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Tons of Released Drugs Taint US Water

By Jeff Donn, Martha Mendoza and Justin Pritchard
Associated Press
April 19, 2009


U.S. 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."

 

 

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