October 26

Science & Ethics Hold Up EPA Nomination: pesticide experiment draws fire

Science & Ethics Hold Up EPA Nomination: pesticide experiment draws fire

Fri, 08 Apr 2005

The Los Angeles Times reports that Senator Bill Nelson of Florida is equally outraged about the Environmental Protection Agency pesticide experiment that would expose 60 poor babies to pesticides to study how much harm they incur:

“The government should not be asking families to turn their babies into guinea pigs,” Nelson said in a statement. “They should be protecting children, not exposing them to pesticides.”

The exposure of children to pesticides puts them at risks of harm–without any potential benefit whatsoever–the question is only the magnitude of harm.

In January 2003 AHRP presented testimony against proposals to lift a government policy prohibiting the use of human beings in experiments testing pesticide effects. The committee was convened by the National Academies of Science (NAS) at the request of the EPA. See:

The NAS report lifted a prohibition that is mandated by The Nuremberg Code–which is the cornerstone of all medical research ethics–setting the parameters of the criteria for “permissible human experiments.”

The NAS at the request of the EPA attempted to legitimize unethical human experiments by claiming the experiments “were ethical provided that strict standards were used” –that’s a non sequitor. By their nature the experiments fail to meet universally adopted ethical standards.

The NAS committee–which included a leading bioethicists and the director of the FDA’s Office of Medical Policy–even “grandfathered” previous, illegitimate human pesticide experiments conducted by pesticide manufacturers: “The academy also said the agency should accept studies conducted before the use of such standards, unless they were fundamentally flawed.”

CHEERS–children’s environmental exposure research study–is the first government sponsored human pesticide experiment (that we are aware of). The experiment was endorsed by EPA’s Stephen Johnson, and was scheduled to be conducted on poor, mostly African American babies in Duval County, Georgia.

The efforts of AHRP–and the effort of two non-government environmental protection organizations–to shut the experiment down, is holding up the confirmation of Stephen Johnson as head of EPA.

The New York Times reports:
“With Mr. Johnson under fire, the agency said it would await a report from a scientific advisory group before making its decision on whether to continue the study. But other statements and private hints from the agency on Thursday gave indications that it would abandon the work, rather than face the public relations battle of fighting charges that it had planned to expose babies to toxic substances needlessly.”

Support our efforts to uphold the ethical principles enshrined in The Nuremberg Code and the Declaration of Helsinki. Hold government agencies and the officials who are entrusted with protecting the health and environment of the American people accountable.

Contact: Vera Hassner Sharav

April 8, 2005
Science, Ethics and a Stalled Nomination

WASHINGTON, April 7 – Last fall, when the Environmental Protection Agency proposed a $9 million study of how infants and toddlers are exposed to and affected by bug sprays, carpet cleaners and other pesticides and chemicals in their homes, it sought and found a generous partner in the American Chemistry Council, which generally seeks less stringent regulations for its members’ products.

The goal of the study, the agency said, was to “fill data gaps” in the scientific knowledge regulators use to make decisions about which pesticides can go on the nation’s hardware shelves. The E.P.A. offered parents as much as $970, children’s clothes like bibs and a camcorder to record their children’s activities. The chemistry council contributed $2 million.

The study, proposed for Florida but interrupted, is now being used by Democrats to stall the nomination of Stephen L. Johnson, a career scientist with years of work in the agency’s pesticide divisions, to be the E.P.A.’s next administrator.

Mr. Johnson has been the acting administrator since Michael O. Leavitt left in January to lead the Health and Human Services Department.

With Mr. Johnson under fire, the agency said it would await a report from a scientific advisory group before making its decision on whether to continue the study. But other statements and private hints from the agency on Thursday gave indications that it would abandon the work, rather than face the public relations battle of fighting charges that it had planned to expose babies to toxic substances needlessly.

On Thursday afternoon, the E.P.A. released a statement saying: “In fall 2004, Deputy Administrator Steve Johnson directed that the Children’s Health Environmental Exposure Research Study be suspended. Since that time, no work has been conducted on the study, nor is any planned.”

The genesis of the study, one of dozens in the past decade in which the agency has pooled its money with that of the companies it regulates, reflects two conflicting realities.

Regulators and industry alike want as much certainty as possible about what common chemicals like those found under many kitchen sinks can do to the most vulnerable human populations. But there is an ethical dilemma about how to acquire that information without hurting the very people who are meant to be protected.

Jeff Goldhagen, who directs the county health center in the Jacksonville, Fla., area, where the study was to take place, described the research as similar to studies in earlier years that looked at the damage children suffered from secondhand cigarette smoke.

“Exposing children to pesticides was not a part of the study,” said Dr. Goldhagen, the director of the Duval County Health Department and a pediatrician. “This was merely a look at those families, in which children live, who use pesticides. What is their exposure?”

In the Jacksonville area, he added, up to 80 percent of the households use pesticides “to control for insects, whether cockroaches, termites, ants, spiders.”

The vocal opposition to the study by two environmental groups was echoed in the Senate this week by two Democrats, Barbara Boxer of California and Bill Nelson of Florida.

Mike Casey, a spokesman for the Environmental Working Group, called it “a spectacularly bad idea.” In modern research involving humans, Mr. Casey said, “you never want to conduct a study in which people stand to get no health benefits.”

Erik D. Olson, a lawyer with the Natural Resources Defense Council, said: “We would argue that if you want to find out what the exposures are to kids that are in homes where pesticides are heavily applied, you can find them out through a random, well-designed look at blood and urine samples of the kids. For $9 million you could do 1,000 kids easily.”

The E.P.A. study was to focus on 60 children.

The whole issue of human testing has been a subject of controversy at the agency for much of the past decade. After the 1996 passage of the Food Quality and Protection Act, which provided for tighter controls on pesticides, the industry began to push for increased human testing.

Unlike medicines, for which drug companies conduct trials on people to establish safety, pesticides have in the past generally been tested on animals. The environmental agency notes the lowest levels that cause noticeable harm to animals and then sets the maximum allowable human exposure as much as 1,000 times lower.

That adjustment is designed to provide a margin of safety to allow for different biochemical processes in animals and people and for the extra sensitivity of young children to certain chemicals.

The chemical industry says human studies are more relevant for regulators guarding human health. They also may provide evidence that the agency could use to loosen some of the more stringent controls.

After the 1996 law, some chemical companies sponsored studies that paid people to expose themselves to toxic chemicals in an effort to show that higher exposure levels were still safe.

In December 2001, Dr. Johnson sought guidance from the National Academy of Sciences on whether his agency should consider such studies in making its regulatory decisions.

“What factors should the agency consider in determining whether to accept, consider, or rely on human studies performed by third parties?” Dr. Johnson wrote in a letter to the academy. “Are there clear boundaries between acceptable and unacceptable human research?”

The academy’s report, released last year, said such studies were ethical provided that strict standards were used, so that there was little chance of harm to people. The academy also said the agency should accept studies conducted before the use of such standards, unless they were fundamentally flawed.

Jamie Conrad, assistant general counsel for the American Chemistry Council, said the council believed that any human testing studies submitted to the agency should comply with the federal testing guidelines. “Our view is that the safety of human subjects is absolutely paramount,” Mr. Conrad said.

The agency, under the pressure of an industry lawsuit, has proposed regulations that incorporate the academy’s recommendations.

But passing scientific muster is not the same as passing public muster, the agency found shortly before the election last fall, when The Washington Post and the Environmental Working Group brought wide public notice to the agency’s partnership with the chemical industry in the Florida research project and the use of inducements to families to participate.

The Democratic attacks made that point anew on Wednesday.

“I’m going to stand up for the health and safety of children in my state,” Mr. Nelson said, announcing on Thursday that he, like Ms. Boxer, was holding up Mr. Johnson’s nomination.

Felicity Barringer reported from Washington for this article, and Kenneth Chang from New York.

Copyright 2005 The New York Times Company


Confirmation of EPA, FDA Heads Stalled
Democrats say the Senate showdowns were provoked by the agencies’ questionable policies, not politics.
By Warren Vieth and Ricardo Alonso-Zaldivar
Times Staff Writers

April 7, 2005

WASHINGTON – Senate Democrats threatened Wednesday to block the confirmations of President Bush’s nominees to head the Environmental Protection Agency and the Food and Drug Administration.

Sens. Barbara Boxer (D-Calif.) and Bill Nelson (D-Fla.) said they were placing parliamentary holds on the confirmation of Stephen L. Johnson as EPA administrator because he had not canceled a controversial program that would pay families to videotape the effect of pesticide exposure on infants through routine spraying in their homes.

In a separate move, Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) said they would block the confirmation of Lester Crawford as FDA administrator because of the agency’s delay in deciding whether to approve the “morning-after” birth control pill for sale without a prescription.

The confirmation showdowns arose from disputes over policies and programs within the two agencies and are not part of any coordinated action, Senate aides said.

But the similar actions appeared to signal a willingness on the part of Democrats to challenge the president more aggressively, and they could complicate White House efforts to win bipartisan support on such issues as Social Security restructuring.

The White House said it intended to stand behind Johnson, a 24-year EPA official who has headed the agency’s pesticide programs since 2001, and Crawford, a pharmacologist who has served as the FDA’s acting commissioner for about a year.

“We will continue to work with the senators to see to it that the president’s nominees are confirmed,” said White House spokeswoman Erin Healy.

The nominations of Johnson and Crawford were part of a second-term shuffle in which nine of 15 Cabinet portfolios changed hands. Although neither the EPA nor the FDA is a Cabinet department, both are high-profile agencies.

Boxer, a member of the Environment and Public Works Committee, said she was asking Senate leaders to place a parliamentary hold on Johnson’s nomination “until further notice,” effectively blocking it from coming to a vote on the Senate floor.

She said she decided to take the unusual step after Johnson told her committee that he had suspended – but not canceled – a program that proposed to pay 60 Florida families to record the effects of pesticide exposure on their infant children.

“Until this program is canceled – no ifs, ands or buts – I am putting a hold on this,” Boxer said after the hearing. “This is completely beyond the bounds. It’s a horrible idea. It’s an immoral idea. It’s harmful to these children.”

The conflict in Johnson’s nomination involves the Children’s Environmental Exposure Research Study, a two-year program that was in the process of signing up participants when Johnson suspended it in the fall. Sixty Duval County families were to receive $970 each – plus a camcorder and children’s clothing – for letting agency officials track the effect of pesticide exposure on children in their first year of life. The American Chemistry Council, a trade group, was to provide $2 million of the program’s $9-million budget.

“The government should not be asking families to turn their babies into guinea pigs,” Nelson said in a statement. “They should be protecting children, not exposing them to pesticides.”

Johnson told the Senate committee he had suspended the program after questions were raised about its propriety and said he was awaiting the results of an external scientific and ethical review before deciding whether it should proceed.

“I will ensure that EPA’s research meets the highest ethical standards,” Johnson said in a letter to Boxer released by his office after the hearing.

Murray and Clinton announced their move to block Crawford’s confirmation after receiving a briefing from the nominee and other FDA officials on the status of the emergency contraceptive.

“We had a meeting and we found it very unsatisfactory,” Murray said. “They were unwilling to give us a clear timeline. The FDA is saying they are trying to cross all the Ts and dot all the I’s on this application because of fear of litigation, which is not a scientific reason to delay approval.”

The morning-after pill, marketed by Barr Laboratories Inc. under the brand name Plan B, does not induce an abortion; it works by stopping ovulation or interfering with fertilization or implantation if a woman takes it within 72 hours of unprotected sex. Currently it is only available by prescription. In December 2003, an FDA expert advisory panel voted 23-4 to make the drug available without a prescription.

But the FDA overruled that recommendation, citing concerns that girls younger than 16 might not be able to use the drug safely without the advice of a doctor. Some religious and social conservatives have complained that making Plan B widely available would encourage promiscuity. Barr submitted a new application to the FDA, requesting approval to sell the drug to those 16 and older without a prescription. That proposal is now before the agency.

“The FDA has been doing nothing but delaying in its handling of Plan B, and every day is another day that women are denied access to a safe and effective method of contraception,” said Amy Allina of the National Women’s Health Network, an advocacy group that supports making the drug more easily available. “It seems clear that political concerns have gotten in the way.”

During his confirmation hearings, Crawford had promised a decision on Plan B within weeks. But Murray said the senators were unable to get a specific commitment during Wednesday’s briefing given members of the Senate Health, Education, Labor and Pensions Committee. “We will not allow this nomination to come for a vote on the floor until a decision is made,” she said.

“The bottom line is that the FDA has had the Plan B application for years, and the American people simply need an answer, yes or no,” Clinton said. “Science should never take a backseat to politics and ideology.”

Murray’s spokeswoman, Alex Glass, said the decision to block a vote on Crawford for the FDA post had nothing to do with opposition by Boxer and other Senate Democrats to the EPA nominee. “There is no coordinated strategy at all,” Glass said. “This is a completely separate issue.”

Erik Olson, a senior attorney with the Natural Resources Defense Council, an environmental advocacy group, applauded the effort to slow Johnson’s confirmation and defended the use of parliamentary holds in such circumstances.

“It is one of the only methods left to insist that the administration respond to difficult questions that they would prefer to avoid answering,” Olson said.

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