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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.




Open Letter to President Donald Trump: Making TrumpCare Work

From Stephen L. DeFelice, M.D.

Chairman, FIM

The Foundation for Innovation in Medicine

EXECUTIVE  SUMMARY

Who can argue that the most efficient path to reduce health care costs is best done by accelerating the discovery of cures of diseases and disabilities? The need for doctor visits, pharmaceuticals, diagnostic tests such as CAT scans and hospitalizations will be substantially reduced. The recently enacted 21st Century Cures Act by Congress, however, is an unfortunate misnomer for it will not deliver the misleading promise of its title. But there is something that will.

The Doctornaut Act will do the job resulting in the accelerated discovery of cures accompanied by a substantial reduction of costs in all our major health systems including what will evolve from any modification of the Affordable Care Act.

The Doctornaut Act addresses the critical step in medical discovery- the testing of a new therapy in a clinical study. Penicillin in a test tube is not discovered until tested in patients with an infection in a clinical study. And this is where our great barriers are. The costs and risks to conduct clinical studies are pervasively  prohibitive blocking the clinical testing of untold numbers of highly promising medical therapies- including cures. As evidence? Just ask yourself, “When was the last cure?”  

The Doctornaut Act will permit courageous physicians to volunteer for clinical studies much more easily than non-physicians by largely circumventing current regulatory barriers. Many more potential therapies will then be tested and more discoveries made, yes, beginning in the short term.

Regarding health care costs, you will be surprised to learn that future projections seldom include cures. Well here’s one that is an eye-opener. The Alzheimer’s Association estimated that the total cost for the treatment of Alzheimer’s disease from the 2010 to the 2050 is $20 trillion, about the size of our current national debt!

I want to alert you that you’ll run across lots of resistance in any attempt to convince the Congress to enact the Doctornaut Act. Over the many years of my efforts to justify the critical importance of the Act to all major segments of our health care community, I’ve encountered, with only one encouraging exception, an unbudgeable resistance to it which underpinnings cannot be explained in a brief op-ed piece .For this reason, an in depth analysis is required and thus the length of this letter.

And now a special note about our veterans and Veterans Administration Hospitals: In this letter I point out how the Doctornaut Act would allow our men and women in the Armed Services to enter into another kind of battle- the battle to conquer disease and disabilities.

Mr. President, I am both prepared and willing to meet with the appropriate members of your administration and Congressional leadership to discuss the Doctornaut Act. And I’m only a phone call away.

Dear Mr. President,

As President, you now have the responsibility to oversee the policies of our multi-institutional national health care delivery system, including the Affordable Care Act otherwise known as ObamaCare, Medicare, Medicaid, the Veterans Administration and, of course, the private health sector such as health insurance companies. Though all sectors of our systems are intertwined, they all call for separate and distinct solutions such as is ongoing in the current ObamaCare discussions. On the other hand, the impact of the Doctornaut Act, a simple twenty- page or less legislative bill, instantaneously enters into all of our systems and the welcomed dual benefits of cures and cost reduction will begin within the short term for each one. Tough to believe? Stay tuned!

Though “care” and “how to deliver it” are the current core missions of our health systems with the critical cost- reduction factor playing a predominant role,  you will be pleasantly surprised to learn that an explanation of why such costs are high has, to my knowledge, never been adequately explained, let alone explored.  Well, here is the obvious the reason why! There are woefully few cures for practically all of the existing common and rare diseases and disabilities ranging from newborns to oldtimers. Do you want proof? Ask yourself, “When was the last cure?” It’s estimated that there are 10,000 known diseases, a 1000 of which are treatable, and new ones such as virulent viruses are on their way. The vast majority of them, however, are without cures. You should know that patients over the age of sixty-five take an average of five pharmaceuticals daily because there are no cures. So the general absence of such therapies is a major reason for our expanding costs.                         

Total health care costs projections, to my knowledge, do not factor in cures which, as you will see later, is a telling reflection of our national lack of hope in our medical discovery system. Here’s an exercise that I would urge you to encourage your competent number crunchers to execute. The Alzheimer’s Association estimated that the total cost for managing this disease from 2010 to 2050 is approximately $ 20 trillion, about the size of our current national debt. Also, imagine the costs of diabetes, cancer and arthritis, let alone the many others over the same period of time. It’s essential that these costs be estimated in order to awaken us to importance of having cure incentive policies such as the Doctornaut Act in order to reduce these enormous costs as well as increasing the well-being and quality of life of men, women and children.

Apart from the 10,000 diseases, there are two other major categories that will need therapies that currently are virtually non-existent. They are designer drugs and biologically altered organisms.

Regarding designer drugs, private, hidden laboratories here and abroad can now synthesize novel mind- altering molecules such as bath salts which are beginning to flood the U.S. market.  Regarding biologically altered organisms, utilizing new gene-altering technology such as CRISPR, harmless bacteria can rapidly and inexpensively be converted to lethal ones within a few weeks and, once distributed as an attempt at biological warfare, can devastate a large segment of our population. One would have to be an incurable optimist not to believe that this is already a work in progress.

As you will see, the Doctornaut Act can play a critical role in combating these two underappreciated imminent national threats.

In my first book, Drug Discovery the Pending Crisis, published way back in 1972 when you were in your twenties and I in my thirties, I wrote, “Our present system of drug discovery is almost designed not to cure the great diseases that confront us. There’s no doubt that many will be cured in the distant future, but it is unfortunate that many must wait.” And sadly enough, history has proven me right which should mightily disturb us all but, puzzling enough, has not and does not. Not even close!

As a successful entrepreneur, you appreciate the importance of a business plan before launching a venture or product where the nature of the marketplace is spelled out and then market tested before the finalization and implementation of its launch. Regarding the nature of our national mindset and policies with respect to health care costs and medical discovery of new promising therapies, I began my market test right after the publication of my first book which has, much to my dismay, been the longest and possibly most frustrating one in American history. A partial list of my efforts include physician and public surveys, lectures, conferences, books, interviews, public relations efforts, meetings with leaders of Congress,  men and women at high levels in the political world, medical and media communities, the results of which are briefly summarized by the responses to the following Six Questions that I generally poised :

The Six- Question Market Test

Question one: “What are the specific reasons why health care costs are so high?” Usually there is a pause which is followed by a few non-focused, rambling opinions lacking consistency. The only consistent response, though not in great numbers, is the high cost of pharmaceuticals which belief appears to be growing.

Question two: “How would you specifically reduce health care costs?” Judging by the response to Question one, it was not surprising to encounter few attempts to answer the question, and those that were offered were also rambling and lacking in consistency except for one- the reduction of health care services. At one of my recent lectures, a knowledgeable gentleman sounded the alarm about future costs. He pointed out that Medicare and Medicaid were enacted in the mid-60’s.  Then the Medicare population was about 19 million; now it’s 57 million and with our aging population it’s projected to be 80 million in 2030. Regarding Medicaid, in 1966 there were 4 million beneficiaries and almost 70 million today.

I asked the gentleman, who also was on Medicare, what specific services that he personally would be willing to surrender. He had none to offer. He, instead, feared that current services would be reduced and not expanded. This is, by far, the most consistent response that I receive when the service- reduction question is asked.

Question three: “When was the last cure?” The response to this question was an eye-opener for only a handful out of the thousands whom I asked had ever even thought about it. Once more, tough to believe- isn’t it? What is revealing is that the one consistent response was polio, which happened in the 50’s! What is another eye-opener, was that I don’t remember anyone- not a single person!- being upset and angry about over a half-century hiatus of what they now learned as being a cureless one despite our booming medical technology. At a few recent gatherings, after I mentioned that in 2015, the FDA approved a record 51 drugs without a single major one being a cure, silence filled the rooms. No anger or, though once more tough to believe, even a smidgeon of curiosity.

What, however, was a consistently common concern and revealing to note and not elicited by me when addressing the cure issue and which is critical to understand what’s primarily on people’s minds, were questions of personal interest regarding potential new therapies on the horizon for the diseases that afflict them or their loved ones.

Question four: “Why don’t we have more cures?” Responses were few and scattered, but, once more, a consistent and disturbing one was to blame the pharmaceutical industry. The belief was that, if the companies discovered cures, they would go out of business. In the early phases of my market research journey, I tried to explain that this isn’t so, for such a policy would lead to corporate suicide, but I ran into a stone wall of receptivity and subsequently stopped trying. Mr. President, this industry certainly has a public relations problem which seems to be increasing. It won’t be easy. The recent Eli Lilly 150 million dollar failure attempt to “cure” early Alzheimer’s went unheeded. A missed educational opportunity, if ever there was one.

Question five: “What do you think about clinical research?” There was little hesitation and much general agreement on this one. It’s dangerous, dangerous and dangerous. In my recent lecture to a large group of distinguished, professional men of diverse backgrounds, the first response to the question came from someone in the last row with a resounding, “Evil.” A few, with passions flowing, mentioned the death of a single patient in a gene clinical study a while back which erupted into a media frenzy and national scandal. When I, as one of my recent examples, asked them why they weren’t upset about the over 700 murders in Chicago last year (2016), which almost all were aware of, silence prevailed.

Our current unbudgeable suspicion of clinical research can be roughly attributed to three historical trigger events. The first was the thalidomide disaster in the late 50’s where newborns in Europe were born with phocomelia with deformed limbs whose heart-rending images were seen on television and in the printed media having a dramatic, emotional impact. It was a media bonanza promoting the message not only of the toxicity of thalidomide but of pharmaceuticals in general. Congress then charged the FDA to broadly stiffen the rules to where clinical safety, by far, exceeded the importance of conducting clinical studies than discovery sparking the birth of our modern clinical research anti-patient Barrier System.

Parallel to this tragedy, Rachel’s Carson’s book, Silent Spring, published in 1962, was a smash hit delivering the unsettling and scary message that unsafe environmental toxins, particularly DDT, are just about everywhere destroying nature’s habitat and threatening humanity. It sparked the broader modern environmentalism movement whose fundamental core message is that of safety, safety and safety which impact spills over to the national mindset of the dangers of clinical research. 

The thalidomide and Silent Spring explosive toxicity messages were also contemporary with the birth of the much larger and broader movement of Consumerism, its core message being that of safety in all walks of our lives from pervasive nutritional warnings of the dangers of what we eat to safe places in our universities for students to escape from perceived toxic microaggressions. Consumerism and its message of life’s general risks are now permanently entrenched in our national psychology.    

Question six: “What is your opinion about the role of clinical research in the discovery of new therapies?”  Except for those at high levels of clinical research community who are understandably knowledgeable of its fundamental role in demonstrating efficacy and safety of therapies, the most consistent responses were blank faces and a stony silence except- here we go again!- the belief that its purpose is to demonstrate safety.

The Doctornaut Act

Now to the Doctornaut Act, its solid and indisputable rationale, immense promise and the puzzling universal cultural negative reaction to it: In the beginning phase of my half-century market test, my major emphasis was directed to the critical importance of clinical research in discovering cures and not so much on reducing health care costs.  I used as examples well known therapies such as penicillin and insulin, pointing out that they were undiscovered until they were tested in patients with bacterial infections or diabetes.  Then I described our formidable anti-patient Barrier System and how the enormous, ponderous, pervasive and smothering regulations and other risk and cost factors eliminate the clinically testing of many present and future promising new therapies and, as an inevitable result, relatively few are tested: and, as day follows night, few cures are and will continue to remain undiscovered for a much longer time than they should.

Mr. President, please be aware of this: There is little doubt that, with our booming technology, a wonderful, surprising new medical treatment or more will soon be discovered which will be generally hailed that all is well in our medical discovery system, where all is forgotten about the 10,000 other diseases and many millions of patients who remain uncured and will remain so for a long, long time. Mr. President, don’t be fooled!
Given this indisputable reality of the anti-patient Barrier System, it makes compelling sense that the overwhelming costs and risks of such barriers be substantially reduced as you, for example, proposed by lowering taxation to companies, a major corporate barrier to innovation. This message is met with few consistent comments except for one: the shaking of heads stubbornly clinging to their firmly held belief of the dangers of clinical studies.  It’s okay to be an astronaut where the fatality rate is very high but worth the risk, but not the risk of being a doctornaut where benefit to, for example, cancer patients would be breathtaking.

(As an aside, you should know that the most enthusiastic supporter of the doctornauts, by far, was the courageous physician astronaut, William Thorton, who experimented on himself while in outer space. It was refreshing conversation among the universal negative ones).

Then I describe the Doctornaut Act as the only doable solution in our national anti-clinical research mindset that has a chance to widely and rapidly open the doors to medical discovery.  It would permit courageous, altruistic medical doctors who are either healthy or patients and who are unquestionably more aware, above all others such as lawyers and ethicists who, among others, now play a more prominent role than doctors in granting the okay to proceed with a study, about the benefits and risks of volunteering for a clinical study of a promising new therapy to much more easily volunteer for clinical studies than non-doctors. This should accommodate our cultural concern about the safety issue regarding non-doctors. Also, such physicians would waive the right to sue which would remove another formidable barrier. If enacted, it would immediately expand our medical research discovery base, especially of the private sector where most of the major medical discoveries are made, to our huge pool of creative men and women innovators who would step to the plate. As a result, many more promising therapies would be clinically tested beginning in the short term inevitably leading not only to new innovative therapies in adults, but also, yes, in children. An anticancer drug discovered in doctornauts can be administered to children. Let’s not forget this critical doctornaut-children connection.

Getting back to designer drugs and lethal biologically modified organisms, we will need treatments and antidotes to them, sometimes at a moment’s notice such as in plague-like conditions. Such therapies must be tested in early clinical studies to assess their utility, but our burdensome anti-patient Barrier System to conduct them cannot work- I repeat, cannot work!- and we are and will continue to be defenseless.

During the Vietnam War I was Chief of Clinical Pharmacology at WRAIR, the Walter Reed Army Institute of Research, where I was involved in research to discover remedies against malaria, radiation, and a variety of toxins that could be used against our military personnel and civilians. With respect to toxins, we collaborated with our colleagues at Edgewood Arsenal. I would urge you to revitalize and enlarge these critical efforts for reasons of national security.

Speed is critical and, Mr. President, the Doctornaut Act will help provide it.

To repeat, the understanding and appreciation of the Doctornaut Act concept has been virtually zero. Interestingly enough, the only consistent response has been related to the dangers of the rogue clinical investigator which, would you believe, was the first media question which I encountered on my 1972 book tour.

You may be wondering why, despite my long-term persistent efforts, physicians have not with opened arms embraced the Doctornaut Act instead of remaining silent on the sidelines. In fact, their responses to the Six-Questions are similar to non-physicians. Risk, not discovery, is their overwhelming concern. I’m talking about medical school deans, heads of departments, presidents of medical societies, world- recognized experts on conducting clinical studies, medical foundation leaders, bioethicists, lawyers, the pharmaceutical industry and government leaders, a representative number of whom from all sectors, except government, of the aforementioned categories were on my clinical research organization board of distinguished international and domestic medial research authorities. A while back Ted Lewers, a physician and former Chair of the American Medical Association Board of Trustees and a FIM board member, at my behest approached the leaders of the American Medical Association regarding the Doctornaut Act, but they were intensely involved in dealing with the government’s increasingly expansive and intrusive role in controlling medical practice. My pitch was that the greater the public prestige of the AMA, the more muscle power that it would bring to the table in dealing with the government. Supporting the effort to cure disease by the Doctornaut Act by our courageous doctors would make the AMA, for none currently exists, the true representative of present and future patients. Unfortunately, this rationale didn’t ring a bell.

You may be also be wondering about the pharmaceutical industry. A while back, Sheldon Gilgore, a physician, one of my longtime close friends and a big-hearted guy, was Chairman of the pharmaceutical company G.D. Searle as well as the President of the PhRMA, the pharmaceutical industry’s trade organization. I approached him about the possibility of the PhRMA supporting the Doctornaut Act though a few knowledgeable veterans of the politics of our health care system had already warned me that it would not. Nevertheless, he was interested and did his own homework by personally polling a number of academic doctors to determine whether they would support it. The result? None, not one, believed that doctors would volunteer to be doctornauts. I also had previously asked many of my doctor academician friends the same question and, with a few exceptions, came up with the same results. Given these and other findings, he rightly concluded that there would be little support to justify a PhRMA effort.

As fate would have it, later on in life he battled a uniquely fatal disease for which there was no cure. Rather than surrender to such a fate, he decided to take a highly risky experimental drug never before given to a human being. He was a true doctornaut.

But, Mr. President, instead of academic physicians, what about practicing ones who are in the trenches treating patients? During the 80’s, FIM conducted a mailing survey to physicians on whether they would volunteer for clinical studies on natural substances without any supervision from the FDA. Three thousand cards were mailed with the following question: “Would you as a physician-patient want the privilege to volunteer for clinical studies on natural substances under the supervision of a physician-clinical researcher without FDA, institutional or other restraints?” Doctor to doctor. Over 10 percent responded and 50 percent agreed with female physicians leading the way. I still have all the post cards for verification for all to see. Today there are approximately 900,000 physicians in our country. If only 20 percent would be willing to be doctornauts that would amount to 180,000 volunteers! The FIM Doctornaut Act proposal, however, stipulates some degree of FDA and Institutional Review Board (IRB) supervision.  
Here’s another eye-opener that will assuredly be used by the anti-doctornaut factions to discredit my credibility and, therefore, the Doctornaut Act. I maintain that there are no true medical specialists with the total experience of developing a pharmaceutical from his/her laboratory discovery of a potential therapy and taking it through the entire costly and risky anti-patient Barrier System requiring the broad know-how necessary to obtain FDA approval. This includes, by the way, the ability to raise money from wherever one can find it. In my first book I called this non-existent specialty, clinical drug development. For example, a cardiologist is trained in the ways of the normal and abnormal heart and has hands-on experiences treating countless patients. This doctor knows and is an expert in the cardiovascular system. One of our best kept secrets is that there are no places to train to be a clinical drug developer. To compound the problem, on the average, it takes more than a billion dollars over about a 12 year period, including from 6 to 11 years spent in clinical trials, to obtain FDA approval for a new therapy. Even if clinical drug developers existed, how could a creative man or woman doctor take it through our anti-patient Barrier System without this amount of funding? They don’t even think about it, let alone give it a try, which is another best-kept secret!

Now here’s another claim that could be used to discredit me. Fate led me to become a solitary clinical drug developer, and I had to learn this specialty on the job. In 1965, I took carnitine, a natural, non-patented substance, from France and personally commandeered it through our FDA system with the unwavering support of the late Claudio Cavazza of Sigma tau, Inc. to obtain approval for Primary Carnitine Deficiency, a previously fatal disease in children. I encountered every barrier possible from having to conduct clinical studies abroad such as at the University of Ljubljana in Yugoslavia  and finding financial supporters later on to help with the huge cost factor in every step of the way. My extensive experience with carnitine sparked my idea of the Doctornaut Act. On the FIM website, Joseph Valenzano, the dedicated and highly respected President of Exceptional Parent, a distinguished, worldwide organization which helps parents and caregivers of children with disabilities and diseases, interviews me regarding my carnitine journey under the title, A Can-Do Way to Reduce Health Care Costs (www.fimdefelice.org).

Regarding the media, I oftentimes see red on how they report on promising new therapies in early studies be it autism, Alzheimer’s or breast cancer. The reporting frequently ends on noting, in a single sentence only, that it will take a long time before it ever reaches the patients, but never- and I mean never- specifically tell us why it takes so long. The reasons? There are primarily two. The first, as I previously pointed out, is the paucity of pharmaceutical experts with hands on experience to turn to in order to learn about the many reasons why. Yet, however, you would think that certain reporters would be curious enough to look into such reasons. This lack of curiosity, this second reason, reminds me of what a frustrated Yul Brynner had to say in The King and I. “It’s a puzzlement.”  

Over the years FIM has launched many a costly public relations efforts and conferences without any outside contributions simply because none understood, let alone was enthused, about the Doctornaut Act.  But for the record, there were two media giants who were, unfortunately, convinced that it would be enthusiastically embraced. The first was William F. Buckley Jr., one of the fathers of our modern conservative movement. After the publication of my first book, my physician colleague and friend of his arranged a dinner with him at the Italian Citizens Club right up the street from Trump Tower, where we discussed the concept of doctornauts and the Doctornaut Act. He, without hesitation, embraced the concept and published a nationally syndicated article supporting it. He believed that it would be widely welcomed as a legislative approach to help conquer disease and disabilities. He called me a few times after my media tour to ask how things were going. Of course, I had nothing positive to report. I remember well, in his baritone vocal range, his attempt to perk up my spirits. “Dr. DeFelice, hang in there. Don’t give up.”

Then there was the FIM board member and highly respected media veteran, Turner Catledge, the former managing editor of the New York Times, who clearly understood the importance of the Doctornaut Act. He promised, “Steve, this should be welcomed news, and I’ll help you spread the word to my media contacts.”  Unfortunately, shortly thereafter, this good man passed away.

There was one bright spot in the doctornaut journey, but, like a fiery comet, it burned out after entering the earth’s atmosphere over Washington. I met with the then Senate Majority Leader and physician, Bill Frist, a number of times and presented the concept of the Doctornaut Act. He quickly caught on and needed little convincing. He circulated a discussion draft of the Act to potentially interested parties with the short title, The Doctornaut Act of 2004 posted on the FIM website. The result? You guessed! It met with zero interest. The silence was deafening, to say the least.

Mr. President, before I go on, I’d like to tell you about one of my favorite, personal objectives. It deals with our veterans and the Veterans Administration Hospitals.  When I was a medical student we made rounds at the Philadelphia VA hospital lead by a dedicated internist and superb teacher, Ralph Myerson. Many of the patients were World War II veterans. I learned a hell of a lot about medicine and got to know many of these men- and what a privilege it was. They were tough guys, indeed, accepting their rendezvous with illness and many times, may I add, bearing their maladies with a therapeutic sense of humor. Today, the VA Administration is under the gun and solutions are being sought including how to treat such conditions as PTSD or Post Traumatic Stress Disorder and combat-induced paralysis, as well as those ailments that affect us all. Many of our current veteran patients are physicians, either patients in the VA hospitals or at home, who are potentially willing doctornauts.  If the Doctornaut Act is passed then, these hospitals can be effectively utilized as sites for clinical studies by veteran physician doctornauts, and let’s not forget, at low costs because of the fixed overheads of these hospitals. And what a wonderful lift it would be to the altruistic spirit and morale of all veterans for they still would be courageous warriors in battle, though of a different kind, in helping our country’s people. Give it some serious thought for it can be done with palpable support by veteran physicians.

I want to warn you: though the rationale supporting the Doctornaut Act is solid, you will be dealing with a huge blind cultural spot of the “cure, care and clinical research triad connection” from practically all sectors of our country. You will receive little support and even significant resistance from certain influential quarters. I’m reminded of the warning of Rudyard Kipling, “Make sure you know what size animal you are before you enter the jungle.”

Why, you may ask, after repeated failures, have I decided to give the Doctornaut Act one more try? It was sparked by a man savvy in the ways of Washington who, by the way, did not vote for you yet believes that, because of your innovative mentality, you would readily grasp the promise and boldness of the Doctornaut Act and have the will to pursue its enactment, despite the formidable odds.

Congress recently enacted the 21st Century Cures Act which title, unfortunately is a misnomer for the title is misleading.  It’s simply a patch-patch, potpourri list of worthy and welcomed objectives, indeed, but whose benefits, though real, will be modest. But, unlike the Doctornaut Act, it is in no sense, a bold historic breakthrough which will dramatically accelerate the discovery of cures and reduce health care costs.

Also, there’s a healthy move afoot for some type of FDA reform. But these efforts as well as the 21st Century Cures Act primarily address the approval process, after a discovery is made, and not the fundamental process of discovery itself.

Mr. President, here’s the main problem. Despite the worthy aforementioned efforts, the anti-patient Barrier System to conduct clinical research will remain largely intact. They are simply not enough to sufficiently penetrate both the obvious and unrecognized hidden components of the anti-patient Barrier System- and the list is long.  Here’s one example that tells it all. My good friend and lawyer for nearly a half a century was recently diagnosed as having early Alzheimer’s. I encouraged him to enter a clinical study with an investigational drug. He sent me the mandatory informed consent document for my review and opinion which described in ponderous, Kantian-like detail the nature of the study. The consent form was twenty-eight pages and he, as a lawyer still with intact intellectual faculties, had problems understanding it. And so did I even though in the past I was one of the original advocates of establishing informed consent and wrote many for different types of clinical studies. My consent forms were rarely longer than two pages, but I usually spent about an hour, one on one and sometimes with family members, reviewing the rationale, risks and benefits of the study and addressing their questions and concerns. Of course, I left the door open for further communication during the entire study.

But here’s the point: My total time spent was, let’s say, about four hours employing my approach from writing the consent form to discussing it with patients. And the patients clearly understood the risks and benefits of the study for I quizzed them.  Just imagine how long it took to compose the twenty-eight page legal document having draft after draft reviewed by third parties and finally approved by a committee which produced a document that even a lawyer-to repeat, his mind was still sharp- and I as an experienced clinical investigator, had difficulty grasping. I would guess it took at least a couple of months and at a high cost. Imagine the time and costs taken for the other multiple barrier requirements before the first patient volunteer would receive even the first dose!

Mr. President, in the final analysis and bottom line, TrumpCare should all boil down to delivering what patients- present and future ones- need and want. What else? Just ask them this single question.  “If you are a current patient, what would you want from our health system?” He or she would say, “Cure my disease.” A current healthy but inevitably future patient would say, “Prevent my disease.” And what is interesting to note is that Congress or any administration has never- and I mean never!-in depth, asked this question and how to tackle and answer it. If there are any doubts, I would be more than pleased to personally defend this difficult to accept fact.

This is a rare opportunity to seize the moment, and, speaking for our present and future patients, which means all of us, I sincerely hope you will enter Kipling’s jungle and make the Doctornaut Act happen. And maybe one way to get it done is to add it on to whatever legislation emerges from the discussions on ObamaCare and FDA reform.