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Authors: Paul A. Offit

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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.

 

I
N 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 another 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.

 

W
E 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?

That's the problem with vaccines. When they work, absolutely nothing happens. Nothing. Parents go on with their lives, not once thinking that their child was saved from meningitis caused by Hib or from liver cancer caused by hepatitis B or from fatal pneumonia caused by pneumococcus or from paralysis caused by polio. We live in a state of blissful denial. But somebody was getting those diseases. Before pharmaceutical companies made the Hib vaccine in the early 1990s, every year about ten thousand children were stricken with meningitis, leaving many blind, deaf, and retarded. Today, fewer than fifty children every year suffer this disease. But who are the thousands of children who aren't getting Hib today? What are their names? We don't know. And that's what makes vaccines—or any prevention—so much less compelling than treatment. We spend hundreds of millions of dollars on bone marrow transplants and lung transplants and kidney transplants and heart transplants. These therapies are extraordinarily expensive, and they certainly don't save money for the health care system or society. But when we know a person who is sick, we'll stop at nothing to help. Unfortunately, we seem perfectly willing to withhold life-saving vaccines when we don't know who is going to be sick. We're willing to take that gamble—a gamble that many children will inevitably lose.

 

R
ELIGIOUS AND CONSERVATIVE GROUPS ALSO OCCASIONALLY OPPOSE
vaccines. For example, the papillomavirus vaccine, capable of preventing the virus that causes cervical cancer, has become a political vaccine.

Every year in the United States, cervical cancer strikes about ten thousand women and kills four thousand. In 2006 the CDC recommended the papillomavirus vaccine for all adolescent girls before they become sexually active. Conservative groups feared that the vaccine would be mandated for all teenagers. They reasoned that papillomavirus is transmitted by a girl's having sex. If she doesn't have sex, she won't catch it. And if she and her partner don't have sex before marriage, then they won't be bringing papillomavirus into the marriage. The message should be abstinence before marriage, not prevention of a sexually transmitted disease by a vaccine that might only encourage sex. Tony Perkins is the president of the Family Research Council. He has no intention of vaccinating his thirteen-year-old daughter. “Our concern is that this vaccine will be marketed to a segment of the population that should be getting a message about abstinence,” said Perkins. Leslie Unruh, leader of the National Abstinence Clearinghouse, agrees. “I personally object to vaccinating children against a disease that is one hundred percent preventable with proper sexual behavior.” Art Caplan, director of the Center for Bioethics at the University of Pennsylvania, disagrees with Perkins and Unruh. “If you want to teach moral behavior to your children, teach it in the home or in the classroom or in the church or synagogue,” he says. “But the notion of withholding a potentially lifesaving vaccine to promote moral behavior is unconscionable.”

 

A
NOTHER FORCE WORKING AGAINST VACCINES IS CAPITALISM.
V
ACCINES
aren't very profitable.

Unlike drugs that are often used every day, vaccines are used, at most, several times in a person's lifetime. So it isn't surprising that the market for drugs is substantially greater than that for vaccines. For example, the pneumococcal vaccine for children, the highest revenue-generating vaccine, had gross sales in 2006 of about $2 billion. But cholesterol-lowering agents, hair-loss products, sexual-potency drugs, or drugs for heart disease, obesity, or neurological problems can earn $7 billion or more per drug per year. Annual revenues for Lipitor, one of several cholesterol-lowering agents, were $13 billion—about twice the revenues for the entire worldwide vaccine industry.

Faced with these finances, companies have gradually abandoned vaccines. Twenty-six companies made vaccines in 1957; seventeen in 1980. Only five—GlaxoSmithKline, Sanofi-Pasteur, Merck, Wyeth, and Novartis—have a significant market presence today. (Many smaller companies also make vaccines, but their combined output accounts for less than 15 percent of the total market.) Within pharmaceutical companies, vaccines compete with drugs for resources—and lose. Because vaccines are made by only a few companies, problems with production often result in vaccine shortages. The influenza vaccine shortages from 2003 to 2005 were just one example. Since 1998, ten of sixteen vaccines routinely recommended for children have been in short supply—specifically, those to prevent measles, mumps, rubella, chickenpox, tetanus, diphtheria, pertussis, influenza, meningococcal infection, and pneumococcal infection. In 2002, Wyeth stopped making the DTaP and influenza vaccines. The decision to stop production had little impact on shareholders but a major impact on children. It precipitated shortages of and rationing for both vaccines. Some children never got the vaccines that they missed, even after the shortages were over.

Fortunately, the news about the vaccine business isn't all bad. Vaccines do have a couple of advantages over drugs. For example, no companies make generic vaccines for the United States market. So vaccines can continue to make a profit long after they're unprotected by patents. Also, unlike drugs, vaccines are recommended for routine use by agencies such as the CDC and the AAP, guaranteeing a market. Newer vaccines, such as those for rotavirus and meningococcus, are likely to make between $500 million and $1 billion per year and the papillomavirus vaccine could bring in revenues that exceed $2 billion. While revenues from vaccines are less than for blockbuster drugs, they are good enough to keep some pharmaceutical companies interested in continuing to make them and to invest in research to develop new ones.

 

I
MAGINE WHAT WOULD HAPPEN IF SOME COMBINATION OF FORCES
caused pharmaceutical companies to stop making vaccines or a critical number of people in the United States to stop using them.

The first disease to appear would be whooping cough (pertussis). Although most people don't realize it, pertussis occurs commonly in the United States. Every year it causes people to suffer prolonged bouts of coughing that last as long as several weeks. About one million teenagers and adults are infected. Adults don't die of pertussis. But babies do. And infants usually catch pertussis from infected adults. Pertussis bacteria cause inflammation in their small windpipes. Sometimes the inflammation is so severe that babies simply stop breathing. If the pertussis vaccine weren't available, babies would almost immediately start to die of pertussis.

Before the pertussis vaccine was first introduced in the 1940s, pertussis killed as many as eight thousand babies every year in the United States. Some people might argue that the 1940s were a long time ago and that we now have at our disposal antibiotics and intensive care facilities that we didn't have then. But antibiotics don't treat pertussis; they only stop transmission of the bacteria, making people with the disease less contagious, not less sick. When immunization rates in England dropped from 80 percent to 30 percent in the late 1970s, more than one hundred thousand children with pertussis were hospitalized, and about seventy died. And that was all within a couple of years of a fifty-point decrease in immunization rates.

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