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HEALTH-JAPAN: Vaccine Fiasco Reveals Serious Policy Flaws

Suvendrini Kakuchi

TOKYO, Feb 24 2003 (IPS) - Hideo Ueno nurses his severely paralysed 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 for little Hana.

Hideo and his wife, along with five other sets of parents, are also hoping that a court ruling – expected on Mar. 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.

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.

They are collectively demanding 350 million yen ( 2.9 million U.S. dollars) in compensation for damages, and 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 immunisation programme 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rendered seriously handicapped, and more than 2,000 reports of adverse reactions to its use, that the vaccine was withdrawn.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 dollars 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 through vaccine production, by pointing out that vaccines are a steady source of income given public immunisation policies.

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

"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 subsidise 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 recognise 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 Labour Ministry revealed that seven million high school girls have not been inoculated against rubella because their parents have stayed away from the programme.

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 immunisation 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 their expiry. In one instance, the vaccines’ expiry date was September 1992.

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

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