November 1st, 2008 The headline of a recent New York Times article was cause for public alarm: “Half of Doctors Routinely Prescribe Placebos.” A casual glance might have given the impression that doctors dispense sugar pills half the time, but this would be a misreading of the reported finding. The article followed a research report that appeared in the October 23rd issue of BMJ (formerly the British Medical Journal). A national survey of 679 U.S. internists and rheumatologists found that half routinely prescribe medication when, in the opinion of the clinician, the benefits “derive from positive patient expectations and not from the physiological mechanism of the treatment itself.”
This definition goes well beyond our usual notion of a placebo as a fake medication, e.g., a sugar pill or an injection of sterile salt water. In fact, only two or three percent of the doctors reportedly used these. Much more commonly the “placebo” consisted of over-the-counter analgesics (painkillers), vitamins, and sometimes antibiotics and sedatives. Leaving the loaded word “placebo” out of it, half the doctors admitted to offering some treatments purely because they are psychologically comforting to their patients.
This nicely illustrates something psychiatrists, and many alternative/complementary healers, have known for a long time: There is no sharp distinction between mind and body. Each affects the other. Feeling ill and seeking help are not mechanical processes, like the engine light coming on in one’s car. A doctor’s attention and concern can help a patient feel better even if no treatment is given. Often medications work for no good reason, or fail to work when they “should.” The doctor-patient relationship is a complex dance of expectations and hopes, full of subtle cues and interactions at conscious and unconscious levels. Western medical science shines a light so bright it can blind us as well as illuminate. Of course doctors sometimes offer remedies that are primarily psychological. How could anyone have thought otherwise?
While I have never given anyone a sugar pill, I have often been faced with choosing among several equally acceptable antidepressants for a patient. The published efficacies, side-effect profiles, and even costs of the medications are essentially the same. Just as I am about to throw a dart into my mental dartboard to pick one, the patient tells me of a friend who had great success with one of them. Suddenly the choice is clear. In such situations I (enthusiastically) prescribe that particular medication due to “positive patient expectations,” and not due to “the physiological mechanism of the treatment itself.” To take another example, occasionally patients tell me that plain aspirin or Tylenol helps them sleep. Who am I to tell them they must be mistaken?
The greatest cliche of medicine, “take two aspirin and call me in the morning,” is a testament to this principle in internal medicine, rheumatology, and similar specialties. If a newspaper headline in 2008 can shock and alarm us over a practice as old as this cliche, Western culture has strayed very far indeed from the essence of healing.
October 25th, 2008 Lately I’ve been pondering one of my professional roles, that of gatekeeper. Among my other duties, I help patients access things they already know they want, but cannot get without my help. Often this boils down to writing a “doctor’s note”: documentation to excuse a work or school absence, qualify for a discount transit pass, receive state disability payments, and so forth. The government or employer relies on me to verify the patient’s entitlement claim. Metaphorically I stand at the gate, deciding whether to grant my patient passage.
This role seems slightly odd if I think about it too long. After all, I do not work for the government or my patient’s employer, and do not really owe them this service. I act on behalf of my patient. Yet professional ethics compel me at times to write reports exactly contrary to a patient’s reason for seeing me in the first place. For instance, sometimes I must say that, in my view, a patient no longer qualifies for state disability. Although I work for my patient, I can end up opposing his or her wishes (which may be different than his or her ultimate interest).
Perhaps the starkest example of this is applying an involuntary legal hold when a patient is acutely suicidal or otherwise dangerous. Psychiatrists tend to think of this as acting in the patient’s best interest — reassuring ourselves that most patients would thank us later when in a calmer and more rational state of mind. In fact, many do. However, some critics of psychiatry point this out as evidence that we are “working for the state,” not our patients.
A related awkward twist on the gatekeeper idea is my growing role as a medication gatekeeper. By this I mean being asked to write a “doctor’s note,” in the form of a prescription, for a medication the patient has already decided he or she wants. A number of potential patients call nowadays having researched their symptoms online, or in some other way having concluded they need a specific medication. They are not seeking my professional opinion or advice, just the prescription.
As with the other kinds of “doctor’s notes” mentioned above, professional ethics compel me to do a good-faith evaluation, and only write the prescription if I believe it is medically indicated. A few patients have fired me in frustration when I did not write the prescription they wanted, my carefully explained rationale notwithstanding.
This is another situation that seems slightly odd if I think about it too long. For one thing, prescription drugs are available from other countries online and without a prescription, although ordering them this way is illegal in the U.S. and potentially dangerous. Thus, in calling me, patients who could otherwise order directly online are taking extra time and expense to get medications the legal and safe way. Yet they are doing so in a manner that attempts to sidestep the safety features built into the process.
Government oversight and regulation of drugs in the U.S. extends back to the late 1800s and saw a turning point in the 1938 Food, Drugs, and Cosmetics Act. Soon after its passage, the FDA began to identify drugs considered unsafe for direct use by patients; they would require a physician’s prescription. However, all legal medications were available over-the-counter until the Durham-Humphrey Amendment of 1951, which revised the 1938 Act to formally distinguish between prescription and over-the-counter medications. This was when physicians became medication gatekeepers. The idea was to protect the public from itself, to impose controls on the use of substances that are addictive, easily misused, laden with common and/or dangerous side-effects, or carry other possibly hidden risks.
However, Americans have decidedly mixed feeling about the state’s role in “protecting the public from itself.” Traditionally, liberals have favored it and conservatives have opposed it when an issue (e.g., gun control) is framed as one of safety. Conversely, when an issue (e.g., recreational drug use) is framed as a threat to the moral fiber of a community, conservatives favor state control while liberals oppose it.
Prescription medications carry both safety and “moral fiber” implications, and often I feel caught in the middle of these swirling political eddies. Not only am I compelled by professional ethics to be a medication gatekeeper if someone sees me for a prescription, it frequently strikes me as the only sensible arrangement. I know about diseases, drug interactions, and other important, relevant facts that the average person does not. In some cases self-prescribing would be like walking through a minefield blindfolded. But other times I find myself wishing the patient had left me out of the equation entirely and simply ordered online. Adult Americans make many, many decisions for ourselves that may be ill-advised and shortsighted, but we are free to make them anyway. In those cases I feel I am part of an interaction that neither party really wants.
Being a gatekeeper is not why I became a psychiatrist. For most of us, it is an awkward, ill-fitting role for a profession that ideally reflects empathy, collaboration, and cooperation. I much prefer being a medication advisor than a rubber-stamper (or roadblock); fortunately, psychotherapy is by nature collaborative and rarely feels like gatekeeping. I am sure I will continue to ponder all of this, and I welcome your thoughts as well.
October 22nd, 2008 Daniel Carlat MD of the popular Carlat Psychiatry Blog, linked to my post about nearly becoming an unwitting speaker for Wyeth. He recounted his own experience speaking for Wyeth in a great New York Times Magazine article last year. Thank you, Dr. Carlat, for welcoming me into the psychiatric corner of the blogosphere.
October 20th, 2008 In my last post, I wrote about how the pharmaceutical industry funds half of the continuing medical education (CME) of doctors, and the risk this may pose for bias in what doctors learn. The influence of industry money on health education goes far beyond this, though. In 2004 I learned first-hand how insidious this influence can be.
I was the medical director of the mental health clinic at California Pacific Medical Center ( CPMC) in San Francisco. One day the hospital’s Community Health Resource Center asked me to participate in a public talk on depression and its treatment. The seminar at a large downtown hotel would feature an actress named Delta Burke who had triumphed over her own depression, a representative from the Mental Health Association of San Francisco, and myself. I would spend 20-30 minutes on recognizing clinical depression and outlining treatment options.
I’ve been an educator my whole career, and was immediately enthused by this opportunity. It was sponsored by my hospital, the Mental Health Association of San Francisco, and a public relations firm I had not heard of, Porter Novelli. Although I was wary of drug companies using such talks as marketing tools, there was no apparent industry connection. I agreed to do it, and asked the caller for any written materials they had to clarify the format.
A number of weeks passed. It may have been only a week before the talk when I received a press release, an outline of the event, and a promotional flyer headlined “Life Beyond Depression: Delta Burke Speaks Out.” I learned that San Francisco was the fourth stop of a national tour called “GOAL! (Go On And Live!)” featuring Ms. Burke. Her message was that, “… it is possible to virtually eliminate the emotional and physical symptoms of depression and go on and live.”
I, too, was listed as a speaker on the press release. It said I would “discuss the warning signs of depression, highlight treatment options, and explain why the virtual elimination of symptoms is the goal of treatment.”
The repetition of this “virtual elimination” phrase made me suspicious. I went to the GOAL website (now defunct). It looked like an innocuous public education effort about depression. There was no mention of any specific antidepressant, although “virtual elimination” was mentioned there, too. Then I saw that the site was copyrighted by Wyeth Pharmaceuticals, makers of the antidepressant Effexor. It all started to make sense: Effexor’s advertising campaign at the time touted the drug’s ability to lower scores on the Hamilton Depression Rating Scale to near-normal levels, i.e., to “virtually eliminate” symptoms.
I explored the Porter Novelli website until I found a page that described their public relations efforts on behalf of their client Wyeth and its product Effexor, including the GOAL website and the series of talks by Ms. Burke. (Although that page is now gone, this blog entry from 2002 clearly links Wyeth, Porter Novelli, the “virtual elimination” phrase — and even Dr. Nemeroff, who was the lead investigator of the study that triggered Wyeth’s promotional campaign. A 2002 Wyeth press release documents the campaign as well.)
I felt I had been duped. I imagined turning the tables by standing at the lectern in the Grand Hyatt ballroom, and instead of giving a talk crafted by Wyeth’s PR firm, I would instead astonish everyone by revealing the subterfuge. I would declare that the audience and I were lured there under false pretenses, as a crass marketing ploy. My denouncement would make the papers.
Of course, it didn’t happen that way. I told the Community Health Resource Center I refused to participate in a veiled pharmaceutical promotion, and suggested they follow suit. Instead they called my chairman to find a last-minute replacement, while someone from GOAL called and pleaded with me to reconsider. My chairman opined with some irritation that our department was obliged to provide someone. And so he did the talk himself, presumably extolling the “virtual elimination” of symptoms just as Wyeth and their PR firm had planned.
My chairman and the Community Health Resource Center, and perhaps the city’s Mental Health Association as well, saw this event as constructive public outreach despite the commercial overtones. I could not. It concerns me when education for the public, or CME for physicians, conceals a disguised ulterior motive. For me, this experience underscored how easy it is to re-brand product promotion as education, and how vigilant we doctors must remain in order to avoid unwitting enlistment in those commercial efforts.
October 18th, 2008 On October 3rd the New York Times reported that several prominent research psychiatrists are under Congressional investigation for failing to report income derived from consulting and speaking for pharmaceutical companies. One of the field’s most renowned and prolific researchers, Charles B. Nemeroff MD of Emory University, stands accused of concealing over $1 million since 2000, thereby violating federal rules aimed at avoiding conflicts of interest in medical research. Senator Charles E. Grassley (R-Iowa), leader of the Congressional inquiry, has also sponsored the “Physician Payment Sunshine Act,” which would require industry to publicly list payments to doctors. Several states already require this, and two drug companies recently announced they will voluntarily list payments to doctors starting next year, even without legislation.
Senate allegations of million-dollar malfeasance are, unfortunately, just the tip of the iceberg. While professional journal articles, newspaper op-ed contributors, and bloggers (e.g., here, here, and here) have documented the problem for years, the public still has little grasp that over half of all continuing medical education (CME) in the US is paid for, legally, by commercial interests. This often takes the form of sponsored talks: Prominent physicians like Dr. Nemeroff are paid to speak to medical audiences about a specific disorder and its various treatments — one of which is nearly always a product of the sponsoring company.
To address the clear potential for bias, CME speakers are required to disclose to the audience any financial ties to industry. However, it is unclear to what extent disclosure matters if the talk is subtly biased anyway. After all, television commercials clearly disclose the company behind an overtly biased sales pitch, yet this form of advertising remains effective. Corporate sponsors also argue that competition among products leads to the necessary scrutiny to arrive at the truth — speakers for Company A will critique drug B, and vice versa. Meanwhile, the sponsored speakers themselves declare their own neutrality (“Money can’t buy me!”), sometimes pointing out that, like Dr. Nemeroff, they are sponsored by so many different companies that they favor no particular product.
Since regular attendance at CME activities is required to maintain a medical license, the mere possibility that this information is slanted ought to raise alarms in the medical community and in the public at large. Yet only a few studies have been done to find out. A recent review of ten empirical studies concluded that “there is no empirical evidence to support or refute the hypothesis that CME activities are biased.” This conclusion has been systematically critiqued by psychiatrist Daniel Carlat MD here and here.
While conflicts of interest during presentations are worrisome enough, the biomedical research being discussed at CME talks is itself heavily funded by industry, leading to concerns (and some troubling data) about bias at even this most basic level of medical knowledge.
The ethical issues here are almost too obvious to point out. Physicians are duty-bound to recommend the best treatment for a given patient, not the treatment presented most persuasively by an industry-paid speaker. Willing receptivity to a possibly biased talk is little better than prescribing possibly tainted medication. Sponsored speakers themselves ought to reflect on the ethics of giving talks they may subtly slant despite their own best intentions. It may be sheer hubris to imagine that one can avoid any hint of favoritism when one’s speaking fee is paid by the manufacturer of a product under discussion. Stepping further back, educational institutions such as medical centers that review and approve CME ought to consider whether the industry money coming in justifies the potential bias coming out. And stepping back again, the medical community as a whole should assess the price paid in professionalism and public trust when it accepts industry largesse.
I’m sorry to report that psychiatry is one of the medical specialties most accepting of Big Pharma money. As a matter of principle, I avoid nearly all industry-sponsored CME (occasionally it is virtually unavoidable), as well as all direct marketing contact with sales representatives. In my next post, I will tell how I nearly became an industry speaker myself without realizing it.
October 17th, 2008 Life seems stressful these days. With the current economic crisis and impending national election, there is a sense of instability in the air. Many Americans have seen their retirement investments dwindle, many others cannot find car or home loans. Most of us wonder what the future will hold.
Acquaintances occasionally ask me if this situation is “good for business.” Do stressful current events lead more people to seek psychiatric help?
At least in the case of economic downturns, apparently not. A recent Wall Street Journal MarketWatch article says that mental health visits decrease in bad economic times, with unfortunate results for patients. But how about seeing a psychiatrist to cope with other stressful events?
In my experience, people either seek my help for internal issues unrelated to current events, or for a repeated pattern of over-reaction to such events — basically, something about them, not the situation. The only common exception is the death of a loved one.
This focus on changing oneself differentiates psychiatry from counseling or “coaching.” Career counselors and life coaches help clients deal with life challenges, without attempting to change the client’s personality or coping skills in any fundamental way. Talking things over with friends or family is similar: You are who you are, the problem is the situation and how to deal with it.
Tranquilizers, too, can help a person deal with stress without changing the person in any fundamental way. Tranquilizers are prescribed mostly by primary-care doctors like internists, family practitioners, and Ob-Gyns. They are best used only occasionally and for short periods of time (days not weeks). Psychiatrists also prescribe tranquilizers, although rarely as the main treatment for a patient’s problems.
Psychotherapy, conducted by a psychiatrist, psychologist, or other mental health professional, aims for more than this. While we can’t do anything about the stock market, we can help clients cope better with stress when it does arise. This is akin to the old saying, “Give a man a fish and he eats for a day. Teach him to fish and he eats for a lifetime.” In addition, psychiatrists are medical doctors who can diagnose and treat conditions, like major depression, that impair coping across the board. Whether the psychiatric treatment consists of medications, psychotherapy, or both, the focus is on the patient, not the stressful situation.
October 15th, 2008 Sometimes potential patients ask whether I am a psychopharmacologist. Often they are not sure what the word means, but have been advised to seek one by a doctor, family member, or friend.
A psychopharmacologist is a psychiatrist who specializes in medication management. It is a self-applied label, as there is no special credential or license for this. All psychiatrists are qualified to prescribe medication. Some make this a primary practice focus, and develop expertise with complicated medication issues. Others virtually never prescribe medication, focusing instead on psychotherapy or some other aspect of practice. Most psychiatrists, at least here in the Bay Area, are somewhere in between.
I am not a psychopharmacologist. My practice leans toward psychotherapy. Nonetheless, like most psychiatrists, I have prescribed plenty of medication over the years. I weigh a variety of treatment options, and try to avoid a “one size fits all” approach. Rarely, a situation of great medical complexity or mystery arises in which I believe a patient would be better served by a true specialist in psychiatric medication — a psychopharmacologist. To be honest, it doesn’t happen very often.
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