Until he was about 15 months old, Jevyn Neves was hitting all his developmental milestones. Then he began to regress. His speech vanished.
After perplexing doctors for more than a year, he was diagnosed with autism.
“He did not play with me like other kids did with their mom,” said his 25-year-old mother, Nicole Bernier, a New Bedford native.
Ms. Bernier believes that her 6-year-old son’s condition was caused by a series of DTP (diphtheria, tetanus and pertussis) and MMR (measles, mumps and rubella) vaccinations Jevyn received during that critical early period of his life.
She and her husband, Antonio Neves, are plaintiffs in a class action lawsuit against Eli Lilly and other pharmaceutical companies who manufactured the mercury-based additive called Thimerosal, used to give these vaccines a longer shelf life.
With Republican Sen. Bill Frist succeeding Trent Lott as Senate majority leader and a recently passed Homeland Security bill inoculating vaccine manufacturers from paying hefty damages, the prospects are dimming for the class action.
“(Sen. Frist) is our public enemy number one,” said Mark Blaxill of Safeminds, a parent advocacy group in the thick of the Thimerosal controversy. “It’s frightening. He is in the forefront of the movement to deprive families of their due process, the prime mover behind complete immunity provisions for Eli Lilly.”
Sen. Frist defended the amendment to the Homeland Security bill on the floor of the Senate last November. He said he fears that without the added legal protections, there will be a chilling effect on vaccine manufacturer’s incentive to fight bioterrorism. “The threat of lawsuits mustn’t be a barrier to protecting the American people,” said Frist before the bill was passed.
Frist said the vaccine injury compensation program, a special vaccine court that caps the payout to families harmed by vaccines, provides adequate recompense.
The families in the class action suit are fighting a statute of limitations specification, which bars compensation three years from the onset of signs and symptoms. “You have a class of individuals who will go uncompensated,” said attorney John Kim of Gallagaher, Lewis, Downey and Kim, of Houston, Texas, one of the two law firms appointed to handle the case.
Drug manufacturing giant Eli Lilly developed Thimerosal in the 1930s and sold it for 40 years. It was used as a preservative in a number of applications other than with vaccines, such as in cosmetics and eye drops.
“It had been considered a medically safe project,” said Dr. Ann Bajart at the Ophthalmic Consultants of Boston, “until we realized that over time, it caused inflammatory conjunctivitis, a reddening of the eyes. The preservative was causing an allergic response.” Mercury-based products would be taken off the market for topical applications in 1985.
Pharmaceutical companies continued to manufacture childhood vaccines with Thimerosal up until a few years ago, when a 1997 report on mercury was submitted to Congress. In 1999, the American Academy of Pediatrics demanded that childhood vaccines stop being produced with the chemical preservative. Three years later, many of these vaccines are still on the shelves.
The amount of Thimerosal in any given vaccine shot was too small to be of any significance 30 years ago when a child received only a few vaccines. Today, the federally mandated vaccine program will have a child injected with anywhere between 25 and 30 shots.
And as autism rates skyrocket, parents are raising concerns of possible links between autism and vaccinations. Republican congressman Dan Burton from Indiana has an autistic grandson.
“I am personally convinced that there is a link,” he said on C-SPAN last month. “Christian received nine shots in one day. Seven of them contained mercury. And two days later he became autistic, he started running around and banging his head against the wall. Severe constipation and diarrhea. Lost his ability to speak well.”
Scientists are confounded. “It appears to be a dramatic increase (in autism),” said Harvard pediatric neurologist Dr. Martha Herbert. Studies indicate a spike of anywhere between 283 and 400 percent in the past 10 to 15 years.
Dr. Herbert is on the forefront of research on autism. She believes that certain children are more vulnerable to “environmental insults,” or changes to their brains and bodies. These children are more susceptible to becoming autistic through environmental agents.
But the question of a connection between Thimerosal and autism has not yet been solved definitively. “We just don’t really know,” she said from her lab at Massachusetts General Hospital. “There is a lot of data suggesting that it does cause problems. And there are a lot of studies that should be done that have trouble being funded.”
Pam Ferro, a registered nurse at Hopewell Associates in Mattapoisett, tests and treats children for autism. “Some parents can tell you to the day. It was like a switch.”
She is convinced that there is a link between Thimerosal and autism. She explained that there is no good test for mercury. Unlike lead, it does not stay in the blood stream. “But one of the tests is a hair analysis. Some of the autistic children were found to have lower levels of mercury (in their hair) than normal children.”
She believes this suggests that some kids do not have the ability to expel the toxic substance from their bodies. “Some kids are able to detox mercury and others cannot,” she claims.
Dr. Herbert is not surprised that the Food and Drug Administration, the Center for Disease Control and the drug companies have chosen not to recall the vaccines. “It would be an admission of guilt more than anything else.”
Eli Lilly spokesman Edward Sagebiel insists that there is “no scientifically credible causal link between Thimerosal and autism.”
Mr. Sagebiel fears that trial lawyers attempting to cash in on the families of autistic children ultimately harm science. “We are seeing our vaccine industry reduced to absolutely nothing,” he lamented. “It is important that (pharmaceutical companies) are not weighing potential liabilities as they undergo the development to find new vaccines.”
And while Dr. Herbert might agree with him, she believes that the reason for this is more a function of inadequate study than hard proof.
A lot of the recent studies on the subject were either “poorly designed” or had “a long list of conflicts of interest.” These are the symptoms of a tragic and disturbing trend that she calls “Epidemic Denial,” the title of her recently published paper.
“Why is it that we don’t fully entertain the (autism-Thimerosal) hypothesis?” she asks. “Because it is too painful. They don’t want to believe that we could make mistakes like this.”
The scientists, government officials and businessmen involved are very proud of the young lives they save through the vaccine program. “These people really want vaccines to be a good thing for children,” said Dr. Herbert.
She is suggesting an endemic intellectual dishonesty in the scientific studies and public relations spheres pertaining to vaccines. “This casts a pall over all of science,” she said. “It puts a bias on what you are allowed and not allowed to think about.”
“I want to protect the pharmaceutical companies as much as possible,” Rep. Burton said last month on C-SPAN.
“We need that research. We need to fight the war on terrorism. But what do you do about these thousands and thousands of children who have been damaged for life?”
Meanwhile, Nicole Bernier acknowledges how onerous the liabilities might be if companies such as Eli Lilly were held liable. “But it will cost our government a whole lot more to educate (these autistic children),” she says. “Taxpayers are paying to support corporate America.”