I take great exception to the portrayal of my comments regarding a hepatitis C study (“A doctor’s pitch, a question of ethics,” Page A1, Sept. 25). I feel obliged to clarify important details and provide additional context.
In speaking at the public forum in Exeter, N.H., where a hospital technician has been accused of infecting patients, I repeatedly emphasized that I was referring to a study, not an approved treatment, and that promising safety and efficacy data from phase 1 and phase 2 trials of these drugs were publicly available.
This forum was an informational session designed to offer facts about hepatitis, its prognosis, and treatment options, including upcoming trials. Those interested in additional information and in being notified once the study was underway voluntarily provided me with their contact information; they were NOT recruited, as implied in the article. All were told that subsequent informed consent would still be required should they be interested in and eligible for the trial.
I believe that alerting patients and families about possible access to investigational therapies is my professional and ethical obligation, particularly for those ineligible for interferon, the only approved treatment.
I also feel it was my responsibility to inform those patients who were contemplating beginning treatment with interferon soon that doing so would exclude them from entering many studies offering alternatives to this burdensome medication, including this study.
Prior to the event, I consulted with Dr. Elizabeth Hohmann, who, as chair of the Massachusetts General Hospital ethics committee, completely agreed with the rationale for providing this information at that time. It was our joint opinion that my approach to the event and the public discussion more than met all ethical clinical research standards, and I stand by my actions.
My sole purpose in speaking at this forum was to provide important and hopeful information to a bewildered Exeter community in great need of clarity.