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“Functional medicine” in practice

Functional Medicine practitioners like to make patients think that this diagram actually means something.

Functional Medicine practitioners like to make patients think that this diagram actually means something.

I’ve frequently written about a form of medicine often practiced by those who bill themselves as practicing “complementary and alternative medicine” (CAM) or “integrative medicine” (or, as I like to refer to it, “integrating” quackery with medicine). I’m referring to something called “functional medicine” or, sometimes, “functional wellness,” which Wally Sampson first introduced to readers of this blog way back in 2008, and continued to educate our readers over multiple posts. Over the years, I’ve tried to explain why the term “functional medicine” (FM) is really a misnomer, how in reality it is a form of “personalized medicine” gone haywire, or, as I like to refer to it, as “making it up as you go along.” Unfortunately, thanks largely to its greatest popularizer, Dr. Mark Hyman, FM is popular, so much so that Bill and Hillary Clinton count Hyman as one of their medical advisors and the Cleveland Clinic, not satisfied with embracing prescientific traditional Chinese medicine, has gone “all in” for FM by hiring Dr. Hyman two years ago to set up a functional medicine clinic. Unfortunately, it’s been “wildly successful” there.

Unfortunately its success is not deserved, at least from a scientific standpoint.
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Posted in: Acupuncture, Basic Science, Diagnostic tests & procedures, Science and Medicine, Traditional Chinese Medicine

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Milestones on the path to integrating quackery with medicine

Integrative medicine

It’s been a long time since I’ve encountered Glenn Sabin. You might remember him, though. He runs a consulting firm, FON Therapeutics, which is dedicated to the promotion of “integrative” health, or, as I like to put it, the “integration of pseudoscience and quackery with science-based medicine. What I remember most about Sabin is how he once proclaimed that “integrative medicine” was a brand, not a specialty. Unfortunately, he was correct in his assessment. Basically, he declared, “CAM [complementary and alternative medicine] is dead. The evolution of evidence-based, personalized integrative medicine, and its implementation in clinic, lives on.” The reason CAM was being killed by its advocates was, of course, because the term CAM contains the word “alternative” in it, and that was a barrier to mainstream acceptance. It didn’t bother Sabin one whit that there’s a lot of unscientific and unproven quackery in the CAM that has mostly become integrative medicine:

It’s true that not all stress reduction techniques, say, Reiki, boast a solid evidence base. But many clinicians who offer services like Reiki do so because they’ve observed it helping many of their patients to relax, thus lessening their need for certain medications. They rationalize that since the intervention is not potentially harmful and their patient is more relaxed and reporting beneficial value, then what difference does it really make if we don’t yet know exactly how it works?

To him, “integrative” health and medicine were the future, mainly because the connotation is much more favorable. To paraphrase how I put it at the time, no longer were CAM practitioners content to have their favorite quackery be “complementary” to real medicine. After all, “complementary” implied a subsidiary position. Medicine was the cake, and their nostrums were just the icing, and that wasn’t anywhere good enough. Those promoting CAM craved respect. They wanted to be co-equals with physicians and science- and evidence-based medicine. The term “integrative medicine” served their purpose perfectly. No longer were their treatments merely “complementary” to real medicine. Oh, no. Now they were “integrating” their treatments with those of science- and evidence-based medicine! The implication, the very, very, very intentional implication, was that alternative medicine was co-equal to science- and evidence-based medicine, an equal partner in the “integrating.”
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Posted in: Acupuncture, Critical Thinking, Medical Academia, Traditional Chinese Medicine

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Medical science policy in the U.S. under Donald Trump

When Dr. Oz met Donald Trump: Somehow this photo just seemed appropriate for this post.

When Dr. Oz met Donald Trump: Somehow this photo just seemed appropriate for this post.

Last week, in an unexpected upset, Donald Trump won the Presidential election in the Electoral College while losing the popular vote and is now President-Elect. Regular readers of my not-so-super-secret other blog know my opinion of this; so I won’t belabor it too much here. If you’re curious, I have written about Donald Trump’s antivaccine views here before in the context of last year’s Republican debates, and, amusingly, I’ve even been at the receiving end of criticism from an “integrative medicine” activist in which my snark was compared to that of Donald Trump and my criticism labeled “Trumpism.” As you might imagine, I was not pleased.

Leaving all that aside and leaving aside how we’ve now had two Presidential elections out of the last five in which the candidate with fewer popular votes became President (no, I’m not a fan of the Electoral College), Donald Trump won fair and square and will be our next President. As an advocate of science-based medicine, naturally I wondered: What can we expect in terms of medical science under President Trump next year? Jann Bellamy already began the discussion on this blog by undertaking a fairly comprehensive overview of the disturbing anti-science positions Donald Trump and many now coming into his new administration espouse. I’m going to do a bit of the same, but I’m going to drill down and focus solely on medical science. While I agree that Trump’s position on human-caused climate change and his stated intent to pull out of important climate treaties and, in essence, cease any attempt to mitigate the effects of human activity on climate change is a looming disaster that our grandchildren and great-grandchildren and beyond will likely curse our generation for, this blog is Science-Based Medicine.
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Posted in: Basic Science, Clinical Trials, Medical devices, Pharmaceuticals, Politics and Regulation

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Cancer quackery from Germany to Australia

Quack, quack

Last week, I wrote about alternative medicine clinics in Germany that offer a combination of alternative cancer cures plus experimental therapeutics administered improperly outside the auspices of a clinical trial. In particular, I discussed two cases. The first was British actress Leah Bracknell, who is raising money to go to one of these alternative cancer clinics to treat her stage IV lung cancer. the second was a British woman named Pauline Gahan, who was diagnosed with metastatic stomach cancer and has thus far spent £300,000 for a combination of vitamin infusions, “detox,” and Keytruda (generic name: pembrolizumab). This is a drug belonging to a new class of promising anticancer therapies known as immune checkpoint inhibitors. It’s FDA-approved for some cancers, but hasn’t yet been shown to be effective against stomach cancer, although there is one phase I trial that is promising and thought to be sufficient evidence to justify phase II and III trials. None of this stopped the clinic to which both Bracknell and Gahan traveled, the Hallwang Private Oncology Clinic.

One thing I noticed about the Hallwang Private Oncology Clinic when I wrote about it is that nowhere did it list the doctors who own and operate it or who consult there. I did find one name, Dr. Jens Nolting, mentioned on patient discussion boards as working at Hallwang. The lack of mention of who runs the clinic and who practices there was an enormous red flag to me, I think for obvious reasons. Fortunately, a commenter with more knowledge than I and thus a better idea of what to Google for, jumped in to comment and helped out. So I thought I’d do a follow-up post and then segue to a report that aired on Australian TV on alternative medicine for cancer there to show the consequences of clinics like this, which are, unfortunately, a problem in many advanced countries. Thus, this post might be a bit “odds and ends”-ish, but it’s a topic that’s been of intense interest to me ever since I discovered the depths of alternative medicine applied to cancer, and I didn’t want to leave last week’s post, in essence, unfinished. Also, there is at least one interesting connection that I hadn’t realized as I wrote my post last week.
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Posted in: Cancer, Health Fraud, Naturopathy, Politics and Regulation, Science and Medicine

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German alternative cancer clinics: Combining experimental therapeutics with rank quackery and charging big bucks for it

Pauline Gahan in front of the Hallwang Private Oncology Clinic
A couple of months ago, I discussed patient deaths at an alternative medicine clinic in Europe, where a naturopath named Klaus Ross had been administering an experimental cancer drug (3-bromopyruvate, or 3-BP) to patients outside the auspices of a clinical trial. 3-BP is a drug that targets the Warburg effect, a characteristic of cancer cells first reported in the 1920s by Otto Warburg in which the cancer cell changes its metabolism to shut off oxidative phosphorylation (the part of glucose metabolism requiring oxygen that produces the most energy) to rely almost exclusively on glycolysis and anaerobic metabolism. From a cancer cell evolution standpoint, one can understand why cancer cells would behave this way, as this change allows them to survive in environments with much less oxygen than normal cells, but the side effect of the Warburg effect is that cancer cells consume a lot of glucose for their energy needs. Indeed, positron emission tomography (PET scanning) takes advantage of this characteristic of cancer cells to use glucose labeled with a positron-emitting isotope that accumulates in cells. The result is that cancer cells, which in general use a lot more glucose than normal cells, light up compared to the surrounding tissue, allowing the identification of areas suspicious for cancer. Targeting the Warburg effect is therefore a strategy to attack cancer cells preferentially.

Since I wrote about the tragic deaths of those cancer patients, I’ve been seeing stories about German alternative medicine cancer clinics popping up in my newsfeed over and over again. Intuitively, you’d think that a scientifically advanced economic powerhouse like Germany would have stricter regulations over the practice of medicine, but, the more I looked into these clinics, the more I realized that there are a lot of quack clinics in Germany every bit as quacky as any clinic in Tijuana, but with a twist. Like Mexican alternative medicine clinics, German clinics often charge enormous sums of money for treatments that range from the unproven to the dubious to pure quackery. However, in addition to the rank quackery, German cancer clinics include legitimate experimental drugs that are as yet unproven and might even only have cell culture or animal evidence supporting its potential efficacy. Indeed, 3-BP is just such an example. It is a legitimate candidate cancer drug that’s in the pipeline, having shown promise in cell culture and animal experiments, but that has no human data from systematic clinical trials yet, just a handful of anecdotes when it was tried in humans under desperate circumstances. Not surprisingly, Klaus Ross’ main clinic is in Germany, and, like so many other clinics there, he was administering an as-yet-unapproved drug to humans.

So, prodded by a couple of recent stories from the UK, I decided to take another look at these German cancer clinics.
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Posted in: Cancer, Clinical Trials, Health Fraud

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Mammography and overdiagnosis, revisited

Reading mammograms
[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.
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Posted in: Cancer, Public Health

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In which we are accused of “polarization-based medicine”

hillary-clinton-donald-trump-presidential-debate

A little over a month ago, I wrote about how proponents of “complementary and alternative medicine” (CAM), now more frequently called “integrative medicine,” go to great lengths to claim nonpharmacological treatments for, well, just about anything as somehow being CAM or “integrative.” The example I used was a systematic review article published by several of the bigwigs at that government font of pseudoscience, the National Center for Complementary and Integrative Health (NCCIH) about CAM approaches for the management of chronic pain. You can read my whole post for yourself if you want the details (and read Edzard Ernst and Steve Novella for more), but the CliffsNotes version consists of two main points. First, the review didn’t really show that any CAM approach worked, given how the authors included so many studies with no placebo or sham control and didn’t systematically assess the quality of the studies. Second, this study is the best publicized example of how NCCIH, looking for a reason to justify itself, has latched on to the opioid addiction crisis in this country and gone “all in” with CAM for chronic pain. Of course, the problem is that none of the real “alternative” treatments show any convincing evidence of efficacy; so NCCIH has to claim exercise (in the form of yoga and Tai Chi, for instance) and various other modalities that aren’t really “alternative” as being part of CAM. True, the authors did try to claim that acupuncture works for back pain and osteoarthritis of the knee, but the flaw of including mostly studies with no placebo/sham control completely undermined that claim. Basically, taken in its entirety, the NCCIH’s systematic review failed to find convincing evidence that any CAM therapy really works for chronic pain.

So I wrote my post, noting also how this review article and its framing of CAM as equivalent to any nonpharmacologic treatment were clearly in line with the last two NCCIH strategic plans, perused the comments our readers left, and pretty much forgot about the study, because fortunately, it didn’t seem to get much traction. (Releasing it right before the Labor Day weekend probably didn’t help NCCIH much.) However, there is one person who did not forget, and that person is John Weeks. Last week, he published a response to the criticisms of the NCCIH review in the Journal of Alternative and Complementary Medicine (JACM) entitled “Polarization-Based Medicine: Protests Against the Mayo-NCCIH Pain Guidance Evoke the Bigotry of the Political Season.”

As they say, it’s on.
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Posted in: Clinical Trials, Critical Thinking, Medical Academia, Politics and Regulation

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When science- and evidence-based guidelines conflict with patient wishes: What’s a doc to do?

Evidence-based medicine triad

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…)

Posted in: Cancer, Diagnostic tests & procedures

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The stem cell hard sell, Stemedica edition

The stem cell hard sell returns.

The stem cell hard sell returns.

I first became more interested in dubious stem cell clinics nearly two years ago, when I learned that hockey legend Gordie Howe was undergoing stem cell therapy in Mexico to treat his stroke. Prominent in stories about Howe were two companies: Stemedica Cell Technologies, a San Diego company marketing stem cell treatments for all manner of ailments, and Novastem a partner company in Mexico that uses Stemedica products. Also prominent in the stories was Clínica Santa Clarita, the Tijuana-based clinic where Howe received his stem cell infusion. As far as I was able to glean, it’s a clinic to which Novastem supplies Stemedica stem cells. Basically, what happened is that Stemedica CEO Dr. Maynard Howe (no relation to Gordie Howe’s family) and VP Dave McGuigan contacted the Howe family late 2014, after having seen news stories about how poorly Gordie Howe was doing, to offer Howe its stem cell therapy.

Unfortunately, Gordie Howe was not eligible for Stemedica’s US-based clinical trial of its stem cell product for stroke because it had not yet been over six months since his last neurologic event and he was not yet neurologically stable. So Maynard Howe and McGuigan steered the Howe family to Novastem, one of Stemedica’s international partners. As a result, under the auspices of a highly dubious “clinical trial” conducted by physicians utterly unqualified to run a decent clinical trial under Mexican regulations that basically allowed “approved” clinics to do anything they want with stem cells, (whose details I discussed at the time), Gordie Howe received Stemedica stem cell infusions at Clínica Santa Clarita.

Because of Gordie Howe’s celebrity and the admiration Howe and McGuigan had for him, Novastem even waived the normal $30,000 per infusion charged to typical patients. From my viewpoint, they used Gordie Howe as a marketing tool, with the waived $30,000 an investment in publicity. Unfortunately Gordie Howe’s son Murray Howe, who happens to be a radiologist, was all too happy to go along, expressing an extreme sense of obliviousness and entitlement in response to questions about whether Clinica Santa Maria treated his father Gordie for free, responding, “You betcha. They were thrilled and honored to treat a legend. Would you charge Gordie Howe for treating him? None of his doctors ever do. I certainly am not going to criticize them for being generous.” Let’s just put it this way. I doubt that Gordie Howe’s other physicians refrained from charging Medicare and whatever insurance Howe had at the time for their services or collecting their copays.
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Posted in: Clinical Trials, Politics and Regulation, Science and the Media

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