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

Blogger’s note: This blog, which is rough going in places, will be presented in either 2 or 3 parts (I won’t know which until next week). I’ll post a part each week until it is complete, but due to overwhelming popular demand I promise to maintain the every-other-week posting of the far more amusing Weekly Waluation of the Weasel Words of Woo/2.

Introduction

On Feb. 25, 2008, the federal Office for Human Research Protections (OHRP) cited Columbia University Medical Center (CUMC) for violating Title 45, Part 46 of the Code of Federal Regulations: Protection of Human Subjects (45CFR§46). The violations involved Columbia’s administration of the NIH-sponsored trial of the bizarre “Gonzalez Regimen” for treating cancer of the pancreas.† The OHRP’s determination letter to Steven Shea, MD, the Director of the Division of General Medicine and Senior Vice-Dean at CUMC, cited ethical problems of a serious kind:

We determine that the informed consent for the 40 of 62 subjects referenced by CUMC was not documented prior to the start of research activities, nor was the requirement for documentation waived by the CUMC IRB for subjects in this study.

It was the second time that the OHRP had cited Columbia for its dubious management of the “Gonzalez” trial. The first occurred in Dec. 2002, after investigators had determined that the trial’s consent form “did not list the risk of death from coffee enemas.” The OHRP listed several other violations at that time, but “redacted” them from the letter that it made available to the public.

The “Gonzalez Regimen”

The full name of the trial, which began in 1999, is:

Prospective Cohort Study of Gemcitabine Versus Intensive Pancreatic Proteolytic Enzyme Therapy With Ancillary Nutritional Support (Gonzalez Regimen) in Patients With Stage II, III, or IV Adenocarcinoma of the Pancreas

The trial ostensibly investigates a “detoxification” regimen advocated by Nicholas Gonzalez, a physician who has been found “guilty of negligence and incompetence on more than one occasion” and has been ordered to pay large, justified malpractice settlements on others. The regimen includes pancreatic enzymes taken by mouth—which, according to the National Cancer Institute (NCI) description, “may help kill cancer cells”—and the following:

Coffee enemas are performed twice a day, along with skin brushing daily, skin cleansing once a week with castor oil during the first 6 months of therapy, and a salt and soda bath each week. Patients also undergo a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest.

Writer Michael Specter described the regimen’s oral medications for an article in the New Yorker several years ago:

The list of supplements that Gonzalez hands out to most patients with solid tumors runs to four single-spaced pages. It includes, in part, sixty freeze-dried, porcine-pancreatic enzyme pills (swallowed in six batches, all of which must be taken with water, and none of which may be taken with food or within an hour of a meal). During breakfast and dinner, each patient must swallow capsules of adrenal medulla, amino acids, bone marrow, selenium 50, thyroid, Vitamin A 10,000, and Vitamin E succinate.

There are separate pills for the lymph, liver, and kidney–all to help balance deficiencies caused by lack of enzymes, or because the body is overwhelmed fighting cancer. During lunch, each patient must take a pill with twenty-five thousand units of beta carotene, as well as pills with copper gluconate, manganese glycerophosphate, potassium citrate, and Vitamin D. Twice each day, whenever it’s convenient, patients must dilute a mixture of black-walnut formula in water and drink it. Patients who suffer from metal toxicity also need to take nine pills of sodium alginate.

In all there are about 150 pills per day. The regimen is “alternative,” not “integrative.”

An “Eccentric” Dentist

Gonzalez inherited most of this regimen and his ideas about cancer from a dentist in Texas. He frequently recounts his experience, beginning as a medical student at Cornell, interviewing

…my mentor, Dr. William Kelley, the eccentric and controversial dentist who, over a 20-year period, developed a very intensive way of treating cancer using diet, supplements, large doses of pancreatic enzymes, the controversial detoxification routines, such as coffee enemas.

[...]

I learned about Dr. Kelley in 1981, after my second year of medical school at Cornell. I was fortunate at the time that I was already kind of being taken under the wing of Robert Good, who, at that time, was president of Sloan-Kettering Cancer Institute.

[...]

I had met Kelley in the summer of 1981. Again, the details of which aren’t important for this session. At that time, he was very controversial. He was just coming off of that Steve McQueen fiasco. Steve McQueen, the actor who did Kelley’s program.

Kelley was desperate to have his work tested. This is 1981, before the NCI had an Office of Alternative Medicine, before there was a National Center for Alternative Medicine, before any of those things were up and running.

It was a very controversial time to be treating cancer patients with nutrition, particularly if you were a dentist and not a physician, so there were all kinds of legal issues involved.

When I met Kelley, he expressed one interest and one intention. Whatever’s said about him or isn’t said about him, whatever people may think or not think about him today in 2000, in 1981 he had one intention. He wanted his work properly evaluated by the orthodox medical community.

He believed he was doing something of value. He also said in our first session that if he was doing something of value it needed to be tested properly so it could be mainstreamed into orthodox medicine where any big therapy belongs. I thought that was a very noble and honorable intention, and he maintained that intent through the next 5 years.

Under Dr. Good’s direction, initially, as a medical student, but subsequently as an immunology fellow in his research group which, at that point, eventually moved to the University of South Florida, I completed an intensive investigation of Kelley’s work.

[...]

We were confronted with an alternative practitioner in 1981, who had treated literally over 10,000 patients using this nutritional program over a 20-year period. It was a mass of information.

One of the first things Kelley did for which I respect him to this day enormously, is he opened all his records to me. There were no secrets. His successes, his failures, the people that loved him, the people that wrote him hate letters, all that stuff was opened to me from the time I first started investigating his work. There were no secrets.

We were confronted with a mass of records. Half of them were in Dallas, where we had an office, half of them were in Washington state; some of them went back 25 years. At one point, he had had a fire in his house, some of his records were destroyed. And I was confronted with this enormous project that Dr. Good was encouraging me to do without the slightest idea how to do it.

[...]

It took eventually 5 years to do that. Of course, I began the study while I was a medical student, continued it extensively while I was a fourth-year medical student. I had a 4-month block of time to really get involved with this. Then during my 2-year immunology fellowship this is primarily what I did.

To the day I die, will be grateful to Dr. Good that he allowed me to do this while I was doing my immunology training. I eventually went through 10,000 of Kelley’s records, evaluated over 1,000 very intensively. By intensive evaluation, I mean, we got complete medical records. I interview all his patients, over 1,000. Of this group, we were able to select 455 that we felt at least met the initial criteria for the second part of the research study. Terrible prognosis, biopsy-proven, radiographic studies either ──── survival or tumor regression. We eventually selected that down to 50 patients that we evaluated — that I evaluated extensively. Some of these patients I interviewed 6, 8, 10 times. Some of them I actually went to their home. We got complete medical records.

I apologize for that voluminous and tedious quotation, but it amounts to a small fraction of a recurrent litany of name-dropping, euphemism, false modesty, other acts of pseudo-self-deprecation, and unfalsifiable claims.

According to Dr. Gonzalez, the result of his 5-year investigation of Kelley’s practice was a 500-page manuscript that he never published: “One Man Alone: An Investigation of Nutrition, Cancer, and William Donald Kelley.” It consisted of detailed case reports of the above-mentioned 50 patients. That manuscript, however, was examined in detail by six physician reviewers for the Congressional Office of Technology Assessment (OTA), as reported in 1990. The OTA reviewers found that

In all cases,…documentation presented in the manuscript was inadequate to confirm critical details of the narrative, and in many cases, it appeared that critical pieces of information did not exist in the medical record at all (e.g., confirmation of metastatic disease), mainly because the patients had not been followed up with tests and scans to determine the status of their disease.

The OTA’s assessment of both Kelley’s regimen and the similar regimen of Max Gerson did not suggest real evidence of efficacy.

Dr. Gonzalez’s CV reveals that he spent much of his 4th year of medical school pursuing his interest in Kelley, and that his postgraduate clinical training consisted solely of an internship (1 year) in internal medicine at Vanderbilt. Above, he admits to having spent most of his ”2-year immunology fellowship” poring over Kelley’s records and writing his manuscript. Thus Dr. Gonzalez’s implicit claims to clinical expertise in general, to specific expertise in oncology, and to expertise in conducting clinical trials are unwarranted.

Or maybe just a Garden-Variety Quack

It is instructive to compare Dr. Gonzalez’s statements about Kelley to statements written by two veteran and savvy health fraud investigators, Stephen Barrett, MD, the acerbic founder and editor of Quackwatch, and his frequent co-author, the late hematologist and nutritionist Victor Herbert, MD, JD:

In the 1960s, William Donald Kelley, D.D.S., developed a program for cancer patients that involved dietary measures, vitamin and enzyme supplements, and computerized “metabolic typing.” Kelley classified people as “sympathetic dominant,” “parasympathetic dominant,” or metabolically “balanced” and made dietary recommendations for each type. He claimed that his “Protein Metabolism Evaluation Index” could diagnose cancer before it was clinically apparent and that his “Kelley Malignancy Index could detect “the presence or absence of cancer, the growth rate of the tumor, the location of the tumor mass, prognosis of the treatment, age of the tumor and the regulation of medication for treatment.”

In 1970, Kelley was convicted of practicing medicine without a license after witnesses testified that he had diagnosed lung cancer on the basis of blood from a patient’s finger and prescribed dietary supplements, enzymes, and a diet as treatment. In 1976, following court appeals, his dental license was suspended for five years. However, he continued to promote his methods until the mid-1980s through his Dallas-based International Health Institute. Under the institute’s umbrella, licensed professionals and “certified metabolic technicians” throughout the United States would administer a 3,200-item questionnaire and send the answers to Dallas. The resultant computer printout provided a lengthy report on “metabolic status” plus detailed instructions covering foods, supplements (typically 100 to 200 pills per day), “detoxification” techniques, and lifestyle changes.

Basic Science: Implausible

As is true for Gonzalez, Kelley also did not concoct the ideas that were the bases for his treatments, but borrowed them from fanciful notions that had begun early in the 20th century. The history is recounted in Mr. Specter’s New Yorker article and in the NCI’s “PDQ Summary,” but is best explained in an article by the late Sloan-Kettering biochemist Saul Green. Green’s essay dismantles each component of the “Kelley/Gonzalez” claim and exposes its most fundamental defect: it fails to acknowledge that cancer is a genetic disease; thus the “daughters” of cancer cells are themselves cancer cells.

What that means is that the Kelley/Gonzalez “detoxification” regimen, even if it were what its name implies (it isn’t), even if it were capable of removing carcinogens (it is not), and even if its several other tenets were valid (they are not), would already be too late once cancer has begun. From the standpoint of basic science, several unanimously unlikely sub-claims add up to a vanishingly unlikely whole.

Empirical Evidence: Implausible

But what about empirical evidence? It is the claim of clinical successes, after all, that constitutes the formal rationale for the study. In public, it seems, Gonzalez is careful not to offer quantitative rates of cure or survival times for patients on his regimen. In numerous places, however, he implies miracle cures of patients who had been on death’s door when he (or Kelly, before him) met them. Such statements can be found on his website, in the New Yorker article, and in lectures. According to a 1998 article by Victor Herbert, moreover, information discovered in the course of a successful $2.65 million malpractice case against Gonzalez suggests that what he tells patients is different from what he tells the press.¹ Dr. Herbert had been one of the plaintiff’s expert witnesses, and thus had access to the evidence:

Gonzalez’s own tape and his subpoenaed office records showed that he stated to [the plaintiff] that he cured 75% of all cancers with his ‘detoxification’ therapy.

He said that the only people he could not cure were those whose ability to be detoxified was destroyed by chemotherapy and/or radiation. He talked her out of the regime, which was scheduled pelvic irradiation to destroy residual endometrial cancer following hysterectomy. Gonzalez represented to her that hair analysis showed that she was full of cancer and cancer toxins, and he would detoxify her by prescribing daily about 150 supplements plus 6 coffee enemas and by doing monthly hair analysis to show her progression to cure.

Subpoena revealed that Gonzalez’s hair analyses for non-existent cancer toxins were carried out on a word processor, not on a hair analyzer. He said her ‘cancer indicators’ were falling, without naming any toxin or indicator…¹

There has been one previous “study,” reported by Dr. Gonzalez himself, purporting to demonstrate a favorable effect of the “Gonzalez regimen” on cancer of the pancreas. According to the NCI,

…a prospective nonconsecutive case series conducted by the developer and an associate, included 11 patients diagnosed with adenocarcinoma of the pancreas (stage II or stage IV). None of the patients had received chemotherapy or radiation therapy, and none had undergone surgical resection with curative intent. All the patients had pancreatic tumors that were either unresected or partially resected. Survival from the time of diagnosis was the only study endpoint, and all 11 patients (including one who left the study) were included in this survival analysis.

The investigators reported a median survival time of 17 months and a mean survival time of 25.2 months for these patients. Nine patients (82%) survived 1 year, five patients (45%) survived 2 years, and four patients (36%) survived 3 years. At the time the study was reported, two patients were alive: one who had survived 3 years, and one who had survived 4 years. The researchers concluded that the 1-year and 2-year survival percentages for this group of patients were superior to those observed for other U.S. patients diagnosed with adenocarcinoma of the pancreas (1-year survival, all stages = 25%; 2-year survival, all stages = 10%).

The key phrase in that summary is “nonconsecutive case series,” which means that Dr. Gonzalez and his associate did not enroll every patient with pancreatic cancer who came along, but selected among them. According to the abstract of his case series, the 11 subjects were accrued over 3 years, between January 1993 and April 1996. Although we don’t know how many potential subjects there were during that time, Gonzalez reported in 1999:

I have followed thousands of patients over the years who have done coffee enemas in some cases for decades: virtually all patients report an increase sense of well being. I have done them myself daily since first learning about them in 1981.

Since he didn’t begin to follow others “doing coffee enemas” until 1987, he must have averaged nearly 200 or more “coffee enema” patients/year over 12 years. They may not all have had cancer of the pancreas, but there may have been many more than 200/yr, and it seems likely that patients with untreatable cancers would have been preferentially attracted by Gonzalez’s claims. Of the four most common malignant tumors—those of colon, lung, breast, and pancreas—that of the pancreas is the least likely to be treatable at the time of its discovery. By these criteria, Dr. Gonzalez may have seen as many as several hundred patients per year with pancreatic cancer, but probably no fewer than 50/yr.

Elsewhere, however, Dr. Gonzalez disputes this, and seems to contradict his previous assertion about “coffee enemas”:

Over the years, I have repeatedly heard the claim that Dr. Isaacs and I must be processing and treating thousands and thousands of new cancer patients each year to obtain the results illustrated by these case reports. In fact, a good friend of mine recently remarked that I must be seeing “350-450” new cases of pancreatic cancer yearly, because we are well known for our success with this particular illness. This is simply not the case. In reality, we see no more than 3-5 new cases a year.

Maybe yes, maybe no. It matters, of course, because the 11-subject case series is meaningless without a denominator, i.e., the total number of patients from which the 11 were culled. I’ve known plenty of patients who lived with cancer of the pancreas for more than one year, a few who lived 2 years, and one who lived 4 years, and I’m not even a cancer specialist. None of those patients “did” the “Gonzalez regimen,” but if they had it would have been a simple matter to compile their case histories in such a way as to cast a favorable light on it. We’ve mentioned such “selective reporting” previously on SBM.

In an article in 1995, philosopher Douglas Stalker argued that such reporting of “best” cancer cases is inevitably misleading:

It is almost axiomatic that if a therapy has been in use for a period of time, some patients will have received the therapy and will also have experienced a positive outcome of their medical problem. The therapy may have caused the positive outcome, or it may not have. A positive case does not tell us about cause and does not distinguish the true from the false therapy hypothesis; positive cases alone do not change the prior probability of a hypothesis.

Stalker showed that the NCI had no idea how to respond to positive case reports, including those involving Laetrile and the first 3 that Gonzalez himself had offered in the early 1990s. Stalker demonstrated the fallacy of the NCI’s “Best Case Series Program” to evaluate “alternative” cancer claims, which began in 1991. It is still in force and does not require that the cases be “consecutive” or that a denominator be reported. He predicted, correctly, that the program was likely to result in the NIH awarding grants for trials of methods for which the evidence was less favorable than that for many plausible chemotherapy regimens that had been automatically dismissed after failing the standard uncontrolled screening test of the day, the Gehan two-stage trial.

How could the NIH have ever allocated $1.5 million of taxpayers’ money for a trial of the “Gonzalez regimen”?

Next Week: The Politics of “Alternative Cancer Cures” and More

[1] Herbert V. The Continuing Case of Nicholas Gonzalez. Scientific Review of Alternative Medicine 1998;2(2):43-44

………………………..

†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: Cancer, Clinical Trials, Health Fraud, Medical Ethics, Politics and Regulation

Leave a Comment (42) ↓

42 thoughts on “The Ethics of “CAM” Trials: Gonzo (Part I)

  1. David Gorski says:

    Yes!

    I’ve always wondered about the Gonzalez protocol and the trial funding it. I’ve had to explain to patients and acquaintances on more than one occasion about the flaws of Gonzalez’s non-consecutive case series. In any case, what happened with this clinical trial is something that I’ve been meaning to look up and do some research on for a long time now, but somehow I never got around to it. I look forward to seeing how this turns out.

  2. Jamie Fitch says:

    Thanks for the insight – I had never heard of this guy. I’ve spent my life thinking the FDA is well run and doesn’t waste money but am quickly learning that’s due to negligence on my part. There’s been a push for clinical trials of ‘traditional’ sub-saharan/eastern medicine in literature and some media lately… As this shows, apparently just the topic is enough to get the money. There’s no need to show that you understand how to conduct a fundamentally sound trial.

  3. Joe says:

    There is an article by Susan Gurney (“Sci Rev Alt Med” 2003-4 7:2 pp. 74-7) about a friend of hers who experienced the Gonzo Protocol. Three messages were significant to me- the first, that they spoke to many doctors at Columbia, and nobody told them he is bat-s**t insane. The second was that her friend’s time was consumed by meeting the requirements of the asinine regimen. Thirdly, he suffered greatly due to lack of appropriate therapy.

    It saddens me that the OHRP only cited a technical violation, and that it was too late to help anyone (the study was closed to new subjects a while ago, certainly all subjects are dead now). I wish criminal charges were filed.

    I know from Orac’s “woo aggregator” http://scienceblogs.com/insolence/2007/11/the_woo_aggregator.php that Columbia has a quack section. What I don’t understand is why the majority of doctors at Columbia did not say “This is obvious abuse of patients, and it will not be tolerated here.” Given his richly-deserved malpractice record, why was he even associated with Columbia?

    How many NCCAM studies are similarly harmful, as opposed to simply silly? The chelation for heart disease comes to mind.

  4. Harriet Hall says:

    I seem to remember some controversy when this trial was in the planning stages. Something about patients being able to choose which arm of the study they were in and too many wanting to be in the treatment arm. Does anyone else remember anything along those lines?

  5. Both Susan Gurney’s article and the lack of randomization are on my agenda, so if you can stand to wait it will all come to pass. On the other hand, if you’d like to make my job easy…
    KA

  6. David Gorski says:

    What I don’t understand is why the majority of doctors at Columbia did not say “This is obvious abuse of patients, and it will not be tolerated here.” Given his richly-deserved malpractice record, why was he even associated with Columbia?

    Two words: Grant money.

    Remember, for every dollar an investigator brings in in federal grant money, the government ponies up an additional 50-70 cents (depending on what the institution has previously negotiated with the federal government) that goes to the institution itself for what are known as “indirect costs” (the costs of maintaining research buildings, etc.). That’s why federal grants are so highly prized by universities; they give by far the highest rate of indirects of any grant agency. Private foundations usually only allocate a small sum for indirects–sometimes even nothing. Consequently, anyone who can bring in federal grant money has a measure of desirability that’s hard to assail.

    Actually, I also rather suspect that it was far more than just the grant money. I’m guessing it was the increasingly accepting culture of academic medicine, where academics don’t want to be labeled as “close-minded” or “intolerant” for criticizing such practices and studies, that prevented any serious criticism.

    Finally, what I seem to recall about the Gonzalez trial as far as randomization goes is that the trial was originally designed as a randomized trial, but no one wanted to be randomized to the conventional therapy arm. Consequently, they rejiggered the trial to make it an “open” trial in which patients could choose the arm. Of course, the interesting thing about this trial is that, even though it’s been closed for some time, I have yet to see any results presented or published.

  7. Joe says:

    Kimball, I look forward to your take on the Gurney article, I gave it my best synopsis.

    Harriet et al, concerning a diagnosis with a long history and a definitive prognosis (e.g., inoperable pancreatic cancer), is a control arm (placebo or current, best therapy) really necessary? Of course, the trial has to be large-enough to account, statistically, for idiosyncrasy. It seems to me that self-selection is not relevant in such cases. But, what do I know?

  8. Harriet Hall says:

    If there is no control arm, then you are limited to comparing your results to other reports of the natural history of the disease, and your populations may not be comparable. And if patients self-select, we don’t know what that means. Are they sicker and more desperate? Are they believers who will be more scrupulous about taking meds as scheduled? Are they more motivated for self-help and maybe doing other things that affect prognosis? There are just too many unanswered questions.

    Even the best-designed studies are subject to so many sources of possible error – the least we can do is design studies to be as rigorous as possible.

  9. BlazingDragon says:

    I’m appalled that such a trial would even be approved, let alone by a place like Columbia. The “slaps on the wrist” after the fact don’t make up for the fact that a lot of people probably suffered a lot before dying in this trial.

    Anything for dollars, I guess? Ugh.

    P.S. Where could I look up exactly what at coffee enema is? If it’s what I think it is, why would this be more useful than a “normal” enema? How would any type of enema be effective for pancreatic cancer? Yeesh.

  10. Harriet Hall says:

    Since you asked…

    For my humorous take on coffee enemas, see http://www.geocities.com/healthbase/coffee_enemas_hall.html

    It comes up number 9 when you google for “coffee enemas.” You might find numbers 1 to 8 amusing too.

  11. pmoran says:

    I share the apparent view that the NIH study is *scientifically* unjustified. Yet clinical studies may occasionally be needed to help reassure cancer patients and the public that we doctors really do know what we are about. Is this one such?

    The NIH study was triggered by Gonzales publishing the small study on pancreatic cancer patients that you rightly criticise. But this was a (very rough) approximation of the kind of Phase l/ll study that we doctors use in the initial evaluation of a cancer treatment. It goes well beyond the usual poor quality testimonial, presenting prospective results in a reasonably appropriate and temperate manner, with biopsy results and all.

    Not to respond positively to this would risk fueling further the perception that the mainstream is irrevocably biased against “alternative” methods and keeps on raising the bar. We can be as clever as we like in tearing such studies apart with a scientifically naive public and desperate cancer patients still being not sure what to think.

    Moreover, this was an opportunity to highlight something else — that kindergarten-level studies of treatment efficacy like these could and should be performed by any cancer quack who claims to be able to cure cancer or bring it into remission. There is no impediment to this, merely the fear of exposing the true worthlessness of the methods. The perception, cultivated by some skeptics, that only complicated controlled trials can tell us anything about cancer treatments has been extremely advantageous for the quacks, because no one can reasonably expect studies of such sophistication from them.

    I am not blind to any of the defects in the Gonzales’ study. My assessment at
    http://www.users.on.net/~pmoran/cancer/Alternative_studies.htm

  12. BlazingDragon says:

    On the one hand, I cannot stop giggling over your article Dr. Hall (the coffee brands list was inspired). On the other hand, I’m flabbergasted that anyone would think that a coffee enema is any better than a good ol’ Fleet enema.

    This sounds an awful lot like chiropractic, where certain nerves control certain diseases, all without any actual proof. Fact-free living is so damned easy… until it bites you in the ass (pun semi-intended).

    pmoran, just because someone makes the trial seem complicated (the pill regimens alone are dizzying, my 90-year-old grandmother with RA, osteoporosis, and heart trouble takes many fewer pills per day) doesn’t mean their trial is worth repeating on larger scale. I understand your instinct in this case (to not dismiss all quackery and woo lest it feed off that dismissal as “proof” that “the man” doesn’t want you to find out), but this particular trial sounds flat-out cruel. To basically take pancreatic cancer patients and NOT give them the option of palliative care while they wait for the end to come is just awful. I can’t imagine running through such rigmarole each day, believing it will save your life. What a cruel, inhuman joke.

  13. pmoran says:

    The trial is broadly ethical because patients have the option of entering the trial or not, and because a lot of cancer patients want to know whether such intensive regimes do help patients with otherwise incurable cancer, and, are in fact using them.

    I would personally have done a different trial, either a Phase l/ll study of the Gonzales method looking for evidence of cancer remission, with patients able to leave the trial once there was clear cancer progression, or a controlled trial comparing it with best supportive care, assessing times to cancer progression, with similar provisos.

    The gemcytabine comparison was presumably thought to be the most ethical approach through not denying patients the present rather modestly successful and reasonably tolerable standard of care, but it cannot answer the question that most cancer sufferers want the answer to –do these commonly employed cocktails of methods work at all?

    There is also a risk that if the results are equivocal (not that unlikely whether the method works or not) ) we will have quacks saying “see our methods work as well as the best available chemotherapy”.

  14. David Gorski says:

    The problem I have with trials such as the Gonzalez trial is not necessarily ethics. If the trial is properly designed it can be ethical. What bothers me is the waste of resources involved that could have been used to study other modalities based on more sound science. There is little doubt in my mind that the Gonzalez trial was not funded primarily based on scientific considerations but rather far more on “political” or “public relations” considerations.

    As far as I can tell, it turned into the debacle that it could easily have predicted to be.

  15. pmoran says:

    David: “The problem I have with trials such as the Gonzalez trial is not necessarily ethics. If the trial is properly designed it can be ethical. What bothers me is the waste of resources involved that could have been used to study other modalities based on more sound science. There is little doubt in my mind that the Gonzalez trial was not funded primarily based on scientific considerations but rather far more on “political” or “public relations” considerations.”

    Largely true. Scientific knowledge is unlikely to be advanced one jot by this study. But it could have tremendous significance for cancer patients being urged by their friends and relatives to use such treatments, and some who are making their lives a misery through trying to apply them The point has not yet been made that most of the core “alternative” precepts are being tested out in this one study.

    I suppose it is a matter of what hat you wish to wear. If your concern is reducing the various adverse impacts of quackery on cancer patients then quite substantial benefits could come from the NIH study (if negative), apart from pre-empting the problem that completely ignoring Gonzales’ rather unique but flawed pilot study can be made to look bad.

    If your dominant concern is that some colleagues seem to have gone soft in the head and need to be shamed out of wasteful divergences from the scientific straight and narrow, then I guess this is shaping up to be the right place.

    Cancer quackery is all about where patients invest their trust, and desperate, frightened people have fragile allegiances. A little nurturing of those allegiances may sometimes be preferable to seemingly inexplicable (to the average patient) aversion to anything “alternative”.

  16. Harriet Hall says:

    I don’t have much hope that negative results of CAM trials will ever lead CAM advocates to give them up. They will always have an excuse to “do one more study.” When treatments are based on belief systems rather than on science or plausibility, no amount of good science can counteract them. People are still using Laetrile.

  17. Fifi says:

    What’s tragic is when people die of cancer because they refuse proven treatments in favor of CAM ones. I only recently found out just how some of this stuff goes. Check out http://www.beatcancer.org which pretends to be support service but is really a front for not only promoting CAM practices but products like JuicePlus (and, of course, the “Dr” in charge who not only takes a salary from the “non-profit” but also serves as a spokesperson for JuicePlus, which the site promotes, and so the circle goes)…and this kind of organization gets to not pay taxes and to ask for donations as a charitable organization?!?

    Note the “medical” sort of graphics (part drug company aesthetic, cadeus prominent, etc). Also note that they don’t even give out any “nutritional” advice for free…obvious under the reiki/placebo rule that people find high priced placebos to be more effective (and I guess it means that only those desperate to believe buy).

    The sCAMming around cancer is outrageous, almost as bad as around AIDS.

  18. Fifi says:

    er, caduceus not cadeus. Snakes on a brain! Almost as bad as snakes on a plane.

  19. Fifi says:

    Though, technically, I guess Hermes’ caduceus is appropriate since it’s the Staff of Asclepius for medical orgs most of the time.

  20. pmoran says:

    “I don’t have much hope that negative results of CAM trials will ever lead CAM advocates to give them up. They will always have an excuse to “do one more study.” When treatments are based on belief systems rather than on science or plausibility, no amount of good science can counteract them. People are still using Laetrile.”

    Again, substantially true. Hard core extremists and heavily invested quacks will never be influenced. But why do you and I bother with any form of anti-quackery activity? It’s because of the wavering majority. We probably have a somewhat distorted view of alternative users overall because vocal extremists and quacks dominate dialogue.

    I once shared the pessimistic viewpoint, but I have been encouraged by recent experience with shark cartilage. where several negative studies have caused it to almost disappear from the CAM portfolio. You never hear it recommended mentioned now in alternative discusssions. The same applied (unfortunately temporarily) after the studies on Laetrile. Megadose oral vitamin C has also largely lost its following as the result of scientific studies.

    I think that we do have a limited ability to shape cancer quackery and make life more difficult for the quacks. Our loyal cancer patients also value, and deserve, reassurance that they are not missing out on anything by eschewing the alternative methods being pressured upon them.

  21. Joe says:

    There was a discussion of the persistence of woo (I am certain it was at “White Coat Underground;” but I cannot locate it). We had a spot of trouble with defining woo since mainstream medicine, before the scientific approach, had a lot of incorrect notions.

    The bottom line, as I recall, was that no woo has disappeared entirely. My best shot was transplantation of goat gonads into human men; but I was assured it is still available.

    I still share the pessimistic viewpoint (and I recently saw something with shark cartilage). We can, however, work to educate medical professionals about it and keep it out of what would otherwise be quality health-care (i.e., no “integrated medicine”).

    BTW, anyone interested in cancer quackery- the ACS has a good, OnLine resource:
    http://www.cancer.org/docroot/ETO/ETO_5.asp?sitearea=ETO

  22. In the remaining parts of this blog I will argue that this trial is unethical, and that a trial of the “Gonzalez regimen” probably could not be designed in an ethical fashion. That is also true for highly implausible medical claims in general (and thus a large fraction of all “CAM” claims), which is a theme I’ve been convinced of for several years. First argued briefly here: http://www.csicop.org/si/2003-09/alternative-medicine.html

    And, in more detail here (the transcript is not, alas, available online): http://web.archive.org/web/20040406213320/http://www.centerforinquiry.net/conference-2004.html

    Thank you, commenters, for bringing up points that are themselves worthy of whole posts (fellow bloggers, take note). The beatcancer.org site is rotten to the core but, in what has become the typical stealth fashion of such organizations, has fooled several mainstream institutions that ought to know better: http://www.beatcancer.org/partners.html

    Another organization that is even worse, in that it has actual hospitals and real cancer specialists in its clutches, is Cancer Treatment Centers of America: http://www.cancercenter.com/

    Even the American Cancer Society has gone soft to an extent (I almost included it as an example in Misleading Language: the Common Currency of “CAM” Characterizations Part I, but I ran out of time). It used to have a “committee on quackery.” That was changed to “questionable,” and then to “CAM.” The explanations of “CAM” cancer claims at the site to which Joe linked range from accurate to bordering on dangerous. Nevertheless, unlike most sites that unwary people assume to be responsible, it still links to Quackwatch and NCAHF (but, in the post-modern version of “balance,” also to the NCCAM–a good source of misinformation).

  23. David Gorski says:

    Kimball,

    FYI, my post tomorrow involves a discussion of an example of a trial of homeopathy that is of greatly dubious ethics.

  24. Joe says:

    Thanks for the remark about the ACS site. I had actually been using it for non-cancer material. They usually summarize and comment on the traditional uses of the subjects they cover. For example, they will note the historical claims for an herb and note whether they are well-substantiated or not.

  25. braveheart says:

    RE# BlazingDragonon 28 Mar 2008 at 7:18 pm

    I’m flabbergasted that anyone would think that a coffee enema is any better than a good ol’ Fleet enema.
    ————————————

    My first reaction to a coffee enema was “Why would anybody do that?” I’m now a convert.

    Not for cancer reasons, just cleansing detox reasons. Only will post about my observable repeatable results. THe coffee enema is described , in part, to stimulate the liver for elimination of toxins (a vague term, of course). My only observation to that is that EVERY TIME I do a coffee enema my blood sugar spikes. Each successive enema is less of a spike. Only explanation is a glycogen release. What else MAY be realeased one can only speculate.

    Second, as regards your statement: “…anyone would think that a coffee enema is any better than a good ol’ Fleet enema…”

    Assuredly, not true. I precede my coffee enema with a thorogh system cleanse of salt water enemas and salt water flushes. (No not a harsh fleet enema) By the time I get to the coffee enema, I am running clean. Virtually no sludge, sedimentation or whatever else you would want to describe as fecal elimination.

    Immediately upon release of the coffee, there is significant sedimentation/sludge released which continues with a follow-up plainwater enema and saltwater flush. Can’t say where it comes from, but the coffee has a definite repeatable observable result to expel matter, which was otherwise content to stay where it was.

  26. Harriet Hall says:

    braveheart,

    You have recounted a personal experience, but this is a science-based medicine blog. Science has not found any indications for what you call “cleansing detox.” All the evidence I have seen says it is useless or harmful. If you have any evidence (from scientific studies) that “cleansing detox” is beneficial, please tell us. Otherwise we will have to write you off as an unscientific “true believer.” You said yourself you were a “convert” which is a religious belief term.

  27. braveheart says:

    Science is about repeatable, observable results. My results are not a subjective account. They are objectively observable and measureable. I post here for the more medically, scientifically inclined to offer an explanation of my results. I won’t argue the term “detox” and why I noted toxins as a vague term.

    Clearly it is not useless and has not in anyway been harmful.

  28. HCN says:

    Braveheart, the plural of anecdote is not data. If you can come up with a paper of an actual study showing the benefits of injesting coffee the wrong way around that is indexed at PubMed, you would have a chance of convincing us of its validity.

    Until then, I will continue to consume all my coffee orally.

    Also, since I just had one of these recently:
    http://en.wikipedia.org/wiki/Colonoscopy … where I got prep by drinking Phospho-Soda and lots and lots of water, I now know what it is like to have a very clean colon. I think I like mine best when it is actually doing what it is supposed to be doing — eliminating the solid wastes from my body with a healthy dose of beneficial bacteria, and lots of good fiber (hmmm… time to go pick the fruit off of my cherry tree!).

  29. Harriet Hall says:

    braveheart,

    We have only your report. Subjective factors can influence observation and reporting. We have no way of knowing if your observations are accurate, if you have failed to notice some confounding factor, or if your observations could be reliably replicated by others in other settings. It’s not up to us to explain your results; it’s up to you to support your claims.

    Even if your observations were unassailable, we have no way of knowing if your interpretation of those observations is correct. You saw some sludge, your blood sugar went up, you felt better. But we have no way of knowing what those observations might mean. We don’t know what was in the sludge, we don’t know what made your blood sugar rise, and we don’t know whether the enema was the cause of your feeling better. We have no idea what the harm/benefit ratio might be.

    Science is about repeatable, observable results that are systematically examined to rule out sources of error, that are published and submitted to peer review, and that combine with other evidence to make a meaningful whole.

    You haven’t offered us a shred of scientific evidence; only a personal testimonial. Why do you think you need to detox? What do you think the toxins are? For the time being, I can only assume that the whole detoxification thing is a myth and a cult. I’m willing to change my mind – just show me some evidence.

  30. Joe says:

    Braveheart wrote “Science is about repeatable, observable results. My results are not a subjective account. They are objectively observable and measureable.”

    That is debatable.

    Practical results, of the sort you offer, are only about your, claimed, “benefits.” You claim “objectivity” for just one observation. We say that a difference only matters if it makes a difference.” You need reliable data that your observations are observed in a larger population, and repeatable, and significant.

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