AP IMPACT: Tons of released drugs taint US water

AP – In this photo taken on Feb. 26, 2009, aeration basins are seen in operation at the Wilmington Wastewater …

manufacturers, including major drugmakers, have legally released at
least 271 million pounds of pharmaceuticals into waterways that often
provide drinking water — contamination the federal government has consistently overlooked, according to an Associated Press investigation.
Hundreds
of active pharmaceutical ingredients are used in a variety of
manufacturing, including drugmaking: For example, lithium is used to
make ceramics and treat bipolar disorder; nitroglycerin is a heart drug and also used in explosives; copper shows up in everything from pipes to contraceptives.
Federal
and industry officials say they don't know the extent to which
pharmaceuticals are released by U.S. manufacturers because no one
tracks them — as drugs. But a close analysis of 20 years of federal records
found that, in fact, the government unintentionally keeps data on a
few, allowing a glimpse of the pharmaceuticals coming from factories.
As
part of its ongoing PharmaWater investigation about trace
concentrations of pharmaceuticals in drinking water, AP identified 22
compounds that show up on two lists: the EPA monitors them as
industrial chemicals that are released into rivers, lakes and other
bodies of water under federal pollution laws, while the Food and Drug Administration classifies them as active pharmaceutical ingredients.
The
data don't show precisely how much of the 271 million pounds comes from
drugmakers versus other manufacturers; also, the figure is a massive
undercount because of the limited federal government tracking.
To
date, drugmakers have dismissed the suggestion that their manufacturing
contributes significantly to what's being found in water. Federal drug
and water regulators agree.
But some
researchers say the lack of required testing amounts to a 'don't ask,
don't tell' policy about whether drugmakers are contributing to water
pollution.
"It doesn't pass the straight-face
test to say pharmaceutical manufacturers are not emitting any of the
compounds they're creating," said Kyla Bennett, who spent 10 years as
an EPA enforcement officer before becoming an ecologist and
environmental attorney.
Pilot studies in the U.S. and abroad are now confirming those doubts.
Last year, the AP reported that trace amounts of a wide range of pharmaceuticals — including antibiotics, anti-convulsants, mood stabilizers and sex hormones — have been found in American drinking water supplies. Including recent findings in Dallas, Cleveland
and Maryland's Prince George's and Montgomery counties, pharmaceuticals
have been detected in the drinking water of at least 51 million
Americans.
Most cities and water providers
still do not test. Some scientists say that wherever researchers look,
they will find pharma-tainted water.
Consumers
are considered the biggest contributors to the contamination. We
consume drugs, then excrete what our bodies don't absorb. Other times,
we flush unused drugs down toilets. The AP also found that an estimated
250 million pounds of pharmaceuticals and contaminated packaging are
thrown away each year by hospitals and long-term care facilities.
Researchers
have found that even extremely diluted concentrations of drugs harm
fish, frogs and other aquatic species. Also, researchers report that
human cells fail to grow normally in the laboratory when exposed to
trace concentrations of certain drugs. Some scientists say they are
increasingly concerned that the consumption of combinations of many
drugs, even in small amounts, could harm humans over decades.
Utilities
say the water is safe. Scientists, doctors and the EPA say there are no
confirmed human risks associated with consuming minute concentrations
of drugs. But those experts also agree that dangers cannot be ruled
out, especially given the emerging research.
___
Two common industrial chemicals that are also pharmaceuticals — the antiseptics phenol and hydrogen peroxide
— account for 92 percent of the 271 million pounds identified as coming
from drugmakers and other manufacturers. Both can be toxic and both are
considered to be ubiquitous in the environment.
However,
the list of 22 includes other troubling releases of chemicals that can
be used to make drugs and other products: 8 million pounds of the skin bleaching cream
hydroquinone, 3 million pounds of nicotine compounds that can be used
in quit-smoking patches, 10,000 pounds of the antibiotic tetracycline
hydrochloride. Others include treatments for head lice and worms.
Residues are often released into the environment when manufacturing equipment is cleaned.
A small fraction of pharmaceuticals also leach out of landfills where
they are dumped. Pharmaceuticals released onto land include the chemo
agent fluorouracil, the epilepsy medicine phenytoin and the sedative
pentobarbital sodium. The overall amount may be considerable, given the
volume of what has been buried — 572 million pounds of the 22 monitored
drugs since 1988.
In one case, government data shows that in Columbus, Ohio, pharmaceutical maker Boehringer Ingelheim Roxane Inc.
discharged an estimated 2,285 pounds of lithium carbonate — which is
considered slightly toxic to aquatic invertebrates and freshwater fish
— to a local wastewater treatment plant
between 1995 and 2006. Company spokeswoman Marybeth C. McGuire said the
pharmaceutical plant, which uses lithium to make drugs for bipolar disorder,
has violated no laws or regulations. McGuire said all the lithium
discharged, an annual average of 190 pounds, was lost when residues
stuck to mixing equipment were washed down the drain.
___
Pharmaceutical company officials
point out that active ingredients represent profits, so there's a huge
incentive not to let any escape. They also say extremely strict
manufacturing regulations — albeit aimed at other chemicals — help
prevent leakage, and that whatever traces may get away are handled by
onsite wastewater treatment.
"Manufacturers have to be in compliance with all relevant
environmental laws," said Alan Goldhammer, a scientist and vice
president at the industry trade group Pharmaceutical Research and Manufacturers of America.
Goldhammer conceded some drug residues could be released in wastewater,
but stressed "it would not cause any environmental issues because it
was not a toxic substance at the level that it was being released at."
Several big drugmakers were asked this simple question: Have you tested
wastewater from your plants to find out whether any active
pharmaceuticals are escaping, and if so what have you found?
No drugmaker answered directly.
"Based on research that we have reviewed from the past 20 years,
pharmaceutical manufacturing facilities are not a significant source of
pharmaceuticals that contribute to environmental risk," GlaxoSmithKline said in a statement.
AstraZeneca
spokeswoman Kate Klemas said the company's manufacturing processes "are
designed to avoid, or otherwise minimize the loss of product to the
environment" and thus "ensure that any residual losses of
pharmaceuticals to the environment that do occur are at levels that
would be unlikely to pose a threat to human health or the environment."
One major manufacturer, Pfizer Inc., acknowledged that it tested some of its wastewater — but outside the United States.
The company's director of hazard communication and environmental toxicology,
Frank Mastrocco, said Pfizer has sampled effluent from some of its
foreign drug factories. Without disclosing details, he said the results
left Pfizer "confident that the current controls and processes in place
at these facilities are adequately protective of human health and the
environment."
It's not just the industry that isn't testing.
FDA spokesman Christopher Kelly
noted that his agency is not responsible for what comes out on the
waste end of drug factories. At the EPA, acting assistant administrator
for water Mike Shapiro — whose agency's Web site says pharmaceutical
releases from manufacturing are "well defined and controlled" — did not
mention factories as a source of pharmaceutical pollution when asked by
the AP how drugs get into drinking water.
"Pharmaceuticals get into water in many ways," he said in a
written statement. "It's commonly believed the majority come from human
and animal excretion. A portion also comes from flushing unused drugs
down the toilet or drain; a practice EPA generally discourages."
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."
Baylor University professor Bryan Brooks, who has published
more than a dozen studies related to pharmaceuticals in the
environment, said assurances that drugmakers run clean shops are not
enough.
"I have no reason to believe them or not believe them," he
said. "We don't have peer-reviewed studies to support or not support
their claims."