Carcinogenicity studies clinical indications

Standard carcinogenicity studies are generally inappropriate for biotechnology-derived pharmaceuticals (12). Macromolecules, unless they are endogenous substances used as replacement therapy, may need to be evaluated for carcinogenic potential if indicated by treatment duration, clinical indication, and patient population. A variety of approaches, such as the ability to support or induce proliferation of transformed cells or to simulate growth of normal or... 

Animal studies have indicated a carcinogenic effect when paracetamol has been administered for prolonged periods in relatively high dosages. However, no clinical data are so far available to corroborate this. The matter cannot be dismissed entirely for the time being, in view of a report (68) of the development of chromosomal aberrations after prolonged use. 

None of the respondents had recently included rodent life-time carcinogenicity studies in safety evaluation programmes for products of biotechnology. The unanimous view was that these studies are generally inappropriate for such products reasons given included the potential for neutralising antibody formation, that the proposed clinical use was either short-term or for a life-threatening indication, or that there is no scientific rationale to conduct such studies (especially with antibodies). 

The decision regarding whether or not to undertake carcinogenicity studies for any product should be based on considerations of the clinical indication (including the severity of the disease, the clinical population, and the duration of treatment), and theoretical concerns about the potential tumorigenicity based on the biological properties of the product. 

A risk-benefit analysis on the use of fennel tea as a colic remedy for infants indicated that studies regarding carcinogenicity of the compound estragole in animal studies were difficult to interpret, as direct translation of animal experimental data to humans is problematic for numerous reasons. The analysis concluded that, based on available clinical and epidemiological data, any cancer risk is negligible and fennel seed is safe for use in infants (Iten and Sailer 2004). 

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