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The FDA's cruel indifference

Sometime in 1976, Jane Wirsig began to speak of her persistent fatigue. One day in 1977, she was doing household accounts when abruptly she stood up and slapped her leg in frustration.

"Something's wrong," she said. "I've forgotten how to subtract."

That was the beginning of an ordeal that would last until she died in 1989. Jane Wirsig was one of the millions of Americans who die by inches of Alzheimer's disease. And Dr. David Kessler doesn't give a damn.

Kessler is commissioner of the Food and Drug Administration. He hears stories like Mrs. Wirsig's story all the time, but he hears with deaf ears. He has heard at length from Woodrow Wirsig, her widowed husband. Wirsig has made himself a one-man parade in support of a drug that might give a few years of useful life to those who suffer from Alzheimer's.

I say Kessler doesn't give a damn for this good reason. The commissioner has demonstrated in the matter of AIDS that if he is sufficiently pushed, he will indeed respond to human suffering. To help AIDS victims he has released such experimental drugs as AZT, even though AZT's effectiveness never has been demonstrated to the FDA's usual standards. Buyers' clubs may import any drugs that AIDS victims believe may be helpful.

But AIDS has a powerful lobby going for it. The whole Hollywood community rallies around. Congress appropriates billions for research. Thousands of AIDS victims turn out for a demonstration on the Mall in Washington. No wonder David Kessler bends over backward for AIDS.

Those who suffer from Alzheimer's have no such publicity machine. When victims attempt to bring in Tacrine from Canada or Europe, an "import alert" demands that the drug be confiscated. A medical association raises funds, and a few people like Woodrow Wirsig of Palm City, Fla., keep agitating, but that is about the size of it.

Last month Wirsig called on the FDA commissioner as a spokesman for Families for Alzheimer's Rights. After their session he politely thanked the commissioner for a "good beginning" in meeting with his group, but this was mostly politeness. Kessler is unyielding in his insistence that the government must have positive, effective evidence that Tacrine is both safe and effective.

Tacrine is a drug developed 10 years ago. Its use in the treatment of Alzheimer's became public knowledge in 1986. Six years have passed in bureaucratic wheel-spinning. There is some evidence that in some cases Tacrine may cause some damage to the liver, but there also is evidence that the damage is easily reversible.

Against that petty complaint stands a mountain of evidence that Tacrine can do wonderful things for some Alzheimer's patients. The FDA sneers at this evidence as "merely anecdotal." Panels of experts have gone over the matter, and the experts have agreed: More data must be obtained. And still more data. And still more data.

Meanwhile, such victims as Jane Wirsig are dying deaths at least as poignant, at least as sad, as the deaths of victims of AIDS. Alzheimer's is incurable. These victims are going to die.

In God's name, one asks David Kessler: Why not let them have this mitigating drug if they believe it will help?

The whole affair cries out for congressional investigation, but Congress is busy running for re-election. A well-staffed investigation could look into scores of questions that Wirsig has raised.

Let us envy the AIDS victims. Some of them, thankfully, are able to obtain some small degree of relief. But for Alzheimer's patients, even a small degree of relief is brutally denied.

Universal Press Syndicate