FDA hit coagulant’s ‘shortcomings’ in ’77

Viral disease specialist testifies for plaintiffs in tainted blood products case


The U.S. Food and Drug Administration withdrew its approval for a blood coagulant in 1977 after a panel concluded it “had major shortcomings” both in efficacy and safety, a former FDA official told a court Tuesday.

Lewellys Barker, a viral disease specialist who participated in the FDA panel’s drug license review of coagulants, including fibrinogen, in the late 1970s, made the statement before the Tokyo District Court as an expert witness for plaintiffs infected with hepatitis C through transfusions of tainted blood coagulants made from pooled U.S. blood.

More than 70 people infected by tainted blood coagulants, including fibrinogen, are suing the government and drug makers for their failure to take such products out of circulation in Japan despite the FDA’s move, in several lawsuits across Japan.

On Tuesday, the plaintiffs’ lawyers quizzed Barker about the FDA panel in hopes of highlighting negligence on the part of Japanese drug regulators and drug makers, who they argue should — and could — have got wind of the FDA’s conclusions yet took no action until the late 1980s.

Barker told the court that the U.S. experts agreed that the risk of fibrinogen transmitting hepatitis C far outweighed the benefits of the product, and that other products with less risk of hepatitis infection were available.

Studies had also shown by then that the use of fibrinogen even worsened the conditions of some patients, he said.

“In the case of fibrinogen, I think the panel had an open-and-shut case,” said Barker, who left the FDA in June 1978 and now serves as chief medical officer at the Maryland-based Sequella Global Tuberculosis Foundation.

The FDA moved to remove fibrinogen from the market in 1977, ahead of the panel’s final report, which was made in 1979.

Also, in 1978, J.R. Bove, another panel member and professor at Yale University School of Medicine, published the panel’s findings in a medical journal called Transfusion.

Barker said the publication is “highly regarded” and “widely read throughout the world” — hinting that the Japanese industry and government officials could well have been aware of fibrinogen’s risks.

“Government people regulating this field are widely inclined to read and are familiar” with the content of the journal, he said.

Barker will be cross-examined by lawyers for the defendants Wednesday.