SMON - How Ciba-Geigy scared the daylights out of Japan

SMON

How Ciba-Geigy scared the daylights out of Japan

   In 1955 a mysterious disease, in some respects resembling polio, made its appearance in Japan. The symptoms were a combination of diarrhea, internal bleeding and various signs of nerve degeneration.

   By 1959 the disease had increased in incidence to epidemic proportions and over the next five years there occurred seven major regional outbreaks in a number of populated districts. Many outbreaks were centered around hospitals--places notorious for spreading disease--with the annual peak occurring in late summer, hinting at an infection spread by insects. The illness appeared to be contagious, but at the same time there were indications to the contrary--patients did not display the symptoms typically associated with infections, such as certain blood abnormalities, fevers or rashes. Despite these anomalies, all investigations focused on identifying the virus responsible.

   By 1964 the epidemic had worsened and new symptoms, including blindness, were occurring. Some patients died. At the 61st general meeting of the Japanese Society of Internal Medicine in May of 1964, the disease was given a formal name: 'Sub-acute Myelo-Optic Neuropathy'--SMON.

   In 1964, the Olympic Games were to be held in Japan and the Japanese Government, now very concerned, launched a formal commission under the leadership of a medical doctor, Professor Magojiro Maekawa of Kyoto University, to investigate the epidemic. The commission was formally addressed to the task of identifying the virus responsible for SMON.

   As the search for the virus continued fruitlessly, it was drawn to the commission's attention that all the SMON patients had been medically treated for diarrhea, about half taking the drug Enterovioform, and the other half taking a drug called Ernaform. Suspicion naturally arose that these drugs could be contributing to the SMON problem, but it was argued that two different drugs could not cause the same disease. And besides, the conviction that SMON was caused by a virus was too firmly entrenched.

   The epidemic continued to progress and in 1967 an alarming new outbreak flared up in Okayama Province. Dozens of elderly women, and some men, were hospitalized, and the numbers were increasing.

   In 1969, the Japanese Ministry of Health and Welfare re-formed the SMON Research Commission, with ten times the funding provided previously, to step up the efforts to discover the feared virus threatening the entire country. Ignoring the evidence that perhaps SMON was not infectious at all, the search was extended to include bacteria as possible suspects. The intensified effort achieved nothing.

   Eventually, the head virologist of the commission, Professor Reisaku Kono, while still holding on to the virus theory, nevertheless decided all possibilities should be investigated, and appointed epidemiologist Dr Itsuzo Shigomatsu to conduct a nationwide survey of all possible risk factors.

   By 1971, with the virus hunt at a dead end, the number of people hospitalized in the Okayama Province accounted for about three per cent of the province's population.

   Though most of the research still focused on finding 'the' virus, other scientists had been looking elsewhere. One, a pharmacologist, Dr Hiroben Beppu, had in 1969 independently noted the evidence previously rejected by the commission, that SMON victims had received treatment for diarrhea with a number of drugs. Upon investigation, these different drugs turned out not to be different at all; they were all made of a substance called Clioquinol but marketed under different brand names and freely available.

   Clioquinol, a Ciba-Geigy product, was considered to be perfectly safe, its effects confined to the digestive tract where it was supposed to destroy germs associated with diarrhea without being absorbed into the bloodstream. However, Dr Beppu demonstrated this belief to be untrue. When he fed the chemical to experimental mice they all died. He had hoped the mice would display the nerve damage associated with SMON, but when they did not do so he discontinued the experiment, not realizing the significance of their deaths.

   The commission's survey revealed also that a number of SMON patients had displayed a strange green coating on their tongues, and other patients had passed greenish coloured urine. Chemical tests revealed the colouring agent to be an altered form of Clioquinol.

   This evidence was enough for Professor Tadao Tsubaki, a neurologist at Niigata University, to state outright his belief that SMON was caused by Clioquinol and not by a virus. This viewpoint, which one would think would have been clear to everybody by now, was not readily accepted, particularly by doctors who habitually and routinely prescribed the drug.

   But the evidence was irreftitable. The SMON epidemic had clearly commenced within a short time after the government's approval for pharmaceutical companies to manufacture Clioquinol in Japan, and it lasted until just after the government finally banned the drug in September 1970. Whereas 2,000 cases were reported in 1969, in 1971 the number of cases had fallen to only thirty-six, in 1972 to three and in 1973 to one.

   Later investigation showed that Clioquinol caused symptoms of SMON in animals too, and that wherever in the world the drug had been used, individual cases of the condition in humans had earlier been reported as associated with the drug. Furthermore, Ciba-Geigy, the international producer of Clioquinol, had knowledge of these incidents but nevertheless continued selling the drug worldwide, a fact that later became the basis of major law suits against them. (The US Food and Drug Administration restricted the sale of Clioquinol ten years before it was banned in Japan.)

   That no epidemic of SMON had occurred elsewhere is explained by several circumstances peculiar to Japan. In Japanese culture the seat of human emotions is regarded to be the stomach, rather than the heart, the Japanese people are very germ conscious; and lastly (but not least), overmedication is more common in Japan than elsewhere because doctors receive payment from the government health insurance for every drug they prescribe. Many SMON 'victims' had histories of taking multiple medications, often together.

   While it is easy to be wise after the event and criticize the Japanese medical establishment for its lamentable inertia in resolving the SMON problem, it can be seen that their performance was no worse than the past and ongoing performance of the establishment everywhere. The reason the highly qualified Japanese professors had not been able to discern what now appears obvious, was explained--at least in part--by Professor Kono who observed that many medical doctors simply refused to recognize that iatrogenic disease could occur. But a more fundamental reason, according to Professor Kono, was the beliefs indoctrinated into virologists generally. He added: 'We were still within the grasp of the ghosts of Pasteur and Koch!'

   Such is the futility--and danger--of the medical obsession with germs and viruses, and the chemical drugs with which doctors hope to destroy them.

   In the words of Professor Duesberg of the University of California, considered to be the most knowledgable virologist in the world:

   'SMON and AIDS are intimately connected; they are only two episodes in a long series of disasters, all emanating from a single, ongoing, selfpropagating scientific program-virus hunting. This research effort, growing relentlessly, has for three decades been misleading science and the public about medical conditions ranging from cervical cancer to Chronic Fatigue Syndrome, from Alzheimer's Disease to Hepatitis C, and many more. All these smaller programs are failing in their public health goals as they prescribe the wrong treatments and preventive measures, while generating unnecessary fear among the lay public.'