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.
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.
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.
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. (more…)
Blogger’s note: This blog, which is rough going in places, will be presented in either 2 or 3 parts (I won’t know which until next week). I’ll post a part each week until it is complete, but due to overwhelming popular demand I promise to maintain the every-other-week posting of the far more amusing Weekly Waluation of the Weasel Words of Woo/2.
On Feb. 25, 2008, the federal Office for Human Research Protections (OHRP) cited Columbia University Medical Center (CUMC) for violating Title 45, Part 46 of the Code of Federal Regulations: Protection of Human Subjects (45CFR§46). The violations involved Columbia’s administration of the NIH-sponsored trial of the bizarre “Gonzalez Regimen” for treating cancer of the pancreas.† The OHRP’s determination letter to Steven Shea, MD, the Director of the Division of General Medicine and Senior Vice-Dean at CUMC, cited ethical problems of a serious kind:
We determine that the informed consent for the 40 of 62 subjects referenced by CUMC was not documented prior to the start of research activities, nor was the requirement for documentation waived by the CUMC IRB for subjects in this study.
It was the second time that the OHRP had cited Columbia for its dubious management of the “Gonzalez” trial. The first occurred in Dec. 2002, after investigators had determined that the trial’s consent form “did not list the risk of death from coffee enemas.” The OHRP listed several other violations at that time, but “redacted” them from the letter that it made available to the public. (more…)
No doubt you’ve come across them before, either on the Internet, printed advertisements, or radio and TV ads: Alternative medicine cancer “testimonials.” They are the primary means by which “alternative” therapies for cancer (or just about any other disease) are promoted and the primary “evidence” that is used to “prove” the efficacy of non-evidence-based therapies. There’s no doubt that they sure can sound convincing. Typically, what you will see or hear is a chipper-looking and -sounding person who claims that this treatment “cured” his or her cancer. These testimonials almost always include many or all of these elements: First, the cancer patient receives the diagnosis, after which she is lost and suffering at the hands of “conventional” doctors, who either cannot or do not wish to understand and who cannot do anything for her. Often, this will take the form of the classic alt-med cliche that the patient was “sent home to die.” Then, when all hope seems lost, the patient discovers an alternative medicine “healer” or treatment. It is not infrequently described in quasireligious terms, like a revelation or something that brings the patient out of the darkness and into the light. Naturally, there is resistance from the patient’s doctors, family, and/or friends, who warn against it, with doctors warning of dire consequences if the patient abandons conventional medicine. But the patient, convinced by dubious practitioners, friends, and, of course, previous testimonials, “sees” that the treatment “works” in a way that medical science cannot and survives. Infused with fervor, the patient now wants to spread the word. Often, the patient is now selling the remedy. Perhaps you’ve seen such testimonials or heard them on the radio and thought: “Gee, this sounds great. I wonder if it works.”
The answer is: Almost certainly not.