By Diether Neubert, Robert J. Kavlock, Hans-Joachim Merker, Jane Klein
Since the thalidomide (Contergan) tragedy approximately 30 years in the past the induction of prenatally-induced morphological or useful defects has been a space of in depth study. chance evaluate of prenatally-induced opposed healthiness results continues to be a tough activity from either experimental information besides asfrom observations in people. within the contributions to this publication 3 significant elements are handled: - Quantitative extrapolations of experimental info to the placement almost certainly proper for guy. - the importance for a threat review with recognize to guy of teenybopper or infrequent structural abnormalities saw in experimental reviews - the long run have to determine congenital dysfunctions (e.g. of the hormone or the immune procedure) beside the current evaulation of structural defects. boundaries in addition to gaps of the current wisdom during this region of easy and utilized examine are mentioned. because the result of prenatally-induced lesions could appear themselves not just pre- yet usually now not prior to past due postnatally, a variety of elements of structural and useful abnormaldevelopment needs to be studied in experimental and scientific investigations.
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Extra resources for Risk Assessment of Prenatally-Induced Adverse Health Effects
It is unlikely, however, that post-marketing surveillance programs set up by pharmaceutical companies would provide useful data on these exposures. The great majority of reports obtained during postmarketing surveillance deal with adverse pregnancy outcomes alone. Physicians and patients have no incentive to send in reports on exposed pregnancies with normal outcomes. Other data collection systems must be developed, possibly systems with prospective follow-up, to collect data on the entire population with exposure during pregnancy.
As you said, it is difficult to detect additional exogenous effects caused by drugs or chemicals above the spontaneous background in man because of the normal fluctuations of these spontaneously occurring effects. Are we not overdoing toxicological evaluations by making tremendous efforts and using an enormous number of animals for possibly only little benefit? Neubert: Manson: I agree that too much emphasis is placed on borderline fmdings in animal studies. The primary responsibility for correcting this imbalance lies with laboratory investigators conducting studies who must be considered the most knowledgeable people to interpret the findings.
38 1. Manson Conclusions Unlike any other area in preclinical safety assessment, the tendency exists to obtain the most severe label possible for use of drugs in human pregnancy (Table 10). This is partially a reflection of abuses in the legal system where any adverse pregnancy outcome in a patient on drug therapy can be attributed to drug treatment, no matter how improbable the association. In this environment, legal risks to pharmaceutical companies are reduced when use of their products during pregnancy is strongly discouraged.
Risk Assessment of Prenatally-Induced Adverse Health Effects by Diether Neubert, Robert J. Kavlock, Hans-Joachim Merker, Jane Klein