An HPV vaccine win!

The Pediatric Insider

© 2012 Roy Benaroch, MD

A terrific study gauging the effectiveness of HPV (Human Papilloma Virus) in Australia shows the power of a national program to fight disease. It works!

In April 2007, Australia started a national, government-funded program to provide HPV vaccine to all young women accessing health services.  After only four years, they found that among vaccinated women, the prevalence of vaccine-preventable HPV infection had dropped from about 30% to 7%. Even among unvaccinated women, the rate of infection dropped by about half. Vaccines help not only the vaccinated, but also the entire community (the opposite is also true—not vaccinating harms not only the child, but the community as well.)

Now that HPV vaccine is also recommended for boys and men, the impact will be even greater. Dramatically reducing HPV infections will lead to a tremendous drop in cancer. This is huge.

HPV vaccination is safe and effective, and is recommended starting at age 11 or 12 for boys and girls. Why wait? Protect your kids, protect us all. More information here.

H1N1 Vaccine: One dose or two?

The Pediatric Insider

© 2009 Roy Benaroch, MD

I seem to be spending a lot of time on H1N1 here, and a lot of time on H1N1 issues in my office. I can see myself, an old retired doctor in 50 years, sitting in my holo-rocking chair, listening to my octophonic MP6 player through my aural uplink (a new, never-released Michael Jackson tune!), reminiscing about the winter of 2009, the Swine Flu. “What’s a swine?” my grandchildren will ask.

 

For now, though, we’re in the thick of it. And some very smart people with brains larger than I are guessing that about a third of us in the USA are going to get this darned thing this winter. A third. Imagine that.

 

We still need to keep this in perspective. That’s a lot of sick people, but the vast majority of children and adults who get H1N1 flu recover fully in about five days. It’s uncomfortable and unpleasant and, well, pretty miserable for five days, but H1N1 has a very low rate of complications. Still, with perhaps 100 million Americans getting ill, even rare complications are going to occur more frequently than I want to see them. Some people are going to get quite ill, some people are going to be hospitalized, and some people are going to die. We should do what’s safe and effective to slow this epidemic.

 

How to prevent it? Stay away from sick people. Wash your hands. Don’t touch your face. Don’t go to work when you’re sick, and don’t send your kids to school when they’re sick. Workplaces should not encourage sick employees to work, and schools should not reward perfect attendance.

 

And please, get the dang vaccine. Forget the AM radio and internet nonsense: the government and the doctors do not want to kill you.

 

Getting all of this vaccine made and distributed has not been an easy task, and I wouldn’t call the government’s efforts one of their finest moments. At my office we’re depending on the folks at the Fulton County Health Department, who’ve so far sent us a tiny smidge of our expected order. With no advance warning, and no word on when we’ll get more. But the overall picture is improving—though the vaccine is dribbing out, it is getting out, and the trickle should become faster soon. Meanwhile, good studies continue to support the safety and effectiveness of immunization.

 

We’ve known for many years that children younger than 9 don’t seem to mount a strong immune response to flu vaccines, especially in their first year of immunization That’s why current recommendations for ordinary, seasonal flu vaccines suggest that if a child less than 9 is getting a flu vaccine for the first time, the dose should be repeated 28 days later.

 

It turns out that the swine flu vaccine is no different—and that’s no surprise, as it’s essentially the same vaccine that’s used to prevent influenza year after year, designed in this case to prevent this new H1N1 strain. The science, the development, the studies, and the factories are all the same as ordinary flu vaccines. Ignore hype that claims this vaccine is somehow more “new” than other flu vaccines.

 

So: it’s recommended by the ACIP (the advisory board on immunization practices of the CDC) that children less than 9 get two doses of the H1N1 vaccine this year for best protection. (Actually, some studies were done using a 10 year cut-off; so in some places the recommendation is up to age 10; but since that recommendation is up to 9 for seasonal flu, that’s the way most health departments and doctors’ offices are handling it.)

 

At the same time, we know that from a public health standpoint that the best way to put the brakes on the epidemic is to get as much of the population immune as quickly as possible. That will prevent the virus from spreading from person to person. Once the “herd” is mostly immune (or at least more immune), then all of us—vaccinated and unvaccinated—will be less likely to come in contact with anyone with flu, and therefore we’ll all be protected.

 

Though two doses are better than one, the CDC does not recommend that doctors “hoard” doses back to ensure that those second doses are given. We’ve been told—and it does make sense, when you think about it—that we ought to get as many kids vaccinated as possible with first doses, and continue vaccinating as long as we have vaccines, as quickly as possible. Since more and more doses are expected to be distributed in the coming weeks and months, it’s probable that second doses will be available, thought it can’t be guaranteed; and the timing might get tricky. Though a minimum of 28 days between doses is recommended, the interval can be longer than this. By the way, this recommendation is identical to what’s been recommended in previous years with ordinary, seasonal flu vaccines. Hoarding has never been encouraged by CDC or World Health Organization guidelines. Though two doses are better than one, one dose is far better than zero, and getting as many people as possible that one dose is going to help your child, and all of us, stuff this H1N1 genie back in the bottle.

 

Older H1N1 wisdom:

H1N1 vaccine after H1N1 illness?

A pandemic primer for parents

Flu: to shot, or not?

 

The CDC’s H1N1 site

H1N1 vaccine after H1N1 influenza?

The Pediatric Insider

© 2009 Roy Benaroch, MD

Liz asked about influenza vaccines. If her son already had the flu this year, should he still get a flu vaccine? The regular seasonal one, the H1N1 one, or both?

If Junior got the flu in the United States so far this year, it was almost certainly the novel-H1N1 strain (the so-called “swine flu.”) In ordinary winters, people who have the flu with a specific viral type are protected somewhat against having that same flu again, at least in the same winter. The protection isn’t 100%, but neither is the protection from the vaccine.

But this isn’t an ordinary winter. We don’t really know if people infected with H1N1 have decent immune protection, or how long it will last. And most people who say they’ve had the flu haven’t been tested with a highly accurate test—the office-based, quick test that’s often used is not reliable for knowing for sure that it’s a case of H1N1 influenza.

Studies in past years have shown that giving an influenza vaccine to someone who’s already had the flu doesn’t seem to increase the rate of adverse reactions or problems.

So the CDC recommends (scroll down to the “prior illness” paragraph) that this year, people who’ve been told that they already had the swine flu should still get the H1N1 vaccine. If I were designing a system to vaccinate the highest-priority patients first, I’d figure your son has at least some immunity; so perhaps other, more at-risk kids ought to be vaccinated first. But for best protection for your son and the community, he ought to be vaccinated as well.

But really, for all of us, the best way to get thru this winter is going to be for as many people as possible to get H1N1 vaccines as soon as possible. At a recent national meeting, smart eggheads from the ivory towers of infectious disease told me that their models show that at least half of us in the Unites States are going to get H1N1 influenza this year—the only way to prevent this is if most of us get vaccinated, and quickly, to interrupt transmission of the virus. If the “herd” is mostly immune, the virus will slink away. But if many of us remain un-immune, then there will always be another nice warm body to infect, and then spread to others.

As for the “seasonal” flu vaccine—I think he ought to get that one, too. Seasonal flus other than this novel-H1N1 will start circulating soon, probably by December, and I would hate to think what a regular flu season on top of this H1N1 flu epidemic is going to look like. I got my flu vaccines, and I’m still stockin’ up on Purell!

Why parents refuse vaccines

The Pediatric Insider

© 2009 Roy Benaroch, MD

Ask 98% of my patients, and they’ll tell you they’ve gotten all of their kids’ vaccines, without qualms or hesitation. Ask the other 2%, and you’ll hear all sorts of reasons why they’ve skipped them. What makes some people look at vaccinations so differently than the rest of us?

Along with clean food and water, vaccinations are generally accepted as one of the greatest public health triumphs of the modern world. We are safe from diseases like polio and measles, which once ravaged millions. We no longer, really, have to worry about most kinds of bacterial meningitis, and we’re able to even prevent some kinds of cancer. Newer vaccines in development include protection against HIV and malaria. At the same time, immunizations are very safe, compared to just about any other medicine or medical intervention. Yet despite their incredible effectiveness and well-documented safety, suspicions remain. Many families choose to skip some or all vaccinations.

We know that vaccine refusers tend to be wealthier, and come from more socially advantaged communities. There also seems to be a neighborhood effect, where people from one small area tends to follow each others’ lead in vaccinating or not vaccinating. But these observations don’t tell us much about the psychology and thinking that leads individual parents to refuse vaccination.

Based on my own observations and conversations with parents who refuse vaccinations, and also with parents who are more eager for vaccines, I’ve come up with my own list of “profiles” of the kinds of parents who are most steadfast in their refusal. I don’t think this list is likely to be complete, and there’s a lot of overlap between the groups. But I think this is a good starting point to understand just where people are coming from. Hopefully, better understanding will lead to improved trust and better decisions for children.

If you are a vaccine refuser, please join in the comments. Does one of these profiles fit you? Have I neglected to understand perhaps your own reasons for refusing vaccines? What sort of information is missing that can help guide parents along this decision? My goal here isn’t to belittle anyone, but to understand and appreciate the concerns of parents. I welcome any comments.

Profile #1: The Government Distruster

I certainly understand that some people feel the government doesn’t always make the best decisions for us. The two parties bicker, and special interests and money seem to have more influence on decisions than the needs of ordinary people. Look at the Clowns in Congress, or service reps at the post office, or IRS telephone screeners– there’s no doubt that government and government employees are not always paragons of virtue and judgment.

Decisions on vaccine recommendations aren’t only made by government employees at the CDC. There is input from all of the major medical associations—pediatricians, family practitioners, internal medicine physicians, obstetricians, and infectious disease specialists are all involved. Specific recommendations are made by the CDC’s Advisory Committee on Immunization Practices, which is comprised of 15 vaccine experts from various fields. There are also vaccine recommendations made by government and health agencies around the world, including the United Nation’s World Health Organization. It is difficult to believe that all of these organizations and experts reviewing the studies and making recommendations have gotten the facts entirely wrong. Though there are some differences in the exact recommendations from country to country, by and large vaccine schedules and recommendations are identical throughout the world.

Some people believe not only that the government is irresponsible and incompetent, but that it’s actually twisted and evil. Like people who believe that the US government itself planned the 9/11 attacks, some people sincerely believe that vaccinations are a great threat to mankind, deliberately put in place by malevolent forces within the government to harm us. To believe this, you have to believe that evil pervades every step throughout government, from the statisticians and analysts at the CDC and university medical centers, all the way up to the surgeon general and president himself. Furthermore, you’d have to believe that this whole vast conspiracy has somehow been successfully hushed up, because there’s no actual evidence for this whatsoever. Is this even remotely possible?

#2 The Science Distruster

Science itself is not a series of facts, or a group of people wearing white coats. It’s a system meant to discern how the natural world behaves, in a way that allows us to predict what will happen in the future. Key features of science include:

• Natural law. There are rules about how things happen, and these rules can’t change. For instance, when a force acts on an object, it’s going to move in a predictable direction, in a predictable way. Natural laws are developed based on observations of real things that happen in real, measurable ways. They can then be tested, to make sure the predictions work accurately and consistently. If an observable case doesn’t fit what we thought of as the natural law, then the law has got to be refined and improved. Though we certainly don’t know how everything works, we’re very reluctant to accept propositions that fly in the face of natural law. You claim you have a machine that extracts energy out of perpetual motion? I want to see it before I believe it. Things that are beyond natural law—the “supernatural”—cannot be part of any scientific theory.
• Testing hypotheses Science relies on experiments. You can’t just say you think something is right, or that something ought to be true based on scientific knowledge. Anything that’s worth knowing through science is testable, and can be tested, and ought to be verified. Things that are not testable (or “unfalsifiable”, a more precise word) are not things that science can support or substantiate. Something like “Michelangelo was a better painter than Da Vinci” isn’t a question that science could test.

Some people who are deeply religious have a distrust of science, but it doesn’t have to be that way. There are many important questions facing mankind for which science may not provide an answer. Why are we here? How should be treat each other? Questions of law, ethics, morals, and aesthetics may not lend themselves to scientific study, and other manners of investigation of these issues are more appropriate. Science is one tool to help us understand their world, but it isn’t the only tool. Trusting science does not have to mean turning your back on religious or other convictions.

Some people refuse vaccines because they do not trust science, or because they feel it is more “natural” to suffer infections. If these infections weren’t good for us, why would they be here on earth? Though “Why do people suffer?” is not a question for science, I personally don’t think that God would have given us the intellect and wisdom to find answers if He didn’t want us to us those answers.

Another potential knock against science: scientists don’t know everything, and don’t pretend to. The very nature of science is to question and to allow new knowledge to replace old. When you read in the paper that a medicine has been found to have a new side effect, that isn’t a failure of science—it means that science did what it was supposed to. Question, learn, repeat; question, learn, repeat. Some people feel more comfortable with absolute truths, but that really isn’t what science is all about.

Which brings us to another problem with science: the language. Scientists use “science terms”—like “This study fails to confirm any link between vaccines and autism,” or “This study adds to the evidence that vaccines are not a cause of autism.” What parents want to read is an unequivocal “Vaccines don’t cause autism.” But it is impossible to completely rule out a negative statement using the tools of science. We can say that the odds against this are very, very small, and getting smaller, but we cannot prove with absolute certainty that it could not possibly in any circumstance at any time be true. Those language of science is exact, but can sound “weaselly” to many people, leading to distrust.

Profile #3: The Big Pharma Distruster

Big Pharma is The Big Boogeyman on the anti-vaccine web sites, and perhaps they do deserve some distrust. Basically, their duty is to their shareholders: to make a profit. Their business is to develop and sell medicines and vaccines, and to make money doing so. Vaccines and medicines create billions of dollars of profit. Does that mean that drug companies cannot be trusted?

It’s wise to view promotional material from drug companies as you would advertising from any other company: with great skepticism. Advertisers want to sell you things, as do drug companies. But most patients don’t buy their drugs or get a vaccine because of ads from the drug companies, but rather because of the advice of their physicians. Distrusting the drug companies because they make money by selling drugs is sort of like distrusting the tire manufacturers for selling you tires, or the paint people for selling paint, or … well, anyone for selling anything. Sure, the computer guy wants you to buy a more expensive computer, and sure, the grocery store wants you to buy more groceries. That doesn’t make people who sell tires or groceries evil or twisted. People who buy things should be wary of salesmen, but c’mon now. Just because a profit is involved doesn’t mean that drug companies are to be trusted less than any other company. If their product is good, you benefit, and they benefit, and everyone wins.

Profile #4: The Doctor Distruster

As I said, most people don’t buy medicines or get vaccines because of the promotional efforts of drug companies, but rather based on the recommendations of their physicians. But can physicians be trusted? Couldn’t we be but shills of the drug and vaccine manufacturers?

There are doctors who’ve accepted quite a bit of money from drug companies, as “experts” or “thought leaders.” Some of them travel around the country, giving talks to other doctors to convince them to use a certain drug or vaccine. I think this is a violation of the trust patients put in their physicians, and I won’t do it. Furthermore, the truth is that the vast majority of physicians are never offered such perks. We’re in the trenches, doing our work, and most of us just don’t attract that kind of fawning attention from the drug companies.

Is it possible that the pharmaceutical companies have fooled the doctors into blindly trusting their vaccines? I don’t think so. Most of us have seen diseases disappear once a vaccine is introduced, and most of us have seen vaccine-preventable diseases in unimmunized kids. Personally, I saw my last case of pneumococcal meningitis kill a patient of mine in 1996, right before the vaccine came out. I would prefer to never see that again.

Physicians as a group are intelligent and motivated—or we wouldn’t have made it this far. We’re certainly not monolithic, single-minded thinkers; many doctors harbor opinions of health issues that are far outside the mainstream. Yet with vaccinations, it’s only a very small handful of fringe doctors who are leery of established immunizations. There is a reason why so many pediatricians are so pro-vaccine.

It’s certainly not the money. Pediatricians actually lose money on some of the vaccines we give; for the majority of them, it’s pretty much a wash. They’re very expensive for us to buy and store, yet we do it because we know it’s best for our patients.

Looking at the trust issue from another angle: I have a mechanic I’ve known for years. When I bring him my car, he tells me what’s wrong, and I pay him to fix it. I know nothing about cars, and I seldom question his advice. Sure, if he suggested something really weird, I’d go elsewhere—but I’ve known him a long time, and he’s earned my trust. Likewise, I’ve seen my own patients for years and years. Parents ask for and want my advice on all sorts of things: feeding, sleeping, school issues, medical problems. I prescribe medications, and we talk about the side effects and risks and benefits, and we make our decisions. I would say that most patients trust my advice—or they’d find another pediatrician. Yet for some reason, for some families, vaccines seem to be a very separate issue. Sure, mom has trusted me as a source of information on everything else, yet immunization issues seem to be “off the table.” Mom would rather make vaccine decisions based on advice from random people she doesn’t know posting on the internet than based on information from me. Why am I perceived as an expert on health and childcare, but not as a trusted source of vaccine information? And if I can’t be trusted for that kind of advice, why are you depending on my judgment for anything else?

Profile #5: Paging Dr. Google

Everyone knows that the internet is a wild place. It’s full of all sorts of information, some great, some outdated, and some wildly misleading. No one believes that a Nigerian price wants to give you millions if you help him transfer assets, yet web sites that spread misleading lies about vaccines have somehow become a leading source of (mis)information for parents.

I’m going to google the word “vaccine” right now, and take a peek at the top 10 sites. I won’t provide links, because I can’t guarantee that any of the information is accurate, but here’s a quick summary of what I get:

• 5 sites with good, useful, dependable information—including information from the CDC and well-established medical sites.
• 2 news stories that more-or-less accurately talk about recent vaccine news. One of the stories has an odd sort of tangent including a brief interview with a well-known anti-vaccine propagandist, who plugs her usual misinformation (that’s irrelevant to the main point of the story, but it’s part of the standard boilerplate for some journalists to interview someone from the short-list of anti-vaccine spokespeople.)
• 3 sites retelling outlandish, truly bizarre misinformation. One strongly suggests that Americans should not get a flu vaccine because they contain squalene, a chemical that they claim caused Gulf War Syndrome. This is just a flat-out lie; there is no vaccine currently licensed in the USA, flu or otherwise, that contains squalene, which hasn’t been conclusively linked to any health problems anyway. The sites link and re-link to old, long-disproven canards based on tiny, unreproducible studies of questionable authenticity, with no effort whatsoever to present the best, most recent research. These sites explicitly state that I as a physician, in cahoots with government and big business, want to poison your child.

If you want good, accurate information that you can trust about vaccines, side effects, and actual real research into vaccine issues, try these sites first:

• The Centers for Disease Control
• The Immunization Action Coalition
• Children’s Hospital of Philadelphia vaccine information center
• Respectful Insolence, a blog that frequently discusses the efforts of the anti-vaccine lobby (this site can be a little salty, but it’s good reading and eye-opening.)

Profile #6: The alternative medicine believer

There isn’t an exact definition for “alternative medicine,” (a term I don’t like) beyond “things outside of mainstream medicine.” Most people feel they just know it when they see it. Because it encompasses such a broad array of philosophies and modalities, from acupuncture to chiropractic to massage to energy healing to prayer to herbal supplements to homeopathy, it doesn’t make a whole lot of sense to lump them all together. Nonetheless, some people feel that these sorts of “remedies” are better than what most doctors prescribe, and some alternative health devotees are suspicious of immunizations.

One argument is that the “natural” remedies of the world of alt-med are somehow better, or less dangerous. This doesn’t make a whole lot of sense—the small pox virus is natural; getting bitten by a tiger is natural; falling 60 feet out of a tree or building is natural. Burning and freezing and starvation and pestilence are as natural as can be. Potent poisons from jellyfish or tropical frogs are natural. Many mushrooms and plants are poisonous, and naturally occurring radiation from elements in the Earth and cosmic radiation cause plenty of cancers. There’s nothing inherently more safe about natural things than about “unnatural” things that come from a laboratory. Sure, medications have side effects, and some can be quite toxic—just like many natural plant products. In fact, if someone tells you they’ve got an herb or something with no toxic effects whatsoever, you ought to think again: any biologically active product, whether a medicine or something “natural”, is going to have multiple effects on a complex living organism. Some will be beneficial, some will be harmful. There’s no such thing as a medicine or herb with no side effects or potential for harm, unless that herb or medicine is 100% placebo.

Alt-med proponents also sometimes feel that manufacturers and businesses involved in alternative health products are more ethical or trustworthy than manufacturers of traditional medicines or vaccines. This is a completely unfounded opinion—just take a quick glance at a sampling of this week’s stories from the world of alternative medicine:

• The FDA has established a web site listing over a hundred bogus products to treat H1N1 influenza. The list currently has 136 (!) specific products, almost all of which are marketed to appeal to alternative-health consumers.
• Resveratrol is the latest product to be marketed heavily through national magazines as a product to reverse aging. There’s no magic cure for aging, despite what they’re trying to sell to you.
• A clinical trial was published looking at the “Gonzales Protocol” for treating pancreatic cancer with hundreds of supplement pills, coffee enemas, and a special diet. The treatment failed miserably—patients pursuing this alternative medicine approach died more quickly and had a poorer quality of life.

(These three examples were all taken from the last 2 weekly issues of Consumer Health Digest, a free listserv from Quackwatch and the National Council Against Health Fraud. You can sign up here.)

There have certainly been abuses and violations of trust from the world of conventional medicine, too. But as an unregulated industry, supplement and alternative health providers are more free to commit fraud and rely on questionable marketing tactics than traditional pharmaceutical and vaccine companies, whose products and advertising materials are tightly regulated.

There’s no logical reason to think that “natural” cures are safer, unless they’re just placebo. There’s plenty of evidence showing that alternative medicine companies are more likely to engage in shady marketing and business practices. Yet distrust of traditional medicine, including vaccinations, seems to be more common among users of alternative medicine modalities.

A very small number of alt-med proponents really goes to the extreme of non-scientific thought—they reject the very notion that infections cause disease, and thus reject all medical preventions and treatments for infection. These believers have a cult-like devotion to their ideas, and no amount of scientific evidence is going to sway them. Though from what I’ve seen few people really believe this, their web sites get plenty of hits from people looking for reliable vaccine information. The philosophy and background of people writing web pages isn’t always transparent, and some people with a vastly different worldview—one that many people would reject as ridiculous—are trying to sway your opinion. Beware the “yellow brick road” of alternative medicine, for far down that path are some truly bizarre beliefs.

Profile #7: Me, too!

This one frustrates me, but it seems to account for a big percentage of non-vaccinating parents. I ask why they’re reluctant to vaccinate, and the answer is something like “Well, a lot of my neighbors don’t,” or, “I heard that lots of people are scared of vaccines,” or, must frustrating of all, just “Well, you know.”

As momma used to say: “If your friends decide to jump off a bridge, are you going to jump too?”

There is a perception that vaccine refusal is a common phenomenon, though overall rates run in the 1-2% range (some individual communities are much higher, but that’s the usual quoted rate for most parts of the country.) The vast majority of parents get their kids immunized—but they don’t talk about it as much as the non-vaccinators. Refusing some or all vaccines is chic, and the people who do it like to talk about it. You might hear of neighbors who skip vaccines for their kids, but you can bet that you won’t hear about the majority of neighbors who get them on schedule. Don’t let the amount of noise made by anti-vaccine spokespeople hide the fact that they’re a very small minority.

Please, decide for yourself what’s best for your children. Rely on advice from people who know what they’re talking about, people who who’ve trusted for years for reliable health information. These decisions should not be made based on flippant whims and rumors.

Conclusion

Many pediatric practices have chosen to “ban” vaccine refusers from their practice. I can see their point of view—it takes a lot of extra time to talk with parents about these complex issues, and some parents become argumentative and, well, ugly about these things. Who wants a fight? The anti-vaccine lobby seems to create an endless stream of rumors and moving targets that are difficult to keep track of and continually swat back down. Besides, medical offices serve many patients with special health care needs, including newborns who are at special risk for vaccine-preventable diseases. Why put those kids at extra risk by allowing unvaccinated children nearby?

Countering this is my own philosophy, that it’s not the kids fault they’re not vaccinated; and with patience and continuous discussions, I can usually get even the most stubbornly misinformed parents to vaccinate. So finally, with a lot of extra work, the kids get protected. That’s my goal.

There should be no doubt that vaccines are very effective at preventing diseases, and are still necessary to prevent serious illnesses. Just one recent example: a study published in May, 2009 showed that unvaccinated kids were 23 times more likely to contract whooping cough than children who were fully vaccinated. Do not doubt that the diseases that are prevented by vaccines are themselves quite serious and sometimes deadly. There are certainly some side effects of vaccines, as there are with any medical intervention, and serious vaccine reactions, though very rare, do occur. In my judgment and that of every respected health care agency, world-wide, the benefits of vaccinations far ought weigh the risks. Please don’t fall for internet hysterics and unfounded rumors. Protect your kids, and make sure they’re fully vaccinated.

Further resources

An Epidemic of Fear: How Panicked Parents Skipping Shots Endangers Us All. From Wired magazine, 10/2009, about just how unhinged antivaccine groups have become, and how their unjustified influence could affect the health of your children.

A review by me of Paul Offit’s Autism’s False Prophets, a book that reviews the long history of anti-vaccine sentiment, and how a very small number of misguided and sometimes malicious characters have steered parts of the autism community to distrust doctors and shovel their money into pointless and sometimes dangerous quackery. The book also offers promising hope for further discovery into the causes and cures of autism.

John Stewart on the daily show with some humor to illustrate the rampant scaremongering that pervades media attention to vaccines.

From Science-Based Medicine, a very well-referenced resource reviewing all of the evidence and the history of the “controversy” regarding vaccines and autism.

Flu: To shot, or not

The Pediatric Insider © 2009 Roy Benaroch, MD

Good news: today, the FDA announced the approval of vaccines to prevent novel H1N1 influenza. It sounds like these immunizations will be available in the coming weeks, and studies in adults performed so far show excellent and rapid immune responses with minimal side effects. Studies looking at children are currently underway, and confirmation of the safety and effectiveness of these vaccines for all ages should be available by the time they’re distributed.

Phew.

My state has one of the highest rates of H1N1 influenza, probably thanks to our twisted, evil preoccupation with starting school too early (oddly, the school boards have not sought my opinion on this matter.) So we’ve been seeing dozens, maybe hundreds, of H1N1 cases in my office. The good news is that no one has been super-super-sick; the bad news is that many kids have been pretty-super-sick, and their parents and siblings are getting it too. Tamiflu can help some, if started early, but really hasn’t proven to be particularly effective. Probably better for most victims to just head to bed, and have chicken soup, tea with honey, and maybe a popsicle or two. Best case scenario: a 4 or 5 day illness, and hopefully no trips to the hospital for children or the parents when they get it.

Other parts of the country have barely started experiencing a spike in H1N1 cases, so the vaccine may indeed be able to avert a huge epidemic—if it’s distributed and used quickly. If a community can get a big chunk of its citizens vaccinated, especially the children, the spread of the virus can be halted.

That’s still a big if. It’s going to be logistically difficult to distribute enough doses of the vaccine quickly enough. Furthermore, some people seem reluctant to accept the vaccine.

Myth: This H1N1 vaccine is new, so it might not be safe.

Fact: Every year’s flu vaccine is “new,” in the sense that they’re made from different flu strains. But the technology and method to make them is identical from year to year, and has been identical for decades. Rates of adverse reactions, serious and non-serious, do not vary from year-to-year, and don’t seem to depend on the strains involved. Nonetheless, safety testing is an essential part of vaccine development, and the H1N1 vaccine has been tested both here and abroad in thousands of patients. Side effects are uncommon, and almost all of them have been very minor.

Myth: Some people “get the flu” from the vaccine.

Fact: The commonly used injected vaccine is not live, and cannot transmit influenza. A small percentage of people run a brief fever or feel a little achey after the flu shot, but that’s not nearly a full-blown case of the flu. The newer, nasal mist flu vaccine is a live vaccine, but the virus used has been adapted so it cannot survive at normal human body temperatures. It cannot transmit the flu.

Myth: Only people who are infirm or elderly get the flu; or only weak people die from the flu.

Fact: Though you’re more likely to die of flu if you have pre-existing illnesses like heart or lung disease, many healthy young adults get very seriously ill with influenza, especially in pandemic years like the one we’re having now.

The best ways to protect yourself and your children against the flu are to practice good hand washing and hygiene, to avoid sick people, and to get flu vaccinations. The flu vaccine not only protects the recipient, but also the whole family, and the community. Where uptake of flu vaccines has been good, there’s a dramatic drop in influenza cases for everyone—including very young babies, who can’t get vaccinated, yet are at very high risk of complications, and including the elderly, in whom vaccinations are ineffective.

It’s not clear now how much H1N1 vaccine can be distributed, or what risk groups will be targeted. It is clear that from a public health point of view, the most important vaccine recipients are school-aged children, because they serve as the reservoir and source of spread of infection for communities.

Right now, immunizations against other flu strains are available—though the injectable kind is running in short supply, as many manufacturers have focused their efforts on H1N1 vaccine. Please, if you have children, get a winter flu vaccine administered as soon as you can, and keep in touch with your pediatrician’s office to find out when H1N1 vaccine will be available in your community. We’re all in this together. Go get your shots.

Media scaremongering and Gardasil

The Pediatric Insider © 2009 Roy Benaroch, MD

Count on routine media outlets to mangle and misinterpret science news and information. The recent brouhaha over the Gardasil vaccine is a typical example of how science writers in big media are far more interested in making a splash than in conveying accurate, useful information.

On August 19, 2009, the Journal of the American Medical Association published “Postlicensure Safety Surveillance for Quadravelent Human Papillomavirus Recombinant Vaccine”, a study reviewing adverse events following administration of Gardasil. That’s Merck’s vaccine designed to prevent infections with the virus that causes genital warts and cervical cancer.

The article was pre-released 2 days early to news outlets, though not to physicians. As is typical, doctors don’t get to read these studies until after “the news” folds, spindles, and mutilates the story for a few days. By the time most physicians get to actually read the report, the news has moved on to some other crisis.

Some headlines, reflecting how the study was reported:

• From US News and World Report, Gardasil Side Effects Tough to Monitor.

• ABC news says Gardasil HPV Vaccine Faces Safety Questions.

• UPI (whose web site boasts “100 years of journalistic excellence,”) proclaimed Report Links Gardasil to Side Effects.

• Yahoo News, in a story from Time magazine, seems to have reached a different conclusion. Their headline reads HPV Vaccine: Study Suggests Gardasil is Safe.

Using the resources of my crack research team (I asked the librarian at Children’s Healthcare of Atlanta to send me a copy of the article, and I read it this past weekend), I can now reveal what the JAMA article actually said. As always, you can depend on me for true Pediatric Insider information.

But first, some required boring background information: infections with Human Papilloma Virus (HPV) are the root cause of genital warts and cervical cancer. This is by far the most common sexually transmitted disease, with almost 80% of US adult women having been infected at some point in their lives. Though most infections with HPV are successfully cleared by the immune system, some infections remain active for a long time, and can eventually lead to serious problems. The virus can also more rarely cause throat and oral cancers, anal problems, and nodules in the respiratory tract of babies that lead to serious, even fatal, respiratory problems.

In 2006 the FDA approved a vaccine called “Gardasil” that had been shown to prevent infections by 4 of the nearly 100 strains of HPV. These four were among the most common strains to cause cancer and warts, and probably account for about 70% of cases of cervical cancer in women.

The study reviewed all side effects reported to the Vaccine Adverse Event Reporting System, a passive government database. Anyone can report side effects to this database, including representatives from Merck (they reported more of the side effects than anyone else), medical personnel, or patients. Any sort of side effect can be reported at any time—the database is meant to cast as wide a net as possible, to collect any possible side effects.

About 23 million doses of Gardasil had been administered during the 2 ½ years of the study period. During that time, 12, 424 adverse events were reported, meaning one in 1850 doses. The most common reactions were fainting (14%), dizziness (14%), nausea (9%), and headache (8%). Of the 12,424 adverse events, 772 were considered “serious”—including allergic reactions, blood clots, and neurologic manifestations. That’s one in about 30,000 doses.

Press reports about this study invariably focused on deaths. The most widely quoted number was 32 deaths reported in the study; of those, 8 were second-hand reports that couldn’t be verified, and 4 didn’t include identifying information. There were 20 verified deaths reported to VAERS for which medical records could be reviewed. The cause of death among these 20 were:

• 4 – unexplained
• 2 – complications of diabetes mellitus*
• 1 – prescription drug overdose*
• 1 – amyotrophic lateral sclerosis (Lou Gehrig’s Disease)*
• 1- bacterial meningitis*
• 1 – influenza*
• 3 – pulmonary embolism; two of the cases were also taking contraceptive pills, a known risk factor for clotting. One of these was also a complication of diabetes mellitus (another cause of PE), but it’s unclear whether that person was also on contraceptives.*
• 6 – cardiac causes including arrhythmias
• 2 – seizures

(These total 21 because one reported case had 2 of these conditions.) I starred items that are clearly related to pre-existing or unrelated cases, though in some instances like the 2 with seizures, it’s not clear whether this was a preexisting problem or not. But liberally counting the ones that might have been caused by Gardasil, there were 12 deaths. Among 23 million doses. That’s one in about 2 million.

And it’s not at all clear that even these 12 deaths were in any way related to Gardasil. Though it seems heartless to say so, there are always some deaths among any group of people, even healthy young adults. I couldn’t find an exact expected death rate for women aged 9-26 (that’s the ages where Gardasil is licensed), but just for comparison I did find the death rate for teenagers 15-19—nationwide in the US, it’s 65 per 100,000 per four years. Assuming ~ 10 million different women got Gardasil over the 2 ½ year period of the study (each patient is supposed to get 3 doses, but most in fact get only 1 or 2), if the death rate of 9-26 year old women is the same as the death rate of 15-19 year old teens (or at least in that ballpark, which is reasonable to assume) then you’d expect (2 ½ * 65 * 10,000,000)/(100 000*4) deaths during the study period, or 4065 deaths. Even if you assume about ½ of these were from car accidents, homicide, and suicide (these are the leading causes of death at that age, though violent death is more common in males), that would still mean you’d expect about 2,000 deaths to be reported.

2,000 deaths expected. But only 32 were reported. This is good news, right? From a statistical point of view, the reported deaths were very much within the rate of deaths that’s expected—in fact, it was far, far lower.

Now, there are some reasonable criticisms of the study. It’s entirely possible that some deaths went unreported—this is a passive system, and someone has to take the time to report deaths. However, after such a dramatic and serious event as a death you’d think at least most families and physicians would make a report. But let’s even assume that only 1 in ten deaths was reported—even then, if there really were 320 deaths rather than 32, that’s still far less than the expected ballpark “background” death rate of 2,000.

Though press reports concentrated on the reported deaths, when you look at the study and the actual numbers the only reasonable conclusion is that there is no increased risk of death after vaccination with Gardasil. Oddly, few of the mass-media outlets reported the study that way.

Of the 772 reported serious reactions, many were self-limited, and many, like the deaths, were clearly not related to vaccination. Clearly, however, this are some true side effects; like any medical intervention, Gardasil has both risks and benefits. But it’s good to know that serious reactions are so rare.

Of the adverse events that did occur at relatively high rates, fainting is one that we ought to be watching out for. If a girl faints after a dose of vaccine, she can fall and hit her head or otherwise injure herself—in fact, that was the most common of the 772 “serious” side effects, an injury after a fall following fainting. For this reason, Gardasil should be administered while the patient is lying down, and afterwards it’s a good idea to stay lying down for about 5 minutes. Note that teenagers, male and female, are apt to faint after other vaccines, blood draws, and other medical procedures, so lying down after any sort of shot is probably a good idea.

There are some important questions about Gardasil that still need answers. It’s unclear how long protection will last, and it’s unclear how Gardasil immunization will effect rates of cervical cancer many years later—those studies just haven’t been done yet, because they take so much time. Reasonable families, given these unknowns, may have misgivings about immunizing now against a disease that shows up so much later. Gardasil vaccination is also very, very expensive—at least $400 for the three doses, and considering that cervical cancer is not common, and can be screened for with pap smears, there may be better uses for these health care dollars. Still, from a safety point of view, the recently published study is very reassuring, and very good news for families considering this vaccine. Too bad many in the press didn’t bother to get their facts straight to present the study in a truthful manner.

A good week for science & parents

It was a good week for science, and a good week for parents. In the long run, it will have been a good week for the many families struggling with children who have autistic-spectrum disorders.

News #1: The entire MMR-autism link has been resting on a study that has now been revealed to be entirely fraudulent. Andrew Wakefield published a paper in The Lancet involving twelve children in 1998. In it, he claimed that they developed autistic behavior very shortly after receiving their MMR vaccinations. He formulated a new theory, that the MMR vaccine caused gut damage that allowed foreign proteins to invade, triggering autism.

This study has been widely refuted, and The Lancet has retracted the paper based on revelations that Dr. Wakefield didn’t reveal money he was taking from plaintiffs’ attorneys seeking damages based on an MMR-autism link. Furthermore, his study has never been replicated; several labs have tried, with uniformly negative results. His own technicians have testified that their results differed from what was published in the paper, and Dr. Wakefield has refused to share his original data or biopsy specimens. Almost all of the co-authors of this paper have seen recanted and asked for their names to be removed.

And now, the nail in the coffin: a reporter has uncovered documents showing that Dr. Wakefield made everything up. The children in the paper didn’t have autism after the vaccines; most already had abnormal symptoms well before receiving the vaccine. And their gut pathology specimens didn’t show any inflammation at all. They were entirely normal, according to hospital records and pathologists reports.

Dr. Wakefield’s study, upon which the entire MMR-autism link was founded, is a fraud. He took money to make up data, and it turns out shortly before publication he sought to patent a new kind of measles vaccine—so he stood to profit mightily by scaring the public away from the existing MMR.

Now, measles is no longer considered “controlled” in Great Britain. As vaccination rates have fallen, the disease is back. Here in the USA, outbreaks of measles and mumps are common.

All the result of the greed of a single man.

For details, with plenty of links to the source material: http://scienceblogs.com/insolence/2009/02/why_am_i_not_surprised_it_looks_as_thoug.php

News #2: The United States “vaccine court” has unequivocally rejected the possibility that the MMR vaccine causes autism. In very strong language, the ‘special masters’ (essentially judges) in the case declared that the scientific evidence overwhelmingly supported the safety of the MMR vaccine.

short summary:

http://www.webmd.com/brain/autism/news/20090212/vaccine-court-rejects-autism-claims

more details, including several quotes from the ruling:

http://www.theness.com/neurologicablog/?p=478

I’d like to say that this should be the end of the MMR hysteria, which I’ve written about before. Unfortunately, the anti-vax movement includes a truly delusional fringe that rejects any sort of science, and certainly isn’t going to care that their entire foundation is a lie. But I’ve found that most parents just want to do the right thing, and with good solid information they’re eager to protect their children. Good for them, and good for all of us.

Best of all, perhaps we can move beyond the entirely discredited vaccine-scare theory and spend more time and research dollars looking into what really does cause autism. That should be a rallying cry of hope for suffering families and their children. It’s time to move on, together, to find a cause and a cure.

For a detailed historical account of autism and the many sleazeballs who’ve taken advantage of suffering families for their own egos and wealth, read Paul Offit’s Autism’s False Prophets, reviewed here.

Book review: Autism’s False Prophets

“A lie gets halfway around the world before the truth has a chance to get its pants on.” – Winston Churchill

The scientific and medical community, finally, has got its pants on.

Don’t split the vaccines

Brook asked a good question: “I am curious to learn more about the timing and combining of multiple vaccines. As a disclaimer, may I please add – I do not fear vaccines, and I certainly think they are helpful and necessary as opposed to harmful to my children. I read that the CDC recommends that the MMR, DTAP, IPV, & Varivax vaccines be administered between the ages of 4 years and 6 years. My pediatric group recommends that all four vaccines be administered at the same visit at the age of 4 years. I wonder why they aren’t spaced such that 2 shots are given at 4 years and 2 shots at 5 years or something similar. Are there advantages to spacing the vaccines? Are there risks in administering multiple vaccines in one visit? Are the shots administered in each of the limbs? Any insight you could offer would be greatly appreciated. I am not sure if I should request that the vaccines be administered over 2 or 3 visits to make sure my child’s immune system isn’t overburdened and he fully benefits from them.”

Giving these vaccines poses no added risk versus giving them all at once, and as a pediatrician who has supervised vaccinations for many years, I’ll tell you that it’s much, much easier on the child to get them all over with at once.

Welcome back, Measles

(with apologies to Gabe Kaplan and the Sweathogs)

Welcome back,

We had a vaccine to knock you out.

Welcome back,

They’re the same families who once laughed about.

Though it’s safe, MMR, it’s been kicked around

You waited for your chance, now you’re back around.

Who’d have thought we’d meet you? (Who’d have thought we’d meet you?)

We’d already beat you. (We’d already beat you.)

The mortality’s a lot, yeah it’s more than just some spots

Welcome back.

Welcome back, welcome back, welcome back.

It’s a travesty. A vocal but entirely misguided minority is succeeding in bringing back a once-vanquished, deadly disease. Measles is truly back, in the United States, Great Britain, and other countries where anti-MMR hysteria has replaced sound science and good thinking.

For more details about how bad science, money, and media hysteria combined to create the illusion that there is controversy whether MMR is safe, read this detailed and very revealing account.