Environmental Data Could Mean Drug-Approval Process Needs Change
WASHINGTON (Reuters Health) Mar 14
A newly-released environmental survey of US streams could have implications for the nation's drug-approval process.
Conducted by the US Geological Survey (USGS), the review of water samples from 139 streams in 30 states found minute amounts of synthetic hormones, antibiotics and other drugs excreted by humans and animals and not successfully removed by sewage plants.
The survey, which was released on Wednesday, did not evaluate whether the trace amounts of pharmaceuticals are actually doing any harm.
Along with pharmaceuticals, the survey tested for other contaminants, such as detergent metabolites and insecticides. At least one drug or other chemical was present in 80% of the streams sampled. Among the most common contaminants were steroids and nonprescription drugs.
The USGS stressed that the streams surveyed were those considered most likely to be contaminated, by virtue of their positioning downstream from areas of livestock production or intense urbanization -- meaning that the survey's findings are not representative of all US streams. And, for the most part, chemical levels did not exceed one part per billion.
Still, the survey results could lead to changes in how the US Food and Drug Administration (FDA) evaluates new drugs. The agency is already required to consider the potential environmental impact of medications as part of the drug-approval process, but Dr. Steven K. Galson, deputy director of the FDA's Center for Drug Evaluation and Research, told The New York Times after the release of the survey that the possibility that the process needs reworking would not be ruled out.
Galson clarified in an interview with Reuters Health that new regulations are just one of the many options the FDA might consider if remedies are needed. He said other possibilities could include revamping the current environmental assessment process and revoking some previously-granted exemptions that were based on data suggesting that certain kinds of drugs had no environmental impact.
"We will look very carefully to see whether the exemptions match up with the data," he said.
Galson added that it is not clear that the contaminants pose a threat to human health. "It's too early to say," he stressed. He noted that the survey results did not take the FDA by surprise. "What would have been surprising is if we didn't find traces," he said.
Critics charge that the agency has been too lax in its assessment of drugs' environmental impact. In an interview with Reuters Health, Dr. Rebecca Goldburg, a senior scientist with the non-profit Environmental Defense Fund, said the agency's current efforts seem hampered by the exemptions it has granted, which were part of a Clinton-era effort to streamline government activities.
Among the categories exempted were naturally-occurring hormones such as estrogen, but in the new survey, about 40% of the streams tested contained small amounts of estrogen or other hormones.
The pharmaceutical industry stressed on Thursday that, even in this latest survey, the drugs and hormones were present in only trace amounts. "In terms of the amount, it is no different than in the past," Pharmaceutical Research and Manufacturers of America's Jeff Trewhitt told Reuters Health. "The track record is one that should be reassuring."
But Environmental Defense Fund Senior Attorney Karen Florini observed that drugs with endocrine activity such as hormones often work at low levels.
Trewhitt acknowledged that some changes might be warranted, but said further evaluation is needed.
A full copy of the survey can be found at http://toxics.usgs.gov.
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