The Health, Labor and Welfare Ministry has decided to state in an internal investigation report to be released soon that it was ill-equipped to gather information and coordinate with affiliated medical research institutes. The ministry explained that it was not able to learn immediately of a 1977 U.S. ban of the hepatitis-tainted products produced by defunct drugmaker Green Cross Corp, sources said.

Green Cross was allowed to continue selling the blood-clotting fibrinogen drugs for another decade. It only began voluntarily recalling them in 1987, after eight cases of hepatitis infection from the agents surfaced in 1986 and 1987.

But the ministry is likely to deny any wrongdoing in neglecting to impose a ban on sales of the product until 1987. It will also deny responsibility for the spread of the disease, claiming there was no hepatitis outbreak before 1987, the sources said Saturday.

The ministry's attitude is likely to inflame the anger of people who contracted the illness, and it may spark lawsuits against the state.

In late March, the ministry began the investigation after the 1977 U.S. ban was reported by the media.

The ministry discovered that as an organization it only learned of the ban in 1984. However, a researcher at the ministry's National Institute of Health, now the National Institute of Infectious Disease, knew about the ban earlier.

Green Cross Corp., now part of Osaka-based Mitsubishi Pharma Corp., learned of the ban immediately in 1977 but waited until 1984 to inform the then Health and Welfare Ministry about it, according to a report by Mitsubishi Pharma submitted earlier to the ministry. The ministry failed to take any action until 1987, when the recalls began.

At least 280,000 patients at hospitals across Japan were given the products, mainly by obstetricians and gynecologists but also by surgeons, physicians and pediatricians.

An estimated 2 million patients were infected with hepatitis C across Japan, medical experts say. They were mainly infected through procedures such as those using tainted blood products.

The agents were primarily used for blood clotting, but they were also used for unauthorized purposes, such as serving as adhesives for cuts and organ incisions.

The Japan Times: Aug. 26, 2002
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