The Needle and the Studies Done
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|Thu, 03-27-2008 - 2:33pm|
The Needle and the Studies Done
Debates over vaccine safety are murky enough to confuse the medical experts. How’s a parent supposed to sort it all out?
by Sari Weston
"Everything looks just perfect!" Dr. G beamed as she finished listening to my enormous pregnant belly. "You can sit back up now," she said, pulling my bovine form upright with a strong grip.
Dr. G was a quirky sort, with a slight lisp and wavy brown hair tacked up on each side of her face with tiny plastic banana clips. She wore an embroidered, full-skirted dress, Dansko clogs, and not a speck of makeup. It was October 2004, and I'd just switched to her small osteopathic family practice from the OB/GYN conglomerate I'd been seeing for the first five months of my pregnancy. Here, even though I'd gained way too much weight already and total strangers were asking if I was carrying twins, I was more than the sum of my pounds: I was "perfect." I loved her immediately.
She turned away to jot something in my file, then turned back to look me in the eye. "I need to ask if you want to get a flu shot while you're here. The recommendation now is for pregnant women in their second trimester to get one."
Her phrasing caught me off guard. In my experience, most doctors would say, "And you need a flu shot" off-handedly while they wrote notes in your file, or they'd simply send the nurse in, already armed with the needle. But Dr. G wasn't writing; she was looking me in the face as if she genuinely believed I had a choice in the matter.
This plucky soul had no idea what she was getting into. We barely knew each other, Dr. G and I. We had yet to have the marathon discussion of the pros and cons of circumcision, or the laborious review of my birth plan (typed out in nine-point font so that I could fit it all on one page and perhaps avoid looking like the high-maintenance micromanager that I was). I'm a Libra; I can't even choose a toothbrush quickly. At the same time, I have the training and curiosity of a scientist, having spent most of my pre-baby work life at a toxicology consulting firm. The result is that complex decisions about things like healthcare can jam up my brain like a computer running too many programs at once.
"I've never had a flu shot," I said, stalling. Then another thing occurred to me. "Does it have mercury in it?"
Aha, her eyes seemed to say, You're one of those. And she settled back into her chair, ready to talk. (That small motion of settling back, of being comfortable with the question, vaulted my tentative love for Dr. G to new heights.)
Yes, the shot did contain mercury, she said. According to her drug rep, roughly the same amount as in a can of tuna. I hadn't eaten tuna since the day I found out I was pregnant.
"Wait," I said. "They're telling pregnant women to avoid eating fish that's high in mercury, yet they're recommending that we get the flu shot? Why would I want to inject mercury right into my bloodstream? Doesn't it cross the placental blood barrier?"
She nodded. "And if you're worried about the mercury, you should know that it's a neurotoxin, and you're in your second trimester, which is when your baby's nervous system is undergoing lots of development."
Hmm. Was she leading me away from the shot? "It seems like it's just not worth the risk," I agreed, "considering I've only had the flu once in the last fifteen years."
"But if you do get it, you should know that pregnant women have a higher rate of complications than the general population," she said. "Women who will deliver during the flu season are advised to get the shot so that they don't transmit the flu to their newborn."
Toward the shot?
She went on: "But I've never, in all my years of practice, had to hospitalize a pregnant patient for the flu."
I started to realize that Dr. G was not about to tell me what to do. I would have to decide this one for myself.
I've lived with myself long enough to know that more information does not necessarily guarantee more certainty in my decisions. But I do know how to find articles in science journals. I went home to do some reading, knowing all the while what I would probably find: a lot of perfectly good studies that directly contradicted one another.
And so it went. I ended up declining the shot, because I simply couldn't get around the idea of shooting myself up with any amount of mercury at the same time I was denying myself lattes and sushi. But I remained uneasy about the decision. Sure enough, the following week the newspapers ran a story linking influenza infection in pregnancy with schizophrenia in offspring. Had I traded mercury poisoning for mental illness? Had I done the right thing?
And if I was driving myself nuts with the decision over a single shot for myself, what was I going to face when the issue of my child's vaccinations came up?
Of all the childhood health issues parents today have to confront, vaccines may be the most controversial. Whether to, when to, how to. Side effects, herd immunity. The politics, the science, the hype.
The controversy fills the papers. In the federal courts, a case rages on over vaccine safety. On one side is the group that believes vaccines are doing our children more harm than good, to blame for ills ranging from lower IQ to brain damage. On the other side, scientists and politicians at the federal level strive to maintain the nationally set vaccination schedule, reminding parents that vaccines have saved millions of lives.
Dig into the morass of vaccine safety literature, and you'll immediately find yourself surrounded by an array of claims, debunkings, ordinary people with extraordinary powers of research, anguished parents throwing their lives into the search for what happened to their children, scientists who are either saviors or slaves to Big Pharma depending on whom you ask, government advisory committees tainted by conflicts of interest, character assassinations on both sides, data that can be interpreted one way or the other depending upon which epidemiologist you're talking to, and high-profile people like model and comedienne Jenny McCarthy publicly blaming vaccines for autism.
So it's not just me being an indecisive Libra. The average parent, with no science training, is genuinely bombarded with conflicting evidence, advice, and fear tactics from both sides. It doesn't help that the science is still out, the studies are often difficult to interpret, and that there are conflicting lines of responsibility at the federal health level.
We all want to do what's best for our children, but in this climate, how can we figure out what "best" really is? How worried should we be? Are we being sold a bill of goods about vaccines?
Say you're waiting with your baby in the pediatrician's office for a nurse to come in with shots, three or four syringes filled with clear liquid. You may have already been given the federally mandated Vaccine Information Statements put out by the Centers for Disease Control and Prevention (CDC), or maybe they'll be in the paperwork handed to you after your baby's already been vaccinated, as often happens.
If your infant isn't screaming or nursing or in need of a diaper change, and if your older child isn't jumping off the examining table, crawling around on the floor, or otherwise creating havoc in the office, you may actually have a chance to look over those sheets before you leave. If not, well, you've just ceded a big decision about your small baby's health to the doctor without much realizing it.
Is this any way to make what can potentially be a life-altering medical choice for your child?
There's an unspoken dichotomy in these so-called well-baby visits. Most doctors believe wholeheartedly in vaccinations; they care for individual children, but they also care about the entire herd, so to speak--all the children in the community and in the country--and feel that the best way to protect the herd is via vaccination.
Parents, on the other hand, are naturally focused on the crosshairs of that singular goal of keeping their child safe. Or, as it says in The Vaccine Reaction, a publication of the National Vaccine Information Center (NVIC), a nonprofit vaccine safety educational organization, "When it happens to you or your child, the risks are 100 percent."
I got lucky with my own doctor. She was willing to get comfortable and talk for a while, to venture with me into the gray area covered by my questions. But even the most willing of doctors usually hasn't received much more than a few hours' training on the topic of vaccines. So when it came time to make a similar decision for my son Jack? Well, I knew enough by then to know I had some homework ahead of me. A lot of homework, in fact.
Ever since the first smallpox scab was pulverized and scratched into the skin of a healthy person, the process of inoculating someone with a disease in order to prevent that disease has seemed, to some portion of the public at least, inherently unsafe and unnatural. (Imagine, for a moment, offering your child up for such treatment--the dirty barn, the fever that followed, the white-knuckled wait until the symptoms subsided and immunity was conferred.) Vaccines have never been without risk; this fact is not disputed by anyone. Almost everyone has a story about somebody they know whose child reacted badly to a vaccine.
These days, articles on vaccines in most mainstream parenting magazines tend to read like bullet points off the American Academy of Pediatrics and CDC websites--which is to say, unequivocally in favor of vaccination. Articles in "alternative" parenting magazines tend not to stray very far from the "vaccines are poison" dogma of the anti-vaccination camp.
That camp pitches a pretty wide tent. In the years since the childhood vaccination schedule expanded past just the measles, mumps, rubella (MMR) and polio vaccines, many, many groups have formed to question the safety of vaccines. Most were started by parents who believe their children were severely damaged by vaccines, such as Barbara Loe Fisher of NVIC; Sallie Bernard of SafeMinds (Sensible Action for Ending Mercury-Induced Neurological Disorders); and J.B. Handley of Generation Rescue. These people have poured their pain into a formidable purpose: raising awareness of vaccine risks, asking tough questions of the Food and Drug Administration (FDA) and the CDC, taking out full-page ads in national newspapers, contributing to government studies and funding their own.
Their questions, charges and countercharges, which are myriad, center on several key topics.
First we have the issue of the use and effect of ingredients other than the antigen (the active ingredient) in a vaccine. The most controversial of these is the mercury-based preservative thimerosal. Parents currently facing the vaccination question can rest a little easier because thimerosal has been removed from all pediatric vaccines in the United States (other than certain flu shots; be sure to ask), but the thimerosal debate shows no signs of cooling off (see "Thimerosal 101" in the magazine for more information).
Thimerosal isn't the only suspect ingredient. Aluminum, which is used to enhance the immune response to the vaccine, is also under scrutiny, along with formaldehyde, fetal calf serum, neomycin, polymyxin B, egg protein, and human serum albumin, to name a few. Most of these ingredients are present in such tiny amounts that they aren't expected to cause any harm except for allergic reactions, and bovine products are required to be sourced from countries free of bovine spongiform encephalopathy.
Aluminum, however, is a telling example of the gaps in our knowledge about vaccine ingredient safety. Here's the deal: Aluminum is ubiquitous in the environment and thought to be harmless when ingested (many antacids contain it). Studies in animals, premature babies, and people with kidney problems, however, have shown that injected aluminum can accumulate in body tissues and cause bone disease and symptoms of central nervous system toxicity, such as developmental delays and encephalopathy.
In fact, the FDA limits the concentration of aluminum in IV feeding solutions to twenty-five micrograms per liter. Consider that an adult on an IV would receive about a liter per day; this means the maximum amount of aluminum that an adult should receive in a particular day is twenty-five micrograms.
Robert Sears, one of the Sears family clan of physicians, recently published The Vaccine Book: Making the Right Decision for Your Child. He points out that a two-month-old baby receiving her first big round of shots will receive a total aluminum dose of 295 to 1875 micrograms, depending upon the brands and combinations of vaccines given. The same applies to the shots commonly given at four and six months of age. "No one has actually studied vaccine amounts of aluminum in healthy human infants to make sure it is safe," he writes.
In other words, the disconnect between what we're doing with children and vaccines, and what we know about the effects--not just of individual vaccines, but vaccines in combination--is jaw-droppingly large.
The second major topic of controversy focuses on the effects that vaccinations may have on the immune system. The rise in chronic immune problems such as asthma, allergies, and autoimmune disorders has caused some parents to question whether vaccinating actually weakens the immune system, either by overloading it, by causing it to mount a more inflammatory response to antigens (as in allergies) or to our own cells (as in autoimmune disease), or by depriving it of the opportunity to strengthen itself by fighting off childhood infections naturally.
The debate here centers on the difference in the way the immune system is presented with and responds to vaccines versus the way it fights natural illness. The concern is that vaccines actually shift the developing immune system to a more harmful, inflammatory response, which can give rise to atopy, the medical term for allergies, asthma, eczema, and the like.
The Institute of Medicine (IOM), a component of the National Academy of Sciences charged with providing (according to its website), "unbiased, evidence-based, and authoritative information and advice concerning health and science policy," rejected a causal link between vaccines and type 1 diabetes (an autoimmune disease) in 2002 but could neither accept nor reject a relationship between vaccines and allergic disorders, particularly asthma. The scientific literature since then presents mixed conclusions on whether vaccination or childhood infections increase atopy later in life.
Next we come to the effects that vaccines may have on the nature of the diseases they target. Measles is one good example of this effect; another is chickenpox.
Before the vaccine against it was created, chickenpox was a normal, if uncomfortable, childhood rite of passage, and the virus was constantly circulating within the community, giving everyone's immune system frequent natural "boosters" over the years and conferring lifelong immunity. Now the CDC recommends that children be vaccinated against chickenpox at around age one, with a booster shot around age five. Because this is a relatively new vaccine, we don't know how universal vaccination will affect the possibility of adults catching chickenpox when their vaccine-derived immunity wanes. It's also not yet known whether the lack of re-challenge from the naturally circulating virus will result in a rise in shingles, a painful resurgence of the chickenpox virus later in life.
A vaccine for shingles has recently been licensed, which could be good news for those now at increased risk. It's also possible, on the other hand, that the chickenpox vaccine itself could provide protection from shingles. At this point, nobody knows for sure. In either case, it seems fair to wonder whether it would have been better to just have accepted chickenpox as a normal part of childhood and left well enough alone.
All of these issues tie into a more social side effect of vaccines: the rising mistrust of the government agencies charged with vaccine safety. This particular emotion is rampant among the anti-vaccination crowd, perhaps for good reasons.
In 2000, the House of Representatives Committee on Oversight and Government Reform investigated conflicts of interest in the FDA and CDC scientific advisory committees on vaccines. The investigators found numerous instances in which committee members with financial ties to vaccine makers were given waivers to participate in the decision-making process. In fact, all members of the CDC's Advisory Committee on Immunization Practices (ACIP) were granted annual conflict-of-interest waivers as a matter of course. The conclusions of the House Committee's Majority Report stated: "The FDA standards defining conflicts of interest are ridiculously broad. . . . That is why a committee member receiving $250,000 a year from the maker of the Rotavirus vaccine, Wyeth Lederle, was granted a waiver and voted in the deliberations. The CDC has virtually no standards because all ACIP members automatically receive annual waivers."
Another big problem: The CDC is charged both with promoting vaccination and ensuring vaccine safety, two objectives that can often be at odds.
In early 2004, scientists in the vaccine safety branch of the CDC complained to an aide from CDC Director Julie Gerberding's office that "conflict of interest was complicating their work" and that "higher-ups scrutinized their findings excessively when they showed harm from a vaccine," reports Arthur Allen in his 2007 book Vaccine: The Controversial Story of Medicine's Greatest Lifesaver.
That summer, Neal Halsey, director of the Institute for Vaccine Safety at Johns Hopkins University in Baltimore and a strong advocate for the removal of thimerosal from childhood vaccines, co-authored a paper in the American Journal of Public Health calling for vaccine safety oversight to be removed from the CDC and given to an independent government agency modeled after the National Transportation Safety Board.
The CDC's response? It chose not to create a separate agency, but to move the safety branch into the director's office in 2005--a change in reporting lines, but not the sort of sweeping change that could ameliorate the agency's credibility problems, at least in the eyes of vaccine skeptics.
So, that was some homework assignment. Given the depth and breadth of anti-vaccine concerns, why would any parent who's done a similar amount of research opt to have his or her child vaccinated?
Simple, say vaccine proponents. You're keeping your baby safe from the ravages of contagious disease that are still killing children every day in the developing world or, perhaps worse, from the effects of diseases in the U.S. for which we already have vaccines.
Dr. Gregory Poland, head of the Vaccine Research Group at the Mayo Clinic in Rochester, Minnesota, outlines his own reasons on his website. "As I went through medical school and residency," he writes, "I knew right then and there that the warrior I was meant to be was the warrior taking on infectious diseases, to prevent them--because I just have a really hard time with death. Unwarranted death, the unexpected death."
Thankfully, most of us live in an insular world in which the death of a child from an infectious disease is a horrific, unnatural phenomenon rather than an everyday occurrence. This great privilege can be attributed to clean water, good nutrition, and medical care--and, yes, at least in part to vaccines. And every day, untold numbers of children are vaccinated (cue ominous music) . . . with no ill effects whatsoever. It's just that their parents aren't writing blogs about it.
Most of us raising kids today have no firsthand knowledge of the illnesses our kids are vaccinated against. We don't know what it is to watch a tiny infant convulsing and gasping for breath as her airways close up with the thick mucus of pertussis, nor have we ever seen a polio ward full of children in iron lungs. So it may be that our perception of risk from the vaccine looms greater than our understanding of the risks associated with catching the actual disease.
While some vaccine critics argue that allowing children's bodies to experience the actual disease helps boost their immune systems, others like Jessica Snyder Sachs, former editor of Science Digest and author of the 2007 book Good Germs, Bad Germs: Health and Survival in a Bacterial World, disagree:
Scientists now understand the immune system is brought up to full strength by the harmless bacteria that normally colonize the human body. In other words, getting sick isn't a necessary part of the equation. Harmless bacteria bring the immune system into a state of readiness without triggering harmful inflammation.
Studies also show that the more infections a child has in early life, the greater his or her risk of inflammatory disorders, heart disease, cancer and premature death in later life. . . . It's important to realize that there's nothing ‘natural' about a childhood full of infections, at least if by ‘natural' you mean what's been normal over the bulk of human evolution. Only with the advent of civilization, the last 5,000 years, has contagious disease taken such a central part in our lives.
In other words, Sachs argues that while letting your kid get chickenpox and measles might be the "natural" thing to do, it may be less healthy for them in the long run than helping them avoid those diseases altogether.
In every household with children, what to do about vaccines comes down to a series of tricky questions. Which are you more afraid of: your two-month-old's catching whooping cough or his getting the DTaP shot? Is your one-day-old newborn really at risk for catching a sexually transmitted disease, or is the Hep B shot being given to her for someone else's convenience? Is it short-sighted or is it sane to expect vaccines to have zero risk? Where do your notions of societal responsibility fit into the equation?
Nor is there much breathing room to weigh the answers. When they come up, we're usually sitting in a doctor's office with a screaming baby; we don't have the luxury of time to research the issue while calmly sipping tea in our easy chairs.
Which is one reason Robert Sears undertook his own book. "Parents have nothing objective and unbiased to read," Sears said in an e-mail interview. " are running scared simply because of the lack of good, solid information."
Sears' book goes a long way toward filling that gap (see "Vaccine Reading Shelf" in the magazine for more recommendations). In it, he proposes several alternative schedules for vaccination, including one that contains only selected vaccines and one that allows for complete vaccination, with priority given to vaccines that address the most dangerous infant diseases and vaccines with the lowest possible concentrations of aluminum.
And this, perhaps as much as anything else I read in my months of research, spoke to me. My husband and I decided to have Jack vaccinated fully, and on schedule, up until about fifteen months. I was willing to vaccinate because I perceived the risks of diseases to be greater for such a small baby, and the diseases, particularly pertussis and the meningitis infections caused by Hib and pneumococcal bacteria, were ones that doctors actually do see in small babies. But we split the schedule so that he only received two shots at each appointment and no large combination shots.
As Jack grows, the choices get a little tougher. As a mother, I don't believe that the government has my individual child's safety in mind when they recommend a particular vaccination schedule. The later vaccines, such as chickenpox and the MMR, target diseases that he is less likely to contract and less likely to have disastrous effects from if he does.
But we will ultimately have Jack fully vaccinated for several reasons. First and most important, he has tolerated all of his prior shots well, without so much as a tiny fever to mark the event. The kid is healthy as a horse. If he'd had any reactions to any vaccines, I'd weigh the risks and benefits differently and our personal vaccination story would probably have a different conclusion. Second, while I share in the general mistrust of the medical establishment when it comes to vaccine recommendations, I don't feel strongly enough against the practice of vaccination to fight it or to lie to get an exemption so that Jack can go to school. (The state where I live allows for exemptions based only on medical reasons--a doctor's determination that vaccination would be harmful to a child's health--or religious beliefs, and my objections to certain vaccines are based on neither.) Finally, I do feel some responsibility to participate in maintaining our public health, the health of our herd.
We'll be spreading out Jack's remaining vaccinations over a long period of time, and splitting out the combination shots whenever we can. Not everyone can make that choice--single working mothers might have a harder time running to the doctor every month for a different shot, for example--but if I can, I'm going to. I make my kid wear a helmet to ride his scooter in our driveway, and I still dress him in footie sleepers so he doesn't get cold at night. So when I'm considering injections into his perfectly healthy body, if I have the time and resources to do so, I'll take the safest route.