Death Points to Risks in Research

That happened on July 2, a Monday. She was tired and out of sorts after a weekend of boating with her husband and daughter, but she had gone to her data-entry job at the secretary of state's office in Springfield and later to Trapp's office.

He recorded her temperature at 99.6, then gave her the shot.

"The next day she woke up and didn't feel good at all. By afternoon she started vomiting," Robb Mohr recalled. "By evening her temperature had shot up to 101."

She spent July Fourth feverish and vomiting. Her family physician told her it was probably just a virus.

When her symptoms worsened and her temperature hit 104.1 on Saturday, she went to the emergency room. Tests indicated a possible infection and signs of liver damage, but she was sent home for more care from her family doctor, according to Robb Mohr and medical records.

Aware of the experiment, Mohr's family doctor called Trapp, who reassured him that the virus was safe -- something Trapp said he had learned at a training session sponsored by Targeted Genetics. But Mohr only got worse, and on Thursday she was admitted to the hospital.

Things went downhill fast, with Mohr's body showing signs of being ravaged by an infection. But tests for standard bacteria and viruses came up negative. With breathing problems and the possibility she might need a liver transplant, she was transferred to the University of Chicago hospital.

Suspecting a possible link to the experimental drug, the doctors in Chicago contacted the FDA.

Federal regulations require a company to report any serious complications that are even "possibly" related to an experimental treatment "as soon as possible" and no later than seven days after learning of it. But Targeted Genetics and Trapp had at first classified the problems as not serious, and later classified them as serious but unrelated to the treatment. So no FDA report was made, and the study went on, with other volunteers unaware of the problems.

That reflects a widespread problem in clinical trials, said Adil Shamoo, a professor at the University of Maryland School of Medicine and editor in chief of the journal Accountability in Research.

"There are no uniform standards for 'adverse events' reporting," Shamoo said. "And there is no motivation to report them. . . . No one wants to show their dirty linen."

Dirty linen can drag down a company's bottom line, and Targeted Genetics, like all companies, puts a lot of work into keeping that line afloat. An interim report on tgAAC94, for example, spoke in June of "very encouraging results" and evidence of "clinical benefit," although, by one measure the company considered key, patients who got high, medium or low doses of the drug did the same as those who got placebos.