New evidence points to Rely super tampons as the main cause of the wave of disease and death from toxic shock syndrome (TSS) that struck women in 1979 and 1980.
The evidence, an unpublished finding by a Wisconsin scientist, surfaced in a Texas court "amid circumstances that smack of suppression of scientific data," an article in today's Journal of the American Medical Association charges.
Rely's role is still not certain. Some experts think Rely alone was not the real cause of the disease, which continues to appear even though Rely tampons were taken off the market three years ago.
Nonetheless, 1981 tests by Dr. Merlin Bergdoll of the University of Wisconsin's Food Research Institute indicated that the disease organism, Staphylococcus aureus, produced massive amounts of toxin--bodily poison--when grown on Rely Super tampons. A scientist working for Procter & Gamble, Rely's manufacturer, repeated the experiments with similar results.
Both Bergdoll and the company resisted disclosure of the results, Bergdoll and a company spokesman said this week. Bergdoll, whose work has been supported in part by Procter & Gamble, said in an interview that he had not published his findings because he is "not completely satisfied" that they are valid. The company spokesman said, "Our in-house research was done partly to assist in defending ourselves, as provided by law."
The company has consistently maintained that no evidence shows Rely's ingredients were defective or linked to illness. Two hundred lawsuits have been filed against the company by toxic-shock victims or their survivors. Most of the suits have been settled out of court.
Last month, a lawyer for a victim suing the company in Fort Worth forced it to produce the unpublished evidence. But the lawyer became ill, a mistrial was declared, and the case must be rescheduled.
Most of this story is told in the AMA Journal's Medical News section by reporter Charles Marwick, and a headline on the article calls the affair a "holdup of toxic shock data."
Starting in late 1979, toxic shock struck hundreds of menstruating women, causing sudden fever, diarrhea and vomiting, then falling blood pressure and sometimes death.
Seventy-one percent of stricken women had used the highly absorbent Rely super tampons. In September, 1980, Procter & Gamble stopped Rely sales.
Independent tests by Bergdoll and Dr. Patrick Schlievert of the University of Minnesota showed that the illness was caused by a Staphylococcus aureus toxin. In one of Bergdoll's experiments, staph germs produced 180 micrograms per milliliter of toxin when grown on a Rely super, but only 42 to 53 micrograms when grown on two other brands.
Schlievert said he does not accept the Wisconsin results. In fact, he said, "our tests show that as you go up in tampon absorbency, you actually inhibit staph growth and toxin production" on that tampon's material.
He thinks the guilty party in toxic shock may be trapped oxygen. The tighter a tampon fits and the greater its absorbency, the more air and blood will be trapped to support bacterial growth.
Trapped air might also help account for toxic shock in non-users of tampons, which often are men, women and children with wounds or burns or operative wounds.
Three things are sure, the researchers agree.
They cannot precisely duplicate the conditions in the vagina in their laboratories, which means the cause of toxic shock in menstruating women may always remain uncertain.
Second, federal research funds to study this disease are now scarce at best, forcing the researchers to seek funds from tampon makers.
And third, the disease continues, though with less frequency. As of last June, the last date of complete reports, 2,204 cases had been reported since 1979, with 103 deaths. Eighty-two percent of the cases are associated with menstruation. This week the Food and Drug Administration said it had confirmed reports of two more cases, not in tampon users but in women who used the new contraceptive sponge, "Today." Both were hospitalized and recovered.
Today's maker, VLI Corp., has agreed to add an "alert" to the package insert it already uses, warning about toxic-shock symptoms. The company called the toxic-shock cases "purely coincidental" but agreed to increase monitoring.