Alzheimer’s Drug Researcher Raps Criticisms by FDA
Dr. William K. Summers, the Arcadia psychiatrist whose work with patients with Alzheimer’s disease has come under federal scrutiny, fired back Wednesday, accusing the U.S. Food and Drug Administration of nit-picking and persecution.
Summers said none of the agency’s recent charges against him undermine his findings concerning the experimental drug, THA, which he reported in 1986 had dramatically improved the memory and living skills of a small number of patients.
“There is nothing of substance that takes away from the conclusions of the study that we published in the New England Journal of Medicine,” Summers said in a press conference. “. . . Their complaints were procedural and picky.”
Quoting Mark Twain, William Shakespeare and the Gospel according to St. John, the 43-year-old physician issued a point-by-point rebuttal of the charges that he misrepresented findings and violated drug-testing rules in his 1986 study.
He said the yearlong federal investigation has left him “financially exhausted” and has “all but arrested” his work with Alzheimer’s patients. He said he terminated his THA study two weeks ago in order to devote his resources “protecting” himself.
“So the pregnant, obvious question of the hour is, why should the FDA pick on Dr. Summers,” he mused. “Do they have something against small investigators? Is there a hidden agenda? Obviously, I can only speculate.”
A spokesman for the FDA in Washington declined Wednesday to respond to Summers’ statements, saying the FDA could not comment on a case under investigation. The agency informed Summers of its findings in a six-page letter dated Jan. 19.
“A letter to a researcher of this type is a very standard letter when significant doubts have been raised about a piece of research,” spokesman William Grigg said Wednesday. He said its aim is to “give a researcher the opportunity . . . to clarify any of the problems.”
Among other things, the letter accused Summers of exaggerating the number of psychological tests administered to patients, and failing to mention that 10 of the 12 subjects in part of the study lived more than 2,000 miles away and were monitored largely by telephone.
The agency said some patients had other illnesses in addition to Alzheimer’s or were on other medications--factors that might have confounded the results. And the auditors said they were unable to identify patients Summers said had resumed employment and golfing.
In response to those charges, Summers said Wednesday that many patients were unable to perform the entire battery of psychological test but that their condition nevertheless was confirmed. He called that criticism “not significant” to the paper’s conclusions.
Summers said his team saw the patients whenever possible. On other occasions, they were monitored by nurses and family members or through testing. He noted it that is not uncommon for seriously ill patients to travel long distances for experimental treatments.
As for the patients on other drugs, Summers said that if anything, those drugs would make it more difficult to demonstrate the benefits of THA. He said that he had identified for the auditors the patients who had resumed old activities but that the auditors did not pursue it.
“It is my belief that this protracted FDA investigation is wasteful and not in the public interest,” Summers said in his press conference.
