Joseph Gabriel

GlaxoSmithKline, Drug Marketing, and the Problem of Disease Inflation

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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:

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Laughing at / with the Dead

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I recently had the pleasure of attending the annual meeting of the American Association for the History of medicine in Baltimore. It’s a great conference, filled with friendly and interesting people doing what academics generally do at such events – talking, schmoozing, drinking, and so on. If you work on the history of health, disease, or medicine I heartily recommend attending. There are always at least a few panels about drugs, and there are always people around who know a tremendous amount about the history of addiction and related topics. Plus, there’s always good food. This year they gave away free Haagen-Dazs ice cream and warm chocolate chip cookies. What’s not to like?

Anyway, I attended a number of interesting presentations at the conference, two of which got me thinking – not so much about the topic of the talks, but about the question of how we talk about the past. The first was a presentation on biomedical research in which the presenter made a number of amusing comments, some of which were at the expense of the people she was talking about. This is actually a pretty common dynamic at this conference – speakers will sometimes describe something objectionable that physicians did in the past, for example, and then sort of smirk or otherwise indicate their disdain for the behavior they are describing; audience members will react by chuckling or perhaps groaning in a sort of “I can’t believe they did that” type of response. In this particular case, the presenter made a few humorous comments about the research subjects who had been experimented on, at one point poking fun at one of their poems that she had discovered in an archive. The poem was admittedly quite bad, but there really wasn’t any reason to include it in the talk except for comic relief. Those people sure did write terrible poetry, didn’t they? Hah hah!

This sort of thing always makes me uncomfortable. It seems to me that we should be respectful of the people we study, even if they are dead and even if we disagree with what they thought or how they behaved. I’m not sure why I feel this way, but I do: it just strikes me as sort of rude to make fun of people, especially if those people don’t have the opportunity to make fun of you back. Of course, I also realize that I’m a bit uptight when it comes to these types of issues, and I recognize that I sometimes come off as a bit of a prig. I mean, really, what’s wrong with poking a bit of fun at people, especially if they aren’t around anymore to take offense? Beats me. All I know is that it makes me squirm in my chair and want to go out and get one of those cookies that I mentioned earlier. So there I sat, listening to the jokes about people being experimented on in years past, feeling both slightly offended and somewhat defensive about my own stuffiness. I probably should have just called it a day and gone back to my room for a nap.

Not Funny!

On the other hand, I also saw a talk in Baltimore in which the presenter was very serious – and I mean very serious – and spent a significant amount of time chastising other historians for not adequately addressing the suffering of the many people who died due to a certain catastrophic event. The speaker didn’t seem to realize that he was speaking to a friendly audience – I mean, historians of medicine are more than happy to talk about death and destruction, and to assign blame for said death and destruction – and he came off as both insufferable and self-righteous. That was a decidedly unfunny talk, and I can’t say that I left it any more pleased than I left the talk about medical experimentation. One was too funny, or perhaps funny in the wrong way, while the other was decidedly not funny enough, or at least not enjoyable enough. In both cases I probably would have preferred to be somewhere else.

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Flying into the Unknown: On the Limits of Addiction History

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Let’s begin with the story of a woman named Anna.

State Reformatory for Women, Bedford Hills, NY

In October 1917 the research staff of the Laboratory of Social Hygiene at the State Reformatory for Women, Bedford Hills, New York, examined a woman who identified herself, at different times and according to different documents, as Anna Dillon, Anna White, Anna Miller, and Anna Murray. Anna was both a heroin user and a prostitute, and the staff of the laboratory examined her closely in order to determine the causes of her deviant behavior. They studied her body in great detail, observing that the lobules of her ears “are attached,” her skin and mucous membranes “anemic,” and her vagina of “medium length and width.” They gave her a large number of psychological tests, eventually determining that she was “of normal mental ability with keen perception and fair reasoning ability.” And finally, they assembled a detailed case history of her life by conducting extensive interviews with her, soliciting documents from other institutions at which she had been incarcerated, and gathering information from her acquaintances. In all this, they sought to investigate and document the causes of her deviant behavior. They searched for an explanation of why she acted as she did in the details of her body, her mind, and the social experiences that made up her life. They collected and analyzed data, working to forge a coherent narrative explaining who she was and why she acted as she did. They did so in part to help her, and in part to advance scientific knowledge about sexual deviancy more generally.

Like our peers at the Laboratory of Social Hygiene, historians of addiction analyze the lives of the people we write about and try to come up with some sort of explanation for why our subjects acted as they did. Like our peers, we do so both out of an interest in the people we study and toward the goal of advancing knowledge more generally; through our work, we hope to find some sort of knowledge with which we can understand the world in which we currently live. Not surprisingly, we have a tendency to look in the same types of places for this information as the people interviewing Anna looked – including, most notably, the socio-economic environment and the physical workings of the body. There are, of course, complex arguments about the relationship between different approaches to explaining addict behavior in the past, and this blog is probably as good a place as any to explore the complexities of these debates – the recent series of posts responding to David Courtwright’s recent essay in Addiction is a great place to start. I do not want to downplay the importance of these debates, but I wonder: are we missing something important about the past when we try to explain it in this sort of way? Do we miss something important about Anna when we interrogate her life through the categories most familiar to us, those of historical and sociological analysis, biological explanation, or some combination? What is it that we hope to accomplish when we move from description to explanation, and what do we gain – or lose – when we do so?

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Aesthetics and the Failure of the FDA’s Cigarette Warning Labels

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Last year the Food and Drug Administration (FDA) approved a series of nine new warning labels for cigarettes. The labels were designed around a series of graphic images intended to highlight the dangers of smoking – a man exhaling smoke through a hole in his throat, a pair of diseased lungs next to a pair of healthy ones, a mouth covered with cancerous lesions, and so on.

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The images were surprisingly explicit, and prompted a storm of controversy. The FDA also instituted rules requiring that the labels cover one-half of the front side of all cigarette packages, that the images be rotated regularly, and other similar measures. Not surprisingly, the tobacco companies sued to stop the new rules from going into effect; not long after, a district court judge in Washington ruled that the new regulations were unconstitutional on free-speech grounds. The labels never went into effect, and the people of America continue to be free to buy cigarettes without having to confront images of diseased lips and people blowing smoke through holes in their necks. 

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Pharmaceutical Suspicion

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Michele Bachman’s implosion on the campaign trail back in late September is now widely accredited to her suggestion that the HPV vaccine causes mental retardation. In an earlier post, I argued that pundits should think twice before dismissing Bachman due to her position on this topic, and while Bachman’s campaign collapsed a lot more quickly than I expected, I continue to think that her arguments about vaccination were potent ones.

"La Vaccine Mort en Avortant de Son Dernier Monstre," ca. 1800

There is a deep distrust of the pharmaceutical industry running through much of American culture – indeed, a Harris Poll last year found that just 11% of Americans consider pharmaceutical companies “honest and trustworthy,” a remarkable finding given that virtually all of us place the products of these companies in our bodies and many of us literally depend upon them for our lives. The idea that the drug companies are deceitful and, perhaps, predatorial is widespread, stretching from the halls of academia to the claims of Scientologists, from right wing populists to the Rainbow Family, from alternative health care practitioners and their allies in the New Age and health food movements, to patient advocacy groups, anti-psychiatrists, and more. Even libertarians, who usually trust just about anyone able to make gobs of money, exhibit a certain skepticism of the pharmaceutical industry when they start talking about legalizing marijuana and other drugs. So what’s going on here?

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Rethinking Patent Medicines

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Side Effects May Include Intellectual Snobbery

Joe Spillane recently pointed us to Caroline Rance’s blog, “The Quack Doctor,” and suggested that her posts – filled with advertisements for  things such as “Carter’s Little Liver Pills” and “Effervescent Brain Salt” –  form a “reasonable platform” for historians to “ask the larger questions about  consumer behavior, medical authority, business interests, and the role of each in shaping everything from health cultures to health care policy.” In that spirit, I’d like to suggest that those of us who write about the history of pharmaceuticals might want to reconsider our dismissive attitude toward the patent medicine industry. Rather than derisively laughing at the industry – look at that advertisement for brain salt! I can’t believe people bought that stuff! – perhaps it is time that we try to understand it on its own terms.

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