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Breast implants and anaplastic large cell lymphoma (ALCL): Is there a link?

I must admit that I have a bit of a love-hate relationship with breast implants. On the one hand, as a breast cancer surgeon, I see them as a major benefit to my patients who are unfortunate enough to require mastectomy in order to control their disease. The armamentarium of techniques for reconstructing breasts after mastectomy generally falls into one of two categories, either various form of muscle flaps or breast implants. However, some women are, for various reasons, not eligible for various muscle flap reconstructions. That leaves either breast implants–or nothing. Certainly, some women are perfectly fine with no reconstruction after mastectomy, but many, if not most, women are not. For these women, it would be difficult to overstate how much of a boon to body image and self-esteem reconstruction can be, particularly given how much better at it plastic surgeons have become over the last couple of decades.

On the other hand, breast implants make my life as a breast cancer surgeon more difficult for a variety of reasons. First, they tend to make mammography more difficult by obscuring part of the breast, thus decreasing the sensitivity of mammography. Good mammography facilities can get around this to some extent by using various displacement techniques, but it takes some effort, and it doesn’t completely correct the problems that implants cause for mammographic screening. Moreover, when a woman who has had implants placed for cosmetic reasons comes to see me for a breast mass or an abnormal mammogram, the presence of the implants can complicate treatment decisions. If the abnormality or mass is close to the implant, we worry about rupturing it in the process, particularly if the implant is not below the pectoralis major muscle. Even when the implant is subpectoral, the muscle overlying it frequently ends up being so stretched out that the muscle in essence forms part of the capsule around the implant and ends up being a lot thinner than you might expect. Let me tell you, my anal sphincter tone is always much tighter when operating near an implant, particularly a silicone implant. True, I’m perfectly capable of removing an implant if it’s accidentally ruptured, but such an outcome is not desirable, particularly with silicone implants, where cleaning up the leaking silicone can be difficult.

It doesn’t help that silicone breast implants have been the subject of controversy since the late 1980s and early 1990s, when thousands of women with silicone implants reported a variety of ailments, including autoimmune disease and a variety of other systemic illnesses. These reports led to a rash of lawsuits and, ultimately, the banning of silicone breast implants for general use in 1992. After that, silicone breast implants were only permitted in women requiring breast reconstruction or women enrolled in clinical trials studying breast implants. This ban was partially lifted in 2006, as evidence accumulated that the claims of autoimmune diseases and increased cancer risk due to silicone breast implants were not supported by clinical and scientific evidence and two products made by Allergan Corp. (formerly Inamed Corp.) and Mentor Corp. Not surprisingly, given that the furor over silicone breast implants as a cause of autoimmune and other systemic diseases is based on about as much solid scientific evidence as the antivaccine furor over vaccines as a cause of the “autism epidemic,” there was widespread criticism of this decision. Even now, it is not difficult to find articles about breast implants with titles like Breast Implants: America’s Silent Epidemic and websites like the Humantics Foundation and Toxic Breast Implants . I do note, however, that the number of such sites and articles does appear to be declining and, at least to my impression, seems to have decreased markedly over the last 10 years or so.

Having reviewed the literature and found evidence for a link between silicone breast implants and the systemic diseases attributed to them to be incredibly weak at best, I had little problem with the FDA’s decision. Actually, the only thing I had a problem with at the time, my opinions of how breast implants interfere with breast cancer detection and treatment notwithstanding, is that the FDA was probably being more cautious than the evidence warranted after 14 years.

Was I wrong?
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Posted in: Cancer, Epidemiology, Politics and Regulation, Public Health

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Obesity Denial

It seems that for every established science there is an ideological group who is motivated to deny it. Denialism is a thriving pseudoscience and affects any issue with the slightest political or social implications. Sometimes, even easily verifiable facts can be denied, as people seem willing to make up their own facts as needed.

Denialists have an easy job – to spread doubt and confusion. It is far easier to muddy the waters with subtle distortions and logical fallacies than it is to set the record straight. Even when every bit of misinformation is countered, the general public is often left with the sense that the topic is controversial or uncertain. If denial is in line with a group’s ideology, then even the suggestion of doubt may be enough to reject solid science.

We see this when it comes to the effectiveness of vaccines, the evolution of life on earth, and anthropogenic global warming. A recent Pew poll shows that the campaign of global warming denial has been fairly successful – while the science becomes more solid around the consensus that the earth is warming and humans are contributing to this, the public is becoming less convinced.

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Posted in: Epidemiology, Public Health

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Lest We Forget: Influenza Can Be Devastating

One of our readers suggested that I review the book The Great Influenza: The Epic Story of the Deadliest Plague in History, by John M. Barry. It’s not a new book (it was published in 2004) but it is very pertinent to several of the issues that we have been discussing on this blog, especially in regards to the current anti-vaccine movement. It’s well worth reading for its historical insights, for its illumination of the scientific method, and for its accurate reporting of what science has learned about influenza.

In the great flu epidemic of 1918, influenza killed as many people in 24 weeks as AIDS has killed in 24 years. It’s hard to even imagine what that must have been like, but this book helps us imagine it. It tells horror stories: children found alone and starving beside the corpses of their parents in homes where all the adults had died, decomposing bodies piling up because there was no one left who was healthy enough to bury them. Sometimes the disease developed with stunning rapidity: during one 3 mile streetcar trip, the conductor, 3 passengers, and the driver died. In another incident, apparently healthy soldiers were being transferred to a new post by train; during the trip, men started coughing, bleeding, and collapsing; and by the time it arrived at its destination, 25% of the soldiers were so sick they had to be taken directly from train to hospital. 2/3 of them were eventually hospitalized in all, and 10% of them died. The mind boggles. (more…)

Posted in: Book & movie reviews, History, Public Health

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Freeways, autism, and correlation versus causation

I have a love-hate relationship with epidemiology.

On the one hand, I love how epidemiology can look for correlations in huge sample sizes, sample sizes far larger than any that we could ever have access to in clinical trials, randomized or other. I love the ability of epidemiology to generate hypotheses that can be tested in the laboratory and then later in clinical trials. Also, let’s not forget that epidemiology is sometimes the only tool available to us that can answer some questions. Such questions generally involve hypotheses that can’t be tested in a randomized clinical trial because of either ethical concerns or others. A good example of this is the question of whether vaccines cause autism. For obvious ethical reasons, it’s not permissible to perform a randomized clinical trial in which one group of children is vaccinated and one is not, and then outcomes with respect to neurodevelopmental outcomes, such as autism and autism spectrum disorders, are tracked in the two groups. The ethical concern with such a study, of course, is the potential harm that would be likely to come to the unvaccinated control group, children who would be left unprotected against common and postentially deadly communicable diaseases.

On the other hand, epidemiology is one of the messiest of sciences, and epidemiological studies are among the most difficult in all of science to perform truly rigorously. The number of factors that can confound are truly amazing, and as a result, it’s very, very easy for an epidemiological study to detect apparent correlations that are either spurious or appear much stronger than the “true” correlation. There can be confounding factors beneath confounding factors wrapped in more confounding factors, the relationships among which are not always apparent. Not infrequently, a condition can appear to be correlated with, for instance, an environmental factor, but in reality that environmental factor and the condition both correlate with a third, unknown confounder. Worse, epidemiologists know that correlation does not necessarily equal causation, but the general public, for the most part, does not, which is why, when anti-vaccine activists, for instance, point out to a rising autism prevalence and then point out that autism prevalence started rising around the same time the vaccine schedule was expanded, to the average layperson the argument sounds compelling. As a result, the design of an epidemiological study is paramount in order to account for or minimize such factors. That’s why I always said I can’t be an epidemiologist. Even though I was very good at math in college, the statistics still made my brain hurt, and I don’t have the patience for the messiness of trying to account for all the possible confounding factors.

However, for all their strengths and flaws, epidemiological studies are an integral part of science-based medicine. They are used to identify predisposing factors to diseases and conditions, environmental contributors to disease, and adverse reactions to drugs, among many other useful pieces of data. That’s why, from time to time, I like to examine epidemiological studies, particularly if they’re epidemiological studies that are getting a lot of press.

The use and abuse of autism epidemiology studies

For instance, studies like this one described in a story in the Los Angeles Times on Friday entitled Proximity to freeways increases autism risk, study finds: More research is needed, but the report suggests air pollution could be a factor:
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Posted in: Epidemiology, Neuroscience/Mental Health, Public Health, Vaccines

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California Forbids Chinese Bloodletting

In November 2010, the California Department of Consumer Affairs (DCA) finally decided to act responsibly and forbid the prevalent practice of Chinese bloodletting by licensed acupuncturists.

The practice became a concern for the DCA when allegations of unsanitary bloodletting at a California (CA) acupuncture school surfaced.

The incident allegedly occurred during a “doctoral” course for licensed practitioners. The instructor was reportedly demonstrating advanced needling and bloodletting techniques. During the process, he took an arrow-like lancing instrument that is called a “three-edged needle” (三棱针), sharpened it with sandpaper, cleaned it with alcohol, and then asked a student-volunteer to roll a towel around his neck (similar to what is depicted in Image 1). The instructor then cleaned the student’s temporal region with alcohol, and punctured a superficial blood vessel with the arrow-like instrument. The student then held his head over the garbage can, gushing blood for a while.

Images 1 & 2. Chinese bloodletting. Image 1 shows a technique used to bleed the head or the face, where a towel is rolled around the neck to control the arterial pressure. Image 2 shows the practice of “wet cupping.”

The ancient practice of bloodletting, with or without cupping, is still widely used in Chinese medicine to remove “stagnant blood, expel heat, treat high fever, loss of consciousness, convulsion, and pain.”1 The amount of blood let depends on the condition, and the location of the incision. A contemporary book recommends letting a tiny amount from a point adjacent to the thumbnail for a condition described as “wind-heat invasion” of the lung. The symptoms associated with this unscientific nomenclature include chills and fever, sore throat, stuffy or runny nose, and a yellow discharge,2 which could correspond to many respiratory conditions, including the common cold, influenza, pneumonia, etc.
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Posted in: Acupuncture, Public Health, Science and Medicine

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Cell Phones and Behavior

Cell phones continue to be a focus of epidemiological studies and public concern, despite the fact that so far there is no compelling evidence of any health risk from cell phones. Concerns are likely to be sparked anew with the report of a study linking cell phone use to behavioral problems in children.

The study, by Divan, Kheifets, Obel, and Olsen, is a follow up of a prior study which showed a correlation between cell phone use in pregnant women and behavior problems in their children. They sought to replicate this study with a larger data set and taking into consideration more possible confounding factors. They found:

Results The highest OR for behavioural problems were for children who had both prenatal and postnatal exposure to cell phones compared with children not exposed during either time period. The adjusted effect estimate was 1.5 (95% CI 1.4 to 1.7).

Conclusions The findings of the previous publication were replicated in this separate group of participants demonstrating that cell phone use was associated with behavioural problems at age 7 years in children, and this association was not limited to early users of the technology. Although weaker in the new dataset, even with further control for an extended set of potential confounders, the associations remained.

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Posted in: Public Health

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Be thankful: No anti-vaccine propaganda at the movies this weekend

It’s Thanksgiving Day here in the U.S., and, despite the crappy economy, there are still things to be thankful for. For instance, skeptical activism can still be effective. On Sunday Skepchick Elyse put out the call to Skepchick readers to complain to movie theaters that were reportedly going to be airing a public service announcement from the anti-vaccine group SafeMinds? (Actually, “public service announcement” is a misnomer; it should be called a public disservice announcement.) The entire PSA was a truly disgusting and deceptive bit of misinformation. In response, Elyse urged Skepchic readers to flood the relevant theaters with complaints about showing an anti-vaccine advertisement prior to its movies.

Now here’s what we can be thankful for: It worked. At least with AMC Theaters. Last night the anti-vaccine propaganda blog Age of Autism, which had been teaming up with SafeMinds to raise money to show these ads during the Thanksgiving holiday weekend admitted as much.

At least for now:

SafeMinds was notified late yesterday afternoon that AMC Theaters has decided to block the SafeMinds Public Service Announcement (PSA) on influenza vaccines with mercury. The PSA alerts parents and pregnant women of the presence of mercury in most influenza vaccines and the ample availability of mercury-free alternatives. The CDC has declined to give a preference for the mercury-free versions, so it is important that the public is aware of its options. AMC’s advertising representative had reviewed and approved the PSA to run in AMC cinemas over the Thanksgiving weekend. A small group of vocal vaccine proponents dismissive of mercury concerns learned of the PSA and bombarded the AMC website, leading to the company’s decision to prevent its release. SafeMinds thanks its supporters who viewed the PSA and contributed to its efforts to educate the public to avoid unnecessary mercury exposure. Mercury in all forms is dangerous, especially to the developing fetus and infants, as referenced on the PSA website www.safemindsflu.org. SafeMinds will continue its mission to educate the public on this important healthcare topic.

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Posted in: Public Health, Science and the Media, Vaccines

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Vaccine Wars: the NCCAM Drops the Ball

If you go to the website of the National Center for Complementary and Alternative Medicine (NCCAM), you’ll find that one of its self-identified roles is to “provide information about CAM.” NCCAM Director Josephine Briggs is proud to assert that the website fulfills this expectation. As many readers will recall, three of your bloggers visited the NCCAM last April, after having received an invitation from Dr. Briggs. We differed from her in our opinion of the website: one of our suggestions was that the NCCAM could do a better job providing American citizens with useful and accurate information about “CAM.”

We cited, among several examples, the website offering little response to the dangerous problem of widespread misinformation about childhood immunizations. As Dr. Novella subsequently reported, it seemed that we’d scored a point on that one:

…Dr. Briggs did agree that anti-vaccine sentiments are common in the world of CAM and that the NCCAM can do more to combat this. Information countering anti-vaccine propaganda would be a welcome addition to the NCCAM site.

In anticipation of SBM’s Vaccine Awareness Week, I decided to find out whether such a welcome addition has come to fruition. The short answer: nope.

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Posted in: Chiropractic, Health Fraud, Homeopathy, Legal, Medical Ethics, Naturopathy, Politics and Regulation, Public Health, Science and the Media

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What does “anti-vaccine” really mean?

We write a lot about vaccines here at Science-Based Medicine. Indeed, as I write this, I note that there are 155 posts under the Vaccines category, with this post to make it 156. This is third only to Science and Medicine (which is such a vague, generic category that I’ve been seriously tempted to get rid of it, anyway) and Science and the Media. There is no doubt that vaccines represent one of the most common topics that we cover here on SBM, and with good reason. That good reason is that, compared to virtually any other modality used in the world of SBM, vaccines are under the most persistent attack from a vocal group of people, who, either because they mistakenly believe that vaccines caused their children’s autism, because they don’t like being told what to do by The Man, because they think that “natural” is always better to the point of thinking that it’s better to get a vaccine-preventable disease in order to achieve immunity than to vaccinate against it, or because a combination of some or all of the above plus other reasons, are anti-vaccine.

“Anti-vaccine.” We regularly throw that word around here at SBM — and, most of the time, with good reason. Many skeptics and defenders of SBM also throw that word around, again with good reason most of the time. There really is a shocking amount of anti-vaccine sentiment out there. But what does “anti-vaccine” really mean? What is “anti-vaccine”? Who is “anti-vaccine”?

Given that this is my first post for SBM’s self-declared Vaccine Awareness Week, proposed to counter Barbara Loe Fisher’s National Vaccine Information Center’s and Joe Mercola’s proposal that November 1-6 be designated “Vaccine Awareness Week” for the purpose of posting all sorts of pseudoscience and misinformation about “vaccine injury” and how dangerous vaccines supposedly are, we decided to try to coopt the concept for the purpose of countering the pseudoscience promoted by the anti-vaccine movement. To kick things off, I thought it would be a good idea to pontificate a bit on the topic of how to identify an anti-vaxer. What makes an anti-vaxer different from people who are simply skeptical of vaccines or skeptical of specific vaccines (for instance, the HPV vaccine)? I don’t pretend to have the complete answer, which is why I hope we’ll have a vigorous discussion in the comments.
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Posted in: Politics and Regulation, Public Health, Vaccines

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What’s The Harm?

Any promoter of science-based medicine often faces the question – what’s the harm? What is the harm if people try treatment modalities that are not based upon good science, that are anecdotal, or provide only a placebo benefit? There are generally two premises to this question. The first is that most “alternative” placebo interventions are directly harmless. The second is that direct harm is the only type worth considering. Both of these premises are wrong.

The pages of SBM are filled with accounts of direct harm from unscientific treatments: argyria from colloidal silver, death from chelation therapy, infection or other complications from acupuncture, burns from ear candling, stroke from chiropractic neck manipulation – the list goes on. You can read anecdotal accounts of such harm on the website, whatstheharm.net. Of course, as we often point out, harm and risk is only one end of the equation – one must also consider benefit. It is the risk/benefit ratio of an intervention that is important. But generally we are talking about interventions that lack any evidence for benefit, and therefore any risk of harm is arguably unacceptable.

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Posted in: Public Health, Science and Medicine

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