Those Active Pharma Ingredients May Be Fishy

In recent years, studies have shown that active pharmaceutical ingredients were found in effluent coming from waste-water treatment plants near manufacturing plants. Now, a new study indicates that APIs were linked to changes in sexual characteristics of a type of fish in a river in France and, therefore, may have further damaging consequences on the larger ecosystem.

The study, which was commissioned by the French environment ministry, examined wild gudgeon in a river near a Sanofi facility that makes steroid compounds. Downstream of the discharge, researchers found that, on average, 60 percent of the fish had both male and female sexual characteristics. But upstream, only 5 percent of the fish exhibited such traits. Male fish living downstream from the plant also had significantly higher blood levels of a protein normally found in eggs than those living upstream.

"Fish living downstream from pharmaceutical manufacture discharge exhibited severe signs of endocrine disruption, high proportion of intersex fish and a male-biased sex ratio," the researchers wrote in Environment International. "Results of this field study argue for deployment of specific monitoring of pharmaceutical factory discharges, capable of assessing of health of fish and aquatic communities."

The discovery is prompting calls for more effective industry oversight. The US, the European Union, the United Kingdom and France do not have regulations limiting the concentrations of pharmaceuticals released into the aquatic environment in either municipal wastewater or in effluent from manufacturing facilities, according to Nature.

"This is a real problem," Wilfried Sanchez, an ecotoxicologist at the French National Institute for Industrial Environment and Risks, and lead author of the study, tells Nature. Sexual abnormalities in gudgeon may not only prevent the fish from breeding, but also signal problems in other species, and a reduction in the fish population could have broader consequences for the river ecosystem, Nature notes.

"People thought this could not happen in a country that has high environmental standards and good manufacturing practices," Patrick Phillips, head of the National Water-Quality Assessment Program at the US Geological Survey in Troy, New York, tells Nature. He was the lead author of a 2009 study that found high levels of APIs from wastewater-treatment plants receiving discharges from pharmaceutical plants. "The evidence from the United States and now from France shows that this is not the case."

As for Sanofi, a spokesman tells Nature that it is difficult to assess the extent of the problem because "no effect has been observed in other fish species." He adds the drugmaker is working with regulators, researchers and ecological associations to identify the cause of the "disturbances," which he says are "probably multi­factorial." Something is fishy, yes?