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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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Diet and exercise versus cancer: A science-based view

Exercise time

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.
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Posted in: Cancer, Epidemiology, Nutrition

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The Cancer Moonshot: Hype versus reality

Joe Biden promotes the Cancer Moonshot initiative.

Joe Biden promotes the Cancer Moonshot initiative.

The Cancer Moonshot. It’s a topic that I’ve been meaning to address ever since President Barack Obama announced it in his State of the Union address this year and tasked Vice President Joe Biden to head up the initiative. Biden, you’ll recall, lost his son to a brain tumor. Yet here it is, nearly eight months later, and somehow I still haven’t gotten around to it. The goal of the initiative is to “eliminate cancer as we know it,” and to that end, with $195 million invested immediately in new cancer activities at the National Institutes of Health and $755 million proposed for FY 2017. My first thought at the time was that that wasn’t nearly enough money to achieve the ambitious goals set out by the President. That has now become particularly clear now that the National Cancer Institute has released the report from the initiative’s blue ribbon panel suggesting ten ways to speed up progress against cancer.
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Posted in: Basic Science, Cancer, Clinical Trials, Politics and Regulation

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“Non-pharmacological treatments for pain” ≠ CAM, no matter how much NCCIH wishes it so

NCCIH #TalkPain

I’ve had the Monday spot on this blog for quite a long time now. While there are many advantages to posting on Monday, not the least of which is having more time to put a post together (although that is also a disadvantage because it incentivizes my taking more time than I sometimes should), one distinct disadvantage is that all the Monday holidays are mine. That leaves me a choice on, for example, Memorial Day and Labor Day every year. It’s a choice with three options: The first is: Don’t post. (Do stop laughing, please. I know it’s me.) The second is: Use a guest post. I thought about this, and there are guest posts in the pipeline, but I don’t like to use a guest post just because I’m feeling lazy. It strikes me as an abuse of being the managing editor. Finally, I could post, which is what I decided to do.

I mainly decided to do a post because late last week there was something to blog about that was pretty important and interesting, courtesy of the National Center for Complementary and Integrative Health (NCCIH), which was formerly known as the National Center for Complementary and Alternative Medicine (NCCAM). Basically, on September 1, the NCCIH published a press release, “Review Examines Clinical Trial Evidence on Complementary Approaches for Five Painful Conditions.” Elsewhere, NCCIH Lead Epidemiologist and first author of the review, Richard Nahin, PhD, MPH, bragged on the NCCIH blog, “New Review Offers Providers and Researchers Evidence-Based Information on Complementary Health Approaches for Pain.” It didn’t take long for headlines to start appearing that said things like:
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Posted in: Acupuncture, Clinical Trials, Medical Academia, Politics and Regulation

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The cruel sham that will not die: Right-to-try marches on in California and beyond

The cruel sham that will not die: Right-to-try marches on in California and beyond

We here at SBM, particularly Jann Bellamy and myself, frequently write about naturopathic licensing laws, noting that naturopaths are relentless. They keep trying and trying to get states to pass laws granting their specialty licensure, and, like the Terminator trying to kill Sarah Connor or her son, they absolutely will not stop, ever, until science-based medicine is dead there are naturopathic licensing laws in all 50 states by 2025. Part of their strategy is that they never give up. No matter how many times a given state legislature denies them what they want, they are soon back, and they keep coming back again and again and again and again until they get the law they want passed. It’s the problem with playing defense, naturopaths can fail as many times as they have resources for, defenders of science-based medicine can’t afford to fail once. Worse, once such laws are passed, naturopaths are back again and again and again and again to keep trying to expand their scope of practice. It never ceases to amaze me that physicians’ groups go ballistic protecting their turf when advance practice nurses lobby to expand their scope of practice to encompass what they are trained for but remain more or less silent when naturopathic quacks push to have the state place its imprimatur on their pseudoscience.

Sadly, I’ve come to the conclusion that “right to try” laws are a lot like naturopathic licensing laws in that respect, only worse. Why worse? Unlike naturopathic licensing bills, right-to-try bills rarely die; most of them pass. In fact, only one right-to-try bill that I’m aware of has ever been successfully resisted and blocked from becoming law, and that required a veto by the governor. I’m referring, of course, to the California right-to-try bill vetoed last fall by Governor Jerry Brown. Amazingly, Brown’s veto held. Well, a new right-to-try bill is back in California, less than a year after the old right-to-try law had been vetoed. Passed in the legislature by overwhelming margins, it’s now back on Gov. Brown’s desk, and he has to decide what to do with it.

Its supporters hope that this time will be different, that this time Gov. Brown will sign the bill. They might be right. The rationale Gov. Brown used when vetoing the bill was that he wanted to wait to see what happened with reform of the FDA Expanded Access (sometimes called “Compassionate Use”) program. It’s quite possible that, despite the FDA moving forward with such reform, right-to-try advocates might persuade the governor that it isn’t enough. They’re wrong. In any case, given the resurrection of the California right-to-try law, now seemed like a good time to review what’s been happening with these laws since last year and discuss the situation in California and at the federal level. It isn’t good for patients or drug development. On the other hand, now that it’s been nearly two and a half years since the first right-to-try law was passed in Colorado, we have time to see just what a sham these laws are.

But first, since it’s been nearly a year since I last discussed right-to-try, let’s review why these laws are so pernicious.
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Posted in: Clinical Trials, Ethics, Politics and Regulation

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The stem cell hard sell

It's generally not a good indication that their treatments work when doctors use the same hard sell techniques as used car salesmen.

It’s generally not a good indication that their treatments work when doctors use the same hard sell techniques as used car salesmen.

Stem cells are magical. Stem cells are all-powerful. Stem cells cure everything. Stroke? No problem! Paralysis? Stem cells’ll fix it. Autism? Yes, even autism.

That’s the narrative one frequently hears about stem cells in the press and courtesy of offshore stem cell clinics and direct-to-consumer marketing of stem cells in the US. Of course, stem cells aren’t mystical and magical, although they are very promising as a treatment for some degenerative conditions. As promising as they are, though, they don’t cure everything. In fact, we don’t even know for sure that they cure anything because for the vast majority of conditions for which stem cells are used in these clinics, they are still at best experimental and at worst completely unproven. In fact, at their worst, they can do great harm.

I learned about the unrelentingly positive spin the media tend to place on stem cell treatments when I first started blogging about Gordie Howe’s stroke and Dr. Maynard Howe (CEO) and Dave McGuigan (VP) of Stemedica Cell Technologies reached out to the Howe family to see if it could help him with its products. When Howe and McGuigan discovered that Howe was not eligible for any of their US clinical trials, they facilitated Howe’s receiving an unproven stem cell therapy through one of its partners in Mexico, Novastem, which uses Stemedica stem cell products to treat patients in its clinic, Clínica Santa Clarita. In the ultimate bit of privilege for a sports hero (or, as I saw it at the time and as it ultimately turned out, an excellent investment for marketing and advertising of Stemedica products) Gordie Howe even received the treatment for free, even though Clínica Santa Clarita charges everyone else around $30,000. Let’s just say that I didn’t find the explanations for waiving this rather massive fee in Gordie Howe’s case to be persuasive, and I was rather disturbed at the entitlement expressed by Howe’s son over it, who didn’t see the ethical problem at all. Nor did I find the excuses given by Stemedica and Novastem for why their clinical trial protocol in Mexico was so substandard.

It turns out that this new, poorly regulated industry operates a lot like the many quack cancer clinics that I’ve blogged about over the years and like a lot of other dubious businesses, such as multilevel marketing scams. This comes in the form of a recent paper in Stem Cells Translational Research by Paul Knoepfler, who describes attending a marketing seminar.
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Posted in: Health Fraud, Science and the Media

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3-Bromopyruvate: The latest cancer cure “they” don’t want you to know about

3-BP: A "safe" and "nontoxic" cancer cure targeting the Warburg effect that quite possibly killed three cancer patients in Germany.

3-BP: A “safe” and “nontoxic” cancer cure targeting the Warburg effect that quite possibly killed three cancer patients in Germany.

I’ve not infrequently written about various dubious and outright quack clinics in different parts of the word with—shall we say?—somewhat less rigorous laws and regulations than the US. Most commonly, given the proximity to the US, the clinics that have drawn my attention are located in Mexico, most commonly right across the border from San Diego in Tijuana for easy access by American patients. Sometimes, in the case of dubious stem cell clinics, they are located in countries like China, Argentina, or Kazakhstan. That’s not to say that there aren’t a lot of quack clinics right here in the US (particularly for stem cell treatments), but, by and large, the clinics doing the truly dangerous stuff tend to be less common in the US.

There is, however, another country where alternative medicine clinics, particularly for cancer, are common and thriving, specifically Germany. I first learned of these clinics when the story of Farrah Fawcett’s battle with anal cancer hit the news nine years ago. Ultimately, she died of her disease at age 62, but before she did she sought treatment at a clinic in Germany, which administered alternative treatments as well as radioactive seed implants, the latter of which, despite sounding nice and “conventional,” were not standard-of-care for recurrent anal cancer. What this led me to learn is that German alternative cancer clinics tend to use both alternative medicine and experimental “conventional” medicine that has not yet been shown to be safe and effective in clinical trials.

I thought of Farrah Fawcett when news about a German cancer clinic hit the news again beginning more than a week ago, when two patients from the Netherlands and one from Belgium died shortly after having undergone treatment at the Biological Cancer Centre, run by alternative practitioner Klaus Ross in the town of Brüggen, Germany. Two others were hospitalized with life-threatening conditions. I didn’t blog about them at the time because the only reports I could find were those sent to me by readers, and they were in German or Dutch. They also didn’t have a lot of detail. Both reported that on July 25, a 43-year-old Dutch woman went to the Biological Cancer Center in Brüggen-Bracht for treatment of breast cancer and that she unexpectedly died on July 30 of unknown causes. The Dutch report stated that the death occurred under mysterious circumstances and that there were two other deaths, that of a Belgian woman the week before, and a Dutch man.

Elsewhere, Irish newspaper TheJournal.ie reports:

Dutch police, who are supporting the inquiry, appealed for information from other patients, as newspapers reported the clinic had been using an experimental transfusion.

Concern was first raised when a 43-year-old Dutch woman with breast cancer complained of headaches and became confused after being treated at the clinic on 25 July.

She later lost the ability to speak, and died on July 30 although the “cause of her death remains unclear,” the German prosecutors said in a statement earlier this week.

Later, it was learned that the identities of the suspected victims were Joke Van der Kolk, age 43; Leentje Callens, age 55; and Peter van Ouwendorp, age 55.

Unfortunately, the early reports were fairly basic, without much detail, and only a couple with any names. Fortunately, now there is an article in Science that reports more. It turns out that the suspected cause of death is an experimental cancer drug known as 3-bromopyruvate (3-BP) that has not yet been approved for use in humans. So what happened?
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Posted in: Basic Science, Cancer, Clinical Trials, Health Fraud

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Dealing with vaccine hesitancy and refusal

How do we deal with parents who would rather their babies face diseases than vaccines?

How do we deal with parents who would rather their babies face diseases than vaccines?

As long as there have been vaccinations, there has been an antivaccine movement, and as long as there has been an antivaccine movement, there have been parents who refuse to vaccinate. In a past that encompasses the childhood of my parents, polio was paralyzing and killing children in large numbers in yearly epidemics, the fear of which led to the closure of public pools every summer. In such an environment, the new polio vaccine introduced by Jonas Salk in the mid-1950s wasn’t a hard sell. In fact, satisfying the initial demand for it was the problem, not parents refusing to vaccinate their children. Since then, more and more vaccines have been developed to protect more and more children from more and more diseases, to the point where the incidences of most vaccine-preventable diseases is so low that, unlike 60 years ago, most parents today have never seen a case or even known other parents whose child suffered from a case. Even as recently as the 1980s, Haemophilus influenza type B was a dread disease that could cause meningitis, pneumonia, sepsis, and death. Since the introduction of the the Hib vaccine a mere quarter century ago, Hib has been virtually eliminated. Most pediatricians in residency now have never seen a case.

As much of a cliché as it is to say so, unfortunately vaccination has been a victim of its own success, at least in developed countries. Parents no longer fear the diseases childhood vaccines protect against, which makes it easy for antivaccine activists to provide what I like to call “misinformed consent,” by spreading misinformation that vastly exaggerates the risk of vaccines compared to the benefit of vaccinating. Parents who believe the misinformation conclude, based on a warped view of the risk-benefit ratio of vaccines, that not vaccinating is safer. Add to the mix fear mongering against the MMR based on Andrew Wakefield and his dubious 1998 case series that popularized the then-recent idea that vaccines cause autism, and it’s no wonder that parents decide that not vaccinating is safer than vaccinating. If you believe the misinformation, it’s not an entirely unreasonable conclusion. Then add to that the easy availability of “personal belief exemptions” to school vaccine mandates in many states, which include anything from religious exemptions to parents just signing a form that says they are “personally opposed” to vaccination, and it isn’t a huge surprise that vaccine uptake has fallen in some areas to the point where outbreaks can occur. It was happening in California and my own state of Michigan. (more…)

Posted in: Politics and Regulation, Public Health, Vaccines

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On the pointlessness of acupuncture in the emergency room…or anywhere else

"This patient's qi isn't flowing the way it should. Consult Acupuncture, STAT!!"

“This patient’s qi isn’t flowing the way it should. Consult Acupuncture, STAT!!”

Sometimes there is a strange confluence of events that dictate what I feel that I need to write about when my turn here at SBM rolls around each Monday. Last week, a reader sent me a rather bizarre acupuncture study, and I thought I might write about that. Then I saw Mark Crislip’s (as usual) excellent deconstruction of the frequent claim by acupuncture apologists that acupuncture “works” by releasing endorphins and thought, “Maybe another topic.” But then, over the weekend, the Friends of Science in Medicine sent me a link to their latest article, a review of acupuncture entitled “Is there any place for acupuncture in 21st century medical practice?” Not surprisingly, the FSM (Friends of Science in Medicine, not the Flying Spaghetti Monster) concludes that the answer is no. However, in stark contrast to that conclusions are studies like the one mentioned above, studies so ridiculous that, when I discuss it, you will hardly believe that anyone thought it was a good idea to utilize the money, time, and precious, precious human subjects to answer such a ridiculous question. After that discussion, I’ll come back to the FSM’s statement and discuss the evidence base (or rather, lack thereof) for acupuncture for pretty much anything.
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Posted in: Acupuncture, Clinical Trials

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