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A Not-So-Split Decision

For those who battle tirelessly against the never ending onslaught of anti-vaccine propaganda, misinformation, and fear, there was great news the other day from Merck. The pharmaceutical company, and maker of the MMR vaccine against measles, mumps, and rubella, has decided not to resume production of the individual, or “split”, components of the vaccine. A Merck representative made the announcement during a meeting of the CDC Advisory Committee on Immunization Practices (ACIP) on Tuesday. During previous ACIP meetings, science experts on that committee presented compelling arguments against  continued, large scale production of the monovalent components of the MMR vaccine, which were echoed by scientists in Merck’s vaccine division. In a moment, I’ll discuss the arguments against the split vaccine, and why this is so important a decision. First, some background on the issue of splitting the MMR.

Merck has manufactured individual measles, mumps, and rubella vaccines on a small scale for various reasons. For example, the monovalent measles vaccine has been recommended during measles epidemics to protect infants 6-12 months of age from infection, and rubella vaccine is given to women without immunity, to protect against congenital rubella syndrome in future pregnancies. But since 1967, the MMR vaccine has been the primary source of protection against measles, mumps, and congenital rubella. The  original recommendation for the use of the combination vaccine at 12 months of age, and the recommendation in 1989 to add a booster dose at 4-6 years, has led to the near eradication of these diseases in the US. But in 1998, the infamous Andrew Wakefield warned the public to avoid the MMR vaccine, and instead opt for the monovalent components, spread out over time. This announcement came during a press conference to announce his also infamous, and thoroughly discredited Lancet paper linking the MMR vaccine to autism. It came as a shock to all of us who understand the importance of the MMR vaccine, and who know of no scientific rationale to split the vaccine. Wakefield claimed he had reason to believe the combined vaccine might lead to autism in some children. Of course, his reason was not based on any scientific evidence, and we now know that he had an undisclosed financial incentive to push people toward a monovalent measles vaccine. To this date, not a single shred of science supports the notion that the MMR vaccine causes autism, nor are there any scientifically plausible reasons that it would. As we know, mountains of data point to just the opposite conclusion. Despite absolutely no scientific rationale for splitting the MMR vaccine, and despite the fact that all of Wakefield’s claims about the MMR vaccine and autism have been thoroughly debunked, the myth lives on. I am still confronted by parents who are worried about the vaccine, and who request, or at least ask about, splitting the vaccine. On my local parents list-serve, the issue constantly rears its head, and each time I attempt to step in to reassure and educate, I am met with a wall of fear and opposition. Because of this irrational fear, pockets of unimmunized children have set the stage for disease outbreaks, and have already led to outbreaks around the country. Just this week I received an alert from the NYS DOH about a mumps outbreak in my own backyard, similar to an alert in July about a measles outbreak. Unbelievably, this doesn’t seem to phase the many parents who have fallen victim to the growing epidemic of vaccine fear.

There are several reasons Merck’s decision about the MMR vaccine is so important. In addition to creating the need for more doctor visits, with more shots, more pain, and at greater cost, splitting the vaccine into individual components prolongs the vaccination process (each component must be separated by at least a month to insure efficacy), increasing a child’s vulnerability to disease. Administration of separate components over prolonged intervals is also less likely to result in completion of the series, than is administration of a single vaccine. But perhaps more importantly, this decision is a vote against irrationality and an anti-scientific worldview that has begun to endanger society. Many parents will be upset and disappointed by Merck’s decision, especially those who were just recently reassured by Dr. Sears that Merck was poised to reintroduce the separate components in 2011. The fact is, this was actually a bad decision for Merck from a purely economic perspective. It costs considerably more to manufacture, produce, and test combination vaccines than monovalent vaccines.  Selling three individual components would also produce more revenue than a single combination product. Nevertheless, the anti-vaccine lobby will most assuredly find a way to paint this decision as a picture of government-industry conspiracy, intent on covering up the truth and depriving parents of a safer choice. One could say “you never win”, but for now I’m just happy we did.

Posted in: Science and Medicine, Vaccines

Leave a Comment (36) ↓

36 thoughts on “A Not-So-Split Decision

  1. DevoutCatalyst says:

    “…One could say “you never win”, but for now I’m just happy we did…”

    Yes, happy good news, thank you Merck!

  2. Lawrence C. says:

    “…this decision is a vote against irrationality and an anti-scientific worldview that has begun to endanger society.”

    What a wonderful bit of good news! It is indeed hard to counter irrational fears and just plain old silliness, especially when going up against the budgets of the “Mercolasearfields” of the world but sometimes the facts in evidence do win. Or to put in a pop culture context in this case, Scully is right and Mulder is wrong.

    To further look at these pockets of irrationality, I often use the old political wisdom: “Follow the money.” In the case of Merck and other companies like them it is in their deepest, most bottom-line moneyed interests to produce safe and effective vaccines. If there was ever any evidence of a conspiracy to “deprive parents of a safer choice” you betchya! it would be ferreted out by some highly motivated trial lawyers and the specific legal immunity enjoyed by these companies would be repealed, retroactively, faster than a Congressperson can palm a twenty.

    But in the case of these pockets of irrationality, where is the money trail? It seems to be a relatively small one in and of itself, centered around a handful of anti-vaccine groups and various kinds of authors and hucksters looking to sell their wares. How come they are so seemingly effective? The only answer seems to be basic ignorance of their audience and an appeal to strong emotions based on the age-old problem of confusing a series of events in time with correlation and causation. It is astonishing to me, still, that so little can be so destructive to so many. Nevermind worldwide epidemics of diseases formerly under some control, how many “privileged” children will die before someone finally realizes that vaccines work, work well and aren’t part of some government-industry-Illuminati-banker-doctor-exoplanetary conspiracy? Will it take the tragic and preventable deaths of celebrity children to convince some that vaccines might be a good thing?

    There is an old saying to the effect that all the good in the world comes from wanting others to be happy and all the suffering in the world comes from wanting only oneself to be happy. The anti-vaccine folks seem to be ready to bring on a lot of suffering for exceptionally self-centered reasons.

  3. overshoot says:

    Good to see you writing on SBM, Dr. Snyder. Nice work.

  4. MrDuncan says:

    The link you provided from the NYSDOH appears to be about a mumps outbreak in which 75% of the cases had two documented doses of mumps vaccine. Is that the right document?

  5. chaoticidealism says:

    I’m not sure why you’re calling this a victory; wouldn’t the availability of a split vaccine reassure more parents into getting their kids properly vaccinated?

    Maybe it’s a philosophical victory, as in, “Merck is getting the point that the vaccine/autism thing is bunk,” but I’d be happier if it were the parents getting the point, personally.

  6. John Snyder says:

    MrDuncan:

    That was the correct link, but I wrote measles instead of mumps. I’ve corrected that, and added another link to a similar outbreak in July which was about measles.

  7. kill3rTcell says:

    MrDuncan, there are more vaccinated people than non-vaccinated people in the population of Brooklyn (I presume, without seeing any actual statistics). The vaccine will not stimulate an adequate immunological response (including memory) in all cases. Not all those vaccinated will be protected from infection (hence the requirement for reaching herd immunity). If there are multiple infected people who only encounter vaccinated people, they will pass the infection on to those vaccinated but without an adequate response to the vaccine.

    At first it seems odd (it’s one of the things the anti-vaxers will hold above their heads and say “Ha! See this stat!”), but with consideration it’s not all that hard to see.

    ~14 susceptible infected children, and ~43 immunised infected children. Given how contagious Mumps is, and just how many others you can expect 14 children to encounter in one day (i.e, many more than 43, including those that come into contact with the virus but not the child) it’s not as it may at first seems.

    Hope this helps :)

  8. Chris says:

    McDuncan, no one has ever said the mumps vaccine was 100% effective. I just looked at the CDC Pink Book mumps chapter, and one estimate they gave was between 71% to 97% effective for two doses. Sometimes it wears off with time, and there are some people who do not get immunity… even after getting mumps… like me, I had it twice before I was 12 years old! Then the vaccine came out, and I have been relatively safe (so please, folks, make sure you don’t give me mumps again! thank you).

    Some herd immunity arithmetic (with pertussis, but the numbers can be similar for mumps):

    Take 1000 people (ignoring the infants under 2 months who cannot be vaccinated, or babies under a year who can only be partially vaccinated), if 5% refuse vaccines then the numbers are:

    950 vaccinated persons (assuming full schedule)
    50 unvaccinated persons

    The pertussis vaccine is actually only 80% effective at worse, so the numbers are:

    760 protected persons
    190 vaccinated but vulnerable persons
    50 unvaccinated persons

    There is an outbreak and it gets spread to 20% of the population, then:

    760 protected persons without pertussis

    38 vaccinated persons get pertussis
    152 vaccinated person who may still get pertussis

    10 unvaccinated persons get pertussis
    40 unvaccinated persons who may still get pertussis.

    This is how more vaccinated persons get the disease than unvaccinated. Even if the infection rate was at 100%, there would still be more of the vaccinated getting the diseases because there are more of them!

  9. John Snyder says:

    MrDuncan and Kill3rTcell:

    That’s correct. A very common misuse of basic statistics is when anti-vaxers point to the fact that, during outbreaks, often more immunized people than unimmunized people get sick. If a child with measles walks into a room of 100 preschool children, 1 of whom is unimmunized, a statistically plausible outcome would be that 6 children will develop measles, the single unimmunized child, and 5 of the immunized children. This is because there is a roughly 5% vaccine failure rate after the first dose of measles vaccine. So, more vaccinated children than unvaccinated children will become infected. Anyone familiar with the simple statistical concept of percentage will quickly see the problem with using this as an example of why vaccines don’t work. But for those who don’t see this, here’s the clarifying point. Suppose that same child with measles walks into a room with 99 unimmunized children and 1 vaccinated child. The most likely outcome would be that approximately 95 children would develop measles. Almost all of the unvaccinated children would get the disease, (the secondary attack rate for measles is over 90%) and the vaccinated child would most likely be protected. So, does the vaccine work?

    Note: While 95% of children are protected after the first dose of measles vaccine, over 99% are protected after the booster dose at 4-6 years of age.

  10. yeahsurewhatever says:

    To this date, not a single shred of science supports the notion that the MMR vaccine causes autism, nor are there any scientifically plausible reasons that it would. As we know, mountains of data point to just the opposite conclusion.

    The opposite conclusion?

    That autism causes the MMR vaccine? V ← A ? Converse implication?

    That the MMR vaccine prevents autism? V → ¬A ? Negational implication?

    That the MMR does not cause autism? V ↛ A ? Nonimplication?

    I’m just saying, be careful how you throw around words like “opposite”. All of these are opposites of the original proposition in some way.

  11. John Snyder says:

    yeahsurewhatever:

    Sorry you had a hard time with that one. I don’t think most people would have too difficult a time understanding the intended meaning, and I don’t think it requires further elucidation.

  12. hokieian says:

    “splitting the vaccine into individual components prolongs the vaccination process (each component must be separated by at least a month to insure efficacy”

    Does this argument make sense from an immunological basis? Why does one component affect the efficacy of the immune response to another component? It seems like if that were the case, the trivalent vaccine would be ineffective.

  13. John Snyder says:

    hokieian:

    Live virus vaccines given simultaneously are effectively immunogenic. However, once a live virus vaccine is given, there is a chance that other live virus vaccines given within a 4 week period may not invoke a satisfactory immune response.

  14. Calli Arcale says:

    I’m a software engineer, not an immunologist, but I’m curious about that as well. My offhand hunch: might it have something to do with the amount of adjuvant provided? Or the fact that these are live vaccines, which might interact with one another in ways which must be accounted for in manufacturing? Dunno. Hopefully someone will answer that, because I’m likewise curious about the rationale for the one-month separation.

    I know there are other vaccines given together without being in the same shot (e.g. I’m pretty sure you can get IPV and DTaP at the same time), so I’m not sure what the limitation is. I know different vaccines cause different responses, so it’s plausible to me; I just want to know more.

  15. hokieian says:

    John, I’m asking what the immunological basis for that is. I’m not sure that it makes sense from an immunological standpoint that one “infection” will prevent mounting an immune response to another “infection”.

    Apparently there is sound clinical evidence for the 1-month period between individual components of the MMR vaccine, I’m just curious about the physiology/immunology behind it.

    You’d think with a PhD in virology, I should know the answer, but I am honestly drawing a blank at the moment.

  16. weing says:

    Actually one infection may interfere with infection by another virus. This was thought to be due to interferon. At least that’s the way I learned it over 30 years ago.

  17. hokieian says:

    weing – Thanks for jarring those neurons awake. I forgot about PKR activation in response to IFN and its effect on ribosome function.

    I would still think that an effective humoral immune response could be mounted to multiple live vaccines given separately.

  18. weing says:

    Worth testing if it hasn’t been done already.

  19. Archangl508 says:

    John,

    Had a question regarding your discussion above about herd immunity. Would you think that the failure rate has to do not just with exposure, but with dose of pathogen as well?

    I would imagine that in any immunization the amount of immunity gained is more of a spectrum, not simply “protected” versus “unprotected”.

    And in any case, there must be some amount of pathogen that you could potentially contact as a sufficiently vaccinated individual that could overwhelm the protection generated by the vaccination.

    So if you’re in the middle of an outbreak of disease in unvaccinated individuals you still are at risk dependent on the amount of pathogen you contact combined with the level of immunity to the pathogen (i.e. A weaker responder would be overcome by lower levels of ontact with pathogen infected individuals).

    Just another way of thinking about the necessity of generating herd immunity for population protection from disease.

  20. johnmayerisadouche says:

    So you win the battle but lose the war?

    Pat yourselves on the back for all the ‘silliness’ that has just been averted. But you know what else has been averted? Lots of people getting vaccinated. I was due to get rubella and my daughter was going to get them separately because of a neurological condition. Now that they’re not going to separate them, those plans are on hold. Can’t imagine we’re the only ones.

    If the true goal is a 100% vaccination rate for everyone’s health and safety, then it really shouldn’t matter how we get there (combo or monovalent), so long as we get there.

  21. John Snyder says:

    hokieian/weing:

    The concern about non-simultaneous administration of live-virus vaccines comes from two 1965 studies demonstrating a reduction in responsiveness to smallpox vaccine following measles vaccine. Another report in MMWR showed that children who received varicella vaccine less than 30 days after MMR vaccination had a 2.5-fold increased risk of breakthrough varicella (i.e., varicella disease in a vaccinated person) compared with those who received varicella vaccine before, simultaneous with, or more than 30 days after MMR.

    Actually, the impact of non-simultaneous administration of measles, mumps, rubella, or varicella is not known. Still, based on the above findings, the recommendation is to wait at least one month between non-simultaneous doses of live virus vaccines.

    See references below:

    Petralli JK, Merigan TC, Wilbur JR. Action of endogenous interferon against vaccinia infection in children. Lancet 1965;2:401–5.

    Petralli, JK, Merigan TC, Wilbur JR. Circulating interferon after measles vaccination. N Eng J Med 1965;273:198–201.

    CDC. Simultaneous administration of varicella vaccine and other recommended childhood vaccines—United States, 1995–1999. MMWR 2001;50:1058–61.

  22. hokieian says:

    Many thanks for the information, John.

  23. SD says:

    In what way is this classified as a “win”?

    [ed. note, generally-useful definition of "win": "At least one person walks away from the deal better than when they entered into it, and nobody else walks away worse off."]

    This is not a medical question; it is a question of consumer choice. Viewed that way, this development is not Win, it is Fail and the mother of Fail. At least one segment of this market has expressed a preference for monovalent vaccine. Their motivations for this preference are largely irrelevant; they want what they want. What you guarantee by cheering the limitation of choice is the non-vaccination of some children (the parents will refuse to vaccinate in a way they believe is harmful) and the migration of other potentially-vaccinated children to black or less-transparent markets (i.e. “I’ll take my kid to Thailand instead”), with the concomitant risks of that migration (vaccines of poor quality, counterfeit product, expired vaccines, &c.)

    Additionally, you celebrate the limitation of financial options for parents; ceteris paribus, a single effective dose of monovalent vaccine is cheaper to some extent than a single dose of polyvalent vaccine – it cannot be otherwise, without subsidy or other price control involved – and therefore a parent of limited means may be better able to afford three vaccinations spread out over time than a single three-dose vaccine administered at one time.

    None of the above strike me as particular “wins”. Perhaps you can explain your position further, so that the “win” becomes apparent.

    Science question: Is there any valid medical or scientific reason, assuming proper scheduling of administration, to *not* immunize with monovalent vaccine? Is the immunity granted by administration of trivalent vaccine superior to that granted by administration of three monovalent vaccines in sequence?

    What this seems to boil down to is a personal preference on the part of SBMers: “Jab them with all three at once, that way we know they’ve got them. No deviation.” While that is appealing from a medical-management standpoint – patient compliance is an eternal problem, anything which eases it is at least some kind of win – it neatly sidesteps the reality that the opinion of the consumer of this service is the only one that matters. When that opinion is ignored – which custom SBM appears to heartily indulge the perpetuation of – the result is predictable and unfortunate.

    (Side note: the traditional chorus at SBM will chime in and observe that all that is required is compulsory-vaccination laws for a solution to this problem. I, the bloodthirsty anarchist, will counter this idea with the observation that the typical result of a *perceived* threat leveled at a parent’s children is usually the death of the threatener at the parents’ hands (in the case of an individual threat), revolution (in the case of an organized, systemic threat), or the contextual equivalent of either. Moreover, once somebody manages to convince enough people that a vaccination scheme targeting their children is not “helpful” but “harmful” – something which has already happened, mind you, and I will again remind the reader that it is only the opinion of the parents of the child targeted for vaccination that matters in this situation – any attempts to increase the level of coercion on the parents involved to establish uniform compliance are interpreted with increasing readiness as validation of the threat.)

    The proper response to a demand for a monovalent vaccination schedule is to give the public what it wants. Unless there is a clear indication that “monovalent vaccination x3 is worse than no vaccination” – much worse, in fact – it is not an abrogation of the medical oath to administer vaccinations in this fashion. Even if patient compliance is a problem – suppose the patient is vaccinated for mumps, but does not return for vaccinations against measles or rubella – there *is a net gain*, in that that patient is now immunized against at least one childhood disease. What you *should* be cheering is the presentation of multiple ways to make sure people are vaccinated: “Hey, *no* *problem*! One-at-a-time isn’t the *best* or *easiest* way to do it, y’know, but let’s make sure the mission is accomplished in whatever way gets it done, okay? Okay? Right. So we’ll give him the mumps vaccine today – this will keep his nuts from possibly swelling to the size of grapefruits and keep you in the running for ‘Grandmother of the Year’ award because he won’t be sterilized by mumpsvirus – that can happen if they get mumps after they hit puberty you know? You didn’t know? Yeah, these diseases are nasty. You don’t even want to know some of the *other* complications. Anyway, so he gets the mumps shot today – he’ll be kind of sick today and probably tomorrow too – then you come back in two weeks for the measles vaccine, and that way he won’t have any complications from measles later in life, like encephalitis and death. Yeah! I am totally serious. People die from measles, you know? It’s bad news – why do you think they make vaccines? Hell, kids in Africa die from it all the time. Yeah, no kidding. God bless the USA, huh? Okay. See you in two weeks. ‘Kay, bye now.”

    (2nd side note: evidence that smallpox vaccine is less efficient after administration of non-simultaneous M/M/R vaccines is slightly less than impressive these days, given that smallpox vaccines are not administered *at all* except in extraordinary circumstance or to people potentially occupationally exposed to variola virus. Since children do not fall into this category (unless USAMRIID or the CDC has something they would like to share with us), arguments that vaccination against smallpox is impacted by administration of multiple monovalent vaccines vs. single doses of polyvalent are, uh, “not compelling”.)

    Make the customers happy. in other words. More ways to make customers happy equals more happy customers, ceteris paribus, which in this particular case equals more happiness for those who like to see higher vaccination rates. Does anyone argue that this is not a desirable outcome?

    (3rd side note: As an idle aside, y’all should probably ditch the term “herd immunity”. Yeah, it’s a term of art. It also conjures mental images of the slaughterhouse. Patients are not cattle and doctors are not herdsmen, unless one is making the rounds at Auschwitz; this notion and its hair-raising implications are presumably not associations one wishes to make with modern medicine. For those who see no need, a simple question; how often do we refer to the “caloric flux” or “theory of infinitesimals”? Yeah. Some terms require updating. It is a good PR move to update this terminology. I would suggest “statistical immunity”, or perhaps “statistical transmissibility attenuation”, something like that – more impersonal, more scientific, more accurate, less condescending. Just a thought. You may wish to grok its numinous Truth before responding.)

    “power to the people!”
    -SD

  24. Dr Benway says:

    Their motivations for this preference are largely irrelevant; they want what they want.

    Parents want doctors who will advocate for what’s best for their kids. When doctors sacrifice that objective for simply pleasing parents, mistrust in doctors increases.

    Example: after thimerosal was removed from vaccines –to please parents, not science– exaggerated fears of thimerosal seemed to increase. A number of times I’ve heard parents say, “they wouldn’t have taken it out of the vaccines if it weren’t a problem.”

    I think we’re failing to educate physicians in how to respond rationally to public health controversies and uncertainty in medicine. Matters of evidence become matters of art, leading to confusion among the public.

    All the more reason to kick so-called “integrative medicine” out of our medical schools. Medical students can’t study science-based therapies and homeopathy without brain injury.

  25. Calli Arcale says:

    I agree that this isn’t an unalloyed “win”. It’s nice to hear that fearmongering about the combined MMR is being ignored. It’s not so nice to hear that, due to cost/profit reasons, another set of vaccines are going away.

    Make no mistake: Merck isn’t discontinuing the monovalent vaccines because they are eschewing pseudoscience or to make a stand against the antivaxxers. They’re doing it for business reasons, which is generally shorthand for “profit returned doesn’t justify cost spent”.

    So on the positive side, we see that the antivaxxers aren’t really making much of an impact on parents, because demand for the monovalent vaccines is clearly low.

    On the negative side, we see yet another symptom of a larger problem: that vaccine manufacturers don’t really make much money off of these routine vaccines, and so it takes very little to get them to stop. There is an ongoing problem that our vaccine production capability is inadequate, and there is no reason to expect the vaccine manufacturers to correct this problem anytime soon — it is not in their interests to do so, as that would cost money. Shortages are already a problem, and I expect that will only get worse as time goes on, and manufacturers achieve monopolies by virtue of being the last man standing.

    So I’m not convinced this is a victory. It would have happened anyway. It’s just another vaccine production line being shut down for business reasons. And it leaves in the lurch people who, for one reason or another, cannot use the trivalent MMR (see comments above for personal anecdotes). Those people now have to rely on herd immunity, which, thanks to Dr Wakefield et al, is now threatened. So this is, at best, a Pyrrhic victory.

  26. Harriet Hall says:

    SD,

    The single vaccines are not cheaper. Three vaccines requiring 3 separate visits can’t be cheaper than one.
    Separate vaccines endanger children. Children who have had vaccine 1 are still vulnerable to diseases 2 and 3 until they return for vaccines 2 and 3.
    There is no scientific rationale for separating the shots. Why should we cater to irrational fears?
    “Make the customers happy”? These are our patients who rely on us for professional advice, not exactly “customers.” We could make a lot of people “happy” by giving them narcotics, but we have a moral duty to do what is right, not what an uniformed person thinks he wants.
    I don’t find the term “herd immunity” condescending. Are you prejudiced against cows?

  27. Joe says:

    Harriet Hall on 29 Oct 2009 at 1:18 pm ““Make the customers happy”? These are our patients who rely on us for professional advice, not exactly “customers.””

    This is what I always recommend: doctors have “patients,” lawyers have “clients,” sCAMmers are merchants and (as such) have “customers.” Whenever one refers to a sCAM customer as a “patient,” it elevates the practice.

  28. Kausik Datta says:

    SD,

    It is a question of consumer choice. Viewed that way, this development is not Win, it is Fail and the mother of Fail.

    ‘Consumer’? I hope you are not a doctor. If you are, I don’t want you anywhere near me when I am ill. The doctor-patient relationship should be one of trust and honesty. As a patient, I want my doctor to dispense sound, evidence- and knowledge-based professional advice. This is NOT the same as a supplier-consumer interaction.

    At least one segment of this market has expressed a preference for monovalent vaccine. Their motivations for this preference are largely irrelevant; they want what they want.

    Once again, this line of logic works if you are in the business of selling consumer items (though even in that business, motivations for public preferences are always given a good deal of credence). However, for a physician, the motivation behind a patient choice is significant and relevant. Sometimes, a choice may decide between life and death, loss or restoration. It is important for a good physician to understand the motivation, if s/he is to offer constructive advice or guidance to the patient. Here is where the question of patient education becomes important. If the preference that an uninformed patient expresses contradicts scientific observation or evidentiary support, it is unethical for the physician to simply give in to the patient’s ‘choice’ without educating him/her first. If you as a patient express a preference for rat poison as a cure for your tummy-ache, do you feel that your physician is obligated to give that to you?

    What you guarantee by cheering the limitation of choice is the non-vaccination of some children (the parents will refuse to vaccinate in a way they believe is harmful) and the migration of other potentially-vaccinated children to black or less-transparent markets (i.e. “I’ll take my kid to Thailand instead”), with the concomitant risks of that migration (vaccines of poor quality, counterfeit product, expired vaccines, &c.)

    I shall give you that you understand the depth of the non-compliance related issues – to some extent. But I think you are overstating the risks in this case. For example, anti-vaxxers would not migrate to a different part of the world to get their children vaccinated. There is no cheering for a ‘limitation of choice’ as you put it; it is rather a recommendation borne out of good sense. Dr. Hall has already indicated how the monovalent vaccines would not turn out to be cheaper when you place a value on every aspect of the affair.

    Is there any valid medical or scientific reason, assuming proper scheduling of administration, to *not* immunize with monovalent vaccine? Is the immunity granted by administration of trivalent vaccine superior to that granted by administration of three monovalent vaccines in sequence?

    Dr. Snyder has already given you references to the evidentiary basis, with the frank admission that the impact of non-simultaneous administration of MMR and varicella is not known. The recommendations are borne out of good biological sense (i.e. a wait period between non-simultaneous doses of live virus vaccines) and financial sense, alluded to by Dr. Hall above. The unfortunate fact that you don’t know the difference between small pox (variola) and chicken pox (varicella) cannot be any one else’s problem as far as compelling arguments go.

    Side note: the traditional chorus at SBM will chime in and observe that all that is required is compulsory-vaccination laws for a solution to this problem.

    No, the chorus at SBM has always been to say that we need better patient education, and we need to effectively counter the lies and misinformation and FUD being spread at many levels amongst general public by certain ignorant individuals with an agendum.

    I, the bloodthirsty anarchist,…

    Ah! Therein lies the nub of the problem. You will apply any rationale, however far-fetched, to counter any idea that you perceive to be ‘threatening’ – regardless of the actual situation, or context, or sense. The anarchist lives in a perpetual sense of paranoia, finding shadows and daggers where none exist. There is no ‘coercion’ of the parents; this is a public health measure – with a long-standing evidentiary support – aimed towards providing better health for everyone, this generation and the next.

    Your dissatisfaction with the term ‘herd immunity’ is quite telling, actually. You think human beings don’t have herds, or perhaps you think humans are way better than other animals – because they were ‘made in the image of’… you know, god?

  29. John Snyder says:

    Calli Arcale:

    Make no mistake: Merck isn’t discontinuing the monovalent vaccines because they are eschewing pseudoscience or to make a stand against the antivaxxers. They’re doing it for business reasons, which is generally shorthand for “profit returned doesn’t justify cost spent”.

    From what I’ve heard, the business end at Merck was actually leaning toward producing and marketing the single component vaccines as another market niche. It was actually persuasive arguments from the vaccine division that turned them around.

    The truth is, combination vaccines are usually more expensive to produce than single component vaccines, and require more rigorous testing for FDA approval. Greater sales of their single vaccines would probably have been more profitable for the Merck.

  30. SD says:

    Sprach Kausik Datta:

    “‘Consumer’? I hope you are not a doctor. If you are, I don’t want you anywhere near me when I am ill. The doctor-patient relationship should be one of trust and honesty. As a patient, I want my doctor to dispense sound, evidence- and knowledge-based professional advice.”

    No, I am not a doctor. I do not have to be a doctor to tell you that yes, the relationship between a patient and doctor is precisely the same as that between the purchaser of any good and the provider of that good. The nature of the good (“medical advice”) is *not relevant* from an economic perspective. Imbuing the doctor-patient relationship with magical qualities does not mean that it actually possesses those magical qualities. (NB: This is one of the numinous Truths that a scientific education will impart to you.)

    Serious question: Do you think there is a magical specialness to the relationship between a priest and a confessor? (This is still an economic good, although the price in this case is non-monetary, and in the physical sense typically restricted to time only.)

    “This is NOT the same as a supplier-consumer interaction.”

    This is a verbalization of a belief in magic.

    “Once again, this line of logic works if you are in the business of selling consumer items (though even in that business, motivations for public preferences are always given a good deal of credence).”

    You appear to misunderstand the meaning of the term “consumer”.

    “However, for a physician, the motivation behind a patient choice is significant and relevant. Sometimes, a choice may decide between life and death, loss or restoration. It is important for a good physician to understand the motivation, if s/he is to offer constructive advice or guidance to the patient.”

    This is beautiful, but also irrelevant. The question of what makes a “good” doctor (i.e. “provider of generally-useful and/or beneficial medical advice”) does not have a thing in the world to do with the mechanics of preferences of consumers in this market.

    People want things. People give other things up to get those things. Sometimes these things are ethereal or open-ended: “I want my child to be healthy.” If that is a want of mine, I begin to seek out providers of things that make my child healthy. When I find those things, I obtain them (“consume” them), typically by exchanging other things I have (time, money) for them. By consuming them, I exclude others from using them (the vaccine given to my child cannot be given to another child, for example). When there is a want for a good and that want is not satisfied, people tend to act in ways that satisfy that want. If there is a desire for, e.g., monovalent vaccine, and that desire is greater than that for all other options (including “no vaccination”), and monovalent vaccine is outlawed, monovalent vaccines will be available on a black market at inflated prices. If there is a desire for those vaccines, again greater than that for all other options including “no vaccination”, and those choices are limited locally but not globally (“Thailand has them, and America doesn’t”), then people will go to Thailand to get them, or arrange to have them shipped from Thailand to the US. This is all Econ 101 stuff, basically. If there is a desire for those vaccines that is *not* greater than other options at that price, e.g. “no vaccination” is desired more than “mono-vaccination at inflated price X” is desired more than “poly-vaccination at normal price N”, then people will not get vaccinated. Surprise: that’s what’s happening now. Behold the majestic clockwork machinery of human affairs.

    Nothing in the above description involves an assessment of the quality of a doctor, nor of the utility of his advice. Perhaps that advice will alter my wants; perhaps it won’t; perhaps I won’t seek it because I don’t want it, believing it to be of no value. These are *all* *irrelevant* to the economic reality of the process of seeking a good (in this case, a vaccine), because that reality does not make reference to *why* people want things, only *that* they want things.

    “Here is where the question of patient education becomes important. If the preference that an uninformed patient expresses contradicts scientific observation or evidentiary support, it is unethical for the physician to simply give in to the patient’s ‘choice’ without educating him/her first. If you as a patient express a preference for rat poison as a cure for your tummy-ache, do you feel that your physician is obligated to give that to you?”

    I will note at this point that there has been no evidence provided that administration of monovalent vaccines is “bad”, either, dodging this question entirely. That it may be more convenient from a patient-compliance perspective to administer the three-in-one shot is, again, irrelevant; is there data to support the assertion that the administration of individual M/M/R shots leads to *more* measles, mumps, or rubella?

    “I shall give you that you understand the depth of the non-compliance related issues – to some extent. But I think you are overstating the risks in this case. For example, anti-vaxxers would not migrate to a different part of the world to get their children vaccinated.”

    If you were convinced that your child were being put at risk and you had no other options, what would *you* do? We see one thing that they are willing to do: refuse to vaccinate their children at all. Is taking a three-month family vacation to Thailand such a stretch, then?

    “There is no cheering for a ‘limitation of choice’ as you put it; it is rather a recommendation borne out of good sense.”

    At the tail end of the blog post: “One could say “you never win”, but for now I’m just happy we did.”, i.e. ‘We are happy that a maker of vaccines has decided to not offer the means to engage in a second option for vaccination.’

    “Dr. Hall has already indicated how the monovalent vaccines would not turn out to be cheaper when you place a value on every aspect of the affair.”

    I think you mean “when the cost of the unnecessary payment for an office visit to the MD to have office staff administer the vaccination is factored in” – a practice I already maintain is asinine, and which I have caviled against in the past – but I was referring to the cost of the vaccine itself, not the cost of the added arbitrary rent-seeking. I maintain that it is prima facie obvious that a single dose of a vaccine purchased individually is less expensive than three of the same doses mixed together and purchased as one unit, although I grant that there is not necessarily a linear relationship between cost and dosing (i.e. savings in preservatives and packaging for trivalent dosing mean that a trivalent vaccination does not necessarily cost three times what a single dose does). I tend to ignore the administration costs because while a doctor may forego charging for administration of the vaccine (e.g. as a public service, personal charity, whatever), the cost of the vaccine itself must be borne by someone, and that someone is invariably the patient to some number of removes.

    “Dr. Snyder has already given you references to the evidentiary basis, with the frank admission that the impact of non-simultaneous administration of MMR and varicella is not known.”

    Then what is the point of arguing over this point? Again, I maintain that you should be happier for a way for customers to be satisfied with getting vaccinated at all. Absent a good argument for the ill effects of serial vaccination, why are you responding?

    “The recommendations are borne out of good biological sense (i.e. a wait period between non-simultaneous doses of live virus vaccines) and financial sense, alluded to by Dr. Hall above. The unfortunate fact that you don’t know the difference between small pox (variola) and chicken pox (varicella) cannot be any one else’s problem as far as compelling arguments go.”

    Thank you, but I do know the difference. (It’s easy to brainfart, though, I grant you that.) I didn’t bring up smallpox in the first place. I was referring to this bit of Dr. Snyder’s response:

    “The concern about non-simultaneous administration of live-virus vaccines comes from two 1965 studies demonstrating a reduction in responsiveness to smallpox vaccine following measles vaccine.”

    Nobody cares about what happens when you vaccinate someone against smallpox, because children don’t get that vaccine anymore. While interesting and potentially indicative of something that requires further study, it is not itself useful in this argument. Things that happen when you do similar things to the topic under discussion do not constitute scientific evidence, they constitute a useful heuristic for proposing a hypothesis about what will happen when we actually *do* that thing. The chickenpox study is same-same, but potentially more relevant, because those vaccines *are* administered today. The thing we want to do: administer individual measles, mumps, and rubella vaccinations, and obtain approximately the same response in terms of “immunity to measles, mumps, and rubella” as if the vaccines had been combined and administered at one time. Preferentially, we would like to do so in a way that does not interfere with (definition of “interfere with”: “… lead to overall decreased effectiveness of…”) other vaccinations. Sorry if that wasn’t clear.

    “No, the chorus at SBM has always been to say that we need better patient education, and we need to effectively counter the lies and misinformation and FUD being spread at many levels amongst general public by certain ignorant individuals with an agendum.”

    Better patient education is great! However, be advised that you are dealing with people who will make up their own minds on the subject, and that it is wise to have something to offer the ones who make up their minds to take the less-traveled path. The availability of monovalent vaccines is a cheap, easy, and effective way to accomplish the goal of vaccinating people, regardless of whatever drives them to that decision, be it FUD, personal preference, contrariness, cost, or whatever.

    ” I, the bloodthirsty anarchist,…

    Ah! Therein lies the nub of the problem. You will apply any rationale, however far-fetched, to counter any idea that you perceive to be ‘threatening’ – regardless of the actual situation, or context, or sense. The anarchist lives in a perpetual sense of paranoia, finding shadows and daggers where none exist.”

    Uh, yeah. Oh-kay. You appear to have a very strange view of the actual internal life of the anarchist. Perhaps you should talk with one, sometime. Hint: start with the etymology of the word.

    “There is no ‘coercion’ of the parents; this is a public health measure – with a long-standing evidentiary support – aimed towards providing better health for everyone, this generation and the next.”

    The concept of “public health”, as currently practiced, actually involves a great deal of coercion. Facile platitudes about “everyone” and “future generations” do not change the factual basis of this assertion, nor the moral implications of this practice, not one iota. This is a discussion for another time and another thread. For now, I recommend you acquaint yourself with the definition of the word “facetious”.

    “Your dissatisfaction with the term ‘herd immunity’ is quite telling, actually. You think human beings don’t have herds, or perhaps you think humans are way better than other animals – because they were ‘made in the image of’… you know, god?”

    Did I say any of the above? No, I said that the term is dehumanizing, offensive to the general public, and alienating. English does not appear to be your primary language, so you may not be aware of this, but ‘herd’ is most commonly used in reference to farm animals, most frequently cows. Humans do not like to think of themselves as herd animals; herd animals are faceless members of a fungible mass whose primary purpose is either slavery (milk or wool production) or slaughter (meat). Humans prefer to think of themselves as beings with well-defined individuality, meriting individual consideration. (Perhaps you would like to change this preference; medicine is probably not the place to start, though.) When the term ‘herd immunity’ is used in a medical context – i.e. in reference to the treatment of human beings – it implies that the “doctor-patient” relationship is closer to a “veterinarian-farm animal” relationship. While this may be an accurate description of how certain doctors view their patients and the public at large, it is a mindset probably best not broadcast to that public; it is a term best updated to something less supercilious. Eternal Truth #1209: Uncomfortable truths are best euphemized if you would like them to *remain* true.

    (A student of communication theory would probably interject at this point that the use of dehumanizing terms, even internally or as specialized terms of art, leads to dehumanizing thought and behavioral patterns as well; thoughts and behaviors are influenced by the choice of words. This is why, e.g., racial slurs are considered inappropriate; when one thinks of a group in dehumanizing terms or uses dehumanizing terms to describe them, one eventually begins to behave in dehumanizing ways towards them. There is adequate historical proof of this to establish it as a given, I believe.)

    I realize that you will not accept this statement without proof, so I propose here an experiment that you can perform to validate it for yourself. The next time you see a group of three or more women that you do not know – at work, on the street, whereever – walk up to them and ask them what herd they are a part of. Observe their response. Repeat this experiment, perhaps with a group of men. (I recommend doing this at a Sturgis rally.) Ask a group of women in front of a group of men, preferably at a bar. What do you find? Is this a pleasant ice-breaker to use to introduce oneself to strangers?

    “moooooooooooo”
    -SD

  31. weing says:

    “I tend to ignore the administration costs because while a doctor may forego charging for administration of the vaccine (e.g. as a public service, personal charity, whatever), the cost of the vaccine itself must be borne by someone, and that someone is invariably the patient to some number of removes.”

    So you do believe in magic.

  32. Kausik Datta says:

    SD

    No, I am not a doctor. I do not have to be a doctor to tell you that yes, the relationship between a patient and doctor is precisely the same as that between the purchaser of any good and the provider of that good.

    Thank goodness you are not a doctor. Were you one, I would pity your patients. You do realize that when it comes to a doctor and patient, the ‘provider’ may not have a ‘return policy’ under all circumstances… And that the ‘goods’ you are purchasing from a ‘provider’ may result in the saving or losing of a life, right? I find the apparent callousness of your attitude – in trying to reduce a doctor-patient relationship to the mere monetary transaction for the sale of a good – quite odious.

    I repeat, as a patient, I want my doctor to dispense sound, evidence- and knowledge-based professional advice. You claim that the nature of a medical advice is not relevant from an economic perspective – a particularly strange claim from someone purporting to think in terms of economics. Medical advice imparted to a patients potentially impacts his/her life; so yeah! The nature of medical advice is relevant all right.

    I think you mean “when the cost of the unnecessary payment for an office visit to the MD to have office staff administer the vaccination is factored in” – a practice I already maintain is asinine, and which I have caviled against in the past – but I was referring to the cost of the vaccine itself, not the cost of the added arbitrary rent-seeking.

    Ah! So you want to have your cake and eat it, too. Well, you can’t! You can’t whine about the cost of vaccine as an argument for a monovalent vaccine over a polyvalent one, yet refuse to take note of the overall cost structure, which includes mechanics of production and logistics of delivery to the end-user. What you find ‘prima facie obvious’ does not, unfortunately, obviate the larger economic realities.

    Imbuing the doctor-patient relationship with magical qualities does not mean that it actually possesses those magical qualities. (NB: This is one of the numinous Truths that a scientific education will impart to you.)

    Apparently, your ‘scientific education’ did not include instructions on how to eschew strawman arguments. I had said that the the doctor-patient relationship should be one of trust and honesty. That is what the tenets of professional ethics demand. There is no magic.

    The question of what makes a “good” doctor (i.e. “provider of generally-useful and/or beneficial medical advice”) does not have a thing in the world to do with the mechanics of preferences of consumers in this market.

    So how do ‘consumers’ (to use your term) choose doctors? What dictates the ‘preference’ of the said consumers for finding a good doctor or an effective therapy? Would you, as one such ‘consumer’, apply the same logic to find an electrician or a carpenter or a plumber? When you want your toilet bowl to be flushed properly and your malfunctioning cistern to be repaired, do you invite every Tom, Dick and Harry to come and take a look, or do you rather wait to find a good, reliable plumber who can fix it? Why do you choose the plumber? Because you want an expert, you want someone who knows his/her job to tinker with your contraptions. How do you know who is a good plumber? You either educate yourself by looking up appropriate information, or someone does it for you.

    That brings me back to the question of patient education. A patient (or a parent) needs to be informed in order to make the correct choice. Before the anarchist/libertarian in you rises in consternation, I am talking about information, the scientifically correct, evidence based information – not FUD; uninformed (or rather as is the norm these days, misinformed) a patient makes a wrong decision – quite common, once again these days, and there is needless injury, suffering and/or loss of lives. A misinformed parent may be “convinced that… [his/her] child is being put at risk”, but not an informed one. In having people not getting themselves or their children vaccinated, we are witnessing the havoc that prodigious misinformation and lies have wrought on the American people. The ill-effects of this would be evident a few years into the future.

    I hope your Econ 101 class did teach you that the supply demand theory works optimally only in a perfectly competitive market. A Public Health measure is not a competition for brownie points by vaccinating maximum number of people. It really is an evidence-based life-saving device, targeted towards specific vulnerable populations, for specific reasons, geared towards a long-term effect. The fact that you dismiss the patient-compliance perspective as irrelevant amply demonstrates that you are ignorant of Public Health and epidemiology.

    The concept of “public health”, as currently practiced, actually involves a great deal of coercion. Facile platitudes about “everyone” and “future generations” do not change the factual basis of this assertion, nor the moral implications of this practice, not one iota.

    More of that same ignorance. You regard any measure involving ‘everyone’ and ‘future generations’ as facile. You view every necessary measure for greater good as coercion. Is this arrant selfishness a hallmark of anarchists/libertarians?

    I said that the term ["herd immunity"] is dehumanizing, offensive to the general public, and alienating. English does not appear to be your primary language, so you may not be aware of this, but ‘herd’ is most commonly used in reference to farm animals, most frequently cows.

    Your strange views on etymology notwithstanding, you have got the concept wrong. Herd does not only apply to farm animals (not even ‘most commonly’); a herd is a large group of animals, a term usually applied to mammals, including whales. Herd immunity simply refers to a state of immunization in a given population so high that an invading infection will not spread and the small non-immunized minority will be protected.

    But your equating ‘herd’ with ‘cows’ has one merit, though. Those who, riding high on herd immunity, claim “I never had flu, and I have never been vaccinated” (a favorite amongst anti-vaxxers) are distinctly bovine in their mental capacity.

    Nyaah… I take that back. I should not insult the cows. I am Indian. Cows are sacred.

  33. daedalus2u says:

    It probably is a net economic benefit for Merc. The largest “cost” is probably the capital tied up in the vaccine which means in the vaccine manufacturing plant and the quality control systems. If they only make all 3 vaccines combined into one, then they all get used up simultaneously. They don’t end up with a surplus of one of the types which goes bad through age before it gets sold. The trivalent vaccine can always be given even instead of a monovalent dose.

    I think this is one of the circumstances where the business interests of Big Pharma actually coincide with what is best for public health.

    Allowing people the ability to choose badly is not good public health.

  34. Calli Arcale says:

    I think you’re right, daedalus2u. It’s gotta be cheaper to make the trivalent vaccine than the three monovalent ones. It may be true that it cost more to get the trivalent approved than it did to get the monovalent ones approved — but that’s a one-time cost. It doesn’t apply to continued production. The most that could be said is that increasing the proportion of trivalent vaccines sold would spread out that cost more beneficially, effectively increasing the profit margin, and actually ditching the monovalent vaccines would increase it even more.

    My only concern is that a few people in this thread have mentioned rare cases where someone really can’t receive all three components. With the monovalent vaccines unavailable, that means they have to give up all three, not just the one they can’t safely get. That would be okay if we had herd immunity, but if the antivaxxers get their way, that won’t be the case for much longer.

    John Snyder:

    From what I’ve heard, the business end at Merck was actually leaning toward producing and marketing the single component vaccines as another market niche. It was actually persuasive arguments from the vaccine division that turned them around.

    But what were the vaccine division’s persuasive arguments? Were they ethical or financial? Perhaps the vaccine division was pointing out how much monovalent vaccine was going to waste, or arguing how much more trivalent vaccine could be manufactured if they could devote the entire production line to it.

    I really doubt they’d have shut down the line if it was going to cost more that way. It had to have been good business to do so.

  35. John Snyder says:

    Calli Arcale:

    I think it was a combination of all of the above. You’re correct that by focusing on only the trivalent vaccine, Merck could devote its full resources into one vaccine, and hence ultimately save on costs. However, the persuasive arguments from the vaccine division representatives on the ACIP panel (vaccine scientists) likely centered around the importance of allocating resources toward the vaccine most likely to result in vaccine series completion, and the fact that choosing to produce monovalent vaccines would have no science-based purpose.

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