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.