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Dealing with Conflicts of Interest in Biomedical Research: IRB Oversight as the Next Best Solution to the Abolitionist Approach
Published online by Cambridge University Press: 01 February 2021
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In the summer of 1995, Thomas W. Parham went to his physician, Peter Arcan, for an ordinary check up. During his visit, Dr. Arcan suggested that Mr. Parham join a clinical trial studying a new drug to shrink enlarged prostates. Mr. Parham was confused because he never had prostate problems, but Dr. Arcan stated that the drug might prevent future difficulties. When asked why he joined the study, Mr. Parham stated, “I just followed his advice, just like if he said to take two aspirin instead of one. He’s a doctor and I’m not.”
Mr. Parham should not have been entered into the study because he had been hospitalized a year earlier due to a chronic slow heart rate, a clear study-exclusion criterion that would disqualify him from being a subject in the protocol. However, Dr. Arcan sought an exemption from the drug company stating that Mr. Parham’s heart rate was only “mildly slow,” failing to report the prior hospitalization. After Mr. Parham began taking the study medication, he complained of fatigue, a symptom of a slow heart rate. Within weeks, after requesting to be taken off the study, he was hospitalized and a pacemaker was implanted for his slow heart rate. The drug’s manufacturer, SmithKline Beecham P.L.C., was paying Dr. Arcan $1,610 for each patient enrolled in the study. The fee covered study expenses, but was sufficient to give the recruiting physician a profit for each subject enrolled.
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