The scars of others should teach us caution.
—ST. JEROME
Many parents had been persuaded by the MMR controversy that vaccines caused autism. When studies exonerated MMR, they reasoned it must be something else in vaccines causing the problem. It wouldn’t be long before they believed they had found it.
FRANK PALLONE IS A CONGRESSMAN WHO REPRESENTS NEW Jersey’s Sixth District. First elected in 1988, he has been a passionate supporter of Native Americans, working to protect the sovereignty of tribal governments. He’s also an environmentalist. Because Pallone lives in a district that includes a string of towns on the Jersey shore, he’s particularly worried about contamination of fish with mercury. In 1997, Pallone attached a simple amendment to an FDA reauthorization bill. Only 130 words long, the amendment would soon lead to chaos. Pallone gave the FDA two years to “compile a list of drugs and foods that contain intentionally introduced mercury compounds and [to] provide a quantitative and qualitative analysis of the mercury compounds in the list.” The bill—the FDA Modernization Act of 1997—was signed into law on November 21, 1997. Few in the press or the public took notice.
One year passed. On December 14, 1998—eleven months before the congressional deadline—the FDA put a notice in the Federal Register again asking food and drug makers to list the amounts of mercury in their products. The Federal Register—a daily publication of federal regulations, legal notices, presidential proclamations, executive orders, funding priorities, grant deadlines, and meetings—didn’t gain the attention of pharmaceutical companies. No one complied. So on April 29, 1999, the FDA made yet another, more specific announcement. A few weeks later, FDA officials received the information they needed. What they found concerned them. By six months of age, infants could receive as much as 75 micrograms of mercury from three doses of the diphtheria-pertussis-tetanus (DPT) vaccine, 75 micrograms from three doses of the Haemophilus influenzae type b (Hib) vaccine, and 37.5 micrograms from three doses of the hepatitis B vaccine—a total of 187.5 micrograms of mercury. (A gram is approximately the weight of one-fifth of a teaspoon of salt. A microgram is one-millionth of a gram.) Everyone at the FDA knew that environmental mercury (known as methylmercury) could cause serious, permanent, and occasionally fatal damage to the nervous system—a lesson learned from an event that had occurred decades earlier at Minamata Bay.
DURING WORLD WAR II, JAPAN’S MOST SOUTHERN ISLAND, KYUSHU, was home to a chemical company that dumped its waste into Minamata Bay. Within months, fish began to float in the bay. Then cats started jumping into the sea and dying—local residents called them “cat suicides.” Seagulls fell from the sky. By the early 1950s, people began to suffer unexplained numbness in their hands and feet, muscle weakness, and a narrowing of their field of vision; some had difficulty walking, swallowing, and hearing; others trembled uncontrollably. In extreme cases, insanity, paralysis, coma, and death followed. By 1956, epidemiologists had found the cause: mercury dumped into the water had been concentrated in shellfish, poisoning consumers. Kyushu’s chemical factory continued to pour mercury into industrial wastewater until 1968. By 2001, mercury had poisoned 3,000 Japanese citizens and killed 600.
FDA OFFICIALS KNEW THAT MERCURY COULD DAMAGE THE NERVOUS system. When they first responded to Frank Pallone’s directive, they also knew that mercury-based preservatives had been used in vaccines for decades. They were the ones who had put it there.
Between 1900 and 1930, companies packaged vaccines almost exclusively in multidose vials, with a typical vial containing ten doses. Because a large percentage of the cost of vaccines is determined by its packaging—sterile glass vials, rubber stoppers, metal tops, and labels—as well as the labor required to fill each vial, multidose vials allowed vaccines to be made much less expensively. Doctors kept these vials in refrigerators in their offices, often for months at a time. To give a vaccine, they would insert a needle through the rubber stopper, pull the liquid up into a syringe, and inject it. Unfortunately, by constantly violating the rubber stopper with a needle, doctors and nurses occasionally contaminated the vial with bacteria. In 1916, in Columbia, South Carolina, a batch of typhoid vaccine contaminated with bacteria caused seventy severe reactions and four deaths. And in Queensland, Australia, in 1928, twelve children injected with a contaminated diphtheria vaccine died from bacterial abscesses and bloodstream infections. By the 1940s, most multidose vials of vaccines contained preservatives to prevent contamination.
The choice to use mercury as a preservative was based on what was available. Before antibiotics were discovered, doctors relied on antiseptics to kill bacteria, the most popular of which was Joseph Lister’s carbolic acid. Other scientists championed other antiseptics. Robert Koch, the father of the germ theory of disease, preferred mercury chloride, which was unfortunately an irritant. Early in the twentieth century, a new, more effective, less toxic derivative of mercury came into favor: ethylmercury. (The most popular mercury-containing antiseptic for home use was called Mercurochrome, a bright- orange-colored liquid used on scrapes and cuts.) Synthesized by the pharmaceutical company Eli Lilly, ethylmercury soon became the most commonly used preservative in vaccines. But rather than use ethylmercury in its pure form, Lilly combined it with thiosalicylate and called it thimerosal.
Before they put thimerosal in vaccines, Lilly scientists first studied it. They found that thimerosal was much better at killing bacteria than other antiseptics. They also found that they could inject hundreds of milligrams of it into rabbits and rats without any harmful effect. Then they gave it to people. In 1929, during an outbreak of bacterial meningitis in Indiana, Lilly scientists gave thimerosal to doctors to treat the infection. It didn’t work. (It would be another six years before the first antibiotic, sulfa, entered the United States.) Although thimerosal didn’t treat meningitis, doctors found that it was safe. Adults injected with 2 million micrograms of thimerosal didn’t suffer symptoms of mercury poisoning; the amount was 10,000 times greater than the FDA later found babies had received in vaccines.
After scientists added thimerosal to vaccines, infections caused by contamination of multidose vials virtually disappeared. For decades, the preservative was used without a second thought. But as health officials added more vaccines to the routine schedule, children received more and more mercury.
ONCE FDA OFFICIALS FOUND EXACTLY HOW MUCH MERCURY WAS in vaccines, they had to determine whether it was a safe amount. So they consulted safety guidelines from four sources: their own agency, the Environmental Protection Agency (EPA), the Agency for Toxic Substances Disease Registry, and the World Health Organization (WHO). What they found surprised them: safety guidelines didn’t exist. Guidelines were in place for environmental mercury (methylmercury). But vaccines contain ethylmercury. (Scientists preferred ethylmercury over methylmercury because it is eliminated from the body much faster.) Although the distinction between methylmercury and ethylmercury—a difference of only one carbon molecule—sounds trivial, it’s not. An analogy can be made between ethylalcohol, contained in wine and beer, and methylalcohol, contained in wood alcohol. Wine and beer can cause headaches and hangovers; wood alcohol causes blindness.
In mid-June 1999, two months after they had determined how much mercury was in vaccines, FDA officials held a meeting to discuss what they had found. Among others, the FDA invited Neal Halsey, a fifty-seven-year-old pediatrician from Johns Hopkins Medical School, to attend. Halsey had been a vaccine insider for more than two decades, serving on advisory committees to the CDC and the AAP. Because these two organizations are almost solely responsible for recommending vaccines in the United States, few could claim greater responsibility for deciding which vaccines American children got and when they got them than Neal Halsey. For several hours Halsey listened while FDA officials pored over reams of data showing that the amount of ethylmercury children received from vaccines had exceeded that recommended by the EPA for methylmercury. “My first reaction was simply disbelief,” said Halsey, “[as] was the reaction of almost everybody involved in vaccines.” Halsey felt misled by how mercury had been listed in package inserts. “In most vaccine containers,” said Halsey, “thimerosal is listed as a mercury derivative, a hundredth of a percent. And what I believed, and what everybody else believed, was that it was truly a trace, a biologically insignificant amount. My honest belief is that if the labels had had the mercury content in micrograms, this would have been uncovered years ago. But the fact is no one did the calculations.” Halsey wondered whether pharmaceutical companies, in an effort to cover up the amount of mercury in vaccines, had purposefully made it difficult for federal advisers to know exactly how much mercury children were getting. “Gradually it came home to me that maybe there was some real risk to children,” he said. Feeling deceived, Halsey was angry and frustrated.
Halsey had also been influenced by an event that had occurred earlier that summer. While canoeing with his family in Maine, he had come across a sign that advised fishermen to “protect your children—release your catch.” Park officials were worried that fish contained quantities of mercury that might harm children. If the government was warning people about eating fish with mercury, Halsey wondered, “Does it make sense to allow it to be injected into infants?”
ALTHOUGH HALSEY WAS CONCERNED ABOUT THE AMOUNT OF mercury in vaccines, several studies available at the time were reassuring. First, studies in the Seychelles, a group of islands in the Indian Ocean, had shown that infants and young children who consumed large amounts of mercury in fish didn’t develop neurological problems. Second, levels of mercury contained in vaccines did not exceed safety guidelines recommended for methylmercury by the FDA, the agency charged with determining the safety of vaccines. Third, EPA guidelines were based on methylmercury, which is eliminated from the body far more slowly than ethylmercury and is, as a consequence, much more likely to accumulate and cause harm. Fourth, EPA safety levels were determined by mercury exposures to the fetus, whose brain and other organs are still developing. By using levels considered to be harmful to the fetus to determine those likely to be harmful to infants, and by extrapolating guidelines for methylmercury to ethylmercury, the EPA had overstated the risk. Finally, several European countries had already removed thimerosal from vaccines without an obvious drop in the rates of neurological problems; but the effect of this change had never been formally studied.
Despite the reassuring information, Halsey wasn’t reassured. That’s because he couldn’t get the results of one particular study out of his mind. Between 1986 and 1987 investigators had studied children who lived on the Faroe Islands, a small group of islands in the North Sea. Children of the Faroes ate whale meat that was heavily contaminated with methylmercury. Researchers examined 1,000 Faroes children, determining the amount of mercury in their umbilical cords and hair. Seven years later they administered a series of tests. They found that children exposed to fairly low levels of mercury while in their mother’s womb didn’t score as well on tests of attention, memory, language, and (to a lesser extent) movement and sight. Unlike studies in the Seychelles, this research showed that relatively small quantities of mercury in food could affect children. (Later, researchers realized that fish from the Faroe Islands were also contaminated with polychlorinated biphenyls [PCBs], confounding the interpretation of their study.) Halsey read this study over and over again. Although he didn’t think that mercury caused autism, he gradually became convinced that it might be causing subtle neurological or psychological problems.
Halsey knew that the best way to determine whether mercury in vaccines was harmful was to compare children who had received thimerosal-containing vaccines with those who hadn’t. Although these studies would come soon, at the time of the FDA meeting they didn’t exist. So Halsey decided to evoke the precautionary principle, exercising caution in the absence of evidence. Unlike Andrew Wakefield, who had made precipitous recommendations against the MMR vaccine, Halsey would not recommend the removal of a component of vaccines necessary to protect children from potentially fatal infectious diseases. He would merely propose that vaccine makers switch to single-dose vials free of preservatives. Although this recommendation would make vaccines more expensive, it was to Halsey a price worth paying given the potential consequences.
HALSEY HAD ONE MORE WEEK AS HEAD OF THE INFLUENTIAL AAP vaccine advisory committee. Convinced that he had to do something quickly, he sprang into action, calling policymakers from the AAP, the CDC, and the National Vaccine Program Office (which coordinates activities of the FDA, the CDC, and the NIH). In late June and early July 1999, Neal Halsey conducted a series of teleconferences that would lead to one of the most momentous vaccine policy decisions ever made.
Few vaccine experts are more respected, more knowledgeable, or more dedicated than Neal Halsey. If he was concerned about something, people listened. “There is no question that it was Neal’s concerns that drove a lot of this early on,” recalled John Modlin, head of the vaccine advisory committee to the CDC. “He expressed a higher level of anxiety than the rest of us did. He wasn’t convinced that there wasn’t harm [caused by thimerosal]. And he was the driving force behind the AAP’s decision.” Halsey’s initial proposal surprised his colleagues: he wanted to stop giving any vaccine that contained thimerosal. “We were vehemently opposed to that,” recalled Jon Abramson, chairman of pediatrics at Wake Forest University School of Medicine and soon to be head of the AAP advisory committee. “Neal got into several heated discussions with someone at the CDC. I finally at one point said that this has got to stop. This screaming is getting us nowhere.” “Neal really dominated the discussion,” said Meg Fisher, another member of the AAP advisory committee. “He was adamant about what had to be done. And I think that most of the rest of the people on the call didn’t feel that they knew the science well enough to have such a strong opinion and were uncomfortable with his opinion. But we didn’t feel we had the ability to stop him. The first call set the scene. By the second call you had had time to read some of the science. And the more we read, the less excited we were to do anything. The more we felt that it was fine to say, ‘OK, let’s get thimerosal out of vaccines [eventually]. ’ But Neal was just so adamant about it.”
Although Halsey didn’t represent the majority at the time, a confluence of events allowed him to prevail. First, Halsey pushed for a quick decision. “Most people don’t realize the urgency with which Neal pushed this issue,” recalled Georges Peter, former head of the National Vaccine Advisory Committee. “What started as a phone call to me on a Sunday night to the drafting of a statement was only about three weeks; most of that was within a ten-day period. And each call gave you the sense of a small snowball running down a mountain gaining in size and momentum to the point where it couldn’t be stopped.”
Also, three key decision makers weren’t readily available: Walter Orenstein, head of the CDC’s National Immunization Program; Jon Abramson, soon-to-be head of the AAP advisory committee; and John Modlin, head of the CDC advisory committee. Orenstein, attending his son’s bar mitzvah in Israel, had to join calls at odd hours. Abramson, who was vacationing in the Canadian Rockies, joined when he could from telephone booths in remote areas. And in mid-May, just before the teleconferences started, John Modlin’s boss—John Brooks, chairman of the Department of Pediatrics at Dartmouth Medical School—was almost killed in a car accident. “It was a tough period,” recalled Modlin.
Typically, vaccine policies are made jointly by the CDC and AAP, occasionally with input from the National Vaccine Advisory Committee. But in this case, the perception that something needed to be done quickly, before these committees were scheduled to meet again, circumvented the process. Walter Orenstein later regretted the lack of vetting through these advisory committees. “To me one of the lessons is to put this through the usual decision-making process,” he said. “What we did at the time was emergency decision making, and we had all sorts of groups involved that normally wouldn’t have been.” Georges Peter agreed. “The usual process by which an [AAP] statement is developed is that every member had to sign off on it before it went to the executive board,” he said. “That process was bypassed. Neal was communicating directly with the executive board of the [AAP], and the statement was drafted. It might have been different if the [CDC advisory committee] had been able to weigh in.”
The choice of teleconferences also helped to determine the outcome. “Had it not been conference phone calls, I don’t think that the decision [to remove thimerosal quickly] would have been made,” said Meg Fisher. “I think if we were all sitting in a room, someone would have gotten up and said, ‘Neal, you’re really off base here.’ When you’re face-to-face you can get the nuances.” “The problem with teleconferences is that there’s no chance to look around the room,” said Georges Peter. “You could be talking to someone at a coffee break, and all of a sudden you realize, my gosh, there are six of us who all feel the same way.” Larry Pickering, a member of the AAP advisory committee, also lamented the use of teleconferences. “Conference calls are fine for certain things,” he said, “but not for major decisions. I personally feel that sitting in a room and looking someone in the eye and really being able to discuss things freely and openly are far superior and should be the way that major recommendations are made. Conference calls are not the way that this should have been done.”
Despite the cauldron in which they found themselves, most people on the teleconferences gradually became convinced that nothing had to be done immediately. “A lot of the [AAP] committee didn’t feel that this was a public health emergency,” recalled Pickering, “and that we should move forward in a logical, systematic, well-thought-out way.” “This was not a bomb that was immediately going to go off,” recalled Peter. But Halsey didn’t want to wait. On June 30, 1999, he called a meeting at the AAP executive offices in Washington, D.C. Before the meeting Halsey made it clear that he was going to ask doctors to use thimerosal-free vaccines for children whenever possible, to eliminate the birth dose of hepatitis B vaccine until thimerosal-free vaccines were available, and to stop immunizing children with influenza vaccines that contained thimerosal. Seeing the risk of potentially fatal infectious diseases as greater than the theoretical risk of thimerosal, most participants were surprised and angered by Halsey’s recommendation. Martin Myers, deputy director of the National Vaccine Program Office, wrote a summary of the meeting. “Although the AAP is a major public health partner, there is great concern that the data do not support moving so precipitously,” wrote Myers. “In addition, the manner by which the public is informed about the potential risk could greatly influence trust in our immunization programs.”
Facing resistance from his colleagues, Halsey played his trump card. “If we weren’t going to do what [Neal] wanted [to stop giving thimerosal-containing vaccines], we were told that he was going to do his own press release,” recalled Myers. “It was very confrontational. We felt there was no alternative.” Myers often thinks back to the events of June 1999. “I think it was necessary to tell the public that we had identified something that needed to be pursued further,” he said. “[But] I think the policy decision we made was wrong. We scared a lot of parents. But I just don’t know how we would have done it differently because Neal kept saying, ‘Well, if you’re not going to do it with me, I’m going to do it.’ I don’t know that we had a lot of options.” Myers doesn’t fault Halsey, whom he always considered to be acting in the best interests of children. “I’ve never questioned his motivations,” said Myers. “He’s a man who really cares about children. I just think he made a terrible mistake. He was convinced that he needed to do this and that he had to convince everyone else to do it.”
Eventually, with the help of Surgeon General David Satcher, the group members reached a compromise. They wouldn’t change their recommendations regarding thimerosal-containing DPT or Hib vaccines, but they would change them for thimerosal-containing hepatitis B vaccine. They reasoned that children born to mothers who weren’t infected with hepatitis B virus were at a very low risk of getting infected. The solution was simple: delay the birth dose of hepatitis B virus in children whose mothers weren’t infected with the virus. This would bring the level of mercury to which infants were exposed in the first six months of life below that deemed to be unsafe (for environmental mercury) by the EPA. It would, they reasoned, spare a public relations fiasco.
Both sides agreed to wait until after the July Fourth weekend to draft a consensus statement. On July 9, 1999, only three weeks after the FDA had held a meeting describing how much mercury was contained in vaccines, the AAP and the Public Health Service (PHS) issued a joint statement. The authors of the statement tried to be reassuring: “There are no data or evidence of any harm caused by the level of exposure [to mercury] that some children may have encountered in following the existing immunization schedule.” Then the statement got to the heart of the matter, weighing relative risks. “The recognition that some children could be exposed to a cumulative level of [ethyl] mercury over the first six months of life that exceeds one of the federal safety guidelines on methylmercury now requires a weighing of two different risks. On the one hand, there is the known serious risk of disease and death caused by failure to immunize our infants. On the other hand, there is the unknown and probably much smaller risk, if any, of neurodevelopmental effects posed by exposure to thimerosal.” The contradictory and confusing juxtaposition of phrases in this statement exposed the tensions among those who had written it. The risk to an infant from thimerosal was described as “probably much smaller” than the risk of disease from failing to vaccinate—the word probablyimplied that the risk from thimerosal might actually have been greater. But with the phrase if any, the risk from thimerosal was also described as potentially nonexistent. A press release issued by the AAP was even more confusing. “Parents should not worry about the safety of vaccines,” it read. “The current levels of thimerosal will not hurt children, but reducing those levels will make safe vaccines even safer.” Critics wondered how removing something that hadn’t been shown to be unsafe could make vaccines safer. Doctors were also confused by the recommendation. But many parents reasoned that the only possible explanation for thimerosal’s precipitous removal was that policymakers thought it was harmful.
One month after the joint statement, the National Vaccine Program Office (NVPO) held a meeting at NIH to talk about what had happened. Typically, the NVPO would have actively participated in setting vaccine policy. Now, they could only stand back and watch. Stan Music, an expert in toxicology and vaccine safety, recalled the meeting. “This was a very frustrating, even disappointing experience,” wrote Music. “I guess I am not used to seeing people who are held up as the experts so thoroughly squander their potential for wise stewardship and lead the world of vaccines down an unnecessarily dangerous path. The rush for judgment and then for action was never addressed. Thimerosal has been maligned irreparably, even though there are no cases of thimerosal toxicity and all the risks are theoretical. Another blow—this time self-inflicted—has been delivered to vaccines.” Vaccine researcher Stanley Plotkin also attended the NIH meeting. He compared the decision to delay the hepatitis B vaccine to the queen’s court in Alice in Wonderland: “First the sentence, then the trial!” he said. Almost everyone agreed that the thimerosal decision had been the wrong one, a fact recorded in the meeting’s minutes. But a transcript of the meeting was never released. Georges Peter later wondered why the outcome of this meeting was never published. “It became pretty clear [during the meeting] that the action that had been taken was precipitous and that you needed far more data before taking this position,” he said. “I asked Marty [Myers, head of the NVPO] if we were going to publish the proceedings and he said, ‘Yes.’ But it never got off somebody’s desk.” As a consequence, few in the press or the public knew that after a review of the data under calmer conditions, most experts didn’t agree with the plan to immediately remove thimerosal from vaccines.
In the wake of the thimerosal decision, CDC officials warned of a growing tide against vaccines. “In spite of the best effort in communication,” they said, “the concept of good and bad vaccines may emerge.” Acutely aware of the litigious climate in the United States, CDC officials further warned: “It is possible that many children born in the 1990s who have serious disorders of unknown etiology will now blame mercury in vaccines for their illnesses. This is particularly likely for illnesses that appear to be increasing, such as autism.”
The CDC statement would be an ominous predictor of future events.
IN OCTOBER 1999, NEAL HALSEY APPEARED BEFORE MEMBERS OF THE CDC’s Advisory Committee on Immunization Practices, asking them to express a preference for thimerosal-free vaccines—in other words, to make it clear to the press and the public that the CDC felt that thimerosal might be unsafe. But the committee rejected Halsey’s request, reasoning that all of the evidence supported the stance that thimerosal at the level contained in vaccines was safe. The committee members’ vote in October 1999 showed that had they been involved from the beginning, a joint statement might never have been written, the hepatitis B birth dose might never have been delayed, and the public might never have been frightened by the theoretical risk of thimerosal. But by the time Neal Halsey appeared before the committee it was too late; events that would soon lead to distrust, litigation, and a handful of new and potentially dangerous therapies for autistic children had already been set in motion. “If I had known what would happen next,” recalled Walter Orenstein, “I would never have gone along with Neal’s plan.”
Halsey could have learned from an event that had occurred several years earlier, one that had shown why it is virtually impossible to exercise the precautionary principle in the United States without significant collateral damage.
IN 1961, A SURGEON NAMED FRANK GEROW NOTICED THAT A PLASTIC transfusion bag filled with blood felt like a human breast. Gerow reasoned that another substance, a gel called silicone, could be used to fill the plastic bag. So he visited representatives of Dow Corning, the leading manufacturer of silicone, and asked if they would be interested in designing a silicone-filled breast implant. (Silicone is made by stringing together silicon and oxygen, two of nature’s most abundant elements. First synthesized before World War II, silicone has been used in artificial joints, heart valves, shunts, disposable needles, and syringes. As a consequence, most Americans have been exposed to silicone.) Gerow felt that the market for breast implants was limitless. Dow Corning agreed. One year later, in 1962, Frank Gerow performed the first silicone breast implantation.
Silicone breast implants became enormously popular, especially among Hollywood actresses and celebrities. Between 1979 and 1992, plastic surgeons put silicone breast implants into more than 100,000 women a year and breast implantation became the third most common cosmetic procedure in the United States, trailing only liposuction and eyelid surgery. A survey conducted by the American Society of Plastic and Reconstructive Surgeons found that 90 percent of women were satisfied with their implants and would choose to have them again.
But the tide was about to turn for breast implants.
In 1982, three women developed muscle aches, joint pain, fatigue, and weakness after receiving breast implants. All three women believed that breast implants had caused their symptoms. (Diseases such as rheumatoid arthritis, fibromyalgia, scleroderma, and lupus—all of which include symptoms related to joints and muscles—are collectively referred to as connective tissue diseases.) Later, an Australian physician reported their stories in the medical journal Arthritis and Rheumatism. Two years later, the lawsuits started. In 1984, a jury awarded $2 million to Maria Stern. Several years later, another jury awarded more than $7 million to Mariann Hopkins; it was one of the largest medical product awards in history.
In November 1990, breast implant litigants got their greatest gift: President George H. W. Bush appointed David Kessler to run the FDA. Kessler was a remarkable and brilliant man. Commuting between Boston and Chicago, he simultaneously received a medical degree from Harvard and a law degree from the University of Chicago, and his work schedule became one of legend. As FDA director, he labored tirelessly on behalf of the American public. “Caveat emptor [buyer beware] has never been—and never will be—the philosophy of the FDA,” he said.
On April 16, 1992, amid growing concerns that silicone breast implants might be harmful, David Kessler banned them from the American market. At the time of the ban, no studies had examined the risk of connective tissue diseases in women who had received breast implants. Because studies hadn’t been performed, Kessler had exercised the precautionary principle, removing breast implants from the market pending further study. He tried to reassure the public that breast implants hadn’t been shown to be unsafe; he just wanted to study their safety before letting any more women use them. But his weak reassurances scared the public, causing many women who had implants to rush to have them removed. One woman, unable to afford the cost of another surgery, tried to remove her breast implants with a razor blade.
Kessler’s removal of silicone breast implants from the market precipitated a flood of litigation. In one year, the number of lawsuits against Dow Corning increased from 200 to 30,000. Many of the lawsuits came from patient advocacy groups set up by lawyers to recruit clients. By 1994, breast implant manufacturers had been brought to their knees, forced to settle a class-action lawsuit for more than $4 billion, at the time the largest medical product settlement in American history. One billion dollars went to the lawyers. In May 1995, Dow Corning filed for bankruptcy.
On June 16, 1994, two months after breast implant manufacturers had agreed to settle the class-action lawsuit, Sherine Gabriel, a professor of medicine and epidemiology at the Mayo Clinic in Rochester, Minnesota, published a paper in the New England Journal of Medicine. Gabriel had evaluated 750 women who had received breast implants and compared them with 1,500 women who hadn’t received them. The rates of connective tissue diseases were the same in both groups. Gabriel’s conclusion was simple: “We found no association between breast implants and the connective tissue diseases and other disorders that were studied.”
Gabriel’s study was the first of many. In 1995, Jorge Sánchez-Guerrero, a researcher in the department of rheumatology and immunology at Harvard Medical School, examined the records of 90,000 women and published their findings, also in the New England Journal of Medicine. Again, women with breast implants were not more likely to have connective tissue diseases. Six more studies followed. Researchers at Wayne State University, the University of Calgary, the University of Kansas School of Medicine, the Johns Hopkins School of Medicine, the University of Pennsylvania School of Medicine, and the Harvard School of Public Health all agreed with Gabriel and Sánchez-Guerrero: breast implants didn’t cause connective tissue diseases.
THE MASSIVE SETTLEMENT OF THE CLASS-ACTION LAWSUIT DIDN’T put an end to breast implant litigation. Fifteen thousand women opted out of the settlement, choosing to seek their own awards in hopes of even greater gain. But there was one problem. When lawyers had settled the class-action suit, no studies had been performed to refute their claims. Now several researchers had published studies exonerating breast implants. When Neal Halsey evoked the precautionary principle in asking for the immediate removal of thimerosal from vaccines, he should have paid much closer attention to what followed in the breast implant story. Because the alliance among fringe scientists, personal-injury lawyers, and advocacy groups; the promotion of bad science; the cottage industry of unnecessary tests and lucrative consulting fees; and the accusation that the scientists who publicly had exonerated breast implants were part of a massive conspiracy funded by industry would all be repeated. The game plan had been set.
Two years after research failed to show a connection between breast implants and connective tissue diseases, a consortium of lawyers paid more than $1 million to a group called Fenton Communications to help them out. With the help of Fenton, a high-powered, well-connected public relations firm based in Washington, D.C., personal-injury lawyers pursued a multipronged strategy to counter the epidemiological studies that had absolved breast implants. First, Fenton promoted the work of an assistant professor of pathology at the UCLA Medical Center, Nir Kossovsky. Kossovsky had injected guinea pigs with silicone and found that it induced an immune response; he believed this explained why women with breast implants got connective tissue diseases. Kossovsky’s argument contained a few holes: guinea pigs didn’t develop connective tissue diseases; women with breast implants weren’t at greater risk of connective tissue diseases; and no one had ever consistently found silicone-binding antibodies in people. Despite these differences, Kossovsky patented his observation, named his test Detectsil (a contraction of “detect silicone”), charged $350 for it, advertised it in magazines, founded a company called SBI Laboratories in Pittsburgh, and spent much of his time testifying on behalf of breast implant litigants.
Kossovsky wasn’t the only one to set up a laboratory to perform such tests. Rahim Karjoo founded American Medical Diagnostics in West Covina, California, and Georgette Vojdani set up Immunosciences Lab in Beverly Hills. These two companies—devoted exclusively to detecting abnormal antibodies in women with breast implants—made millionaires of their founders. Douglas Shanklin and Douglas Smalley developed the “Silicon Sensitivity Test” or SILS, the flagship product of Memphis Pathology Laboratory in Memphis, Tennessee. And Scott Tenenbaum at Tulane University licensed his test, which sold for $200, to Autoimmune Technologies. Tenenbaum’s diagnostic test—like all of the others—didn’t detect silicone-binding antibodies because women with silicone breast implants didn’t produce them. Still, Fenton promoted these scientists as having made important contributions to understanding how breast implants caused connective tissue diseases.
Later, the Institute of Medicine (IOM) reviewed hundreds of epidemiological and biological studies and concluded that breast implants didn’t cause connective tissue diseases. But plaintiffs’ lawyers and breast implant recipients claimed the IOM was part of a conspiracy to mislead the American public—a conspiracy financed by breast implant manufacturers. Plaintiffs’ lawyers harassed Sherine Gabriel, the lead author on the first study exonerating breast implants. They wrote letters to the New England Journal of Medicine claiming she was biased and deeply embedded in the pocket of the manufacturing industry. They issued subpoenas, forcing Gabriel to comply with their wide-ranging and work-intensive demands. Gabriel later recalled the pressure of being the first to publish a paper that countered well-funded, highly motivated advocacy groups backed by personal-injury lawyers. “The magnitude of the demands [from personal-injury lawyers] was staggering,” she said. “They wanted over eight hundred manuscripts from researchers that were here; they wanted hundreds of databases, dozens of file cabinets, and the entire medical records of all Olmstead County [Minnesota] women whether or not they were in the study. It has taken a huge amount of time and it has been extremely stressful. It has severely compromised my ability to do research.” Which was, she suspected, the point. If plaintiffs’ lawyers could tie up Sherine Gabriel, she would be less able to perform follow-up studies that further undermined the credibility of their position.
Gabriel wasn’t the only investigator targeted by personal-injury lawyers. Marcia Angell, executive editor of the New England Journal of Medicine and author of Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case, also came under attack. “I was subpoenaed twice,” said Angell. “They wanted a large number of documents that don’t even exist, alleging contact between me and the manufacturers. They thought the manufacturers paid me.”
Fenton’s efforts to counter good science failed, and plaintiffs who had rejected the settlement watched their cases fall apart. On November 17, 2006, the FDA lifted its ban on silicone breast implants. An editorial in the Wall Street Journal added a postscript to the controversy: “While we’re glad the FDA has overturned fourteen years of politicized medicine by approving silicone breast implants, it’s worth remembering the enormous price that has been paid: to the credibility of the legal system, in jobs lost, and in public health. And it’s worth asking what is more toxic: the silicone implants preferred by thousands of women, or the trial bar that purports to ‘protect’ them.” Despite the Journal’s protests, the temporary loss of silicone breast implants in the United States didn’t exact much of a toll on human health.
For vaccines, however, the price would be much greater.
When public health agencies delayed the birth dose of hepatitis B vaccine, children suffered. Ten percent of hospitals, frightened by the notion of giving a thimerosal-containing vaccine to newborns, ignored recommendations and simply suspended the hepatitis B vaccine for all newborns. One three-month-old child born to a mother infected with hepatitis B virus in Michigan died of overwhelming infection, having failed to receive the vaccine in the nursery. Six babies in Philadelphia born to mothers infected with the virus also never got vaccinated, putting them at high risk of developing severe liver disease or liver cancer later in life. “I think stopping the birth dose of hepatitis B vaccine was an absolutely horrendous mistake,” said Martin Myers. “It was one of the worst public policy decisions that we’ve ever made.”
In retrospect, Neal Halsey and public health agencies hadn’t exercised the precautionary principle—a principle that assumes that there is no harm in exercising caution. Rather, they had set sail on a grand experiment, believing that the harm caused by thimerosal was greater than the harm caused by disrupting the hepatitis B immunization program. One journalist, in an article for the New York Times Magazine, wrote, “If the autism trend begins to recede now that thimerosal has been removed, it could certainly suggest a cause. If it does decline, we might have Neal Halsey to thank.”
The next few years would determine whether Neal Halsey’s caution had paid off.