Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
San Francisco Chronicle - The Voice of the West, 901 Mission Street, San Francisco, CA 94119 - Thursday, February 20, 1997 -Page A18
Chronicle Staff and Wire Report
A single lot of Profilnine SD, which is widely distributed in the United States, came from a plasma pool that showed possible signs of HIV antibodies, said Alpha Therapeutic Corp. and the U.S. Food and Drug Administration.
The lot in question is labeled CS6210A.
An FDA official stressed that a single inconclusive test result triggered the product quarantine. So far, all other tests have shown no signs of the AIDS virus in the Factor IX concentrate or the plasma from which it came.
A representative of the Irwin Memorial Blood Bank in San Francisco said it does not distribute Profilnine.
"We don't yet know how this happened or indeed what it signifies. There is a mystery to be solved," Dr. Jay Epstein, director of the Office of Blood Research and Review at the FDA, said yesterday.
Pooled plasma products are made from multiple units of donated blood. Epstein said the plasma appears to have been properly screened when it was collected in late 1996.
Alpha Therapeutic asked distributors and purchasers of the product to set it aside until the investigation is complete. Patients were advised "to use alternative lots pending resolution of our safety concerns," the company said in a one-paragraph statement released Tuesday.
The product is one of several available to the 1,500 to 3,000 Americans suffering from the rare hemophilia B, known as Christmas disease, Epstein said.
Depending on the severity of their illness, they might use the blood factor anywhere from once a year to several times a week, he said.
The FDA learned on Friday that a British regulatory agency got a questionable positive test result for a sample from the pool, "suggesting, but by no means proving that there was antibody to HIV in the pool from which the product was made," Epstein said.
Results were negative when the samples were given direct virus tests using sensitive polymerase chain-reaction techniques.
Karen White, a company spokeswoman, said she could provide no further details on how many units of the potentially tainted product may have been involved.
"It leaves us with a very, very low level of concern that anything is amiss with the product," Epstein said.
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