Fear of infection results in recalls of gamma globulin Doctors, hospitals report difficulty in getting drug for their patients


MONTEREY, Calif. -- Thousands of patients will be without their "immune system in a bottle" because of fears that the plasma supply has been infected with a malady closely related to "mad cow" disease.

Since January, the U.S. Food and Drug Administration has issued a series of recalls of gamma globulin -- a medicine of concentrated antibodies derived from human plasma -- fearing the blood product was infected with Creutzfeldt-Jakob disease.

Though the drug is best known as an antidote for Hepatitis A, it is also used to treat diseases ranging from AIDS and pediatric HIV to Alzheimer's and leukemia.

A leukemia patient from Carmel Valley, Calif., who asked not to be identified, took gamma globulin once a month until her doctor told her it was no longer available.

Her white-blood-cell count has since dropped, leaving her exposed to infection. She's not sick yet, she said. "But I'm already beginning to fall down. I get tired very easily now."

Monterey physician Grant Swanson treats 12 people with gamma globulin. The shortage, he said, "leaves them at greater risk for infection, but my hands are tied."

Creutzfeldt-Jakob, a neurological disease that causes loss of muscle control and eventually death, is closely related to what has been called "mad cow" disease, which caused British beef to be pulled off shelves in European markets in the past year.

Since October, there has been a chronic shortage of gamma globulin. Doctors and hospitals say they are unable to get the drug. Patients are beginning to fall ill.

Both the medical and regulatory communities are aware of the shortages, which have gone largely unreported.

Because the disease can be transmitted through blood, the blood products industry has been asked to take extra precautions with donor pools.

But more than half of all companies that make plasma products are not in compliance with good manufacturing practices, said Anne Marie Finley, an investigator for a congressional committee with jurisdiction over the FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health.

Finley said there is no upper limit on the number of donors in a plasma pool, and the number can reach almost 500,000.

"If you make these huge pools, you vastly increase the chances of infection, but it's economically efficient [for the manufacturers] to make the pools as large as possible," she said, adding that in the past, donors have returned to tell companies that they have been exposed to Creutzfeldt-Jakob.

There have been 24 FDA withdrawals of globulin-related products since the beginning of 1997, and the FDA requested an industrywide quarantine on the drug until tests for Creutzfeldt-Jakob can be perfected, with exceptions for patients who have Hepatitis A.

Five companies manufacture gamma globulin. Only Los Angeles-based Alpha Therapeutic Corp. has had so few problems with tainted plasma that it is still allowed to sell the drug.

"We take a lot of heat simply because we're out there. But here we are, one company trying to fill the need of five," said John Gross, director of professional services for Alpha Therapeutic.

Patients with low white-blood-cell counts and low platelet levels can take gamma globulin intravenously to restore their immune systems.

The drug costs $90 a gram and is administered according to a patient's body weight. A 150-pound person will pay $1,225 for an average monthly treatment, according to the industry's list price.

Fred Modell, founder of a New York-based foundation that serves as a clearinghouse for immunodeficiency information, said the recalls of gamma globulin were an overreaction on the part of the FDA. "We're trying to bring it to the attention of regulatory agencies and ask them to please allow these patients to survive," he said.

Pub Date: 12/14/97

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