MS takes toll as patients wait for scarce new drug

December 26, 1993|By Jonathan Bor | Jonathan Bor,Staff Writer

This was the year medical science finally unleashed a drug that slows the course of multiple sclerosis, and Lisa Schenning would take it tomorrow if she could. Perhaps, it could stave off the attacks that progressively rob sensation from her hands, weaken her right side and cloud her vision.

But instead of the drug, she has lottery number 21,126. That means she may have to wait until early 1995 to get Betaseron, even though the drug was approved by the Food and Drug

Administration last summer.

In a turn of events that has surprised, frustrated and angered many people with MS, the company marketing Betaseron found itself unprepared to satisfy the flood of patients wishing to take it. So the company devised what it calls a "random access" system -- a lottery by any other name -- to determine who gets the drug now and who must wait.

In August, Berlex Laboratories gave patients a three-week window to register for the drug, then let its computer put them in random order. Some 67,000 patients signed up. Everyone is guaranteed the drug. The only question is when.

"You feel angry, disappointed, hopeful, confused," said Ms. Schenning, 25, who recently took leave from her job with a Baltimore accounting firm when an MS attack left her so weak she couldn't rise from her chair.

She has recovered substantially and now walks with a slight limp but uncanny vigor. Still, she cannot escape the fact that each attack dims her vision a little more.

Someday, she may go blind.

"I've had two attacks," Ms. Schenning said. "Both were at the end of the year, around Christmastime. What if I don't get the drug until the end of next year? Maybe I won't have my vision anymore when the drug comes."

Now there's hope

Like many patients who weren't lucky enough to draw low numbers in the Betaseron lottery, Ms. Schenning tempers her anger with understanding. She realizes that after decades, researchers have at last given MS sufferers a drug on which to hang their hopes.

"Finally, there's something out there. There was nothing before."

Multiple sclerosis, which afflicts an estimated 300,000 people in the United States, occurs when the immune system unaccountably attacks the myelin sheath that protects nerve fibers of the brain and spinal cord. This causes a confusing "cross-talk" between fibers, slowing and sometimes interrupting signals that control such functions as movement, balance, feeling and sight.

The disease may cause dizziness, impaired vision, numbness, tingling, incontinence and paralysis. The symptoms vary from patient to patient and tend to worsen with age -- but at a rate that is utterly unpredictable.

For many people, the disease flares in attacks that can occur months or years apart -- a pattern known as "relapsing-remitting." Typically, the symptoms subside between attacks, but not totally. Each attack leaves the patient weaker, never knowing when the next flare-up will occur and what its effects will be.

Betaseron is a genetically engineered drug that seems to suppress the autoimmune attacks. It's no cure -- no one has figured out how to eliminate the attacks -- but a clinical trial completed this year demonstrated that the drug reduced their frequency by about 30 percent.

Buying more time

The three-year trial raised justifiable hopes that MS sufferers can buy more time between attacks and possibly slow the long-term course of their illness.

So far, the drug is not for everybody. It has been tried only on people in the early stages of relapsing-remitting disease, a subgroup that accounts for about one-third of all sufferers. Accordingly, the FDA has approved distribution to these patients.

Betaseron costs about $10,000 a year and is covered by most insurers.

Jeffrey Latts, Berlex's vice president for clinical research and development, said the company wasn't surprised by the volume of patients eager to take Betaseron. The real surprise came more than a year earlier, when preliminary test results indicated that the drug might work.

Over the past decade, test after test had produced nothing but failure.

Although Betaseron was more than a year way from market approval, Dr. Latts said, the company realized the one plant making the drug couldn't possibly satisfy the demand after it was approved.

Expanding to meet demand

Seeing this, the biotechnology firm that makes Betaseron for Berlex started expanding its production capacity early in 1992. The company, Chiron Corp., expects that by 1995 it will be able to meet demand for the drug.

"I've talked to a lot of physicians and a lot of patients," Dr. Latts said. "All would prefer that we had more Betaseron. But the majority realize we are doing the best we can do given the limitations of supply."

At the heart of the problem is the wondrous technology by which Betaseron is produced. Rather than mixing chemicals in a laboratory, Chiron coaxes the drug from nature.

'Smart bacteria'

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