Galileo's Middle Finger (29 page)

After some discussion, I wrote with Ellen another piece for the Hastings Center’s online
Bioethics Forum,
this one called “
Bad Vibrations
.”
Anne prepared legal letters
to the various individuals charged with protecting subjects at Cornell and at the federal level. And I called Dan Savage, the sex-advice writer and LGBT advocate, and asked him to help us out. Although I now understood that investigative health journalism had, thanks to the Internet, shrunk like an ice cube in the sun, I knew a prominent pundit like Dan could position this story to really matter nationally. In our phone call, Dan made clear he was fully committed to doing so. I explained to him that we needed this one to keep leveraging the dex story as well, to keep it from getting buried as an internal controversy and put away, now that McCullough et al. had marked us as not worth believing. Various journalists had started to look into dex, but none of them had published on it. Maybe with this, with a
pattern
of abuse of this population at Cornell, we might get some journalistic light shone.

On June 16, 2010—right about the middle of the calendar year that I still was thinking couldn’t get much worse—
Bioethics Forum
published “Bad Vibrations,” and
Dan Savage pushed it hard for us
. None of us expected what followed: The blogosphere exploded with the news that culturally motivated female genital cutting wasn’t just something that happened in Africa, it was going on in the United States—this in spite of the fact that these surgeries were something I and many others had been talking about for the last fifteen years!

But as I had suspected might happen in the great Rube Goldberg machine of the American media, the noise about Dix Poppas’s scalpels and vibrators led
Time
magazine’s editors to finally publish an “unrelated” article they’d been sitting on, a terrific piece of reporting on prenatal dex for CAH by a reporter named Catherine Elton. (OK, I’m sure it didn’t hurt that I contacted Elton to tell her about the Poppas kerfuffle, hinting she might want to tell her editors to piggyback on it.) The
Time
article
came out only two days after “Bad Vibrations,” and it began:

When Marisa Langford found out she was pregnant again, she called Dr. Maria New, a total stranger, before calling her own mother. New, a prominent pediatric endocrinologist and researcher at Mount Sinai Medical Center in New York City, is one of the world’s foremost experts in congenital adrenal hyperplasia. . . . “Dr. New told me I had to start taking dexamethasone immediately,” says Langford, 30, who lives in Tampa. “We felt very confident in someone of her stature and that what was she was telling us was the right thing to do.” . . . Langford says also that neither New nor her prescribing physician mentioned that prenatal dexamethasone treatment is an off-label use of the drug (an application for which it was not specifically approved by the government) or that the medical community is sharply divided over whether dexamethasone should be used during pregnancy at all.

Elton’s
Time
report also relayed the story of a twenty-four-year-old mother named Jenny Westphal “who took dexamethasone throughout her pregnancy at the recommendation of another doctor” and who “feels misled. Like Langford, she was not asked to give informed consent. Unlike Langford, however, her daughter, now 3, who has CAH, has also had serious and mysterious health problems since birth, including feeding disorders, that are not commonly associated with her adrenal-gland disorder.” Westphal had been looking online, and had apparently heard our alarms, just as I had hoped the exposed mothers would. (The reporter Elton had found these mothers on Listservs where they were talking about our call for a federal investigation.) “I was outraged, frustrated, and confused,” Westphal told
Time.
“Confused, because no one had ever warned me about this. I wasn’t given the chance to decide for myself, based on the risks and benefits,
if I wanted the treatment or not
.”

Then the very next day came the news, in the specialty paper
Endo Daily
,
that the big medical consensus group had finally announced its stance on prenatal dexamethasone for CAH: “Prenatal treatment of CAH [should] continue to be regarded as an experimental procedure. Prenatal treatment should not be conducted on a routine basis but should be confined to formal clinical study situations under institutional review board protocol.” The article went on to say that “the task force was hampered by the lack of high-quality data. Of 1,083 ‘candidate studies’ originally identified, only four met the quality criteria [for scientific reliability] agreed upon by the sponsoring groups” for further analysis. (Two were from the Swedish group, two from New’s group.) The sparse, scientifically weak data that did exist suggested “modest improvement” in genital outcomes, and “side effects” that included stillbirth and malformation. The task force chair, a physician who had once worked with New at Cornell, told
Endo Daily
bluntly, “
This is not standard of care
.” I alerted the signatories to our letter, to try to bolster their confidence that we had done the right thing.

 • • • 

F
OR SOME TIME,
Anne, Janet, and Ellen had been noting to me the extent to which for Maria New, the goal of medical intervention in these cases wasn’t just a girl who looked good, but one who behaved according to New’s notion of femininity. New was joined by her close collaborator, the Columbia University psychologist Heino
Meyer-Bahlburg
, in her focus on gendered behaviors in females with CAH. In a 1999 paper entitled “What Causes Low Rates of Child-Bearing in Congenital Adrenal Hyperplasia?” Meyer-Bahlburg had put it this way:

CAH women as a group have a lower interest than [non-CAH-affected] controls in getting married and performing the traditional child-care/housewife role. As children, they show an unusually low interest in engaging in maternal play with baby dolls, and their interest in caring for infants, the frequency of daydreams or fantasies of pregnancy and motherhood, or the expressed wish of experiencing pregnancy and having children of their own appear to be relatively low in all age groups.

 • • • 

W
HAT COULD BE
DONE
about CAH-affected women’s “unusually low interest” in being mommies? The end of Meyer-Bahlburg’s article gave a clue: “Long term follow-up studies of the behavioral outcome will show whether [prenatal] dexamethasone treatment also prevents the effects of prenatal
androgens on brain and behavior
.”

In a similar vein, in 2010, Maria New coauthored an article in the
Annals of the New York Academy
of Sciences
that construed a lack of interest in babies, in “women’s” activities, and in having sex with men as being “abnormal” for women—abnormal enough to justify attempts at prevention with prenatal dexamethasone: “Gender-related behaviors, namely childhood play, peer association, career and leisure time preferences in adolescence and adulthood, maternalism [interest in becoming a mother], aggression, and sexual orientation become masculinized in 46,XX girls and women with 21OHD deficiency [CAH]. These abnormalities have been attributed to the effects of excessive prenatal androgen levels on the sexual differentiation of the brain and later on behavior.” New and her coauthor concluded, “We anticipate that prenatal dexamethasone therapy will reduce the
well-documented behavioral masculinization
.”

As I was slow to figure out, the interest by New and her collaborators in whether one could prevent tomboyism and lesbianism with prenatal dex actually had been an open secret within the specialist medical scene. My friend the Michigan pediatric psychologist David Sandberg had spoken to this in the
Time
magazine article when he said that New’s presentations could give “clinicians the idea that the treatment goal is normalizing behavior.” He had added, “To say you want a girl to be less masculine is
not a reasonable goal of clinical care
.”

Just after the
Time
article on dex emerged, figuring we had gotten people to start noticing the apparent research abuses and that it was time to go public about this problematic political facet of prenatal dex, Ellen, Anne, and I put together another essay for
Bioethics Forum,
showing that New and her collaborators had been seeking to see if prenatal sex could lower
rates of tomboyism and lesbianism
. At my request,
Dan Savage again helped us out
. Now the media beyond
Time
finally went wild on prenatal dex. But what did the story become? The story of “
the anti-lesbian drug
.” Anybody could write passionate commentary on that. Debating the prevention of homosexuality didn’t take any actual work to understand or explain things like FDA protections and institutional review boards—the stuff we most cared about in terms of the CAH-affected families’ rights. I went from chewing tinfoil to chewing tacks.

On and on this went, and I became ever more selfishly regretful at having pulled the lid off this can of worms. My life seemed stalled in this uncomfortable mess, and there seemed to be no resolution in sight. Then all of a sudden, seven months after we had sent off our letters of concern, resolution of a sort
did
arrive. In early September 2010, in a pair of short memos,
the OHRP and the FDA indicated
they had done some poking around.

And they had found nothing worth pursuing.

OHRP found that Dr. New had enrolled some pregnant women in IRB-approved trials years back at Cornell (they didn’t say how many of the hundreds she was claiming to have “treated” through her clinic), and she had IRB approval now for the retrospective studies at Mount Sinai. The OHRP reviewers also accepted Dr. New’s defense that at Mount Sinai she wasn’t the one actually writing the prescriptions. Implication: How could she be held responsible?

For his part, the
FDA investigator revealed
that in 1996 the FDA had given Dr. New an “investigative new drug” exemption, which he claimed had been “for the administration of dexamethasone during pregnancy for the purpose of preventing virilization in females with congenital adrenal hyperplasia.” If this was true, it meant that the FDA had basically decided in 1996 that the fetal experiment was not special enough to warrant extensive FDA review. This seemed astonishing—the FDA, where Francis Kelsey had stopped thalidomide, thought this intentional fetal experiment hadn’t warranted careful FDA review? So the investigator claimed. Beyond this, he simply noted the debate over prenatal dex in the literature, said more studies would be helpful, and reiterated that doctors can use drugs off-label if they believe the benefits justify the use.

Maria New wasn’t doing anything actively prohibited by regulation, in the estimation of the federal investigators. The OHRP and FDA concluded that we had no case.

Within about twenty-four hours of the feds’ announcement,
AJOB
officially issued the published version of the McCullough and Chervenak paper. Of course, the “coincidental” timing amplified by several orders of magnitude the claims made in the
AJOB
target article. The fallout was pretty predictable. The Kansas City–based Center for Practical Bioethics, new home of
AJOB
’s editor-in-chief Glenn McGee, hosted a triumphant
podcast with Larry McCullough
essentially declaring victory over us unethical transgressive types and plugging the latest issue of
AJOB.
For his part, Maria New’s chief collaborator in dex, Heino
Meyer-Bahlburg, announced the Feds’ nonfindings
along with the
AJOB
issue on the big sex-research discussion list, the one that happens to be run out of Northwestern by Mike Bailey. My in-box flooded with messages. I read them all as
you were so wrong
.

I
HAD BEEN EXCITED
by the idea of asking the FDA and OHRP to help with prenatal dex not only because I believed those agencies would have the power to do something the medical societies couldn’t, but also because I had imagined impartial and well-informed investigators—those accountants on white horses. Hard as I had tried to look for evidence that our read of the situation might be wrong, I could never be completely objective. A team of government investigators, on the other hand—they would go in as the ultimate scholars, without allegiances, conflicts of interest, loyalties, agendas, or relationships that might complicate their thought patterns.

Because I had believed this, I had told myself that, whatever the agencies found, I would simply accept it. If they found we were right, well, that would be very satisfying, because then rigorous scientific practices might finally begin around this intervention. Researchers—including Maria New—would know that freedom of inquiry entails a responsibility for just research practices. The CAH-affected families might finally have their rights respected, especially the right not to be subject to experimentation without their consent, and other researchers watching might be more inclined to stick to the rules about informed consent. If the government investigators looked at the facts and somehow found we were wrong, well, accepting that judgment would show that we were putting ourselves second to the truth, the universe was functioning right, and we were behaving ethically.

Nevertheless, I never really believed they
could
find that there was nothing wrong with this picture. How could so many people, so many medical practitioners and researchers, looking at it and being outraged, be completely wrong about what seemed so obviously to be an ethical travesty befalling these families? Even if you didn’t care about intersex rights the way I did, you had to see how wrong this was. Yet so the government had ruled: we had no case. For someone like me, who had journeyed a long way to come to the firm belief that following the evidence is the most important ethical principle in democracy, the government’s findings meant that not only had I been wrong, but perhaps I had behaved unethically.

Of course, that’s what the
AJOB
guys, especially Larry McCullough, were saying everywhere they could. One might think that, having studied by now so many researchers who’d been accused on the national stage of unethical transgressions, I might have had some sense of how to manage my own condition in the days just after the one-two punch of
AJOB
and the feds’ nonfinding. Instead I could only watch myself experience the progression of emotions brought about by being labeled an unethical researcher: feeling by turns disgusted with myself and utterly wronged, alternately hiding and lashing out, having a sense of mental house arrest, and general catastrophizing. Mostly I felt as if I had utterly failed the families involved. On that shocking day in early September when the Feds and
AJOB
aligned to write us off, it was as if something cracked in my brain. Over the next few weeks, it felt like the crack just kept getting wider.

Well, when you get what feels like a diagnosis of terminal cancer, it helps to have friends who point out that you’re not dead
yet
. That job fell to Aron, Ellen, and Anne. The main thing they did was to point out over and over again, until it clicked, that while the government said they didn’t find anything worth pursuing according to
their
investigation and a narrow reading of the regulations, that didn’t mean we’d actually been wrong about
the ethics.
It certainly didn’t mean we were wrong to do what we had done to try to protect these families’ rights and health. Aron asked me this: How often in the history of major medical ethical travesties has the government, when called upon to act, done the right thing the first time around? I couldn’t think of a single case. Some people in the FDA had given Frances Kelsey
a hard time on thalidomide
, and it had taken
thirty years
after the finding that DES causes cancer in prenatally exposed humans for the FDA to withdraw approval of its use in humans—and then only because the drugmaker had finally
asked
the FDA to do so. Maybe government agencies weren’t superhuman after all. Maybe I had just been incredibly naive.

Aron also hinted that, when trying to understand where to go from here, instead of looking to stories like Chagnon’s and Bailey’s—wherein the odds had been long that the truth would ever get sorted out in public—I should look instead to what I had learned in my research from people who had persevered in their work on their own in spite of being accused of being enemies of the people. As a result, although I had become a science historian partly out of my adoration of Stephen Jay Gould, the arch-critic of sociobiology, now I found myself looking to Gould’s nemesis, Harvard naturalist Edward O. Wilson, for professional and psychological guidance. The year before the dex disaster, when I was researching Napoleon Chagnon’s story, Nap had bugged me to talk to Wilson, both because of how Wilson had helped Nap get through the Tierney tunnel, and because of what Wilson himself had been through for his vigorous defense of sociobiology, a field that had greatly offended many on the left. I still had my notes from a phone interview with Wilson in which he had talked to me about how he’d weathered being maligned and kept his focus on the big picture of his scholarship, scholarship aimed at helping lay people understand themselves.

To be honest, before I talked to Wilson that day for nearly two hours, it had never occurred to me that he could have really suffered. He seemed to me too famous, too stately, too smart, too polished to have ever had his feathers seriously ruffled by anyone. Yet when I spoke with him, Wilson movingly described what it felt like to be repeatedly, publicly accused by his Harvard colleagues, Richard Lewontin and Gould, of promoting a dangerous right-wing science in his quest to help humans understand their own nature. Lewontin and Gould denounced Wilson’s work on sociobiology, for example accusing him in a group open letter to the
New York Review of Books
of “join[ing] the long parade of biological determinists whose work has served to buttress the institutions of their society by exonerating them from responsibility for social problems.” This letter made clear what Wilson’s kind of biological determinism had led to historically: anti-immigration laws, sterilization laws, and ultimately “the eugenics policies which led to the establishment of gas chambers in Nazi Germany.” At Harvard, positioning themselves under the banner of Science for the People, Gould and Lewontin, along with lesser-known scientific critics, had opposed Wilson’s alleged science against the people. A group called the Committee Against Racism (CAR) aggressively protested Wilson’s “racist lies” on the Harvard campus. In 1977, riffing on the criticisms of Gould and Lewontin, a CAR flyer warned, “Sociobiology, by encouraging biological and genetic explanations for racism, war and genocide, exonerates and protects the groups and individuals who have carried out and benefitted
from these monstrous crimes
.”

Before
talking to Wilson
, I’d thought it couldn’t have been so bad before the Internet. But of course Lewontin and Gould were famous and beloved by the Left. They could rapidly publish almost anything they wanted about Wilson and his science, and with fewer venues for public debate, each of these attacks had a big impact. As I discussed with him how easily an individual’s research and public identity could be distorted, Wilson told me he could relate: “Gould and Lewontin could do something like that, change your identity to evil.”

I had asked Wilson if there had ever been a group of colleagues who had actively defended him at Harvard. He answered:

No. Unfortunately, no. In fact, I had several close friends in the Organismic and Evolutionary Biology Department who would sometimes speak to me and just say they were sorry it was happening. One was my close colleague Bert Hölldobler. We were working all the time together in the lab and field. We would spend long periods of time talking about it and trying to figure it out, trying to understand Lewontin. He gave me his unstinting support, and made it clear to Lewontin and others. But no one else said anything or did anything. I think they kind of weren’t one hundred percent sure about me. They thought maybe there was something to what Lewontin or Gould were saying. No one [except Hölldobler] ever offered any sympathy or any kind of help. I know at one point Lewontin had unleashed some outrageous statement and [Harvard biologist] Ernst Mayr read it and he spoke to Lewontin and asked, “Why are you doing this? Why are you attacking Ed all the time?” And the response Mayr reported to me was that Lewontin said in effect, well, it’s just my nature or personality.

I asked Wilson to share the advice he would give to a younger scholar caught in his position, knowing one’s motives and research were being widely distorted in the public sphere. At the time, I had no idea I’d be finding solace in his response only a year later. He answered:

I think I would tell him or her to ignore it. Pay attention, I mean, and respond if there is some really scurrilous thing being said. But, as much as possible, ignore it, and keep working. And you’ll win in the end. I know it isn’t easy during fights. I always said to myself, “Don’t get into a pissing contest with a skunk.” Looking back, if you ask me, what I most resent about all that period, I think the answer, the older I get, the farther behind this gets, as it recedes, I must resent the amount of time I wasted. I spent countless hours talking with journalists writing stories about this. They’d come to me and say, “Well, Professor Lewontin just said so-and-so, Professor Gould just said so-and-so.” Or, “I’ve read in the latest thing that they’ve said this. What do you say to that?” they’d ask me. I couldn’t sit by and let them say something that was in fact declaring me a racist and a proto-Nazi. I couldn’t say, “No comment.” I just wasted enormous amounts of energy and just pure time I could have used for something much more valuable. So my advice would be, this too shall pass. Ignore it as much as you can. Conduct yourself with dignity and with courtesy and let it pass.

Looking back at this interview with Wilson, hoping that I would someday again feel capable of helping people through my work, I drafted marching orders for myself: Stop thinking the press will get it right. Stop thinking you need them to get it right. Keep working for the long term. Disengage from the immediate fight and focus on knowing more, knowing as much as you can.

But in the short term, how to work past my sense of having failed at protecting the rights of families affected by CAH and intersex? For that, I found a possible answer in the survival advice I’d also collected the year before dex from the famous psychology researcher
Elizabeth Loftus
. Today Loftus is generally recognized as having been right—that human memory is fallible and that you can actually implant false “memories” in a person. However, in the late 1990s, Loftus had found herself in very deep trouble over her work challenging recovery of repressed memories of alleged child sexual abuse. She and a colleague, Melvin Guyer of the University of Michigan, had decided to research the index case of recovered memory. They had ended up gathering evidence that suggested that the poster child for repressed memory of childhood sexual abuse, a woman identified in the 1997 case study as Jane Doe, almost certainly did not experience the childhood sexual abuse at the hands of her mother that had been described in the context of an ugly custody battle. Loftus and Guyer had used public documents and interviews to make their case that the girl’s “memories” of abuse likely resulted from suggestions made to Jane Doe when she was a child, not from actual events.

Before Loftus and Guyer could publish, Jane Doe—whose
real name is Nicole Taus
—made formal complaints,
saying her privacy was being violated
. As one might expect, people who believed they had recovered memories and psychiatrists engaged in memory recovery angrily rallied against Loftus and Guyer. Eventually cleared by their universities,
the two went on to publish
their exposé, but Taus proceeded to litigation. Given that Loftus and Guyer had employed conventional investigative journalistic methods and had not even published Taus’s real name you would think the case would have been quickly dismissed. But as the claims and counterclaims became ever more complex, the suit survived, making it all the way to the California Supreme Court—and taking over a great chunk of the researchers’ lives.

In the end, they prevailed
. Because Loftus’s story had already been so well documented, what I had wanted to know most from Loftus when we had talked was how she had survived and continued to advocate for those wrongly accused through allegedly recovered memories. Now in my dex mess, I had advice from her to make my own. Some of her strategies seemed obvious: You keep working, you pay good lawyers, and you hold trustworthy friends and colleagues near. But one of her strategies had surprised me: She told me that during the worst years, she took up the habit of watching the Lifetime television network. She explained that the same basic story in different guises runs over and over again on Lifetime, the story of a woman facing tremendous adversity who somehow sticks it out and survives. Loftus’s approach made her philosophy clear: If you think you’re working for the greater good, you take the knocks and keep working, doing good research to figure out reality. You stop worrying about yourself. And so—staying firmly focused on the work that matters—you survive.

Knowing there probably wasn’t going to be a good historian who would do the work to tell me what actually happened with the whole prenatal dex scene, I realized that what Aron was telling me was right: I had to stop acting like a beaten dog and act like a professional historian. I had to treat this like a new major historical project, and I had to have the patience to work on it as long as it took to figure it out. As I made findings, I would have to present and publish them in scholarly arenas and in the mainstream press, so that people could see the evidence I’d found and help bring justice to bear. It might take several years, but this project was important enough to give years, because this really did look like DES all over again, even as to the reluctance of the government to stop the travesty, recalcitrance in the name of letting individual doctors decide what is best for their patients, no matter the science, no matter the ethics. If I did this work right—if I focused on truth and justice and not on my own misery—eventually I would help the CAH- and intersex-affected families and the ethical medical researchers, as I had originally set out to do.