(JA)Pharmaceutical company lied about drug's safety

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Sunday, March 18, 2001

 

Company lied about drug's safety

 

Report comes on heels of user deaths

Mainichi Shimbun

 

The family of a man who died from the side effects of a drug are demanding

to know why the pharmaceutical company that produced it " lied " about its

safety.

 

Drug company Nippon Roche submitted a report to the former Ministry of

Health and Welfare in April 1999 saying its drug Inhibace, also known as

Cilazapril, had a positive effect on the man's symptoms.

 

The report came only days after a man died.

 

The 61-year-old unnamed man was in July 1998 diagnosed by a private doctor

as having high blood pressure. While attending hospital, he received a

number of depressors to improve his condition. But after he began using

Inhibace in January 1999, he suffered various symptoms such as diarrhea and

fever attacks, and his skin began peeling.

 

In March that year, the private doctor judged that his condition was caused

by the medicine, and he was admitted to the National Hospital Tokyo Disaster

Medical Center in Tachikawa, Tokyo. He stopped using Inhibace, but his

symptoms did not improve. He died on April 15, with his death attributed to

a lack of sodium in his blood caused by his skin condition.

 

The deceased man's family filed for a relief benefit from an

extra-departmental body of the Ministry of Health and Welfare, now the

Ministry of Health, Labor and Welfare, in July 1999. After deeming that

" side effects of Inhibace " were responsible for the man's death, the body

sent his family a compensation payment of 7.57 million yen.

 

In April that year, however, Nippon Roche had sent a report on the patient

to the ministry stating that, " although such side effects as swelling of

blood vessels and dermatitis can be seen, symptoms in the patient are

getting better. " The company was required to resubmit the report in June

that year after it was deemed insufficient because clinical tests had not

been performed on patients after they had received the medicine, but the

second report was the same.

 

" According to the report, my husband kept on living for two years, " said the

man's 61-year-old wife. " I can't forgive [the company]. I want them to

explain to me why they produced the deceitful report. "

 

The extra-departmental body informed Nippon Roche when it investigated the

man's cause of death and made the payment to his family, but after that, no

reports of his death were sent to the ministry.

 

The ministry requested that Nippon Roche submit a revised report on the

medicine on Feb. 21 this year after it confirmed to Mainichi reporters early

in February that the man had died.

 

Under the Pharmaceutical Affairs Law, pharmaceutical companies are required

to inform the Minister of Labor, Health and Welfare of deaths caused from

the side effects of medicines within 15 days of the patient's death. The law

also requires medical institutions to cooperate in the provision of

information on drug side effects.