The Wall Street Journal - Wednesday, 9 October 1996
David P. Hamilton

In the interim, more than 1,800 Japanese hemophiliacs became infected. To date, more than 400 have died, reports Wednesday's Wall Street Journal.

Japan wasn't alone in letting bureaucratic concerns override public safety where AIDS was concerned. In France, health officials knowingly distributed some HIV-tainted blood products for six months in 1985 to sell off state-owned inventories.

The U.S. Food and Drug Administration didn't order a recall of potentially tainted plasma products until 1989, six years too late.

But many Japanese see this scandal as emblematic of a much larger problem with the cozy government/business relationship known as Japan Inc. - "iron triangles" of mutual interest that bind bureaucrats, industry executives and, in this case, the medical establishment.

In cases ranging from Japan's accident-plagued nuclear-power program to its creaky financial system, similar iron triangles have effectively shielded important decisions from public scrutiny, subordinating interests of ordinary citizens to those of big companies.

These alliances can effectively keep out imports and prop up domestic business - and, in a worst-case scenario like this one, endanger lives.

"In the Ministry of Health and Welfare, the most important goal is to protect industry," says Masao Miyamoto, a former Health Ministry bureaucrat and the outspoken author of "Straightjacket Society," a biting critique of Japanese bureaucracy. "People come next."

So far, the scandal has netted former Health Service Bureau Director Akihito Matsumura, the president and two former executives of blood-products maker Green Cross Corp., and a prominent hemophilia researcher.

(Matsumura and the researcher were charged with criminal negligence; prosecutors in Osaka won't say on what charges they arrested the Green Cross officials, though it has been widely leaked in the Japanese news media that they, too, were charged with criminal negligence).

The arrest last week of Matsumura, who issued only a "voluntary" recall of contaminated blood products, sent a particularly aggressive signal, since prosecutors rarely second-guess Japan's powerful bureaucrats.

Thanks to a single man - Japanese Health Minister Naoto Kan, a maverick politician who earlier this year forced his ministry to dig up a remarkable paper trail of incriminating internal documents - the influence of the iron triangle in the AIDS scandal is especially clear.

The scandal has also brought to light a strange drama in which, during a single week in 1983, ministry officials reversed themselves and abruptly decided to bar imports of safe heat-treated blood products.

The same health professionals also apparently covered up the case of a hemophiliac who should have been classified as Japan's first AIDS victim, helping to divert attention from the danger.

The tale begins in 1983, as concern in Japan over hemophiliacs and AIDS began to mount. The U.S. Centers for Disease Control had recently announced five new cases of AIDS among hemophiliacs, strong evidence that the disease could be spread via blood.

Hemophiliacs, whose blood often doesn't clot, are vulnerable to viral infections because they depend on blood products that supply clotting factors, such as the so-called Factor VIII.

At the time, Factor VIII could only be created using blood pooled from thousands of donors, making the products likely conduits for infectious agents.

Japanese pharmaceuticals companies routinely made Factor VIII from imported U.S. blood components. This was an especially important business for Green Cross, which dominated the Japanese market for such products.

Then in March 1983, the U.S. Food and Drug Administration approved Hemofil T, a new blood product from Travenol Laboratories Inc., now a unit of Baxter International Inc.

Hemofil T was heat-treated to kill the hepatitis B virus, and the method seemed likely to kill any AIDS-causing virus as well.

Atsuaki Gunji, the newly appointed head of the Health Ministry's Biologics and Antibiotics Division, saw the health dangers and was apparently ready to pave the way for imports from the U.S. company.

"Japan relies on imports from the U.S. for 90% or more of its blood plasma, and AIDS is a matter of serious concern," Dr. Gunji told the Yomiuri Shimbun, a major Japanese daily, on May 26, 1983.

One of Dr. Gunji's deputies, Toshihiko Hirabayashi, began meeting regularly with officials at Travenol's Japan unit; in May 1983 he allegedly told them that the Health Ministry would speed approval of Hemofil T by skipping lengthy clinical tests, according to a 1994 affidavit filed by Shigetoyo Oguri, at the time an employee in Travenol Japan's pharmaceuticals division.

Baxter declined to make Oguri or any other official available for interviews, although a spokeswoman said the company believes the affidavit accurately portrays the facts. Hirabayashi declined to comment.

The affidavit was included in a lawsuit against the government and makers of blood products, filed on behalf of hemophiliacs who contracted AIDS.

Dr. Gunji established a research team to study the dangers. To head it, he turned to Takeshi Abe, a Teikyo University professor who was one of the nation's leading hemophilia experts.

At the team's first meeting on June 13, 1983, Dr. Gunji pressed the case for heated blood products, two members of that panel said this year in testimony before the Japanese Diet, or parliament.

According to the testimony of Juzo Matsuda, a Teikyo University professor and one of the few whistleblowers in the scandal, Dr. Gunji said that because the spread of AIDS had rendered unheated Factor VIII products then in use "extremely dangerous," he wanted the panel to discuss "emergency imports of heated blood products."

Through his wife, Dr. Matsuda declined to comment for this story. By early July 1983, the Health Ministry appeared ready for action.

Another of Dr. Gunji's deputies, Kiyomichi Fujisaki, drew up a blunt set of marching orders on July 4 that stated, "Have the research team recommend the use of heated blood products."

The memo, released by the Health Ministry earlier this year, further stated: "Direct Travenol to quickly submit an application for the import of heated Factor VIII blood products...Issue administrative guidance to the industry so that companies won't handle products using unheated materials from the U.S."

Fujisaki noted that financial damage to Green Cross and other big Japanese pharmaceuticals companies was "unavoidable," since they were woefully unprepared to make the heated blood products themselves.

But the Health Ministry had longstanding ties to Green Cross, which had become something of a haven for retired bureaucrats.

For one, Dr. Gunji's direct superior, Pharmaceutical Affairs Division Director Kazumi Mochinaga, had worked in the late 1960s as a deputy to Renzo Matsushita, a former bureaucrat who joined Green Cross in the 1970s and became its president in 1983.

In Japan, such a situation usually establishes two men as senpai and kohai - literally, as senior and junior in a lifelong relationship. Mochinaga, now a three-term legislator in the Diet, sought Matsushita's help for his first run at the Diet in 1985, he told the daily Mainichi Shimbun in an interview earlier this year.

The legislator declined repeated requests for interviews for this story. Matsushita also declined an interview request prior to his arrest by police on Sept. 19.

Dr. Abe - who was arrested in connection with the scandal this past Aug. 29 - had also forged close ties with Green Cross and other pharmaceuticals companies.

Dr. Abe frequently met with Green Cross officials to offer technical advice, and sometimes delivered paid lectures about treatment procedures, on at least one occasion receiving nearly $900 at today's exchange rates, says Green Cross public-relations manager Yoshiyuki Yatsuyanagi.

In mid-1983, Green Cross donated about $90,000, at today's rates, to a hemophiliac foundation then planned by Dr. Abe. That amount was quickly matched by four other pharmaceuticals companies.

Dr. Abe's lawyer says the researcher was never swayed by the financial assistance from Green Cross or the other drug firms. "Our relationship with Dr. Abe started in the 1960s, and nothing changed when he became head of the AIDS research team," Green Cross's Yatsuyanagi says.

Nonetheless, over seven mysterious days in July 1983, bureaucrats and doctors alike dropped their earlier concerns about the threat to hemophiliacs.

What came next was a long process of delay, obfuscation, and cover-up that had the effect of justifying the continued sale of unheated Factor VIII products by Green Cross and other companies.

Within the Biologics Division, a second memo by an unknown author dated July 11 completely overturned Fujisaki's week-old argument for importing heat-treated blood products.

"There are suspicions regarding the effectiveness and safety of these (heat-treated) blood products," stated the division's memo, which was also released by the Health Ministry earlier this year.

Any special exception for the import of heat-treated products, the memo noted, "would create an unfortunate precedent."

Fujisaki, who was transferred to a remote post in central Japan just a few months after the memo incident, told ministry investigators that the earlier missive was only an internal discussion paper. He declined to be interviewed for this story.

In October of that year, Travenol was informed that Hemofil T would have to go through a complete set of clinical trials that would take at least a year, according to Oguri's affidavit.

Dr. Gunji and his former subordinates now deny that they ever believed emergency imports of the safe blood products were necessary. Dr. Gunji, who declined repeated requests for an interview, also denied in Diet testimony ever suggesting the use of heated Factor VIII products to the research team.

He also said he hadn't been convinced of Hemofil T's safety or efficacy at the time.

Dr. Abe's AIDS research team also shifted into reverse, and during the next several months edged away from substantive discussion of heated blood products.

What's more, it began what turned into an elaborate coverup of Japan's first AIDS victim, a 48-year-old male hemophiliac under Dr. Abe's care at Teikyo University Hospital, who died July 5, 1983, of a then-unknown immune disorder.

When the research team first discussed the patient's case in June, the panel appeared ready to take swift action. "If we had confirmed the diagnosis of AIDS at that time, the government would have been forced to allow emergency imports of heated blood products," Dr. Matsuda told the Diet in testimony last April.

By the time of the team's second meeting on July 18, however, news of the patient had broken in the Japanese news media, unleashing a wave of alarmist coverage that AIDS had "landed" in Japan.

In the crush of media attention, the panel voted to deny that the patient had died of AIDS, with Drs. Abe and Matsuda dissenting.

But the vote established a party line that took on a life of its own; later that day, Dr. Abe told a news conference that the patient didn't have AIDS, but was suffering from "quasi-AIDS," possibly brought on by steroid use.

Evidence now shows that the Teikyo University hemophiliac really had died of AIDS, a fact that Dr. Abe and the Health Ministry continued to suppress for almost the next two years.

The following year, Dr. Abe sent blood samples from 48 of his hemophiliac patients to the U.S. laboratory of Robert Gallo, a co-discoverer of the AIDS virus, for examination with a newly developed AIDS test.

On Sept. 6, 1984, Dr. Gallo's laboratory responded in a letter that nearly half of Dr. Abe's patients, including the Teikyo University Hospital hemophiliac, had tested positive for AIDS. The letter was released earlier this year by the Health Ministry.

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