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

Laetrile and the Politics of NIH-Sponsored trials of “Alternative Cancer Treatments”

Part I of this blog ended by asking how, in light of the implausible and arduous nature of the “Gonzalez regimen” for cancer of the pancreas, and the unconvincing “best case series,” the NIH could ever have decided to fund a trial of it.† This entry will begin to answer that question. In so doing it may seem to veer from the original subject, but hold on to your seats: what you’ll find here is a piece of the treasure map that leads to the Mother Lode of Fool’s Gold that is government-sponsored “CAM” research.

All historical accounts of the encroachment of implausible claims into the research agenda of the NIH must begin with Laetrile. By that is meant all implausible claims, not merely those having to do with cancer. Elsewhere we have traced the history of “chelation therapy” for coronary artery disease, and have shown that its origins as a political movement, eventually leading to an unethical, $30 million, 2000 subject NIH trial, were intimately associated with people and organizations advocating Laetrile—the most lucrative health fraud ever perpetrated in the United States. In that essay we offer evidence that the creation of the NCCAM itself was at least partly attributable to the history of Laetrile and its advocates. Several good histories or partial histories of the Laetrile debacle are available online, including here, here, here, here, here, and here. The best,¹ but one that does not seem to be available online, is by the recently deceased dean of historians of American quackery, James Harvey Young.

If Young were still alive, I suspect that he would agree that the NCI’s decision in the late 1970s to fund a trial of Laetrile to settle the matter “once and for all,” in the words of Director Arthur Upton,¹ was a mistake. The initial attempt to solicit case reports from Laetrile-prescribing physicians yielded only a tiny fraction of the cases that the NCI had expected. Nevertheless, the sum of information thus generated, together with what was already known about Laetrile, should have convinced the NCI to go no further. The NCI, however, arrived at the opposite conclusion, in part because it had no idea how to evaluate such cases, as Douglas Stalker explained in his 1995 article cited in Part I of this blog. The eventual prospective trial, an uncontrolled but well-performed case series, was headed by the Mayo Clinic cancer researcher Charles Moertel, who had been the first to call for a Laetrile study. It showed, beyond any reasonable doubt, that Laetrile was both dangerous and a complete failure.

Hard-core Laetrile advocates rejected that finding, as expected after Laetrile kingpin Robert Bradford had brought an unsuccessful lawsuit attempting to block the study before it was completed, and after disparaging statements made by other advocates before it had begun.¹ ² Upon publication of Moertel’s report in 1982, Bradford opined:

The whole thing is a put-up deal to discredit Laetrile. It was a phony test, and I’m not surprised at the results.¹

That was the opinion of Laetrile advocates in general and, although stated with less vehemence, of a few apologists in academia. Even Linus Pauling, who had become a crank in his old age, wrote an opposing letter to the New England Journal of Medicine.² Notwithstanding those opinions, some think that the Moertel study was the prototype for demonstrating the social value of trials of implausible medical claims (IMC). The late NCCAM Director Stephen Straus, for example, in attempting to refute our fellow blogger Wally Sampson’s arguments against the NCCAM’s agenda, claimed in 2001 that the demand for Laetrile had “abated markedly only after competent studies showed it to be ineffective.”

The Early Courtship of an Odd Couple: Quackery and EBM

In fact, the demand (or at least the supply, and hence the public health menace) had abated markedly in 1979, after the Supreme Court’s decision in the Rutherford case had upheld the FDA’s decision to regulate Laetrile as a “new drug.” That ruling, for practical purposes, made Laetrile illegal.¹ ² In the history of Laetrile, however, we can detect both roots of the political “CAM” movement—in the virulent, paranoid, but well-organized and well-funded Laetrile advocacy organizations, virtually every one of whose principals was a member of the arch-right-wing John Birch Society—and the more subtle harbingers of what would become Evidence-Based Medicine’s (EBM) self-imposed, if unwitting failure to reckon with implausible claims. Those harbingers can be found, for instance, beginning on p. 16 of FDA Commissioner Donald Kennedy’s Decision in 1977 to declare Laetrile a “new drug”:

1. Objective Evidence of Effectiveness

The courts have thus determined that, as a matter of law, no ‘general recognition’ of a drug’s effectiveness can exist absent adequate and well-controlled clinical investigations…. There are no clinical investigations of Laetrile’s effectiveness, published or otherwise…

There is…an apparent lack of public understanding of what the required studies consist of and why they are required. The Commissioner will thus include in this opinion a discussion of what adequate and well-controlled studies are and why they are needed.

That language must have seemed utterly reasonable at the time, particularly in the context of a much larger statement that included overwhelming evidence against Laetrile. It is now clear, however, that IMC advocates eventually came to view access to taxpayer-sponsored trials of their pet claims as a right of citizenship—not as a decision rightfully based on scientific promise. In this era of EBM and its tunnel-vision for controlled clinical trials to the near-exclusion of all other evidence, the words of the Commissioner, of Moertel , and of a few other scientists at the time could be interpreted as an invitation to such folly.

If that sounds farfetched, consider the Authors’ Conclusions in the abstract of the 2006 Cochrane Review of “Laetrile Treatment for Cancer”:

The claim that Laetrile has beneficial effects for cancer patients is not supported by data from controlled clinical trials. This systematic review has clearly identified the need for randomised or controlled clinical trials assessing the effectiveness of Laetrile or amygdalin for cancer treatment.

That astonishing statement is due to the singular blind spot in EBM’s “evidence” calculus, as originally discussed here and here.  The abstract of the Cochrane Review for Laetrile, without any apparent sense of irony, also offers this:

OBJECTIVES: The aim of this review was to assess the alleged anti-cancer effect and the possible harms of Laetrile as a sole or adjunctive therapy in cancer treatment.

SELECTION CRITERIA: Randomized clinical trials (RCTs) and non randomized controlled clinical trials (non-RCTs).

MAIN RESULTS: No RCTs or non-RCTs were found, so no abstraction of outcome data could be performed in this systematic review.

The absurdity of the marriage of EBM and IMC is again exposed. It seems plain—but not, apparently, to the Cochrane authors and like-minded EBM puppets. Can they really believe that absent “RCTs or non-RCTs” there is no basis upon which to judge “the alleged anti-cancer effect and the possible harms of Laetrile as a sole or adjunctive therapy in cancer treatment?” Laetrile is one of the most well-considered quack claims in history. The evidence against it, even without considering Moertel’s study—its extreme biological implausibility, its persistence having been an obvious matter of lucrative health fraud, its advocates having been sociopathic criminals, its “miraculous” cures having been revealed as illusory, its ineffectiveness and risk of cyanide toxicity having been demonstrated in prospective animal studies performed by real scientists and by numerous unfortunate cases of desperate cancer sufferers—is overwhelming.

One of the authors of the Cochrane Laetrile review was Edzard Ernst, whose enigmatic views are illustrated by that review and by his previously quoted, perfectly fallacious dismissal of “a priori plausibility,” which stand in sharp contrast to his considerable insight into the process of IMC advocacy:

A[n]…important point relates to a repetitive pattern in the scientific investigation of “bogus” therapies. Proponents first manage to mobilize supporters to campaign in their favor. This brings financial gain. When skeptics ask about the evidence, the burden of proof is swiftly put on their shoulders, and the lack of evidence is made to look like a “conspiracy” of orthodoxy against the alternative. If scientists then decide to rigorously test the method, its proponents would celebrate this as a breakthrough for their method. Again, this amounts to financial gain. Subsequently, a study may prove that the method is ineffective. Proponents now claim that the research was flawed, did not adhere to their protocol, or was wrongly analyzed. The press coverage yet again brings financial gain. This pattern repeats itself with depressing regularity, e.g., when Laetrile or Di Bella’s cancer cure were promoted.

Ernst is absolutely correct about that “repetitive pattern.” Then how can he ignore its obvious conclusions? One is that scientists should NOT “decide to rigorously test [a 'bogus'] method” other than for the same reason that they propose to test any other method: that there is genuine scientific promise. In particular, noisy, obnoxious, and even well-funded and politically-connected advocacy is, in the absence of scientific promise, a terrible reason to decide to rigorously test a method. That lesson is the legacy of the NCI’s Laetrile trial and why we can now judge it to have been a mistake. Another obvious conclusion is that emotional advocacy—by scientifically-naive individuals who, for various reasons not relevant to natural processes, believe in the IMC in question—must count against the prior probability of the claim being valid. Douglas Stalker called that a “source reason for prior probability ranking” and gave several examples.

The Odd Couple Ties the Knot

I cannot, in this entry or even in several, present a comprehensive history to convince you, dear readers, of my assertion about Laetrile and government-sponsored IMC research in the U.S. It is my hope that someone with more time and historical savvy than I have, perhaps the scholarly heir to James Harvey Young, will eventually do that. Instead I’ll offer a few more clues next week—no, more than clues: compelling, albeit incomplete pieces of evidence. I’ll present them not according to chronology, but in such a way as to induce each to help explain the next to be discussed, and so on. Forgive me if that doesn’t work.

That’s all for now; important houseguests have arrived: Andrea and Enriqueta. This blog may require 4 parts or more.

The W^5/2 will appear over the weekend.

1. Young JH. Laetrile in Historical Perspective. In: Young JH. American Health Quackery. Princeton, Princeton Univ. Press 1992, pp. 205-55

2. Bross IDJ; Pauling L; Culbert ML. Laetrile. NEJM 1982;307(2):118-19

……………………………….

†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 Academia, Politics and Regulation

Leave a Comment (44) ↓

44 thoughts on “The Ethics of “CAM” Trials: Gonzo (Part II)

  1. apteryx says:

    You make an excellent case. I would previously have assumed that the Laetrile trial was scientifically merited, but with the citation of prior negative results from a large case series and animal studies, you have convinced me that it was not. Just one little quibble – you write:

    “Another obvious conclusion is that emotional advocacy—by scientifically-naive individuals…—must count against the prior probability of the claim being valid.”

    That doesn’t seem to follow. The fact that laymen believe in a putative treatment should not affect what the basic sciences of physics, biochemistry, etc. have to say about its plausibility. All surviving traditional practices could be said to be “advocated” by “scientifically naive individuals,” but there are also non-MDs who publicly or privately promote conventional treatments (e.g., Ritalin, aggressive treatment of prostate cancer) based on their personal experiences or emotional impressions of the issues. Their beliefs may not be scientifically grounded, but they do not affect the likelihood that those treatments are beneficial.

  2. qetzal says:

    apteryx:

    I agree that in principle, emotional advocacy need not count against prior probability. In practice, however, I agree with Dr. Atwood’s point. Historically, strong emotional advocacy correlates inversely with scientific merit. This seems to be true not just for advocacy in favor of unproven treatments (Laetrile, megavitamin supplementation, ets.), but also for negative advocacy against proven treatments (e.g. anti-vaccination).

    Dr. Atwood:

    You commented:

    [FDA Commissioner Donald Kennedy’s] language must have seemed utterly reasonable at the time, particularly in the context of a much larger statement that included overwhelming evidence against Laetrile. It is now clear, however, that IMC advocates eventually came to view access to taxpayer-sponsored trials of their pet claims as a right of citizenship—not as a decision rightfully based on scientific promise.

    In fact, I think Kennedy’s statements were and still are reasonable. He was addressing the legal issues relevant to whether FDA could ban Laetrile in the US. Hence the discussion of what sort of evidence is required to show general recognition of safety and effectiveness – namely, adequate, well controlled clinical studies.

    He could have confined his analysis to showing that such studies did not exist. That would have been sufficient to ban Laetrile. Instead, as you allude, he included an assessment of the inadequate case studies, as well as the negative animal data, showing that there was no scientific basis to use Laetrile, much less adequate basis for FDA approval.

    He was even more blunt in his preface, calling Laetrile “a major health fraud in the United States today.”

    I agree with you that IMC proponents have come to feel they are entitled to public research dollars for their pet treatments. But I don’t see how that links to Kennedy’s statements. If anything, Kennedy argued the same point you do – that prior probability and preclinical data are key components in deciding whether a treatment is plausible.

  3. daedalus2u says:

    I have to agree with apteryx,

    “Another obvious conclusion is that emotional advocacy—by scientifically-naive individuals who, for various reasons not relevant to natural processes, believe in the IMC in question—must count against the prior probability of the claim being valid.”

    This is a clear ad hominem argument. Bogus arguments of any type count for zero, they do not count for negative.

    This happens to be a very frustrating issue for me in my nitric oxide research. As soon as I bring up any “anecdotes”, even as anecdotes, everything else I say is completely ignored or discounted to negative. The “definition” of anecdote is somewhat variable. Some call any data with n=1 subject an “anecdote”, even when the measurements are instrumental and many sigma above background and measured on multiple instances. Even when those results are presented by someone who is not “scientifically-naïve”, and the results are completely consistent with the scientific literature.

  4. apteryx says:

    I think I know what he was feeling. If you first encounter some product being touted by a website that claims it will cure everything, rants about a giant conspiracy to suppress it, and puts a LOT of WORDS in CAPS… well, your immediate assumption is “This is cr*p,” and for personal decision-making purposes that’s valid inductive reasoning! But there’s been some suggestion that individuals’ estimates of “prior probability” might be scientific judgments with enough weight to justify refusing to study a treatment or even rejecting positive results from, potentially, any number of clinical trials and animal studies. This has already looked to some readers, including me, like setting a moving bar: one standard for conventional medicine, a harder (sometimes literally unmeetable) standard for CAM or TM. If “prior probability” estimates are going to look like anything beyond an expression of personal bias, they have to be justified only with reference to basic science. “Homeopathy can’t work according to presently accepted chemical and physical theories” is one thing; “Web sites have been talking this remedy up without scientific citations, therefore it can’t work” is something else altogether.

  5. qetzal says:

    So you don’t think it’s true that when people make factual claims based on bogus arguments and emotional appeals, those claims are more likely to be false?

  6. daedalus2u says:

    qetzal, whether something is true or false has nothing to do with who is making the claim and how delusional and unrealistic their reasons are for making the claim. A claim that is unsupported and has no informational content is completely independent of the facts of the situation. Such an argument doesn’t change the probability the claim is true or false.

    If I say you need iron in your diet because iron can be made into steel and with enough iron your muscles will become like steel, that doesn’t change the dietary requirement for iron. I could make up thousands of similar completely bogus reasons why iron in the diet is necessary. None of them change the factual basis for the requirement of iron.

    I know there are an infinite number of false statements about why iron is good for you. None of them change the finite number of true statements about why iron is a necessary nutrient.

  7. qetzal says:

    deadalus2u,

    I agree that an irrational argument doesn’t make a claim untrue. But, in my experience at least, people are more likely to make irrational arguments about untrue claims.

    If that’s true, than a high proportion of irrational arguments for a claim reduces its likely truth value. Not because the arguments make it untrue, but because people disproportionately choose untrue claims when making irrational arguments.

  8. Great comments.

    I hadn’t the time to reply until now, but here goes. The easy answers are those resulting from my not having made myself clear to begin with. Qetzal made the point that FDA commissioner Donald Kennedy’s arguments about controlled trials were and are reasonable because they had to do with the legal requirements pertinent to “new drug” (or not) status. That is correct, and I should have made that distinction.

    To wriggle out of it, however (don’t you love how authors almost never admit to having been just plain wrong?), I’ll try to clarify what I meant: first, I don’t disagree with the passage, nor do I think Kennedy shouldn’t have written it; rather, I lament its unfortunate (but unforseeable) long-term effect on notions of “rights to taxpayer-sponsored trials”–which, even though his ‘controlled trials’ argument was based on court opinions, I maintain is a reality.

    In retrospect, those passages needed the caveat that much more evidence of other kinds would have been required before Laetrile could have become a candidate for a controlled trial. Perhaps he didn’t include that because he considered only the legal requirements for drug approval–on the bottom of p. 17 he did add a footnote about safety studies being required before studies of effectiveness–but his entire, comprehensive statement went well beyond strictly legal requirements (I think), so there was plenty of opportunity to make the point. Again, I don’t impugn him for not having done so, I merely wish he had; he couldn’t have known, at the time, what we know now.

    By the way, Kennedy’s statement is an example of just how complete the “establishment’s” evaluations of IMCs can be (the Congressional Office of Technology’s (OTA) “Unconventional Cancer Treatments” is another example). It refutes virtually every “conspiracy theory” argument that has been made about the “suppression” of Laetrile. Too bad it’s been mostly forgotten.

    Second: the simple answer to apteryx’s initial point about prior probability and source (with which I mainly agree, but will now juke my way around) is that in the case of Laetrile and many other claims–Gonzalez comes to mind–it is ONLY “emotional advocacy by scientifically-naive individuals who, for various reasons not relevant to natural processes, believe in the IMC in question,” that first presents itself for evaluation by others.

    I’m not talking about botanicals with a long tradition of use, or pharmaceuticals that have been studied at least somewhat rigorously and are subsequently touted (or not) by users based on personal impressions. I’m talking about new claims that come out of left field. I would argue (and so did Donald Kennedy, beginning on p. 26: “testimony of experts”) that if those promoting the claim are limited to the likes of Dan Burton, John Birchers, and a couple of MDs and quasi-credentialed PhDs making a bundle selling the stuff, its prior probability must be viewed as far lower than if it comes from Charles Moertel. Kennedy summarized the point on p. 35, albeit in citing a court opinion: “The weight to be given the testimony of such persons, of course, must correspond to their expertise…”

    Regarding the greater issue raised by daedalus and implied by q and a, that including “source reasons” in a prior probability calculus is an ad hominem argument: I don’t think we disagree, once we agree on the parameters of the claim and on what is meant by “source reasons,” as the paragraph above began to explain. If we know nothing about the claim other than who is making it, what their backgrounds are, whether or not they stand to profit from a favorable view of it, etc., than it seems to me that it is inescapable that such information must figure into a prior probability estimate. Sure, once we know much more–the basic science, animal studies, or whatever–”source reasons” become less significant, possibly to the point of no significance at all, as in the examples offered by apteryx and daedalus. (But not always. Think: trials sponsored by patent-holders).

    The distinction between knowing only about the source and knowing more is not merely technical or trivial, because a decision to proceed with an investigation of a new claim, always at the expense of investigating some other new claim, will sometimes be made at or close to the mere “source” stage. I would argue, but not here and now, that much of the research agenda of the NCCAM is just that.

  9. daedalus2u says:

    Dr. Atwood, I must continue to disagree. If we know nothing about the claim other than who is making it, then the claim cannot be evaluated on a scientific basis. Incorporating source factors into a prior probability calculation may be useful when making social, political, legal, economic or other non-scientific judgments. It may even be rational to do so, but then any judgments are fundamentally not scientific judgments.

    I think this is one of the very big problems with individuals trying to evaluate approaches they do not understand. There are usually two reasons for that, ignorance on the part of the individual trying to do the evaluating, and because the thing being evaluated is nonsense. Distinguishing between those two cases is not always easy. It takes time and effort for an evaluator to understand the science behind the basis for the claim. If the evaluator is unwilling to expend that effort and the claim cannot be understood, then often the evaluator defaults to a social judgment and states “this claim is nonsense” whether it is or is not.

    It is a very difficult problem, to evaluate one’s expertise when one is a non-expert. Usually people overestimate how much they know and then underestimate how much they are ignorant of. This problem goes both ways. People ignorant of topic XYZ are not going to understand XYZ based explanations and will instead attribute explanations based on non-XYZ things that they are knowledgeable. This is essentially what Thomas Kuhn talked about in his “structure of scientific revolutions”. Scientists have unacknowledged fundamental paradigms that they working within, and have extreme difficulty working outside those paradigms even when those paradigms are wrong. Millikan couldn’t accept Einstein’s photoelectric effect for decades, long after everyone else had accepted it based on data that Millikan had generated. Millikan “knew” that light was a wave even though his own data showed it exactly fit Einstein’s equations proving that it wasn’t. Millikan’s paradigm of light being a wave was correct in many instances. It was not correct where Einstein’s photoelectric equations held.

    If we are going to include source factors reflecting reliability of the information source (i.e. the person making the claim) then we also need to formalize how we make that reliability claim so we can evaluate that claim with some semblance of objectivity. I think this relates to some of my current work on “theory of mind”, vs. “theory of reality” (which I see as the fundamental trade-off along the autism spectrum). Essentially to understand another human, you need to emulate that human’s thinking processes with sufficient fidelity to understand how they are thinking. Usually people do that with their “theory of mind”. You need a “theory of mind” that is sufficiently similar to be able to understand the “theory of mind” of the other individual, but sufficiently different that judgments can be made independently of the “theory of mind”. Usually what people “go with” is how similar the person’s “theory of mind” is to their own, does the person look like me, talk like me, have the same religion, the same beliefs, etc. Usually that causes the independence to “fail” and delusional beliefs are easily adopted. What is likely important in choosing a friend or a mate is the similarity of the two “theories of mind”, but that is fundamentally unimportant in figuring out scientific reliability of the information source. A “theory of mind” is only good for social calculations involving a sufficiently similar “theory of mind”. The universe is not constrained to follow human social characteristics implicit in any specific “theory of mind”. When interacting with a human with a sufficiently similar “theory of mind”, one “knows” (actually feels that one knows) how they are thinking, and can “trust” (actually feels that one can trust) them. When dealing with a human with a sufficiently different “theory of mind”, these feelings of trust and understanding are not present. It then “feels right” to discount their ideas to zero or even negative because they can’t be “trusted”. This is the essence of the argumentum ad Hitlerum.

    What is important in producing feelings of “trust” between two humans is the similarity of their two “theories of mind”. These “feelings” are based on social calculations, not on any objective reality. This is why homeopaths “feel” that they can “trust” other homeopaths. They have the same “theory of mind” and are also in the same delusional mind set. I think this is why all the CAM practitioners “trust” each other. They are all fighting against the common enemy, decisions based on a “theory of reality”.

    A large part of a social “theory of mind” type “argument” is the attempt to psychologically “project” your “theory of mind” onto your opponent so that they adopt it as their own. If that “theory of mind” is frankly delusional, this is termed “drinking the Kool-Aid”.

    There are two fundamental ways of arriving at a “theory of mind” (note this explanation uses analogies at near (beyond?) the limit of their appropriateness (but to fit this into a brief comment, something has to give;)). There is the usual method which has much of the “social computation” occurring in neural structures specific for those computations, i.e. “hard wired”. The other method is to “emulate” the social computation in more flexible neural structures i.e. emulate it in software. A software emulation has the advantage that it can be better analyzed, but it is much slower and much more computationally intensive and not as high resolution. The results of the emulation of social computation are then also more independent of the analysis. The “output” isn’t “feelings” that feedback and affect the computation (so much).

    I think this is where the Autism Spectrum comes in. My perspective is that where an individual is along the autism spectrum determines to what extent that individual’s “theory of mind” and “theory of reality” are “hard wired” or “emulated”. It is more complicated than that, there are both acute effects (which determine the acute functional connectivity) and neuroanatomy effects (which affect the “hard wired” vs. “emulated”). There is plasticity that affects this too. I think the antipathy that is sometimes felt toward people on the ASD spectrum relates to their lack of a shared “theory of mind”, so they cannot be “trusted”. Because they lack the “theory of mind” structures of the neurologically typical, their “theory of mind” cannot be altered (as easily) by projection.

    As I see it, ASDs use their “theory of reality” to emulate a “theory of mind”. NTs use their “theory of mind” to emulate a “theory of reality”. I think the effort and difficulty that NTs (in general) have doing science is because they are “emulating” a “theory of reality” using their “theory of mind”, and a “theory of mind” is ill suited to emulate a “theory of reality” because feelings are the major output. I think the difficulty and fatigue that ASDs have in social interactions has to do with the effort required in emulating a “theory of mind” and doing social computations in “software” using a “theory of reality”.

    To summarize, if you are going to use social calculation to figure something out, then what ever you figure out is a social judgment, not a scientific judgment. No matter how much your social judgment “feels” like it is a scientific judgment, it isn’t.

  10. apteryx says:

    Dr. Atwood -

    I basically agree with everything in your last comment. But you write:

    “Sure, once we know much more–the basic science, animal studies, or whatever–”source reasons” become less significant, possibly to the point of no significance at all,… (But not always. Think: trials sponsored by patent-holders).”

    This seems to be one of those moving-bar issues. Pharmaceutical trials are usually paid for and controlled by the drug companies, but we do not consider that that invalidates all such trial results. Some argue that equally large and expensive trials should be required before traditional botanicals are sold – people will often demand, in specific language, “manufacturer-funded studies.” Yet sometimes the same people will turn around and claim that positive results from a study are meaningless because “it was funded by the manufacturer” – implication being that the data were therefore somehow skewed. Can CAM manufacturers who find money to pay for trials get the same benefit-of-the-doubt as do Big Pharma manufacturers who have much larger profits at stake?

  11. pmoran says:

    Kimball : ” — emotional advocacy by scientifically-naive individuals who, for various reasons not relevant to natural processes, believe in the IMC in question —”

    With cancer quackery, the “various reasons” for belief are clear. Personal testimonials are compelling to the lay person. An even wider public isn’t quite sure what to believe and deserves the strongest reassurance we can muster that no useful “alternative” cancer methods are being overlooked. Cancer is tough on them.

    We all agree that routine investigation of alternative methods is no answer. How best to explain ourselves to the public, then?

    I believe that every time a cancer patient comes to harm from using a quack cancer method it is to some extent due to the medical profession’s poor public relations, including its tendency to make non-transparent (to the man in the street) in-house pronouncements concerning “alternatives” and to then go about its own business assuming that this should be good enough for everyone. This is why I cringe at some of the material appearing here. The “we know best” approach has been tried for over fifty years and doesn’t work very well with the general public even though we undoubtedly DO know best It doesn’t even always work with doctor/scientists who should know better, as is evidenced by the frustrated tone of some recent posts on this blog.

    Can we do better? A possible strategy, one that I have been exploring on my amateurish web site and that others have also on occasions employed, is to try to educate the public as to what a good cancer treatment might look look like should one actually arise from within “alternative” medicine. This can then be contrasted with the grossly inferior testimonial level evidence provided by the “alternative” cancer industry and more influentially by well-meaning cancer patients. This is a component of un/believability that has had only passing mention here, apart from one post from David. Yet patient testimonial is THE underpinning of all cancer quackery, and possibly also its greatest vulnerability, when you come to examine it more closely.

    I fear the first educational task is on ourselves, because we have been tuned to not give any consideration at all to uncontrolled clinical observations (anecdote). We need to first accept that quality anecdotal material can have force in *some* medical settings, not necessarily as proof of anything, but as a signal that something useful may be going on. This would certainly apply to a collection of objective remissions or cure of those kinds of cancer that are very predictable in their behaviour, reliably diagnosable and objectively measurable.

    So, how many here have asked themselves: “what kind of cases, and how many, within recent experience, would lead me to be prepared to try out an alternative cancer treatment?” This is more easily defined than you might first think, and you will then find that there is a definable and sizeable gap between what we personally would consider solid clinical evidence (and the criteria that medical researchers use themselves when testing out a cancer treatment) and the very best that alternative methods can muster.

    Can we explain this to the public, instead of tending to dismiss anything anecdotal simply because it is not a controlled trial? It is usually is weak evidence, but we should be able to explain precisely why.

    Such an approach would have many potential advantages with cancer quackery — less so in other healthfraud settings. It can provide a fairly clear threshold of “anecdotal” or other uncontrolled clinical evidence (such as simple prospective case series a la Gonzales), beyond which everyone knows that we might investigate a method further, but below which we definitely will not.

    It is less subjective and less variable from modality to modality than other matters relating to believability. It may be more easily understood by those with little exposure to basic medical science, for there is a limited body of medical knowledge to grasp. Once understood, a person can use the same tools to evaluate any new quack claim instead of having to explore a whole new area of scientific knwoledge. Importantly, it puts the onus of evidence squarely back onto the quacks, where it always belonged.

    It would have the additional benefit of helping to explain to a largely uncomprehending public a key matter: why the mainstream is not being influenced by material that is convincing or confusing to them.

  12. Harriet Hall says:

    Do you think it would do any good to point out how MANY different mutually incompatible testimonial-based remedies are on offer, compared to one science-based consensus in the scientific community?

    Even if you are willing to accept a treatment on the basis of testimonials, what rational basis can you have for choosing one over another?

  13. pmoran says:

    Harriet: > Do you think it would do any good to point out how >MANY different mutually incompatible testimonial-based >remedies are on offer, compared to one science-based >consensus in the scientific community?

    Maybe. Someone would be bound to point out that scientific consensus can be wrong.

    > Even if you are willing to accept a treatment on the basis of >testimonials, what rational basis can you have for choosing >one over another?

    I did not say “accept a treatment”. I am talking about trying to describe the threshold that might suggest to doctors that a treatment is worth further evaluation. The first step would be attempts to replicate the results.

    And this is not “testimonial” in any ordinary sense – I am talking about case reports with biopsy proved established cancers of the type not normally prone to spontaneous remissions, that display clear-cut remission using objective tests and with the use of no other treatment than the claimed one. The cases need to be contemporary — you can go and examine them yourself and look at their biopsy slides and the before and after CT scans, marker studies etc. etc, just as you might if they were to be enrolled in a mainstream clinical trial of a cancer treatment or published in a mainstream medical journal. And there must be more than one of them — for me a mere three cases of this solidity would suffice, if within the recent experience of the one practitioner or method. What would work for you? Anything?

    The point of the exercise is that if the quack cures work as well as typically claimed or as implied by the other testimonials, their proponents should be able to produce such cases quite regularly. It is an achievable goal for them, yet everyone seems to want to believe that sophisticated controlled trials are the only next step up from the usual execrable alternative testimonial. That’s not so. Not even remotely.

    Ideally proponents would set out to perform an extremely simple prospective case series, using patients who can ethically meet these criteria. Most of their cases will not be suitable, so it is a pity for them not to make careful use of the ones that would make for the best test of their methods.

    I am, of course, not putting this forward with any realistic expectation that any quack will ever do this, or even need to do this. Any method that REALLY works on established cancer will sell itself, because doctors will be also seeing the results and the media will be onto it in a flash. Quack medicine is not carried out in isolation.

    No, this is basically a thought experiment designed to better enable the public to understand that the evidence that the alternative cancer industry and other cancer patients are providing to them is bunk, that they deserve better, and that there are no excuses for not getting it.

    I am well aware that I lack the verbal and exposition skills that you and other writers on this blog display. But do try to see beyond my clumsy prose. I have studied this area very intensively.

  14. David Gorski says:

    Dr. Moran,

    You do a fine job of explaining yourself, and your prose is not “clumsy.”. You haven’t convinced me, but I see your point. I hope you will continue to point out where we may go too far. I may not always agree with your assessment, but the reality check is useful.

  15. Dr. Moran said, “I am talking about case reports with biopsy proved established cancers of the type not normally prone to spontaneous remissions, that display clear-cut remission using objective tests and with the use of no other treatment than the claimed one. The cases need to be contemporary — you can go and examine them yourself and look at their biopsy slides and the before and after CT scans, marker studies etc. etc, just as you might if they were to be enrolled in a mainstream clinical trial of a cancer treatment or published in a mainstream medical journal. And there must be more than one of them — for me a mere three cases of this solidity would suffice,…”

    I would think that if a doctor saw three cases of the type described by Dr. Moran that he would at the very least be intrigued and watch carefully for others, and that if he explained this to patients and told them that it was that kind of phenomena that would cause him to take claims seriously and to want to study further the treatment they were associated with that many listening to him would conclude at the very least that he was “open minded”. I would also suspect that it would have the benefit I think Dr. Moran wants. It would convince many cancer patients that there was no good reason to “try” unproven and disproven therapies that did not have at the very least that level of evidence, for lack of a better word, to support them. However, I also suspect that there would be many who would try them anyway, hoping against hope for a miracle. In other words, I think the problem of quackery can be contained but not eliminated.

    When people make outrageous claims to me about “remedies”, I usually ask how to verify them independently. I ask if they will give their doctor permission to speak with me or send me copies of their medical records. If the story is about someone else, I ask if they will give me the name and # of the person making the claim. So far I’ve had one or two promises of independent verification, but no deliveries.

    On the other hand, I have had many write to tell me that they have gotten argyria from a silver supplement who have sent me copies of their biopsy reports when I requested them. I explain that I will never identify them without their permission but that in order to file their case in my “confirmed” folder, I need hard evidence.

    So I think Dr. Moran’s idea is excellent, not foolproof, but excellent, from a patient and PR point of view.

  16. When I first learned of the silver fraud, I gathered evidence and looked for an author to hire to write my web page. I couldn’t find one. Journalists were afraid of the “science”. I said, “What science?” It hadn’t gotten to the level of science. The claims were that the stuff had been shown to be effective against 650 diseases which the salesmen knew the public would interpret to mean effective “in vivo”. So show me the cases? Show me the people who had specific diseases, proof that they had them and proof that after receiving no treatment besides silver they are disease free. If they can’t do that, and they couldn’t, but continue making the claims, most people in the media and general public realize that the claims are false.

    My point is that when you try to expose quack products there is a lot of evidence to look at before getting to the scientific. It is the kind of evidence Dr. Barrett often presents. It is the kind of evidence that is being presented on websites about the German cancer quack Ryke Geerd Hamer
    http://www.ariplex.com/nmwiki/index.php?title=Ryke_Geerd_Hamer_%
    whose “New German Medicine” is now being used in the US & Canada as well as Europe.
    http://www.renointegrative.com/nature.html

  17. daedalus2u says:

    rjstan, no amount of looking at non-scientific evidence can produce a scientific answer.

    The decision to fund a research program is fundamentally a non-scientific decision.

    The decision to sell a particular compound is fundamentally a non-scientific decision.

    A patient’s decision to choose one treatment over another is fundamentally (for that patient), a non-scientific decision, unless that particular patient is sufficiently well versed in the science to make a scientific decision.

  18. Lotsa points to answer; little time to do it, so please overlook the short shrift.

    pmoran, don’t underestimate your prose. I agree with David. I have two opinions (and they are strictly opinions) about your well-presented thesis regarding losing patients to woo by virtue of our seeming to be above it, or not explaining science well enough or whatever. First, we must be true to medical ethics, no matter what else we do. If that means losing a few patients, so be it. Patients are free agents, and we can only do so much to influence them. To the extent that we don’t do that as well as we might (which is obviously true in some cases), we might do better. But our ethical obligation is to science and truth; it is not, as many modern physicians would have it and as much as we may lament sometimes losing patients to woo, to seducing patients to stick with us no matter what, if the “what” includes engaging in a charade about “integration” or “complementary therapies” or other meaningless platitudes. I know you didn’t mean it precisely that way, but that’s what it almost inevitably leads to, in the current climate of widespread scientific naivete.

    Which leads to my second opinion: I agree with you that scientific illiteracy is the biggest problem. But that is both part of, and a separate issue from the issue of how-to-be-a-doctor in the here and now. To the extent that it is part of the current doctor-patient interaction, we must all do the best that we can, understanding that it won’t always work (see opinion #1). The lasting solution is to raise the general level of scientific literacy. That involves teaching critical thinking in schools, trying to affect how science is portrayed in the public domain, creating blogs such as this one, and other such things. I hope you don’t think of the material presented here as an example of the “we know best approach.” Although we may sometimes make jokes at the expense of quacks, the point of this blog is not to dismiss woo out of hand, but to explain why. If you sometimes cringe at what you read here, perhaps we’re not explaining ourselves well enough.

    Most of us on this blog—all of us, actually—are active in organizations that spend time and money on the project of improving scientific literacy in society in general. We do what we do here because this is what we’re interested in and what we’re somewhat good at. If you “Google” the name “Eugenie Scott,” you’ll get an idea of what’s being done in schools.

    Pmoran, two responses to specific points that you made: 1. yes, to the lay person suffering from cancer, the various reasons for belief include being impressed by personal testimonials, but that isn’t the only reason. Another is being persuaded by snake oil salesmen who are good at persuading. In my blog I rarely, if ever, refer to the patients themselves as the main sources of such persuasion, because they usually are not. When it comes to influencing the NIH, legislators, medical schools, etc., it’s the vendors who are mainly doing the influencing. In my opinion (again, only an opinion) society was better off when it labeled such vendors as charlatans preying on desperate people, instead of the current list of euphemisms.

    2. Your scheme for evaluating cases submitted by practitioners of IMCs is well-meaning but is essentially similar to the “best case series” scheme that the NCI instituted in 1991, and that has backfired—as the Gonzalez fiasco shows, although I’ve not yet finished the story. I’ll write more about that this week, but in the meantime try to get a copy of the Stalker article (Mt. Sinai J Med, 1995) that I cited in Part I.

    Daedalus: I agree with you that merely knowing who the claimant is does not tell us about the science, but science and probability are not synonymous. What knowing who the claimant is does tell us, sometimes, is how likely it is that we will find legitimate science behind the claim. To prove this to yourself, think of hypothetical examples of two different claimants making the same claim: Kevin Trudeau and Stephen Hawking, for example.

    Apteryx: trials being paid for by pharmaceutical companies does not invalidate the results; it reduces, to some extent, our trust that “positive” results are not due, at least in part, to bias (for which there is good reason to be concerned). It’s not all or nothing; it’s a matter of probability. Trial sponsors and investigators can minimize such concerns by registering trials beforehand, by including contractual statements freeing investigators from having their data controlled by the sponsor, making protocols transparent, and more. That would be true for herb companies as well as for regular drug companies. Nevertheless, there could still be grounds for reducing the PP (that the investigators hope to receive more grant money from the same source, for example). This doesn’t mean that patent-holders shouldn’t sponsor trials; what it means is that after there appears to be enough evidence from those trials to warrant approving the product, there probably ought to be one final RCT paid for by someone other than the patent holder.

  19. pmoran says:

    KA> Lotsa points to answer; little time to do it, so please overlook the short shrift

    PM Likewise. Don’t feel you have to respond to all of this. Do look at the end bit about best case series. .

    KA> pmoran, don’t underestimate your prose. I agree with David. I have two opinions (and they are strictly opinions) about your well-presented thesis regarding losing patients to woo by virtue of our seeming to be above it, or not explaining science well enough or whatever. First, we must be true to medical ethics, no matter what else we do. If that means losing a few patients, so be it. Patients are free agents, and we can only do so much to influence them.

    PM Individually, that is so. Yet we can make things worse at the collective level if we treat them and their advocates with disrespect. Disrespect can range from ridicule that is based upon the possession of a privileged intellectual position (which I admit sometimes has its place), to not feeling it necessary to try to explain to an uncertain public precisely why all the tales of miraculous cures that they encounter on the Internet and from fellow cancer patients don’t prove what they are supposed to, and almost invariably don’t even show what they supposed to.

    PM You will find very little material, anywhere, that deals with this — certainly none that is likely to be encountered by the general public. Another aspect to this discussion should be how to get important material before the public. Mainly only other skeptics will read this blog.

    KA>To the extent that we don’t do that as well as we might (which is obviously true in some cases), we might do better. But our ethical obligation is to science and truth; it is not, as many modern physicians would have it and as much as we may lament sometimes losing patients to woo, to seducing patients to stick with us no matter what, if the “what” includes engaging in a charade about “integration” or “complementary therapies” or other meaningless platitudes.

    PM I also dislike meaningless platitudes, even when about ethics and science, matters I also value. Our primary responsibility is to our present and future patients, and we even, in my view, have some responsibility to the patients that avoid us, despise us, and complicate our practices.

    K>I know you didn’t mean it precisely that way, but that’s what it almost inevitably leads to, in the current climate of widespread scientific naivete.

    PM Explaining ourselves better to patients leads to all that? I know you don’t mean this.

    Which leads to my second opinion: I agree with you that scientific illiteracy is the biggest problem.

    PM The public is results-oriented rather than science-oriented as is indicated by the inordinate influence of personal testimonial and the fact that even scientists can themselves be swayed by it. We need to focus upon those aspects of medical knowledge that bear upon assessing results. That happens to be simpler with cancer than most other medical conditions.

    Explaining all the reasoning behind the double-blind placebo-controlled randomized controlled trials needed to asses some kinds of medical claim is nightmarish. That is why I wonder whether the interests of good science and public safety may be best served by admitting that they all work as placebo and concentrating upon making the public aware of the severe limitations this imposes upon them. But that is another story that I also don’t expect anyone to accept at first sight.

    K A>Most of us on this blog–all of us, actually–are active in organizations that spend time and money on the project of improving scientific literacy in society in general. We do what we do here because this is what we’re interested in and what we’re somewhat good at. If you “Google” the name “Eugenie Scott,” you’ll get an idea of what’s being done in schools.

    KA> Pmoran, two responses to specific points that you made: 1. yes, to the lay person suffering from cancer, the various reasons for belief include being impressed by personal testimonials, but that isn’t the only reason. Another is being persuaded by snake oil salesmen who are good at persuading. In my blog I rarely, if ever, refer to the patients themselves as the main sources of such persuasion, because they usually are not.

    PM Yes, that is a factor. I’m not so sure that it is the major one. Most patients with cancer get on the Internet and find out what others are doing or recommending. In either case, the credibility of the snake oil salesmen can be seriously undermined by revealing the worthlessness of the testimonials that any quack cure must have to survive.

    K> When it comes to influencing the NIH, legislators, medical schools, etc., it’s the vendors who are mainly doing the influencing. In my opinion (again, only an opinion) society was better off when it labeled such vendors as charlatans preying on desperate people, instead of the current list of euphemisms.

    PM I have little personal knowledge as to who is doing what in those arenas , but there is a no doubt that there is a lot of sincere belief behind it, even in relation to the worst cancer quackery and the silliest medical claims. We should respect that.

    AK>2. Your scheme for evaluating cases submitted by practitioners of IMCs is well-meaning but is essentially similar to the “best case series” scheme that the NCI instituted in 1991, and that has backfired–as the Gonzalez fiasco shows, although I’ve not yet finished the story. I’ll write more about that this week, but in the meantime try to get a copy of the Stalker article (Mt. Sinai J Med, 1995) that I cited in Part I.

    PM I am saddened that you think this. It is the communication problem. In the early best case series there were no pre-defined criteria as to what kind of cases were worth submitting, no guidelines as to how they would be evaluated, no indication as to what threshold of evidence might trigger a favorable opinion, and no commitment as to what might happen if a favourable opinion is reached. They left the doctors with maximum maneuverability and the claimants with no comeback, contributing greatly to the perception that doctors can be quite slippery when it comes to evaluating seemingly good evidence from alternative sources.

    PM In contrast, my approach enables me to lay down a clear public challenge to anyone who thinks they have a cancer cure, asking for precisely the kind of cases that might actually demonstrate that occurring (what else?), advising how they will be evaluated and also roughly how many such cases would lead me to personally lobby for further investigation of the method. The numbers would have to take into account that some cancers are very variable in their behaviour. Note that as yet there is no talk of proof of anything or of endorsement of the method.

    Look upon it as describing the point where preliminary empirical evidence would start to outweigh even extreme scientific and source implausibility. Any consideration of plausibility must allow for the existence of such a point and alternative advocates are entitled to know what it is. This is an opportunity to counter the common allegation that the mainstream constantly raises the bar “alternatives” have to jump over.

    PM I think I have seen Stalker’s paper but I would like to see it again to refresh my memory of it. I would appreciate a copy or a source if available online..

  20. daedalus2u says:

    Using the identity of who is making the claim as input to determine whether the claim is true or not has several problems. If the data is unreliable, it is unreliable for any purpose, either as evidence for, or as evidence against the claim. I understand that there is the tendency to believe that unreliable evidence in favor of something is reliable evidence against it, but that is simply not the case. That is an error of using social reasoning for factual matters. A dishonest person may deliberately tell you the opposite of the truth, but reality doesn’t “lie”.

    There are usually four aspects to a claim, the data, the analysis, the conclusion and the person who puts it together. We can question the data, the analysis or the conclusion but if those check-out, who puts it together is unimportant. If we are unable to examine the data, the analysis or the conclusions, perhaps examining the person who puts it all together may have some utility, but really very little.

    My experience has been that when the individual making the claim is considered to be unreliable (usually via undefined and unstated criteria which change and are unrelated to the issues being discussed but often include not having the “right” degree from the “right” place), everything gets discounted to zero or negative. Data from the literature is discounted because it is “cherry-picked” (even if it is not). The analysis is discounted because there is some evidence (which often is cherry picked) against it. The conclusion is rejected because it goes against “conventional wisdom” (which is in fact wrong and is the exact point the proponent is trying to make).

    I appreciate that I am talking about the rare instance where a non-conventional idea put forward by someone new to a field is actually correct rather than the very common instance where non-conventional ideas are in fact wrong.

    I am not talking about “extraordinary” claims, claims that contradict much data that is in the literature. I am talking about “ordinary” claims, claims that are completely consistent with the data in the literature. Einstein’s photoelectric effect for example. There was nothing “extraordinary” about it. It exactly fit all the data in the literature. The only thing it didn’t fit was the model that light was a wave. The model that light was a wave didn’t fit the data in the literature. Einstein’s photoelectric model was “more ordinary” than the light is a wave model because it fit the data better.

    Millikan had the extraordinary presupposition that light was a wave (extraordinary because that model didn’t fit known data), and with that extraordinary presupposition had rejected the ordinary supposition of the photoelectric effect. Skeptico talked about this a while back using the example of Christianity. With the extraordinary presupposition of an infinitely powerful and infinitely beneficent God, the resurrection of Jesus is simply an ordinary expectation.

  21. Pmoran,

    Here is why I thought that your case report scheme is essentially similar to the NCI’s.

    Yours:

    “…case reports with biopsy-proved established cancers of the type not normally prone to spontaneous remissions, that display clear-cut remission using objective tests and with the use of no other treatment than the claimed one. The cases need to be contemporary — you can go and examine them yourself and look at their biopsy slides and the before and after CT scans, marker studies etc. etc, just as you might if they were to be enrolled in a mainstream clinical trial of a cancer treatment or published in a mainstream medical journal. And there must be more than one of them — for me a mere three cases of this solidity would suffice, if within the recent experience of the one practitioner or method.”

    The NCI’s:

    “1. Definitive Diagnosis of Cancer
    There must be a documented cancer diagnosis through a tissue biopsy or fine needle aspiration, or in the case of some leukemias and a few other cancer types, appropriate blood testing.

    2. Documentation of Disease Response
    There must be documented disease to follow radiographically, or through other validated indicators of tumor response (e.g. M protein level in patients with multiple myeloma) during treatment with the alternative therapy. Measurement of the tumor(s) before treatment and during or after treatment is required.

    3. Absence of Confounders
    The patient should not have received concurrent treatments with known therapeutic potential (e.g. chemotherapy or radiation therapy). There should be sufficient time between the end of any conventional anticancer therapy and the beginning of an alternative therapy to minimize the probability that a response was due to the conventional therapy.

    4. Documented Treatment History
    There must be documentation that the patient received the conventional and alternative therapies described, dates of interventions, and responses of the tumor to all interventions received by a patient during the period in question.”

    ( http://www.cancer.gov/cam/bestcase_criteria.html )

    It is true that the NCI doesn’t specify the number of cases that would move it to perform a prospective trial:

    “It is difficult to predefine an exact number of cases necessary to obtain a recommendation for prospective research. The quality of the cases is more important than the quantity. The more high-quality cases that can be presented, the greater the probability of a recommendation for NCI-initiated prospective research will be.”

    As far as I can tell, that is the only substantive difference between the two schemes.

    Your own language suggests to me that you are not so sure about the necessity or utility of a case report scheme:

    “I am, of course, not putting this forward with any realistic expectation that any quack will ever do this, or even need to do this. Any method that REALLY works on established cancer will sell itself, because doctors will be also seeing the results and the media will be onto it in a flash. Quack medicine is not carried out in isolation.”

    In that you are absolutely correct. Laetrile pushers presented woefully few case reports, even though the rules had not yet been written:
    http://content.nejm.org/cgi/content/abstract/299/10/549

    Gonzalez presented non-consecutive case reports that won him his grant, but he has apparently failed to complete the study, now that he’s being observed. He telegraphed his intentions even before it began by claiming that tumor regression should not be necessary, because survival and quality of life might be improved even in the absence of tumor regression (I don’t necessarily disagree with that, although it is somewhat implausible, but coming from Gonzo it should have been a warning sign—the source does mean something when we know its history). Now he’s claiming that the trial couldn’t have worked because “conventional experts” poisoned it by influencing subjects to be noncompliant. Handy. I’ll get into that more this week or next week.

    More recently, the NCI has decided, on the basis of “Best Case Series,” that homeopathy and “insulin potentiation therapy” “have been found to warrant NCI-initiated research.” (see p. 10 of the 2005 Annual Report: http://www.cancer.gov/cam/cam_annual_report.html )

    Next, although I agree with you that “there is a lot of sincere belief behind it, even in relation to the worst cancer quackery and the silliest medical claims,” I do not agree (here’s the rub) that “We should respect that.” I’m not saying that we should be short or rude with patients. What I am saying is that we cannot distinguish between calculating charlatans and deluded-but-well-meaning quacks, nor should we bother to try.

    This is a topic for a blog in itself, but in brief: part of the reason for the recent cave-in of medicine to “CAM” pushers is that the middle class, genteel children of the ’50s and ’60s who now populate academic medicine can’t really believe that people who seem sincere, and are moderately capable of speaking and writing, could be sociopaths. That trusting phenomenon—a kind of neo-romanticism—is a naivete that comes from privileged, sheltered upbringing, if you’ll excuse the cliche.

    It is dangerously wrong. Not all quacks are sociopaths, but many, especially those who have had enough formal education to know better, probably are. Gonzalez is so obvious an example that it is incredible to me that he has been taken seriously; it was exactly such examples that lulled me out of my own sheltered upbringing to recognize the emperor’s nudity. Sociopaths themselves run the gamut from being completely sincere about their beliefs (OJ likely believes that he is innocent) to being self-conscious snake oil salesmen, but they all seem sincere. Given that, it is not our job to make distinctions about intent, nor could we if we tried.

    In responding to patients, our job is to evaluate the claims themselves. In responding to quacks, our job is to expose them as quacks. Intent is irrelevant. I don’t respect anything about quacks or their apologists in medicine, other than that I am aware that stupidity makes trouble for the unwary, so in some cases I feel sorry for them. But just as in law “ignorance is no excuse,” so it is with science and medicine.

    Again, please don’t confuse this with how I think we should talk to patients about such things. In that we probably agree.

  22. Doctors, what are your goals? I suspect that the bloggers primary goal is to keep what they call “woo” out of scientific medical institutions and that the secondary one is to keep the general public from falling for quackery and being injured and killed by snake oil.

    If I am correct, I would suggest that you keep forums like this pretty much limited to academics and have people like Peter Moran and Harriet Hall post extensive informational webpages covering general medical topics far broader than Peter’s present webpage.

    I say this because I believe that the main problem is one of communication and education. The general public lacks enough knowledge of basic medicine to make informed decisions. In order to provide it to them, it must be presented or communicated in a way that will first draw and hold their attention and then actually explain things to them.

    As a lay person and teacher, it is my opinion that Drs. Moran and Hall have a talent for communicating with the general public, and they obviously also have the required knowledge.

    It is important to communicate with the general public for two reasons. First and obviously because they need and want the facts and the tools to evaluate the evidence presented regarding treatment options. Second, in today’s world it is the lay people, the “non-experts”, who are being heard and “running the show” so to speak when it comes to setting government and institutional policies.

  23. Thank you, Rosemary, for reminding me of something else that I wanted to say (and I know you already know it). There is a great site on the Web for the general public to look at if it wants information about “CAM”: Quackwatch. It has received numerous awards. It has existed longer than the NCCAM site or other apologist websites. It has an enormous amount of information. It is written in exactly the same sort of plain, non-technical, honest and critical prose that its editor and predominant author, Steve Barrett, used when he wrote for Consumer Reports in the ’80s, when he was regularly quoted by Ann Landers and other mainstream sources—before the current era of euphemism and pandering to sociopaths became de rigueur.

    The problem is not the lack of communication and education (there is also the related NCAHF site and others). The problem is that the neo-”CAM experts” at the NCCAM, medical schools, most commercial health websites and elsewhere have blacklisted accurate sources because they don’t know or won’t admit that that quackery exists and that most of “CAM” is exactly that. I’m all for good new sites, but how will they avoid being similarly shunned by “trusted” sources unless they conform to the current code of subterfuge, euphemism, and pretending that every form of “healing” has validity?

  24. Dr. Atwood, you are correct. I am familiar with QW and Dr. B. In fact I even get some of his hate mail because he gives my email address and says I will answer questions on silver supplements. Unlike him, I respond and in the same tone as the correspondents have written which really surprises most of them. I have the greatest respect for Dr. Barrett and the tremendous amount of work that he has done. I’ve met him personally. He is one of several doctors and scientists who has graciously reviewed articles I’ve written for accuracy. We have had a few disagreements. He once suspended me from his Health Fraud list which I’m rather expecting you to do soon here too.

    Obviously, QW and the affiliate sites are very valuable, but I think that there is still a need for a different type of site in addition to those exposing CAM and in addition to the Skeptic sites. I think that the general public needs more information sites on general medicine topics. For example, sites explaining what cancer is. How there are different kinds of cancer. What treatments are available. What antibiotics do. When antibiotics should be used and when they shouldn’t, etc.

    I know that there are institutions that have sites like that, but I think that many in the general public would feel more comfortable with individual doctors’ sites and from reading material by Drs. Moran and Hall I think they have the talent to communicate with the general public or at least with those in the mainstream of the general public, not those on the fringes who believe in magic and alt med.

    I’m sure that in addition to those two there are many others who have the talent to communicate with the general public maybe even some of the veterinarians could do veterinary sites. Of course, that doesn’t mean that any of them have the time or desire.

    But I seriously suggest that you all think about it.

  25. pmoran says:

    Rosemary, yes, you have picked up on something that initially inhibited me from raising certain matters. The dominant target of the blog and a legitimate one, seemed to be inappropriate rapprochements of medical institutions with CAM.

    Nevertheless the subjects discussed do overlap with those that we have to touch upon when trying to explain medicine to the general public. Understanding anecdotal evidence in depth is critical when dealing with cancer quackery. The role/non-role/nature of placebo medicines is an extremely complex subject but crucial to any overall attitude towards the public’s use of CAM, as also is the acknowledgment of some serious limitations of present-day conventional medicine in relation to some of the matters the public desires relief from. Uncertainty on such scores may underlie some of the unwillingness of certain circles to take a strong stand against CAM.

  26. Joe says:

    Rosemary, pmoran and Kimball- I find your discussions useful. Thanks.

  27. pmoran says:

    Kimball, I intentionally said “*early* best case series”, thinking of the old Gerson, Laetrile. Burzinski, Revici examples that gave rise to the troubles we both have described. These occurred before we even had reliable ways of diagnosing and tracking cancer.

    I was aware that the NIH was recently being more specific concerning the cases desired, having seen their request for best cases on the use of 714X. I admit I was not aware how closely their present recommendations resemble mine, although I notice that the page you referred me to was last updated in 2006 — they may have been reading my web site! :-)

    It should of course be no surprise. I think all doctors know what a convincing case should look like. The problem is that it does not take much sleight of hand to sneak in cases that look as though they are showing established cancer going away but actually aren’t quite doing that, as I describe on one of my web pages http://www.users.on.net/~pmoran/cancer/Brenneranecdote.htm

    I wager pounds to peanuts that this phenomenon, together with the desperation to find ANY “alternative” cancer method worth investigating, is what has influenced the NCCAM to go ahead with the homeopathy/cancer study, if they do, and that it did not involve adherence to my best case guidelines (did anyone even go to India and examine those cases?).

    Insulin potentiation therapy is a special case because it undoubtedly can produce remissions in sensitive cancers — my understanding is that these practitioners are often using near-normal doses of chemotherapy. I seriously doubt if the NIH will have any solid basis for investigating IPT and whatever that basis is their actions cannot be blamed upon the best case approach we have defined.

    Also, is my “best case series challenge” actually shown to be working, if these are the only cancer cures that the NCCAM has been able to find worthy of investigation in recent times? Why aren’t representatives of the dozens of other cancer cures banging on their door with arms full of case notes and CT scans?

    The reason they aren’t, and this can be patiently explained to the public, is that they must already know that their methods don’t usually have any effect at all on established, measurable cancer. It is the public explanatory aspect of this venture into the arena of anecdotal material that is most important, although surely any alternative method that did work would initally signal its activity by producing such cases, just radiotherapy or nitrogen mustard did when they were first found to shrink cancers. I don’t think anyone ever said ” here’s a thought — let’s let’s do a randomised controlled trial on XXX to see if it might cure cancer”.

    I was interested in your comments about Gonzales. I didn’t know any of that. Sounds like typical quack behaviour. Is this documented anywhere?

    I was never impressed by him or his case series, but one can argue that a body charged with investigating any promising alternative cancer methods could not possibly ignore even such a superficially scientific study. Also, does anyone know what happened to the two (supposed) pancreatic cancer patients who were still alive after three or four years at the time of publications of the study? That also was not easy to ignore.

    I was looking forward to the results of this study, because it should have provided confirmation that several popular alternative modalities don’t produce cancer remission.
    .

  28. Harriet Hall says:

    Re the usefulness of Quackwatch:

    I did some googling today. When I googled for “Amen Clinics” my Quackwatch article “A Skeptical View of SPECT Scans and Dr. Daniel Amen” came up number 3, and when I googled for “Perricone” my Quackwatch article “A Skeptical View of the Perricone Prescription” (co-authored with Stephen Barrett) came up number 4.

    Both of these refer to “borderline” treatments by legitimate medical doctors rather than outright quackery or even alternative medicine. People are already reading Quackwatch. The website also features a Healthfraud discussion list that Peter Moran and I participate in, and people frequently write in asking about questionable products or new treatments that have not been written up on Quackwatch. Someone on the list usually comes up with an answer.

  29. pmoran says:

    Quackwatch is a brilliant site but its pre-eminence has also resulted in it being demonised by the “alternative” faithful, even cleverly characterised as presenting a breakaway position from a medicine that is otherwise seeking an alliance with alternative medicine. This is a disadvantages of respected medical institutions having serious truck with CAM.

    I am not sure how much influence this nonsense has with the general public, but I do often see people being warned off Quackwatch. So perhaps the more more skeptical web sites the better — also the more people there are trying to talk sense on “alternative” discussion and mailing lists and referring people to good information sites the better.

  30. Dr. Hall, QW is a very valuable site used by many people, but it is primarily presenting evidence about what doesn’t work. In addition to that the general public desperately needs information on what does work, how it works and why.

    One small example of this need, people constantly write to me and tell me about in vitro studies showing that a silver supplement killed bacteria. (Such lab reports are posted on the Internet. I have been contacted by many scientists who have tested many silver supplements in vitro and never gotten positive results. Some have published this. I have contacted the head of the microbiology dept. at one university where one of the reports originated and posted his response with his permission in an FAQ.) Most people in the general public don’t know the difference between in vitro and in vivo, between a disinfectant and an antibiotic. When they write to me, I explain that silver like alcohol, bleach, peroxide, etc. is a disinfectant that kills many germs on contact but that silver drugs were used before the advent of antibiotics and didn’t work. I try to explain the difference between in vitro and in vivo and usually say that you can use alcohol to disinfect a wound but vodka doesn’t prevent or cure pneumonia. A few people are very grateful for my explanations. Others don’t believe them at all.

    I am sure that you, Peter or one of the other medical doctors or scientists on the list or a group of you together could write articles on very basic simple topics like that far better than I can and that that would go a long way towards educating the general public and making them realize that MDs and scientists are people too. For goodness sake, I think some of you actually even suffer and die from the exact same diseases that the rest of us do.

    This is a very bad example, but the only one I can think of. You can’t know what night is until you’ve experienced day. You can’t know what CAM is until you’ve gotten at least a basic understanding of scientific medicine.

    The Health Fraud list is very valuable. I met many scientists and MDs there who have very graciously educated me, reviewed my material for accuracy and been available to answer questions. Most people there identified themselves and used their email addresses which is good and bad. Quacks monitored the list and sent threatening private emails that intimidated some people. But a good many people in the general public will be intimidated by such a list just because there are so many experts there. It also offers quacks equal opportunity to speak as long as they remain polite. As you all know, many quacks can sound just like real doctors and scientists to those who don’t know the topic and since they aren’t constrained by the facts, they can often be more convincing than real scientists. Other people simply are not interested in all the health scams discussed on HF. They just want reliable information about a disease or condition or about a scientific drug or therapy. Searching the Internet, they may stumble on a site that they believe is providing that when it is really a quack site.

    I left the HF list years ago along with several real scientists. We were horrified by the personal attacts on Emily Rosa and her TT study, the one that was published in JAMA. The attacks were conducted by some of the Skeptics who were not scientists. (If anyone doesn’t know, Emily was 9 yo when she did her study.) We were also horrified about what they said about the safety of silver supplements without any evidence to back them up, but I believe they did that because they were angry at me. We left the HF list because Dr. Barrett let them carry on like that but censored me, and I think a few others, when we answered back in the same tone. (This is one of a few disagreements Dr. B and I have had over the years.)

    I’m thrilled by the scientific knowlege so many people on this list have and by so much great writing talent. I wish I had email addresses to contact you privately. If anyone wants to contact me off list about any of this, please wrtie to either: rjstan@together.net or rosemary@rosemaryjacobs.com

  31. Harriet Hall says:

    “the general public desperately needs information on what does work, how it works and why.”

    For that, the general public has only to ask their doctor.

    And there is already plenty of good information out there. The NIH, the American Cancer Society, the ACOG Patient Page, etc. I highly recommend the American Academy of Family Physicians website, which has a section for patients, with clear, concise explanations of many common conditions, for instance this one about ear infections in children: http://familydoctor.org/online/famdocen/home/children/parents/common/ent/055.html

    Stephen Barrett has come up with a good rule of thumb that will rule out most of the websites with unreliable information: avoid websites that are selling anything.

  32. Joe says:

    I have a question about obtaining information from doctors. How does one know it is accurate? Several years ago I heard an interview of a doctor who opposed quackery. When asked why he was so vocal about it, he explained that when one of his patients had terminal cancer, she asked him if there was a clinical trial that offered hope. He got her enrolled in one, and she was ill-served by a quack. I wonder, if this (diligent, rational and caring) doctor was bamboozled- what defense do the rest of us have?

    “Credentials and affiliations” don’t always help- see the Gonzo protocol discussed here. He was working at Columbia despite multiple, well-earned malpractice convictions (not errors- irrational thought). Moreover, one can arrogate the title of “Director of the Kearney (NJ) Multiple Chemical Sensitivity Institute” [note, I made that up]; that sounds impressive without meaning anything desirable.

  33. With regard to obtaining medical information Dr. Hall wrote, “For that, the general public has only to ask their doctor.”

    I have a friend with a Ph D in chemistry who is retired after 30 years of developing drugs. He holds drug patents. He belongs to a large HMO. I cannot begin to explain the frustration he goes through trying to “ask” his doctor which includes specialists, the family doctor who is the “gatekeeper” and the Pharm D overseeing his coumadin.

    If a professional finds communication impossible, what chance does the average person have?

    Dr. Barrett’s rule of thumb about not trusting a website selling something is excellent. I think it should be obvious to all consumers, but it isn’t and how many consumers have heard it? We all have strengths and weaknesses. Many MDs and scientists just aren’t very good at communicating. Many lay people who do not have any background in medicine are not comfortable talking with them or asking them questions. Many people have to hear or read something more than once or in different forms before it gets through. I often get people who have read Dr. Barrett’s article on silver who get my email address on his site write to me asking if I recommend taking it. The first few times I was surprised because my reading of his article makes it clear that no one should take it. But we all have different learning curves.

    One of the many reasons that alt. med. is so popular is because MDs are not communicating well with patients for many reasons such as lack of ability, work load, etc. Alts have noticed and stepped in to fill the gap.

  34. If your goal is to stand around the cyber watercooler and discuss your profession, academic medicine with colleagues, it is IMO a very valid one that serves a good purpose. However, if your goals are to: maximize the benefits the public gets from medicine and minimize the harm caused them by it; or, to influence policy and public opinion so that by and large the public is offered the most effective, safe and efficient medicine available, then I think that for starters you will have to hire marketing professionals to learn the best ways to objectively evaluate your efforts to see how well they work at achieving your goals. It is rather ironic that alts are accutely aware of and excellent at the “science” of marketing but completely unaware of the science of medicine while so many advocates of scientific medicine appear to be unconcerned about whether or not anyone other than the choir even hears and listens to the facts they are presenting.

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