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JAMA REJECTS COALITION LETTER CHALLENGING
DTC STUDY CONCLUSIONS

Reprinted below is a Letter to the Editor of the Journal of the American Medical Association that was rejected for publication.

The Coalition is concerned that both the JAMA article and its press coverage entirely missed the primary public policy point that in the absence of DTC advertising prompting patients to “ask your doctor”, a majority of doctors faced with a patient exhibiting the symptoms of major depression fail to prescribe an antidepressant drug, a key standard of care.

Furthermore, the data suggest that patients who ask about the suitability of a drug as a result of DTC advertising are more likely to receive standard of care treatment for depression -- clear evidence of the value of DTC in this therapeutic area.

The Coalition believes that this incident demonstrates once again a widespread, biased evaluation of DTC advertising. Indeed, this kind of coverage seems all too representative of a common, anti-marketing sentiment in the professional and consumer community.

The Coalition seeks to counter that sentiment with factual information whenever possible, and is disturbed by the JAMA's refusal to enable the Coalition to attempt to clarify the public record.

May 16, 2005
Philadelphia, PA

To The Editor:

Congratulations to Kravitz et al (JAMA 293(16): 1995-2002) for producing the first, peer-reviewed simulation study that clearly demonstrates the value of the idea of direct-to-consumer (DTC) prescription drug advertising as an information and motivation tool for both physicians and consumers.

Since the impact of advertising per se was not the subject of the study, but rather the simulated effects of advertising, the reported study outcomes should be read only as an inquiry into physician-patient relations, with at least one surprising result, and not as an evaluation of DTC.

It is particularly noteworthy that any request for prescription drugs in the context of presenting symptoms for major depression or adjustment disorder resulted in an increase in prescribing, the provision of “minimally acceptable care,” and the avoidance of under treatment.

If these results are what occur in “real life” as a result of DTC advertising, and not just in a simulation exercise, surely they must be recognized as a positive public health outcome of DTC.

Do the effects of patient requests vary by clinical indications? Yes. Fifty-four percent of the simulated patients (SPs) with major depressive symptoms received prescriptions vs only 34% of those pretending to have adjustment disorders – a suggestion that practitioners may be considerably more wary of the latter diagnosis for which there is no consensus treatment.

Does it make a difference whether requests are specific or general? Yes. In the context of major depressive symptoms, general requests are honored more frequently than specific requests (76% vs 53%), while the opposite occurs in the context of adjustment disorder symptoms (55% for specific requests vs 39% for general requests), which data tends to support the hypothesis that physicians do make discriminating decisions in the face of different patient presentations.

One important question overlooked by the authors is: Why should a brand-specific request for an antidepressant medication for major depression be honored less frequently than a general request (53% vs 76% -- a greater than 40% difference)?

Does the specific request trigger latent resentment on the part of some physicians who may perceive a specific request as a challenge to their authority? Could it be a negative physician response to the perceived intrusion of “advertising” into their professional lives? Or is it something else?

Kravitz et al also conclude that “In adjustment disorder, brand-specific requests stimulated excessive care,” a conclusion that seems unwarranted. The issue here may not be “excessive care” or, by implication, excessive prescribing, but simply a physician’s desire, in the context of a difficult diagnostic challenge for which there are no consensus treatments, to “do something” to try to effect a positive outcome. While this approach may offend proponents of “evidence-based medicine,” it seems unwarranted to characterize such a time-honored and compassionate medical practice as “excessive care”.

Finally, if the Kravitz et al study is to be used as a platform for criticism of DTC advertising as Hollon’s polemic suggests (JAMA 293(16) 2030-2033), it should fail. To the best of my knowledge, no antidepressant has ever been DTC-advertised as a treatment for “adjustment disorder,” a cornerstone of the Kravitz et al study and, in my opinion, the positive outcomes outlined above more than outweigh any hypothetical but unproven risks.

Harry A. Sweeney
Chairman, CEO
Dorland Global Corporation
One South Broad – 11th Floor
Philadelphia, PA 19107

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