His position echoes that of a line of federal drug and water regulators as well as drugmakers, who concluded in the 1990s — before highly sensitive tests now used had been developed — that manufacturing is not a meaningful source of pharmaceuticals in the environment.
Pharmaceutical makers typically are excused from having to submit an environmental review for new products, and the FDA has never rejected a drug application based on potential environmental impact. Also at play are pressures not to delay potentially lifesaving drugs. What's more, because the EPA hasn't concluded at what level, if any, pharmaceuticals are bad for the environment or harmful to people, drugmakers almost never have to report the release of pharmaceuticals they produce.
"The government could get a national snapshot of the water if they chose to," said Jennifer Sass, a senior scientist for the Natural Resources Defense Council, "and it seems logical that we would want to find out what's coming out of these plants."
Ajit Ghorpade, an environmental engineer who worked for several major pharmaceutical companies before his current job helping run a wastewater treatment plant, said drugmakers have no impetus to take measurements that the government doesn't require.
"Obviously nobody wants to spend the time or their dime to prove this," he said. "It's like asking me why I don't drive a hybrid car? Why should I? It's not required."
After contacting the nation's leading drugmakers and filing public records requests, the AP found two federal agencies that have tested.
Both the EPA and the U.S. Geological Survey have studies under way comparing sewage at treatment plants that receive wastewater from drugmaking factories against sewage at treatment plants that do not.
Preliminary USGS results, slated for publication later this year, show that treated wastewater from sewage plants serving drug factories had significantly more medicine residues. Data from the EPA study show a disproportionate concentration in wastewater of an antibiotic that a major Michigan factory was producing at the time the samples were taken.
Meanwhile, other researchers recorded concentrations of codeine in the southern reaches of the Delaware River that were at least 10 times higher than the rest of the river.
The scientists from the Delaware River Basin Commission won't have to look far when they try to track down potential sources later this year. One mile from the sampling site, just off shore of Pennsville, N.J., there's a pipe that spits out treated wastewater from a municipal plant. The plant accepts sewage from a pharmaceutical factory owned by Siegfried Ltd. The factory makes codeine.
"We have implemented programs to not only reduce the volume of waste materials generated but to minimize the amount of pharmaceutical ingredients in the water," said Siegfried spokeswoman Rita van Eck.
Another codeine plant, run by Johnson & Johnson subsidiary Noramco Inc., is about seven miles away. A Noramco spokesman acknowledged that the Wilmington, Del., factory had voluntarily tested its wastewater and found codeine in trace concentrations thousands of times greater than what was found in the Delaware River. "The amounts of codeine we measured in the wastewater, prior to releasing it to the City of Wilmington, are not considered to be hazardous to the environment," said a company spokesman.
In another instance, equipment-cleaning water sent down the drain of an Upsher-Smith Laboratories, Inc. factory in Denver consistently contains traces of warfarin, a blood thinner, according to results obtained under a public records act request. Officials at the company and the Denver Metro Wastewater Reclamation District said they believe the concentrations are safe.
Warfarin, which also is a common rat poison and pesticide, is so effective at inhibiting growth of aquatic plants and animals it's actually deliberately introduced to clean plants and tiny aquatic animals from ballast water of ships.
"With regard to wastewater management we are subject to a variety of federal, state and local regulation and oversight," said Joel Green, Upsher-Smith's vice president and general counsel. "And we work hard to maintain systems to promote compliance."