Retail pharmacies have a sugar pill problem. Homeopathic “remedies” may look like conventional medicine when they’re stocked on pharmacy shelves, like the photo above. But unlike conventional medicine, homeopathic products don’t contain any “medicine” at all. They are effectively sugar pills – placebos. Not surprisingly, there is convincing evidence to show that homeopathy is useless as a medical treatment, and fundamentally incompatible with a scientific understanding of medicine, biochemistry and even physics. Questions have been raised about the ethics of selling homeopathy in pharmacies to consumers who may not realize what they’re buying. This growing practice is attracting sharp criticism from other health professions. So why do pharmacies sell them? And what will it take for pharmacies to change? (more…)
Archive for Public Health
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.
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?
If there’s one thing that unites all countries and cultures, it’s our love of caffeine. Whether it’s coffee, tea or other foods, caffeine is the most widely consumed drug in the world — more than alcohol, and more than tobacco: 90% of adults worldwide consume caffeine daily. At doses found in food and beverages, the effects are predictable and the side effects are slight. But natural or not, caffeine is a drug; isolate the pure substance, and the risks change. It would be difficult for most people to drink 16 cups of coffee in a row, but that’s the equivalent of just one teaspoon of caffeine powder. If that doesn’t hospitalize you, a tablespoon of the powder will probably kill you. Yet despite the risks, there are no restrictions on the sale of caffeine powder. You can buy a 1kg bag for $35, which provides the caffeine of about 5,000 cups of coffee. Caffeine powder is freely available to buy because regulators treat it differently – not because of its inherent properties, but because it’s “natural” and sold as a dietary supplement rather than a drug. This is a regulatory double-standard that harms consumers. It’s leaving a body count. And it needs to change: (more…)
The FDA recently announced it would send field staff out to collect samples of commercially-manufactured raw dog and cat food. The samples will be analyzed for Salmonella, Listeria monocytogenes and E. coli, all of which have been found in raw pet food, in the animals who eat it, in their feces, on their bodies after eating it, in the areas they inhabit, and on their owner’s bodies. Not surprisingly, this has led to both pet and human infection and illness. If the FDA finds pathogens, it could result in a recall, a press release and Reportable Food Registry Submission. The next day, the CDC joined the effort to curb illness caused by pathogens in raw pet food by posting information on safe handling.
Because of the risk to public health, and the lack of any proven benefit of raw pet food diets, the FDA does not recommend them.
However, we understand that some people prefer to feed these types of diets to their pets.
And why is that? For some of the same reasons humans follow absurd diet fads: the “lone genius” discovery, it’s “natural,” anecdotal evidence, appeal to antiquity, anti-corporate sentiment, and “holistic” practitioner recommendations.
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.
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.
The Merriam-Webster Dictionary defines science as:
Knowledge about or study of the natural world based on facts learned through experiments and observation.
Knowledge as distinguished from ignorance or misunderstanding.
While this should distinguish science from pseudoscience, those who practice the latter often lay claim to the same definition. But one of the major differences between science and pseudoscience is that science advances through constant rejection and revision of prior models and hypotheses as new evidence is produced; it evolves. This is the antithesis of pseudoscience. At the heart of pseudoscience-based medicine (PBM) is dogma and belief. It clings to its preconceptions and never changes in order to improve. It thrives on the intransigence of its belief system, and rejects threats to its dogma. Despite the constant claims by peddlers of pseudoscience that SBM practitioners are closed-minded, we know that, in fact, PBM is the ultimate in closed-minded belief. Of course, those of us who claim to practice SBM aren’t always quick to adopt new evidence. We sometimes continue practices that may once have been the standard of care but are no longer supported by the best available evidence, or perhaps may even be contradicted by the latest evidence. Often this is a byproduct of habituated practice and a failure to keep current with the literature. While this is certainly a failure of modern medicine, it is not an inevitable outcome. It is not emblematic of the practice of medicine, as it is with PBM. When medicine is science-based, it strives for continual improvement based on modifications around emerging evidence. (more…)
Pepsi has announced that it will remove aspartame from its formulation of diet Pepsi products in the US this year. Apparently this is a reaction to a 5% drop in the sales of Pepsi. Seth Kaufman, vice-president of Pepsi, said “Aspartame is the number one reason consumers are dropping diet soda.”
This move comes in the same week that Chipotle announced it is removing GMO food from its food chain. Unlike Pepsi, who cited only public opinion, Chipotle went one step further and directly cited pseudoscientific fears of GMOs as their justification. (But that’s another story.)
Like GMOs, aspartame has been widely studied and found to be safe, but remains the target of fear-mongering and conspiracy theories. It is not clear why this one food additive has continued to be the target of a fake controversy, other than that fears and conspiracies can take on a life of their own. The best example of anti-aspartame conspiracy theories comes from Janet Starr Hull, who wrote:
I will never accept the news of aspartame safety. I think it is a “business” decision to discredit/discount the research results that aspartame DOES cause cancer, major nerve disorders, birth defects, and brain imbalances. Think about it – can you imagine the chaos that will occur when the truth of aspartame dangers is accredited. The FDA has known about the dangers, the corporations have known about the dangers, and the medical community (if it is really worth anything) has known about the dangers.
That is a common claim of conspiracy theorists – the truth is being suppressed out of fears that it will bring chaos if revealed. I think our society will survive Pepsi moving over to a different sweetener. (more…)
The practice of infectious disease (ID) is both easy and difficult. If you read my ID blog on Medscape you are aware of my trials and tribulations in diagnosing and treating infections.
ID is easy since, at least in theory, diseases have patterns and an infecting organism has a predictable epidemiology and life cycle. So if you can recognize the pattern and relate it to the life cycle and exposure history, you can often make a diagnosis before the cultures come back.
My favorite story is the time I was asked to see a young girl with endocarditis. The history was she had a week of fevers, headache and myalgia that went away for five days, returned for a week, went away for five days and returned yet again.
So I asked her “How was your vacation at Black Butte?”
The look of astonishment on her face as she asked how I knew she had been to Black Butte was so satisfying. (more…)