Galileo's Middle Finger (32 page)

If OHRP had done a full investigation in 2010—if the agency had bothered to look up its own 2003 investigation at Cornell, as I later did—I think it would have found as much reason to be concerned as we had. Instead, an e-mail obtained via FOIA of the 2010 investigation shows the head of OHRP thanking Nelson for
suggesting that OHRP rely on his work
. That is what OHRP did—relied largely on Nelson for OHRP’s conclusions.

OHRP was not alone in heavily relying on Nelson’s review. A couple of months after the federal findings emerged,
AJOB
published a piece by Maria New extensively quoting Nelson’s FDA memo and concluding, “The recent reports by the Office of [
sic
] Human Research Protections and the FDA therefore make crystal clear that my research on prenatal treatment of CAH is and always has been both legally and
ethically proper at every level
.” The article included no disclosure of the FDA official’s (Nelson’s) relationship with
AJOB
. When we asked
AJOB
to make this disclosure and to correct New’s article’s title to make clear that the federal government had not “vindicated” the intervention,
the editors refused
. Thanks to Nelson and the rest of the
AJOB
editorial team, the medical literature continues to include a supposedly peer-reviewed article that says that the FDA has vindicated prenatal dexamethasone for CAH.

When we set out to petition the FDA, I felt sure that the agency would at least stop Maria New from advertising prenatal dexamethasone for CAH as having “been found safe for mother and child,” because the language seemed to be the kind you’re only allowed to use for FDA-approved drug indications.
New is subject to no such limitation
. Thanks to a loophole New is still driving a truck through, only two classes of people—employees of a drug’s maker and researchers with active FDA investigator status—are prohibited from advertising an off-label use as “safe and effective.” Because New doesn’t have appropriate FDA investigator status for this intervention, she isn’t subject to the prohibition. Under current regulations, if you unethically study a drug use, you can also unethically advertise it. As a Hail Mary play, I tried appealing to
the “bad-ad” division of the FDA
. The staff of that division never even acknowledged my letter.

 • • • 

S
WEDEN REMAINS THE
only place where prenatal dexamethasone for CAH has been studied using a prospective, long-term tracking approach with full ethics board oversight and informed consent throughout. Just two months after the U.S. agencies decided our letters of concern were unfounded, the Swedish clinical researchers studying prenatal dex were so alarmed by their results that they went to their ethics committee to tell them they would no longer provide the intervention in Sweden even if a woman was willing to sign up for a prospective clinical trial.
They shut it down
.

The Swedish group continues to track those already dosed. In a
study of forty-three children
given prenatal dex for CAH, results show that in the quest to sex-normalize the females, boys who are “accidentally” exposed may be genitally and behaviorally feminized. This study also confirmed earlier findings of impaired verbal working memory in exposed children who turned out not to have CAH. In terms of major side effects among the forty-three children tracked, researchers documented a total of eight “severe adverse events.” This is an astonishingly high rate, albeit one that requires a larger study to establish whether these problems were caused by the drug. The “events” included growth disorders like the one described by the American mother in the
Time
magazine article, a mood disorder requiring hospitalization, and three cases of mental retardation. (Just to be clear:
7 percent
of the prenatally exposed children in this prospective cohort have mental retardation. That’s about ten times the normal rate.) In response to these findings, the Swedish team has declared it “unacceptable that, globally, fetuses at risk for CAH are still treated prenatally with DEX without follow-up.”

In 2012, two years after we made our complaints to the feds, New’s research group, led by Heino Meyer-Bahlburg, published a
retrospective convenience-sample study
of prenatal dexamethasone for CAH. The group looked at cognitive function in sixty-seven children prenatally exposed, including eight CAH-affected girls and fifty-nine boys and CAH-unaffected girls, a tiny portion of the number of children New told the NIH she has had in her prenatal treatment studies. While the new study’s finding “contributes to concerns about potentially adverse cognitive after effects of such exposure,” in sharp contrast to the Swedish data, this study by New’s group found some
positive
outcomes in terms of brain function—i.e., the exposed children appeared to do
better
on some measures than children never exposed! The paper noted that the result was confusing, and considered what it might mean. Among those considerations was not the most obvious possibility: the sample was
highly skewed
.

FOIA provided us a copy of the design for the retrospective follow-up study to be carried out with Heino Meyer-Bahlburg. This is how I discovered that the design specifically stated as one of the “exclusion criteria for all groups” this: “mental impairment which
prevents understanding of questionnaire
.” In Sweden, 7 percent of those exposed show mental retardation. In the United States, those who may be significantly cognitively damaged by the drug won’t even make it into the study.

In the United States, pregnant women offered prenatal dexamethasone for CAH remain essentially unprotected by the Office for Human Research Protections and the Food and Drug Administration. Doctors who believe the intervention is safe and effective can even advertise it as such. (
Maria New still does
.) If an American mother or her child is harmed by it, the family’s only recourse is to sue. In order to win such a lawsuit, the family would need to prove that the harm was caused by the prenatal dexamethasone. Without high-quality scientific studies of the intervention—prospective, long-term studies involving large enough numbers of subjects to show statistical significance—this would be almost impossible.

Back in September 2010, when I was acting like a beaten dog in response to the federal findings—before I took another three years to figure out what really happened—my dex-worried friend David Sandberg at the University of Michigan said to me something very useful: The people we’ve always really cared about are the mothers and the children, not Maria New. We can’t stop her, but maybe we can make sure everyone knows the truth. David asked me to keep working, specifically to see if I could make sure there wasn’t a single obstetrician, genetic counselor, or pregnant woman considering prenatal dexamethasone for CAH who didn’t know that this drug use is experimental and dangerous.

This is not how informed consent is supposed to work, but as I write, if you Google “prenatal dexamethasone for CAH,” that’s the message you get.
The top hit
is a scholarly article I coauthored with Ellen Feder and Anne Tamar-Mattis documenting what really happened in the history of this intervention.
The second hit
is a support group page discussing the “controversy.”
The third
hit is a report I cowrote for the medical news literature letting doctors know that prenatal dex continues to be considered experimental and in need of IRB oversight.
The fourth
is the
Time
magazine article.
The fifth
is the Swedish report of harm.
The sixth
is the
Bioethics Forum
article in which we documented New’s use of prenatal dex to try to prevent lesbianism and tomboyism.

The seventh
is an article I wrote for
The
Atlantic
. It’s about how I discovered by accident, from a pregnant woman writing to me, that fertility doctors are using dexamethasone on their pregnant IVF (in vitro fertilization) patients on the hunch that it might prevent miscarriages. As was the case with diethylstilbestrol (DES), there is no evidence that dexamethasone is effective or safe for miscarriage prevention. There are no studies of this use. I tried to find an investigative health reporter willing to research and write this story. Finding none, I did it myself. My editor at
The
Atlantic
had previously told me—while we were having coffee literally in the shadow of the Watergate Hotel—that I should avoid investigative work. He said
The
Atlantic
’s Health section simply didn’t have the resources to support it. Perhaps because he has an MD, he published this one anyway.

What do you do when you realize the Fourth Estate is dying, and there are no accountants on white horses in Washington? The answer now seems obvious to me: You work harder. You find compatriots in the ivory tower—the kind of people who don’t mind difficult questions that may take years to answer and that might get you in a heap of trouble—and you work, together, as long and as hard as you can.

I
N THE LATE
1980s, the Polish labor movement known as Solidarity grew so powerful that it did what many had thought impossible: It peacefully forced the Iron Curtain back. In my own family, this meant not only a blessed end to the occupation that had lasted since the Allies had handed Poland over to the Soviets to keep the peace; it also meant, more practically, that my mother could go back to Poland for the first time since she had left, in 1947, at the age of eleven.

In the summer of 1990, my older brother, my father, and I went with her. I was twenty-four, two months shy of moving to Indiana to start my new life in the academy. This was an astonishing time to be in Poland. A nation that had long been silenced and used by the Soviets had burst forth suddenly into noisy liberation. A country that had been painted gray by years of corrupt socialism was rapidly painting itself red and white again.

We found ourselves one day in a crowded city square—I think it was in Gdansk, a city on the Baltic coast—where an enormous crowd had gathered in happy anticipation. A ritual that was occurring all over Poland was about to be enacted here. A large crane had been used to carefully hoist a big statue of Lenin that for decades had been watching over the square. Ostensibly this statue was in the process of being moved by workers to a “safe location,” but everyone knew what was really going to happen. At the appointed time, the crowd drew back, the crane operator raised the statue a little higher, and the giggling crowd muttered the Polish equivalent of oopsie-daisy. A moment later, the crane operator raised his arm ceremoniously and pushed a button, dropping the statue and smashing it into a thousand pieces. A roar went up, bottles came out of jackets and bags, and singing commenced. Freedom. Were it not for the big Polish mustaches and all the vodka, I would have thought I was in Philadelphia in July 1776. In any case, I suddenly felt lucky to have grown up always conscious of the stark contrast between Poland under the Soviets and my life in America.

A couple of days later, we spent some time visiting my mother’s extended family in the place where she had lived in poverty throughout the war, a tiny farming village still comprised of only a handful of families. I was trying to follow the rapid-fire, happy conversations, but having ever learned only a few words of Polish, I spent most of my time trying to remember how I was related to each of these people. In the 1980s, some of the older ones had managed to visit us on tourist visas. As I watched these great aunts and uncles now sharing food with my parents, I remembered these same people sitting in our Long Island kitchen as my mother sewed twenties into the linings of their coats; she had explained to me that American currency would go a long way on the black market when they got home.

Noticing my brother and me sitting so quietly, my mother suggested that we take a walk with her around the area. (My father’s multiple sclerosis made it impossible for him to walk more than a few feet, so we left him with our cousins.) On the walk, our mother kept exclaiming how small the hills appeared to be compared to her childhood memories. I reminded her jokingly that there’s a reason for Poland’s name. (It means “land of the plains.”) My brother joked back that he was under the impression Poland’s name actually translated to “invade here.”

Suddenly, on a little hill my mother seemed to specifically remember, we came upon a perfectly tended single grave. I couldn’t make sense of this. First of all, Poles bury their dead in proper cemeteries, not on random hills. Second, it was pretty clearly the grave of a
German
soldier from the war, and yet someone had been carefully keeping it up all those years; the surrounding grass had been cut back, and flowers were placed around the stone.

I asked my mother what all this meant. She told us that, during the war, a village nearby had been found to be harboring Jews, and a Nazi officer had given one of his soldiers an order to kill everyone in the village. This was standard practice, meant as punishment and as a warning to others. But the soldier had refused. As a result, his officer had shot him dead, on the spot. Those who had somehow survived had honored the soldier with this burial.

My mother then quietly mumbled something religious in Polish and made the sign of the cross. Involuntarily, I made the same gesture.

When I was about sixteen, right around the time I gave up on Catholicism, my mother gave me a rare glimpse into the worldview presumably bequeathed to her by this war. While we were folding laundry together, perhaps knowing the guilt I was feeling over losing my religion, she suddenly said to me that she didn’t think dogma was particularly useful in most instances. In most situations in which you find yourself, she said, if you could stop and think clearly—think beyond your immediate self and beyond your predictable loyalties—you could tell what was the right thing to do and what was the wrong thing. Being good, she observed, meant being good to others, including strangers. And that was pretty much enough to live by. But how can you know the right thing to do? Human reasoning, she said—referring now explicitly to Socrates and Plato—human reasoning is imperfect. Human bias keeps us from perfect vision of what is happening around us. But the quest for truth—the quest to understand the world around us—must ultimately be how you enact the good.

 • • • 

W
HEN
I
JOINED
the early intersex-rights movement, although identity activists inside and outside academia were a dime a dozen, it was pretty uncommon to run into
evidence-based
activists. Even rarer were data-oriented scholars who purposely took on advocacy work. Today, all over the place, one finds activist groups collecting and understanding data, whether they’re working on climate change or the rights of patients, voters, the poor, LGBT people, or the wrongly imprisoned. It’s also pretty easy to find university-based, data-oriented scholars in medicine, climate studies, and law who spend much of their time out of the ivory tower going to legislatures, courts, and policy meetings to advocate for marginalized individuals and endangered populations. Attention to evidence in the service of the common good is at perhaps an all-time high. People doing advocacy are smarter, and the smartest people often now do advocacy.

The bad news is that today advocacy and scholarship both face serious threats. As for social activism, while the Internet has made it cheaper and easier than ever to organize and agitate, it also produces distraction and false senses of success. People tweet, blog, post messages on walls, and sign online petitions, thinking somehow that noise is change. Meanwhile, the people in power just wait it out, knowing that the attention deficit caused by Internet overload will mean the mob will move on to the next house tomorrow, sure as the sun comes up in the morning. And the economic collapse of the investigative press caused by that noisy Internet means no one on the outside will follow through to sort it out, to tell us what is real and what is illusory. The press is no longer around to investigate, spread stories beyond the already aware, and put pressure on those in power to do the right thing.

The threats to scholars, meanwhile, are enormous and growing. Today over half of American university faculty are in non-tenure-track jobs. (Most have not consciously chosen to live without tenure, as I have.) Not only are these people easy to get rid of if they make trouble, but they are also typically loaded with enough teaching and committee work to make original scholarship almost impossible. Even for the tenure-track faculty, in the last twenty years, universities have shifted firmly toward a corporate model in which faculty are treated as salespeople on commission. “Publish or perish” was the admonition when I was in graduate school, but today the rule is more like “external funding or expulsion.” (I am, as I write, facing this myself at Northwestern.) Our usefulness is not measured by generation of high-quality knowledge but by the volume of grants added to the university economic machine. This means our work is skewed toward the politically safe or, worse, the industrially expedient. Meanwhile, administrators shamelessly talk about their universities’ “brands,” and lately some are even checking to see if their faculty are appropriately adhering to “the brand.” Yet more evidence of a growing and scary corporate mentality. Add to this the often unfair Internet-based attacks on researchers who are perceived as promoting dangerous messages, and what you end up with is regression to the safe—a recipe for service of those already in power.

The pressure to get ever more grants and to publish early and often has also led to a system wherein work is often published before it’s ready—before it is really finished and, more important, before it is really checked. Indeed, as I’ve wandered from discipline to discipline, I have again and again come across a stunningly lazy attitude toward precision and accuracy in many branches of academia. (Legal scholarship is the one notable exception.) Outsiders to academia would probably be shocked to overhear the conversations I have with science, medicine, and humanities scholars and journal editors about the need to fact-check work. It’s not that they argue with me.
They ask me what I’m talking about.
The push is to get the work out, to get that publication line on your productivity report, to score the high impact factor—all goals born of a system that supports individual competition for funding over the common need for a reliable body of knowledge. Who needs fact-checking when accuracy is not rewarded and sloppiness is rarely punished?

Perhaps most troubling is the tendency within some branches of the humanities to portray scholarly quests to understand reality as quaint or naive, even colonialist and dangerous. Sure, I know: Objectivity is easily desired and impossible to perfectly achieve, and some forms of scholarship will feed oppression, but to treat those who seek a more objective understanding of a problem as fools or de facto criminals is to betray the very idea of an academy of learners. When I run into such academics—people who will ignore and, if necessary, outright reject any fact that might challenge their ideology, who declare scientific methodologies “just another way of knowing”—I feel this crazy desire to institute a purge. It smells like fungal rot in the hoof of a plow horse we can’t afford to lose. Call me ideological for wanting us all to share a belief in the importance of seeking reliable, verifiable knowledge, but surely that is supposed to be the common value of the learned.

What privilege such people enjoy who can say there is no objective reality, no way to ascertain more accurate knowledge! I know from experience, these are people who typically claim to speak on behalf of the marginalized and the oppressed, yet they have not sat and learned enough anatomy and medicine to know what a clitoroplasty actually involves in terms of loss of tissue and sensation; they have not witnessed what happens to the minds and bodies of scholars falsely accused of crimes against humanity; they have not had to watch prenatal dexamethasone being advertised as “safe for mother and child” while knowing from a literature search that there is not a single decent scientific study to support such a claim. If they don’t want to believe that there’s an objective reality as to what a glucocorticoid does to a four-week-old embryo, then how are they to understand how much the truth matters to justice? These must be people who have never had to fear enough to desperately need truth, the longing for truth, the gift of truth. Surely, the “scholar” who thinks truth is for children at Christmastime is the person who has never had to fear the knock of the secret police at her door.

 • • • 

G
ALILEO COULD NOT
have been put under house arrest for suspicion of grave heresy in America. Sounds banal, I know—but as we face a time when we are mature enough to understand that activism aimed at social progress but conducted without facts amounts to a pointless waste of resources, and the people best poised to do fact-collection are under siege from multiple sides—this is worth meditating on for a moment.

Galileo could not be arrested for suspicion of grave heresy in America. Why is that?

The reason is that the activists who founded the United States—the Founding Fathers—understood the critical connection between freedom of thought and freedom of person. They understood that justice (freedom of person) depends upon truth (freedom of thought), and that the quest for truth cannot occur in an unjust system. It’s no coincidence that so many of the Founding Fathers were science geeks. These guys were rightly stoked about the idea that humans
working together
had it in their power to know and to improve the world—scientifically, technologically, economically, politically. These were men of the Enlightenment who had broken through dogma into a fantastic new vision for humankind: crowdsourcing. No longer would knowledge and power flow from top down, following archaic rules of authority and blood inheritance. In science as in political life, the light of many minds would be brought to bear to decide together what is right and is just. In such a system, a man arguing for a new vision of the universe could never be arrested merely
for the argument
, no matter how much it threatened those in power.

So here’s
one tiny historical story
I wish that activists and scholars today would return to—because it would help them see why they have to value the same things.

America, 1776: The Declaration of Independence is finally signed, formally renouncing British rule and articulating a new vision of human liberty. There was no Internet in 1776, of course, to spread the good news, so the news had to be spread by other means. Knowing that the people of Philadelphia needed to be informed of the monumental turn of events, John Nixon climbed up on a platform and read the declaration aloud to an assembled crowd.

Here’s the thing: The platform Nixon climbed up on had been erected seven years earlier, and not for political purposes. It was put up in 1769 by the American Philosophical Society (the scientific society founded by Benjamin Franklin) so that one of their members, the astronomer David Rittenhouse, could make formal observations of the transit of Venus—the passage of that planet across the face of the sun. Rittenhouse was working with the support of his peers to further the post-Galilean understanding of the universe. The platform was put up to look at the sky.