"Pesticide" Testing on Humans-----------

Ken Cook, president of the Environmental Working Group, an activist organization in Washington that has tracked the human research trend, called the testing questionable. "Would you want your kid to participate in a study like this?" (My question is even more basic, what good does it do to only test the active ingredient when you are using/ignoring all of the "inerts", contaminants, metabolites, and any/all synergistic effects?)
 

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Subject:      "Pesticide" Testing on Humans-----------
 Date:         Thu, 23 Dec 1999 12:57:51 -0500
From:         Stephen Tvedten <steve@getipm.com>
Organization:     Get Set Inc. (www.getipm.com)

To:     Lyndon Hawkins <hawkins@empm.cdpr.ca.gov>
          State of California, Department of Pesticide Regulation
          Integrated Pest Management

 
Dear Lyndon, I thought you might like to read an article that was published Sunday, December 19, 1999, entitled:  Lincoln Lab Is Only One in U.S. to Test Pesticides on Humans - By Jake Thompson.  COPYRIGHT 1999 - OMAHA WORLD-HERALD CO.

Washington - In the only known testing of its kind under way in the United States, MDS Harris Laboratory in Lincoln has been conducting pesticide research on humans.

Researchers this year asked volunteers in Nebraska to swallow small doses of a pesticide (active ingredient) to examine its potential harmful effects on people.

The study was one of 14 submitted to the Environmental Protection Agency that involve people ingesting 10 different pesticides. The 13 other studies were on volunteers in the United Kingdom.

Together, the studies are at the heart of a debate among scientists, ethicists and pesticide makers about the scientific value, the standards for and the moral justification of testing pesticides (only the active ingredients) on humans.

While some at the EPA, which regulates pesticides, see clear value in these human studies, which are legal, many do not, said John Carley, special assistant in the EPA's Office of Pesticide Programs.

"There are many people at the agency who are troubled by the fact this testing has ever gone on and is going on, or might ever go on in the future," Carley said.

The EPA recently established a panel to review human testing.

For the MDS Harris research, some of the 60 volunteers swallowed a capsule containing chlorpyrifos, a pesticide (active ingredient) widely used on crops as well as in schools, hospitals and 20 million homes to kill such pests as termites, ticks, cockroaches and fire ants. The pesticide (entire formula) is commonly marketed as Lorsban or Dursban.

Some of the 60 volunteers were part of a control group and were given a placebo. The volunteers earned $460 for their participation. Carley said participants in Great Britain are paid twice as much.

Earlier this year, the EPA concluded that chlorpyrifos poses high risks to millions of Americans because it can disrupt the nervous system.

Supporters of the research said it is hoped that the tests will show how much of the pesticides (active ingredient) can be ingested without any noticeable harm to people. Those supporters note that doses given to the volunteers fell well under a toxic dose.

According to results from the MDS Harris study, volunteers who swallowed the pesticide capsules reported developing one incident each of nausea, vomiting, abdominal pain, shortness of breath, impairment of sensation and chest pain. Those symptoms were possibly or probably related to ingesting the pesticide, according to the study. (One "incident" too much!)

MDS Harris declined to discuss the study, referring questions to its client, Dow Chemical, the principal maker of chlorpyrifos.

But Dr. Jim McClurg, MDS Harris' president of life sciences, said all of its studies follow international rules protecting participants and are reviewed by independent experts before and after the work. McClurg said the Lincoln-based company, founded in 1933, has clinics in a handful of cities worldwide and does a large amount of research on the clinical development of drugs.

Garry Hamlin, a spokesman for Dow AgroSciences, said Dow sought the human research to add to the 3,600 previous research studies and reports on the pesticide. They involved lab studies, animal research and studies of people who apply the pesticide or routinely work in areas in which it is applied.

Direct testing on human volunteers can help clear up uncertainty that exists between animal studies and the eventual impact on people, he said.

The previous research guided the dosage levels in MDS Harris' study so that it "would not cause any harm to the volunteers," Hamlin said.

Ken Cook, president of the Environmental Working Group, an activist organization in Washington that has tracked the human research trend, called the testing questionable. "Would you want your kid to participate in a study like this?"  (My question is even more basic, what good does it do to only test the active ingredient when you are using/ignoring all of the "inerts", contaminants, metabolites, and any/all synergistic effects?)

The American Crop Protection Association says that human tests are safe and that the compounds studied are widely found in small concentrations in the environment and the nation's food supply.

For years, the EPA has neither required nor encouraged human tests. And while such tests flourished in the 1960s and 1970s, according to Carley, concerns about the ethics and safety led most companies to discontinue such tests.

Then, in 1996, Congress passed the Food Quality Protection Act, which required stricter protections for children from pesticides.

Attempting to show that their products are safe, large pesticide makers resumed testing their pesticides on people to aid in the government's risk assessment. The argument is this: Human studies are more accurate than animal studies and might establish a higher safe dose. (ONLY OF THE ACTIVE INGREDIENT.)

In May 1998, the EPA published a federal notice that human tests might be helpful in assessing safety risks.

When criticism of the notice surfaced, the EPA set up a special advisory panel to recommend a refined policy that considers the safety, ethics and conditions for human tests.

The advisory panel held its second meeting Nov. 30. An EPA background paper for the meeting noted that the agency accepts other human tests, such as those studying people who apply pesticides on fields and for businesses.

But the agency said that the 1996 law "may have unintentionally created an incentive" to test pesticides in human volunteers.

"These studies raise difficult scientific and ethical questions we are not yet able to answer, and we are deeply concerned about them," the background paper states.

The pesticide makers compare the pesticide studies to what are called Phase 1 clinical drug tests commonly submitted to the U.S. Food and Drug Administration. In those tests, the objective is to determine adverse reaction levels to a drug.

Jeffrey Kahn, a bioethicist at the University of Minnesota and an EPA advisory panel member, said the pesticide tests are fundamentally different.

The ultimate goal in drug tests is to make people healthy, he said, but the pesticide tests help determine at what levels of exposure (SOME HEALTHY) people become  (acutely) sick.

Further, the drug tests usually involve people who already are ill, while the pesticide tests seek (ONLY) healthy (ADULT) subjects.

"I think there's a question of how much risk healthy individuals should bear when there's not a clear benefit to the person," Kahn said. "All of the risk is to the individual subjects, and all the benefits are to society or the companies producing these chemicals (POISONS)."

Another issue before the advisory panel is whether human pesticide studies are statistically valid.

Dr. Herbert Needleman of the University of Pittsburgh, who is a member of the advisory panel, said the sample size in the 14 studies sent to the EPA was too small. One examined seven subjects and another examined 50, he said.

That cannot help establish what is called a no-effect level, a government standard below which there is no noticeable reaction. A study would need from 1,000 to 5,000 human participants to be statistically correct, Needleman said.

Ray McAllister, senior director of scientific and regulatory policy for the Washington-based crop association, disagreed. He said that the studies are valid because they examine enzyme function, which varies in humans anyway. So finding a response in a small number of human pesticide testers could be translated to the population at large, he said.

It's also important, McAllister said, that the testing subjects volunteer and are informed of the substance they are taking, the dosage and its risks.

A copy of the informed-consent form was included in the study sent to the EPA. The seven-page form explains that the test involves chlorpyrifos, sketches its effects on the nervous system, outlines how the study will be conducted and warns that there are 15 potential adverse reactions, including headache, dizziness, abdominal cramps, tremors and tightness in the chest.

It also has a pregnancy-related warning: "Although animal studies indicate little or no risk in humans, the possible side effects to a fetus or embryo are unknown."

Of the volunteers in the MDS Harris study, 30 were men and 30 were women. Slightly more than one-third were 18 to 25 years old, the rest in their late 20s to early 50s. Most were nonsmokers.

The volunteers were enlisted through ads in newspapers and on MDS Harris' Internet site, such as one ad that says, "EARN EXTRA MONEY. Make a Difference by Assisting in Medical Research. "

Participants were given health screenings and drug and alcohol tests to determine medical history and fitness. They were told that the test material was a registered insecticide, according to the study.  (How many sick/ill people/babies will be exposed to only the active poison ingredient?  How can you "scientifically" ignore the dangers of the bulk of the POISON formula?)

The volunteers were given capsules with either chlorpyrifos or the placebo. They were given pills three or four times a day.  Their vital signs were tracked and urine and blood samples were collected by MDS Harris staff.

The study used two phases and several groups to examine the effects of a rising dose of chlorpyrifos, documents show.

Lyndon, this "study" will obviously not show the true dangers/risks of using  Lorsban/Dursban.  Nor will it look at chronic exposure problems, synergistic health effects and/or even  the possibility of using any safe alternatives.

For the record, I have safely and effectively removed all of the pests inside and outside in over 350 schools, and I have never needed to use any "registered", volatile pesticide POISONS!   When will it be "legal" (in your opinion) to use safe, unregistered alternatives in California?

Respectfully,  Stephen L. Tvedten

---

Comment added to Mr. Tvedten's email to Lyndon Hawkins

Subject:   Re: "Pesticide" Testing on Humans-----------
   Date:   Fri, 24 Dec 1999 11:15:25 EST
   From:  DrRappMD@aol.com
     To:   info@safe2use.com

Your children are participating in the exposures all the time in schools, in homes, when playing on pesticides lawns. The  question is not should we expose them but what is happening to those who are exposed. You want answers.
Start checking the many who are becoming ill on a daily basis from "routine unavoiidable" pesticide poisons. quit playing games. Not only the children but all of us are now in  danger.

Doris J Rapp, MD

The human testing issues boil down to two things;
1. If you are testing only part of the ingredients of a product, it is of value, only in relation to that part studied and it can miss the synergistic effects of multiple chemical exposures at the same time. This is what happens with pesicide expsoures. To check oly one part is sheer folly and a waste of time and money and human health.

2. You need to give the amount of the chemical that causes the blood levels we are seeing in patients who are ill. If only the healthiest volunteer to e tested, and are given only a partical dose of exposure of only part of the ingredients of the pesticide, it can easily give a most fallacious indication of safety.

When will they wake up. I still say. The answer is to expose monkeys and do brain images. Show that the brains are damaged and the changes are what we are seeing in children and adults who are exposed.   maybe that will wake them up. We have lots of people who are exposed purposely all the time. Check out the farm workers, the pregnant women's
children, the brains of those people whowork in the fields andspray the chemicals.  We must stop the game playing.

Doris J Rapp, MD