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The uncertainty surrounding mammography continues

Screening mammography

Mammography is a topic that, as a breast surgeon, I can’t get away from. It’s a tool that those of us who treat breast cancer patients have used for over 30 years to detect breast cancer earlier in asymptomatic women and thus decrease their risk of dying of breast cancer through early intervention. We have always known, however, that mammography is an imperfect tool. Oddly enough, its imperfections come from two different directions. On the one hand, in women with dense breasts its sensitivity can be maddeningly low, leading it to miss breast cancers camouflaged by the surrounding dense breast tissue. On the other hand, it can be “too good” in that it can diagnose cancers at a very early stage.

Early detection isn’t always better

While intuitively such early detection would seem to be an unalloyed Good Thing, it isn’t always. Although screening for early cancers appears to improve survival, the phenomenon of lead time bias can mean that detecting a disease early only appears to improve survival even if earlier treatment has no impact whatsoever on the progression of the disease. Teasing out a true improvement in treatment outcomes from lead time bias is not trivial. Part of the reason why early detection might not always lead to improvements in outcome is because of a phenomenon called overdiagnosis. Basically, overdiagnosis is the diagnosis of disease (in this case breast cancer but it is also an issue for other cancers) that would, if left untreated, never endanger the health or life of a patient, either because it never progresses or because it progresses so slowly that the patient will die of something else (old age, even) before the disease ever becomes symptomatic. Estimates of overdiagnosis due to mammography have been reported to be as high as one in five or even one in three. (Remember, the patients in these studies are not patients with a lump or other symptoms, but women whose cancer was detected only through mammography!) Part of the evidence for overdiagnosis includes a 16-fold increase in incidence since 1975 of a breast cancer precursor known as ductal carcinoma in situ, which is almost certainly not due to biology but to the introduction of mass screening programs in the 1980s.

As a result of studies published over the last few years, the efficacy of screening mammography in decreasing breast cancer mortality has been called into question. For instance, in 2012 a study in the New England Journal of Medicine (NEJM) by Archie Bleyer and H. Gilbert Welch found that, while there had been a doubling in the number of cases of early stage breast cancer in the 30 years since mass mammographic screening programs had been instituted, this increase wasn’t associated with a comparable decrease in diagnoses of late stage cancers, as one would expect if early detection was taking early stage cancers out of the “cancer pool” by preventing their progression. That’s not to say that Bleyer and Welch didn’t find that late stage cancer diagnoses decreased, only that they didn’t decrease nearly as much as the diagnosis of early stage cancers increased, and they estimated the rate of overdiagnosis to be 31%. These results are in marked contrast to the promotion of mammography sometimes used by advocacy groups. Last year, the 25 year followup for the Canadian National Breast Screening Study (CNBSS) was published. The CNBSS is a large, randomized clinical trial started in the 1980s to examine the effect of mammographic screening on mortality. The conclusion thus far? That screening with mammography is not associated with a decrease in mortality from breast cancer. Naturally, there was pushback by radiology groups, but their arguments were, in general, not convincing. In any case, mammographic screening resulted in decreases in breast cancer mortality in randomized studies, but those studies were done decades ago, and treatments have improved markedly since, leaving open the question of whether it was the mammographic screening or better adjuvant treatments that caused the decrease in mortality from breast cancer that we have observed over the last 20 years.

Given that it’s been a while since I’ve looked at the topic (other than a dissection of well-meaning but misguided mandatory breast density reporting laws a month ago), I thought now would be a good time to look at some newer evidence in light of the publication of a new study that’s producing familiar headlines, such as “Mammograms may not reduce breast cancer deaths“.

Here we go again.
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Posted in: Cancer, Public Health

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The war in California over nonmedical exemptions to school vaccine mandates, part 2

The war in California over nonmedical exemptions to school vaccine mandates, part 2

Last week, in the run-up to the 4th of July holiday weekend, something happened that I truly never expected to see. SB 277 became law in the state of California when Governor Jerry Brown signed it. In a nutshell, beginning with the 2016-17 school year, the new law eliminates nonmedical exemptions to school vaccine mandates. When last I wrote about SB 277 for this blog three weeks ago, I explained why I thought it was unlikely that SB 277 would ever become law, so that California could join West Virginia and Mississippi as the only states that do not permit religious or personal belief exemptions to school vaccine mandates. Basically, it was because California is not Mississippi or West Virginia. It’s a hotbed of antivaccine activism. Although statewide vaccination rates are high, there are a number of areas where antivaccine and vaccine-averse parents have led to low vaccine uptake with resultant outbreaks of vaccine-preventable diseases. Most recently, a large outbreak centered at Disneyland served as the catalyst that made it politically possible for a bill like SB 277 even to be seriously considered by the California legislature. Even so, given that California is home to a number of antivaccine celebrities such as Rob Schneider, Alicia Silverstone, Bill Maher, Charlie Sheen, Mayim Bialik, and Jim Carrey, antivaccine pediatricians such as “Dr. Jay” Gordon and “Dr. Bob” Sears, and many of the activists at the antivaccine crank blogs Age of Autism and The Thinking Moms’ Revolution, I was not optimistic.

I was mistaken in my pessimism, and I’m happy about that. I’m grateful to all those who didn’t see passing this law as an impossible task, such as Senators Richard Pan and Ben Allen, and who worked tirelessly to see it through, as some of our regular readers did. I was also pleasantly surprised that Governor Jerry Brown didn’t betray California children by watering down the bill with a signing statement, as he did three years ago when an earlier bill (AB 2109) was passed to make it more difficult for parents to obtain personal belief exemptions to school vaccine mandates.

So since SB 277 is law in California, what now?
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Posted in: Politics and Regulation, Public Health, Religion, Vaccines

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NCCIH and the true evolution of integrative medicine

NCCIH and the true evolution of integrative medicine

There can be no doubt that, when it comes to medicine, The Atlantic has an enormous blind spot. Under the guise of being seemingly “skeptical,” the magazine has, over the last few years, published some truly atrocious articles about medicine. I first noticed this during the H1N1 pandemic, when The Atlantic published an article lionizing flu vaccine “skeptic” Tom Jefferson, who, unfortunately, happens to be head of the Vaccines Field at the Cochrane Collaboration, entitled “Does the Vaccine Matter?” It was so bad that Mark Crislip did a paragraph-by-paragraph fisking of the article, while Revere also explained just where the article went so very, very wrong. Over at a blog known to many here, the question was asked whether The Atlantic (among other things) matters. It didn’t take The Atlantic long to cement its lack of judgment over medical stories by publishing, for example, a misguided defense of chelation therapy, a rather poor article by Megan McArdle on the relationship between health insurance status and mortality, and an article in which John Ioannidis’ work was represented as meaning we can’t believe anything in science-based medicine. Topping it all off was the most notorious article of all, the most blatant apologetics for alternative medicine in general and quackademic medicine in particular that Steve Novella or I have seen in a long time. The article was even entitled “The Triumph of New Age Medicine.”

Now The Atlantic has published an article that is, in essence, The Triumph of New Age Medicine, Part Deux. In this case, the article is by Jennie Rothenberg Gritz, a senior editor at The Atlantic, and entitled “The Evolution of Alternative Medicine.” It is, in essence, pure propaganda for the paired phenomena of “integrative” medicine and quackademic medicine, without which integrative medicine would likely not exist. The central message? It’s the same central (and false) message that advocates of quackademic medicine have been promoting for at least 25 years: “Hey, this stuff isn’t quackery any more! We’re scientific, ma-an!” You can even tell that’s going to be the central message from the tag line under the title:

When it comes to treating pain and chronic disease, many doctors are turning to treatments like acupuncture and meditation—but using them as part of a larger, integrative approach to health.

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Posted in: Acupuncture, History, Medical Academia, Naturopathy, Science and the Media

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In which I steal a title: Is medicine a scientific enterprise?

Abraham Flexner (left) and Richard Dawkins (right): Enemies of medicine?

Abraham Flexner (left) and Richard Dawkins (right): Enemies of medicine?

A week ago, I attended the Center For Inquiry Reason for Change Conference, where I participated in a panel on—what else?—alternative medicine with—who else?—Harriet Hall and our fearless leader Steve Novella. Before the panel, we all gave brief talks on areas that we consider important. As you might expect, I chose to give a brief introduction to what I like to call “quackademic medicine,” defined as the pseudoscientific medicine being practiced and studied in academic medical centers. As I like to do in order to drive the point home about just how bad it’s become, I chose a couple of truly egregious examples of just how much quackery has infiltrated medical academia. First, I mentioned how the Cleveland Clinic has embraced reiki, which, as I’ve described many times before, is in reality faith healing that substitutes Eastern mysticism for Christian beliefs. Although I could have buried the audience in examples, the other example I happened to choose was this:

Yes, that is exactly what you think it is. It’s the official Twitter account of the Mayo Clinic promoting “energy therapies,” of which reiki is one of the most popular varieties. Basically, these are “therapies” in which it is claimed that the practitioner can either (1) manipulate the “life energy” fields of the patient (e.g., healing touch) or (2) channel “healing energy” into the patient from a source (e.g., reiki). And here was the Mayo Clinic promoting this magical mystical nonsense, linking to an article on its official website entitled “Energy Therapies Offer Support in Healing for Cancer Survivors“:
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Posted in: Science and Medicine

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The war in California over nonmedical exemptions to school vaccine mandates

The war in California over nonmedical exemptions to school vaccine mandates

As I write this, I am currently at the Center for Inquiry (CFI) Reason for Change conference, where on Friday Steve, Harriet, and I did a panel on—what else?—alternative medicine and how it’s become “integrative medicine.” As a result, I’ve been very busy, which means that parts (but by no means all) of this post will look familiar to those of you who follow me at my not-so-super-secret other blog. However, it occurred to me after we did our panel discussion that there are important things happening in California that we’ve only barely touched on here on this blog. I’m referring, of course, to a bill (SB 277) that’s wending its way through the California legislature. SB 277, if passed, would eliminate nonmedical exemptions to school vaccine mandates. That’s not to say we haven’t discussed the issue of nonmedical exemptions, of which there are two types: religious and personal belief exemptions (PBEs), which can all be simply described as PBEs. Both Steve Novella and I have addressed them on SBM. For example, when an earlier bill (AB 2109) was passed that mandated that parents seeking PBEs consult with a physician or other listed health care professionals (which, unfortunately, included naturopaths) before a PBE would be granted, I documented how the antivaccine movement strenuously objected even to this minor tweak in the law that would make PBEs slightly more difficult to obtain. Unfortunately, even though, against all expectations, the bill passed, Governor Jerry Brown sabotaged it with a signing statement that betrayed California children by reinstating, in essence, religious exemptions. Specifically, Gov. Brown ordered the California Department of Public Health to include a check box on the form that parents could check to say they have religious objections to vaccines. Parents who checked that box could thus bypass even the anemic requirement to consult with a pediatrician before being granted a PBE.

The problem with nonmedical exemptions to school vaccine mandates is that vaccine-averse and antivaccine parents tend to cluster mostly in areas where white, affluent people live, as demonstrated in California and my own state of Michigan. So, even though antivaccinationists frequently tout high statewide vaccination rates as evidence that the process for obtaining PBEs does not need to be tightened up, they are disingenuously using a straw man argument against vaccine mandates, because it’s the pockets of low vaccine uptake that compromise local herd immunity that are the problem. We see these in Oregon, California, Michigan, and many other states with PBEs, and we also know that ease of obtaining PBEs is correlated with more PBEs and more outbreaks of vaccine-preventable diseases.

All of this came to a head earlier this year with what is now known as the Disneyland measles outbreak, a large multistate outbreak originating at Disneyland and traced to unvaccinated children. This outbreak so shocked California that the unthinkable happened. The possibility of passing a law eliminating nonmedical exemptions to vaccine mandates, something virtually everyone would have considered as much a fantasy as many of the characters played by the recently deceased great Christopher Lee played during his career, suddenly became an attainable goal. Senators Richard Pan and Ben Allen introduced SB 277, which would eliminate the personal belief exemption for children attending state licensed schools, daycares, and nurseries in California.
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Posted in: Politics and Regulation, Public Health, Vaccines

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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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Let food be thy medicine and medicine be thy food? The obsessive worship of “medicinal foods”

Let food be thy medicine and medicine be thy food? The obsessive worship of “medicinal foods”

Let food be thy medicine and medicine be thy food.

– attributed to Hippocrates

Who said anything about medicine? Let’s eat!

– attributed to one of Hippocrates forgotten (and skeptical) students

 

Who hasn’t seen or heard Hippocrates’ famous quote about letting food be your medicine and your medicine your food? If you have Facebook friends who are the least bit into “natural” medicine or living, you’ve almost certainly come across it in your feed, and if you’re a skeptic who pays the least bit of attention to what’s going on in the quackosphere you will almost certainly have seen it plastered on a picture as a meme, either using a picture of Hippocrates or pictures of plates of green, leafy vegetables, or both. I like to view the fetishization of “food as medicine,” to cite Hippocrates, as one of the best examples out there of the logical fallacy known as the appeal to antiquity; in other words, the claim that if something is ancient and still around it must be correct (or at least there must be something to it worth considering).

Of course, just because an idea is old doesn’t mean it’s good, any more than just because Hippocrates said it means it must be true. Hippocrates was an important figure in the history of medicine because he was among the earliest to assert that diseases were caused by natural processes rather than the gods and because of his emphasis on the careful observation and documentation of patient history and physical findings, which led to the discovery of physical signs associated with diseases of specific organs. However, let’s not also forget that Hippocrates and his followers also believed in humoral theory, the idea that all disease results from an imbalance of the “four humors.” It’s also amusing to note that this quote by Hippocrates is thought to be a misquote, as it is nowhere to be found in the more than 60 texts known as The Hippocratic Corpus (Corpus Hippocraticum).

As Diana Cardenes argues:

But Hippocratic doctors clearly saw a difference between food and medicines. In fact, food was considered as a material that could be assimilated after digestion (e.g. the air was also food) and converted into the substance of the body. For example, food was converted into the different parts of the body such as muscles, nerves, etc. By contrast, the concept of medicines at the time was a product which was able to change the body’s own nature (in terms of humor quality or quantity) but not be converted into the body’s own substance. Thus a food wasn’t considered a medicine. A possible root of the food-medicine confusion is the following cryptic phrase found in the work On Aliment: “In food excellent medication, in food bad medication, bad and good relatively”.3 This text is nowadays attributed to the Hellenistic period, but was considered to be Hippocratic in Antiquity by Galenus in particular.

Now, it is certainly true that Hippocrates and his followers used diet to treat many illnesses, it’s not really clear what sort of success they had. However, this ancient idea that virtually all disease could be treated with diet, however much or little it was embraced by Hippocrates, has become an idée fixe in alternative medicine, so much so that it leads its proponents twist new science (like epigenetics) to try to fit it into a framework where diet rules all, often coupled with the idea that doctors don’t understand or care about nutrition and it’s big pharma that’s preventing the acceptance of dietary interventions. That thinking also permeates popular culture, fitting in very nicely with an equally ancient phenomenon, the moralization of food choices (discussed ably by Dr. Jones a month ago).
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Posted in: Cancer, Nutrition

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As in 2014, “right-to-try” laws continue to metastasize in 2015, part 2

As in 2014, “right-to-try” laws continue to metastasize in 2015, part 2

When I wrote a week ago about the sham that is “right-to-try”, one criticism (among many) that I made of these misguided, profoundly patient-unfriendly laws was that I have as yet been unable to find a single example of a patient who has managed to obtain access to an experimental therapeutic through such a law, much less been helped by it. So-called “right-to-try” laws, of course, claim to provide a mechanism by which patients with terminal illnesses can obtain access to experimental therapeutics not yet approved by the FDA but still in clinical trials. They are, as I’ve pointed out, a cruel sham, placebo legislation that makes lawmakers feel as though they’ve done something good but do nothing of substance for patients while providing them with false hope. The federal government through the FDA controls drug approval, which means that states can’t compel a drug company to provide a drug to a patient, and most drug companies would not want to risk jeopardizing approval of their drug, which is what could happen if they grant access to an investigational drug under right-to-try and the patient suffers an adverse event. After all, the success rate for drugs that have passed phase 1 (which is all that right-to-try requires) in phase 3 trials is only on the order of 9-12%, meaning that that’s the most optimistic probability that such drugs would benefit a patient. In reality, it’s almost certainly much, much lower.
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Posted in: Clinical Trials, Politics and Regulation

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Should placebos be used in randomized controlled trials of surgical interventions?

Randomized controlled trial

Alone of all the regular contributors to this blog, I am a surgeon. Specifically, I’m a surgical oncologist specializing in breast cancer surgery, which makes me one of those hyper-specialized docs that are sometimes mocked as not being “real” doctors. Of course, the road to my current practice and research focus was long and involved quite a few years doing general surgery, so it is not as though I am unfamiliar with a wide variety of surgical procedures. Heck, I’m sure I could do an old-fashioned appendectomy, bowel resection, or cholecystectomy if I had to. Just don’t ask me to use the da Vinci robot or, with the exception of the case of a cholecystectomy, a laparoscope, although, given the popularity of robotic surgery, I sometimes joke that I really, really need to figure out how to do breast surgery with the robot. After all, if plastic surgeons are using it for breast reconstruction, surely the cancer surgeon should get in on the action.

I keed. I keed.

Clinical trials of surgical procedures and placebo controls

I have, however, from time to time addressed the issue of science-based surgery, and this weekend seems like as good a time to do so again, given that I just came across an article in the BMJ reporting a systematic review of the use of placebos in surgical trials. It’s a year old, but worth discussing. Before I get to discussing the nitty-gritty of this particular trial, let me just note that the evaluation of surgical procedures for efficacy and safety tends to be more difficult to accomplish than it is for medications, mainly because it’s much harder to do the gold standard clinical trial for surgical procedures, the double-blind, placebo-controlled randomized clinical trial. The two most problematic aspects of designing such an RCT in surgery, as you might imagine, are the blinding, particularly if it’s a trial of a surgical procedure versus no surgical procedure, and persuading patients to agree. I’ll deal with the latter first, because I have direct personal experience with it. (more…)

Posted in: Clinical Trials, Surgical Procedures

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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, and leaves opponents open to false—but seemingly convincing—charges of callousness towards the terminally ill on the order of enjoying drop kicking puppies through flaming goalposts.
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Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

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