LINKING PHARMACEUTICALS IN THE ENVIRONMENT TO HUMAN FERTILITY
Scientific interest has grown recently in a reported decline in human fertility that could be linked to exposure to environmental chemicals. During the past three decades, studies have shown that pesticides, heavy metals and other industrial toxins in the environment can mimic reproductive hormones and disrupt the endocrine system. However, little research has been done on the presence of pharmaceutical products (PPs) in the environment, if and how they enter the food chain, and their effects on human fertility. There is no information available on the transmission, fate, bio-transformation and photo-transformation of pharmaceutical products, which are used worldwide in large quantities (compared to agrochemicals). As part of the European Union's drive to ensure food safety and quality, the nine partners of the Specific Targeted Research Project known as F&F will work to determine whether pharmaceutical products are present in food and whether they affect human fertility.
AN INTEGRATED APPROACH
Only about 50 out of thousands of commercially used pharmaceutical products have been studied for their effects on human fertility. Few methods are available for simple, efficient acquisition and pre-concentration of these substances from environmental and food samples for analysis. To improve knowledge, the three-year STREP F&F will integrate research from its six partners from the European Union and three from Israel. Participants include risk assessors, managers, clinical epidemiologists, endocrinologists, biochemists, as well as experts in biochemical and chemical diagnostics. They will develop and validate highly specific, sensitive and reproducible diagnostic assays (at the parts per trillion level) able to handle large numbers of samples at high rates and low cost.
Using new and existing analysis tools, researchers will screen pharmaceutical products - mainly estrogens, androgens and progestogen-like compounds commonly used for birth control, menopause relief, menstruation regulators, anti-inflammatory drugs and chemotherapeutic drugs - and their metabolites. They will determine how they get into food and what effects they have on the brain-gonad reproductive axis. Blood, milk and urine samples will be monitored for PP residues and the possible correlation between the occurrence of the drug residues, fertility problems and dietary habits will be examined on a gender basis. They will study the mechanisms of action and clinical epidemiology of these substances, and their effects on food safety, with emphasis on cumulative health risks posed by a wide range of environmental pollutants. This should make it possible to identify and characterise pharmaceutical products' endocrine-disrupting activity and their risks for fertility, based on regional and socio economic factors and gender. F&F will establish exposure scenarios in Europe, identifying vulnerable groups such as pregnant women and children.
PRIORITY PRODUCT LIST
F&F will produce a scenario-specific prioritisation list of pharmaceutical products with high potential to affect human fertility, and information on their action mechanisms, transmission routes and longterm effects. It will produce diagnostic, clean-up and purification methods for these PPs in food, and a set of standard operating protocols describing analytical methods used for the validation process. It will help determine methods to prevent or minimise the effects and risks of food-borne pharmaceutical products.
The project will present findings to the public via knowledge pools and a website, and it will conduct a final-year workshop for the European scientific and clinical community and the pharmaceutical industry.
List of Partners
- Analyst Research Laboratories (Israel)
- The Volcani Center, ARO (Israel)
- The National Institute for Public Health (The Netherlands)
- Aarhus University Hospital (Denmark)
- INRA-CNRS - Physiologie de la Reproduction et des Comportements (France)
- Centre Universitaire-UFR Biomédicale, Paris (France)
- Factline Webservices GmbH (Austria)
- Wessex Institute of Technology (UK)
- OSM-DAN (Israel)
- Full title:
- Pharmaceutical products in the environment: development and employment of novel methods for assessing their origin, fate and effects on human fecundity
- Contract n°:
- Project co-ordinator:
- Haim Martin Schlesinger, Analyst Research Laboratories, firstname.lastname@example.org
- Scientific director:
- Miriam Altstein, The Volcani Center, ARO
- EC Scientific Officer:
- Valérie Rolland, email@example.com
- EU contribution:
- € 1.7M
- Specific Targeted Research Project