Migraine victims hope new drug will work


August 06, 1991|By Alyssa Gabbay

For Trudy Stanley, the pain begins in her eyes. From there it travels swiftly to the top and back of her skull, causing her head to throb and pound violently. If it's one of her "incapacitating" migraine headaches -- which occur two or three times a week -- she'll soon start vomiting.

Sometimes Ms. Stanley's pain is relieved by lying down in a dark room or getting an injection of ergotamine (a commonly used migraine drug) or having a belt tied tightly around her forehead. Occasionally nothing works at all.

"Sometimes I beat my head against the wall because it hurts so much," said Ms. Stanley, 39, who lives in Overlea-Fullerton. "I just completely lose it. I get to a point where I can't handle the pain anymore."

As one of approximately 8 million Americans who suffer from migraines, Ms. Stanley is eagerly following developments about sumatriptan, a new drug for migraine headaches.

Not yet approved for routine use by the Food and Drug Administration, the drug has attracted much attention since studies last week reported that it provides quick, effective relief with few side effects.

"If it worked, I'm sure that it would change my life," said Ms. Stanley, whose headaches forced her to leave her job with a catering firm eight years ago.

Headache specialist Dr. Neil Raskin, who teaches at the University of California School of Medicine, said sumatriptan "signals the beginning of a new era in this sort of treatment."

Many doctors, however, are cautioning their patients not to regard the drug as a panacea. They warn that the drug has not been tested on a big enough sample of migraine sufferers, that any medication this new might have unanticipated side effects, and that the treatment won't be cheap. And they don't expect it to be approved by the FDA for widespread use until 1993. (FDA officials won't comment on when the drug might become available.)

Still, the results of experimental studies indicate much room for hope. A study published in the Aug. 1 New England Journal of Medicine reported that more than 90 percent of 639 patients injected with sumatriptan experienced improvement in the severity of their symptoms within two hours of treatment. Another study also showing a high success rate for sumatriptan was published in the June 5 Journal of the American Medical Association.

Along with other beneficial effects, sumatriptan is able to abort severe headaches even when the headache is in full swing, studies indicated. Other drugs lack this capability.

Not surprisingly, headache sufferers who haven't found relief elsewhere are looking forward to trying this new drug.

Doctors are taking a cooler approach. Hidden side effects are an important consideration, they point out. Since the drug is so new -- testing on humans didn't begin until 1986 -- no one knows how it will affect patients after many treatments.

"There's always some question of safety when you're dealing with a new drug," said Brian Mondell, director of the Baltimore Headache Institute and an assistant professor of neurology at the Johns Hopkins University School of Medicine. "Migraines are always debilitating, but you don't want to cause more trouble than you've already got."

So far, all noted side effects of sumatriptan have been relatively minor. They include scalp tingling, dizziness and flushing.

Sumatriptan also may be expensive and difficult to administer. In the Netherlands, where it has been on the market for two months, the drug costs $32 per injection, according to a spokesman for its maker, Glaxo Inc. (The Netherlands is the only country where sumatriptan is now on the market, though it was recently approved for use in New Zealand.) For the drug to be effective, it must be administered by injection, which means patients must visit their doctors for treatment.

Additionally, several questions have arisen about the drug's JTC effectiveness. Results in the New England Journal of Medicine study showed that a substantial number of people whose headaches disappeared with treatment experienced a recurrence of head pain later in the day, as Joel R. Saper of the Michigan Headache and Neurological Institute in Ann Arbor noted.

"There's the chance that we'll find that 50 percent of the people who take it at 1 p.m. will get their headaches back by 6 p.m.," said Dr. Saper, who nonetheless called sumatriptan an "important addition to the arsenal of migraine drugs."

Moreover, as Dr. Wolfe noted, since the study compared sumatriptan to a placebo, rather than to other migraine drugs, there's no way of knowing whether the drug will help those who need it most desperately: that small percentage of acute migraine victims for whom currently available medications do not work.

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