<< Previous Section | < Previous Page | Next Page > | Next Section >> Case: Remembra (page 2 of 2) Three and one half million dollars and two years later, a potent CR agonist was available for testing. It was called Remembra. The IRB, with an inquiry from the university President urging expediency, approved the Phase I and II trials. In a total of 25 subjects the pharmacokinetics and acute toxicity studies were completed satisfactorily. As Dr. Zhivago gears up for the clinical test of Remembra, she learns that her NIH renewal was not going to make the grade because of poor recent productivity. She thinks, "If this works, I won't need to keep applying for grants." While the IRB was initially reluctant to approve Dr. Zhivago's role in both managing and carrying out he Phase III placebo controlled double blinded trial, with a little institutional encouragement the protocol was approved and Zhivago began testing Remembra on mentally retarded adolescents who required special schooling. Even though the study was double-blinded, the progress on Remembra was so dramatic that everyone thought they knew who was taking the real drug. Treated students were able to learn and retain much more rapidly than ever before. Enthusiasm at the school got out and reached university administration, which reveled in the possibility that one of their investments might pay off. About 3 months into the six-month trial it was noted that some of the participants began to have episodes of sweating and confusion that came and went. The teachers and investigators reported these events and when the Data and Safety monitoring Board was informed, one of the investigators suggested measuring the blood sugar during episodes and sure enough, the symptoms were found to be due to hypoglycemia (very low blood sugar). Since there were no severe episodes and the episodes were treatable with orange juice, the DSMB suggested providing frequent meals and teaching the families and teachers of the students how to treat hypoglycemia. The IRB required an amendment to both the protocol and the consent form recognizing the adverse event. By the fifth month the adolescents were gaining a lot of weight and on one occasion a participant went into hypoglycemic coma and had to be treated in the E.R. The DSMB decided to stop the trial for safety reasons even though the participants on Remembra were learning at an impressive rate and the teachers wanted it continued. The DSMB heard an appeal from the university president for the sake of the mentally retarded to continue the study but they did not budge. One of the teachers told the story of Remembra to the N.Y. Times, which published a long article on the story. Shortly thereafter Dr. Zhivago received a call from a major drug company about the possibility of developing Remembra as a treatment for diabetes. What conflicts of interest exist in this scenario? Remembra has potential. How can the ethical issues surrounding its testing be resolved? How does the idea of improving on human intelligence strike you ethically? If you were the CEO of LEARN what actions would you take now? << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 4 Quick Links Conflicts of Interest (COI) Definitions Consequences of a COI Government Intervention Industry Sponsorship Professional Societies Clinical Practice Guidelines Other Initiatives COI in Financial Consulting Cases Bibliography Chapter 4 Download (PDF)