<< Previous Section | < Previous Page | Next Page > | Next Section >> Case: Unsatisfactory Study A large drug company identified a series of small molecules that stimulated the release of growth hormone leading to the increased production of the anabolic hormone IGF1, which normally declines profoundly with aging. It decided to conduct trials in elderly physically disabled people with low IGF1 levels to increase the circulating IGF1, and thus produce the beneficial effects of GH therapy, but using a single pill a day. If there were beneficial effects, they could thus be achieved inexpensively. Extensive animal trials showed enhanced GH secretion without perceived adverse effects. Phase I and phase II trials were quite successful in that there were no short-term ill effects and the drug reliably increased IGF1 levels in a dose-dependent manner. The phase III trial was double blinded and involved 35 centers. The participant population was that of partially disabled persons over the age of 65. Most of them were over 75. (65 is considered young these days). In addition to several blood collections, utilizing a machine that gave objective recordings of power and load, numerous measures of muscle strength were taken every two months in a six-month trial. During the conduct of the study the clinical trials coordinators saw that some of the participants experienced functional improvements but that was not seen in the muscle strength testing. One man stopped using a cane, for example and several others improved their ambulation significantly. About four months into the study, a few participants developed overt hyperglycemia while a few others experienced a decrease of glucose sensitivity. The company stopped the study at six months and has denied numerous entreaties by the investigators to analyze and publish it. The investigators do not have access to the data. It is rumored that the company gave up research into the whole category of compounds. Recent studies of GH administration to the elderly have shown deterioration of glucose tolerance and some instances of overt diabetes. GH is being utilized at an increasing rate in the care of older persons who can afford its costs, even though it is not approved for that purpose and insurance companies will not pay for it. Questions: What are the issues raised by this case? Is there research misconduct here? Would there be different issues if the drug had been FDA approved and the trial was a Phase IV trial. How would society best be served? << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 8 Quick Links Malfeasance and Misconduct Definitions Process Whistleblowing Litigation, the New Approach to Research Management The Importance of Trust Cases Bibliography Chapter 8 Download (PDF)