Health policy is best when it stands on the shoulders of rigorous scientific research—for example, restricting tobacco makes sense because it’s proven to reduce cancer rates and mortality. But sometimes health policy is built on a slightly shakier premise; one that balances sound science with the need to avoid controversy. The government’s policy on the pandemic swine flu vaccine is an example of this latter approach.
The decision to make the vaccine voluntary for health care workers (except in New York) is one way the government has avoided public outcry. The decision by the Center for Disease Control to not add adjuvants—substances that activate the immune system and make the vaccines more powerful—to the shots, even though doing so would have helped alleviate the delays and shortages we are currently experiencing, is another. Neither of these decisions was rooted in evidence-based concerns about public safety. And they ultimately reduce the widespread health benefits of the vaccination campaign.
As I discussed in this post, if health care workers aren’t vaccinated they run the risk of infecting their vulnerable patients. And as Scott Gottleib pointed out in the Wall Street Journal;
“Adjuvants allow a smaller supply of vaccine stock to be stretched across more doses. These adjuvants are included in H1N1 vaccines world-wide, but not in the U.S….An adjuvanted H1N1 vaccine being used in Europe contains 3.75 micrograms of vaccine stock. The same vaccine in the U.S., without the adjuvant, requires 15 micrograms of vaccine for equal potency. If we used adjuvants, we could have had four times the number of shots with the same raw material.”
The government is right in yielding to caution when it comes to vaccines. After all, we are asking healthy young people (not to mention pregnant women and babies) to be vaccinated for a disease that is widespread, but not overwhelmingly lethal. But the policy decisions health officials made about the H1N1 shots also reflect their understanding that the public still has ambivalence about vaccines in general. The number of vaccine “decliners”—parents who refuse to have their children vaccinated—has grown, as has the level of pseudoscience and misinformation in the media.
Take the case of adjuvants. This summer the CDC released a statement that announced the agency's policy–and it was recently reiterated on the agency's website;
“[O]nly unadjuvanted vaccines will be used in the United States during the 2009 flu season. This includes all of the 2009 H1N1 and seasonal influenza vaccines that will be available for children and adults in both the injectable and nasal spray formulations. None of these influenza vaccines will contain adjuvants.
2009 H1N1 vaccines with adjuvants are being studied to determine if they are safe and effective. Experts will review these data when they are available. There is no plan at this time to recommend a 2009 H1N1 influenza vaccine with an adjuvant.”
Despite this statement, reports that the H1N1 vaccine contains adjuvants and high levels of thimerasol—a preservative that has been linked by vaccine-opponents to autism—are still rampant on the Internet and even in media reports. Dr. Kent Holtorf, an “infectious disease expert” is one oft-quoted source who makes these false charges weekly on Fox News and on conservative talk radio. This “board certified endocrinologist” believes that “the swine flu vaccine is more dangerous than the disease itself” and seems to be the only person these shows can find to whip up the public fervor against vaccination.
Fox News was also the source of the well-publicized story of Desiree Jennings, a comely, 25-year-old cheerleader for the Washington Redskins who reportedly was stricken with dystonia—a serious neurological and muscular illness—ten days after receiving a seasonal flu shot. A video of Jennings, speaking in a stilted, halting voice, struggling to tell her story was broadcast around the world and she became the poster child for anti-vaccine activists; living proof that the shots were just plain dangerous.
The only problem, according to this post by Steven Novella, a neurologist at Yale’s School of Medicine, for his blog NeuroLogica, virtually all neurologists disagreed with that assessment and insisted that Ms. Jennings had a “psychogenic movement disorder,” (i.e. a psychological condition) not dystonia. Then patient advocates for the dystonia community got involved, forcing Fox to run a follow-up story that included interviews with experts who said Jennings did not, in fact, have dystonia. Still, the video is all over the Internet and the damage is done to the public’s perception of the shot’s safety.
In many ways, distrust of the swine flu vaccine has its roots in controversy over the anthrax vaccine, a shot that is mandatory for most of the nation’s armed forces. In the early 1990’s, that vaccine was linked to Gulf War Syndrome, a multi-symptom condition that includes chronic fatigue, muscle pain, neurological problems and skin rashes and is believed to affect one in four Gulf War veterans
The suspect in this case was squalene, a naturally-occurring substance derived from shark liver oil that was believed to be used by the military as an adjuvant in the anthrax vaccine. The military denied using squalene in the shots, but in one study, blood tests confirmed that a large portion of those personnel suffering from the syndrome had circulating antibodies to squalene.
Since then, investigations have shown that 1) the anthrax vaccine provided to the military did not use squalene as an adjuvant ingredient and 2) since squalene is made by the liver and present in many products, most people naturally have antibodies to squalene circulating in their blood. Many studies have found no association between squalene and Gulf War syndrome; the most recent of which ran in the May 2009 issue of the journal Vaccine.
Yet, if you go to any number of “natural health” websites or those associated with anti-vaccine groups, you will still see undisputed charges that Gulf War Syndrome is due to the anthrax vaccine and that the H1N1 vaccine contains squalene. In fact, the vaccine distributed worldwide by WHO and other international agencies does contain squalene—as have most of the seasonal influenza vaccines available for many years in this country. But, as noted above, the CDC made a conscious decision to not use squalene, or any other adjuvant, in the swine flu vaccine.
Of course, fear of the swine flu vaccine also has roots in the lingering charge that vaccines cause autism. Study after study shows no link between vaccines and autism, and organizations like the Institute of Medicine, the World Health Organization, the Food and Drug Administration, and the American Academy of Pediatrics, have explicitly rejected the possibility of a link.
For years the focus of some autism advocates was on the mercury-based preservative thimerasol as the culprit. It’s worth noting that thimerasol has not been used in childhood vaccines since 2001 and autism rates continue to increase every year. The latest focus for vaccine opponents is the claim that it’s the growing number of vaccines required for each child that causes autism—a charge that again, has yet to be backed up by science. Still, the CDC decided to avoid controversy and focused on providing the nasally-administered versions of the H1N1 vaccine and single dose vials because they do not contain thimerasol.
In the end, the government has taken the path of least resistance when it comes to swine flu this year. That is probably the most expedient path—but I think eventually we will need to sort out the rampant misinformation concerning vaccine safety in this country. There will undoubtedly be other—perhaps more deadly—viral epidemics emerging in the future. Developing a national program that focuses on better vaccine manufacturing techniques and identifying the safest and most effective vaccine ingredients like adjuvants and preservatives before the next crisis hits is very important. It
is also important to have a national program to confront the pseudoscience and misinformation surrounding the vaccine issue.
Vaccines are an important defense against infectious disease. And we should be worried that long-gone diseases like measles, mumps, whooping cough and diphtheria could make a comeback. But there’s more. By ceaselessly focusing on the vaccine link to autism, Gulf War syndrome and other assorted ills, we are prevented from delving more deeply into finding the true cause—or more likely, mix of causes both environmental and genetic—of these troubling illnesses.
I received both the seasonal and the H1N1 vaccine this fall. In general, I am a believer in vaccines and get the flu vaccine (almost) every year.
However, I recently read a well written article in the November issue of the Atlantic that asked the question: “How effective is the flu vaccine in preventing flu”. The answer appears to be a lot less clear than I thought.
I recommend this article to those that wish to give serious consideration to our policy about the flu vaccine and anti-viral therapy.
Some worrisome new studies on the safety of vaccines—-
A New study out shows male infants who got vaccinated had a 3 fold increase in autism.
Hepatitis B Vaccination of Male Neonates and Autism
Annals of Epidemiology, Volume 19, Issue 9, Pages 659-659
C. Gallagher, M. Goodman
Another new study out this week showed a single does of thimerasol containing vaccine caused developmental delay in all the primates it was given to.
Neurotoxicology. 2009 Oct 2. [Epub ahead of print]
Delayed acquisition of neonatal reflexes in newborn primates receiving a thimerosal-containing Hepatitis B vaccine: Influence of gestational age and birth weight.
Hewitson L, Houser LA, Stott C, Sackett G, Tomko JL, Atwood D, Blue L, Railey White E, Wakefield AJ.
While there are some studies that do not show an association, negative studies do not prove that there is no association, only that in that study there was less than a 95% chance that there was a cause and effect. So if the study found that that there was a say 50%, 80% or 90% chance that vaccines caused the condition in question the study is considered negative. It is not proving there is no association. You cannot ignore the data.
Looking at the science, there is certainly reason to have concerns of the vaccines.
Stephanie,
Here is information from Johns Hopkins University School of Public Health on the safety profile of the Hepatitis B vaccine, including announcements from the CDC from 1999 about the availability of a preservative-free Hep-B vaccine for infants. The vaccine given to infants hasn’t contained thimerasol since 2001.
http://vaccinesafety.edu/cc-hepb.htm
As to this study that purports to show a 3-fold higher incidence of autism in boys who received the Hep-b vaccine: 1) it was a poster displayed at a conference, 2) there are many problems with the way the study was conducted, data was analyzed, etc. For example, the autism group had only 33 kids total. Of these, 9 of 31 (29%) were given the HepB vaccine. Compare this to 1,258 of 7,455 (17%) of the non-autism group who were given the HepB. Also, many of the boys studied were born before the Hep-b vax was introduced. The other recent study anti-vax folks point to as providing evidence that the Hep-b vax causes autism involves monkeys given the vaccine at birth. The only problem is that the Hep-b vax hasn’t contained thimerasol since 2001 so the researchers had to add it to the commercial vaccine they used in the study. Finally see this post from the Respectful Insolence blog that provides an exhaustive critique of this and other such anti-vax studies, http://scienceblogs.com/insolence/2009/10/some_monkey_business_in_autism_research_1.php
The point of my post was really to highlight what a colossal waste of time/intellectual energy this insistence on the harmful role of vaccines in serious problems like Gulf War syndrome and autism. We need to find the real answers to what is causing such suffering not trying to twist data to fit our ideological leanings.
Legacy Flyer,
I have read the Atlantic piece and while it raises interesting issues, it is really about basic research and doesn’t impact health policy.
Naomi,
The idea that “basic research” shouldn’t have an effect on “health policy” is a strange one.
Some of the authors quoted in the Atlantic study raise the question of whether the flu vaccine is effective. This question cannot be ignored if we hope to have a rational, evidence based policy on immunization for the flu.
There are problems with all studiees so you cannot ignore the data because it is not what fits your agenda.
Studies show that the biggest influence on the results of randomized controlled trials are who funds it, some showing that it is 300% more likely to be favorable for the funding company.
Association between industry funding
and statistically significant pro-industry findings
in medical and surgical randomized trials
CMAJ • FEB. 17, 2004; 170 (4)
Reported Outcomes in Major Cardiovascular
Clinical Trials Funded by For-Profit and
Not-for-Profit Organizations: 2000-2005
JAMA. 2006;295:2270-2274
You say it is a harmful waste of time to find the truth? Any person can say simple things like it is never been proven that the earth is round and attack any study to the contrary. None are so blind as those who don’t want to see!
An excellent and temperate analysis of the need to strike a balance between optimal science and public acceptance. Even so, vaccine conspiracy theories are unlikely ever to die, and so “eternal vigilance” is the price of adequate vaccination as it is the price of liberty.
The concern that thimerosal poses a danger to human vaccinees has been analyzed in extraordinary detail, based on data from a large multitude of studies, and the evidence for its safety is now incontrovertible, but we will continue to see challenges. This illustrates a problem with deference to public opinion. When thimerosal concerns were first widely circulated, it was already known to be safe, but to appease the public, the CDC decided to eliminate it from many vaccines. The result was not the sigh of relief one might have expected, but rather a cry of “See, we knew it all along. What else are they hiding from us?” from the conspiracy addicts. At this point, it is probably best simply to state calmly that the issue is settled, refer to appropriate literature when necessary, and let those who refuse to believe remain unpersuaded.
The safety and efficacy of influenza vaccination is also established beyond any reasonable controversy in the scientific literature. I reviewed this subject here on October 15 in commenting on another blog from Naomi, and anyone interested in the data should visit that blog on swine flu for the details.
More on swine flu vaccination here –
http://tpmcafe.talkingpointsmemo.com/talk/blogs/fredmoolten/2009/10/faith-healing-does-not-prevent.php
Fred,
Have you read the recent article in the Atlantic about the efficacy of flu vaccines and anti-virals?
What is your opinion of the information presented there?
Legacy – I read the Atlantic article, reviewed the relevant literature including an important BMJ study, and discussed this topic previously – here on October 15 in a comment on Naomi’s earlier blog on swine flu, and in the TPM blog I linked to regarding the current blog. In my judgment, the article made serious misstatements, and did not provide efficacy data to challenge abundant evidence that influenza vaccination is safe and effective. The one legitimate point I thought it made, after I reviewed the literature, is the uncertainty about the efficacy of seasonal flu vaccination in the very elderly, where in fact it may not be very effective because of inadequate immune responses in this group. In other populations, including the “younger elderly” (e.g., age 60-75) vaccine efficacy appears to be well confirmed. The article did not directly address studies on the swine flu vaccine, but I provided links to several sources demonstrating its efficacy and safety, and additional confirmatory safety data have since emerged. See the reference to the NEJM article I had cited for some very recent efficacy data.
I have not similarly reviewed studies on the efficacy of the antivirals. I have heard anecdotal reports of efficacy, but not looked at data from controlled trials, although I think there is probably evidence on this point from clinical trials.
An addendum to my just-posted comments on flu vaccines hasn’t appeared, so I’ll repeat it, with apologies if it turns out to be a duplication. I just wanted to add a reference to a very recent NEJM paper that I probably didn’t reference in earlier discussions. It provides evidence for the immunologic efficacy of the H1N1 vaccine, and implies clinical efficacy by analogy with seasonal flu vaccines of comparable immunologic potency. More direct clinical evidence probably won’t be available for many months. The NEJM reference is
http://content.nejm.org/cgi/content/full/NEJMoa0907413
Some vaccines are critical. Flu vaccines are generally not. Flu is usually a self-limiting disease that does not kill people or leave them permanantly damaged. (please dont’t bring up 1918-20 which is being re-studied)
The 35,000 season “flu deaths” that the CDC reports per year is dishonest.
These are usually frail and elderly people many of whom are already dying.
Dr. Rick Lippin
Southampton,Pa
Fred,
Thanks. As I said, I get the flu vaccine every year and encourage my wife to do the same. I have no worries about the safety of the vaccine, but the Atlantic article raised questions about the efficacy.
One of the points that the Atlantic article raised that resonated with me is that because the flu vaccine is considered to be effective, it becomes
“unethical” to do a controlled trial of its effectiveness.
Just got back from a conference on Emergency Radiology. As you probably know, in the US, immobilization is the “standard of care” for spine fractures. I am sure it would be considered “unethical” not to immobilize someone with a spine fracture because we “know” it helps prevent further injury. It turns out that in Malaysia, they don’t “know” about immobilization and don’t practice it. I am sure that you have guessed the punchline – their results are equivalent to ours, patients that are not immobilized (in Malaysia) appear to do just as well as those that are (in the US).
Do you think you could get a study in which you randomly assigned patients to be immobilized or not through your IRB?
Legacy Flyer – You raise an important point. Controlled trials have in fact been done to demonstrate the immunologic effectiveness of flu vaccines – i.e, the generation of neutralizing antibodies. By extension, this implies clinical effectiveness because of the known correlation between antibody levels and resistance to infection by most viruses, including influenza, as well as the ability of antibodies to neutralize viruses in vitro.
It may not be ethical, but in any case is impractical to conduct large scale population studies on the clinical effectiveness of flu vaccines. In theory, one could conduct small scale trials – e.g., in a nursing home – but that would probably not pass an IRB.
However, controlled trials are not the only means of assessing effectiveness. The many epidemiologic studies that are in the literature attest to the correlation between vaccination and resistance to illness and death from influenza. By themselves, they are persuasive but not conclusive. In conjunction with the immunologic studies, however, they would put an enormous burden of proof on anybody who would interpret their results in any other way.
I’ll also take the opportunity here to respond to Rick Lippin’s comments. The recognition that influenza is a killer of major proportions is not limited to the CDC or to the United States, but is shared worldwide, within the health services of European nations, by the WHO, and elsewhere. The case fatality rate is low, but fatalities are high because of the huge number of cases spawned by an epidemic. With the current swine flu epidemic, the most vulnerable are not the elderly, who probably have some residual immunity from earlier H1N1 viruses, but rather children and young adults. Hundreds of children and thousands of adults have already died, and more deaths are expected. I believe it would be irresponsible not to recommend vaccination for those who are at risk.
Nice post, thanks for sharing this wonderful and usefull information with us.
An excellent and temperate analysis of the need to strike a balance between optimal science and public acceptance. Even so, vaccine conspiracy theories are unlikely ever to die, and so “eternal vigilance” is the price of adequate vaccination as it is the price of liberty.
Green Tea
I believe everyone should get a H1N1 flu Vaccine shots except anyone who’s ever had a severe reaction to a flu vaccination, infants under 6 months old and anyone with a fever. If your child does need a flu shot, your pediatrician is the best place to start looking, but if they aren’t offering flu vaccine this year, you might check with your local health department, hospital, or pharmacies, and get one wherever you can.
How nice to read an article that is so detailed and scientific,by someone
who seems to lean to the left, poltically.
I hope some of my Liberal friends will take the time to read this, instead of the sensationalist fruitloop garbage posted all over the net, which seems to be based on research that is 5-10 years old!
Simple question I must ask: What is the profitability of the vaccine and how much of a driver is that to the economy and any group involved in putting money in their pockets. I am sure the intention with some groups are good, whereas others are driven by monetary needs. Things easily get skewed by money. Also, the Long term effect… obviously unknown.
The percentage of CFS patients who recover is unknown, but there is some evidence to indicate that the sooner symptom management begins, the better the chance of a positive therapeutic outcome. This means early detection and treatment are of utmost importance. CDC research indicates that delays in diagnosis and treatment may complicate and prolong the clinical course of the illness.
Great site,this information really helped me , I really appreciate it. Thanks a lot for a bunch of good tips.
On December 15, 2009, One of the five manufacturers supplying the H1N1 vaccine to the United States recalled thousands of doses because they were not as potent as expected. The French manufacturer Sanofi Pasteur voluntarily recalled about 800,000 doses of vaccine meant for children between the ages of six months and 35 months. The company and the Centers for Disease Control and Prevention(CDC) emphasized that the recall was not prompted by safety concerns, and that even though the vaccine is not quite as potent as it is supposed to be, children who received it do not need to be immunized again.
However, I recently read a well written article in the November issue of the Atlantic that asked the question: “How effective is the flu vaccine in preventing flu”. The answer appears to be a lot less clear than I thought.
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