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How a cancer trial ended in betrayal

With billions at stake, research universities become partners in commerce - and medicine pays a price.

June 24, 2001|By Douglas M. Birch and Gary Cohn | By Douglas M. Birch and Gary Cohn,SUN STAFF

That summer, Bugg asked Sams to hire Renee Peugeot, a 35-year-old nurse and the wife of Harry W. Snyder Jr., the scientist running the study for the company. Sams agreed, assigning her to help him with the study. Neither Bugg nor Sams seemed concerned that the husband and wife had a financial interest in seeing the trial succeed.

"At the time, I really didn't think anything about it," Bugg says.

When Lange arrived at the Birmingham research center that fall, he was greeted by Peugeot. She was upbeat and buoyant, Lange says, but also someone to be reckoned with, someone who gave the impression of being in charge.

Lange and 21 other T-cell lymphoma patients at Birmingham were given two number-coded tubes of cream and told to use one on a cancerous patch on the left side of their body, the other on a patch on their right. Every few weeks, the patients would come to the hospital for examinations, including measurement of their patches and other tests.

The FDA required so-called double-blind studies of BCX-34. Neither patients nor investigators were supposed to know which tubes held the drug, which the placebo. That information was recorded on "randomization schedules" that were drafted before the trial and locked up at BioCryst.

Those documents served as the keys to secret codes. No one was supposed to use those keys to see any results before the end of the trial, to guard against bias - conscious or not - in evaluating the drug's effects.

Unnerving doubts

Lange sheepishly walked down hospital corridors in a drafty gown, carrying a jug filled with urine for testing. He let Sams take pictures of his thighs and buttocks to illustrate talks at scientific meetings. At one point, Sams summoned Lange to say that a test indicated he might have the virus that causes AIDS. Lange spent a terrifying night before Peugeot reported that it was a false alarm.

Lange now shrugs it off. "It was worth it to me if I could help find a cure for the disease," he says.

Marcia Houchens also signed up for the trial. Her first husband died of cancer in his 40s. Her sister died of cancer. So, when Houchens received a diagnosis of cutaneous T-cell lymphoma, she was frantic. She was referred to Sams, who she said steered her into the BCX-34 study without offering the standard treatments.

"They had me believing this was my only hope," she says.

During examinations, Peugeot and Sams had what some patients thought was the unnerving habit of disagreeing about the size and redness of cancerous patches, or lesions. Peugeot often saw substantial improvement in the lesions where the physician saw little or none.

"She said that my lesions were gone," Lange recalls, though he could still see them. Houchens, too, was told she was cured. She didn't believe it, either.

Sams was dubious as well. But it was Peugeot's assessments that wound up on patients' charts. She even recommended BioCryst stock to Sams and others at the hospital. Sams said he didn't follow her advice.

"There was no way I would own stock in a company in which I was doing the studies," he later testified. Still, he liked Peugeot's optimistic nature. "She was always enthusiastic and always very positive. It was a breath of fresh air. It was wonderful."

Sams acknowledged that he gave his assistant "total responsibility" for the study. It was a serious breach: The principal investigator in a drug study is the person who must ultimately answer for its conduct.

If Sams trusted Peugeot, others learned not to. Dr. William J. Cook was hired from the university in September as BioCryst's medical director and Snyder's boss. Peugeot overheard Cook ask another BioCryst executive about a missing number in a patient's chart. Peugeot immediately wrote a number in. When Cook asked what she was doing, Peugeot said she recalled the figure from an examination more than a week earlier.

"Did you see what she just did?" the astonished executive asked after Peugeot left the room.

"Anybody knows you can't do that," Cook replied.

Peugeot's husband, Harry Snyder, was a respected scientist who taught at Cornell University's medical school before working in the biotech industry in Seattle. He joined BioCryst in 1993 to help run clinical trials.

More than a month before the BCX-34 studies ended in January 1995, Snyder wrote to colleagues, claiming that the drug was working, even though it was a blind study and he had no legitimate way of knowing the results. In early January, Peugeot and Snyder bought BioCryst stock, adding to their shares and options. At one point, they owned BioCryst stock and options worth $600,000, court records show.

When Snyder's data were analyzed at the end of the trial, BCX-34 seemed to have had impressive results. The company issued a news release in early February 1995, announcing that the drug had proven highly effective in treating psoriasis and, more important, the skin cancer.

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