Re: Critics slam chemical report: Scientists note flaws in bisphenol A study; lawmaker wants ban ... (Milwaukee Journal Sentinel) Oct. 24, 2008

[Guest guest]

The FDA is so dastardly and corrupt, it boggles my mind that they can

get away with the crap they pull. How can we stop this agency from

lying to people the way they continually do? I, for one, have had

enough of their constant garbage and I hope the next administration

has enough balls to stop them dead in their tracks. This entire

corrupt agency is a waste of taxpayers money.

>

> http://www2.jsonline.com/story/index.aspx?id=809667

> Critics slam

> chemical report ( Milwaukee

> Journal Sentinel) 10/24/2008 2:14:54 AM

> Critics slam chemical report

> Scientists note flaws in bisphenol A study; lawmaker wants ban

> By SUSANNE RUST and

> MEG KISSINGER srust@...

> Posted: Oct. 24, 2008

> Lawmakers, scientists and advocacy groups

> intensified their criticism Thursday of a government report

declaring bisphenol

> A to be safe.

> • A group of 36 international scientists

> issued a blistering assessment of the Food and Drug Administration

report,

> calling it seriously flawed.

> • A congressman whose committee oversees

> the FDA wrote the commissioner, renewing his call for a ban of the

> controversial chemical.

> • An advocacy group demanded that the

> FDA cancel its meeting next week to discuss the draft.

> The Journal Sentinel reported Thursday that

> the draft was done primarily by representatives of the plastics

industry and

> those with an interest in downplaying concerns about the chemical.

Bisphenol A,

> used in baby bottles and other hard plastic, has been detected in

the urine of

> 93% of Americans tested. Hundreds of studies have found it to cause

health

> problems in laboratory animals, including cancer, diabetes, heart

disease,

> hyperactivity, autism and reproductive failure.

> The newspaper found reviews of studies in the

> FDA draft had been supplied by a consulting firm that also worked

for chemical

> makers. A review of studies that was included in the draft had been

> commissioned by Hentges, executive director of the American

Chemistry

> Council's group on bisphenol A. The council represents chemical

companies and lobbies

> Congress on their behalf.

> The Environmental Working Group, a watchdog

> health group, issued a statement Thursday saying the newspaper's

most recent

> report proves a glaring conflict of interest that should render the

draft

> meaningless.

> " An agency that once epitomized

> independent, impartial expertise in the service of public health has

> degenerated to a disgraced stenographer for the chemical and plastics

> industry, " said Ken Cook, president of the organization.

> The report was the second to raise questions

> about conflicts of interest regarding the agency. The newspaper reported

> earlier this month that Philbert, chairman of the

subcommittee reviewing

> the draft, is founder and co-director of a science center that

received a $5

> million donation from an anti-regulation activist who considers

bisphenol A to

> be " perfectly safe. " Gelman, the donor, said he discussed his

> views about bisphenol A with Philbert on several occasions.

> Philbert's subcommittee is expected to release

> its review of the FDA draft in the next few days. It is scheduled to

meet in Washington , D.C. ,

> on Oct. 31 to discuss the results. Cook's group renewed its request

to the FDA

> on Thursday to cancel that meeting. The FDA declined to comment.

> Lawmaker demands ban

> U.S. Rep. J. Markey (D-Mass.), who

> serves on the committee that oversees the FDA, sent a letter to

Commissioner

> von Eschenbach on Thursday citing the Journal Sentinel

reports, and

> asking for the agency to follow Canada 's

> lead and declare the chemical to be toxic and ban it from use in

children's

> products. Canada

> on Saturday became the first country to declare the chemical a toxin.

> The FDA also declined to comment on Markey's

> letter.

> The FDA's draft, released in August, found no

> cause for worry about bisphenol A, which is found in thousands of

household

> products, including baby bottles, infant formula containers and the

lining of

> aluminum cans.

> That finding is at odds with the conclusions

> of the FDA's own advisers from the National Toxicology Program. The

NTP announced

> in September that the chemical is of some concern for effects on the

> development of the prostate gland and brain, and for behavioral

effects in

> fetuses, infants and children. The NTP also found some concern for the

> neurodevelopment of young children, infants and fetuses.

> Article blasts FDA draft

> Also on Thursday, a group of three dozen

> scientists from around the world issued a scathing review of the

FDA's draft,

> calling it misguided and scientifically flawed.

> The article, which is published online in the

> government-sponsored journal Environmental Health Perspectives, says

the draft

> used guidelines and protocols that gave an unfair advantage to industry

> scientists.

> The guidelines, known as " Good Laboratory

> Practice, " give greater credibility to studies that use more animals.

> National Institutes of Health guidelines limit the number of animals

that can

> be tested by government scientists and those who work for many

publicly funded

> institutions.

> The FDA's task force report on bisphenol A

> dismissed or gave lesser credence to hundreds of studies that showed the

> chemical caused harm. These studies were conducted by government and

academic

> scientists, using state-of-the-art techniques and methods but did

not have the stamp

> of Good Laboratory Practices.

> Instead, the agency relied on a handful of

> industry-funded studies that had the stamp, even though they were

flawed in

> other ways.

> Two of the studies accepted by the FDA were

> rejected by its advisory group at the National Toxicology Program.

> Another industry study, accepted by the FDA

> and called the " gold standard " of studies, was criticized by an

> earlier review by the National Toxicology Program. That panel said

the study

> used a strain of rat that was insensitive to the effects of

estrogen, and

> therefore wouldn't detect bisphenol A, a chemical that was developed

as a

> synthetic estrogen.

> Another FDA-approved study, also funded by

> industry, used protocols that were out of date and methods that

wouldn't screen

> for the effects at low doses.

> " The bottom line is that each of the four

> major studies cited by the FDA were flawed, " said J. Myers,

lead

> author of the critical review and chief scientist of the nonprofit group

> Environmental Health Sciences.The standard used by the FDA " does not

> guarantee quality, reliability or validity in the scientific

process, " he

> said.

> s, a professor of occupational

> and environmental health at Washington University

> and who was not an author of the review, said the regulatory process

clearly is

> flawed.

> " The discord between the National

> Toxicology Program, Health Canada

> and the FDA spotlights the limitation of the FDA's approach, " s

> said.

> Sales of the chemical reached $6 billion

> worldwide in 2007.

> Harrington, spokeswoman for the

> American Chemistry Council, said her group was unable to respond to the

> scientists' article Thursday.

>

[Guest guest]

Yep, very much like the people who put them in

office. We sure could use another Kessler.

Lynda

At 01:39 PM 10/25/2008, you wrote:

>The FDA is so dastardly and corrupt, it boggles my mind that they can

>get away with the crap they pull. How can we stop this agency from

>lying to people the way they continually do? I, for one, have had

>enough of their constant garbage and I hope the next administration

>has enough balls to stop them dead in their tracks. This entire

>corrupt agency is a waste of taxpayers money.

>

>

> >

> >

>

<http://www2.jsonline.com/story/index.aspx?id=809667>http://www2.jsonline.com/st\

ory/index.aspx?id=809667

> > Critics slam

> > chemical report ( Milwaukee

> > Journal Sentinel) 10/24/2008 2:14:54 AM

> > Critics slam chemical report

> > Scientists note flaws in bisphenol A study; lawmaker wants ban

> > By SUSANNE RUST and

> > MEG KISSINGER srust@...

> > Posted: Oct. 24, 2008

> > Lawmakers, scientists and advocacy groups

> > intensified their criticism Thursday of a government report

>declaring bisphenol

> > A to be safe.

> > • A group of 36 international scientists

> > issued a blistering assessment of the Food and Drug Administration

>report,

> > calling it seriously flawed.

> > • A congressman whose committee oversees

> > the FDA wrote the commissioner, renewing his call for a ban of the

> > controversial chemical.

> > • An advocacy group demanded that the

> > FDA cancel its meeting next week to discuss the draft.

> > The Journal Sentinel reported Thursday that

> > the draft was done primarily by representatives of the plastics

>industry and

> > those with an interest in downplaying concerns about the chemical.

>Bisphenol A,

> > used in baby bottles and other hard plastic, has been detected in

>the urine of

> > 93% of Americans tested. Hundreds of studies have found it to cause

>health

> > problems in laboratory animals, including cancer, diabetes, heart

>disease,

> > hyperactivity, autism and reproductive failure.

> > The newspaper found reviews of studies in the

> > FDA draft had been supplied by a consulting firm that also worked

>for chemical

> > makers. A review of studies that was included in the draft had been

> > commissioned by Hentges, executive director of the American

>Chemistry

> > Council's group on bisphenol A. The council represents chemical

>companies and lobbies

> > Congress on their behalf.

> > The Environmental Working Group, a watchdog

> > health group, issued a statement Thursday saying the newspaper's

>most recent

> > report proves a glaring conflict of interest that should render the

>draft

> > meaningless.

> > " An agency that once epitomized

> > independent, impartial expertise in the service of public health has

> > degenerated to a disgraced stenographer for the chemical and plastics

> > industry, " said Ken Cook, president of the organization.

> > The report was the second to raise questions

> > about conflicts of interest regarding the agency. The newspaper reported

> > earlier this month that Philbert, chairman of the

>subcommittee reviewing

> > the draft, is founder and co-director of a science center that

>received a $5

> > million donation from an anti-regulation activist who considers

>bisphenol A to

> > be " perfectly safe. " Gelman, the donor, said he discussed his

> > views about bisphenol A with Philbert on several occasions.

> > Philbert's subcommittee is expected to release

> > its review of the FDA draft in the next few days. It is scheduled to

>meet in Washington , D.C. ,

> > on Oct. 31 to discuss the results. Cook's group renewed its request

>to the FDA

> > on Thursday to cancel that meeting. The FDA declined to comment.

> > Lawmaker demands ban

> > U.S. Rep. J. Markey (D-Mass.), who

> > serves on the committee that oversees the FDA, sent a letter to

>Commissioner

> > von Eschenbach on Thursday citing the Journal Sentinel

>reports, and

> > asking for the agency to follow Canada 's

> > lead and declare the chemical to be toxic and ban it from use in

>children's

> > products. Canada

> > on Saturday became the first country to declare the chemical a toxin.

> > The FDA also declined to comment on Markey's

> > letter.

> > The FDA's draft, released in August, found no

> > cause for worry about bisphenol A, which is found in thousands of

>household

> > products, including baby bottles, infant formula containers and the

>lining of

> > aluminum cans.

> > That finding is at odds with the conclusions

> > of the FDA's own advisers from the National Toxicology Program. The

>NTP announced

> > in September that the chemical is of some concern for effects on the

> > development of the prostate gland and brain, and for behavioral

>effects in

> > fetuses, infants and children. The NTP also found some concern for the

> > neurodevelopment of young children, infants and fetuses.

> > Article blasts FDA draft

> > Also on Thursday, a group of three dozen

> > scientists from around the world issued a scathing review of the

>FDA's draft,

> > calling it misguided and scientifically flawed.

> > The article, which is published online in the

> > government-sponsored journal Environmental Health Perspectives, says

>the draft

> > used guidelines and protocols that gave an unfair advantage to industry

> > scientists.

> > The guidelines, known as " Good Laboratory

> > Practice, " give greater credibility to studies that use more animals.

> > National Institutes of Health guidelines limit the number of animals

>that can

> > be tested by government scientists and those who work for many

>publicly funded

> > institutions.

> > The FDA's task force report on bisphenol A

> > dismissed or gave lesser credence to hundreds of studies that showed the

> > chemical caused harm. These studies were conducted by government and

>academic

> > scientists, using state-of-the-art techniques and methods but did

>not have the stamp

> > of Good Laboratory Practices.

> > Instead, the agency relied on a handful of

> > industry-funded studies that had the stamp, even though they were

>flawed in

> > other ways.

> > Two of the studies accepted by the FDA were

> > rejected by its advisory group at the National Toxicology Program.

> > Another industry study, accepted by the FDA

> > and called the " gold standard " of studies, was criticized by an

> > earlier review by the National Toxicology Program. That panel said

>the study

> > used a strain of rat that was insensitive to the effects of

>estrogen, and

> > therefore wouldn't detect bisphenol A, a chemical that was developed

>as a

> > synthetic estrogen.

> > Another FDA-approved study, also funded by

> > industry, used protocols that were out of date and methods that

>wouldn't screen

> > for the effects at low doses.

> > " The bottom line is that each of the four

> > major studies cited by the FDA were flawed, " said J. Myers,

>lead

> > author of the critical review and chief scientist of the nonprofit group

> > Environmental Health Sciences.The standard used by the FDA " does not

> > guarantee quality, reliability or validity in the scientific

>process, " he

> > said.

> > s, a professor of occupational

> > and environmental health at Washington University

> > and who was not an author of the review, said the regulatory process

>clearly is

> > flawed.

> > " The discord between the National

> > Toxicology Program, Health Canada

> > and the FDA spotlights the limitation of the FDA's approach, " s

> > said.

> > Sales of the chemical reached $6 billion

> > worldwide in 2007.

> > Harrington, spokeswoman for the

> > American Chemistry Council, said her group was unable to respond to the

> > scientists' article Thursday.

> >

>

>