A Maverick's Odyssey: One Doctor's Quest to Conquer Disease: The Story of Stephen L. Defelice, M.D. and Fim, the Foundation for Innovation in Medicine

By Michael Mannion

Can we quickly alter our health care system so that we can discover new medical breakthrough therapies and make them rapidly available to patients? The answer to this critical question is a resounding Yes!

Dr. Stephen L. DeFelice has put forthhis creative solution to this critical problem through conferences, talks, articles, books and the efforts of his Foundation for Innovation in Medicine, FIM.His solution has yet to catch on so its tremendous promise remains to be fulfilled. But things may be about to change dramatically.

Dr. DeFelices answer seems simple at firstperhaps too simple. Its called Doctornauts, the term he coined to describe physicians who can more easily volunteer for clinical studies than the rest of us. These physician-volunteers can be the subjects in clinical trials that the general public cannot participate in because of legal and ethical concerns.

Doctornauts has the potential to help patients all over America--immediately and immensely. This book tells the story of Dr. DeFelice and of his life-long passion, not only to prevent and treat illness, but also, to conquer disease through his innovative approach to increasing medical discovery and improving medical treatment.

Perhaps the single most important aspect of the Doctornaut concept becomes evident when it is understood who it will most helpyou!

• Language: English
• Publisher: AuthorHouse
• Release date: Nov 14, 2007
• ISBN: 9781463462123

Book preview

A MAVERICK’S ODYSSEY

ONE DOCTOR’S QUEST

TO CONQUER DISEASE

The Story of Stephen L. DeFelice, M.D.

and FIM, the Foundation for

Innovation in Medicine

MICHAEL MANNION

SKU-000233373_Text.pdf

AuthorHouse™

1663 Liberty Drive, Suite 200

Bloomington, IN 47403

www.authorhouse.com

Phone: [phone]

© 2007 Michael Mannion, Dr. Stephen L. DeFelice, M.D. All rights reserved.

No part of this book may be reproduced, stored in a retrieval system, or transmitted by any means without the written permission of the author.

First published by AuthorHouse 6/10/2009

ISBN: 978-1-4343-2682-9 (sc)

ISBN: 978-1-4343-2683-6 (hc)

ISBN: 978-1-4634-6212-3 (ebk)

Library of Congress Control Number: 2007906170

Printed in the United States of America

Bloomington, Indiana

Front Cover Photo of Stephen L. DeFelice, M.D. by

Frank C. Dougherty for The New York Times

Back Cover Photo of Stephen L. DeFelice, M.D. by

Phil Mansfield for The New York Times/Redux

Contents

CHAPTER ONE

Why I Wrote This Book

First Impressions

All the World’s A Stage

Old Italian Neighborhood Values

The Long and Winding Road

CHAPTER TWO

The Crusade: Accelerating Innovation and Discovery

CHAPTER THREE

From Carnitine to Doctornauts: DeFelice and Medicine at Odds

Nutraceuticals: What Are They?

The Nutraceutical Research and Education Act (NREA)

Doctornauts:

Why Do So Many Not Get It?

CHAPTER FOUR

A Toast – Roast to Dr. DeFelice

Sal Scognamillo, Co-owner and Chef

Pat DeFelice

Old Friends

Dick DiMeo, M.D.

Dick Fleming

Bobby Thomson

Phil Meisel

Anthony Martinez, III Esq.

Cyril Siewert

Gerard Pilley, Ph.D.

Richard Rosenberg, Esq.

Joseph DiPalma, M.D.

Joseph Valenzano

Sheldon Gilgore, M.D.

Aram Chobanian, M.D.

Richard Rivlin, M.D.

Cory Ser Vaas, M.D.

John Marino

Mark Hallett, M.D.

Jay Skyler, M.D.

Howard Slatken, C.P.A.

David Laudati

Bruno Modanesi

Robert Dormer, Esq.

Patricia Park

This Author’s Conclusion

EPILOGUE

Crossroads, Clinical Trials and - a Congressman to the Rescue?

Endnotes

CHAPTER ONE

Why I Wrote This Book

There are a number of persuasive reasons why I considered writing a book about Stephen L. DeFelice, M.D. However, what convinced me to go forward with this project is his claim that medical technology already exists that can either cure disease or greatly diminish its personal and social impact. But these new medical tools are not being tested. This unfortunate situation also holds true for future medical therapies with great potential.

After listening very closely to his story, I am thoroughly convinced he is on the right track. Dr. DeFelice has a unique track record when it comes to medical discovery. His experiences involve scientific laboratory work, personal medical discoveries, and broad experience in clinical studies. Dr. DeFelice also has hands-on knowledge of the marketing health sector, the economic factors that affect medical discovery, federal regulations concerning health care, and dealing with Congress about these issues.

The late Dr. Louis Lasagna, one of the most respected world authorities concerning medical discovery, stated, I have never run across anyone like Dr. DeFelice with such broad and intense personal involvement for so many years in all aspects of medical innovation in his great quest to bring much needed new therapies to those in need. He has passionately lived and toiled within the system for almost 40 years and he, perhaps more than any other, understands its strengths and weaknesses and what remedies are appropriate. There is none like him.

Dr. DeFelice claims that the big problems stifling innovation

are the high cost and risk of testing potential medical break-throughs in clinical studies. Too many exciting advances remain stuck in the laboratory and never see the light of day. If the costs and risks of conducting clinical research could be reduced, then more potential medical breakthroughs could be tested and many valuable treatments would soon be available.

And how does Dr. DeFelice intend to accomplish this? All that Congress has to do is pass the Doctornaut Act, he said. If passed, powerful medical weapons against cancer, heart disease, Alzheimer’s, arthritis, autism, various types of paralysis and many other conditions will follow within a very short period of time. The puzzling problem is that, with the exception of former Senator and Senate Majority Leader Bill Frist, M.D., no one has caught the message.

First Impressions

My first contact with Dr. DeFelice came over a decade ago. The Foundation for Innovation in Medicine (FIM) was holding a conference called The Nutraceutical Revolution at the Waldorf-Astoria in Manhattan. As I crossed the lobby, escorting relatives who were on their first visit to New York, I caught a glimpse of the banner for the conference in my peripheral vision.

The staff members at the table outside of the meeting room were friendly and helpful when I introduced myself as a medical writer. They gave me a packet full of information about the event, the Foundation and Dr. DeFelice. Later, when I met the good doctor in person, he asked what had attracted me to his event.

One word, I said.

Nutraceutical! He said proudly.

No, I smiled. Revolution!

In the spirit of full disclosure, let it be said at the outset that this writer is a fan of Dr. DeFelice who greatly appreciates his work. All writers have a bias and that is this author’s bias.

What were my first impressions of him? Great energy; optimistic; effervescent; intellectual; ambitious; caring; blunt; pragmatic; shrewd; philosophical; impulsive; reflective; realistic; hopeful. And all with a wonderful sense of humor. Most of all, it was apparent that Stephen L. DeFelice is his own man. First impressions may be lasting impressions but they do not tell the whole story.

Is it possible for one person to truly know another? Can a writer understand the subject of his or her book well enough to give the reader a sense of who that person really is? That is always a challenge for anyone writing about the life of another.

In this book, I have turned to Dr. DeFelice’s family, friends and colleagues for their impressions of him and for anecdotes that tell something of who he is. And the author will have his own impressions and experiences to share. But how much of this is a projection of those telling their stories and how much is characteristic of the subject?

All life stories, perhaps especially those of the most famous, are suspect in one way or another. If you read the New Testament, is it only Jesus Christ you are encountering, or are you also meeting Matthew, Mark, Luke and John? The same analogy holds for Socrates and Plato. But there is an added difficulty when the subject of the book is a dynamic figure like Dr. DeFelice, who is still growing and changing, a man of complex and sometimes contradictory qualities. It is my hope that out of the diversity of perspectives provided, the reader will be able to get an accurate sense of who Stephen L. DeFelice is and why the Doctornaut concept is so important to him.

All the World’s A Stage

Like all of us, he has his public and private sides. In public, he is a serious man of business, medicine and science; a man of integrity; an innovator; creative developer of projects, and something of a maverick. In his personal life, he is a man of great charm, bonhomie, and camaraderie. He is passionate, spirited, loyal. He is an extrovert who enjoys himself at social gatherings and also a man who can quietly enjoy the great arias of Verdi and Puccini alone in his study with a glass of port and his favorite pipe.

But in a way, isn’t he, like the rest of us, an actor playing these roles? In a sense, our public and private personalities are the characters we have created for ourselves along life’s way. As these characters, we wear our masks before the world and before the mirror. The actor Marlon Brando was once praised by an interviewer for his unique acting talents. He, agreeing with Shakespeare, replied that he did nothing special, insisting that we are all acting all the time. He stated that actors can simply perform their assigned roles self-consciously at will, while most people cannot.

Since we play many roles before many audiences, we can sometimes seem to be a bundle of contradictions. Dr. DeFelice manifests many seeming contradictions in his life, that is, in the roles he plays. For example, he is a maverick who is also an insider. He is a conservative who has rebellious ideas and impulses. His thoughts about health and healing are outside the box of conventional thinking but he is deeply involved in the mainstream of medicine and business. In his work, he demonstrates a physician’s desire to heal alongside an entrepreneur’s goal of earning a good living.

Behind the mask is the true face, who we really are. But who are we, really? How many of us truly know ourselves? The most ancient philosophical advice quoted in our culture is Know thyself. This counsel remains as valuable, and as little heeded, today as it was thousands of years ago.

But Dr. DeFelice has a good sense of who he is. There is an introspective, questioning aspect to his nature that is as strong as his outgoing social side. He is a student of the great classical philosophers—Plato, Aristotle, Aquinas—and he applies what he has learned to himself, our society and his work. Let’s go back to the beginning, to the old neighborhood, to get a sense of who Dr. DeFelice was at the start of his journey. Let’s go to his childhood home.

Old Italian Neighborhood Values

Home is an emotionally charged word, either positively or negatively, for almost everyone. The word Home is infused with all the feelings each of us has about the people, places and things that helped shape who we are. In The Wizard of Oz, all Dorothy wanted to do was to get back home. Thomas Wolfe, the acclaimed American novelist, famously titled a book You Can’t Go Home Again.

Some of the finest songs by The Beatles, who left working class life in Liverpool to travel to every continent on Earth, revolve around the theme of returning home. Bob Dylan, who was raised in the small-town of Hibbing, Minnesota, left home at age 18 for New York City right after he graduated high school. He wrote, When I left home/the sky split open wide/I never wanted to go back there/I’d rather have died.

Dr. DeFelice has strong positive memories of his home. He has fond recollections of his life in the Italian-American section of Philadelphia in which he was reared. Although he now lives in an affluent section of New Jersey, a long way, in terms of material things, from the home of his youth, he has never really left the old neighborhood. Many of the values that guide him today were formed there and have served him in good stead ever since. It is in these values that the old world lives on.

In his first novel, Old Italian Neighborhood Values, written at age 67, Dr. DeFelice recreates the world of his past. His writing is sometimes realistic, sometimes nostalgic and on other occasions it is a romanticization of the past. But the novel does capture essential traits of the people, the values and the daily life of the old neighborhood.

Family life was the bedrock on which his character was formed. It was there he became prepared for the trials and tribulations of life. It was at home that he saw early on the necessity of one family member helping the other, and that this cooperation continued to his extended family and, sometimes, beyond it to his neighbors. He saw that the members of his family, and of his Italian-American community, formed very close, tight relationships in which, in one way or another, love was always present.

Although there was a scarcity of money in those days, he learned first-hand about the dignity of work. Starting at age 10, he has always held a job and is still going strong at age 71. Even in difficult times, there was a sense that life is a privilege and it is to be lived with great gusto. Dr. DeFelice has written that he noticed an ability among those he grew up with to smile at tragedy. As unusual as this may sound, this somehow lightened the burden of the pain. The emotional impact of tragedy was not suppressed or repressed; it was not denied. But in a curious way, the suffering was made more bearable.

There was also joy and abundant laughter in those days. Italian music filled the air at that time, from the great Napolitano songs from the old country to the sublime arias of Verdi sung by incomparable talents like the great Caruso. And there was always food and vibrant conversation around the kitchen table.

He recalls with affection the almost nightly ritual of family members, aunts, uncles, cousins, second cousins, in-laws, coming to his home, ostensibly to pay respects to his grandfather and grandmother. However, these gatherings were actually more like a kind of modern-day support group. But personal feelings were not nearly as openly expressed, except by one or two members of the family. It was his mother and father who held court. His grandmother did not get heavily involved unless a situation was really getting out of hand. His grandfather couldn’t have cared less.

Dr. DeFelice said, "Strangely enough, friends and neighbors were rarely invited to our home under any circumstance. As a kid, I sometimes wondered about that. I guess it was because there were so many family members with so many problems there was little room left for neighbors and friends.

They would all, from different family branches, come pouring through the door arriving within a five-minute period shortly after we had finished dinner. We had no television, so we were frequently listening to the radio shows such as the Lone Ranger, Captain Midnight or Batman among others. They usually left a little after nine when I was listening to a very scary program called the Inner Sanctum.

Dr. DeFelice, obviously ruminating on his early childhood, suddenly changed the subject. "It is difficult for the modern American mind to conceive of a situation where there are no telephones. In my early youth, we did not have one in our home. Communications among family members had to be carried out face-to-face which is psychologically different than by telephone or email. And nobody wrote letters in the old neighborhood, to say the least.

Let me tell you a story of an important lesson of life that I learned when the first telephone was installed in our home. It was a party line shared by three or four other homes. When no one was around, I used to very carefully lift the receiver to listen to the conversations of the others. You had to be very careful when you did this for, if you lifted it too rapidly, the other party would hear a ‘click’ and tell you to get your ass off the phone. At first, it was very exciting because being nosey and finding out what’s going on with others is a compelling force of the human condition. And oftentimes I wonder why even to this day.

At first, this secret eaves-dropping was an exciting experience for the young boy. But, after a couple of weeks, the thrill quickly disappeared. Virtually all the conversations dealt with downer or depressing subject matter, Dr. DeFelice recalled, and I decided I didn’t like the negative aspect of life and never listened in again. Not only that, but the lesson learned was that I never wanted to be that way.

As the doctor frequently did during our interviews, he would look into outer space thinking about things. He abruptly said, Let’s get back to the family nocturnal visits! We had a very small row home where my parents, grandparents, my older brother and I lived. My current living room itself almost equals the space of the first floor. When the family members entered, they immediately went past the living and dining rooms to the kitchen. At that point, my mother would immediately give me the order to go to Bauman’s Bakery to buy cinnamon buns, coffee cakes and tea biscuits with raisins. The order never varied.

The doctor then smiled, looked straight into my eyes and said, "You know that life is complex and that little things oftentimes mean a lot. You see, Freddy Bauman was a classmate of mine and I would feel a pang of guilt—at least early on—because I loved the cinnamon buns made by Katie’s Bakery which were tasty and crispy but not too chewy or dry on the inside. The result? Each night I went to two bakeries!

"After the family members were seated around the kitchen table, the volume would increase to operatic levels. The members with problems that would require immediate attention would emotionally, and I mean emotionally, pour forth their problems and woes. Then the arguments on what was the best advice were exchanged among the other members as they munched on their pastries and sipped their coffees. Heated as they were, there were frequent intervals of hearty laughter, sometimes accompanied by tears. I watched and admired how my father and mother, in different ways, held court in a subtle but effective manner, asking the appropriate questions and changing the subject at the right times.

"I’ll never forget Josephine, the daughter of my father’s first cousin, Minigouch. We all loved and felt sorry for her. I always looked forward to her visit because it was real downright theater, Italian style. About a second or two after the members were seated, she invariably burst into tears and usually complained, in detail, about her husband, Babs, who was a sweet guy but an all-day happy alcoholic who couldn’t hold a job, a rare bird in those days. She was a rich personality and everyone had compassion for her.

I spoke about smiling at misfortune and this was the routine amongst the members of the kitchen Roundtable—only it was square. The periodic laughter, intermingled with solid advice, was the perfect formula to encourage Josephine, and others, to understand and handle their significant life problems.

I asked Dr. DeFelice what was the most important thing he learned while listening to his relatives around the kitchen table. He quickly answered, There were many lessons, but the major one is the critical importance of family as an institution to teach and protect its members. As you know, I am now, in my later years, writing novels that deal with social messages. It was inconceivable that, when misfortune would occur such as illness or serious financial troubles, a family member would be left to handle his or her problem alone. Inconceivable! Think about the multiple impacts of individual difficulties on the family, ranging from love to life-long security—not Social Security. Now families are disrupted, be it by divorce or by geographical separation. Family members live great distances from one another and this inevitably diminishes family bonds. People are finding a different kind of love and protection, the love derived from friends—which is evanescent as hell and can’t be relied upon, particularly long-term.

When I asked Dr. DeFelice to share more of his vision of the good and bad consequences of rapid social change fueled by technology, he was, for some reason, reluctant to do so. But he did make a few observations. He said he was particularly concerned about what was happening to women. In his view, they are paying a much higher price than men because of changes in society. Within the past few years, he has met about a dozen divorced women ranging in age from the late thirties to the early fifties. He noted that all of them regularly visited their therapists, before as well as after their divorces, as an aid, as he said, To help them navigate through the turbulent streams of modern life. Dr. DeFelice calls this phenomenon the modern mental ménage à trois. He discussed with these women the particulars of this type of relationship.

Invariably their therapists were women, not men. Dr. DeFelice believes that women therapists were people whom they could more easily relate to when discussing their problems. From his standpoint, the therapists compete with the husbands in the marriage relationship. And Dr. DeFelice further believes this is often a detriment to the marriage. He claims he has little knowledge of what is going on with men in these situations.

Dr. DeFelice mused, Josephine, in my opinion, had family therapists who were much, much more effective in maintaining the harmony of the family members’ marital relationships. I’m very old fashioned, he said I still believe what I learned when I was a kid and what has been reinforced by my adult experiences—that women are the foundation of the family and that the weakening of the family will lead to what Plato preached, namely, government control of family life. Which I believe is now happening—rapidly.

Then Dr. DeFelice made a surprising intellectual leap and said with great passion, All that is happening in our great country since the early 1960s points to a mentality of insecurity which makes it difficult for us to accept the beauty and nobility of Doctornauts! I asked him to elaborate on the last point but he replied, That’s the subject matter of a long essay or short book. Let’s talk about it later on.

The days of Dr. DeFelice’s youth were also characterized by a great love for America and a profound belief that, with hard work, the American Dream would come true. At that time,