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Legislating Ignorance

Child-GUN

Science is under attack, and not just from anti-vaccine celebrities and parents with degrees from Google University. Scientific illiteracy is being woven into the very fabric of our society through legislative assault. If you dismiss this as alarmist hyperbole, you haven’t been paying close enough attention.

Every day thousands of pediatric health care providers throughout the country provide safety advice to patients and their parents during routine health maintenance visits. As part of this important routine we ask a series of standard questions to assess the safety of our patients’ environment. Some of these questions are easy and straightforward, and some are more personal and potentially awkward for patients and their parents, including questions pertaining to sexual practices and preferences and psychosocial history. An important series of questions focuses on potential hazards in the home, such as how toxins and medicines are stored, how pools are secured against curious toddlers, and whether there are guns in the home and how they are stored and secured. Parents are usually appreciative of the advice we provide, and thankful for our concern and attention to these issues. Occasionally patients or parents are taken aback by some of these questions, and very rarely they prefer not to answer them (in my 20 years in practice, I can recall only one time this has occurred). We ask these questions because accidental injuries and deaths are common occurrences in the pediatric population, and there is good evidence that patients tend to follow the advice we provide our patients. (more…)

Posted in: Legal, Medical Ethics, Politics and Regulation, Public Health, Science and Medicine

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Fun With Statistics

Statistics is the essential foundation for science-based medicine.  Unfortunately, it’s a confusing subject that invites errors and misunderstandings.  We non-statisticians could all benefit from learning more about statistics as well as trying to get a better understanding of just how much we don’t know. Most of us are not going to read a statistics textbook, but the book Dicing with Death: Chance, Risk, and Health by Stephen Senn is an excellent place to start or continue our education. Statistics can be misused to lie with numbers, but when used properly it is the indispensable discipline that allows scientists:

 …to translate information into knowledge. It tells us how to evaluate evidence, how to design experiments, how to turn data into decisions, how much credence should be given to whom to what and why, how to reckon chances and when to take them.

Senn covers the whole field of statistics, including Bayesian vs. frequentist approaches, significance tests, life tables, survival analysis, the problematic but still useful meta-analysis, prior probability, likelihood, coefficients of correlation, the generalizability of results, multivariate analysis, ethics, equipoise, and a multitude of other useful topics. He includes biographical notes about the often rather curious statisticians who developed the discipline. And while he includes some mathematics out of necessity, he helpfully stars the more technical sections and chapters so they can be skipped by readers who find mathematics painful. The book is full of examples from real-life medical applications, and it is funny enough to hold the reader’s interest. (more…)

Posted in: Book & movie reviews, Science and Medicine

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Supreme Court Saves Nation’s Immunization Program

The Supreme Court of the United States made a ruling the other day that has profound implications for the health of millions of children. Since October 12, 2010, The Court has been quietly deliberating the case of Bruesewitz v. Wyeth, inc. The case centers on Russell and Robalee Bruesewitz’s allegation that their 18 year old daughter, Hannah, was irreversibly injured by a DTP vaccine she received when she was 6 months old. What is important about this case is not the allegation itself (I will discuss its merits, or lack thereof, in a moment), but the ramifications the ruling has for the future of childhood immunization in this country. The Supreme Court’s ruling against the Bruesewitz’s and in favor of the U.S. vaccination program was the right one, and safeguards our children from the irrationality of the anti-vaccine movement. Some important background is necessary here to understand why this is so.

Prior to the development of effective vaccines, diphtheria, tetanus, and pertussis were common diseases, terrifyingly familiar to all parents. Death records from Massachusetts during the latter half of the 1800’s indicate that diphtheria caused 3-10% of all deaths. In the first part of the 20th century, these dreaded organisms still caused illness in hundreds of thousands of people each year in the United States. These are devastating diseases which, if not resulting in death, often produced severe and permanent damage to those afflicted. In the 1920’s, vaccines against each of these scourges were finally developed, and in the mid 1940’s the combined DTP vaccine was introduced. The vaccines were so effective that cases of these deadly infections were practically eliminated. Today, few parents know the terror once routinely wrought by these pathogens.

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Posted in: Legal, Science and Medicine, Vaccines

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CAM and the Law Part 4: Regulation of Supplements and Homeopathic Remedies

Another major set of legal standards that apply to alternative medicine are the laws and regulations that govern the manufacturing and availability of homeopathic and herbal remedies and dietary supplements. Although there is less ambiguity in these standards than in some of the areas I’ve covered previously, there are certainly loopholes aplenty available to avoid the need for any truly scientific standards of evaluating safety and efficacy. This is perhaps the area in which the triumph of politics over science is most vivid.

Regulation of Homeopathic Remedies

The Food and Drug Administration was constituted as the agency responsible for regulating medicines and most foods by the Food, Drug, and Cosmetic Act (FDCA) of 1938. The FDCA has been updated and amended in various ways since then, but it is still the primary law governing the regulation of prescription and non-prescription substances used to treat illness. The law identifies substances acceptable for sale as medicines as those listed in its official compendia, the United States Pharmacopeia-National Formulary (USP-NF) and the Homeopathic Pharmacopeia of the United States (HPUS). The HPUS was a list of homeopathic remedies first published by the American Institute of Homeopathy, a professional body for homeopaths, in 1897 and now published and maintained by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), an independent organization of homeopathic “experts.” The inclusion of homeopathic remedies as accepted drugs in the original legislation was primarily due to the efforts of Senator Royal Copeland, a physician trained in homeopathy and one of the principle authors of the FDCA.1
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Posted in: Homeopathy, Legal, Science and Medicine

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

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Since when did an apologist for the antivaccination movement, Dr. Jay Gordon, become an “expert” in vaccine law?

I am an alumnus of the University of Michigan twice over. I completed a B.S. in Chemistry with Honors there in 1984 and then I stayed on to do obtain my M.D. in 1988. I look back very fondly on those eight years spent in Ann Arbor, as several of my longtime friendships were forged or solidified during those years. Consequently, I still care about the place. Indeed, I even once tried to see if I could get a position in the Department of Surgery there a few years back, but unfortunately the “fit” just wasn’t there at the time. That’s why it distresses me when I see my alma mater suffer from a self-inflicted wound, almost as much as the plight of the Michigan Wolverines bothers me, given that never before in my life (at least not since I was old enough to pay attention), have the Wolverines sucked so badly and so hard. Given that level of football futility, though, I consider it even more important that my alma mater not provide any more ammunition to those who would enjoy making fun of it. It doesn’t matter to me that I never went to law school at Michigan; it’s all part of the same campus to me.

This time, the embarrassment comes in the form of an article in the Michigan Law Review by a person who has previously been a subject of posts by both Dr. Novella and me. I’m referring to Dr. Jay Gordon, whom we have both–correctly, I believe–labeled as being, if not fully anti-vaccine, at least a prominent and major apologist for the anti-vaccine movement. Unfortunately, because he is the pediatrician taking care of Jenny McCarthy’s son Evan, he has gained even greater prominence in the antivaccine movement than ever, to the point where he gave a speech last summer to the antivaccine “Green Our Vaccines” march on Washington and where he is regularly called up by TV producers to give a false “balance” whenever a discussion of vaccines and/or autism comes up. He also wrote the foreword to Jenny McCarthy’s latest paean to autism quackery and attack on vaccines as the cause of autism in which he blithely repeated some of the worst distortions of the antivaccine movement. Unfortunately, Dr. Gordon lacks the intestinal fortitude to stop the piteous denials any time he is called out for his parroting of antivaccine pseudsocience and to embrace his inner antivaccinationist. Then, at least, we wouldn’t be treated to the spectacle of his simultaneously claiming he is “pro-safe vaccine, not anti-vaccine” while at the same time saying he “doesn’t give a lot of vaccines” and admitting that parents have actually had to persuade him to vaccinate “reluctantly.”

So what was the topic of the Michigan Law Review article that Dr. Gordon was apparently asked to pen? It’s actually an interesting question from a legal, political and civil rights standpoint, specifically: Whether or not parents should be held legally liable for refusing to vaccinate their children. Not surprisingly, Dr. Gordon took the “no” position. Unfortunately, as we’ve come to expect of Dr. Gordon, he uses a number of highly dubious arguments. However, more interesting to me, having had a nearly four year history sparring online with him off and on, was the seemingly “kinder and gentler” antivaccine stance that he took in this article.

But first, let’s take a look at the debate. The symposium published in First Impressions (the online companion to the Michigan Law Review) was entitled Liability for Exercising Personal Belief Exemptions from Vaccination, and it contained the following articles:

  1. Choices Should Have Consequences: Failure to Vaccinate, Harm to Others, and Civil Liability by Douglas S. Diekema.
  2. Parents Should Not be Legally Liable for Refusing to Vaccinate their Children by Dr. Jay Gordon.
  3. Unintended Consequences: The Primacy of Public Trust in Vaccination by Jason L. Schwartz.
  4. Challenging Personal Belief Immunization Exemptions: Considering Legal Responses by Alexandra Stewart.
  5. Gambling with the Health of Others by Stephen P. Teret and John S. Vernick.
  6. The Problem of Vaccination Noncompliance: Public Health Goals and the Limitations of Tort Law by Daniel B. Rubin and Sophie Kasimow

There were a number of fascinating issues raised here. Although it’s obvious that universal vaccination is a public health policy good, given that the higher percentage of vaccinated children, the greater the herd immunity, there is always the nagging question of how far the state should go to mandate vaccination in a free society; i.e., how much coercion is acceptable to bring about maximal levels of vaccination? In other words, what is the proper balance between the needs of society as a whole and the rights of the individual? The next interesting legal and moral question is whether parents who refuse to vaccinate should be held liable for injuries to other children if their unvaccinated child passes on an infectious disease. Personally, I tend to believe that it is entirely reasonable to require vaccination as a precondition for school or day care and that exemptions should be primarily medical in nature. I grudgingly allow that the freedom of religion guaranteed in the First Amendment probably requires religious exemptions (although I do not understand why religion should be given such a privileged place in society that it can endanger public health), I am far less convinced that philosophical exemptions should be mandated. I realize many may disagree with this position, but I would hope that our disagreements would be based on (1) the best science regarding the benefits and risks of vaccination and (2) honest beliefs regarding the proper balance between public health concerns and individual liberty. Clearly, this is an area of debate. I also tend to believe that if parents refuse to vaccinate their child and that child passes an infectious disease to another child, then those parents should be potentially legally liable. Indeed, Douglas Diekema argues this position very well.

Unfortunately, Dr. Gordon does not meet at least condition #1 above. He does not base his arguments on the best science.
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Posted in: Politics and Regulation, Public Health, Vaccines

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