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 Cox, senior
scientist at the Land Institute, a nonprofit agriculture research center in Salina, Kan. Cox 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 Renee 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?"
