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H1N1 Update

I know we have been focusing on the vaccine issue extensively, but this is crunch time and the anti-vaccine forces are relentless. We are now facing a regular seasonal flu spiked with the H1N1 pandemic. Our best weapon against morbidity and mortality caused by the flu is information, and yet the public is being barraged with misinformation designed to encourage poor choices and thereby result in maximal morbidity and mortality.

I confess I was never impressed with FDR’s famous quip, “All we have to fear is fear itself,” – I think there is plenty else to fear. But his sentiment is very appropriate to the current situation – fear mongering around the seasonal flu and H1N1 vaccines is what we have most to fear.

And of course, as is almost always the case, accurate information is complex and requires a nuanced understanding. This creates uncertainty, which is easy to exploit to manufacture unreasonable fear.

The anti-vaccine fear mongers are playing every card in the deck. They are arguing (falsely) that H1N1 is not severe enough to warrant getting the vaccine, that the vaccine does not work anyway, and that there are unacceptable or unknown risks to the vaccine. In the most extreme cases, bizarre conspiracy theories are brought to bear, but I will not discuss these here as anyone compelled by such fantasies is likely beyond the reach of any information I could provide.

Mark Crislip has already provided an excellent overview of the evidence for seasonal flu vaccine efficacy in adults. To summarize – the evidence is complex and mixed, but there is compelling evidence that the flu vaccine works as designed, in that it produces protective antibodies against influenza. There is also evidence that it decreases morbidity and complications from the flu, although it is less clear if it decreases the number of flu cases. Further, the efficacy of the vaccine depends highly on how well the strains vaccinated against match the circulating strains.

Efficacy also depends highly on compliance – the percentage of the population (especially those likely to spread the flu to vulnerable populations) who get the vaccine.

The bottom line is that the vaccine works enough to make it worthwhile, and it is extremely safe. At a time when health care costs are crushing our economy, it is also worth pointing out that it is cost effective.

And yet confidence in the H1N1 vaccine is decreasing under the onslaught of scare mongering and misinformation. A recent survey of UK nurses found that 47 percent do not plan on getting the H1N1 vaccine, while only 23 percent said they would. This is concerning because health care workers are perceived as having more authority with the public, and because protecting the sick and elderly likely depends most on their health care providers getting vaccinated.

It is also important to note that the H1N1 vaccine has a big advantage over the seasonal flu vaccine – the match between the vaccine and the circulating virus is high. This is perhaps the biggest predictor of efficacy for the flu vaccine.

How Bad Is It?

The evidence so far indicates that, as predicted, H1N1 is now making its second circuit through Western countries, including the UK, Canada, and US. The CDC reports that flu cases are increasing rapidly, and are exceeding the normal number of cases that would be seen at this time of year from the seasonal flu. By all reports, we are in for a heavy flu season. It does not look like the 1918-1919 pandemic, but a bad flu season is still a concern. The average flu season kills 30,000 Americans and 500,000 worldwide.

Statistics from August 30 to October 3 in the US indicate: Influenza and Pneumonia Syndrome – 12,384 hospitalizations and 1,544 deaths, of those influenza was confirmed in laboratory tests in 3,874 and 240 respectively.

Compared to the seasonal flu H1N1 is about as deadly overall, but kills a higher proportion of those who are otherwise young and healthy, and also is more deadly for pregnant women. About 1% of people infected with H1N1 get a severe form of the flu likely requiring hospitalization and at high risk of death.

Is the vaccine safe?

There is a range of concerns that have been raised about the vaccine. These range from those that are reasonable and should be raised about any new intervention at one end, to outrageous conspiracy mongering at the other. Of course, those who raise appropriate concerns hate to be painted with the same brush as the conspiracy theorists, and so I will make that distinction at the outset. And, as stated above, the conspiracy theories are beyond the scope of this entry.

I would file under appropriate concerns the fact that the previous H1N1 pandemic vaccine from 1976 resulted in an increased risk of Guillain Barre Syndrome (GBS) – about 1 per 100,000 people vaccinated. The seasonal flu vaccine in the last 32 years has resulted in excess cases of GBS of about 1 in 1 million. While we expect that the H1N1 vaccine will likely have the same risk of GBS as the seasonal flu vaccine, the US and UK have instituted monitoring systems (essentially encouraging doctors to report cases of GBS following vaccination) as an early warning if the H1N1 vaccine has a higher risk of GBS.

I discuss the issue of GBS in more detail here, but the bottom line is that the risk of GBS ranges from low to very low, and it will be monitored. Also, early experience with the H1N1 vaccine has not resulted in any cases of GBS, so at the very least the risk is not high.

Most of the concerns brought up about the H1N1 vaccine I consider to be unreasonable fear mongering. For example, anti-vaccinationists have tried to raise fears about adjuvants in the vaccine. They consistently fail to point out that the versions of the vaccine approved by the FDA for use in the US do not contain adjuvants.

Adjuvants are substances added to vaccine to increase the immune response. This allows for the use of less viral material in the vaccine. Vaccine adjuvants are all extensively tested and are generally safe. Any reactions are extremely rares, and certainly much less likely than morbidity from the disease the vaccine is targeting.

Harriet Hall has already addressed the fear mongering surrounding squalene and other adjuvants here, and David Gorski addresses similar concerns here.

Another concern that is brought up is that one can get sick from the vaccine itself. Bill Maher infamously stated recently on his show that the vaccine “injects disease” into the arm. The injectible version of the vaccine does not contain “disease” – it is a killed virus vaccine, and it is impossible to get the flu from the vaccine. The nasal spray vaccine does contain a live virus, but it is an attenuated virus – meaning that it is weakened so as not to cause illness but only to provoke an immune response. There is a small risk that attenuated viruses will spontaneously mutate and revert back to a more virulent form, but the risk is very small.

And, of course, the now classic vaccine scare mongering regarding thimerosal, a mercury-based preservative, is being trotted out. These claims are wrong on multiple levels. We have already dealt extensively with the false claim that thimerosal is unsafe. A thorough review and reference list can be found here. Thimerosal is safe in the doses used in vaccines.

Further, the single-shot version of the seasonal and H1N1 flu vaccines, and the nasal vaccine, all do not contain any thimerosal. Thimerosal is only used in the multi-shot version of the vaccine, to prevent contamination.

Conclusion

While there is uncertainty and reasonable concerns regarding the flu vaccine, and more research is welcome, current evidence is sufficient to recommend that the vaccine is safe and effective. The bottom line with any medical intervention is risk vs benefit. The benefit of the H1N1 vaccine far outweighs the minimal risk.

Further, the more people who get the vaccine the more effective it will be. At this rate, we are unlikely to achieve herd immunity, but everyone who gets vaccinated will not only provide themselves with a level of protection, but will also protect those around them.

It is still too early to tell how severe the H1N1 pandemic will be, but at least it will result in a bad flu season. It is also clear at this point that the pandemic will be significantly worsened by fear-mongering against the most effective defense we have against the flu – the vaccine.

There is a body count attached to this unreasonable fear, justifying FDR’s famous words.

Posted in: Public Health, Vaccines

Leave a Comment (132) ↓

132 thoughts on “H1N1 Update

  1. Draal says:

    Flu vaccines induces a immune response resulting in antibodies against the flu. No doubt about it. The evidence supports that vaccination will prevent cases of infection by around 50%. I can point to a number of studies that conclude that the percent cases with flu symptoms do not decrease, and I bet there are ones that do. Does vaccination provide 75-100% effectiveness against a specific flu virus? Not likely.

    I have to agree that the data is a tiny bit lacking. There is no double-blind flu vaccine study on mortality rates. Support that it does is based on meta-analysis. There will never be a double blind flu vaccine trial on the high risk groups in the US (the ones that make up the majority of 30,000/yr deaths related to the flu). So I am not 100% convinced that the flu vaccine prevents deaths.

    So what got me thinking last night was: Not all virus vaccines work. What came to mind are HIV and Hep C. Tested HIV vaccines do in fact induce an immune response. Does it work? Not to my knowledge. But just because there is a proven antibody response to a vaccine does not equal immunity.
    Common knowledge says that the flu viruses are constantly mutating year to year (that’s why a new vaccine is produced each year). That reminded me of the HIV too. The influenza and HIV are two separate classes of viruses for sure but both can mutate and evade the immune system.

    A little clarification to put my doubt to rest would be greatly appreciated.

  2. Draal says:

    Just to throw this out there….
    1/3 of the costs of health care are attributed to unnecessary procedures. The government has spent billions of dollars stockpiling anti-virus medicines and ordering vaccines.
    Is there any economic data that proves preventative flu vaccine costs are lower than the cost of hospitalization of flu patients? On the surface that sounds a bit morbid but when it comes to health care costs it’s important. There are studies that unequivocally find that more medical procedures does NOT equal lower mortality rates. In fact, more procedures equals more chances of complications and human error. As much as we pay for health care, we are ~35 in the world in life expectancy.
    On a fee per bases system, doctors are making money by prescribing more procedures including unnecessary ones. So if you plan on getting the flu vaccine, get it from the state clinics for free and stick it to those greedy doctors. Help lower health care costs!

  3. Ed Whitney says:

    For mortality rates, the issue is not “double-blind” but rather whether the studies are well randomized. Mortality studies do not really require blinding of the observers to the treatment group, unless there is to be a Monty Python-like “dead parrot” disagreement between observers as to the status of a patient.

    Randomization issues are, however, critically important, since observational studies are vulnerable to the “healthy user” effect, in which there is preferential selection of vaccine by healthier adults who are at lower risk of all-cause mortality. Perhaps some later comments will throw light on this difficult issue.

  4. gaiainc says:

    Draal: “So if you plan on getting the flu vaccine, get it from the state clinics for free and stick it to those greedy doctors. Help lower health care costs!”

    I hope you are being facetious, because really, providing the flu vaccine doesn’t make doctors a huge amount of money. Probably somewhere around $0.5-1 (and I am pulling this number out of my butt). Not that it will really matter this influenza season as the CDC saw fit to prioritize community pharmacies in receiving the seasonal flu vaccine rather than medical centers. I have heard the reasoning, I don’t agree, but I’m not the CDC in charge of distribution.

  5. SF Mom and Scientist says:

    Draal – in general, preventative medicine is highly cost-effective. The cost of a flu shot is low compared to treating the flu, and also compared to time lost due to illness. In a lot of large companies, flu shots are given to employees for free, because it the cost of the flu shot is much less than the cost of lost days of work.

    I am really sick of hearing people talk about “greedy doctors”. The doctors who administer flu shots are generally pediatricians and primary care doctors. When I take my son to the pediatrician, I am shocked at how little he gets paid between our co-pay and what insurance pays. I’m not sure how many “greedy” people would go to school for years, gathering a large amount of loans, to get paid a relatively low amount.

  6. nitpicking says:

    In all fairness, it’s a lot more than a buck. My doc gets a copay of $20 for the inoculation plus whatever the insurance company kicks in, less the cost of the vaccine and disposable needle. It’s probably profitable enough–I hope so, because I like my doc and don’t begrudge him earning some money.

  7. Draal says:

    yesh, it was a joke. but with a grain of truth to it. Listen to The American Life, 10-9-09 episode “More is Less” to learn a bit on how doctors have contributed to the sky rocketing costs of health care. Basically, doctors get paid for each procedure performed, so the more the merrier. And don’t forget they also get money for the visit to the doctors office on top of administering the vaccine. http://www.thisamericanlife.org/Radio_Archive.aspx#10
    Personally, I got a tetanus shot last year on the behest of my life partner. The shot cost $60. The visit cost $60. My insurance covers only $60 per preventative visit every 2 years (seriously). So I ended up paying $60 out of pocket to cover the balance. So, given the choice of getting a flu shot for free from the CDC, or going to my GP and paying $60 for the visit and whatever the flu vaccine costs (and the H1N1 would even be extra), I want the free one.

    Our taxes are paying for the CDC so lets use their services!

  8. Sid Offit says:

    In general, preventative medicine is highly cost-effective.

    ——————————————

    That’s an urban myth

    http://online.wsj.com/article/SB10001424052970204005504574235751720822322.html

    http://www.foxnews.com/story/0,2933,528968,00.html?sPage=fnc/health/diabetes

  9. weing says:

    I don’t get it. I can’t charge for an office visit if a patient just comes in for a flu shot. Am I doing something wrong? No wonder I’m losing money.

  10. magra178 says:

    Thank you so much for covering this so extensively. many comments:

    first, in relation to your quote, did you read Paul Offit’s NYT op-ed about “nothing to fear except flu itself?” He was on Talk of the Nation on NPR monday as well
    http://www.npr.org/blogs/talk/2009/10/october_12th_show.html

    second: I very much appreciate those out there trying to inform the public, and it’s well worth the effort, but many informed people who want to get the vaccine may not even be able to get it. Currently in my city (of about 500K) only the public schools have gotten it and the health department just got the nasal spray, only giving it to 5-18 year olds with chronic conditions. They say they will be getting more, but it is unknown if it will be available to the general public (not sure if my 1 year old will even be able to get it, and it seems unlikely at this point if myself or my husband will be able to get it).

    third: to Sid Offit (hmm, I mentioned an Offit earlier, relation?)

    I too have read articles about how preventative medicine does not seem to be cost effective, one I’m not convinced yet, I do believe the current data, but when so many people don’t do preventative medicine, can we be sure? And, even if everyone did it and it wasn’t cost effective, I agree with an MD’s point of view I read, I feel it is morally responsible. Even if not cost effective, if it saves people’s lives, it’s worth it. I realize you weren’t making a statement whether or not to do preventative medicine, I just thought I’d put that out there.

    last: I just want wanted to say hi to SF mom and Scientist; I often agree with your posts, and am a mom and scientist as well, and always happy to see others!

  11. wales says:

    As with influenza vaccine efficacy, questions abound with regard to vaccine impact on influenza mortality.

    http://archinte.ama-assn.org/cgi/content/abstract/165/3/265

    This study concludes: “We could not correlate increasing vaccination coverage after 1980 with declining mortality rates in any age group. Because fewer than 10% of all winter deaths were attributable to influenza in any season, we conclude that observational studies substantially overestimate vaccination benefit.”

    This piece discusses 20th century flu mortality trends and vaccination:

    http://www.ajph.org/cgi/content/full/98/5/939

    “Historical influenza mortality data contain many relevant implications for influenza vaccination campaigns. The overall decline in influenza-attributed mortality over the 20th century cannot be the result of influenza vaccination, because vaccination did not become available until the 1940s and was not widely used until the late 1980s. This rapid decline, which commenced around the end of World War II, points to the possibility that social changes led to a change in the ecology of influenza viruses. I found that declining mortality rates occurred simultaneously with expanded influenza vaccine coverage since 1980, especially for the elderly (65 years and older). However, recent research suggests that vaccination is an unlikely explanation of mortality trends. A 2005 US National Institutes of Health study of over 30 influenza seasons “could not correlate increasing vaccination coverage after 1980 with declining mortality rates in any age group.” Other research has reviewed available international studies of inactivated influenza vaccine effectiveness and efficacy. One study concluded that “evidence from systematic reviews shows that inactivated vaccines have little or no effect on the effects measured.” Considered in light of the data presented here, these studies imply that other causes–such as an improvement in living conditions or naturally acquired immunity from similar strains of influenza virus–may have been partially responsible for the declining trends in recorded influenza mortality. “

    Here’s a recent and informative piece that addresses important topics related to influenza mortality analysis and confusion surrounding true cause of death (influenza versus pneumonia) as well as impact of vaccines on pneumonia mortality.

    http://www.ajph.org/cgi/content/full/99/S2/S225

    “Published data suggest that a substantial number of secondary bacterial infections occurred during the 1918–1919 pandemic, and some of these infections are now likely preventable. For example, pneumococcal conjugate vaccine is 18% to 30% effective in preventing pneumonia in children and therefore could reduce mortality associated with secondary pneumococcal pneumonia in a future pandemic. However, this vaccine is not licensed for use in adults, and even if it were used widely, it would be unlikely to prevent substantial mortality in the United States, because the seven serotypes included in the vaccine cause less than 20% of invasive pneumococcal disease among adults. Pneumococcal polysaccharide vaccine, which is recommended and licensed for use in all adults aged 65 years and older, is considerably less effective against invasive pneumococcal disease among persons with chronic illnesses, a population that is substantially larger today than it was during any of the 20th-century pandemics. There is little evidence that this vaccine is effective in reducing all-cause pneumonia and mortality. In addition, improvements in care of the critically ill have not been shown to reduce mortality from pneumococcal disease.”

    Reuters recently stated that the US govt is spending $6.4 billion on this year’s flu vaccination campaign. The economic benefit of this expenditure needs to be examined closely given the variance of opinion as to vaccine effectiveness and impact on mortality.

  12. Peter Lipson says:

    Yeah, well, none us the folks writing here is ignorant of the pitfalls of our medical system and the problems with how doctors are reimbursed—except that it’s not primary care docs who benefit from that system, but sub-specialists. We don’t really do procedures, and I can tell you fur-realz that we do not make any significant money on vaccination. We usually cover our costs—usually.

  13. Peter Lipson says:

    That being said, the cost of your tetanus vaccine was trivial in the big picture. Countries that don’t have wide-spread vaccination (like Pakistan) have horrible tetanus rates that go up as soon as there is any disruption (like earthquakes).

    After Katrina, we would likely have seen many cases if not for our vaccination.

  14. Draal says:

    weing, sorry to hear you’re going out of business. If doctors can’t charge for a flu shot visit only, well, good. Insurance companies and state laws vary greatly so I’d be surprised if it was a universal policy.
    Since you are in the know, what does your practice (as you alluded to), pay and what do you charge for the flu shot? (Is it a standard rate across the board or depend on the person’s insurance coverage or age or whatever?)

    Back on topic.
    People, go get a flew shot. It won’t kill you. It possibly could save you. yep.

  15. Peter Lipson says:

    Such a depth of ignorance, it’s no wonder we can’t get any real health care reform.

    Some folks object to the idea of doctors being paid to do what they are trained to do.

    I’m gonna call my plumber and see if he’ll fix a little leak for free.

  16. Draal says:

    Yup. You got me pegged. Stupid is as stupid does.
    Why don’t I just pay the nurse who administers the flu shot directly, who gets paid a salary, regardless of the number of tasks she’s asked to perform??

    The second that money is suggested for motivating a doctor’s decision, we get defensive doctors. As i previously mentioned, listen the “More for Less” episode of This American Life. Then tell me I’m being ignorant when I question the a la carte service.

    1. I do not recommend someone to not get a flu shot. 2. I do recommend checking out the CDC clinics for more information on the services they provide. What’s wrong with free over fee, huh?

  17. wales says:

    question: why do my comments from Archives of Internal Medicine and the American Journal of Public Health take over 45 minutes to moderate?

  18. Scott says:

    If they’ve got enough links, they get held up in moderation. There they will remain until somebody has a chance to get to them – and keep in mind that they’ve all got day jobs. 45 minutes, or even a few hours, is far from unreasonable.

  19. wales says:

    Thanks Scott. In the future I will break my long-winded comments into separate comments.

  20. wales says:

    ah there’s my comment back at 3:17 pm. thanks.

  21. weing says:

    wales,

    I can just see you debating whether to use a parachute or not. Life is tough when you don’t have all the data you want, isn’t it?

  22. weing says:

    I guess you would just have to make that leap of faith.

    Sorry. I just couldn’t resist.

  23. weing says:

    Draal,

    Sorry if I gave you the impression that I am going out of business. I just don’t make money on flu shots. I guess it’s because I don’t charge for an office visit when they come in just for a flu shot. I can charge whatever I want but get paid whatever the insurance has decided it will pay for them, and the last I looked it barely covers my vaccine cost, never mind shipping, syringe, staff to pull the chart for recording and refiling.

  24. Peter Lipson says:

    weing, stop your whining. Obviously you are just out there as a rapacious middle man taking the hard earned money of patients instead of letting them get what they need without the intercession of some sort of self-deluded would-be deity.

  25. @Draal

    “Yup. You got me pegged. Stupid is as stupid does.
    Why don’t I just pay the nurse who administers the flu shot directly, who gets paid a salary, regardless of the number of tasks she’s asked to perform?”

    A statement so screwed on so many levels up it’s not even wrong or worthy of Deconstruction.

    “2. I do recommend checking out the CDC clinics for more information on the services they provide. What’s wrong with free over fee, huh?”

    It depends on why the free service is there, who it’s intended for, how many people it has resources to service, and how it’s financed. If everyone who could otherwise afford to get the service through their regular health care plan avails themselves of free clinic services, we’ll have to allocate more public money to provide those free services, because nothing is free, the money comes from somewhere- in this case, our income taxes & government borrowing.

  26. wales says:

    Not the same thing, weing. I wear a seat belt everyday and a helmet when I bicycle. I do perform more due diligence when it comes to medical interventions.

  27. Even though I don’t work in the health care industry, am I still evil because the only reason I come into work every day is because they pay me to?

    I mean I don’t really have any altruistic desire to provide IT engineering services to these people at all; I’m probably more evil than an MD, since many of them are at least partially motivated to help people sometimes.

    Should I at least refuse to accept some portion of my salary because it’s more than I need to just pay for the minimum requirements to sustain my existence?

  28. weing says:

    wales,

    No need to be consistent.

  29. weing says:

    Karl,

    You sure are greedy. No wonder that EHR is going to cost me so much. Greed and selfishness are constants like gravity. I never trust anyone who pretends to altruism.

  30. Draal says:

    @Karl
    “it’s not even wrong” why thank you.
    “our income taxes & government borrowing.” yup, we pay for it so lets use it. Fact is, the government can bargain for a lower cost per vaccine than a hospital or private practice. Hence, the government can help lower total health care costs. Rather, people that have insurance would rather go to their GP and get a flu shot. And guess what, the insurance spreads the cost incurred by means of premiums. As you know, premiums have gone up 130% since 2000. So maybe if more people used government services, their premiums would go down.

    One anecdote: I have a family member that works for the county and was recruited to help administer flu vaccines. Guess what, he’d wish more people would take advantage of the CDC’s services. As it is, only a minority of people receive the flu shot. Now isn’t it the CDC’s job to prevent outbreaks? Just let them do their job.

  31. halincoh says:

    I truly think that collectively, the physicians of this blog, including some of my personal correspondences with Dr. Joseph Albietz, have done an incredible job of informing the lay public about these vaccinations in general, and for providing the important details and trends of H1N1 to those of us specifically in private practice. The format actually provided easier access of information than the CDC itself. Thank you all for your due dilligence

  32. gaiainc says:

    Draal: “As you know, premiums have gone up 130% since 2000. So maybe if more people used government services, their premiums would go down.”

    HAH! or Yeah, right or when pigs fly or when insurance companies are no longer for-profit, private adventures whose primary purpose is not to take care of people or contain health care costs or promote health, but to make money for shareholders and their executive boards. Insurance companies are in the business to make money. Period. Any handwaving to the contrary is just that-handwaving. As for the government bargaining for lower prices, I would love for them to do that, but they don’t. Instead we get a mess like Medicare Part D and I need to get off my soapbox. Doctors are not the primary reason our health care costs are what they are. However, we sure are an easy target and not surprisingly that makes us defensive and annoyed, especially the crazy ones of us still trying to do primary care.

    So get your flu shots if you can from where you can. The life you help may just be your own.

  33. Deetee says:

    In the UK there has been relentless criticism of General Practitioners recieving payment for vaccinations.
    Currently GPs are paid around £7.50 to provide seasonal flu vaccine. Once the costs of equipment, storage, staff etc is taken into account that’s not very much.

    GPs have agreed to get paid £5.25 for each swine flu vaccine administered. They will probably have to set up additional clinics to do this, as the target population differs from usual seasonal vaccine. The seasonal programme is already under way and those needing both vaccines will need to be recalled. They will personally make very little from this. One GP I know has calculated it will amount to as little as £0.20 per patient per GP, before tax.

    Sensationalist headlines suggesting GPs will make £27k each from the programme are shameful. They assume all the money goes straight into the GPs pockets, all the patients in the practice will get vaccinated (perhaps 20-30% will do so) and they have the costs wrong (it will be £5.25 per vaccination).

    http://www.dailymail.co.uk/news/article-1203126/27-000-swine-flu-bonus-GPs-earn-107-000.html

  34. Dr Benway says:

    In the UK there has been relentless criticism of General Practitioners recieving payment for vaccinations. Currently GPs are paid around £7.50 to provide seasonal flu vaccine.

    If that’s a gravy train, I assume that GPs in the UK don’t have to pay for rent, utilities, secretaries, accountants, custodial services, computers, malpractice, CMEs, etc.

    Sweet!

  35. wales says:

    Weing, I just noticed your jibe about my lack of consistency. Over 225,000 deaths occur in the US annually from iatrogenic causes. When seat belts and helmets become the third leading cause of death in the US I will give them the same due diligence I give to medical interventions.

    Starfield B. Is US Health Really the Best in the World? JAMA, July 26, 2000, Vol 284, No. 4

  36. DanaUllman says:

    The anti-vac people are the fear-mongers?

    And those who encourage people to get the flu vaccine are not fear-mongering at all? They are “love mongers” who love people to take drugs even if the evidence for their efficacy is in serious doubt or extremely modest at best…and heck, we should then make the flu vaccine MANDATORY for health workers.

    Let’s make antibiotic use mandatory too…and chemo…and anti-depressants.

    And yet, in England, only 10-20% of health workers will take this vaccine:
    http://www.guardian.co.uk/world/2009/oct/11/swine-flu-pandemic-vaccine-nhs

    The fear-mongering issue presented here is a classic example of a one-side argument that ignores any other side.

    By the way, why is it that no one is mentioning the new ATLANTIC article on the questionable efficacy of the flu vaccine?
    http://www.theatlantic.com/doc/200911/brownlee-h1n1

    Oh, I know why: people here are anti-intellectual!

  37. wales says:

    I appreciate the link to the Atlantic article, I look forward to reading it. Along the lines of Ullman’s comment I notice that when comments are posted here with links to legitimate peer-reviewed journals which call into question the efficacy of influenza vaccines and their impact upon mortality there are no responses. Or the response is that those studies “may be right” but we should still all get vaccinated. Is that science based medicine?

  38. Mark Crislip says:

    I read the Atlantic article.

    It suffers from the assumption that the vaccine has to have a binary effect on individuals: it prevents death or disease in individuals.

    The Skeptic that came yesterday in the mail has an essay on evolution where the author has a sentance to the effect that in considering evolution, people have problems going from the individuals to populations.

    Same with vaccines. I still find the Ontario data compelling and the data read as a whole equally compelling, if flawed, that there is population benefit from the vaccine.

  39. wales says:

    When doctors advise their patients are they advising individuals or populations?

  40. Mark Crislip says:

    Both, and more. I am, after all, a holistic doctor who must consider the bio-psycho-social-spiritual-environmental ramifications off all aspects of my advice.

  41. wales says:

    I think I will stick to doctors who make recommendations according to my individual health. After all doctors have a fiduciary obligation to individual patients.

    Btw you gave short shrift to the lengthy and well written atlantic article. The article stresses the importance of science over doctrine. Right up the sbm alley no?

  42. wales says:

    Call me selfish but when I pay a professional, be it a cpa, attorney, doctor or plumber I want advice for myself, not my neighbor.

  43. Mark Crislip says:

    My entry on vaccine efficacy is basically my response to the Atlantic article.

    Again with the binary. The line between individual health and public health is a gray one.
    I have no problems offering the vaccine to decrease your risk of infection and to help the population as a whole. I first have to maximize your health, but if I can have a broader effect, so much the better.

    When I discuss the vaccine I emphasize that the benefits may be for them, but that they may, at no risk but a sore arm, be helping their neighbor.

    Although I have many who refuse no matter what I say, if there is someone who is uncertain, that is usually the argument that tips them into getting the shot: potentially protecting friends, family and patients.

    Watching TV and reading the blogosphere one often gets the feeling that the US is filled with selfish, self centered narcissists. At work and in the clinics, altruism, the need to help others, is often a surprisingly effective motivator for medical staff and patients. Many people are not selfish.

  44. wales says:

    The number of health care workers refusing to get vaccinated somewhat contradicts your comments. But bravo for you if the selfish gambit works. Perhaps others prefer to “give” in other ways.

  45. Dr Benway says:

    When you brush your teeth you expose yourself to more antigens than are present in any vaccine.

    Listen to this: it’s the sound of pertussis aka whooping cough. Would you get vaccinated even though you personally might not benefit but you might reduce the risk of babies going through that?

    Were a child in my presence struggling to breathe like the one in that audio recording, I’d move heaven and earth to help. What the f*ck is a tiny shot?

    F*ckin’ anti-vax hypochondriac pussies.

  46. David Gorski says:

    It suffers from the assumption that the vaccine has to have a binary effect on individuals: it prevents death or disease in individuals.

    Indeed. It also seems somewhat based on a common fallacy that the author seems to share somewhat with anti-vaxers, namely that a vaccine has to be 100% effective and 100% safe in order to be worth bothering with.

  47. Mark Crislip says:

    You would be surprised the number of people who get their first ever vaccine if I spend the time wandering the hospital with the vaccine carts. Few turn me down. I give lots of information with humor and a smile. And I am careful to tell them they don’t have to do it, think about it and come back later.

    Oddly, I have noticed that a large number of people trust me when I talk about infections. Go figure.

  48. David Gorski says:

    The other thing about The Atlantic article that I found revealing. It truly does suggest that Tom Jefferson does have an ax to grind about the flu vaccine. Remember, he originally accepted an invitation to speak at the NVIC conference a couple of weeks ago but backed out when he found out that he’d be sharing a stage at the awards banquet with Andrew Wakefield. It’s to his credit that he backed out at the last minute, but that he ever accepted in the first place worries me.

  49. wales says:

    What a crew. Benway’s comments are worthy of the adolescent behavior he attributes to Jay Gordon’s patients. Crislip is the smiling vaccine ice cream man. Gorski continues ad nauseum with the ad hominen attacks on Jefferson rather than addressing the science (me thinks Gorski has an axe to grind). You guys should take this show on the road.

    Yikes.

  50. Dr Benway says:

    So you’re not concerned about the 10,454 pertussis cases in the US in 2007, wales? That audio clip failed to move you?

  51. Peter Lipson says:

    What about me?

    Oh, and we did take it on the road, and hope to do so again.

  52. wales says:

    Well since you ask, the cries of gross incompetence and calls for censure by the state medical board regarding Jay Gordon are mere sound and fury, signifying nothing. You claim that he opens himself to legal action, which is ironic coming from someone mouthing libelous remarks. Stick to the science guys, that is after all your stated MO and specialty.

  53. Peter Lipson says:

    btw, every comment thread you troll through boosts the hit count and raises money for the cause. thank you.

  54. David Gorski says:

    You guys should take this show on the road.

    Not only did we take this show on the road, but Steve, Joe, Harriet, and I had the honor of speaking in front of over a thousand people at TAM7 in July.

    We hope to go for more in 2010.

  55. cheglabratjoe says:

    Sheesh. Medical doctors finally take off the kid gloves w.r.t. vaccines after being the punching bags of everybody from atheists to celebrities, and the response is to call them mean and silly.

    I can’t imagine how you respond to antivax websites, wales. If Crislip encouraging health care workers to get vaccinated is ridiculous, what does that make Bill Maher? Or do the antivaxxers get a free pass because you sympathize with them?

  56. Mark Crislip says:

    “Crislip is the smiling vaccine ice cream man. Gorski continues ad nauseum with the ad hominen attacks”

    I suppose smiling vaccine ice cream man is a complement then?

    Actually, I snorted with a laugh when I read that. For a variety of reasons I have temporarily moved to white coats after 19 years of sport coats and when asked why I say that thanks to the economy I am moonlighting as a good humor ice cream salesman. Perhaps I should sell a few choco-taco and make a little money while I give the vaccines. Might help the cardiologists as a by product.

  57. wales says:

    everytime someone accurately points out that the s is missing from the sbm site the subject gets changed.

    btw benway, as I’m sure you know from past exchanges on this site, the pertussis cases are there despite the US 95% kindergarten vaccination rate because the pertussis component of Dtap is 85% effective at best.

    And by the way, 10,000 pertussis cases in 2007 is down from 25,000+ cases in 2004.

  58. weing says:

    “Weing, I just noticed your jibe about my lack of consistency. Over 225,000 deaths occur in the US annually from iatrogenic causes.”

    Really? You believe everything you read? BTW regarding the articles you linked to. I checked them out. Funny, that I didn’t get the same impression that you did. I wonder why?

  59. wales says:

    cheglabratjoe, I don’t care a fig what “anti-vax” people state. I do have a problem when self-titled science mavens veer off into ad hominen diatribes.

  60. weing says:

    “And by the way, 10,000 pertussis cases in 2007 is down from 25,000+ cases in 2004.”

    Yes. And if we didn’t vaccinate any of the little tikes the cases would be down to 0?

  61. Peter Lipson says:

    /kitchen table….

  62. wales says:

    weing, I doubt if you and I would get the same impression from reading a phone book. If you’re questioning the legitimacy of the data contained in the JAMA article, have at it. But vague hand waving is meaningless.

    Actually, I only linked to the one JAMA article. I did not cite the IOM report on the same subject, or others.

  63. wales says:

    dr. crislip, i thought you’d enjoy the ice cream man comment.

  64. David Gorski says:

    I can’t imagine how you respond to antivax websites, wales. If Crislip encouraging health care workers to get vaccinated is ridiculous, what does that make Bill Maher? Or do the antivaxxers get a free pass because you sympathize with them?

    Indeed. For anti-vaxers, civility is a one-way street. They can say that defenders of vaccines are hopelessly in the pockets of big pharma, that they’re corrupt, evil, venal, and arrogant, but if we point out the errors and nastiness from the anti-vaccine movement, we are painted as the arrogant and vicious ones.

  65. wales says:

    The degree of arrogance and viciousness in ad hominem attacks doesn’t concern me. It’s the irrelevance to the topic at hand that I find bothersome.

  66. Peter Lipson says:

    /getting out popcorn

    wales, you’ve made no substantive points that I can see, other than a quasi-libertarian argument for “freedom” suffused with thinly veiled contempt for medical professionals, the motivation for which has not been made clear.

    I haven’t actually seen a coherent point in your little rants.

  67. halincoh says:

    I had a conversation with a mother today regarding the flu vaccines. Interestingly, she was all for the H1N1 vaccine, but not the seasonal flu vaccine. She alluded to doing her research and I gently, but firmly corrected the validity of her sources. I find it fascinating that she was able to rationalize one vaccine, but not the other. I think this indeed can be traced to the concept of fear, as Steve introduced at the beginning of this thread. Fear is motivating this mother to get the H1N1 and fear is motivating her to not get the other; not the facts, but propaganda or the media or perception. In one scenario, the fear is weighted in one direction. In the other scenario, it’s in the opposite direction. In the end, I told her that if she is truly interested in understanding the details of all sides of the issues regarding vaccines ( and she truly seems to be interested ) that she should read Paul Offit’s book. She intently wrote it down. I hope she reads it. If, at the ground root level, utilizing the nuturing relationship between physician and patient as an opportunity to teach, perhaps patient’s fears can be counterattacked with facts and reassurance, and maybe, just maybe, we can help diminish the impact of the anti-vaxers and save a few lives while we’re at it.

  68. wales says:

    Another attempt to pigeonhole into a category, if “anti-vax” doesn’t fit, try “libertarian” instead of addressing the facts. I have made several comments about the lack of evidence for flu vaccine efficacy and mortality reduction. I leave it to readers to decide what is substantive, political pigeonholing or comments on the issues.

  69. Dr Benway says:

    I was under the impression that our old friend wales was a naturopathic or chiropractic propaganda bot of some sort feigning an intellectual interest in the nuances of vaccine science. He or she has seemed like an actor playing out a fantasy of “how the science persons of science-land comport themselves amongst the public.”

    So the little “harumph!” paragraph was refreshing.

    But I don’t thing it was the suffering baby that cracked the surface. I think it was this: “F*ckin’ anti-vax hypochondriac pussies.

    Wales doesn’t liek bad language. Dying babies, however, do not offend.

    Selfish filibustering time-wasting hypochondriac puss-puss antivaxer.

  70. wales says:

    PS Dr. Lipson, as for thinly veiled contempt, are you a psychologist too, or just another omniscient mind reader? I have great respect for my physicians. Is it the Starfield paper that’s got your dander up? Does that mean Barbara Starfield has contempt for physicians because she wrote the piece? I believe she is a practicing physician, or at least was when it was written.

    Benway, go have a drink, you need it.

  71. wales says:

    It is a bit ironic that the impetus for my citation of the Starfield report on iatrogenic causes of death was a physician needling me about why I should treat vaccines the same as parachutes, seat belts and helmets. The reason for citing the Starfield paper was to point out that medical interventions have inherent uncertainties and risks and therefore deserve appropriate due diligence, not to express contempt for medical professionals. Perhaps it hit a nerve with some of you physicians.

  72. weing says:

    wales,

    Never mind the phone book. Why would I get a totally different impression from reading those articles? Is it possible that we are reading to confirm our biases?

  73. Peter Lipson says:

    I may have misread the literature on iatrogenesis. Have vaccines been cited as a major cause of iatrogenic morbidity and mortality?

  74. weing says:

    I was not referring to Starfield. I have my own opinion about her stand. I agree with some of what she says but definitely not all. I have a problem with the comparisons with other countries statistics. Something doesn’t jive there.

  75. weing says:

    Peter,

    I can’t believe you fell for that. Have you forgotten autism?

  76. wales says:

    Wing of course its possible. Dr. Lipson the jama article I believe mentions 100,000 deaths attributable to adverse reactions to medications.

  77. wales says:

    But what about the lack of evidence for mortality reduction by flu vax?

  78. Peter Lipson says:

    wales, you didn’t even dodge that artfully. We were talking about vaccines, you made statements about iatrogenic harm (something about which I’ve written a great deal) and I asked basically what do the two have to do with each other. You are in essence claiming that there is a great deal of iatrogenic injury (without adequate benefit) and that vaccination makes up a non negligible portion of this.

    Either retract your statement, clarify it, support it, or admit that you are so blinded by ideology that you can’t think any better than an intoxicated lemur.

  79. weing says:

    wales,

    I forgot. You’re not into skydiving and can’t make a leap of faith. There is definitely a lack of evidence for mortality reduction from parachutes too.

  80. Draal says:

    I too have been asking for clarification on the mortality claim that the seasonal flu vaccine saves lives.
    K, here goes:
    1. there is no double-blind study on the mortality rates of the benefits on the flu vaccine.
    2. Only meta-analysis indicates that there is a a mortality benefit between unvaccinated and vaccinated.
    3. Those same studies also indicate that vaccinated people show a substantial decrease in overall mortality rate, greater than what would be associated with flu related deaths. Specifically, vaccinated people had a 27% to 30% decrease in deaths from all causes (magic vaccine). (ANNALS OF INTERNAL MEDICINE Volume: 123 Issue: 7 Pages: 518-527 Published: OCT 1 1995)
    4. It’s been proposed that “health users” preferentially get vaccines and accounts for the lower mortality and morbidity rates.

    A double-blind study on high risk groups with the seasonal vaccine that looks at mortality rates will never be done in the US. It’s illegal.

    I’m not saying the flu vaccine doesn’t work. I’m saying that the claim that the flu vaccine prevents deaths has some suspicious evidence backing it up. Decreased morbidity? Sure. Decreased mortality? Maybe.

    ————————————————————

    Side point: A vaccine induced antibody response does not equal immunity. Case and point: HIV (and Hep C?) vaccines induce antibody response but do not confer any immunity.

  81. Peter Lipson says:

    we dont have vaccines for hiv and hcv. we do for other diseases. we use science rather than rectal extraction to arrive at this knowldege.

  82. Draal says:

    nice rebuttal.
    I’m asking, earnestly, for clarification on mortality. No need to be an ass.

  83. Draal says:

    And I was referring to experimental HIV vaccines that have been tested but have showed little to no promise. Obviously we don’t have one for the general public.

  84. Peter Lipson says:

    comparing retroviruses to influenza is a bit problematic. we’re talking about very different organisms. HIV produces about 3 billion virions daily and has a very high mutation rate with lots of antigenic variation. This is not true for flu.

  85. wales says:

    Though the entire topic of parachutes, vaccines and iatrogenesis was a sidebar, I thought I was very clear about my meaning. Medical interventions have risks and uncertainties. I believe they require much more due diligence and caution than seat belts and helmets. I do not consider seat belts and helmets remotely comparable to vaccines with regard to risk and unintended consequences.

    VAERS data provide one example of the uncertainty surrounding vaccine injury and adverse events. I have had this discussion numerous times on this site. Now you will regal with me with the incredible hulk VAERS anecdote and inaccurate comments about the massive impact of litigation on VAERS data. The vast majority of VAERS reports are made by vaccine manufacturers and physicians. Litigation accounts for less than 1% of VAERS reports. And yes I understand that correlation does not equal causation, but it does not rule out causation and it does highlight uncertainty. No proof of risk is not the same as proof of no risk.

    Now you will attempt to evade the issues of flu vaccine efficacy and mortality reduction in favor of personal criticism. The purpose of my original comments today was to discuss influenza vaccine efficacy and mortality reduction. I have failed abysmally. Although Dr. Crislip as usual gave his honest opinion without dodging, for which he deserves respect.

    No one has cogently addressed the issue of the flimsy rationale for expensive mass influenza vaccination campaigns given widely varying degrees of vaccine efficacy and the lack of mortality reduction.

    As T. Jefferson stated in the Atlantic article “We have built huge, population-based policies on the flimsiest of scientific evidence. The most unethical thing to do is to carry on business as usual.”

  86. Peter Lipson says:

    IOW, you brought up an inflammatory point, got mad when questioned, and changed the subject.

    You’re small time. Real small time.

  87. weing says:

    “No one has cogently addressed the issue of the flimsy rationale for expensive mass influenza vaccination campaigns given widely varying degrees of vaccine efficacy and the lack of mortality reduction.”

    Since you have made up your mind that the rationale is flimsy, and we do not have the type of evidence of efficacy and mortality reduction that you seek, what could we possibly say that would allow you to make that leap of faith with a parachute? As I told you before, my reading of the literature that you referenced, regarding the vaccines, led to an interpretation at variance with yours. Hey, I’m just a lowly internist. What the hell do I know. Maybe, I misread it. Maybe you read into it what you wanted. It’s your life. I can’t promise you that if you use a parachute you’ll land safely and not in a tree, or water, but I recommend you use one anyway.

  88. wales says:

    FYI, the “change of subject” is an attempt, which I have made many times today, to get back to the topic of vaccine efficacy and mortality reduction. It really doesn’t matter what you think of my attempts to change the subject, it appears to me that you are fixating on one subject to avoid the other (influenza). At least the Atlantic published an informative article.

    “small time” them’s fightin’ words, at least on the local elementary school playground.

  89. Draal says:

    Peter, are you able to address my main concern about the claims on mortality? (and there are effective vaccines for retroviruses; and the flu vaccine is reformulated each year due to genetic drift; and the HIV infection has several stages going from very low levels to the 3 billion/day; but this is going off topic so I withdraw my original side comment until someone addresses my original concern)

  90. Draal says:

    “Since you have made up your mind that the rationale is flimsy, and we do not have the type of evidence of efficacy and mortality reduction that you seek, what could we possibly say that would allow you to make that leap of faith with a parachute?”

    Because this is a skeptical blog, I feel it’s proper to question any claims being made. I accept the claim that the flu vaccine decreases morbidity. There are tightly controlled studies to back this up. However, the paucity of studies claiming decreased mortality should make any skeptic take a closer look.
    And when did skeptics rely on faith?

  91. Mark Crislip says:

    Re: mortality. Jefferson focuses on direct mortality and much of the benefit of the flu vaccine is indirect.

    The best data, and I think it is excellent, if indirect, is the Ontario data:

    http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.0050211

    We have a natural experiment now with h1n1 and can watch mortality rates as vaccine coverage expands. Some clever statistician will look back over the year and be able to tell mortality rates in vaccinated and unvaccinated and since we are giving the vaccine to the young, it should be a group that can have a good vaccine response.

  92. wales says:

    Good luck draal. Don’t hold your breath. Good night.

  93. Draal says:

    Mark, thank you so very much for actually finding a decent reference that addresses my concern. I obviously missed in my searches so thank you!

  94. weing says:

    If I put on a parachute (faith) and jump out of a plane, I make sure my life insurance premiums are paid up. Skepticism and faith, all in one.

  95. Mark Crislip says:

    Evidently no one read my post from last week, with all the references and everything. http://www.sciencebasedmedicine.org/?p=2040

    But I have teenage kids. I am used to talking to myself :)

    Anyone for a Choco Taco?

  96. cheglabratjoe says:

    Oh, come on now, Mark. wales would much rather piss, moan, and misuse Latin terms than go read your article. But, you did make it easier for him this time by providing a link, so maybe he’ll take the trouble to click it.

  97. Draal says:

    Yeah, sorry. I started skimming through it after a while. Short attention span generation. Yes, please pass the Choco Taco.
    I feel better now.
    I think this is a good point for me to move on to other things.

  98. skepsis says:

    May I point to this Dutch study: Influenza- and respiratory syncytial virus-associated mortality and hospitalisations by Janse et al. (http://erj.ersjournals.com/cgi/content/full/30/6/1158).

    The study aim was to “Retrospectively during 1997–2003, Dutch national all-cause mortality and hospital discharge figures and virus surveillance data were used to estimate annual average influenza- and RSV-associated excess mortality and hospitalisation using rate difference methods.” “839,303 all-cause deaths and 1,551,598 hospitalisations for URTI, LRTI, CVC and others were registered.”

    Mortality figures/100000 were:
    Age Flu RSV summer peri
    group season w21-39
    0–1 5.3 5.0 5.4 5.4
    2–17 0.4 0.3 0.4 0.3
    18–49 2.1 2.1 2.0 2.1
    50–64 12.8 12.6 11.9 12.3
    65 110.5 105.7 92.9 98.9

    As you see there are small differences between flu, RSV and summer until patients get old (for details see http://erj.ersjournals.com/cgi/content/full/30/6/1158/T2). Hospitalization rates were elevated for especially RSV in the youngest and generally in the oldest and high-risk patients. (http://erj.ersjournals.com/cgi/content/full/30/6/1158/T3, http://erj.ersjournals.com/cgi/content/full/30/6/1158/T4).

    The Dutch influenza vaccination program has resulted in a vaccination rate of 71% of the low-risk elderly population and 86% of the high-risk elderly (http://www.onderzoekinformatie.nl/nl/oi/nod/onderzoek/OND1317903/).

    So a vaccine may decrease hospitalization for high-risk groups.

    “Definition of study periods
    With minor modifications, study periods were defined according to Izurieta et al. 20. For each winter season, from week 40 of 1 yr to week 20 of the next, the influenza virus-active period was defined as the periods of at least two consecutive weeks in which each week accounted for 5% of the season’s total number of laboratory-confirmed influenza cases 20. Similarly, the RSV-active period was defined as the period of at least 2 consecutive weeks in which each week accounted for 5% of the season’s total number of RSV-positive patients. The period with influenza predominance was defined as the influenza virus-active weeks with <5% of the season's total number of positive tests for RSV 20. The peri-seasonal baseline period was defined as periods of at least two consecutive weeks within week 40–20 in which each week accounted for <5% of the season's total number of influenza and RSV-positive cases. The summer baseline period was defined as week 21–39. Unlike the study of Izurieta et al. 20, the weeks in which para-influenza virus was isolated were not excluded from the study as (sporadic) isolates were reported throughout the year. For the same reason, weeks in which sporadic isolates of the influenza virus and RSV were reported during summer baseline period were not excluded from the study.
    During the study period there were 92 influenza and/or RSV-active weeks; 46 weeks of influenza predominance, 42 weeks of RSV predominance, and only 4 weeks of both influenza virus- and RSV-activity”

  99. gaiainc says:

    So reduction in morbidity is not desirable, only mortality? Really? That’s a rather narrow view of the value of an intervention. Being sick for 2-4 weeks is not something my patients nor I can afford. For some of my patients it is a cause for termination (or at least places them at risk for termination). For others, not earning a wage for that long will ruin them financially. They literally cannot afford it. If a vaccine can help them prevent that period of illness, then I see no reason not to recommend it, particularly given the incredible safety record of vaccines in general and the influenza vaccine specifically. Reduction in morbidity is important even if there is no reduction in morbidity. IMHO, that is more than enough reason to recommend both influenza vaccines.

    And Dr. Crislip? I’d like a Klondike bar please.

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