One of my goals in writing for this blog is to educate the general public about how to evaluate a scientific study, specifically medical studies. New studies are being reported in the press all the time, and the analysis provided by your average journalist leaves much to be desired. Generally, they fail to put the study into context, often get the bottom line incorrect, and then some headline writer puts a sensationalistic bow on top.

In addition to mediocre science journalism we also face dedicated ideological groups who go out of their way to spin, distort, and mutilate the scientific literature all in one direction. The anti-vaccine community is a shining example of this – they can dismiss any study whose conclusions they do not like, while promoting any horrible worthless study as long as it casts suspicion on vaccines.

Yesterday on Age of Autism (the propaganda blog for Generation Rescue) Mark Blaxill gave us another example of this, presenting a terrible pilot study as if we could draw any conclusions from it. The study is yet another publication apparently squeezed out of the same data set that Laura Hewitson has been milking for several years now - a study involving macaque infants and vaccinations. In this study Hewitson claims a significant difference in brain maturation between vaccinated and unvaccinated macaque infants, by MRI and PET analysis. Blaxill presents the study without noting any of its crippling limitations, and the commenters predictably gush.

The first (and really only) thing you need to know about this study is that it involves 9 vaccinated monkeys and 2 controls. That’s right – just 2 controls. The fact that Hewitson bothers to do statistical analysis on such a small set of subjects is laughable. Let’s keep in mind that most pilot studies turn out to be wrong – they are called pilot studies because they are intended to point the way to further research, not as a basis for any conclusions. Serious researches recognize that pilot studies are shots in the dark – and that counts even for good pilot studies, which this is not.

If the outcome were something hard and dramatic – like survival vs death, then 2 subjects would be a reasonable pilot study. But in this case Hewitson is doing a somewhat tricky measurement of brain volume changes over time and binding of opioid ligands in the amygdala. It is also worth noting that there were originally 4 controls, but one was eliminated due to improper protocol. We never learn what happened to the third monkey, we are just told there is data on two controls. This kind of missing data, especially when the overall numbers are so pathetically low, is very concerning.

She is also making multiple analyses (another red flag by itself), which means she can compare multiple variables looking for any difference. Then she invokes the sharpshooter fallacy and declares any change she does find to be clinically meaningful. So while there is no difference in brain volume or amygdala volume between exposed and unexposed monkeys, she finds differences in the change over time. We don’t know if still other variables were looked at and not reported – this is another weakness of pilot studies and why follow up studies replicating the specific effects reported are necessary before any conclusions can be drawn.

As further evidence of looking for any difference then declaring that the outcome of interest, we can look back to Hewitson’s 2008 reporting of her monkey data, in which she wrote:

“Compared with unexposed animals, exposed animals showed attenuation of amygdala growth and differences in the amygdala binding of [11C]diprenorphine.”

But in the current study she finds increased amygdala growth in exposed monkeys:

Not surprisingly, given the different maturational trajectories in exposed vs. unexposed animals, (unexposed decreasing and exposed increasing) there was a statistically significant interaction between exposure and time on total amygdala volume (Wald ?2=10.93; P=0.001). However, there were no significant main effects on total amygdala volume of either exposure (Wald ?2=0.75; P=0.39) or time (Wald ?2=1.14; P=0.29).

So which is it? Reading the results of the current study, especially in light of previous publications, gives the overall impression of a random scatter of data with incredible cherry picking in order to make the argument that there are any meaningful results at all.

Taken by itself, this is a worthless study. The numbers of subjects is too small to do any meaningful analysis. The results are all over the place, and not even consistent with prior publications by the same authors. The analysis is also far-fetched. Hewitson argues that both thimerosal-containing vaccine and MMR (which does not contain thimerosal) contribute to the alleged brain changes she is reporting. While the word “autism” does not appear in her report, Blaxill is concluding in his reporting that these brain changes are the same as those found in autism (an absurd conclusion given how non-specific these changes are, even if real, which cannot be concluded from this study). The anti-vaccine agenda is now clear – they get to have their cake and eat it too. They can now argue that an interaction between thimerosal and MMR cause or contribute to autism, through completely independent mechanisms, apparently.

To put this study further into context, this research is being conducted by the Thoughtful House Center for Children – Andrew Wakefield’s home after he was essentially kicked out of the UK and subsequently struck off. Wakefield’s name, however, does not appear anywhere on the current study, although he was listed as final author on previous publications from the same research. Apparently his name has become too toxic for the Thoughtful House.

The current study also appears in a obscure journal, Acta Neurobiologiae Experimentalis – which dedicated an entire issue to publishing dubious research on autism. The same issue includes two articles by the father and son Geier team – other vaccine and autism researchers who are off in their own world and whose research cannot be replicated.

Conclusion

This current study, as well as the entire macaque research program by Hewitson, is a good example of terrible research. The subject numbers are far too small for any meaningful statistics, and the outcomes being followed are numerous and tricky with a random scatter of results not even consistent between different publications of the same research.

What we have is far worse than ideological reporting and spinning of the scientific research – apparently we have the ideological conduction of research in the first place. This is similar to the research program of Benveniste on homeopathy.

In general it is a good rule to be suspicious of research that seems to be unique to one researcher or research team and is out of step with the broader research community. Unfortunately, such research contaminates the literature and is easily exploited to confuse the media and the public who often do not distinguish crank research from legitimate science.

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Crossposted on NeuroLogicaBlog

Others reporting on this study:

Respectful Insolence – Orac also points out that Hewitson failed to disclose her COI – that she has a child with autism who is part of the Autism Omnibus suit.

Ibrb – Author, Sullivan, also points out that amygdala size should increase in macaques, so it is especially odd that the non-exposed monkeys’ amygdalas shrank. That makes no sense, and is likely due to the quirkiness of having only two controls. So the authors conclusions are entirely based upon a weird result in their tiny control group – i.e. this is completely bunk science.

There are two topics about which I am a crank. The first, as you might have guessed, is alternative medicine. The other is pharmaceutical reps. Drug companies are somewhat schizophrenic. They have amazing scientists who invent drugs that treat an astounding array of diseases. Then, they take these drugs and turn them over to marketing, to be sold with all the enthusiasm and truthiness of a late night infomercial.

In the spirit of openness, I will say that I have not talked to a drug rep in 20 years. As far as industry supported gifts and food, I have not taken a pen or eaten pizza from industry in almost 30 years, since I was a fourth year medical student. I have accepted one gift over the years. Years ago, when the Pfizer rep left, he sent me Fleets enema with a Unasyn sticker on it. I still have it in my office, unused. But you never know when it might come in handy.

Being an absolutist about industry gifts does have downsides. It is distracting to sit in an auditorium filled with the smell of pizza and not eat any; somehow the PB&J I bring with me doesn’t smell as sweet. Administration has received one letter complaining about me that was ostensibly from an employee, but curiously was printed from a windows folder that had the same name as the levofloxacin rep. Just a coincidence, I am sure.

As an Infectious Diseases fellow I was the on call physician for the hospitals antibiotic stewardship program where expensive or problematic drugs had to be approved before they could be released from pharmacy. It was curious how there would be spikes in approval requests, often for drugs that the surgical resident couldn’t pronounce correctly. Ain’t no drug called ciprofloxacillin, although there should be. Investigation revealed that these spikes often occurred shortly after a service was treated to a good dinner by the drug rep. Hmm. Funny thing, that. Probably just another coincidence. I remember once as an intern late at night trying to decide what antibiotic to give a patient and I decided to prescribe what was embossed on my pen. Turned out Bic was not on the formulary.

Over the years it has been rare to find a physician as extremist as I am. It is curious, since the literature supports the concept that interaction with pharmaceutical reps is detrimental to patient care: docs who interact with reps are more likely to prescribe expensive and/or inappropriate drugs after being detailed. When pointed out, every doctor tells me the same thing: That may be true of others, but I am not swayed by information provided by drug reps. It is the one area of science-based medicine to which most physicians are immune, and understandably so: who wants to jeopardize free pizza? Most of the literature on the topic is collected at nofreelunch.org, which appears to be under construction. It all may be publication bias, but I know of no reference that demonstrates improved patient care as a result of physicians interacting with drug companies.

So imagine my surprise when someone came out in favor of physicians learning from drug companies. Over at Slate.com is “Appetite for Instruction. Why Big Pharma should buy your doctor lunch sometimes,” by Jessica Wapner.

It starts out sedately enough “The war against industry-sponsored medical education is in full tilt.” War? It is an interesting choice of words. I might have started by writing “physicians are finally reclaiming their integrity after whoring for 50 years,” but I have a dog in the fight.

But with the mounting concern about ties between doctors and the pharmaceutical industry, commercially supported medical education is being axed from hospitals and university medical centers around the country. Not only is this change unfortunate for anyone with a doctor, but it also doesn’t make any sense.

It does make sense if you bother to read the extensive literature. The preponderance of data strongly suggests that medical practice and research is altered, and not for the better, by interaction with pharma. She quotes only one reference in her article in support of drug company sponsored education.

There is no substitute for a small group of people listening to a doctor talk about how to treat a disease. And there is no substitute for the commercial support required to run such programs. In a recent study, academic researchers were paid a modest honorarium to travel around the country teaching more than 14,000 doctors about new treatment guidelines for high blood pressure. Each researcher met with small groups of doctors to educate them about the latest advances. In counties where the most sessions took place, adherence to the guidelines rose by more than 8 percent. In counties with the fewest such sessions, adherence decreased by 2 percent. The approach that the pharmaceutical industry has been taking for years is actually an effective way to educate doctors.

The “recent study” refers to “Impact of the ALLHAT/JNC7 Dissemination Project on thiazide-type diuretic use.”

I pulled the article, and it does not say what the author thinks it says. What a surprise. The academic researchers were educating physicians about generic medications, it was “was supported by contract N01-HC-35130 from the National Heart, Lung, and Blood Institute (NHLBI), as well as an NHLBI mentoring award (RSS, K24HL086703),” not pharmaceutical money, and if they were paid an honorarium it is not mentioned in the reference.

Academic detailing, or counter-detailing, is what is done to try and give evidenced based, minimally unbiased information about treatments in an attempt to give practitioners information free from pharmaceutical company spin and bias.

Academic detailing incorporates many of the approaches used in pharmaceutical marketing. By using persuasive, individualized small group or one-on-one communication of key points, detailing can summarize findings, suggest concrete changes in practice patterns, and explore potential barriers to change. In addition, by targeting specific physicians recognized as opinion leaders, resources can be concentrated on locally influential prescribers.

Several systematic reviews have examined the effectiveness of academic detailing in changing clinical practice and found this type of intervention to be effective. The effectiveness of academic detailing is described as ranging from small to strong with results that are consistently favorable. The effectiveness of academic detailing in affecting prescribing practices is particularly prominent. In this situation, even small changes in prescribing may be important when the population affected is large or where large cost differences exist between alternative medications.

Academic detailing is the Spock without the goatee.

The effects of the intervention was modest:

The ALLHAT/JNC7 Dissemination Project was associated with a small effect on thiazide-type diuretic use consistent with its small dose and the potential of external factors to diminish its impact.

What external factors may have impacted the results?

…There was substantial questioning of the ALLHAT findings by recognized hypertension authorities, as well as by the pharmaceutical industry, that likely reduced the potential impact of the results on clinical practice.

So the authors suggest that using inexpensive, effective generic drugs for hypertension are being undermined by drug companies.

The take home message is that academic detailing, using the methods of drug reps but not their funding, is an effective alternative to pharma-financed education. It so irritates me when I read the original reference and discover it was almost completely misrepresented or misunderstood. I suppose she will be writing for Medical Voices next.

When Consumer Reports discusses cars, it is education. When Chrysler discusses cars, it’s an advertisement, even if they are having Dale Earnhardt Jr. as the discussant.

She also says the lack of pharmaceutical-sponsored education has lead to an increase in the misuse of drugs. No reference. So I went looking. Pubmed? Nothing. Google? The only reference is her article.

Stephen Hanauer, one of the clinical investigators who developed Remicade and who has been paid to speak to doctors about it, explains that as Remicade teaching sessions have been nixed, misuse of the drug has risen and Hanauer thinks that the two phenomena are connected.

The basis of the increased misuse is the experience of Dr. Hanauer. Well. Good enough for me. Lets get him back on the paid speaker trail, ASAP. Patient care depends on it. Even if the literature suggests that it is interaction with drug companies that more commonly leads to more medication mis-prescribing. Who are you going to believe, the published literature or the anecdotes of Dr. Hanauer?

He has been paid to speak. I wonder how much, because the money can be substantial.

However, the largest median payments were for research ($6593; range, $109-$922,239), speakers ($1430; range, $118-$154,188), consulting ($1000; range, $121-$334,180), and unspecified purposes ($1000; range, $100-$331,947).

I have always thought as part of mentioning conflicts of interest at the start of a talk, speakers should be required to give a dollar amount of direct and indirect (food, hotels, airfare etc) payments they have received. Does anyone think $154,188 isn’t going to buy something? I know if I were making that kind of cash as a speaker in this economy, I would want to keep the cash cow alive. But I really shouldn’t suggest others are subject to base motivations for their actions — I sound too much like Mike Adams.

Of course, if the drug company doesn’t provide food, no one will come to the talks.

But surely there must be other options. Can’t doctors meet with the experts in the absence of fancy cheese? Not necessarily. Teaching sessions often take place during the lunch hour. As Hanauer, who practices at the University of Chicago School of Medicine, describes, the elimination of paid lunches sent hungry doctors to the cafeteria instead of the lecture hall. “But the lines were so long that they missed the conference,” he says. “So attendance at our grand rounds conferences went to miniscule.” Now the doctor has a sandwich but isn’t up to date on how to treat a serious disease. That may sound silly, but it’s often the mundane reality. “There are sometimes times when residents have to choose between lunch and a conference,” Richard Goldberg, an oncologist at the University of North Carolina, wrote in an e-mail.

I just had to laugh. At my hospital system, administration takes education seriously and there is lunch provided at Grand Rounds. We get a sandwich and a lecture. University of Chicago is evidently not all that serious about the ’school’ part of their title. Or, I don’t know, try planning ahead: it is Wednesday and we’ve had Grand Rounds every Wednesday at noon for the last 100 years, maybe I will pack a sandwich. Pu-lease. If my doc doesn’t have enough on the ball to plan for eating at conference, I don’t want them prescribing my Remacaid.

Of course, I don’t know how I manage to keep up in my field with no pharmaceutical support. I can’t read journals, can’t use websites like Medscape (I am a paid blogger for Medscape, so of course I suggest them), can’t go to conferences, can’t listen to podcasts, can’t attend meetings, can’t do the MKSAP. There is such a wealth of educational opportunities in medicine to keep up you have to be either lazy or stupid not to find them. It does takes discipline and time to keep up. I spend a minimum of 24 hours a month on CME. If you want job that requires no continuing medical education, perhaps you should be a naturopath or homeopath. Part of being an MD is the endless education it takes to stay current.

The problem is that drugs have more and different uses than the FDA approved indications and the only way that information can be disseminated is pharma sponsored education.

Only way? Sure worked for Neurontin.

…ParkeDavis executive reportedly told Franklin,

I want you out there every day selling Neurontin. . . . We all know Neurontin’s not growing for adjunctive therapy, besides that’s not where the money is. Pain management, now that’s money. Monotherapy [for epilepsy], that’s money. . . . We can’t wait for [physicians] to ask, we need [to] get out there and tell them up front. Dinner programs, CME programs, consultantships all work great but don’t forget the one-on-one. That’s where we need to be, holding their hand and whispering in their ear, Neurontin for pain, Neurontin for monotherapy, Neurontin for bipolar, Neurontin for everything. I don’t want to see a single patient coming off Neurontin before they’ve been up to at least 4800 mg/day. I don’t want to hear that safety crap either, have you tried Neurontin, every one of you should take one just to see there is nothing, it’s a great drug…

The Neurontin marketing plan consisted of both general strategies such as the promotion of Neurontin use among high-prescribing physicians and cultivation of thought leaders and tactical programs. Local physicians were recruited, trained, and paid to serve as speakers in “peer-to-peer selling” programs, which the company saw as “one of the most effective ways to communicate our message.” Academic leaders were solicited with educational grants, research grants, and speaking opportunities; some received up to $158,250 over a 4-year period. Advisory boards and “consultants” were convened so that the firm could cultivate relationships with them and deliver “a hard-hitting message about Neurontin.

Marketing “tactics” included education, publications, and research whose promotional intent was disguised, in addition to more transparent activities, such as advertising and sales visits. “Educational programs” reflected the belief that “medical education drives this market!” Teleconferences involving practicing physicians were moderated by physicians who were paid as much as $176,100 over 4 years. ParkeDavis formed speakers bureaus and sought “strong Neurontin advocates and users to speak locally for Neurontin.” “Unrestricted educational grants” were made to for-profit medical-education companies that produced programs to discuss unapproved uses of Neurontin and to grant credit approved by the Accreditation Council for Continuing Medical Education.

Yep. That’s what I want for continuing medical information, programs that resulted in payments “of more than $430 million to resolve criminal charges and civil liabilities.” Of course, industry has learned their lesson. I can trust industry, and my patients life and health, with information about off-label indications provided by an industry that stands to profit from giving me the information. “There’s an old saying in Tennessee — I know it’s in Texas, probably in Tennessee — that says, fool me once, shame on, shame on you. Fool me, you can’t get fooled again.”

She concludes:

But the entanglement caused by for-profit drug development can’t be undone by eliminating the free lunch. As one physician suggested, perhaps pharmaceutical companies should be required to pay for medical education. After all, if companies are going to unleash new drugs into the world, shouldn’t they be responsible for teaching people how to use it? Ousting commercial support is creating a huge chasm in medical education, leaving doctors not only hungry but also starved for knowledge.

No, but it is a start. Physicians can take responsibility for their own education. And lunch isn’t free. In the end, our patients pay for it. The price of drugs, in part, takes into account the cost of advertisement. Maybe you feel it is fine for the underinsured to pay $1500 out of pocket for a 10-day course of linezolid, but I can’t justify my patients indirectly subsidizing my pizza and education.

While we are at it, let’s have MacDonalds be responsible for teaching nutrition, Nintendo teach us about fitness, lobbyists determine congressional voting, tobacco companies provide research cancer and oil companies tell us the cause of global warming. “The only way that information can be disseminated is ‘fill in the industry’ sponsored education” indeed.

Perhaps as professionals, doctors should be responsible for their own education, especially when the lives and health of their patients may depend on it.

The conclusion of the only other journal article referenced sums it up:

… attending sponsored CME events and accepting funding for travel or lodging for educational symposia were associated with increased prescription rates of the sponsor’s medication. Attending presentations given by pharmaceutical representative speakers was also associated with non rational prescribing.

That’s the chasm being created by banning pharma-sponsored education: more rational prescribing, more physician integrity and patient trust, better education and information. I can live with that, and so can my patients.

NB: I posted this on Health Care Renewal a couple of days ago, figuring that Dr. Gorski’s post would suffice for the SBM readership (he and I had discussed the topic while at TAM8 last week). But Managing Editor Gorski has asked me to repost it here, which I’m happy to do. I am especially pleased to demonstrate that I am capable of writing a shorter post than is Dr. Gorski.

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On July 7, President Obama appointed Dr. Donald Berwick as Administrator of the Centers for Medicare and Medicaid Services (CMS). Dr. Berwick, a pediatrician, is well known as the CEO of the non-profit Institute for Healthcare Improvement (IHI), which “exists to close the enormous gap between the health care we have and the health care we should have — a gap so large in the US that the Institute of Medicine (IOM) in 2001 called it a ‘quality chasm’.” Dr. Berwick was one of the authors of that IOM report. His IHI has been a major player in the patient safety movement, most notably with its “100,000 Lives Campaign” and, more recently, its “5 Million Lives Campaign.”

Berwick’s CMS gig is a “recess appointment”: it was made during the Senate’s July 4th recess period, without a formal confirmation hearing—although such a hearing must take place before the end of this Senate term, if he is to remain in the position. A recent story suggested that Obama had made the recess appointment in order to avoid a reprise of “last year’s divisive health care debate.” The president had originally nominated Berwick for the position in April, and Republicans have opposed “Berwick’s views on rationing of care,” claiming that he “would deny needed care based on cost.”

A “Patient-Centered Extremist”

If there is a problem with the appointment, it is likely to be roughly the opposite of what Republicans might suppose: Dr. Berwick is a self-described “Patient-Centered Extremist.” He favors letting patients have the last word in decisions about their care even if that means, for example, choosing to have unnecessary and expensive hi-tech studies. In an article for Health Affairs published about a year ago, he explicitly argued against the “professionally dominant view of quality of health care”:

I think it wrong for the profession of medicine—or any other health care profession, for that matter—to “reserve to itself the authority to judge the quality of its work.” I eschew compromise words like “partnership.” For better or worse, I have come to believe that we—patients, families, clinicians, and the health care system as a whole—would all be far better off if we professionals recalibrated our work such that we behaved with patients and families not as hosts in the care system, but as guests in their lives. I suggest that we should without equivocation make patient-centeredness a primary quality dimension all its own, even when it does not contribute to the technical safety and effectiveness of care.

A new definition. My proposed definition of “patient-centered care” is this: The experience (to the extent the informed, individual patient desires it) of transparency, individualization, recognition, respect, dignity, and choice in all matters, without exception, related to one’s person, circumstances, and relationships in health care.

Does this mean that Dr. Berwick would also eschew professional, i.e., expert, judgment in favor of patients’ wishes? In a word, yes:

Evidence-based medicine sometimes must take a back seat. First, leaving choice ultimately up to the patient and family means that evidence-based medicine may sometimes take a back seat. One e-mail correspondent asked me, “Should patient ‘wants’ override professional judgment about whether an MRI is needed?” My answer is, basically, “Yes.” On the whole, I prefer that we take the risk of overuse along with the burden of giving real meaning to the phrase “a fully informed patient.”

Dr. Berwick is not so naive as this opinion might suggest. He envisions a “mature dialogue” in such a case, and argues that “if, over time, a pattern emerges of scientifically unwise or unsubstantiated choices…then we should seek to improve our messages…” He also admits that there might be an occasional patient whose demands are so unreasonable that “it is time to say, ‘No’.” That exception, he argues, should not dictate the rule.

There are situations in which most civilized people would agree with Dr. Berwick’s view of ‘patient-centeredness’. In both the Health Affairs article and in his recent address to the 2010 graduating class of the Yale School of Medicine, he offered real examples of petty, arbitrary hospital rules causing unnecessary sorrow for patients and their loved ones. It is in such contexts that he makes a convincing case that health professionals ought to behave “as guests in their lives.” In an interview for the New York Times, he argued:

We don’t have a standard of services or processes that are comfortable for patients. We have built a technocratic castle, and when people come into it, they are intimidated.

Nothing to disagree with there. To create that standard, moreover, would not undermine settled medical practice ethics—it would celebrate them, even as it rightly embarrasses the profession for having taken so long to do so.

Enter the Woo

Eschewing the scientific basis for modern medical practice, however, is another matter. In February of 2009, Dr. Berwick gave a ‘keynote’ address at the IOM and Bravewell Collaborative-sponsored Summit on Integrative Medicine and the Health of the Public. He shared the podium with Mehmet Oz, Dean Ornish, Senator Tom Harkin, and other advocates of pseudoscientific health claims. I wrote about the conference at the time, mainly to call attention to its misleading use of the term “integrative medicine“: literature emanating from the Summit characterized it as “preventive” and “patient-centered,” whereas the only characteristic that distinguishes it from modern medicine is its inclusion of various forms of pseudomedicine.

I noticed that Dr. Berwick was on the speaker roster, which I found disappointing: I imagined that he had either gone over to the Dark Side or, perhaps, was sufficiently naive about the topic to have been duped; or, more likely, that he had cynically accepted the offer to further his ambitions. I didn’t bother to listen to his speech until the CMS appointment was announced a few days ago.

It is troubling, to say the least. Dr. Berwick did not argue, as he had in the NYT piece, that “If we doctors feel a person is going to make unwise choices, we have to take on the responsibility of being teachers, educators and informers.” Rather, he praised his fellow speakers, most of whom were spouting nonsense, for their “reach” and “eloquence.” He praised the IOM for its “glorious record…in pursuit of better designs in health care…traditional, allopathic curative care and now migrating into this distinguished and important new arena.” He mentioned homeopathy and acupuncture, not to wonder why they should be promoted as effective, but merely to warn that they will fail—presumably in some economic sense—if they try to compete with each other for reimbursement.

Such language, and Dr. Berwick’s very presence at the Summit, were a far cry from advocating “patient-centeredness.” What they amounted to was a generous endorsement of pseudoscientific practices and of the socio-political movement that promotes them. Even granting some naivete on his part (he called himself “an amateur at this topic”), he must have known this. Such an endorsement, unlike tearing down the “technocratic castle,” has ethical implications at least as profound as those that Dr. Berwick tacitly or explicitly relies upon to support his arguments for patient-centeredness.

“Physicians have no Immunity to Moral or Ethical Constraints”

The relevant medical ethics treatises (reviewed here) are in substantial agreement that it is unethical for physicians to prescribe scientifically implausible methods or to refer patients to other practitioners for the same purpose. They are also in agreement that it is unethical to prescribe a placebo to a patient while claiming that the treatment has specific biologic activity—a point that has been vigorously argued in the UK this year, with regard to homeopathy. These ethical tenets are not mere odes to nerdy, sciency thinking; they are matters of honesty and integrity—fundamental bases for ethical interactions between physicians and patients.

In 1983, philosophers Clark Glymour and Douglas Stalker published an article in the New England Journal of Medicine titled “Engineers, cranks, physicians, magicians.” They framed modern medicine as follows, comparing it to what was then called “holistic medicine” (the article is quoted extensively here):

Medicine in industrialized nations is scientific medicine. The claim tacitly made by American or European physicians, and tacitly relied on by their patients, is that their palliatives and procedures have been shown by science to be effective. Although the physician’s medical practice is not itself science, it is based on science and on training that is supposed to teach physicians to apply scientific knowledge to people in a rational way.

The practice of medicine in the United States and in other industrialized nations is a form of consultant engineering…

That statement is just as accurate now—even more so, in this era of Evidence-Based Medicine—as it was nearly 30 years ago, even if some might find the likening of medicine to engineering displeasing. Nor is it at odds with almost any definition of “patient-centeredness,” other than one that presumes that the patient’s desires trump the physician’s ethics:

A physician engineer can act as consoler; nothing in either logic or social psychology forbids it. But certain combinations are impossible or extraordinarily unlikely. A physician engineer cannot honestly claim powers of magic or occult knowledge. The principles governing scientific reasoning and belief are negative as well as positive, and they imply that occult doctrines are not worthy of belief. Moreover, physician engineers have no immunity to moral or ethical constraints. On the contrary, they are by training and by culture enmeshed in a tradition of rational thought about the obligations and responsibilities of their profession.

Dr. Berwick—if he really believes what his presence and words at the “Integrative Medicine” Summit imply—is playing with ethical fire. (If, as I hope, he doesn’t really believe those things, he’s playing with ethics of another kind). Will we begin to see pseudomedicine “integrated” into Medicare and Medicaid? That is certainly the expectation of those who observed Dr. Berwick’s performance at the Summit, and who appear intent to hold him to his word.