In the dining room of Malcolm Potts’s quaint Berkeley Tudor home, everything seems very proper and very English, from the Old World prints and the Union Jack doormat to the 3 p.m. teatime. But if you squint to decipher the designs on Potts’s teacup, you see that each whimsical squiggle is a condom decked out in a different fashion. One is stuck with a safety pin and labeled “The Punk.” “The Skier” is ice blue, topped with a pompom hat. “The Cattle Farmer” naturally has black splotches.
We are convened here for the biweekly meeting of Pelagius, a company that Potts founded last year to make the birth control pill available without a prescription. Since the ’60s, Potts has been arguing that the pill shouldn’t remain locked behind the pharmacy counter. It’s hugely inconvenient for women, not to mention an obstacle to those without insurance or a doctor or to those who just forgot it on a weekend getaway.
This session’s Pelagius update includes news that the company is ahead of schedule in acquiring a pill, which makes naming the new product a priority. Potts, setting down his cup, quips, “Eve, perhaps? After all, she started the whole problem.” A pause. “We could go Jane, as in, ‘Every Jane needs one,’” Potts tries, his eyes twitching deviously. “Diana is quite a nice name,” he adds, nodding toward me. “She’s got bows and arrows and things.” I smile and shoot back, “Goddess of the hunt and all.” Potts, a professor of public health at the University of California, Berkeley, looks pleased.
“Or Hymen — you have to use it to lose it?” he says, chortling.
Pelagius’s co-founder Samantha Miller, a feisty biotech licensing veteran, offers, “What about Kate — for Kate McCormick?” In the 1950s, McCormick, a rich widow, funded the development of the first birth control pill.
Potts and his team — which includes a third co-founder, Nap Hosang, a Kaiser Permanente OB-GYN-turned-entrepreneur — are just days away from a purchase agreement that would give them the rights to manufacture and sell a previously approved, well-respected oral contraceptive. Last year they began approaching the five pharmaceutical companies that control all oral contraceptives, hoping to license their product. Four said no; one said yes. That company had acquired the pill in a merger but doesn’t work in women’s health and wasn’t selling it. “We got crazy lucky,” Miller tells me. “In licensing, you almost never get what you go out looking for.”
This find is the reason the group believes it can succeed where previous groups have failed. It is one thing to evangelize for bringing the pill to the people; it is quite another to have a product to take to the FDA and to request a change to over-the-counter status. “To do that you need to own the intellectual rights,” explains Potts.
The effort also comes at a propitious moment politically. In 2013, the FDA, after a decade-long deliberation, moved emergency contraception (Plan B) over the counter. (In France, the change to over the counter in 1999 precipitated a 72 percent increase in use in five years.) California and Oregon just became the first states to take the pill “under the counter” legislatively, which means women can get a prescription from their pharmacist. Big societies like the American College of Obstetricians and Gynecologists and the American Medical Association have issued statements supporting the switch to over the counter. And, most remarkably, Republicans have introduced Senate legislation proposing the change, though Planned Parenthood calls the bill a sneaky end run around Obamacare’s stipulation that prescription birth control be covered. Still, the cynical reaction hasn’t stopped Carly Fiorina from stumping on the campaign trail this summer for the pill to be available without a prescription.
Pelagius is named after a fifth-century monk who refuted the idea that sex is a sinful act, and Potts has spent much of his eight decades as a modern-age Pelagius, attempting to decouple sex from reproduction. Born in 1935 near Newcastle, England, he studied medicine and earned his Ph.D. in embryology from Cambridge. He jokes that his interest in obstetrics was sparked by his male cat — who turned out to be female and died in kitten-birth. In the ’60s, while practicing as an OB in North London, he performed a curettage “practically every other night,” scraping a woman’s uterine lining to keep her from bleeding out after a botched home abortion. “It seemed to me a crazy way that women had to do this,” he says. Along with inventor Harvey Karman, Potts published the first papers on the manual vacuum aspirator, a tool still in use worldwide for abortions and incomplete miscarriages. And in 1965, when unmarried women were being denied the pill, Potts opened a clinic funded “using a bit of Francis Crick’s Nobel prize money” — Crick was a like-minded acquaintance — to provide them with it. Soon he was going on late-night TV and saying that it would be a service to mankind if the pill were available in vending machines and cigarettes required a prescription. He advised Parliament on the Abortion Act 1967, which legalized the procedure, and shortly after became the first medical director of the International Planned Parenthood Federation.
In the Pelagius meeting, Miller presses ahead with the company’s to-do list: talking with a possible distribution partner; drafting language for the label; and, early next year, launching #liberatethepill on Indiegogo to begin raising the $10 million they believe they’ll need to go through the FDA approval process. (They are also recruiting investors and have already raised the first $1 million necessary to license the pill.) On their current timeline, they hope to get approval in 2019.
No pill manufacturer has ever requested a switch to over the counter, since prescription profits are higher. The application requires Pelagius to run usage studies proving that the directions are clear (“Should be pretty easy: Take one a day,” says Potts), that their manufacturing is sound, and that women for whom the pill is risky can self-identify. I press Potts for the most likely snag in their plan. “I should say hypertension. Women with high blood pressure ought not be on the pill. But nowadays you can stick your finger in a machine at the mall and know that about yourself.”
After the meeting, Potts shuffles to the credenza and brings over several scrapbooks from his career. Flipping to a random page, he points to a yellowed news clipping about the run-up to the abortion act. “This is the time we actually tried to change the abortion law in England,” he says. Nearby is an article titled “The Pill Is Safer Than Cricket.” “You are more likely to die as a young cricketer or footballer,” he reads aloud. He looks over his glasses. “There is so much misinformation. Of course nobody ever heard about the 500 people who died taking Viagra,” he says. “People assume that Tylenol and decongestants are safe — actually the birth control pill is much safer!”
The pill may in fact have advantageous effects on women’s health. “For most of the 200,000 years people have walked the planet, women lived in hunter-gatherer societies, having four to six children and breastfeeding each for several years. Women would have 30 to 50 menstrual cycles in a lifetime,” Potts says. “To have 300 to 400, like many women today, is unnatural.” He sighs. “It’s why I argue we should see the pill as slightly more natural than not taking it.” Every time a woman has a menstrual cycle, he explains, lots of cells in the body multiply to produce the lining an egg needs to implant. The more often the cells divide, the more likely that a mistake will occur, which is the reason certain cancers track closely with number of periods — a 39-year trial of 23,000 pill-takers recently found that women taking the pill not only lived longer but had significantly lower rates of ovarian and uterine cancer. While on the pill, women do not ovulate, which reduces the rate of this monthly cell division. And “we can affect patterns of menstruation,” Potts says. “I like to tell women, ‘You can have your period on bank holidays in August — or never again.’”