Galileo's Middle Finger (44 page)

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 hyperadrenalstates/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.

Kyriakie Sarafoglou was hired
:
Anonymous, “Medical College Pays $4.4 Mil Settlement,”
The Cornell Daily Sun
, Sept. 15, 2005, http://cornellsun.com/blog/2005/09/19/medical-college-pays-44-mil-settlement/. She was hired into this position in August of 2001 according to the report of an investigation conducted by Adam Asch of Cornell at the request of David Hajjar, Dean at Cornell’s medical school, on November 4, 2002 (obtained by FOIA).

financial and ethical irregularities
:
See Bernard Wysocki Jr., “As Universities Get Billions in Grants, Some See Abuses: Cornell Doctor Blows Whistle over Use of Federal Funds, Alleging Phantom Studies,”
Wall Street Journal,
Aug. 16, 2005): A1.

concerning irregularities
:
in a memo with the subject line “Protocol # ????-???,” Sarafoglou noted to Cornell administrator Valerie Johnson that two of New’s protocols appeared to be exact duplicates, “each requesting $172,025” in terms of budget.” She asked, “How is this possible if they are separate studies?” and asked if the “same [100] patients will now undergo the same tests as they did” in another protocol; “Does this make sense?” New responded to Johnson in a letter dated December 5, 2002, that “I do not understand why the reviewers need to continually compare two protocols. Further, there’s no contraindication by the NIH to overlapping protocols.” (Obtained via FOIA.)

internal Cornell report
:
See Asch to Hajjar, November 4, 2002. According to this report, Sarafoglou put her concerns to Gerald Loughlin, Chair of Pediatrics, on September 10, 2002.

anguished message
:
Kyriakie Sarafoglou to Kristina Borror of OHRP, December 28, 2003 (obtained via FOIA).

“informed consent could be found”
:
Review of Neil H. White for OHRP, May 20, 2004 (obtained via FOIA).

“children as subjects of research”
:
Review of Bruce Gordon for OHRP, May 21, 2004 (obtained via FOIA).

angry memo
:
This was obtained via FOIA and has a subject line referring to New’s main CAH IRB protocol at Cornell (#0296-223). This memo is further discussed below.

New reporting to her IRB
:
Two examples located via FOIA: (1) Reviewer “Dr. Aledo” reporting on a meeting with Maria New on April 9, 2001, about her umbrella CAH IRB protocol: “112 accruals[,] 0 refusals[,] withdrawals[,] complaints.” Aledo recommended approval for another year. (2) Reviewer “Dr. Aledo” reporting on a meeting with Maria New on April 8, 2002, about the same protocol: “35 accruals[,] 0 withdrawals[,] refusals[,] complaints.” Aledo recommended approval for another year. See also the 1997 letter cited next.

in a letter to her IRB
:
Maria I. New to Dorothy Hilpmann, IRB Chair, April 4, 1997, subject “Annual Renewal Report for Protocol #0296-223CRC.” (Obtained via FOIA.)

a publication she had co-authored
:
the publication cited in the letter was Mercado et al., “Extensive Personal Experience.”

undertook a massive review
:
For a discussion of this earlier OHRP investigation, see Dreger, Feder, and Tamar-Mattis, “Prenatal Dexamethasone,” pp. 289–90.

extraordinary step of requiring review
:
See Patrick J. McNeilly for OHRP to Antonio M. Grotto and Jeffrey M. Cohen of Weill College of Medicine of Cornell University, July 21, 2004, subject “Human research subject protections under Multiple Project Assurance (MPA) M-1185 and Federalwide Assurance (FWA) 93.” (Obtained via FOIA.)

letter dated May 24, 2004
:
Patrick J. McNeilly for OHRP to Antonio M. Gotto, and Jeffrey M. Cohen of Weill College of Medicine of Cornell University, May 24, 2004; quotation on p. 7, item 15 (obtained via FOIA).

a lot of back-and-forth
:
See Jeffrey M. Cohen, Weill Medical College of Cornell, to Patrick J. McNeilly, OHRP, June 29 and August 31 2004. (Obtained via FOIA.)

New wrote back a curt memo
:
Maria I. New to Jeff Cohen of Cornell, fax transmission dated August 9, 2014. (Obtained via FOIA.)

in practice
:
Indeed, one interesting line in her grant renewal from 2001 seems to confirm this approach of treating the pregnant women as patients at Cornell while naming them as research subjects to NIH: “Sources of human subjects are referrals from local and distant physicians who care for pregnant women at risk for having a fetus with CAH.” But a few lines later, New adds: “Prenatal diagnosis and treatment are performed for clinical indications and are not primarily research purposes.” See 2001 “Application for Continuation Grant,” 47. See also the discussion of the fetuses treated at Mount Sinai, below.