Sex-linked Effects of Pharmacotherapy

Simatupang, Abraham (2015) Sex-linked Effects of Pharmacotherapy. In: Women & Health: Towards a better understanding and environment for the future. Fakultas Kedokteran Universitas Kristen Indonesia, Indonesia, Jakarta, pp. 41-47. ISBN 978 602 1651 68 1

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Abstract

After rigorous pre-clinical trials on cells, organs and animals had been done to a promising active substance, it is usually followed by clinical trial which uses human. Clinical trial comprises of three phases and one trial called post-marketing surveillance and each phase has its own objectives and characteristics. Efficacy and safety are two important factors for judging and reviewing new drugs in clinical trials. In phase one, as the drug for the very first time is applied to human body, (young) men are recruited and used particularly to determine pharmacokinetics (PK) and pharmacodynamics (PD) profiles of the drug. In phase two and three the drug are tested in patients to proof the efficacy and safety of the drug. Unfortunately, in most clinical trials, especially in early development phases, women were often not substantially recruited. Therefore, women are underrepresented in clinical trials to show the efficacy and safety issues of new drugs. The backgrounds for not recruiting women in clinical trials are many, among others are due to the possibility of toxic effects on reproductive system. The teratogenicity of thalidomide in the 60s, which then was approved for anti-emesis of pregnant women, made many drug regulatory bodies strictly forbid to include women in reproductive phase to be included in clinical trial. However, when the drug is released and used in the market, it will be also prescribed for women and adverse drug reactions can emerge. Some reports show that women are more likely experience adverse events than men have been increasing. Therefore, appeals and advocacy for increasing the number of women in clinical trials have been increased recently. This article discusses the pros and cons of carrying out clinical trials in women.

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