Dr. William K. Summers, the Alzheimer's disease researcher embroiled in a protracted wrangle with federal officials over his work with the experimental drug THA, has received a partial vindication from a UCLA faculty committee that reviewed his work.
While the five-member committee found severe shortcomings in the design, execution and reporting of Summers' controversial study, the group found that those limitations did not undermine the conclusion that the drug had helped some of the patients studied. The group also found no evidence of any intention to mislead.
"The committee saw enough data to be convinced that this study was (actually) done, with some slippage 'twixt intention and execution," said Dr. Daniel X. Freedman, executive vice chairman of the department of psychiatry. "And it was not manufactured."
Summers' surprising finding that THA had dramatically improved the memory and living skills of a small number of patients prompted widespread public interest in the unproven treatment after his November, 1986, report in the New England Journal of Medicine.
But other researchers and the U.S. Food and Drug Administration questioned Summers' techniques and conclusions. And 20 months later, the Arcadia psychiatrist remains engaged in discussions with the agency over whether he will be allowed to extend his research.
Summarizing the UCLA committee's findings, Freedman noted in a five-page report that Summers' study arose out of his private psychiatric practice and was done without the manpower and financial backing available to researchers sponsored by a university or a drug company.
The committee said Summers has produced many of the documents the FDA initially said were missing, and those documents did not affect the study's results. The committee also accused the specialists who examined the article in advance for the journal of failing to scrutinize Summers' methods.
Freedman said in his report that the committee found that Summers and his co-authors demonstrated that THA has some effect on mental function. However, the precise effect and its frequency and potency remain to be determined, Freedman said.