Contents


About the Foundation


Stephen L. DeFelice, MD


DeFelice Commentaries


NREA, Nutraceutical Research and Education Act


Television Debates
and Videos


Library


Conferences


Links


Contact Us


Board of Directors


Senator Harkin on FIM




Google

Home


The Patient Always
Gets Screwed


Promising Ovarian Cancer Therapy Blocked

Carnitine-Ovarian Cancer Promise and a Failed Attempt at a Clinical Study


When Was The Last Cure?


Translational Science - How Doctornauts Can Help


Senator Tom Harkin (D-IA) has been one of the leaders in Congress on Translational Science.


Doctornauts Barry Marshall and Lukas Wartman: Living Proof of the Urgent Need for the Doctornaut Act



View the Discussion Draft of the Doctornaut Act Prepared by Former Senator Bill Frist.




A Personal Note to Congressman Lance for A National Cure Policy


Dear Congressman Lance,

I salute you for your support of MODDERN, the Modernizing Our Drug and Diagnostic and Regulatory Network Cures Act. I noticed the word “cures” is in the title. I’m sure you’re aware that our track record for finding cures for disease and disabilities is a pretty abysmal one. One major and puzzling reason being that Congress has never considered, let alone enacted, a national cure policy. It has, instead, exclusively on a health care one. Witness today’s national debate where there is no mention of cures.

Though we met before, I’d like to introduce myself. In 1965, I brought carnitine, an unpatented natural substance, into the United States from France. Working with others in academic medicine and the pharmaceutical industry, I managed to obtain two FDA Orphan Drug approvals, one of which has saved the lives of children and the other for renal dialysis patients. I’ve personally experienced, unlike anyone in the United States who I’m aware of, almost all the barriers to medical discovery in my carnitine adventure. For this reason I formed my educational foundation whose primary mission is to accelerate medical discovery.

To the point: One unrecognized formidable barrier to medical discovery are the costs, risks and frustrations to conduct clinical studies the critical step in medical discovery for all dis- eases and disabilities be they rare, chronic, acute or subacute. To effectively decrease these barriers I proposed that doctors be able to more easily volunteer for clinical studies by enacting the Doctornaut Act. My colleague physician friend and then Majority Leader, Bill Frist, agreed and circulated a draft of the Act, which is posted on my foundation’s website. For certain reasons, it did not move forward. In an attempt to re-introduce the Act, I’ve met with Congressmen and pharmaceutical industry executives who are concerned about health issues such as my old colleague, Senator Tom Harkin and, your colleague, John Crowley, both good people, to garner support for the Act.

Here is a potential historic challenge for your consideration: Gather a very small group of experts to address three simple questions. Firstly, “What are the costs, risks and frustrations which retard clinical research?” Secondly, “How can we ’acceptably and simply’ reduce such risks, costs and frustrations beginning in the very near term?” and, thirdly, “Making the obvious assumption that, if barriers to clinical research are significantly reduced and the discovery of cures speeded-up, how much will health care costs be reduced?” As an example, if a cure of a single disease, Alzheimer’s, were discovered today, The Alzheimer’s Association estimates the cost reduction over the next 40 years at $40 trillion.

In my day, I’ve chaired dozens of think tanks let alone conferences, and I would estimate that, with the proper preparation, this gathering would take a day and a half.

Congressman Lance, this may sound too good to be true but, because of the huge potential outcomes, I believe that a day and a half of your time is worth the effort. Think about it.

Stephen L. DeFelice, M.D. Chairman, FIM, the Foundation for Innovation in Medicine