GlaxoSmithKline, Drug Marketing, and the Problem of Disease Inflation

Earlier this month, the Department of Justice announced that the pharmaceutical giant GlaxoSmithKline had agreed to settle criminal and civil complaints related to its illegal marketing of the popular antidepressants Paxil and Wellbutrin from the late 1990s through the mid-2000s. In addition to a number of other offenses, the settlement also covered allegations that the company had failed to report safety data to the Food and Drug Administration (FDA) for its diabetes drug Avandia. In order to settle the case, the company agreed to plead guilty to promoting Paxil and Wellbutrin for uses that had not been approved by the FDA. The company also agreed to pay $3 billion in criminal and civil fines, which might seem like a huge amount of money until you realize that Paxil, Wellbutrin, and Avandia earned the company at least $28 billion during the period covered by the settlement. As one industry analyst commented, “a $3 billion settlement for half a dozen drugs over 10 years can be rationalized as the cost of doing business.”

For those of us interested in the machinations of Big Pharma, neither GlaxoSmithKline’s behavior nor the terms of the agreement are particularly surprising. Over the past decade these types of settlements have become increasingly common. In 2007, for example, Purdue Pharma settled for the relatively modest sum of $634 million for illegally promoting OxyContin as less addictive than other painkillers. In 2009, Eli Lilly settled for $1.4 billion for illegally marketing Zyprexa for the treatment of dementia, among other problems, despite being approved only for the use of schizophrenia and bipolar disorder. In the same year, Pfizer settled for $2.3 billion for illegally promoted its painkiller Bextra, and in 2011 Merck agreed to pay $950 million to settle complaints that it had illegally marketed Vioxx. In May of this year, Abbott Laboratories settled for $1.6 billion for illegally marketing an anti-seizure drug. Any day now, the Justice Department is expected to announce that Johnson & Johnson has settled claims that it illegally promoted Risperdal, a drug currently approved for the treatment of schizophrenia. The expected settlement is about $2.2 billion. Earlier in the year, a judge in Arkansas had ordered the company to pay $1.2 billion in fines for hiding the dangers of the drug in its promotional efforts. I could go on, but I think you get the point.

There is a tremendous amount to be said about all this, most of which isn’t good, but for the moment I want to focus on the effort to promote drugs for so-called “off-label” use. Under the 1938 Food, Drug, and Cosmetic Act (and subsequent amendments and laws), it is illegal for pharmaceutical companies to promote drugs for uses that are not approved by the FDA, or for the treatment of patients that are outside of the approved age range, or to promote the use of drugs at higher doses than for which they are approved. However, it is perfectly legal for physicians to prescribe drugs for any condition, to any patient population, and in any amount that they see fit. The result is that there is a tremendous incentive for companies to promote their products illegally: Continue reading

The Points Interview: David Herzberg

Editors’ Note: We’re delighted to bring Points readers another installment (number sixteen) in the “Points Interview” series.  Today, we’re getting happy with David Herzberg, author of Happy Pills in America: From Miltown to Prozac (The Johns Hopkins University Press, 2009).  David Herzberg has been a Contributing Editor here at Points, and is also an Associate Professor in the Department of History at SUNY-Buffalo (where he also hosted the recent conference of the Alcohol and Drugs History Society).

Describe your book in terms your mother (or the average mother-in-the-street) could understand.

Happy Pills is a cultural history of Miltown, Valium, and Prozac—three of the best known, Cover of Happy Pills in Americamost widely used, and controversial medicines in the postwar era.  It tells their medical and commercial stories, but also asks why they became so faddish and contentious, and how their fame (and infamy) influenced medical and popular ideas about consciousness and identity.
The book begins in the 1950s, when Miltown became the first “blockbuster” tranquilizer and an early icon of biological psychiatry.  The drug’s celebrity was the product of several developments:  intensified popular marketing of prescription drugs; increased medical and public attention to anxiety as an illness, led in part by Freudian psychiatry; and a burgeoning consumer culture primed to deliver technological wonders in the name of comfort and convenience for the middle classes.
But Miltown’s popularity didn’t sit well with everyone; in fact the prospect of eradicating anxiety made some people quite nervous.  The tranquilizer and its successors quickly became embroiled in postwar gender battles and the explosive politics of the “war against drugs,” and Happy Pills traces these stories to their combined conclusion in a feminist campaign against Valium addiction in the 1970s.  This was a most unusual anti-drug campaign, targeting sexism in drug companies and the medical system rather than stoking fear of addicts.  It capped off a decade of challenges to the pharmaceutical industry, and was part of a broader effort by reformers to rethink the boundaries between “drugs” and “medicines.”

Happy Pills ends with a look at the emergence of Prozac and other antidepressants in the late 1980s and 1990s, and the accompanying revival of popular belief in wonder drugs.  Why was this resurgence so successful when the drugs themselves turned out to be far from revolutionary?  Prozac’s boosters, I argue, took new findings in brain science and used them to create a story that was as much political as it was scientific:  miraculous new consumer goods now made it possible to pick and choose personalities—identities—in a utopian free market of accessorizable selfhood.  However exaggerated such promises may have been, they proved a powerful cultural vehicle for pushback against feminist-era drug critics, and a fitting vision of identity and personal change for an increasingly conservative era.

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