FDA’s Deputy Commissioner Joshua Sharfstein covers up mercury-neurological harm nexus

FDA Deputy Commissioner Joshua Sharfstein has given his seal of approval to major mercury exposure for millions of America’s children and unborn children – and to covering up both the neurological risks and the flawed rulemaking process.

Despite admitting that amalgam causes mercury exposure -- and despite knowing that mercury causes neurological harm to developing brains -- Sharfstein rejects putting on contraindications for amalgam, rejects putting on warnings on amalgam and evenrejects a requirement that dentists tell patients that amalgam is mainly mercury.

Sharfstein even withdraws FDA’s website warning that dental mercury can cause permanent neurological harm to children and unborn children. Sharfstein’s rule actually says FDA wants to stop a decline in amalgam sales. At Joshua Sharfstein’s FDA, commerce trumps safety.

When the Republicans ran FDA, to their real credit, they put this warning on the FDA website: “Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.” Upon assuming power, the Democrats withdrew this warning, covering up the fact that mercury from amalgam causes permanent harm to young children and kills unborn babies. Is this the change we Americans voted for?

Washington is famous for the revolving door -- those in the party out of power takes highly paid corporate positions, then returns to government to bail out their benefactors. The new FDA Commissioner, Margaret Hamburg, worked in the Clinton Administration, then went out and became a director at the dental products colossus Henry Schein, earning a quarter million dollars a year for the handful of hours it takes to be a director. Corporations do this because they know the other party will return to power, at which time the corporations will call in their chits.

Upon becoming Commissioner, Dr. Hamburg owned between $250,000 and $500,000 of Henry Schein stock. Certainly the Harvard-educated Hamburg knew the amalgam rule had the potential to affect her stock value. She could have done the right thing -- recuse herself from the rule. Instead, she worked on the rule for a while, then recused herself gradually, first by “deciding not to participate,” then finally “recusing.” Certainly her next-in-command, Deputy Commissioner, Joshua Sharfstein got the message that there was more at stake than good government.

On what date did Hamburg sell her Schein stock? What work did Hamburg do on the rule before she recused herself? What work did she do protecting amalgam from regulators while at Schein? Through her lawyer, Hamburg refuses to answer any of these questions. Ironically, Sharfstein heads a new a FDA “transparency task force.” A perfect first project would be to expose the Hamburg-Henry Schein links.

Joshua Sharfstein had the opportunity to protect children from amalgam, to save unborn babies and nursing babies from mercury exposure, and to warn us all that amalgam exposes us to toxic mercury. He came to Washington as a child advocate, but changed his stripes once he saw the revolving door game in action. Throwing his reputation out the window, Joshua Sharfstein chose to ally with the amalgam industry and cover up the mercury, turning his back on the children of America...

Just as Margaret Hamburg has embarrassed President Obama for bringing back revolving-door government, Joshua Sharfstein has embarrassed the President for deciding not to reduce the use of mercury in oral health care. If ever a President entered office as an inalterable opponent of mercury, it is Barack Obama, who wrote a law banning mercury exports and who is working for a treaty to phase out man-made mercury by a date certain. But at FDA, his appointee Sharfstein is sabotaging the President’s policies by hiding the mercury from Americans and hence keeping amalgam sales going into the indefinite future.

FDA doesn’t even defend its rule on the science. FDA admits it does not know if mercury fillings are safe for children six and under, or for nursing mothers whose mercury goes through the breast milk, or for pregnant women whose dental mercury No, it’s not science -- it’s about commerce. FDA wants Americans to keep buying amalgam.

The children of America have lost. Another generation will be mercury toxic.

Need further evidence on who won? Just yesterday (Aug. 5), Henry Schein’s CEO Stanley Bergman offered this salute to Dr. Hamburg:

"I would like to extend on behalf of the company, our Board and our shareholders our sincere thanks to Dr. Margaret Hamburg, who has served as the Director of Henry Schein Company's Board since 2003. Dr. Hamburg left our Board following her confirmation as Commissioner of the U.S. Food and Drug Administration. We would like to thank Dr. Hamburg for the insight she shared with the Henry Schein Board throughout the years and wish her continued success."

Hamburg claims she broke her ties with Schein three months ago. But Schein’s CEO issues his thank-you the day after the FDA rule was published in the Federal Register. Margaret Hamburg may not be in the hip pocket of Henry Schein Inc, but Schein’s CEO sure thinks she is. And he has the evidence to show it: a rule that allows Schein to sell amalgam to anyone, a rule that covers up the mercury, a rule that contains propaganda to be used by Schein to defend against the upcoming class action suits.

FDA bans mercury in all veterinary products. The new FDA, under Margaret Hamburg and her Sancho Panza, Joshua Sharfstein, have decided that children don’t merit the protection FDA gives horses and dogs.

The Washington big-shots have direct access to Joshua Sharfstein. So should you: his e-address is JMSharf1@fda.hhs.gov Why not write him yourself? Talking points follow

--- Charles G. Brown, National Counsel

Consumers for Dental Choice
6 August 2009

Questions to consider asking Deputy Commissioner Sharfstein

(1) Dr Sharfstein, why, under your rule, are children less important than horses and dogs when it comes to mercury exposure?

(2) Why did you Democrats withdraw FDA’s website warning that dental mercury can cause neurological harm to children and unborn children, which the Republican Commissioner agreed to last year?

(3) Will your new “transparency task force” disclose the details of your boss’s ties with Henry Schein, or will she be allowed to cover it up like you cover up the risks of ental mercury?

(4) Does President Obama know that you approved a rule that will keep Americans from learning that amalgam is mainly mercury, and does the President know about Commissioner Hamburg’s conflict of interest with Henry Schein?