At Your Own Risk

Some patients join clinical trials out of desperation, others to help medicine advance. Who is to blame if they get sick--or even die?

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For another, there was evidence in the literature that hexamethonium might be unsafe. Togias did a search and didn't turn that up, but after-the-fact searches using different search engines and databases did turn up references to the potential risks to humans. The FDA also raised questions about the informed-consent forms that Roche and two other subjects had signed. On them, hexamethonium is referred to as a "medication" and as "[having] been used as an anesthetic"--giving subjects a false sense that it was an FDA-approved medicine and therefore safe. An outside review board commissioned by the hospital noted in a report, "The consent form is not meant to reassure the subject, quite the contrary, it is meant to raise every possible concern that might be relevant to the subject's participation."

Another criticism: Togias failed to report that his first subject (Roche was the third) had developed a cough. It went away, and Togias assumed it had to do with a viral infection making the rounds at Bayview at the time. To be safe, he added a buffer solution to the hexamethonium--but without informing the IRB, which he should have done. That omission may be a reflection of the prevailing sentiment at many hospitals: that the IRB and its review process are a bureaucratic pain in the neck, not a clinical necessity.

In the end, nobody could say that strict compliance would have saved Roche. But even the possibility haunts everyone involved. "If all things leading up to doing that study had been perfect and she had died, it still would have been a horrible event," says Dr. Edward Miller, dean and CEO of Johns Hopkins Medicine, "but I would have felt better about the fact that we had done everything humanly possible to prevent it."

Johns Hopkins' response to the crisis, as in Oklahoma and at the University of Pennsylvania, was to rereview all its clinical trials and completely restructure its institutional review system; Johns Hopkins also brought in an outside IRB to evaluate all new applications until the process is complete. The University of Oklahoma, for its part, is spending hundreds of thousands of dollars to create a model system for human-subject protection--including requiring its researchers to become certified in subject safety. And last July, Penn instituted a new policy on financial conflicts of interest: any potential conflict, whether it involves funding or financial stakes in the outcome of the trial, must be reviewed by both the IRB and by a separate, university-wide panel of experts from the law school and ethics departments.

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