fetaldex.org

FOIA’ed materials

 

Items of interest from documents obtained through the Freedom of Information Act (FOIA):

  1. material from New’s grant showing 2004 MSSM IRB approval for a project called “prenatal diagnosis and treatment” dated September 2, 2004, signed by Jeffrey Silverstein, the same fellow who told the OHRP in 2010 that there was no research on pregnant women involving prenatal dex for CAH for this purpose at MSSM: Silverstein to NIH 2004 on New IRB approval.pdf Dr. Silverstein appears to have told the OHRP in 2010 that this was just a retrospective outcome study, in spite of the name of the project not referring to retrospective outcomes. Now notice...

  2. ...material from New’s grant progress report in 2006 seeming to show that the project, so far as her progress report was concerned anyway, did specifically involve using the drug on fetuses; note that on page three of her research progress report, she reports diagnosis/treatment of 27 fetuses during her time at Mount Sinai, and she tells the NIH “our conclusion is that prenatal diagnosis and treatment are safe and effective.” 2006 grant progress galloping ahead.pdf

  3. material from Maria New’s grants regarding investigation into “the success of DEX in suppressing behavioral masculinization”: 12.97 suppressing masculinization.pdf

  4. material from Maria New’s grants indicating that “preventative prenatal dexamethasone exposure is expected to improve [the] situation” of women with CAH “remain[ing] childless and single”: 2.96 childless and single.pdf

  5. material from Maria New’s grants regarding the effect of CAH and dex on “behavioral effects ranges from mild or marked tomboyish behavior of childhood to increased adolescent/adult bisexuality and lesbianism”: 12.97 spectrum of behavioral effects - risks.pdf

  6. material from Maria New’s grants regarding reduction of masculinization in the boys treated with dex, and saying “reduction of behavioral masculinization” in girls “might indicate lessened problems of gender adjustment that are seen in some girls with CAH”: 7.01 lessened problems of gender adjustment.pdf

  7. material from Maria New’s grant correspondence indicating New had to relinquish her positions and salary at Cornell following the fraud case over New’s grant and preceding her move to Mount Sinai (see also below for more), apparently indicating that New was asking the NIH to help her financially after she relinquished her Cornell salary and positions: 2.03 New requests salary support.pdf

  8. material indicating NIH staff recommends New be given more NIH funding since she no longer has her Cornell salary and position: 7.02 NIH recommends salary support.pdf

  9. material suggesting the NIH paid New salary support out of a MERIT (!) award fund after she no longer had her Cornell salary and positions, this apparently following the fraud case centered on her NIH grant: 4.03 date WCMC salary stopped.pdf

  10. AJOB target article author Frank Chervenak named as “key personnel” in Maria New’s grant, shown on the last page of this document: New grant Chervenak consultant.pdf.

  11. But wait, there’s more: Here’s Chervenak saying to “Maria” that he’d be pleased to help out with New’s grant. This is in direct contradiction to lead-author Laurence McCullough's claim to Dreger on May 17, 2010, that "None of the authors of the paper [insisting that Dreger et al. call off the federal investigations into New, Cornell, and Mount Sinai]: has any economic, professional, or any other kind of conflict of interest with regard to the content of our paper; has collaborated with Dr. New in her research, been funded on her grants, or served in any advisory capacity to her in her research". Note also that Chervenak is the director of Maternal-Fetal Medicine and chair of OB/Gyn at Weill-Cornell.  McCullough did not disclose that he has active affiliations with Weill-Cornell and with Mount Sinai School of Medicine; he listed Baylor as his only academic affiliation on the paper, neglecting to reveal to readers his relationships with the institutions at the center of the investigations he demanded we call off. (Ironically, Weill-Cornell calls Chervenak and McCullough “world leaders in prenatal medial ethics.” Well, in the scholarship of it anyway.)

  12. email from the FDA investigator revealing that he was negotiating an editor-in-chief position with AJOB, including an allowance of $10,000/year for editorial assistance, while he was conducting the FDA investigation AJOB was being used to try to stop: FOIA Nelson FDA AJOB-PR position.pdf

  13. Larry McCullough writing to OHRP to give them the paper calling us “unethical and transgressive” for calling for the federal investigation, without revealing his COIs: FOIA McCullough to OHRP calling us unethical.PDF


Materials obtained through alternate routes, also of interest:

  1. Federal False Claims Act action against Weill Medical College of Cornell regarding Maria New’s NIH grant number 5M01RR006020: CornellGovernmentComplaint_000.pdf. Grant abstract here. See also the Wall Street Journal article reporting Weill Cornell settling the complaint for $4.4 million.

  2. Weill Medical College of Cornell University has been found by the Office for Human Research Protections to have had problems with their IRB system, particularly in regard to treatment of child subjects. Maria New is one of the researchers named in the determination letter: OHRP determination letter - problems at WCMC.pdf