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Thursday
Feb162012

« In Which The Dalkon Shield Has A Paralyzing Effect »

Way of Control

by ALICIA PUGLIONESI

People invent things for a lot of reasons. Oral contraceptives were invented because in 1951 the founder of Planned Parenthood asked a renegade Harvard biologist to come up with a “magic pill” to prevent pregnancy. Margaret Sanger had seen a lot of bad devices during a lifetime of battling for women's reproductive rights: ineffective douches, shoddy condoms, snake-oil powders and tablets that exploited people's ignorance or desperation. She envisioned a modern, scientific tool for controlling fertility, something (short of sterilization) that would take the guesswork out of women's hands.

When the Pill received FDA approval in 1960, it was supposed to sweep the contraceptive market clean of confusing and antiquated options. Women were largely enthusiastic about this; 1.2 million of them were taking the Pill by 1962, when reports of side effects began flooding the mailboxes of Searle Pharmaceuticals, the Pill's manufacturer. The earliest Pills contained a lot of hormones – roughly five times the amount used in today's oral contraceptives – and the industrial-strength dosage caused problems ranging from nausea and depression to blood clots and strokes.

ms. sanger

If the Pill was supposed to be the cutting edge – another magic bullet brought to you by modern science – the intrauterine device, or IUD, was a primitive stone arrowhead. Doctors weren't sure how it worked, but throughout history various cultures had recognized that foreign objects inserted into the uterus could prevent pregnancy. Drug companies and researchers were learning some things from the saga of the Pill: first, that millions of women wanted convenient, invisible birth control and were willing to suffer some pain to get it; and second, that hormonal contraception was vulnerable to attack on the grounds that a ten milligram daily dose of progesterone can really mess you up. Entrepreneurial researchers decided to dust off the IUD and make it new, safe, and modern.

By 1969, journalist Barbara Seaman had collected enough Pill horror stories to write a book publicizing the risks of oral contraceptives, The Doctor's Case Against the Pill. The United States Senate called a public hearing in which, notoriously, no women were invited to testify and female critics had to shout from the audience. Even so, things were looking bad for the Pill as a parade of experts confirmed its tendency to cause life-threatening blood clots. Among the medical experts summoned was a Baltimore gynecologist named Hugh Davis.

United States Patent 3856016, Hugh Davis' laparoscopic occlusion clipHugh Davis was obsessed with inventing things. By the time he landed a job at Johns Hopkins Hospital, he had already created thirty pioneering laparoscopic instruments (used to operate inside the body through a single small incision), establishing the type of minimally-invasive surgery that patients expect today. He had worked with the best doctors and surgeons in the world. They reported that he was a real whiz-kid with an ego of troubling proportions. Davis' enthusiasm bordered on the manic: he would put his twelve-year-old son, Bruce, to work testing surgical tools, and then work until four in the morning tweaking the designs.

Birth control was the hot topic in elite medical circles when Davis arrived at Hopkins in the early 60s – not so much because of the Sexual Revolution, but because this was the heyday of The Population Bomb, when demographers were pretty sure that humanity was headed for apocalyptic global famine due to overpopulation. The Pill seemed like a talisman against a peculiar fear of certain American policymakers, namely that too many poor, dark-skinned people were having too many babies. Davis prescribed it to patients at his fertility clinic serving the East Baltimore neighborhood around Hopkins, a low-income area where many people depended on free health services. The vaguely sinister subtext of “population control” wasn't on Davis' radar, though; the problems that interested him were the concrete ones. He was dismayed by the Pill's negative side-effects on his patients, and because Davis considered himself an inventor first and a doctor second, he decided to invent an alternative to oral contraceptives – a new, safe, modern IUD.

United States Patent 3782376, Dalkon Shield

Plastic casts of the female uterus started showing up on the Davis family mantlepiece. One problem with previous IUDs was expulsion – the body's natural mechanism for getting rid of foreign objects. To keep his IUD from being spat out, Davis fitted it to the shape of the uterus – the eponymous “shield” form. For extra security he gave it prongs, like a barbed arrowhead. The shield stayed in, even when women wanted to get it out; doctors would soon realize that the prongs embedded themselves in the wall of the uterus and in some cases pierced through it.

The prongs led to another design modification. Removing Davis' IUD required so much force that it needed an extra-strong string, one with multiple filaments wound together. The multi-filament string was a fun-slide for bacteria to invade the uterus. Davis realized the danger, so he covered the multi-filament string with a sterile sheath. The sheath was open at both ends, however, exactly like a pathogenic fun-slide. It's hard to say what made him decide that bacteria would not creep up the open pathway and cause infections. He wanted to move quickly and produce and sell his IUD, but he also seems to have sincerely believed that the problem was solved – or that he was not capable of solving a problem badly. In the late 1960s Davis started switching patients at his free clinic from the Pill to a buggy-looking plastic device that would become known as the Dalkon Shield.

This brings us up to 1970, when Davis testified before Congress that the Pill was too dangerous and women deserved a safer alternative. That same year he started manufacturing Dalkon Shields and sold the rights to A.H. Robins, Co., a Virginia pharmaceutical company, for $750,000 plus a share of profits. Millions of women who were suspicious of the Pill or had experienced its hormonal roller-coaster began clamoring for IUDs. Because he didn't disclose his investment in the Dalkon Shield, no one had any reason to be suspicious of Hugh Davis when he published studies demonstrating its safety and effectiveness.

Of course, he stood to gain a lot. But nothing in his prior life suggested that Davis was a striver after money and fame. He never applied for promotions or full professorship at Hopkins and never went into lucrative private practice. It may well be that he wanted the Dalkon Shield inserted into uteri across the nation because he genuinely believed it was the best contraceptive choice for women.

Then something happened that the people who do corporate damage control call a mishap or an oversight. You could see where this was going with the prongs and the multi-filament string of doom, but millions of doctors and patients were completely unprepared for the Dalkon Shield's side effects. The resulting injuries and deaths could have been prevented by experts in positions of public trust: drug company officials, journal editors, the FDA. Whenever one of these mishaps occurs it raises serious questions about trust – how much should you trust the government, or a corporation, or an expert – but it reaches a whole other level of acrimony when the mishap is inflicted by profiteering men upon the vulnerable bodies of women. The picture is more complicated, of course, but that's how the the Dalkon Shield incident has been remembered in America, if it's been remembered at all.

It's hard to fathom exactly what trust meant back then, and how deeply embedded it was in the American psyche. You would go to the doctor and he would write you a prescription, you would go to the pharmacist to have it filled, and the pharmacist would hand you a bottle of pills. Nowhere on that bottle would it say what kind of pills were inside, because you simply didn't need to know. That went doubly for women. If you walked into his East Baltimore clinic, Hugh Davis would tell you that the safest and most effective form of birth control was the Dalkon Shield, and there was no reason to imagine he might be wrong except that it really hurt.

Most of the victims' stories follow a similar narrative arc: it hurt but the doctor said you'd get used to it; it didn't stop hurting and the doctor said it was all in your head. Women felt sick, but the testimony of their own bodies wasn't sufficient to overturn what scientific research had established as a safe practice. Eventually women started dying, which provoked expert scrutiny into Davis' completely inadequate IUD research on a small sample of clinic patients. The onslaught of Dalkon Shield lawsuits wound up in the hands of A.H. Robins, which pulled all the typical dirty moves to avoid accountability.

the "Flying Uterus" ad

Here the fate of the corporation and the fate of the inventor diverged. A.H. Robins would declare bankruptcy and sell out for a profit, fighting all the while to deny compensation to women injured by the Shield. It was nothing personal, just the kind of mishap that can occur when you manufacture medical devices. While this litigation churned on, Hugh Davis thoroughly lost his mind.

It's hard to say whether the Dalkon Shield ruined Davis' medical career, or whether he ruined it himself by refusing to move on in the aftermath. He stopped showing up for work, and Hopkins let him retire quietly at 55. Before the Shield, his children hardly saw him; post-Shield he holed himself up in their family home, fending off lawyers and complaining of a malicious plot against him. Fearing retribution by plaintiffs, he hired a bodyguard. He devoted manic episodes to inventing new devices that he imagined would redeem his reputation. Paranoid and erratic, he terrorized his wife and two children until one day he disappeared altogether.

When he surfaced in a downtown Baltimore church, his family committed Davis to a psychiatric ward, where he did stints for the next ten years. He agreed to medication and stabilized in time to die of pancreatic cancer in the comfort of his home. In the Baltimore Sun's retrospective, Brian Davis suggests that it wasn't exactly guilt that drove his father over the edge, or remorse for the pain he had caused. Hugh Davis just couldn't believe that he was wrong. For a long time he insisted that the Dalkon Shield incident was an act of sabotage by his competitors; eventually he wouldn't talk about it at all. If he felt regret about hurting others, it was filtered through the lens of his ego: to apologize he would need to face his own fallibility, and that pivot point was where psychic paralysis set in.

Davis had a similar paralyzing effect on the IUD. After the Dalkon Shield, IUDs were not okay in the United States. No one would sell them, no one would make them, no doctor would recommend one to a patient because it had the savor of consumer safety disaster about it. In the rest of the world, IUD research continued apace. Enough time has passed that maybe the German makers of Mirena, which is very safe and advertised incessantly on daytime TV, can afford to ignore history. The regulatory take-home lessons have already been enshrined in policy: do long-term randomized trials, don't let inventors test their own products. The puzzle of Hugh Davis remains. Is it inevitable that someone who needs to invent so badly be blind to the ways in which the things he has created can hurt?

Alicia Puglionesi is the senior contributor to This Recording. She is a writer living in Baltimore. You can find an archive of her writing on This Recording here. She last wrote in these pages about the douche. She tumbls here.

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