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The “Gonzalez Trial” for Pancreatic Cancer: Outcome Revealed

A Review

Dr. Lipson’s “detoxification” post on Thanksgiving Day and Dr. Gorski’s recent post about “Gerson Therapy” were timely, because last weekend I noticed something that I should have noticed months ago. Before delivering the punch line, let me remind you, Dear Reader, of the nature of the topic. The regimen advocated by Nicholas Gonzalez is a variation of a “detoxification” treatment for cancer that has been around, in one form or another, for more than 50 years (“Gerson Therapy” is another example).† Here is the National Cancer Institute’s (NCI) description:

Patients receive pancreatic enzymes orally every 4 hours and at meals daily on days 1-16, followed by 5 days of rest. Patients receive magnesium citrate and Papaya Plus with the pancreatic enzymes. Additionally, patients receive nutritional supplementation with vitamins, minerals, trace elements, and animal glandular products 4 times per day on days 1-16, followed by 5 days of rest. Courses repeat every 21 days until death despite relapse. Patients consume a moderate vegetarian metabolizer diet during the course of therapy, which excludes red meat, poultry, and white sugar. 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.

As unlikely as it may seem, in 1999 American taxpayers began paying for people with cancer of the pancreas to be subjected to that regimen, in a trial sponsored by the National Center for Complementary and Alternative Medicine (NCCAM) and the NCI, conducted under the auspices of Columbia University. Gonzalez provided the treatments. A few months ago I presented a multi-part treatise on the “Gonzalez regimen” and the trial. It demonstrated that all evidence, from basic science to clinical, including the case series that supposedly provided the justification for the trial, had failed to support any real promise (the case series had previously been considered by reader Dr. Peter Moran, who also found them wanting).

It showed that the impetus for the trial, as has been true for other regrettable trials of implausible health claims, can be traced not to science but to the reactionary politics of anti-intellectual populism: initially to Laetrile and to the “Harkinites,” and more recently to the Honorable Dan Burton (R-IN). It reported that there were major problems with the Gonzalez trial from the outset, and that for at least one subject the regimen was more torture than therapy. It reported that for unclear reasons the trial had come to a halt a couple of years ago, and that it appeared that there would never be a report of its findings.

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Posted in: Cancer, Clinical Trials, Medical Academia, Medical Ethics, Politics and Regulation

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On the dangers of using valid placebo controls in clinical trials of acupuncture

ResearchBlogging.orgI don’t recall if I’ve ever mentioned this before on this blog, but there was a time when I was less skeptical of acupuncture than I am now. It’s true. Don’t get me wrong, though. I never for a minute considered that the whole rigamarole about “unblocking” or “redirecting” the flow of that mystical life force known as qi had anything to do with whether or not acupuncture did or did not have efficacy treating disease or other conditions. That was clearly a holdover from the pre-scientific medicine times in which most beliefs about the causes of disease involved either the wrath of the gods or vitalism, the latter of which is, when you come right down to it, the philosophical basis upon which many “complementary and alternative” (CAM) modalities are based, especially the so-called “energy healing” modalities, such as reiki, therapeutic touch, and, of course, acupuncture.

However, because unlike so many other “energy healing” methods, acupuncture involved an actual physical action upon the body, namely the insertion of thin needles into the skin to specified depths, it did not seem to me entirely unreasonable that there might be some sort of physiological effect that might produce a therapeutic result. At least, that’s what I used to think until I actually started paying attention to the scientific literature on acupuncture. That’s when I started to realize that “there’s no ‘there’ there,” if you know what I mean. Horribly designed studies with either no controls or utterly inadequate controls tend to be the norm in the acupuncture “literature” (if you can call it that). Moreover, acupuncture was touted as having value for conditions and procedures for which there is no plausible (or even mildly plausible) physiological mechanism by which it could be reasonably postulated to have an effect. Arthritis, allergies, headache, back pain, gastroesophageal reflux disease (GERD), Parkinson’s disease, post-operative nausea, hot flashes in breast cancer patients caused by the anti-estrogen drugs they have to take, infertility, it doesn’t matter. Seemingly acupuncture can do it all; it’s the Swiss Army knife of CAM therapies. Moreover, the “explanations” given to explain “how acupuncture works” seemed increasingly less plausible to me. Most of these explanations involve counterirritation or the release of opioids, and I’ve had an increasingly hard time believing that, even if these mechanisms are at play, they could have anything other than nonspecific effects, with no mechanism to explain how acupuncture could possibly do all things attributed to it. One rule of medical skepticism is that you should be very skeptical of modalities that are touted to be useful for a wide variety of medical conditions that have very different pathophysiology. Indeed, a funny thing happens when rigorous placebo controls are introduced, and that’s sometimes the placebo control does better than the “true” acupuncture; i.e., the evidence for acupuncture, taken in its totality, is completely compatible with placebo effect.

As Harriet Hall put it in her excellent analysis of a study purporting to show that acupuncture is useful for GERD:

This study falls into the category of what I call Tooth Fairy science. You could measure how much money the Tooth Fairy leaves under the pillow, whether she leaves more cash for the first or last tooth, whether the payoff is greater if you leave the tooth in a plastic baggie versus wrapped in Kleenex. You can get all kinds of good data that is reproducible and statistically significant. Yes, you have learned something. But you haven’t learned what you think you’ve learned, because you haven’t bothered to establish whether the Tooth Fairy really exists.

One area that acupuncturists keep needling away at is infertility. Somehow, in the CAM community it’s become conventional wisdom that acupuncture can somehow increase the chance of success for couples undergoing in vitro fertilization (IVF). Indeed, early this year I wrote about a meta-analysis that concluded that acupuncture did actually increase the success rate of IVF and why it did not show what its authors thought it showed. Tooth fairy science, indeed.

Now comes yet another study being publicized in the media that examines once again the question of whether sticking needles into women before they undergo IVF can increase their chances of conceiving. I could not help but be extremely amused by the title given to the ScienceDaily story about it: Placebo Acupuncture Is Associated With Higher Pregnancy Rate After IVF Than Real Acupuncture. You have to love a headline like that, and opening paragraphs like this:
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Posted in: Acupuncture, Clinical Trials, Medical Academia, Science and the Media

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“Integrative Medicine Experts”: Another Barrier to Effective Discipline

This is the final entry in the current series having to do with state regulation of physicians.† It is the final one merely because I’m tired of the topic, for now. There is plenty more to write about, including an event that occurred only yesterday right here at my own hospital. I’ll give a preview of that at the end of this post, but first we’ll look at another recent event.

Dazing Arizona  

Arizona’s citizens, more than most, can expect to be bamboozled by pseudomedicine. We’ve seen that the Arizona Board of Homeopathic Medical Examiners has, for years, provided a regulatory safe haven for quacks with MD and DO degrees. Although I haven’t previously mentioned it in this series, which is about quack medical doctors, Arizona is also a haven for another group of quacks: “naturopathic doctors.” Like its homeopathy board, Arizona’s Naturopathic Physicians Board of Medical Examiners has been less than committed to protecting the public from its licensees. In each board’s case, the state Office of the Auditor General has suggested numerous fixes, but there has been little indication of improvements.

Nor would improvements be expected: in the words of Edzard Ernst,

Those who believe that regulation is a substitute for evidence will find that even the most meticulous regulation of nonsense must still result in nonsense.

Arizona is also the home of one of the first academic “integrative medicine” programs, begun by Andrew Weil at the University of Arizona. We have previously seen examples of misleading language emanating from that program. We’ve also seen the program’s inordinate effect on the Federation of State Medical Boards (FSMB). We’ve seen examples of the writings of Kenneth Pelletier, one of the U of Arizona program’s consultants to the FSMB. A recent disciplinary case in Arizona illustrates the potential danger of a state medical board seeking consultation from another “integrative medicine expert” from that program.

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Posted in: Health Fraud, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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“Urban Zen” and homeopathy at Beth Israel Medical Center, or: Dr. Gorski destroys his chances of ever being invited to join the faculty at BIMC or the Albert Einstein College of Medicine

I guess I never really wanted to work in Manhattan anyway. At least, that’s what I keep telling myself.

I mean, why on earth would I want to? What’s the attraction? Living in the heart of it all, all those shows and all those amazing cultural activities, all those world-class restaurants? Being close to Boston, Philadelphia, and other cool East Coast cities, which are all just a quick Acela train ride away? Who cares about those things, anyway?

Apparently I don’t, because I’m about to destroy my chances of working at what has been considered one of the premiere academic hospitals in New York City, specifically Beth Israel Medical Center, an academic affiliate of the Albert Einstein College of Medicine. It’s possible for me to have been ignored when I first included the Albert Einstein College of Medicine and its affliated Continuum Center for Health & Healing in my roll call of shame as a medical center that has not just added woo to its offerings, but actively embraced it. At the time I originally discovered it, though, its offerings seemed limited to fairly mild woo, the usual stuff like acupuncture, what I like to call “gateway modalities” that centers embrace first because they’re relatively tame and commonplace. All too commonly, though, dabbling in gateway modalities leads to the “hard stuff,” outright quackery with zero scientific basis like homeopathy, reflexology, and craniosacral therapy. Such is the pathway an academic medical center follows when it degenerates from science-based medicine to what Dr. R. W. famously dubbed “quackademic medicine,” usually driven by a few famous true believers, which, alas, is exactly what happened at fearless leader Steve Novella’s institution of Yale, thanks to Dr. David Katz and his “more fluid concept of evidence.”

In any case, last week, I realized that I’ve been completely neglecting the aforementioned roll call of shame. Perusing it, I now realize that it’s been over five months since I did a significant update to it. You just know that, given the rate of infiltration of unscientific medical practices into medical academia as seemingly respectable treatment modalities that there must be at least several new additions to this roll of shame. Alas, even today, having been shamed myself by the realization of my failure to keep the list updated, I’m not going to do the full update and revamping that the Roll Call of Quackademic Medicine cries out for. However, that doesn’t mean I can’t do a piecemeal addition here and there. That doesn’t mean I can’t point out new additions as they pop up, even if it takes me a while to find the time to give the list the facelift it cries out for. It doesn’t mean I can’t call out hospitals like Beth Israel when they fall into woo, especially when they dive into quackademic medicine in a big way for cancer patients.
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Posted in: Cancer, Homeopathy, Medical Academia, Science and the Media

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A natural product of his environment

I’m delighted to have the opportunity to join this outstanding group of medical professional bloggers in adding my natural products angle to the application of science-based medicine.  With the exception of Dr. Gorski, who holds MD and PhD degrees, I believe I am the first “only a PhD” to be invited to SBM.  However, I have spent much of my career training, and training with, physician-scientists; so enthusiastic am I about the special qualities of the physician-scientist that I married one (or, rather, she chose to marry me, truth be told.).  Conversely, I view the invitation to write here as a responsibility in representing what my fellow basic scientists bring to bear on discussions of the scientific arguments for and against modalities classified broadly as complementary and alternative medicine or integrative medicine.

Why write about herbal medicines and natural products?

I have long been interested in bringing objective scientific information to the public, perhaps as early as my college years in bars while visiting my working-class hometown of Wallington, NJ, or while shooting darts with Philadelphia cops across from my undergrad apartment.  Any chat I’d have with an old buddy or bartender about drugs, cancer, or drugs and cancer would invariably draw some interest from fellow patrons overhearing my discussions.  These were usually followed by, “Hey, aren’t you Frankie Kroll’s boy?,” or “I’ve heard the government is hiding the cure for cancer – do you have any inside dope on that?”
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Posted in: Herbs & Supplements, Medical Academia, Pharmaceuticals, Science and Medicine, Science and the Media

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Is medical academia just following academia?

Is Medical Academia repeating Academia’s history? In a recent essay in a small-circulation, specialized periodical, Academic Questions, Prof. John M. Ellis, emeritus Professor of Literature at the University of California, Santa Cruz, recounts the past 4-5 decades of changes in liberal arts departments in US colleges. (How Preferences Have Corrupted Higher Education, Acad Quest, 2008; 21(2):265-274)  One modern academic controversy not needing recounting is the takeover of liberal arts departments by post-modernist theology and the partial takeover of universities themselves by radical politics dating from the 1960s.  But as recounted by Prof. Ellis, the fifty-year metamorphosis has not only changed universities, but has produced a branching network of intended and unintended consequences.

We have noted before that medicine is both a science and a practice that reflects current social attitudes and mores. (I minimize the aliquot of art, persisting from prior centuries; cultural influences being a more accurate term.) But the changes in universities now reflect in the normative thinking and mores of the modern medical school – at least a nucleus of them.  Thus Dr. Ellis’s observations may be a metaphor or template for a medicine of the next several decades.

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Postmodernist attacks on science-based medicine

The postmodernist critique of science consists of two interrelated arguments, epistemological and ideological. Both are based on subjectivity. First, because of the subjectivity of the human object, anthropology, according to the epistemological argument cannot be a science; and in any event the subjectivity of the human subject precludes the possibility of science discovering objective truth. Second, since objectivity is an illusion, science according to the ideological argument, subverts oppressed groups, females, ethnics, third-world peoples.

Postmodernism and science

I detest postmodernism.

Well, it’s not really postmodernism per se that I detest. In the humanities, I don’t mind it so much, although reading postmodernist texts in college did make my head hurt. I suppose that in the humanities postmodernism provides a sometimes useful methodology for providing insights into interpretation of a wide variety of subjects in literature and the arts, although much of the time it seems to exist mainly to try to make texts mean exactly the opposite of what the words on the page say. Relying as it does on deconstruction, which is primarily a form of literary analysis, postmodern analysis is built on questioning the assumptions underlying any text, “deconstructing” its meaning. The problem is, it’s rare that a postmodernist critique of anything doesn’t consist of some of the densest, most impenetrable verbiage in existence.

Since I don’t claim to be a philosopher, and I haven’t studied postmodernism since college, I don’t intend to embarrass myself by trying to do a detailed–ahem–deconstruction of what postmodernism is. Many are the trees that have been killed to write books trying to explain what postmodernism is and how to apply it to various subjects. I do know, however, that postmodern philosphy is skeptical–even nihilistic–when it comes to the values of what is considered “modernity.” Unfortunately, to some, science is one of these modern values that is viewed with extreme skepticism, even to the point of representing the very essence of science as nothing more than one narrative among many. True, Spiro was writing primarily about anthropological science, but medicine is a “soft” enough science to be just as easily attacked in such a manner, and postmodernists don’t limit themselves to the “soft” sciences, anyway. Even worse, these sorts of arguments often claim that science (or, in this case, evidence-based medicine) is nothing more than a sort of hegemony of the power structure being imposed upon the very definition of “data” or “reality,” the implication that it’s us white males whose hegemony is being served (and whose hegemony, presumably, must be resisted) doing the imposing, as if there are no inherent characteristics in science that make it a more reliable means of assessing reality as it exists than, for example, personal anecdote and “experience.”

No wonder woo-meisters and those who hate the very concept of evidence-based medicine (as opposed to the deficiencies in how EBM ranks evidence, which in fact were the reason why this blog is called Science-Based Medicine and not Evidence-based Medcine) love postmodernism so much. It’s the perfect tool for them to appeal to other ways of knowing and try to make it seem as though scientific medicine is no more valid a construct to describe reality than that of the shaman who invokes incantations and prayers to heal, the homeopath who postulates “healing mechanisms” that blatantly contradict everything we know about multiple areas of science, or reiki practitioners who think they can redirect “life energy” (or qi) for therapeutic effect. In the postmodernist realm all are equally valid, as there is no solid reason to make distinctions between these competing “narratives” and the “narrative” of scientific or evidence-based medicine.

Perhaps the best quick explanation of how postmodernism is used to attack science comes from Rob Helpy-Chalk:

Knowledge was always in some way relativized to culture, so that it was possible to talk about many “equally valid ways of knowing” of which enlightenment science was only one. For instance, contemporary biologists say that the cassowary (an ostrich-like creature) is a bird, albeit one that cannot fly. The Karam people of New Guinea, who live alongside the cassowary, say that the cassowary does not belong in the same category as the birds (which they call yakt) but bats do belong to that category. So who’s to say that the biologists are right and the Karam are wrong? Knowledge is all relative.

Claims to knowledge were also always in some way “constructed” or “socially constructed” in the postmodernist movements. This meant that they had less to do with grasping the way the world actually works and more to do with creating social structures that advanced the interests of the people who claimed to have knowledge. The science of thermodynamics was not really a description of the properties of heat. It was about convincing people to buy steam engines and arranging society so that they would be happy when they bought one.

Thus, one of the key tenets of some strains postmodernism is that knowledge is relative and “socially constructed,” usually for the purpose of reinforcing the existing power structure or furthering the interests of the “elite” who have the knowledge. It is therefore not surprising that critics of evidence-based and science-based medicine would find postmodernism to be a very attractive philosophical mantle in which to wrap their objections to the science that does not support their favored understanding of how disease works or what treatments are effective. After all, if all knowledge is relative, then why shouldn’t their way of knowing be just as valid as that of science, given that in the postmodernist view as used (or, as many philosophers would characterize it, abused) by “postmodernist” critics, science is just “another narrative.”
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Posted in: Basic Science, Clinical Trials, Medical Academia, Science and Medicine

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The New England Journal of Medicine Disappoints

On July 31 of this year, a collective groan could be heard emanating from critics of pseudomedicine. The causative factors (which is medical bombast for “the cause”) were two book reviews published in the usually staid New England Journal of Medicine (NEJM):

Integrative Oncology: Incorporating Complementary Medicine into Conventional Cancer Care

Edited by Lorenzo Cohen and Maurie Markman. 216 pp., illustrated. Totowa, NJ, Humana Press, 2008. $79.95. ISBN 978-1-58829-869-0.
Reviewed by Donald I. Abrams

Alternative Medicine? A History

By Roberta Bivins. 238 pp., illustrated. New York, Oxford University Press, 2008. $35. ISBN 978-0-19-921887-5.
Reviewed by Teresa L. Schraeder

The Wooification of Medical Journals

I’ll review the reviews, but first let’s consider why their presence in the NEJM is so disturbing. The NEJM is the most widely read and cited medical journal in the world. Among American journals, the top three are usually reckoned to be the NEJM, the Journal of the American Medical Association (JAMA) and, at least for internists, the Annals of Internal Medicine (Ann Int Med). The extent to which each journal has sacrificed its integrity for the promotion of the recent wave of pseudomedicine has varied among the three: the NEJM rarely and, for the most part, unwittingly; JAMA famously in 1998 and occasionally since; and the Ann Int Med repeatedly and embarrassingly, most notably with a series of puff pieces on “CAM” that spanned several years and violated the Annals’ own policies regarding funding disclosures by authors and editors.

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Posted in: Book & movie reviews, Cancer, Medical Academia

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Animal rights terrorists endanger science-based medicine

I’m a bit ticked off right now, enough that I thought I’d break with tradition and do an extra post today. Don’t worry; it’ll be brief. It will also be angry, more so than you are perhaps used to hearing on this blog. However, I think my anger is justified, and I hope that Steve Novella–and you–will understand. I view the problem that I am about to discuss to be at least as serious a threat to science-based medicine as any infiltration of woo into medical schools or residency programs.

Remember back in February, when I discussed how animal rights terrorists had been harassing a researcher at the University of California Santa Cruz (UCSC)? At the time, protesters attempted a home invasion of a researcher, leading to a police response where a home was searched by the police. This time around, however, these animal rights thugs have turned violent–again:

SANTA CRUZ — The FBI today is expected to take over the investigation of the Saturday morning firebombings of a car and of a Westside home belonging to two UC Santa Cruz biomedical researchers who conduct experiments on animals.

Santa Cruz police officials said Sunday the case will be handed to the FBI to investigate as domestic terrorism while local authorities explore additional security measures for the 13 UCSC researchers listed in a threatening animal-rights pamphlet found in a downtown coffee shop last week.

“The FBI has additional resources and intelligence into groups and individuals that might have the proclivity to carry out this kind of activity,” police Capt. Steve Clark said. “The FBI has a whole other toolbox of tools for this kind of investigation.”

The front porch of a faculty member’s home on Village Circle off High Street was hit with a firebomb about 5:40 a.m. Saturday, police said. The bomb ignited the front door of the home and filled the house with smoke, police said. About the same time, a Volvo station wagon parked in a faculty member’s on-campus driveway on Dickens Way was destroyed by a firebomb, police said.

Clark described the bombs as devices, which he said investigators have seen used by animals rights activists in the past, as “Molotov cocktail on steroids.”

That no one was seriously injured or died, especially the researcher’s children, is incredibly fortunate. As in previous cases, these two firebombing attacks were the culmination of a campaign of intimidation:

This appears to be the latest in a string of incidents targeting UCSC researchers and others in Santa Cruz.

Fliers identifying 13 UCSC scientists, some of whom use mice, fruit flies and other nonprimate creatures in their research, were discovered at a downtown coffee shop Tuesday. The fliers say, “Animal abusers everywhere beware; we know where you live; we know where you work; we will never back down until you end your abuse.” The names, home addresses, home phone numbers and photos of researchers were published on the fliers.

Fruit flies? Drosophila? How messed up do you have to be to threaten violence over Drosophila experiments? Why aren’t they threatening violence over the trillions upon trillions of E. coli or yeast that die in the name of science in molecular biology labs every day?
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Posted in: Basic Science, Medical Academia, Politics and Regulation, Science and Medicine

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Resistance is futile? Hell, no! (A call to arms)

Well, I won’t back down
No, I won’t back down
You can stand me up at the gates of hell
But I won’t back down

Gonna stand my ground
Won’t be turned around
And I’ll keep this world from draggin’ me down
Gonna stand my ground
And I won’t back down

From “I Won’t Back Down” by Tom Petty, 1989

This week, in a little bit of a departure, I have a minor bone to pick with our fearless leader and his podcast partner in crime Rebecca Watson (a.k.a. the Skepchick), who both managed to annoy me a bit the other day. (Don’t worry, Steve and Rebecca, I still love you guys…)

I’ll explain. You see, I had originally had a much different topic in mind for this week. Indeed, I even had my post mostly written by Saturday morning, when I had to take care of some mundane personal business, namely getting an oil change and some minor work done on my car. Since I need my car to commute to work and the maintenance needed was relatively minor, I decided to wait for the work to be done. As is my wont when sitting in waiting rooms with nothing much else to do, I decided to plug my earphones into my iPhone and catch up on some podcasts. Since the dealer also had free wifi, I brought my laptop along as well, the better to finish up my originally intended post.

The first thing I realized as I perused the list of unlistened-to podcasts was that I had fallen far behind in listening to one of my favorite podcasts, The Skeptics’ Guide to the Universe. To begin catching up, I decided to start with what was at the time the most recently available episode, specifically the July 9 podcast, figuring I could work my way back to through the earlier ones and thereby catch up with at least two episodes before my car was ready. In the second segment (beginning around 14:31 minutes into the podcast), Steve Novella and crew discussed a bit the recent news that the National Institute of Mental Health was trying to resurrect a dubious and highly unethical clinical trial proposed to test chelation therapy as a treatment for autism, referencing his excellent post on this very blog about why the trial is scientifically dubious (at best) and totally unethical. So far, so good.

Then the conversation veered into another area that I agree with, namely the utter uselessness of National Center for Complementary and Alternative Medicine (NCCAM) and how its main purpose is more proselytization for “alternative” and “complementary” medicine than actual rigorous scientific research, as I pointed out before in one of my earliest posts for SBM. As Steve pointed out that, for all the hundreds of millions of dollars spent by NCCAM, not a single new medicine or treatment has been added to the armamentarium of modern medicine, nor, even more importantly, have CAM practitioners abandoned a single bit of unscientific medicine due to any of the negative studies. Indeed, their enthusiasm hasn’t been dampened in the least. This line of discussion led to the question of whether we, as skeptics and advocates of science- and evidence-based medicine need to rethink and refocus our efforts.
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