Eye Misery

It is an unsightly affliction. Victims of blepharospasm suffer from continual eyelid muscle spasms that clamp the lids closed for seconds to minutes. In effect, sufferers are left blind. Over the past six years, however, more than 2,300 Americans have had their blepharospasm symptoms eased by an experimental drug called Oculinum. But now nationwide testing has been halted because the manufacturer says he is no longer able to find an insurance company that will sell him affordable liability coverage. Apparent reason: Oculinum is made from botulinus toxin, the deadly bacterial poison that causes botulism.

Until the drug was developed, sufferers were forced to rely on largely ineffective medications or disfiguring surgery. But Oculinum brought them almost instant relief. Injected into the tissue around the eye, it paralyzed the spasming muscles for as long as three or four months, thereby preventing them from squeezing the lids shut. Mattie Lou Koster, 74, of Beaumont, Texas, had her last injection of Oculinum in May. "It was a miracle," she exclaims, "the thrill of being able to open my eyes. Now I see through slits, when I can see." Other patients who used Oculinum, including some suffering from crossed eyes (strabismus) or muscle spasms of the face, neck and vocal cords, are clamoring for the drug. Says Neurologist Joseph Jankovic of the Baylor College of Medicine in Houston: "All of our patients have reversed to their original condition."

The developer and manufacturer of the drug, Ophthalmologist Alan Scott, lost his liability insurance last year. In January, unable to find another insurer willing to charge a reasonable premium, he notified doctors who were participating in the Oculinum trials that without coverage he would no longer be able to supply the drug. Because people associate the drug with botulism, ! Scott told the New York Times, insurers are afraid they will be hit with huge damage suits if any untoward side effects occur. He notes that among some 7,000 patients who have received the drug to date, side effects have been temporary and mainly limited to drooping eyelids, excessive tearing and double vision. None have yet brought suit.

A number of Oculinum patients are pressing the Food and Drug Administration to approve the drug for market soon, believing that such a decision might ease insurers' fears. But the FDA is adamant about following proper procedures. Says Deputy Commissioner John Norris: "We can't make new standards just for Scott's product."