Prime suspect in as many as 16 patient deaths across the country. A controversial blood plasma made by a Long Island company has been reported as a prime suspect in as many as 16 patient deaths across the country, more than twice the number first acknowledged by government officials earlier this year.
Among the cases newly identified by Newsday in government records were three deaths at the University of Chicago Hospitals in 1999. definite , two women, ages 28 and 52, and a man, 66 – because they developed blood clots that were not a normal outcome of their health problems, hospital spokesman John Easton said.
Newsday reported in May that six liver transplant patients at Cedars-Sinai Medical Center in Los Angeles died after receiving the blood product, known as SD plasma, which was designed to make transfusions safer. Days later, Food and Drug Administration officials said there had been four more deaths. Government records obtained by Newsday this summer have identified an additional six deaths of patients who received the plasma made by V.I. Technologies, formerly of Melville.
newly discovered deaths include that of a patient at Washington County Medical Center in Hagerstown
Besides the Chicago cases, the newly discovered deaths include that of a patient at Washington County Medical Center in Hagerstown, Md., who died in 1999 after being transfused with the plasma. A hospital spokesman said V.I. Technologies investigated the Maryland death and found its product was not at fault.
Two liver transplant patients who received the plasma at unknown hospitals also died, FDA records show. Agency officials would not identify all the hospitals where the deaths occurred.
In all 16 cases, the blood plasma was listed as the primary suspect medication in death reports submitted to the FDA. V.I. Technologies manufactured the plasma for the American Red Cross, which sold it to hospitals across the country.
FDA spokesman Jason Brodsky confirmed last week that as of Aug. 26, the number of death reports naming SD plasma as suspect had climbed to 16.
Medical experts say it appears the plasma, known as SD plasma because of the solvent detergent scrubbing method used to cleanse it of dangerous viruses caused deadly blood clots to form. In order to market the expensive high-tech plasma, at $125 per unit it cost more than twice as much as traditional plasma – the Red Cross obtained ordinary blood plasma from donors and contracted with V.I. Technologies, which processed it.
company pooled the plasma in batches, each containing donations from 2,000 donors
The company pooled the plasma in batches, each containing donations from 2,000 donors, and scrubbed it free of viruses such as HIV and hepatitis C, using a process developed by the New York Blood Center in Manhattan. The plasma remained on the market following the deaths but V.I. Technologies stopped making it in 2001.
A spokeswoman for the company declined to answer questions about SD plasma and the deaths.
“That no longer is our product and we don’t have any comment at this time,” said Francesca DeVellis, senior director of investor relations for V.I. Technologies. The company has moved to Watertown, Mass.
Clotting wasn’t the only problem associated with some of the SD plasma transfusions.
Two of the Chicago patients received units of SD plasma from batches contaminated with parvovirus B19, which can be dangerous to infants, pregnant women and people with poor immune systems, FDA records show. The FDA recalled 90,000 units of the contaminated plasma in 1999. Brodsky, the agency spokesman, said “it is unlikely that parvo was implicated in the fatalities.”
FDA did not send its own investigators to probe the death
In the death in Maryland, which claimed an 82-year-old man, Dr. Chris Dempsher, head of the blood bank at the Maryland hospital, said the FDA did not send its own investigators to probe the death. The FDA, which doesn’t have enough investigators to probe all complaints it receives, often allows companies to investigate their own products.
Unlike the Los Angeles patients, who received large quantities of SD plasma, the Maryland man received only two or three units. The man developed a “hive-like reaction” after the transfusion but didn’t die for several weeks, Dempsher said.
“Actually, as the investigation went on with this particular patient, they decided the adverse outcome was infections,” Dempsher said. “The clinician in the case and the consultants [from V.I. Technologies] felt it was not caused by the plasma.”
Arthur Caplan, chairman of the department of medical ethics at the University of Pennnsylvania Medical Center in Philadelphia, said permitting companies to investigate their own product makes no sense. “The ability to retain the perception of an independent investigation evaporates when the company is basically responsible for policing itself,” he said.
The clinical significance of low levels of Protein S is unknown
Transfusion experts say it now appears the solvent detergent process used to rid SD plasma of dangerous viruses depleted the normal amount of a substance it contains called Protein S. Scientists believe the reduced amount of Protein S may have contributed to the clotting problem. FDA officials knew about the reduced Protein S levels in SD plasma when they approved it in 1998.
When asked whether the FDA had decided that the Protein S levels posed no safety problems, FDA spokesman Brodsky would only say: “The clinical significance of low levels of Protein S is unknown.”
Brodsky said FDA officials reviewed all 16 deaths but he would not say what they found. The FDA issued its most serious type of alert, a black-rimmed box surrounding a printed warning that appears on product labels for SD plasma in March 2002 soon after Newsday began inquiring about the Los Angeles deaths.
The warning advised doctors that SD plasma could cause dangerous blood clots in patients with serious liver disease, apparently due to low levels of certain clotting-related substances, including Protein S.