The federal government should investigate the deaths of two cancer patients at the National Institutes of Health who died after they received transfusions of blood that a military blood bank deemed contaminated, a public advocacy group said today.
Internal investigations by the NIH and the Walter Reed National Military Medical Center, both in Bethesda, Md., "are not adequate to remedy this serious problem," Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, wrote in a letter to Health and Human Services Secretary Kathleen Sibelius and Defense Secretary Leon Panetta.
In an afternoon interview, Wolfe said he urged the two cabinet secretaries to have their agencies determine how infected blood products could have reached the NIH and ultimately killed patients. Without "an immediate external investigation," other patients at the military hospital, the NIH "and possibly military personnel in the field, may be exposed to these entirely preventable risks," his letter said.
The investigations need to begin "quickly, to make sure they've identified exactly where the problem is, and most important, they've remedied it," Wolfe said.
Wolfe, whose work at the NIH decades ago involved platelets, the blood components that transmitted deadly infections to both patients, called it "inconceivable" that they died from tainted blood, which should never have left the blood bank except as medical waste. "The best way of ensuring that infected blood or blood components (never gets used) is to get rid of them."
In a statement released early this evening, NIH spokesman John Burklow said the NIH was "deeply saddened by the deaths of two patients who were participants in clinical research at the NIH Clinical Center."
Both patients received platelets "from an outside source that were labeled as suitable for transfusion," but developed bacterial sepsis. After the NIH learned the platelets were contaminated, "the patients and their families were informed, and every effort was made to treat their infections. We're doing everything we can to make sure this never happens again."
Sandy Dean, the public information officer for the Walter Reed National Military Medical Center, which now serves the Army, Navy, Marines and Air Force, said the tainted blood came from the old Walter Reed Army Medical Center in the District of Columbia, which closed in August as part of the merger with the Bethesda National Naval Medical Center.
"Our thoughts and prayers, of course, go out ot the families involved," Dean said. the integrated medical center in Bethesda "is deeply committed to the highest quality of care and we take every step possible to ensure that we consistently meet these high standards."
Wolfe learned about the deaths from a confidential source, an NIH physician who cared for one of the two patients said. He said that since his letter went out in the morning, "I've had confirmation from someone independent of the first source."
The whistleblower, whom Wolfe called Dr. X, said both patients, whose identities also have been kept confidential, were weakened by chemotherapy and needed transfusions of platelets, which make blood sticky, to stop their bleeding. However, the NIH had run out of platelets, so it used platelets sent by the military blood bank. Wolfe said it appeared that the military facility knowingly sent tainted blood to the NIH, although it remained unclear whether that blood was labeled as contaminated when it was sent. Infected blood normally is destroyed.
"There was so much bacteria in these solutions" that both patients went into septic shock, a result of an overwhelming bacterial infection of the blood, "less than an hour" after receiving platelets from the military's blood bank July 25, Wolfe said. Sepsis can lead to a drop in blood pressure, which sends the body into shock and may cause major organs to shut down. Dr. X's patient developed multiple organ failure and died on Sept. 7. The other patient, under the care of another physician, died in August.
Patient Deaths 'Entirely Preventable,' Wolfe Charges
The whistleblower told Wolfe he was unaware of the bacterial contamination until his patient went into shock. He then sent the platelet container to pathologists, who later that day informed him that the platelets his patient received were "grossly contaminated" with Morganella morganii, a bacterium that lives in the gut but can be fatal to people with compromised immune systems, such as chemotherapy patients, diabetics and the elderly. Blood cultures of both patients confirmed Morganella infections, Wolfe said.
"My conclusion, based on the information provided by Dr. X, is that the deaths from overwhelming sepsis from infected platelets were entirely preventable had proper blood bank procedures been followed at the NMC," Wolfe said in his letter to Sebelius and Panetta. According to the account Wolfe sent to the two secretaries, Dr. X informed his patient's partner about the source of the Morganella infection and several weeks later, was prohibited from seeing the patient. To this day, the doctor "has not been informed about the results of investigations as to why these deaths occurred."
In addition to requesting immediate investigations, Wolfe said he also asked that inspectors general at both agencies undertake longer-term investigations to make sure the problem doesn't recur.