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Conflicts of Interest - Case G1

Cynthia Walsh, M.D., an associate professor of medicine, is a prominent academic cardiologist. Her personal financial investments include significant stock holdings in three publicly traded biotechnology firms. She is approached by one of these firms to be a lead investigator in a therapeutic trial of a novel agent for preventing tissue damage from myocardial infarction (MI). This will be a randomized double-blinded, placebo-controlled clinical trial (neither patient nor physician will know whether the drug under investigation or a placebo is being used in a given patient). Dr. Walsh is quite familiar with the preliminary animal and cell biology work in the area and believes that there is an excellent chance that this new drug will result in a significant improvement in survival and reduce damage to the heart muscle. She even thinks this novel agent may reduce the risk of heart failure and irregular beats.

Dr. Walsh's group is one of the few cardiology groups fully prepared to carry out this investigation, which is why she was contacted, and a clinical fellow suited to manage the study is available. She cares for a large number of patients with MI and believes that she could enroll numerous patients efficiently. The drug will only be available to her patients if her group participates in the trial. The company is offering $5,000 for each patient enrolled and the money would really help both her salary and the division budget. As a lead investigator, she will become much better known and will likely experience an increase in referrals if the trial succeeds.

Questions:

  1. Is Dr. Walsh's participation in this study appropriate? Justify your position.
  2. Does Dr. Walsh have a conflict of interest? If so, what is the nature of the conflict? How could it be mitigated? Would the nature of the conflict of interest be different had she not already owned stock, but instead had been offered stock as a form of compensation for conducting the study?
  3. If Dr. Walsh already believes the drug is an improvement based on the literature emanating from animal experiments, can she honestly assign patients randomly to treatment or placebo? What if she believes the drug is deleterious because of its adverse effects on the kidney late in the course of treatment?
  4. What should the role of the university be in this case?
  5. During study of the first few patients, it becomes apparent to Dr. Walsh that she can tell who is on the active drug because the patients get a facial flush. Might that further influence her ability to remain objective? What considerations apply in answering that question?
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