Unproven Methods of Cancer Management

Iscador

After careful studs' of the literature andother information available to it, the American Cancer Society does not have evidence that treatment with Iscador, anextract of mistletoe, results in objectivebenefit in the treatment of cancer in humanbeings. Lacking such evidence, the American Cancer Society would strongly urgeindividuals afflicted with cancer not to participate in treatment with Iscador.

The following is a summary of information on Iscador in the American CancerSociety files as of June 1. 1982. No implication of agreement by the Society withthe contents of any proponent material isto be construed because of the Society'sreference to it.

Background

Iscador, a preparation made from variouskinds of mistletoe (namely. those growingon apple. fir, pine, oak, and elm trees), orViscuin album, was first proposed for thetreatment of cancer in 1920, by RudolfSteiner, PhD (deceased), founder of theSociety for Cancer Research, in Arhesheim, Switzerland. and introduced in thetreatment of human cancer as early as1921 2Iscador is developed and producedby the Society for Cancer Research, a nonprofit. tax-exempt charity largely supported by private donations.2

Iscador gained a great deal of visibilityfrom 1920 through 1969, from its propo

nents and from articles that appeared inAnnual Reports of the Society for CancerResearch in Arlesheim. .3.4For a nine-yearperiod, the American Cancer Society received no inquiries regarding Iscador, norwas aware of any publicity concerning itsuse. However, the proponents claim thatin 1978, almost 2,000,000 ampuhes weresold in countries where Iscador is prescribed and that about 30,000 patients aretreated with this substance each year.2

Proponents

Principal proponents of Iscador are RitaLeroi, MD. President of the Society forCancer Research, Arlesheim, Switzerland;its authorized American agent, Marvin I.Weinberger, Belmont, Massachusetts; andHenning Schramm, MD, of Weheda AG,the pharmaceutical company in Switzerland that packages and markets Iscador.2

Proponent Claims

According to the proponents. Iscador isrecommended for treatment of inoperabletumors, preoperative treatment of tumors,as the adjuvant therapy of solid tumors,and for precancerous conditions when indicated. While the drug has been approvedfor use in Austria, Switzerland, and WestGermany, and is said to be used in France,Holland, Eastern Europe, the United King

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dom, and Scandinavia, no attempt has beenmade to conform to US standards. 2.S

The proponent literature states that“¿�Iscadoris not a purified or even synthesized product, but a very compLex naturalplant extract prepared in a special way andstandardized in a biological procedure.―2The dry extract from mistletoe juice contains a basic protein fraction with 10 components differing in molecular weight from14,000 to 125,000. Three components witha molecular weight of about 3,000 are saidto account for about 60 percent of this fraction. Two additional components have beenisolated. One has a chain of 27 amino acidsand is called Viscotoxin; the other is 16amino acids long. Free amino acids account for approximately 14.0 mg per gramof extract. High L-arginine levels have beenfound. Tests have also shown the presenceof a lectin-hike component. Several othermaterials such as inositol, choline, acetylcholine, various alcohols, and sugar havebeen allegedly identified in Iscador.2

The rationale of Iscador treatment andthe research on which it depends are basedon the school of thought called anthroposophy. The proposed anthroposophical concept of cancer is that an active principlecalled a “¿�form-givingprinciple― lies behind cancer-controlling mechanisms.2

Special characteristics of Iscador aresaid to be that it inhibits tumor cell growthand “¿�enhancesthe controlling effect of theform-giving organization so that controlover the tumor may be regained.―2

Administration of the drug to humanpatients is usually by intravenous injectionbut it may also be given subcutaneously. 2.6

Current Status

From October 1978 to October 1981 theAmerican Cancer Society received a number of letters and telephone calls from theproponents of Iscador urging the Societyto withdraw from distribution its statementon Iscador, originally published in 1965and revised in 1971 .7The reason given wasthat the Society's statement was said tocarry great weight in Europe and on thisaccount several countries are reluctant toregister the substance.28

In response, the proponents were informed that the Society's role with regardto unproven methods of cancer management was limited to gathering relevant information and disseminating it to both thelay public and members of the healthprofessions, and that the Society is not aregulatory agency for therapeutic agents.They were also informed of the UnitedStates Food and Drug Administration(FDA) regulations governing introductionof new drugs into medical practice. Further, they were advised to publish supporting data in one or more widely read,peer-reviewed medical journals, and to getin touch with the FDA.@

In 1979, the American Cancer Societyreceived from the Society for Cancer Research, Arlesheim, approximately 17 clinical and chemical papers dealing with theeffects of mistletoe extract on humans.b0The data were submitted to two expert consultants for evaluation. Their independentconclusions were that no evidence had beenprovided that Iscador has anticancer activity against human cancer.―'2

In May 1980, the Society received fromMr. Weinberger a document tithed, “¿�Iscador—A Summary Review.― This includedclinical data and an extensive bibliographyof 25 publications and 14 unpublished manuscripts.2'3 The Summary Review was resubmitted to the consultants for evaluation.The consensus of the consultants was thatthere was little change from the materialpreviously reviewed.'@

In August 1981, Dr. Henning Schrammcame to the United States to urge the Society to modify its position. The Society'srole as an educator in the matter of cancer therapeutic drugs was reiterated. Dr.Schramm was made aware that Mr. Weinberger had informed the Society that his“¿�clientsare actively pursuing discussionswith the FDA.―5At that time Dr. Schramminformed the Society that they are at leastseveral years from being ready to apply tothe FDA for an Investigational New Drug(IND) permit to conduct clinical trials inthe United States.'6 He later informed theSociety that he is aware of the FDA standards and has stated that “¿�TheFDA regulations are devised for chemically

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definable substances and as such are notcompatible with a drug hike Iscador thatrepresents a whole plant extract.―8

In October 1980, the American CancerSociety Medical Library conducted a searchof the medical and scientific literature andobtained copies of four scientific papers onIscador, mistletoe, or Viscwn album. Thesefour papers were published in the BritishHomeopathic Journal; Experientia; Therapie der Gegenwart; and Zeitschrift fuerKrankempflege.'7

Another search of the medical and scientific literature was conducted by the ACSMedical Library in December 1981. It wasdetermined that an American study of Iscador had been conducted by the Department of Pathology and Surgery of theUniversity of Chicago in Chicago, Illinois.The published paper indicated that certainbiological properties of Iscador were dem

References

onstrated; it stimulates the thymus glandand speeds up the regeneration of bloodforming cells after exposure to x-rays.'8

An animal study with Iscador also hasbeen reported by the University of Southern California School of Medicine atLos Angeles. The study indicated thatcytotoxic alkaloids were extracted fromEuropean Iscador. According to in vitrostudies with mouse and human leukemiacells, growth was inhibited by the mostactive of these alkaloids.'9

At California State University, Fullerton, a study was conducted that showedthat Iscador had beneficial effects on copper metabolism in rats with tumors, buttumor growth rates were not significantlyreduced.2°

Finally, Iscador has not been testedand found by the FDA to be safe and effective in treating cancer in humans.@

1. Society for Cancer Research, Arhesheim,Switzerland, Research Institute Hiscia, 9thYearly Report. January, 1958.2. Iscador—A Summary Review, Society forCancer Research, Arhesheim, Switzerland,March. 1980.3. Society for Cancer Research, Arhesheim,Switzerland, Yearly Report. 1962.4. Society for Cancer Research, Arlesheim,Switzerland, Annual Report, 1968—1969.5. Letter from US Food and Drug Administration to ACS. Inc. October, 20, 1980.6. Leroi R: Postoperative treatment of breastcarcinoma with Viscum album. Helv Chir Acta44:403, 1977.7. Iscador. American Cancer Society, Inc(Statement) 1965/71.8. Letter from Henning Schramm. MD to ACS.Inc. October 7, 1981.9. Letter from ACS. Inc. to Marvin I. Weinberger, January 22, 1981.10. Bibliography on Iscador (literature sent toACS. Inc. by Society for Cancer Research, Arlesheim, Switzerland) 1965—1979.11. Letter from Emil J. Freireich, MD to ACS,Inc. November 5, 1979.12. Letter from Daniel S. Martin, MD to ACS,Inc. May 5. 1980.

13. Bibliography on Iscador, in Iscador—ASummary. Arhesheim, Switzerland, Society forCancerResearch,March,1980,pp94—101.14. Letter from Emil J. Freireich, MD to ACS,Inc. June 18, 1980.15. Letter from Marvin I. Weinberger to ACS,Inc.May 25,1981.16. Information received from HenningSchramm, MD at a meeting with representativesof ACS. Inc. G. Congdon Wood, PhD and Robert Task, in August. 1981.17. Bibliography on Iscador, Literature Search,Medical Library, American Cancer Society, Inc,1980.18. Hunter R, Lyon E, Rentea R: BiologicProperties of Iscador: A Viscum album Preparation. Departments of Pathology and Surgery,University of Chicago. US Canadian Divisionof the International Academy of Pathology44:43—48,1981.19. Khwaja T, Diaz CB, Papoian T. et al: Studies on cytotoxic and immunologic effects onViscum album (mistletoe), abstracted. Proc AmAssoc Cancer Res, 1980.20. Linder MC, Murillo C: Mistletoe ExtractsPrevent Changes in Copper Metabolism whichOtherwise Occur in Rats with Tumors, abstracted. XIII International Cancer Congress.1982.

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