[Pharmwaste] The chemical bisphenol A has been known to pose severe health risks to laboratory animals. AND THE CHEMICAL IS IN YOU.

DeBiasi,Deborah dldebiasi at deq.virginia.gov
Mon Dec 3 11:15:49 EST 2007


http://www.jsonline.com/story/index.aspx?id=692145



CHEMICAL FALLOUT: JOURNAL SENTINEL WATCHDOG REPORT 

WARNING: The chemical bisphenol A has been known to pose severe health
risks to laboratory animals. AND THE CHEMICAL IS IN YOU.

It's in baby bottles, soda cans and 93% of us. It causes breast cancer,
testicular cancer, diabetes and hyperactivity in lab animals, according
to 80% of studies analyzed by the Journal Sentinel. But U.S. regulators
side with the chemical-makers and say it's safe.

By SUSANNE RUST, MEG KISSINGER and CARY SPIVAK

srust at journalsentinel.com

Posted: Dec. 2, 2007

For more than a decade, the federal government and chemical-makers have
assured the public that a hormone-mimicking compound found in baby
bottles, aluminum cans and hundreds of other household products is safe.


But a Journal Sentinel investigation found that these promises are based
on outdated, incomplete government studies and research heavily funded
by the chemical industry. 

In the first analysis of its kind by a newspaper, the Journal Sentinel
reviewed 258 scientific studies of the chemical bisphenol A, a compound
detected in the urine of 93% of Americans recently tested. An
overwhelming majority of these studies show that the chemical is harmful
- causing breast cancer, testicular cancer, diabetes, hyperactivity,
obesity, low sperm counts, miscarriage and a host of other reproductive
failures in laboratory animals.

Studies paid for by the chemical industry are much less likely to find
damaging effects or disease. 

U.S. regulators so far have sided with industry by minimizing concern
about the compound's safety.

Last week, a panel commissioned by the National Toxicology Program
released a report finding bisphenol A to be of some concern for fetuses
and small children. It found that adults have almost nothing to worry
about.

Its recommendations could be used by the U.S. Environmental Protection
Agency and other regulators to assess federal policies on how much
bisphenol A is safe and may have huge ramifications for the
multibillion-dollar chemical industry.

The panel said it considered more than 700 studies by university
scientists, government researchers and industry-funded chemists. It
picked the work it felt was best and threw out the rest. 

The Journal Sentinel found that panel members gave more weight to
industry-funded studies and more leeway to industry-funded researchers.

* The panel rejected academic studies that found harm - citing
inadequate methods. But the panel accepted industry-funded studies using
the same methods that concluded the chemical does not pose risks.

* The panel missed dozens of studies publicly available that the Journal
Sentinel found online using a medical research Internet search engine.
The studies the panel considered were chosen, in part, by a consultant
with links to firms that made bisphenol A.

* More and more university researchers and foreign governments are
finding that bisphenol A can do serious damage in small doses. But the
panel rejected studies mostly submitted by university and international
government scientists that looked at the impact at these levels.

* The panel accepted a Korean study translated by the chemical
industry's trade group that found bisphenol A to be safe. It also
accepted two studies that were not subjected to any peer review - the
gold standard of scientific credibility. Both studies were funded by
General Electric Co., which made bisphenol A until it sold its plastics
division earlier this year. 

"This undermines the government's authority," said David Rosner,
professor of history and public health at Columbia University. "It makes
you think twice about accepting their conclusions."

Panel chairman Robert Chapin, a toxicologist who works for Pfizer Inc.,
the pharmaceutical giant, defended his group's work.

"We didn't flippin' care who does the study," said Chapin, who worked as
a government scientist for 18 years before joining Pfizer. 

If the studies followed good laboratory practices and were backed with
strong data, they were accepted, Chapin said.

Created to act as hormone
Bisphenol A was developed in 1891 as a synthetic estrogen. It came into
widespread use in the 1950s when scientists realized it could be used to
make polycarbonate plastic and some epoxy resins to line food and
beverage cans.

With the advent of plastic products such as dental sealants and baby
bottles, the use of bisphenol A has skyrocketed. The chemical is used to
make reusable water bottles, CDs, DVDs and eyeglasses. More than 6
billion pounds are produced each year in the United States. 

In recent decades, increases in the number of boys born with genital
deformities, girls experiencing early puberty and adults with low sperm
counts, uterine cysts and infertility prompted some researchers to
wonder whether the prevalence of bisphenol A could be interfering with
human development and reproduction.

Scientists began looking for a link between bisphenol A and spikes in
cancer, obesity and hyperactivity. Others, such as Patricia Hunt, simply
stumbled onto it.

Hunt, a scientist at Case Western Reserve University, was investigating
the connection between maternal age and Down syndrome in 1998 when all
of her laboratory mice, including those not treated in any way, began
exhibiting chromosomal abnormalities.

Her investigation revealed that bisphenol A was leaching from the
animals' polycarbonate cages, and it was the chemical that had caused
the problems.

Ana Soto, a researcher at Tufts University, began noticing that her lab
mice treated with bisphenol A were a lot fatter than her other mice.

More alarming still was the work scientists found in their breast and
prostate cancer research. They injected cancer cells in test tubes of
bisphenol A and watched as the cells grew rapidly, even at doses lower
than what people are normally exposed to. Reports such as these sparked
fear that bisphenol A could become the new lead or asbestos. 

As scientists' suspicions grew, regulators repeatedly reassured the
public that the chemical was safe. The Food and Drug Administration and
the EPA routinely pointed to studies by government regulators in the
1980s that found no serious effects.

In 1998, the National Toxicology Program formed the Center for the
Evaluation of Risks to Human Reproduction to look at why so many people
were unable to conceive or carry their babies to term. Scientists were
suspicious of the environmental impact from chemicals, including
hormone-mimicking chemicals such as bisphenol A. 

Last year, two groups of scientists were appointed by the federal
government to gauge bisphenol A's risks. 

One panel was purely academic, made up of 38 international experts in
bisphenol A who work for universities or governments. In an August
report, they found a strong cause for concern.

Levels of bisphenol A in people were higher than the levels found to
cause harm in lab animals, the panel said. The average level found was
above what the EPA considered safe.

The other group, led by Chapin, included 12 scientists. The members were
chosen because of their lack of detailed knowledge about bisphenol A.
The idea was that the group would serve as an impartial jury, Chapin
said.

It considered 742 studies conducted over the past 30 years.

The non-expert panel was less alarmed about bisphenol A's effects.

The non-expert panel's report was posted Monday on the center's Web site
without a press release or fanfare. When the panel released an earlier
draft, critics assailed it as arbitrary, biased and incomplete.

The sharpest response came from bisphenol A experts, many of whom had
their work rejected by the non-expert panel. Even those whose work was
accepted were critical of the findings.

"When panels that are sponsored by the government come out with reports
and say that there is not convincing evidence yet, that gives me great
concern, knowing what I do about some studies showing that there are
effects," said Gail Prins, professor of physiology at the University of
Illinois at Chicago and an expert in bisphenol A.

The federal government will now weigh the reports of both the expert and
non-expert panels before assessing safe levels of bisphenol A.

Studies found widespread effects

Before reviewing the panel's reports, the Journal Sentinel analyzed 258
studies spanning two decades. All studies involved live animals with
spines - those species scientists consider most relevant to people. The
studies were found on PubMed, an online search engine used by
researchers. 

Four out of five studies found that bisphenol A caused problems in the
lab animals tested, ranging from allergies to reproductive deformities.
The vast majority of these studies were funded by government agencies
and universities.

One federally funded study found that rats exposed to bisphenol A before
birth were at increased risk of developing precancerous prostate
lesions. Another study, funded by the U.S. and Argentine governments,
found that the chemical increased the likelihood of rats developing
mammary tumors. 

Just 12% of the studies found that bisphenol A had no ill effects. Most
of those studies were paid for or partially written by scientists hired
by the chemical industry.

A study funded by the Society of the Plastic Industry found that
bisphenol A did not pose harm to developing rats. Another study
discounted any reproductive effects on exposed rats. The authors
included scientists affiliated with Shell Chemicals, Dow Chemical Co.
and General Electric - all then makers of bisphenol A.

Two studies actually determined that bisphenol A may be beneficial. One
funded by drug-maker Eli Lilly & Co. said it could lower cholesterol in
rats. The other study said the chemical might prevent or cure breast
cancer in rats.

Industry scientists dispute any claims that bisphenol A is harmful to
humans.

"Our view is consistent with what has been concluded by government and
scientific bodies around the world, which is that bisphenol A is not a
risk to human health based on the weight of scientific evidence," said
Steven G. Hentges, executive director of the American Chemistry
Council's Polycarbonate/BPA Global Group. Hentges called the newspaper's
review superficial.

Norman Fost, founder and director of the medical ethics program at the
University of Wisconsin-Madison, said industry and academic studies come
to radically different conclusions all the time. Fost would not comment
directly on the panel's work because he hadn't studied it. But he said
the universe of scientific research is replete with studies conducted by
organizations with a vested interest. 

"It's up to us to be skeptical, cautious and critical when we consider
how much of their work to believe," said Fost, who is chairman of an FDA
committee looking at the ethics of pediatric studies.

Human safety levels
Bisphenol A is just about everywhere. But trying to get a handle on how
much of the chemical a person can tolerate is not easy. 

The government established a safety level for bisphenol A about 20 years
ago - well before most scientific studies on the chemical had been
conducted. The government considers a safe daily level of bisphenol A to
be 50 micrograms per kilogram of body weight. For a 200-pound person,
that would be the equivalent of no more than one drop of the chemical
every five days. 

The American Chemistry Council says an average adult would have to
ingest more than 500 pounds of canned food and beverages every day for
an entire lifetime to be at risk. The chemical industry based those
conclusions on its own research.

Others say there is no way to know how much bisphenol A one is exposed
to when microwaving dinner in a plastic container, eating tuna from a
can or drinking from a reusable plastic water bottle. 

"Even if you go out of your way to avoid products, you don't know all of
your exposures," said Soto, the bisphenol A expert from Tufts. "At the
end of the day, you may have cut your exposure by 5 percent or by 95
percent. We just don't know."

Because bisphenol A is so ever-present in the environment, there are
many ways to be exposed to it. But the biggest risk comes from those
products that people put in their mouths or that come directly into
contact with food, scientists say.

A number of studies looked at how bisphenol A affects lab animals at low
doses. Bisphenol A experts say that the chemical works like a hormone
and, therefore, needs to be tested at low doses where much damage can be
done.

"This is basic endocrinology," said Frederick vom Saal, a biologist at
the University of Missouri who has been studying bisphenol A for more
than a decade. "You learn this in any introductory class. Hormones work
on an extremely sensitive system."

For instance, it only takes 40 parts per billion of the hormone MIS to
produce male sexual organs in the human embryo. That's about one drop in
15 bathtubs of water. 

Two groups of scientists - from the National Academy of Sciences and the
National Toxicology Program - have called for the U.S. government to
radically overhaul the way it tests chemicals to include these low
doses. But the government has yet to do so. Instead, it continues to
cite the government studies from the early 1980s that focused only on
high doses.

Of the 258 studies reviewed by the Journal Sentinel, 168 studies looked
at low-dose effects of bisphenol A.

The vast majority - 132 studies- found health problems at low doses,
including hyperactivity, diabetes and genital deformities. All but one
of those studies were conducted by non-industry scientists. Nearly
three-fourthsof the studies that found the chemical had no harmful
effects were funded by industry.

But Chapin's panel did not accept any studies that found an effect at
low doses in its review of 742 studies. 

Once the panel weeded out studies it believed had been done poorly, no
studies remained that showed effects from low doses, Chapin said.

"There's a lot of bad science out there," he said. 

Most of the low-dose studies the Journal Sentinel reviewed - including
some the panel rejected - were published in reputable scientific
journals.

Prins, the bisphenol A expert from the University of Illinois at
Chicago, said she was a late convert to the idea that the chemical
causes harm at low doses. She changed her mind after reading repeated
studies.

Then she saw it in her lab. 

"We gave very small doses to male rats and saw cancerous lesions form on
their prostates," Prins said. 

For the panel to dismiss low-dose effects is a fatal flaw, she said. 

Chapin conceded that the panel did not give equal weight to studies that
considered low-dose effects, the levels that most people are exposed to
every day.

"I'll admit it. We may be off in like totally uncharted territory,"
Chapin said. 

The chemical industry defended the panel's choice of studies, noting
that their scientists have been unable to replicate the work of some
university scientists.

"Replication is a hallmark of science, and studies that cannot be
replicated cannot be accepted as valid," said Hentges of the chemistry
council.

Panel's work studied
The Journal Sentinel reviewed the work that the panel did, comparing
each of its two drafts and the final report, together totaling more than
1,000 pages. 

Two of the panel's four chapters considered the same kind of studies the
newspaper reviewed - looking at the effects of bisphenol A on live
animals. In one of those chapters, focusing on reproductive toxicology,
20 studies by either government or academia were tossed. No study that
disclosed it had been funded by industry was rejected.

Chapin said they gave greater weight to studies that used more animals.
Critics say only the chemical-makers can afford to conduct studies with
more animals.

The panel failed to apply consistent standards, the newspaper's review
found.

Not all studies recorded the kind of feed, caging, bedding or specific
type of animal used. Those factors can influence the studies' results.

Chemical industry researchers used the same methodology in studies the
panel accepted that caused other studies to be rejected. They included
studies that used a single high dose and injected rats with bisphenol A
rather than having the chemical administered orally. Chapin's panel
rejected some studies, including those conducted by Soto, because they
used an oil called DMSO to administer bisphenol A to rats.

"That just helps compounds waltz into cells," Chapin said.

But Chapin's panel accepted another study that used DMSO, never citing
that oil as a limitation or concern.

The panel also accepted a study by Shell Chemical, Dow Chemical and
General Electric that found no effects from bisphenol A. The same study
also found no effects when rats were exposed to the powerful chemical
diethylstilbestrol, or DES - a compound known to cause reproductive
harm. 

The rats' resistance to DES should have been an immediate red flag,
critics said. But the panel accepted the research. 

Consulting firm fired
Chapin's group has been dogged by controversy from the beginning. Last
year, conflict-of-interest concerns were raised regarding the panel's
use of Sciences International. The Virginia-based consulting firm had
been hired to choose and summarize research for panel members. However,
it had not been revealed that Sciences International had clients that
included bisphenol A producers. 

The company was fired in April, and the National Institutes of Health
audited the firm's report. It found no conflict, and the company is
credited in the final report.

Chapin dismissed criticisms against the panel.

"I'm tired of having my credibility as a scientist questioned when the
panel bent over backwards to apply standards of good scientific conduct
. . . evenly across the board," Chapin said. "My accusers have a great
deal more bias than I do.

"They are not unbiased," Chapin added, "even though they keep holding
themselves up as the white hats, the pure, the only holders of the cup
of scientific chastity."

The newspaper found dozens of studies of bisphenol A that were not
brought to the panel's attention.

Among them was a 2005 study that determined the chemical disrupted brain
development in rats at very low levels. The panel also missed a study
last year by Yale University researchers that found the chemical altered
reproductive tract development in female mice exposed in the womb.
Again, the researchers found these effects at low levels - below what
the EPA considers safe.

"I'm surprised because my understanding was after all the hoo-ha was
raised about Sciences International, the NTP went out and did its own
search," Chapin said. "That's weird."

In one study accepted by Chapin's panel, the work was translated into
English by the American Plastics Council, a division of the American
Chemistry Council. The Korean study found that the sperm density and the
reproductive systems of male rats were not harmed by bisphenol A. 

Rosner, the public health professor, said that practice "immediately
raises eyebrows."

"You have to have a neutral party doing the translations," he said.
"It's the only way to really trust the accuracy."

Michael Shelby, director of the government agency that selected the
panel to evaluate bisphenol A, acknowledged that the translation could
be called into question. However, he denied any conflict.

Chapin said panel members agreed that they wanted to see any data they
could, regardless of how they got it. 

"I hear what you're saying about the perception," Chapin said. "Too
bad."

Two studies, both funded by industry, were not peer reviewed, the
newspaper found. Peer review is considered the foundation of scientific
credibility. Most scientific journals will not publish a study unless it
is peer reviewed. 

The studies found no effects from bisphenol A, and were funded by
General Electric in 1976 and 1978. They were accepted despite concerns
similar to those that led the panel to disqualify academic and
government studies. They included a small sample size of animals, the
use of high doses and questions about the statistical methodology.

The panel also accepted at least a dozen studies that had not been
published in any scientific journal - another check and balance in the
scientific community to maintain high standards.

Shelby said the panel considered studies that were not peer reviewed if
they included sufficient details. 

Even scientists on the panel who agreed with the findings say they are
uneasy about broad claims that bisphenol A is safe.

Jane Adams, a professor at the University of Massachusetts, doesn't
allow her teenage son to get dental sealants because of her worries
about bisphenol A. 

"I am concerned about this chemical," she said. "Much more research
needs to be done."

Simon Hayward, another panelist, agrees. 

"Where there's smoke, there's fire," said Hayward, professor of prostate
biology at Vanderbilt University Medical Center. "There is definitely
enough smoke to be worried."

Rosner, the public health historian, says bisphenol A's potential for
danger is too great to allow its widespread use without being certain of
its safety. Consider what happened with lead and tobacco, he said.

"The government needs to work with caution," he said, noting that we
have lived well for thousands of years without this chemical. "Until we
know that it is safe, it is more prudent to avoid it." 





Deborah L. DeBiasi
Email:   dldebiasi at deq.virginia.gov
WEB site address:  www.deq.virginia.gov
Virginia Department of Environmental Quality
Office of Water Permit Programs
Industrial Pretreatment/Toxics Management Program
PPCPs, EDCs, and Microconstituents
Mail:          P.O. Box 1105, Richmond, VA  23218 (NEW!)
Location:  629 E. Main Street, Richmond, VA  23219
PH:         804-698-4028
FAX:      804-698-4032



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