provide rapid decisions regarding new treatments. Science must become a tool that is focused on cures, and not just a vehicle for academics to get themselves published. The TDA would set new regulatory approval requirements designed specifically for terminal disease drugs and be independent of the FDA. These new guidelines would provide patient access to new treatments after a phase I safety study of 32 patients and one phase II study of at least 100 patients, rather than the thousands of patients currently required for phase III studies. This will greatly speed drug approvals and reduce the cost, both of which would incentivize industry to work with the TDA and focus on cures. Industry would be eager to pay for working in such an accelerating setting that would greatly simplify the development path. To further speed progress and incentivize entrepreneurs, industry, and innovation, Congress should legislate that terminal disease drugs be afforded marketing exclusivity for 15 years post-approval without regard to patent requirements (similar to what the Waxman-Hatch Act did for Orphan drugs in 1983). This would open vast amounts of public domain science for exploitation that is currently gathering dust on library shelves, not patentable and therefore unable to be developed to anyone's profit. This would provide an explosive incentive for applied research focused on these death sentence diseases. It is important that the great science resource and industry talent we have be managed and channeled directly to this task. The best solution to healthcare is to reduce the demand for it, and this long-overdue partnership between research, regulation and the industry focused on cures will facilitate that, save the economy, millions of lives and very likely enjoy bipartisan support. Dr. Marangos is the author of "A Roadmap for Curing Cancer, Alzheimer's and Cardiovascular Disease," published by Elsevier Press. Thinking of submitting an op-ed to the Washington Examiner? Be sure to read our guidelines on submissions.
Since the passage of the Affordable Care Act in 2010, healthcare has become a lot less affordable, and Washington has now essentially admitted defeat in trying to fix it. The latest evidence comes from an analysis by the Commonwealth Fund, which found that premiums for employer-sponsored insurance plans are rising at twice the rate they were before Obamacare.