“the panel said that the institute added substances not authorized by the government to flu vaccines and blood products for hemophilia patients”
- DEC 3, 2015
The health ministry inspected the premises of a major manufacturer of blood products and vaccines Thursday, a day after an investigative panel accused it of using unauthorized additives and of falsifying records.
The ministry’s action suggests that Chemo-Sero-Therapeutic Research Institute, or Kaketsuken, may yet be subject to punitive measures by the government.
The third-party panel, set up by the institute after allegations of misconduct surfaced in May, found the use of unauthorized additives and data manipulation stretching back over roughly 40 years.
An anonymous whistleblower got in touch with authorities, tipping them off about what was going on.
In a report that was submitted to the Health, Labor and Welfare Ministry on Wednesday, the panel said that the institute added substances not authorized by the government to flu vaccines and blood products for hemophilia patients and tweaked the proportions of ingredients without permission.
Furthermore, with regard to blood products, Kaketsuken lied to government officials during biennial inspections, the report alleged.
Calling such acts “aberrant” and representing “arrogance” by researchers, the panel accused the firm of violating the Pharmaceuticals and Medical Devices Law.
The panel pointed out that senior Kaketsuken officials, including director Seiji Miyamoto, failed to halt the malpractice despite knowing about it.
In a bid to cover up what was going on, Kaketsuken officials allegedly falsified records, making it look as though the products were manufactured correctly.
When they could not produce the needed historical documents, they artificially aged the faked papers by exposing them to ultraviolet radiation.
On Wednesday, Kaketsuken announced Miyamoto’s resignation.
Each member of the board of directors either resigned or was demoted.
The panel alleged that the institute conducted malpractice in a bid to get its products to market quickly and to ensure stable supplies. In all, it said, Kaketsuken falsified data on 31 manufacturing processes.
None of the products has caused serious side effects so far, but the scandal has outraged some patients, especially hemophiliacs, who were victimized in a separate scandal involving blood products infected with HIV.
Kaketsuken was one of the defendants involved in group lawsuits filed in 1989 by hemophiliacs who contracted HIV through blood products.
More than 1,400 hemophiliacs contracted HIV from blood products administered in the late 1970s and early 1980s. About 500 of them have since died.
“They simply lack the ethics and governance standards a pharmaceutical company is expected to have,” said Jugo Hanai, 53, leader of a nationwide association supporting victims of drug-induced diseases. “Such a malpractice wouldn’t last this long if the whole company hadn’t been involved in it.”
The civil case was settled in 1996, but Kaketsuken was heavily criticized for putting its interests before those of the patients.
“It seems they have drawn no lessons from the case,” said Hanai, who was among the plaintiffs in the HIV case.
He added: “The government, failing to detect their misconduct, is also responsible.”
Meanwhile, the panel failed to determine whether Kaketsuken fabricated data on its vaccines, the shipment of which was temporarily suspended in September after it was found that unauthorized methods were used in their production.