Court’s $5M spermicide ruling puzzles doctors

Press, 8 February 1985, Page 6

Court’s $5M spermicide ruling puzzles doctors

By

JUDY GRANDE,

of

“The New York Times” (through NZPA) Washington Every year between 300,000 and 600,000 women get pregnant while using a contraceptive* jelly that is supposed to kill sperm. One of those women, a Tennessee economics professor, has just been awarded SUSS.I million because her daughter was born with serious birth defects. The award by Federal District Judge Marvin Shoob last week in Atlanta — the first of its kind concerning a spermicide — has sent shock waves through the legal and scientific communities. But physicians and scientists, including some in the Federal Government who have ’studied spermicide use, are puzzled at the outcome of the case because the mescal evidence is inat best.

The highly emotional debate over whether the , Ortho-Gynol Contraceptive Jelly, made by Ortho Pharmaceutical Corporation of Raritan, New Jersey, actually left Mary Maihafer’s daughter with one arm, a cleft palate, a deformed hand, and only 10 per cent vision in one eye is likely to continue for years. A large part of that debate questions the duty of a manufacturer to warn women of a suspected risk, no matter how small or unproven it may be. Caught in the middle are the women who used a spermicide and are now pregnant anyway. Also caught are the millions of women who are not pregnant, but each day have to choose which form of birth control is the best and safest for them. These women have been told that of the most-Bgec-

tive contraceptive methods — the pill, the intra-uterine device, and diaphragm used with a jelly — the latter is considered the safest. Now a Federal judge issues a ruling that instills a new fear — it may be safe for the woman, but not the unplanned child. About five scientific studies hint at a possible link between spermicides and birth defects, particularly limb reduction, Down’s syndrome, and hypospadias, an abnormality of the penis. But they are far from conclusive, and even their authors suggest that much more study is needed. Dr Hershel Jick, of the Boston Collaborative Drug Surveillance Programme, compared 763 infants of mothers who had received a spermicide with 3902 infants whose mothers had not. He found, in his study published in 1981, that there were congenital malformations in

2.2 per cent of the infants of mothers who had received a spermicide, compared with 1 per cent in the comparison group. But Dr Jick has said that the study is not conclusive, that more research is needed. And some scientists say that the statistically insignificant defects that turned up in a few studies may be because of chance. On the other side there are studies, several done by Ortho, that find no link between spermicides and severe birth defects. Dr Jose Cordero, of the Federal Centre for Disease Control, in Atlanta, conducted one. He said that he had found nothing to suggest a problem with spermicides. Even if the theory that a spermicide can cause foetal malformations is accepted, it is not clear whether they would stem from a damaged that fertilises

the ovum, or from absorption of the spermicide during the first few weeks of pregnancy. There has been little comment on the case from government officials, including those at the United States Food and Drug Administration, which at one time considered requiring warnings. In June, 1983, Dr Solomon Sobel, director of the F.D.A.’s division of metabolic and endocrine drugs, wrote a memo to the director of over-the-counter drugs concerning spermicides. It said, “As you have stated, the agency has not yet asked for a pregnancy warning. However, I feel that we, perhaps, are now at the point where it would be prudent to request such a warning in the labelling.”

Five months later an F.D.A. advisory committee recommended against that, concluding “ there was

insufficient evidence to warrant a special warning”. Ortho, citing the F.D.A. action, said, “The overwhelming weight of evidence is against the judge’s finding. ... A warning on the product is not only unjustified but counterproductive.” One of the eight members of the F.D.A. committee was Dr Robert Brent, who later testified on behalf of Ortho at the Maihafer trial. Dr Brent, chairman of the Department of Paediatrics at Philadelphia’s Jefferson Medical College, says that the scientific studies lead him to believe there would be more risk from aspirin and some vitamins than from a spermicide. The main ingredient is a detergent, he says. “You probably absorb more in your shampoo than in your spermicide.” The spermicide reaching the foetal

area would be so diluted, “it’s like taking a grain of detergent to do a wash”. “As drugs go, this is pretty safe,” he says. Judge Shoob would not comment on his decision, which said that the company knew its product caused birth defects and should have put a warning on the label. The judge’s feeling was that if there were any doubt about its safety, why not add a warning label, says James Simmons, an Atlanta lawyer who represented the mother. Mr Simmons also says that the judge was not swayed by the F.D.A. opinion because the agency had been wrong before, and because it relied on so many Ortho studies. “The studies are not the evidence that my child was injured by spermicide,” Mr Simmons concedes. “But the studios did not disprove my

case either. “We were able to prove within a reasonable degree of certainty that the spermicide caused this child’s birth defects.” The National Women’s Health Network petitioned the F.D.A. for a warning on spermicides in 1982, telling women that the effect of the drug on the unborn baby was unknown. Sybil Shainwald, of the Network says, “Women should choose with the full knowledge of the consequences. They don’t panic and stop buying. Look at the sales of the sponge (the contraceptive sponge). Look at the sales of the pill. Women have a right to make a choice.” The F.D.A. says that the warning issue is not closed, citing three more studies on spermicides and birth defects, the results of which have been published.