On 10/08/09, the NIH and Science through press releases announced the following remarkable information: Consortium of Researchers Discover Retroviral Link to Chronic Fatigue Syndrome (CFS.) From Science on line:
Scientists have discovered a potential retroviral link to chronic fatigue syndrome, known as CFS, a debilitating disease that affects millions of people in the United States. Researchers from the Whittemore Peterson Institute (WPI), located at the University of Nevada, Reno, the National Cancer Institute (NCI), part of the National Institutes of Health, and the Cleveland Clinic, report this finding online Oct. 8, 2009, issue of Science.
“We now have evidence that a retrovirus named XMRV is frequently present in the blood of patients with CFS. This discovery could be a major step in the discovery of vital treatment options for millions of patients,” said Judy Mikovits, Ph.D., director of research for WPI and leader of the team that discovered this association. Researchers cautioned however, that this finding shows there is an association between XMRV and CFS but does not prove that XMRV causes CFS.
I will write occasional posts instead of being on a regular schedule. The reasons: There are more contributors than positions. Newer people to the field have more ambition and belly fire. I have a number of projects and papers to finish in increasingly limited time and decreasing efficiency. So have at it. Meanwhile, some non-random thoughts.
I am as concerned with social and political expression of pseudoscience as with its errors. Health care reformers can be just as pseudoscientific as sectarians who want to restructure the scientific edifice. Political ideologues want to centralize the medical system without solid evidence that their substitute would work, let alone work better. Sectarians already see a national government system as an opportunity for expansionism. Mark Hyman, the Functional Medicine promoter, met with the White House staff, displaying his vision of medicine under a federal plan. Word is out that other sects have also had input. Many hold suspicions that the proposals front for more ambitious formulations. I am suspicious of their confidence – that they can fix a complex, fluxing system using epidemiology, mathematical models, treatment paradigms, and top-down control. I might accept some proposals if it were not that all constructed systems are intrinsically inefficient, political, and corruptible. The closer the agents of control are to the controlled, the more control the controlled have over the controllers – if you can follow that.
When I started this series on Functional Medicine, David Gorski suggested looking at Mark Hyman’s web page, which I had seen months before, but thought did not reveal much. That was a wrong. It shows a lot, and I suggest bloggers et al review it.
So I decided on a fourth “functional medicine” (FM) installment, in search of what it FM really is. On the Mark Hyman web page and in his Public TV monolog fund-raiser, Hyman follows a seven point outline of what he believes Fuctional Medicine (“FM”) is. If one follows the 7 “keys” as he writes, optimum health, “ultra-wellness” happens. Here are the points:
- Environmental inputs
- Gut & digestive health
- Energy/Mitochondria/Oxidative Stress
- Mind body
Let’s look at one example.
A unknown number of Functional Medicine adherents broadcast call-in programs on radio stations. One FM physician, a Dr. “D” in Northern California graduated from UC Davis School of Medicine (Central California’s Sacramento Valley.) I find her program fascinating, requiring some attentive listening.
Dr. D’s recommendations for people’s complaints and conditions are often complex, a chimera of standard explanations and therapies, but painted with a variety of views that are anything but standard. The problem I found was that some of each answer was rational – especially the logic of her differential diagnosis – but suddenly spun out into space with unfamiliar methods or some recognizable as one component or another of sectarianism. Some answers had no relationship to the problem at hand, but seemed to be plucked out of a firmament of independent ideas, theories, ideologies, and personal anecdotes – a medical Separate Reality.
One can be carried along by an answer that sounds on surface reasonable because of the confidence and the delivery’s vocal tone. Her voice is medium-low, sort of a mezzo or contralto. It’s a voice ideal for advice; confidence oozes. Some of her separate reality recommendations she precedes with a biochemical or physiological explanation, so the shifting from standard to “separate reality” grids goes so smoothly, the usual recognizable red flags may not spring up.
In searching for just what FM is, one has to in a way read between lines. Claiming to treat the “underlying cause” of a condition raises the usual straw man argument that modern medicine does not, which of course is untrue. It also implies that there are underlying causes known to them and not to straights. FM claims to treat chronic disease which FM claims is inadequately treated by medicine. FM claims to be a more advanced approach both in conceptual thinking and in practical management. Such claims are on the face doubtful, but hard to disprove. The way to find out would be to analyze cases they manage and critique them.
I tried to see specific examples of treatments but the web page text book links were not working at the time. I understand others have seen the contents and perhaps can add some information. I sense a difference between “CAM” and FM – at least among the MDs and DOs - is that FMers tend to use methods and substances with some degree of scientific or biochemical rationale, even if not proved, moreso than many of the CAMers. Many seem to practice both systems or do not distinguish between the two systems. In order to get a sense of the degree to which FM is known, I requested from the web page the names of practitioners in a 50 mile radius of my home (near Palo Alto, Calif.). The names ranged from Santa Cruz (40 miles) to Berkeley (50) and San Francosco (40) and Marin County (Sausalito – 50 miles) The population of that area is about 5 million. They sent 46 names: MD/DO 31 – (including a nephrologist formerly on the staff of my teaching hospital) PhD 1 DC 8 Lac 3 ND 2 RN 1 Because I had become aware of FM only 1-2 years ago, I thought 46 was a relatively large number. The Web page lists four text books published in the past few years. A manuscript of the first one is available on line for downloading (not functioning when I tried.) . 21st Century Medicine: A New Model for Medical Education and PracticeMonograph Set – Functional Medicine Clinical Monograph Set – CME Available Textbook of Functional Medicine Clinical Nutrition: A Functional ApproachAs mentioned, I could not activate the links to those books, and did not have time to get to them individually. No authors were listed.
Functional Medicine – What is it?
After extensive searching and examination, my answer is still – only the originators of “FM” know. Or, at least one must assume they know, because so far as I can see, I certainly see nothing that distinguishes “FM” from other descriptions of sectarian and “complementary/Alternative Medicine/” practices. A difference may lie in the advocates’ assumptions to have found some “imbalance” of body chemistry or physiology before applying one or more unproved methods or substances. From what I could determine, the “imbalance” or dysfunction is usually either imaginary or at least presumptive. And the general principles are so poorly defined as to allow practioners vast leeway to apply a host of unproven methods.
I figured there would be several ways to find out. One would be to read FM’s material – mainly what “they” placed on the Internet. Another would be to enter the system and find out as a patient or as a prospective practitioner what it is that “FM” claims to be. The third would be to listen to a practitioner or advocate on tape, disk, radio, etc.
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.
POLITICS. We have a tacit understanding to exclude politics from the blog, but current events are pushing the borders. It’s not our fault, other forces are on the move. At the border last year was the Iraqi civilian body count issue precipitated by articles in The Lancet. That’s when politics intrudes into medical research and literature.
Other borders are matters of licensure, and of permitted and rejected methods and materials, encoded into licensure, food and drug laws, and a myriad of administrative edicts and court decisions. One can’t escape the politics of those, especially when Congress and states start to control as commercial entities, areas that historically belong in culture: professional behavior codes, codes of traditional relationships between physicians and patients, for instance. These are under further pressures of conformity and legal sanctions enforced by the power of central government.
Steve Salerno (web site: www.journalismpro.com, blog: www.shamblog.com), author of the WSJ article on “CAM” and the NCCAM last December that precipitated the Chopra, and Co. responses, brought to attention a recent House hearing at which Congr. Riley (D, Ohio) queried Sec. Sibelius whether she was aware of “mindful meditation” as a cost-saving method that should be included in any federal health plan.
Here we go again. Ten to 15 years ago it was Sen. Harkin legislating research and practice from halls of Congress resulting in the Office of Alternative Medicine and NCCAM. That legislation resulted in financed medical school courses, multiple more lectures and demonstrations, and now med school divisions with endowed chairs, scores to hundreds of employed associates, and with little to no scientific feedback or oversight.
In the three prior posts of this series I tried to analyze some of the defects in the randomized clinical rials (RCTs) of homeopathic remedies for childhood diarrhea. The first entry showed that the first two RCTs’ (done in Nicaragua) methods could not produce a meaningful result because of the way the RCTs were set up (methods.) The second entry showed that the results obtained in the first two trials were meaningless clinically even if assumed to have resulted from more legitimate methods. The same applied to the third trial in Nepal, analyzed in the third entry.
This entry will suggest that the authors’ fourth paper (Jacobs J, Jonas WB, Jimenez-Perez M, Crothers D. Homeopathy for childhood diarrhea: combined results and metaanalysis from three randomized, controlled clinical trials. Pediat Inf Dis J, 2005;22:229-234.)- a meta-analysis (MA) of the data from the three RCTs resulted in conclusions equally as meaningless as those of the three trials.
The MA authors – several of the same workers from the three RCTs – begin by agreeing that the data from the RCTs, taken individually, were of borderline significance:
In our previous three studies, we evaluated the use of individualized homeopathic treatment of childhood diarrhea … The results of the two larger studies (n = 81, n = 116) were just at or near level of statistical significance. Because all three studies followed the same basic study design , […] we analyzed the combined data from these three studies to obtain greater statistical power. In addition we conducted a meta-analysis of effect-size difference […] to look for consistency of effects.
MAs and systematic reviews (SRs) are the two consensus methods for summarizing data from multiple individual studies. The inclusion and search methods of RCTs for SRs and MAs are similar, but the objectives of the two are a bit different, as are the forms of the reports. In SRs, the results are summarized in more in narrative form, whereas in MAs the data are treated mathematically and the results are defined in statistical terms. Thus authors of SRs are freer to speculate on the degree of confidence that a method is effective based on what is shown by the numbers of positive and negative RCTs collected. Authors of MAs usually limit their comments to what the mathematical formulation of the summarized data show.
The previous post of this series analyzed the results of the 1994 Pediatrics paper purporting to show a statistically significant effect of homeopathic preparations on acute childhood diarrhea in a population in Nicaragua. That clinical trial followed a pilot study that also had shown a small but statistically significant effect of homeopathic remedies.
A moment here for explanation as to why I am going through these old studies. Reports like the four or five in this series made headlines. They are also so well cloaked in manipulated data and overdrawn conclusions that press and even academicians accept their conclusions – and even overdraw more. This is still going on.
Over the past thirty years some of us informally and gradually developed semi-systematic ways of analyzing these increasingly scientific-appearing claims of sectarians (sCAMmers.) Errors, inconsistencies and falsifications we recognize now were not so obvious decades ago. SCAMmers developed imaginatively new methods as their fields progressed. We in the science-based or knowledge based medicine field have been trailing along, detecting their tricks and twists as they developed, and like street sweepers behind horses, picking up their excrement (metaphor to force attention.) Yesterday’s lucid post on the latest acupuncture study by Steve Novella exemplifies this expertise (no offense intended.)