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A temporary reprieve from legislative madness

While doctor visits for influenza-like illnesses seem to be trending downward again, and ”swine flu” is becoming old news, I’d like to draw attention to an H1N1 story that has received very little coverage by the mainstream media.

Doctors in several states can now protect their most vulnerable patients from the H1N1 virus without worrying about breaking the law. In order to save lives, several states have announced emergency waivers of their own inane public health laws, which ban the use of thimerosal-containing vaccines for pregnant women and young children.

Legislators in California, New York, Illinois, Missouri, Iowa, Delaware, and Washington state have enacted these science-ignoring laws in response to pressures from the anti-vaccine lobby and fear-struck constituents. Except for minor differences, each state’s law is essentially the same, so I will focus on the one from my state of New York.

New York State Public Health Law §2112 became effective on July 1, 2008. It prohibits the administration of vaccines containing more than trace amounts of thimerosal to woman who know they are pregnant, and to children under the age of 3. The term “trace amounts” is defined by this law as 0.625 micrograms of mercury per 0.25 mL dose of influenza vaccine for children under 3, or 0.5 micrograms per 0.5 mL dose of all other vaccines for children under 3 and pregnant women. Because thimerosal (and thus, mercury) exists only in multi-dose vials of the influenza vaccines (both seasonal and novel H1N1), this law really only applies to these vaccines. The mercury concentration of the influenza vaccines is 25 micrograms per 0.5 mL, which therefore makes their use illegal. Unfortunately, the only form of the H1N1 vaccine initially distributed, and that could be used for young children and pregnant women, was the thimerosal-containing form. The thimerosal-free vaccine was the last to ship, and in low supply, and the nasal spray is a live-virus vaccine, not approved for use in pregnancy or children under 2. That meant, without a waiver of the thimerosal ban, these groups could not be vaccinated.

There is no scientific evidence that thimerosal in vaccines poses any risk to children,  pregnant women, or their fetuses. In fact, the evidence contradicts the claims by the anti-vaccine lobby that thimerosal in vaccines is a cause of autism. On a multitude of levels there is ample reason to reject any link between thimerosal and autism:

1. All of the legitimate studies to date have failed to demonstrate any link.

2. The apparent increase in autism cases has continued even after the removal of thimerosal from vaccines.

3. Finally, and a usually neglected part of the story, the kind of mercury contained in thimerosal (ethylmercury) is very different from the kind produced by industrial pollution, and that ends up in the fish you eat (methylmercury). While methylmercury becomes concentrated in the body’s tissues (most importantly the brain) and thus remains for prolonged periods, ethylmercury is much more rapidly eliminated, and is therefore much less readily stored by the body. Recent studies have demonstrated just how different the pharmacokinetic properties of these two types of mercury are in the bodies of infants. This is important when we consider the US EPA “reference dose” (RfD) for mercury. This is the upper level daily amount, over a lifetime, of a substance that is considered safe to the most sensitive individuals in a population. The RfD for mercury set by the EPA is 0.1 micrograms per kilogram of body weight per day. Many people who believe the thimerosal-autism link point to the fact that, before thimerosal was removed from vaccines, some infants received a total daily dose of mercury from vaccines that came close to or exceeded the EPA’s RfD for mercury. Keep in mind, however, that the RfD was based on long-term, life-time daily exposures, not one time or even multiple time exposures. Also, as a safety factor the RfD was set 10 times higher than the actual estimated safe level. But most importantly, the RfD for mercury is based on data for methylmercury, not ethylmercury. That is, all the assumptions about the hypothetical dangers of exceeding the RfD for mercury, on potentially a few occasions, are based on an RfD for the wrong kind of mercury. As discussed above, the data on the pharmacokinetics of ethylmercury suggests a very different, and far less concerning picture for thimerosal in vaccines.

But let’s return to the legislation at hand. Besides their inclusion under this thimerosal ban, what else is exceptional about pregnant women and children under the age of 3? Well, they happen to be at greatest risk for serious complications of H1N1 disease, and are considered to be the highest priority populations for receipt of the vaccine. So, ironically, those at greatest risk for severe morbidity and mortality from the disease, and who are at the top of the list for getting the vaccine, aren’t permitted by law to receive it. Until, that is, states began issuing emergency waivers of these absurd laws.

To be fair, written into the law is a provision for the Comissioner of Public Health to waive the law during times of vaccine shortage or in the event of a severe outbreak. The important point, however, is what the very existence of these laws reveals about the power of the anti-vaccine lobby and a fear-stoked constituency. The fact that 7 states have enacted laws banning thimerosal-containing vaccines, and that there is similar legislative activity occuring in several other states, is a testament to the power of fear over reason, and the struggle of science to gain a foothold in our national consciousness. Although California has also temporarily waived their thimerosal ban, California’s secretary of Health and Human Services, Kim Belshe, issued this dark-aged rejoinder,

We take very seriously the expressed concerns that mercury in vaccines causes autism and remain committed to full implementation of [the law]

One of the greatest dangers of this trend away from a scientific view of medicine, and toward a more individualistic or even democratic one, is the solidification of this group think into the bedrock of legislation. The legislative process, shaped by constituencies, lobbies, and the personal leanings and beliefs of legislators, is frighteningly susceptible to irrational and anti-scientific forces. Glaring examples of this can be seen in the enactment of the Dietary Supplement Health and Education Act of 1994, the formation of the National Center for Complementary and Alternative Medicine in 1998, the establishment of Title V, Section 510 of the Personal Responsibility and Work Opportunity Reconcilitation Act (A.K.A. abstinence only education) in 1996, and the numerous insurance equality laws most states have enacted to mandate insurance coverage of chiropractic treatemnts, and other so-called “CAM” providers. This last type of legislation is particularly concerning. The newly formed Institute for Science in Medicine is currently working to address stealth provisions in health care reform legislation, now being debated in the Senate, that seek to legitimize “CAM” practitioners and mandate insurance coverage for a wide array of medically invalidated treatments. If this legislation is passed, more anti-science will be foisted upon our nation’s system of health care.

A quote from the recent New York Times review of Michael Specter’s new book, “Denialism“, sums up this trend toward “giving the people what they want” in health care. Although democracy is a wonderful way to run a nation, it isn’t how we develop science-based medicine.

…for better or worse, people are more skeptical of authority than they used to be and want to think for themselves, which includes grappling with the minutiae of science. Not so long ago, for example, patients rarely questioned doctors before undergoing surgery or taking their pills (for example, estrogen replacement therapy to prevent heart attacks), a blind obedience to authority that arguably cost many more lives than, say, vaccine refusal does now. What we are seeing is the democratization of science…

Give the people what they want, damn the evidence.

Posted in: Politics and Regulation, Public Health, Science and Medicine, Vaccines

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12 thoughts on “A temporary reprieve from legislative madness

  1. windriven says:

    Better still would be getting those idiotic laws off the books entirely. State sanctioned know-nothing-ism is malfeasance writ large.

    Individuals have every right to embrace whatever foolishness appeals to them so long as the consequences of that embrace do not impact the rest of us. Someone who chooses woo over SBM for treating malignant melanoma is making a personal choice. May s/he rest in peace.

    Vaccination, on the other hand, impacts not just the individual but the entire herd. Enshrouding anti-vaccine fantasies in the cloak of law is simply indefensible.

  2. Todd W. says:

    This sounds like it should be one of the next issues for the ISM, as it poses a more immediate risk for public health than some of the other big issues that need to be taken care of (DSHEA, mandatory insurance coverage of quack CAM treatments, etc.).

  3. twaza says:

    Whatever the evidence, this is a misuse of the legislature. Laws should for frameworks, not micromanagement. The legislature should be strengthening the health and regulatory systems, not undermining them. Experts may not always be right, but on technical matters they are wrong a lot less often than politicians and lobbyists.

  4. klh says:

    There is one problem that unhinges every – very well put forth – argument here for me. And that is the so-called evidence-based medicine itself. I also trust the scientific process, but also know that it’s sometimes not the results that are called into question, but the very design and methodology of the research itself. Science might be objective, but human design is not always.

    Pharmaceutical companies and their products have revolutionized modern medicine, without doubt. They’ve produced some life-saving and necessary therapeutics, without which we would surely see higher death rates from certain diseases or chronic illnesses. Having said that, as their reach, influence and prominence has grown, so has the absolute wealth of disease categories (ever-expanding) to be treated with pills. More importantly, however, are the very extensive relationships that pharmaceuticals have with doctors (and medical students), other healthcare providers, consumer groups, lobbies, the FDA and other public interest groups. (this is not conspiracy theory stuff – just fact). Bottom line, this is a for-profit business that, by its very nature, must always grow its business in order to thrive – and it must answer to its stakeholders. As disease categories and disease states continue to expand, and new drugs are created to treat them, the line between ethical, objective science and (perhaps unethical, if not dangerous at times – with such examples as MER/29, and the SSRIs in adolescents) “drug mongering” becomes fuzzy. Please understand, regardless of whether what they do is right or wrong – scientific or playing with the “facts” – this causes rational people to ask questions.

    Far from being a conspiracy theory – a thorough look at the objective history of the expansion of the post WWII pharmaceutical is enough to make one question whether the very business of producing scientific evidence doesn’t sometimes taint the science. Some 90% or more of clinical trials are commissioned by pharmaceuticals – around a particular drug – and managed by clinical research organizations who often work with academic institutions. The data from these trials are then often sent to medical writers who write an article based on the evidence. Opinion leaders are often recruited to be the designated “author” of these articles, though they may not have either seen the raw data themselves, nor written a single word of the paper. That the gap between what the raw data (not available to the public – if you know otherwise, I would love to know) reveals and what is actually made public often has important discrepancies is cause enough for concern. Does this mean that I, and others, think they are trying to kill us? NO! Absolutely not…but I can imagine that in the world of the pharmaceutical as business, with data traveling along so many lines, so far removed from any contact from a human “subject” in the study (let alone a human being in all their complexity) that the integrity of the information can become lost. It has already happened, as the public has seen with certain drugs that revealed themselves to be dangerous…while the raw data revealed the possibility that they could be dangerous, though no one knew. So what would make us thing it couldn’t happen again?

    Please understand. This is hard for the average consumer to grapple with. Many of us are not idiots, and are not irrational. What we can see are discrepancies that we must then deal with. In the meantime, we cannot shut out the voices who claim harm has been done, when our trust in the science as produced by big business is called into question. This should be understood. When a pharmaceutical claims that “evidence” has shown no harm can come from mercury in the vaccine, for example, this statement is then filtered – at least for me – through a series of considerations based on what I know about the “business” (from studies I’ve read to people I’ve spoken with) and it causes me to ask questions. Again, I don’t believe that they are trying to intentionally harm people – but if you don’t ask the right questions, then can get the “wrong” answers. It’s trust in the scientific process as carried out by these companies that is in question. And when the decision that ones makes based on the information one has – vaccinate/not vaccinate, for example – impacts a young baby for whom you are responsible, the decision becomes overwhelming. (I cannot begin to tell you how many times I’ve wished I had this implicit trust of the “evidence”).

    It seems to me that this site – full of good information – is often populated by like-minded people. That makes sense, but I’ve seen on other comment boards people being called “trolls” and people saying things like “don’t feed the trolls” when engaging with people who might not agree with the information given. I hope that this is not the case here. If they wanted to talk to people who only thought like themselves then they could start their own yahoo group or something. However, if this information is meant to try and convince others, then a respectful dialogue might facilitate that a bit better than the name-calling. Accusations of quackery do not help either. In order to present an argument in a manner meant to convince others (as they are), it’s better not to be insulting and combative – thereby drawing a clear line in the sand between us and them. Not accusing anyone here of that, but was just overwhelmed by it after reading another article on this site.

    Thanks for listening…

  5. qetzal says:

    klh,

    Thanks for your thoughtful comments. I understand the frustration you must feel in trying to decide whether to trust a statement (e.g. “thimerosal in vaccines is not dangerous”), knowing that it’s in someone else’s interest to convince you that’s true.

    I have a PhD in molecular biology and have spent 20+ years in biotech, with most of that time being devoted to developing novel human drugs. But there are still lots of cases where I don’t know enough to fairly evaluate such claims either.

    My advantage is that I have enough relevant training and background that I can often learn enough in a short time to feel comfortable making an evaluation. I agree most consumers are easily intelligent enough that they could do the same, if only they had the necessary background understanding.

    I’m very curious, however, if you have any ideas from a consumer perspective that might help you in these situations? Using the thimerosal example, can you think of anything that would make it easier to trust the safety claims (short of having to learn all the relevant science, of course)?

  6. Pattoye says:

    klh,

    Those are very relevent concerns. There are a lot of significant concerns regarding the way pharmaceutical reseach is done, such as the fact that positive studies are published for review overwhelmingly disproportionate to negative ones.

    One thing I would like to point out is that the body of research regarding mercury/thimerosol in vaccines was largely funded and organized through public means, not private ones. I hope that could help give you some peace of mind regarding this specific issue.

    As far as the broader issue of trusting pharmaceutical research, I’m afraid I can offer little help. I’m not sure allaying those concerns would even be a good thing to do. But much can be gleaned by looking at the source of a peer reviewed article, it just takes a fair amount of time and background information to really be able to sift through it all, which isn’t feasible for most people under most circumstances. However flawed the system might be, I do really believe that it is the best source of information we currently have at our disposal and while we should certainly fight for better information, we must make due with the information that we have, so long as it is put in the context of its source.

  7. klh says:

    Qetzal and Pattoye,

    Thank you both for your thoughtful responses.

    Qetzal – If you don’t know enough in a lot of cases – then there’s certainly no hope for me! I’m not really certain how to respond to you question about what might allay consumer concerns. I suppose as consumers we have different opinions about the subject – based on our level of knowledge and experience. Having said that, I think if I knew that there were protective measures in place that monitored the conflict of interests issue – with more transparency – I would feel better. Without going into to much detail here, I found this on the NEJM site – http://content.nejm.org/cgi/content/full/NEJMp0810200 – the IOM’s recommendations for controlling conflict of interests in medicine. What do you think?

    Additionally, I know a few people who would like to have the opportunity to speak with someone – outside of their doctor’s office, where they typically feel extremely rushed – about any and all aspects related to pharmaceuticals. Do you know of the concept of science shops? I suppose this website could serve such a purpose, although it seems differing opinions are often met with hostility and insults (unfortunately).

    Pattoye – Thank you for the information on thimerosol. It does help me to know that. Would you be able to point me in the direction of these studies?

    I understand your comment about making due with the information we have. And about peer-reviewed journals. But, I’m having a hard time with this conflict of interests issue. (I realize David Gorski wrote about this recently, but I haven’t been able to access it for some reason). Again, it’s not about causing intentional harm, but downplaying possible side-effects, manipulating data to produce the appearance of more efficacy, or interpreting the data in a manner that suggests something that may not be self-evident in the data. I’m only reiterating concerns, not necessarily facts (though there have been cases of worse happening, I know). These are still concerns. Do you think that IOM’s recommendations – or elements of them – could ameliorate some of these issues?

    Thanks again…

  8. edgar says:

    You know the thimerasol issue is a really sticky one for me. Not because I believe it is unsafe, I think the evidence is pretty clear, but it seems to me that (in general) chemicals should be proven safe BEFORE they are used. Call me a firm believer in the precautionary principle.
    Otherwise it is quite possible that there will com a day that there will be reccomendations to restrict in the intake of healthy foods like fish due to contamination. Oh wait.

  9. Scott says:

    The standard safety tests for any drug were done on the thimerosal-containing vaccines. So the precautionary principle was satisfied.

  10. BKsea says:

    In response to klh’s reasonable concerns, I think the fact that there are numerous cases of drugs found to be dangerous after approval shows that the system works. No approval system could possibly guarantee that every drug has an acceptable safety profile – that is why there is post-market surveillance. When a reasonable concern is raised, it is carefully reviewed for scientific plausibility and supporting data. If necessary, additional studies are conducted and the product may be pulled off the market.

    On the other hand, we can’t just pull everything off of the market based on any concern. If the science does not support the concern, it is time to move on. I think it could be argued that the thimerosal scare has done a disservice to us all. Thimerosal has an extensive track record and superb safety profile. Yet, because of the baseless concerns, it has largely been eliminated from vaccines in favor of other preservatives. What is the safety profile of these preservatives? Shouldn’t that concern us more?

  11. qetzal says:

    klh,

    I support most of the IOM’s recommendations. (I might quibble over a few details.) Realistically though, the calls for voluntary reforms are well-intentioned but probably naive. It will likely require action by federal agencies like NIH, HHS, & Congress to get many of those things to happen.

    I haven’t run across the term “science shops” before. It sounds like an interesting concept, but not without problems. Depending on who you were talking to about pharmaceuticals, and exactly what info you were seeking, there could be problems with liability, practicing medicine without a license, etc. Besides, the people who know the most about prescribing drugs are the MDs who are already prescribing them. IMO, it’s fine to want to seek additional input on drugs. But if you find that you routinely distrust what your MD recommends, to the point that believe someone else’s advice over theirs, you need to find a new MD.

    That said, one resource that people often overlook is their pharmacist. They know a lot about drugs, and it’s part of their job to answer their customers’ questions.

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