TIME: Almanac 1993/TIME Almanac 1993.iso/time/072991/0729352.000

Text File | 1992-08-28 | 3.5 KB | 79 lines

                                                                                MEDICINE, Page 52

Still No Relief from Alzheimer's


Despite public pressure, the FDA will not approve a touted drug
until there is more evidence that it really works


    Woodrow Wirsig shudders to recall his wife Jane's gradual
10-year decline from Alzheimer's disease. At the low point, she
was mute and immobile. But then in 1987, as part of an
experimental program, she was put on the drug tacrine. "Within
weeks," says Wirsig, of Palm City, Fla., "she could walk and
talk and recognize me from 90 ft." Such stories have given
tacrine a reputation as a Lazarus drug, the one medication that
could recall to life loved ones who are losing control of their
minds and bodies.

    But access to the experimental drug is strictly limited,
and for years desperate families have been pressing the Food
and Drug Administration to make it widely available. Last week
an FDA advisory panel issued a strong rebuff. After reviewing
all the clinical studies, the panel agreed 8-0 that tacrine
"did not show a clinically meaningful benefit." Moreover, the
danger of its causing liver damage is significant, the group
said.

    The tacrine controversy underscores one of the most vexing
of medical issues: should the regulatory process be eased for
drugs aimed at deadly diseases that do not respond to any other
treatment? Vigorous lobbying by AIDS activists has led the FDA
to expedite release of two drugs that appear to alleviate
symptoms of that fatal infection. Inspired by that example,
families of Alzheimer's patients have been demanding similar
treatment.

    The clamor for tacrine, also known as THA (for
tetrahydroaminoacridine), started in 1986 when the New England
Journal of Medicine reported a study in which 16 of 17 patients
given the drug had shown marked improvement. The results seemed
miraculous, but they made scientific sense: the brains of
Alzheimer's victims have abnormally low levels of acetylcholine,
a chemical that carries impulses from one nerve to another.
Tacrine inhibits production of an enzyme that breaks down the
chemical messenger, thus presumably making more acetylcholine
available.

    According to Warner-Lambert, which has U.S. marketing
rights to the drug, a National Institute on Aging study of 200
patients at 16 hospitals found that among those receiving
tacrine, more than 40% showed some improvement in performing
mental or physical tasks. Based on this and other data, the
company asked the FDA last March for approval to market tacrine
as the first drug treatment for Alzheimer's.

    After that request was rejected by the FDA's advisory
panel, the agency suggested that Warner-Lambert apply for more
limited marketing, the strategy used to release the AIDS drugs.
Under the plan reviewed last week, up to 50,000 patients would
have been given the drug under close scrutiny. But the advisory
panel's vote on lack of efficacy made the plan moot for now.
"There was concern that a very bad precedent could be set if the
scientific standards were lowered," says Steven Ferris, a
neurobiologist at New York University Medical Center, who
chaired the committee. The group has recommended another study
of tacrine's effectiveness. In the meantime, the FDA is hewing
to the line that, as with any drug, benefits must clearly
outweigh risks.

    By Anastasia Toufexis. With reporting by Ginia
Bellafante/New York and Dick Thompson/Washington