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Originally published Sunday, December 26, 2004 at 12:00 AM

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A rising force in drug-safety debate

As a medical student, Dr. Bruce Psaty angered some professors when he refused to kill and dissect a dog. Fellow students ostracized him when he declined to attend banquets paid...

Seattle Times staff reporter

As a medical student, Dr. Bruce Psaty angered some professors when he refused to kill and dissect a dog. Fellow students ostracized him when he declined to attend banquets paid for by drug companies.

But more than two decades later, as the drug-safety debate heats up, those same ethical standards and freedom from drug-company ties are raising the Seattle researcher's profile.

Last month, Psaty testified before a U.S. Senate panel on studies linking the painkiller Vioxx to heart attacks and strokes, following drug giant Merck's move to pull Vioxx from the market.

This month, he was lead author of a report in the Journal of the American Medical Association (JAMA) that concluded drug-maker Bayer knew of problems with its cholesterol-lowering drug Baycol at least a year before removing it from the market in 2001.

And he continues to provide expert advice to Sen. Charles Grassley, R-Iowa, who is drafting a bill that would open drug-trial results to greater public scrutiny.

By his own account, Psaty — an English scholar, medieval expert and former high-school football player — never sought attention. Indeed, his daily routine of trolling through drug literature, applying for grants and designing studies may sound dull. But with questions about the safety of widely used drugs coming to light, his work has taken on renewed significance.

Even since his congressional testimony, new studies suggest that popular painkillers Aleve and Celebrex also may increase the risk of heart attacks and strokes.

Psaty, 54, said the U.S. has become the world's testing ground for drugs with new molecular structures.

In the early 1980s, just 3 percent of such drugs were approved first in the U.S., one study published in JAMA found. But by 1998 — after Congress passed rule changes to speed the Food and Drug Administration's drug-approval process — 60 percent of the world's new substances were approved first in the U.S.

Psaty and other top researchers are now calling for the FDA to demand more rigorous trials before approving new drugs. He also wants a new safety office, independent from the FDA, to watch for problems after drugs hit the market.

Drug-company representatives maintain the drug-approval process is keeping consumers safe.

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"Even those who have offered some skepticism, given recent events, still agree the FDA is the gold standard for safe medications," said Court Rosen, a spokesman for the drug-manufacturers trade group PhRMA. "Not a drug agency in the world comes close to being as respected."

Under attack

The FDA is coming under attack from within, especially from Dr. David Graham, an FDA whistle-blower who stunned the Senate panel last month by listing five drugs approved by the government that he thinks may be dangerous. In an interview, Graham praised Psaty's work.

"He is one of the nation's experts in this kind of field. It's a relatively small field in terms of people who do it well," Graham said. "The problem with many in the field is that they become encumbered by industry funding."

Graham said his bosses at the FDA did not speak to him after his testimony, canceled meetings and threatened to "exile" him to a dead-end job. But recently the wider medical community has rallied behind him, he added.

Psaty, who practices as a general internist at Harborview Medical Center as well as co-directing the University of Washington's Cardiovascular Health Research Unit, also knows what it's like to incur the wrath of powerful interests.

In 1995, he led a study he presented to the American Heart Association raising safety concerns about blood-pressure drugs Procardia and Adalat. Psaty came under attack.

Academic consultants "issued blistering critiques, publicly questioned the investigators' integrity and emphasized dubious contraindications ... generally without disclosing their company ties," wrote five Seattle researchers — including Psaty and his UW dean, Gil Omenn — in a New England Journal of Medicine paper titled "The Messenger Under Attack."

Omenn said he didn't hesitate to defend Psaty. "Companies don't like bad news, and this was a very well done study," Omenn said.

In the aftermath, drug-company Pfizer used public-disclosure laws to demand "every piece of paper I had ever touched," Psaty said. The company later withdrew the request. But the Psaty family, including daughter Sarah, 7 years old at the time, were shaken and began screening calls.

From English to medicine

Psaty grew up in New Jersey and earned his undergraduate degree from Princeton University. He studied English, eventually getting a doctorate before turning to medicine.

"I remember Bruce as a very inventive guy and a lot of fun," Princeton friend and Indiana Gov.-elect Mitch Daniels said through a spokesman.

Later, as a graduate student at Indiana University, Psaty helped launch a program teaching English and literature in prisons. Psaty said his audience, starved for information and interaction, loved the courses. Poet Jared Carter, a longtime friend, agrees.

The program went well, said Carter, until its leaders persuaded the university to enroll some of the prisoners in campus classes. "A couple turned out to be utter thugs," Carter said. "They terrorized people and had to get sent back to prison."

After finishing his doctorate in 1979, Psaty entered Indiana University medical school and met his future wife, Sue, a research nurse. Then the detail-oriented student discovered computers.

"He and the desktop computer were a marriage made in heaven," Carter said. "It was a chance for him to be thorough with a complicated piece of gadgetry."

From there it was a small step to epidemiology, which he studied at the UW in the 1980s. He became an expert in drugs that affect the cardiovascular system, especially those that relieve high blood pressure.

In the medical-research field that is awash with industry money, Psaty's first — and last — significant connection to a drug company came in 1991 when he landed funding for a three-year pilot study on the connection between hormone-replacement therapy and strokes. The funding came from the Merck company's foundation.

Psaty said that Merck's rivals used that connection against him during the 1995 controversy, which convinced him he needed a clean separation. While many researchers perform studies paid for by drug companies, Psaty gets almost all his research money from the National Institutes of Health.

"It's a lot of work to be independent. I am writing grant proposals all the time," he said. "It's not an easy life. But it helps avoid even the appearance of a conflict of interest."

Criticizes marketing

Psaty says he's frustrated that doctors and patients alike are often swayed by the intense promotion of new brand-name drugs. When it comes to lowering blood pressure, for example, cheap generics such as low-dose diuretics often do the same job more safely, he said.

He's also concerned that drug companies avoid looking for possible downsides when testing new drugs. For instance, much of Merck's Vioxx testing excluded patients with heart conditions, skewing final results, he said.

Even trial names, supposedly acronyms, suggest marketing campaigns. The Vioxx trials were named "Vigor" and "Approve."

"The studies are treated as advertising material, not science," Psaty said. "Looking at this as a physician and scientist is distressing."

But Rosen, the drug manufacturers' spokesman, said companies comply with regulations that require them to tell the FDA of possible safety concerns within two weeks of the information becoming available. He added that only a tiny proportion of drugs approved by the FDA over the last two decades have been withdrawn.

"The fact is that science is not perfect, and it's a consensus-building process," Rosen said. "People have to weigh the benefits against the risks."

In his recent report on Baycol, Psaty used internal Bayer documents that surfaced during litigation to help show that the company knew of a link between the drug and rhabdomyolysis, an unusual and sometimes fatal muscular disorder, at least a year before Baycol was withdrawn in August 2001.

One such internal memo reads: "The large percentage of patients experiencing CK [an enzyme marking muscle damage] elevations led to a consensus by the committee not to publish the results of this study."

Bayer responded in JAMA that its marketing of Baycol before the withdrawal was "responsible, appropriate, and consistently motivated by concern about the safety and welfare of patients."

Whistle-blower Graham says work such as Psaty's is increasingly important.

"I think that it's invaluable to have a knowledgeable epidemiologist that understands the consequences to the public when drug safety is ignored," Graham said.

"He is able to help spread the message that Vioxx was a national catastrophe, that many people were hurt, and that the FDA failed in its primary mission" to protect people from unsafe drugs.

Nick Perry: 206-515-5639 or nperry@seattletimes.com

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