Bypass pharmaceuticals/Rachel's 702

From: Michele Gale-Sinex (mgs@rprogress.org)
Date: Tue Jul 11 2000 - 16:22:55 EDT


Howdy, all--

How I wish I had time to discuss this piece at length. Over the past 8
years (that I've been with SANET) we've talked about half a dozen different
times about veterinary pharmaceuticals showing up in the environment. Most
recently I think it was a discussion of antibiotics passed through livestock.

This piece is about human drugs, bypassing bodies and finding their way
into water, etc. And how pharmaceutical companies' big-profit incentives
are the engine driving this. Peter has done a wonderful job of telling this
complex story here.

peace
mish

>=======================Electronic Edition========================
>. .
>. RACHEL'S ENVIRONMENT & HEALTH WEEKLY #702 .
>. ---July 6, 2000--- .
>. HEADLINES: .
>. PAY DIRT FROM THE HUMAN GENOME .
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>
>
>PAY DIRT FROM THE HUMAN GENOME
>
>The human genome -- the blueprint for making a human being -- has
>been almost completely cataloged. "Today we are learning the
>language in which God created life," said President Clinton,
>announcing the accomplishment June 26.[1] Under a banner headline
>on page 1, the NEW YORK TIMES called it "an achievement that
>represents a pinnacle of human self-knowledge."
>
>The 3 billion genetic instructions that form a blueprint for
>human life have now been cataloged, but the meaning of most of
>those instructions remains unknown. Therefore, the practical
>significance of deciphering the book of human life remains murky
>except in one area: many new pharmaceutical drugs will soon be
>possible. Unfortunately, this is a mixed blessing. A raft of new
>drugs may benefit those humans who need and can afford them, but
>new drugs make serious trouble for the natural environment and
>for many of the non-human creatures living there. Even for
>humans, drugs already represent a major environmental challenge
>-- arguably the most difficult chemical challenge that we face.
>The environment is already heavily polluted with drugs and
>personal care products that have passed through humans, entered
>sewage treatment plants and then been discharged into waterways.
>(See REHW #614.) Increased drug pollution of our waterways --
>including our drinking water -- is one of the dark sides of the
>human genome project -- a dark side that few acknowledge.
>
>News reports of the human genome achievement have been dominated
>by "gee whiz" predictions of accelerating pharmaceutical
>advances, with no hint of any problems. The NEW YORK TIMES said,
>"The successful deciphering of this vast genetic archive attests
>to the extraordinary pace of biology's advance since 1953, when
>the structure of DNA was first discovered and presages an era of
>even brisker progress."[1] The TIMES went on to quote Dr. Gillian
>R. Woollett, representing the Pharmaceutical Research and
>Manufacturers of America, a drug manufacturers' trade
>association: "The rate of change is absolutely incredible. It's
>actually changing the way drug development is even conceived,"
>said Dr. Woollett.[3]
>
>The next day the business section of the TIMES explained how
>companies are "finding gold in scientific pay dirt: ...Genomics
>companies are using different methods to build businesses out of
>the genome," the TIMES said, offering three examples: "Incyte
>Genomics Inc. of Palo Alto, Calif., sells access to a database
>about genes to drug companies. Millennium Pharmaceuticals of
>Cambridge, Mass., is using genomics to understand disease
>processes to develop drugs. Human Genome Sciences of Rockville,
>Md. is developing drugs and selling its information," the TIMES
>wrote.[5] Notably, all three examples of commercial exploitation
>of the genome involve new drugs.
>
>Last December two scientists -- Christian G. Daughton and Thomas
>A. Ternes -- writing in ENVIRONMENTAL HEALTH PERSPECTIVES, a
>respected, peer-reviewed journal, pointed out the relationship
>between the human genome project and new drugs: "The enormous
>array of pharmaceuticals will continue to diversify and grow as
>the human genome is mapped. Today there are about 500 distinct
>biochemical receptors at which drugs are targeted.... The number
>of targets is expected to increase 20-fold (yielding 3000 to
>10,000 drug targets) in the near future...."[6] Daughton and
>Ternes go on to say, "Escalating introduction to the marketplace
>of new pharmaceuticals is adding exponentially to the already
>large array of chemical classes, each with distinct modes of
>biochemical action, many of which are poorly understood."
>
>Daughton and Ternes say that the quantity of pharmaceuticals and
>personal care products entering the environment each year is
>roughly comparable to the amounts of pesticides used each year.
>Huge quantities of prescription drugs and biologics, diagnostic
>agents, "neutraceuticals," fragrances, sun-screen agents and
>numerous other classes of compounds enter the environment each
>year, without any government agencies taking notice. As daughton
>and Ternes point out, these chemicals tend to have several
>worrisome characteristics:
>
>** Many are very long-lived, many break down into other
>long-lived compounds with their own peculiar chemical
>characteristics, and almost nothing is known about their movement
>in the environment;
>
>** Pesticides tend to enter the environment in seasonal pulses.
>In contrast, pharmaceuticals and personal care products (PPCPs)
>enter the environment continuously via domestic and industrial
>sewage systems and via wet-weather runoff (for example, from
>confined animal feeding operations such as hog factories).
>
>** Unlike many pesticides, most drugs and personal care products
>have not been examined for adverse environmental effects.
>Daughton and Ternes comment, "This is surprising especially since
>certain pharmaceuticals are designed to modulate [change]
>endocrine and immune systems and cellular signal transduction and
>as such... have obvious potential as endocrine disruptors in the
>environment."[6,pg.908]
>
>** Many of these chemicals are designed to have profound
>physiologic effects, so it would not be surprising if they were
>found to affect fish, shellfish, birds, worms, frogs, insects,
>and other forms of life.[6,pg.925]
>
>** With pharmaceuticals, unpredicted and unknown side effects are
>often the norm: "The possible actions and biochemical
>ramifications on nontarget aquatic biota are even less
>understood; many are totally unknown," Daughton and Ternes say.
>
>** "It is important to recognize that for many drugs, their
>specific modes of action even in the target species are also
>unknown. For these drugs, it is impossible to predict what
>effects they might have on non-target organisms." [6,pg.923]
>
>** Most drugs don't cure illnesses, they control symptoms -- they
>lower cholesterol levels or blood pressure, or they alleviate
>pain or depression, or they revive limp libidoes. However, to
>achieve these results, they must be taken continuously, often for
>many years. Therefore, even relatively short-lived PPCPs can
>cause chronic exposures because they are continuously infused
>into the environment;
>
>** Aquatic organisms are captives of their aquatic environment so
>must endure perpetual exposure;
>
>** The bioaccumulation/bioconcentration potential for at least
>some PPCPs matches that of organochlorine compounds;[6,pg.910]
>
>** Some PPCPs show "very high acute aquatic toxicity" while
>others "can elicit constellations of significant but subtle
>effects across numerous species."[6,pg.910]
>
>** It must also be recognized that even though individual
>concentrations of any drug might be low, the combined
>concentrations from drugs sharing a common mechanism of action
>could be substantial."[6,pg.925]
>
>** Most chemical researchers don't have the tools needed to look
>for these chemicals in the environment. Researchers use gas
>chromatography (GC) and mass spectrometry (MS). The signals
>produced by such analytic equipment are compared to "spectral
>libraries," allowing unknown chemicals to be identified. But the
>standard spectral libraries available from U.S. Environmental
>Protection Agency (EPA), the National Institute of Standards and
>Technology (NIST), and the National Institutes of Health (NIH) do
>not include most pharmaceuticals. Therefore typical researchers
>are not prepared to identify pharmaceuticals in the environment.
>
>** Daughton and Ternes list 66 classes of pharmaceuticals,
>including antidepressants; cancer chemotherapy drugs;
>tranquilizers and psychiatric drugs; pain killers of many kinds;
>anti-inflammatory drugs; many kinds of antihypertensives (blood
>pressure reducers); antiseptics; fungicides; anti-epileptics;
>bronchodilators (such as albuterol); many lipid regulators or
>anti-cholesterol agents; chemicals to increase the contrast in
>x-rays; muscle relaxants; anti-psychotic drugs; oral
>contraceptives; anorectics (diet pills); antibiotics; and
>synthetic hormones (estrogen and thyroid). Details about the 200
>most popular prescription drugs in the U.S. in 1999 can be found
>at www.rxlist.com/top200.htm. These 200 reportedly account for
>two thirds of all the prescriptions filled each year in the U.S.
>
>** Most exposure to drugs and personal care products occurs in
>the aquatic environment, but it also occurs on land: "...the
>primary source for terrestrial exposure is probably from disposal
>of biosolids [sludge] from [sewage treatment plants] and from
>animal wastes both applied to land and stored in open-air pits
>(waste lagoons)..." [6,pg.925]
>
>** Daughton and Ternes say, "Theoretically, [pharmaceuticals and
>personal care products] in sewage sludge applied to crop lands
>could be taken up by plants."[6,pg.921] Surely everyone can agree
>that this problem should be examined carefully BEFORE allowing
>sewage sludge to be mixed with soil.
>
>Is this a new problem? Daughton and Ternes show that, "It
>therefore was clearly recognized over 20 years ago that the
>continual, daily introduction of kilogram quantities of drugs
>from a given [sewage treatment plant] into receiving waters could
>result in sustained concentrations with the potential to lead to
>exposures in aquatic organisms." [6,pg.925]
>
>But for 20 years regulatory officials and drug corporations have
>pretended that the problem does not exist, perhaps because they
>have no idea what to do about it. Now the problem seems about to
>get worse for three reasons: (1) The genome-induced gold rush to
>produce new drugs, mentioned above; (2) the Internet, which is
>allowing people to purchase drugs that they previously could not
>get their hands on; and (3) recent public hearings by the U.S.
>Food and Drug Administration (FDA) to consider allowing many
>prescription drugs to be sold without a prescription. The last
>time FDA held such hearings, in 1972, 600 drugs switched from
>prescription to non-prescription status.[7]
>
>Christian Daughton, a scientist with U.S. Environmental
>Protection Agency, is aggressively urging environmental
>scientists to pay more attention to this problem. However
>Daughton acknowledges that the problem may already be too large
>for detailed scientific analysis: "In the final analysis, given
>the vast array of mechanisms of drug action and side effects, the
>total number of different toxicity tests possibly required to
>screen the effluent from a typical [sewage treatment plant] could
>be impractically large." [6,pg.923]
>
>In June of this year, Daughton and others organized a scientific
>conference in Minnesota.[8] There, Glen R. Boyd, a civil engineer
>from Tulane University in New Orleans reported finding drugs in
>the Mississippi River, in Louisiana's Lake Ponchetrain, and in
>Tulane's tap water. In all the waters tested, Boyd and his team
>found low levels of the anti-cholesterol drug clofibric acid
>along with the pain killer naproxen and the hormone estrone. In
>Tulane's tap water, estrone averaged 35 parts per trillion with a
>high of 80 parts per trillion.
>
>Naturally, the water-dwelling creatures will bear the brunt of
>all this because they cannot escape civilized peoples' habit of
>urinating and defecating in all the available fresh water. At the
>Minnesota meeting in June a team of scientists reporting finding
>male carp and walleyes producing "sky high" quantities of
>vitellogenin, an egg-yolk protein normally made only by females.
>In 1998, Environment Canada, Canada's federal environmental
>agency, reported high levels of estrogens and birth control
>compounds in the effluent of sewage treatment plants nationwide.
>Chris D. Metcalfe of Trent University in Peterborough, Ontario
>created laboratory conditions similar to those found by
>Environment Canada and he reported in June that those conditions
>cause some fish to become intersex -- having the characteristics
>of both males and females. Metcalfe has found intersex white
>perch in the Great Lakes.
>
>** Daughton and Ternes say, "A major unaddressed issue regarding
>human health is the long-term effects of ingesting via potable
>waters very low subtherapeutic doses of numerous pharmaceuticals
>multiple times a day for many decades." [6,pg.923] What will it
>mean to raise our babies on water contaminated with low levels of
>birth control drugs and athlete's foot remedies plus Viagra,
>Prozac, Valium, Claritin, Amoxicillin, Prevachol, Codeine,
>Flonase, Ibuprofen, Dilantin, Cozaar, Pepcid, Albuterol,
>Naproxen, Warfarin, Ranitidine, Diazepam, Bactroban, Lotrel,
>Lorazepam, Tamoxifen, Mevacor, and dozens of other potent drugs,
>along with hair removers, mosquito repellants, sunburn creams,
>musks and other fragrances? No one knows, but evidently we're
>going to find out, learning by doing.
> --Peter Montague
>
>============
>
>[1] Nicholas Wade, "Genetic Code of Human Life is Cracked by
>Scientists," NEW YORK TIMES June 27, 2000, pg. 1.
>
>[2] Nicholas Wade, "Now the Hard Part: Putting the Genome to
>Work," NEW YORK TIMES June 27, 2000, pg. D1.
>
>[3] Kenneth Chang, "Incomplete, Project Is Already Paying off,"
>NEW YORK TIMES June 27, 2000, pg. D1.
>
>[4] Andrew Pollack, "Is Everything for Sale?" NEW YORK TIMES June
>28, 2000, pg. C1.
>
>[5] Andrew Pollack, "Finding Gold in Scientific Pay Dirt," NEW
>YORK TIMES June 28, 2000, pg. C1, C12.
>
>[6] Christian G. Daughton and Thomas A. Ternes, "Pharmaceuticals
>and Personal Care Products in the Environment: Agents of Subtle
>Change," ENVIRONMENTAL HEALTH PERSPECTIVES Vol. 107 Supplement 6
>(December 1999), pgs. 907-938.
>
>[7] Sheryl Gay Stolberg, "U.S. May Ease Sale of Drugs Over the
>Counter," NEW YORK TIMES June 28, 2000, pg. A1.
>
>[8] Janet Raloff, "Excreted Drugs: Something Looks Fishy,"
>SCIENCE NEWS June 17, 2000, pg. 388.
>
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