The explanation you give of the curtailment of the Gonzales study is a mainstream fiction.

The Truth About The NCI-NCCAM Clinical Study

Re: Gemcitabine Compared With Pancreatic Enzyme Therapy Plus Specialized Diet (Gonzalez Regimen) in Treating Patients Who Have Stage II, Stage III or Stage IV Pancreatic Cancer.

Project Number: P30-CA13696

Many of you are aware that in 1998, the NCI approved funding for a large scale clinical study, in which my nutritional-enzyme therapy would be compared to the best available chemotherapy in the treatment of patients diagnosed with inoperable pancreatic cancer. My colleague Dr. Linda Isaacs and I initially approached this project with some enthusiasm, believing it to be a wonderful opportunity to bring the conventional academic world and “alternative” researchers, so often at odds, together for the benefit of science and for patients suffering terrible illness. But as the years passed we came to realize with some disappointment that there was no new dawn breaking, no new age of cooperation between the academic and alternative universes, that the same biases against treatment methods developed outside of the mainstream still reigned supreme, and that scientists and physicians at the highest levels of academia would do anything, even change the truth to prove an unconventional therapy has no value. Eventually, under the direction of the supervisors from Columbia (the site for the project), from the National Cancer Institute (NCI) and the National Center for Complementary and Alternative Medicine (NCCAM), the study degenerated into a morass of mismanagement, meaningless and manipulated data, the welfare of patients put at risk, and sadly, cover-up of the mismanagement right into the office of Dr. Elias Zerhouni, former NIH Director. Repeatedly now we’ve seen the meaningless data of a mismanaged study used in the effort to “prove” my treatment worthless, and undermine my 28 years of hard, determined research.

In August 2009, I learned quite serendipitously that Dr. John Chabot, the Principal Investigator at Columbia, along with his Columbia cohorts had managed to publish an article in the Journal of Clinical Oncology that implies falsely the study proves chemotherapy more effective than my treatment. Even as I write this article, the JCO paper is being widely disseminated through the internet as if it were a legitimate report of a well run study with no questions asked. My enemies particularly, and the enemies of alternative medicine in general, have latched on this article and its purported data as a tool that can finally, once and for all, discredit and silence me.

But the truth, as I will show, is quite different from what Dr. Chabot and colleagues would like the world to believe. As a start, though the article claims that the clinical trial in question proves chemotherapy far superior to my nutritional-enzyme regimen, it illustrates only that a group of patients intensively treated with the triple agent chemotherapy regimen GTX (Gemzar, Taxotere and Xeloda), and provided the most aggressive high-tech supportive care available in the US, fared better than a group of largely untreated or minimally treated patients with advanced pancreatic cancer given little supportive care, who were dubbed “Gonzalez” or “enzyme” patients. Dr. Chabot, in charge of patient selection for the greatest part of the study, repeatedly entered patients who did not fulfill the specific entry requirements, and who were far too ill to comply with the dietary-nutritional treatment.

Furthermore, reading the JCO article, one would not realize that the project was beset by managerial lapses almost from its inception, and that the Office of Human Research Protections, an oversight group at the NIH, at our request conducted a two year investigation of the study’s supervision under Dr. Chabot. The OHRP findings, as posted on their website, reveal that Dr. Chabot, solely in charge of evaluating and approving study candidates for entry for the greater part of the study, had admitted 42 out of 62 total patients improperly, including 40 who were not appropriately consented – a devastating finding of managerial failure. Appropriate informed consent is of course a basic tenet of any legitimate clinical exercise, yet Chabot failed even to mention the OHRP investigation or findings in his JCO article, a deliberate and very serious oversight. Nor does the article inform the reader that right now the Inspector General’s office of the Department of Health and Human Services, at my request and at the request of Congressman Dan Burton of Indiana, has launched an investigation to help determine if the activities of Dr. Chabot and the other managers go beyond simple mismanagement, into collusion to cover up the mismanagement and use corrupted data to undermine my treatment.

Though the grant was originally approved at the NCI solely because of my efforts, though the grant was awarded to study my treatment, though Dr. Isaacs and I were in charge of treating all nutrition patients and remained investigators throughout, I was unaware that the Columbia team was attempting publication in JCO. I believe Chabot tried to sneak this article into the peer reviewed literature without my knowledge to discredit me, create a firestorm, and blunt the Federal investigations into his mismanagement of the study that are currently in progress. Bizarrely, neither the peer reviewers assigned to assess the article for JCO nor the journal editors bothered to contact me, to ask why I was not listed as a co-author on an article evaluating a study that existed only because of my work and efforts. In fact, we first learned of the article’s publication through the National Library of Medicine alert system. The day we became aware of the article on August 20, 2009 I filed a formal complaint of misconduct with the editors at JCO, who admitted to me they knew nothing about the OHRP investigation or findings, or even that I was an active participant in the study. If you read the article you will note that Chabot craftily nowhere states that Dr. Isaacs and I were in charge of treating all nutrition patients, hoping perhaps to minimize the chance the JCO editors would contact me and hear our side.

I have recently completed a lengthy manuscript on the mismanagement, written so that the supervisors at Columbia, the NCI and NCCAM could not ultimately cover up and bury their actions. Though the issues discussed at length in the book are many and complex, the problems with the trial can be summed up in three categories; multiple instances of gross mismanagement by Dr. Chabot and the NCI and NCCAM supervisory personnel as now confirmed by official government investigations; attempts to cover up the mismanagement right up to the office of Dr. Zerhouni, NIH Director and in the published article; and most tragically, the deliberate attempts using various approaches including changing data to insure my treatment would appear worthless.

Many of you know the background of my treatment, but I think a brief retelling might be helpful. In 1981, as a medical student working under Dr. Robert A. Good, at the time Director of the Sloan-Kettering Cancer Institute, I became aware of the work of Dr. John Beard, the English scientist who more than 100 years ago first proposed that pancreatic enzymes – normally thought to serve only a digestive function – represented the body’s main defense against cancer, and would be useful as a cancer therapy. Though at the time many physicians utilizing Beard’s enzyme approach reported good success with the treatment, the conventional medical world never accepted Beard’s hypothesis, and when he died in 1924, he died in obscurity. Subsequently, innovative researchers rediscovered Beard’s thesis and kept the idea alive, though to date only on the fringes of the academic medical world. Over the years, the followers of Dr. Beard, particularly the controversial dentist William Donald Kelley, have expanded the original concept to include individualized dietary and nutritional supplement protocols.

I learned of Beard’s work from the late Dr. Kelley, who used the enzyme therapy with some evident success in his patients diagnosed with advanced cancer. Subsequently my research into the enzyme approach convinced me that Beard and his proponents were correct about its value against advanced cancer, and I have devoted my professional life to getting the treatment the recognition I believe it deserves.

Note that my work has been reviewed and funded in amounts of many millions of dollars by both The Procter & Gamble Company and Nestle, two very conservative companies. Statements of support are on my website from Dr. JP Jones, former Vice President for Research at P&G (now retired) and Pierre Guesry, M.D., former Vice President for Research at Nestle (also now retired) and formerly Medical Director of the Pasteur Institute. Dr. Jones while at P&G nurtured and funded the work of Dr. Barry Marshall - whom all thought was crazy for suggesting bacteria cause ulcers, but who ultimately earned the Nobel Prize for his controversial thesis.

In 1993, I first presented cases from my private practice at the National Cancer Institute, as part of their initial efforts to evaluate unconventional approaches to cancer. As a result of that meeting, the NCI suggested I pursue a pilot study of patients with appropriately diagnosed inoperable pancreatic cancer who had no viable options within the conventional medical world. This study was supervised by eminent academicians, brought to completion without difficulty, and the significantly positive results – the best ever reported in the literature for advanced pancreatic cancer - were published in a peer reviewed journal in June 1999.

Based on the preliminary data from that study, in 1998 the NCI Director at the time, Dr. Richard Klausner, approved funding in the amount of $1.4 million for a phase III controlled trial in which my nutritional-enzyme regimen would be compared to the best available chemotherapy, again in the treatment of patients with inoperable pancreatic adenocarcinoma. Columbia University Medical Center in New York, at the urging of Dr. Karen Antman, at the time Director of Oncology there, agreed to be the home site for the clinical trial, with Dr. John Chabot, Chief of General Surgery, as Principal Investigator. Dr. Wendy Smith and Dr. Jeff White were assigned to supervise the study within the NCI.

As the project developed the National Center for Complementary and Alternative Medicine suggested they be involved and offered to provide the actual funding, which the NCI agreed to accept. Dr. Linda Engel and more recently, Dr. Jack Killen were assigned from the NCCAM office to help oversee the project. Eventually, the protocol received appropriate Columbia IRB, NCI and FDA approval.

It is important to remark, in terms of the nature of the misconduct evident in the handling of this study and its data, ours is a lifestyle and intensive nutritional treatment that patients must pursue on their own at home, unlike chemotherapy that only requires patients show up in the doctor’s office. Patients must diligently follow a prescribed diet, and ingest some 150 or more supplements to be taken at precise times throughout the day. The pancreatic enzyme component of the therapy, which we believe provides the main anti-cancer effect, is currently unavailable in intravenous or intramuscular forms and must be taken orally. We frequently prescribe up to 100 capsules or more of these enzymes in divided doses daily so patients must be able to swallow to succeed with the regimen. Since patients administer the therapy at home, they must be able to care for themselves to some degree; those bedridden, or extremely debilitated, in the final stages of the disease, or those requiring hospitalization, cannot proceed with the therapy. We have no illusions about our approach; we cannot help someone days from death, nor would we ever attempt to treat such a patient in our private practice.

By its very nature, the regimen requires discipline and some determination, as does any lifestyle intervention; patients must be motivated, or else, as we learned long ago, they will not follow through with its day to day application. And patients with obvious mental illness most likely cannot effectively pursue this treatment.

Initially, Dr. Antman agreed that in order to achieve our goal, a fair evaluation of my therapy, we needed to enter patients into the nutritional arm physically able, psychologically capable and emotionally willing to adhere to the therapy. Admission of those too ill to proceed with the treatment, such as patients unable to eat, mentally ill patients, or subjects with little discipline or motivation could lead easily to epidemic poor compliance and meaningless results.

As the final written protocol for study took shape in 1998, I worked with Dr. Antman and the late Dr. Ernst Wynder, a strong supporter and expert in clinical trial design, to define the precise entry requirements for patients that would help insure the admission of subjects capable of complying with the prescribed nutritional regimen. Eventually, Dr. Antman and her team at Columbia, who were in charge of formulating the final written protocol, incorporated many of our suggestions into the final draft to help assure, at least on paper, that only suitable candidates would be entered. As a start, all patients, to be eligible, had to be admitted into the study within eight weeks of biopsy diagnosis. Since inoperable pancreatic cancer represents one of the most aggressive and deadly of malignancies, it seemed reasonable to enter patients within a specified time frame after diagnosis. In addition, to be eligible, study candidates had to be able to eat normally or near normally, an absolutely critical requirement for our dietary and nutritional therapy.

Candidates had to be free of any form of mental disability “preventing informed consent or intensive treatment,” to quote the written protocol for the trial, and express the motivation to pursue the home-based treatment plan. Furthermore, the rules of the study required each patient have at least one supportive live-in family member, willing to help with the nuts and bolts of the treatment. We long ago learned that those with advanced cancer need assistance on a daily basis to comply appropriately with the regimen. Finally, each patient seeking entry who met all these basic criteria was to sign an official statement of informed consent as required for all NCI clinical trials, acknowledging the purposes, risks, and possible benefits associated with the nutritional therapy.

Though Dr. Isaacs and I began this clinical trial with considerable optimism, as time passed we realized that the team from Columbia under Dr. Chabot, as well as the supervisors from the NCI and NCCAM seemed to have little incentive to bring the trial to a legitimate and successful completion. Trouble began in earnest in July 2000 when at the insistence of the National Cancer Institute, Dr. Isaacs and I were removed from any involvement with the evaluation and admission of candidates into the nutritional arm of the trial, leaving the Principal Investigator, Dr. John Chabot, with absolute total dictatorial control over patient admission to both groups, with no appeal possible. The NCI rationalized our exclusion from this all-important process claiming that our involvement would open the way to some sort of ill-defined “bias.” However no one supervising the study from the NCI or NCCAM ever considered that Dr. Chabot had arrived with his own set of biases – including a serious and undeclared conflict of interest that should have prevented him from serving as Principal Investigator for the study. As discussed below in some greater detail, as the study reached its conclusion, we learned solely through our own investigations that Chabot, working with his Columbia colleagues, had helped develop the very chemotherapy regimen being used against our treatment in this clinical trial – giving him a significant vested interest in “proving” his own chemotherapy regimen superior to our nutritionally-based regimen.

I will sum up the major points illustrating the mismanagement, its cover-up, and what we believe to be the use of corrupted data to undermine our treatment. In the following discussion, I list events in chronological order.

1. The grant for this study was originally awarded to me directly by the NCI in 1998, though NCCAM eventually agreed to fund the full project. When Columbia agreed to be the study site, the money then went directly to Columbia, but it was originally awarded because of my efforts. Strangely, when we last checked the Columbia official website, under Chabot's biography he lists my grant as his, as if he had earned it. This is completely false. The fact is, the grant was approved and awarded during a face-to-face meeting between me and the then NCI Director, Dr. Richard Klausner, held in the office of Congressman Dan Burton. At least nine other people witnessed this meeting, including NCI staff accompanying Dr. Klausner, at least one member of Congressman Burton's staff in addition to the Congressman himself, several officials from the NIH, and at least one non-government expert. During this meeting Dr. Klausner stated that based on the promising preliminary pilot study results (the data had not yet been formally published) the NCI would support a large scale, controlled trial of my therapy in patients diagnosed with advanced pancreatic cancer. At that point, I had never even heard of Chabot and he had nothing to do with the earning of the grant.

2. My colleague Dr. Linda Isaacs and I were investigators throughout the study’s duration, from its beginnings in 1998 to its end. This is an important point, because Dr. Chabot has falsely claimed that we quit the study.

3. We hoped that the explicit entry criteria would offer us at least some protection from the admission of trial subjects unsuited for our nutritional therapy. Nonetheless, despite the clearly written requirements, over the years of the study Dr. Chabot repeatedly entered patients into the nutritional arm that we believed failed to fulfill one or more of the objective criteria. Three patients assigned for treatment with us despite our objections had been diagnosed by biopsy well over 8 weeks before entry, and should not have been admitted. Many accepted patients were in the final terminal stages of their disease, obviously too debilitated (one arrived in our office in a wheelchair unable to stand) to proceed with the therapy. We have identified 11 patients entered into the nutrition arm whose appetites were so poor they could never possibly have adhered to the prescribed regimen.

Dr. Chabot admitted three patients who, because of mental disability, we believe should have been disqualified, and one with no family or social support. We estimate that another 10 of the admitted patients lacked the drive, motivation, or faith in the treatment to stick with it for any length of time. And finally, Dr. Chabot sent three patients for treatment with us as if they had been properly consented who, as it turned out lacked any evidence of the required signed informed consent, in obvious violation of the written protocol and Federal regulations.

Discounting overlap – several patients should have been disqualified for more than one reason – we estimate conservatively that 16 individual patients of the 39 admitted into the nutrition arm did not fulfill the written entry criteria. And though we complained about the problem repeatedly to the various study supervisors, Dr. Chabot insisted we had to treat the patients in question nonetheless.

4. Dr. Isaacs and I were particularly concerned about the entry of patients who had not been properly consented. By 2003, we were aware that Dr. Chabot had entered three patients into the nutritional arm for whom no evidence of signed informed consent existed. In the first case, Dr. Chabot’s own staff admitted the form had never been signed. We spent over two years attempting to find out what happened to the consent forms in the other two cases, during which time Dr. Chabot failed to provide a reasonable explanation for the oversight. His mishandling of informed consent in these three patients represented to us evidence of very serious managerial lapses.

5. Frequently, even in those cases where Dr. Chabot did qualify patients within the eight week cutoff, he kept them waiting many weeks before rendering his decisions about their eligibility for the nutrition arm - five weeks in one case between the first contact of the patient with Chabot's office and his official approval for entry. During this time, as they waited for Chabot’s decision, these patients, all diagnosed with advanced pancreatic cancer, received no treatment. We believe such delays not only helped undermine the legitimacy of the data, but put patients’ welfare at risk, depriving them of their window of opportunity for response. All of this I document, case by case, with the actual records to prove the point, in my manuscript which we plan to publish.

Overall, we have calculated that 26 of the total of 39 patients admitted into the nutrition arm had been diagnosed by biopsy four or more weeks before meeting with us for their initial consultation, and 17 had been accepted six or more weeks from biopsy. We have calculated for all 39 nutrition patients an average delay between biopsy diagnosis and entry into the study of 36 days, or slightly more than five weeks – not insignificant for a disease as relentlessly aggressive as pancreatic adenocarcinoma. Since it takes at least another week for patients to order and receive the supplements and begin the therapy after their visit, it isn’t surprising that with so much valuable time lost, many nutrition patients were, at the point they tried to begin the regimen, simply too sick to comply.

One patient, diagnosed with liver metastases, not only was entered more than four weeks after biopsy, but upon returning home and before he could begin his treatment had to be hospitalized due to an intestinal obstruction, the result of adhesions forming after a previous operation for kidney cancer. After emergency surgery he remained hospitalized for a full five weeks before discharge, at which time he tried to begin his therapy, having lost considerable treatment time. He could never adequately comply but Dr. Chabot insisted this patient be considered a properly entered, properly treated Gonzalez failure.

We do not know how quickly the chemotherapy patients were admitted into the study to begin treatment after their biopsy, since Dr. Chabot never shared that information with us. We do know from our long experience with evaluating patients diagnosed with pancreatic cancer that most begin conventional treatment quite soon after diagnosis, often within 24-48 hours. Since the disease is so deadly, usually the oncologists mobilize very quickly. We wonder if for those patients diagnosed at Columbia – known as a center for the aggressive treatment of the disease - this rule would have applied. Of course, some of the group may have been diagnosed at an outside hospital, then referred to Columbia for treatment, but even in these cases, we doubt that the lag time between diagnosis and the beginning of therapy would have routinely been six or more weeks – even 10 and 11 weeks - as was true with the nutritional patients. Unfortunately, we just don’t know the whole story. But if there was a significant difference in the average time lag between diagnosis and the beginning treatment in the two groups, such a discrepancy would make comparison even more meaningless – particularly for an aggressive disease like pancreatic cancer, where the window of opportunity for response to therapy can be measured in weeks.

6. There were two standards for patient care for each of the two arms. All of the chemotherapy patients were treated at Columbia under the supervision of Dr. Robert Fine, who has achieved some fame in the field for his very aggressive supportive care given to patients with pancreatic cancer. On the other hand, our patients, who lived all over the country, were left to fend for themselves, only in one case given the type of supportive care offered the chemo patients.

7. In December 2004, at a time 35 of 39 nutrition patients had been entered, we first became aware that Dr. Chabot had admitted patients diagnosed with far more advanced disease into the nutrition arm, compared to those qualified for chemotherapy. Specifically, by that point, approximately 68% of the patients admitted into the nutrition group had been diagnosed with advanced stage IV disease (the worst), the great majority too ill to comply with our treatment. Among the chemotherapy patients, 38.5% were at stage IV. This imbalance made the data even more meaningless.

8. Dr. Isaacs and I were concerned about the number of patients admitted who did not satisfy the written entry criteria for the study – but also, by the large number of subjects entered who never, or just briefly, or incompletely followed the prescribed nutritional regimen. Many of the non-compliers, often admitted despite our protests, were so physically disabled they simply could not follow the program; others were psychologically or emotionally unsuited to comply with a self-administered nutritional therapy. Others, though technically meeting the entry criteria, simply chose not to comply. Whatever the causes might be, by the end of the project we calculated that at most perhaps six patients of a total of 39 qualified for the nutrition arm – and even this is a liberal accounting - actually adhered to the treatment plan to any significant extent.

9. Unfortunately, at the insistence of Dr. Antman the written protocol, against our objections, contained an “intent to treat” provision, meaning that any patient sent to us, even if the patient never followed the program for a single day, would be included in the data tabulation as a “Gonzalez patient” and as if fully compliant. Consequently, the great number of patients, the majority in fact, admitted into the nutrition arm by Chabot who did not comply, because of this “intent to treat” rule, would all be considered “Gonzalez enzyme treatment failures”. In essence – as we warned the various supervisors – Dr. Chabot, whether deliberately or not, eventually created a group of largely untreated patients labeled as the “enzyme arm” who were being compared to patients aggressively treated with chemotherapy – and provided all the high-tech supportive care available at Columbia.

10. Based on the many serious problems evident in the management of the study, throughout 2004 and into early 2005 at the regularly held group meetings we expressed our grave concern that under Dr. Chabot’s direction many patients had been admitted into the nutrition arm unable to comply, such as those unable to eat adequately, and ultimately that the data was meaningless. In frustration with the lack of response from Dr. Chabot and the NCI-NCCAM team, I wrote a 29-page letter to the chief NCCAM supervisor, Dr. Jack Killen, a career NIH oncologist, dated January 7, 2005. In this letter, I detailed many instances of patients admitted into the nutrition arm whom we believed did not meet the entry requirements, who were unsuited for any number of reasons for our rigorous nutritional therapy, and who ultimately did not comply. I also carefully addressed the evidence showing that Dr. Chabot was admitting healthier patients into the chemotherapy arm compared to those whom he qualified for our nutritional treatment.

11. In response, and based on my assessments and complaints, Dr. Linda Engel, the official NCCAM spokesman for the study, wrote a letter to Dr. Chabot, copied to me, dated January 27, 2005, in which she clearly acknowledged the legitimacy of my concerns. She concurred with my conclusion that with the entry of so many patients to the nutrition arm who had failed to comply adequately, the data for the trial had no meaning. In the letter she states in part:

There have been numerous and very difficult scientific, operational, and procedural challenges in carrying out this trial. These have been well documented and frequently discussed.

…In spite of everyone’s best efforts, it appears as if the current design and implementation of the study may have resulted in accrual into the two study arms of patient populations that are not comparable. As a consequence, it is very difficult (if not impossible) to ascertain treatment effect with certainty.

Given all of the challenges, the surprising outcomes, and the uncertainties about balance between the two arms, it is highly likely (if not certain) that reviewers of the data from this study will raise substantive and legitimate concerns about the comparability of the two populations. As a consequence, it is virtually certain that the controversy surrounding the study will not be settled by the data from it.

Dr. Engel then discussed the value of continuing the study as it has been designed and implemented:

The December 13 discussion with the team was very illuminating in that nothing materially altered this assessment. With respect to the specific matters raised in Dr. Gonzalez’ letter, we will make only two brief comments:

We discussed at considerable length his concerns about the probable accrual of patients unable to comply fully with the nutrition arm of the protocol. It was our impression that everyone in the room basically agreed that, despite best efforts, there is in fact, reason to be concerned about this issue, and that it clouds interpretation of the data.

12. Despite his promises to us in early 2005 that in the future he would enter more suitable subjects, Dr. Chabot continued sending us patients for treatment who were clearly too ill to comply. Furthermore, he seemed overly enthusiastic that the chemotherapy patients, most at the time diagnosed with earlier stage disease, were surviving longer than our group of largely untreated, non-compliant stage IV patients. When despite many promises the serious problems and mismanagement continued, we started to wonder if Dr. Chabot might be undermining the nutrition arm so that the chemotherapy regimen might appear to be more effective than our treatment. Dr. Isaacs and I began to investigate Chabot and to our astonishment learned, as the published scientific literature clearly confirmed, he had worked very closely with his Columbia colleague Dr. Robert Fine developing the very “GTX” chemotherapy regimen being used against our treatment in the clinical study. Dr. Chabot appears as co-author with Dr. Fine on multiple articles appearing in the scientific literature during the very time of our clinical trial lauding the GTX regimen, though we had not been told of the severe conflict of interest. We had naively assumed that Chabot, a surgeon, would have no involvement with the development of GTX. To make matters worse and the conflict of interest more egregious, Dr. Fine was in charge of treating all chemotherapy patients entered into our trial.

13. This undeclared conflict of interest should have precluded Chabot from serving as Principal Investigator of our study, a role that requires no emotional, intellectual or financial tie to either treatment being evaluated. Once we learned of Chabot’s involvement with Dr. Fine’s research, we suspected that while much of the mismanagement – such as the failure to obtain appropriately signed consent forms – might indicate carelessness in the supervision of the trial, many of the oversights, such as the repeated entry of patients too ill to comply with our regimen, might be deliberate, to help guarantee chemotherapy would look more effective.

14. Because Chabot had complete total dictatorial control over admissions of all patients into the study for nearly its entire duration (initially we were allowed veto power but this was revoked in 2000) we have no idea how he entered the chemotherapy patients. We wonder if Chabot and Fine, co-researchers at Columbia, cherry picked subjects from other GTX studies running concurrently to ours, entering patients into the chemo arm of our study who already seemed to be responding. This is conjecture, but based on some very strong evidence. We hope that the ongoing Federal investigations might determine how and why these patients were entered.

15. As the study wound down, we began to investigate other members of the supervisory team assigned to our clinical trial at the NCI and at NCCAM. To our astonishment, we learned that the chief member of the NCCAM team, Dr. Jack Killen, had earlier managed the disastrous HIV-nevirapine study in Africa, while he worked at the Institutes of Allergy and Infectious Disease. Many consider this study one of the most mismanaged studies in the history of the NIH, involving, as did our study, failure to obtain informed consent, the welfare of patients put at serious risk, changing of records to cover up mismanagement and make the data look better. This study eventually became the target of Congressional investigations and investigations by the Institute of Medicine, which confirmed the gross mismanagement. Apparently, the NIH moved Dr. Killen over to NCCAM just as the scandal of NIH-nevirapine broke in the press in 2004-2005. All this was kept secret from us, and we knew nothing about Dr. Killen’s past until we began our own investigation. I cover Dr. Killen’s involvement with HIV-nevirapine in depth in my book.

16. Subsequently, a NIH employee frustrated about the mismanagement of our study contacted me, informing me that the NIH looked at our clinical study as a useful dumping ground for their troubled employees they didn’t want to fire, because of friendships or political connections. I have no proof of course whether this was official NIH policy.

17. Based on evidence presented to him, Congressman Dan Burton of Indiana, long a supporter of my research, in a letter dated November 4, 2005, filed a formal complaint against the study's managers with Dr. Elias Zerhouni, at the time Director of the NIH. Dr. Zerhouni responded by denying any mismanagement based on false information provided by NCI and NCCAM staff. His four page letter states in part:

Thank you for your letter, dated November 4, 2005, in which you wrote to me out of concern for the National Institutes of Health’s (NIH) management and evaluation of complementary and alternative medicine projects, in particular, the nutritional pancreatic supplement protocol initiated by Dr. Nicholas Gonzalez. NIH appreciates your interest and commitment to advancing complementary and alternative medical research. I have consulted with the National Cancer Institute (NCI), which currently administers the grant for this project, and the National Center for Complementary and Alternative Medicine (NCCAM), which currently funds the grant, regarding the issues you raise and would like to take this opportunity to address all of your concerns.

Dr. Gonzalez has raised very serious allegations against Dr. Chabot in terms of the conduct of this trial. Based on his interest and expertise in pancreatic cancer, Dr. Chabot agreed to direct the trial after the protocol was finished. We have seen no evidence to support Dr. Gonzalez’s assertion of scientific misconduct by Dr. Chabot or his staff. It is our understanding that rules of clinical trial management were strictly adhered to by the Columbia research staff at every point in this process. The protocol was prospectively set and followed in order to avoid any insertion of bias. Dr. Chabot remained steadfast to the predetermined trial design and discussed with Dr. Gonzalez the critical nature of maintaining a predetermined trial design and assuring its ethical oversight by an impartial data and safety monitoring board, which is charged with deciding whether the evolving safety and efficacy data in any clinical study warrants continued patient enrollment, treatment, and follow up.

Dr. Gonzalez alleges that Dr. Chabot required him to accept patients who did not fit the established protocol. We have seen no evidence to support this claim. ..

Dr. Zerhouni, while writing that he contacted NCI and NCCAM staff never contacted me, in any way. And the NCI and NCCAM staff he trusted so much misled him, since by that point I had made it clear that multiple patients had been admitted, such as those with no evidence of signed consent and those admitted beyond the eight week cut-off from biopsy diagnosis, who failed to meet the entry criteria. These mishaps were hardly a secret at the time Dr. Zerhouni wrote his letter.

18. In answer to Dr. Zerhouni’s misguided letter to Congressman Burton, over a five month period beginning January 2006 I completed a 352 page response, which Congressman Burton himself sent to Dr. Zerhouni. At that point, Dr. Zerhouni agreed an investigation was in order.

19. In June 2006, we filed a formal complaint against Chabot with the Office of Human Research Protections, the NIH group charged with overseeing the management of Federally funded clinical trials. Based on the data I presented, OHRP launched a formal investigation.

20. Because we suspected that Dr. Chabot might try to salvage a corrupted study by rushing into publication in the peer review literature an article discrediting me, and thereby blunting the incipient Federal investigation, in late June 2006 I wrote Dr. Chabot and the other study supervisors warning them not to attempt publication with Federal investigations beginning. In part, the letter, dated June 30, 2006, states:

For your own benefit, and for the benefit of the others involved from the NCI and NCCAM, I strongly suggest that you withhold any publication. Though you may all believe the study has been appropriately managed, I have been in discussion with a number of regulatory agencies who do not share your perspective. I am aware that shortly, two very serious investigations into the management of the trial, and those involved with it, will be beginning.

You continue to deny that you admitted any patients into the nutrition arm who did not meet the explicit entrance criteria of the study and continue to position yourself as the defender of the written protocol. In fact, the situation is quite different from what you claim; you have already admitted to us in e-mails and at the group meetings as the minutes confirm, that you accepted and sent to us for treatment at least two patients as if they had been properly consented when in fact no signed consent forms had been obtained. Though you, and the other supervisors seemed remarkably unconcerned about this oversight, the written protocol for this study, NCI regulations, and as I have been told, Federal law require that all subjects entered into clinical trials such as ours must sign informed consent. Oral consent is not a valid substitute, and I have been clearly and strongly told that no IRB can, years after the fact, declare the oversight inconsequential. Not only did you enter patients without the required documents, but you seemed reluctant to give us an explanation as to what happened despite our repeated e-mails regarding the matter sent over a two year period.

As another illustration of management lapses and protocol violations, you entered two patients into the nutrition arm long after the eight week window from biopsy despite our complaints, and despite the clearly written protocol requirements.

I could go on, as you might surmise, for many pages. However, at this point, I do not believe this letter to be the appropriate place to detail each and every management failing. Suffice it to say that Dr. Isaacs and I find the indifferent attitude of some of the government scientists toward obvious violations of the written protocol and the conduct of the trial rather astonishing, since it was their responsibility, not ours, to follow up and intervene to correct such problems when they became evident.

None of the supervisory staff – not Chabot, not Killen from NCCAM, not White or Smith from the NCI – bothered to respond.

21. As we evaluated the final data for the study ourselves, we discovered that Chabot had changed the statistics on the nutrition patients significantly, in a way that made our patients look less advanced compared to the chemotherapy patients. In effect, these changes helped blunt our criticism that the two groups weren’t comparable, if for no other reason, because of the inequality in the staging distribution. Specifically, he eliminated two stage IV patients from the nutrition arm without an explanation, and inappropriately changed the staging on five nutrition patients from stage IV to a lesser stage, though the records confirm that these patients warranted stage IV classification.

22. Though we assumed the issue of publication had been laid to rest with Federal investigations in progress, on December 3, 2006, I was contacted by Dr. Boris Pasche, Oncology Editor at the Journal of the American Medical Association (JAMA). He informed me that Chabot and colleagues, without my knowledge, had submitted an article to JAMA for publication. Dr. Pasche became very suspicious while reviewing the article because he knew the clinical study was an evaluation of my treatment, yet I was not listed as a co-author. Furthermore, in the body of the paper Dr. Chabot included a paragraph claiming I had refused to cooperate with the writing of the article and had quit the study, all false. I knew nothing about the article, and had not quit the study. Dr. Pasche in turn knew nothing about the OHRP investigation or Congressman Burton's complaint to the NIH Director. He told me Chabot should never have submitted the article with Federal investigations in progress, and that JAMA would reject the article with a warning to Chabot not to attempt publication elsewhere.

23. Dr. Pasche, an astute scientist, made the very pertinent comment that the study was flawed beyond salvation because the alleged "control" group, the GTX regimen, was itself experimental, so the trial essentially compared two experimental treatments - a concern we had ourselves raised. In an appropriate clinical study testing a “new” therapy – in this case, our nutritional regimen – must be compared to a control group receiving the best available standard approach. If no standard exists, then the control group receives no treatment or a placebo. In the case of our study, the FDA-approved “standard” treatment for pancreatic cancer was the drug Gemzar, by itself. The GTX regimen was, and is today, an experimental regimen developed at Columbia consisting of Gemzar with two additional chemotherapy drugs, Taxotere and Xeloda. So the comparison in our study, from a methodological perspective, was severely flawed, as Dr. Pasche realized.

24. Dr. Pasche sent me a copy of the proposed JAMA article, which contained false information, such as the claim all patients entered into the study met the protocol requirements, when in fact by that point all involved with the study knew that Chabot had entered multiple patients lacking any evidence of the legally required signed consent forms, and who had been entered beyond the eight week cut-off from biopsy. My June 30, 2006 letter to Dr. Chabot had discussed these very patients, so he was fully aware they had failed to meet the entry criteria. And, as Dr. Pasche had warned me in our phone conversation, Dr. Chabot falsely stated in the article that I had refused to cooperate with the writing of the article and had “elected not to continue participating in the study,” both blatantly untrue statements.

25. Reading the article one would also assume that all nutrition patients had complied fully with treatment but simply failed to respond. Nowhere does Chabot discuss Dr. Engel’s letter of January 2005, in which she clearly stated that comparison between the nutrition and chemotherapy groups was essentially meaningless since, as we long complained, few in the nutrition arm had complied adequately. Chabot then concludes that the chemotherapy patients fared far better than the nutrition patients without once mentioning that few in the nutrition group had complied with the therapy.

26. Though in the body of the JAMA submission Chabot repeatedly claims the chemotherapy patients did much better than those entered for nutrition, the data within his own article shows the truth to be different. A graph appearing at the end of the appendix of the article, never discussed in the actual text, presents the survival curves for the two groups. This graph clearly reveals that at the time of submission no chemotherapy patient had lived to three years, and that the two longest survivors of the study at that time were two of our patients, including one who lived nearly three and a half years, and this despite the fact that so few in our group had complied.

27. I myself filed a complaint of misconduct with the Dean of Columbia, and copied Chabot. Neither the Dean nor Chabot responded, and now more than two and a half years later, I have yet to hear the final outcome of my complaint. Chabot remains at Columbia, active in research and patient care.

28. Two days later I had a lengthy conversation with Dr. Catherine DeAngelis, Editor in Chief of JAMA, who was not at all happy that Chabot would try and publish an article in her journal without notifying anyone of the ongoing Federal investigations. She told me she intended to file a complaint of misconduct against Chabot with Columbia because of his actions. I do not know if Dr. DeAngelis did file a complaint.

29. In June 2008, two years after initiating its investigation, OHRP determined that Chabot had admitted 42 out of a total of 62 patients improperly, including 40 who had not been properly consented. Chabot was required to acknowledge his misdeeds, and Columbia was required to set up a program to retrain its staff in research methodology – a stinging indictment of Chabot’s failed management of the trial. These findings are all contained in the OHRP determination letter of June 2008 posted on their website.

30. The OHRP findings were, in our opinion, devastating in terms of any defense Chabot might offer about his study management skills, with 40 of 62 total patients admitted who were not properly consented. However, we were not happy that OHRP did not, in our opinion, properly address multiple other examples of inappropriate admissions. I actually wrote an extensive letter after the OHRP determination findings appeared, documenting in great detail my remaining concerns.

31. For example, the OHRP determination letter refers to two patients we claim have no evidence of informed consent (as documented by the records). But there were actually three. A patient entered by Chabot into the nutrition arm in 2002 as if properly consented, who subsequently did not comply with our treatment, turned out not to have signed the consent form, as Dr. Chabot's own staff admitted to us. In all subsequent data analysis this patient mysteriously was never counted as a study patient, though she was sent to us for treatment. Furthermore, the OHRP letter does not include as improper admissions those patients who clearly could not eat normally at the time of entry as required by the entry criteria.

32. We have learned that OHRP did not in essence conduct its own investigation, but turned the investigation over to Columbia, then relied on Columbia's findings, allowing the fox to guard the henhouse. As devastating as the findings ultimately are for Chabot, I do not think it unreasonable to consider that Columbia may have had a vested interest in downplaying my complaints, to protect its reputation and the reputation of its staff from the allegations raised by a non-Columbia physician who practices a controversial alternative/nutritional approach to cancer.

33. OHRP lacks jurisdictional authority to investigate fraud, and whether the mismanagement in this case, such as the admission of multiple patients clearly too ill to comply with our treatment, was in part deliberate or not. Since the OHRP official report, Congressman Burton and I have filed formal complaints with the Inspector General of the Department of Health and Human Services, to address the issues not within the purview of OHRP.

34. I had hoped with the OHRP official findings, Chabot and his colleagues would refrain from further attempts at publication. So I was quite astonished to learn on August 20, 2009, that Dr. Chabot and his Columbia cohorts had without our knowledge successfully managed to publish an article similar to the JAMA paper in the August 2009 issue of the Journal of Clinical Oncology (JCO), the official journal of the American Society of Clinical Oncology, allegedly the premier professional organization for oncologists. Though the grant for this study was originally awarded to evaluate my treatment, though Dr. Isaacs and I were investigators throughout the study, though we treated all nutrition patients entered into the trial and essentially served as the watchdogs for the project, no one from JCO bothered to contact me before publication of the paper. We believe this oversight constitutes, if not legal, certainly intellectual negligence. We learned about its publication through the National Library of Medicine internet alert service which informed us of the article, which we then read online.

35. We believe in many respects the JCO article is deliberately misleading. In it, Dr. Chabot does now report that five patients had been admitted beyond the eight week cut-off, but he makes no mention anywhere of the OHRP investigation that found he had admitted 42 of 62 patients inappropriately, including the 40 improperly consented. Even the number of patients admitted beyond the eight week cut-off, five, makes no sense, since OHRP reported two patients improperly admitted in this regard, and we calculated three. Who are the other two or three Chabot now mentions?

36. In the JCO article, Chabot misstates the truth about the missing consent forms, and the number of patients improperly consented. He writes that informed consent was an issue in only one case, in which he claims the form was signed but misplaced. This statement contradicts his own previous statements, in which he acknowledged that more than one patient had been admitted without evidence of the required consent, a violation of the study protocol, and Federal regulations. And over the many years of the study, never before had he told us, when we repeatedly inquired about the missing forms, that any had been signed and misplaced. Furthermore, he completely ignores the OHRP findings which found he had admitted 40 total patients who had not been properly consented.

37. Once again, as in the JAMA submission, Chabot claims the chemotherapy patients lived far longer on average than those assigned to the nutrition arm. However, he fails to mention anywhere that the majority of nutrition patients, for whatever reason, failed to comply. He does not once reference anywhere Dr. Linda Engel’s January 2005 letter in which she clearly affirmed that because so many patients had been admitted into the nutrition arm who failed to adhere to the prescribed regimen adequately, comparison between the chemotherapy and nutrition patients was most likely invalid and pointless. Reading the JCO article one would assume that all patients other than the five he mentions had been properly admitted, complied fully, and failed to respond.

38. In the JCO article, Chabot now claims the longest two survivors were chemotherapy patients, including one who had lasted four years. In the GTX approach, Dr. Fine prescribes aggressive chemotherapy in patients diagnosed with initially inoperable pancreatic cancer, hoping to shrink these tumors sufficiently to allow then for surgical resection. Patients whose tumors are operable after chemotherapy tend to fare better than patients treated solely with chemotherapy. However, the written protocol for our study specifically excluded patients with operable disease however they might have arrived at the operable state. We wonder if these two long term survivors Chabot now describes in his JCO article might have undergone surgery. We have no way of knowing, since he never once discussed either the JAMA or JCO paper with us.

39. Nowhere in the JCO paper does Dr. Chabot acknowledge that he worked closely with Dr. Fine developing the GTX regimen being used in the trial; in fact, he denies any conflict of interest.

40. Chabot claims in the JCO article, as he did previously in the JAMA submission, that the chemotherapy patients fared far better not only in terms of survival, but in terms of their quality of life. However, he fails to state the very pertinent fact that most of the patients entered into the nutrition arm did not pursue the treatment properly, many virtually not at all. Dr. Engel's January 2005 letter confirms this point. Chabot very effectively created what he calls the enzyme arm which in reality consisted of largely untreated patients, which he then compares with patients very aggressively treated with chemotherapy – and perhaps, with chemotherapy and surgery.

41. In the JCO article, Chabot claims there were 55 total patients entered into the trial. In the JAMA article, he claimed there were 58. OHRP correctly determined, after two years of investigation, there were 62. Chabot keeps changing the data for reasons that are unexplained. Why?

42 Chabot reported both in the JAMA submission and in the JCO article that the Data Safety and Monitoring Board (Committee) (DSMB) at Columbia, ultimately responsible for overseeing clinical trials at the institution, decided to stop the study early based on the number of “events,” that is, deaths in the nutrition arm. In layman’s terms, this means that Columbia terminated the study because it appeared that the chemotherapy patients had survived far longer than those assigned for nutritional treatment. But Chabot admitted to me that he never told the DSMB at Columbia that the majority of patients entered into the nutrition arm were either too sick or for whatever reason had been unable to comply with treatment, and that multiple patients had been admitted improperly consented. I suppose that to admit such mismanagement would have tarnished his image at his institution, but this deliberate oversight - which he refused to correct even when confronted by me - I believe was misleading at best.

43. The day the JCO article first appeared I contacted the editorial offices of JCO in Virginia, and was directed to a Mr. Chris Bohn, one of the editorial staff. I informed Mr. Bohn that JCO had published a deliberately misleading article and immediately explained my reasons for thinking so. Mr. Bohn appeared to be completely unaware of the two-year OHRP investigation and the findings. He was completely unaware of the many managerial lapses, of the earlier attempt to publish the article in JAMA and its rejection there. He knew nothing about my misconduct complaint with the Dean of Columbia.

44. In the days that followed, in an attempt to be collegial, I sent enormous amounts of information to the editors at JCO to document my allegations. According to e-mail exchanges with JCO staff, the journal has launched an internal investigation. However, despite the findings of the OHRP investigation that appears on that group’s website – findings left out of Chabot’s paper - JCO refused to take down the article. I have been told that their internal investigation might take 90 days, meanwhile, the article stays on the site for all to read as if it were a legitimate report of a legitimate scientific effort. Subsequently, despite the evidence provided that the article could not be trusted, JCO published the print version.

45. Unfortunately, the NCI website and the NCCAM website now discuss the JCO article as if it were legitimate, and link to it, compounding the circus.

46. This is not the first time the Journal of Clinical Oncology has published a deliberately misleading article. The October 13, 1995 issue of the Journal contained the now debunked and completely fraudulent report “High-dose chemotherapy with hematopoietic rescue as primary treatment for metastatic breast cancer: a randomized trial,” authored by the now infamous WR Bezwoda of the University of Witwatersrand, South Africa. In this article, Bezwoda and colleagues reported significant treatment benefit for autologous bone marrow or peripheral blood stem cell transplant after high dose chemotherapy, compared to standard chemotherapy, in the treatment of women with metastatic breast cancer.

The use of bone marrow or, is it is known today, stem cell transplantation, in patients diagnosed with recurrent, metastatic, or poor prognosis breast cancer serves as a cautionary tale of over-zealous oncologists promoting a toxic therapy that fits their world view despite the lack of credible evidence. By 1994, the oncology profession, working with aggressive lawyers and patient advocacy groups, had forced insurance companies through a serious of lawsuits to pay for the procedure, though no real evidence existed to support its use. Patients, lawyers and the oncologists used the media very effectively, painting insurance companies as heartless, cold blooded victimizers, denying an obviously useful therapy to the most desperate of patients, women with metastatic breast cancer. In 1993, even Congress got into the fray, with 54 of its members demanding insurance companies be forced to pay for this presumed life-saving but expensive procedure, with costs ranging from a minimum of $75,000 to $250,000 and up. No one seemed to care too much, other than the insurance companies, that no evidence actually existed to prove this expensive and potentially deadly treatment – which can kill 10-30% or more of patients during therapy - actually benefited women with the disease.

To make a long story short, eventually, the National Cancer Institute decided in its wisdom that it might make sense to test the procedure in controlled clinical trials, to determine if this therapy – by the early 1990’s already in routine use – worked. By the mid-1990s, five such studies had been completed, four of which showed no benefit at all. A fifth, the famed South African study published in JCO in October 1995 showed a significant benefit over conventional chemotherapy, claiming a complete response rate of 51% for BMT versus 4% - truly a remarkable difference. Although the results seemed far too good to be true, I remember so well the media, as well as the scientific establishment, lauding the one study that described a benefit.

Fortunately, a few honest researchers began to question the one positive study and its methodology, since the data was so strongly at variance with that of the other four trials - and with common sense. However, the NCI refused to support an independent evaluation of the South African data, and JCO refused to investigate or retract the article. However, when the author declined to open up his books to appropriate scrutiny by fellow oncologists, the legitimacy of the data came into question. Eventually, a formal investigation into this miraculous Bezwoda trial concluded the whole affair was a fraud, and the data created out of thin air. Yet despite the total fabrication, the oncology profession at large had ignored early warning signs, so desperate were doctors to believe this therapy – again, which fit their belief in the value of chemotherapy – must show benefit. In fact, in 1999, after serious doubts had been raised about the article’s legitimacy, the American Society of Clinical Oncology which publishes JCO invited Bezwoda to give the honored plenary session lecture at one of their international conferences. It wasn’t until 2001, six years after the initial publication, when faced with indisputable evidence that the article was fraudulent, that JCO finally retracted the document. The JCO handling of the Bezwoda article hardly inspires much confidence in their review process or motivation to investigate obvious fraud.

The May 4, 2002 issue of the British Medical Journal published a lengthy summary of the entire fiasco, written by physicians associated with the Brown University Medical School, and entitled “Presumed benefit: lessons from the American experience with marrow transplantation for breast cancer.” I suggest anyone naïve enough to believe that conventional physicians in general, and oncologists in particular, are objective, scientific practitioners employing only proven methods of treatment as is often stated or implied, should read this article. The authors place the concept of unproven medicine where it rightly belongs, smack in the middle of the conventional medical world.

47. In my e-mail and hard copy exchanges with JCO, I have made it clear that their peer review and editorial process has been incompetent, for publishing without question a misleading and in many important respects false article about my work without contacting me first. The process at JCO in my estimation seems lacking even in the rudiments of simple fact checking or due diligence. The comparison with JAMA’s response to essentially the same paper – which they appropriately rejected - is stunning, to say the least. Since this is not the first flub at JCO, its handling of this article under the editorial direction of Dr. Daniel Haller of the University of Pennsylvania should call into question the integrity of any article ever published within. If once again a paper filled with false and misleading information – such as the omission of the findings of a two-year Federal investigation into the study’s management - can make its way into JCO, one must wonder how many other articles with false and misleading information have been published at that journal.

48. JCO did not respond to my e-mail statement that it was their obligation to take down the deliberately misleading and largely false article. I believe, considering the amount of documentation I have given JCO, including the link to the OHRP website determination letter, their continued publication of the article is certainly disappointing. I for one am surprised by their attitude, since I can think of no greater harm to a professional journal or its editors than to have published yet another article that was deliberately misleading in fact and intent.

49. Dr. Karen Antman, currently Dean of the Boston University School of Medicine, formerly Chairman of the Department of Oncology at Columbia, was listed as a co-author on the JAMA submission, and is a co-author on the current JCO published article. Dr. Antman was formerly President of the American Society of Clinical Oncology that published the Journal, so I wonder if she did not use her insider influence to get the article published.

Summary

I believe it is improper and unethical for Chabot to have repeatedly attempted publication of an article about my therapy without notifying me beforehand, when I served not only as an investigator, but also, as it turned out the watchdog for the study.

I believe it is improper and unethical - and I have been told a possible violation of Federal regulations - for Chabot to have published an article with no mention of the two-year Federal investigation that found him guilty of multiple cases of mismanagement in the admission of patients, involving two-thirds of all subjects.

I believe it is improper and unethical for Chabot, in both the JAMA and JCO articles, to ignore Dr. Engel's thoughtful letter of January 2005, in which she reported the official NIH position that the chemotherapy and nutrition groups were not comparable, written at a time when nearly all nutrition subjects had been admitted.

I believe it is improper for Chabot to change the data repeatedly, for example now claiming in the JCO article 55 patients had been admitted, claiming in the JAMA article 58, all at odds with the official government accounting of 62.

I believe it is improper for Chabot, without an explanation, to eliminate two stage IV patients from the nutrition arm and to have downstaged five stage IV patients to a lesser stage, helping to make the chemotherapy patients appear more advanced.

I suspect that Chabot and his colleagues at Columbia, at the NCI and at the NIH, hope that because they are all powerful conventional researchers at powerful academic and government institutions, that no one will take Dr. Isaacs and myself, the “alternative” practitioners seriously. If this is indeed their motivation, they are misguided.

Dr. Isaacs and I, after years of struggling against indifference, contempt, and disregard for the basic tenets of appropriate scientific investigation, will continue the fight in defense of scientific truth and will continue to challenge those in positions of scientific authority, such as Dr. Zerhouni, who used and continue to use their power to protect their favored academic colleagues by ignoring gross mismanagement and perhaps worse. We will continue to fight in defense of scientific truth however strong or determined the powers against us may be, because one should do no less.

As a final note, after the JCO article appeared, the NCCAM website quickly provided a link, with no mention of the study’s very checkered past. I subsequently wrote to Dr. Josephine Briggs, NCCAM’s current Director, expressing my disappointment that NCCAM would link to that article as if it were legitimate, when NCCAM staff assigned to supervise the project know full well of the managerial lapses that poisoned the data. I ended my letter by stating:

I would have thought that NCCAM of all places would have been proud that it was the alternative practitioners, Dr. Isaacs and myself, who insisted the study abide by the requirements of appropriate clinical trial methodology, while the conventional academicians, including Dr. Killen, did absolutely nothing to address our many legitimate complaints.

Indeed, though the clinical trial ultimately did not address the basic question of my therapy’s effectiveness, it does show something perhaps far more important. This ten-year fiasco should illustrate to everyone, once and for all, that scientists and researchers at the highest levels of academia, even within the NIH and NCI can be indifferent to the truth, indifferent to the tenets of appropriate clinical trial management and protection of patients, and can be driven by political expediency and career advancement. Perhaps as debate over government control over health care swirls around us, as a final lesson this study and its history over many years should teach us that those in government who couldn’t even competently or honestly manage a single simple clinical trial should be running nothing, let alone our entire health care system.