EPA Opens the door for testing bug killers on People

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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.

 

Donadaghovi AiSv Nv wa do hi ya do

(Til next we meet, Walk in Peace)

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