For more than 40 years, a longtime Japanese drugmaker apparently carried out an elaborate subterfuge worthy of a grand conspiracy theory. Chemo-Sero-Therapeutic Research Institute, known as Kaketsuken, acknowledged violations and a massive cover-up lasting for decades.Chemo-Sero-Therapeutic Research Institute
The government has suspended shipments of 7 types of Kaketsuken products and is considering whether to block more of them. So far, Japan's Ministry of Health, Labor and Welfare told the Japan Times and other publications, it has received no reports of serious side effects that may have been associated with Kaketsuken's tainted products.
In the wake of the report of a third-party panel and subsequent admission of guilt by the company, the ministry conducted a surprise inspection at Kaketsuken headquarters in a search for evidence behind the allegations. The ministry's first act was expected to be issuance of a business-improvement order.
The violations were revealed in the panel's report, which was commissioned by the institute center on blood products, but Kaketsuken also produces nearly a third of Japan's vaccines, according to reports.
Kaketsuken works with leading drugmakers such as Daiichi Sankyo and Takeda Pharmaceuticals on seasonal flu shots and other products and has a wide reach in the country and a series of licensing pacts with companies abroad.
According to the report cited by media outlets, as far back as at least 1974, the company violated Japan drug regulations involving blood products by using additives and production methods that had not been authorized by the government.
Regulators apparently first got wise to the violations as early as 1977, leading the company to devise an elaborate cover-up plan involving two types of production records, one of them fake and intended for the eyes of government inspectors. The operation included a type of code on certain pages of production reports so they could be pulled quickly from the papers made available to inspectors.
Kaketsuken employees went as far as to forge certain reports and age them artificially with ultraviolet rays to replace past reports that revealed the earlier violations, reports said. Employees were handed scripts to use in answering inspector questions, the report said. It also said the subterfuge covered 31 production processes the company used.
Not only did the company use additives that had not been approved, according to the third-party report, but it also changed a heating process without authorization. As recently as last year, Kaketsuken was investigated for using expired raw materials, leading a department head to alert the managing director to a likely "whistleblower" in the plant. Still, the government discovered unauthorized production methods during an inspection last May.
Kaketsuken not only faces government penalties, but it may also have to revisit an out-of-court settlement it reached along with other blood producers involved in a huge 1980s scandal surrounding HIV/AIDS-tainted blood products. The government found violations at the time and in 1996 Kaketsuken settled with plaintiffs, the papers stating the company knew it had a duty to produce safe products.
Since the same managing director, Seiji Miyamoto, signed that report and formally acknowledged that violations continued up to now, the 1980s HIV-scandal plaintiffs could be moved to seek a new settlement. Miyamoto resigned just before the panel's report was revealed. Board members also either resigned or were demoted.