The disturbing discovery that the only drug approved by the FDA to treat people with Alzheimer's disease, ergoloid mesylates (brand names: Hydergine, Hydergine LC, Deapril-ST), is ineffective and may make some people worse has resulted in a petition to ban the drug. About 1.4 million Americans are severely affected by Alzheimer's disease, which has no known cause, and several million more people have milder symptoms of the disease. Ergoloid mesylates have been used for decades to treat Alzheimer's disease, which is also known as senile dementia.
The petition, filed last month with the FDA Commissioner by Ralph Nader's Public Citizen, cited a randomized, placebo-controlled study published in The New England Journal of Medicine (16 August 1990) as the first methodologically-sound study" of ergoloid mesylates. The study suggests that the drug is "ineffective, costly, and possibly harmful." The petition demands immediate "Dear Doctor" letters be sent to physicians notifying them of the drug's questionable safety and effectiveness.
The above-cited study of 80 older adults diagnosed with "probable Alzheimer's disease" randomized half of the group to Hydergine LC three times daily for six months while the other half took a placebo (sugar pill) for the same period. At the end of the study the researchers concluded that the drug produced "no notable beneficial effects on our patients." The behavioral and mental deterioration observed in both drug and placebo groups was measured by five standard tests given at the start of the study and again at 12 and 24 weeks. The research team was surprised that those taking the drug did worse on two tests than those on the placebo, although only the differences in one test were statistically significant. The investigators could only speculate that ergoloid mesylates might accelerate the progression of disease or have a previously unrecognized direct toxic effect.
COPYRIGHT 1991 Center for Medical Consumers, Inc.
COPYRIGHT 2004 Gale Group