Science-Based Medicine

Medicine is simultaneously both easy and hard. As an Infectious Disease doctor, my day can be summed up with the phrase “me find bug, me kill bug, me go home.” Sometimes it is just that simple. A lot of the time it isn’t. I may not be certain what the infection is, or even if the patient has an infection, or allergies and/or antibiotic resistance limit therapeutic options, the host has co-morbidities that limit effectiveness, and the patient has no financial resources for the needed treatment.

I am lucky, since most infections are acute, make people feel terrible, and require a relatively short course of therapy during which the patient feels better. I rarely have to worry about compliance with the treatment plan; it is the rare patient, usually a heroin user or a particularly irascible old man, who will not follow through with their antibiotic course. I do not have to worry about chronic or symptomless diseases like diabetes or hypertension or the complications of obesity where long term compliance often limit therapeutic success. Long term it is difficult for many people to stick with their therapeutic plan, much less their diet and exercise resolutions.
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Colorado’s “degreed” naturopaths (NDs) are nothing if not persistent. Starting in 1994 they have tried seven times to convince legislators that the Colorado’s public needs protection from what “traditional” naturopaths (traditionals) do, and that the best way of providing that protection, they claim, is to bestow licensure on the guys with the college degrees. The irony in this is that the NDs could well be the more dangerous practitioners.

Legislators have been largely sympathetic to the concerns of the more numerous traditionals who fear the loss of their right to work as naturopaths. The NDs have tried neutralize these opponents by reassuring them they could continue to practice naturopathy, but the traditionals don’t buy that. And they won’t easily forfeit the title of “naturopath” to which they believe to have more claim.

So what we have here in Colorado is near 20-year turf war between two types of naturopaths: the NDs who seek legislation to transform naturopathy into a protected guild, and the traditionals who are happy with the status quo. There is no love lost between these groups. Legislators repeatedly advise them to resolve their differences before asking for licensure again, but they haven’t gotten close to détente.

Colorado NDs have made no secret of their economic motivations. Before the 2011 legislative session, the Colorado Association of Naturopathic Doctors (CAND) was reinvigorated by the passage of the Patient Protection and Affordable Care Act which has this “non-discrimination” provision:

(a) Providers- A group health plan and a health insurance issuer offering group or individual health insurance coverage shall not discriminate with respect to participation under the plan or coverage against any health care provider who is acting within the scope of that provider’s license or certification under applicable State law. This section shall not require that a group health plan or health insurance issuer contract with any health care provider willing to abide by the terms and conditions for participation established by the plan or issuer. Nothing in this section shall be construed as preventing a group health plan, a health insurance issuer, or the Secretary from establishing varying reimbursement rates based on quality or performance measures. [Sec. 2706]

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One of the themes of science-based medicine is to be suspicious of any form of medicine that is not science-based. In other words, beware of dodgy qualifiers placed before “medicine,” such as: “alternative”, “integrative”, or “complementary” – those that imply that something other than science or evidence is being used to determine which treatments are safe and effective. I would also include “traditional Chinese” medicine in the dodgy category.  A recent article defending Traditional Chinese Medicine (TCM) provides, ironically, an excellent argument for the rejection of TCM as a valid form of medicine. The authors, Jingqing Hua and Baoyan Liub, engage in a number of logical fallacies that are worth exploring.

Their introduction sets the tone:

Traditional Chinese medicine (TCM) has a history of thousands of years. It is formed by summarizing the precious experience of understanding life, maintaining health, and fighting diseases accumulated in daily life, production and medical practice. It not only has systematic theories, but also has abundant preventative and therapeutic methods for disease.

It may be trivially true that TCM has a long history, but it is hard to ignore that the placement of this statement at the beginning of a scientific article implies an argument from antiquity – that TCM should be taken seriously because of this long history. I would argue that this is actually a reason to be suspicious of TCM, for it derives from a pre-scientific largely superstition-based culture, similar in this way to the pre-scientific Western culture that produced the humoral (Galenic) theory of biology.

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In writing about science-based medicine, we give a lot of attention to medicine that is not based on good science. We use bad examples to show why science is important and how it is frequently misapplied, misinterpreted, misreported, or even wholly rejected. It’s a pleasure, for a change, to write about a straightforward example of the best of science-based medicine in action. The book Heart 411 is such an example.

The medical literature is a jungle of conflicting and complicated studies. It’s difficult for novices and even for sophisticated non-specialists to navigate. It’s useful to have experts as guides who can apply their knowledge, experience, and judgment to analyze the data and put everything into perspective. I can’t imagine anyone more qualified as guides to “matters of the heart” than the authors of this book. Heart surgeon Marc Gillinov and cardiologist Steven Nissen practice at the Cleveland Clinic, which has been ranked as the number one heart hospital by U.S. News & World Report for the last 15 years and is currently ranked 4th best hospital overall. They have treated more than 10,000 heart patients over 30 years of clinical practice and have also done extensive research and published hundreds of articles in peer reviewed journals. Their book contains everything they would like their patients to know about the prevention, diagnosis, and treatment of  heart disease.  It amounts to an owner’s manual for the heart.  Continue Reading »

A couple of weeks ago, Jann Bellamy wrote about “legislative alchemy” in the new year, in which CAM mischief works its way into state legislatures. Specifically, she mentioned the case of legislators in Vermont trying to declare in law that naturopaths are primary care physicians, who can serve as a patient’s medical home without supervision by real doctors.

Rosemary Jacobs, whose life was altered irrevocably when she developed agyria due to colloidal silver noticed another aspect of this new proposed law:

I recently learned that Vermont licenses naturopaths, NDs, as physicians and that they have a state sanctioned formulary, a list of drugs they can prescribe and administer to patients. To my horror, the 2009 formulary includes “colloidal silver preparations” to treat eye infections and “silver” which they can administer intravenously.
http://www.vtprofessionals.org/opr1/naturopaths/info/Naturopathic Physician Formulary 20091211.pdf [pdf download]

I was horrified because of the danger this poses to patients, the incredible ignorance it shows on the part of naturopaths, and because NDs had, without my knowledge, been licensed in Vermont to administer prescription drugs and other strange substances like silver and tin, do physical exams and order the same diagnostic tests that MDs order.

How had this happened without my knowledge? I have been following alternative medicine for 15 years and warning people about the danger of ingesting silver, an alternative “remedy”, because I don’t want anyone else disfigured by it like I was over 50 years ago.

Silver drugs were used by medical doctors before the advent of antibiotics. Although they didn’t work, they permanently turned many people blue and gray. The condition is called argyria. It was formerly common, and is well documented and understood by scientists.

If NDs had known as much about medicine as I, an educated consumer, do, they would have searched the medical literature before including anything in their formulary. If they had done that, they would have seen that: there are no studies showing that ingesting silver in any form or amount offers benefits; colloidal silver does not treat eye infections; taking silver internally or putting it in your eye can result in permanent discoloration.

Colloidal silver is nonsense. There’s no evidence that it is good for anything. Rosemary also revealed to me something I didn’t know before, namely that there’s another woo-friendly Senator that I didn’t really know about: Bernie Sanders, who, according to her, helped naturopaths become players in the medical marketplace.

It is with some trepidation that I write this, given that I realize this post might lead to charges that I’ve allowed myself to become so open-minded that my brains fell out, but I think the issues raised by what I’m about to discuss will make our readers think a bit—and perhaps spark some conversation. Because I’m in a bit of a contrarian mood, I’ll take that risk, although it’s possible I might end up with the proverbial egg on my face. As our regular readers know, the issue of the health effects of radiation from mobile phones has been a frequent topic of this blog. The reasons are obvious because fear mongering claims not based in science are frequently made in the lay press and in books (for example, Disconnect by Devra Davis) and, unfortunately, also by some physicians and scientists. Moreover, like homeopathy, the issue demands a discussion of prior probability and plausibility based on basic science alone, but the issues are a bit less clear-cut. Whereas the tenets of homeopathy clearly violate multiple laws of physics and chemistry, it is possible, albeit very unlikely, that radio waves might produce significant biological changes.

There’s also sometimes a maddening dogmatism on the part of some physicists that it’s “impossible” that long term exposure to radio waves could possibly cause cancer because such electromagnetic waves do not have anywhere near enough energy to cause ionization and thereby break chemical bonds. While it is certainly true that such radio waves can’t break chemical bonds and the likelihood that the radio waves from cell phones can cause cancer appears very low based solely on physics considerations, all too often the arguments made based on physics considerations alone use a simplistic understanding of cancer and carcinogenesis as their basis. It’s not for nothing that I have referred to such arguments as being based on a high school or freshman level of understanding about cancer—or just an outmoded understanding that prevailed a decade or two ago but today no longer does. Bernard Leikind, for instance, argued and famed skeptic Michael Shermer accepted that, because the radio waves used in cellular communications are too low energy to break chemical bonds and do not produce significant heating compared to other sources, “cell phones cannot damage living tissue or cause cancer.” Note the implicit assumption: That it is somehow necessary to “damage” living tissue in order to cause cancer. That’s an assumption that is arguably quite simplistic and ignores knowledge we’ve gained about epigenetics and how potential metabolic influences might cause cancer. Cancer is associated with characteristic cellular metabolic abnormalities, and determining which is responsible for the formation of cancer, metabolic abnormalities or gene mutations, has become a “chicken or the egg”-type of question.

I do not in any way believe that cell phone radiation actually is a cause of cancer because, unlike the case in homeopathy, where multiple well-established laws of physics would have to be overturned for homeopathy to work, I find the argument that a causation is “utterly impossible” far less persuasive than some physicists do when it comes to cell phone radiation and cancer. Even dismissing the “impossibility” argument, however, clearly such a link is at the very least incredibly implausible on physics considerations alone, as I have pointed out time and time again. Add to that the nearly completely negative epidemiological data in which only one group of researchers has been able to produce apparently “positive” studies, and my personal conclusion is that we probably already have enough data to reject a connection between radio waves and cancer and don’t need any more new large epidemiological studies; following up long term results on the ones already under way should be sufficient. That is not the same thing as arguing that radio waves have no significant biological effect, which is what, in essence, the argument from physics is based on. In fact, the inspiration for the rest of this post came from a meeting I had last week with a scientist and that scientist’s talk for our cancer center’s weekly Grand Rounds. What I learned did not demonstrate that cell phones cause cancer or even that they might cause cancer. Not even this scientist claimed his results were consistent with cell phone radiation causing cancer; in fact, he quite clearly stated they were not. However, what I learned from him cast some doubt (to me, at least) on the assumption that radio waves cannot have profound biological effects. In fact, ironically enough, this scientist is proposing the use of amplitude-modulated (AM) radio waves to treat cancer. I’m not yet convinced by any stretch of the imagination that this researcher is on to something, but his findings made me think about the perils and pitfalls of declaring something “impossible” solely on basic science considerations, because he has some very intriguing results that I can’t find a compelling reason to dismiss.

And, at least as of now, there’s no known physical mechanism that can explain his findings. Leaving aside the possibility of fraud or some sort of systematic bias that is not apparent in the methods sections of the papers I’m about to summarize, either he’s found something new and potentially promising, or he’s somehow very, very wrong.
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I’m traveling this week, checking out pharmacy practice internationally, and looking for signs of science-based medicine. Instead of a post, here are the links to two podcasts I recently recorded that will be of interest to SBM readers. Sit back, press play, and enjoy.

Point of Inquiry: Dispensing Skepticism

I recently spoke with Karen Stollznow for the Point of Inquiry podcast. This discussion focused on the role of the pharmacist and the need for science-based pharmacy practice. We touched on a lot of issues including the changing role of the pharmacist, the ethical responsibilities of pharmacists when it comes to products like homeopathy, what compounding pharmacies do, what generic drugs are, what an expiry date means, what pharmacists think about vitamins and other supplements, and more. You can listen to the podcast here.

Skeptically Speaking: The Common Cold

I was recently the guest of Desiree Schell on Skeptically Speaking, where we spent an hour discussing the prevention and treatment of the common cold. You can listen to the podcast, and I’ve compiled a long list of related links and references on cold treatment for your reading pleasure too.

A new review published in the BMJ once again opens the question of the risks vs benefits of daily aspirin as a prevention for heart attacks and strokes. The reviewers looked at nine randomized trials involving over 100,000 patients and found that aspirin is effective in reducing heart attacks and strokes, but also increases the risk of gastrointestinal bleeding and that in some patients this risk outweighs the benefit.

This is an old and enduring controversy, and one with significant public health ramifications. Aspirin is an anti-platelet agent – it inhibits platelets, the cell fragments in the blood that are the first line against bleeding, from aggregating (clumping together). Platelets aggregate in order to quickly stop bleeding from damaged veins or arteries. But they can also aggregate around cholesterol plaques in arteries, causing a large thrombus (blood clot) that can block off the artery, or that can break off and lodge in a downstream artery (an embolus) and cause a stroke or heart attack.

By inhibiting platelet aggregation daily aspirin reduces the risk of forming a thrombus or embolus, and thereby reduces the risk of heart attack or stroke. Of course, the real story is always more complex than our straightforward explanations. There is some research to suggest that the anti-inflammatory effects of aspirin may also be important to their role in reducing vascular risk. The relative contribution of anti-platelet and anti-inflammatory effects have not been fully teased out. Further, the anti-inflammatory effects of daily aspirin may have non-vascular benefits, like reducing the risk of some cancers.

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Many years ago, when I was a naïve and gullible teenager, I read about a home treatment for constipation that involved rolling a bowling ball around on the abdomen. I was intrigued, thought it sounded reasonable, and might even have tried it myself if I had been constipated or had had a bowling ball to experiment with. Many decades later, with the advantages of a medical education and experience in science-based medicine and critical thinking, I encountered a treatment that reminded me of the bowling ball: visceral manipulation (VM), a practice developed by a French osteopath and physical therapist, Jean-Pierre Barral. This time I was far more skeptical. VM may be more sophisticated than a bowling ball, but its effectiveness and safety are equally dubious.

Visceral manipulation (VM) will probably be unfamiliar to most of my readers, but its promoters say it has been adopted by osteopathic physicians, “allopathic” physicians, doctors of chiropractic, doctors of Oriental medicine, naturopathic physicians, physical therapists, occupational therapists, massage therapists and other licensed body workers. Its origin follows the path of many other alternative health systems. Like chiropractic, ear acupuncture, iridology, EMDR, and others, it was developed by one individual based on his personal observations and experiences without any kind of proper testing. Like the others, it started with a single patient: in Ignaz von Peczely’s case an owl with a spot on its iris, in D.D. Palmer’s case a janitor whose hearing allegedly improved after something was done to his back, in Barral’s case a patient who said he had felt relief from his back pain after going to an “old man who pushed something in his abdomen.” From a single case they extrapolated to a general belief about disease causation and a whole diagnostic and/or treatment system.

How is VM Done?

A video shows Barral demonstrating his skills.  He “listens with his hands” to detect tension (elsewhere the perception is designated as a thermal phenomenon). His diagnostic process begins by “listening with the hands” on the top of the patient’s head to determine the lateralization or general area of the problem. Then his hands “listen” to the areas of concern to further localize the problem.  In this demonstration he detects something in the stomach which he says could be from decreased acidity or emotional tension. Then he listens to the skull repeatedly with both hands, does something simultaneously to the neck and abdomen, and finally he is satisfied that his hands are telling him that he has corrected the problem. Continue Reading »

As the sole cancer surgeon among our stable of Science-Based Medicine (SBM) bloggers, I’m probably the most irritated at the infiltration of pseudoscience into academia (or, as we sometimes like to call it, quackademic medicine) in the realm of cancer. Part of the reason, of course, is that cancer is so common and that the consequences of adding pseudoscience to cancer therapy are among the most devastating. Witness, for instance, the use of Gonzalez therapy to treat pancreatic cancer, a form of quackery that harms patients and resulted in incredibly unethical and disastrous clinical trial of Gonzalez quackery versus chemotherapy whose results were entirely predictable, given the lack of prior plausibility of the treatment: Gonzalez protocol patients did worse, with no evidence that the therapy impacted the natural history of the disease and the Gonzalez patients scoring lower on quality of life measures. Or look at what happens when patients with breast cancer choose quackery over science-based therapy.

I realize that “complementary and alternative medicine” (CAM) or, what quackademics like to call it now, “integrative medicine” (IM) is meant to refer to “integrating” alternative therapies into SBM or “complementing” SBM with a touch of the ol’ woo, but I could never manage to understand how “integrating” quackery with SBM would do anything but weaken the scientific foundation of medicine. Moreover, weakening those foundations would have more consequences than just “humanizing” medicine; weaker scientific standards would allow not just ancient quackery like traditional Chinese medicine (TCM) into academia, but it would also provide an opening for drug and device companies to promote their wares under less rigorous requirements for evidence. There’s also perhaps a touch of personal embarrassment involved. After all, oncology and cancer surgery tend to be specialties that are the most steeped in science. If I had to rank specialties for how science-based they are, I’d certainly put oncology near the top, which is why I tend to come down so hard on “integrative oncology” and, even worse, “naturopathic oncology.”

Consequently, I was doubly disturbed several months ago when I learned that the director of the National Institutes of Health, Francis Collins, had agreed to be the keynote speaker at the Eight International Society for Integrative Oncology Conference in Cleveland, OH. I say “doubly” disturbed because it disturbed me that Francis Collins would agree to speak at such a function and, perhaps even more, because the host institution was Case Western Reserve University, the institution where I both completed my surgery residency and my PhD in Physiology and Biophysics. Sadly, it now appears that my old stomping grounds at University Hospitals has been thoroughly infiltrated with quackademic medicine, as evidenced by this clinical trial of reiki for psoriasis that’s making the rounds of news services and the offering of acupuncture, reiki, and even reflexology at various UH facilities through the University Hospitals Connor Integrative Medicine Network. Let me tell you, there was none of this pseudoscience going on when I finished my residency there in 1996. Seeing it there now provokes a reaction in me not unlike Sylvester Junior’s reaction when his father Sylvester embarrasses him, particularly when I noted that the director of the CWRU Comprehensive Cancer Center, Dr. Stanton L. Gerson, was to give one of the keynote talks, entitled, “The Future of Integrative Oncology.” (Hint for those of you not familiar with classic Looney Tunes cartoons: A paper bag is involved.) I guess that by expressing my extreme disappointment and embarrassment that the institution where I learned to become a surgeon has during the last 15 years gone woo, I’ve probably just killed any opportunity I might have to work at the Case Comprehensive Cancer Center ever again. Oh, well, add it to the list, along with Beth Israel and my alma mater the University of Michigan.)

Back when I first learned about it, I thought about blogging the meeting, but without much concrete to go on, given the copious other SBM-related topics to blog about, all I could do was to write a critical open letter to Dr. Collins about his decision to accept the offer to be the keynote speaker at the Society for Integrative Oncology (SIO). Then yesterday I saw popping up in my e-mail a notice from the American Society of Clinical Oncology (ASCO), along with a link to a story in its publication The ASCO Post entitled NIH Director Calls for Rigorous Evaluation of Integrative Medicine to Provide Evidence of Efficacy.

Et tu, Dr. Collins?
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