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, internalbleeding and various signs of nerve degeneration.

   By 1959 the disease had increased in incidence to epidemic proportionsand over the next five years there occurred seven major regional outbreaks in a numberof populated districts. Many outbreaks were centered around hospitals--places notoriousfor spreading disease--with the annual peak occurring in late summer, hinting atan infection spread by insects. The illness appeared to be contagious, but at thesame time there were indications to the contrary--patients did not display the symptomstypically associated with infections, such as certain blood abnormalities, feversor rashes. Despite these anomalies, all investigations focused on identifying thevirus responsible.

   By 1964 the epidemic had worsened and new symptoms, includingblindness, were occurring. Some patients died. At the 61st general meeting of theJapanese Society of Internal Medicine in May of 1964, the disease was given a formalname: "Sub-acute Myelo-Optic Neuropathy"--SMON.

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

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

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

   In 1969, the Japanese Ministry of Health and Welfare re-formedthe SMON Research Commission, with ten times the funding provided previously, tostep 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 wasextended to include bacteria as possible suspects. The intensified effort achievednothing.

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

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

   Though most of the research still focused on finding "the"virus, other scientists had been looking elsewhere. One, a pharmacologist, Dr HirobenBeppu, 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. Uponinvestigation, these different drugs turned out not to be different at all; theywere all made of a substance called Clioquinol but marketed under different brandnames and freely available.

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

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

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

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

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

   That no epidemic of SMON had occurred elsewhere is explainedby several circumstances peculiar to Japan. In Japanese culture the seat of humanemotions is regarded to be the stomach, rather than the heart, the Japanese peopleare very germ conscious; and lastly (but not least), overmedication is more commonin Japan than elsewhere because doctors receive payment from the government healthinsurance for every drug they prescribe. Many SMON "victims" had historiesof taking multiple medications, often together.

   While it is easy to be wise after the event and criticize theJapanese 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 performanceof the establishment everywhere. The reason the highly qualified Japanese professorshad not been able to discern what now appears obvious, was explained--at least inpart--by Professor Kono who observed that many medical doctors simply refused torecognize that iatrogenic disease could occur. But a more fundamental reason, accordingto 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 withgerms 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."