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    AP IMPACT: Tons of released drugs taint US water

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    olddrummer66
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    AP IMPACT: Tons of released drugs taint US water

    Post by olddrummer66 on Sun Apr 19, 2009 11:39 pm




    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."

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