Faster access to drug heartens MS patients

September 13, 1994|By Jonathan Bor | Jonathan Bor,Sun Staff Writer

Patients who thought they would have to wait as long as 1 1/2 years to start taking the first medication to show promise against multiple sclerosis have been dealt a pleasant surprise: speedy access to the drug.

Last year, a national lottery determined the order in which 60,000 people would receive scarce supplies of the drug, Betaseron. That decision produced disappointment for patients like Lisa Schenning, 26, of Hagerstown, who were anxious to take it immediately.

In the computerized drawing, Ms. Schenning received number 21,126 -- along with Berlex Laboratories' prediction that she would have had to wait until early next year to get her first dose. Meanwhile, she would have to hope that the unpredictable disease wouldn't get worse.

But for her and thousands of other patients, the wait wasn't nearly as long as expected.

Production has gone much faster than foreseen at a California laboratory run by the Chiron Corp., a biotechnology corporation that makes Betaseron in a joint venture with Berlex. Also, the drug's high price -- about $10,000 a year -- has caused an undisclosed number of patients lacking adequate insurance to cancel plans to take it.

These and other factors accelerated Betaseron's distribution to qualified patients. As a result, Ms. Schenning was notified as early as last March that Berlex was ready to ship her first month's supply.

"Even with all the negative publicity, the rate they moved was amazing to me," said Ms. Schenning. "It was over a year sooner than I was expecting to get it. I was really happy for that."

As it turned out, however, she cannot take the drug until November -- the month she is due to deliver her first baby. Experiments on laboratory animals suggest the drug can cause miscarriages. Besides, pregnant women typically gain heightened immunity from MS attacks.

Multiple sclerosis, afflicting some 300,000 people in the United States, occurs when the immune system attacks the myelin sheath that protects nerve fibers of the brain and spinal cord. This slows and sometimes interrupts signals that control movement, feeling and sight.

The disease causes dizziness, impaired vision, numbness and tingling in the extremities, incontinence and paralysis.

For some patients, the disease causes a steady worsening of symptoms. For others, it flares in attacks followed by remission that can last months or years. Each relapse leaves the patient weaker, never knowing when the next flare-up will happen or what its effects will be.

Betaseron is a genetically engineered drug that seems to suppress the autoimmune attacks. In August 1993, the U.S. Food and Drug Administration approved it for patients with the "relapsing-remitting" syndrome who have yet to experience severe symptoms.

Dr. Kenneth Johnson, a leading MS researcher at the University of Maryland Medical Center, said yesterday that some patients had inflated expectations of the drug's capabilities and decided not to take it when they learned its limitations. Although studies showed that Betaseron lengthened the time between MS attacks -- making the downward spiral slower in some cases -- it didn't actually reverse symptoms that were already established.

To make the drug, scientists infuse bacteria with the human gene for beta interferon, a human protein that seems to inhibit the immune system attacks. The result is "smart bacteria," living factories that produce the drug at a painstakingly slow pace.

Despite pent-up demand among patients desperate for help, Berlex and Chiron had announced last fall that they wouldn't be able to serve everyone for more than a year.

But Dr. Jeffrey Latts, a Berlex vice president, said last week that Chiron was able to expand its only production facility -- in Emeryville, Calif., -- much faster than expected, replicating equipment used during the experimental phase. Next year, Chiron plans to begin production at a second plant in Puerto Rico.

So far, about 30,000 people are taking Betaseron. He would not say how many patients in the lottery passed up their opportunity to take the drug when their turn finally arrived -- in part because some delayed their final decision while weighing factors such as their ability to pay.

Dr. Johnson agreed that the drug's hefty price, coupled with lack of insurance coverage, is a major reason why some patients have declined the drug.

"Because this is the first drug and because it's a whole new concept in human therapeutics, I suppose [the companies] decided they had a right to charge a premium for it," he said.

"It's also one of the reasons why we want to find other therapeutics that might do better or complement Betaseron. We hope they might provide some competition."

Laurie Huse of Montpelier, Vt., said she was lucky enough to have a prescription plan that covers practically the entire cost of Betaseron. Al

though she drew number 49,944 in the Berlex lottery and wasn't supposed to receive the drug until mid-1995, she was delighted to get her first dose last April.

Ms. Huse, who injects the drug every other night, said it produced chills and muscle aches the first time, but the side-effects tailed off after that. She credits a protective dose of Tylenol, recommended by patients on a computer bulletin board.

Even though the drug is supposed to slow -- not reverse -- progression of multiple sclerosis, Ms. Huse, 44, said that she feels better than she has in years.

"It may be that I just wanted this drug so badly," she said. "It's the first positive opportunity for MS patients. They can't promise you a rose garden, but there's something where there was nothing before. That makes me feel better."

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