The Side Effects of Truth

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SHORTLY AFTER Merck pulled Vioxx from the market last September, Graham began carrying an index card full of phone numbers in his breast pocket. The little scribbles of red and black ink were his lifelines, contacts to a dozen supportive congressional staffers and reporters who'd sought him out after he went public. It had become clear that he wouldn't survive long in his job without help from some heavyweight defenders.

Iowa Senator Chuck Grassley, the Republican chairman of the Finance Committee, became his primary protector. "It's people like this who give us the opportunity to know that something is wrong, helping me do my job," Grassley says. He believes the industry has far too much influence on FDA deliberations over safety. "There should only be one chair at the table," he says, "and that is for the American people."

The only way to resolve the FDA's dangerous conflict of interest, according to Graham, is to create an independent center for drug safety, situated on one side of a fire wall; those who study efficacy and recommend approvals would be on the other side. Researchers would report their findings to scientists with no stake in the performance of the drug. But this is a more drastic change than the agency is likely to implement of its own accord. The FDA has made other gestures: It has announced a new committee to monitor safety issues, asked for an investigation of its procedures by the Institute of Medicine, and proposed reassigning about 20 scientists to work on drug safety.

Jeff Trewhitt, the spokesman for PHRMA, rejects Graham's solution out of hand. "He seems to start from the premise that the drug-safety program is broken, and we don't accept that premise at all," Trewhitt says, adding that any new regulation "could mean slower delivery of new medicines to patients." That view has also been embraced by the White House, which maintains close ties to the drug industry and its more than 600 lobbyists. During a television interview, Andy Card, chief of staff to President Bush, said that the administration's handling of the Vioxx recall was "a testament to the FDA and how they do their job."

This leaves the prospect of real systemic change at the FDA in the hands of Congress. Indeed, throughout history, safety scandals have regularly sparked congressional action. The agency itself was established by Congress in 1906 after a wave of adulterated or dangerous drugs was exposed in the press, including a "headache powder" containing acetanilide that caused heart attacks. In 1962, Congress began forcing pharmaceutical companies to test drugs after doctors distributed doses of a pill called thalidomide to pregnant mothers, a sedative later shown to cause birth defects.

But the scale of the Vioxx scandal appears, in sheer numbers, far greater than any other in the nation's history, and Congress has yet to respond. Not only has the drug been widely used—peaking in 2001 at 25 million prescriptions—but it has increased by two- or threefold the risk of one of the most common causes of death, heart attack.

IN FEBRUARY, six months after the Vioxx scandal broke, Graham still finds himself struggling to get the word out. His latest research, based on the records of 651,000 California Medicaid patients, raises safety concerns about other drugs in the same class as Vioxx. Mobic, a popular painkiller still viewed as safe, appears to be increasing heart attack rates by about 37 percent. Celebrex, a blockbuster pain medication from Pfizer, increases rates by about 25 percent in high doses. Although the findings are not statistically conclusive, the study adds key data to the medical literature. But Graham's superiors aren't interested. The email Graham receives before heading to his son's Boy Scout meeting asks him to focus only on "the key studies in the published literature." According to Graham, he can present only one unpublished study, a report paid for by Merck.

Graham's most powerful defender comes to his aid: Senator Grassley sends a terse letter to the acting FDA commissioner, Lester Crawford, demanding an explanation of why Graham can't present his data. Grassley gives Crawford a deadline for responding: February 16, opening day of the three-day FDA advisory committee meeting. The gathering is held in an overstuffed Hilton conference room in Gaithersburg, Maryland, a suburb of Washington, D.C., covered with rolling parking lots and B-rated shopping malls. Broadcast trucks ring the hotel, and the hallways are crowded with cameras. Just hours before Steven Galson, Graham's supervisor, is to welcome the 32 scientists assembled from around the country, Crawford intervenes. The backtracking is brazen. "It goes without saying," Galson says in his opening remarks, "that all FDA staff are free to make any presentation without fear of any retaliation." Graham, who is scheduled to speak the next day, leaves the meeting to hastily redesign his presentation.

When he returns the following day, he's wearing the same coat and the same tie. In the previous three weeks, he has lost two more pounds. "I'd like to take this moment to thank Dr. Crawford for his leadership, for making it possible for me to present our preliminary data from a study from California Medicaid," he tells the gathered scientists. He presents his findings on the dangers of Mobic and Celebrex in high doses. About Vioxx, he says the risks associated with taking high doses are "probably more significant than smoking or diabetes or hypertension." Then he challenges the FDA to begin shifting its assumptions when it considers a new drug. "Let's start out at the beginning assuming the drug isn't safe."

On the third day of the conference, Graham dips outside the meeting room for a break and is immediately surrounded by a scrum of reporters. The committee of 32 scientists was nearly unanimous in acknowledging the dangers Graham presented to the FDA six months earlier. But they voted by a narrow margin to keep the two most troublesome painkillers, Vioxx and Bextra, on the market, calling instead for tighter restrictions on distribution. Ten of the scientists were consultants for the manufacturers of the drugs in question. Had they not been allowed to vote, according to an analysis by the Center for Science in the Public Interest, both Vioxx and Bextra would have been recalled.

The reporters ask Graham for his reaction. "The fact is, debate is happening," he says. It may be one of the last times he finds himself in the public spotlight as a federal researcher. If the experience of others is repeated, he'll be sidelined within the agency and denied any meaningful projects over the coming year. Despite Grassley's backing, he expects to be pushed out of his job. Standing outside the conference, however, Graham still has the power to speak out—and infuriate his government employer. "Sunlight is the best disinfectant," he tells the surrounding crowd. "This is more sunlight on the problem."

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Michael Scherer is the Washington correspondent for Mother Jones.

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