The New England Journal of Medicine (NEJM) is published on Thursdays. I mention this because this is one of the rare times where my owning Mondays on this blog tends to be a rather large advantage. Fridays are rotated between two or three different bloggers, and, as awesome as they are as writers, bloggers, and friends, they don’t possess the rabbit-like speed (and attention span) that I do that would allow me to see an article published in the NEJM on Thursday and get a post written about it by early Friday morning. This is, of course, a skill I have honed in my not-so-super-secret other blogging identity; so if I owned the Friday slot I could pull it off. However, the Monday slot is good enough because I’ll almost always have first crack at juicy studies and articles published in the NEJM before my fellow SBM partners in crime, unless Steve Novella managed to crank something out for his own personal blog on Friday, curse him.

My desire to be the firstest with the mostest when it comes to blogging about new articles notwithstanding, as I perused the table of contents of the NEJM this week, I was shocked to see an article that made me wonder whether the editors at NEJM might just be starting to “get it”—just a little bit—regarding “integrative” medicine. As our very own Mark Crislip put it a little more than a week ago:

If you integrate fantasy with reality, you do not instantiate reality. If you mix cow pie with apple pie, it does not make the cow pie taste better; it makes the apple pie worse.

Lately, though, I’ve been more fond of a version that doesn’t use fancy words like “instantiate”:

If you integrate fantasy with reality, you don’t make the fantasy more real. You temporarily make your reality seem more fantasy-based, but reality always wins out in the end.

The part about the cow pie needs no change, although I think ice cream works a bit better than apple pie. Your mileage may vary. Feel free to make up your own metaphor inspired by Mark’s.

In any case, in the Perspective section, I saw three articles about “patient-centered” care:

As I and several of my fellow SBM bloggers have pointed out, the whole concept of “patient-centered” care, as worthy as it is in theory, is all too often in practice co-opted by promoters of unscientific, pseusocientific, and faith-based health care modalities to justify quackery. That’s why the fourth article on the list surprised me:

What’s the Alternative? The Worldwide Web of Integrative Medicine by Ranjana Srivastava, F.R.A.C.P.

When I saw this title, I was rather expecting apologetics about “integrative” medicine. What I got instead was an article that would have been appropriate right here on this very blog, a post about a woman who had fallen prey to a dubious test promoted at an “integrative” health fair and the devastating results of that test. That’s why I was suprised.

After all, let’s look at the record of the NEJM over the last couple of years. What is still considered to be one of the best medical journals in the world, if not the best, appears to be the victim of a conscious effort on the behalf of its editors to dethrone itself as king of medical journals through its increasing acceptance of the spin placed on medical science by those who would integrate fantasy with reality in medicine in the hope of improving medicine. Unfortunately for them reality has a way of always winning out in the end, just as the cow pie wins out in Mark’s metaphor.

For me, the first sign of major trouble appeared back in the summer of 2010, when the NEJM published what was on the surface an unremarkable study that found that tai chi appeared to have a beneficial effect on symptoms in patients with fibromyalgia. Indeed, I remember it well because its publication coincided with my trip to Chicago to give an invited talk to the Chicago Skeptics, the Women Thinking Free Foundation, and CFI-Chicago. (Hey, come to think of it, it’s been a long time since then. Maybe the skeptical crew would want to invite me out again to give a talk. But I digress…) In any case, part of what was so annoying about the article is that, as I put it, the NEJM completely and uncritically let the authors spin their results in—shall we say?—an “alternative” frame. As I pointed out at the time, let’s say that tai chi is the greatest thing since sliced bread and that it alleviates fibromyalgia pain and stiffness better than anything we’ve yet come up with. Let’s assume all of those things are true, just for the moment: what thought comes to mind to you? I know what thought comes to mind to me. What on earth is “alternative” or “complementary” about such a finding? In reality, such findings would simply indicate that certain forms of low-impact exercise could help fibromyalgia symptoms, which is not anything particularly surprising at all, given what we already know about fibromyalgia. In the interim, this NEJM article has been touted far and wide by apologists for “complementary and alternative medicine” (CAM), or, as they prefer to call it these days, “integrative medicine.”

Around about the same time, the NEJM published an even more credulous article about acupuncture in its Clinical Therapeutics section. As I described at the time, it was a clinical vignette, a little case presentation if you will, by Dr. Brian M. Berman, who has managed in a brief period of time to become the foremost popularizer of acupuncture in academic medical centers. In this vignette, the acupuncture was presented as a perfectly fine alternative for low back pain, and, as both Mark Crislip and I described, Berman did some pretty creative spinning to make it seem as though evidence favored acupuncture.

Since then, there have been other examples of the once-venerable NEJM falling for what can best be described as utter nonsense. In fact, even when publishing what could be a scientifically interesting and medically useful paper on placebo effects, its editors allowed the authors, led by Ted Kaptchuk, to spin the results in a way to imply that patients can have symptomatic relief without actual reversal of the underlying physiologic derangement that caused their symptoms in the first place and that that’s OK. In this case, the disease was asthma, and the paper published showed that placebo acupuncture resulted in asthma patients feeling better but didn’t reverse the airway constriction that led patients to feel short of breath in the first place. Peter Lipson quite properly described this as “folly,” but it’s worse than that. The NEJM doubled down and published an accompanying editorial by Daniel Moerman, who is about as postmodernist as it gets and all about “meaning” in the doctor-patient interaction. I’m going to quote the same passage from his editorial now that I quoted then, in which Moerman makes an explicit plea for placebo medicine based on the concept of patient-centered care:

The authors conclude that the patient reports were “unreliable,” since they reported improvement when there was none — that is, the subjective experiences were simply wrong because they ignored the objective facts as measured by FEV1. But is this the right interpretation? It is the subjective symptoms that brought these patients to medical care in the first place. They came because they were wheezing and felt suffocated, not because they had a reduced FEV1. The fact that they felt improved even when their FEV1 had not increased begs the question, What is the more important outcome in medicine: the objective or the subjective, the doctor’s or the patient’s perception? This distinction is important, since it should direct us as to when patient-centered versus doctor-directed care should take place.

For subjective and functional conditions — for example, migraine, schizophrenia, back pain, depression, asthma, post-traumatic stress disorder, neurologic disorders such as Parkinson’s disease, inflammatory bowel disease and many other autoimmune disorders, any condition defined by symptoms, and anything idiopathic — a patient-centered approach requires that patient-preferred outcomes trump the judgment of the physician. Under these conditions, inert pills can be as useful as “real” ones; two inert pills can work better than one; colorful inert pills can work better than plain ones; and injections can work better than pills.

Which brings us to today, skipping over the recent incident where the NEJM apparently has decided that accepting dubious advertisements is acceptable. The article about the cancer quack begins with a patient who out of curiosity wanders into an “integrative” health exhibition, and this is what happens:

Out of curiosity, an impressionable woman in her 30s attends an integrative medicine exhibition; having recently had a child, she’s been sleep-deprived and wants to investigate natural remedies. At the seminar, she wins a door prize — a blood test that promises to diagnose cancer. She was considering getting a blood test anyway and seizes this opportunity for a more comprehensive workup. After all, you can’t be too careful about avoiding cancer.

Weeks later, she receives a call from an apologetic but alarmed stranger telling her she has advanced cancer.

“How do you know?” she gasps.

“Your blood test is positive for circulating tumor cells.”

“What does that mean?” she cries.

He sends her a three-page report and tells her to seek immediate help. She spends a nail-biting week awaiting an appointment with the recommended integrative health expert.

Glancing at the report, the expert declares, “You have advanced non-small-cell lung cancer. You need treatment now.” The woman is petrified: Has her teenage smoking habit come back to haunt her?

“Are you sure?” she asks.

“Absolutely. There are circulating tumor cells in your blood.”

Tears streaming down her face, the woman asks, “What now?”

Ten years ago, it was whole body scans, which, while not really advertised as “integrative” or “alternative” produced the same sorts of results: Terrified people who thought they had a horrible disease based on an “incidentaloma.” The end results were frequently multiple additional imaging tests, with the concomitant unnecessary doses of radiation, invasive procedures, and even surgeries to try to determine whether these incidentalomas were actually cancer or anything else to worry about. Because the prevalence of abnormalities on such scans is so high, the fraction of these “false alarms” was (and remains) very high. The result is that such highly sensitive tests indiscriminately applied to a population in which the likelihood of the disease being sought is low are far more likely to cause harm through false alarms that result in further tests than they are to save lives through early detection. Sure, there will be the occasional “save,” in which a potentially deadly tumor is discovered at a very small size and resected. Certainly that is what the whole body scanning businesses that sprouted up a decade ago and have now (thankfully) mostly gone away would tout in their advertisements. What they wouldn’t tell you is the cost, how many were harmed or how many were sent off on wild goose chases compared to the rare person who might have been saved by such a pickup.

After hearing the recommendation of the “integrative practitioner” that she undergo a 12-week course of intravenous vitamin C, at a cost of $6,000, the patient decided to seek out an oncologist. As I’ve pointed out time and time again, vitamin C has pretty much failed as a potential treatment for cancer, its advocacy by a Nobel Laureate notwithstanding. Basically, it requires incredibly high doses of vitamin C. There might be a very modest antitumor effect at incredibly high doses, but it’s such a long run for a short slide that it doesn’t really make sense to use, particularly given that there is evidence that vitamin C at high concentrations can interfere with convention chemotherapy treatments.

But let’s get back to the “diagnosis.” A decade ago, it was full body scans. Apparently today it’s “circulating tumor cells.” (And, of course, thermography is forever.) Remember how extensively I’ve written about how earlier detection is not always better? Overdiagnosis, detection bias that favors less aggressive cancers among screening-detected cancers, stage migration (the “Will Rogers effect”), and a number of other confounders make it difficult to determine just when and how often to use good screening tests for which we have data from very large population-based studies and clinical trials, like mammography. There remains controversy to this day regarding when and how to screen for breast cancer and even whether to screen for prostate cancer. In the meantime, trying to screen for lung cancer using CT scans has largely been a failure.

So here we have a quack—yes, a quack—looking for circulating tumor cells (CTC) in the blood of a young woman in whom there is no strong reason to suspect cancer other than a distant smoking history. Who knows if the test is valid? That is, of course, the first thing I would question, given where the company was promoting its wares and what the “integrative” practitioner recommended. But let’s for the moment assume that there were circulating tumor cells in a woman with no known tumor? Do we know what to do with such things? No! We have no idea. Measuring circulating tumor cells in the blood is a hot area of research right now, which is no doubt why “integrative” practitioners are apparently offering such tests, to capitalize on the interest. In any case, the research that is going on is primarily focused on using CTCs as prognostic markers in patients diagnosed with cancer and for following response to therapy, and, even in those situations, they have not been validated to the point where they have become standard of care. Measuring CTCs is still, at best, experimental, and there is as yet no good evidence that they will be useful as screening tools in populations not at high risk. Scientists still argue over the proper cutoff points for patients with cancer; they have no idea what to use as a cutoff measurement in healthy patients. As Max Wicha put it, not all detected cells are bad and not all bad cells are detected.

The rest of the story goes something like this. A skeptical friend of the woman suggested that she should have a scan, and she had a cousin of hers, who happened to be a physician, order a chest X-ray and CT scan (which is another excellent example of why physicians should not treat family members), which revealed “two tiny nodules, 2 mm each in diameter.” On the radiology report were those waffle words that clinicians dread reading, “Clinical correlation is recommended in the context of a smoking history” (which is another reason physicians should not order tests whose results they won’t know what to do with). After trying to get in to see a thoracic surgeon, the patient is referred to an oncologist’s office, that of Dr. Srivastava, the author of the paper. This is what happens next, as described by Dr. Srivastava. I’ll quote as liberally from the article as I think I can and still be in the bounds of fair use, because, oddly enough, even though the three articles on patient-centered care are free for the download on the NEJM site, this article on cancer quackery is not. I wonder why. In any case, on with the story:

“There’s no evidence of cancer,” I reply, seeking to reassure her.

Instead, her tone sharpens: “But I have circulating tumor cells! How can you say that?”

Incredulous, I try to explain too many things. The blood test is a long way from being validated for clinical use. It was unscrupulous even to offer it. Does it make sense to her that it was sent to an unheard-of overseas laboratory for processing? Why did no one recommend that she see an oncologist?

Rolling her eyes, she counters, “I’ve heard that I need a PET scan. And if the spots light up, this test will have been my lifesaver.”

She is right on one count: the surgeon she sees orders a PET scan, saying he needs to be sure. She loses sleep over the results — the surgeon’s appointment is 2 weeks away, and she wants to schedule the operation. Feeling sympathetic, I tell her the PET scan was clear and the two small nodules seen on the first CT have disappeared; the radiologist thinks they were probably transient foci of inflammation.

But any relief the woman feels is ephemeral. “So what does that mean?” she asks. “The PET scan is faulty?”

“There is no cancer,” I reiterate.

“But someone has seen cancer cells,” she insists.

“That was not a validated test — not something we currently use to diagnose cancer,” I protest.

Dr. Srivastava goes around and around with the patient, trying to reassure her that she does not have cancer. She largely fails. The patient insists on being followed by her because she thinks she has a tiny cancer somewhere that’s just waiting to blossom, leading Dr. Srivastava to lament, quite appropriately, “How does one ‘disprove’ a serious diagnosis once its specter has been raised by an unqualified ‘expert’?” How indeed? I’ve had the same sort of problem with women who come in with thermograms convinced that they have breast cancer and wanting a double mastectomy. Fortunately, this is not common, at least not in my practice. Very fortunately.

Dr. Srivastava then hits the nail on the head:

At one time, the worst offense one encountered was someone prescribing a few herbs to a desperate patient who’d exhausted all other means of treatment. The usual thinking was, “At this stage, it can’t do any harm.” But insidiously and alarmingly, “alternative medicine” has crept from offering last-ditch treatments to making diagnoses. As the cancer armamentarium has expanded with targeted therapies, unscrupulous practitioners of alternative therapy have devised competing offers that sound at least as impressive to the average patient, who is often marginally health-literate and eager to embrace the promise of a cure without toxicity. But the radical, completely unregulated, and often dangerous options on offer can and do cause harm.

After describing the sorts of quack treatments she’s seen her patients use, Dr. Srivastava then drives to the heart of the matter when she points out:

The practitioners never write directly to oncologists and refuse to be accountable for their actions. Unauthorized to order tests, they tell patients, “Ask your doctor to do these bloods,” or “You need to have a scan to see whether the microwaves are working.”

Alternative therapies need meet no burden of proof except a patient’s gullibility. One never hears of alternative therapies that failed: the patient merely waited too long to try them. For every patient who openly discusses such treatments, there must be many who assume the treatments aren’t worth mentioning to “traditional” oncologists. After all, to make integrative health the multibillion-dollar industry it is, people must be supporting it; those people are our patients.

Physicians would be naive to ignore the elephant in the room. Integrative medicine comes in many forms — some useful, but many dangerous. It also comes at tremendous personal and societal cost. The initial expenditure may come from patients’ pockets, but often the health care system eventually inherits the problem. Although there’s probably no way of calculating the psychological cost, for many it is high and unending.

Indeed. Maybe I’ll send Dr. Srivastava an invitation to write a post or two for SBM. She sounds like my kind of doc.

All of this brings us back to “patient-centered” care and how it relates to the article about the cancer quack. Indeed, I wonder whether the NEJM editors are actually starting to “get it” by tacking Dr. Srivastava’s article on to the end of the NEJM Perspectives section. Think back to Dr. Moerman’s definition of “patient-centered care.” Now look at what we are told in the first article, by Ruben and Tinetti:

Perhaps the most important barrier to goal-oriented care is that medicine is deeply rooted in a disease-outcome–based paradigm. Rather than asking what patients want, the culture has valued managing each disease as well as possible according to guidelines and population goals.

Ultimately, good medicine is about doing right for the patient. For patients with multiple chronic diseases, severe disability, or limited life expectancy, any accounting of how well we’re succeeding in providing care must above all consider patients’ preferred outcomes.

Dr. Bardes writes in the third article:

“Patient-centered medicine” is the newest salvo in these ancient debates. As a form of practice, it seeks to focus medical attention on the individual patient’s needs and concerns, rather than the doctor’s. As a rhetorical slogan, it stakes a position in contrast to which everything else is both doctor-centered and suspect on ethical, economic, organizational, and metaphoric grounds.

But what does that mean? Ruben and Tinetti discuss prioritizing patients’ desired outcomes and helping them to achieve these outcomes, as long as they are possible. Dr. Bardes likens the relationship between doctor and patient as one of equals, like two binary stars orbiting a common center of gravity, a double helix, whose strands circle each other, or even the caduceus, with two serpents intertwined. I have to hand it to Dr. Bardes, he’s a poetic guy, but he goes too far. While patient and physician might be equals as human beings, in terms of medical knowledge they are not. If they were, then the patient arguably would not need the physician and would be able to handle his health problems himself. A better way of looking at it would be that the physician is the expert consultant, whose skill and knowledge the patient requests, while the patient is free to accept or refuse the physician’s advice. This is not the same as the old paternalistic model, where the doctor ordered and the patient acquiesced, because the patient is actively involved in seeking advice and can reject that advice. In other words, the relationship is more equal, but not exactly equal.

Now let’s think of what extreme patient-centered care would mean in the case of the woman described by Dr. Srivastava. This woman wanted more tests either to prove she didn’t have cancer or to remove the tiny 2 mm masses that were suspected to be cancer. That was her greatest concern, and medicine could address that quite easily by doing what the patient wanted; i.e., either operating on her or otherwise treating her. As it is, Dr. Srivastava could very easily have simply taken the patient on as a regular and seen her periodically, ordering tests every so often to assuage her fears. That would have been less potentially harmful than doing additional tests or even surgery. A physician could (and some do) build up lucrative practices of just such “worried well.” Would that be patient-centered care? It would certainly be giving the patient what she wants and placing the patient’s desires over that of the physician’s.

Certainly many “integrative” practitioners have wholeheartedly embraced the concept of patient-centered care. However, they have done so more out of a desire to be able to justify placebo medicine. If it makes the patient feel better, it must be better, you know, just like the sham acupuncture that made the asthma patients feel better without reversing their underlying airway constriction. Those patients felt great and probably would continue to feel great until they turned blue. “Patient-centered care” is easy when it devolves into giving the patient what she wants without consideration of science. Real patient-centered care is hard and must contend with situations where what the patient wants is unrealistic or impossible.

Certainly a better model is the one described by Barry and Edgman-Levitan, which calls for shared decision-making:

For some decisions, there is one clearly superior path, and patient preferences play little or no role — a fractured hip needs repair, acute appendicitis necessitates surgery, and bacterial meningitis requires antibiotics. For most medical decisions, however, more than one reasonable path forward exists (including the option of doing nothing, when appropriate), and different paths entail different combinations of possible therapeutic effects and side effects. Decisions about therapy for early-stage breast cancer or prostate cancer, lipid-lowering medication for the primary prevention of coronary heart disease, and genetic and cancer screening tests are good examples. In such cases, patient involvement in decision making adds substantial value.

This is probably true, but it depends upon the patient being provided with scientifically valid information to help guide their part of the shared decision-making process. I’ve frequently referred to a concept that I like to call “misinformed consent.” Basically, that’s how practitioners of unscientific nonsense will exaggerate the benefits and minimize the risks of their recommendations, all the while exaggerating the harms and minimizing the benefits of conventional therapies. A particularly apt example is the antivaccine movement, which tries to convince people that vaccines don’t work and are very dangerous. CAM practitioners do the same thing in their vision of “patient-centered care,” but informed consent is not optional, and without informed consent patient-centered care cannot work.

I wonder whether the editors realized that they just might be making a statement when they juxtaposed Dr. Srivastava’s article about what happens when “integrative” care runs rampant with three articles describing the very “patient-centered” care that such practitioners take advantage of. It’s not possible to have real patient-centered care without real informed consent, and “integrative medicine” relies on misinformed consent.


Posted by David Gorski

Dr. Gorski's full information can be found here, along with information for patients. David H. Gorski, MD, PhD, FACS is a surgical oncologist at the Barbara Ann Karmanos Cancer Institute specializing in breast cancer surgery, where he also serves as the American College of Surgeons Committee on Cancer Liaison Physician as well as an Associate Professor of Surgery and member of the faculty of the Graduate Program in Cancer Biology at Wayne State University. If you are a potential patient and found this page through a Google search, please check out Dr. Gorski's biographical information, disclaimers regarding his writings, and notice to patients here.