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Drugmaker Kaketsuken raided over decades of alleged faked records, illegal additives

Kyodo

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When they could not produce the needed historical documents, they artificially aged the faked papers by exposing them to ultraviolet radiation.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.

  • GBR48

    Bowing, apologies, demotions and resignations are not enough. This criminal fraud may have endangered the health of many innocent people and anyone found guilty of such behaviour should serve time in prison.

  • disqus_vBekJrf7g5

    The hits to ‘Japanese quality’ keep coming! It’s like living in China! In fact, China is better coz bowing and ‘It’s very regrettable’ wouldn’t be enough- these people would get the death penalty!

  • Paul Johnny Lynn

    One more to add to the list of companies with flagrant disregard for rules, standards and the health and safety of their customers and employees. If companies like this are not going to be sufficiently punished by responsible authorities, they should be “outed” on the internet and social media. If customers take their business to companies they can trust, perhaps companies might see the economic viability of NOT lying and cheating!

  • Judith

    Welcome to the world of drug company corruption. We are being forced to receive vaccines from these criminal organisations in many Western Countries. No wonder there is a growing movement questioning the safety of vaccines:

    ” Merck has known for a decade that its mumps
    vaccine is “far less effective” than it tells the government, and it
    falsified test results and sold millions of doses of “questionable
    efficacy,” flooding and monopolizing the market, a primary caregiver
    claims in a federal antitrust class action. Alabama-based Chatom Primary Care sued Merck on Monday, the week after the unsealing of a False Claims Act complaint two relators filed in 2010.
    Those relators, Stephen Krahling and Joan Wlochowski, were Merck virologists
    who claim in their unsealed complaint that they “witnessed firsthand the
    improper testing and data falsification in which Merck engaged to
    artificially inflate the vaccine’s efficacy findings.” http://www.courthousenews.com/

    Pfizer was fined $2.3 billion, then the largest health care fraud settlement and the largest criminal fine ever imposed in the United States. Pfizer pled guilty to misbranding the painkiller Bextra with “the intent to defraud or mislead”,The government alleged that Pfizer also promoted three other drugs illegally: the antipsychotic Geodon, an antibiotic Zyvox, and the antiepileptic drug Lyrica.

    Merck agreed to pay a fine of $950 million related to the illegal promotion of the painkiller Vioxx, which was withdrawn from the market in 2004 after studies found the drug increased the risk of heart attacks. Over 60,000 people are believed to have died from Vioxx. No Director went to jail.

    2012 GlaxoSmithKline agreed to pay a fine of $3 billion to resolve civil and criminal liabilities regarding its promotion of drugs, as well as its failure to report safety data. GlaxoSmithKline also pled guilty to failing to disclose safety information about the diabetes drug Avandia to the FDA.

    2013 Johnson & Johnson agreed to pay a $2.2 billion fine to resolve criminal and civil allegations relating to the prescription drugs Risperdal, Invega and Natrecor. T

    2009 Eli Lilly was fined $1.42 billion to resolve a government investigation into the off-label promotion of the antipsychotic Zyprexa. The government also alleged that Lilly targeted primary care physicians to promote Zyprexa for unapproved uses and “trained its sales force to disregard the law.”

    2010 AstraZeneca was fined $520 million to resolve allegations that it illegally promoted the antipsychotic drug Seroquel.

    2012 Abbott was fined $1.5 billion in connection to the illegal promotion of the antipsychotic drug Depakote.

  • Judith

    Welcome to the world of drug company corruption. We are being forced to receive vaccines from these criminal organisations in many Western Countries. No wonder there is a growing movement questioning the safety of vaccines:

    ” Merck has known for a decade that its mumps
    vaccine is “far less effective” than it tells the government, and it
    falsified test results and sold millions of doses of “questionable
    efficacy,” flooding and monopolizing the market, a primary caregiver
    claims in a federal antitrust class action. Alabama-based Chatom Primary Care sued Merck on Monday, the week after the unsealing of a False Claims Act complaint two relators filed in 2010.
    Those relators, Stephen Krahling and Joan Wlochowski, were Merck virologists who claim in their unsealed complaint that they “witnessed firsthand the improper testing and data falsification in which Merck engaged to artificially inflate the vaccine’s efficacy findings.”

    Pfizer was fined $2.3 billion, then the largest health care fraud settlement and the largest criminal fine ever imposed in the United States. Pfizer pled guilty to misbranding the painkiller Bextra with “the intent to defraud or mislead”,The government alleged that Pfizer also promoted three other drugs illegally: the antipsychotic Geodon, an antibiotic Zyvox, and the antiepileptic drug Lyrica.

    Merck agreed to pay a fine of $950 million related to the illegal promotion of the painkiller Vioxx, which was withdrawn from the market in 2004 after studies found the drug increased the risk of heart attacks. Over 60,000 people are believed to have died from Vioxx. No Director went to jail.

    2012 GlaxoSmithKline agreed to pay a fine of $3 billion to resolve civil and criminal liabilities regarding its promotion of drugs, as well as its failure to report safety data. GlaxoSmithKline also pled guilty to failing to disclose safety information about the diabetes drug Avandia to the FDA.

    2013 Johnson & Johnson agreed to pay a $2.2 billion fine to resolve criminal and civil allegations relating to the prescription drugs Risperdal, Invega and Natrecor. T

    2009 Eli Lilly was fined $1.42 billion to resolve a government investigation into the off-label promotion of the antipsychotic Zyprexa. The government also alleged that Lilly targeted primary care physicians to promote Zyprexa for unapproved uses and “trained its sales force to disregard the law.”

    2010 AstraZeneca was fined $520 million to resolve allegations that it illegally promoted the antipsychotic drug Seroquel.

    2012 Abbott was fined $1.5 billion in connection to the illegal promotion of the antipsychotic drug Depakote.