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

ResearchBlogging.org

Review

One of the more bizarre and unpleasant “CAM” claims, but one taken very seriously at the NIH, at Columbia University, and on Capitol Hill, is the cancer “detoxification” regimen advocated by Dr. Nicholas Gonzalez:

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.

Veteran SBM readers will recall that in the spring of 2008 I posted a series of essays* about this regimen and about the trial that compared it to standard treatment for subjects with cancer of the pancreas. The NIH had funded the trial, to be conducted under the auspices of Columbia, after arm-twisting by Rep. Dan Burton [R-IN], a powerful champion of quackery, and much to the delight of the “Harkinites.”

In the fall of 2008 I posted an addendum based on a little-known determination letter that the Office for Human Research Protections (OHRP) had sent to Columbia during the previous June. The letter revealed that the trial had been terminated in October, 2005, due to “pre-determined stopping criteria.” This demonstrated that Gonzalez’s regimen must have been found to be substantially worse than the current standard of care for cancer of the pancreas, as ineffective as that standard may be. I urge readers who require a review or an introduction to the topic to read that posting, which also considered why no formal report of the trial had yet been made available.

Now, finally, the formal report has been published online by the Journal of Clinical Oncology (JCO):

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Posted in: Cancer, Clinical Trials, Health Fraud, Herbs & Supplements, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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SBM in primary practice: one student’s experience

EDITOR’S NOTE: Dr. Jones is off this week; fortunately, we have this guest post by Tim Kreider, our science-based medical student. Enjoy!

My first clerkship of my third year of medical school was Family Medicine, and I had a great experience. After the first two years spent mostly with books and then a three-year interlude in a basic science lab, these past five weeks were my first extended foray into the world of patient care. I had a few lectures and seminars on campus, but most days were spent in a primary care office learning on the job. I was assigned to an office attached to a community hospital with a Family Medicine residency program, so I was able to work with both attending physicians and residents in training. I learned a lot and gained some much needed confidence regarding my clinical exam skills, which were rather rusty after grad school.

I have heard as a criticism of the SBM mission that practicing medicine “in the real world” is different from what evidence-obsessed, ivory tower dwellers think it should be. Therefore I approached my Family Medicine clerkship as my first chance to see the challenges and realities of practice outside the university setting. How would the practice of community-based physicians compare to the perhaps lofty ideals espoused by academics? (more…)

Posted in: Medical Academia, Science and Medicine

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Needles in the skin cause changes in the brain, but acupuncture still doesn’t work

ResearchBlogging.orgI don’t recall if I’ve mentioned it on SBM before, but I went to the University of Michigan. In fact, I didn’t go there just for undergraduate studies or medical school, but rather for both, graduating with a B.S. in Chemistry with Honors in 1984 and from medical school in 1988. In my eight years in Ann Arbor, I came to love the place, and I still have an affinity for it, even though it’s been over 20 years since I last walked about the campus as a student, although I have been back from time to time for various functions, most recently to see Brian Deer speak last winter. True, I’m not fanatical about it, as some of my contemporaries and friends who attened U. of M. with me back in the 1980s (and, sadly, the string of losses to Ohio State and the definitively mediocre last season Michigan had last year make it very hard to be a Michigan football fan these days). However, I do have considerable affection for the place. It molded me, trained me in science, taught me medicine, and provided me the basis for everything I do professionally today.
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Posted in: Acupuncture, Clinical Trials, Medical Academia, Science and the Media

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‘Acupuncture Anesthesia’ Redux: another Skeptic and an Unfortunate Misportrayal at the NCCAM

A Neglected Skeptic

Near the end of my series* on ‘Acupuncture Anesthesia’, I wrote this:

Most Westerners—Michael DeBakey and John Bonica being exceptions—who observed ‘acupuncture anesthesia’ in China during the Cultural Revolution seem to have failed to recognize what was going on right under their noses.

I should have added—and I now have—Arthur Taub’s name to that tiny, exceptional group. Taub, a neurologist and neurophysiologist at Yale, was a member of a delegation of Americans sent to China to observe ‘acupuncture anesthesia’ in May of 1974, about a year after Dr. Bonica‘s visit. The delegation included several prominent anesthesiologists. Their report,  Acupuncture Anesthesia in the People’s Republic of China: A Trip Report of the American Acupuncture Anesthesia Study Group, was published in 1976 and is available in its entirety here. Excerpts follow (emphasis added):

Pain is a subjective experience. Judging whether an individual is in a state of pain depends on observations of the subject’s behavior, including verbal reports to the observer…When there is no evidence of pain, the observer can adopt one of three positions: (more…)

Posted in: Acupuncture, Medical Academia, Science and Medicine, Science and the Media

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The clinician-scientist: Wearing two hats

About a week ago, Tim Kreider wrote an excellent post about the differences between medical school training and scientific training. As the only other denizen of Science-Based Medicine who has experienced both worlds, that of a PhD and that of an MD, and as the one who two decades further along the path than Tim (give or take a couple of years), his musings reminded me of similar musings I’ve had over the years, as well as emphasizing yet again something I’ve said time and time again: Most physicians are not scientists. They are not trained like scientists; they are trained to apply scientific knowledge to the care of their patients. That’s what science-based medicine is, after all, applying science to the care of patients. Not dogma. Not tradition. Not knowledge of antiquity. Science.

Leave dogma, tradition, and “ancient knowledge” to practitioners of “alternative medicine.” That’s where they all belong. Whether you want to call it “alternative medicine,” “complementary and alternative medicine” (CAM), or “integrative” medicine (IM), it rarely changes and almost never abandons therapies that science finds to be no better than placebo, whereas scientific medicine is, as it should be, ever changing, ever improving. I’ll grant you that the process is often messy. There are often false starts and blind alleys, and physicians are all too often reluctant to change their practices in response to the latest scientific findings. We sometimes even joke that for some practices, it takes the supplanting of one generation of physicians with a new generation to get rid of some practices. But change does come when the science and evidence are there. Indeed, for example, in response to evidence that a bacterium, H. pylori, causes duodenal ulcers, medical practice changed in a mere decade, which is about as fast as anyone could do the science and clinical trials to show the validity of the new concept. Although CAM practitioners like to hold up the example of Barry Marshall and Robin Warren, the researchers who discovered that H. pylori causes most duodenal ulcers, as an example of how researchers with radical ideas are ostracized, but that story is largely a myth, as our very own Kim Atwood showed.

The application of science to medicine is a difficult thing. It takes basic scientists and clinicians, but the two of them exist in different worlds. Or so it often seems. That’s why some individuals seek to straddle both worlds. Tim is one such person. So am I. Unfortunately, most people don’t understand what we do very well. We wear two hats. In my case, I’m a surgeon, and I’m a scientist. In Tim’s case, he’s a scientist and a physician, but he doesn’t yet know what kind of physician he will end up being. At the risk of sounding somewhat arrogant, I believe that we, and others like us, represent an important element in bridging the gap between basic science and clinical science, in, essentially, building a more science-based medicine.
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Posted in: Basic Science, Clinical Trials, Medical Academia

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Medical training versus scientific training

This month I will begin my third year of medical school, after a three-year break for laboratory research. Living alternately in the worlds of med school and grad school has prompted me to reflect on differences between these training programs.

[Obvious disclaimer: I have studied at a single institution, and only for five years.]

I am enrolled in a dual-degree MD/PhD program. About 120 US medical schools have such programs, and the National Institutes of Health funds a third of them (MSTP). The schedule of such programs is generally: 2 years of medical school (culminating in USMLE Step 1), 3+ years of graduate school (culminating in dissertation and PhD), and then the last 2 years of medical school (which I begin this month). The most popular residency choices for MD/PhD graduates are internal medicine, pediatrics, and pathology (match data). Other residencies that attract these graduates include dermatology, neurology, ophthamology, and radiology (survey data). The hopes of those funding the MD/PhD training programs and of those accepting the graduates is that these individuals will become physician-scientists, bridging the divide between lab bench and patient bedside with insights from both. (more…)

Posted in: Medical Academia, Science and Medicine

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Cancer research: Going for the bunt versus swinging for the fences

A couple of weeks ago, our resident skeptical medical student Tim Kreider wrote an excellent article about an op-ed in NEWSWEEK by science correspondent Sharon Begley, in which he pointed out many misconceptions she had regarding basic science versus translational research, journal impact factors, and how journals actually determine what they will publish. Basically, her thesis rested on little more than a few anecdotes by scientists who didn’t get funded or published in journals with as high an impact factor as they thought they deserved, with no data, science, or statistics to tell us whether the scientists featured in her article were in fact representative of the general situation. Begley’s article caught flak from others, including Mike the Mad Biologist and our very own Steve Novella. Naturally, as the resident cancer surgeon and researcher, I had thought of weighing in, but other issues interested me more at the time.

In retrospect, I rather regret it, given that this issue crops up time and time again. In essence, it’s a variant of the lament that pops up in the press periodically, when science journalists look at survival rates for various cancers and ask why, after nearly 40 years, we haven’t yet won the war on cancer. Because of his youth, Tim probably hasn’t seen this issue crop up before, but, trust me, every couple of years or so it does. Begley’s article and the NYT article strike me as simply “Why are we losing the war on cancer?” 2009 edition.

Now the New York Times has given me an excuse both to revisit Begley’s article and discuss yesterday’s front page article in the NYT Grant System Leads Cancer Researchers to Play It Safe. Basically, they are variants of the same complaints I’ve heard time and time again. Now, don’t get me wrong. By no means am I saying that the current system that the NIH uses to determine which scientists get funded. Those who complain that the system is often too conservative have a point. The problem, all too often, however, is that the proposals for how to fix the problem are usually either never spelled out or rest on dubious assumptions about the nature of cancer research themselves.
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Posted in: Basic Science, Cancer, Medical Academia, Politics and Regulation

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An Original: Richard de Mille, Carlos Castaneda, Literary Quackery

An Original: Richard De Mille, Carlos Castaneda, and Literary Quackery

I was away in Nature – with a real capital N,  and decided to insert an allegory this week instead of a medical subject. The genesis here was a sweeping of the mind and brushing away of cobwebs and detritus called worries and other preoccupations.  The application to this here blog is – methodology. The experience is one of discovery, and of loss, and of bearing the burden of inaction.   

 

Some thirty or more years ago a family member became enamored of a new book, The Teachings of don Juan by an unknown author, Carlos Castaneda. But mention the name now and one gets one of two responses: Who is that?  Or, Oh, he is that literary fraud.  But in the late 1960s – 1970s, two social movements had captured imaginations of youth, academics, and much of the intellectual world. They made fantasy seem plausible, and fraud seem believable – psychedelics and postmodernism.

Advocates of psychedelics, most of whom experienced drug-induced alterations,  promoted revolutionary psychological ideas such as drug-induced multiple realities.  The other, postmodernism, was and is the intellectual and philosophical movement originating in academia that similarly views of reality(ies) as possibly multiple.  (The relation, if any, to alternate universes and relativity theories in physics I have to leave to philosophers.) But the ‘60s and ‘70s were decades of several revolutions in social and personal thought – paradigm changes – that brought fairy tales, delusions, and irrationality onto realms of plausibility, from which we are still reeling, and trying to deal with. 
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Posted in: Book & movie reviews, Faith Healing & Spirituality, Medical Academia

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Cranks, quacks, and peer review

Last week, I wrote one of my characteristically logorrheic meandering posts about what turns a scientist into a crank or a doctor into a quack. In a sort of continuation of this line of thinking, this week I’ll turn my attention to one of the other most common characteristics of a crank, be he scientific crank (i.e., a creationist), a quack, or historical crank (i.e., Holocaust deniers), specifically how he views the peer review system.

Not suprisingly, one of the favorite targets of pseudoscientists is, in fact, the peer review system. Indeed, it’s a very safe thing to say that, almost without exception, cranks really, really, really don’t like the peer review system for scientific journals and grant review. After all, it’s the system through which scientists submit their manuscripts describing their scientific findings or their grant proposals to their peers, and their peers make a judgment whether manuscripts are scientifically meritorious enough to be published and grant applications scientifically compelling enough to be funded. Creationists hate peer review. HIV/AIDS denialists hate it. Anti-vaccine cranks like those at Age of Autism hate it. Indeed, as a friend of mine, Mark Hoofnagle pointed out a couple of years ago, pseudoscientists and cranks of all stripes hate it. There’s a reason for that, of course, namely that vigorous peer review is a major part of science that keeps pseudoscientists from attaining the respectability that science possesses and that they crave so.
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Posted in: Medical Academia, Politics and Regulation, Science and Medicine

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“Acupuncture Anesthesia”: a Proclamation from Chairman Mao (Part III)

A Digression: The Politics of Chinese Medicine in the People’s Republic of China (The Early Years)

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A Partial Book Review: Chinese Medicine in Early Communist China, 1945-63: a Medicine of Revolution, by Kim Taylor

Mao’s was a complex personality. He was by nature a control freak, highly secretive, quickly suspicious, ruthless in revenge. These were all personal characteristics that were to determine the flow of politics in early Communist China. (Taylor, p. 4)

We have already seen that attempts to create ‘acupuncture anesthesia’ began in the People’s Republic of China (PRC) in 1958. As suggested by the title of this series, this resulted from neither rigorous research nor the serendipity that occasionally heralds important discoveries. Rather, the apparent prominence of acupuncture in health care in the PRC was a matter of governmental fiat. Even before the Communist victory in 1949, it was clear to Chairman Mao Zedong that there were not enough ‘Western’ trained physicians to handle the massive health problems of the country, which included an infant mortality rate of 1 in 5, an overall death rate of 30 per 1000 per year, and widespread disability. Most of this was due to malnutrition and infectious diseases, including many that sound exotic and ominous to the modern ear:

…schistosomiasis, filariasis, ancyclostomiasis, Kala-azar, encephalitis, plague, malaria, smallpox and venereal disease…measles, dysentery, typhoid, diphtheria, trachoma, tuberculosis, leprosy, goitre, Kaschin-Beck’s disease…(Taylor, p. 103)

Pre-scientific Chinese medicine, acupuncture in particular, was identified by Mao and other Communist leaders as worthy of cultivating:

Our nation’s health work teams are large. They have to concern themselves with over five hundred million people [including the] young, old, and ill. This is a huge enterprise, and one that is extremely important. Thus our responsibility weighs heavily…At present, doctors of Western medicine are few [10,000-20,000], and [thus] the broad masses of the people, and in particular the peasants, rely on Chinese medicine to treat illness. Therefore, we must strive for the complete unification of Chinese medicine. –Mao Zedong, 1950, quoted in Taylor (p. 33)

Taylor writes that there may have been 500,000 doctors of ‘Chinese Medicine’ at the time. It is tempting to conclude that Mao’s call for the ‘unification of Chinese medicine’ was a cynical way to make it appear that the Chinese Communist Party (CCP) could provide adequate health care in a much shorter time than would be required to train sufficient numbers of modern physicians and to build and equip modern facilities. This is undoubtedly true, but Taylor argues that there were additional considerations:

…Mao evidently saw the profession of Chinese medicine not so much as a therapeutic practice, but more as a large, and therefore significant, body of people. Mao’s support of Chinese medicine during this time can be linked to a concern for adequate health care manpower, and by extrapolation, to a concern for social stability. If the Chinese medical practitioners were ignored and not forcibly, as it were, integrated into the new Communist society, and if their medicine was not encouraged, it would mean hundreds of thousands of people would be without a livelihood. Including their dependents, this would mean that there would be hundreds of thousands of people without any means of support. It is likely that Mao interpreted the more serious problem to be one of economics, and the importance of keeping people usefully employed within society, rather than the dangers of supporting a potentially ineffective medicine. (Taylor, p. 35)

Mao also wrote:

Although we should have an all-round and correct understanding of Chinese medicine, Chinese medicine also has to transform itself. We must accept this slice of our old heritage critically. To look down upon Chinese medicine is not correct. To claim that everything about Chinese medicine is good, or too good, this is also not correct. Chinese and Western medicines must unite. (Mao Zedung, 1954, quoted in Taylor, p. 35)

Thus there was, according to Taylor, to be a ‘scientification’ of Chinese medicine. This did not mean ‘scientific’ in the familiar sense:

In Mao’s definition of this ‘new democratic culture’, he was to use three words which were to describe its development. These were ‘new’ (xin), ‘science’ (kexue), and ‘unity’ (tuanjie). The term ‘new’ implied free from superstition and the heavy links to a feudal past. Instead the components of the new culture would have to be forward moving and enterprising. Mao advocated that such a change would be possible through the use of ‘science’. By ‘science’ Mao was not so much referring to the science linked with the Western investigation of nature, but more to the Marxist ideal of science as the criteria for true knowledge. For Mao stated that ‘this type of new democratic culture is scientific. It is opposed to all feudal and superstitious ideas; it stands for seeking truth from facts, it stands for objective truth and for unity between theory and practice’. ‘Unity’ was the third criterion in the building up of a new China. Everybody had to join together and fight for the same cause, and this included all classes of Chinese society, from the upper bourgeoisie to the peasantry, so long as their beliefs were not against those of the Party. It also implied a unity of knowledge, and this had particular implications for the revolutionary intellectual. (Taylor, pp. 15-16)

In other words, as Mao later asserted,

In the future there will be only one medicine; that is to say a [single] medicine guided by the laws of dialectical materialism, and not two [separate] medicines. (Quoted in Taylor, p. 35)

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