Therapeutic Dose: Playing the Villain

Movie still from "The Constant Gardener": Rachel Weisz and Ralph Fiennes star as Tessa and Justin Quayle.

The movie — based on a John le Carré novel — is fiction, but Le Carré said his story was “tame as a holiday postcard” in comparison to what drug companies are actually doing in Africa. The book’s publication followed several high-profile cases in which drug manufacturers were accused of conducting potentially dangerous trials without the informed consent of their human subjects.In 2001, a group of Nigerian families took Pfizer to federal court, claiming that the manufacturer had tested the bacterial meningitis drug Trovan on their children without their knowledge. Some of the children died, and the suit questioned whether Pfizer, in testing Trovan, neglected to offer the children a more proven antibiotic. The court eventually ruled that the case could not be tried in the U.S.Clinical trials are big business and, not surprisingly, are being outsourced overseas. Like Africa, India has become a popular testing ground — for its huge patient base, genetic diversity and low costs. One study estimated that clinical trials that might cost $150 million to conduct in the U.S. could be done for 60% less in India.While public scrutiny of clinical trial data has increased, there’s not much oversight of trials being conducted in the developing world. “Nobody’s watching it,” says Vera Hassner Sharav, president of the Alliance for Human Resource Protection. “And that’s because nobody’s putting up the money to do it .” The major media, she notes, has not written much on the issue since a Washington Post series in 1998.The biggest change that needs to happen, Hassner Sharav says, is for FDA to accept data from foreign clinical studies only under an investigational new drug (IND) application, as it does with domestic trials, and not post facto.Pharmaceutical firms are doing a lot of good in the developing world, Damon Ansell of the Africa policy group Uhuru reminds us (see "Pruning the Constant Gardener"). Uganda’s Infectious Disease Institute has trained more than 320 doctors to treat AIDS, funded mostly by Pfizer, Inc. “In the fight to save lives in Africa, we must respect the complexity of the problems involved,” Ansell says.But the public is unequivocal in its impression of our industry — we’re the bad guys. (Manufacturing, while not to blame for the image problem, is guilty by association.) Gallup’s latest poll on industry image puts pharmaceuticals near the bottom of the list — slightly higher than oil and gas and the legal field (see chart below). “Supersize Me” notwithstanding, the restaurant industry was tops.In the restaurant biz, manufacturer and consumer are divided only by the kitchen door. In the drug industry, the division spans time and distance. We need important issues to bring us together, if only for two or three hours in a dark movie theater.Top- and Bottom-rated Industries, 20051. Restaurant 2. Computer 3. Farming/agriculture 4. Grocery 5. Retail . . . . . . 21. The federal government 22. Pharmaceutical 23. Healthcare 24. The legal field 25. Oil and gas Source: Gallup poll of 1001 adults