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Science-based medicine versus the Flint water crisis

This is exactly the sort of cover story you don't want to see about your city in TIME.

This is exactly the sort of cover story you don’t want to see about your city in TIME.

One aspect of science-based medicine that is not covered frequently on this blog, aside from vaccines and antivaccine pseudoscience, but perhaps should be, is the intersection of SBM and public health. Unfortunately, living as I do in southeast Michigan right now, I’ve been on the receiving end of an inescapable lesson in what happens when the government fails in its mission to enforce science-based public health issues. I’m referring, of course, to what has become known worldwide as the Flint water crisis. The Flint water crisis has become so famous that unfortunately it now has its very own Wikipedia page. That is not an “honor” I like to see for my state, and I’m sure the residents of Flint, which is an hour’s drive north of where I live, would agree. This crisis provides an unfortunate illustration of what can easily happen when multiple layers of government fail in a science-based public health task as basic as providing clean water to the citizens they ostensibly serve.

For those of you who haven’t heard of it yet, the Flint water crisis refers to the ongoing contamination of the tap water in Flint, MI with unacceptably high levels of lead that resulted from change in its water supply nearly two years ago to Flint River water. Because river water is more corrosive than the previous supply that came from Lake Huron (why I’ll explain later) and Flint river water was not properly treated to decrease that corrosiveness, the new water leached lead from old pipes. This resulted in the contamination of the drinking water with dangerous levels of lead in many homes in the city. In addition, there has been a marked increase in the number of cases of Legionnaires’ disease thought to be linked to the new water supply.

I was born and raised in Detroit. My parents didn’t move to the suburbs until I was ten years old, and I stayed in southeast Michigan until I graduated from medical school and ended up in Cleveland for my surgical residency and, ultimately, my PhD work. From there I bounced to Chicago and New Jersey. Then, in 2008, nearly twenty years after I had left my hometown, I ended up back in the Detroit area. The point of this story is that my roots in the Detroit area run deep. Michigan is my state, for better or for worse, which is why I get annoyed when bad things happen here. I particularly become outraged when a preventable tragedy occurs here, one that science told us how to prevent but the government went ahead and did anyway. It’s a horrific tale of how science was basically ignored because of politics, and legitimate scientific concerns about a policy that changed the water source for an entire city were downplayed, derided, and even denied by state officials at every level of government. The story has now gone international. Indeed, our state and the city of Flint are featured on the cover of this week’s TIME Magazine.
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Posted in: Politics and Regulation, Public Health

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The cost of repealing mandatory motorcycle helmet laws

GRcartoon

It’s a seldom mentioned aspect of my professional history that I used to do a lot of trauma surgery in my youth. I did my residency at a program that included a county hospital with a busy trauma program where I saw quite a bit of vehicular carnage and an urban hospital (which has since closed) where I saw a fair amount of what we in the surgery biz call gun and knife club action. During my time as a PhD student, I moonlighted as a flight physician for the local helicopter rescue service, Metro Life Flight, where I took care of patients with everything from cardiac disease requiring transfer to the Cleveland Clinic to near-drownings during the summer at the Lake Erie resorts, particularly Put-in-Bay, to obstetrical transfers (which terrified me) to, of course, the unfortunately copious run-of-the-mill vehicular trauma. I saw the sort of tragedy that could result. Then, in the late 1990s, as I did research for my surgical oncology fellowship in Chicago, I also moonlighted as a trauma attending at a local suburban level II trauma center.

At that point, I realized that trauma was not my thing, as I couldn’t see myself at my present advanced age doing the sort of physically and emotionally demanding work that required fast decisions. It stressed me out too much; which is part of the reason why I went into surgical oncology in the first place. However, I have an appreciation for those who do do trauma. I also realize that trauma is, in a way, the “purest” form of surgery in that it involves taking a body broken by mechanical forces and trying to repair it, all the while keeping the patient alive until the repairs can heal. I will, however, miss the enjoyment I get hearing presentations on tree stand falls during hunting season.

I don’t mention my youthful flirtation with trauma surgery so much because I think it’s something so fascinating that I must tell it. (If that were the case, I’d have been mentioning it much more frequently in my blogs and social media than I have before.) Rather, it lets you know why I was so distressed when this story was forwarded to me a few days ago. It’s a Reuters report entitled “Injuries soar after Michigan stops requiring motorcycle helmets“:
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Posted in: Politics and Regulation, Public Health, Surgical Procedures

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Michigan HB 5126: Who thought it was a good idea to make it easier for parents to obtain nonmedical exemptions to school vaccine mandates and harder for local county health officials to do their jobs?

The Michigan House of Representatives: Not the sharpest knives in the drawer.

The Michigan House of Representatives: Not the brightest bulbs on the Christmas tree.

We have a problem with antivaccinationists here in Michigan. It’s a problem that’s been going on a long time that I first started paying attention to in a big way a few years ago when we started seeing pertussis outbreaks again due to low vaccine uptake. It’s a problem that’s persisted as last year we suffered from outbreaks of pertussis and measles, again because of pockets of low vaccine uptake. And what is the reason for these pockets of low vaccine uptake? Well, consistent with what we already know, namely that the risk of pertussis outbreaks is elevated in states where exemptions to school vaccine mandates are easier to get, it’s because our state is one of the worst in the country when it comes to nonmedical exemptions to vaccines. Indeed:

Michigan has one of the highest vaccine-waiver rates for kindergartners in the country, three times the national median, according to the Centers for Disease Control and Prevention. And the number of kindergartners getting vaccine waivers is growing. In five years, it’s increased 23 percent, the CDC says.

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Posted in: Politics and Regulation, Public Health, Vaccines

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On “integrative medicine” and walking and chewing gum at the same time

Walk and chew gum at the same time

I didn’t think I’d be discussing Dr. David Katz again so soon. In fact, when Mark Crislip (who clearly hates me, given how often he sends me links to articles like this) sent me a link to Dr. Katz’s latest article, “Cleaning the House of Medicine“, published—where else?—in The Huffington Post, that home for “reputable” quack-friendly bloviation since 2005, when I first read the article, my first reaction was that Katz must surely be trolling us here at SBM. At first, I wasn’t going to respond to him again. However, Katz’s article represents a very common misconception about science-based medicine that is worth refuting. It is not my intention to be arguing back and forth with Dr. Katz every couple of weeks, but I did think it worth one more round. I think you’ll understand why by the end of this post.

First, however, a brief recap is in order for readers who might not have been following the discussion over the last month or so. It all started a couple of weeks ago, when Jann Bellamy, in response to a special issue of the American Journal of Preventative Medicine edited by Katz and dedicated to making the case for integrative medicine in preventive medicine training, quite correctly discussed how “integrative medicine” is always all about the “potential.” Indeed, after having spent considerable sums of federal grant money studying the “integration” of pseudoscience into medicine with respect to preventive care, the journal couldn’t come up with any concrete examples how integrative medicine adds anything (other than quackery) to medicine. Dr. Katz, who is well-known in the world of quackademic medicine for his infamous 2008 speech in which he asserted that physicians need to use a “more fluid concept of evidence” in evaluating treatments, particularly “complementary and alternative medicine” (CAM), responded with another HuffPo article entitled “Science and Medicine, Fools and Fanatics: The ‘Fluidity’ of Woo“. In lieu of reasonable, science-based arguments, Dr. Katz’ article was little more than a rant that consisted mainly of outrage that mere mortals lacking his awesome academic credentials had had the temerity to question his awesomeness and dedication to science coupled with an accusation that we are just too rigid and simplistic in our thinking to understand the subtle complexities of how different standards of evidence must be applied to complex patients. Steve Novella and I both responded that we understand just fine, explained how doctors do this all the time without using quackery like naturopathy and homeopathy (both of which Katz has advocated), and pointed out his argumentum ad ignorantiam with respect to energy medicine.

There’s where I thought it would end. Unfortunately, I was mistaken. On Friday, Katz launched another broadside at us, couched in the form of an argument that medicine must “clean its own house” before worrying about his quackademic medicine. It’s something I hear often enough that I thought it would be worth responding to, even if Dr. Katz was indeed trolling us.
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Posted in: Critical Thinking, Medical Academia, Quality Improvement, Surgical Procedures

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The horrible consequences of seeking “natural” immunity: Naturopathy and Whooping Cough

Whooping cough isn't pretty

This is what whooping cough looks like. It sounds even worse.

If there’s one area of “alternative” medicine that saddens (and angers) me, it’s the antivaccine movement. Most alternative medicine only risks harm to the user. But antivaccinationists threaten public health. Their actions can harm the most vulnerable in our society – often children, and others who depend on the herd immunity that vaccination provides. After my last few naturopathy vs. science posts I thought I’d take a bit of a break with another subject. However, last week ex-naturopath (and friend of the blog) Britt Hermes flagged a post from a naturopath that stunned me. Here was antivaccinationism and naturopathy, all rolled into a blog post about three children with a parent that doesn’t vaccinate. Heather Dexter, who claims to be a “Board Certified Naturopathic Doctor” in Michigan, blogs at likemindedmamas.com. She recently used her blog to describe, in astonishing, horrific, gut-wrenching detail, how she let three of her children suffer with whooping cough without seeking proper medical attention. The post was pulled down after a few days, but has recently reappeared with some modifications. (The original post, which I am quoting from below, has been archived and can be found here or here). I strongly encourage you to read the entire post in its entirety. Because amazingly, not only did Heather Dexter let her three children suffer through weeks of pain with whooping cough, she also subjected them repeatedly to invasive (and useless) alternative medicine. Yet she claims to have no regrets. (more…)

Posted in: Naturopathy, Vaccines

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Medical marijuana as the new herbalism, part 4: Cannabis for autism

Medical marijuana as the new herbalism, part 4: Cannabis for autism

When I first started writing about the claims made for medical marijuana and the cannabis oil derived from it, it didn’t take long for me to characterize medical claims for cannabis as the “new herbalism,” as opposed to pharmacognosy, the branch of pharmacology devoted to the study of natural products. The reason is simple. Although I support legalization of marijuana for recreational use, when I look at how medical marijuana has been promoted as a “foot-in-the-door” prelude to legalization, I see testimonials and flimsy evidence ruling over all. I see all the hallmarks of alternative medicine herbalism and none of the hallmarks of pharmacology. Here’s what I mean. Pharmacognosy examines an herb, plant, or other natural product and seeks to identify the chemicals within it that have pharmacological activity against a condition or a disease, the better to purify and isolate those chemicals and turn them into drugs. Herbalism, on the other hand, emphasizes the use of whole plants or extracts from plants, rather than the isolation of the most active compounds. Thus, herbal remedies often contain hundreds, or even thousands, of different compounds, of which only one or a few are active. Even extracts, such as cannabis oil, contain many compounds.

In contrast to pharmacognosy, herbalists make the claim that whole herbs and plant components possess a synergy that is missing from the purified active constituents and/or that the mixture is safer than the pure components because one compound can reduce the side effects of another without reducing therapeutic efficacy. When looked at closely neither claim stands up to scrutiny. Synergism between plant constituents is rare and very difficult to demonstrate, for example. In essence, herbalism turns back the clock 200 years to a time before scientists had developed the techniques and abilities to isolate active ingredients with pharmaceutical activity. Moreover, herbalism, in contrast to pharmacognosy, emphasizes anecdotes over scientific evidence.

Indeed, in my previous posts in this series on medical marijuana, one theme has emerged, which is that cannabis—specifically, a class of active chemicals in marijuana known as cannabinoids—has potential for some diseases but is not the panacea claimed by its proponents. It does not cure cancer, for instance, contrary to glowing testimonials promoted by people like Rick Simpson. For other conditions, the evidence is either not particularly compelling or only mildly promising.

So I reacted with considerable dismay on Friday night when I saw this news report on the 11 o’clock news, “Michigan panel recommends allowing marijuana for autism“:
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Posted in: Herbs & Supplements, Politics and Regulation

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Mandatory breast density reporting legislation: The law outpaces science, and not in a good way

Over the years, our bloggers here at Science-Based Medicine have written time and time again about the intersection of law and science in medicine. Sometimes, we support a particular bill or law, such as laws to protect children against religion-inspired medical neglect; laws making it harder for manufacturers of homeopathic “medicines” to deceive the public; or California Bill AB 2109, a bill whose intent was to make it more difficult for parents to obtain nonmedical exemptions to vaccine mandates but whose implementation after being passed into law was profoundly sabotaged by Governor Jerry Brown. or, more recently, California SB 277, a bill currently wending its way through the California legislature that would eliminate nonmedical exemptions to school vaccine mandates and has, not surprisingly, engendered extreme resistance from the antivaccine crowd, including by Robert F. Kennedy, Jr. In the vast majority of cases we explain how the law lets us down when it comes to science in medicine, and, unfortunately, examples are many: Naturopathic licensing laws; supplement regulation (or, more appropriately, lack of regulation); misguided, deceptive, and patient-hostile “right-to-try” laws; state laws regulating medical practice that allow quackery to flourish unchecked; laws regulating pharmaceutical cost transparency that ask the wrong question.

The case I will discuss here is unusual in that it is a case of the law getting ahead of what the science says in a manner that will likely do little, if any, good for patients, cause a lot of confusion until the science is worked out better, and end up costing patients money for little or no benefit. I am referring to laws mandating the reporting of high-breast-density to women with dense breasts undergoing mammography. These laws are sweeping the country (albeit not as rapidly as “right-to-try” laws), with a total of 22 states having passed them as of today since Connecticut became the first to do so in 2009. The most recent of these laws went into effect in my own state of Michigan exactly one week ago:

Women with dense breast tissue — the sort that can hide potentially deadly tumors from routine mammograms — must be notified in writing and encouraged to consider additional tests under a new state law that is effective Monday.

While mammograms remain the gold standard for detecting breast tumors, they’re less reliable in almost half of women with dense breast tissue. Dense or fibrous tissue shows up as splotches of white on a mammogram — so do tumors.

That will likely surprise many of the millions of women who rely on mammography for catching the earliest signs of cancer, said Nancy Cappello. The Connecticut woman was shocked in 2004, when her gynecologist found a lump — advanced cancer that had already spread to her lymph nodes — just months after a mammogram deemed her cancer-free.

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Posted in: Cancer, Politics and Regulation, Public Health

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As in 2014, “right-to-try” laws continue to metastasize in 2015

As in 2014, “right-to-try” laws continue to metastasize in 2015

Last year, I did several posts on what I consider to be a profoundly misguided and potentially harmful type of law known as “right-to-try.” Beginning about a year and a half ago, promoted by the libertarian think tank known as the Goldwater Institute, right-to-try laws began popping up in state legislatures, which I likened to Dallas Buyers Club laws. Both Jann Bellamy and I wrote about how these laws are far more likely to do harm than good, and that is a position that I maintain today. The idea behind these laws is to give terminally ill patients access to experimental drugs—in some cases drugs that have only passed phase I testing—that might help them. It’s an understandable, albeit flawed argument. After all, it’s perfectly understandable why terminally ill patients would fight for drugs that give them hope, and it’s just as understandable why politicians and the public would see such a goal as a good thing. In practice, as I will explain again in the context of this update, such laws are far more likely to harm patients than help them. Indeed, as you will see, in the year since the first wave of right-to-try laws have passed, not a single patient that I can find has obtained access to experimental drugs under a right-to-try law, much less been helped by them.

Unfortunately, given how effectively “right to try” has been sold on grounds of providing terminally ill patients hope and as a matter of personal freedom, it’s clear that this wave is not going to abate. Since Colorado passed the very first right-to-try law almost exactly a year ago today, a total of 17 more states now have passed passed similar legislation, the most recent being Tennessee, and 22 others have introduced legislation. It’s a good bet that right-to-try will pass in all of those states, because, as I’ve explained many times before and in many interviews, if you don’t understand clinical trial ethics and science, opposing the concept of right-to-try comes across like opposing Mom, apple pie, and the American flag. It also leaves opponents open to false—but seemingly convincing—charges of callousness towards the terminally ill on the order of taking pleasure from drop kicking yipping puppies through flaming goalposts. (I exaggerate, but only slightly, I assure you.)
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Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

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Using the fear of Ebola to promote the placebo legislation that is “right to try”

rick-snyder

Perhaps the most pervasive medical conspiracy theory of all involves stories that there exist out there all sorts of fantastic cures for cancer and other deadly diseases but you can’t have them because (1) “they” don’t want you to know about them (as I like to call it, the Kevin Trudeau approach) and/or (2) the evil jackbooted thugs of the FDA are so close-minded and blinded by science that they crush any attempt to market such drugs and, under the most charitable assessment under this myth, dramatically slow down the approval of such cures. The first version usually involves “natural” cures or various other alternative medicine cures that are being “suppressed” by the FDA, FTC, state medical boards, and various other entities, usually at the behest of their pharma overlords. The second version is less extreme but no less fantasy-based. It tends to be tightly associated with libertarian and small government fantasists and a loose movement in medicine with similar beliefs known as the “health freedom” movement, whose members posit that, if only the heavy hand of government were removed and the jack-booted thugs of the FDA reined in, free market innovation would flourish, and the cures so long suppressed by an overweening and oppressive regulatory apparatus would burst the floodgates. Under this views, these cures, long held back by the dam of the FDA, would flow immediately to the people, and there would be much rejoicing. (Funny how it didn’t work out that way before the Pure Food and Drug Act of 1906.) Of course, I can’t help but note that in general, in this latter idea, these fantastical benefits seem to be reserved only for those who have the cash, because, well, the free market fixes everything. At least, that seems to be the belief system at the heart of many of these conspiracy theories.

The idea that the FDA is keeping cures from desperate terminally ill people, either intentionally or unintentionally, through its insistence on a rigorous, science-based approval process in which drugs are taken through preclinical work, phase 1, phase 2, and phase 3 testing before approval is one of the major driving beliefs commonly used to justify so-called “right-to-try” laws. These bills have been infiltrating state houses like so much kudzu, and the Ebola outbreak has only added fuel to the fire based on the accelerated use of ZMapp, a humanized monoclonal antibody against the Ebola virus, in some patients even though it hadn’t been tested in humans yet (more on that later). Already four of these laws have been passed (in Colorado, Missouri, Louisiana, and now Michigan) with a referendum in Arizona almost certain to pass next week to bring the total to five states with such laws. Basically, these laws, as I’ve described, claim to allow access to experimental drugs to terminally ill patients with a couple of major conditions: First, that the drug has passed phase I clinical trials and second that the patient has exhausted all approved therapies. As I’ve explained before more than once, first when the law hit the news big time in Arizona and then when a right-to-try bill was introduced into the legislature here in Michigan, they do nothing of the sort and are being promoted based on a huge amount of misinformation detailed in the links earlier. First, having passed phase 1 does not mean a drug is safe, but right-to-try advocates, particularly the main group spearheading these laws, the Goldwater Institute, make that claim incessantly. Second, they vastly overstate the likelihood that a given experimental drug will help a given patient. The list goes on.
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Posted in: Cancer, Clinical Trials, Pharmaceuticals, Politics and Regulation

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The false hope of “right-to-try” metastasizes to Michigan

Nurse administers chemotherapy

Ed. note: Please read disclaimer in Dr. Gorski’s profile!

There are times when supporting science-based health policy and opposing health policies that sound compassionate but are not are easily portrayed as though I’m opposing mom, apple pie, and the American flag. One such type of misguided policy that I’ve opposed is a category of bills that have been finding their way into state legislatures lately known as “right to try” bills. Jann Bellamy and I have both written about them before, and with the passage of the first such bill into law in Colorado in May, I had been meaning to revisit the topic. Although “right-to-try” laws are a bad policy idea that’s not new, versions of such bills having been championed by, for example, the Abigail Alliance for at least a decade, the recent popularity of the movie Dallas Buyers Club appears to have given them a new boost, such that Colorado state Senator Irene Aguilar even frequently referred to her state’s right-to-try bill as the “Dallas Buyers Club” bill. It’s a topic I’ve been meaning to revisit since the news out of Colorado, but apparently I needed a nudge, given that it’s two months later now.

Unfortunately, that nudge came in the form of a right-to-try bill (Senate Bill 991) being introduced into the legislature in Michigan by Senator John Pappageorge and unanimously passing, almost without comment by the committee and certainly with minimal news coverage, through the first hurdle, the Michigan Senate Health Policy Committee. In parallel, the same legislation (House Bill 5651) has been introduced into the Michigan House of Representatives.
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Posted in: Cancer, Pharmaceuticals, Politics and Regulation

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