Research on Iscador (1999)
  

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By: Dr. Maria Linder

Robert Gorter, M.D. and his associates at the European Institute for Ontological and Immunological Research in Berlin, are carrying out clinical studies on Iscador, supported by Hiscia (Society for Cancer Research), the producers of Iscador. The objective is to have Iscador accepted by medical communities around the world, including the US, for treatment of cancer and HIV.

In the US this requires approval by the Food and Drug Admin­istration (FDA). Dr. Gorter has permits (Investigators’ INDs) that allow clinical trials on Iscador, and we have been carrying on the required studies, which are in various stages of completion, for some years now. All the plans (protocols) for these studies, and the result­ing data, are approved and reviewed by the FDA.

The first IND obtained was for subjects with HIV infection, as Iscador functions to enhance immunity. The first aspect (Phase 1) of all FDA trials is to prove lack of toxicity and to understand some­thing about its storage, metabolism and excretion through pharmaco­kinetic studies. The FDA approved Phase I human clinical trials on the basis of information from European studies and clinical experi­ences. For example, records from the Lukas Clinic indicate no toxic­ity on the part of cancer patients taking the drug for more than 20 years, and no adverse effects if taken during pregnancy and lactation.

The next stage (Phase 2) is to find the appropriate dosages and to begin to prove efficacy. Finally, Phase 3 is large efficacy trial, in­volving hundreds of patients in several centers.

With regard to Iscador, studies on HIV are at Phase 3, cur­rently being carried out in Europe and South Africa (where there is a large incidence of AIDS). Phase 1 and 2 studies showed no toxici­des, as expected, and suggest that Iscador slows the progression of HIV, which should be proved in the ongoing Phase 3 trials.

As concerns cancer, Phase 2 trials are underway in connection with cervix dysplasia. However, because the Iscador would be used during the child bearing years, and thus by younger women the FDA is much more stringent in its testing demands. We are con­tinuing to negotiate just what we will have to do to satisfy them that Iscador is not "genotoxic" or carcinogenic . They have our data of 50 years on subjects, including women in pregnancy, who took Iscador for many years, but they need to fill in certain blanks on their forms.

Working with the FDA has not been easy. They are not used to dealing with plant extracts which contain many different substances, all or some of which may have 'activity'! They are used to dealing with single, pure substances. I think that in the process of working with them, they have learned from us and we from them as well, and we are hopeful that this will make Iscador recognized for what it is truly able to do in cancer and immune-dysfunction diseases. This, in turn, will help the recognition of anthroposophical medicine.

 

Dr. Maria Linder is a professor of biochemistry at California State University, Fullerton.





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