Precision Medicine offers precision, but not certainty
Precision medicine is a development that promises to tailor treatments to the individual patient based on genetic and other molecular and cellular analyses. In his 2015 State of the Union address, President Obama announced the Precision Medicine Initiative. A website for Precision Medicine claims to offer “perfect care for every individual.”
Much of what we read about precision medicine gives the impression that it provides certainty. That’s a false impression. As David Hunter pointed out in a recent article in The New England Journal of Medicine, it may actually increase uncertainty. (more…)
[Editor Note: This is a greatly expanded version of my initial thoughts on a study about mammography published in the New England Journal of Medicine last week on my not-so-super-secret other blog. It’s such an important topic that I thought SBM should see my discussion too, and I couldn’t just cut and paste it. You deserve original material.]
I knew it. I just knew it. I knew I couldn’t get through October, a.k.a. Breast Cancer Awareness Month, without a controversial mammography study to sink my teeth into. And I didn’t. I suppose I should just be used to this now. I’m referring to the latest opus from H. Gilbert Welch and colleagues that appeared in the New England Journal of Medicine last week, “Breast-Cancer Tumor Size, Overdiagnosis, and Mammography Screening Effectiveness.” Yes, it’s about overdiagnosis, something I’ve blogged about more times than I can remember now, but it’s actually a rather interesting take on the issue.
Before 2008 or so, I never gave that much thought to the utility of mammographic screening as a means of early detection of breast cancer and—more or less—accepted the paradigm that early detection was always a good thing. Don’t get me wrong. I knew that the story was more complicated than that, but not so much more complicated that I had any significant doubts about the overall paradigm. Then, in 2009, the United States Preventative Services Task Force (USPSTF) dropped a bombshell with its recommendation that mammographic screening beginning at age 50 rather than age 40 for women at average risk of breast cancer. Ever since then, there have been a number of studies that have led to a major rethinking of screening, in particular screening mammography and PSA testing for prostate cancer. It’s a rethinking that affects discussions even up to today, with advocates of screening arguing that critics of screening are killing patients and skeptics of screening terming it useless. Depending on the disease being screened for, the answer usually lies somewhere in between. Basically, screening is not the panacea that we had once hoped for, and the main reason is the phenomenon of overdiagnosis. Before I go on, though, remember that we are talking about screening asymptomatic populations. If a woman has symptoms or a palpable lump, none of this discussion applies. That woman should undergo mammography.
There’s a misconception that I frequently hear about evidence-based medicine (EBM), which can equally apply to science-based medicine (SBM). Actually, there are several, but they are related. These misconceptions include the idea that EBM/SBM guidelines are a straightjacket, that they are “cookbook medicine,” and that EBM/SBM should be the be-all and end-all of how to practice clinical medicine. New readers might not be familiar with the difference between EBM and SBM, and here is not the place to explain the difference in detail because this post isn’t primarily about that difference. However, for interested readers, a fuller explanation can be found here, here, here, and here. The CliffsNote version is that EBM fetishizes the randomized clinical trial above all other forms of medical investigation, a system that makes sense if the treatments being tested in RCTs have a reasonably high prior probability of translating to human therapies based on basic science mechanisms, experimental evidence in cell culture, and animal experiments. Using Bayesian considerations, when the prior probability is very low (as is the case for, for example, homeopathy), there will be a lot of false positive trials. Such is how EBM was blindsided by the pseudoscience of “complementary and alternative medicine” (CAM) or, as it is called now, “integrative medicine.”
However, for purposes of this post, SBM and EBM can be considered more or less equivalent, because we are not going to be discussing CAM, but rather widely accepted treatment guidelines based on science, both basic and clinical trial science. I merely mention this difference for completeness and for new readers who might not be familiar with the topics routinely discussed here. For purposes of this post, I’m talking evidence-based guidelines from major medical societies. More specifically, I want to address the disconnect between what patients often want and what our current guidelines state. It’s not just patients either, but doctors; however, for purposes of this post I’m going to focus more on patients. It’s a topic I’ve addressed before, in particular when it comes to breast cancer, where I’ve discussed changes in the mammography screening guidelines and Choosing Wisely guidelines for breast cancer. There are many other examples that I haven’t discussed. (more…)
One of the most effective spin techniques used by advocates of “integrative medicine” (also sometimes called “complementary and alternative medicine,” or CAM for short) to legitimize quackery has been to claim basically all non-pharmacologic, non-surgical interventions as “integrative,” “complementary,” or “alternative.” Thus, science-based interventions such as diet changes to treat and/or prevent disease, exercise, and other lifestyle alterations are portrayed as somehow so special that they need their own specialty, “integrative medicine,” even though they are simply part of medicine. I pointed this out a mere two weeks ago when I discussed the National Center for Complementary and Integrative Health (NCCIH) review of non-pharmacological treatments for pain. It was a systematic review that was essentially negative but spun as positive for some interventions and lacked some key analyses that a good systematic review includes, such as assessment of the quality of the studies included and evaluating them for bias.
Such were my thoughts over the weekend as I got into a Twitter exchange with an advocate of integrative medicine who was touting the benefits of diet as a cancer preventative and how a course in nutrition “opened her eyes.” That in and of itself wasn’t particularly annoying, although I strongly suspect that the nutrition course she took was not given by actual registered dietitians or other experts in science-based nutrition (she wouldn’t say when questioned). What was annoying is that she trotted out some tropes beloved by integrative medicine proponents, such as the claim that most doctors don’t do prevention because they get paid to treat. She was called out for it:
Oddly enough, on the same day a post from the American Society of Clinical Oncology (ASCO) came up in e-mail lists that discussed the actual evidence for the utility of diet and exercise for cancer prevention. It’s almost as though Twitter were telling me it was time for me to discuss this issue from a science-based perspective. So I will attempt to do so.
When tested, therapeutic touch (TT) practitioners failed to detect the human energy field they thought they could feel. Experimental setup from Rosa et al., from JAMA, 1998, 279 (13)
A study out of Iran titled “Therapeutic touch for nausea in breast cancer patients receiving chemotherapy: Composing a treatment” was recently published in the journal Complementary Therapies in Clinical Practice. It is a great example of the Tooth Fairy science that permeates much of the research in complementary and alternative medicine. In Tooth Fairy science, researchers attempt to study a phenomenon without first determining whether it exists.
What is therapeutic touch?
Therapeutic touch (TT) is a type of energy medicine; practitioners claim to be able to:
- sense a patient’s “human energy field” with their hands,
- manipulate the energy field by moving their hands near (but not touching) a patient’s skin surface, and
- thereby improve the patient’s health.
TT was the delusional invention of a nurse and a theosophist, and it has no scientific basis. Scientists can detect and measure minute energies down to the subatomic level, but they have never detected a “human energy field.” And when TT practitioners were tested on their ability to detect such a field, they failed miserably.
“Therapeutic touch is pure vitalism, the belief in a soul or animating force,” writes Paul Ingraham, “exactly like the Force in Star Wars, and just as fanciful. Auras and life energy do not exist and cannot be felt, let alone manipulated therapeutically.”
Despite the combination of extreme implausibility and a total lack of evidence, TT is taught to nurses in many otherwise reputable institutions, and there are more than 90,000 practitioners worldwide. There is even a Therapeutic Touch International Association that claims TT is evidence-based. It is not.
TT practitioners believe they are helping patients. That belief is reinforced by seeing patients improve due to the natural course of illness, suggestion, and the “placebo” or nonspecific contextual effects of the provider/patient encounter. They allow confirmation bias to overcome scientific reality, and they do poorly-conceived research seeking further confirmation. Since the studies are designed to show that TT works rather than to ask if it works, they find evidence that is convincing to believers but not to the scientific community as a whole. (more…)
It turns out that the use of certain forms of CAM makes it less likely that breast cancer patients will receive the chemotherapy they need.
So-called “alternative” medicine is made up of a hodge-podge of health care practices and treatments based on beliefs that are unscientific, pre-scientific, and pseudoscientific. These modalities include practices as diverse as homeopathy, traditional Chinese medicine, reflexology, reiki and other forms of “energy medicine” based on vitalism, chiropractic, and naturopathy, and that’s a short list of the quackery that falls under the rubric of the term “alternative medicine.” Unfortunately, this unscientific, pre-scientific, and pseudoscientific hodge-podge of treatments rooted in nonsense is rapidly being “integrated” into real medicine, thanks to an unfortunately influential movement in medicine whose members have been seduced into thinking that there might be something to them and view “integrating” them into medicine as means of practicing more “holistic” and “humanistic” medicine. This “integration” started out by being called “complementary and alternative medicine” (CAM) but now among believers the preferred term is usually “integrative medicine,” largely because it eliminates the word “alternative,” which implies (correctly) that the modality is not real medicine, and “complementary,” which implies a subsidiary status, a status of being nice to have but not essential.
Particularly harmful is the hostility towards conventional medicine that often strongly correlates with use of alternative medicine. Indeed, some people even choose to rely on alternative medicine instead of real medicine to treat cancer. Unsurprisingly, the results of such a decision are generally not very good. Actually, they are almost always terrible. Very, very terrible indeed. Not surprisingly, the use of alternative medicine is associated with bad outcomes. Cancer patients who might have survived die because of it. It’s not as though it hasn’t been studied either, although the main studies I’m aware of tend to look at the bad outcomes in patients who choose alternative medicine. There is another question, and it’s one that a new study published in JAMA Oncology last week seeks to answer. It’s a study that briefly made the news, producing headlines like:
This is a panel showing some of the pathologic criteria for distinguishing invasive encapsulated follicular variant of papillary thyroid carcinoma from noninvasive. This is real science. Sayer Ji’s rant is not.
If there’s one lesson that we here at Science-Based Medicine like to emphasize, it’s that practicing medicine and surgery is complicated. Part of the reason that it’s complicated is that for many diseases our understanding is incomplete, meaning that physicians have to apply existing science to their treatment as well as they can. The biology of cancer, in particular, can be vexing. Some cancers appear to progress relentlessly, meaning that it’s obvious that all of them must be treated. Others, particularly when detected in their very early stages through screening tests, have a variable and therefore difficult to predict clinical course if left untreated. Unfortunately, some people, such as Sayer Ji, don’t understand that. They like their medicine black and white, and if physicians ever change guidelines in order to align them more closely with scientific understanding, they write blisteringly ignorant articles like “‘Oops… It Wasn’t Cancer After All,’ Admits The National Cancer Institute/JAMA.”
Not exactly. An expert panel recommended reclassifying a specific thyroid lesion as not cancerous based on recent science. It’s called medicine correcting itself. Admittedly, this reclassification was probably long overdue, but what would Mr. Ji rather have? Medicine not correcting itself in this situation? In any case, when last I met Mr. Ji, he was happily abusing the science of genetics to argue that Angelina Jolie and other carriers of deleterious cancer-causing mutations don’t need prophylactic surgery because lifestyle interventions will save them through epigenetics, which to “natural health” enthusiasts like Mr. Ji seems to mean the magical ability to prevent any disease. Most recently, he has appeared on the deeply dishonest “documentary” about alternative medicine cancer cures, The Truth About Cancer, to expound on how chemotherapy is evil. His rant about the reclassification of a non-encapsulated follicular variant of papillary thyroid cancer as not cancer is more of the same, as you will see.
Mike Adams seems to view me this way. It started out funny, but isn’t so funny any more. Of course, Galadriel was offered The One Ring and its great power, but declined it because she was afraid of what she would become. Maybe I am like Galadriel after all.
I decided to write this post for Science-Based Medicine because I’ve taken notice of recent posts Mike Adams has written about me, mainly because they are riddled with misinformation, fabrications, and lies. Even though at least two of his claims about me made me laugh out loud because of their utter ridiculousness, much of the rest of his recent writing about me has been downright defamatory, libelous even.
The stupid stuff
Before I get into the really nasty stuff, let’s look at the stupid stuff. It’s not that the nasty stuff isn’t also stupid, but here I arbitrarily decide to divide the discussion into parts about when Adams amuses me and when he disgusts me. If there’s one lesson I’ve learned from Adams’ attacks on me, it’s that, apparently, I have incredible power—possibly even superhuman! I mean, seriously. Adams really does seem to think that I have massive power over what Wikipedia does and does not publish about vaccines and medicine! Indeed, as I thought last night about what to write and even ended up staying up until 2 AM to do so (mainly because I was so exhausted after a day in the operating room that I crashed on the couch between 8 and 11 PM), I was half-tempted not to disabuse him of his apparent delusions about my overwhelming power. After all, if Adams really does think that I have so much power, why would I want to reveal to him the truth that I do not? On the other hand, far less amusing are Adams’ attempts to link Karmanos Cancer Center and me to the criminal Dr. Farid Fata, a lie by insinuation that is despicable even by his low standards. What should I expect, though, from someone who’s been running scams since Y2K and posting threats against GMO scientists?
Of course, I am not naïve enough to believe that Adams doesn’t actually know damned well that I don’t have that level of influence on Wikipedia. Rather, it’s all a sham, a con man’s patter, to convince his readers that I’m a major player in a conspiracy to manipulate health articles on Wikipedia from behind the scenes. He uses such fabricated stories as tools to fire up his gullible and stupid followers. Does Adams even realize how ridiculous his articles come across with their overwrought language? In fact, I laughed out loud when I read that Arianna Huffington and I “are not directly murdering children, but they are doing everything in their power to kill any truthful discussion about vaccine damage (that might save children)” and then this:
Women looking for relief from hot flashes will be disappointed if they think acupuncture will help them.
Arguably, one of the most popular forms of so-called “complementary and alternative medicine” (CAM) being “integrated” with real medicine by those who label their specialty “integrative medicine” is acupuncture. It’s particularly popular in academic medical centers as a subject of what I like to refer to as “quackademic medicine“; that is, the study of pseudoscience and quackery as though it were real medicine. Consider this. It’s very difficult to find academic medical centers that will proclaim that they offer, for example, The One Quackery To Rule Them All (homeopathy). True, a lot of integrative medicine programs at academic medical centers do offer homeopathy. They just don’t do it directly or mention it on their websites. Instead, they offer naturopathy, and, as I’ve discussed several times, homeopathy is an integral—nay, required—part of naturopathy. (After graduation from naturopathy school, freshly minted naturopaths are even tested on homeopathy when they take the NPLEX, the naturopathic licensing examination.) Personally, I find this unwillingness of academic medical centers that offer naturopathy to admit to offering homeopathy somewhat promising, as it tells me that even at quackademic medical centers there are still CAM modalities too quacky for them to want to be openly associated with. That optimism rapidly fades when I contemplate what a hodge-podge of quackery naturopathy is and how many academic integrative medicine programs offer it.
If you believe acupuncturists, acupuncture can be used to treat almost anything. Anyone with a reasonable grasp of critical thinking should recognize that a claim that an intervention, whatever it is, can treat many unrelated disorders is a huge red flag that that intervention is almost certainly not science-based and is probably quackery. So it is with acupuncture; yet, that hasn’t stopped the doyens of integrative medicine at the most respected medical schools from being seduced by the mysticism of acupuncture and studying it. I can’t entirely blame them. I must admit, there was a time when even I thought that there might be something to acupuncture. After all, unlike so many other CAM interventions, acupuncture involved doing something physical, inserting actual needles into the body. However, as I critically examined more and more acupuncture studies, I eventually came to agree with David Colquhoun and Steve Novella that acupuncture is nothing more than a “theatrical placebo.”
A new year is upon us yet again, and Science-Based Medicine has been in existence for eight years now. It seems only yesterday that Steve Novella approached me to ask me to be a contributor. Our part-serious, part-facetious predictions for 2016 notwithstanding, one thing about 2016 is certain: I will almost certainly encounter some form of cancer quackery or other and deconstruct it, probably multiple forms. In any case, a topic I’ve been meaning to write about is based on a couple of studies that came out three weeks ago that illustrate why, even if a patient ultimately comes around to science-based treatment of his cancer, the delay due to seeking out unscientific treatments can have real consequences.
When a patient with breast cancer comes in to see me, not infrequently I have to reassure her that she doesn’t need to be wheeled off to the operating room tomorrow, that it’s safe to wait a while. One reason, of course, is that it takes years for a cancer to grow from a single cell to a detectable mass. The big question, of course, is: What is “a while”? Two studies published online last month attempt to answer that question. One study (Bleicher et al) comes from Fox Chase Cancer Center and examines the effect of time to surgery on breast cancer outcomes; the other (Chavez-MacGregor et al) is from the M.D. Anderson Cancer Center and examines the effect of time to chemotherapy on outcome. Both find a detrimental effect due to delays in treatment.