DIRECT TO CONSUMER ADVERTISING

This is the first in a series of articles concerning Direct to Consumer (DTC) advertising in medicine. DTC is a scourge that encourages gratuitous medical care including public overmedication, overtreatment and inappropriate use of public resources. When combined with rising physician overhead and paperwork, and diminished physician reimbursement, it can compromise physician integrity. It is modern "snake oil" salesmanship under the self-righteous guises of "free speech" or "informing the public," and it fleeces the public for corporate profit without improving public health.

THE DOCTRINE OF THE LEARNED INTERMEDIARY

By definition, lay people are not sufficiently grounded to make diagnoses and develop treatment plans or to weigh the risks against the benefits of procedures, medications and devices. They usually do not realize that there is no problem they can have that a surgeon can’t make worse with his knife or an internist can’t make worse with his medications. They certainly are in no position to fully comprehend detailed product circulars or to make the fine distinction among various FDA approved devices or medications for a particular condition and purpose. The physician is the learned intermediary between the manufacturer and the patient. Pharmaceutical and medical device manufacturers have used this defense to shift liability for their products from themselves to physicians. Doctors, armed only with their scientific (not business or legal) educations seem more than willing to take on these risks.

The Law
The term learned intermediary was first used by the 8th Circuit Federal Court in 1966 (Sterling Drug v. Cornish) and has become an accepted principle in federal and most state courts. The concept goes back at least to 1948 when the New York Superior Court in Marcus v. Specific Pharmaceuticals felt that there was no reason to believe that a physician would disregard his own judgment in deference to that of a manufacturer and if he did so, he would not prescribe without knowing what the manufacturer recommended. In Alm v. Alcoa (1986, Texas) the court held that once a prescribing physician is warned of a danger by the manufacturer, the manufacturer has no further responsibility to recipient patients. Thus, the doctrine of the physician as the learned intermediary (with all its implied liabilities) is well established in common law.
There have been a few exceptions to this doctrine (e.g.. mass immunization and sometimes, family planning medications). In Garside v. Osco Drug (1991, Massachusetts), the Federal District Court held that by advertising directly to the public, the company bypasses the doctor-patient relationship and reduces his role as "learned intermediary." In Shanks v. Upjohn (1992, Alaska) the court felt that the doctor’s role is reduced when the corporate marketing strategy is designed to appeal directly to the public.

This is an area of evolving case law and some courts have felt that direct-to-consumer advertising can mitigate, if not abrogate the doctrine. In the Norplant contraceptive litigation (1999), the 5th circuit in Texas held that Direct-to-Consumer advertising (DTC) of the product did not abrogate prescribing physician liability since the plaintiffs never saw the advertising. They added that "whether a drug manufacturer's use of DTC is ever grounds for creating an exception to the learned intermediary doctrine remains to be seen." They sent the case back to the Texas Supreme Court. In 2004, the New Jersey Supreme Court encouragingly took the view that ". . . the doctrine does not apply to the direct marketing of drugs." So while there is hope, this will not be the last word on the subject, particularly with a White House in the pocket of the pharmaceutical industry and a political system that empowers industry lobbyists with bottomless largesse from unconscionable medication pricing.

The FDA
There are FDA regulations concerning advertising. An ad must contain a "true statement of information in brief summary relating to side effects, contraindications, and effectiveness." This was interpreted to require the equivalent of the fine print blurb in a professional journal or packed with a device or medication, too long for a "sound-bite," effectively precluding radio and television DTC. In 1997, the FDA simplified and loosened the regulations to permit DTC advertisements that:

• does not mislead (whatever that means)
• states the product’s most important (again, whatever that means)
• risks and indications in "consumer-friendly" language.
• provides a toll-free number (and/or now informative internet
  address) for package insert level information and/or refers listeners to their advertisements.
• refers users to pharmacists and physicians.

With an expansive view of these more liberal requirements, television DTC has intensified and, as is natural to the beast, manufacturers have become more and more hyperbolic in touting their products with emotional appeal. They now spend as much or more on DTC than they spend marketing to the profession.
Proscription of advertising is a relative concept. To the extent that people purchase medical devices and services with their own cash, the payor is the patient/beneficiary and can be his own learned intermediary: caveat emptor. However, when people believe something is an entitlement or know it will be paid for by a third party, the payor is no longer the patient/beneficiary and has no fiduciary reason to be a reliable or reasonable gatekeeper. The hawking of pharmaceuticals, devices and treatments to an over-entitled population is an unreasonable load on any third party payor system, government or otherwise. Absent moderation by the expenditure of personal assets, significant gratuitous overutilization of resources is encouraged and supported, if not inevitable.

Pernicious Procedure Propaganda
Recently, purveyors of knee replacement hardware have been marketing their products DTC on television. Depuy (a large orthopaedic hardware manufacturer) went a step beyond the usual testimonial by a celebrity or a person who was "not a doctor but played one on TV." After exclaiming that "if you have knee pain you may need a knee replacement" (relatively few people with knee pain need knee replacement), they went on about a specific design (rotation) difference between their hardware and that of their competitors. There are often many ways to reach an acceptable medical goal, but this ad implied that if your doctor didn’t use their prosthetic components, your result might have less range of motion and your doctor might not be up to snuff.

The majority of people do not understand the effects of sample size, blinding, multiple variables, track record and other confidence determinants on statistics, and the selection of orthopaedic implants is a complex calculus. Outcomes are dependent on literally hundreds of variables, not the least of which is the uncertainty of working in a biologic system. Newer devices do not have lengthy track records or proven longevity and, like pharmaceuticals, need to find their proper place over time. For example, what would a patient make of a recent study in the venerable orthopaedic peer-reviewed Journal of Bone and Joint Surgery (86A: 10, 10/04, p. 2257) noting that ". . . the use of a mobile bearing that allowed free anterior-posterior translation did not regularly restore femoral rollback and did not improve range of motion after total knee arthroplasty compared with the findings seen in association with the use of a rotating platform (. . . randomized controlled trial . . . no significant difference but narrow confidence intervals)."

More recently, in the same standard reference (JBJS, 87A: 10, 10/05, p. 2290), in comparing fixed and mobile bearing knee prosthetics at a minimum of 4.5 years ". . . found no advantage of the mobile-bearing arthroplasty over the fixed-bearing arthroplasty with regard to clinical results . . . The risk of bearing subluxation and dislocation in knees with the mobile-bearing prosthesis is a cause for concern and may necessitate early revision." Clearly, patients need a learned intermediary to analyze this information, but the admonition "ask your doctor" adversely impacts the doctor patient-relationship since a doctor cannot fully explain the impact of this data to an average patient in a reasonable period of time.

There are subtle differences in prosthetics depending on the design criteria, and it takes the understanding of a "learned intermediary" to choose which characteristics are most important to for a particular patient in the surgeons technique. It is well known that the best results occur when a surgeon uses the method with which he is most experienced. Ultimately, when dealing with a learned intermediary, a patient must rely on the physician's knowledge and experience.

But why is this a problem? Consider the patient who mentions the Depuy ad. The physician responds simply or spends uncompensated time trying to explain differences among prosthetics arcane to the person without foundation. The surgery occurs and the patient develops a stiff knee (a common occurrence related primarily to patient factors). The patient then again sees the Depuy ad on TV and thinks to himself (never one to shoulder the blame), "If that doctor had listened to me, I wouldn’t have this stiff knee." I leave the rest to your imagination and that of your malpractice carrier.

Conclusions
It is inappropriate for a patient to be concerned over the details of a complex surgical procedure. Whether I use a Beaver or Bard-Parker blade is not their business. In general patients are not sufficiently sophisticated to direct a treatment plan that is the distillation of medical education, training and experience. Despite industry exhortations, DTC is entirely motivated by profit. Combined with third party payment and a narcissistic sense of entitlement, the result is expensive, inappropriate and gratuitous overutilization.

Physicians have legal and ethical obligations to assess the risks, benefits and appropriateness of any product used to treat a patient and this is difficult enough without contending with the duress of irrelevant badgering. In the perfect world of the learned intermediary, a physician is not responsive to marketing coercion and offers only academically pure options. Yet it is an inescapable fact that we are both learned intermediaries and denizens of the marketplace. HMOs, utilization review, hospitals, government and market share forces test our resolve. The "patient awareness" ruse notwithstanding, pharmaceutical/device manufacturers and hospitals only use DTC because doctors will usually succumb to the pressure and it boosts profits.

It is lucky for patients that a person must consult with a physician to obtain prescription medication or devices. We must not forget that with our authority comes significant risk that sticks like Velcro. Direct-to-Consumer advertising is a treacherous concept that increases medical costs by emphasizing the least important and most profitable features of a medication or procedure. It hyperbolically and irrelevantly misinforms and induces inappropriate resource utilization. Even worse, it is an opprobrious assault on the doctor-patient relationship that further intensifies physician liability exposure.

ETHOS and ERUDITION

There was a time, not so long ago, when physicians held a special and honored place in society. Perhaps we couldn’t actually do much, but people came to us for many things, philosophical and medical. A physician was expected to be erudite and some still are. Recently, I was conversing with a resident at surgery and commented that something he proposed epitomized hubris. He had no idea what I meant by the word – and neither did the anesthesiologist!

So what, they didn’t know the meaning of an exotic Greek word. But hubris, like many a ten-dollar word is more than pedantic vocabulary. It is a metaphor, shorthand for an understanding of the pride that goeth before a fall and the story of Icarus who flew too close to the sun with disastrous result. Closer to home, it is the story of Asclepias, born of Apollo and a mortal mother who was killed by Zeus because he raised the dead. The metaphor is clear: monkey with the forces of life and death and risk grave consequence. I often notice that physicians shrink from ethical conflict and political debate and this is good reason to ponder our past and current place in society.

I read a dissertation on the “art” of medicine by a physician attempting to translate the analog intuition of clinical acumen into a digital construct using statistics and probability theory – not unlike the goals of the “evidence-based” medicine movement. But the intuitive diagnostic leaps that good physicians make are only a small part of the art. The public needs us to be reservoirs of humanistic cultural evolution. For this, and to flirt with matters of life and death, we each need to develop principles, intuitive ethics and facility with a cultural metaphor that flows from millennia of critical thought and inquiry.

The Renaissance Man was the product of classical education. Classical education included not only the primitive technology and science of the time, but facility with the prior sapience. Hippocrates, the “father” of modern medicine (460-377 B.C.E.) worked on classical mathematical problems such as squaring the circle and duplicating the cube. The Greek physician Galen (130-200 C.E.) had interests in agriculture, architecture, astronomy and philosophy until he concentrated on medicine, and then his thoughts dominated European medicine for a thousand years. In the 12th century, Maimonides was a physician, scholar and philosopher. These were models for the Renaissance, and post-Renaissance medical development was replete with Renaissance Men.


The Problem
Physicians used to be classically educated people, savants who then focused on medicine. To some extent, this is still true, but in recent years, those who aspire to become physicians have been electing to narrow their foci sooner and sooner. A firm basis in the classics of Western Civilization and a survey of the breadth of existing non-scientific knowledge is no longer emphasized in pre-medical education. We fool ourselves into thinking that ethical discretion can be taught in a medical school short course on “nurture-craft” or “cultural sensitivity.”

One can passively absorb ethical and moral constructs from religions or professional codes and these will be, by and large, tried and mostly true. However, over time, just as Western religions require reformation, so do moral and ethical codes for professionals. It is the nature of social evolution that new problems arise and solutions flux. To be stable and flexible at the same time, ethos must come from within, supported by a firm foundation in the historic cultural metaphor and tempered by individual effort and creativity.

We are slowly but surely chipping away at each new physician’s important knowledge of the roots of civilization that enables the public to respect us as more than technicians. Technicians have a place in the provision of medical care, but they cannot lead and they should not guide others’ decisions. Some doctors feel more comfortable as technicians, perhaps because they have become educationally ill-equipped to delve into the underpinnings of what we do. They may know the facts of life, but are they conversant with the ideas, ideology and philosophy that elevate our existence and make it worthwhile?

The ability to make ethical decisions, the kinds of things that patients and their families expect of us, requires foundation. The classical education is meant to be a sturdy framework for more intensely focused inquiry. Aristotle defined virtue as the ability to act in accordance to what one knows is right. Rigorous study develops virtue. Focus can occur with concentration or exclusion, and the difference is crucial. It is insufficient to skip to science and then narrow the field of inquiry to internal medicine or surgery and then subspecialty without having mastered a broader historical perspective.


The Reasons
All professions are not created equal, and all do not have the same ethical underpinnings. It is the duty of physicians to offer people only the services we believe they need, not necessarily those that they want. In other professions, the duty and relationship to the client is a focused advocacy. For us, the gray zone is broad and treacherous. To be cogent, our expertise must convey enlightenment drawn from eclectic scholarship; and this makes all the difference.

While they may coexist, cost and time pressures can create an inverse relationship between science and art. In medicine, financial rewards are diminishing, while medical education is increasingly expensive both in money and time. One’s Weltanschauung suffers when these pressures apply. We have been beaten down by the forces of business and “health maintenance” schemes. The need to make a living can drive us to divest ourselves of the obligation to enlighten the public with our particularly cogent views that are based on what we do.

There are generational issues. Those who begot the intellectual tradition of medicine in the mid 20th Century were influenced by the Great Depression. Now there is the culture of “me,” and a practical approach to the profession that diverts us from aggressive and public pursuit of more lofty, but more compromising ideas. Some of us have emulated our corporate oppressors and have taken a quarterly approach to the job; and learn to ignore the societal impact implicit in every decision we make.


Yin and Yang
Plato (427-347 BCE) in his Republic, analyzed the educational and experiential prerequisites of a “Philosopher King” by dividing education into music (from the root muse and referring to all of the “arts” and the subtleties of metaphor, as in fables) and gymnastics (athletics, but in this case representing craft and technology). He felt there was a delicate balance between gymnastic and musical education and that overemphasis of gymnastics produced “savagery and hardness,” while excessive music spawned self-indulgent “softness and gentleness,” not so different from the Eastern (Taoism, Han dynasty synthesis, 207 BCE - 9 CE) concept of Yin and Yang. He said the two “may be fitted together in concord, by being strained and slackened to the proper point;” begging the question, what is the proper point? And is the proper point the same in all eras and at all stages of cultural evolution?

Medicine is a complex business that balances the best of the Yin and the Yang. Women are nurturers, well suited to half of the physician equation. Men are well suited to the other half. To be a physician, each must supplement his/her gender propensity with the appropriate learning to create harmony. Not a unique thought: music and gymnasium, Plato.

One might think there is just too much to know and we must specialize to a point where a classical education is excess baggage. The sheer volume of data, the difficulty of the material and the desire for a cost-effective curriculum that keeps the pre-medical process within a four-year paradigm seems a seductive excuse for truncation or elimination of the college level classical education. When my Sesame Street sound-bite afflicted children complained that a particular teacher didn’t make the subject matter fun, I told them that in the vast intellectual sea upon which their scholarly boat must float, learning is an engine that is only occasionally fun, more often work; but there is something that is always fun: KNOWING.

Leaders should have prior ethical and philosophical insight to draw upon when encountering something new. College should be where we learn the “wisdom of the fathers” and practice the manipulation and augmentation of antecedent thought to solve modern problems. For physicians, erudition is critical so that we do not devolve into mechanics, purveying the technical result until our patients sense that we are without philosophy and perceive us as not caring. We cannot abandon this role to non-physician bioethicists and the art of medicine (sans much science) cannot become the realm of alternative and holistic practitioners.

I lament the demise of physicians as effective societal thinkers and thought leaders. It is not that we do not have the capacity; the selection process assures that most of us do. But we should not squander our brilliance on mere technical feats. Classical knowledge and perspicacity can shield us from the doctrinaire and the demagogue. All of us need to have well-founded, well-reasoned opinions on issues such as:

• Is relentless indiscriminate medical care green (good for Gaea)?
• In the largest sense, medical care is a narcissistic business which primarily consists of the services of others for the one. Does medical care really belong among the basic necessities of food, shelter and clothing or is there an element of privilege as there is in housing, transportation, plumbing and the like?
• There is no perpetual motion, no cold fusion and there cannot be open-ended medical care for everyone. Can society afford us to think otherwise?
• Abortion, euthanasia and the death penalty.
• Quality verses quantity of life; the demise of the extended family and its support of the elderly – good?, bad? Does it even matter . . . and why?
  $ Commercial advertising of medical procedures and prescription medications.
• Professional-ism, generalist-ism and specialist-ism.
• The world fundamentalist movement and its effect on scientific inquiry.

No one can do this for us and we have an obligation to society to vociferously press our special point of view. We need people to respect our opinions on these issues at least as much as they respect those of politicians, lawyers, pundits and wonks. In short, our leadership must be supported by a respect for our erudition.

We must re-institute much of the classical education in pre-medical education and then retain a working knowledge of the ideas of our forefathers so that we can build on them, not reinvent them. We need to have the comfort of KNOWING that kindles the enthusiasm of open discourse, cultivates a valid ethos, and makes our arguments compelling. We must regain the hearts and minds of the public and assist, if not lead our society through difficult times ahead.