By Jim Schutze
By Rachel Watts
By Lauren Drewes Daniels
By Anna Merlan
By Lee Escobedo
Eventually Paul was diagnosed with Crohn's disease, an autoimmune disorder that strikes the bowels and intestines. Did the vaccine trigger the disease? Joan is convinced it did. Yet, she says, not one physician--not even the specialists at Texas Children's Hospital, where Paul still receives monthly checkups--has bothered to investigate the possibility.
Joan says the doctors and specialists who have examined Paul have suggested that she's a "crazy, hysterical mother" for trying to convince them that the vaccine was responsible for his illness. Joan admits that watching her child deteriorate for unknown reasons "almost drove us off the deep end." And so did her attempt to talk reasonably with doctors who had no answers but somehow knew it couldn't have been the vaccine that made her son ill.
About six months ago, Paul's condition suddenly started improving. He began to eat everything in sight. His stamina returned. He has since shaved 15 seconds off his best time in the butterfly, and recently he ran a mile in under six minutes.
Paul will be ready for college in another year or so. Joan has heard about proposals in some states that will require college freshman to receive a hepatitis B booster immunization before they can attend class. Joan says that if that's the case, her son won't be attending college. "There's no way," she says, and you can tell she means it, "I will ever allow him to receive another shot."
Meanwhile, she's afraid other parents will have to go through the same maddening experience she did before someone decides to get to the bottom of all the adverse reactions that are being blamed on the hepatitis B vaccine.
"I object to [public-health officials] not doing the proper studies before giving it to kids," she says. "But until people start standing up to be counted, that's never going to happen."
In Texas, children must receive 33 doses of nine different vaccines before they can attend school, including three shots of DTP (diphtheria, tetanus, and pertussis); three shots of MMR (measles, mumps, and rubella); four doses of oral polio vaccine; four injections of HbCV (influenza); and three doses of hepatitis B vaccine.
With few exceptions, Texas' vaccine requirements mirror the recommended immunization schedule issued every year by the federal Centers for Disease Control. Texas, like most states, quickly adopts the CDC's every recommendation as a mandate. And why not? The cost is largely borne by the federal government, which buys the vaccine from the manufacturer and sells it to the states at reduced prices. States that administer enough vaccinations to meet certain compliance levels set by the CDC are rewarded with grants. In some states, including Texas, parents eligible for public assistance face cuts in benefits if their children are not fully vaccinated.
"I call it vaccination without representation," says Michael Belkin, a Wall Street analyst-cum-vaccine-safety-advocate from New York, whose newborn daughter died 12 hours after receiving the hepatitis B vaccine. "No one is representing the interests of children or their parents."
Indeed, the CDC doesn't even wait until a new vaccine is licensed for commercial use before recommending that it be administered to the nation's children. In early 1998, for example, the CDC's Advisory Committee on Immunization Practices voted unanimously to add a vaccine against rotavirus to the federal regimen after the manufacturer, Wyeth-Lederle, assured committee members that approval from the Food and Drug Administration was in the works.
"Children's vaccines, once they are licensed, are automatically shoved into the mandatory vaccine schedule," says Barbara Fisher, executive director of the National Vaccine Information Center, a watchdog group that bills itself as the oldest and largest vaccine-safety group in the country. Pressure from Fisher's group over contaminated lots of DTP vaccine in the 1980s led to the creation of the National Childhood Vaccine Injury Act, a federal no-fault program that has paid out more than $1 billion in compensation for vaccine-related injuries and death.
But while the act has been a good thing for vaccine-injured people, it has also helped protect the drug companies that manufacture the vaccines from liability. The act authorizes an excise tax on certain vaccines, which is set aside to fund the compensation program. According to Isabel Claxton, of Merck's vaccine division, the compensation act is needed to protect the existing vaccine supply. Right now, there are only two U.S. vaccine manufacturers: Merck & Co. and Wyeth-Lederle, a company based in Europe. The rest, Claxton says, couldn't stand the heat from safety advocates.
"All the other companies that did research and development and manufacturing and distribution of vaccines dropped out in the 1980s because of issues like this," says Claxton. "One dose of our mumps, measles, and rubella vaccine takes 13 months to get to the market--13 months--from the petri dish to the pediatrician's office. For a lot of companies, it wasn't worth the time to continue in that environment of the 1980s, which was so litigious."
Maybe so. But there's little doubt that the coordinated, worldwide effort to eliminate disease through immunization has certainly made it worthwhile to be in the vaccine business today. In 1990 vaccines were a $500 million market. Today, they're worth well over $1 billion to just a handful of conglomerates, including manufacturers of the two most widely used hepatitis B vaccines, Merck and SmithKline Beecham. Wyeth-Lederle, which manufactures one of the longest-running vaccines on the U.S. market, oral polio, has experienced a 300 percent increase in revenue since 1986.