Pill Pushovers

The Big Fix: How the Pharmaceutical Industry Rips Off American Consumers by Katherine Greider, Public Affairs, 189 pages, $14.00

A couple of months ago, I was invited to give a presentation for the psychiatry department at another medical school. The topic was medical ethics, and I was planning to talk especially about the growing influence of the drug industry on psychiatry. Just as I was about to be introduced, the psychiatrist who had invited me leaned over and whispered, "Do you mind if I thank Janssen Pharmaceuticals for sponsoring your presentation?"

I should have known. According to The Wall Street Journal, the drug industry now funds 40 percent of continuing medical education in United States medical schools. In most fields that figure would be shocking. Imagine nutritionists allowing 40 percent of their professional education to be funded by McDonald's and Burger King, or political scientists allowing 40 percent of their graduate seminars to be paid for by the weapons industry. Yet most American doctors do not seem to be bothered by industry-sponsored education. So ubiquitous are the marks of the drug industry in hospitals and medical schools -- logos on pens and notepads, drug reps in the hallways, pizzas for the residents and "consulting fees" for the faculty -- that doctors no longer even notice that the industry is there. Having drug companies pick up the bill for medical education has come to be the norm.

The most outspoken voices opposing the growing influence of the drug industry have come not from ethicists but from activist groups and muckraking journalists such as Katherine Greider. Greider's book, The Big Fix, which just came out in paperback after being published last year, is a lucid, well-researched account of the ways in which the drug industry -- through its political lobbying, advertising, patenting strategies and payoffs to doctors -- has managed to become the single most profitable business in America. This is not a book for experts. There is little in The Big Fix that has not been reported elsewhere, either in the press or in the medical literature, and, unfortunately, the book is not referenced. But Greider does a fine job of weaving these various strands into a coherent narrative. The result is a timely diagnosis of the industry's current tactics, problems and methods of influence -- and an alarming picture of the industry's power.

Greider informs us, for example, that during the 1999-2000 election cycle, the pharmaceutical industry spent more than any other industry in America on political lobbying -- more than automakers, the oil and gas industry, insurance companies or tobacco manufacturers. It spent $177 million to hire 625 lobbyists from 134 firms, including 21 former members of Congress. It also spent $60 million on issue ads and gave $20 million in campaign contributions. A decade ago, according to the Center for Responsive Politics, political contributions from the drug industry were split about equally between the two major parties. Today, three-quarters of drug-industry contributions go to Republicans.

The Big Fix also documents the now familiar ways in which the industry funnels money and gifts to doctors in order to generate more prescriptions -- sponsoring "educational events" in exotic locations, distributing gifts and free drug samples, offering doctors honoraria or "consulting fees" to listen to promotional pitches, and paying them to enroll patients in "seeding trials" of newly approved drugs. The number of drug representatives employed to make promotional pitches directly to doctors rose by 57 percent in the 1990s, from 56,000 in 1990 to almost 88,000 in 2000.

Less familiar are the ways in which the industry has begun to sell drugs by selling illnesses. As industry profits have grown, so have the number of new disorders -- from social anxiety disorder and premenstrual dysphoric disorder to erectile dysfunction and irritable bowel syndrome. The industry sells these disorders by funding patient-support groups, sponsoring public-awareness campaigns, funding symposia and special journal issues devoted to the disorders its drugs treat, and distributing "educational" literature to physicians. "We're creating patient populations just as we're creating medicines," says one marketing executive quoted by Greider, "to make sure that products become blockbusters."

Yet even as the drug industry has stepped up drug promotion at universities and teaching hospitals, it has dramatically decreased its funding of university research. Now much of that funding goes to the private sector. In 1991, 80 percent of drug-industry money for clinical trials went to academic health centers. By 1998, more than half went instead to new commercial entities called Contract Research Organizations (CROs). CROs manage every aspect of a clinical trial. They design it, recruit subjects, analyze the data and submit it to the Food and Drug Administration. They do it for a fee, of course, but they do it faster and more cheaply than university physicians. For academic publication, CROs and the drug industry can rely on another type of commercial firm: medical education and publishing companies, which employ professional writers to ghostwrite academic articles and mainstream academic researchers to sign their names. Ethical oversight is provided by yet another commercial entity: independent, for-profit research ethics boards, or Non-Institutional Review Boards (NIRBs). NIRBs charge CROs and other clients a fee for examining their research and certifying that it is ethically sound.

This new commercial frontier is also proving lucrative for bioethicists, who are soliciting grants from drug companies, working for NIRBs, and serving as paid consultants for the drug and biotech industries. Last year, after some uncomfortable scrutiny by the press, a task force appointed by the American Society for Bioethics and Humanities and the American Society for Law, Medicine and Ethics issued a report on for-profit bioethics consultation with the drug industry. This report was supposed to be the profession's answer to outsiders skeptical of industry-funded bioethicists. Instead, to the astonishment of many observers, the task force fully endorsed the practice of bioethicists accepting payment from the drug industry. In fact, it even endorsed bioethics advertising. Of the 10 authors of that report, eight disclosed that they had accepted industry funding themselves.

Yet there are signs that the public mood may be shifting. Last year, TAP Pharmaceuticals (no relation to The American Prospect) paid $875 million to settle charges that it had illegally manipulated the Medicare and Medicaid programs. Schering-Plough has just announced that it may be indicted in a federal investigation into its drug-marketing practices, and that it may also face charges of obstruction of justice. In April, Bayer paid $257 million to settle charges that it had hidden the drug prices it was charging Kaiser Permanente for the drug Cipro. Warner-Lambert is currently being investigated for allegedly promoting its epilepsy drug Neurontin illegally for unapproved uses. Warner-Lambert is a subsidiary of Pfizer, which is also the object of a highly publicized lawsuit over its clinical trials of Trovan for bacterial meningitis in Nigeria. (Pfizer, under attack for its ethics, has been very generous to bioethicists, donating money to bioethics and medical humanities programs at the University of Toronto, University College London and the University of Pennsylvania, where it has funded a project titled, appropriately enough, "Ethics and Physician Compensation.")

Of course, as virtually everyone (except doctors and bioethicists) now concedes, industry money does influence clinical judgment. Studies have demonstrated that doctors who take gifts or consulting fees from a drug company are more likely to prescribe that company's drugs and to ask that these drugs be stocked by their hospital. Clinical researchers who are funded by a drug company are more likely to come up with findings that favor the company's drugs. Two years ago, researchers here in Minneapolis found that prescriptions for a psychiatric drug tripled immediately after an industry-funded presentation in their hospital.

This may soon change. On April 28, the U.S. Office of the Inspector General (OIG) issued a new guidance paper for drug manufacturers warning that many current marketing practices may violate federal anti-kickback legislation. The OIG guidance is apparently intended to curb the industry's more outrageous efforts to get doctors to prescribe its drugs -- such as paying them honoraria to listen to promotional lectures over dinner or to sign their names to ghostwritten articles. But it is also intended to prohibit the industry from making secret agreements and payoffs to insurers and managed-care organizations to keep drug prices high. The big fix that Katherine Greider documents just might be coming undone.

Carl Elliott is an associate professor at the University of Minnesota's Center for Bioethics and the author of Better Than Well: American Medicine Meets the American Dream.

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