Galileo's Middle Finger (28 page)

It helped that just a few weeks after our letters went to the feds, a clinical insider leaked me a draft of a forthcoming new medical consensus on prenatal dexamethasone for CAH. Besides acknowledging that “the mechanism of dexamethasone’s action in the fetus is incompletely understood” and confirming that high-quality efficacy and long-term safety data were virtually nonexistent twenty-five years into the practice, the authors admitted that “the condition being treated, while fraught with emotional complexities, is
directed toward a cosmetic outcome
rather than aiming to
preserve life or intellectual capacity
.” (Prevention of the urogenital sinus as the true goal, my ass.) Given all this, the authors concluded, “We recommend that prenatal therapy continue to be regarded as experimental, and be pursued only through research protocols approved by the local Institutional Review Boards at centers capable of enrolling a sufficiently large number of participants in such protocols—alone or in collaboration with other centers—to
yield precise findings
.”

Here was yet another major medical attempt to stop promotion of this high-risk game as standard care. And this was no minority report; the document had been put together (and put together
before
we ever started making noise) by the Endocrine Society, a group Dr. New had for decades helped lead.
The cosponsors
included the American Academy of Pediatrics, three major pediatric specialist groups, and even the support group that had long been New’s supporter and promotion venue.

Of course, it being a leak of a draft consensus, I didn’t dare share this beyond the closest insiders. I worried that our activism might paradoxically cause the consensus group to pull back in the published version, wanting to distance themselves from the people who had sicced the Feds on a fellow physician. If there’s one intervention almost all specialists recommend, it’s closing ranks against activists.

All I could do was wait and hope the government workers on whose plate this had landed would be moved to action. I kept picturing them as accountants on white horses.

 • • • 

I
N
M
AY,
on one of the first warm days of spring, I checked my e-mail just after a lazy outdoor lunch with a friend and found that my in-box had exploded with the same message forwarded to me by colleagues all over the country. I opened and read one. My heart starting pounding like timpani in my left ear. The
American Journal of Bioethics
had just sent out
a formal call for responses
to a new “target article” slamming our call for a federal investigation on prenatal dex. The article was called “A Case Study in Unethical Transgressive Bioethics: FetalDex.org’s Letter of Concern about the Prenatal Administration of Dexamethasone.” (FetalDex.org was the public Web domain I’d set up to be transparent about our efforts and to educate families, reporters, and doctors about what was known and unknown about prenatal dex.) Reading the abstract made it feel like a fast swarm of bees was entering my head through my eye sockets:

On February 3, 2010, a “Letter of Concern from Bioethicists” was sent by fetaldex.org to report suspected violations of the ethics of human subjects research in the off-label use of dexamethasone during pregnancy by Dr. Maria New. . . . We provide a critical appraisal of the Letter of Concern and show that it makes false claims, misrepresents scientific publications and websites, fails to meet standards of evidence-based reasoning, makes undocumented claims, treats as settled matters what are, instead, ongoing controversies, offers “mere opinion” as a substitute for argument, and makes contradictory claims. The Letter of Concern is a case study in unethical transgressive bioethics. We call on fetaldex.org to withdraw the Letter and co-signatories to withdraw their approval of it.

I quickly downloaded the full manuscript, and could easily see that these charges made against our group were absurd. Chief among the accusations was the contention that we’d made our complaint to the Feds without performing a systematic review of the literature—the type of major scientific review that is rightfully conducted by epidemiologists, not ethicists. The truth was that, even without such formalized epidemiological study, we and the critics before us had
plenty
of evidence-based reasons to raise concerns about what Maria New had been doing with these families, much of it from Dr. New’s own pen. The target article’s authors also objected that we cited only the array of research that suggested potential harm from prenatal dex, and not New’s group’s more optimistic literature, as if the presence of a lively debate between New and her large number of physician-critics negated all the ethical and scientific problems. (Translation: “If something is controversial, then there is no truth.”)

In fact, the target article’s authors used a 2002 medical society position paper on the intervention to show “that there is substantial difference of opinion concerning whether prenatal treatment of CAH is a research endeavor.” This was supposed to prove that doctors varied widely in their opinions about prenatal dex—that some might agree with New, and some might disagree. What the target article’s authors didn’t tell readers is that
that 2002 position paper
—a joint statement from the European and American pediatric endocrinology societies—actually concluded this:

We believe that this specialized and demanding therapy should be undertaken by designated teams using nationally or multinationally approved protocols, subject to institutional review boards or ethics committees in recognized centers. Written informed consent must be obtained after the balanced review of the risks and benefits of treatment. Families and clinicians should be obligated to undertake prospective follow-up of prenatally treated children whether they have CAH or not.

In other words, the pediatricians signing on to this position statement in 2002 weren’t, as the target article authors implied, saying, “This is controversial”; they were essentially saying, “Use prenatal dexamethasone for CAH only as the Swedish group has, not as Maria New has.”

The target article authors went on to insist that because New told them that she personally had written only one prescription for prenatal dexamethasone for a pregnant woman—because allegedly “the referring obstetrician obtains consent and writes the prescription”—we were wrong to go after her. But as everyone involved knew, Maria New openly and personally took credit in her online clinic advertisements for having “treated”
over six hundred women
with prenatal dex. (In the 2001 presentation of which I had a recording, she had told the CAH-affected families that her Cornell clinic had “conducted [more] prenatal diagnosis and treatment . . . than
everybody else in the world put together
.”) In another instance of diversion from the real issues, the authors assured readers that New had IRB approval for the follow-up studies that she was doing years after prenatal exposure. To reiterate, those retrospective follow-up studies were never our concern. Our concern had always been that the women didn’t benefit from IRB oversight
when they were pregnant,
when they would have had a chance to give or refuse informed consent to the drug experiment. Most bizarrely, the term “transgressive bioethics” was being used to signify that we had wandered out of bioethical theory and actually done something to defend patients’ rights. How depressed should we be, I asked Ellen, when standing up for patients’ rights makes us “transgressive” as ethicists?

The lead author of this target article was none other than Larry McCullough, the Texan bioethicist who had been fiercely criticizing us on the bioethics e-mail list. Why was this guy so doggedly coming at us? The name of the article’s second author, Frank Chervenak, suggested an answer. Chervenak, as I soon learned, was McCullough’s lifetime collaborator; they had by that point published over 150 ethics articles together. What was Chervenak’s professional position? Chair of Obstetrics/Gynecology and director of Maternal-Fetal Medicine at . . . wait for it . . . Weill Cornell Medical College, where over six hundred dex interventions had apparently occurred when New worked there—almost certainly, as New claimed, far more than anywhere else in the world. Without ever saying so explicitly in the paper, Chervenak was obviously defending his own institution against our calls that Cornell be investigated, and presumably defending the department
he was in charge of
. But the average reader of the paper simply wouldn’t pick up on this without an explicit disclosure, and the paper included no such thing. McCullough, Chervenak, and two colleagues had produced a paper that looked like an objective accounting of how incredibly wrong we were. It was, in fact, crafted to write us off as an activist group and to show that activists are unscientific and uninterested in facts.

My head was killing me. It wasn’t that I couldn’t take a debate. What upset me was the fact that this article would carry the legitimacy of real scholarship and it would be indexed in the medical literature—meaning that all the people who had trusted my word when they signed the letters would be labeled unethical and intellectually incompetent in a “peer-reviewed” article. The lay reader would have
no idea
about the reality behind the
American Journal of Bioethics
(
AJOB
), the journal publishing this. I knew the truth about
AJOB
and how it operated. It was founded and still run with a nearly complete
lack of transparency
by Glenn McGee, a man whose behavior was so questionable he had become the subject of a six-page spread in
Scientific American
entitled “
An Unethical Ethicist
?.”

But who would ever suspect that the
American Journal of Bioethics
might be fundamentally unscholarly—even unethical—in its publishing practices? What were the odds the government investigators would see
AJOB
and this article for what they were? More likely they could just decide that our “peers” had judged our actions “unethical” and “transgressive.” No doubt that was the goal of this article—to undermine the investigation, to conclude this was a fight between some feminist versus establishment bioethicists.

Sure that I’d lose, I did try calling foul.
I wrote to McCullough
to tell him to correct the manuscript so that it did not confuse the Web site FetalDex.org with the group of academics who signed the letters of concern. I asked McGee to move to correct the paper’s inaccuracies and also asked him to share with me whatever conflicts of interest McCullough and Chervenak had disclosed. In response, McCullough claimed to me that his group had no meaningful conflicts of interest to disclose. Right.

I tried to keep my wits, but here was the thing ringing around in my head: I didn’t personally know most of the people who signed the letter. With McCullough et al. now calling them unethical and transgressive—would some disavow our letters? Say I’d misled them? Were these guys going to not only undo the federal investigation, but ruin my reputation in the process?

I hadn’t come here to defend myself. I mean, at the superficial level, it seemed reasonable for them to come after me; I myself had said in my work on controversies that one should always examine the accuser as much as the accused. But with the way McCullough and company were framing the discussion, I was starting to fear I had achieved exactly the
opposite
of what I’d hoped when I’d dreamed of using this case to inspire others to do this kind of evidence-focused work to stop truly unethical research practices on truly vulnerable people. Instead of showing a way to behave like a scholar who also cares about social justice, I had attracted criticism so venomous, it might well scare other academics completely off the path of advocacy. It might simply encourage people to believe there
is
a hopeless division between those who truly care about science and those who claim to care about social justice.

 • • • 

A
S IF THINGS
were not complicated enough, another problem suddenly appeared on my radar. Because of the dex work, I had been back in close contact with an old intersex-activist colleague, Janet Green, a middle-aged patient advocate born with CAH. In that late spring of 2010, Janet said to me, “Listen, I’m thrilled you’re back and working on dex, but I hope when you’re done with that, you’ll turn your attention to the vibrators.” I joked that I was always happy to turn my attention to a vibrator, but then asked what she was talking about. She explained that she was referring to work being done by Dr. Dix Poppas, the pediatric urologist at Weill-Cornell who happened to be Maria New’s favorite surgeon for clitoroplasties, including clitoral-reduction surgeries. Basically Poppas was taking girls, aged six and up, whose clitorises he’d earlier surgically shortened for psychosocial reasons, and having them come in for a follow-up exam involving what he called “clitoral sensory testing” and “vibratory sensory testing.” He’d make them lie back on an exam table, fully conscious, while he brushed these little girls’ inner thighs, labia majora, labia minora, vaginal openings, and clitorises with a cotton-tip swab. While he did this to them, he’d ask them to report on a scale of 0 to 5 how well they could feel his stroking. Then he’d do the same with a medical vibratory device: vibrate the little girl’s inner thigh, vibrate her labia, vibrate her clit. Janet pointed me to the paper where all this was published, in the
Journal of Urology,
in 2007
.

As I read the paper, astonished, I kept thinking about one thing: the place where Poppas performed these surgeries and his follow-up stimulations was the New York–Presbyterian Hospital—the very hospital where Poppas’s predecessors had amputated Bo’s clitoris. Not sure what to do, I called a phone meeting of Janet, Ellen, and Anne Tamar-Mattis, JD, a California-based legal advocate for intersex rights and for several months now a key colleague in the prenatal dex work. (Anne had sent her own legal analyses to the Feds to back up our letters and had also arranged a group letter from intersex adults.) As we talked, we had no doubt we would have plenty of company in feeling outraged. Like New, Poppas also seemed to be violating key research regulations; he had no advance IRB approval to be doing these examinations, even though they seemed quite clearly designed to collect data—data he used to respond to critics like us who said that his clitoroplasties were of high risk to a girl’s sexual sensation.