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


Cato Institute's
Regulation Magazine article by Dr. Louis
Lasagna on Dr. DeFelice and Carnitine


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.



Stephen L.
DeFelice, M.D. - Founder, and Chairman



Click Here to View Our Policy Proposal for the Doctornaut Act with an Additional Open Letter to President Trump: "Making TrumpCare Work"

March 2017 - The Doctornaut Reform Proposal is Released:
Stephen L. DeFelice, M.D.: An Open Letter to President Donald Trump: Making TrumpCare Work


Read all of Dr. DeFelice's Proposal to Reduce Healthcare Costs from the August 2016 Exceptional Parent Magazine


Prominent Research Physician Points to Cures As Key to Holding down Medical Costs


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Why children need Doctornauts

Dear Parents of Children with Diseases and Disabilities: Pay Attention for They Desperately Need Doctornauts. Itís Time to Get Angry- and Active!


In previous posts I emphasized how physicians or doctornauts who volunteer for clinical studies can rapidly speed up the discovery of medical breakthroughs and cures . In the past, I also emphasized that doctornauts, though adults, can do the same for children. Unfortunately, I wasnít successful in getting the message across to you, their parents.

Last week I had dinner with my old and kind friend, Joseph Valenzano, the dedicated founder and President of Exceptional Parent (EP), a long Ėstanding, highly respected educational organization which deals with children with diseases and disabilities. During dinner he urged me- to tell the truth, he really gave me hell- not to give up on educating you, the parents, on how doctornauts can dramatically help your children. Joeís a very persuasive guy, so here I go again!

There are two categories of childhood maladies, one that are relatively common and the others rare. The latter are oftentimes called orphan diseases. In the former category are conditions such as cerebral palsy, asthma, diabetes, leukemia, brain tumors, autism, and ADHD. In the latter category it is estimated that there are plus/minus 6000 conditions most of which are of genetic origin. Because of their small populations and , therefore, for economic reasons, relatively few clinical studies are conducted on them. One source reports that 30% of children with rare diseases will die before their fifth birthday. The encouraging news is that genetic discoveries in more common childrenís diseases will be effectively applied to many of them.

Letís take an example on how adult doctornauts with Parkinsonís disease can help children with Cerebral Palsy. Parkinsonís is caused by the destruction of certain brain cells. There are various ways to treat this disease. One is with pharmaceuticals. But there is often a problem with promising drugs in animal studies because of what is called the blood brain barrier- which prevents them from getting to the brain. Successful research on ways to eliminate the blood brain barrier in doctornauts with Parkinsonís can also be applied to cerebral palsy children. Discoveries made in doctornaut Parkinson disease patients with stem cell implants, insertion of genes into cells and even the use of electric devices to control movement among others are all applicable not only to Cerebral Palsy children but also other central nervous system diseases of children.

Hereís another example: letís say a brilliant researcher has an out-of-the Ėbox idea on a new therapy for leukemia which FDA and hospital committees would not approve for clinical studies because they believe itís too risky. But because of the Doctornaut Act a physician with leukemia can and does volunteer, and the therapy proves to be very effective. This same therapy would then be available to children with this disease as well as adults.

( FYI, there are many bright researchers with creative therapeutic ideas which are never tested let alone made public because of the barriers to clinical research. And they remain unknown because there is no place for them to go to have their ideas evaluated in a clinical study. In addition to the establishment, these folks are essential to speed up medical discovery).

Awhile back- before some of you were born!- I brought carnitine into the United States and conducted the first clinical study in adults in patients with hyperthyroidism. Because of its availability it was tested clinically in children with the fatal disease, Primary Carnitine Deficiency, and eventually approved by the FDA saving a number of childrenís lives.

You may wonder why there has been little interest in the Doctornaut Act. Despite my personal efforts, with the exception of physician and former Senate Majority Leader, Bill Frist, who had a discussion draft of the Doctornaut Act circulated but failed to attract support, I donít have a clear answer except the well accepted general rule that there is an establishment system which very rigidly regulated where bold ideas are not well received. Thereís an old saying that progress is disagreeing with the established experts. Also, patients are not aggressive and understandably surrender their lives to the rules of the system. But there has been one dramatic exception to this rule that tells us that mountains can be moved. Itís AIDS patients. In the early days of AIDS there was little support to conduct research on this fatal disease. The angry AIDs patients then got together and launched an extremely effective public relations campaign , strongly supported by mass media, resulting in enormous sums of money poured into AIDS research. And this effort handsomely paid off with the discovery of very effective, life-saving breakthrough therapies.

Physician Doctornaut Survey on Natural Substances

Because of my experience with the natural substance, carnitine, I, being trained mainly to study artificial, patented pharmaceutical drugs, turned my attention to the non-patented, largely ignored world of natural substances be they legally considered a food or a drug. And what a discovery it was! The promise is enormous, but because of the difficulty of obtaining strong enough patents to economically justify the investment required to at least conduct a single solid clinical trial on them, their promise continues to be largely undiscovered.

To overcome the lack of economic incentives to conduct clinical studies on natural substances, FIM conducted the first and, I believe, only physician doctornaut survey at that time- and perhaps since- by mailing the following postcard to 3,100 doctors, medical doctors and osteopaths, asking them to respond to the question, over 50% responded in the affirmative.



I then conducted a personal phone call survey to many of them asking whether they would do the same with pharmaceuticals and medical devices and the response was also similar. Today there are approximately 900, 000 physicians in the United States. If 50% are willing to be doctornauts, then there would be over 400,000 physicians willing to volunteer for potential new therapies at low cost dramatically increasing the speed and breadth of medical discovery!

Even if, today, it were only 20%, it would leave us with an enormous pool of courageous doctors. Certainly, in our current culture there would have to be some type of regulation which the Doctornaut Act would provide but, if structured properly, the impact would be the same.

Stephen L. DeFelice, M.D., Letter to the Pope: The Number Theory of the Human Signaler, Unlike Bioscientism, Supports the Existence of a God-driven Human Evolution


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Click here to read the letter to the Pope


Nutrition Stymied: The Nutraceutical Solution"

Professor Stephen L. DeFelice, M.D.
Plenary Lecture September 9, 2014
XXV National Congress of the Italian Chemical Society - SCI - The University of Calabria



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This year marks the 25th anniversary of the coining of the term nutraceutical by Dr. DeFelice. Click here to read more.

New Articles:


Click here to view an archive of Dr. DeFelice's articles in the Westfield Leader.


THE FIM INITIATIVES: CURE CARE, HEALTH CARE COST REDUCTIONS, AND THE DOCTORNAUT ACT

For inexplicable reasons, we have a cultural blind spot regarding the critical importance of clinical research or studies and its essential role in accelerating discovery of new medical breakthrough therapies as well as helping reduce health care costs. We seem to have forgotten that penicillin and insulin are only discovered in clinical studies. Block that step and the medical discovery rate goes down. It is generally recognized that there are formidable barriers to conducting clinical studies dramatically raising the cost and risks but, strangely, there are few voices making the connection between such barriers and the disappointing track record of the discovery of new medical therapies despite our enormous scientific, technological capacity. Has anyone wondered why we can go to the moon but cannot cure the common cold?

What also is not appreciated is that high cost and risky barriers to clinical research encourage companies to develop high cost medical - health products. It naturally follows that if the barriers to clinical research are substantially reduced, then low cost products also will be clinically tested and developed competing with high cost ones. This will result in significant health care cost reduction.

Now here's where the Doctornaut Act comes in: For historical reasons our country is extremely suspicious and apprehensive about clinical studies. Any attempts to reduce the barriers to clinical research and make it much easier for patients to volunteer to test potential new medical breakthroughs simply will not succeed. But if we do this with physician volunteers or Doctornauts then we believe that this would not only be an acceptable solution but a highly welcomed one. Who can argue against physicians willing to take greater risks to help their patients?

And what is highly encouraging is that it is a very simple and easily understood Act which could quickly be passed and the accrued benefits realized within the very near future.

Also, it is important to note that the Doctornaut Act would not compete with any health care system but, instead, would be complementary to it.

Christopher Reeve, after learning about a study in which paralyzed rats were made mobile again by a new treatment, and also knowing how long it takes for laboratory discoveries to become available to patients, said, "If only I were a rat!" This simple but tragic wish says it all.

The four documents listed below support and clarify the rationale and importance of the Doctornaut Act.

Discussion Draft of the Doctornaut Act(Introductory Page):
This draft was requested and circulated for comments by the former Republican Senate Majority Leader and physician, Bill Frist. Dr. DeFelice had a number of discussions with Dr. Frist on the importance of physician volunteers or Doctornauts to more easily volunteer for clinical studies to accelerate the discovery of new medical breakthroughs. He, as a former clinical researcher, readily agreed with the doctornaut rationale. Read>

Doctornauts:Good for Patients and Health Care Costs Reduction:
This op-ed piece was accepted for publication by the editor of perhaps the most prestigious widely read conservative publication. It, without explanation, was subsequently rejected. I've modified the piece somewhat for this website. Read>

THE DOCTORNAUT ACT
A Proposal by FIM:
Published in 2003 is an analysis of why the Doctornaut Act is needed and guidelines for it.
To make this happen it it critical that Congress
hear from you regarding your support of this
Act by contacting your local Congressional representatives and Senators. Read>

CURE CARE VS. HEALTH CARE -
A Virtual Congressional Hearing
Over the years I've tried by intensive educational efforts, without success, to bring about general change that would speed up the discovery of new medical therapies for the treatment of disease, disabilities and other conditions that ail us by establishing a "health cure" policy. In this article I thought that by presenting FIM's arguments in a make-believe Congressional hearing on "cure care" would be readily understandable. Regarding health issues, I've been following the White House and Congress since the early sixties. The overwhelming majority of hearings and policies have dealt with "health care" such as Medicare, Medicaid, availability of pharmaceuticals at reduced or no costs and the recent Obamacare. None, unbelievable as it may seem, has dealt with "health cure".
Read>