Kelley, William Donald, DDS; Gonzalez, Nicholas, MD; Cancer; Pancreatic cancer; Kelley nutritional cancer treatment
One Man Alone: My Investigation of Dr. William Donald Kelley
by Nick Gonzalez, MD
In July 1981, after my second year of medical school at Cornell, a good friend and successful writer called me asking if I knew anything about Dr. Kelley and his strange nutritional treatment for cancer. I had certainly heard of him by that point. Some eight months earlier, his name had been splashed across all the newspapers and TV news shows, vilified as the practitioner supervising the treatment of the actor Steve McQueen, who in November 1980 had lost his battle with advanced mesothelioma. 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 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 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 money-driven “quack” portrayed in the media. She instead found him painfully shy, convinced that his therapy had value and devastated by the media assaults.
Apparently, Kelley himself had survived terminal pancreatic cancer in the early 1960s, when he still practiced conventional orthodontics. With four young children, and facing an early death, Kelley desperately sought some way to beat the disease. Through trial and error, 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 cancer. The rest, she said, with some irony, was history.
At this point in his life, Kelley said, he only wanted to have his regimen fairly evaluated in clinical trials. When she asked him to explain his treatment, a 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. As she told me, she couldn’t be sure if Kelley was 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 tracked him down. In some frustration, Kelley began a train trip to New York, where he intended to stay for several days before flying back to Dallas. My friend wanted to meet with him in person during his stay, to explore the possibility of a book, and wanted me to meet with him also, to help her determine if he was crazy, brilliant, or perhaps both. I had seven years’ journalism experience under my belt before going to medical school, so she thought my combination of reporting and scientific training might help her sort through Kelley’s level of authenticity. Initially, I balked, having little interest in meeting some controversial alternative cancer therapist. But she persevered, and at last I agreed .
I remember 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. At our first meeting, he was indeed shy, so soft-spoken that initially I had trouble hearing him. We sat together awkwardly 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. But when I asked him about his treatment, quickly his face became animated, his voice strengthened, and the words began to flow. With great authority he discussed his concepts of autonomic physiology, the use of diet and supplements to manipulate the nervous system, the British embryologist 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.
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 scrutiny. Here, Kelley told me that this was just what he wanted—and apparently for all the right reasons.
Fortunately, one of my Cornell mentors was 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 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 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 him regularly to discuss my interest in cancer research, an interest he encouraged enthusiastically.
As I sat across from a now-enlivened Dr. Kelley, 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 agreement—Dr. Good had told me 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 records. I told him that I was in the middle of a commitment, and I couldn’t be sure whether Dr. Good would even be interested in such a project. But I admired Kelley’s no-nonsense approach and agreed to try to speak with Dr. Good that afternoon.
After the meeting, I immediately went up to Dr. Good’s office atop the main Sloan-Kettering building. When I arrived, 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 went to tell him I was there. 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 around his methods, he was perhaps truly on to something. Dr. Good, who knew of the McQueen controversy, listened attentively. 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. And then he said what has remained with me for all the years since that fateful meeting: even if Dr. Kelley turned out to be a charlatan, I would learn a lot of medicine by trying 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 chosen 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, saying 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 seize the attention of any fair-minded researcher.
So the following day, I went to Dallas. 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, 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.
Second, he 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. Unfortunately, that fall Dr. Good left Sloan-Kettering for the University of Oklahoma to set up a cancer research center and bone marrow transplant unit. He assured me that he would continue to guide and support my “Kelley study,” even long distance.
Despite Dr. Good’s absence, my investigation did progress, though slowly because of the enormous demands 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 my fourth year. Although Dr. Good had left Cornell, he would continue as my research supervisor.
I spent most of the allotted time in 1982 at Kelley’s farm, in the foothills of the high Cascades. I accomplished much during my stay, but the rigors of internship essentially ended 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.
Once in Oklahoma, I devoted most of my time to the “Kelley study.” 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, 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, and put my findings into a monograph as partial fulfillment for my fellowship training.
I began with a series of chapters describing the theory behind Kelley’s therapy, with supporting evidence if available, as well as a history of the trials he had endured over the years. I then presented 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 relatives, 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 of three to six months.
When I handed my finished manuscript to Dr. Good in the spring of 1986, I felt a sense of accomplishment. 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.
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.
After finishing my fellowship, I decided to move back to New York to concentrate on getting the monograph published—an effort that ultimately failed completely. Not that it 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. Some editors just didn’t believe that the records could be real. Others accepted the data as legitimate but thought that the book would generate so much controversy that it might jeopardize their careers.
Meanwhile, Kelley had closed his Dallas office and was no longer seeing patients. His practice had never really recovered from the attacks brought on by his involvement with McQueen, so financially he was in terrible shape. He moved to Philadelphia during the summer of 1986 to live with 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 I heard about the investigation, a representative of the OTA contacted me, wishing to see a copy of the “Kelley manuscript.”
I sent the monograph off, but then heard nothing for months. When I finally called the OTA to find out what had happened, a staff scientist who spoke with me seemed 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, never to speak to him again. 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. But 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. 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. Such exposure helped generate a great deal of enthusiasm for the manuscript, as we began receiving frequent requests for the book from all over the country. We complied as best as we could, binding up multiple copies of the typed monograph to meet the demand.
In February 1990, the OTA finally released its preliminary report. Despite all the initial hopes that this would be an objective evaluation of promising unconventional methods, the OTA document was little more than a 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 as negatively as possible. While three pages were devoted to discussing Kelley’s legal problems, nowhere did they even mention my intensive study of his records—although they had had a copy of my monograph for three years. One would have thought that the OTA, if sincerely interested in an objective scientific assessment, would have featured my monograph and 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, members of Congress and activists blasted the agency for its biased report. In particular, the exclusion of my monograph created quite a stir. The OTA was sternly instructed to redo its investigation and rewrite its official review; however, the final version appearing in late 1990 seemed to me only more of the same. Now forced to include mention of my Kelley study, the OTA writers still seemed determined to give it as little credit as possible.
In the early 1990s, 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.
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. We have fortunately attracted considerable interest and support from 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 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 author, 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, 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 staff. Overall, we believe the project fell victim to the same biases that affected the OTA investigation of 15 years earlier.
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, having for some time used the internet to spew bizarre political ideas, infused with a strong dollop of anti-Semitism. Often, I seemed to be the target of his venom. But I forgave his misguided wrath, brought on by years of rejection by the academic world and the media. In his theories of “metabolic typing” and 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 met over the years. But he was so far ahead of his time, he simply fell off the edge of the universe.
With the collapse of our NCI-NIH study, we have begun 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 to make my Kelley study available 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 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.
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.
Those interested in the complete monograph can learn more about it at www.dr-gonzalez.com.
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