The government was informed in 1984 of the risk of hepatitis C infection through a number of blood products but failed to take action to regulate their use in Japan for three years, sources said Friday.

The latest revelation confirms suspicions that inaction by the then Health and Welfare Ministry aggravated the spread of diseases among people who were administered the products in the 1980s.

Green Cross Corp., a now-defunct major manufacturer of blood products, reported to the health ministry in 1984 that products similar to its blood-clotting agent fibrinogen had been banned in the United States in 1977 due to the risk of hepatitis infection, the sources said.

However, the ministry did not take any regulatory action until Green Cross began voluntarily recalling the drugs in 1987, after eight cases of hepatitis C caused by the drugs had surfaced in Aomori Prefecture between 1986 and 1987.

In April 1987, Green Cross introduced the new, heated version of the products that did not cause infections.

Green Cross, now part of Osaka-based Mitsubishi Pharma Corp., submitted documents to the ministry in 1984 for re-examination of its license to make the drugs, which had been originally granted in 1964, the sources said.

The documents included a file stating that the U.S. Food and Drug Administration had revoked fibrinogen production licenses in the United States in 1977 after the products were found to pose the risk of transmitting hepatitis, they said.

Japan’s Central Pharmaceutical Affairs Council, which reviews the safety and effectiveness of commercially sold drugs after a certain period following their release, began re-examining the license for Green Cross, but it had not reached a conclusion before the 1986-1987 outbreak.

The Health, Labor and Welfare Ministry is now questioning officials who had authority during the 1984-1987 period as to why they did not take prompt action, the sources said.

Chikara Sakaguchi, minister of health, labor and welfare, told reporters Friday that he will examine the ministry officials’ actions following the 1977 ban by U.S. authorities.

The drugs, produced and sold by Green Cross, caused an estimated 10,000 people to contract the hepatitis C virus, mainly in the 1980s, according to Mitsubishi Pharma.

The products were administered to at least 280,000 patients at hospitals throughout Japan, mainly by obstetricians and gynecologists, but also by surgeons, physicians and pediatricians.

The products were primarily used as blood-clotting agents, but they were also used for purposes they were not designed for, including as an adhesive for cuts and organ incisions.

The health ministry has been criticized for its slow reaction to foreign bans on medical products using human tissue, which subsequently resulted in a series of medical disasters here including the infection of hemophiliacs with HIV through tainted blood products, as well as cases of people who contracted Creutzfeldt-Jakob Disease via imported dura mater transplants.

In a time of both misinformation and too much information, quality journalism is more crucial than ever.
By subscribing, you can help us get the story right.