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    "An Epidemic of Fear"
    By Josh Witten | October 21st 2009 01:00 PM | 12 comments | Print | E-mail | Track Comments
    About Josh

    Welcome to the home of the rugbyologist. Come along as I wander far and wide (and near, too), stop to smell the roses of intellectual fancy, and...

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    Now I know why Becky reads Wired. Writer Amy Wallace takes a critical look at the vaccination debate in this excellent article ("An Epidemic of Fear"). Instead of relying on false balance (not all opinions are equal) to flesh out the article, Wallace looks at the research and evidence presented for the various claims. And, Wallace does not shy away from drawing conclusions based on the evidence. While long (and I know Scientific Blogging readers -or at lease the rugbyologist readers - are not faint of heart), Wallace manages to keep the human interest throughout, an area in which scientists have struggled.

    *Hat tip to Steven Novella.

    Comments

    Hank
    I haven't read it yet, though I am staring at the cover on my desk.  I will affirm again it is up to us to not circle the wagons around suspect vaccines lest we lose a lot more in the mainstream.   Too many scientists have adopted a mentality that all vaccines must be defended or it will put a chink in the armor of important ones - an odd stance since if you ask most scientists if pharmaceutical marketing departments should be trusted, they will say 'no'.

    When big companies start pushing new vaccines on the heels of lawsuit losses for ever more remote problems, they lose credibility.  Hopefully we (well, Wired too) can continue to let people know what is hype and what is valuable or we run into problems like this, where people - and not just fringe kooks - can't trust the information they get and opt not to get vaccines because they believe the cure is worse than the problem.
    jtwitten
    All claims should be evaluated on their evidence. Both the terms "good" and "suspect" should be decided on the merits of the data. With vaccines, safety and efficacy are only part of the equation. It is also important to understand if the vaccine cost is worth the epidemiological benefits (see below about smallpox). For the HPV vaccines, safety and efficacy are established, but the epidemiological value is less clear. The Gardasil adverts only point out safety and efficacy, as people make purchases based on their perceived risk, not on the society as a whole.

    I found that Wallace's article strikes a good balance here, for example pointing out the reasons Paul Offitt (a reputed pro-vaccine zealot) opposed distributing the smallpox vaccine (i.e., cost-benefit did not support that vaccine).
    Hfarmer
    Part of the problem is the way officials describe the evidence on TV.  They say well this vaccine was made the same way as the seasonal flu vaccine therefore it must be safe.  That does not inspire confidence.  
    To speak plainly the things that people worry about are for the most part impossible.  Such as worrying that vaccine will cause autism, and other such dubious things.  

    What could have made a difference would be something like having the first family all get their shots on TV.  Die hard conspiracy theory types would not be convinced, but that would do it for most people. 
    Science advances as much by mistakes as by plans.
    Gerhard Adam
    All claims should be evaluated on their evidence. Both the terms "good" and "suspect" should be decided on the merits of the data.
    That's the problem.  Where's the data?  What information is one to trust?  Invariably most people are forced to make an assessment with little or no information beyond what they are told.   Therefore credibility is essential if such information is to be accepted. 

    If people don't have the time, expertise, or inclination to assess the data (assuming it's available), then they will act according to their past experience with those same authority figures. 

    In effect, many people are assessing their risks by considering what happens if they do nothing compared to the risks if the sources of information aren't to be trusted.  Right or wrong, most people are tired of being "marketed" to and frankly don't trust anyone that stands to make a profit for believing them.  Few would argue that even the news is being "marketed", so how does one get objective information (after all the Daily Show is only 30 minutes long)?
    Mundus vult decipi
    jtwitten
    I just gave you a link to a well-written article on the topic. It is freely available. It even has references. Otherwise, try the Centers for Disease Control or the Food and Drug Administration. They have search engines. Teh CDC has lists of scientific references to support their conclusions.
    Gerhard Adam
    I read the article and agree that it is well written.  Even as the article indicated, vaccines like RotaTeq are a clear cash cow with a 17 times mark-up.  This doesn't exactly inspire confidence that anyone really cares about health.   At a cost of $4 to produce and $69.59 to sell, see if anyone will buy the argument that they aren't more interested in their profitability than the health of their patients.  I'm not opposed to companies or individuals making reasonable profits, but I have to admit, that's a tough sell to figure that one out.  Even in arguing that such profits are necessary to fund research for newer drugs, such a position sounds more like an excuse especially when record profits are posted.

    However, a perfect example occurred on CNN while I was typing this.  The CDC just extended the expiration dates of Tamiflu for lot B1042 (as an example) from a manufacturer's expiration date of Jan. 2005 to May 2011.  While this is the most extreme lot value, it raises questions when one considers how people have been told time and again, that they shouldn't keep drugs past their expiration dates.  Yet, suddenly a six year spread becomes acceptable.

    We've also seen how the pharmaceuticals and government has stepped in to prevent consumers from obtaining drugs from other countries (i.e. Canada) where they might be cheaper under the guise that their safety couldn't be assured.  Yet, we find that a significant part of our drug manufacturing is occurring overseas where there are fewer controls and oversight.

    While I don't disagree with you on the scientific aspect of vaccinations, I still believe that the public perception is that neither the government nor the corporations are trustworthy enough to take anything they say as having the public's interests at heart.  It is no different that the behavior we've seen in the financial sector, where after receiving their bail-outs they thumb their noses at the taxpayers by indulging themselves in more benefits and bonuses.

    Coupled with the overall uncertainties about the economy and jobs, it is little wonder that the average person is adopting the position that everything they hear is either an outright lie or a distortion intended to advance someone else's agenda.
    Mundus vult decipi
    jtwitten
    I'm not saying trust the government or companies. Far from it. Occasionally, their opinion happens to line up with the evidence. Usually, the probability of that happening is about random. Conspiracy theorists believe that the correlation is worse than random.
    kerrjac
    Cool article, I like how it pits science against pseudo-science.

    I still think I'd be a bit more comforted about the issue by a frank discussion of other vaccines that are suspected to be dangerous.

    The vaccine-autism link is the most widely publicized, but there's a moderate hand-full of other vaccine associations, particularly those against the earlier swine flu outbreak, anthrax, and lyme disease. These vaccines have all been associated with neurological disease or symptoms, the onset of which is often insidious, in some cases gradual, and unmeasurable, or poorly measured, by biomarkers. Controversy surrounds these vaccines, but enough distrust has built up to prevent public acceptance. Miss-associating correlation with cause is still possible, however, these vaccines were mostly given to adults, meaning you can't simply pit the associations on the worried mom phenomena. Furthermore, their associations with neurological impairment and suspected autoimmune symptoms puts 'adult' side-effects to these vaccines in roughly the same ballpark as autism.

    From the perspective of science rather than public policy, the important part isn't convincing the public that vaccines are safe; it's studying averse reactions to vaccines and using them to learn more about associated conditions and/or vaccination. Less widely publicized - but doubly fascinating - were genetic similarities between those who those who reported long-term debilitating side effects from the lyme vaccine and sufferers of chronic lyme.
    jtwitten
    Safety is of the utmost importance and it is important to understand the reasons for side effects and adverse reactions in current vaccines and old vaccines. It is not, however, appropriate to declare that because there were issues before, that those issues are still legitimate. We have learned a lot about immunology since the 1970s and we are still learning a lot. Comparing a 1970s flu vaccine to one in 2009 is not comparing two like things. One must be very careful with the rhetoric here as this confusion is exploited by the anti-vaccination Luddites on a daily basis.

    You also continue to ignore the fact that there is NO correlation between vaccines and autism. Correlation is not causation, but no correlation is no causation.
    kerrjac
    Correlation is not causation, but no correlation is no causation.
    That's assuming that you've controlled for necessary confounds or, particularly, analyzed possible moderators, which becomes even more important when trying to make sense of relatively rare events among a large amount of people. The lyme vaccine, for instance, only placed those patients at risk who had a specific genotype. Isolating such variables - through careful forethought and theory - can reduce a great amount of noise, to the point where it can make the difference between correlation and no correlation, not to mention prove invaluable in moving science forward rather than wading through pseudo-science.
    jtwitten
    Essentially, you are postulating that a false, broad scale panic is coincident with a real, small effect phenomenon (a small signal is diluted by confounders). Yours is the much more complicated hypothesis. It neither passes Occam's Razor, nor does it have a jot of supporting evidence. Rare effects are of course possible, but the risk of those rare occurrences must be balanced by the benefit. 
    This is a field I work in rather often.

    The unwritten minimum scientific standard for claims of health and safety is 99.5% accuracy in about 30 different categories of design, manufacturing, testing, storage, and marketing.

    With FDA, drug products must meet a stricter standard. In all situations the burden of proof and documentation is on the manufacturer and marketing company.

    For injectable vaccines and pharmaceuticals the standards are a lot higher with tolerance of parts per million, billion, or trillion depending on the identified risk.

    Then there are 5 danger classes to describe the potential risk and the required protection.

    The bottom line on a vaccine, is there is always some risk that has to be weighed against the benefits.

    Every product has a Drug Master File available from the FDA. Anyone who wants to read a file cabinet full of documents is welcome to do so.

    That doesn't meet the needs of an average consumer.

    The FDA tries to act as an impartial judge to balance the risks and benefits. It has a lot of regulations to deal with and a lot of products to regulate.

    I guess the FDA work load has increased faster than the budget during the past 20 years. So if the public wants better information, they should provide better support.

    The problem I see in public is there really isn't any rational and impartial source of information reaching the general public on a regular basis, and the public is not well prepared to make value judgments on the information they have. It is more of an emotional choice driven one way or another by media journalism.

    As a specialist in the field, I have a lot of reservations about using a new product that is unfamiliar to me, especially after listening to a 50 word disclaimer on the advertisements, or reading the 4 pages of instructions that come with the product.

    This article and the replies to it are from educated scientific people who seem to have some of the same difficulties I have.

    A few years a go there was an uproar in the military when highly trained and disciplined officers were refusing direct orders to receive Anthrax vaccine.

    In that case I really wonder if there was an impartial judge balancing the scales. A lot of credibility was lost at that point, and has not been regained.

    FDA might feel pressured at times from the government administration, but I don't believe it affects the decisions that are made.

    An extension of 6 years is unusual for a regulated product. More often the extension is 4 years or 2 years. To get an extension, the product must undergo testing with a validated method, with a prescribed sample size, and frequency.

    I don't get too excited about an expiration date being extended. What it means is there have not been many problems in people who received it, and there is an intensified testing program by the manufacturer.

    The cases I get concerned about are the new products that are pushed forward quickly.

    There is always some reason why the product is approved quickly, but also a risk of not knowing all of the effects.

    I lived many years with socialized medicine overseas, and all of the same concerns existed there about safety of medicines and vaccines. In those countries there is a national health care branch of government in addition to agencies like the FDA that help to make value judgments. Often I find reasons to refer to what the foreign health care agencies are saying about a particular question.

    About the cost and profit, I don't worry too much about it, although I do ask for a less expensive substitute. In socialized countries, the pharmaceutical companies do well, and doctors live in nice houses. When the care is free it abused to the point that it becomes rationed and delayed by a waiting time. In America drug companies have cyclical earnings , and on average are not much more than other companies.

    What we are missing in America is a national health care agency to help make values judgments. In the past the surgeon general has filled that need on occasions, but is not well equipped for every question.