Testing Bug Killers on People

[Guest guest]

theeagle-l , " Robert Lederman "

<robert.lederman@w...> wrote:

 

 

Village Voice

http://www.villagevoice.com/issues/0328/tracy.php

EPA Opens the Door to Testing Bug Killers on People

Spoon-Feeding Poison

by Tennille Tracy

July 9 - 15, 2003

 

(illustration: Anthony Freda)

 

The Bush administration is now moving to endorse the testing of

noxious and

lethal chemicals on human beings. Since this spring, despite rife

opposition

from the medical community, the Environmental Protection Agency has

quietly

begun lifting a 1998 ban on accepting such research. Once the

prohibition is

gone, which will likely happen next year, chemical companies will

have the

full support of the federal government to dose healthy young men and

women

with the latest insecticides, rodenticides, and fungicides.

 

This marks the second round in a fiery debate over pesticide tests

using

people. In the late 1990s, a group of doctors and public health

advocates

noticed that pesticide companies were conducting a growing number of

these

trials as part of attempts to get government approval. The advocates

railed

against the EPA and balked at the agency's failure to enforce ethical

standards. The " EPA does not routinely require companies who conduct

human

experiments to . . . follow any ethical protocol, " noted a 1998

report from

the Environmental Working Group.

 

Later that year, with criticism mounting, the agency prohibited its

offices

from using human data in new pesticide registrations. Some companies

continued the testing, however, saying it was necessary to determine

health

risks. But they also preferred that method because they got more

favorable

readings from dosing people as opposed to lab rats.

 

The tests appear to defy the very essence of the Hippocratic oath,

" First,

do no harm. " Unlike tests for exploratory vaccines and medicines,

pesticide

studies offer zero benefits for participants. They're designed to

find the

level at which concoctions of orange juice and bug spray won't send

people

crawling toward death, and are considered a glowing success only when

nothing happens. Independent researchers say the tests' scientific

value is

highly suspect.

 

But there's big money at stake, especially with the EPA considering

new

restrictions or outright bans on a number of products. On March 31,

the

Office of Management and Budget, the White House's rule review board,

signed

off on a rough draft of a new policy that would again allow the EPA to

accept the test results.

 

Doctors, environmentalists, and public health advocates have been

fighting

the change. When the EPA first took up the idea, medical experts

began to

pore over a stack of human tests. They found many of the studies were

cloaked in claims of valid research but were dominated by practices

that

belonged in the annals of medical farce. " A reasonable person might

conclude

that they were specifically designed to fail to show effects of the

pesticides, " said Dr. Alan Lockwood, a member of Physicians for Social

Responsibility and a neurology professor at the State University of

New York

at Buffalo.

 

Vermin killers have a nasty history. In 1934, Nazi Germany whipped up

the

first batch of pesticides-organophosphates, in scientific parlance-

for use

as a chemical weapon. Although the toxic soup never made it to the

front

lines, I.G. Farben, the company that manufactured it, found it could

be

marketed as bug sprays and rodent zappers.

 

Today, big chemical companies are fans of human research because it

encourages less stringent standards. With data from lab animals, the

EPA

assumes the predicted hazards for humans would be greater by a factor

of 10.

It's called the " inter-species rule, " adopted by Congress to account

for

potential differences between reactions in, say, a two-year-old child

and a

mature lab rat. Testing on humans lets a company duck the automatic

increase.

 

That translates directly into several billion dollars for the

pesticide

industry, which annually sells nearly 4.5 billion pounds of chemicals-

at a

profit of more than $6 billion. Manufacturers have an outsized

financial

incentive to push for testing on humans, warned Dr. Lynn Goldman, the

EPA's

pesticide director under President Clinton and now a professor at the

Johns

Hopkins Bloomberg School of Public Health. " EPA must of course be

mindful at

all times of the test sponsors' interests in performing tests and, of

course, of the almost overwhelming economic incentives that companies

have

to find ways to market more of their products, " she said in January,

testifying before the National Academy of Sciences.

 

Critics say the companies give sparse attention to decent testing

procedures

and that nearly every aspect of the testing seems driven by the need

to get

EPA approval.

 

Take, for example, a 1999 test conducted by the Lincoln, Nebraska-

based MDS

Harris Laboratory. A handful of subjects were administered Dow

Chemical's

chlorpyrifos, a direct descendant of Hitler's nerve agents. MDS

Harris had

recruited the group of healthy young men and women by assuring them

their

health would be preserved, and by handing out juicy compensation

checks.

They were told in consent agreements that low doses of chlorpyrifos

" have

been shown to improve performance on numerous tests of mental

function, "

implying that the chemical could propel them into a new realm of

genius.

" The consent process was inadequate, deceptive, or both, " Dr.

Lockwood said.

" This makes it sound like chlorpyrifos is good for you and may make

you

smarter-a clear deception. "

 

Nevertheless, when none of them died, fainted, or delivered farewell

speeches while clutching their hearts in agony, Dow submitted a

glowing

report of the pesticide to the EPA and eagerly awaited registration

approval. Just one year later, on June 8, 2000, the EPA determined

that

chlorpyrifos, a widely employed pesticide, posed an " unreasonable

threat "

and said residential uses should be expeditiously restricted.

 

In another experiment, conducted in 1997 at the Central Toxicology

Laboratory, researchers gave oral doses of dichlorvos, a common

insecticide,

to a group of six young men. When four of them suffered a dangerous

drop in

vital enzyme levels, they had to withdraw from the test. With only two

subjects able to complete the doses, the Central Toxicology Laboratory

announced that " no symptoms or adverse effects . . . were reported. "

They

skirted the fact that two-thirds of the participants had to drop out

and

effectively asserted that the results derived from two people

adequately

reflected the potential harm to 266 million U.S. citizens.

 

And there is potential harm. Pesticides eat away at an enzyme called

cholinesterase, which plays a key role in all physical movement. It

sweeps

away chemical debris between nerve cells, allowing those cells to

fire up to

1,000 electric impulses to each other every second. Pesticides break

down

cholinesterase, leaving millions of chemical messages to clog the

works. In

mild cases, this leads to nausea, sweating, uncontrollable drooling,

headaches, and vomiting. In severe cases, it causes muscular tremors,

abnormally low blood pressure, loss of bowel functions, slowed heart

rates,

and even death.

 

But test groups rarely get that sick. And that's no surprise,

considering

their size and make-up. They're usually limited to between six and 50

people, typically young and healthy adults who are paid anywhere from

$300

to $1,000. The studies are advertised in local newspapers or on

college

campuses, specifically targeted to attract people from low-income or

minority communities.

 

Pesticide companies insist that trying out their wares on you and your

neighbors allows idiosyncratic human reactions to surface. " These

safety

factors are necessary, " said Ray McAllister, vice president for

science and

regulatory affairs for CropLife America, a lobbying group

representing 41

corporations, including Dow, DuPont, and Monsanto. " If we don't know

how

humans react, then we can't be confident of safety. "

 

The industry is lining the campaign coffers on Capitol Hill. In the

five

years since the EPA stopped looking at human research, the Center for

Responsive Politics reports, companies providing agricultural

services and

products donated more than $20 million to political campaigns, almost

70

percent of which went to Republicans.

--- End forwarded message ---