World's highest drug levels entering India stream

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World's highest drug levels entering India stream

http://news.yahoo.com/s/ap/20090125/ap_on_re_as/pharmawater_india

By MARGIE MASON, AP Medical Writer Margie Mason, Ap Medical Writer –

2 hrs 54 mins agoPATANCHERU, India – When researchers analyzed vials

of treated wastewater taken from a plant where about 90 Indian drug

factories dump their residues, they were shocked. Enough of a single,

powerful antibiotic was being spewed into one stream each day to

treat every person in a city of 90,000.

And it wasn't just ciprofloxacin being detected. The supposedly

cleaned water was a floating medicine cabinet — a soup of 21

different active pharmaceutical ingredients, used in generics for

treatment of hypertension, heart disease, chronic liver ailments,

depression, gonorrhea, ulcers and other ailments. Half of the drugs

measured at the highest levels of pharmaceuticals ever detected in

the environment, researchers say.

Those Indian factories produce drugs for much of the world, including

many Americans. The result: Some of India's poor are unwittingly

consuming an array of chemicals that may be harmful, and could lead

to the proliferation of drug-resistant bacteria.

" If you take a bath there, then you have all the antibiotics you need

for treatment, " said chemist Klaus Kuemmerer at the University of

Freiburg Medical Center in Germany, an expert on drug resistance in

the environment who did not participate in the research. " If you just

swallow a few gasps of water, you're treated for everything. The

question is for how long? "

Last year, The Associated Press reported that trace concentrations of

pharmaceuticals had been found in drinking water provided to at least

46 million Americans. But the wastewater downstream from the Indian

plants contained 150 times the highest levels detected in the U.S.

At first, Joakim Larsson, an environmental scientist at the

University of Gothenburg in Sweden, questioned whether 100 pounds a

day of ciprofloxacin could really be running into the stream. The

researcher was so baffled by the unprecedented results he sent the

samples to a second lab for independent analysis.

When those reports came back with similarly record-high levels,

Larsson knew he was looking at a potentially serious situation. After

all, some villagers fish in the stream's tributaries, while others

drink from wells nearby. Livestock also depend on these watering

holes.

Some locals long believed drugs were seeping into their drinking

water, and new data from Larsson's study presented at a U.S.

scientific conference in November confirmed their suspicions.

Ciprofloxacin, the antibiotic, and the popular antihistamine

cetirizine had the highest levels in the wells of six villages

tested. Both drugs measured far below a human dose, but the results

were still alarming.

" We don't have any other source, so we're drinking it, " said R.

Durgamma, a mother of four, sitting on the steps of her crude mud

home in a bright flowered sari a few miles downstream from the

treatment plant. High drug concentrations were recently found in her

well water. " When the local leaders come, we offer them water and

they won't take it. "

Pharmaceutical contamination is an emerging concern worldwide. In its

series of articles, AP documented the commonplace presence of minute

concentrations of pharmaceuticals in U.S. drinking water supplies.

The AP also found that trace concentrations of pharmaceuticals were

almost ubiquitous in rivers, lakes and streams.

The medicines are excreted without being fully metabolized by people

who take them, while hospitals and long-term care facilities annually

flush millions of pounds of unused pills down the drain. Until

Larsson's research, there had been widespread consensus among

researchers that drug makers were not a source.

The consequences of the India studies are worrisome.

As the AP reported last year, researchers are finding that human

cells fail to grow normally in the laboratory when exposed to trace

concentrations of certain pharmaceuticals. Some waterborne drugs also

promote antibiotic-resistant germs, especially when — as in India —

they are mixed with bacteria in human sewage. Even extremely diluted

concentrations of drug residues harm the reproductive systems of

fish, frogs and other aquatic species in the wild.

In the India research, tadpoles exposed to water from the treatment

plant that had been diluted 500 times were nonetheless 40 percent

smaller than those growing in clean water.

The discovery of this contamination raises two key issues for

researchers and policy makers: the amount of pollution and its

source. Experts say one of the biggest concerns for humans is whether

the discharge from the wastewater treatment facility is spawning drug

resistance.

" Not only is there the danger of antibiotic-resistant bacteria

evolving; the entire biological food web could be affected, " said

Stan , senior scientist at the Land Institute, a nonprofit

agriculture research center in Salina, Kan. has studied and

written about pharmaceutical pollution in Patancheru. " If Cipro is so

widespread, it is likely that other drugs are out in the environment

and getting into people's bodies. "

Before Larsson's team tested the water at Patancheru Enviro Tech Ltd.

plant, researchers largely attributed the source of drugs in water to

their use, rather than their manufacture.

In the U.S., the EPA says there are " well defined and controlled "

limits to the amount of pharmaceutical waste emitted by drug makers.

India's environmental protections are being met at Patancheru, says

Rajeshwar Tiwari, who heads the area's pollution control board. And

while he says regulations have tightened since Larsson's initial

research, screening for pharmaceutical residue at the end of the

treatment process is not required.

Factories in the U.S. report on releases of 22 active pharmaceutical

ingredients, the AP found by analyzing EPA data. But many more drugs

have been discovered in domestic drinking water.

Possibly complicating the situation, Larsson's team also found high

drug concentration levels in lakes upstream from the treatment plant,

indicating potential illegal dumping — an issue both Indian pollution

officials and the drug industry acknowledge has been a past problem,

but one they say is practiced much less now.

In addition, before Larsson's study detected such large

concentrations of ciprofloxacin and other drugs in the treated

wastewater, levels of pharmaceuticals detected in the environment and

drinking water worldwide were minute, well below a human dose.

" I'll tell you, I've never seen concentrations this high before. And

they definitely ... are having some biological impact, at least in

the effluent, " said Dan Schlenk, an ecotoxicologist from the

University of California, Riverside, who was not involved in the

India research.

And even though the levels recently found in Indian village wells

were much lower than the wastewater readings, someone drinking

regularly from the worst-affected reservoirs would receive more than

two full doses of an antihistamine in a year.

" Who has a responsibility for a polluted environment when the Third

World produces drugs for our well being? " Larsson asked scientists at

a recent environmental research conference.

M. Narayana Reddy, president of India's Bulk Drug Manufacturers

Association, disputes Larsson's initial results: " I have challenged

it, " he said. " It is the wrong information provided by some research

person. "

Reddy acknowledged the region is polluted, but said that the

contamination came from untreated human excrement and past industry

abuses. He and pollution control officials also say villagers are

supposed to drink clean water piped in from the city or hauled in by

tankers — water a court ordered industry to provide. But locals

complain of insufficient supplies and some say they are forced to use

wells.

Larsson's research has created a stir among environmental experts,

and his findings are widely accepted in the scientific community.

" That's really quite an incredible and disturbing level, " said

Sharp, senior analyst at the Washington-based Environmental Working

Group. " It's absolutely the last thing you would ever want to see

when you're talking about the rise of antibiotic bacterial resistance

in the world. "

The more bacteria is exposed to a drug, the more likely that bacteria

will mutate in a way that renders the drug ineffective. Such

resistant bacteria can then possibly infect others who spread the

bugs as they travel. Ciprofloxacin was once considered a powerful

antibiotic of last resort, used to treat especially tenacious

infections. But in recent years many bacteria have developed

resistance to the drug, leaving it significantly less effective.

" We are using these drugs, and the disease is not being cured — there

is resistance going on there, " said Dr. A. Kishan Rao, a medical

doctor and environmental activist who has treated people for more

than 30 years near the drug factories. He says he worries most about

the long-term effects on his patients potentially being exposed to

constant low levels of drugs. And then there's the variety, the

mixture of drugs that aren't supposed to interact. No one knows what

effects that could cause.

" It's a global concern, " he said. " European countries and the U.S.

are protecting their environment and importing the drugs at the cost

of the people in developing countries. "

While the human risks are disconcerting, Sharp said the environmental

damage is potentially even worse.

" People might say, 'Oh sure, that's just a dirty river in India,' but

we live on a small planet, everything is connected. The water in a

river in India could be the rain coming down in your town in a few

weeks, " she said.

Patancheru became a hub for largely unregulated chemical and drug

factories in the 1980s, creating what one local newspaper has termed

an " ecological sacrifice zone " with its waste. Since then, India has

become one of the world's leading exporters of pharmaceuticals, and

the U.S. — which spent $1.4 billion on Indian-made drugs in 2007 — is

its largest customer.

A spokesman for the Pharmaceutical Research and Manufacturers of

America, representing major U.S. drugmakers, said they could not

comment about the Indian pollution because the Patancheru plants are

making generic drugs and their members are branded. A spokesman for

the Generic Pharmaceutical Association said the issues of Indian

factory pollution are " not within the scope of the activities " of

their group.

Drug factories in the U.S. and Europe have strictly enforced waste

treatment processes. At the Patancheru water treatment plant, the

process is outdated, with wastewater from the 90 bulk drug makers

trucked to the plant and poured into a cistern. Solids are filtered

out, then raw sewage is added to biologically break down the

chemicals. The wastewater, which has been clarified but is still

contaminated, is dumped into the Isakavagu stream that runs into the

Nakkavagu and Manjira, and eventually into the Godawari River.

In India, villagers near this treatment plant have a long history of

fighting pollution from various industries and allege their air,

water and crops have been poisoned for decades by factories making

everything from tires to paints and textiles. Some lakes brim with

filmy, acrid water that burns the nostrils when inhaled and causes

the eyes to tear.

" I'm frustrated. We have told them so many times about this problem,

but nobody does anything, " said Syed Bashir Ahmed, 80, casting a

makeshift fishing pole while crouched in tall grass along the river

bank near the bulk drug factories. " The poor are helpless. What can

we do? "

___

AP National Writer Martha Mendoza contributed to this report from

California.