FDA Allows Doctor to Continue Testing Alzheimer’s Drug

Dr. William K. Summers’ controversial research into an experimental drug for Alzheimer’s disease will be allowed to continue under an agreement worked out this month between the Arcadia psychiatrist and the U.S. Food and Drug Administration.

Under the agreement, Summers must abide strictly by federal research rules that the FDA accused him of violating in his study, which concluded 2 1/2 years ago that the experimental drug THA had caused “dramatic” improvement in Alzheimer’s patients.

Specifically, Summers must personally conduct and supervise research activities that the FDA accused him of delegating to others. He also agreed, in a May 4 letter to the FDA, to keep accurate patient records and not deviate from his approved research plan.

“His problems were more in the areas of sloppiness and lack of understanding of exactly what is required in the conduct of a truly high-class, scientific study,” Dr. Alan Lisook, chief of clinical investigations for the FDA, said Thursday.

Summers, however, insisted in an interview that the agreement with the agency contains nothing he has not already done. He said any perceived shortcomings in his work were mere technicalities and the conclusion of his study remains valid.

“If they actually had anything, they would have gone the legal route,” Summers said of the FDA, which began investigating him in 1987. He likened the investigation process to having been turned upside down and shaken until small change fell out of his pockets.

The FDA in the agreement did not address the question of the effectiveness of the drug.

Summers attracted the attention of the FDA in November, 1986, when he published in the New England Journal of Medicine a report stating that the drug, also known as tacrine, had improved memory function in 16 out of 17 patients Summers had studied.

According to Lisook, the agency then embarked upon an audit of Summers’ records because of the potential significance of his study. Word of his findings had attracted worldwide interest and set in motion a large, nationwide study of the drug, which is now under way.

Alzheimer’s, a progressive brain disorder that impairs thinking and behavior, is the fifth leading cause of death in the United States. It affects 2.5 million Americans, and there is no effective treatment or cure.

The FDA investigation culminated in January, 1988, in a six-page letter accusing Summers of “repeatedly or deliberately” violating research rules by submitting false information, deviating from his study plan and failing to maintain adequate records.

For example, the FDA accused Summers of failing to mention that 10 of 12 subjects lived more than 2,000 miles away and were monitored largely by telephone. He had failed to provide evidence that he had actually conducted certain tests he claimed to have done, the FDA said.

The FDA also said Summers had failed to account for about 6,250 capsules of the drug during a one-year period and had failed to follow federal rules requiring that all patients give their “informed consent” before participating in drug trials.

In the new agreement, outlined in letters between the agency and Summers, Summers agreed to personally conduct various parts of the study--a condition Lisook said was intended “to guard against excessive delegation to other people,” including patients’ relatives.

Summers also agreed to adhere strictly to his study plan, keep accurate and adequate records, ensure that adequate records are kept, obtain the informed consent of patients and keep close track of distribution of the drug.

Also at the request of the FDA, Summers has written to the New England Journal of Medicine clarifying aspects of his methodology that the agency felt he had misrepresented. That letter, approved by the agency, is to be published as a letter to the editor.

In an interview Thursday, Summers insisted the agreement included nothing he was not already doing. He said that he sees all of his patients regularly and that any shortcomings in record-keeping were “within the range of error that is typical for this type of work.”

“What we did was human science,” Summers said.

Only 11 of the 45 original patients in Summers’ study remain on the drug, Summers said. Seven were asked to drop out for failure to abide by study rules. Of the others, about half have died and the other half have dropped out because their spouse or caretaker died.