TECHNOLOGY	FEBRUARY 2, 1998 VOL. 151 NO. 5
	Persona Non Grata Disappointment with a sophisticated contraceptive device forces couples and doctors to reevaluate risk By NINA PLANCK /LONDON nplanned pregnancies are nothing new to staffers at the British Pregnancy Advisory Service. Every method sometimes fails--the condom, the diaphragm, even the Pill. But the disgruntled pregnant women who began to visit B.P.A.S. clinics at the rate of a dozen per week in March 1997 were different. They had been relying on a new high-tech contraceptive device called Persona, introduced just five months earlier. "They felt more disappointed than most," says B.P.A.S. spokesman Keith Ricketts. "More let down." That may be because Persona arrived in Britain in October 1996 with as much hype as hope. A computerized aid for the natural family planning method often known as rhythm, the $80 device was billed as a revolution in contraception--one that promised natural sex without hormones or gadgets. Using simple urine tests, the sophisticated software in the hand-held plastic device tracks two hormones and tells a woman when she is fertile and when she isn't. On the fertile days--signaled by a red light--she should abstain or use another method, like the condom. On infertile days, the green light gives a go for unprotected sex. Persona was an instant hit for its Bedford-based maker, Unipath, which sold 100,000 in the first year. But the device requires careful use to be reliable, and from the beginning a sprinkling of women found themselves unexpectedly pregnant. And their numbers grew. Now, in clinics all over Britain, B.P.A.S. and another non-profit family planning service, Marie Stopes International, each advise 50 to 60 pregnant women per month about unplanned Persona babies. Some are angry enough to sue. At least two law firms are assembling scores of clients for possible action against Unipath; the government agency Legal Aid has approved funds for 15 suits--enough for the case to be ruled a group action. After a series of complaints and a formal investigation, the Department of Health's Medical Devices Agency warned couples who would find pregnancy "completely unacceptable" not to use Persona. But Unipath stands by its reliability. "We've done everything ethically," says Keith May, the company's vice president of research and development. That many of the thousands of women who rushed to buy Persona, only to be disillusioned, is a cautionary tale of faith in technology, human error, risk assessment and the seductiveness of marketing. A somewhat chastened Unipath abandoned one crucial advertising claim that accompanied the introduction of Persona: it no longer asserts that Persona's reliability is "comparable to the condom," which is 98% reliable. But it stands by its claim that the device is 94% reliable--a figure endorsed by the mda on the basis of Unipath's clinical trial data, which the mda pronounced sound. "What everyone is learning," says a Unipath spokeswoman, "is that many women find it difficult to understand contraceptive reliability. We thought [the condom comparison] would help. Now we're just saying that Persona is 94% reliable and being very explicit about what that means." Explicit indeed. Persona's latest ads, a response to a storm of bad press, still tout the device as a major scientific advance. But they also say: "If maximum reliability is your concern, Persona is not for you." Put starkly, 94% means that six in 100 women who use Persona properly for one year--or, more startling, one in 17--will get pregnant. Farm wife Diana Allison, 32, wishes that message had been more clear. A pharmacist told her Persona was "as safe as the contraceptive pill." But in the third month of using Persona Allison became pregnant with a fifth child. She is now opting for sterilization--and she has retained a lawyer. Another woman with a Persona baby is Susan Bellingham, a nurse in Cornwall. She says, "We just felt cheated" by the comparison to the condom's reliability. Yet she expresses something many women who've used Persona feel: a wistfulness for the hope the little gadget generated. "It's such a good idea," she says. Bellingham is only one of many women who seek natural, reliable contraception for sex free of hormones and interruption. Despite the reports of pregnancies, Unipath still sells 1,000 units a week in the U.K. alone. Persona, which was welcomed by Catholics, is also available in Italy, Ireland, the Netherlands and Germany. But what many couples who tried the natural way may not have bargained for was this: using Persona correctly is more trouble than taking the Pill with breakfast. The monitor must be consulted daily and urine tests must be conducted eight times a month. But the biggest inconvenience is abstinence--or using a barrier method--on red-light days. When B.P.A.S. surveyed 188 women who became pregnant using Persona, 43% confessed to unprotected sex on "red days," and there was evidence of other misuse and error. Persona is not itself a barrier to conception, but merely a software program that displays information about a woman's fertility. What couples choose to do with that information, like sex itself, is not always a question of science.
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