One Man Alone: My Investigation of Dr. William Donald Kelley

A Better Cancer Detox

By: Dr. Nicholas Gonzalez

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It is sometimes hard to believe that 27 years have now passed since I first began my investigations of the controversial alternative cancer therapist and dentist William Donald Kelley. In July 1981, after my second year of medical school at Cornell, a good friend and successful writer called me one afternoon asking if I knew anything about Dr. Kelley and his strange nutritional treatment for cancer. I had certainly heard of Kelley by that point. Some eight months earlier, his name had been splashed across all the major and minor newspapers and TV news shows, vilified as the practitioner supervising the treatment of the actor Steve McQueen, who in November 1980 lost his battle with advanced mesothelioma in a Mexican clinic. The stories had continued for many months even after McQueen’s death, and though I hadn’t followed the case too closely and knew little about Kelley, I thought the vicious attacks against him somewhat peculiar. After all, McQueen had suffered a malignancy that was – and still is – incurable in the conventional world. Kelley had tried, I thought, and hadn’t succeeded; hardly a grievous sin, since all practicing oncologists try and fail, with many if not most of their patients.

My friend, always looking for a hot new book to write, thought Kelley might make a good subject for a potboiler. She got in touch with him and, to her surprise, found him to be quite the opposite of what she had expected: the celebrity-chasing, money-driven, greedy “quack” portrayed in the press and on TV, trolling for dollars among the most vulnerable – those diagnosed with incurable cancer. She instead found him shy, painfully so, convinced that his therapy had value and devastated by the media assaults.

Apparently, my friend told me, Kelley himself had survived terminal pancreatic cancer in the early 1960s, when he still practiced conventional orthodontics. With four young children to worry about and facing an early death, Kelley desperately sought some way to beat the disease. Through trial and error, using himself as a guinea pig, he serendipitously put together the therapy that saved his own life. Once recovered, he began to apply what he had learned to others facing equally catastrophic fates with terrible cancer. The rest, she said, with some irony, was history.

At this point in his life, Kelley said, he only wanted the chance to have his regimen appropriately and fairly evaluated in clinical trials. When she asked him to explain his treatment, a very complicated approach involving individualized diets, individualized supplement protocols, large doses of pancreatic enzymes, and coffee enemas, she said his comments about the biochemistry of nutrition went far over her head, nonscientist that she was. As she told me, she couldn’t be sure if Kelley was truly a genius on to something extraordinary, or simply an inarticulate peddler of snake oil.

At the time, Kelley maintained an office in Dallas but in recent weeks had sequestered himself at a remote organic farm he owned in Washington State. There he hoped to avoid the media, but some enterprising reporter had managed to track him down. In some frustration, Kelley had taken a long train ride across Canada to escape the press and a failed romantic relationship – the victim, apparently, of his newfound notoriety. Now he was soon scheduled to arrive in New York, where he intended to stay for several days before flying back to Dallas. She wanted to meet with him face to face during his stay in town, to explore further the possibility of a book, and for me to meet with him as well, to size him up, to help her determine if he was simply crazy, or brilliant, or perhaps crazy and brilliant. I had seven years of journalism experience under my belt before going to medical school, including stints under some legendary editors, so she thought my unusual combination of reporting and scientific training might help her sort through Kelley’s level of authenticity.

Initially, I balked at the suggestion, having little interest in meeting some controversial alternative cancer therapist. But she persevered, even offering to pay me for my time. Finally, after considerable prodding I agreed to meet with him (for no charge, I might add). I was in fact pretty bored, spending the summer in the research lab of one of the professors who had taken me under his wing, the late Walter Riker, for years chairman of pharmacology at Cornell. Though Dr. Riker was a wonderful mentor, I felt restless, finding the laboratory work somewhat tedious. Journalist that I was at heart, I was looking for an adventure, even if only a minor one, and Kelley might just fit the bill. So several days later, I trudged out to the Forest Hills offices of a chiropractor known to my writer friend who had agreed to set up a lunch so we might all get together somewhat informally.

I remember so well my first glimpse of Kelley: he was tall, six foot two or three, with blue eyes and a narrow, haggard pale face topped by a mop of gray hair. He wore a gray suit, white shirt, and blue tie, and walked with a distinctive limp – the result, as I would learn, of the metastatic cancer that 20 years earlier had ravaged his body.

At our first meeting, Kelley was indeed shy, appearing uncomfortable, so soft-spoken that initially I had trouble hearing him. We sat together awkwardly in the chiropractor’s consulting office, as I tried to get the conversation going. We talked about his trip across Canada, his recent romantic breakup, and the harassment he had endured over Steve McQueen. When I then asked him about his treatment, quickly his face became animated, his voice strengthened, and the words began to flow. He became a totally different person than the bumbling, nervous man he had been only a minute previously. With great authority he discussed his concepts of autonomic physiology, the use of diet and supplements to manipulate the nervous system, the British embryologist and researcher John Beard who had first used pancreatic enzymes to treat cancer some 80 years earlier. The ideas came fast and furious, somewhat overwhelming my two years of medical-school knowledge. I tried to hold my own, but quickly realized that whatever the press or the world thought about Kelley, he was one smart man.

Further into our conversation, I asked him what he wanted, and he answered without hesitation: As he had told my writer friend, he believed this therapy had value, but it needed to be evaluated in appropriate clinical studies in an academic medical setting. If after such testing the regimen proved to be of benefit against cancer, he said it needed to be in the hands of the conventional medical world, where it might be properly studied and made available to those patients who wanted an effective nutritional approach. And if it turned out the therapy had no value, he needed to know so that he could close his office down and “go fishing.”

I thought his answer a far cry from what would be expected from an alternative practitioner – usually portrayed by the conventional medical world as unwilling to accept the challenge of rigorous clinical and laboratory scrutiny. Here, Kelley told me that this was just what he wanted – and apparently for all the right reasons.

Fortunately, I had as one of my Cornell mentors Robert A. Good, MD, PhD, then director of Sloan-Kettering Institute for Cancer Research – the “founder of modern immunology,” as the press called him, and the most published author in the history of medicine. He was a man of many interests and of great accomplishments; though he originally trained in pediatrics, he also had earned a PhD in physiology and, before arriving at Sloan-Kettering, had been head of the Department of Pathology at the University of Minnesota. As a pathologist, internationally known as he might have been, he was essentially self-taught – a very unusual circumstance for such an expert in the field. He once told me how odd it seemed at times for him to have supervised a department in a field in which he had not one hour of formal residency training.

However, his fame – including a Time magazine cover in 1973 – came because of his pioneering work in immunology. He helped unravel the workings of the thymus gland, previously considered a “vestigial” organ but which he demonstrated to be the ultimate regulator of immune function. Dr. Good also, along the way, supervised the first bone marrow transplant in history in 1969, opening up a whole field of high-tech therapeutics. To round out the picture, he had developed a strong interest in nutrition, particularly in terms of how diet and specific nutrients influence immune activity.

I had begun meeting with Dr. Good regularly at his invitation to discuss my interest in cancer research, an interest he encouraged enthusiastically. Whatever might be said of Dr. Good (and indeed he was a most controversial man himself in his lifetime) and whatever his responsibilities at Sloan-Kettering, he always took time to meet with students, to discuss their scientific interests, as if he had no more pressing business. I once read (although I’ve never had the statement verified) that more of his fellows have gone on to professorships at US medical schools than from any other research group in history.

As I sat across from a now-enlivened Dr. Kelley, in this chiropractor’s office in Queens, I mentioned that I knew Dr. Good and might approach him to ask the best way to proceed with an evaluation. Dr. Kelley stopped cold midsentence, before explaining that for years, Dr. Good had been his hero, the one person in the conventional medical world whom he believed had a mind open enough to allow an investigation of a treatment method such as his. I nodded, in total agreement – Dr. Good did have an insatiable curiosity that at times could lead to dead ends, or even to spectacular controversy. On the other hand, he had told me in conversation that as a scientist, one must always look beyond the tried and true for the next new advance.

After several hours’ talking, Kelley explained that he was leaving for Dallas the following day, and wanted me to come with him, so I could start evaluating his treatment and his records. I told him that I was in the middle of a commitment to Dr. Riker, and I couldn’t be sure whether Dr. Good would even be interested in such a project, particularly one that Kelley wanted to begin so soon. But I admired Kelley’s no-nonsense approach, and agreed to try to speak with Dr. Good that afternoon.

After the subway ride back to Manhattan, and my return to the Cornell medical campus on the Upper East Side, I immediately went up to Dr. Good’s office atop the main Sloan-Kettering building. When I arrived, I heard his typically enthusiastic booming voice talking to someone over the phone about some scientific conference. I asked his secretary if it would be possible for me to see him, even if for five minutes. She told me to have a seat, and when he was off the phone, went in to tell him I was there, without an appointment. I heard him say, “Send Nick in, always happy to see him.”

My five minutes turned out to be an hour. I reviewed in great detail my meeting with Dr. Kelley and my belief that, despite the controversy swirling about his methods, he seemed to be serious about his work, perhaps even truly on to something. Dr. Good, who knew of the McQueen controversy, listened attentively, periodically interjecting comments or asking pertinent questions. He seemed genuinely intrigued. When I broached Kelley’s suggestion that I accompany him back to Dallas the following day, Dr. Good immediately told me that I should go, and not think twice about it. He was sure that Dr. Riker would understand. And Dr. Good then said what has remained with me for all the many years since that fateful meeting: even if Dr. Kelley turned out to be a total charlatan, I would learn a lot of medicine by going down to Dallas to sort out what was going on in his office. A student always learns best, he said, when pursuing a project of his own devising, rather than an assignment picked by someone else. I couldn’t have agreed more.

Dr. Good did offer some suggestions on how to proceed with my preliminary review. He asked that I try to locate charts of patients who had been appropriately diagnosed with poor-prognosis cancer and, by the standards of conventional oncology, were alive years beyond what would normally be expected. He seemed particularly interested in records of any survivors of metastatic pancreatic carcinoma, telling me that if I could find even one patient diagnosed with the disease who had lived five years on this nutritional regimen, he would be impressed, since to his knowledge no one else in medicine anywhere had such a case. Though a single example might not prove to everyone’s satisfaction that Kelley’s therapy had value, it certainly should grab the attention of any fair-minded researcher.

So the following day, I was on a plane with Kelley, to begin a search through his charts. Kelley, as promised, opened his patient files to me without hesitation. I spent many hours each succeeding day poring over his records, and what I found I thought was quite remarkable: patient after patient with properly diagnosed advanced cancer, including pancreatic carcinoma, who had done well under Kelley’s care, either in terms of disease regression or significantly prolonged survival.

After two weeks of nonstop work, I bundled up a bunch of Kelley’s charts along with my extensive notes and returned to New York. Dr. Good and I subsequently spent several hours together, reviewing what I had found, such as a patient with advanced metastatic pancreatic carcinoma, alive seven years after diagnosis, and another patient diagnosed with acute myelocytic leukemia, as deadly as pancreatic cancer, whose disease went into remission within months of beginning the Kelley treatment after chemotherapy proved ineffective. Dr. Good offered the usual caveats about my most preliminary of findings, but told me nonetheless he was impressed by the cases I had presented, impressed enough to encourage me to continue a formal investigation of Kelley’s records.

Over the next few weeks, as summer came to an end, I met several times with Dr. Good, as we gradually devised a plan to evaluate Kelley’s therapy. Dr. Good and I were on uncharted ground, since to our knowledge no academic group had ever attempted an objective evaluation of an unconventional therapy or practitioner.

Dr. Good did warn me early in our discussions that a retrospective evaluation of Kelley’s files such as he proposed could not be used to “prove” definitively the efficacy, or its lack, of Kelley’s approach. Only a prospective controlled clinical study could do that. But Dr. Good insisted that the project could yield useful data if done properly. He often remarked, not only to me but to others, that carefully documented case reports can teach us much about the potential of a new approach. Great advances in medicine often begin with observations of even a single patient whose disease might have taken an unusual course while receiving some new treatment.

As the plan took shape, Dr. Good suggested that I become familiar with the details of Kelley’s treatment, its theoretical framework, and any evidence from the medical literature to support his methods. That would be a first step. Then, to evaluate Kelley’s patients, he recommended a two-pronged approach. First, he proposed that I put together a series of 50 patients appropriately diagnosed with a variety of poor-prognosis cancers who subsequently did well, either in terms of documented disease regression or unusual long-time survival, which could only be attributed to the nutritional regimen. I was to write up each case at some length, providing along with my report copies of pertinent medical records to substantiate the diagnosis and response. Dr. Good said that if I could find 50 such patients from a single practitioner’s files, he would be impressed.

As a second component, Dr. Good requested that I track down every patient diagnosed with pancreatic cancer who had consulted with Kelley during a specific time period and write each of these up as well. Since pancreatic adenocarcinoma represents one of the most deadly, treatment-resistant cancers, Dr. Good believed that if Kelley had any success at all with this particular disease, the academic research world would have to take his treatment seriously.

I began the project in earnest during my third year of medical school, in whatever free time I might have in the evenings and on weekends. Unfortunately, that fall Dr. Good left Sloan-Kettering for the University of Oklahoma, far removed from the academic power centers of the East, to set up a cancer research center and bone marrow transplant unit. Before he left, he assured me that he would continue to guide and support my “Kelley study,” even long distance. Though I felt relieved that the project would continue, my dream of pursuing research under him at Sloan had come to a crashing end.

Despite Dr. Good’s absence, my investigation did progress, though slowly because of the enormous demands of the third year of medical school. But with Dr. Good’s help, the Cornell dean approved a four-month block of time allowing me to continue my investigation as an independent study during the fall of my fourth year. Although Dr. Good had departed from Cornell, he would continue as my research supervisor.

I spent most of the allotted time in 1982 at Kelley’s farm, situated in the Methow Valley of Washington State, in the foothills of the high Cascades. He had lived there from 1976 until 1981, while maintaining an office in the nearby town of Winthrop, population 200. After the McQueen fiasco, he had moved back to Dallas, where he had practiced for many years, but most of his records remained at his home in Washington.

I accomplished much during my stay in Winthrop, but the rigors of internship essentially put a stop to my efforts. Halfway through the year, Dr. Good invited me to join him in Oklahoma as a full fellow after finishing my internship – a position usually offered only after completion of residency. He wanted me to help staff the immunology and bone marrow service, but promised that I would have considerable time to continue my Kelley work. I accepted at once, and after completing my internship moved to Oklahoma.

With his blessing, I devoted most of my time there to the “Kelley study.” Then, after a year, I followed Dr. Good to All Children’s Hospital and the University of South Florida in Tampa/St. Petersburg, where he moved again to set up a cancer research program and bone marrow transplant unit. There, after another year of hard work in Florida, I brought my investigation to a close. By that point, I had interviewed and evaluated over 1000 of Kelley’s patients, concentrating on a group of some 455 who had done exceptionally well under his care, and put my findings into a monograph as partial fulfillment for my fellowship training.

In its writing, I adhered to the format suggested by Dr. Good for my overall approach to the research, with an introductory series of chapters describing in some detail the theory behind Kelley’s therapy, with supporting evidence if available. I also included in this first section a history of the trials he had endured over the years. I then presented in some detail 50 case reports representing 26 different types of cancer (counting the different subtypes of lymphoma as distinct neoplasms), with accompanying medical records. The monograph concluded with my evaluation of Kelley’s experience with pancreatic carcinoma.

The pancreatic part of my investigation proved to be most revealing. I eventually identified 22 patients with the diagnosis who had consulted Kelley between 1974 and 1982. I had been able to document that ten of the patients, all deceased, had not followed the program for a single day. In my interviews with surviving family members I learned that most had gone off to follow some other treatment largely because of opposition to this unconventional approach expressed by their doctors or family. For these, I determined an average survival of 63 days, quite typical for patients in that era with the inoperable form of the disease. This group, we agreed, could serve as an informal “control.”

A second group of seven patients, also all deceased, complied only partially and for limited time periods ranging from four weeks to 13 months, before abandoning the therapy. Again, surviving family members whom I interviewed reported strong opposition from the patients’ conventional physicians and/or relatives as the most common reasons for discontinuing the regimen. The mean and median survival for this group ran 302 days, certainly far longer than would be expected.

Five patients, all alive when I completed my research, had complied fully. The median and mean survival for this group exceeded eight years, certainly a remarkable statistic in view of the deadly nature of pancreatic cancer, with an average life expectancy reported in the range of 3 to 6 months.

When I handed my finished manuscript to Dr. Good in the spring of 1986, I felt a sense of accomplishment. Five years earlier, Dr. Good had presented me with a challenge, which I thought I had adequately met. And he, after reviewing the text over the following days, thought that I had found evidence to support my original belief that Kelley’s nutritional regimen might offer significant benefit to patients with advanced cancer.

Unfortunately, Dr. Good no longer had the financing, the resources, or the power base that would have allowed for further laboratory and clinical studies under his tutelage. After several conversations, we agreed that as a next step I should try to get the monograph published in its entirety as a free-standing book, with perhaps portions structured in article form suitable for the peer-reviewed conventional medical journals. Dr. Good thought that publication was essential to get the data out into the world to stimulate discussion, and hopefully encourage further research funding.

As for my own future, after finishing my fellowship, I decided to move back to New York to concentrate on getting the book and/or articles published – an effort that ultimately failed completely. Not that the monograph didn’t generate interest, for indeed it did. A top-flight New York literary agent agreed to represent the manuscript, which he thought might have an explosive effect in the scientific world. However, over the next year, no publisher, either trade or scientific, agreed to back the book, nor would any medical journal consider excerpting portions, even a case report or two. Some editors just didn’t believe that the records could be real, that an unconventional nutritional therapy could reverse advanced cancer. Others accepted the data as legitimate, but thought that the book would generate so much controversy that it might jeopardize their careers .

I still have in my possession one letter from that time, written by an editor of a well-known conventional medical journal. When the rejection letters from publishers began piling up, Dr. Good suggested that I send my monograph to this particular editor, a friend whom he had known for years, for his assessment. Before sending him anything, I first called the man, who seemed nice enough, and who expressed his extraordinary respect for the renowned Dr. Good. I subsequently forwarded the manuscript to him, hoping for a fair reading, perhaps even an offer to publish a case report or two. Several weeks later the editor wrote a blistering letter, not to me but to Dr. Good, saying that he had only read a few pages but that that was enough to know what he was dealing with. He warned Dr. Good that he had been “hoodwinked” by a typical “scam artist” – meaning me – who was about to drag him into fraud and controversy. Even Dr. Good, who had mailed me a copy of the letter, seemed shaken when we discussed the editor’s remarks over the phone.

Meanwhile, Kelley had closed his Dallas office for a variety of reasons, and was himself no longer seeing patients. I think he had become burnt out by years of hard work with the very sick, and by the relentless harassment by regulatory agencies, the conventional medical world at large, and the media. To make matters worse, his practice had never really recovered from the attacks brought on by his involvement with McQueen, so financially he was in terrible shape. Completely broke, Kelley moved to Philadelphia during the summer of 1986 to live with a former patient of his, a woman physician who later became his significant other. There he had intended to wait for publication of the book – which he saw as his professional salvation – but as the possibility of this outcome faded, Kelley lapsed into a severe depression.

We experienced a glimmer of hope in early 1987, while Kelley still lived in Philadelphia. I had learned of a government-sponsored investigation into alternative cancer therapies under the auspices of the Office of Technology Assessment (OTA), a now-defunct federal agency charged with evaluating controversial scientific issues at the behest of Congress. Word reached Kelley and me that activists within the alternative world thought that this project might be the big breakthrough that everyone hoped for, finally bringing recognition to legitimate unconventional approaches. And shortly after learning about the investigation, a representative of the OTA contacted me, having heard of my “Kelley manuscript” and wishing to see a copy.

I dutifully sent the monograph off, but then heard nothing for months. When I finally called the OTA myself to find out what had happened, a staff scientist who spoke with me seemed vague and noncommittal about the time line for the project. Subsequently, as the OTA study dragged on with no end in sight, Kelley became suspicious, even paranoid, at one point accusing me of being part of a CIA plot to steal his therapy for government, another time angrily saying that I had deliberately sabotaged publication of my own report. As his conversations became increasingly irrational, I finally ended all contact with him in July 1987, and never would speak to him again. Despite the unpleasant break, I actually felt sorry for him, suspecting that years of stress, the endless attacks, and his many disappointments had finally taken their toll. But still convinced of the value of Kelley’s therapy, and with the options dwindling, I decided to begin seeing patients myself, using the enzyme treatment. I thought that someone needed to keep the therapy alive, as Kelley himself deteriorated mentally.

By 1988, I had given up any hope of having the monograph published, but still thought that the OTA project might bring my research – and poor Dr. Kelley – the recognition that each deserved. Unfortunately, the OTA investigation seemed to be going nowhere, as 1989 came and went. But during that period, as our practice (that of myself and colleague Dr. Linda Isaacs) flourished, knowledge of my “Kelley study” began to spread, particularly within the alternative medicine underground, through a word-of-mouth network in those days before the Internet. Well-known activists and practitioners began to inquire about my research, and during the late 1980s, several widely read alternative journals discussed my “Kelley study” favorably. Robert Atkins, the famed diet doctor, invited me on his popular radio show several times specifically to discuss my investigation conducted under Dr. Good. Word even spread abroad; in late 1989, a mainstream journalist from Japan interviewed me for a planned book reporting on promising alternative approaches. (I still have a copy, in Japanese, with a photograph of my Kelley monograph prominently displayed.) Such exposure helped generate a great deal of enthusiasm for the manuscript, as evidenced by the frequent requests we began receiving for the book coming in from all over the country. We complied as best as we could, binding up multiple copies of the typed monograph to meet the demand.

A short time afterward, in February 1990, the OTA finally released its preliminary report, running over 500 pages. Despite all the initial hopes that this would be an objective evaluation of promising unconventional methods, the OTA document was little more than an inept boondoggle, considered by many to have been organized for one purpose: to discredit alternative approaches to cancer once and for all. The monograph did include an 11-page section on Kelley, clearly created to portray him in as negative light as possible. Though the OTA writers devoted three pages to discussing Kelley’s legal problems over the years, nowhere in the text did they even mention my intensive study of his records – though by that point they had had a copy of my monograph in their possession for three years. It was as if my lengthy effort just never happened. One would have thought that the OTA, if sincerely interested in an objective scientific assessment, would have featured my monograph and my research project, representing as it did the first attempt by an academic group to evaluate a nontraditional cancer treatment.

The OTA’s missteps did not go unchallenged. During subsequent hearings in Washington, both members of Congress and activists blasted the agency for its biased report, which seemed to have deliberately excluded any information that might support the efficacy of any alternative approach. In particular, the exclusion of my monograph, the existence of which by that time was no secret, created quite a stir. Though I didn’t attend the hearings, I have been told that at one point a well-known journalist and alternative proponent waved a copy of my manuscript in front of the assembled Congressional committee and OTA staff, then threw the hefty document across the room.

Though the OTA was sternly instructed to redo its investigation and rewrite its official review, the final version appearing in late 1990 seemed to me only more of the same. Now forced to include mention of my five-year “Kelley study,” the OTA writers appeared to me determined to give it as little credit as possible. Unfortunately, critics of alternative medicine still reference the report 18 years later as if it were a legitimate study, instead of what it really was: a badly conceived and ineptly conducted waste of government money.

In the early 1990s, for reasons I still don’t understand, Dr. Kelley actually sued both Dr. Good and me in Pennsylvania. From my readings of the court papers, which Kelley apparently wrote himself, he seemed to be accusing Dr. Good and me of colluding to prevent publication of my own manuscript! The case was quickly thrown out when Kelley, acting as his own lawyer, threatened a judge at a preliminary hearing. He was banned, I have been told, from ever again entering a Pennsylvania court. I am sure that this little episode did not endear Dr. Kelley to my former mentor Dr. Good.

In the years since, our practice, our reputations, and all too often, the controversy surrounding our work have continued to grow. And along the way, my Kelley study remained a lightning rod for both sincere interest and dismissive criticism, the latter usually expressed by those who never have seen the manuscript. The situation reached an odd climax of sorts in 1995, when a frail Dr. Good, long outside the academic mainstream, appeared on a national television show, claiming that the patients in my evaluation study “didn’t have cancer.” His statement I thought bizarre, since he himself had reviewed all patient records and in many cases the pathology slides, before approving each case included in the monograph. He was afraid, I suspect, of being dragged into a major controversy about an alternative nutritional treatment for malignant disease. Even if Kelley had become a nuisance by that point, and a persistent one at that, Dr. Good still should have told the truth – after all, it’s the responsibility of any scientist to do so.

Despite all this, we have fortunately attracted considerable interest and support from both industry and government; over the years, Procter & Gamble and Nestlé have invested considerable time, effort, and money to help us develop and research our treatment methods. We have presented at the National Institutes of Health (NIH), before the National Cancer Institute (NCI), and before a Congressional hearing, and have completed a pilot study of our treatment, funded by Nestlé, in patients with advanced pancreatic cancer. The very positive results from this preliminary clinical trial, which we published in the peer-reviewed literature in 1999, led the NCI to approve funding for a large-scale investigation of our work, comparing our nutritional approach with the best available chemotherapy in patients diagnosed with advanced pancreatic cancer. This project represented the first effort of the government institutions to test a primary nutritional/alternative treatment in a head-to-head comparison with a conventional approach against a very deadly disease. This study certainly generated considerable interest and once again controversy, prompting the normally staid New Yorker magazine to publish a lengthy and generally flattering profile of me in February 2001. The writer, Michael Specter, discussed at some length – and with great, much appreciated objectivity – my Kelley investigation of years earlier.

Though we initially approached our NCI-NIH project with great enthusiasm, unfortunately, after eight years and thousands of hours of hard work on our part, the trial deteriorated into a morass brought on by poor management on the part of the staff heading the trial. Overall, we believe that the project fell victim to the same biases that infected the OTA investigation of 15 years earlier, biases that we think ultimately sabotaged the study.

Dr. Good died in 2003 of esophageal cancer at age 81, I suspect still worried that he would be dragged into some sort of scandal over his involvement in supervising my Kelley study. I hadn’t spoken to him since 1987, when I first set up my practice in New York. In January 2005, Kelley succumbed to congestive heart failure, brought on by damage done by his cancer of 40 years earlier. He died angry and alienated from just about everyone, having for some time used the newfound power of the Internet to spew forth bizarre political ideas, infused with a strong dollop of anti-Semitism. Often, I seemed to be the target of his venom. But I nonetheless forgave his misguided wrath, brought on by years of rejection by the academic world and the media, and too often their vicious disdain. Despite his eccentric behavior in later years, in his theories of “metabolic typing” and in his use of enzymes and detoxification routines, Kelley was surely on to something. I still think of him as a most brilliant man, perhaps the most brilliant of all the many smart people I have had the good fortune to meet over the years, including more than one Nobel Laureate. But he was so far ahead of his time – perhaps outside of his time is a better way to think of him – that he simply fell off the edge of the universe.

With the collapse of our NCI-NIH study, we have decided to begin publishing a series of books on the history, theory, and application of our nutritional therapy. As part of this effort, we realized that it was finally time, after all these years, to make my Kelley study available for the first time in book form. This project and this monograph started me on my journey, and we think it appropriate, with all the interest and controversy it has generated, to get the document out into the world so that those who wish to know more about us can review the work and judge it for themselves. I believe that open-minded readers will find the time well spent and, hopefully, appreciate the effort that went into this five-year project.

Certainly, this monograph has had a most unusual history over the past 22 years, particularly when one considers that it has not even been previously formally published. It has been the subject of a misguided federal review, thrown across a Congressional hearing room, discussed at length in a Japanese book, litigated in a Pennsylvania courtroom, debated on national TV, and described in the pages of the erudite New Yorker. It has been lauded as a major breakthrough against cancer, dismissed as inconsequential, and despised as dangerous quackery.

When I myself look at the monograph, at what I accomplished against all odds beginning nearly three decades ago, I clearly remember how determined I was to do the job right. My Kelley study may not have been perfectly executed, and it may never satisfy the critics who see nothing good in what we do, but none of that matters to me today. When all is said and done, it was above all a most honest effort, pursued with the enthusiasm of a young scientist just feeling the excitement of real discovery; and the memory of that excitement will never be tarnished by any criticism, however strong or persistent. Discovery is of course the essence of all scientific inquiry; and I am only and forever grateful that I had the opportunity to have been allowed, even briefly, to experience that unparalleled joy. In his or her lifetime, a scientist could hope for no greater reward than that.

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