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Editorial: Full disclosure

Patients (or their parents) need to know a drug's risks

Tuesday, May 02, 2000

No one will ever know with absolute certainty what killed 9-month-old Gage E. Stevens. But the fact that this baby was one of at least 80 people who died while taking the anti-heartburn drug Propulsid makes it reasonable to assume that the drug could have played a role.

Coroner Cyril Wecht's decision to change the child's death certificate to indicate heart arrhythmia, a known side effect of the drug, rather than SIDS, seems equally reasonable.

Children's Hospital, where the child had been enrolled in a clinical trial of Propulsid before his death last November, argues that there had been no evidence of arrhythmia. But as both Dr. Wecht and Children's Medical Director Donald R. Fischer agree, there is no way to prove what caused Gage Stevens' death.

What is most disturbing about the case is that the consent form that the parents signed allowing Gage to be part of the trial said, incorrectly, that the drug had been approved for infants. The hospital said that the claim was made because it believed the approval was imminent, but that is hardly an acceptable explanation.

It's impossible to know whether Gage's parents, Scott Stevens and Gretchen Stewart of Munhall, would have agreed to Gage's participation had they known. But that shouldn't be a matter of conjecture.

It is crucial that medical consent forms be clear, straightforward and honest. The risks must be precisely spelled out so that participants understand exactly what the possible cost is for what possible benefit. The problem is, people seeking relief from chronic pain or discomfort are frequently willing to overlook the danger posed to a tiny percentage of the population in the hope that the drug will work the miracles that will restore their quality of life.

Doctors no doubt understand the psychological factors at play and must therefore be all the more scrupulous in presenting the facts. That is especially the case when the subject is a child. Gage's parents say they didn't realize the serious side effects that were associated with Propulsid when they agreed to allow Gage to be part of the study. The child had suffered from heartburn and chronic diarrhea, and he was taking the drug to see if it was effective and safe in treating acid reflux in children.

No parent would risk seeing his child die in exchange for possibly alleviating troublesome but not life-threatening symptoms. Gage's parents never considered the possibility that their son would be among the tiny percentage who would experience heart problems, even though the consent form indicated that heart abnormalities were a side effect. It is up to doctors to make sure that parents understand that even if the side effects are rare, they are still real.

There is something of a Catch-22 in the whole process, however. If parents fully recognize the risks, they will be less likely to enroll their children, making it more difficult to conduct the trials.

But doctors often prescribe drugs for purposes other than those for which they were approved and for populations on whom they weren't tested. Doctors sometimes just cut the dosage to accommodate the lower weight of children without fully comprehending what effect a child's metabolism and body chemistry might have on how the drug works.

At least 19 children died while taking Propulsid, for example, but Gage Stevens was the only one of those 19 who was part of a Food and Drug Administration approved drug study. That study was finally stopped in March, four months after Gage's death.

It is impossible to completely eliminate risks in testing new drugs, and such tests remain essential. But despite the obstacles that full disclosure might present in the advancement of medical science, it is crucial that participants, or in this case their parents, understand exactly what they are getting into.

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