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Tons of released drugs taint US water
By JEFF DONN, MARTHA
MENDOZA and JUSTIN PRITCHARD, Associated Press Writers - Mon Apr 20,
1:45 AM PDT U.S. manufacturers, including major drug-makers, 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 drug-making: 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, drug-makers 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 drug-makers 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 drug-makers 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 drug-makers
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 drug-maker 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, drug-makers 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 drug-makers 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 drug-makers 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 drug-making 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 drug-makers 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." ___ Associated Press Writer Don
Mitchell in Denver contributed to this report.
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