U.S. Puts Alzheimer’s Drug on the ‘Fast Track’
The federal government has put a promising experimental drug for Alzheimer’s disease on a “fast track” toward possible licensing, a move triggered by a controversial report by a California psychiatrist in November that the drug produced dramatic improvements in a small group of patients.
The government has authorized a study this summer that will involve more than 300 Alzheimer’s patients at 17 medical centers throughout the country, according to Dr. Andrew Monjan, acting head of neurosciences at the National Institute on Aging.
In a telephone interview Friday, he said researchers expect to know within a year whether the drug, tetrahydroaminoacridine or THA, shows enough promise to warrant widespread use.
Gained National Attention
THA gained nationwide attention seven months ago when a team of Los Angeles researchers reported in the New England Journal of Medicine that the drug had dramatically improved the memory and living skills of 12 patients for a year or more.
That report said one subject was able to resume most of her homemaking tasks and another, a retiree, resumed playing golf daily. In other patients as well, the researchers noted significant improvements in “activities of daily living, such as self-feeding at the family table, where total care had previously been required.”
Since its publication, the report, whose principal investigator is Arcadia psychiatrist William K. Summers, has been roundly attacked by other researchers. In the current issue of the New England Journal of Medicine, for example, there are six letters criticizing various technical aspects of the study’s design.
The letters noted--and Summers had conceded--that some of his subjects had conditions such as Parkinsonism or stroke in addition to Alzheimer’s--which may have confused the results. Also, some of the patients had been on medications in addition to THA.
Difficult to Judge
Such considerations, the critics said, make it difficult to accurately judge whether the behavioral changes were due to THA or something else.
Summers also was criticized for the arrangement in which patients who received the experimental treatment had to pay the costs--an unusual departure from traditional biomedical research in this country, which generally is provided for free. Patients paid $12,100 a year in order to be a part of the study.
Summers’ Nov. 13 report touched off a nationwide clamor for the drug, which led the FDA to order him to discontinue his fee-for-research mode of operation. An FDA spokesman said the agency took such action because “it appeared that commercialization was occurring with an unapproved drug.”
Seek to Avert Criticism
Monjan said that the upcoming study had been designed by experts in such a way as to avert the kinds of criticisms that were directed at Summers’ earlier investigation. Also, he said, subjects will not be charged.
Besides the FDA and the National Institute on Aging, the Alzheimer’s Disease and Related Dementias Assn. and an unnamed drug company have been involved in designing, funding and conducting the study. Summers is to serve as a member of the steering committee.
Monjan said the names of the 17 centers will be announced in late July or early August.
The THA development follows a late May announcement by the FDA that it had approved a new policy to speed the availability of experimental drugs to seriously ill or dying patients if preliminary tests show them to have promise.
