Another Failure of Risk Management System: a case of SMON

This broken body of mine still serves for the society,
Today I still move on the street (on the wheelchair),
A poem by the SMON victim (chanting No More SMON)

Another Failure of Risk Management System: a case of SMON
SMON (Subacute-Myelo-Optico-Neuropathy): is caused by the side-effects of an anti-diarrheal drug containing Clioquinol or Chinoform. It was firstly treated as a strange disease of unknown virus because the disease had a number of characteristics common to polio epidemic widespread in Japan. That made the virologists and other medical researchers kept concentrated in finding the virus instead of other root causes. More importantly the causes of the SMON were prolonged due to the fact that the doctors could not anticipate the disease was resulted by their medical prescription or simply the large doses of Clioquinol drug.

The symptom: it first appears abnormal symptoms such as diarrhea and pain. Then it affects the peripheral nerve, posterior and lateral columns of the spinal cord and the optic nerve, causes such neurological manifestations as strange sensation of paresthesia and pain, difficulty in walking, visual disturbances, recto-vesicle dysfunction and the like caused complete blindness and death in serious cases (GPSS, 1978).

Impact: The officially recognized victims were 11,000 though the actual number could reach up to 30,000. Beside the above mentioned symptoms of SMON, the victims not only physically suffered, but economically and psychically hurt because of discrimination, insult (that the victims tried to produce fake claims in order to get compensation), and marriage problem (some were divorced, denied to be married by the family, and forced to live alone).

Main responsible actors and implications: This disease indicates a failure of hazard identification and risk estimation by which three main actors involved: pharmaceutical firms, government regulators and doctors. Since 1933, there were reports abroad about the harmful effect of Clioqunol and risk prohibition measures: 1961?FDA in US listed Clioquinol as indication ?needed medicine; 1965?use of the drug to cats and dogs banned in the UK; and 1968: prophylactic use of the drug prohibited in Sweden.

Yet, the Clioquinol, which came to be used in Japan by 1930s, gained the status of an ?enteric drug? (use for diarrhea) on no firm ground that make it way for regulation-free marketing drug in 1939. By 1955 to 1960?s, the production started to increase sharply though other countries banned the drug use. This revealed a lack of risk management system and global communication on the risk impact. The failure of risk assessment is also due to the lack of feedback mechanism to monitor the adverse effects of drug. At the meantime, there was collusion between Ministry of Health and Welfare with the company (the Chief of Pharmaceutical and Supply Bureau of the Ministry was welcomed to a seat of the board of the Union of Pharmaceutical companies, GPSS, 1978). This clearly shows that corruption mainly contributed to the failure of this risk assessment. In addition, the ?Health Insurance System? which granted people to free health care or partial payment was another factor to the disease outbreak combined with unprofessionalism of some doctors. People enjoyed that medical service and therapy, while the doctors also took it for granted as they could earned extra by the warranted payment whenever they practiced therapy and medical prescription. Consequently, with marketing promotion from the pharmaceutical company, unprofessional doctors kept giving excessive doses of Clioquinol to patients. That proves a business-oriented mind of the company and the doctors on the cost of people?s life.

Patients? Struggle: Similar to Minamanta Disease, victims were burdened to prove the case and struggled to proceed with the court. At the end, all of them, except three patients, agreed to the conciliation agreement that the district courts recommended. It is difficult to justify whether the justice should be put more priority as they were burdened with prolonged legal procedure and continued legal fighting with the company and the government, while some of victims passed away. In spite of this justice compromise, there were two laws were consequently promulgated: The revision of the Medicine Law and the Relief Fund for Adverse Drug Reaction Victims Law (these are aimed to protect the health and safety of people on the drug policy and offers a more rigid criteria for drug approval).

The case of Ms. Yuriko Tanaka: she is currently the chair of Association of SMON Victims in Tokyo. She happened to be the SMON victims in her college life while she was the smart student and the only girl in her school. This disease did not only affect her study life, but her relationships with the family of her to be husband. Her husband?s parents rejected their marriage because she is SMON victims. However, they decided to get married without parents? approval. Though she was lucky to deliver two healthy sons, she suffered much pain and being hospitalized for years (She spent one month in hospital and about one year in bed at home after her first baby delivery and another five months in hospital and two and half years in bed at home for her second baby). It took her much time to regain the strength of her normal physical condition as a SMON patient. Regardless her disease, she has been strongly struggling for her life and for other SMON patients. Her inspiring message to us is that: 1) Please deliver the SMON message throughout the world and help stopping any harmful effect including medical use or environmental harm; 2) Be hopeful:

?Please do not depressed,
Do not work so hard,
Please do not give up,
Forget your pain,
Believe in success in someday”

This SMON should be an influential case to relevant stakeholders including government, policy makers, doctors, as well civil society to be cautious about the safety and effectiveness of medical usage and other supplies which may result in harm. Also, adequate mechanisms can be taken so that stakeholders can reevaluate the hazard and its associated risks. There must be a mechanism for risk communication and monitoring with both government and civil society.

Reference:
Watanabe Shinichi (2009, winter) ?Economic Development and its Risks to Life, Environment and Community: The case of SMON,? Risk Management under Globalization Class, International University of Japan.

GPSS (1978): ?No More Yakugai SMON, Appeal from Japan, Tokyo,? (GPSS: group of plaintiffs of SMON Suit at Tokyo District Court).
SMON Lecture (March 03, 2009) by Ms. Yoriko Tanaka, the Chari of Association of SMON Victims in Tokyo. Ellison, B. and Duesberg, P. (1996): ?The SMON Fiasco,? available at
http://www.virusmyth.com/aids/hiv/besmon.htm