About the Foundation

Stephen L. DeFelice, MD

DeFelice Commentaries

NREA, Nutraceutical Research and Education Act

Television Debates
and Videos




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Board of Directors

Senator Harkin on FIM



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.

The Dilemma of Medical Practice: Unknown Outcomes

Another Case for the Passage of the Doctornaut Act

We are increasingly questioning the benefits of weapons used in medical practice ranging from diagnostic tests to drug therapies. Recently, a coffee shop friend and mother of a 12-year-old male child told me that her son was diagnosed with ADHD and placed on Adderall. She was also told that he would be on the medication for a number of years. Though the initial clinical response was encouraging she was more than concerned about his future. She asked me what the long- term benefits versus risks of taking the drug  are when taken chronically. I told her I would call my colleague who is an expert in this field. As I suspected, the overall benefit –to- risk evaluation, even with dramatic improvement of the clinical symptoms, is not clear.

A recent, thought- provoking op-ed piece in the New York Times by physician, H. Gilbert Welch, clearly spells out the dilemma that we face which will continue for a long time to come. He mentions how hormone replacement therapy to healthy middle-aged women was standard practice until long- term studies raised concerns over cardiac and breast cancer risks. He also claims that routine testing of P.S.A. levels in men has led to unnecessary surgery for prostate cancer and to complicate matters, the results of which may not have reduced cancer deaths. As another case in point, he describes how mammograms are increasingly detecting microscopic breast tumors, D.C. I. S.  or ductal carcinoma in situ. The appropriate treatment is unknown. Some doctors treat it aggressively and some don’t. All concerned are awaiting a clinical outcome study which leaves the patient in a hell of a mess.

 Dr. Welch also raises an example of costs in outcome studies when comparing colonoscopy, are very expensive, versus the testing of occult blood in the stools, which is very inexpensive, to detect colon cancer. The Affordable Care Act or Obamacare established The Patient –Centered Outcomes Research Institute whose mission is to fund clinical studies to evaluate such comparative treatments. A study is planned to evaluate these two cancer detection modalities in 50,000 patients! No cost is mentioned but take a guess! It will take almost forever to organize and complete the study and perhaps too late to save the lives of a number of patients if, for example, one test is inferior to the other. But, even if the study is completed, there’s a good chance that the results may be questionable not only with this but other outcome studies.

 The Greek physician, statistician and meta- researcher, John Ioannidis is generally recognized as the world’s expert on exposing the faulty conclusions of clinical studies. They include those conducted by the highest-level physicians whose studies are published in the most prestigious medical journals. He claims that up to ninety percent of published information which doctors rely on either in conducting research or in the practice of medicine, is somehow flawed and oftentimes incorrect.

The man must have enormously high concentrations of cellular mitochondria and carnitine for he has published papers with 1,328 co-authors at 538 institutions in 43 countries. Last year he was invited to speak at 1000 events but only managed to handle 5 per month. His research covers a broad spectrum of categories including those which deal with prayer and heart surgery. One study reported that prayer is beneficial to patients with respect to survival while the other detrimental.

Many studies are difficult to design because the outcomes are not clear cut such as those with insulin in diabetic coma, penicillin in lobar pneumonia and the polio vaccine. Also, the problems with conducting studies are not limited to medicine but are common in all sectors such as physics and particularly economics.

Conclusion:  We can only resolve the benefit-risks, clinical outcomes of a relatively small number of medical modalities. To test most of them would take forever, bankrupt our treasury and produce lots of equivocal results and the patient pays the price. That’s the reality that none has faced and we must stop fooling ourselves.

What then is the solution?  One irrefutable solution is to significantly cure a number of diseases which will markedly decrease the need for medical outcome studies. The Foundation for Innovation in Medicine has launched the Cure Care Initiative to enact the Doctornaut Act which will accelerate the discovery of medical cures.