About five times a month, Charles Robinson, a hemophiliac, uses a medical treatment manufactured from human blood to help clot his own blood.
Two weeks ago, he received a letter from the distributor -- the American Red Cross -- informing him that some of the blood-clotting factor he uses might contain blood from a donor who later developed a rare, fatal brain disease called Creutzfeldt-Jakob disease (CJD).
The product had been withdrawn from the market about three weeks before Mr. Robinson was notified.
The risk that he or anyone else could have been infected with Creutzfeldt-Jakob disease (CJD) is "near zero," according to medical professionals. But Mr. Robinson and other hemophiliacs say the way patients learn about such recalls is too leisurely and too impersonal.
The approach to retrieving recalled blood products is a worrisome example of the lack of communication and regulation within the blood product industry, they say. On Thursday, U.S. Food and Drug Administration advisory committee is scheduled to discuss this approach.
"I think there has been gross insensitivity to the people who used this factor," said Mr. Robinson, a Baltimore resident. "I was very shocked that all I got was this letter. . . . It was the kind of letter you'd expect to get if your car was recalled."
During the early 1980s, an estimated 10,000 hemophiliacs nationwide were infected with human immunodeficiency virus, which causes AIDS, because they used contaminated blood-clotting factor, the medical treatment meant to save their lives.
Subsequently, the threat of infection caused by blood products -- no matter how small the risk -- is horrifying for hemophiliacs and their families.
"It's not that they recalled these products," said Mr. Robinson, who is HIV positive. "It is that there was no way offered to help us deal with this emotionally. The hemophilia community has been through this already and even if the risk is significantly less dangerous than with HIV disease, it is still significant to us."
Beginning last month, four organizations -- Miles Inc., Baxter Healthcare Corp., Sandoz Pharmaceuticals Corp. and the American Red Cross -- voluntarily withdrew a number of products made from blood or blood derivatives. Among them were clotting factor, used by hemophiliacs; albumin, used to increase blood volume in trauma victims; and intravenous immunoglobulin, used to bolster patients' natural immunity.
"Voluntary withdrawal" means the organizations, though they consult the FDA, decide on their own to take a product off the market, said Monica Revelle, a spokeswoman for the FDA, which regulates the blood industry.
According to the agency, withdrawals and recalls within the blood industry are frequent and occur for a variety of reasons, ranging from mislabeling to more serious problems such as threat of infection.
The contamination this fall occurred in two separate incidents: Two blood donors -- one who gave blood to Baxter Healthcare Corp. and one who was a frequent Red Cross blood donor -- were diagnosed with Creutzfeldt-Jakob disease (CJD). Both have died.
CJD annually affects 1 in a million people nationwide and causes dementia similar to that seen in Alzheimer's patients, said Dr. Richard Johnson, director of the Department of Neurology at Johns Hopkins Hospital. A defining symptom of CJD is jerky motions made by the patient.
Ten percent of the time, the disease is handed down in families; the other 90 percent of cases have no known cause, he said.
There is no test for the disease, so blood donors have no way of knowing whether they carry it until identifying symptoms appear.
The extent of the most recent withdrawal is difficult to estimate because the units of measurement vary by product, by disease and by patient.
"The simple answer is, 'It's big,' " said Dr. Peter Page, chief medical director for the American Red Cross. "It affects a large number of lots, each lot includes thousands of vials, and so it affects enough product to treat thousands of patients."
A sick donor can have a widespread effect on blood products because of the way the industry works: The American Red Cross gathers whole blood from volunteers and sends plasma and other components to companies such as Baxter and Miles. Those companies then divide the plasma into smaller components, which are used to make other blood products.
Physicians say the risk of CJD being transmitted by blood or blood products is extremely low. Though the disease has been transmitted by human tissue -- such as in corneal transplants -- and by a growth hormone made of the human pituitary gland, which has been taken off the market, doctors say there are no reports of its transmission by blood.
"Obviously, you would not want to use the units of blood; it is perfectly reasonable that the product be removed from the market. But I don't think there is any imminent danger," said Dr. Johnson.
Nonetheless, the estimated 400 hemophiliacs in Maryland and their families say their community deserves greater consideration in such product withdrawals.
Some heard about the product withdrawal nearly a month after it occurred. Some learned about it from National Hemophilia Foundation medical bulletins or by word of mouth. Others, such as Mr. Robinson, say they received inadequate -- and frightening -- information.
"It is totally ridiculous how they did this. The whole thing is very upsetting," said Emma Miller, whose hemophiliac husband died of AIDS. Mrs. Miller learned about the withdrawal last week from a newsletter.
As acting president of the local chapter of the National Hemophilia Foundation, Mrs. Miller says there should be a more efficient information network for hemophiliacs and their families, particularly those already dealing with AIDS.
"[A newsletter] is no way to learn about a recall if you're giving your child factor that may be contaminated," she said.
Faye Carey of Abingdon, whose 4 1/2 -year-old son was administered some of the recalled factor, also received the news last week via a newsletter and said she felt that too many questions were left unanswered.
"We go through our product in about a month's time," she said. "You aren't going to find too many people with any of this left. [The newsletter] doesn't address what to do if you've already used it. It is very unnerving."