Vaccinated Page 19
During the 60 Minutes interview with Ed Bradley, Wakefield said, “I would have enormous regrets if [my theories] were wrong and there were complications or fatalities from measles.” Wakefield was right in predicting that parents would soon watch children suffer and die of measles, but he overestimated his capacity for regret. Although study after study showed that MMR never caused autism, Wakefield remains unrepentant, wedded to a hypothesis that he considers nonfalsifiable. Still seeing himself as a champion of children, a man devoted to keeping them safe from vaccines foisted on the public by greedy pharmaceutical companies and inept public health officials, he asks, “Should we stop, should we go away, should we stop publishing because it is inconvenient? I’ve lost my job. I will never practice medicine in [England] again. There is no upside to this. But if you come to me and say, ‘This has happened to my child,’ what’s my job? What did I sign up to do when I went into medicine? I’m here to address the concerns of the patient. There’s a high price to pay for that. But I’m prepared to pay it.”
Andrew Wakefield remains a man committed to saving children from the “harm” of the MMR vaccine, even though no harm exists. And because it’s hard to unring the bell, some parents in the United States, England, and the world still refuse to give the MMR vaccine to their children, fearing that it causes autism.
WHEN SCIENTIFIC EVIDENCE CONVINCINGLY REFUTED WAKEFIELD’S notion that MMR caused autism, antivaccine activists in the United States didn’t stop. They shifted their vaccines-cause-harm hypothesis to thimerosal, a mercury-based preservative contained in some vaccines. Thimerosal, they said, was causing autism. Again, Hilleman found himself in the middle of the fray.
The controversy started innocently enough. In 1997 Congress passed the FDA Modernization Act. The bill, which received little attention from the media at the time, required health officials “to compile a list of drugs and foods that contain intentionally introduced mercury compounds and [to] provide a quantitative analysis” of those compounds. In response, health officials started adding up the amount of mercury in a variety of medical products, including vaccines.
At the time of the bill, the most common preservative used in vaccines was thimerosal. Because of earlier tragedies, pharmaceutical companies had been adding thimerosal to vaccines since the 1930s. Before adding thimerosal, between 1900 and 1930, companies packaged vaccines almost exclusively in multidose vials. A typical vial contained ten doses. Because a large percentage of the cost of vaccines is determined by the cost of the 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 less expensively. Doctors kept these vials in their office refrigerators. When they gave vaccines to children, they would insert a needle through the rubber stopper, pull up the liquid into a syringe, and inject it into the arms of their patients. Unfortunately, by constantly violating the rubber stopper with a needle, doctors and nurses would inadvertently contaminate the vial with bacteria. Children given the eighth, ninth, or tenth dose from a vial were at greater risk of bacterial infection than those given the first dose. Bacteria that contaminated vaccines caused abscesses at the site of injection, as well as severe and occasionally fatal infections. In the first two decades of the twentieth century at least sixty children were known to have died of bacterial infections caused by multidose vaccines that didn’t contain preservatives.
Early in the twentieth century, scientists found that small quantities of mercury prevented bacteria from growing. Although it was also known that large quantities of environmental mercury—known as methyl mercury—could cause permanent brain damage, small quantities appeared to be harmless. As an added precaution, pharmaceutical companies chose a type of mercury not found in the environment—ethyl mercury—because it was eliminated from the body much more quickly than environmental mercury but still killed bacteria. (Some people might remember the mercury-containing orange-colored antiseptic Mercurochrome, used to prevent bacterial contamination of cuts and scrapes in the 1950s, 1960s, and 1970s.) Although ethyl mercury and methyl mercury sound similar, they’re quite different. An analogy can be made between ethyl alcohol and methyl alcohol. Ethyl alcohol, contained in wine or beer, can cause headaches and hangovers. Methyl alcohol, otherwise known as wood alcohol, causes blindness. By the late 1930s, ethyl mercury had been added to several vaccines, and infections caused by contaminating bacteria virtually disappeared.
During the next seventy years, pharmaceutical companies made many new vaccines, packaged them in multidose vials, and added thimerosal as a preservative. But as children received more and more vaccines, the quantity of mercury they received also increased. When the FDA determined the amount of mercury contained in vaccines in the late 1990s, it found that infants could be injected with as much as 187.5 micrograms. (A gram is approximately the weight of one-fifth of a teaspoon of salt. A microgram is one-millionth of a gram.) Officials consulted federal safety guidelines for ethyl mercury and found that there were none; guidelines existed only for methyl mercury. So they decided to use the guidelines established for methyl mercury to determine the safety of ethyl mercury. Public health officials consulted safety guidelines from three groups: the FDA, the Environmental Protection Agency (EPA), and the Agency for Toxic Substances Disease Registry (ATSDR). They found that the amount of mercury that children received in vaccines was two times greater than safety levels recommended by the EPA but didn’t exceed those recommended by the FDA or ATSDR. The American Academy of Pediatrics (AAP) and the federal Public Health Service (PHS) saw the intentional administration of mercury to children at levels that exceeded EPA safety guidelines as a public relations nightmare. In October 1999 the two organizations issued a statement that they hoped would “maintain the public’s trust in immunization”: they asked that thimerosal be removed from vaccines as quickly as possible. The advisory stated that thimerosal wasn’t being removed because it was known to be harmful but because it would make “safe vaccines safer.” Critics wondered how removing an ingredient that hadn’t been shown to be harmful could make a vaccine safer. Subsequent events would show that this attempt to reassure the public will probably remain forever as an example of how not to communicate theoretical risks.
Pharmaceutical companies complied with the AAP-PHS directive to remove thimerosal from vaccines. With the exception of the influenza vaccine, they eliminated it by packaging vaccines in single-dose vials. Although health officials tried to reassure the public that thimerosal hadn’t been shown to be harmful, parents wondered why pharmaceutical companies would act so precipitously to remove it if there wasn’t a problem. Again, no one jumped on this series of events more quickly, more passionately, or more effectively than a small but vocal group of parents of children with autism.
In the wake of the removal of thimerosal from vaccines, several powerful forces came together. Parents of children with autism saw the mercury debate as a possible solution to their problems. If mercury caused autism, then using chemicals that removed mercury from their children might help. Personal injury lawyers saw the controversy as a large and tempting pool of money. If mercury caused autism and if pharmaceutical companies knew that they had exceeded federal safety guidelines, companies would be liable for damages. Given that tens of thousands of children were diagnosed with autism every year, the money to be made from settlements and awards seemed limitless. The media saw the issue as a great man-bites-dog story: vaccines, claimed for years to be a life-saving product, were actually causing harm. And politicians saw the vaccines-cause-autism controversy as a way to show sympathy for grieving parents while drawing the light of television cameras. All they had to do was to ban mercury-containing vaccines from their states—politically, not a very heavy load to lift.
In the summer of 2005, all of these forces erupted on the American scene.
Robert F. Kennedy Jr., supported by plaintiff lawyers, wrote an exposé for Rolling Stone magazine titled “Deadly Immunity.” In h
is article, Kennedy painted a picture of greedy pharmaceutical companies, sheep-like doctors, and public health officials trying to cover up a problem that had occurred on their watch—and was now spiraling wildly out of control.
Arnold Schwarzenegger of California became the first governor to prohibit vaccines containing thimerosal from his state. Others soon followed his lead. Because the supply of thimerosal-free influenza vaccine was limited, Schwarzenegger had essentially prohibited many of California’s children from receiving a vaccine that prevented influenza—a disease that every year in the United States still causes the hospitalization of one hundred thousand children and the deaths of a hundred.
Finally, the advocacy group Safe Minds commissioned a reporter, David Kirby, to write a book about the thimerosal-autism controversy. Kirby had never written a story about health, science, medicine, or vaccines before. But with funding from a wealthy California financier, the book, Evidence of Harm, became one of the best-selling health books in the United States. Don Imus interviewed Kirby several times on his national radio program. Tim Russert interviewed him on Meet the Press. Indeed every major television and radio outlet trumpeted the Evidence of Harm story: a story of intrigue, secret meetings by the CDC, and public health officials asleep at the switch. Everyone, it seemed, was in the pocket of pharmaceutical companies. For months after the publication of Evidence of Harm, the thimerosal-autism story dominated the news. The media portrayed the story as little guy (parents) versus big guy (pharmaceutical companies)—a story they knew most Americans would love.
The growing fear that mercury in vaccines caused autism soon led to tragedy. On April 3, 2005, a five-year-old autistic boy, Tariq Nadama, visited the office of Dr. Roy Eugene Kerry in Portersville, Pennsylvania. Kerry rolled up Tariq’s sleeve, inserted a needle into his vein, and injected him with ethylenediaminetetraacetic acid (EDTA), a chemical that binds to mercury and helps to remove it from the body. EDTA therapy has never been shown to improve symptoms of autism, is not approved by the FDA for this purpose, and can be quite dangerous. About ten thousand children now receive mercury-binding therapy every year, spurred largely by the precipitous removal of thimerosal from vaccines. There remains no evidence that this therapy helps. Five minutes after the injection Tariq had a heart attack and died.
Supported by the media attention that they had helped to generate, personal injury lawyers filed 350 claims in federal and state courts seeking billions of dollars in compensation. (As of March 2007, pharmaceutical companies had spent about $400 million in their defense, and they hadn’t gone to court yet.) Maurice Hilleman soon found himself in the middle of the fray. A Washington-based personal injury lawyer named James A. Moody leaked a memo to Myron Levin, a medical writer for the Los Angeles Times. In the early 1990s Hilleman had written the memo to Gordon Douglas, then the head of the Merck Vaccine Division. Moody claimed that an unnamed whistle-blower, stricken by conscience, had given the memo to him. (Actually, the memo had been given to plaintiffs’ lawyers as part of the normal discovery process prior to trial.) In the memo Hilleman stated that “the mercury load [in vaccines] appears rather large.” Personal injury lawyers are using Hilleman’s memo as the smoking gun that proves that companies were aware of the unacceptably high levels of mercury in vaccines well before the FDA Modernization Act. But Hilleman also stated in his memo that “the key issue is whether thimerosal, in the amount given with the vaccine, does or does not constitute a safety hazard. However, perception of hazard may be equally important.” Hilleman, like the AAP and PHS, was concerned about the media and advocacy groups. But because Hilleman also knew that mercury was present in the environment, he wasn’t sure whether the quantity of mercury contained in vaccines was an important addition. “It appears essentially impossible based on current information,” he wrote, “to ascertain whether thimerosal in vaccines constitutes or does not constitute a significant addition to the normal daily input of mercury from diverse sources.”
After writing his memo, Hilleman reviewed more recent studies and concluded that the quantity of mercury in vaccines wasn’t harmful, a belief supported by several facts.
Mercury, part of the earth’s crust, is released into the environment in the form of inorganic mercury by volcanic eruptions, burning coal, and water erosion of rocks. It is then converted from inorganic to organic mercury—specifically, methyl mercury—by bacteria in the soil. Methyl mercury then enters the water supply and eventually the food chain.
Because methyl mercury is everywhere, it’s unavoidable. Mercury is in water, infant formula, and breast milk. A breast-fed child ingests about 360 micrograms of methyl mercury in the first six months of life, twice the quantity of mercury contained in vaccines before its removal. And the mercury in breast milk is methyl mercury, excreted much more slowly from the body—and therefore much more likely to accumulate—than the ethyl mercury contained in vaccines.
Because babies encounter far more mercury in their environment than they do in vaccines, Hilleman believed that mercury in vaccines was never harmful, but he was savvy enough to know that it might be perceived as harmful. Nevertheless, Hilleman later regretted writing the memo. “I didn’t think that it would get into the hands of people who couldn’t think at all. Myron Levin [from the Los Angeles Times] never talked to me. And there was no whistle-blower at Merck. They misinterpreted what I was saying. My concern was that the public wouldn’t know the difference between ethyl mercury and methyl mercury, because public perception is not often informed by science. But then the personal injury lawyers got a hold of this.”
Later, five studies performed on three continents clearly showed that the incidence of autism was the same in children who received vaccines that did or did not contain thimerosal. The Institute of Medicine, an independent organization within the National Academy of Sciences, reviewed these studies and concluded that thimerosal didn’t cause autism. Perhaps the best study, published in July 2006, took advantage of a natural experiment that occurred in Canada between 1987 and 1998, when the quantity of thimerosal in vaccines varied. Between 1987 and 1991, vaccinated babies in Montreal received 125 micrograms of thimerosal; between 1992 and 1995, they received 225 micrograms; and after 1996 they received 0 micrograms. If thimerosal caused autism, the incidence of autism should have been much higher in children born between 1992 and 1995 than in those born after 1995. In fact, the opposite was true. The incidence of autism was higher in babies born after 1995 than in those born before 1995. Similarly, studies in Denmark, a country that had abandoned thimerosal as a preservative in 1991, found an increase in autism several years later. These increases in autism rates were most likely due to a broadening of the definition of the disease to include autistic spectrum disorder, Asperger’s syndrome, and pervasive developmental disorder.
Although thimerosal at the level contained in vaccines doesn’t cause autism, the financial incentives of those interested in keeping this controversy alive make it unlikely that it will die down anytime soon.
IN ADDITION TO ANTIVACCINE ACTIVISTS, PERSONAL INJURY LAWYERS, and an occasionally irresponsible media, other obstacles stand in the way of vaccines. For example, we are choosing not to afford them.
In the early 1950s, there were four vaccines: diphtheria-tetanus-pertussis (DTP) and smallpox. Together, these vaccines cost less than $2, and people paid for them out of their own pockets. About 40 percent of children in the United States were immunized—a rate similar to that in many developing countries today.
In the 1970s, there were seven vaccines: DTP, MMR, and polio. The price for all of these vaccines was less than $50. People still paid for the vaccines themselves, and immunization rates rose to 70 percent.
By the mid-1990s, there were ten vaccines: DTaP (which included the new pertussis vaccine), MMR, polio, Hib, hepatitis B, and chickenpox. The price for these vaccines had risen to hundreds of dollars, and many parents couldn’t afford them. With more vaccines at greater cost, the large private market for vaccines was dwarfed by an
other payer: the federal government. In the early 1990s, Bill Clinton found it unconscionable that uninsured or underinsured children in the United States weren’t getting the vaccines that they needed. So he created the federal Vaccines for Children (VFC) program. With federal funds in place, immunization rates rose from 70 to 90 percent, and several diseases were completely or virtually eliminated.
By 2006, the CDC had placed sixteen vaccines on the routine schedule, adding rotavirus, meningococcus, influenza, papillomavirus, pneumococcus, and hepatitis A. The cost for these vaccines was more than $1,000. The federal government and insurance companies were now spending about $3 billion a year on vaccines. (Although $3 billion sounds like a lot of money, it’s only about one-tenth of 1 percent of the almost $3 trillion that the United States spends every year on health care.) Unfortunately, at a time when vaccines required the most support, the federal government became an unreliable and inconsistent buyer, cutting back on a program that gave money directly to states to buy vaccines. Vaccine funding was at a crisis. As a consequence, many states that had previously purchased all vaccines for their children couldn’t afford them. Forced to choose, some states didn’t provide the pneumococcal vaccine, and others didn’t provide the meningococcal or papillomavirus vaccines. States were forced to decide which infectious diseases they would prevent and which they would allow to continue to cause suffering and death.
Our willingness to pay for the treatment of people who are sick but not to prevent disease in those who aren’t is rooted in the myth of invulnerability.
WE NEVER BELIEVE THAT A DISEASE IS GOING TO HAPPEN TO US—UNTIL it happens to us.
In the 2002 movie John Q, Denzel Washington plays a father, John Quincy Archibald, whose son needs a heart transplant. If the boy doesn’t get the transplant, he’ll die. John tries patiently, then desperately, to get his insurance company to pay for the transplant. But it refuses. Because John can’t afford the transplant and because the hospital surgeons are unwilling to perform the operation for free, the boy is essentially sentenced to death. Like any parent, John cannot stand by and watch his son die. So he takes over the hospital at gunpoint. Anyone watching this movie can identify with his anguish. But what if there were a vaccine that prevented heart damage? Would John have been as passionate, committed, and ultimately crazed years earlier if his son had been denied the vaccine, not knowing for sure that he might benefit?