Alzheimer’s Disease

I have an interest in treatments for Alzheimer’s disease and at the present time in two promising treatments before the Food and Drug Administration. In large part I wish to unsully my reputation (“Study Finds Drug Helps Some Alzheimer’s Patients,� Nov. 11).

I believe that if tacrine (THA or Cognex) and a sister drug, mentane (HP-029), are released by FDA, that someone will actually go back to our original paper and replicate our study.

None of the papers published since our study have actually repeated what we did. From the outset, the other neuroscientists have strived to “improve� upon our study. One result of the improved methods was the very flawed study in the Oct. 29 New England Journal of Medicine. This study design was heavily influenced by Dr. Leber and Dr. Temple of the FDA. It used one-fourth to one-third of our dosages and measured the outcome with some insensitive instruments. It was similar to giving one-half of a single aspirin for a headache and asking on a scale of one to three how one felt. Not very accurate. It is remarkable that a positive drug effect was shown.

The FDA is one of the most influential federal agencies. They influence 25% of all dollars spent (not health dollars) in the United States. As such they greatly influence the economy.

A more careful examination of the Food and Drug Administration’s actions since the late 1970s reveals that there has been a distortion of its twin goals: efficacy and safety.

WILLIAM K. SUMMERS, MD

Albuquerque, N.M.