Coley developed the theory that post-surgical infections had helped patients to recover better from their cancer by provoking an immune response. In 1891 he began to experiment by deliberately causing this phenomenon, injecting streptococcus bacteria directly into people being treated; later because this had the adverse effect of causing infection, he switched to using dead bacteria. Coley published the results of his work as a case series, making it difficult to interpret them with confidence. According to the American Cancer Society, "More research would be needed to determine what benefit, if any, this therapy might have for people with cancer".Cancer Research UK say that "available scientific evidence does not currently support claims that Coley's toxins can treat or prevent cancer". People with cancer who take Coley's toxins alongside conventional cancer treatments, or who use it as a substitute for those treatments, risk seriously harming their health.
By 1901, the development of x-rays as a cancer treatment showed great promise. In particular, the therapy resulted in immediate tumor destruction and pain relief. Although Coley claimed successful treatment of hundreds of patients, the absence of proven benefit or reproducibility led to broader emphasis on surgery and on the newly developing field of radiation therapy. This decision was borne out by the eventual successful treatment of millions of people worldwide with radiation therapy.
Coley arranged for a wealthy friend to provide funds to purchase two x-ray machines for his use. However, after several years of experience, Coley came to the conclusion that the effect of that primitive x-ray therapy in the untrained hands of experimenters was localized, temporary and not curative. The scientific majority disagreed, most notably his contemporary James Ewing. His contemporary critics cited the dangerous and unpredictable effects, predominantly the fever caused by the bacteria, that the vaccine had upon individuals weakened by cancer. Furthermore, the vaccine had to be made to a patient's exact needs, making it more labour-intensive, time-consuming and expensive.
In 2009, Coley's theory that immune systems in humans functioned in a cycle was demonstrated by a research team led by Associate Professor Brendon Coventry, which could have significant ramifications for cancer treatment.
In 2005, drug makers including Pfizer and Sanofi-Aventis had a renewed interest in modern versions of Coley's Toxins; Pfizer has acquired the Coley Pharmaceutical Group, set up in 1997.
The historical results of Coley vaccine therapy are difficult to compare with modern results. Coley's studies were not well controlled and factors such as length of treatment and fever level were not adequately documented. Many of his patients had also received radiation and sometimes surgery. According to the analyses of Coley Nauts and Starnes, treatment success correlated with length of therapy and the fevers induced by the toxins.
Coley's daughter, Helen Coley Nauts (1907–2001) established the nonprofit Cancer Research Institute in 1953 to study her father's work. The organization has since become a leader in funding research in immunology and tumor immunology at universities and hospitals worldwide.
^Coley WB (1893). "The Treatment of Malignant Tumors by Repeated Innoculations of Erysipelas: With a Report of Ten Original Cases". American Journal of the Medical Sciences. 10: 487–511.
^That erysipelas could cause cancerous tumors to regress was known at least as early as the 1860s. See:
Tanner, Thomas Hawkes (1863). "A clinical report on cancer of the female sexual organs". The British and Foreign Medico-chirurgical Review, …. 32: 151–153. On p. 152, Tanner noted that the French surgeon Alfred-Armand-Louis-Marie Velpeau had been unusually successful in treating cancers: " … the only difference [that] he [viz, Tanner] can discover "between M. Velpeau's cases and those of other surgeons is this, that a much larger number of them suffered from erysipelas after the operation of excision than commonly happens." "
Collins, Maurice Henry (1864). On the Diagnosis and Treatment of Cancer and the Tumours Analogous to It. London, England: John Churchill and Sons. pp. 150–152. From p. 150: "With regard to the effect of erysipelas, a strange notion has existed in the minds of several independent observers. … It is that erysipelas is antagonistic to cancer; when a patient recovers from a severe attack of erysipelas after removal of the cancerous part, she is more safe from relapse." Collins then cites cases of "Mr. Tanner" and "Mr. Smyly".
The German surgeon Wilhelm Busch observed cases in which erysipelas caused regression of tumors:
(Editorial staff) (4 June 1866). "Niederrheinische Gesellschaft für Natur- und Heilkunde in Bonn. Aus der Sitzung der medicinischen Section vom 14. März 1866" [Lower Rhine Society for Science and Medicine in Bonn. From the session of the medical section on 14 March 1866]. Berliner klinische Wochenschrift (Berlin Clinical Weekly Journal) (in German). 3 (23): 245–246. From p. 245: "Prof. Busch bespricht den Einfluss, welchen heftige Erysipele zuweilen auf organisirte Neubilden ausüben." (Prof. Busch discussed the influence which severe erysipelas sometimes exerts on organized new formations [i.e., new malignancies in the lymphatic glands].)
(Editorial staff) (23 March 1868). "Niederrheinische Gesellschaft für Natur- und Heilkunde in Bonn. Aus der Sitzung der medicinischen Section vom 13. November 1867" [Lower Rhine Society for Science and Medicine in Bonn. From the session of the medical section on 13 November 1867]. Berliner klinische Wochenschrift (Berlin Clinical Weekly Journal) (in German). 5 (12): 137–138. From p. 137: "Prof. Busch theilt eine neue Beobachtung über den Einfluss mit, welchen heftige Erysipele auf die Rückbildung von Geschwülsten haben, die hauptsächlich aus zelligen Wucherungen bestehen. In der Sitzung vom 14. März 1866 hatte er die ihm zu Gebote stehende Beobachtungen besprochen, bei welchen zufällig entstandene Erysipele eine Resorption der zelligen Massen ohne Eiterung hervorgebracht hatten." (Prof. Busch reported a new observation of the influence which severe erysipelas has on the regression of tumors, which mainly arise from cellular proliferation. In the session of 14 March 1866, he had discussed the observations that were at his disposal, in which cases erysipelas that had arisen incidentally had brought about a resorption of the cellular masses without suppuration.)
Volkmann, Richard (1869). "Erysipelas, Rose, Rothlauf". In Pitha, Franz von; Billroth, Theodor. Handbuch der allgemeinen und speciellen Chirurgie … (in German). vol. 1, pt. 2. Erlangen, (Germany): Enke. pp. 128–186. From pp. 173-174: "§. 177. Zum Schluss muss ich noch dem höchst eigenthümlichen Einfluss erwähnen, den intercurrente Erysipele zuweilen auf die rasche Resorption entzündlich gewucherter oder indurirter Gewebe und selbst eigentlicher Geschwülste haben." (§. 177. In conclusion, I must mention the most strange influence that intercurrent erysipelas sometimes has on the sudden resorption of tissues that proliferated by inflammation or hardened and even of actual tumors.)
Lücke, Albert (1869). Handbuch der allgemeinen und speciellen Chirurgie … : Die Lehre von den Geschwülsten in anatomischer und klinischer Beziehung [Handbook of General and Special Surgery … : The science of tumors in their anatomical and clinical aspects] (in German). vol. 2, pt. 1. Erlangen, (Germany): Ferdinand Enke. p. 31. From p. 31: "Auch Erysipelas in den verschiedensten Formen und Graden kann von der gesunden Haut ausgehend in den Geschwülsten Eiterung, Zerfall und Verjauchung erzeugen." (Also erysipelas in its most varied forms and degrees can cause – from the healthy skin to the tumor – suppuration, disaggregation, and putrefaction.)
Fehleisen, Friedrich (1883). Die Aetiologie des Erysipels (in German). Berlin, Germany: Theodor Fischer. p. 20. From p. 20: "Die ersten Angaben über die Heilwirkung des Erysipels stammen aus dem 17. Jahrhundert. … ganz unbestreitbar ist endlich die Thatsache, dass manche Geschwülste durch ein Erysipel zum Verschwinden gebracht worden sind." (The first indications about the healing effects of erysipelas come from the 17th century. … finally quite indisputable is the fact that some tumors have been made to vanish by erysipelas.)
^Bainbridge, William Seaman (1914). The Cancer Problem. New York, New York, USA: Macmillan Co. pp. 333–334.
^Levine DB. The Hospital for the Ruptured and Crippled: William Bradley Coley, third surgeon-in-chief 1925–1933. J HSS 2007 Feb; 4(1):1-9.
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