Japan MMR legal case

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Susan

HEALTH-JAPAN: VACCINE MANUFACTURER SUED OVER DEATHS
Global Information Network; New York; Feb 25, 2003;
Suvendrini Kakuchi;

Abstract:

In December 1993, the parents filed a suit against the
Research Foundation for Microbial Disease for Osaka
University, a manufacturer of the measles, mumps and
rubella (MMR) vaccine. Among the plaintiffs are
parents of a child who lapsed into a coma two days
after the vaccine and never recovered.

A ministry official acknowledged that the MMR case is
a "horrifying accident", but added that without
vaccines, the risks posed to children could have been
much greater. Six diseases, including polio and
diphtheria, are covered under a mandatory immunization
policy for schoolchildren.

Furthermore, the MMR case has brought to light a
disturbing lack of transparency on the part of the
authorities - vaccines were reportedly given to tens
of thousands of children even after the drugs' expiry.
In one instance, the vaccines' expiry date was
September 1992.

Full Text:
(Copyright 2003 by Inter Press Service/Global
Information Network)

TOKYO, Feb. 25 (IPS) -- Hideo Ueno nurses his severely
paralyzed youngest daughter around the clock. The
13-year-old Hana was a playful and healthy child until
she

contracted encephalitis after being vaccinated in 1991
for measles, mumps and rubella.

"We never will forgive ourselves for giving her the
vaccination," said her heartbroken father.

In the years of suffering since, the Ueno couple have
written about the horror of seeing the disease
progress rapidly in their daughter and their vigils at
special hospitals in the hope for a cure.

Hideo and his wife, along with five other pairs of
parents, are also hoping that a court ruling --
expected on March 13 - will give a measure of
compensation and justice from which to rebuild their
lives. "We desperately hope the March hearing will
ease our guilt a little," added Ueno.

They are collectively demanding $2.9 million in
damages and asking that the manufacturer of the
vaccine take responsibility for the fate of their
children.

It is a landmark case for Japan -- the first time a
vaccine manufacturer has been sued.

Masako Koga, who is monitoring the issue at the Japan
Consumers Union, said: "Manufacturers usually are let
off the hook because vaccines come under a public
immunization program that puts the responsibility on
the government. The lawsuit challenges this policy for
the first time."

The Japanese experience with the mandatory MMR vaccine
was anything but ordinary.

Released in 1989 for mandatory use, MMR was promoted
as a breakthrough. Yet a bare three months after its
use was made mandatory, doctors were already warning
parents about side effects.

It was only five years later, following the deaths of
three children with others rendered seriously
handicapped, and more than 2,000 reports of adverse
reactions to its use, that the vaccine was withdrawn.

In 1993, the government had paid compensation of
$160,000 to each of the families whose children died.
But the enormous public outcry against the vaccination
could no longer be ignored, and its use was stopped.

It was an issue that rocked Japan and continues to be
cited elsewhere - in Britain this month, thousands of
parents have refused to let their children be take an
MMR injection because of similar fears.

"The MMR issue illustrates the blatant disregard for
public safety on the part of the government," says
Tameki Moori, a physician and critic of government
health policy.

He accuses the government of promoting the interests
of pharmaceutical companies and claims that vaccines
are a steady source of income given public
immunization policies.

However, Masaki Shigeo, a researcher at the Japan
Pharmaceutical Manufacturers Association, firmly
rejects accusations that vaccines are a big money
maker.

"Vaccines production comprises only 11 percent of the
income of the manufacturer of biological products," he
explained, "and that is only 3.9 percent of all
pharmaceutical products".

Their monetary importance to Japan's pharmaceutical
industry may be contested, but vaccines continue to be
regarded as deadly.

Reports this month say that through the winter, seven
people have died and 162 suffered from side effects
like shock, headaches and vomiting after being given a
flu vaccine.

It is a grim toll that has boosted Moori's campaign,
for he sees the vaccine as "unnecessary and dangerous"
and wants its use stopped.

"For 40 years," he said, "Japan was the only country
in the world that made the flu vaccine mandatory for
schoolchildren, till evidence of damage was so clear
that the government had to finally change its status
to voluntary in 1995."

That step did not seem to have prevented the Diet, or
parliament, from passing a bill in October 2001 that
will subsidize senior citizens - those over 65 - to be
covered by the vaccine to prevent complications from
influenza.

Under the law, the government will "advise" the
elderly to undergo the shot, a change from its earlier
"voluntary" basis.

Mindful of public concern, the bill includes the
provision that the state will bear medical costs and
disability pensions in cases where patients suffer
health problems arising from adverse reactions to the
vaccine.

Health activists are not convinced - they say victims
face huge difficulties in getting the state to
recognize the side effects from vaccine use.

Atsushi Kurihara, who describes himself as a supporter
of the plaintiffs in the MMR case, calls the situation
"hopeless". He said: "There are no clear guidelines
from the state that help victims seek compensation for
malpractice."

Such a breakdown in communication has only led to
widespread fear, which was fuelled by the MMR case. In
January, a report by the Health, Welfare and Labor
Ministry revealed that 7 million high school girls
have not been inoculated against rubella because their
parents have stayed away from the program.

"All we are asking for is safe vaccines," said Koga,
"not to stop production or hurt the business of pharmaceuticals."