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The Ethics of “CAM” Trials: Gonzo (Part V)

Part IV of this blog ended by observing that the NIH-funded trial of the “Gonzalez regimen” for cancer of the pancreas,† to have begun in March, 1999, was in trouble almost as soon as it started. As originally designed, it was to have been a randomized, controlled trial comparing gemcitabine, the standard chemotherapy, to the “Gonzalez regimen” of pancreatic enzymes, “supplements,” twice-daily coffee enemas, and other purported methods of “detoxification.” By June, 1999, according to Dr. John Chabot, the Columbia University surgeon acting as Principal Investigator (PI) of the trial, only 3 of the first 50 potential subjects had agreed to be randomized, and none of the three met the eligibility criteria. By January, 2000 it had become clear that the trial would not accrue a sufficient number of subjects if it remained randomized, because almost all of the potential subjects were intent on being in the “nutritional,” ie, the Gonzalez arm.

Trouble with Randomizing

The investigators at Columbia therefore decided to change the protocol to a “single-armed, non-randomized case-cohort study where patients will only be enrolled in what was the nutritional arm.” Paradoxically, PI John Chabot had recently explained, at the 1999 Comprehensive Cancer Care Conference of James Gordon’s Center for Mind-Body Medicine, why this would not be a scientifically sound design:

Would it be possible to allow patients to choose what arm of the trial they want to be on?

Giving individualized treatment in a non-random fashion is more realistic than randomizing, but unfortunately, randomizing was necessary to maintain the validity and integrity of the study in the face of traditional criticism.

Language similar to Chabot’s gratuitous, final phrase has become a staple gesture used by academic researchers speaking to “CAM” audiences. It appears to answer the perpetual special pleading of IMC advocates by passing the buck to unnamed “traditional critics,” as if the issue were not really one of “validity and integrity.” Chabot himself later admitted to being one of those critics, at a 2001 meeting of the White House Commission on Complementary and Alternative Medicine Policy, chaired by Gordon:

The vast majority of people who call with interest are only interested in alternative medicine approaches.  Patients who express interest in this protocol are generally healthier than the overall population of patients that I see in my practice with advanced pancreatic cancer.  The way this protocol, and, I suspect, many are designed, the patients who meet the eligibility criteria are clearly healthier than the general population of advanced pancreatic cancer patients.

One has to be very careful coming to any conclusions comparing these patients with the general population of pancreatic cancer patients.

I will stop at my third observation. The effects of psychosocial support and delivering hope to these patients is not insignificant. In the absence of a blinded, randomized trial, separating these effects from the physiologic and pharmacologic effects will be a major challenge in trial design.

Trouble with Regulators

It was not long after the protocol was changed that the trial began to draw the attention of the federal Office of Human Research Protections (OHRP). In 2002, a determination letter from the OHRP to Columbia stated:

OHRP finds that the informed consent documents reviewed and approved by the Institutional Review Board (IRB) for this study did not list the risk of death from coffee enemas.

The 2002 OHRP letter listed 7 additional complaints, but each of these was “redacted” from the public copy. We would love to know what they were. In 2003 the OHRP sent another determination letter to Columbia, revealing problems that the agency itself likely did not recognize as being as worrisome as they were. Among them:

(1) Department of Health and Human Services (HHS) regulations at 45 CFR 46.110(b)(2) permit use of expedited procedures for review of minor changes to previously approved research during the period for which approval is authorized. OHRP finds that the CUHS institutional review board (IRB) employed expedited procedures to review changes that exceed this limitation. On January 20, 2000, the CUHS IRB received a request from the principal investigator to approve an amendment to the protocol that included eliminating the randomization and adding a patient questionnaire. It appears that approval of this amendment was done in an expedited manner.

(3) OHRP finds that the informed consent documents reviewed and approved by the CUHS IRB for this study failed to adequately address the following elements required by HHS regulations at 45 CFR 46.116(a)(1):

(a) An explanation of the purposes of the research. The IRB-approved protocol stated that “primary endpoint is survival….” However, the informed consent document stated that “the purpose of this research study is to determine whether enzyme-nutritional therapy is as effective as a drug called gemcitabine for treating pancreatic adenocarcinoma.”

(b) A complete description of the procedures to be followed, and identification of any procedures which are experimental.

(i) The protocol included an evaluation of nutritional status by a “subjective global assessment” questionnaire and a questionnaire regarding quality of life. These assessments were not mentioned in the informed consent document.

(ii) The informed consent document referred to the alternative regimen as “pancreatic proteolytic enzyme therapy” or “enzyme-nutritional therapy” and throughout referred to the study as involving “treatment” and “therapy.” The only treatment or therapy available on the protocol was gemcitabine; therefore it appears that the experimental procedures were not accurately described in the informed consent document.

Corrective Action: OHRP acknowledges that the informed consent document will be revised to state the purpose of the study more directly, to refer specifically to the questionnaires and assessments noted above, and replace the words “treatment” and “therapy” with the term “experimental regimen” or similar. OHRP finds that these corrective actions adequately address the above finding and are appropriate under the CUHS FWA.

(4) HHS regulations at 45 CFR 46.116 require that informed consent information be in language understandable to the subject or the subject’s legally authorized representative. OHRP finds that the informed consent document approved by the CUHS IRB for this study appeared to include complex language that would not be understandable to all subjects, such as alleviating, persist, emesis, anorexia, myalgias, arthralgias, transient intolerance, abdomen and pelvis.

A Troubling Case History

Readers who know something about both human studies ethics and the nature of the Gonzalez regimen will have sensed, while reading the charges quoted above, the pungent aroma of rat. This blog will discuss the ethics of the trial at length, but first it will summarize the experience of an unsuspecting artist in his 40s, the father of two boys, who was diagnosed in March of 2002 with cancer of the pancreas and made the mistake of submitting himself to the trial. The story can be told only because a friend of the patient, mathematician Susan Gurney, wrote and published it in the Scientific Review of Alternative Medicine:

My friend’s wife was a believer in homeopathic medicine. She and others in her community suggested that he look into a protocol run by Nicholas Gonzalez, MD….His protocol was being funded by the National Institutes of Health and the National Center for Complementary and Alternative Medicine and implemented at Columbia Presbyterian. My friend’s surgeon [Dr. Chabot] was one of the investigators.

…my friend decided that the Gonzalez protocol seemed to offer the most hope for survival…[he] arranged to meet with Dr. Gonzalez during the 2 weeks that followed his recovery from surgery to determine whether or not he was eligible for the trial. He was encouraged when he was found to be acceptable. Dr. Gonzalez told him that in order to meet the criteria one had to be still strong enough to follow an arduous regimen

During this time I also investigated the Gonzalez protocol. I had obtained a copy of an article by Michael Specter in the February 5, 2001 issue of the New Yorker magazine. The article seemed to indicate that although this protocol had been funded by the NIH, there was some debate as to its value by physicians at Columbia Presbyterian. I was disturbed to read that Dr. Gonzalez had been successfully sued and that New York State had made attempts to remove his license…I placed a call to Dr. Chabot’s office. It was not returned.

Dr. Gonzalez advised my friend to have fillings from his teeth removed by a dentist in Connecticut, which he did on April 16. He had just begun the vitamin and enzyme protocol, which was very time-consuming…His wife was by that time already extremely busy obtaining all the pills and food that were required for the Gonzalez regimen.

That same day I called Karen Antman, MD, head of oncology at Columbia Presbyterian…she said that my friend had been offered many different treatment options, and had chosen the Gonzalez one. She encouraged me to do further research.

On April 17 I once again called Dr. Chabot’s office and spoke with his secretary, saying that I had some questions about the Gonzalez trial. I was informed that I should speak to Michelle Gabay, the nurse who was running the protocol…[but] she had no answers to my questions about Gonzalez protocol results.

My friend was determined to try as hard as he could to maintain the regimen, which is extremely difficult. He had been told that pain might be an indication that the tumors were being dissolved, and that he could expect weight loss as he was detoxifying his body. I saw him on April 26, when he told me that he was in more pain. It was obvious that he had lost a significant amount of weight. In the next few weeks he was to describe himself to his mother as looking like “a concentration camp victim from Auschwitz.”

He was having difficulty sleeping. Whether this was because of coffee enema stimulation or because he was experiencing ever-increasing pain and stress, I do not know…but [he] said that he was going to stick with this regimen until the next appointment, when he would get the results. He was determined to give it his utmost effort.

I told him that I was going to attend the annual conference of the American Society of Clinical Oncology (ASCO) and would report on other options to him. Once at ASCO, I learned quickly and definitively that the Gonzalez protocol was a fraud; no mainstream doctors believed it was anything else and they were surprised that anyone with education would be on it.

During the following month, my friend lost 30-40 pounds and became so weak that he could no longer walk his dog around the block. The pain was becoming unbearable, and he was eager to be evaluated and have another scan.

My friend was not scanned until Sunday, June 2, when he received bad news. The tumors had progressed. The Gonzalez regimen had not worked.

On Monday he made an appointment with Dr. Sherman, the oncologist at Columbia Presbyterian…

By this time my friend was extremely thin and weak. He was given prescriptions for pain medication and chemotherapy, and scheduled for additional intravenous therapy the following week.

….He felt better in June,…[but although he] started eating regular food and sipping concentrated food supplements, he was unable to gain weight and did not show an obvious early response to his 3 chemotherapy treatments…

Over the Fourth of July weekend…his lungs filled with fluid. He was rushed to [the] hospital….Over the course of that month he stabilized somewhat, but he continued to weaken. He went home on July 26, intending to talk to his doctor, who had been away that week. He did not live to have the conversation.

By Sunday, hospice care was called in and he died a few days later, in the early morning of August 1, 2002. That he died was not surprising, as pancreatic cancer is a terminal disease. That he died as quickly and brutally as he did, however, is tragic.

We had [had] many conversations about treatment options…but the Gonzalez protocol quickly overwhelmed him; first by being impossibly time-consuming and then by being so physically debilitating. Had he realized this in early April, he would have had a real chance to examine his options. But once the decision was made to begin the Gonzalez protocol, with the apparent support of those involved in his care at Columbia Presbyterian, he became committed to it.

By remaining neutral about the Gonzalez regimen, physicians at Columbia Presbyterian who place patients in this trial effectively preclude them from starting other options, because of the demands it places on patients and their families. If physicians believe they are truly being neutral by not fully explaining the Gonzalez protocol’s nature to cancer patients, it is they who are in denial.¹

Physicians may quibble slightly with Ms. Gurney’s assessment, noting that the course of her friend’s illness—the pain, weakness, insomnia, weight loss, and early death—was entirely consistent with that of untreated cancer of the pancreas alone. That is true, but it is still possible that his particular course was made worse by the arduous regimen. There is no denying that his pain could have been largely mitigated, that he would have had more useful time during his last few months if he hadn’t been on the Gonzalez regimen, and that he would have had a better chance of responding to standard treatment or to a rational nutritional regimen if these had begun earlier.

Troubles with Human Studies Ethics

“A Clinically Competent Medical Person”?

It is also clear that some of the medical practices reported by Ms. Gurney amounted to incompetent nonsense. An example was Gonzalez’s having instructed the patient to have his fillings removed, almost certainly to relieve presumed mercury poisoning from dental amalgams—a common “CAM” canard (was that part of the protocol?). Also included were Gonzalez’s having told the patient that “pain might be an indication that the tumors were being dissolved, and that he could expect weight loss as he was detoxifying his body.”

Such claims are similar to those that the New York State Board for Professional Medical Conduct had described in its Findings of Fact in 1994:

For all patients A through F, the Hearing Committee found that Respondent failed to correctly interpret signs and symptoms of disease progression…, in some cases attributing symptoms of cancer progression to non-compliance with his protocol.

The Hearing Committee…finds that Respondent’s treatment of Patients A through F was incompetent within the meaning of New York State Education Law Section 6530 (5) in that it demonstrated a lack of requisite skill and knowledge.

…the Hearing Committee sought both training appropriate for Respondent’s practice, the vast majority of whose patients have some form of cancer, and experience in a setting that would acquaint Respondent with the broader aspects of practice, including the entire cycle of death and available palliative aspects of treatment of the terminally ill.

The 1998 Consent Order agreed:

In the treatment of all the patients in this case, the Respondent demonstrated that he lacked the basic understanding of the disease from which all the patients were suffering. For example, in the case of Patient C, the Respondent describe the Patient as being stable, doing fine or in a rebuilding process, when the Patient was suffering increasing pain and showing other symptoms which demonstrated the marked progression of her disease. In the case of Patient F, the Patient showed symptoms such as progressive inflammation, crusting and weeping of the breast and increased pain, which were the result of metastatic disease, but which the Respondent attributed to toxicity and a repair and rebuilding process.

The Review Board sustains the Hearing Committee’s Determination ordering the Respondent to undergo retraining in oncology.

Relevant human studies treatises stipulate certain qualifications for investigator/practitioners. The Helsinki Declaration is explicit:

Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given consent.

The physician may combine medical research with medical care, only to the extent that the research is justified by its potential prophylactic, diagnostic or therapeutic value. When medical research is combined with medical care, additional standards apply to protect the patients who are research subjects.

The Belmont Report requires that IRBs consider the practices of the pertinent physician, with the implication that those practices meet acceptable standards of care:

Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy. This need not cause any confusion regarding whether or not the activity requires review; the general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.

The NIH also has certain requirements for investigator/practitioners, although these are more difficult to find. According to the 2001 Request for Applications (RFA) for another NCCAM-sponsored trial:

Biographical sketches for all key investigators must be provided. In addition, applications must name a Senior Investigator for each trial site in the consortium that will be responsible for on-site clinical and scientific implementation, direction and management of the trial protocol….Senior Investigators must have substantial experience in the treatment and management of CAD and in the design, implementation and evaluation of clinical trials.

If we change “CAD” to “cancer of the pancreas,” it seems likely that similar requirements should have applied to Gonzalez (the trial corresponding to the RFA quoted above is also in violation of those requirements, but that is another story).

The New York Board’s opinions quoted above should have been part of the deliberations of any committee—the scientific review group at the NIH or the Columbia Institutional Review Board (IRB), for example—charged with passing judgment on the trial. We can safely assume that either Gonzalez’s history was not made available to those committees or, if it was, that the committees reneged on their responsibilities.

Uninformed Consent, Inappropriate Subject Selection, and Lack of Clinical Equipoise

We have already seen, in the OHRP’s determination letters of 2002 and 2003, that until at least 2003 the Gonzalez trial’s consent information was woefully inadequate. I wonder if the new one is any better. In 2003, using the Gonzalez regimen as an example, I argued that the information offered to prospective subjects of trials of implausible claims is likely to be misleading:

Plausibility also figures in informed consent language and subject selection. How many subjects who are not wedded to “alternative medicine” would be likely to join a study that independent reviewers rate as unlikely to yield any useful results, or in which the risks are stated to outweigh the potential benefits? Are informed consents for such studies honest? In at least one case cited in the following paragraph, the answer is “no.” Nor may subjects who prefer “alternative” methods be preferentially chosen for such research even if they seek this, because “fair subject selection requires that the scientific goals of the study, not vulnerability, privilege, or other factors unrelated to the purposes of the research, be the primary basis for determining the groups and individuals that will be recruited and enrolled” (Emanuel et al. 2000).

The Office for Human Research Protections recently cited Columbia University for failure to describe serious risks on the consent form of its “Gonzalez” protocol for cancer of the pancreas, funded by the NCCAM (OHRP 2002). The study proposes to compare the arduous “Gonzalez” method, which is devoid of biological rationale, to gemcitabine, an agent acknowledged by the investigators to effect “a slight prolongation of life and a significant improvement in . . . quality of life.” Nevertheless, a letter from Columbia to prospective subjects states, “it is not known at the present time which treatment approach is best [sic] overall” (Chabot 1999). The claim of clinical equipoise, or uncertainty in the expert medical community over which treatment is superior–necessary to render a comparison trial ethical–is not supported by the facts (Freedman 1987).

Ms. Gurney’s article provides additional, compelling evidence that the Gonzalez protocol did not meet the standard of clinical equipoise:

…at ASCO, I learned quickly and definitively that the Gonzalez protocol was a fraud; no mainstream doctors believed it was anything else and they were surprised that anyone with education would be on it.

The “mainstream doctors” of the American Society of Clinical Oncology must be judged representatives of the pertinent “expert medical community.”

I am aware that “clinical equipoise,” as a prerequisite for a trial being judged ethical, has been challenged. Nevertheless, the challenges do not impinge upon the points made here, nor have they resulted in a consensus opinion that “clinical equipoise” no longer be considered a requirement for a trial.

There are many other reasons that the Gonzalez trial is unethical, but I will limit this discussion to three more: scientific reasons, the fallacy of popularity, and the need for independent review.

Science and Ethics

There is a consensus, among those who consider human studies ethics, that a study must be scientifically sound in order to be ethical. According to the Council for International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS; Geneva, Switzerland:1993. Quoted here):

Scientifically unsound research on human subjects is ipso facto unethical in that it may expose subjects to risks or inconvenience to no purpose.

The Helsinki Declaration agrees:

Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and on adequate laboratory and, where appropriate, animal experimentation.

There is no body of basic science or animal experimentation that supports the claims of Gonzalez.

Emanuel and colleagues, writing in JAMA in 2000, asserted:

Examples of research that would not be socially or scientifically valuable include clinical research with…a trifling hypothesis…

I assert that highly implausible claims ought to be viewed as “trifling hypotheses.”

The Fallacy of Popularity

Virtually all of the research agenda of the NCCAM has been justified by the assertion that implausible claims that are popular require research, merely because people are using them. Referring to the opinions of the late NCCAM Director Stephen Straus, Science Magazine wrote in 2000:

Scientific rigor is sorely needed in this enormously popular but largely unscrutinized field….Most of these substances and treatments have not been tested for either safety or efficacy.

As surprising as it may be to some, however, a method’s popularity may not supercede the interests of individual trial subjects. According to the Helsinki Declaration:

In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society.

The Belmont Report agrees:

Risks and benefits of research may affect the individual subjects, the families of the individual subjects, and society at large (or special groups of subjects in society). Previous codes and Federal regulations have required that risks to subjects be outweighed by the sum of both the anticipated benefit to the subject, if any, and the anticipated benefit to society in the form of knowledge to be gained from the research. In balancing these different elements, the risks and benefits affecting the immediate research subject will normally carry special weight.

The U.S. Code of Federal Regulations is unequivocal:

The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. (CFR §46.111)

The Requirement for Independent Review

As explained by Emanuel and colleagues:

Investigators inherently have multiple, legitimate interests—interests to conduct high-quality research, complete the research expeditiously, protect research subjects, obtain funding, and advance their careers. These diverse interests can generate conflicts that may unwittingly distort the judgment of even well-intentioned investigators regarding the design, conduct, and analysis of research.

…[thus] for much of clinical research, review should be done by a full committee of individuals with a range of expertise who have the authority to approve, amend, or terminate a study.

Emanuel and colleagues suggested that it is IRBs that provide such independent reviews, but we have already shown that IRBs can only be expected to act according to the information made available to them by the investigators. We have shown, in addition, that the ”expert medical community” need be involved in such independent reviews. Individuals with the requisite expertise may or may not be members of the pertinent IRB.

Next Week: Politics Makes for Bad Science (Redux), and the Regrettable (Non-)Outcome of the Gonzalez Trial

1. Gurney S. Socially Harmful but Unapparent Effects of the NCCAM-Columbia University-Gonzalez Protocol. Sci Rev Alt Med 7 (2):74-77 (Fall/Winter 2003-4)

……………………………..

†The “Gonzalez Regimen” Series:

1. The Ethics of “CAM” Trials: Gonzo (Part I)

2. The Ethics of “CAM” Trials: Gonzo (Part II)

3. The Ethics of “CAM” Trials: Gonzo (Part III)

4. The Ethics of “CAM” Trials: Gonzo (Part IV)

5. The Ethics of “CAM” Trials: Gonzo (Part V)

6. The Ethics of “CAM” Trials: Gonzo (Part VI)

7. The “Gonzalez Trial” for Pancreatic Cancer: Outcome Revealed

8. “Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part I: Results)

9. “Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part II: Loose Ends)

10. Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 1

11. Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 2

Posted in: Clinical Trials, Health Fraud, Medical Academia, Medical Ethics

Leave a Comment (43) ↓

43 thoughts on “The Ethics of “CAM” Trials: Gonzo (Part V)

  1. David Gorski says:

    Ugh. I had no idea just how bad this trial was.

    That poor patient. Not only did he die of what was in essence untreated pancreatic cancer, but the regimen to which he submitted himself clearly made his remaining months on earth much worse than they had to be, particularly given his untreated pain. Pancreatic cancer as it grows can cause horrible pain as it invades retroperitoneal structures. However, there are very good palliative treatments, such as CT-guided alcohol ablation of the celiac plexus nerves, that can do a great deal to relieve that pain and make the patient’s last remaining weeks and months much easier to bear. If it is true that this patient was not offered such palliative procedures by Gonzalez, it goes beyond unethical. Such a failing to meet the minimum standard of care as not offering palliative procedures for pain relief in a terminally ill cancer patient (or any patient, for that matter) borders on the criminal.

  2. BlazingDragon says:

    I also find it horrible that the guy could have been trying to enjoy his last few months with his wife and children (to whatever extend possible when one knows one will die), but instead his wife was consumed with getting all the ingredients for this ridiculous regimen and doling them out and I assume his children became afterthoughts while both the man and his wife were consumed with this horrible regimen.

    This doesn’t border on criminal… I think it IS criminal. Of course, Gonzales’s excuse will be that these palliative treatments will “interfere” with his stupid regimen and negate all of it’s “positive effects on the treatment of the cancer.”

    The man should have his medical license revoked (and word spread to all 50 states so he can’t just move to a new state) and be in jail… not continuing to treat cancer patients.

  3. pmoran says:

    David: “Ugh. I had no idea just how bad this trial was.

    That poor patient. Not only did he die of what was in essence untreated pancreatic cancer, but the regimen to which he submitted himself clearly made his remaining months on earth much worse than they had to be, particularly given his untreated pain. Pancreatic cancer as it grows can cause horrible pain as it invades retroperitoneal structures. However, there are very good palliative treatments, such as CT-guided alcohol ablation of the celiac plexus nerves, that can do a great deal to relieve that pain and make the patient’s last remaining weeks and months much easier to bear. If it is true that this patient was not offered such palliative procedures by Gonzalez, it goes beyond unethical. Such a failing to meet the minimum standard of care as not offering palliative procedures for pain relief in a terminally ill cancer patient (or any patient, for that matter) borders on the criminal.”

    PM > I am learning a lot about the background to this study, too.

    However, surely the above is as much the fault of the trial protocol, and those running the trial, as Gonzales’. How on earth could they not have ensured that *all* patients received adequate palliative care? The report of the 1994 hearing against Gonzales would have forewarned everyone that this kind of thing was likely to happen within Gonzales’ practice.

  4. daedalus2u says:

    Those on the IRB who approved it and allowed it to continue without adequate supervision should be sanctioned also.

    In my opinion, IRBs (and the institutions that constitute them) should have legal culpability for malpractice such as this.

    In my opinion the excuse that “the PI told me X” holds as much weight as does the excuse “I was only following orders”.

  5. eldereft says:

    I <3 my friendly neighborhood IRB. They reduce the likelihood of waking up to more almost unremittingly depressing stories like this.

  6. pec says:

    “it is still possible that his particular course was made worse by the arduous regimen.”

    But everyone knows that chemotherapy for cancer is arduous also! And you know chemotherapy doesn’t cure pancreatic cancer, yet you prescribe it anyway!

  7. pec says:

    http://www.ncbi.nlm.nih.gov/pubmed/10368805?dopt=Abstract

    What is wrong with continuing research on this regimen? There are reasons to think it might help some patients, and it probably can’t be any worse than conventional cancer treatments, which are WELL KNOWN to be horrible.

  8. Joe says:

    pec, you continue to plumb the depths of ignorance. Do you know what is meant by “palliative therapy”? Gonzo’s victims were denied that while on his fantasy regimen.

    I asked if you could be more ignorant (when you suggested preventive medicine originated with quacks??!!), it seems the answer is “yes,” you can be more ignorant. Does your ignorance embarrass you? I reckon not; you flaunt it with wild abandon.

  9. wertys says:

    As always pec, you have not thought this through. The abstract you link to proves nothing. It tries to compare a sample to 10 patients to the results of a nation-wide registry of all pancreatic cancer. Any result from such a poorly thought-out, statistically-underpowered study is uninterpretable, whether positive or negative.

  10. pec says:

    If someone has incurable cancer you should not prevent them from trying alternative treatments., even if those treatments are still experimental and lack solid evidence. Terminal patients are allowed to try experimental mainstream treatments, after all.

    It’s amazing that you wail about the difficulty of this treatment, forgetting completely the suffering caused by mainstream chemotherapy.

    How was this patient deprived of palliative treatment? If he had wanted nerves to be destroyed to stop the pain, don’t you think he could have requested that?

    It’s pretty insane to imply this patient would have felt better with a standard treatment he knew would fail. At least he gave it a try. The method is still being studied, so someone thinks it’s worth throwing some funding at. Some animal studies were promising.

    You don’t have to hate a regimen just because it doesn’t involve toxic chemicals, radiation and invasive surgery.

    I don’t know if Gonzalez is right or wrong; I have no opinion. But to be outraged about an alternative solution when your own “solution” is a complete failure — well that’s just amazing.

  11. Pec, could you back up a minute. You are covering so many things at once. For starters you speak of the “suffering caused by mainstream chemotherapy” and of regimens that use “toxic chemicals, radiation and invasive surgery”.

    Have you experienced these things yourself or seen their effects in people undergoing treatment? If so, how many times? Have you ever seen, read or heard about a case of untreated cancer?

    I had a lumpectomy and radiation therapy for breast cancer in 1984. I was nauseous after the surgery but that passed quickly. I was frustrated when I couldn’t raise my arm to wash my hair. That may have been the day after surgery. I’m not sure. I had some pain in my arm but not for long. I was annoyed by the limited range of motion in my arm but got over that fast with time and exercise. I didn’t feel anything with radiation although it made me very tired and hungry. I ate ravenously and still lost weight.

    Obviously we are all different and the cancer I had was very treatable because I discovered it at an early stage, but I seriously doubt that my experience is that unusual. It is certainly far better than what I’m sure I would have experienced without treatment or with any of the alt therapies out there.

    Scientific medicine does not cure all cancers. Neither does it claim to, but it does cure many and there are lots of us alive today because of surgery, radiation and chemotherapy and lots of us who don’t think that those treatments were all that bad.

  12. pmoran says:

    Pec, you are potentially a very valuable contributor to this blog, because you display the kind of thinking that we critics of cancer quackery have to try and understand.

    Tell me, how is it that you “have no opinion” on the Gonzales method after all that you have read here? Do you *still* find Gonzales’ Pilot study convincing, or do you simply mistrust anything that skeptics say?

    Also, if the present study of Goinzales method revealed that no patient went into remission with it and lengths of survival were about what you might expect without treatment, would that change your opinion, or would you mistrust those results, too?

    And what do you mean when you say that the conventional approach to cancer is a “complete failure”. Do you have personal knowledge of the overall results of the present treatment of cancer, did you read this somewhere, do you happen to know some patients who fared badly, or is this another manifestation of a general mistrust of the imainstream?

    I personally look forward to the results of the Gonzales arm of this trial because I believe (if properly performed — a bit uncertain) it will show all cancers progressing quite rapidly despite his treatment. That information will be useful to a lot cancer patients. I am, like you, not yet convinced that we should ignore questions that they might like to see answered.

  13. daedalus2u says:

    The Gonzales regime is something that could easily be done in animals. It would be cheaper, faster and could use enough animals to show statistical significance. Tumors could be implanted or injected so that all animals are the “same”. Animals could be sorted at a certain stage of progression so the comparison of control vs. treatment groups would be excellent.

    Why hasn’t it been tested in animals first?

    I know the answer; desperate patients don’t pay for research on animals that won’t produce results before they are likely to die. A negative result in animal research won’t allow testing to progress to humans where patients will pay for it.

  14. David Gorski says:

    Excellent question and observation.

  15. pec,

    Dr. Moran has more patience with you than do I, but I worry that some of your erroneous assertions, if left unanswered, will be assumed to be true by others who lack medical knowledge, possibly to their detriment or to the detriment of their friends or family. Pancreatic cancer is a common disease. Therefore you get a detailed response, and I hope this is the last time that it will be necessary. Above you write:

    “What is wrong with continuing research on this regimen? There are reasons to think it might help some patients, and it probably can’t be any worse than conventional cancer treatments, which are WELL KNOWN to be horrible.”

    Each of those points has been asked and answered in this 5-part blog (please do your homework):

    1. There are no reasons to think the “Gonzalez regimen” works. It’s “theory,” having been born prior to any knowledge of molecular genetics, has nothing to do with what cancer is: a genetically stable change in cell division and other cell characteristics. It is filled with other ridiculous claims, eg, proteolytic enzymes are absorbed in appreciable quantities through the GI tract, then somehow know to go straight to the cancer cells to kill them, without wreaking havoc elsewhere; “toxins” can be measured by hair analysis and flushed out of the body by coffee enemas–even if this were true, which it is not, it would have no effect on cancer.

    At the time the study began, there were no animal studies to support it, contrary to your assertion. Since then there has been one study in mice (not “some”) that looked only at pancreatic enzymes, not at coffee enemas and the rest. It is touted by Gonzalez but is not, in fact, supportive of his regimen. It’s authors concluded that the difference between the two groups was due to better nutrition for the mice in the treatment arm. See: http://www.dr-gonzalez.com/mice04.htm
    This does not translate to humans because human patients need not be deprived of rational nutrition, whereas it’s easy to see that Ms. Gurney’s friend was deprived of exactly that. It is likely that the combination of coffee enemas and the >100 other pills/day, fruit juices, and the rest (not in the mouse study, remember) caused such diarrhea that he had little useful absorption of nutrients from his GI tract.

    Gonzalez’s case series, to which you linked as if this blog had ignored it, is useless for reasons discussed at length in the blog and on Dr. Moran’s own website.

    2. The Gonzalez regimen is far worse than “conventional cancer treatments,” by which you presumably mean the current standards of care for cancer of the pancreas. The story of Ms. Gurney’s friend is a nightmare far worse than the usual course of even this very bad disease, when treated by competent physicians.

    3. The current standard treatments for cancer of the pancreas are not “well known to be horrible.” There is no reason that a patient should be in horrible pain, for example. The patient described by Ms. Gurney did not know, nor should he have had to know, to “request…nerves to be destroyed to stop the pain.” Gonzalez should have offered him competent treatment for his pain (read the quotation from the Helsinki Declaration: “The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given consent.”). Instead, he told the patient, in essence, that increasing pain was to be applauded.

    Your gratuitous “nerves to be destroyed” phrase, clearly designed to shock and scare patients away from a humane, innovative treatment, reveals your bias and ignorance, in spite of your usual claims of neutrality. If even one future patient shies away from such treatment because of having read your comment, shame on you.

    Not all chemotherapeutic agents are the same, it may surprise you to learn. Gemcitabine, the current standard for cancer of the pancreas, is not particularly arduous and works well enough to be useful, which is why competent physicians recommend it. It has been shown to “effect ‘a slight prolongation of life and a significant improvement in . . . quality of life’,” as quoted above and as was known by John Chabot, the PI of the Gonzalez trial.

    4. “What is wrong with continuing” this version of research on the Gonzalez regimen is that it has been blatantly, sadistically unethical, as Part V above has demonstrated in spades. If there were any reason to think that there might be something to it (there isn’t), the ethically-sound course would be to begin with basic science and animal studies–many, not one–as required by the Helsinki Declaration and as is the norm for non-”CAM” hypotheses that are far more plausible to begin with.

    5. In the meantime no one here is saying, as you claim, that we should “prevent [patients] from trying alternative treatments.” What we should prevent is licensed physicians from practicing quackery. Even more crucially, we should be outraged that the government and an otherwise respected medical school appear to endorse the method as worthy of study and that they employed the practitioner himself, who had already demonstrated himself to be a dangerous charlatan, as the investigator in charge of taking care of the experimental subjects.

    6. Dr. Moran’s wistful hope, that the trial might be useful to finally put the claim to rest, is shared by many reasonable people who have not fully examined the relation between science and human studies ethics, as I hope I explained adequately in the text above. The trial is unethical; the end cannot justify the means. Moreover there will be no end: the trial came to a grinding halt a couple of years ago, as I will discuss this week. The reason it came to a halt is entirely related to why it was a bad idea in the first place.

    7. Your other gratuitous comments, “the suffering caused by mainstream chemotherapy” and “You don’t have to hate a regimen just because it doesn’t involve toxic chemicals, radiation and invasive surgery,” for example, are of the usual “strawman” variety. Just as we modern physicians would love it if there were magical energy fields that could “heal” people, we would also love it if there were a Star Trek-like remote control device that we could aim at cancer patients and make them well. We would love it if there were foods that they could eat that would make them well. So far, there are not.

    I no longer think you are merely foolish, pec. I now think that you are dangerous to others, and as far as I’m concerned you are no longer welcome to make gratuitous, fatuous comments.

  16. pec says:

    “we would also love it if there were a Star Trek-like remote control device that we could aim at cancer patients and make them well.”

    Actually an engineer recently invented a device to kill cancer cells using radio waves. I don’t think it will cure cancer, because I think malignant cells are more of a symptom than a cause,of disease. But at least his invention should be less harmful than the current standard treatments.

    And notice he’s an engineer, not an MD. Maybe MDs are just too stuck in their conventional thinking. You just love the standard treatments, and you’re just thrilled every time a new cancer drug prolongs life a little tiny bit.

  17. David Gorski says:

    The patient described by Ms. Gurney did not know, nor should he have had to know, to “request…nerves to be destroyed to stop the pain.” Gonzalez should have offered him competent treatment for his pain (read the quotation from the Helsinki Declaration: “The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given consent.”). Instead, he told the patient, in essence, that increasing pain was to be applauded.

    Yes, nerve ablation to which I refer is a long-accepted palliative treatment for pain from pancreatic cancer. It’s very effective. In fact, it’s so effective that it used to be considered worth doing open surgery to perform; surgeons would open the abdomen to inject alcohol around the celiac plexus nerves and thus ablate them. Nowadays, fortunately, it can be done percutaneously under CT-guidance. It does destroy the nerve endings, but they tend to grow back. However, percutaneous injection of these nerves with alcohol often gives four months of good pain relief, which in pancreatic cancer is usually enough, and if it isn’t the procedure can be repeated. Here is a description of such nerve blocks from the Johns Hopkins University website:

    Celiac Plexus Block

    For pain from pancreatic cancer that does not respond to other measures or when taking oral or topical medication leads to unacceptable side effects, an alcohol nerve block may be performed. This procedure provides pain relief by acting directly on the nerves which carry painful stimuli from the diseased pancreas to the brain. This nerve group is referred to as the celiac plexus. A local anesthetic is injected into the nerve root of the celiac plexus. This is an invasive procedure that uses either ultrasound or CT scan guidance to locate the celiac nerve plexus. Needles are placed through the skin (percutaneous) and alcohol is injected on each side of the aorta on either side of the celiac axis. This procedure is performed by anesthesia pain specialists in an outpatient setting. This nerve block may last for up to 3 to 4 months as the nerves were “numbed” and the block tends to wear off over time. A percutaneous alcohol nerve block can be performed to reduce pain and to reduce the need for high doses of oral opioids. Nerve blocks can be done as an outpatient procedure. Percutaneous nerve blocks may be repeated in a patient with a previous block that has worn off. The patient may also take any pain medication as needed but the hope is that the patient will not require as high a dose of opioids to provide pain relief and maintain quality of life.

    Newer Alternatives

    Newer alternatives are available. Thorascopic splanchnicectomy is a minimally invasive procedure that cuts specific nerve branches. This technique is done under general anesthesia. Results appear promising for significant pain relief but the duration of pain relief remains unknown. Another technique is the endoscopic ultrasound-guided celiac plexus nerve block. This approach uses a endoscope to look into the stomach and then place a needle through the stomach to inject the celiac plexus nerves. It appears to be safe and effective but more studies are needed to compare to other available methods.

    The point is that “conventional” medicine offers a fairly large array of palliative treatments to make the lives of pancreatic cancer patients as pain-free as possible for their remaining few months, including drugs, nerve blocks, radiation therapy, and thoracoscopic splanchnicectomy (cutting of the splanchnic nerves), among others. The patient described was offered none of those options, and Dr. Atwood’s point stands: If Dr. Gonzalez is either unaware of these options to treat pancreatic cancer pain or unwilling to use them, he has no business treating pancreatic cancer patients. Most cancer patients these days do not have to die in unrelenting unbearable pain. For most patients, the pain can be controlled at least to the point that it is bearable. It should not be up to the patient to be required to investigate these alternatives. A competent physician should be aware of them and offer them to the patient, not allow the patient to die with untreated pain from untreated pancreatic cancer. Allowing that to happen was utterly unacceptable and unethical.

  18. David Gorski says:

    Actually an engineer recently invented a device to kill cancer cells using radio waves. I don’t think it will cure cancer, because I think malignant cells are more of a symptom than a cause,of disease. But at least his invention should be less harmful than the current standard treatments.

    If you’re referring to radiofrequency ablation, it’s by no means a cure for cancer and actually has a fairly limited usefulness. Mostly, it’s used to ablate tumors in the liver of patients who are not good surgical candidates or who have metastatic disease from a colorectal cancer primary in both lobes of the liver, precluding surgical resection for cure.

  19. Harriet Hall says:

    pec said,
    “Maybe MDs are just too stuck in their conventional thinking. You just love the standard treatments, and you’re just thrilled every time a new cancer drug prolongs life a little tiny bit.”

    Any MD would be thrilled to have any new treatment that is safer or more effective. We just want some reasonable evidence before subjecting our patients to onerous and potentially harmful untested regimens.

  20. pec says:

    The regimens you are using now are onerous and very often do not work. It would be nice if you could at least admit that.

  21. Harriet Hall says:

    pec said,

    “The regimens you are using now are onerous and very often do not work. It would be nice if you could at least admit that.”

    We do admit that.

    I suspect they are less onerous than you think, and I suspect they work more often than you think. We tend to hear about the horror stories and not hear about the patients who sailed through their chemo in comfort. We hear about the ones who die because there is an end point; we don’t hear as much about the ones who had chemo 5 years ago and are doing well but can’t be definitively declared “cured.”

    We know they don’t always work, but they work often enough (they work much better in some cancers than others). We can’t foresee which individuals will be helped, but we can say statistically how many cures, remissions and palliative effects we will get.

    When my mother developed metastatic breast cancer many years ago, the doctors told her very clearly that chemotherapy for her type of cancer had only been evaluated in 3 studies. In 2 studies there was no effect; in the 3rd, it prolonged life by a small percentage. They told her about expected side effects (nausea, hair loss, infections, etc.). They gave her the option of chemo or no treatment but pain control when the time came. If I had been her, with that information, I probably would not have chosen chemo.

    She chose chemo, had some of the expected side effects for about a year, and was back to normal after that. She had no recurrence of cancer, and lived to die of old age a quarter of a century later. My point in telling this anecdote is not that she survived (which she might have anyway) but to show that the doctors were very upfront about admitting the limitations of what they had to offer at that time, and they did not urge chemo on her but let her choose.

    Any treatment is a gamble. If you take penicillin for pneumonia, you might die of anaphylactic shock or get other complications. If you don’t take penicillin, your body might fight off the infection anyway without it, so you might have taken it unnecessarily. But giving penicillin to all patients with pneumonia saves a lot of lives, and most of us would choose to take it.

    There is a risk/benefit ratio to any treatment, and different patients will be comfortable with different ratios.

  22. pmoran says:

    “Dr. Moran’s wistful hope, that the trial might be useful to finally put the claim to rest, is shared by many reasonable people who have not fully examined the relation between science and human studies ethics, as I hope I explained adequately in the text above. The trial is unethical; ”

    There was never any reason to believe that the endoscopic washing out of osteoarthritic knees would be a useful treatment for the average patient with osteoarthritis, yet this procedure was being performed by orthopedic surgeons by the thousands. This made it ethical, in the minds of many, to subject a control group of patients to a sham operation involving a general anaesthetic and skin incisions that were then sewn back up again. That study was also most unlikely to advance scientific knowledge except in a negative way, but it was made necessary by the need to ensure that medical practice corresponded closely to the ideal as disclosed by proper scientific study.

    What is different here? You have even used the appalling distress of a patient who had been led to believe in the Gonzales method, in an argument against producing the kind of information that spare other patients from the same.

    There is a suppplemetary role for some investigation of quack methods. If we are to have influence with the public, with the legislature or the legal system we have to at least sometimes be shown to be right in our judgement. As I have said before, “It just ain’t plausible” is an argument that mainly only carries weight with those who already know that.

    David Gorski’s piece shows how we are up against it. The reason that it is so difficult for medical boards to do anything about quackery is that they know that the isntant they do anything they will be assailed by deluded patients and that they cannot rely upon the suuport of politicans or the judiciary. They know that the onus of proof will be reversed. Everything is skewed against them. They will be asked for proof whereas the

    going through the same reason for some sort of skewed reason for not bothering to answer questions that this patient might have liked to ask of the scientific patients are asking every day.

    There are many good reasons for not investigating alternative methods *as a routine* but the ethical side of things will be very case specific. I believe this argument is weak.

  23. The big problem with studying highly implausible alternative methods is that it is a lose-lose proposition for SBM. The history has clearly shown that negative studies to not end the use of such procedures and treatments. CAM practitioners are not evidence-based to begin with – they are demonstrably unaffected by negative evidence.

    Negative studies lead only to excuses – not a change in practice. At best it leads to a change in marketing – rebranding the same old nonsense.

    Yet – if we don’t study it, then we are accused of being dismissive, not giving it a fair chance, and suppressing alternative ideas.

    It’s lose lose because the problem is unscientific medicine – which you cannot fix by doing science.

    But – I am still willing to support well-designed studies in specific cases, that are transparent, and actually study safety and efficacy in a definitive way. The only benefit, as far as I can see (other than the scientific information itself, which is of little value because highly implausible modalities are very likely to be negative, so finding that they are negative doesn’t actually add much information) is that it gives us some political capital to champion science-based medicine.

    But this support is tentative and temporary, because again history paints a dismal picture. What typically happens is that the proponents get a huge PR boon out of the very fact that their treatment is being studied, then the negative results are dismissed and swept under the rug. I think the net PR value may be negative. In the end they say – “this study showed the potential of this new treatment and that it deserves further study.” And that’s when the data is dead negative. They also milk any non-significant trend, and of course they trumpet bad data whenever it goes in their direction.

  24. pmoran says:

    I had a key board accident, and sent my comment prematurely. Here it is as it should be — (Please delete the previous one if you can)

    “Dr. Moran’s wistful hope, that the trial might be useful to finally put the claim to rest, is shared by many reasonable people who have not fully examined the relation between science and human studies ethics, as I hope I explained adequately in the text above. The trial is unethical; ”

    There was never any reason to believe that the endoscopic washing out of osteoarthritic knees would be a useful treatment for the average patient with osteoarthritis, yet this procedure was being performed by orthopedic surgeons by the thousands. This made it ethical, in the minds of many, to subject a control group of patients to a sham operation involving a general anaesthetic and skin incisions that were then sewn back up again. That study was, like the Gonzales one, most unlikely to advance scientific knowledge except in a negative way, but it was necessary to ensure that medical practice is being guided by proper scientific study, as far as is practical.

    What is different here? You have even used the appalling distress of a patient who had been led to believe in the Gonzales method, in an argument against producing the kind of information that might spare a few other patients the same. In the long run all scientific medical study is performed for the benefit of patients, not some indefinable something called science, or even the satisfaction of the finest ethical sensitivities.

    The fact that many of our patients and a most of the public would like us to investigate these methods should count for a little. It is revealing that nearly every patient wanted to go into the nutritional arm of the Gonzales trial, presumably after considerable background briefing. What does this mean for the question at hand?

    There is a wider beneift from the occasional investigation of implausible methods. It supports in the public mind the concepts that SBM hopes will prevail. It shows that implausible methods don’t, in fact, usually work when put to the test. It adds force to our explanations as to why quack methods can seem to work, and why we are right to hold out for better evidence from those making the claims..

    We are to some extent already riding on the back of numerous studies showing that once popular alternative methods are ineffective. Much of our credibility with the public may hang upon such evidence, combined with habitual but easily undermined public trust.

    David Gorski’s piece exemplifies the almost intractable problem we are trying to deal with. The reason that it is so difficult for medical boards to do anything about quackery is that they know that the instant they try, they will be mobbed by deluded patients (invariably). They know that they cannot rely upon support from politicans, the media, or the judiciary. They know that the onus of evidence will be reversed. They will be asked for “eternal truth” standards of proof whereas the quacks simply have to keep on raising doubt. This is why such prosecutions are so difficult.

    There are many good reasons for not investigating alternative methods *as a routine*, but the ethics will be case specific and observer-dependent. It is not clear that the ethical problems with this trial could not have been overcome at the planning stage or by a different design.

  25. Pec said, “The regimens you are using now are onerous and very often do not work. It would be nice if you could at least admit that.”

    Once more Pec how do you know that the regimens are onerous and what is your direct or indirect experience with untreated cancer if any?

    Do you have any statistics showing how often the regimens don’t work and how often they do? How about statistics for specific types and stages of cancer and specific treatments?

    When you say it would be nice if “you” admit that “very often” those regimens don’t work, are you referring to the MDs here or MDs in general?

    Quite frankly I’ve heard MDs accused of many things but claiming that cancer treatments always work or that they are without side effects are not among them. How could they even get away with such claims while so many of them are engaged in research meant to develop effective treatments?

  26. Joe says:

    Dr. Moran, sorry I cannot retrieve the citation; but, on another site, there was a discussion of quack methods that went out of use when disproven. While we had some trouble defining it (many quack ideas were held by 19th century “mainstream” physicians) none of us could cite nonsense that had disappeared entirely (although they may be gone from medicine). I don’t imagine the Gonzo treatment ever had much traction in medicine; but I doubt its failure at Columbia will kill it. At best, it will move to clinics outside our borders.

  27. Harriet Hall says:

    Laetrile had NO plausibility or credibility; it was invented for a stock market scam. It was scientifically tested and failed but is still being used in Mexico.

    Joe is right. When a treatment is not based on good science, good science is not likely to make it go away. Hope springs eternal, and true believers never change their minds.

  28. pmoran says:

    Joe and Harriett, I am sure you will agree that there is no solid data on which any of us can make a firm evidence-based judgement as to how influential scientific studies are on the use of quack treatments. For all we know, quackery might be more prevalent than it is, if it were not for the numerous studies that have already been performed.

    We are each simply talking from judgements that are based upon our own observations and to a lesser extent upon orthodox skeptical belief that I once shared. My belief has changed, based upon what is being talked about and recommended on the most active Alternative Cancer mailing lists that I can find. I have been frequenting such sites for over 15 years (with brief holidays when I cannot keep my mouth shut and get booted off. I now have to use my son’s email and keep quiet).

    I do agree that studies have no influence on the beliefs of the quack. I never said they would. But the focus should be on the cancer patient — we will never go far wrong if we first ask ourselves what is in their best short and long term interests, making allowances for the fact that they are making critical decisions with extremely incomplete and distorted medical understanding and under extreme pressure from illness, relatives and friends. If we want to discourage the use of quackery, a high-handed, “we know best” stance and arcane argument from plausibilty (to us) are just not going to cut it against other imperatives. This is why it may be wise to sometimes back our opinions up with solid data.

    Yes, if you do a google search on Laetrile or shark cartilage you will probably find places that are still selling them. But if you want to know what the public thinks, or what they are being told, or what are the popular treatments, go to the newsgroups and mailing lists.

    There, you won’t now find people talking about the Di Bella Method, shark cartilage or the Holt treatment since those methods were examined in prospective studies or close exmination of his cases. Laetrile has had a recent resurgence, mainly in tne form of apricot kernels that canning companies must be thrilled to be able to sell off to cancer sufferers, but this is against a background of rather muted claims. It is not the major quack treatment that it once was, being promoted by fairly obvious hobbyists rather than the more credible doctors that were previously involved with it.

    We have a clash oif opinion on this point. I am prepared to hear more argument on the matter, as I allow that some of the things I have observed could simply be due to the tendency for the popularity of alternative cancer treatments to wax and wane with novelty and fashion. And even with the evolution of scientific study, as is shown by teh present interest in intravenous vitamin C.

    I was prepared to support the Gonzales (not in the same format). I still do, to some extent. partly because it will test out a lot of presently popular alternative modalities in one go, which is useful when talking to patients, and partly because our cancer patients will never have the ability or opportunity to assess Gonzales’ rather unique study in the way that we have, with background material that even I have never seen before (and note pec’s response). But above all, it was an example on display of how the mianstream is prepared to investigate even highly implausible treatment methods if supported by something more than the usual low-quality testimonial evidence.

  29. Dr. Moran,

    I’ll try to answer your answer to me, but I have little time in the next few days, so please be patient if it is done piecemeal. First, let me say that I applaud your project even if I disagree with some of your opinions. Your knowledge of these issues is substantial, and your website has much useful information. Your distinction between the quacks and the patients is well taken, and demonstrates that the phenomena are of the sort that we can never understand in a rigorous way–similar to economics and other social sciences, alas–and thus will forever remain matters of educated opinion, at best.

    Now for the “buts,” not necessarily in the order in which you presented them:

    “You have even used the appalling distress of a patient who had been led to believe in the Gonzales method, in an argument against producing the kind of information that might spare a few other patients the same.”

    I know you don’t really believe that this subject’s misery would be justified, in retrospect, by using it as an example to try to dissuade others from similar fates; but in the aggregate, that is what is implied by “producing the kind of information that might spare a few other patients the same.” The fact that some naive, hapless people may choose to be treated by a dangerous quack in no way justifies experts who understand the “arcane argument from plausibilty” exposing innocent subjects to trials of such treatments, unless, perhaps, the condition and the treatments are of minimal risk (a topical cream for baldness, for example). Even if some might argue for that justification when there is more than minimal risk, it doesn’t pass ethical muster, whether we like it or not. The treatises that I quoted above are clear: the well-being of the individual research subject trumps the “popularity” argument. There is wiggle room, but it requires, at the least, honest, informed consent.

    Put another way, imagine composing the honest, informed consent (not the “led to believe” one that must have been presented to Ms. Gurney’s friend, for example) that would accompany the trial of the Gonzalez regimen that you favor. I won’t offer my version because I don’t have time and because I don’t think you need my two cents. You know what’s honest and what isn’t.

    The knee arthroscopy for osteoarthritis study is hardly comparable to the Gonzalez trial, and I don’t have time to discuss it at length, but: First, if the arthroscopic study was as you presented it, then it was, indeed, unethical, and two wrongs don’t make a right. It was not really as you presented it, however: a) it was not implausible (debris, both loose and attached, in arthritic knees could certainly contribute to pain and dysfunction in a vicious cycle sort of way, so why not clean them out periodically? Then again, I agree that the outcome was the expected one). b) the risks were very close to minimal, though not quite (that may surprise many readers, but it’s true: general anesthesia and short, sterile, peripheral surgical procedures in healthy people are considerably safer than driving your car; the pain associated with that particular procedure is not much). c) the informed consent MAY have been honest. If it was, it gets into the “wiggle room” realm.

    Next: why denigrate our hard-won expertise and professionalism by calling it “a high-handed, ‘we know best’ stance and arcane argument from plausibility”? Would you say the same about a lawyer, a commercial airline pilot, an accountant, a civil engineer, an astronaut, or many other experts whose knowledge necessarily includes much that is technical, esoteric, complex, and difficult for even smart, educated people to understand without specific training? I try to explain my views to people as well as I can, as I’m sure you do, but I have no qualms about saying, when push comes to shove, “you choose that irrational, dangerous, expensive, and useless ‘remedy’ at your own risk. Know that those who are hyping it know little or nothing of what they claim, whereas those of us who know vastly more know baloney when we see it, and would never send our loved ones to such a fate.”

    You can’t save everybody. Enough for now.

  30. apteryx says:

    A lawyer, maybe yes. A pilot or an astronaut who is snowing me under with jargon from his/her field (or worse, just telling me that it’s too hard for me to understand) is probably not trying to convince me that I need to pay him for more extensive services than I otherwise might. The lawyer might be. So might the oncologist. Perhaps the average motivation of a cancer quack is 90% profit and 10% desire to help, whereas the average motivation of an oncologist is 90% desire to help and 10% profit. Even discounting the fact that his definition of “help” may be “extend existence as long as possible, at whatever cost,” this still creates a reason for patients to do some fact-checking rather than just doing whatever he tells them.

  31. pmoran says:

    Kim >”I know you don’t really believe that this subject’s misery would be justified, in retrospect, by using it as an example to try to dissuade others from similar fates; but in the aggregate, that is what is implied by “producing the kind of information that might spare a few other patients the same.” The fact that some naive, hapless people may choose to be treated by a dangerous quack in no way justifies experts who understand the “arcane argument from plausibilty” exposing innocent subjects to trials of such treatments, unless, perhaps, the condition and the treatments are of minimal risk (a topical cream for baldness, for example). Even if some might argue for that justification when there is more than minimal risk, it doesn’t pass ethical muster, whether we like it or not. The treatises that I quoted above are clear: the well-being of the individual research subject trumps the “popularity” argument. There is wiggle room, but it requires, at the least, honest, informed consent.

    Yes, point taken. I hope patients were told “doctors don’t expect this to work” before most opted for the nutritional arm of the Gonzales study.

    Also, in the real world and *for this particular clinical context only*, the harm done to patients with inoperable pancreatic cancer and their family finances by the notion that obsessive nutrition, supplements, enzymes and various means of boosting the immune system and detoxification (nearly all the major themes in present alternative cancer care) offers some small chance of cure, probably outweighs the overall benefits of chemotherapy. At least in a properly conducted controlled trial we can establish escape clauses for those who are obviously not being benefited by either approach and offer chemotherapy then.

    If patients chose to continue to use the method once it has been shown not to stop cancer growth in even one of the forty (?) cases in the Gonzales arm of this trial, then I would feel more justified in regarding them as “naive and hapless”. Actually, they are folk very like you and me who are simply grasping at any straw that might save or prolong their lives.

    Kim > “Next: why denigrate our hard-won expertise and professionalism by calling it “a high-handed, ‘we know best’ stance and arcane argument from plausibility”? Would you say the same about a lawyer, a commercial airline pilot, an accountant, a civil engineer, an astronaut, or many other experts whose knowledge necessarily includes much that is technical, esoteric, complex, and difficult for even smart, educated people to understand without specific training? ”

    PM > No, because quackery only flourishes in medicine. Only there do do useless methods seem to work well enough to mislead a lot of intelligent and vocal people. People will also not fly in plane that only “might” stay up in the air, but a cancer patient will happily spend $25,000 a month on a treatment on the mere off-chance that it might cure them.

    I have no wish to denigrate our profession except when it appears to want to distance itself from the intimate concerns of its patients, and one of those, these days, is: “where do I apportion my trust?” I think we may have to keep earning that trust.

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