Stomping Through A Medical Minefield

It is not easy, however, to trump human experience with science. No matter how convincing the data—and pediatricians, scientists and the CDC want the public to know that it is—doubt lingers. Autism Speaks, the nation's largest autism-advocacy group, is awarding $3.6 million for research on potential environmental factors, including the vaccine components mercury and aluminum. The group says it must "affirm the public confidence in the safety of vaccines." Lisa Jo Rudy thinks the additional science is warranted. She doesn't believe vaccines caused her 12-year-old son's autism, but she won't rule them out as a factor for other kids. Rudy, who writes about autism for About.com, says the anger directed at Offit is "an enormous overreaction." He's become a lightning rod, says Rudy, "the incarnation of badness." Still, she's not surprised that Offit's absolutism aggravates his critics. "I don't think he's walking into this like an innocent into the woods," she says.

Recently, Offit set off a flurry of angry postings when he said that a baby's immune system could handle as many as 10,000 vaccines. Then he upped the ante, saying it was probably "closer to 100,000." Offit's assessment is based on data showing the vast capacity of a child's immunological response. Parents who worry that children are getting too many shots too soon (the CDC schedule calls for about 28 immunizations against 14 diseases by age 2) were incensed. "Let's see how many of these vaccinations Offit can withstand. May I administer the 10,001st?" wrote one user on AgeofAutism.com. The outrage is triggered by Offit's approach, says Dan Olmsted, Age of Autism's editor: "He basically says the case is closed. He's very dismissive of anyone who disagrees." And critics charge that Offit, one of three patent holders of a vaccine against rotavirus—which causes severe diarrhea and kills half a million children a year worldwide—is dependent on drug companies and motivated by greed. They call him "Dr. Proffit."

Offit isn't apologizing. He acknowledges that he got a "small percentage" of the $182 million Children's Hospital of Philadelphia received when it sold its interest in future royalties for the vaccine RotaTeq. (He won't give a precise amount, but says "it's like winning the lottery.") And he has served as both a paid and unpaid member of a scientific advisory board at Merck, which makes RotaTeq. Drug companies routinely hire experts as consultants, despite concerns by some that these relationships can undermine scientific credibility. But Offit says money has never been his motivator. At the age of 5, he spent three weeks in a polio ward, where he was housed to recover from clubfoot surgery. "It caused me to see children as very vulnerable and helpless and, I think, drove me through the 25 years of the development of the rotavirus vaccine," says Offit. Frankie Milley, who started a national organization called Meningitis Angels after losing her 18-year-old son, Ryan, to the disease, says Offit readily hands out his number to parents concerned about vaccine safety. "He truly hurts for children who are suffering or who have died," she says.

Scientific studies cannot prove a negative, so researchers must be cautious in the language they use to describe results. Because Offit refuses to garble the message, fellow scientists say, he is the perfect target. "He happens to be blessed with the gift of gab, and he's been willing to step up and be in the battle," says Dr. Edgar Marcuse, a pediatrician at Seattle Children's. "It requires a kind of offense and aggressiveness that's absolutely necessary to set the record straight." Dr. Peter Hotez, a professor and vaccine researcher at George Washington University, says government health officials should take a bolder stand in reassuring the public. Hotez feels as strongly as Offit does about the science (saying vaccines cause autism, he says, "is like saying the world is flat"), but, like other busy scientists, he's less willing to enter the fray. "Here's someone who has created an invention that saves hundreds of lives every day," says Hotez, whose daughter, 15, has autism, "and he's vilified as someone who hates children. It's just so unfair."

Bonnie Offit, a pediatrician, tours the autism Web sites late at night after her husband goes to sleep. "He's not the man they've created an enemy out of," she says. She wishes his critics knew him the way she does—a gentle, sweet, salt-of-the-earth guy. "What I've learned in all this is to stick to the truth, talk about the science," says Paul Offit. "It's not about me, it's about the data." Above all else, it's about doing right by the children.

© 2008