The Coming Plague (70 page)
Authors: Laurie Garrett
Back in 1977, a Denver pediatrician, James Todd, reported having treated seven children, aged eight to seventeen, for an acute life-threatening ailment he called Toxic Shock Syndrome. The children were infected between 1975 and 1977 with bacteria S.
aureus
, which had taken hold in their bodies in an unusual manner, secreting a poison into the youngsters' bloodstreams.
10
The unidentified toxin produced a host of symptoms in the children: fevers of over 102°F, diffuse red rashes all over their bodies, the death and subsequent shedding of skin cells, a marked and dangerous drop in blood pressure, vomiting, diarrhea, muscle aches, kidney dysfunction, liver failure, elevated blood clotting and platelet formation, mental confusion, and loss of consciousness.
aureus
, which had taken hold in their bodies in an unusual manner, secreting a poison into the youngsters' bloodstreams.
10
The unidentified toxin produced a host of symptoms in the children: fevers of over 102°F, diffuse red rashes all over their bodies, the death and subsequent shedding of skin cells, a marked and dangerous drop in blood pressure, vomiting, diarrhea, muscle aches, kidney dysfunction, liver failure, elevated blood clotting and platelet formation, mental confusion, and loss of consciousness.
One of Todd's patients was a fifteen-year-old girl who had a heavy vaginal discharge and was in a state of shock for two days. Though she eventually survived, the teenager was at death's door for eight days, periodically losing consciousness, and she lost two toes to gangrene. Her vaginal discharge contained a strain of S.
aureus
bacteria that was remarkable for two features: it was genetically resistant to the entire penicillin class of antibiotics, and it appeared to secrete some unique toxin.
aureus
bacteria that was remarkable for two features: it was genetically resistant to the entire penicillin class of antibiotics, and it appeared to secrete some unique toxin.
Two of Todd's patients were less fortunate than the teenager: one boy died, and another developed “shock lung” that required a laparotomy and resuscitation.
“We suggest that the toxic-shock syndrome is a new staphylococcaltoxin-related disease,” Todd's group wrote, adding that “the acute illness which we have described and called the toxic-shock syndrome seems to affect older children.”
Todd scoured the medical literature for clues, hoping to find evidence that somebody had previously noted such a severe reaction to Staphylococcus infection. He discovered the strange account of a twelve-year-old girl in New York City who developed what looked like scarlet fever in 1927. But it wasn't scarlet fever; it couldn't have been, because the girl was infected with staph bacteria, not the streptococci that caused the bright crimson rashes that were the hallmark of The Fever.
11
Back then, Dr. Franklin Stevens, at the Columbia University College of Medicine and Surgery in Manhattan, treated that ailing girl, whose fever topped 105°F. Her body was covered with “raspberry-like reddened spots,” Stevens wrote, and the child complained of pain in her thigh: the result of an unknown injury. When pus was drained from the wound, it was found to be full of staph bacteria.
11
Back then, Dr. Franklin Stevens, at the Columbia University College of Medicine and Surgery in Manhattan, treated that ailing girl, whose fever topped 105°F. Her body was covered with “raspberry-like reddened spots,” Stevens wrote, and the child complained of pain in her thigh: the result of an unknown injury. When pus was drained from the wound, it was found to be full of staph bacteria.
The New York physician soon saw two more strange
Staphylococcus-
caused scarlet fever cases, in a pair of eight-year-old boys. Much as Todd would do in 1978, Stevens puzzled over the occurrences and marched off to Columbia's medical library in search of clues. He happened upon the 1899 account of rabbit experiments conducted by a German physician, Von Lingelscheim. The German scientist produced scarlet fever in the animals by injecting them with S.
aureus
.
Staphylococcus-
caused scarlet fever cases, in a pair of eight-year-old boys. Much as Todd would do in 1978, Stevens puzzled over the occurrences and marched off to Columbia's medical library in search of clues. He happened upon the 1899 account of rabbit experiments conducted by a German physician, Von Lingelscheim. The German scientist produced scarlet fever in the animals by injecting them with S.
aureus
.
Fourteen years later, in 1941, in Baltimore, Drs. Henry Aranow and W. Barry Wood spent three months struggling to save a fifteen-year-old girl who also suffered from scarlet fever, due, again, to S.
aureus
. The Baltimore girl's symptoms seemed to be a perfect blend of those seen in Stevens's twelve-year-old in New York and Todd's fifteen-year-old Denver case. Like the New York girl in 1927, the Baltimore teenager complained of pain in her thigh, ran a 105°F fever for days, and had “raspberry” formations all over her skin. And as was the case with Todd's ailing teen, the Baltimore girl had discharges from her vagina that were found in the laboratory to be filled with
Staphylococcus
.
12
aureus
. The Baltimore girl's symptoms seemed to be a perfect blend of those seen in Stevens's twelve-year-old in New York and Todd's fifteen-year-old Denver case. Like the New York girl in 1927, the Baltimore teenager complained of pain in her thigh, ran a 105°F fever for days, and had “raspberry” formations all over her skin. And as was the case with Todd's ailing teen, the Baltimore girl had discharges from her vagina that were found in the laboratory to be filled with
Staphylococcus
.
12
During the mid-1970s Japanese pediatrician Tomisaku Kawasaki noticed another odd syndrome in children, involving
Staphylococcus
infection that produced skin shedding and loss of fingers and toes.
13
Todd had no idea whether Kawasaki syndrome, as it was subsequently called, was a manifestation of the same illness he was seeing among Denver children. Certainly, there were differences. The Japanese children were far more likely to suffer heart infections, while Todd's kids seemed to go into shock. In addition, the Japanese children seemed to be much younger than Todd's.
On the other hand, Kawasaki syndrome surfaced in Japan at about the same time Todd first noted TSS cases in Denver.
14
Staphylococcus
infection that produced skin shedding and loss of fingers and toes.
13
Todd had no idea whether Kawasaki syndrome, as it was subsequently called, was a manifestation of the same illness he was seeing among Denver children. Certainly, there were differences. The Japanese children were far more likely to suffer heart infections, while Todd's kids seemed to go into shock. In addition, the Japanese children seemed to be much younger than Todd's.
On the other hand, Kawasaki syndrome surfaced in Japan at about the same time Todd first noted TSS cases in Denver.
14
Meanwhile, Minnesota state epidemiologist Dr. Andrew Dean reported finding five TSS cases during 1979. Both the Wisconsin and Minnesota cases involved teens and adults, about 95 percent of whom were female.
Following the 1980 New Year, the CDC issued an alert to physicians, noting that an apparently new syndrome was surfacing, involving an ancient organismâS.
aureus
.
aureus
.
As calls poured in from around the country during February 1980, the CDC decided to form a task force to investigate the phenomenon, led by the agency's Drs. Bruce Dan, George Schmid, and Kathryn Shands. Dan was in charge of the epidemiological detective work, Shands of laboratory analysis of the staph stains collected from TSS victims. Schmid oversaw group operations.
By May 1980 the federal agency had confirmed forty-three more cases of Toxic Shock Syndrome, and some commonalities were beginning to emerge.
15
The most striking of these were that 95 percent of the cases were female, and 95 percent of the females were menstruating at the time they developed TSS. In most instances, TSS struck on the second or third day of their periods.
15
The most striking of these were that 95 percent of the cases were female, and 95 percent of the females were menstruating at the time they developed TSS. In most instances, TSS struck on the second or third day of their periods.
The race was on to solve the Toxic Shock mystery, and from the outset the investigation was fraught with scientific backstabbing, rivalries, name-calling, and controversyâmost played out in the bright glare of television lights and news photographers' flash bulbs. There would be little interestfree information for public digestion.
One of the first controversies concerned the CDC's definition of Toxic Shock Syndrome, which was drafted by Shands and Todd in February 1980. Though it underwent revisions during the year, the basic case definition remained that of an acute syndrome involving a high fever, scarlet fever-like rash, skin peeling, radically lowered blood pressure, and at least three of the following systemic symptoms: diarrhea and vomiting; muscle aches; vaginal or throat infection; kidney malfunction; liver failure; disorientation or confusion.
16
By focusing on such acute cases, critics charged, the CDC was missing a large pool of people who suffered a milder form of the ailment, and thus underestimating the full extent of the emergence of what might be a new strain of
Staphylococcus
.
16
By focusing on such acute cases, critics charged, the CDC was missing a large pool of people who suffered a milder form of the ailment, and thus underestimating the full extent of the emergence of what might be a new strain of
Staphylococcus
.
“We're using a case definition that is epidemiological, not clinical,” Minnesota state epidemiologist Dr. Michael Osterholm said diplomatically. “That means we miss a lot of cases. But it also means that all the cases we name are genuine. The trade-off is that there is no way to answer basic science questions about why these people developed acute shock syndrome, while others who were infected with
Staphylococcus
developed mild or even no symptoms.”
Staphylococcus
developed mild or even no symptoms.”
Among the first 100 cases reported to the CDC, the agency selected 43 that met the stringent definition of TSS. That meant 57 cases went unexploredâat
least some of which might have proven to be milder manifestations of staph infection. As publicity increased, so did the number of ostensible TSS cases that fell outside of the CDC definition.
least some of which might have proven to be milder manifestations of staph infection. As publicity increased, so did the number of ostensible TSS cases that fell outside of the CDC definition.
Throughout the summer of 1980 the number of reported TSS cases rose steadily, reaching 408 reports between January 1975 and October 1980. Of those 408, 14 were in men. The men, of course, had contracted the disease through means other than tampon exposure. They were the anomalies. In five years, 394 cases had occurred in women, 40 of whom had died. Some 95 percent of those women had been menstruating at the time, and 100 percent were tampon users.
The news coverage was terrifying. “Teenager dies of tampon use. Details at eleven!” “Toxic Shock Syndrome survivor tells her story tonight on
Eyewitness News
.” “Centers for Disease Control warning women to beware of tampons. Stay tuned for more!”
Eyewitness News
.” “Centers for Disease Control warning women to beware of tampons. Stay tuned for more!”
Most American women reacted with a sense of helplessness: how could something which had become such an essential part of women's lives turn out to be potentially deadly?
The staphylococcal strain responsible for TSS was genetically resistant to all penicillin-class antibiotics. Many of the acute cases had suffered previous, milder forms of the disease, suggesting that there was some sort of cumulative effect. To the degree that the Minnesota, Wisconsin, and CDC laboratories could be certain, on the basis of currently available technology, the recent TSS sufferers were all infected with the same staph strain. There was absolutely no evidence of person-to-person transmission of the microbes. The outbreaks seemed to cluster in distinct geographic areas of the United States, notably the midwestern states of Wisconsin and Minnesota.
And, according to the CDC, most of the female TSS cases involved superabsorbent tampons. In September 1980 the CDC released its third report,
17
pointing the finger at Rely tampons. In a controlled study of forty-two TSS victims and another pool of non-TSS tampon users, the CDC found that 71 percent of the TSS victims used Rely brand tampons. Other brands came in with markedly lower incidences of TSS: Playtex was used by 19 percent of the cases, Tampax 5 percent, Kotex 2 percent, and OB 2 percent. The CDC pointed out that “consumer use of Rely tampons has increased as the apparent incidence of TSS has increased.”
18
17
pointing the finger at Rely tampons. In a controlled study of forty-two TSS victims and another pool of non-TSS tampon users, the CDC found that 71 percent of the TSS victims used Rely brand tampons. Other brands came in with markedly lower incidences of TSS: Playtex was used by 19 percent of the cases, Tampax 5 percent, Kotex 2 percent, and OB 2 percent. The CDC pointed out that “consumer use of Rely tampons has increased as the apparent incidence of TSS has increased.”
18
The CDC's investigation also found that a third of the TSS sufferers had had a previous episode of milder menstrually associated symptoms. And the agency suggested that “tampons play a contributing role, perhaps by carrying the organism from the fingers or the introitus into the vagina in the process of insertion, by providing a favorable environment for growth of the organism or elaboration of toxin regardless of the manner in which the organism is introduced, or by traumatizing the vaginal mucosa and thus facilitating local infection with S.
aureus
or absorption of toxin from the vagina.”
aureus
or absorption of toxin from the vagina.”
Though the CDC was convinced that Rely was the bad actor in TSSâand had so informed Procter & Gamble prior to the September 19 release of the agency's findingsâthe federal scientists were aware that state epidemiologists in Minnesota and Wisconsin had evidence that weakened their case. Osterholm's group surveyed all female TSS cases that had occurred in Minnesota since early 1979, finding that only 35 percent used Rely. Though more TSS sufferers had used Rely compared with matched non-TSS women (35 percent versus 18 percent), the rates were markedly lower than those reported by the CDC.
On September 22, just days after the release of the CDC report, Procter & Gamble voluntarily removed Rely from the marketplace. And they went a step further: together with the Food and Drug Administration, the company designed a massive ad campaign telling women
not
to use their product. The campaign, which began October 6, ran on network television and radio and in over 1,200 newspapers nationwide for four weeks. The FDA, meanwhile, urged women to get rid of their existing supplies of Rely, and recalled inventories of the product from stores nationwide.
19
not
to use their product. The campaign, which began October 6, ran on network television and radio and in over 1,200 newspapers nationwide for four weeks. The FDA, meanwhile, urged women to get rid of their existing supplies of Rely, and recalled inventories of the product from stores nationwide.
19
Procter & Gamble wouldn't comment on the cost of the campaign, but it clearly was in the tens of millions of dollars. It was unprecedented. As one FDA official privately put it: “We're not used to having such strong company cooperation in a product removal case. And we've never seen a company volunteer to spend millions of dollars to tell people
not
to buy their product.” Procter & Gamble, for their part, couldn't be accused of pure altruism. As company representative Marjorie Bradford put it: “Procter & Gamble makes over eighty-eight consumer brands of household and hygiene products. We must maintain a reputation for safe and effective products.” Bradford didn't mention the half dozen lawsuits filed by consumers of Rely.
not
to buy their product.” Procter & Gamble, for their part, couldn't be accused of pure altruism. As company representative Marjorie Bradford put it: “Procter & Gamble makes over eighty-eight consumer brands of household and hygiene products. We must maintain a reputation for safe and effective products.” Bradford didn't mention the half dozen lawsuits filed by consumers of Rely.
Together with the FDA, the company ran hundreds of market surveys, testing their “do not use our product” ads on women in shopping malls all over America. According to the FDA the ads were 97 percent effective in conveying two messages: don't use Rely, and avoid use of all tampons until the Toxic Shock mystery is solved.
The “don't use Rely” campaign was not applauded by all. In their ads Procter & Gamble quoted the CDC as saying, “Women can almost entirely eliminate their risk of TSS by not using tampons. Women who choose to use tampons can reduce their risk by using them intermittently during each menstrual period.” The other manufacturers were outraged, and expected to see their future tampon sales plummet. Tampax took out ads in
The New York Times and Washington Star
denouncing Rely, and offering their product as a healthy alternative.
The New York Times and Washington Star
denouncing Rely, and offering their product as a healthy alternative.
The American College of Gynecologists, representing most of the nation's 23,000 gynecologists, issued a warning to women during the first week of October: avoid using tamponsâ
all
tampons.
all
tampons.
Quietly, some non-CDC scientists involved in investigations of TSS cases
were nervous about the agency's position on Rely, and tampons generally. As Osterholm put it: “We had a hepatitis A outbreak in Minnesota a few years ago among people who ate hot dogs. We took tough action and moved quickly on the hot dogs. But it turned out the culprit was the relish. You've got to be very careful about these associative findings.”
were nervous about the agency's position on Rely, and tampons generally. As Osterholm put it: “We had a hepatitis A outbreak in Minnesota a few years ago among people who ate hot dogs. We took tough action and moved quickly on the hot dogs. But it turned out the culprit was the relish. You've got to be very careful about these associative findings.”
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