Galileo's Middle Finger (41 page)

I wrote again five days later
:
Alice Dreger to Brandon Centerwall, personal e-mail communication, Feb. 16, 2009.

“or sharing it with others”
:
Brandon Centerwall to Alice Dreger, personal e-mail communication, Feb. 18, 2009.

His four-page letter
:
Brandon Centerwall to Alice Dreger, personal communication, Feb. 18, 2009, e-mail received Feb. 20, 2009.

teaming up with Andrew Wakefield
:
Interview by Dreger of Frechione.

University of Pittsburgh
:
I wrote to the University of Pittsburgh on July 7, 2009. A response came from Kathleen M. Dewalt on July 23, and I answered on July 27. On July 30, Dewalt wrote to say Tierney “is not currently appointed.” I answered on July 31: “Because your message of July 23 used the present tense for Patrick Tierney’s appointment at the Center for Latin American Studies, I take it that the ending date of the appointment can be noted in my work as late July, 2009. . . . I assume also your message means Mr. Tierney no longer has any appointment with the University of Pittsburgh. If I have any of this incorrect, please let me know. If I do not hear from you further, I’ll assume I have these facts right.” Dewalt did not correct my understanding.

Robert Cox
:
Robert S. Cox, “Salting Slugs in the Intellectual Garden: James V. Neel and Scientific Controversy in the Information Age,”
Mendel Newsletter,
Feb. 2001, www.amphilsoc.org/mendel/2001.htm#slugs.

Charlie took me down to the stacks
:
This visit occurred on June 30, 2009. Charles Greifenstein reviewed my draft description of this visit and in reply suggested no changes except perhaps mentioning more of the security aspects of the APS archive (Charles Greifenstein to Alice Dreger, personal e-mail communication, Jan. 26, 2011).

James Neel to Mr. Hobert E. Lowrance
:
James V. Neel to Hobert E. Lowrance, Mission Aviation Fellowship, Apr. 4, 1968, copy in Neel papers, American Philosophical Society, Philadelphia.

Thomas Headland had confirmed
:
See Thomas N. Headland, “When Did the Measles Epidemic Begin Among the Yanomami?”
Anthropology News
42, no. 1 (2001), 15–19, www.sil.org/~headlandt/measles1.htm.

Peacock Commission
:
James Peacock, Janet Chernela, Linda Green, Ellen Gruenbaum, Philip Walker, Joe Watkins, and Linda Whiteford, “Report to Louise Lamphere, President of the American Anthropological Association, and the Executive Board of the American Anthropological Association: Recommendation for Investigation of
Darkness in El Dorado
,” known as the Peacock Report, Jan. 21, 2001, copy provided to me by Raymond Hames, now retrievable at http://anthroniche.com/darkness_documents/0612.pdf.

When Hames resigned
:
Raymond Hames, “My Resignation Letter” (from El Dorado Task Force), 2002, http://anthroniche.com/darkness_documents/0514.htm; Raymond Hames telephone interview with Alice Dreger, June 23, 2009; approved version returned July 6, 2009.

They had so rushed it
:
Peacock et al., “Peacock Report,” 3: “In order to meet the deadline of January 22 for circulation of reports to the Executive Board, this report is submitted without explicit approval by all members of the Task Force of this final draft.”

Trudy Turner told me
:
Trudy R. Turner, telephone interview with Alice Dreger, Aug. 24, 2009; approved version returned Sept. 16, 2009.

Janet Chernela
:
Janet Chernela, telephone interview with Alice Dreger, Aug. 10, 2009, approved notes returned Aug. 15, 2009.

Yanomamö spokesperson who claimed
:
This is discussed in Dreger, “
Darkness
’s Descent,” 239.

Jane Hill
:
Jane Hill, telephone interview with Alice Dreger, July 15, 2009; approved version received July 16, 2009.

“I don’t remember the circumstances”
:
Ibid.

batch of photocopies
:
Obtained via e-mail from Sarah Hrdy, Nov. 6, 2009.

gave me permission
:
Hill provided permission via e-mail to me on Nov. 6, 2009.

“Burn this message”
:
Jane Hill to Sarah Hrdy, personal e-mail communication, Apr. 15, 2002; used with permission. Also reproduced in Dreger, “
Darkness
’s Descent,” 237.

Louise Lamphere
:
I note in Dreger, “
Darkness
’s Descent,” 240, that “I asked Lamphere to confirm or deny this on the record, and she has not.”

“disagreed with their theoretical bent”
:
Francesca Bray to Alice Dreger, personal e-mail communication, Oct. 9, 2009, used with permission.

HBES meeting
:
Alice Dreger, “Darwin’s Dangerous Critics: Evolutionary Biology and Identity Politics in the Internet Age,” paper presented at annual meeting, Human Behavior and Evolution Society, California State University–Fullerton, May 30, 2009.

At UCSB
:
See Hagen, Price, and Tooby,
Preliminary Report
.

University of Michigan
:
See Nancy Cantor, “Statement from University of Michigan Provost Nancy Cantor on the Book,
Darkness in El Dorado
, by Patrick Tierney,” Nov. 13, 2000, http://ns.umich.edu/Releases/2000/Nov00/r111300a.html.

Chuck Roselli
:
See John Schwartz, “Of Gay Sheep, Modern Science and Bad Publicity,”
New York Times,
Jan. 25, 2007, www.nytimes.com/2007/01/25/science/25sheep.html.

twenty thousand e-mails
:
This account is based in part on interviews with Roselli and Newman: Charles Roselli, telephone interview with Alice Dreger, Nov. 5, 2008, approved notes received Nov. 8, 2008; Jim Newman, telephone interview with Alice Dreger, Oct. 23, 2008, approved notes received Nov. 8, 2008. Roselli and Newman also reviewed a draft of this section on Oct. 11, 2012, and agreed the representation is accurate.

“defend researchers this way”
:
Interview with Newman.

“‘back to work’”
:
Ibid.

CHAPTER 7: RISKY BUSINESS

promoting a high-risk drug regimen
:
See 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, no. 3 (2012): 277–94. For examples of New’s clinic’s promotion of the intervention, see “Prenatal Diagnosis and Treatment of Congenital Adrenal Hyperplasia,” Maria New Children’s Hormone Foundation, www.newchf.org/testing.php (accessed July 30, 2014). See also Elizabeth Kitzinger, “Prenatal Diagnosis & Treatment for Classical CAH,”
CARES Foundation Newsletter
2, no. 1 (Winter 2003): 15, www.caresfoundation.org/productcart/pc/news_letter/winter02-03_page_9.htm. See also the discussion of Maria New’s 2001 presentation below.

Dr. Maria New
:
See “Biography: Dr. Maria Iandolo New,” at http://www.nlm.nih.gov/changingthefaceofmedicine/physicians/biography_234.html.

recommend the intervention
:
See, for example, Kitzinger, “Prenatal Diagnosis,” and the discussion of New’s 2001 presentation below. The CARES (Congenital Adrenal Hyperplasia Research, Education & Support) Foundation has also enabled New’s promotion of prenatal dexamethasone for CAH by, for example, posting New’s biography calling hers “the only large center that provides prenatal diagnosis of CAH and prenatal treatment of affected females to prevent genital ambiguity,” at www.caresfoundation.org/productcart/pc/scientific_medical.html.

“found safe for mother and child”
:
See “Prenatal Diagnosis and Treatment,” Maria New Children’s Hormone Foundation.

studies of efficacy and long-term safety
:
For a review of how little was actually known about the safety and efficacy of prenatal dexamethasone for CAH in 2010, see 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. This article was published after the OHRP and FDA investigations (discussed in the next chapter) were completed, but the absence of data that it demonstrates was readily apparent to anyone who conducted a basic medical literature search.

changing brain development
:
See, for example, Hideo Uno et al. “Neurotoxicity of Glucocorticoids in the Primate Brain,”
Hormones and Behavior
28, no. 4 (Dec. 1994): 336–48. See also the concerns raised in Svetlana Lajic, Anna Nordenström, and Tatya Hirvikoski, “Long-Term Outcome of Prenatal Treatment of Congenital Adrenal Hyperplasia,” in Christa E. Flück and Walter L. Miller, eds.,
Disorders of the Human Adrenal Cortex
(Basel: Karger, 2008), 82–98. For a discussion of concerns from animal studies about prenatal dexamethasone increasing cardiovascular disease risk, see Svetlana Lajic, Anna Nordenström, and Tatya Hirvikoski, “Long-Term Outcome of Prenatal Dexamethasone Treatment of 21-Hydroxylase Deficiency,”
Endocrine Development
20 (2011): 96–105.

“the only clinic in the United States”
:
See “Prenatal Diagnosis and Treatment,” Maria New Children’s Hormone Foundation; and Kitzinger, “Prenatal Diagnosis & Treatment for Classical CAH.”

funding to study, retrospectively
:
Evidence of the outcomes study was readily available: “Determining the Long-Term Effects of Prenatal Dexamethasone Treatment in Children With 21-Hydroxylase Deficiency and Their Mothers,” ClinicalTrials.gov, http://clinicaltrials.gov/ct2/show/NCT00617292.

“
have not been determined
”
:
Ibid. (
Emphasis added
)

large “accumulated” clinical population
:
See p. 2 of M. I. New, “Androgen metabolism in childhood,” grant application R01 HD00072-33A1 (approved), National Institutes of Health (New York: Cornell University Medical College, 1996) where New refers to the “large population of prenatally-treated infants” she had “accumulated” for study.

trying to put a stop
:
See Dreger, Feder, and Tamar-Mattis, “Prenatal Dexamethasone.”

a complete absence of any properly controlled scientific studies
:
This was to be confirmed in the systematic review and meta-analysis published later that year by Fernández-Balsells et al., “Prenatal Dexamethasone.” There has been no placebo-controlled trial of prenatal dexamethasone for CAH and no trials with outcomes judged by independent observers. While the Swedish team has performed a prospective study, New’s U.S. group has tracked outcomes past birth only retrospectively, typically using low-level techniques like phone surveys and questionnaires rather than physical examinations. For an example of the phone survey approach, 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. 12 (2001): 5651–57. For an example of the use of retrospective questionnaires, see Heino F. Meyer-Bahlburg et al., “Cognitive and Motor Development of Children with and without Congenital Adrenal Hyperplasia after Early-Prenatal Dexamethasone,”
Journal of Clinical Endocrinology & Metabolism
89, no. 2 (2004): 610–14.

see if the intervention works in animals
:
For example, the FDA Web site assures consumers that, in the long process toward approval for drug indications, “companies, research institutions, and other organizations that take responsibility for developing a drug . . . must show the FDA results of preclinical testing in laboratory animals and what they propose to do for human testing.” See Food and Drug Administration, “The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective,” www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm. In 1964, the Declaration of Helsinki codified as its first Basic Principle that clinical research “should be based on laboratory and animal experiments or other scientifically established facts.”
Declaration of Helsinki
, 18th World Medical Assembly, Helsinki, 1964.

The Swedish data
:
See Tatya Hirvikoski, et al., “Cognitive Functions in Children at Risk for Congenital Adrenal Hyperplasia Treated Prenatally with Dexamethasone,”
Journal of Clinical Endocrinology & Metabolism
92 (2007): 542–48. It’s interesting that an early report from New’s group on cognitive outcomes hinted at similar possible adverse effects: see 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. See below for a discussion of later outcomes studies by New’s group.