The Placebo Effect: Debunking the Distortion of the Media Lens

The quality of national medical reporting continues to horrify my sensibilities: there unfortunately remains a widespread lack of sophistication in the translation of medical discoveries to information that is meaningful and relevant to the general public. The most recent example is a study in the BMJ (formerly British Medical Journal) “Prescribing “placebo treatments”: results of national survey of US internists and rheumatologists” (BMJ 200;337:a1938). In this study, the authors surveyed 679 physicians (approximately 50% internal medicine physicians, 50% rheumatology specialists) with the goal of ascertaining their self-reported practices of prescribing placebos. The authors conclude that “US internists and rheumatologists commonly recommend ‘placebo treatments.’ Vitamins and over the counter analgesics are the most commonly prescribed. Physicians who use placebo treatments may not be fully transparent with their patients about their use. Where, or under what circumstances, recommending or prescribing placebo treatments is appropriate remains a topic for ethical and policy debates.”

Given the fast pace of news reporting in the age of the Internet, it would not be surprising if the vast majority of medical correspondents writing on this topic did not read the five page research article in full. The more likely case is that the writers skimmed the half-page abstract and extrapolated from the audacious claims of the authors. Accordingly, the claims expand from “half of US internists and rheumatologists commonly recommend placebo treatments” to “half of US physicians” to “US physicians regularly prescribe placebos.” While a comprehensive critical review of the research article might only be feasible to well-educated physicians and researchers with more time to mull over the details, the one paragraph “Study Limitations” section just above “Conclusions” is not out of reach of the general reader. The authors, as is required of writers publishing in respected medical journals, openly discuss the significant limitations to their study:

• “Moderate response rate“: The survey’s response rate was 57% and hardly allows for convincing generalization to the population of physicians targeted.

• The survey was attached to a broader survey on Complementary and Alternative Medicine (and the study was funded by the National Center for Complementary and Alternative Medicine (NCCAM), and Department of Bioethics, at the NIH), and the authors appropriately note that the physicians who responded to the survey may be more predisposed to prescribing placebos in association with more open attitudes toward alternative medicine practices (which often rely heavily on the placebo effect for therapeutic efficacy). Many physicians view alternative medicine practices unfavorably or with a substantial degree of skepticism, and it is less likely that this large population of physicians were represented in this study.

In addition to these limitations noted by the authors, there are other important drawbacks to the study:

• Selection Bias: The authors picked internal medicine and rheumatology, “a group of physicians who commonly treat patients with debilitating chronic clinical conditions that are notoriously difficult to manage.” In doing so, the authors are unable to convincingly generalize their findings to the wider population of physicians that includes other medicine subspecialties (cardiology, pulmonology, gastroenterology, dermatology, nephrology, endocrinology, etc.), surgical specialties, obstetricians and gynecologists, psychiatrists, neurologists, and other “generalists” such as pediatricians, geriatricians, emergency medicine physicians, and family medicine physicians. Furthermore, these patients are those that are most likely to use alternative medicine therapies due to the often insufficient treatments options provided by allopathic (Western) medicine: current medication regimens, surgical treatments, or behavioral or physical therapies may offer modest or moderate benefits without a complete (or more effective) cure (that patients are seeking). Nonetheless, the authors inappropriately generalize in their conclusions, and in making a falsely generalized claim, allow medical news reporters to sensationalize the story. The medical news reporters are equally at fault for failing to realize that these two groups of physicians do not represent the entire population of U.S. physicians. Looking at it another way, most Americans do not have “debilitating chronic clinical conditions that are notoriously difficult to manage,” and not all physicians regularly treat the patients that do. [I wonder if these medical news reporters have also written in the past about excessive subspecialization in American medicine, and yet now try to contend that internists are representative of the whole population of physicians?]

• Handpicking the Disease: The survey provided by the authors asks physicians about how they would treat fibromyalgia in a theoretical patient. The authors and medical news reporters are quick to conclude that this example is representative of the treatment of all diseases, but fibromyalgia is not. Fibromyalgia is a pain disorder of unknown etiology and, more relevant to this discussion, has insufficient treatment options at this time. A wide variety of medications are recommended or suggested as being potentially useful in the treatment of this disease, including antidepressants, pain killers (such as acetaminophen), and anxiolytics (such as benzodiazepines) in addition to behavioral modification, massage therapy, etc. The disease likely has psychiatric, neurological, orthopedic, and rheumatological aspects, but in the absence of a focused interdisciplinary effort to determine the best standard of care for this disease, internists and rheumatologists are left without standards.

Review, then, the design of this study:
Step 1: Pick a disease that is notoriously difficult to treat -> fibromyalgia
Step 2: In the design of the survey, have a theoretical situation that explains that clinical trials have shown the efficacy of a dextrose pill (a sugar pill or “placebo”, e.g. evidence-based medicine suggesting the efficacy of a drug of unknown mechanism)
Step 3: Ask the physicians if, based on this “evidence,” they would consider prescribing the medication for a disease with no universally effective standard of care

The results of the survey were moderate: 24% very likely, 34% moderately likely, 31% unlikely, 10% definitely not (remember: among a group of physicians who might not be altogether opposed to the idea of alternative medicine). Even then, the authors use this “sugar pill” example and extrapolate the results to other “placebos”: over the counter pain medications, vitamin pills, sedatives, and antibiotics. However, these medications are not necessarily placebos: they have demonstrated physiologic effects on the body that can be suspected, with reason, to have an positive effect on the management of a disease. For example, fibromyalgia is a pain disorder. Doesn’t it make sense to treat a pain disorder with acetaminophen, a widely used and available pain killer? (On the other hand, non-steroidal anti-inflammatory drugs, or NSAIDs, have not been found to be as effective and are not as likely to be prescribed.)

Notably, the authors do state they asked about specific drugs used as placebos with an explicit use of the term “placebo” in the question, and I do not contend that there are no physicians who knowingly prescribe “placebos.” However, I do not think that most physicians, even aware of the power of the placebo effect in improving patient outcomes, would regularly use placebos that might not also have a physiologic effect, such as painkillers, sedatives, or antibiotics. The authors interpret the notion that these physicians “recommend treatment primarily to enhance patient expectations” as meaning that the physicians are intentionally deceiving patients. I suspect that this issue of medical ethics is overblown: while U.S. physicians are no longer permitted by the medical establishment to withhold important treatment information from patients (as a means of influencing their decisions), it is precisely within the normal bounds of a physician’s clinical reasoning, acumen, and approach to determine how they will discuss treatment options with their patients. Is it wrong for a physician to instill positive connotations in a prescribed treatment when saying the following?:

• “This medication doesn’t work for everyone, but when it does, it has worked very well.”
• “This disease doesn’t have a lot of good treatments, but we can try one option at a time of the options we do have to see if one will work for you.”
• “It’s not known what causes the pain, but I can recommend pain medications for you to help deal with that symptom.”

Or must they revert to:

•”This treatment doesn’t work 80% of the time.”
•”This disease doesn’t have any recommended standard of care.”
•”No one knows what causes the pain in your disease. There is no evidence that painkillers help manage this symptom.” [Note: There is also no evidence that stethoscopes help improve patient care. If the study hasn't been done yet, there's no evidence!]

Concluding Thoughts

The authors try to address an ethical issue that they believe represents a degree of deception on the part of physicians in the patient-doctor relationship. Medical news reporters have taken the opportunity to capitalize on this story to continue a long history of attempts to degrade and criticize a profession that is more respected than their own (and generally makes more money). Neither consider the study an attempt by supporters of Complementary and Alternative Medicine to equate allopathic (Western) medicine with alternative medicine practices (relying on the placebo effect). Neither address the possibility that the underlying issue with the “placebo effect” is that its measurable therapeutic efficacy suggests that the treatment of all patients has a psychiatric component and that mental health is addressed in every treatment of every patient.

Caveat of the placebo effect: Publishing your story in a national newspaper doesn’t make it true.

[Disclaimer: I have an intellectual interest in Complementary and Alternative Medicine (CAM) practices and have previously written and argued that more appropriate research should be conducted on the efficacy of CAM therapies. I am also acutely aware of the agendas and motivations fueling research in CAM modalities as well as the experiences of CAM practitioners. I do not specifically support any CAM therapies, but I do think that physicians should be aware of CAM therapies used by their patients and that the field of medicine should find ways of considering other ideas without feeling threatened or insulted. In other words, physicians need to learn to argue intelligently and knowledgeably for or against specific CAM therapies.]

Filed under: Improving Medicine, News Analysis

Like a Doctor

Envy is one word I could use to describe my feelings toward my fiancée’s medical training experiences thus far. In particular, she recently described to me that during her second month of her inpatient Medicine clerkship, she has gone home each day feeling that she, as an individual, has made a significant contribution in the lives and medical care of her patients. Compared to other clerkships, the Medicine clerkship is often one of the most interactive and engaging of training experiences during the third year of medical school as junior students tend to be allocated more responsibility over the care of their patients than in other fields. It is often said at my medical school that once students have completed their Medicine clerkships, they are very well prepared for the training opportunities and challenges in their other clerkships (so it may be advantageous to schedule the clerkship early).

Unfortunately, unlike my fiancée who was able to schedule both Surgery and Medicine core clerkships during the first six months of her junior year, I will not be able to train in Medicine until the second half of my junior year (beginning in January) due to the suboptimal tri-annual lottery system at my school that left me with an undesirable lottery number at the beginning. I do not regret starting off my junior year with Neurology and Psychiatry, but I found myself in an energy-consuming preclinical-to-clinical transition during Neurology and feeling underwhelmed by the under-utilized “patient advocate” student role in the inpatient Psych ward. In Pediatrics, I have again found expectations to be low with respect to student contributions to patient care and have even been rebuffed repeatedly when I volunteered to admit patients on my own (which I had done several times during my Neurology clerkship) despite demonstrating at least a passable degree of competence. My next rotation, Obstetrics and Gynecology, is unlikely to offer more interactivity than my previous rotations, and so I am looking forward to January 5, the start of my Medicine clerkship.

When discussing this notion of student contribution with my stepmom, a teaching physician, she was quick to assert that junior medical students have important roles in medical teams (especially as patient advocates, information collectors, history takers, etc.). While I agree with this idea, I think that self-motivated medical students don’t want to be medical students: we want to be doctors. On a daily basis as medical students, we might be able to hit the ball and advance to first base (e.g. contribute through our regular duties of patient progress notes and exams, collecting data for rounds, etc.), but it is uncommon for us to hit a home run (an individual contribution with significant medical benefit) and even more rare to hit a grand slam and really have our contribution serve as the lynch pin for a patient’s team-based medical care. Some educators use the “RIME” pneumonic mnemonic to describe a medical student’s ideal evolution from Reporter to Interpreter to Manager to Educator. Up to this point, I think I have primarily served as a Reporter (e.g. collecting patient information from the history, physical exam, labs, and other diagnostic studies for the real doctors) and Interpreter (although this is primarily nominal since all of my attending physicians and residents have been excellent clinicians who do not need a medical student to help them interpret the data, so the interpretation has primarily been for my educational practice). Both of these roles can be performed just as well and as easily by those paid to do these jobs: interns, residents, and attendings. The student, at best, can save them time and effort and perhaps even help keep their elders young and on their toes (by asking good questions and by being enthusiastic and interested). Occasionally, I have had the opportunity to serve as Educator for my medical teams: in one instance beyond teaching opportunities mandated by my clerkship or requested by my residents, I made my Neurology team aware of the FDA’s concerns over Avandia/rosiglitazone when we were planning to start a patient on a thiazolidinedione (which steered the decision toward an alternative medication). However, I have rarely had the opportunity to play a significant role in the management of the diseases of my patients, the Holy Grail of the junior medical student.

Nonetheless, I had one small taste of this joyous ability yesterday in a Pediatric Specialty clinic. I was seeing a teenage patient with Sickle Cell Disease who was well-managed and adherent to her treatment regimen and was living the life of an ordinary teen. During this routine checkup, she presented a new problem: severe, recurrent headaches. While I have had the opportunity to occasionally apply my knowledge from Neurology and Psychiatry to perform detailed neurological exams (in the absence of a Neurology consult) and to address psychosocial issues, here was an opportunity for me to actually be the expert. After taking a detailed history of her headaches, I was able to determine that the patient had migraines (rather than a headache related to her Hemoglobin SS disease): the headaches were recurrent and lasted from midday to bedtime, were unilateral without spread, caused sensitivity to light and sound, lacked responsiveness to acetaminophen, were relieved by sleep, and were accompanied by a maternal history of migraines. My attending and I were first considering Excedrin for the patient, an over-the-counter medication that is commonly helpful for migraine patients. However, I was concerned about its ingredients: I knew that it contained acetaminophen and caffeine (a vasoconstrictor), but I could not remember the third agent. The physician and I could not find information on Excedrin in Epocrates (why do some of the most common OTC drugs seem to be missing from this database?), so I decided to check medical resources online because I was concerned about the patient’s concurrent mild thrombocytopenia and anemia. Lo and behold, the third agent is aspirin (which would be contraindicated in this thrombocytopenic patient)! At this point, I recommended to the physician that we consider a one-month trial of a triptan to treat her migraines, and this is the course of action we eventually took. Besides coming up with the right diagnosis and the correct treatment for this patient, I also had the opportunity to educate her about how and when to take the medication and about migraine headaches.

Home run!

Filed under: Apollo's Experiences, Medical School

The Lowest Common Denominator

“Negative ads move numbers, they may, but do we have to go to the lowest common denominator? I don’t think so.” – Senator John McCain

I believe that the attitudes, beliefs, and conduct of our leaders are often reflective of our own: by their example, we consciously or subconsciously find guidelines for acceptable behavior. Unfortunately, I suspect that we are consistently lowering expectations and standards of behavior as we repeatedly aim for the lowest common denominator. While I was disappointed when George W. Bush was elected President of the U.S. for the first time in 2000, I was deeply disturbed when he was reelected in 2004: to me, that result spoke to the generalized acceptance of proven mediocre leadership. Instead of seeking leadership demonstrating intelligence, wisdom, and a deeper and more sophisticated understanding of issues facing our country, many voters preferred leaders who they believe are “more like me.” Speaking in the vernacular, oversimplifying stances on issues, and focusing more on appearance of decisions and actions than on the substance of the decisions and actions appears to have been sufficient for much of the past eight years. While it is fortunate that these tactics have been less successful for the McCain-Palin campaign, it is still disheartening seeing prominent examples of the celebration of unapologetic incompetence.

Unfortunately, I think that the lowering of expectations and standards sometimes penetrates into the training of future physicians in medical school. One of the best trends in medical school education has been the transitioning of preclinical courses to Pass/Fail grading: this new policy has created a widespread change in the attitudes of medical students toward cooperation and teamwork, particularly since today’s medical students were once subjected to the cutthroat atmosphere of premedical education. Accordingly, medical students now like to talk about “gunners,” students who have few or no bounds in what they might do to accomplish the highest level of academic achievement, as social pariahs. Another popular saying is “P=MD”, suggesting that passing is sufficient and perhaps even the ideal goal (e.g. exert the minimum effort that is sufficient to pass).

While I am sympathetic to all of these notions, it worries me where this road might lead. For much of my life, I have bought into the idea that “if I want something done right, I will have to do it myself,” but I have spent the past several years learning, practicing, and teaching leadership through empowerment of others and highly supportive teamwork. In my eyes, the highest priority for a team is the task at hand, not the rewards for each individual, because a good team takes care of each of its members and does not overuse or abuse any member. Last year during a training session led by fourth year medical students to prepare us (second year students) for life on the wards, I spent a great deal of time thinking about the notion of “sandbagging” and the warnings that the senior students had about this behavior. “Sandbagging” typically occurs when a student makes a teammate look bad in the eyes of the residents or attending physician. What bothered me most about this idea was that the fourth year students could not provide a clear definition of this behavior: on the one hand, answering a question asked directly to another student is obviously inappropriate and easy to avoid, but how far do the boundaries of this behavior extend? With this in mind, I was very surprised when a fellow student privately accused me of sandbagging when I asked questions about the student’s patient (that I had helped admit from the ED while on call) and demonstrated some knowledge of the patient’s social history that the student had not elicited. I was immediately apologetic and felt bad about any effect of my actions on his feelings or appearance, but as I thought about the situation more, my remorse turned to questioning and even anger. Later, the resident on the team assured me that my action was not inappropriate, did not seem like sandbagging, and was reflective of the nature of a clinical team: each member contributes and each member should be involved in the care of each of the team’s patients. What, then, was the nature and purpose of the impassioned accusation?

Something seems very wrong to me when our country entertains or supports the idea of electing politicians who lack a sophisticated understanding of policy issues and are proud of their ignorance. Something seems very wrong to me when one’s appearance (as a medical student) is a greater priority than furthering discussion on a patient’s medical care. I, for one, do not buy into the culture of desirable mediocrity, and it helps me better appreciate my classmates and colleagues who show excellence with grace and give me something to aspire to and are willing to help me learn.

Filed under: Apollo's Experiences, Medical School