The National Institute of Mental Health (NIMH) supports doing a study on the effects of oral chelation therapy in autism. The proposal is highly controversial, is drawing criticism from many scientists, but has popular support among parents who believe this type of therapy might help their children with autism. The proposal raises many questions about the ethics of biomedical research.
Chelation and Autism
Chelation therapy is a legitimate FDA approved treatment for heavy metal poisoning. The drugs used for chelation, such as disodium EDTA, bind to heavy metals so that they can be removed from the body. Chelation drugs can be given either orally or intravenously. The treatment is somewhat risky because it can also remove needed electrolytes, like calcium, from the body or causes shifts in the electrolytes that can cause arhythmias and changes in brain function. There are reported cases of cardiac arrest and death due to chelation.
Chelation therapy has a long history of quackery – not for its intended use but for other uses for which there is no evidence. The classic example of this is the use of chelation therapy to treat atherosclerosis to prevent heart disease. This claim persists despite the utter lack of evidence for efficacy and the fact that all proposed mechanisms have been shown to be flawed or false.
A really snazzy new invention allows doctors to see inside their patients’ hearts as never before: the CT angiogram. It produces gorgeous 3-D video images of the beating heart in action. It allows us to see the blood flow through the heart’s chambers and it shows any plaque in the coronary arteries. Cardiologists are understandably excited about this new tool. Too excited. Some of them are using it indiscriminately and are getting half their income from using it.
On June 29, 2008 the New York Times published an excellent article entitled “Weighing the Costs of a CT Scan’s Look Inside the Heart.” A commenter on this blog has quoted from that article to criticize scientific medicine, and it brings up some important points that deserve a closer look.
With any new technology, the important question is whether it really improves patient outcome or just increases the cost of healthcare. These scans are a huge improvement for visualizing the heart. But are they any better than older diagnostic methods at actually preventing heart attacks or prolonging life? We don’t know yet. Will they cause harm through over-diagnosis? We don’t know yet. Will they cause radiation-induced cancers? We think they might. What’s the risk/benefit ratio? We don’t know yet.
Oprah thinks she knows. She’s urging her viewers to get tested. But she may not be the best source of medical advice. (more…)
One of the more annoying duties I used to have several years ago at our cancer center was to “show the flag” at our various affiliates by attending their tumor boards. I say “annoying” not so much because the tumor boards themselves were onerous or even uninteresting but rather because traveling to them used to cut into my already limited time for research, given that these tumor boards were always scheduled on days on which I didn’t have to be in clinic or the operating room. In other words, they always took place on my research days.
One of our affiliates was a nearly an hour and a half drive away, and many of them were close to an hour away. When you add up travel time and the tumor board, that’s easily more than three hours eaten up, all too often right in the middle of the day. In actuality, though, several of the tumor boards themselves were quite good, one of which being the aforementioned one that required nearly a 90 minute drive to reach. (It helped that they served a really nice breakfast there, too, but they also have really stimulating discussion about various cancer cases.) One of the weird things about these tumor boards is that I was viewed as–and I quote–the “outside expert.” This was particularly disconcerting the first year I had the job. There I was, fresh out of fellowship, being looked up to as the “expert” by physicians, many of whom who may have been in practice for 10, 20, or even 30 years. Somehow I managed to muddle through without making too big a fool of myself. These days, years later, I almost even feel as though, for breast cancer at least, I am worthy of the appellation of “outside expert.” Experience does matter, I guess.
The “Science” and Ethics of “Natural Medicines” (and Nutrition) cont.
This is the continuation of a discussion concerning the explicit claim of “naturopathic physicians”* to being experts in the use of “natural medicines,” defined as “medicines of mineral, animal and botanical origin.” Last week’s post established that the cult has chosen to profit from the “retail selling of medications,” as evidenced by the relevant Position Paper of the American Association of Naturopathic Physicians (AANP) and by that organization’s having made a deal with a drug company to make profits for both itself and its members.
The Position Paper observes that such selling “could be construed as a conflict of interest on the part of the physician.” That is true, if embarrassingly understated: anyone representing himself as a physician, who both recommends and sells the same medications for a profit, has conflicting interests. The conflict undermines his claim to offering responsible advice regarding those medications, and as such is a breach of medical ethics.
The AANP’s deal with MotherNature.com was even worse: by promoting such peddling in a formal, institutional fashion, NDs and their national organization went beyond the already widespread problem of practitioners hawking drugs. It is unclear whether the deal still exists, by the way: MotherNature.com was a victim of the “dot com” bust of a few years ago. It has since been resurrected, but a quick perusal of its new website fails to reveal the old AANP relationship. Nevertheless, I have seen no evidence to suggest that the AANP has changed its view of that sort of deal.
Are NDs Truly “Learned Intermediaries” in the Use of “Natural Medicines?”
This entry discusses the other part of the claim of expertise: that, aside from their conflicting interests, NDs have real knowledge of “natural medicines.” It will become clear during the discussion that the purported naturopathic expertise in nutrition—another standard claim—is also under review. I will include or cite abundant evidence for my assertions, because I’ve found that a predictable response of representatives of the highest levels of “naturopathic medicine” is to flatly deny them. I apologize again for including excerpts from previously published material.
King Arthur: Now stand aside, worthy adversary.
Black Knight: ‘Tis but a scratch.
King Arthur: A scratch? Your arm’s off.
Black Knight: No it isn’t.
King Arthur: What’s that, then?
Black Knight: [after a pause] I’ve had worse.
King Arthur: You liar.
Black Knight: Come on ya pansy.King Arthur: [after Arthur's cut off both of the Black Knight's arms] Look, you stupid Bastard. You’ve got no arms left.
Black Knight: Yes I have.
King Arthur: Look!
Black Knight: It’s just a flesh wound.Monty Python and the Holy Grail
I am, I think, in a minority on this blog, in that I do not think there is a placebo effect. Period. None. Zip. Zero. Nada. Zilch.
For analysis purposes, I divide the lack of placebo effect into outcomes that do not occur with objective measurement and those that do not occur with subjective measurement.
Why the dichotomy? Those studies where there have been an active treatment, a placebo treatment and an observation group, have demonstrated no difference between observation and placebo (1). To summarize from the conclusion of the compelling NEJM review:
“We found little evidence in general that placebos had powerful clinical effects. Although placebos had no significant effects on objective or binary outcomes, they had possible small benefits in studies with continuous subjective outcomes and for the treatment of pain. Outside the setting of clinical trials, there is no justification for the use of placebos.”
Savvy consumers are familiar with the classic scam of the “bait and switch” – in practice if not the term itself. My wife and I ran across it when we were shopping for our first car. We needed a bargain and so we were attracted to the ads that promised a new Colt for only $9,000 (that’s the bait). Of course when we got to the dealership they were all out of Colts with the configuration advertised, but they had plenty of others that had different options that cost several thousand dollars more (that’s the switch).
It’s a basic and very successful form of deception, and so even though there are laws against such practices it is impossible to eliminate in all its various and more subtle forms. It even permeates scientific, political, and other intellectual endeavors – anytime a more palatable idea or claim is put forward to represent the less acceptable truth.
Science, however, requires transparent honesty to function properly, and therefore scientific practitioners must vigilantly guard against the cognitive bait and switch. Generic intellectual virtues incorporate this vigilance – they include the need to unambiguously define terms, to make claims as specific and operational as possible, and the use of valid logic. Beware of any claims that subtly violate these rules because they are probably setting you up for a bait and switch.
The purveyors of unscientific medical claims have become as expert at this classic deception as the slickest used-car salesman – in fact they have left the hawkers of dubious transportation in the dust.
Sandra Nette is a prisoner, condemned to spend the rest of her life in the cruelest form of solitary confinement. Her intact mind is trapped in a paralyzed body and she is unable to speak. She can move one arm just enough to type on a special keyboard. She cannot swallow or breathe on her own, and must be frequently suctioned. She feels sensations and is in pain. Her condition is known as “locked-in syndrome” and has been described as “the closest thing to being buried alive.” She is suing those responsible for her cruel fate and I hope she wins.
She was a healthy 40 year old woman who wanted to stay healthy. She did all the right things like watching her weight, eating right, and not smoking. She followed the advice of a chiropractor to include regular maintenance chiropractic adjustments in her health regimen. On September 13, 2007 she had the last adjustment she would ever have.
There was nothing wrong with her. She didn’t see the chiropractor for headaches, neck pain, back pain or any other complaint. She went for a “tune-up” that she thought would help keep her healthy. The chiropractor did a rapid-thrust adjustment on her neck. Right afterwards, she complained of feeling “sore, dizzy and unwell.” She tried to leave but had to sit down. The chiropractor failed to recognize the medical emergency, and instead of calling an ambulance he recommended that she would benefit from purchasing massage therapy from his clinic. He let her leave the office and drive home alone. She only made it part way. (more…)
Dr. Sampson’s droll post on Thursday written from the point of view of an advocate of unscientific “alternative” medicine modalites (these days known as “complementary and alternative medicine”–abbreviated “CAM”–or “integrative” medicine), coupled with Dr. Atwood’s most recent contribution to his ongoing series on how the mish-mash of a little valid herbal medicine mixed with a whole lot of woo otherwise known as the “profession” of naturopathy is pushing for greater legal legitimacy, depressed me mightily. The posts depressed me because they are but more evidence of just how effective advocates of non-science-based medicine have been over the last several years at twisting the linguistic landscape to their advantage and winning. Indeed, I’ve written about this before on this very blog, including my (in)famous list of medical schools that have embraced CAM and my lament about a medical school that has even gone so far as to “integrate” so-called “integrative” medicine into every aspect of its curriculum from day one of the first year. These disheartening trends accompany and draw succor from the $120 million a year budget of that center of woo in the heart of the National Institutes of Health, the National Center for Complementary and Alternative Medicine, the equal amount of money coming yearly from, alas, the National Cancer Institute, and, of course, the financial clout of the Bravewell Collaborative.
Things are not looking good for science-based medicine in academia right now. I say this in particular because I just learned of a press release issued three weeks ago by Andrew Weil and his University of Arizona Program in Integrative Medicine that, as Emeril Lagasse would say, “Kicks it up a notch,” but not for the better.
The press release begins:
Playing with More than a Full Deck!
The passage submitted in the W^5/2 #7 wasn’t an easy one, but intrepid translators, for the most part, offered waluable insights:
Readers were virtually unanimous in the opinion that author Jean Watson, when she uttered it, must have been in an, er, alternative state of consciousness. I can’t imagine what gave them that idea. I mean look at her. No, the answer lies elsewhere, but was unknown even to your faithful judge until after he had posted that fateful entry: Ms. Watson can be nothing other than a High Priestess in the Mysterious Order that shall henceforth be known as the Hazy and Harrying Hermeneutics of Hermano©!
The “Science” and Ethics of “Natural Medicines”
This and the next entry in the current “Naturopathic Medicine” series* deal with the cult’s claim of expertise in “natural medicines” or “natural remedies.” These include herbs (“botanicals”), glandular extracts, vitamins, and minerals. A large fraction of the Textbook of Natural Medicine (TNM), “the most thoroughly researched and carefully referenced text on natural medicine,” is devoted to these agents. They are keys to the practice of naturopathy and to a core claim of “naturopathic physicians” that legislators tend to swallow: that NDs offer something that most MDs do not.
During the deliberations of the Massachusetts Special Commission, NDs produced Dr. Alan Trachtenberg, a fresh-faced ingenue who had briefly been Acting Director of the federal Office of Alternative Medicine, to testify on their behalf. He suggested to the Commission that naturopaths could be the “learned intermediaries” that the public needed to help make sense of the myriad “natural remedies” that became freely available in the wake of the Dietary and Supplement Health and Education Act of 1994 (DSHEA). This is from his written testimony:
Another advantage of state licensure, is that the holder of a professional license who provides or recommends a product, then becomes responsible for the quality and safety of a product. In an unregulated marketplace, such a learned intermediary can be invaluable to the consumer. Since naturopaths do often provide dietary supplements and herbal products directly to their patients, it is vital that they have an enforceable code of professional ethics. Such a code of ethics becomes enforceable with State licensure.
It is also beneficial for the patient to have a practitioner who knows enough about biochemistry, physiology, pharmacology, and physical diagnosis to adequately assess a patient’s clinical response to a product. These products are essentially complicated but unregulated drug mixtures. My understanding is that licensable naturopathic doctors have all taken these courses during their four years of training and passed standardized exams that test their mastery. There is no such quality assurance for the other kind of naturopathic practitioner.
Instead of relying on Dr. Trachtenberg’s “understanding,” let’s submit his two assertions—that of a “code of ethics” and that of “mastery” of the topic of “natural medicines”—to real scrutiny. In doing so I confess that I have plagiarized, to some extent, pieces that I’ve written elsewhere.