WASHINGTON, Aug. 2 (UPI) -- Enforcement reports released on a weekly basis by the Food and Drug Administration highlight a slew of blood products recalled because they were potentially contaminated with HIV, malaria or other deadly diseases, and some consumer advocates worry the products are being transfused into patients in some cases.
The FDA's enforcement reports released in July document numerous ongoing and completed recalls of risky blood products, some of which date back to 1997, but the reports do not specify whether all of the questionable items were retrieved or if any patients received them.
The Committee of Ten Thousand, a group consisting of hemophiliacs who contracted HIV infections via tainted blood products, pays particularly close attention to blood-supply problems and thinks the risky blood products are a concern to everybody.
"This is a big problem," Corey Dubin, COTT's president, told United Press International, adding that he thinks people have received these risky items.
"First of all, they rarely recall in time to prevent transfusion of dangerous product," said Dubin, who contracted hepatitis C and HIV via contaminated blood products.
He noted an incident several years ago in which a batch of blood product was contaminated with bacterium, but by the time the recall was announced, members of his group already had received tainted transfusions. Fortunately, the bacterium turned out to be benign, but if it had not been, the patients would have received the bad batch and could have become ill, he said.
Dubin said the blood supply has become safer in recent years due to increased screening, "but there are still big holes in the system that could really lead to some bad situations."
The most recent FDA enforcement report, dated July 27, comprises 35 pages of recalls of more than 80 blood products that either were potentially contaminated or processed incorrectly.
The FDA did not respond to an e-mail and a phone call from UPI requesting comment.
A spokeswoman for the AABB, formerly known as the American Association of Blood Banks, told UPI the recalls are conducted by the blood banks, and they -- not the FDA -- verify when a product is recalled.
"The actions are initiated by the blood bank long before the FDA knows anything about it," said the spokeswoman, who requested anonymity. She noted that a recall might occur more than a year before the FDA announces it in its enforcement reports -- in some cases it can be up to five years.
An instance in 2000 cited in the July 27 report involved 22 units of blood products collected in North Dakota from a person who previously tested positive for antibodies to HIV and distributed to Austria.
In another recall that began in 2001, source plasma that repeatedly tested positive for antibodies to HIV was distributed. The 2005 report termed the recall as complete.
The AABB spokeswoman said the companies follow up to see if any of the donations were transfused, and she was not aware of anyone contracting a disease via contaminated blood products.
"In many instances, we will notify the person who received it if there is something we think is wrong," she said, adding that she did not "have any firsthand knowledge" of people getting infected through tainted blood products.
The enforcement reports document two instances in which blood products that might have been contaminated with a bacterium called Staphylococcus aureus "were implicated in an adverse transfusion reaction." One occurred in Ohio and one in Illinois.
Asked why blood is collected from risky donors in the first place, the spokeswoman said the donors may have informed the blood bank later that they had tested positive for a disease or developed an illness, so the blood banks may issue a recall for that reason.
In some cases, the screening is not conducted properly initially. In the largest recall listed in the July 27 report, 513 units were recalled because they were "collected from donors whose health history screenings were inadequately performed." The units were distributed to facilities in Arizona, Florida, Nevada, North Dakota, South Dakota, Tennessee and Texas.
Six units of blood products were recalled because they were "collected from a donor considered to be at increased risk of exposure to new variant Creutzfeldt-Jakob Disease," also known as the human form of mad cow disease. It is a fatal, incurable brain-wasting illness. The products were collected in Kentucky and distributed to unspecified locations in California. In another instance, 68 units collected from a person at risk of vCJD were collected and distributed to North Carolina and California.
In several instances, blood products collected from people who had traveled to malaria-endemic areas were distributed before being recalled.
Dubin criticized the FDA for not being aggressive enough in enforcing blood safety.
"Very rarely are the blood banks sanctioned or fined," Dubin said. "The FDA says the ultimate tool is to pull their licenses but rarely does that happen and rarely does the agency use enforcement tactics that will sting a blood bank," he said.
The AABB spokeswoman acknowledged that fines and sanctions are "not ordinarily" levied against blood banks in these recall cases.
Dubin said more resources should be devoted to recruiting increasing numbers of healthy blood donors instead of relying on screening tests to weed out risky donations.
"We don't do what we need to do so we always come up short in the end," he said. "And then we justify using a risky donor pool and say technology will save us. Innocent people who shouldn't get hurt are going to get hurt."
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