Dear Colleagues in Washington,

The Foundation for Innovation in Medicine (FIM), as described on this website, believes that a very simple new law, the Doctornaut Act, will effectively both accelerate the discovery of medical cures and breakthrough therapies and significantly reduce Medicare-Medicaid costs beginning in the short term.  The gateway to achieve both objectives is to relax the barriers to clinical research by having physicians more easily volunteer for clinical studies, which the Doctornaut Act will permit.

Regarding physician volunteers for clinical research or doctornauts, FIM has expended lots of efforts for over three decades without much success, and you may legitimately wonder why.  Frankly speaking, so do I. We have a definite cultural blind spot to the importance of clinical research.  Only recently have a few bold and visionary doctors and scientists, such as NIH Directors, Drs. Elias Zerhouni and Francis Collins along with a small number of supporters, stepped forward to make the case for Translational Science and the critical importance of clinical research. But the problem of the barriers to clinical research began about half a century ago so why has it taken Congress so long to act? Also, the media coverage of the Translational Science movement was meager, which bespeaks of our cultural blind spot. Though I applaud this movement, it is limited in scope and impact.

You may believe that the proposed solution of the Doctornaut Act is just too simple to be true. Well, I can assure you that the more that you read and think about what’s written on this website, you will at least come to the conclusion that it might have merit. To add to your motivation to consider the Doctornaut Act, what proposals are out there on effective ways to robustly increase our medical discovery system and reduce health care costs except by reducing services?

I spend lots of time reviewing exciting new therapeutic leads.  Two recent laboratory studies reported exciting promising findings for the treatment of multiple sclerosis and cerebral palsy. In a mouse-multiple sclerosis model, four lipids, which are natural components of the lining of nerves, were injected and found to both limit and reverse the severity of  some aspects of this condition. Rabbits with an induced form of cerebral palsy were injected with an anti-inflammatory drug hooked on to a tiny nanoparticle which helps deliver drugs to cells. Normal movement was nearly fully restored. Regarding cardiovascular disease, nanoparticles were injected into pigs and rats after they underwent laboratory- induced heart attacks where heart cells are damaged. The treatment produced the growth of new heart blood vessels followed by a significant improvement in cardiac function.

Make no mistake about it, because of the formidable barriers to conduct clinical studies, particularly for creative individual physicians, it will take a long time, if ever, before these and other very promising medical modalities discovered in animal studies will be tested in humans.  Doctornauts will insure that many of them will be.

Some have the impression that doctornauts will only volunteer for high- risk studies. Not so. They will participate in blood level studies to cell implants in the failing heart.

How will Americans react to physicians willing to take greater chances to volunteer for clinical research studies in order to discover better therapies for them? A joint venture, wide-ranging survey between Research! America and JZ Analytics reported what I find both surprising and highly encouraging, Most Americans would be willing to pay more taxes to increase spending for medical research. There are other findings which strongly support Americans concern about their health.

To my knowledge, Congress has never had a hearing on ways to create a “general” productive medical discovery system. Now is an excellent opportunity to do so and hear what others have to recommend, as well as a good time to evaluate the Doctornaut Act.

“Certitude is for fools”, wrote the great Scottish philosopher, David Hume. But my father told me a number of times, “Son, there’s an exception to every rule.” Regarding the Doctornaut Act, I agree with my father.