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
- Is Dr. Walsh's participation in this study appropriate? Justify
- 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?
- 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?
- What should the role of the university be in this case?
- 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