Part IV of this blog ended by observing that the NIH-funded trial of the “Gonzalez regimen” for cancer of the pancreas,† to have begun in March, 1999, was in trouble almost as soon as it started. As originally designed, it was to have been a randomized, controlled trial comparing gemcitabine, the standard chemotherapy, to the “Gonzalez regimen” of pancreatic enzymes, “supplements,” twice-daily coffee enemas, and other purported methods of “detoxification.” By June, 1999, according to Dr. John Chabot, the Columbia University surgeon acting as Principal Investigator (PI) of the trial, only 3 of the first 50 potential subjects had agreed to be randomized, and none of the three met the eligibility criteria. By January, 2000 it had become clear that the trial would not accrue a sufficient number of subjects if it remained randomized, because almost all of the potential subjects were intent on being in the “nutritional,” ie, the Gonzalez arm.
Trouble with Randomizing
The investigators at Columbia therefore decided to change the protocol to a “single-armed, non-randomized case-cohort study where patients will only be enrolled in what was the nutritional arm.” Paradoxically, PI John Chabot had recently explained, at the 1999 Comprehensive Cancer Care Conference of James Gordon’s Center for Mind-Body Medicine, why this would not be a scientifically sound design:
The cornerstone of science-based medicine is, of course, scientific research. The integrity and quality of biomedical research is therefore of critical importance and to be thoughtfully and jealously guarded, if we care about maintaining an optimal standard of care. There are many threats and hazards to the institutions of medical research – mostly ideological. One that has not been discussed much on this blog but has been in the news recently is that of conflict of interest. Upon close examination this is a more complex issue than it may at first appear.
The most recent controversy over conflicts of interest were sparked by an article published in JAMA in which the authors allege that published studies that downplayed the risks of Vioxx (A Cox-2 inhibitor marketed as a pain killer that was removed from the market for increased cardiac risk) were in fact ghost-written by employees of Merck, the manufacturer of Vioxx. The names of two academic researchers were then attached to the studies to give them legitimacy. If true this is a damning episode, and no one would reasonably disagree with the contention that companies writing research on their own products represents an unacceptable conflict of interest. For the record, both Merk and the one surviving academic deny the accusations completely.
Why aren’t there more women in science and medicine? Just because we lack certain anatomical dangly bits, does that mean we’re less capable? Apparently Harvard’s president Lawrence H. Summers thought so. In a classic case of foot-in-mouth disease, he suggested that innate differences between men and women might be one reason fewer women succeed in science and math careers. His comments (in 2005) predictably set off a media feeding frenzy. I won’t even attempt to get into that nature/nurture controversy. Whatever the statistical generalities, the fact is that individual women can and do succeed in those careers. What really matters is whether qualified women today have a fair opportunity to choose their profession and rise in it.
Something very interesting is happening in medicine. It’s happening slowly, quietly, and steadily, with no help from affirmative action programs.
At the beginning of the 20th century about 5 percent of the doctors in the United States were women. In 1970, it was still only 7 percent. By 1998, 23 percent of all doctors were women, and today, women make up more than 50 percent of the medical student population. In 1968 only 1.2% of practicing dentists were women. By 2003, 17% of dentists were women, and 35% of dentists in new active private practice were female. (more…)
Much to the relief of regular readers, I will now change topics from those of the last two weeks. Although fun and amusing (except to those who fall for them), continuing with such material for too long risks sending this blog too far in a direction that no one would want. So, instead, this week it’s time to get serious again.
A few weeks ago, I wrote about factors that lead to the premature adoption of surgical technologies and procedures or the “bandwagon” or “fad” effect among surgeons. By “premature,” I am referring to widespread adoption “in the trenches,” so to speak, of a procedure before good quality evidence from science and clinical trials show it to be superior in some way to previously used procedures, either in terms of efficacy, cost, time to recover, or other measurable parameters. As I pointed out before, laparoscopic cholecystectomy definitely fell into that category. The popularity of the procedure spread like wildfire in the early 1990s before there was any good quality data supporting its superiority to the “old-fashioned” gold standard procedure of open cholecystectomy. Another example, although not nearly as dramatic because the number of patients for whom the procedure would be appropriate is much smaller, is transanal endoscopic microsurgery. However, the difficulties in practicing science- and evidence-based medicine don’t just include fads and bandwagon effects. The example of laparoscopic cholecystectomy notwithstanding (which was largely driven by marketing and patient demand), surgical culture is deeply conservative in that it can be very reluctant to change practice even there is very strong evidence saying that they should.
That’s What I’m Talkin’ ’bout!
The new single-paragraph paradigm for the W^5/2 seems to have worked: there were 13 Waluations for the paragraph submitted in W^5/2 #3, every one of ‘em good. Several themes emerged; I’ll discuss them in no particular order.
- When did you stop beating your wife? The passage charges that the “biomedical model,” by which is apparently meant modern medicine, does not consider anything other than “disturbances in biochemical processes.” “Holistic medicine,” on the other hand, recognizes the Complex Interplay Between Multiple Factors. DVMKurmes, pmoran, and wertys each exposed the ahistoricity of this claim.
- Back to the Future. Speaking of ahistoricity (is that a word?), two readers, wertys and Falx, noticed a paradox: the proposed “paradigm shift” of “medicine today” always involves the resurrection of discredited, pre-scientific notions of yesterday.
- Dr. Feelgood. Several readers, including DVMKurmes, Michelle B, rjstan, wertys, Stu (m’man!), Calli Arcale, and overshoot, alluded to the preference of at least some Woo-Seekers for feeling good (“a healing model”) over being good (“the curative model”). I admit that my shorthand description of the point is oversimplified, but there is truth in it nonetheless. The “feelgood” phenomenon is not to be confused with the similarly named
- Feelings…Very Special Feelings. Alotta people just want, well, their feelings to be validated. Not that there’s anything wrong with that, but if it’s at the expense of competent medical care, as rjstan, Stu, and Falx noted, they could be Takin’ Trouble by the Tail. Or at least Losin’ a Lotta Lettuce.
- It Takes a Worried (wo)Man to Sing a Worried Song. Both rjstan and DBonez called attention to the current societal obsession with “health,” frequently called “wellness,” which is an indispensable part of the “CAM”-scam. As rjstan and pmoran pointed out, many of the obsessed have nothing wrong but a surplus of funds. Why don’t those people just getta life?
- By Hook and By Crook. Tools honed on Madison Avenue are in the kits of sCAMsters, say DVMKurmes, Michelle B, Stu, and ShawnMilo. That they are.
- Mastering the Art of Zen Cooking. A lotta “reduction” makes my eyes glaze, so I was pleased that at least one reader, overshoot, cited the passage for its tired misportrayal of the “scientific reductionist view.” One o’these weeks we’ll discuss that at some length.
- The Well-Hewn Tune of Thomas Kuhn is misrepresented by those we impugn, as asserted by wertys and implied by Joe. Another topic to discuss at more length some time.
- The Autobiography of Malcolm X…prophecies that…his…brother…Michael X…will…one day…rail…against…so-called…integrated…medicine.
This Week’s Entry:
A shaman is a type of spiritual healer distinguished by the practice of journeying to nonordinary reality to make contact with the world of spirits, to ask their direction in bringing healing back to people and the community. The journey is a controlled trance state that practitioners induce by using repetitive sound (drums, rattles) or movement (dancing) and occasionally by consuming plant substances (e.g., peyote or certain mushrooms). Characteristically experiential and cooperative, shamanic healing is found worldwide. It is fundamental to much traditional European, African, Asian, and Native American Indian folk practice and is rapidly gaining popularity among nonnative urban Americans, in which setting it is sometimes called neo-shamanism.
The Misleading Language and Weekly Waluation of the Weasel Words of Woo series:
- Lies, Damned Lies, and ‘Integrative Medicine’
- Integrative Medicine: “Patient-Centered Care” is the new Medical Paternalism
A Review; then Back to the Gonzalez Regimen†
Part I of this blog introduced the topic of the “Gonzalez regimen” for treating cancer: “Intensive Pancreatic Proteolytic Enzyme Therapy With Ancillary Nutritional Support” and “detoxification” with twice daily coffee enemas, daily “skin brushing,” “a complete liver flush and a clean sweep and purge on a rotating basis each month,” and more. The topic was occasioned by the federal Office for Human Research Protections having recently cited Columbia University, for the second time, for violations of human subject protections in its NIH-funded trial of Gonzalez’s method as a treatment for cancer of the pancreas.
Part I discussed the implausible and bizarre regimen and cited Gonzalez’s troubles with malpractice suits and with the New York medical board during the 1990s. It ended by wondering what could have induced the NIH to give a $1.5 million grant to Columbia University to study the method.
Parts II and III began to answer that question, tracing some of the key events and individuals from the Laetrile wars in the 1970s to the NCI-funded trial of Laetrile reported in 1982, to the ”immuno-augmentative therapy” (IAT) battles of the mid-’80s, to the Report on “Unconventional Cancer Treatments” by the Congressional Office of Technology Assessment (OTA) in 1990, which in turn led to the NCI adopting its “Best Case Series Program” in 1991.
The end of Part III hinted that the conspiracy mongering that had greeted every attempt by the government to explain its positions on implausible cancer treatments, from Laetrile to the OTA report, ultimately led to the creation of the Office of Alternative Medicine (OAM) at the NIH, also in 1991. There is plenty of evidence for that, both from the conspiracy mongers themselves and from more level-headed observers. Each time the government acted—to fund a trial of Laetrile, to solicit the OTA report and propose a study of IAT, to establish the NCI “Best Case Series” program, and to establish the OAM—it was not because of scientific or medical considerations, but because of political pressure. More on that from time to time, but now back to Dr. Gonzalez.
This is a slight departure from the usual fare of pseudoscience, but a matter that should concern us because of the vulnerability this matter confers on medicine – the borderline practices of major medical centers. The article can be viewed here.
Several days ago the San Francisco Chronicle printed a second article about the plight of a 37 year old woman (EP) with an inflammatory breast cancer who was denied insurance coverage for an expensive treatment, high-dose chemotherapy with autologous bone marrow (or stem cell) transplant or infusion (HDCT/BMT or SDI.) The institution is the MD Anderson Cancer Center in Houston. The problem is that although the treatment is effective, it is no moreso than moderate dose HDCT without the marrow or stem cell infusion, and also is more expensive and has significant morbidity.
Inflammatory breast cancer is a highly aggressive form that is usually regarded as “advanced” when diagnosed, that is, spread beyond the breast and regional lymph nodes. One cannot tell from the article whether EP’s cancer spread is documented or implied. But because of the poor prognosis and presumed incurability in either case, options are limited. In the 1980s -90s, HDCT/BMT was thought to be a promising method on the basis of studies that showed a prolonged disease-free and overall survival compared to results of prior studies using more conservative treatment. The problem then was that the studies were uncontrolled.
A new study sheds more light on the question of what is causing the recent increase in the rate of diagnosis of autism. Professor Dorothy Bishop from the University of Oxford studied adults who were diagnosed in 1980 with a developmental language disorder. She asked the question – if these people were subjected to current diagnostic criteria for autism, how many of them would be diagnosed today as having autism? She found that 25% of them would. (Bishop 2008)
This epidemiological question has been at the center of a controversy over whether or not there is a link between vaccines (or the mercury-based preservative, thimerosal, that was previously in routine childhood vaccines) and autism. The primary evidence for this claim put forward by proponents of a link is that the number of diagnoses of autism increased dramatically at the same time that the number of vaccines routinely given to children was increasing in the 1990′s. They are calling this rise in autism an “epidemic” and argue that such an increase requires an environmental factor, which they believe is linked to vaccines.
That the number of new autism diagnoses is dramatically increasing is generally accepted and not a point of debate. The historical rate of autism is about 4 per 10,000 and the more recent estimates are in the range of 15-20 per 10,000 (30-60 per 10,000 for all pervasive developmental disorders of which autism is one type). (Rutter 2005) The controversy is about what is causing this rise in diagnoses. There are two basic hypotheses: 1) That the true incidence of autism is rising due to an environmental cause, 2) That the rise in incidence is mostly or completely an artifact of increased surveillance and broadening of the definition of autism. These two hypotheses make specific predictions, and there is much evidence to bring to bear on their predictions – this recent study only being the latest.
Charlatan: America’s Most Dangerous Huckster, the Man Who Pursued Him, and the Age of Flimflam, by Pope Brock, is not only a rip-roaring good read, but it brings up serious issues about regulation of medical practice and prosecution of quackery. It tells the story of John R. Brinkley MD, who transplanted goat glands into people, and of Morris Fishbein MD, the editor of the Journal of the American Medical Association, who tried to stop him.
Brinkley was a colorful character whose very first job was a scam, selling a patent remedy. He went to medical school but never finished, eventually buying a diploma elsewhere for $100. A bigamist, drunkard, liar, and con man of incredible audacity, he built up an empire of quackery that made him filthy rich. Apart from his medical adventures, he practically invented modern political campaigning techniques, revolutionized advertising, and was almost single-handedly responsible for popularizing country music and the blues with his radio station.
An impotent patient supposedly told Brinkley, “Too bad I don’t have goat nuts.” So Brinkley gave him some. A few weeks later he went back for a refresher course in surgery (which he failed because of drunkenness and poor attendance). He began to feel that he was gifted and should not be bound by the “jealous sheep ethics” of the AMA. (more…)
I have to apologize for last week’s post. I’m not apologizing for the subject matter (the obsession that reigns supreme among some alt-med aficionados over “cleansing” their colons to “purge toxins” and achieve the super-regularity of several bowel movements a day). Rather, I’m sorry I probably didn’t emphasize quite strongly enough just how disgusting one of the links that I included was. Among all the glowing testimonials found there touting how lovers of that “clean feeling” inside felt after having supposedly rid themselves of all that nasty fecal matter caked on the walls of their colons and achieved the Nirvana of many bowel movements a day (or, as one happy customer put it, “awesome adventures in the bathroom” and another put it, “I have not noticed anything really weird come out of me yet, but I am sure that there will be”), there were also links to various pictures people took of their own poop, complete with graphic descriptions. A couple of years ago when I showed an acquaintance of mine the Dr. Natura website shortly after I had discovered it, he declared it the “grossest thing on the web.” Sadly, I had to assure him that it was not–not by a longshot. However, I will try spare you any links to anything significantly grosser, preferring instead to leave finding them as an exercise for interested readers.
After having apologized for perhaps grossing out some of our readers, who come to this site for science- and evidence-based discussions of various so-called “complementary and alternative medicine” therapies, not pictures of the various excretions of the human body proudly lined up by the humans who produced them, I thought about what might be a suitable followup this week to such a topic. There really is only one followup that’s appropriate to this stuff, believe it or not. The problem with which I wrestled is that it really is pretty much as disgusting as last week’s topic, if not more so. (You’ll soon see why.) So there I was, trapped on the horns of a dilemma. Hesitating only momentarily, though, as any good general surgeon would do (remember, before I specialized in breast cancer surgery I was a general surgeon, as prone to dive into big brown on the loose as any other general surgeon), I decided just to dive in to the topic as I would have in the old days dived into a particularly foul belly full of purulence, particularly since this week’s “CAM” modality of choice claims to be able to take away a big chunk of the “bread and butter” practice of general surgery by curing a common surgical disease without all that nasty cutting, even if these days it’s almost always done laparoscopically.
So, are you ready for liver flushes? Of course you are. Don’t you want a way to “remove gallstones without surgery“?
Of course you do.