Public needs more data on vaccine side effects

Public needs more data on vaccine side effects

http://mdn.mainichi.co.jp/news/archive/200303/17/20030317p2a00m0oa020000c.html

The Osaka District Court found Osaka University's Research Institute for Microbial Diseases and the central government guilty of negligence last Thursday, and ordered both parties to pay compensation to the families of a child who died, and a child who suffered serious side effects from measles-mumps-rubella (MMR) vaccinations.

The culpability of the Research Institute for Microbial Diseases, which manufactured the mumps vaccine used in the MMR injections, is indisputable, because it produced the vaccine using a process different from the one for which it had received government approval.

The court ruled that it is possible to establish a causal relationship between the side effects suffered by those who had been immunized with the MMR vaccinations, and changes made in the manufacturing process.

The defective MMR vaccinations had been used over a four-year period, causing serious side effects, and 1,065 people were provided with relief under the preventive vaccination law. The court ruled that there was a lack of commitment to the approved manufacturing process at both the research institute and manufacturing plant. The research institute must instill a safety-first attitude and take every step to ensure that side effects are eliminated.

And we hope that this verdict will prompt other pharmaceutical makers to recheck their safety procedures. The central government's oversight of the Osaka research institute was also called into question.

The central government plays the lead role in implementing vaccination programs to protect society as a whole, so its supervisory responsibilities with regard to vaccinations are even greater than in the case of ordinary pharmaceuticals. The court ruled that the government was not obligated to halt the manufacturing of the vaccines.

But at the very moment that it learned that the vaccines had a high side effects rate, the government preferably should have imposed a temporary ban. When a pharmaceutical product causes side effects which could prove lethal to large numbers of people, it is only proper to stop administering or prescribing the product, and to take a second look at safety issues.

In this case, delays in reaching a decision to ban the vaccine magnified the number of victims. In the 1970s, victims of defective vaccines and their family members filed a spate of lawsuits, and these trials dragged on into the 1990s. The courts frequently ordered the government to compensate victims because it had not taken adequate measures to protect the public.

But it took the Osaka District Court nearly 10 years to issue its verdict in this MMR case. The courts need to make an effort to speed up trials. After the revision of the preventive vaccination law in 1994, vaccines were administered on a voluntary instead of mandatory basis.

The Ministry of Health, Labor, and Welfare, and the various prefectural governments need to disseminate more information on side effects and provide counseling so that people will be able to make an informed decision on vaccinations. Immunization programs will not be effective unless sufficient information is provided to the public.

The same lessons apply to the administration of pharmaceuticals. The lack of publicity about the side effects associated with Iressa, a lung cancer drug, for example, has caused suffering in large numbers of patients.

The central government and drug manufacturers need to provide the public with more information in order to reduce the extent of damages caused by defective vaccines and pharmaceuticals. (From the Mainichi Shimbun, Mar. 16)

http://mdn.mainichi.co.jp/news/archive/200303/17/20030317p2a00m0oa020000c.html