Issels® Immuno-Oncology - The Skeptic's Dictionary (original) (raw)

The Issels® Immuno-Oncology treatment originated with German physician Josef M. Issels (1907-1998) who set up a clinic in Bavaria in 1951. Issels believed that cancer is a "systemic disease" requiring a "holistic" therapy that "boosts the immune system" and removes sources of inflammation such as the tonsils and teeth.note 1 At his clinic he treated patients with Coley's toxins (inert bacteria) hyperthermia, diet, injection of viruses, oxygen-ozone treatment, and psychotherapy, among other things. He claimed to be able to cure incurable cancers and attracted many desperate patients to his clinic.

In 1960, he was charged with fraud (for promising cures to terminal patients) and manslaughter (for the deaths of three patients who died under his care after refusing surgery that might have saved their lives). He was found not guilty on the fraud charge, but guilty on the manslaughter charge. The latter, however, was reversed in 1964 by the German Supreme Court, apparently because the court believed Issels was sincere and really believed his treatment cured cancer patients.*

In 1970, a committee of British cancer researchers visited Issels's clinic and issued a report in The Lancet on March 6, 1971, which stated that while Issels "believes implicitly in the treatments he gives," he is misguided in his beliefs and his treatment is "ineffective." The British visitors saw 121 patients at the Bavarian clinic but found none with complete tumor regression. The British group saw another 48 patients for whom successful treatment of advanced cancer was claimed. Of those, 28 seemed to have no evidence of disease when treated, 6 were treated with cytotoxic drugs by Dr. Issels, 2 had their tumors surgically removed, and 1 probably never had cancer. Of the remaining 11 patients who might have received some tumor response at the clinic, 8 "rested on slender evidence" and the final 3 "showed unusual features" such as scar tissue from radiation mistakenly identified as tumors. On the basis of this report, plus the lack of independent trials of the Issels treatment, the American Cancer Society described the treatment as not having evidence of objective benefit in the treatment of cancer in human beings in its 1971 report on Unproven Methods of Cancer Management. To this day, Issels treatment remains unproven and an "alternative" to standard cancer treatment given nowhere except at the Issels clinic located in Tijuana, Mexico.

According to the Issels.com website:

After his death in 1998, Dr. Josef Issels’ legacy has been continued with the same integrity and dedication by his wife and collaborator for 40 years, Ilse Marie Issels, and their sons, Dr. Christian N. Issels [a naturopath, not an MD] and Hellmut J. Issels. They have since carried on his work with remarkable results.

The "remarkable results" are not documented in scientific studies or clinical trials, however. Documentation consists primarily of testimonials and publications by Issels or his colleagues. No independent clinical trial on the Issels treatment has been done since the 1971 rejection by the American Cancer Society. The closest thing to scientific evidence for the Issels treatment is presented on the issels.com page on statistics.

1. Josef M. Issels, M.D. reported in “Immunotherapy in Progressive Metastatic Cancer, A Fifteen Year Survival Follow-up” Clinical Trials Journal (London) 1970. 7, NO. 3, A Peer Review Paper, pp. 357-366, that out of 370 patients with various cancers who were given the Issels Immunotherapy, shortly after surgery or irradiation, 322 (87%) were alive and well after five years without relapse or detectable metastases.

Forget for the moment that this is a report from an interested party and not an independent clinical trial. All the patients had surgery or radiation treatment before their Issels Immunotherapy. Even if all the data is accurate, there is no way of knowing what, if any, of the 87% 5-year survival rate was due to the Issels treatment. There was no control group. A proper study would have randomly assigned half the cancer patients to a group that did not get the Issels treatment after surgery or radiation therapy. We have nothing meaningful to compare to the 87% statistic. It is not difficult to understand why the American Cancer Society could look at this study and say there is no evidence of objective benefit from the Issels treatment.

2. John Anderson, M.D., Teaching Professor at King’s College Hospital, London, reported 17% cures of histologically verified metastatic malignomas by the Issels Immunotherapy. The independent randomized study comprised 570 patients with various cancers after all conventional methods were exhausted (General Practitioner, March 1971, pp. 15-16, London).

Anderson may have reported the 17% cures by the Issels treatment, but the link to this report does not indicate who did the study, how it was done, or where it was done. Anderson is quoted in the report as saying "I am prepared to set up a double blind clinical trial in the Department of Medicine at King’s to reproduce and test the Issels therapy regime as far as possible under the conditions under which I have observed it." But there is no evidence that Anderson ever actually did such a clinical trial. An Issels supportive page indicates that the 17% figure came from Issels himself and was not the result of a randomized study with a control group.

3. The rest of the statistical data supporting the Issels treatments consists of several in-house reports on non-randomized studies with no control groups.

The main appeal of the Issels treatment seems to be the testimonials and the list of swell-sounding "non-toxic" protocols presented on the issels.com website:

The Issels® Integrative Immuno-Oncology protocols have two lines of approach, each aspect is of equal importance and both complement each other:

Therapies specifically directed against the cancer cells and tumors, such as non-toxic cancer vaccines and cell therapies, as well as gene-targeted cancer therapies and personalized standard cancer treatment protocols if needed.

Non-toxic immunobiologic core treatment to alter the tumor microenvironment which plays a pivotal role in cancer progression or regression and healing. Our treatment program is applicable for all types and all stages of cancer, either in combination with standard treatments or on its own.

Sounds impressive. So does the following:

Issels® Integrative Immuno-Oncology protocols include various combinations of the following modalities depending on individual diagnosis.

• Autologous Dendritic Cell Cancer Vaccine
• Coley’s Mixed Bacterial Vaccine
• Prostate Cancer Vaccine
• Activated Natural Killer Cells – Also known as NK Cells
• Autologous Cytokines to continue boosting the immune system during the home care program
• Extracorporeal Photopheresis
• Lymphokine-Activated Killer Cells – Also known as LAK Cells
• Stem Cell and Lymphokine-Activated Killer Cell Procedure
• Systemic Hyperthermia.

Despite the medical gobbledygook, there has been no substantial study of the Issels treatment that can be reasonably described as proper and independent. Ever. Not before the 1971 American Cancer report and not in the more than 35 years since. The testimonials can be persuasive, but the prospective patient should set aside the emotional boost in hope they give to those desperate for treatment when all else has failed. Remember that the dead, the patients for whom the treatment did not work (like Bob Marley and Lillian Board)note 2 cannot give their testimonials and the Issels folks are not going to remind you of their failures. We have no way of knowing whether those giving their testimonials had other treatments such as surgery, chemotherapy, or radiation before undergoing the Issels regimen. We have no way of knowing of any errors in diagnosis or prognosis. Randomized control group studies would eliminate much of the doubt and uncertainty raised by a collection of anecdotes. Finally, without independent evaluation of the Issels treatment, all the evidence for it is biased and presented by interested parties.

So, despite a very scientific, swell-sounding list of protocols on the issels.com website and despite many emotionally appealing anecdotes, I think it is safe to say that there is no evidence of objective benefit in the treatment of cancer in humans by the Issel method.

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note 1. The idea of removing teeth, tonsils, and other body parts to remove sources of inflammation was popularized in the United States by psychiatrist Henry Andrews Cotton (1876–1933), medical director of the New Jersey State Lunatic Asylum. Cotton believed that mental illness resulted from untreated infections in the body and practiced what he called "surgical bacteriology" on patients. He not only removed their teeth and tonsils, but also "frequently spleens, colons, ovaries, and other organs." He seems to have based his belief in surgical bacteriology from observing that patients with high fever are often delusional and hallucinate. It's hard to believe today but Cotton was "lauded in The New York Times and the local press, as well as international professional publications, for having been a pioneer seeking a better path for the treatment of the patients in mental hospitals."

Issels's practice of removing sources of inflammation is puzzling, given his belief that it was inflammation that led to the disappearance of tumors in some people.

note 2. In Bob Marley, the Untold Story, Chris Salewicz describes Marley's decision to go to Issels's clinic in Bad Wiessee, Bavaria, called the Sunshine House Cancer Clinic. Marley had been diagnosed in 1977 with malignant melanoma. In 1980, the doctors at Sloan Kettering, who had been treating Marley with radiation, told him there was no more they could do. From 1939 to 1945, Issels was an SS officer in Hitler's Wermacht, and one wonders if it was during that time that he began experimenting on humans. Salewicz describes the Sunshine House as "hostile and alien." Marley was treated for two hours a day from November 1980 until he left the clinic in May 1981, dying in Miami on route home to Jamaica.

See also natural cancer cures and integrative oncology.

further reading

William Coley, Quack or Prophet? by Gabe Mirkin, MD "Today, many mainstream scientists believe that a cure for cancer will come from getting a person’s immune system to do a better job of killing cancer cells in the same way that it kills germs. This research focuses on stimulating the immune system with

• antibodies and other agents made from animals, humans or in the laboratory to attack and kill cancer cells without also killing normal cells,
• natural bacteria or genetically modified bacteria,
• drugs to stimulate the immune system to destroy cancer cells, or
• bacteria and viruses made to carry cancer treatments into cancer cells.

Cancer research now involves many immune hormones and cytokines such as tumor necrosis factor, interferons and streptokinase. Vaccines are being developed for treatment of colon, melanoma and other cancers. The injection of the tuberculosis vaccine called BCG is used to treat bladder cancer.

Scientists still have not found a safe way to stimulate the immune system to kill cancer cells permanently without also harming the patient." (emphasis added)

What is Coley’s toxins treatment for cancer? Cancer Research UK "Available scientific evidence does not currently support claims that Coley’s toxins can treat or prevent cancer....The original formula for Coley’s toxins is no longer available. Current formulas use killed bacteria called Streptococcus pyogenes and Serratia marcescens. Supporters of this treatment suggest that the bacteria directly boost the immune system to kill the cancer cells. Some people think that the treatment stimulates a natural protein called tumour necrosis factor (TNF). But other doctors think that it stimulates another protein called interleukin 12 (IL12).

The treatment causes a high temperature. Some people think that cancer cells are more sensitive to heat than normal cells and that the high temperature kills the cancer cells.

Although some cancers did shrink in patients treated by Dr Coley, in others his treatment didn't help. Other researchers have found it difficult to repeat his [alleged] successes."