Galileo's Middle Finger (43 page)

“to establish that prenatal treatment with dexamethasone is safe”
:
The same year New was describing dex as “safe” at the CARES Foundation meeting (ibid.), she told the NIH in her “Application for Continuation Grant,” “We must now establish that prenatal treatment with dexamethasone is safe and has no long-term consequences”; Maria I. New, application for continuation grant, “Androgen Metabolism in Childhood,” grant 5-R37-HD00072-37 (approved), National Institute of Child Health and Human Development (New York: Weill Cornell Medical College, 2001), quotation on p. 46. She specifically listed “prenatal treatment” as part of her “research plan” (p. 43). In the same grant application, New also told NIH: “This study is conducted . . . by FDA permission” (p. 47); I show below that there is no evidence she had such permission. As noted below, as late as 2006 she was still specifically naming dex-exposed fetuses as subjects of research for NIH grant purposes.

“human subjects of research”
:
In her 2001 “Application for Continuation Grant” (ibid.), New described the sources of her human subjects this way: “Sources of human subjects are referrals from local and distant physicians who care for pregnant women at risk for having a fetus with CAH” (p. 47). Naming “the strengths of our group,” New told the NIH, “We are the only group in the United States carrying out prenatal diagnosis and treatment of CAH and have thus accumulated a large population of prenatally treated patients to study” (p. 34).

resources to weather criticism
:
A classic example is that of Chester M. Southam who attempted infecting patients at the Jewish Chronic Disease Hospital with cancer, and who went on to be promoted within his field. See Chapter 17, “Illegal, Immoral, and Deplorable,” in Rebecca Skloot,
The Immortal Life of Henrietta Lacks
(New York: Crown Publishers, 2010).

code meant for Nazis
:
See Susan M. Reverby,
Examining Tuskegee: The Infamous Syphilis Study and Its Legacy
(Chapel Hill: University of North Carolina Press, 2009), pp. 189, 193.

“letter of concern”
:
Ellen K. Feder, Alice Dreger, Hilde Lindemann, et al., to the FDA Office of Pediatric Therapeutics, the Office for Human Research Protections, Mount Sinai Medical Center, Weill Medical School of Cornell University, and Florida International University, February 3, 2010, known as “Letter of Concern from Bioethicists,” reproduced at http://fetaldex.org/letter_bioethics.html.

“we agree with Dr. Miller”
:
The quote from Miller appeared in Walter L. Miller, “Prenatal Treatment of Classic CAH with Dexamethasone: Con,”
Endocrine News,
Apr. 2008, 16–18.

OHRP and the FDA had let us know
:
The OHRP response came from Kristina C. Borror to Ellen K. Feder and Anne Tamar-Mattis, Feb. 26, 2010. The FDA response came from Dianne Murphy to Ellen K. Feder, Feb. 8, 2010.

group of Boston clinicians
:
David A. Diamond et al., “Not Fetal Cosmetology,”
Bioethics Forum,
Mar. 8, 2010, www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=4528&blogid=140.

in the response
:
Alice Dreger, Ellen Feder, and Hilde Lindemann, “Prenatal Dex: Update and Omnibus Reply,”
Bioethics Forum,
Mar. 18, 2010, www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=4569&blogid=140.

“when the risks are non-trivial”
:
Walter L. Miller to Alice Dreger, quoted with permission; also quoted on p. 284 of Alice Dreger, Ellen K. Feder, and Anne Tamar-Mattis, “Prenatal Dexamethasone for Congenital Adrenal Hyperplasia: An Ethics Canary in the Modern Medical Mine,”
Journal of Bioethical Inquiry
9 (2012): 277–94.

bioethics e-mail discussion list
:
This exchange occurred on the Medical College of Wisconsin bioethics Listserv ([email protected]) starting in late Jan. 2010.

report on 532 pregnancies
:
See Maria I. New et al., “Extensive Personal Experience: Prenatal Diagnosis for Congenital Adrenal Hyperplasia in 532 Pregnancies,”
Journal of Clinical Endocrinology & Metabolism
86, no. 2 (2001): 5651–57. An earlier paper from New and her team reporting on 239 pregnancies made no mention of any IRB approval or oversight; see Arlene B. Mercado et al., “Extensive Personal Experience: Prenatal Treatment and Diagnosis of Congenital Adrenal Hyperplasia Owing to Steroid 21-Hydroxylase Deficiency,”
Journal of Clinical Endocrinology and Metabolism
80, no. 7 (July 1995): 2014–20.

“preserve life or intellectual capacity”
:
Phyllis W. Speiser et al., “Congenital Adrenal Hyperplasia Due to Steroid 21-Hydroxylase Deficiency: An Endocrine Society Clinical Practice Guideline,” draft dated Aug. 31, 2009, 80 pp.; quotations at 13, 19. A different version (with the same conclusion) was eventually published as Phyllis W. Speiser et al., “Congenital Adrenal Hyperplasia due to Steroid 21-Hydroxylase Deficiency: An Endocrine Society Clinical Practice Guideline,”
Journal of Clinical Endocrinology and Metabolism
95, no. 9 (Sept. 2010): 4133–60. All of the lines quoted here remained the same from draft to final publication except for deletion of the line “the condition being treated, while fraught with emotional complexities, is directed toward a cosmetic outcome rather than aiming to preserve life or intellectual capacity.” The line was replaced with: “Prenatal treatment of CAH is directed toward reducing the need for surgery, rather than toward preserving life or intellectual capacity.”

“yield precise findings”
:
Speiser et al., “Congenital Adrenal Hyperplasia,” draft, 13.

the cosponsors
:
They were the American Academy of Pediatrics, Androgen Excess and PCOS Society, CARES Foundation, European Society for Endocrinology, European Society for Paediatric Endocrinology, Lawson Wilkins Pediatric Endocrine Society, and the Society of Pediatric Urology.

a formal call for responses
:
The target article abstract with a call for applications to respond was released by the
American Journal of Bioethics
on May 14, 2010. The
AJOB
target article was eventually published with responses (and with an amended title) as Laurence B. McCullough et al., “A Case Study in Unethical Transgressive Bioethics: ‘Letter of Concern from Bioethicists’ About the Prenatal Administration of Dexamethasone,”
American Journal of Bioethics
10, no. 9 (Sept. 2010): 35–45.

that 2002 position paper
:
See Joint LWPES/ESPE CAH Working Group, “Consensus Statement on 21-Hydroxylase Deficiency from the Lawson Wilkins Pediatric Endocrine Society and the European Society for Pædiatric Endocrinology,”
Journal of Clinical Endocrinology and Metabolism
87, no. 9 (Sept. 2002): 4048–53, at 4048.

over six hundred women
:
See “Prenatal Diagnosis and Treatment,” Maria New Children’s Hormone Foundation; and Kitzinger, “Prenatal Diagnosis & Treatment for Classical CAH.”

“everybody else in the world put together”
:
See New, presentation of Nov. 14, 2001.

lack of transparency
:
See my collaborator Hilde Lindemann’s June 2011 resignation letter from
AJOB
’s editorial board at Brian Leiter’s blog, http://leiterreports.typepad.com/blog/2011/06/editorial-misconduct-at-another-philosophy-journal-the-case-of-the-american-journal-of-bioethics.html. Glenn McGee responded to Lindemann in the comments.

“An Unethical Ethicist?”
:
Brendan Borrell, “An Unethical Ethicist?,”
Scientific American,
June 16, 2008, www.scientificamerican.com/article.cfm?id=glenn-mcgee. See also Brendan Borrell, “Alden March Bioethics Institute Picks Up the Pieces After Glenn McGee’s Ouster,”
Scientific American,
July 7, 2008, www.scientificamerican.com/article.cfm?id=bioethics-institute-picks.

I wrote to McCullough
:
This exchange occurred via e-mail on May 17 and 18, 2010. In an e-mail to me, copied to his coauthors and McGee, McCullough stated, “None of the authors of the paper: 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; has ever published a paper with Dr. New; has ever written a prescription for a pregnant patient in one of Dr. New’s trials; has ever ‘acted as an ethics advisor to those administering, promoting, or researching this use of prenatal dex.’” As shown below, this was not true for McCullough and Chervenak.

Journal of Urology
, in 2007
:
Jennifer Yang, Diane Felsen, and Dix P. Poppas, “Nerve Sparing Ventral Clitoroplasty: Analysis of Clitoral Sensitivity and Viability,”
Journal of Urology
178, no. 4, pt. 2 (Oct. 2007): 1598–1601.

“Bad Vibrations”
:
Alice Dreger and Ellen K. Feder, “Bad Vibrations,”
Bioethics Forum,
Hastings Center, June 16, 2010, www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=4730.

Anne prepared legal letters
:
See Anne Tamar-Mattis to Jerry Menikoff, Director, Office for Human Research Protections, June 25, 2010, http://aiclegal.files.wordpress.com/2010/06/poppas-ohrp-letter.pdf.

Dan Savage pushed it hard for us
:
Dan Savage, “Female Genital Mutilation at Cornell University,”
SLOG
, June 16, 2010, http://www.thestranger.com/slog/archives/2010/06/16/female-genital-mutilation-at-cornell-university&view=comments.

Time
article
:
Catherine Elton, “A Prenatal Treatment Raises Questions of Medical Ethics,”
Time,
June 18, 2010, http://content.time.com/time/health/article/0,8599,1996453,00.html (accessed July 30, 2014).

“if I wanted the treatment or not”
:
Ibid.

Endo Daily
:
Anonymous, “Draft CAH Guideline Revealed Monday,”
Endo Daily,
June 19–22, 2010, 8, www.nxtbook.com/tristar/endo/day4_2010/index.php?startid=8.

“This is not standard of care”
:
Ibid. For the final version of the consensus document, see Speiser et al., “Congenital Adrenal Hyperplasia . . . Clinical Practice Guideline.”

Meyer-Bahlburg
:
Heino F. L. Meyer-Bahlburg, “What Causes Low Rates of Child-Bearing in Congenital Adrenal Hyperplasia?”
Journal of Clinical Endocrinology and Metabolism
84, no. 6 (June 1999): 1844–47; quotation at 1845–46.

“androgens on brain and behavior”
:
Ibid., quotation at 1846.

Annals of the New York Academy
:
Saroj Nimkarn and Maria I. New, “Congenital Adrenal Hyperplasia due to 21-Hydroxylase Deficiency: A Paradigm for Prenatal Diagnosis and Treatment,”
Annals of the New York Academy of Sciences,
no. 1192 (Apr. 2010): 5–11, quotation at 9.

“well-documented behavioral masculinization”
:
Ibid, 9.

“not a reasonable goal of clinical care”
:
Sandberg quoted in Elton, “Prenatal Treatment.”

rates of tomboyism and lesbianism
:
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. We later expanded on this in Dreger, Feder, and Tamar-Mattis, “Prenatal Dexamethasone.”

Dan Savage again helped us out
:
Dan Savage, “Doctor Treating Pregnant Women with Experimental Drug to Prevent Lesbianism,”
SLOG
, June 30, 2010, http://www.thestranger.com/slog/archives/2010/06/29/doctor-treating-pregnant-women-with-experimental-drug-to-prevent-lesbianism.

“the anti-lesbian drug”
:
See, for example, Sharon Begley, “The Anti-Lesbian Drug,”
Newsweek,
July 2, 2010, www.newsweek.com/anti-lesbian-drug-74729 (accessed July 31, 2014).

the OHRP and the FDA indicated
:
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; Robert M. Nelson of FDA “through” Dianne Murphy of FDA to Kristina C. Borror for OHPR, Aug. 30, 2010, reproduced at http://fetaldex.org/correspondence_files/FDA_to_OHRP_Aug_30_2010.pdf.

FDA investigator revealed
:
Ibid.

podcast with Larry McCullough
:
Glenn McGee with Laurence McCullough, “A Case Study in Unethical Transgressive Bioethics,”
Bioethics Channel,
Center for Practical Bioethics, Sept. 7, 2010, http://www.fluctu8.com/podcast-episode/a-case-study-in-unethical-transgressive-bioethics-84701-69055.html.

Meyer-Bahlburg announced the Feds’ nonfindings
:
Heino F. L. Mayer-Bahlburg to SEXNET, [email protected], Sept. 3, 2010, “DSD Matter.”