FDA Ethicists Undisclosed Conflicts Of Interest in Prenatal Dex Case

by Alice Dreger and Ellen K. Feder


[A 2014 article that details the questionable practices of modern medicine which both involves fraud and an overt application of eugenics rather than health care.  It is offered as a public service information source along with the caveat to beware of scientific studies which are usually wrong. . [Emphasis - DNI] - ED]

Newly available documents show conflicts of interest for the FDA ethicist who investigated a fetal drug experiment.  

Pediatric endocrinologist Maria New, now at Mount Sinai School of Medicine in New York, is an internationally-recognized specialist in congenital adrenal hyperplasia, a genetic condition that can cause female fetuses to develop intersex (in-between male and female) genitals. For over a decade, Dr. New has encouraged pregnant women at risk of having a child with congenital adrenal hyperplasia to take the steroid dexamethasone starting as early as 3 weeks of pregnancy to try to prevent intersex development.

Dr. New has consistently described this extremely controversial off-label (i.e., not government-approved) use as safe and effective. In truth, there has never been a placebo-controlled trial of this use, and the only long-term prospective trial ever conducted resulted in so many “severe” adverse events that, in 2010, that study’s research team (a Swedish group) went to their ethics board to say they were halting the use altogether.

Dr. New’s aggressive “safe and effective” promotion of this fetal intervention—an intervention designed to cross the placenta and change fetal development—would be shocking enough. But we were shaken in late 2009 when we discovered that, even while she was direct-to-consumer advertising the intervention as having been “found safe for mother and child,” she was taking NIH grant money to study retrospectively whether it was safe and effective.

 In February of 2010, we along with thirty colleagues in bioethics and allied fields sent letters of concern to the U.S. Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) asking them to investigate the actions of Dr. New. At the FDA, the investigation was assigned to Robert “Skip” Nelson, a pediatric ethicist. Documents obtained through a Freedom of Information request suggest that Nelson proposed to OHRP that he handle the main part of the prenatal dexamethasone investigation for that agency as well. Ultimately the OHRP findings relied largely on a memo provided to them by Nelson as an FDA official.

While the federal investigation was ongoing, in May of 2010 the American Journal of Bioethics (AJOB) circulated a manuscript (in advance of publication, inviting open peer commentaries) attacking our letters of concern, saying they represented an instance of “unethical transgressive bioethics.”

At the time, we were not aware of conflicts of interest in the federal investigation or the AJOB article, because none were disclosed. Here is what we now know, including from material obtained just this week through the Freedom of Information Act:

First, neither the original AJOB manuscript (May 2010) nor the final published article (September 2010) included a conflict of interest statement from the authors. The lead author, Larry McCullough, failed to disclose that he held paid positions with the two medical schools implicated in the investigation (Mount Sinai and Cornell). The second author, Frank Chervenak, failed specifically to disclose that he was (and still is) Chair of Obstetrics and head of the Maternal-Fetal Medicine unit at the medical school where New “treated” over 600 pregnancies with prenatal dex.  Chervenak also failed to disclose that he served as “key personnel” on New’s NIH grant.

Responses to our Freedom of Information requests show that Larry McCullough gave the AJOB original manuscript to the federal investigators at OHRP prior to publication, in an attempt to undermine the claims in our complaints. No conflict of interest disclosures were attached to the manuscript. This suggests that OHRP personnel would have seen the McCullough and Chervenak criticisms of our request for an investigation, but would not have known of the authors’ conflicts of interest.

Second, it appears that Nelson did not disclose to his FDA or OHRP colleagues that he was a member of the editorial board of AJOB – the journal in which the criticisms were published. One might feel less concerned about this particular undisclosed conflict were it not for the fact that, like the AJOB target article, Nelson’s official FDA findings on prenatal dex misrepresented key facts, including whether the FDA had previously reviewed New’s use of this steroid on first-trimester fetuses.

Third, this week we have obtained additional material through our Freedom of Information request showing that Nelson was, in fact, developing an even deeper relationship with AJOB while he was conducting the prenatal dex investigation. At the very time Nelson was investigating our complaints, he was also negotiating to become editor-in-chief of a new AJOB journal, AJOB Primary Research (since renamed AJOB Empirical Bioethics).

A May 2010 email conversation between Nelson and others at the FDA shows that Nelson was to be compensated by AJOB not only with the editor-in-chief title, but also with $10,000 per year, for editorial assistance. In the email conversation about the new position with AJOB, Nelson never disclosed that the journal was being used to aggressively (dare we say “transgressively”?) undermine complaints he was investigating.

Curiously, Nelson’s FDA memo and the associated OHRP findings on prenatal dex were released on virtually the same day in September 2010 that AJOB published the McCullough and Chervenak “target article” and responses to it. The timing of this “coincidence” was openly celebrated by Glenn McGee, then editor-in-chief of AJOB: “With the release of the September issue of the Journal, both the FDA and OHRP have released letters responding to the complaints that are the subject of the Target Article…”

What might once have been thought fortuitous timing must now be examined through the lens of conflicts of interest, as we now know that, by September 2010, Nelson was working in titled and compensated positions for both the FDA and AJOB.

Fourth, in December 2010, AJOB published a “vindication” by Dr. New that consisted mostly of a long quote from Nelson’s FDA response to our letter. Consistent with the established pattern of non-disclosure, nowhere in conjunction with New’s “vindication” does one find disclosure of Nelson’s dual role as FDA investigator and key member of the AJOB editorial team.

We have repeatedly appealed to the editorial board of AJOB to add disclosures to all the dex-related publications. That has gotten us nowhere, except to force disclosure of who is on the AJOB conflict-of-interest committee. The committee includes Larry McCullough, specifically representing AJOB Empirical Bioethics, the journal given to Skip Nelson.






Alice Dreger and Ellen K. Feder 

Alice Dreger, PhD, is Professor of Clinical Medical Humanities and Bioethics at Northwestern University Feinberg School of Medicine. @alicedreger

Ellen K. Feder is Associate Professor of Philosophy and Religion at American University, and author of Making Sense of Intersex: Changing Ethical Perspectives in Biomedicine, just issued by Indiana University Press.


[Note:  Might wander through the typical profiles of the “bioethicists” identified in the following article: The article originally appeared here 

Larry McCullough, one of the founders of “bioethics”, pop control, research using children, pro-human embryonic stem cell research, etc.:  https://www.google.com/#q=%22Larry+McCullough%22+%22bioethics%22

Frank Chervenak, M.D., ObGyn specialist in maternal and fetal medicine, pro-abortion and woman’s rights, anti-personhood for the unborn, pro-euthanasia, etc.: https://www.google.com/#q=%22Frank+Chervenak%22+%22bioethics%22+%22controversy%22

Glenn McGee, partner with bioethics founder Art Caplan, pro-“designer babies” and human cloning, implicated in conflict of interest in the Celltex corruption case, etc.:  https://www.google.com/#q=%22Glenn+McGee%22+%22bioethics%22

Skip Nelson, Senior Pediatric Ethicist at FDA, promotes research using children, etc.:  https://www.google.com/#q=%22Skip+Nelson%22+%22bioethics%22&start=10

See also “Charges of editorial misconduct at American Journal of Bioethics (AJOB), at: 

http://www.healthnewsreview.org/2011/06/charges-of-editorial-misconduct-at-american-journal-of-bioethics/.

For an extensive analysis and critique of “bioethics”, with extensive references, see my article, "What is 'bioethics'?" (June 3, 2000), UFL Proceedings of the Conference 2000, in Joseph W. Koterski (ed.), Life and Learning X:  Proceedings of the Tenth University Faculty For Life Conference (Washington, D.C.:  University Faculty For Life, 2002), pp. 1-84, at:

http://www.lifeissues.net/writers/irv/irv_36whatisbioethics01.html.  As a First Generationer in this “bioethics”, I hold one of the few Ph.D. concentrations in bioethics the field from the KIE and Dept. of Philosophy, Georgetown University (1991).

--  DNI]




A Comprehensive Clinton Body Count

{The number of bodies associated with both the Clintons and the current administration further suggests that the Committee of 300 has complete control over U.S. politics.  People who possess information not wanted to be released to the public or are in a position to stop a committee objective turn up dead. In the parlance of the Committee of 300, these are known as 'wet jobs.' - Ed.}

 

Breaking News 


(Thomas Dishaw) The Clinton’s reign of terror lasted 8 years in America, but  the impact of his decisions will last a lifetime in this country. Economic Policy, the implication of NAFTA & GATT, and a public affair that shook the nation are just some of the events people associate with him. As most of you know “The Clinton Chronicles”  has been floating around the web for a few decades.  This grainy, over-dubbed documentary debuted in 1994 on a limited VHS run and ended up selling approximately 300,000 copies making it a cult classic in the conspiracy world.


Accusations  of drug running, money laundering, murder and womanizing were brought to the forefront in this gutsy,  tell all documentary. Going hand in hand with the documentary is the Clinton Kill List, another urban legend that,  according to  the almighty Snopes,  is false.  Snopes, the most reliable place on the web, believes “Clinton hasn’t been quietly doing away with people who oppose him ” making the Clinton Body Count FALSE and me just another conspiracy theorist.  {SNOPES has been caught falsifying information. - Ed.}

Below is a comprehensive list of 48 mysterious deaths connected to the clintons that have grave implications.

1 – James McDougal – Clinton’s convicted Whitewater partner died of an apparent heart attack, while in solitary confinement. He was a key witness in Ken Starr’s investigation.
 

2 – Mary Mahoney – A former White House intern was murdered July 1997 at a Starbucks Coffee Shop in Georgetown. The murder happened just after she was to go public with her story of sexual harassment in the White House.
 

3 – Vince Foster – Former white House councilor, and colleague of Hillary Clinton at Little Rock’s Rose Law firm. Died of a gunshot wound to the head, ruled a suicide.
 

4 – Ron Brown – Secretary of Commerce and former DNC Chairman. Reported to have died by impact in a plane crash. A pathologist close to the investigation reported that there was a hole in the top of Brown’s skull resembling a gunshot wound. At the time of his death Brown was being investigated, and spoke publicly of his willingness to cut a deal with prosecutors.
 

5 – C. Victor Raiser II and Montgomery Raiser, Major players in the Clinton fund raising organization died in a private plane crash in July 1992.


6 – Paul Tulley – Democratic National Committee Political Director found dead in a hotel room in Little Rock, September 1992… Described by Clinton as a “Dear friend and trusted advisor.”
 

7- Ed Willey – Clinton fund raiser, found dead November 1993 deep in the woods in VA of a gunshot wound to the head. Ruled a suicide. Ed Willey died on the same day his wife Kathleen Willey claimed Bill Clinton groped her in the oval office in the White House. Ed Willey was involved in several Clinton fund raising events.
 

8 – Jerry Parks – Head of Clinton’s gubernatorial security team in Little Rock. Gunned down in his car at a deserted intersection outside Little Rock. Park’s son said his father was building a dossier on Clinton. He allegedly threatened to reveal this information. After he died the files were mysteriously removed from his house.
 

9 – James Bunch – Died from a gunshot suicide. It was reported that he had a “Black Book” of people which contained names of influential people who visited prostitutes in Texas and Arkansas.


10 – James Wilson – Was found dead in May 1993 from an apparent hanging suicide. He was reported to have ties to Whitewater.


11- Kathy Ferguson, ex-wife of Arkansas Trooper Danny Ferguson, was found dead in May 1994, in her living room with a gunshot to her head. It was ruled a suicide even though there were several packed suitcases, as if she were going somewhere. Danny Ferguson was a co-defendant along with Bill Clinton in the Paula Jones lawsuit. Kathy Ferguson was a possible corroborating witness for Paula Jones.


12 – Bill Shelton – Arkansas State Trooper and fiancee of Kathy Ferguson. Critical of the suicide ruling of his fiancee, he was found dead in June, 1994 of a gunshot wound also ruled a suicide at the grave site of his fiancee.


13 – Gandy Baugh – Attorney for Clinton’s friend Dan Lassater, died by jumping out a window of a tall building January, 1994. His client was a convicted drug distributor.


14 – Florence Martin – Accountant & sub-contractor for the CIA, was related to the Barry Seal Mena Airport drug smuggling case. He died of three gunshot wounds.


15 – Suzanne Coleman – Reportedly had an affair with Clinton when he was Arkansas Attorney General. Died of a gunshot wound to the back of the head, ruled a suicide. Was pregnant at the time of her death.


16 – Paula Grober – Clinton’s speech interpreter for the deaf from 1978 until her death December 9, 1992. She died in a one car accident.


17 – Danny Casolaro – Investigative reporter. Investigating Mena Airport and Arkansas Development Finance Authority. He slit his wrists, apparently, in the middle of his investigation.


18 – Paul Wilcher – Attorney investigating corruption at Mena Airport with Casolaro and the 1980 “October Surprise” was found dead on a toilet June 22, 1993 in his Washington DC apartment. Had delivered a report to Janet Reno three weeks before his death


19 – Jon Parnell Walker – Whitewater investigator for Resolution Trust Corp. Jumped to his death from his Arlington, Virginia apartment balcony August15, 1993. He was investigating the Morgan Guarantee scandal.


20 – Barbara Wise – Commerce Department staffer. Worked closely with Ron Brown and John Huang. Cause of death unknown. Died November 29, 1996. Her bruised, nude body was found locked in her office at the Department of Commerce.


21- Charles Meissner – Assistant Secretary of Commerce who gave John Huang special security clearance, died shortly thereafter in a small plane crash.


22 – Dr. Stanley Heard – Chairman of the National Chiropractic Health Care Advisory Committee, died with his attorney Steve Dickson in a small plane crash. Dr. Heard, in addition to serving on Clinton’s advisory council personally treated Clinton’s mother, stepfather and brother.


23 – Barry Seal – Drug running pilot out of Mena, Arkansas, death was no accident.


24 – Johnny Lawhorn Jr. – Mechanic, found a check made out to Bill Clinton in the trunk of a car left at his repair shop. He was found dead after his car had hit a utility pole.


25 – Stanley Huggins – Investigated Madison Guarantee. His death was a purported suicide and his report was never released.


26- Hershell Friday – Attorney and Clinton fund raiser died March 1, 1994 when his plane exploded.


27 – Kevin Ives and Don Henry – Known as “The boys on the track” case. Reports say the boys may have stumbled upon the Mena Arkansas airport drug operation. A controversial case, the initial report of death said, due to falling asleep on railroad tracks. Later reports claim the two boys had been slain before being placed on the tracks. Many linked to the case died before their testimony could come before a Grand Jury.

THE FOLLOWING PERSONS HAD INFORMATION ON THE IVES/HENRY CASE:

28 – Keith Coney – Died when his motorcycle slammed into the back of a truck, July 1988.

29 – Keith McMaskle – Died stabbed 113 times, Nov, 1988

30 – Gregory Collins – Died from a gunshot wound January 1989.

31 – Jeff Rhodes – He was shot, mutilated and found burned in a trash dump in April 1989.

33 – James Milan – Found decapitated. However, the Coroner ruled his death was due to “natural causes.”

34 – Jordan Kettleson – Was found shot to death in the front seat of his pickup truck in June 1990.

35 – Richard Winters – A suspect in the Ives / Henry deaths. He was killed in a set-up robbery July 1989.

 

THE FOLLOWING CLINTON BODYGUARDS ARE DEAD: 36 – Major William S. Barkley Jr. 37 – Captain Scott J. Reynolds 38 – Sgt. Brian Hanley 39 – Sgt. Tim Sabel 40 – Major General William Robertson 41 – Col. William Densberger 42 – Col. Robert Kelly 43 – Spec. Gary Rhodes 44 – Steve Willis 45 – Robert Williams 46 – Conway LeBleu 47 – Todd McKeehan