Findings on Alzheimer's Drug Challenged

Author(s): Robert Steinbrook

This article reports an FDA probe into the scientific conduct of Dr. William Summers, principle author on a study published in the New England Journal of Medicine about the effects of THA, a drug, on Alzheimer's patients. The probe was initiated after receiving several letters from concerned scientists. The FDA alleged that Dr. Summers falsified and fabricated information and asks Dr. Summers to respond. In addition, Dr. Summers is accused of research bias and failing to respect the rights of research participants. Dr. Summers is also accused of asking the participants to pay to be in the study; about 12,000 dollars a year. Dr. Summers responded to the accusations in a letter writing that he stands by his research and that the FDA are tyrants who have a hidden goal of undermining his project. The article also reports that current independent research on the same drug, generated by the firestorm of interest that Dr. Summer's reported findings spurred, was halted because of a discovery of THA's toxicity. Some participants in this trial developed "abnormal" liver function blood tests.

Abstract by Elysa R. Koppelman, Ph.D.

National Academy of Engineering