On several mornings last week, a line some 800 people would through the corridors of Japan Medical College Hospital awaiting the dispensation of the "Maruyamaa vaccine," Japan's most controversial drug.
It has been that way for several years at the clinic operated by the vaccine's discovered, Dr. Chisato Maruyaa, but the lineup last week was something special: A week earlier, a governement drug-screening panel had ruled there is no evidence that the vaccine effectively combats cancer.
Still the people, relatives of terminally-ill cancer patients, are lining up -- and Maruyama takes their presence as a vote of confidence.
"In other cases where drugs were declared ineffective, the people stopped coming," the 79-year-ld physician recalled. "In this case, they keep coming. Because of their strong support, I will go on."
Maruyama's battle with the government's medical authorities is a major public issue throughout Japan this summer. Thousands of patients defend use of the vaccine. Politicians demand that it be certified as useful.
Maruyama has no doubts. He shows visitors X-rays of his successes. Here, he says, is a tumor on the lung of an 80-year-old man. There is an X-ray taken after four months' use of the vaccine. The tumor is gone.
He said he has documented hundreds of cases of patients who, certified as terminally ill, enjoyed years of prolonged life after relying on the vaccine. Last September, he said, the cases of 25,047 patients were recorded. Of that total, 2,437 lived for more than three years and another 473 survived for five years.
"It can prolong life, and there are no side-effects," the doctor claimed, "and the patient can live with less pain."
But last week, after five years of considering the Maruyama vaccine, the Ministry of Health and Welfare's Central Pharmaceutical Affairs Council ruled that the drug's manufacturer had presented no evidence to show it was effective against cancer.
"We did not say it was effective," a ministry official, Kiyoshi Toda, observed. "We just said that no evidence was presented showing that it was effective."
Toda explains the conflicint opinion by pointing out that the drug's manufacturer did not present any data on patients who received the vaccine through Maruyama's own clinic -- the patients on whom he bases his claims. The data came from patients at other hospitals that also dispense the vaccine he developed.
The ministry's committee examined 441 cases in which Maruyama's drug was used alone against cancers. "We checked each case of the 441 separately and found it was not effective," Toda said. "Some patients started to feel better and had better appetites, but there were no cases in which the tumor actually grew smaller."
Maruyama said that no cases in his own clinic were presented to the council, to avoid suspicion it had submitted tainted evidence designed to prive his point. Cases at other hospitals were used instead.
Maruyama developed the vaccine in the 1940s as an agent to fight tuberculosis and leprosy, and in 1965 began dispensing it to cancer patients whom doctors described as incurable. More than 140,000 cancer patients have been treated so far and relatives of 100 new patients come to his clinic every day it is open. They pay 5,000 yen (about $23), in the form of donations to the clinic, for a 40-day supply of the vaccine.
The drug's manufacturer has supplied vaccine to Muaruyama's clinic in hopes it someday will be certified as a usable medicine. If the drug council's opinion is upheld by two reviews later this summer, the vaccine cannot be marketed commercially in Japan and the manufacturer may cease making it.
With thousands of patients worried that the vaccine may disappear, the council's opinion has become a significant political issue. A committee of Diet (parliament) members has urged that it be licensed for commericial sales, pointing to the number of patients who claimed relief after taking it.
Maruyama said in an interview that he believes his vaccine is being discriminated against by the ministry's drug-screening council. Two other anticancer drugs were certified usable after one- and two-year testing periods, while his own application was not ruled on for five years. In the middle of that period, he said, the council decided to ask for evidence that the vaccine prolonged lives of patients. That added more time to the testing period.
Maruyama also pointed out that the chairman and one member of the screening council are physicians who developed another popular anticancer drug already on the market.
He said that if his drug is approved for commercial sale, it would be highly profitable, and the other two companies would be in for "a shock."
His point is being taken up by a citizens' committee composed of cancer patients and their families. The committee intends to ask the minister of health and welfare to punish and dismiss fromthe council the chairman and member who were involved with developing an anticancer drug already on the market with which Maruyama's vaccine would be competitive.