FDA – much reform needed

FDA’s Own Documents Show Cascade of Wrongdoing

Documents we continue to obtain from FDA under the Freedom of Information Act paint a picture of an agency that has engaged in wrongdoing — and knows it.

1. While owning stock options in Henry Schein Inc., Commissioner Margaret Hamburg indeed did participate in the amalgam rule-making, presiding at a July 1 policy meeting “to secure feedback from the Office of the Commissioner” and to discuss the rule’s “next steps.”  Having received over a million dollars for the easy lifting of being a corporate “director,” Hamburg repeatedly disregarded warnings to stop:  the ethics contract she signed, an admonition from her financial advisor, and two letters from me.

2. Hamburg sidekick Joshua Sharfstein entered at the last minute to rubber-stamp the rule that covers up the mercury and conceals warnings of neurological harm to children and unborn babies that FDA had already agreed to.  Sharfstein has become so knee-deep in this morass that just yesterday he cancelled a meeting with Congresswoman Diane Watson, who demands an explanation for such a horrible rule.

3. After Hamburg complained to her corporation that “there are constraints on my activities while I hold any interest in Schein,” Schein officials offered her a special favor — they agreed to cancel the options before their expiration date (something that even Hamburg’s financial advisor had said was not possible) so that the Commissioner could start regulating Schein sooner.  Hamburg agreed and the deal was signed on July 28 – the day the amalgam rule was announced.

4. Henry Schein benefited enormously from the rule, with its stock jumping $1.50.  In an email exchange, the Commissioner “severed” her relationship to Schein (two days after the rule was announced), but assured Schein’s general counsel that she hoped her “friendships” at Schein “will outlast the period of my recusal.”  In response, the general counsel noted that Schein is “indebted” to her for her “service” at FDA.

5. The Commissioner’s husband, Peter Fitzhugh Brown, was marketed to the American people as an “expert in artificial intelligence.”  Actually, he is a hedge fund trader, an officer at Wall Street colossus Renaissance Technologies.  Hamburg secretly enlisted Peter Brown into FDA’s inner circle to participate in FDA deliberations as to how to deal with the amalgam rule’s fall-out, where he could advise agency press aides and policy makers and be advised by FDA lawyers — and get valuable insider information for his day job (an FDA Commissioner has a huge impact on stock values of major corporations).  Renaissance Technologies traded $6 million in Schein stock during the second quarter alone.

We are fighting back.

A) Fifty-seven (57) good Iowa folks have written FDA critic Senator Chuck Grassley to ask him to investigate the horror show at FDA, http://www.toxicteeth.org/Hawkeyes%20to%20Grassley.pdf They included my five page letter, with 15 attachments – which goes through this problem chapter and verse (of what we know so far, keeping in mind FDA blocks release of most records).  http://www.toxicteeth.org/Hawkeyes%20to%20Grassley.pdf

B) Jim Turner filed an excellent petition for reconsideration, raising a wide variety of major issues – both procedural (such as Hamburg’s ethical problems) and substantive (such as FDA’s nonsensical and unsubstantiated decision not to tell consumers about the mercury because giving patients something to talk about would discourage discussion with dentists). http://www.toxicteeth.org/Petition%20for%20Recon%20Final.pdf

C)  Thirty-nine (39) Members of Congress, so far have signed onto the Watson-Burton resolution calling for FDA to disclose the presence and risk of the mercury.  It’s House Resolution 648; check with your Representative to see if she or he has signed on yet.

FDA Commissioner Margaret Hamburg entered FDA through the revolving door from Henry Schein Inc., the nation’s #1 amalgam seller; participated in the rule-making despite a trio of warnings; corralled her staff into making false denials about it; cut a deal with benefactor Schein on the day the amalgam rule was announced; and brought a hedge fund trader dealing in Schein stock into FDA’s inner circle.  Small wonder that Hamburg’s chief press henchman calls for an “end game” against those seeking to unmask the wrongdoing.

Charlie

30 October 2009

Charles G. Brown, National Counsel
Consumers for Dental Choice
316 F St., N.E., Suite 210, Washington, DC 20002
Ph. 202.544-6333; fax 202.544-6331
charlie@toxicteeth.org,
www.toxicteeth.org
Working for Mercury-Free Dentistry

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