by Alice Dreger
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 Caus
es 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.”
CHAPTER 9: DOOMED TO REPEAT?
a hard time on thalidomide: See Nancy Langston, Toxic Bodies: Hormone Disruptors and the Legacy of DES (New Haven: Yale University Press, 2010).
New York Review of Books: Elizabeth Allen et al., “Against ‘Sociobiology,’” New York Review of Books, Nov. 13, 1975, http://www.nybooks.com/articles/archives/1975/nov/13/against-sociobiology.
“from these monstrous crimes”: Quoted in Ullica Segerstrale, Defenders of the Truth: The Sociobiology Debate (Oxford, UK: Oxford University Press, 2000), 181.
talking to Wilson: Alice Dreger, telephone interview with Edward O. Wilson, Aug. 24, 2009.
Elizabeth Loftus: Elizabeth Loftus reviewed and agreed with this account of our conversation on February 13, 2012.
real name is Nicole Taus: See Carol Tavris, “Whatever Happened to ‘Jane Doe’?” Skeptical Inquirer 32, no. 1 (Jan.–Feb. 2008), www.csicop.org/si/show/whatever_happened_to_jane_doe.
saying her privacy was being violated: See Carol Tavris, “The High Cost of Skepticism,” Skeptical Inquirer 26, no. 4 (July–Aug. 2002): 41–44, http://www.csicop.org/si/show/high_cost_of_skepticism/.
the two went on to publish: Elizabeth F. Loftus and Melvin J. Guyer, “Who Abused Jane Doe? The Hazards of the Single Case History: Part I,” Skeptical Inquirer 26, no. 3 (May–June 2002): 24–32, http://faculty.washington.edu/eloftus/Articles/JaneDoe.htm.
In the end, they prevailed: See Tavris, “Whatever Happened to ‘Jane Doe’?”
I hired a lawyer and sued: Alice Dreger v. U.S. Department of Health & Human Services, Food & Drug Administration, and Office for Human Research Protections, United States District Court, Western District of Michigan, Southern Division, filed Oct. 3, 2011, 1:2011-cv-01059.
ethics canary in the modern medical mine: Hence the subtitle I gave our paper on the matter: 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.
Cornell clinic in 1986: This date comes from a faxed letter from Maria I. New to Jeff Cohen of Cornell’s medical school dated August 19, 2004, obtained via FOIA, and is confirmed in 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.
drug trials were not rigorous: See the critical analysis of New’s studies in Mercè M. Fernández-Balsells et al., “Prenatal Dexamethasone Use for the Prevention of Virilization in Pregnancies at Risk for Classical Congenital Adrenal Hyperplasia Because of 21-Hydroxylase (CYP21A2) Deficiency: A Systematic Review and Meta-Analyses,” Clinical Endocrinology 73, no. 4 (2010): 436–44.
some results: Mercado et al., “Extensive Personal Experience.”
New’s first Cornell IRB application: Maria I. New, IRB application (approved) for project entitled “Steroid 21-Hydroxylase Deficiency: Inborn error of steroid synthesis” (New York: New York Hospital-Cornell Medical Center Institutional Review Board: 1985), obtained via FOIA.
sixteen years: New noted that she was now checking the boxes in a letter to Owen Davis, Chair of the Cornell IRB, on March 21, 2001, subject “Annual Review Report for Protocol #0296-223CRC” (obtained via FOIA). That said, a year later, there is an IRB application from New for prenatal dex marked “received Mar 15 2002” on which she again did not check the boxes for “pregnant women” or “fetuses”; see Maria I. New, “Request for Approval of Investigation Involving Use of Human Subjects,” Protocol 0296-223 (obtained via FOIA). Similarly, in 2003, the Cornell IRB approved a minor revision of New’s IRB protocol to “clarify” that “The correct age criteria should read, ‘Newborn to 100 years’” without apparently noticing that it should really have read “fetuses to 100 years.” The request was from Maria I. New to David Behrman, Chair of the Cornell IRB, March 4, 2003, subject “Protocol #0296-223”; approval returned April 21, 2003 from Behrman to New (obtained via FOIA).
1985 consent form: This formed part of the 1985 IRB application noted below. We also discuss this in Dreger, Feder, and Tamar-Mattis, “Prenatal Dexamethasone.”
“transient and reversible suppression”: Ibid., p. 9e.
updated information: For example, New’s consent forms did not incorporate notice of the potential harms in terms of temperament and behavior as reported by New’s own group in P. D. Trautman et al., “Effects of Early Prenatal Dexamethasone on the Cognitive and Behavioral Development of Young Children: Results of a Pilot Study,” Psychoneuroendocrinology 20, no. 4 (1995): 439–49, nor of the potential somatic effects (including failure to thrive and delayed psychomotor development) reported in Svetlana Lajic et al., “Long-Term Somatic Follow-up of Prenatally Treated Children with Congenital Adrenal Hyperplasia,” Journal of Clinical Endocrinology & Metabolism 83, no. 11 (1998): 3872–80. Maternal “side” effects are also downplayed on New’s consent forms in spite of reports in the literature of “significant maternal side effects” including “Cushingoid facial features, severe striae resulting in permanent scarring, and hyperglycemic response” in addition to “hypertension, gastrointestinal intolerance, or extreme irritability”; see S. Pang, A. T. Clark, L. C. Freeman, et al., “Maternal Side Effects of Prenatal Dexamethasone Therapy for Fetal Congenital Adrenal Hyperplasia,” Journal of Clinical Endocrinology & Metabolism, vol. 75, no. 1 (1992): 249–53.
As late as 2004, Cornell’s IRB: Maria I. New, Consent form for clinical investigation (IRB approved) for project entitled “Hypo- and hyperad
renalstates/prenatal diagnosis and therapy” (New York: New York Presbyterian Hospital-Weill Medical College of Cornell University: 2004), obtained via FOIA.
than any other researcher: See, e.g., p. 2 of New’s 1996 grant application, Maria I. New, “Androgen metabolism in childhood,” grant application R01 HD00072-33A1 (approved), National Institutes of Health (New York: Cornell University Medical College, 1996); see also p. 34 of her 2001 application for continuation grant, 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).
2001 grant renewal application: See New, 2001 “Application for Continuation Grant,” 34; emphasis added.
2,144: See New, 2001 “Application for Continuation Grant,” 42.
By 1996, the NIH was specifically: New’s 1996 NIH application reported that “genital abnormalities and often multiple corrective surgeries needed affect social interaction, self image, romantic and sexual life, and fertility. As a consequence, many of these patients, and the majority of women with the salt-losing variant [of CAH], appear to remain childless and single. Preventative prenatal exposure is expected to improve this situation”; see p. 38 of Maria I. New, “Androgen metabolism in childhood,” grant application R01 HD00072-33 (approved), National Institutes of Health (New York: Cornell University Medical College, 1996). In a related application packet, New specifically promised to try to determine “the success of DEX in suppressing behavioral masculinization”; see p. 17 of Maria I. New, “Androgen metabolism in childhood,” grant application R01 HD00072-33A1 (approved), National Institutes of Health (New York: Cornell University Medical College, 1996). In her 2001 “Application for Continuation Grant,” New reiterated the same interest in prenatal dex: “Our studies of the outcome in CAH patients with respect to gender, cognition, and social function will provide vital information on the validity of our [prenatal] treatment protocol”; quotation at 44.