I write a lot of critical articles. It’s nice to be able to write a positive one for a change. I received a prepublication proof of The Mayo Clinic Book of Home Remedies: What to Do for the Most Common Health Problems. It is due to be released on October 26 and can be pre-ordered from Amazon.com. Since “quackademic” medicine is infiltrating our best institutions and organizations, I wasn’t sure I could trust even the prestigious Mayo Clinic. I was expecting some questionable recommendations for complementary & alternative medicine (CAM) treatments, but I found nothing in the book that I could seriously object to.
In two weeks, yours truly will be participating in the 2010 Lorne Trottier Public Science Symposium at McGill University in Montreal. This year, the theme is Confronting Pseudoscience: A Call to Action. I’ll be speaking with Ben Goldacre and Michael Shermer on Monday, October 18 from 5 to 7 PM on the Threat of Pseudoscience. On Tuesday, October 19, the ever-amazing Randi will speak on investigating paranormal claims. Unfortunately, the organizers couldn’t get Randi on the same stage with us because he couldn’t make it to Montreal from TAM London in time for Monday night; so this is the next best thing. Randi deserves the stage to himself anyway.
Obviously, I can’t wait, although I must admit that I’m rather nervous. To share the stage with Michael Shermer and Ben Goldacre and to get to hang out with them plus Randi, well, that’s more than I could have hoped for or imagined. It leaves me feeling like Wayne in this clip, with Shermer, Goldacre, and Randi as Alice Cooper (very appropriate, given Randi’s history of having done the effects for Alice Cooper’s stage show back in the 1970s):
So, if you happen to be in the Montreal area or can get there on October 18 and/or 19, come on over to McGill. It’ll be a rousing good skeptical time. I don’t yet know what Ben Goldacre and Michael Shermer will be discussing, but I’ll be speaking about cancer quackery (although I probably won’t be able to resist a brief commentary on quackademic medicine). I’ll also be on Dr. Joe’s radio show on CJAD 1010.
Several of the bloggers here at SBM have repeatedly criticized various clinical trials for so-called “complementary and alternative medicine” interventions for various conditions and diseases (or should I say dis-eases?) for being completely unethical. Examples include the misbegotten clinical trial for the Gonzalez protocol for pancreatic cancer, which — surprise, surprise! — ended up showing that patients undergoing Dr. Gonzalez’s combination of 150 supplements a day, dietary manipulations, and coffee enemas, actually did much worse than those undergoing standard of care, despite how depressingly poor the results of standard of care are; clinical trials of homeopathy in Honduras and other Third World countries, which both Wally Sampson and I lambasted; and ongoing clinical trial of chelation therapy for cardiovascular disease. I’ve also criticized the “autism biomed” movement, that amalgamation of parents who believe that vaccines cause autism and yet are willing to subject their children to all sorts of quackery to “cure” the “vaccine injury” of uncontrolled and unethical experimentation on autistic children. As valid as all these criticisms are, it is important to recognize that science-based medicine is not free of its own abuse of ethics.
A couple of weeks ago, I wrote about the concept of clinical equipoise. Clinical equipoise is a critical concept in any clinical trial. Basically, a state of clinical equipoise exists when there is genuine scientific uncertainty over which of the options being tested in/on living, breathing human beings is better, and any clinical trial in which a state of clinical equipoise does not exist is at the very least ethically dodgy and probably downright unethical. For example, when the occasional anti-vaccine activist argues for a randomized controlled clinical trial comparing vaccinated children and unvaccinated children, it’s easy to shoot that idea down as unethical because there is no clinical equipoise. The children receiving placebo vaccines would be put at a much higher risk of suffering harm compared to the vaccinated children because they would be left unprotected against life-threatening diseases. In the realm of conventional medicine, the reason that few cancer clinical trials involve a placebo control group anymore but instead test a new therapy either against the standard of care or with the standard of care is because in many, if not nearly all, cases placebo use in a cancer patient is unethical when there exists effective therapy, even if the therapy is not all that effective. What all this boils down to is that science is only part of the basis of science-based medicine. Medical ethics must take precedence. After all, arguably the most efficacious way to test a new antibiotic would be to infect people with the bacteria the antibiotic treats and then divide these people up into a placebo control group and a group receiving the antibiotics to see how each group does. After all, this is the sort of thing that the Nazis and Japanese did during World War II, and the same sort of dehumanization and abuse of research subjects that every ethical precept regarding human subjects research that has been developed since then, such as the Helsinki Declaration of 1964, has been designed to prevent.
Unfortunately, medical scientists in the U.S. have not always lived up to these precepts. The most famous example is arguably the Tuskegee syphilis experiment, in which poor black men with syphilis were studied and the control group denied effective therapy for syphilis even after it was known that penicillin was an effective treatment for syphilis. This study spanned 40 years, from 1932 to 1972, and is justifiably held up as one of the worst examples of research misconduct in American history, if not the history of the world. The shock the revelation of this study to the American public in 1972, when it learned of men dying of syphilis, women contracting syphilis, and babies being born with congenital syphilis, all unnecessarily, led to Belmont Report and the establishment of the Office for Human Research Protections (OHRP).
It turns out that there was an even worse atrocity against medical science perpetrated by U.S. investigators in Guatemala over 60 years ago that only now has come to light in stories in the New York Times, MSNBC, and elsewhere. So bad was the offense that Secretary of State Hillary Clinton and Secretary of Health and Human Services Kathleen Sebelius have issued a formal apology to the Guatemalan government for the experiments in which Guatemalan prisoners were intentionally infected with syphilis and then treated with antibiotics, an apology that President Obama reiterated in a personal telephone call to Guatemalan President Alvaro Colom on Friday.
…can be found here, at the Cancer Research Blog Carnival.
A 1997 publication by the Foundation for Chiropractic Education and Research, supporting the vertebral subluxation theory, noted that “…we [chiropractors] have successfully distanced the concept of a chiropractic subluxation from that of an orthopedic subluxation.”1 When discussing “subluxations” or misaligned vertebrae, however, chiropractors often fail to point out the difference between an orthopedic subluxation and a chiropractic subluxation. Reference to subluxations in medical literature is often presented as support for the practice of chiropractic as a method of adjusting vertebral subluxations to “restore and maintain health.”
In the eyes of the public, the chiropractic vertebral subluxation theory has confused the definition of the word “subluxation,” a common medical term. Unlike the mysterious, undetectable and asymptomatic chiropractic “vertebral subluxation complex” alleged to be a cause of disease, a real vertebral subluxation, that is, an orthopedic subluxation, can be a cause of mechanical and neuromusculoskeletal symptoms but has never been associated with organic disease.
Subluxations: Real and imaginary
An orthopedic subluxation, recognized and named as such since the days of Hippocrates, is a painful partial dislocation. Simple misalignment of a vertebra, also referred to as a “subluxation,” is commonly caused by disc degeneration, curvatures, spondylolysis, and structural abnormalities. Such a subluxation may or may not be mechanically symptomatic and can be seen on a plain x-ray image. In the absence of pathology such as disc herniation or osteophyte formation, these common vertebral subluxations or misalignments rarely affect spinal nerves and have never been associated with organic disease. Spinal nerves supply musculoskeletal structures. The body’s organs are supplied primarily by autonomic nerve ganglia and plexuses located outside the spinal column and by cranial and sacral nerves that pass through solid bony openings, providing overlapping nerve supply independent of any one spinal nerve that passes between two vertebrae.
An orthopedic subluxation, a true vertebral misalignment, or a mechanical joint dysfunction that affects mobility in the spine is not the same as a “chiropractic subluxation” that is alleged to cause disease by interfering with nerve supply to organs. Such a subluxation has never been proven to exist. There is no plausible theory and no credible evidence to support the contention that “nerve interference” originating in a single spinal segment can cause an organic disease.
Chelation is the provision of a substance to increase the body’s excretion of heavy metals. In poisoning situations (lead, aluminum, iron, etc.), chelation is medically necessary, objectively effective, and approved for use. But the same term has a completely different meaning in the alternative medicine universe, where proponents often believe heavy metal toxicity is the “one true cause” of disease, and chelation can undo microvascular inflammation, atherosclerosis, and even aging itself. From early days as an unproven treatment of coronary artery disease, its use has expanded to include autism, Alzheimer’s disease, cancer, and dozens of other diseases. Today, chelation is widely available. Regrettably, my own profession, pharmacy, facilitates this pseudoscience by manufacturing and selling chelation products.
Provoked urine tests are a common entry point to chelation therapy. Patients are given a product to provoke heavy metal excretion. The urine is tested and the patient is informed that they’re “toxic” and require chelation. Unfortunately, these results are meaningless and provide no evidence that chelation is medically necessary. But that’s the justification used for advocating a treatment regimen that will be useless at best and fatal at worst. A recent Medical Letter review concluded:
Medical Letter consultants believe that the use of chelation therapy in non-standard protocols for unsubstantiated indications should be discouraged. The results of provoked urine testing are not an acceptable basis for such treatment.
Providing chelation to patients isn’t a straightforward matter. It’s typically an intravenous infusion (though there are some oral products). Unless you’re part of the dubious TACT trial, which has administration centres across the United States and Canada, there are few products commercially available. For example, edetate calcium disodium (EDTA) is approved for sale in the United States but not Canada. Edetate disodium (also called EDTA) is not approved for sale in either country. But these products are widely available: they’re manufactured by pharmacists in pharmacies.
Over the last decade there has been a needed discussion about the relationship between politics and science. This has mostly been spawned by the perceived “Republican War on Science,” at the center of which is the global warming debate. In reality, both ends of the political spectrum (as evidenced, for example, by the Huffington Post) tend to trump science with ideology. That is the nature of politics. But at least the issue has been raised.
Briefly, defenders of science have pointed out that science should inform politics, not the other way around. Ideologues should not be allowed to put their thumb on the scale of science in order to get the result their ideology demands. Further, the optimal policy emerges from an honest assessment of the relevant science. Values still come into play for many issues, so science alone is not enough, but the science has to be right.
Within medicine this issue often involves the regulation of the standard of care and public health policy. An example of the former is the law passed last year is Connecticut that essentially exempts professionals who treat “chronic Lyme disease” from the standard of care – the department of health cannot act against their license for treating this controversial condition with unproven therapies.Rather than allowing experts to determine the standard of care, which is an ever moving target, this law locks into place a very controversial, and in my opinion dubious, practice.
I first became aware of chiropractor Eric Pearl through the reprehensible movie The Living Matrix. Several months ago I reviewed that movie and described its segment featuring Pearl as follows:
A 5 year old with cerebral palsy was allegedly healed by “reconnective healing” by a chiropractor who is shown waving his hands a few inches away from the child’s body. Problem: There was no medical evaluation before and after to determine whether anything had objectively changed, and video of the child after treatment shows that his gait is not normal.
I have since learned that Pearl is far more than an eccentric oddball. He is a whole industry. He is teaching his “reconnective healing” methods to others worldwide through seminars in several languages, he engages in aggressive marketing, he offers practice-building advice to his many disciples, and he even foists his beliefs on groups of impressionable young children. I use the word disciples intentionally because there are strong religious overtones to this healing method.
What is Reconnective Healing?
“The Reconnection” is similar to therapeutic touch, but goes much farther. He does not need to physically touch patients because they can feel his touch without any contact. They close their eyes and he moves his hands around their bodies but several inches away. They feel a presence, see colors unknown on Earth, and often see angels (one particular angel is George, a multicolored parrot). Afterwards, they report miraculous healings of “cancers, AIDS-related diseases, epilepsy, chronic fatigue syndrome, multiple sclerosis, rheumatoid and osteoarthritis, birth disfigurements, cerebral palsy and other serious afflictions.” (more…)
PRELUDE: THE PROBLEM WITH SCREENING
If there’s one aspect of science-based medicine (SBM) that makes it hard, particularly for practitioners, it’s SBM’s continual requirement that we adjust what we do based on new information from science and clinical trials. It’s not easy for patients, either. To lay people, SBM’s greatest strength, its continual improvement and evolution as new evidence becomes available, can appear to be inconsistency, and that seeming inconsistency is all too often an opening for quackery. Even when there isn’t an opening for quackery, it can cause a lot of confusion; some physicians are often resistant to changing their practice. It’s not for nothing that there’s an old joke in medical circles that no outdated medical practice completely dies until a new generation of physicians comes up through the ranks and the older physicians who believe in the practice either retire or die. There’s some truth in that. As I’ve said before, SBM is messy. In particular, the process of applying new science as the data become available to a problem that’s already as complicated as screening asymptomatic people for a disease in order to intervene earlier and, hopefully, save lives can be fraught with confusion and difficulties.
Certainly one of the most contentious issues in medicine over the last few years has been the issue of screening for various cancers. The main cancers that we most commonly subject populations to routine mass screening for include prostate, colon, cervical, and breast cancer. Because I’m a breast cancer surgeon, I most frequently have to deal with breast cancer screening, which means, in essence, screening with mammography. The reason is that mammography is inexpensive, well-tested, and, in general, very effective.
Or so we thought. Last week, yet another piece of evidence to muddle the picture was published in the New England Journal of Medicine (NEJM) and hit the news media in outlets such as the New York Times (Mammograms’ Value in Cancer Fight at Issue).
The bar on this blog is set high. The entries are often complete, with no turn left unstoned. Yet, not every topic needs the full monty with every post. The blog has extensive evaluations on many topics, and new medical literature doesn’t require another complete analysis. Many new articles add incrementally to the literature and their conclusions need to be inserted into the conversation of this blog, like a car sliding into heavy traffic. My eldest son just received his driver’s license, and car metaphors are on my mind. As are crash metaphors and insurance metaphors.
So in response to this need, a need only recognized by me, I give you Short Attention Span SCAM. Occasionally I will summarize a few recent studies and their key points as they relate to prior posts at SBM.