By telling parents that diabetes, multiple sclerosis, asthma, allergies, seizures, mental retardation, paralysis, and autism are all caused by vaccines, Barbara Loe Fisher—whether intentionally or not—puts the burden of their children’s illnesses squarely on the shoulders of those parents. If only they hadn’t gotten their children vaccinated, none of these horrors would have happened. But now it’s too late; the only thing left is to be angry—angry at a government lost in bureaucracy, pharmaceutical companies in it for the money, and doctors who don’t care. By claiming that vaccines cause chronic diseases, Fisher contributes to this cycle of guilt, anger, and blame.
Barbara Loe Fisher is a lightning rod for the media. She is a powerful voice during congressional hearings. And she is the one-stop shop for parents concerned that vaccines are hurting their children. But for all the attention she garners—for all the magazine stories and radio and television interviews—studies have consistently failed to support her concern that vaccines are causing chronic diseases. At the same time that Fisher diverts the media away from real problems with vaccines, one vaccine-safety advocate, working quietly and behind the scenes, has accomplished a great deal. His name is John Salamone.
Salamone was born in upstate New York, in the town of New City. When he was nineteen years old, while studying journalism and government at the University of Maryland, he became the youngest legislative director in Congress. Later, he handled congressional affairs for the Immigration and Naturalization Service. After fifteen years with the government, Salamone moved to the private sector, heading the nonprofit National Italian-American Foundation.
In 1990, Kathy and John Salamone brought their son David to their pediatrician’s office in suburban Washington, D.C., to get his vaccines—one of which was Albert Sabin’s oral polio vaccine. Two weeks after the visit, the Salamones noticed something wrong with their son. “He couldn’t turn over,” John said. “He could only move his head back and forth.” David Salamone was completely paralyzed below the waist. Eventually he regained the use of his left leg, but his right leg withered. Doctors fitted David with a leg brace and he learned to walk with a gait that, according to John, resembled “a drunken sailor.” David’s diagnosis was elusive. “The doctors were quite perplexed,” recalled Salamone. “They couldn’t figure it out because, let’s face it, not too many doctors these days are experts in polio. They just simply diagnosed him with a neuropathy of unknown etiology.”
David wore the heavy leg brace and started physical therapy. “They noticed that he was in pain,” said Salamone, “which was unusual for his condition. And so they sent us to a rheumatologist at Georgetown [who] said, ‘Let me just try some tests here.’ For the first time, at age three, after being sick quite a bit and always on antibiotics, he was diagnosed with [a congenital immune deficiency]. [Children with severe immune deficiencies are more likely to be paralyzed by the oral polio vaccine.] So now they had figured out why he was sick all of the time with these flu-like symptoms. Then they started to put it all together, to connect the dots and figure out that he got polio from the vaccine.”
Salamone learned that a safer vaccine (Salk’s), unavailable in the United States, had been used in countries such as Sweden, Norway, and Finland and some provinces in Canada with success, completely eliminating polio. He wanted to know why health officials in the United States used Sabin’s vaccine instead of Salk’s when the former caused a rare but dangerous side effect and the latter didn’t. So, John Salamone became a vaccine-safety advocate, founding an organization called Informed Parents Against Vaccine-Associated Polio (IPAV). “At first you feel guilt,” recalled Salamone. “Because you say to yourself, ‘we brought our child to the doctor and gave him polio.’ Then we got mad, upset, when we found out that there were other options of polio vaccine out there. So we said to ourselves, ‘Why wouldn’t they be giving that to everyone? Why would you even take a chance?’ Then we found out that there were a number of kids every year who were getting polio from the vaccine and I started to identify them little by little and communicate with those families. And in the meantime I wrote to my congressman and I wrote to the White House and I wrote to anyone I could write to and really it was falling on deaf ears. It seemed that if the price was a dozen kids or so a year that got polio from the vaccine well then that was just the price of having a universal vaccine program.”
John Salamone changed polio-vaccine policy in the United States after his son, David, suffered a crippling side effect. (Courtesy of Joseph M. Valenzano, Jr.)
The turning point came in 1993, when Salamone was asked to speak before the Institute of Medicine. He remembered what happened: “The next thing you know an [Associated Press] article picked up on my story and before you knew it I was getting calls from all these newspapers. At one point I was in Italy and somebody called me up and said there’s a full page in the Washington Post on the front page of the health section with a picture of you and David and the whole polio story.”
Salamone knew that if he were to change policy, he was going to have to convince the Advisory Committee on Immunization Practices (ACIP), which advises the CDC. “From there I decided that the only way we were going to make a change was to convince the ACIP and people down at the CDC that there was a need to make this change,” recalled Salamone. Every time the ACIP discussed the polio vaccine, John Salamone was there. And every time the AAP held its annual meetings, Salamone was sitting behind a booth manned by several children paralyzed by the vaccine. Salamone converted statistics into real people. Always respectful, clear spoken, and passionate, he was very persuasive. By 1998, the ACIP had switched to the inactivated polio vaccine, eliminating paralysis caused by the live, weakened vaccine. John Salamone’s advocacy had everything to do with that change.
In 2008, after twenty-five years with the National Italian-American Foundation, John Salamone retired. He and Kathy now live in Mount Holly, Virginia. “I was lucky,” recalls Salamone. “My degree is in journalism and my background is the Congress. If you believe in a God, He picked the right family to have a son who got polio from the vaccine. Because I had the combination of the ability to write and I had good contacts in Washington.” Salamone argues that successful vaccine advocacy depends on two things: “I think what worked was organizing families [and] getting the media involved. If the media hadn’t picked up on this, I would never have had my opportunity to go before the committee.”
In many ways, John Salamone and Barbara Loe Fisher are similar. Both are passionate advocates, both are superb writers and powerful speakers, both have had ready access to the media, and both have had the opportunity to make their case in front of congressional committees. But whereas Salamone’s concerns have been supported by science, Fisher’s haven’t. “[Fisher’s group] sends me material and I put it in the circular file,” says Salamone. “It seems to me that we can’t be guided by bad science. It would be reckless to go out there and attribute certain side effects to a vaccine when they’re not documented by science. Attacking vaccines with bad science and bad information is nothing short of reckless and irresponsible.”
Ironically, Salamone found that Barbara Loe Fisher’s group hurt his efforts to change policy. When Salamone manned a booth at AAP meetings he was often confronted by angry physicians: “Their response, candidly, was not great. My biggest problem was that when you talked about vaccine injury, you were immediately labeled as anti-vaccine. They wanted to put me in the same category as the Fishers of the world, the organizations that had a broader agenda of reducing if not eliminating many of the vaccines. To the contrary, I was pro-vaccine. But I was pro-vaccine safety. I was knowledgeable enough to know the history that many more people’s children and adults have been saved by vaccines than have ever died from them.”
Although John Salamone and Barbara Loe Fisher are both vaccine-safety activists, they have different core beliefs. First: Barbara Loe Fisher doesn’t trust doctors. This distrust was born of a time when she felt that they had lied about—or
at least neglected to mention—harmful effects of pertussis vaccine. And she never forgot it. She portrays doctors as elitists and frauds. In A Shot in the Dark, referring to doctors, she quoted Shakespeare’s Measure for Measure:
But man, proud man,
Drest in a little brief authority,
Most ignorant of what he’s most assured,
His glassy essence, like an angry ape,
Plays such fantastic tricks before high heaven
As make the angels weep.
As the years passed, Fisher’s anger toward doctors, scientists, and public health officials only intensified. She accused them of deception: “Do public health authorities and pediatricians really think that mothers and fathers are going to passively accept the brain-damaging and killing of their children with unsafe vaccines? Do they really believe that the letters written after their names will protect them when the public knows the whole truth about what they have done to so many innocent children around the world?”
She accused them of not caring: “The medical ‘experts’ are not infallible and they are not immune from the desire for power, money, and fame. The failure to value the life of each individual child by writing off some children as expendable in service to the rest is at the root of much of the distrust educated parents have for the mass vaccination system and those who operate it.”
And she likened them to doctors in Nazi Germany: “We would do well to remember what happened in pre-World War II Germany, when doctors were legally allowed to kill anyone in society considered to be a threat to the public health and welfare. Are we preparing for the day when doctors can not only kill handicapped newborns but also handicapped older children and adults, including the vaccine-injured who face a lifetime of long-term care?”
John Salamone had every reason to question doctors. When his son got the oral polio vaccine, he was never told that there was a chance he could suffer permanent paralysis. But Salamone didn’t see doctors as evil. Rather, he believed he could convince them that choosing Sabin’s vaccine over Salk’s was illogical and dangerous. He believed that he could appeal to their ability to reason—that they were human and would respond humanely. And he was right. Salamone’s rational advocacy earned the respect of doctors and policy makers. The secretary of health and human services asked him to serve on the Advisory Commission on Childhood Vaccines and, later, the ACIP—the very committee he had implored to switch to a safer polio vaccine.
In contrast, Barbara Loe Fisher, rather than appreciating the researchers who spent millions of dollars on studies to answer her questions, had disdain for them. She believed that studies that failed to support her beliefs were useless—or, worse, fabricated. “Those determined to deny an association between vaccine-induced inflammatory conditions in the body usually like to use retrospective, case-controlled ‘studies’ that look at old medical records,” she blogged. “Using pencils and calculators to dismiss causal associations between vaccines and chronic diseases is easier than having to look at real live patients.... The pathetic attempts by the pencil pushers to write off onset of brain and immune dysfunction after vaccination in previously healthy people as just a ‘coincidence’ will not wash. The people, whose lives have been ruined by doctors too proud to admit harm being done, will not let them get away with it.” Fisher’s anger wasn’t limited to blog postings. In July 2002, at a meeting of parents, public health officials, doctors, and representatives from pharmaceutical companies, she berated the group. One attendee recalled, “On the last day of the meeting, Roger Bernier, the chief architect of the event, was [telling] everyone how important it was that we were all there participating in developing a plan for how we could all work together on vaccine safety issues. He spoke about the importance of the meeting, praised everyone for being there, and said that we were all being pro-active in moving ahead with this plan, before we had a crisis. Fisher was the next to speak. She was fiery. She retorted, ‘We are in a crisis. And if we don’t move forward with this plan, there will be a bloodbath! More government hearings—you bet! More media stories—absolutely!’”
In the early 1980s, Barbara Loe Fisher watched personal-injury lawyers win hundreds of millions of dollars in settlements and awards for alleged victims of pertussis vaccine. It was in a courtroom, not a scientific venue, that Fisher found a sympathetic ear. But with the birth of the National Childhood Vaccine Injury Act in 1986, parents now had to go through a special court. In 2009, this court would be put to the test. Again, vaccine activists and lawyers would seek hundreds of millions of dollars in compensation. It would be their next big bet. This time the complaint wasn’t epilepsy or mental retardation or learning disabilities; it was autism. And there was every reason to believe that the success of the pertussis litigation was about to be repeated.
CHAPTER 6
Justice
He handed us fiction after fiction and we printed them all. Because we found him—entertaining. It’s indefensible. Don’t you know that?
—CHUCK LANE, SHATTERED GLASS
On February 12, 2009, the Vaccine Injury Compensation Program (VICP) issued a verdict that made international headlines. For several years the VICP had considered five thousand cases brought by parents claiming that vaccines had caused their children’s autism. The trial, called the Omnibus Autism Proceeding, was unusual; only once before had vaccine court considered what amounted to a class-action lawsuit. If successful, the action threatened the viability of a program that had once saved vaccines. It was a seminal, defining moment.
And the verdict surprised everyone.
During the twenty years of its existence, the VICP had been generous with its money. Plaintiffs had several ways to win. The program could simply concede that a claim was valid. For example, money was immediately given to any child paralyzed by Albert Sabin’s oral polio vaccine. If a suspected injury (such as autism) wasn’t considered to be valid, federally appointed judges called “special masters” heard the cases in vaccine court. If the special masters denied the claim, three options remained. The petitioner could appeal to the United States Court of Claims or, failing that, to the Federal Circuit Court of Appeals; or, failing that, could sue vaccine makers in state courts. Over the years the amount of money available to the VICP, which came from a federal excise tax on every dose of vaccine, got bigger and bigger; by 2009, the program had $2 billion at its disposal and the average award was $900,000.
Vaccine court was an unusual place. When it first started awarding money in 1988, the compensation table was relatively loose and the VICP compensated injuries that weren’t caused by vaccines. For example, in 1992 it ruled that DTP had caused a child’s epilepsy, even though the child in question had Rett Syndrome, a genetic disorder known to cause seizures. The court also routinely compensated parents whose children died from Sudden Infant Death Syndrome even though studies had shown that SIDS wasn’t caused by vaccines. Other awards were even more bizarre. Petitioners successfully claimed that a child’s crying or irritability or sleepiness following DTP was evidence of brain damage leading to attention deficit disorder. One lawyer later acknowledged that at least a third of all claims against DTP weren’t valid. Probably the best example of the carnival-like atmosphere of vaccine court was the complaint by one petitioner that, following a rabies shot, her dog was “stupider.”
In 1995, everything changed. To applause from the medical community, the VICP’s vaccine-injury-compensation table was tightened. No longer could parents successfully claim that DTP vaccine caused permanent brain damage or SIDS or genetic disorders. Barbara Loe Fisher, who had helped create the program, was angered by the change. “The federal compensation system that we were told would be ‘simple justice for children’ has become a cruel joke.” Fisher had no need to worry; the procession of inexplicable rulings had only begun.
First was the strange case of Margaret Althen. On March 28, 1997, Althen, forty-nine years old, received tetanus and hepatitis A vaccines. Two weeks later, she suffered headaches and blurred vis
ion. Following a series of medical tests, Althen’s doctors diagnosed a disease similar to multiple sclerosis. By the time the Althen case appeared before the VICP, abundant evidence existed that vaccines didn’t cause her condition. So, the special master turned down Althen’s request for compensation. But judges in the Federal Circuit Court of Appeals disagreed. They argued that plaintiffs’ lawyers had to do only three things: propose a theory for how a vaccine could cause a disease, propose a logical sequence of cause and effect, and show that the two events were connected in time. Plaintiffs’ lawyers didn’t have to provide any epidemiological or biological evidence to prove their case. All they had to do was show that a disease had followed a vaccine and propose a theory for how it could have happened—a very low bar.
Next was the Capizzano ruling. On May 3, 1998, Rose Capizzano received her second dose of hepatitis B vaccine, following which she developed a rash and stiff, painful joints. Later, doctors diagnosed rheumatoid arthritis. Again, evidence refuted the notion that hepatitis B vaccine caused rheumatoid arthritis. So the special master rejected the claim. But, as had been the case with Margaret Althen, the Federal Circuit Court of Appeals overturned the decision. Judges in the Appeals Court noted that Capizzano’s doctor believed the vaccine had caused her arthritis, and that was good enough for them. They ruled, “Medical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether a logical sequence of cause and effect show[s] that the vaccination was the reason for the injury.” This ruling meant that the treating physician could trump medical consensus, trump the weight of epidemiological and biological evidence, and trump decades of collective clinical experience. All could be cast aside by the opinion of one doctor.
Deadly Choices: How the Anti-Vaccine Movement Threatens Us All Page 10