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June 2008

Direct-to-Consumer Advertising: A Bargain Discarded?
By Richard P. Mills, MD, MPH, Chief Medical Editor, EyeNet

The other evening a television advertisement for Requip, a treatment for restless legs syndrome, caused me to have an irresistible urge to move my legs to get the remote and change the channel. Then it occurred to me, as it does anytime I hear a diagnosis that didn’t exist when I was a medical student, that I might be suffering from this condition without my knowledge. So I went online, and, not surprisingly, I found a manufacturer-sponsored Web site,, and a patient support group, the RLS Foundation, funded in part by the manufacturer of Requip. Not to belittle the agony that patients with severe forms of the condition may suffer, but it strains credibility that up to 10 percent of American adults may suffer from the condition, including myself (sometimes I tap my foot for no reason).

I began to mutter about the skyrocketing cost of health care and wondered about the effect of direct-to-consumer advertising (DTCA) of prescription drugs. So I did a little research on the subject and was surprised by the results.

The story begins about a century ago, when the AMA was looking for allies to combat the “patent medicine” makers’ efficacy claims in DTCA. Not only were these claims often patently false, but the medicines could be obtained without a prescription, cutting the physician out of a fee. The AMA found allies among the (then) relatively small firms that manufactured the pure drugs that were compounded by pharmacists according to the physician’s prescription. The AMA called these firms “ethical” drug houses. The bargain was that, in return for giving up lucrative patent medicines and DTCA, companies could expect that physicians would welcome into their offices pharmaceutical representatives and the drug information they brought. But in 1997, the FDA relaxed its formerly restrictive rules on DTCA, and from then through 2005, spending on DTCA increased 330 percent to 2.6 percent of pharmaceutical sales. By comparison, retail value of free samples is a staggering 11.2 percent of sales.1

DTCA usually begins within a year of FDA approval of a drug whose approved indication is for a chronic disease.1 The effect of DTCA is to increase the number of doctor visits for the advertised condition, but the resulting increase in the prescription rate affects all drugs in the class, not just the advertised one.2 To be effective, DTCA must expand the whole market, not just steal from somebody else’s market share. Thus, advertising tends to be most intense when there are few competitors within a drug class or indication, as is the case with Requip.3

It can certainly be argued that information that causes patients to seek medical care and receive treatment for bona fide disease is in the public interest. Since it doesn’t seem to result in a disproportionate share of prescriptions for the most expensive alternative drug, DTCA isn’t as bad as I had started out thinking. But the proliferation of DTCA gives one pause to rethink the bargain that physicians made with the “ethical” drug houses; maybe we ought not to be so receptive to the marketing directed at us, which unequivocally leads to prescribing more expensive alternatives.

But getting back to my own underdiagnosed restless legs, I am reminded of the savant who observed that good health is simply the condition of being inadequately worked up.

1 Donohue, J. M. et al. N Engl J Med 2007;357:673–681.
2 Iizuka, T. and G. Z. Jin. J Econ Manage Strategy 2005;14:701–727.
3 Iizuka, T. J Industrial Econ 2004;52:349–379.