The Value of a Drug

Both articles in this issue of the Hastings Center Report ask questions about medical decision-making and expensive new drugs. The lead article asks how one would choose from among two or more drugs available to treat a condition, and it takes the physician's perspective. Drugs receive FDA approval if, under the ideal conditions of a clinical trial, they are shown to be safe and noticeably better than a placebo. But that's a relatively low bar—a threshold standard for being put on the market. It's often not enough to choose to use a drug. Physicians need to know not only whether a drug is better than a placebo, but also how it compares against other drugs already out there, under the conditions of actual use. And there's very little information available about those comparisons.

Sabin and colleagues argue for collecting information about drugs' effectiveness by means of "cluster randomized trials," in which groups of people—communities, patients in a practice, participants in a health plan—are randomly assigned to receive different drugs. CRTs have not caught on in part because of concerns about the ethics of making these assignments. Sabin et al. argue that if various conditions are met (there is uncertainty about which drug is better, physicians are given leeway to choose whichever drug they wish in order to meet the special needs of particular patients, and the fact of participation is made public), then informed consent need not be sought from individual patients.

The following article, by Adrienne Martin, looks at the patient's perspective and takes up a very different question. Martin asks how hope affects a patient's ability to understand her medical needs and make decisions about her health care, and whether it might impair her ability to give informed consent. She argues that hope frames patients' thinking by affecting how they take in information, and that this makes a patient more vulnerable to being exploited—not merely by out-and-out charlatans, but even by very well-meaning people who encourage patients' hopes in ways that inadvertently skew their thinking. Hope also makes it more difficult for patients to resist a company's marketing blandishments. If the company is offering a last-ditch treatment, patients' hopes may enable it to charge an exorbitantly high price for the drug—a price that is itself exploitative.

Both articles also have implications both for good care of patients and for the wise use of health care resources. Only by comparing drugs head to head can we know that a new and more expensive regimen is actually an improvement in care. And, according to Martin, only by setting up structures that prevent companies from always charging whatever the market will bear can we prevent them from exploiting patients' hopes.

Both papers also attempt to prevent emotional considerations from inappropriately affecting medical care: Martin wants to account for how patients' hopes can lead them astray—or make them susceptible to being led astray—and Sabin et al. want to prevent physicians from being drawn always to the newest and latest—and well marketed—regardless of whether it is better.