Galileo's Middle Finger (45 page)

OHRP would later tell us
:
Kristina C. Borror for OHRP to Ellen K. Feder and Alice Dreger, Sept. 2, 2010, reproduced at http://fetaldex.org/correspondence_files/OHRP_response_Sept_2_2010.pdf.

Cornell’s word to OHRP
:
Mary Simmerling for Cornell to Kristina Borror for OHRP, July 29, 2010. (Obtained via FOIA.)

until Sarafoglou’s complaints
:
The first audit I can find occurred in late 2002 as a response to Sarafoglou’s complaints; see Asch to Hajjar, November 4, 2002. It only included 50 patient charts and the method of chart selection is unclear.

angry whistleblowing memo
:
As noted above, this was obtained via FOIA and has a subject line specifically referring to New’s main CAH IRB protocol at Cornell (#0296-223).

consistently led the NIH to believe
:
All of Maria New’s NIH grant materials from 1996 forward that I have obtained include discussions of prenatal dexamethasone treatments as part of her experimental research. Even when she discussed retrospective follow-up studies, she also specifically discussed new pregnancy exposures as part of her ongoing research plan. See below for a discussion of how this did not change when she moved to Mount Sinai.

in 2006, in a research progress report
:
Maria I. New, “Androgen metabolism in childhood,” grant progress report 5-R37-HD00072-42 to Department of Health and Human Services, Public Health Services (New York: Mount Sinai School of Medicine: 2006), quotation on p. 3. (Obtained via FOIA.)

letter from the head of Mount Sinai’s IRB
:
Jeffrey H. Silverstein, IRB Chair of Mount Sinai School of Medicine, to NIH, subject “GCO Project #04-0469 0001 01 PE,” September 2, 2004 (obtained via FOIA). It is unlikely that the 2004 project called “prenatal diagnosis and treatment” was a retrospective study of the sort that Silverstein said in 2010 had IRB approval, because in his letter to the OHRP in 2010, Silverstein said that the title of the retrospective study was “Long Term Outcome in Offspring and Mothers of Dexamethasone-Treated Pregnancies at Risk for Classical Adrenal Hyperplasia Owing to 21-Hydroxylase Deficiency”; see Jeffrey H. Silverstein for Mount Sinai School of Medicine to Kristina C. Borror of OHRP, August 2, 2010 (obtained via FOIA). New’s IRB applications at Cornell consistently distinguished between the prenatal interventions and the retrospective studies.

same administrator who told the OHRP
:
Silverstein to Borror, August 2, 2010.

Mount Sinai administrator told OHRP
:
Ibid., 8.

New had written to the NIH
:
Maria I. New to Duane Alexander, dated February 12, 2003, “Re: 4-R37HD00072-38.” (Obtained via FOIA.)

writing her a big check
:
NIH Staff, administrative increase/administrative supplement, staff recommendation “re. Maria I. New,” signed April 3, 4, and 7, 2003. (Obtained via FOIA.) In an email exchange on April 1, 2003, Barbara L. Pifel of Cornell told Angelos Bacas of NIH grant management that September 1, 2002 was “when Dr. New stopped receiving salary.” (Obtained via FOIA.)

perpetual motion machine
:
Aron C. Sousa, “The Dex Diaries, Part 4: A Perpetual Motion Machine of NIH Funding?” Aug. 21, 2012, http://fetaldex.org/diary04.html.

“which are part of the research”
:
Remark by “Dr. Aledo,” minutes of the Committee on Human Rights in Research of Cornell University Weill Medical College, September 29, 2003. (Obtained via FOIA.)

McCullough told OHRP
:
Laurence B. McCullough to Kristina C. Borror of OHRP, April 23, 2010. (Obtained via FOIA.)

at the medical schools of Cornell and Mount Sinai
:
See Alice Dreger and Ellen K. Feder, “FDA Ethicist’s Undisclosed Conflicts of Interest in Prenatal Dex Case,” Apr. 17, 2014, http://impactethics.ca/2014/04/17/.fda-ethicists-undisclosed-conflicts-of-interest-in-prenatal-dex-case.

served as “key personnel”
:
Frank A. Chervenak to Maria I. New, Apr. 15, 2003, regarding Rare Diseases Clinical Research Network grant proposal RR-03-008, reproduced at http://www.fetaldex.org/AJOB_Chervenak.html. (Obtained via FOIA.)

Robert “Skip” Nelson
:
See Robert M. Nelson of FDA “through” Diane Murphy of FDA to Kristina Borror for OHPR, Aug. 30, 2010.

negotiating a new
AJOB
journal editorship in chief
:
See Dreger and Feder, “FDA Ethicist’s Undisclosed Conflicts.”

to hire an editorial assistant
:
Vince Tolino, FDA Director of Ethics and Integrity, advised Nelson in e-mail discussions about this new position that it would look “cleaner” if a university used the money to pay a grad student to be an editorial assistant to Nelson. This correspondence is reproduced at http://fetaldex.org/updates_files/FOIA%20Nelson%20FDA%20AJOB-PR%20position.pdf.

was keeping track
:
Robert “Skip” Nelson to Jerry Menikoff, Kristina C. Borror, and Michael A. Carome, e-mail communication, Sept. 1, 2010, subject line “FDA Memo to OHRP re Dex for CAH” (obtained via FOIA): “Let us know when it will be posted.”

Nelson had told everybody
:
See Nelson through Murphy to Borror.

the 1996 exemption letter
:
Solomon Sobel for the FDA to Maria I. New, Cornell Medical Center, February 7, 1996 (obtained via FOIA).

without full FDA review
:
In fact the 1996 letter (ibid.) notes, in boilerplate language, that an IND exemption can only be provided if “the route of administration, dosage level, patient population, and other factors do not significantly increase the risks,” which surely would not have been true when aiming the intervention at fetuses.

no recollection of the matter
:
e-mail exchange between Alice Dreger and Solomon Sobel of the FDA, July 19, 2010. The reason I contacted Sobel at this time was that New had told a journal editor with whom I was communicating that “Prenatal dexamethasone treatment has been FDA approved by Dr. Sobel,” and I was trying to understand what she meant. For details, see Dreger, Feder, and Tamar-Mattis, “Prenatal Dexamethasone.”

shredded during an FDA move
:
Robert “Skip” Nelson to Jerry Menikoff, e-mail communication, June 14, 2010 (obtained via FOIA): “Thanks. I just learned that exemption letter documentation ([one inch of text redacted], certainly ones from 1996) were shredded for the move to White Oak [redacted].” See also Nelson’s e-mail to Diane Murphy at FDA, Sept. 25, 2010: “Other than the copy of the IND exemption letter that was sent by Cornell as part of their package in response to the OHRP inquiry, there are no known FDA records pertaining to the IND.” (Obtained via FOIA.)

suggesting that OHRP rely on his work
:
“And thanks again for coming up with the plan for using the FDA memo”; Jerry Menikoff replying to Robert “Skip” Nelson, e-mail communication, Sept. 1, 2010 (obtained via FOIA).

“ethically proper at every level”
:
Maria I. New, “Vindication of Prenatal Diagnosis and Treatment of Congenital Adrenal Hyperplasia with Low-Dose Dexamethasone,”
American Journal of Bioethics
10, no. 12 (2010): 67–68.

the editors refused
:
The exchange is reproduced at http://fetaldex.org/AJOB_Sept_2012.html.

New is subject to no such limitation
:
This was explained to me in e-mail correspondence with Robert “Skip” Nelson, May 24, 2011. See also Nelson through Murphy to Borror, Aug, 30, 2010.

the “bad-ad” division of the FDA
:
Alice Dreger to FDA Division of Drug Marketing, Advertising, and Communications, Sept. 10, 2010.

They shut it down
:
This news first came to us via a conversation between Ellen Feder and Svetlana Lajic (a member of the Swedish team), in an e-mail from Lajic to Feder, Sept. 19, 2011, subject “Question about your study of dexamethasone”; quoted in Dreger, Feder, and Tamar-Mattis, “Prenatal Dexamethasone,” 285. The Swedes later published this information in Tatya Hirvikoski et al., “Prenatal Dexamethasone Treatment of Children at Risk for Congenital Adrenal Hyperplasia: The Swedish Experience and Standpoint,”
Journal of Clinical Endocrinology and Metabolism
97, no. 6 (2012): 1881–83.

study of forty-three children
:
Ibid.

retrospective convenience-sample study
:
Heino F. L. Meyer-Bahlburg et al., “Cognitive Outcome of Offspring from DexamethasoneTtreated Pregnancies at Risk for Congenital Adrenal Hyperplasia due to 21-Hydroxylase Deficiency,”
European Journal of Endocrinology
167 (2012): 103–10.

highly skewed
:
Analysis of this paper was provided in an epilogue to Dreger, Feder, and Tamar-Mattis, “Prenatal Dexamethasone.”

“prevents understanding of questionnaire”
:
Maria I. New, “Long-Term Outcome in Offspring and Mothers of Dexamethasone-Treated Pregnancies at Risk for Classical Congenital Adrenal Hyperplasia Owing to 21-Hydroxylase Deficiency,” Rare Diseases Clinical Research Network, research protocol, (New York: Mount Sinai School of Medicine, 2007), 25 (obtained via FOIA).

Maria New still does
:
See “Prenatal Diagnosis and Treatment of Congenital Adrenal Hyperplasia,” Maria New Children’s Hormone Foundation, www.newchf.org/testing.php (accessed Aug. 1, 2014).

The top hit
:
Dreger, Feder, and Tamar-Mattis, “Prenatal Dexamethasone.”

The second hit
:
Svetlana Lajic, “Prenatal Treatment of Congenital Adrenal Hyperplasia” (undated), at http://www.caresfoundation.org/productcart/pc/prenatal_treatment_cah.html.

The third
:
Alice Dreger, Anne Tamar-Mattis, and Ellen K. Feder, “Experimental Status of Prenatal Dexamethasone for CAH Re-Affirmed,”
Endocrine Today
, October, 2011, at http://www.healio.com/endocrinology/news/print/endocrine-today/%7B547e98a4-7f10-495a-a01e-c5719cea8071%7D/experimental-status-of-prenatal-dexamethasone-for-cah-re-affirmed.

The fourth
:
Catherine Elton, “A Prenatal Treatment Raises Questions of Medical Ethics,”
Time,
June 18, 2010.

The fifth
:
Tatya Hirvikoski et al., “Prenatal Dexamethasone Treatment of Children at Risk for Congenital Adrenal Hyperplasia: The Swedish Experience and Standpoint,”
Journal of Clinical Endocrinology and Metabolism
97, no. 6 (June 2012): 1881–83, doi:10.1210/jc.2012-1222.

The sixth
:
Alice Dreger, Ellen K. Feder, and Anne Tamar-Mattis, “Preventing Homosexuality (and Uppity Women) in the Womb?”
Bioethics Forum,
Hastings Center, June 29, 2010, www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=4754&blogid=140.

The seventh
:
Alice Dreger, “IVF on Steroids: The Dangerous Off-Label Use of ‘Dex’ During Pregnancy,”
The Atlantic
(January 13, 2013), at http://www.theatlantic.com/health/archive/2013/01/ivf-on-steroids-the-dangerous-off-label-use-of-dex-during-pregnancy/267187/.

CONCLUSION: TRUTH, JUSTICE, AND THE AMERICAN WAY

one tiny historical story
:
I am indebted to Charles Greifenstein of the American Philosophical Society for introducing me to this historical story.

EPILOGUE: POSTCARDS

Journal of Urology
:
Richard S. Hurwitz, “Long-Term Outcomes in Male Patients with Sex Development Disorders—How Are We Doing and How Can We Improve?,”
Journal of Urology
184, no. 3 (2010): 821–32.

Swiss National Advisory
:
Swiss National Advisory Commission on Biomedical Ethics, NEK-CNE,
On the Management of Differences of Sex Development: Ethical Issues Related to “Intersexuality”
(Berne: Nov. 2012), Opinion No. 20/2012, http://www.nek-cne.ch/fileadmin/nek-cne-dateien/Themen/Stellungnahmen/en/NEK_Intersexualitaet_En.pdf.

special rapporteur on torture
:
Juan E. Méndez,
Report of the Special Rapporteur on Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment,
Human Rights Council of the United Nations, Feb. 1, 2013, www.ohchr.org/Documents/HRBodies/HRCouncil/RegularSession/Session22/A.HRC.22.53_English.pdf.

a recent study
:
Jürg C. Streuli et al., “Shaping Parents: Impact of Contrasting Professional Counseling on Parents’ Decision Making for Children with Disorders of Sex Development,”
Journal of Sexual Medicine
10, no. 8 (Aug. 2013): 1953–60, doi: 10.1111/jsm.12214. See also Ellen K. Feder,
Making Sense of Intersex: Changing Ethical Perspectives in Biomedicine
(Bloomington: Indiana University Press, 2014).

through the American courts
:
M.C., a minor by and through his parents
Pamela Crawford and John Mark Crawford v. Dr. Ian Aaronson, Dr. James Amrhein, Dr. Yawappiagyei-Dankah, Kim Aydlette, Meredith Williams, etc.,
Civil Action No. 2:13-cv-01303-DCN (U.S. District Court for South Carolina, Charleston Division), filed May 14, 2013.