Death in test haunts Hopkins researcher

Scientist: Friends say the doctor nearly quit after a fatal experiment but hopes to get back to healing.

January 27, 2002|By Tom Pelton | Tom Pelton,SUN STAFF

In the final hours of her life, Ellen Roche lay unconscious in a bed at the Bayview Medical Center's intensive care unit, her shallow breathing forced by a mechanical respirator. Around her gathered her family, her doctors and an anxious professor wearing black wire rim glasses.

The professor, Dr. Alkis Togias, was not there to treat the patient. He was seeing the horrific conclusion of an experiment he had begun a month earlier, when he offered the healthy 24-year-old woman $365 to inhale chemicals to provoke an asthma-like reaction.

One of those chemicals destroyed her lungs and shut down other organs. And so on that warm June evening, Roche's family assembled in her hospital room, asked her doctors to turn off her life support machinery and watched her die.

That moment had devastating consequences. Roche's family has had to endure a terrible loss. The Johns Hopkins medical school has been humiliated by federal regulators, who temporarily suspended all human experimentation at the school in July and forced an overhaul of its system for reviewing studies.

And Togias?

Since he walked out of that hospital room, his career has been frozen in time. He still goes to work every day. But for months, virtually all he did was meet with investigators - sitting through hundreds of hours of questions and turning over reams of documents. The university has not punished him, but it has not let him resume his studies.

Although he received supportive e-mails and comments from many fellow asthma researchers, he feared that other Hopkins scientists blamed him for the suspension of their work and the taint to the university, said those who know him.

Togias became depressed and thought about resigning. But he decided to continue because asthma research is what he knows and loves, say friends and colleagues.

"Togias was very shaken, very hurt," said Dr. Stokes Peebles, an allergy researcher at Vanderbilt University. "All doctors have patients who die, but you don't ever want a healthy person to die."

Six months after the shutdown, the university has reapproved almost all the 2,600 halted experiments - except those led by Togias.

In addition to canceling the experiment in which Roche was enrolled, the university aborted or suspended nine of Togias' other studies, involving about 1,100 volunteers. Togias wants to resume two or three of these.

But the federal Food and Drug Administration, which can prohibit researchers from experimenting on humans, has not decided what restrictions, if any, it will impose on Togias, said agency spokesman Lawrence Bachorik. And it is not clear when the university will allow him to once again recruit volunteers.

"Hopkins officials have imposed extraordinary measures to ensure that any future research conducted by Dr. Togias will not only be rigorously re-reviewed by the institutional review board, but also ... pose no unusual risks," said medical school spokeswoman Joann Rodgers.

Togias declined to comment for this article, noting respect and sympathy for the Roche family, said his attorney. The lawyer, Daniel Kracov, said, "He is dedicating all of his time to implementing the corrective action plan in full cooperation with Johns Hopkins."

That plan requires the vice dean for research, Dr. Chi Dang, to supervise any studies that Togias conducts. Togias must also take a course in safety regulations, among other measures.

Some question whether Togias should ever be allowed to experiment on humans again because he made so many serious errors in the study that killed Roche.

Federal investigators concluded that Togias was negligent for giving Roche a chemical, hexamethonium, not approved for humans, failing to find medical journal articles that linked the chemical to lung disease and neglecting to warn volunteers about the risk.

But Togias' friends say it would be unfair to destroy a promising career because of one tragedy.

They describe him as a talented, honest and diligent scientist who feels terrible about what happened and is working hard to make research at his asthma center safer.

Scientists anguish over what to do with researchers like Togias, a well-meaning doctor who nevertheless violated his profession's guiding principle of doing no harm. Should his career end? What should happen to a good scientist who makes a bad mistake?

Two who pursued healing

Togias and Roche knew each other fairly well. They often passed each other in the halls of Hopkins' Asthma and Allergy Center on the Bayview campus in East Baltimore, one of the world's leading research labs in that field.

Togias (pronounced Toy-us) is a serious and reserved 44-year-old with wavy black hair and a gentle accent that hints at his upbringing and medical education in Greece. He lives on a cul-de-sac in Bethesda with his wife and two sons, ages 6 and 8.

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