Childless inventor pushed for home pregnancy test kit

The home-testing wand has become a bit of everyday magic now as the test allows women to quickly begin prenatal care or get an abortion.
The home-testing wand has become a bit of everyday magic now as the test allows women to quickly begin prenatal care or get an abortion.PHOTO: ISTOCKPHOTO

To get product accepted, pioneer fought gender discrimination

In 1967, Margaret Crane was a product designer at Organon Pharmaceuticals, sketching face-cream bottles and ointment jars.

One day, as the 26-year-old walked through a lab at the firm's headquarters in New Jersey, she saw rows of test tubes that twinkled under the industrial lights.

"What are these?" she asked one of the scientists.

Pregnancy tests, he said. A doctor would collect his patient's urine and send it to the firm's lab for analysis. The results would be sent back to the doctor, who would then inform the patient.

Ms Crane saw another possibility: Why not cut out the doctor entirely?

This was the dawn of the sexual revolution, when abortions were generally illegal and 26 states in the United States barred single women from obtaining birth control.

The tale of the home pregnancy test is not unique. Breakthroughs that give patients control over their bodies are often resisted. Again and again, the same questions come up: Are patients smart enough? Can they handle bad news? Do they have the right to private information about their bodies?

Many a single woman slipped on a ring before entering the medical office and added a Mrs to her name. Few laws protected "girls" in the workplace from gender discrimination and bosses had the right to lay off women who became pregnant.

"I knew women who had had abortions and went through misery to find one," Ms Crane recalled.

She understood what an at-home pregnancy test would mean: It was a way for a woman to peer into her own body and to make her own decision, without anyone else - husband, boyfriend, boss or doctor - getting in the way.

That night, she started building her prototype, eventually coming up with a user-friendly version of what she had seen in the lab.

Inside a clear plastic box that had held paper clips, she fitted an eyedropper, along with a test tube that sat just above a mirror.

The customer would squeeze a few drops of urine into the tube and then peer through the transparent wall of the box at the mirror. In its reflection, she could watch the bottom of the test tube, where a compound was reacting with the drops. If, in two hours, a red circle appeared, she was pregnant.

Ms Crane brought her model to work and begged her managers to consider her idea.

They said no. Their market was doctors and doctors would hate a product that made their services seem less necessary. Her managers also seemed terrified by scenarios in which hysterical women killed themselves.

Fifty years later, it is hard to recall why her idea seemed so disturbing. Today, eight out of 10 women learn they are pregnant from a device bought at the drugstore.

The test allows women to quickly begin prenatal care or get an abortion. The home-testing wand has become a bit of everyday magic.

And yet the test did not become available in the US until 1977, 10 years after Ms Crane proposed it.

Her story offers a lesson about the social and political forces that can keep even trusted and easy-to- use medical tools out of the hands of patients and, especially, the hands of young female patients.

Chemists, biologists and engineers made the technology possible. But it took Ms Crane - an artist - to grasp the meaning of the device and to fight for it.

She did not start fighting right away. After her bosses said no, she retreated. But an executive suggested her concept at the firm's parent company in the Netherlands and the Dutch greenlighted the project.

No one bothered to inform Ms Crane. In 1968, she heard that her bosses were going ahead with the home pregnancy test. She decided to crash a meeting to discuss the new product.

She found her boss with a group of freelance product designers. To appeal to females, the male designers had covered the proposed models in flowers and frills.

She thought this was insane: Who would want to analyse her urine in a box with a tassel? She slid her prototype with the others and took her seat at the table, challenging her boss to throw her out. He did not.

An adman, Mr Ira Sturtevant, had been hired to oversee the marketing strategy. He inspected the prototypes and pounced.

"This is what we're using, isn't it?" he asked, holding up Ms Crane's model. No, her boss said. "That's just something Meg did for talking purposes." He claimed it would be too expensive to make.

Ms Crane was sure of two things: She would prove that her model could be affordably manufactured and distributed to women. And she would spend the rest of her life with Mr Sturtevant.

Her model won in the end because it was the only one that would reliably allow customers to perform the lab work and view results.

In 1969, Organon applied for a patent, with Ms Crane listed as the inventor. "They had me sign my rights away for US$1," she said. She never did get that dollar.

Happily, her work required that she meet Mr Sturtevant. They were soon living together and running their own advertising consultancy.

In 1970, Organon prepared to introduce a home pregnancy test in Canada and hired the couple to oversee it. The Predictor test appeared a year later, with the slogan "Every woman has the right to know whether or not she is pregnant" and Ms Crane had the satisfaction of seeing the test at stores in Montreal.

But it stirred up a lot of debate. When a mail-order New York firm tried to sell Organon test kits in 1971, it faced opposition from the US Public Health Service. Some regulators worried that "frightened 13-year-olds" would be the main users of the test kits.

But after the product became available in the US in 1977, it appealed instead to college-age and married women, many of them desperately hoping for children.

The tale of the home pregnancy test is not unique. Breakthroughs that give patients control over their bodies are often resisted. Again and again, the same questions come up: Are patients smart enough? Can they handle bad news? Do they have the right to private information about their bodies?

When home HIV tests were being developed in the 1980s, they inspired the same kind of fears, including unfounded dread that if people learnt bad news alone at home, they would kill themselves.

The Food and Drug Administration approved the first home HIV test kit only in 1996. Customers would take a blood sample at home, mail it to a lab and hear the results over the phone. The first rapid, truly private, HIV home test did not reach stores until 2012.

In most areas of the US, women still need permission from a doctor to buy birth control pills, even though they are arguably safer than a lot of other drugs now sold over the counter.

It is true that some women with conditions like liver disease, breast cancer and hypertension may be at risk of developing complications from the pill, but labels can warn them against using it.

"I think the medical profession grossly underrates human abilities," said cardiologist Eric Topol, a professor at Scripps Research Institute. "Doctors don't feel consumers have the wherewithal to make a diagnosis, even if they're using validated strategies like the pregnancy test."

Prof Topol encourages patients to use their smartphones to keep track of their heart rate, blood pressure and glucose levels, and even to do electrocardiograms to detect heart arrhythmias at home.

Those who do can often uncover problems that are invisible to their doctors. He said: "Patients know what's going on in their lives and can put the information into context."

Smartphone cameras can detect problems like jaundice, ear infections and melanomas. Some of these tools are already performing as well as doctors in making the right diagnostic calls.

Consumers do need to be protected from false advertising and faulty devices. But they do not want to be protected from information about their own bodies. The popularity of these products proves this.

Despite all the fear-mongering about home pregnancy tests, American women embraced them. By 1978, home testing was a US$40 million market. It no longer seems the least bit controversial today.

And what happened to Ms Crane? She and Mr Sturtevant lived happily for 41 years in a series of enviable Manhattan apartments - without marrying or having children - until his death in 2008.

"I was so lucky," she said.

In 2012, I became part of her story when I wrote a short article for The New York Times Magazine about the history of home pregnancy testing and did not mention her.

"Frankly, your story made me sit up," she told me. She realised that if she stayed silent, her memories might be lost forever.

So she dug up the original Predictor prototype and auctioned it off as the first of its kind. Its purchase by the Smithsonian's National Museum of American History attracted a flurry of attention.

Now, because the Smithsonian sale helped to establish her as a groundbreaking American inventor, "people come up to me, women and a surprising number of men, to thank me", Ms Crane said. "I'm very pleased about that."

NEW YORK TIMES

A version of this article appeared in the print edition of The Straits Times on August 09, 2016, with the headline 'Childless inventor pushed for home pregnancy test kit'. Print Edition | Subscribe