摘要：Recent highly publicized withdrawals of drugs from the market because of safety concerns raise the question of whether these events are random failures or part of a recurring pattern. The inverse benefit law, inspired by Hart's inverse care law, states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively the drugs are marketed. The law is manifested through 6 basic marketing strategies: reducing thresholds for diagnosing disease, relying on surrogate endpoints, exaggerating safety claims, exaggerating efficacy claims, creating new diseases, and encouraging unapproved uses. The inverse benefit law highlights the need for comparative effectiveness research and other reforms to improve evidence-based prescribing. In 1971, Julian Tudor Hart proposed his inverse care law: “The availability of good medical care tends to vary inversely with the need for it in the population served.” 1 (p405) Hart added that the law “operates more completely where medical care is most exposed to market forces.” 1 (p405) A takeoff on the inverse square law of physics, the inverse care law attracted attention because it articulated “something everyone knew but nobody said,” which many have subsequently found useful as a heuristic for guiding research and interpreting data. 2 (p18) In a similar vein, we offer the pharmaceutical inverse benefit law: the benefit-to-harm ratio of drugs tends to vary inversely with how aggressively the drugs are marketed. Like Hart, we offer our law as a heuristic device and not as a precise mathematical model. Like Hart's law, the inverse benefit law runs counter to commonly held beliefs. First, one might think that the characteristics of the drug itself, not marketing, would determine the benefit-to-harm ratio. Second, the industry prides itself on discovering improved pharmaceuticals, so we have been conditioned to believe that heavily marketed new drugs are both more efficacious and safer than older drugs. Finally, many assume that the US Food and Drug Administration approval process precludes marketing of unsafe or ineffective drugs. In the past decade, however, many new drugs were found to be less effective or less safe than originally thought. 3 – 5 According to the pharmaceutical industry's self-image, these events represent unavoidable risks and bad luck. But the inverse benefit law holds that they form a pattern that reflects the current realities of the industry's attempts to maximize sale through aggressive marketing. We focused on marketing drugs to physicians and not directly to consumers. The industry, however, generally coordinates its marketing activities closely, so that marketing of drugs to consumers and prescribers is often interrelated.
