No.7
The Generation of the Maruyama Vaccine (Specific Substance of Mycobacterium=SSM) and its Application to Medical Treatment
Toru Kameya, MD
Shizuoka Cancer Center Hospital and Research Institute, Shizuoka, Japan.
This SSM was generated in 1944, the year before the Pacific War came to an end.
The dermatologist Dr. Chisato Maruyama first made enquiries into the effect of SSM in response to illness directly after the war in 1947. In this year, Dr. Maruyama reported there was an extremely great effect of the SSM on tuberculosis occurring in the skin. His medical report says that from within 18 cases of skin tuberculosis, 11 cases were almost completely cured (Nihon Ijishinpou No. 1228: 440-441, 1947). Afterwards, during the next 20 years, the extremely great effect on skin tuberculosis came to be understood with repeated tests. Reports saying there had been a complete recovery due to administration of SSM increasingly came to be published and there was a flood of requests from dermatologists throughout Japan wishing to use SSM.
Specifically, although there are various types of skin tuberculosis as shown in TABLE 1, by 1964, 308 skin tuberculosis patients from within 495 were almost completely cured and 38 were substantially improved, meaning SSM was extremely effective.
Up until then most medicines had been ineffective, meaning that SSM was the only effective remedy. Doctors of dermatology were very impressed and went to procure the vaccine.
However for better or for worse, it was just at this time that specific drugs for tuberculosis were discovered.
The first was Streptomycin. As this drug was discovered, doctors of dermatology increasingly parted from the Maruyama vaccine and came to use Streptomycin and other newly discovered anti-tuberculosis drugs.
Up until 1964, Dr. Maruyama struggled to remove the side-effects of the SSM that extracted the polysaccharide compound of tuberculosis bacilli. As many as 170 derivatives of the vaccine were produced and put through repeated trial and error after which the doctor confirmed that Maruyama vaccine C had almost no side-effects and no deterioration in effectiveness. The chemical composition of the vaccine currently employed is almost completely identical with the vaccine generated with the name C.
Hansen's disease is, as you know, the sickness of the skin formerly called leprosy(Rai in Japanese), and patients afflicted with it were sectioned in leprosy sanatoriums. The doctor focused his attention on the fact that Mycobacterium leprae, the cause of leprosy, has common characteristics with the tuberculosis bacilli, and from this period he used SSM in the medical treatment of Hansen's disease. He reported that there was a complete response to leprosy complications including the nerve paralysis of the skin, for which other medicines had been generally ineffective (TABLE 2). From this it was seen in the data that the vaccine was effective for 100 leprosy patients including 43 patients who had their sweat function restored due to the vaccine although a characteristic of leprosy is the loss of the sweat function and 27 patients who started to have sensation restored.
From this period, Dr. Maruyama studied the suppression of skin tumour size increase by SSM separately from skin tuberculosis and Hansen’s Disease. At the same time, Dr.
Maruyama had the impression that since leprosy had started to be treated with the new medicine, cancer had increased in patients at leprosy sanatoriums even though cancer had been scarce in the patients of tuberculosis and leprosy sanatoriums before. Accordingly he arrived at the conjecture that SSM might not just be effective against tuberculosis and leprosy but also against general cancer. He thereupon made a bold start on administering SSM to terminal cancer patients.
The first he started work on was skin cancer. Having acquired the feeling that it might somehow be considerably effective, he first used SSM on ordinary cancer in 1968. The first example of usage was on a 74-year-old woman in whom cancerous implants on abdominal cavity were already developing through gastric cancer, which is to say an advanced cancer patient. In such patients, objects cannot pass from the mouth. Upon making a surgical incision into the abdomen, there was a tumour the size of a fist in the stomach that was in a state such that it could not be removed, and so the operation was finished by an ileostomy using a tube from the jejunum towards the skin. The cancer could not be removed at all. From the 46th day after the operation the vaccine was injected once per day. 110 days after commencement of the injections, the patient could eat ordinary food. The tumour could not be felt. On the 175th day after commencement of injections, the ileal tube was no longer necessary and was removed, meaning that the patient had returned to health. This is the first case where the vaccine worked spectacularly.
Dr. Maruyama went on to use the vaccine on various cancer patients. As shown in TABLE 3, the vaccine was used on 158 cancer patients up until 1968. From within these it can be seen from TABLE 3 that the vaccine was considerably effective in 30 cases and was recognised to be effective in 68 cases, meaning that it was effective against the cancer of 98 patients from within a total of 158.
I would like to introduce cases that medically and objectively prove that Maruyama vaccine (SSM) is effective against the following varieties of cancer.
1) Stomach Cancer
In Japan, stomach cancer has an extremely high rate of occurrence. Moreover, once it advances to a certain degree it is almost impossible to be cured completely. Even if the most up-to-date medical treatment is applied, it does not heal easily. Although amongst early-stage cancer patients and the patients for whom operations are possible there are people who are donsiderably improved, complete cure is difficult for patients who progress past such a stage.
What becomes of the patients in the case the currently most advanced chemotherapy is performed on advanced stomach cancer? One year after the therapy, less than half are surviving. After the passage of two years, less than 20% are surviving. Moreover, the current situation of advanced stomach cancer is such that only a few percent of patients are still surviving after four years.
Accordingly, although longer survival is possible to a certain extent using the latest anti-cancer agents, there are almost no people who are completely cured. That is to say, even if they give a life prolonging effect, anti-cancer agents cannot completely heal cancer.
First I would like you to look at a case where the Maruyama vaccine was used (Figure 1). In spite of advanced stomach cancer, this patient survived more than four years and eight months. A stomach resection was performed immediately after the discovery of stomach cancer in August 1974 and anti-cancer agents were applied at two-month intervals but this was eventually stopped. However in September 1976 multiple metastases were discovered in the liver. Upon using the Maruyama vaccine constantly from three months after (December 1976), the metastases of the liver completely disappeared in March 1977.
This is a case where the effectiveness of the Maruyama vaccine on the advanced stomach cancer of one patient was objectively confirmed. Allow me to introduce a thesis that researched to what degree the Maruyama vaccine was effective in advanced stomach cancer using many patients.
At around 1980, pharmaceuticals called 5Fu and mitomycin(MMC) were used in chemotherapy for advanced stomach cancer that could not be operated on. We can see the difference in the case of just chemotherapy (66 patients, right graph) and that where the Maruyama vaccine is concomitantly used (32 patients, left graph) in Figure 2. For example, on the horizontal axis of the left graph, 50% of patients are surviving at 5.5 months. However in the case of chemotherapy alone, 50% of patients have already died at the period of three months. In contrast 28.1% of patients are still surviving after 12 months in the case the Maruyama vaccine is concomitantly used. However in the case where only chemotherapy is used, only 1.5% of patients are alive at 12 months of the graph, with almost all dying before one year have passed. This is data collected by Dr. Hattori and which clarifies that the Maruyama vaccine has a life prolonging effect greater than that of chemotherapy alone. This was the report in 1980.
reported by the media, causing great repercussions on cancer patients and the rest of society. As a result the Ministry of Health and Welfare and cancer researchers subordinate to the Ministry came to the conclusion that the vaccine had no effect. Consequently, the Maruyama vaccine arrived at the deeply regretful situation whereby it was not acknowledged as a therapeutic medication for cancer, in contrast to the anti-cancer cytotoxic chemotherapeutic agents that are popularly applied even today.
However even in this condition, cancer patients who had used the Maruyama vaccine exceeded 380,000 people in 2009.
I would now like to introduce data for stomach cancer acquired at Maruyama vaccine establishments up until 1984 (Figure 3).
7280 people from amongst late stage cancer patients acquired the Maruyama vaccine at vaccine facilities in 1984 (Figure 3). Accordingly, looking at the results of application, there are many horizontal bars here. The vertical axis is the number of years the Maruyama vaccine was used, by which one may think of as the number of years since the patient started to use the Maruyama vaccine. Persons who only used the vaccine for less than one year number 5206. Persons who used it for more than one year but less than two number 1140. We pass through the numbers 396, 168, 100, and even after five years, 85 people from within 7280 were coming to receive the Maruyama vaccine, which means they have survived for five years or longer.
As for why we can interpret it this way, the Maruyama vaccine is prescribed in 40 day dosages and so persons coming to receive it are prescribed every 40 days. Accordingly, if a patient lives longer than 40 days it means they come to receive the vaccine again one time or more. It can be understood that this person is still healthy, or at least still alive. For this reason, it means that it was proven that 85 people from within 7280 late stage stomach cancer patients live for five years or longer.
I feel it might be beneficial if we compare this with the survival rate of patients undergoing the aforementioned latest chemotherapy treatment.
2) Lung Cancer
I will now talk about lung cancer patients.
In Japan, the most common death by cancer is due to lung cancer.
There are many people for whom lung cancer cannot be cured by an operation. Within this group, non-small-cell lung cancer, that is, not small cell lung cancer, accounts for the greatest part of lung cancer, however in the case that a life prolonging effect cannot be expected through operation or radiotherapy alone, prolonging the life of the patient is attempted through standard treatment with anti-cancer agents. This strategy has already been continuing for 30 years, which is to say from around 1980. It was in 1995 that precise data was first presented showing that chemotherapy prolonged life a little bit in the case of lung cancer (Figure 4).Until that time, there had been people who, due to various data, said that chemotherapy had no life prolonging effect and that on the contrary, its application only led to an early death.
Similarly to stomach cancer, most advanced lung cancer patients die within two years. Nevertheless, it can be read from this graph that the survival rate of “supportive care + chemotherapy” patients is significantly longer than those of “supportive care only”. “Supportive care” means the use of painkillers and nutrients without the application of anticancer agents.
I will now introduce a case where a patient survived for a long period with advanced stage lung adenocarcinoma (the most common non-small cell lung cancer) using the Maruyama vaccine (TABLE 4).
This was a stage IV adenocarcinoma. Although stage IV is an extremely advanced condition, there was a patient who survived for seven years with it. This was a 61-year-old male diagnosed as having lung cancer. Examination through computed tomography images and other means, this patient had stage IV lung cancer meaning he was in a condition whereby he already had distant metastasis and the cancer had metastasised to his brain. In such condition, the lung cancer and the tumour was removed by operation. Next the metastasis of the brain was removed by operation followed by radiotherapy applied to the brain. This is a medical case whereby it was confirmed that the patient survived for seven years after detection of the cancer in a condition of absolutely no chemo-radiotherapy during the period. It is also a case whereby injections of Maruyama vaccine were continued the whole time as from August 1987 until June 1994.
90% of patients with advanced adenocarcinoma of the lung (60-70% of stage IV non-small-cell cancer is adenocarcinoma) who were treated with chemotherapy had died within one year up until this point. However, when the Maruyama vaccine was used on 2566 advanced lung cancer patients in the 1970s, it was recorded at the vaccine therapy research facility of the Nippon Medical School Hospital that 116 patients (4.5%) survived three years or longer and 25 patients (0.9%) survived five years or longer. (Hirai T et al: Nippon Ijishinpou No. 3007, 43-46, 1981)
This kind of long-term survival was almost unimaginable with the chemotherapy of that time alone.
However, the five-year survival rate for general patients was also improved to 8% through the usage of the latest gene-targeted chemotherapeutic agents including Iressa (Gefitinib) with which you are acquainted.
3) Colon Cancer
Next I will talk about colon cancer. 119,363 patients were recorded as having colon cancer in U.S.A. in the period from 1991 - 2000 with the exclusion of rectal cancer (Figure 5). The survival curve for each degree of progression is shown in this diagram. The patients are classified by degrees of progression into the four disease stages I, II, III, IV with the most advanced one being stage IV. When 60 months (5 years) has lapsed, only 8.1% of patients with stage IV are still surviving.
When Maruyama vaccine was used for even this kind of advanced colon cancer, it can be seen that long period survival cases of from 10 to 30 years exist (TABLE 5). In these cases, chemotherapy was applied concurrently and so we don't truly know how effective either the chemotherapy or the vaccine was, but generally speaking there were these cases of survival for when both or the vaccine alone was used. Also, even when not used in conjunction with chemotherapy, 6 cases were confirmed where the patients lived from 10 to 30 years using the Maruyama vaccine alone.
4) Liver Cancer
Next I will give a case of a hepatoma(liver cell cancer) patient and he made an almost complete cure by means of SSM alone(Figure 6 to 9)
This is a 66-year-old male. He is a patient for alcoholic cirrhosis due to alcoholism.
People who drink a lot of alcohol over a long period of time often suffer from this condition. This person was previously diagnosed with cirrhosis of the liver.
A tumour of diameter approximately 2.5 cm was found on the hind of the liver by image diagnosis CT (computed tomography) of the liver (Figure 6).
Along with examinations other than imaging, this was determined to almost certainly be liver cell carcinoma.
The chest x-ray of Figure 7 was taken into account and the judgement that it was at stage IV B (terminal stage) was made. It was the wish of the patient and the family that anti-cancer agents should not be used. As they also did not wish for an embolization (a method whereby the liver cell cancer is destroyed by inserting a tube into blood vessel approaching the tumour and blocking the vessel) application of the Maruyama vaccine alone was started. Astonishingly, the fact is that from two weeks after, the patient's laboured breathing and general malaise disappeared, an increase in appetite was recognised, and four months later the patient was reinstated and became able to commute to his workplace. Also, prior to using the vaccine, numerous metastases had been seen in both sides of the lungs as in Figure 7. These metastatic lung nodules completely disappeared one month after SSM injection (Figure 8).
There is a definite evidence that this was a situation whereby the cancer had truly disappeared can be seen well in Figure 9. In most cases of hepatoma, the substances α-fetoprotein (AFP) or PIVKA-II appear in the blood. These rapidly decreased after the Maruyama vaccine was used and almost completely normalised. In other words it can only be said that the hepatoma itself almost completely disappeared within the body. In addition, this patient did not use an anti-cancer agent. Radiation was also not used. An embolization was not performed. Whichever way one looks at it one has no choice but to consider this a cure due to Maruyama vaccine.
5) Ovarian cancer
Next I will introduce a case in which the effectiveness of SSM can be considered to have been remarkable against ovarian cancer.
This is a stage IIIC advanced state ovarian cancer patient. Eight years after the operation, she is a healthy 60-year-old woman, for the present (June 2010).
Her right groin had swollen and walking had become a problem, so there was obviously some abnormality there. At first it was thought possibly to be a hernia of the groin and this was examined. And it was seen that the lymph nodes of that area were swollen. Upon removing this and examinating it with a microscope it was determined to be lymph-node metastasis of adenocarcinoma. From its histology and location it was judged most likely to be metastases of an ovarian cancer. When the abdominal cavity was searched by gynaecologic surgeons, there were evident tumours in the ovaries. Accordingly, the ovaries, womb (uterus), omentum and the lower intra-abdominal lymph nodes were all removed. A pathologic investigation of the operated materials revealed the stage to be IIIC, namely advanced cancer of the ovary. At the time of the operation anti-cancer agents were administered intra-abdominaly just once. After which, when the abdomen was closed and the situation monitored, a characteristic ovarian cancer marker that appeared in the blood rapidly decreased.
Three years after the operation a tumour of about 3 x 5 cm was discovered on an image of the right lower quadrant. As this was thought to be a tumor recurrence, the patient immediately underwent another operation. A tumour with the shape of a boiled egg was attached to the appendix and as much as it was attempted, not all could be removed and a bit of tumor tissue was left behind.
The removed tumour was judged to be an ovarian cancer metastasis. Furthermore, the tumour, which was below the diaphragm, could not be eradicated on this occasion either. Accordingly, the operation was unavoidably concluded with part of the cancer still remaining. This would of course be a worry for the patient and so the operation was finished with a single intra-abdominal injection of an anti-cancer agent called Cisplatin. As the anti-cancer agent was much toxic and annoying to the patient, the agent was not used at all, afterwards.
Instead, she has been continuing with Maruyama vaccine injections from the onset of the illness (from directly after the first operation) until present time. However, from this point, tumour markers in the blood decreased until presently (June 2010), nine years and one month later, where there are no indications of recurrence and no subjective symptoms.
Ovarian cancer may make progression completely different from that of lung and stomach cancer, and the survival rates differ considerably. In case of ovarian cancer, it is considered important to remove as much as possible of the tumour that is visible to the eye when the abdominal cavity is exposed to the surgeon.
As can be seen from Figure 10, when advanced cancer is treated with chemotherapy immediately after the operation, survival is possible for a considerably long time. Approximately 60% of people continue living for over 12 years after onset of the illness. If chemotherapy is not performed immediately after the operation, most patients do not survive more than seven years due to this “delay in chemotherapy”, with most passing away at around three or four years.
However, this patient undertook virtually no chemotherapy. She underwent surgery twice. With this and Maruyama vaccine, there is the potential to achieve survival that resembles “chemotherapy after surgery”, and it may be that the effectiveness of Maruyama vaccine administration, continued through from just first surgery to the present time for nine years and one month, is comparable to that of chemotherapy after surgery without delay.