Vaccinated (20 page)

When the
Sunday Times
revealed that a personal injury lawyer had supported Wakefield's study, Richard Horton, the editor of the
Lancet
, was shocked. “There were fatal conflicts of interest in this paper,” he said. “If we had known [about them], it would have been rejected. As the father of a three-year-old who has had the MMR, I regret the adverse impact this paper has had.” Simon Murch, one of the co-authors of Wakefield's paper, was also caught off guard: “We never knew anything about the £55,000—he had his own separate research fund. All of us were surprised. We were pretty angry.” Six years after Wakefield's publication, in September 2004, ten of the thirteen original authors withdrew their support of Wakefield. In a strongly worded letter to the
Lancet
they said, “We wish to make it clear that in this paper no causal link was established between the vaccine and autism, as the data were insufficient. However, the possibility of such a link was raised. Consequent events have had major implications for public health. In view of this, we consider now is the appropriate time that we should together formally retract the interpretation placed on these findings in the paper.”

The Royal Free Hospital fired Andrew Wakefield, and the General Medical Council in England filed eleven charges against him for misconduct. Wakefield sought refuge in the United States, first working in Florida and later in Texas, constantly lecturing an anxious public about the dangers of vaccines. To many, Wakefield remains a hero, a tragic figure bravely standing up against a medical establishment determined to crush him.

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.

 

W
HEN SCIENTIFIC EVIDENCE CONVINCINGLY REFUTED
W
AKEFIELD'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 his 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.”