The New York Times - September 27, 1984
Philip M. Boffey, Special to the New York Times

They said that the use of the blood product, fresh-frozen plasma, has increased tenfold over the past decade despite a "paucity of definitive indications" of its medical value and "mounting evidence of its potential risks, which include viral hepatitis and possibly AIDS."

The authorities, members of a panel convened by Federal health agencies to make recommendations for physicians, found that many patients who receive fresh-frozen plasma "can be managed more effectively and safely with alternative" treatments, including the re-use of their own blood components and the use of donated blood products that have less risk of transmitting infectious disease.

Various panelists stressed that they were not suggesting that patients should avoid blood transfusions, an indispensable therapy in modern medicine, or refuse to accept the plasma component of blood when it is clearly required. They said they were simply concerned that the sharply increasing and indiscriminate use of fresh-frozen plasma was subjecting many patients to some risk of disease when safer blood products could avoid most of that risk.

The group's findings, a result of a three-day conference held at the National Institutes of Health in suburban Bethesda, Md., were presented in an eight-page statement.

Expanding on the report at a news conference, panel members said that some 3.5 million patients receive transfusions of blood or blood products each year. As many as 700,000 of those now receive fresh-frozen plasma, usually in combination with other blood products, the panel members said. This plasma is a watery fluid that makes up about 55 percent of the volume of the blood and is usually frozen promptly after it is drawn for later use. The remaining 45 percent of the volume of blood consists of cellular elements, such as red and white blood cells.

Although blood transfusions once consisted largely of blood drawn essentially intact from donors, in recent years the trend has been to split donated blood into components, including red blood cells that transport oxygen throughout the body, white blood cells that fight disease, platelet cells that help blood clot, plasma that transports nutrients and other essential substances throughout the body and various components of the plasma that are used to combat shock, treat hemophiliacs, or meet other medical needs.

Such therapy allows a single donation of whole blood to serve the needs of several different patients, each of whom may need only one component of the original donated blood.

Wide Use Lamented

The panel lamented that the fresh- frozen plasma component is being widely used by doctors for surgical and medical purposes in which its effectiveness has not been proven and its safety is in doubt. At the news conference, Dr. James L. Tullis, an emeritus professor from the Harvard medical school, who served as chairman of the 11-member panel, estimated that 90 percent of the current use of fresh-frozen plasma is unwarranted. Other members of the panel nodded their agreement.

Perhaps the greatest overuse, some said, is to replace blood lost in cardiac surgery. Another typical misuse, panelists said, is to combine the plasma with red blood cells when other combining fluids could be used with less risk.

The panel cited studies indicating that 3 percent to 10 percent of the patients who received multiple transfusions of whole blood or red blood cells developed viral hepatitis as a result, and it estimated that the same percentages would hold true for transfusions of fresh-frozen plasma.

The panelists cited one estimate that perhaps 20,000 to 70,000 cases of viral hepatitis are transmitted each year through fresh-frozen plasma. But they cautioned that eliminating all of those plasma transfusions would not necessarily eliminate all of the disease, because the patients were receiving other blood products that might also transmit the virus.

Some panelists stressed that many of the patients who contract hepatitis virus through transfusions are not even aware that they have the disease because the symptoms are either mild or unnoticed.

Possible AIDS Link Noted

The panelists warned that the plasma might "possibly" transmit the virus believed to cause AIDS, or acquired immune deficiency syndrome, but they acknowledged that there is no firm evidence of such transmission. Although 82 of 6,000 reported AIDS cases have been linked to blood transfusions, each of the 24 victims who received fresh-frozen plasma also received other blood components, leaving analysts uncertain which component might have carried the virus.

The best alternative to the plasma use, the panel said, is "a comprehensive program of blood conservation," in which patients, whenever possible, donate their own blood in advance of surgical procedures to be saved and reinserted in surgery. Other alternatives recommended by the panel included a variety of blood products and components that can be heated or otherwise sterilized to eliminate traces of virus. For example, albumin, a plasma component used to combat shock from blood loss, can be purified by pasteurization, the panel noted.

The fresh-frozen plasma cannot be heated without destroying its value, the panelists said. They also noted that, while screening tests have been developed to detect and eliminate blood containing some viruses, the tests cannot detect all forms of hepatitis or all potential virus threats.

Reasons for Increased Use

The panelists said they were mystified about the reasons for the surge in use of fresh-frozen plasma when there is evidence of risk and little evidence of need or effectiveness. The panel's statement blamed this increase on "multiple factors," possibly including the decreased availability of whole blood as doctors shifted to component therapy.

Various panelists and scientists attending the health conference blamed the surge on a marketing push from blood banks, the high cost of some alternatives to plasma, a faulty process of educating physicians or a belief by many doctors that it is better to give plasma, which contains myriad critical components, than try to determine exactly which of those components a particular patient needs.

The panel urged doctors to restrict the use of fresh-frozen plasma to a relative handful of patients, including those who need certain kinds of coagulation proteins; a select group requiring massive transfusions; certain patients with immune deficiencies, and some patients with liver disease, among others. These were estimated to make up perhaps 10 percent of the total now receiving the plasma.

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