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Rogue bureaucracy seeks to subvert decision of FDA scientific panels

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Charlie Brown <charlie@...> wrote: From: "Charlie Brown" <charlie@...>"Charlie Brown" <charlie@...>Subject: Rogue bureaucracy seeks to subvert decision of FDA scientific panelsDate: Thu, 16 Nov 2006 19:29:19 -0500 Rogue bureaucracy seeks to subvert decision of FDA scientific panels As you know, on Sept.

7, two scientific panels decisively rejected the FDA staff’s pseudo-science that mercury fillings are safe. Unwilling to accept the fact that they are wrong, the FDA’s Center for Devices & Radiological Health is using its best bureaucratic skills to keep the science out and the politics in. In Washington, the Center for Devices is well known for ignoring science, the public, and the rest of FDA itself -- it is called “FDA’s Neglected Child”

in both a Supreme Court opinion and a Congressional report. In the arena of mercury exposure, the Center for Devices defies policies of the FDA itself, sticking to the 19th Century notion that mercury exposure causes “allergies”(!). The lead dentist at the Center, Dr. Runner, is a career advocate of mercury fillings; she helped engineer the notorious LSRO/BETAH contract, where the government defied the competitive bidding laws to pick an unqualified meetings planner, who in turn was directed to handpick a consultant for Big Tobacco -- all with the shared goal of providing a biased literature review favorable to mercury fillings. Runner gave a veto to the American and California Dental Associations over FDA Consumer Updates on amalgam, and in 2002 tried to enact a policy where dentists would disclose the zinc in amalgam but hide the mercury. Defying both the Food, Drug & Cosmetic Act and the National Environmental Policy Act, the Center on Devices refuses to classify mercury fillings, will not do an environmental impact statement, and allows mercury amalgam sales under an illegal process that skirts proof of safety requirements. That’s why Moms Against Mercury and eight other petitioners sued FDA earlier this year. That case will be argued before the federal court in 2007. Based on this abysmal record of favoring pro-mercury dentists instead of children, Consumers for Dental Choice petitioned to remove this biased Dental Devices Branch from overseeing amalgam regulatory issues. On October 26, the #2 person in the Center for Devices fired a shot across the bow at our movement. Deputy Director Kahan said that the Center wants the issue to remain under the thumb of Runner’s Dental Devices Branch. That is, they have decided to “circle the wagons” in favor of protecting mercury fillings. Since Kahan, an attorney, and her boss Schultz, a physician, favor control by an ADA-oriented dentist, it would appear that Dr. Schultz and Ms. Kahan favor professional courtesy over the health of America’s

children. The battle is far from over. A tug of war is going on inside FDA, with the Center on Devices maintaining a cover up of the mercury in amalgam from the American people, while the scientific panels call for action to protect pregnant women, children, and the hypersensitive, and to give warnings to the rest of us. At some point, only the Commissioner, Von Eschenbach, can make the call. It’s time that Center for Devices Director Dan Schultz, MD, and Deputy Director Kahan, Esq., answer to the American people. If you want to write to inquire why they appear to rank professional courtesy to pro-mercury dentists over the health threat of mercury exposure to America’s children, please do so. Dan Schultz, MD, Director, Center on Devices, FDA dbs@... Kahan, Esq., Deputy Director, Center on Devices, FDA: lzk@... Thank you Charlie G. Brown, National Counsel Consumers for Dental Choice 1725 K St., N.W., Suite 511, Washington, DC 20006 Ph. 202.822-6307; fax 822-6309 charlie@..., www.toxicteeth.org

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Oh, Rogene....I'd better get to bed. I am so angry about the lies

we've been fed. My mouth is FULL of mercury fillings...I don't have

the coverage or the cash to have them removed. HELP!!! It's so

frustrating.

Pray for peace for me!

Love,

Sunny :)

From: " Charlie Brown "

<charlie@...>

> " Charlie Brown " <charlie@...>

> Subject: Rogue bureaucracy seeks to subvert decision of FDA

scientific panels

> Date: Thu, 16 Nov 2006 19:29:19 -0500

>

> st1\:*{behavior:url(#default#ieooui) } Rogue

bureaucracy seeks to subvert decision of FDA scientific panels

>

> As you know, on Sept. 7, two scientific panels decisively

rejected the FDA staff's pseudo-science that mercury fillings are

safe. Unwilling to accept the fact that they are wrong, the FDA's

Center for Devices & Radiological Health is using its best

bureaucratic skills to keep the science out and the politics in.

>

> In Washington, the Center for Devices is well known for ignoring

science, the public, and the rest of FDA itself -- it is

called " FDA's Neglected Child " in both a Supreme Court opinion and a

Congressional report. In the arena of mercury exposure, the Center

for Devices defies policies of the FDA itself, sticking to the 19th

Century notion that mercury exposure causes " allergies " (!). The lead

dentist at the Center, Dr. Runner, is a career advocate of

mercury fillings; she helped engineer the notorious LSRO/BETAH

contract, where the government defied the competitive bidding laws to

pick an unqualified meetings planner, who in turn was directed to

handpick a consultant for Big Tobacco -- all with the shared goal of

providing a biased literature review favorable to mercury fillings.

Runner gave a veto to the American and California Dental Associations

over FDA Consumer Updates on amalgam, and in 2002 tried to enact a

policy where dentists would disclose the zinc in

> amalgam but hide the mercury.

>

> Defying both the Food, Drug & Cosmetic Act and the National

Environmental Policy Act, the Center on Devices refuses to classify

mercury fillings, will not do an environmental impact statement, and

allows mercury amalgam sales under an illegal process that skirts

proof of safety requirements. That's why Moms Against Mercury and

eight other petitioners sued FDA earlier this year. That case will

be argued before the federal court in 2007.

>

> Based on this abysmal record of favoring pro-mercury dentists

instead of children, Consumers for Dental Choice petitioned to remove

this biased Dental Devices Branch from overseeing amalgam regulatory

issues. On October 26, the #2 person in the Center for Devices fired

a shot across the bow at our movement. Deputy Director Kahan

said that the Center wants the issue to remain under the thumb of

Runner's Dental Devices Branch. That is, they have decided

to " circle the wagons " in favor of protecting mercury fillings.

Since Kahan, an attorney, and her boss Schultz, a physician,

favor control by an ADA-oriented dentist, it would appear that Dr.

Schultz and Ms. Kahan favor professional courtesy over the health of

America's children.

>

> The battle is far from over. A tug of war is going on inside

FDA, with the Center on Devices maintaining a cover up of the mercury

in amalgam from the American people, while the scientific panels call

for action to protect pregnant women, children, and the

hypersensitive, and to give warnings to the rest of us. At some

point, only the Commissioner, Von Eschenbach, can make the

call.

>

> It's time that Center for Devices Director Dan Schultz, MD, and

Deputy Director Kahan, Esq., answer to the American people. If

you want to write to inquire why they appear to rank professional

courtesy to pro-mercury dentists over the health threat of mercury

exposure to America's children, please do so.

> Dan Schultz, MD, Director, Center on Devices, FDA

> dbs@...

> Kahan, Esq., Deputy Director, Center on

Devices, FDA:

> lzk@...

> Thank you

> Charlie

> G. Brown, National Counsel

> Consumers for Dental Choice

> 1725 K St., N.W., Suite 511, Washington, DC 20006

> Ph. 202.822-6307; fax 822-6309

> charlie@..., www.toxicteeth.org

>

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