In U.S., Few Alternatives To Testing On Animals: critics say, hundreds of thousands of mice, rabbits, hamsters and dogs continue to suffer and die unnecessarily in tests ... Washington Post April 12, 2008

[Guest guest]

From a silent sisterCrazy!-------------------------------------------------------

In

U.S. , Few Alternatives To Testing

On Animals

Panel Has Produced 4 Options in 10 Years By

Gilbert M. Gaul

Washington Post Staff Writer

Saturday, April 12, 2008; A01 Each

year, American doctors inject more than 3 million doses of Botox

to temporarily smooth their patients' wrinkles and frown lines. But before each

batch is shipped, the manufacturer puts it through one of the oldest and most

controversial animal tests available. To check

the potency of its product under federal safety rules, Allergan

Inc. injects mice with Botox until it finds a dose at which half of the

animals die -- a rough gauge of potential harm to humans. Animal

protection groups consider "lethal dose 50," as the test is known, to

be "the poster child for everything that's wrong with animal

testing," said s, vice president for animal research issues

at the Humane

Society of the United States. "It's as bad as it gets, poisoning

animals to death." Allergan

officials say they have no choice. Without a federally approved safety test

that does not use animals, a company spokeswoman says, lethal dose 50 "is

by default the required test." The

controversy over the Botox test highlights the slow pace of government efforts

to replace or reduce the large numbers of animals used by pharmaceutical

companies, chemical manufacturers and consumer firms to ensure that their

products are safe for people. A decade after Congress created a panel to spur

the development of non-animal tests, only four such tests have been approved

out of 185 reviews, according to the panel's records. Several

of the panel's original backers now consider the system broken. As a result,

critics say, hundreds of thousands of mice, rabbits, hamsters and dogs continue

to suffer and die unnecessarily in tests for pesticides, household cleaners,

sunscreens and other products. "We

were thrilled when the legislation was passed," said Sara Amundson, a

former official with the Doris Day Animal League who was involved in creating

the panel. "It's shocking to look back and see how little we have

accomplished." The

federal panel is known as the Interagency Coordinating Committee on the

Validation of Alternative Methods, or ICCVAM. Representatives of 15 federal

agencies make up the committee. Instead

of acting as an advocate for companies and nonprofits proposing non-animal

tests, the panel has become an obstacle, animal welfare groups say. They point

to Europe,

where a similar panel has approved 34 alternatives to animal tests and has

another 170 in its pipeline. Critics say the

U.S. panel is slow and favors older

animal tests that have never gone through the same rigorous scientific review. The

executive director of the U.S. panel, S. Stokes, said in a statement that his group "has

successfully reviewed over 185 test methods" and that the four

alternatives it has endorsed "have significantly reduced the number of

animals required for safety assessments, and provided for improved welfare of animals

used in safety evaluations." One alternative has saved "at least

36,000 animals annually," Stokes said. Members

of the panel also contend that it is unfair to compare Europe and the

United States because the laws, rules and expectations are different. Europe has legislation mandating the use of non-animal tests. The

United States only recommends their use. Nevertheless,

some U.S. company officials and scientists said they have delayed or abandoned their

proposals for non-animal tests because panel reviews are protracted and

expensive. Others consider panel members biased in favor of animal tests that

in some cases date back to the 1920s. "One

should ask why after years of existence they have reviewed so few tests,"

said Neil Wilcox, a former Food

and Drug Administration official involved in the creation of the committee. "The

fundamental reason, in my opinion, is that the ICCVAM process has become

recognized as an obstacle to getting tests validated as opposed to helping

having tests validated," said Wilcox, now director of regulatory and

scientific affairs for -

Corp. An e-mail

exchange last summer between the panel's chair and other government scientists

reinforced the suspicions of animal advocates that panel members are resistant

to newer tests. In the exchange, copies of which were obtained by The

Washington Post, the scientists discussed two recent papers by a prominent

European researcher favoring an alternative approach known as evidence-based

toxicology. One scientist asked what they could do "to combat these

papers." The chair, Marilyn L. Wind, responded: "What I see is them

trying to build a case to not use animals for testing."

Sandler of the group People

for the Ethical Treatment of Animals called the e-mail "disturbing.

Why are they using phrases like 'to combat these papers'? That has no place in

there." Wind

declined to discuss the exchange but said in an e-mail to The Post that the

panel "has a proven track record" of advancing animal safety. Stokes

stressed that panel members work closely with their European counterparts. In

February, at its 10-year anniversary celebration, the panel released a

five-year plan, with a goal of assuming a greater leadership role in promoting

research, development . . . and regulatory acceptance of alternative test

methods." Wilcox,

of -, was not impressed. "The five-year plan is not a

strategy," he said. "It's a reiteration of what they're doing. It's

certainly not a vision." 'A New World ' For more

than half a century, companies have tested chemicals, drugs and cosmetics on

animals to prove that their products are safe. Poisons are fed to rats and mice

to determine what dose may be harmful to humans. Chemical compounds are dripped

on the skin and eyes of rabbits to check for irritation. Vaccines are given to

mice before being made available to the public. Animal

welfare groups contend that millions of animals are used in such tests each

year. But no one knows for sure. Unlike rules covering animals used in medical

research, there are no federal reporting requirements for mice and rats, which

account for most of the animals used in product testing. Some

scientists argue that animals provide the most reliable way to gauge the

effects of toxins and drugs on humans. Others contend that newer tests take

advantage of advances in biology and computer science, offering a potentially richer

array of safety data. "The

reason we use animal tests is because we have a comfort level with the process

.. . . not because it is the correct process, not because it gives us any real

new information we need to make decisions," said Melvin E. Andersen,

director of the division of computational systems biology at the Hamner

Institutes for Health Sciences near Raleigh,

N.C.

"Animal tests are no longer the gold standard," he said. "It is

a marvelously new world." Allergan

officials say that in recent years they have reduced their use of animals by

one-third but declined to disclose the number, citing company confidentiality. Many

firms say they have stopped using the lethal-dose method in favor of a test

that uses fewer animals. But Allergan officials say that, for assessing

potency, their only choice is the lethal dose test. In 2005,

the Humane Society requested that ICCVAM review non-animal alternatives to the

Botox test. A panel of scientists gathered in 2006 and produced a draft report

of the meeting in August 2007. But nearly a year later, the Humane Society's s

said he is still waiting for a final report and for direction from the federal

group on what additional research is needed. "It's

great that ICCVAM held its workshop and drew some attention," said

s, a former member of the federal panel's scientific advisory committee.

"But that alone won't get us to the finish line. We need to move beyond

the animal methods and figure out which one or two of the replacements are the

most promising." Scientists

who have gone before ICCVAM contend the process is unduly cumbersome, with

multiple layers of review and panels that include scientists who are not

familiar with regulatory issues or are not experts on non-animal tests. "The

big problem with the peer review panel was that many of them were chosen for

their knowledge of the general field but didn't have a real understanding of

what they were there to do," said Kristie Stoick, scientific and policy

adviser to the Physicians

Committee for Responsible Medicine. Stoick

closely followed a panel that recently reviewed a series of alternatives for a

rabbit test used to measure bacteria levels in blood products and other

materials. The panel rejected the alternatives, which have been used in

Europe for years. Stoick said that several of the panel's

observations and recommendations "seemed nonsensical, irrelevant or

inappropriate. Too often it seems that panelists have unreasonable expectations

regarding every minute detail of the alternative methods, without a clear

understanding of the limitations of the current animal-based methods." That view

was echoed by Willett, director of science policy for People for the

Ethical Treatment of Animals. "People just assume de facto that animal

tests are relevant to humans without scientific evidence," she said.

"It's not fair to make non-animal tests go through this [approval] process

but not make the others." One

result of the delays is that some companies use non-animal tests in-house but

are still required to perform animal tests to meet regulatory requirements. "Companies

are putting infinitely more money into the development of alternatives and are

much more aware of . . . new in vitro methods than government regulators,"

said Rodger Curren, president of the nonprofit Institute for In Vitro Sciences

in Gaithersburg,

which works with consumer products companies to develop non-animal tests. "But

the regulators say, 'You still have to prove to me that it's safe using an

animal.' " The European Plan Europe began moving away

from animal testing more than 20 years ago. The European

Commission voted in 1986 to require the use of alternative tests wherever

possible. It later banned animal testing for cosmetics and passed other rules

affecting chemical makers. The

European

Center for the Evaluation of Alternative

Methods, or ECVAM, was created in 1991. It has more than 60 employees and a

budget of $25 million, about 10 times the size of its American counterpart.

Another important difference: The European panel researches and develops

non-animal tests, while the U.S. committee does not. "Some

animal tests haven't changed in 60 years," said Hartung, head of

the European group. "The tests are frozen in time. This is not science.

Science is always moving ahead." Hartung,

who helped write the papers discussed in last summer's e-mail, said he was not

surprised by the response from some

U.S. scientists: "When you say

something new, there is resistance to change." Of the 34

alternative tests accepted for use in Europe, only a handful have been approved

by the U.S. panel and are used by regulatory agencies. The small number has

fostered a perception among some European scientists and officials that

U.S. scientists

are more comfortable with animal tests and do not trust their work. "It

is something difficult to prove," said Manfred Liebsch, a German scientist

in charge of alternative tests at the Federal Institute for Risk Assessment in Berlin.

"My perception . . . is based on nothing but a serious gut feeling and the

fact that almost all of ICCVAM's activities have in fact been slowing down

everything." In his

statement, Stokes said, "The ICCVAM process is very rigorous." As a

result, "alternative test methods evaluated in Europe often may need to be

reevaluated in the . . . United

States ." Last

June, the National

Research Council, the scientific advisory arm of the National Academies,

called for a fundamental rethinking of the traditional methods used to assess

the risk of chemicals and toxins. "I

think ICCVAM is being leapfrogged by the science," said Chad B. Sandusky,

a former Environmental

Protection Agency scientist who now directs research for the Physicians

Committee for Responsible Medicine. "I've sort of written them off."

No virus found in this outgoing message.

Checked by AVG.

Version: 7.5.519 / Virus Database: 269.22.13/1376 - Release Date: 4/13/2008 1:45 PM