The best way to think of an ECMO—the initials stand for Extracorporeal Membrane Oxygenation—is as an external artificial heart and lung that’s used when an infant is experiencing extreme organ failure so that the body can use all its energy to get better. It’s less of a single device than a series of machines: One pumps blood into the body; another filters the blood; a third circulates oxygen into and carbon dioxide out of the lungs. Like most extreme life-saving measures, the use of an ECMO machine carries with it serious risks. As long as Brie was hooked up to the machine, she’d need two nurses and a respiratory therapist by her side at all times.
The Romagueras are intensely religious people, and the night of what they hoped would be the operation that would save their daughter’s life, they stood in a hallway of Ochsner’s pediatric ICU and prayed. For hours on end, they recited the Rosary: “Blessed is the fruit of thy womb, Jesus,” they murmured. “Pray for us sinners, now and at the hour of our death.” Finally, at around 5:30 in the morning, they received word: Brie had survived her surgery. Still, the doctors said, they strongly recommended that the Romagueras not visit their daughter. Because Brie’s body was unable to expel waste, the interstitial space between her skin and the web of tissue that surrounds all the body’s internal structures had filled with fluid, causing her to balloon to eight times her normal size. “They told us, ‘This is not the same child,’ ” Danielle says. Two weeks after she’d checked into the hospital and six weeks after she was born, Brie was too big to fit into a diaper.
For two days, Danielle and Ralph heeded the doctors’ advice, until waiting helplessly away from their child became too much to bear. Even after being warned in the starkest terms imaginable of what to expect, the Romagueras were shocked when they saw their daughter. It wasn’t just that they could barely recognize her—it was that they had no point of comparison for the unconscious baby lying in front of them. “It’s like, take a Cabbage Patch Kid and then double or triple it,” Danielle says. “That’s about how big she was.”
The next days were an exhausting blur. That weekend, the doctors said they had some good news: Brie’s kidneys had begun to do a little work on their own, raising the possibility that her other organs might begin to heal as well. Then, on Monday, doctors noticed a spot on the right side of her brain. This was not wholly unexpected—hemorrhaging is an unavoidable risk of the blood-thinner Brie had to be given so long as she was hooked up to the ECMO machine—and there was still a chance that Brie might escape any permanent damage. There was also a chance, the doctors said, that even if Brie survived, she might need to use a feeding tube for the rest of her life. For the time being, the only thing to do was monitor the situation: If the hemorrhaging could be halted, Brie could remain on the ECMO machine; if it did not, her brain would fill with blood and the machines would have to be turned off.
On Tuesday morning, Brie’s EEG brought a sliver of hope: The bleeding had stopped. Wednesday’s exam showed the same thing. On Thursday, the Romagueras were picking at their lunch in the hospital cafeteria when Ralph’s cell phone rang. The latest results were in. “They just told us to come back up,” Danielle says.
By the time the Romagueras got back to Brie’s unit, all four of the pediatric intensive care unit’s doctors were waiting for them. The bleeding on the right side of Brie’s brain was still clotted off, they said, but now there was extensive bleeding on the left side. It was time to turn off the machines that were keeping Brie alive. “They told us she could live for a little while once the machines were off,” Danielle says.
It took a doctor and three nurses to turn off the machines. Technically they weren’t supposed to move her when she was on ECMO because of where the tubes were connected, but we hadn’t held her in two weeks—since she’d been on the ventilator—so the doctor said, “We’re going to get as many staff members as we need in here so mom and dad can hold their baby while she’s still alive.” . . . This doctor made sure that there were seven or eight people there to move her so that my husband and I could hold her before she passed away. And she survived probably for about a half an hour once the machines were turned off.
On March 6, seven weeks and three days after they became parents, Ralph and Danielle Romaguera held their daughter in their arms as she died. Had she survived, she would have been scheduled to receive the first dose of the pertussis vaccine four days later.
To this day, the Romagueras do not know how Brie contracted whooping cough. Because it often goes undiagnosed, it can be difficult, if not impossible, to track the disease through a population. What the Romagueras do know is that, prior to her hospitalization, the only place Brie had visited aside from her doctor’s office was Danielle’s parents’ house. No one there was ill and nobody outside the family had been there at the time. According to CDC officials, the most likely scenario is that an infected child had coughed while in the waiting room during one of Brie’s visits to her pediatrician, but, as Danielle says, “we have no idea where it started.”
One result of the growing number of deaths like Brie’s is a greater awareness about pertussis. Today, the AAP, the CDC, and many state health departments have audio recordings of whooping cough attacks on their Web sites, and it’s unlikely there’s a pediatrician in the country who isn’t aware of the disease’s warning signs. Even when properly diagnosed, 50 percent or more of infants with pertussis are hospitalized, but only around 2 percent develop permanent brain damage or die, making it all but certain that had Brie been diagnosed today, she would have survived.
Less than a year after Danielle and Ralph Romaguera buried their baby daughter, Danielle gave birth to a son named Trey. A couple of years after that, Michael was born. The pain of the Romagueras’ loss remained strong, but for the most part they kept their anguish to themselves.
Then, not long after what would have been Brie’s fifth birthday, Danielle noticed Jenny McCarthy appearing on TV to tell viewers about how vaccines had caused her son’s autism. “It upset me,” Danielle says. “I noticed a lot of TV shows that probably your everyday mom watches that allow celebrities to come on and state their side about how they don’t vaccinate their kids because they believe it’s connected to autism.”
Danielle went online and found the contact information for some of the shows that had given McCarthy a platform to disseminate her message, including The Oprah Winfrey Show, Good Morning America, and The View. “I e-mailed them afterward and said, I can’t believe you don’t present the other side. There are people out there listening to you that are about to have a baby, and they’re just listening to this side and thinking, ‘I can’t vaccinate my child.’ And you’re not telling these mothers what can happen if they don’t.” At times, Danielle’s frustration grew to be so intense that she wished she’d let her husband document Brie’s final days:
One thing I remember was in the hospital, I kept telling him, Don’t you dare take a picture of her. . . . I was like, This is not how I want to remember my child. . . . [But] sometimes I wish I had a picture to show people that this is what a baby looks like when they’re hooked up to five machines and is ten times their size. This is what happens to a child who comes down with these diseases.
It’s gotten to this point, and I guess I shouldn’t be, but it’s gotten to be disgust. . . . [Jenny McCarthy] is giving medical advice to people who are listening. . . . It’s been proven that vaccines don’t lead to autism, but those studies don’t get the kind of media coverage that someone like Jenny McCarthy does.
Danielle never heard back from any of the shows she wrote to. In the spring of 2009, The Hollywood Reporter broke the news that Winfrey’s production company had signed McCarthy to a multiyear development deal. “Like other Winfrey protégés-turned TV moguls, among them Rachael Ray and Dr. Phil,” it read, “McCarthy has been a frequent guest on The Oprah Winfrey Show, [where she] talked to the chat queen about her struggles with her son’s autism in conjunction with the publication of her best-selling books.” According to the story, th
e deal would start with a blog on Oprah.com and would eventually include a range of projects on different platforms—“including a syndicated talk show that the actress/author would host.”
Just as McCarthy’s latest venture was being announced, Danielle learned she was pregnant again. The couple’s third son was born that December. They decided to name him Gabriel—in honor of the sister he’ll never get a chance to meet.
58 The sound of a whooping cough fit is unmistakable. Throughout history, the disease has been given vividly descriptive names: “dog’s bark” in Italian, “howling of wolves” and “braying of donkeys” in German, and “boisterous laughter” in Old English.
CHAPTER 24
CASUALTIES OF A WAR BUILT ON LIES
By the start of 2009, the debate over the connection between autism and vaccines had been raging for more than a decade. Already, the effects of this manufactured controversy—on the public’s perception of vaccines and public health policy, on worldwide vaccination rates, and on the reemergence of infectious diseases—had arguably been greater than the combined effects of all the other immunization controversies of the previous one hundred years.
Another factor that differentiated this dispute from previous ones like Lora Little’s campaign against smallpox inoculations and the debate over the DPT vaccine was the Omnibus Autism Proceeding, which had been set up after the United States’ Vaccine Court was flooded with thousands of autism-related claims in the early 2000s. The implications of the Omnibus on the perceived legitimacy of worldwide vaccination efforts were obvious to everyone involved. Throughout their careers as federal judges, the Special Masters presiding over the Vaccine Court had worked as impartial arbiters. They had never been part of the public health sector and had no stake in vaccine development. Fairly or not, a ruling in favor of the families suing the government would be interpreted as conclusive proof that in certain circumstances vaccines could cause autism.
It was with these stakes in mind that in the summer of 2002, Gary Golkiewicz, the Chief Special Master, met with representatives from the Department of Health and Human Services, the Department of Justice, the Food and Drug Administration, and a Petitioners’ Steering Committee (PSC) made up of five lawyers representing more than four thousand families to hash out a framework for the proceedings. Together, they decided that the Omnibus Proceeding would examine three separate “causation” theories: The SafeMinds hypothesis that thimerosal could cause autism, the Wakefield hypothesis that the MMR vaccine could cause autism, and a composite theory that thimerosal and the measles virus working together could cause autism. The petitioners would choose three test cases for each theory, and the trials for each one of the separate theories would occur simultaneously.59
With so much riding on the outcome, the PSC made clear from the outset that its clients would need significantly more time than would normally be allotted to assemble the necessary research to support their contentions. As a result, they were given a full year to submit a list of witnesses. The rest of the process was expected to drag out as well, and final rulings were not scheduled to be handed down until the summer of 2004.
It didn’t take long before it became obvious that even that goal would not be met: It wasn’t until 2005 that the discovery process, which produced hundreds of thousands of pages of government documents, was completed. That summer, the PSC received a further extension to assemble a list of experts willing to support the theories upon which it was basing its claims. When that deadline rolled past, another extension was granted. Finally, on Valentine’s Day 2006, more than three and a half years after the framework for the Omnibus had been laid out, the petitioners’ lawyers handed in the names of the doctors and scientists who were prepared to back up their claims under oath.
Sixteen months later, on June 11, 2007, opening arguments in the first Omnibus Autism trial were made in a federal courthouse in Washington, D.C. The suit filed by the parents of Michelle Cedillo, who at twelve years old was largely confined to a wheelchair and continued to require around-the-clock medical care, was selected as the first test case for the dual-causation hypothesis. The Cedillos’ claim was broken down into three interdependent parts: The thimerosal Michelle had received in the hepatitis B, DPT, and Hib vaccines led to the “dysregulation” of her immune system; her weakened immune system was unable to defend against the live measles virus she received as part of the MMR vaccine; and the resultant measles infection had overwhelmed her brain, thereby causing autism. Outside of the widely discredited research performed by a mutually reinforcing community of autism advocates, DAN! doctors, and fringe scientists, none of those claims had ever been shown to be true. Proving a single step in that proposed chain would have been a mammoth undertaking; providing sufficient evidence to support all three was a monumental challenge.
That Monday morning, when the proceedings were called to order, Michael and Theresa Cedillo wheeled Michelle into the courtroom. Large headphones, which one reporter compared to those worn by heavy machine operators, covered her ears. Throughout the brief period of time in which she remained present, Michelle grunted loudly and hit herself in the face. For close observers of the story, it seemed apparent that one tactic of the Cedillos’ lawyers was to highlight the sheer magnitude of Michelle’s suffering. Vaccine author Arthur Allen described both sides’ opening statements in a blog post on his Web site:
With their body language, the lawyers for the claimants and the defense in the case reflected what has always been true about the vaccines-cause-autism theory: one side appeals to the heart, the other to the brain. The claimants’ lawyers, Tom Powers of Portland and Sylvia Chin-Caplan of Boston, spoke with inflection and warmth and turned to face the audience in the courtroom. The government’s lawyer, the colorless-seeming Vince Matanoski, spoke to the special masters—the judges who will decide the case.
The logic behind that strategy became apparent not long after Chin-Caplan called H. Vasken Aposhian, her first witness, to the stand. Aposhian, a professor at the University of Arizona whom Allen described as “an elderly, hard-of-hearing toxicologist with a halo of white hair surrounding his large bald pate,” had written an expert report detailing how thimerosal caused “injury to the developing brains of human embryos and young children” such as Michelle. Chin-Caplan kept her questions straightforward and direct, and for the most part Aposhian’s replies were similarly matter-of-fact.
During the cross-examination, which was conducted by a Justice Department lawyer named Linda Renzi, Aposhian’s responses weren’t nearly as cogent: He seemed distracted and confused, and at times appeared to be unable to describe his own work. At one point, Renzi asked Aposhian about one of the two case studies upon which he’d relied to reach his conclusions:
RENZI: Would you like to see the paper by Davis that we’re talking about?
APOSHIAN: If it’s that one, yeah. Yes. Now I remember this one, yes. What is your question about it, please?
RENZI: There was a child in that study who actually had prenatal exposure to methylmercury. Is that correct?
APOSHIAN: Again, I haven’t read this paper for years. If you say it’s correct, I’ll have to accept it.
RENZI: Well, you cited it in your report, which you wrote on February 16, 2007. So if you haven’t read this article in years—
APOSHIAN: Which said what about a pregnant woman?
RENZI: Well, you cited the paper so I assumed you were aware of the study.
APOSHIAN: I don’t think in my paper I say there was a pregnant woman involved. I could be wrong, but, again, I have to read so many papers.
. . .
RENZI: So you don’t know whether, in the article that you cite, whether one of the family members was exposed to the methylmercury through consumption of the pig prenatally?
APOSHIAN: Since this is a court of law, I want to be absolutely truthful and I have the sneaking suspicion one may have been but I’m not positive.
A couple of minutes later, Aposhian seemed not to realize
that he was holding a copy of the report he’d prepared specifically for the trial:
RENZI: In your report, on page six—
APOSHIAN: Page six of this article?
RENZI: Of your report. I’m sorry sir, of your report.
APOSHIAN: Could someone get me my report? If I had known that—
RENZI: I think we handed you your report sir. You should have it.
APOSHIAN: Thank you. Okay. Page six. All right. Now I have page six.
Even those farcical moments weren’t as damning as when Renzi asked Aposhian if there was a single paper or peer-reviewed article that supported his thesis regarding thimerosal’s effects on the human brain. “The hypothesis was made less than three or four weeks ago,” he replied, “so the answer is no.” It was a jaw-dropping acknowledgment that the mechanism through which Michelle Cedillo and thousands of other children’s injuries were supposed to have occurred had been fleshed out for the first time less than a month before the Omnibus hearings had begun.
As unimpressive as Aposhian might have been, his testimony never quite crossed the line into the surreal. The same could not be said of Vera Byers, the doctor who claimed that Michelle’s immune system had been damaged by vaccines. At one point while she was being cross-examined, Byers, whose primary employer was a Shanghai-based company that sought to get “classic Chinese herbs” approved for use in FDA clinical trials, began to giggle inexplicably. Later, when she was asked how she determined effective control readings for her experiments, she replied, “You’re making faces at me. You are.” After one of the three Special Masters observing the trial told Byers she could look at them if she preferred, she nodded at Special Master Patricia Campbell-Smith and said, “She’s much more attractive. Thank you.” Even when Byers managed to answer the question at hand, her testimony wasn’t particularly helpful to Michelle’s case: When asked how she knew that different types of mercury affected the body in different ways, she explained that she’d been “educated by Dr. Aposhian . . . not specifically for this trial, but for the investigation of mercury in the human body for litigation purposes.”
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