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DRUG INDUCED SUFFERINGS IN JAPAN

−THEIR PAST,PRESENT & FUTURE AND ROLES OF JAPANESE SCIENTISTS AND TECHNOLOGISTS
The Millennium Symposium on Science, Society and Human Rights: Implementation of the UNESCO Declaration on Science and the use of Scientific Knowledge for the 21st Century. /University of Regina, Canada/August 24 - 26, 2000
Drug Safety and Medical Care Research Committee of the JAPAN SCIENTISTS ASSOCIATION

KATAHIRA K(Tokyo Medical & Dental University), ○FUJII M(Yoyogi Hospital)*, MUTA S(Ohta Hospital), KANAOKA C(Aoba Pharmacy), HOMMA R(former staff of the NIID),NIU K(Nippon Chemiphar Co.), KUROSU M(Nihon Medical Collage), MAKINO T(Nihon Fukushi University)

■ A CJD Victim appeals...

"I am a plaintiff of the CJD lawsuit. My elder brother died of CJD.
He died without knowing what his illness was and what hurt him so severely. He was seized with anxiety and fear. He was not able to even ask us for help, because the tainted dura matter had deprived him of all the abilities to act. Whenever I listen to the court I feel that the concerned drug companies and the Government of Japan are making the same excuse, stating that they could not predict the serious risk until the large number of patients with CJD was known. How would the officials of the Ministry of Health and Welfare and the workers of the companies feel if the disease were to inflict any of their loved ones and deprive them of all the abilities to live? Would they still continue to take the "so what?" attitude and use the same excuse? .... I strongly hope to settle the score for my brother. I sincerely hope for the earliest possible solution of this problem and at the same time, expect that this problem be known more and more broadly."

; It has been found however that the Government of Japan took no step to ban the sales of the product until 1997, despite the fact that the Government knew the product's harmful effects in the 1970's and it was banned from use in 1987 in the United States.

■ Definition of YAKUGAI

#Adverse Drug Reaction (ADR):
Effects of drugs in general, which may unavoidably be involved in the use of drugs

#Drug-induced suffering ("YAKUGAI"):
Health damage caused by drugs on a social scale because the information to show their harmful effects is neglected or ignored (or, interrupted, concealed or distorted), in other words, an artificial, or a socially made, suffering which can be avoided from the first if no such an action is taken

■ Characteristics of YAKUGAIs in Japan

1950's: 1) YAKUGAI became a social problem
2) Ethical drugs were responsible for most of YAKUGAIs, except those due to OTC whichtook place in the beginning part of the period
1950's - 1960's 3) Prolonged, large-dose administration of drugs.
1980's - 1990's 4) YAKUGAI diversified to include those due to some agents, including diagnostic medicines, drug additives and "special" drugs, and those due to drug-drug interaction.

■ Brief History of YAKUGAI in Japan

1961 Thalidomide/1970 Qlioquinol (SMON) /1971 Chloroquine /1987 Drug-induced AIDS /1989 Vaccination /1992 inductive drugs of labor /1993 Solivudine /1996 Drug-induced CJD /1997 fenoterol

■ Thalidomide

; The Government of Japan was saying that no scientific evidence could be found for Dr. Lenz's Report and that the Grunentar Company withdrew its product Kontelgan because the media made a great fuss about it.

■ Clioquinol (SMON)

; The total number of the sufferers shows a marked contrast to its worldwide total number of 200. For this, the prolonged, large-dose administration of the drugs has been said to be the main reason.

■ Unheated Blood Products Contaminated with HIV

; The fact that the use of the products might cause AIDS had already been known in 1982 in the United States. In Japan, this fact came to be known by some drug companies, the MHW and some hemophiliac specialists including Dr. T. Abe. But they rejected alternatives, the urgent importation of heated blood products from the United States. Therefore, it was not until 1985 that hemophiliacs became able to use heated blood products.

■ Measures by the Japanese Government against YAKUGAIs

  1. Plaintiff victims of YAKUGAI won the cases by being backed by nationwide supportive movements.
  2. After the said three YAKUGAI cases, the defendant drug companies and the Government compensated the sufferers and promised to prevent the reoccurrence of YAKUGAI.
  3. The Government has made revisions of the relevant law and systems, but they are still unsatisfactory.

■ Possible Risks Involved in Deregulatory Measures

; The measures to deregulate the provisions of drug safety hold dangerous implication and more strengthened control over drug companies is required.

■ JSA's Research Activities and Movements Regarding SMON

May, 1974 The Medicine and Drug-induced Suffering Problems Study Committee was established in JSA, with SMON as its main subject

; The Committee was resolved in 1987 because the SMON problem was considered to have ended by and large. YAKUGAI did not discontinue, however. We are now faced by the drug-induced CJD problem. JSA has planned to deal with one of YAKUGAI problems in the 13th CSSC to be held late in 2000 in Osaka.

■ Necessity of Criticism、Necessity of the organization of scientists

* Louis Pasteur, a bacteriologist:
"Without criticism, nonfarm foundation is provided for everything"
* Kinnosuke Ogura, a mathematician:
"We must have solid critical spirit"; "We must pursue the truth with unyielding spirit"
* Cited from "World Without War" by Dr. J.D.Bernal:
"The best he can hope for to further his work is to take his place in an organization of scientists"(the rest is omitted) --

; The Japan Scientists Association (JSA) is only one group in Japan, which has Japanese scientists in overall scientific fields as its members. Since its initiation in 1965, JSA, with the aim of making research activities and action, has pursued its activities to identify and solve different problems facing human beings.
Originally, the roles of medicine lie in relieving patients from pain, and it cannot be definitely allowed to artificially hurt anyone in the interest of individual person or company. In the face of the 21st Century, it is urgently required for us to build safe and healthy society. For this purpose, every scientist and technologist should take responsibilities and active initiatives as far as possible.

□ Social factors in repeated occurrence of drug-induced complaints in Japan (1)

I. Factors promoting or facilitating occurrence of drug-induced complaints
  1. Drug companies' attitude of pursuing their own interests, and their policies of mass-production and mass-consumption while making light of or ignoring the safety of drugs
  2. Government's attitude of fawning upon (major) drug companies, and the medical and pharmaceutical administration making light of the safety of drugs
  3. Easygoing attitude toward drug therapy among general medical workers, especially among doctors
  4. Tendency to fawn upon the drug companies in the medical and pharmacological fields

□ Social factors in repeated occurrence of drug-induced complaints in Japan (2)

II. Reasons why repeated occurrence of drug-induced disorders was not prevented
  1. Failure to establish a scientific approach in the medical and pharmacological fields
  2. Tardy response of medical workers, especially doctors, toward drug-induced disorders
  3. Failure of health education of the general public
  4. Lack of awareness by people of public health and human rights

*1 E-MAIL motohiro@econ-net.or.jp

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