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Clinical trials of homeopathy versus “respect for science”

Trojan Rabbit

A few months ago, Steve Novella and I published an article in Trends in Molecular Medicine entitled “Clinical trials of integrative medicine: testing whether magic works?” It was our first foray together into publishing commentary about science-based medicine versus evidence-based medicine, using a topic that we’ve both written extensively about over the years on this blog and our respective personal blogs. Specifically, we discussed whether it is worthwhile to do randomized clinical trials (RCTs) testing highly improbable treatments, such as reiki and homeopathy, both of which have no physical basis to believe that they do anything whatsoever. As I’ve said many times before, reiki is simply faith healing in which Eastern mysticism is substituted for Christian beliefs, and homeopathy, as we’ve discussed many times here on SBM, is vitalistic sympathetic magic with no evidence to support its two laws.

To our surprise, that article generated a fair amount of press (for example this), with accounts of it showing up in the media in various places and Steven and I being asked to do a fair number of interviews. Part of the reason, I suspect, is that the editor made the article available for free for a month after its initial publication. (Unfortunately it’s back behind the pay wall again.) Part of the reason is that, intuitively, it makes sense to people not to waste money testing what is, at its core, magic. When I followed up that publication with an article criticizing “integrative oncology” in Nature Reviews Cancer entitled “Integrative oncology: Really the best of both worlds?“, the target was well and truly on my back. Indeed, let’s just say that the Society for Integrative Oncology and the Consortium of Academic Health Centers for Integrative Medicine (CAHCIM) are quite unhappy with me. When both their letters to the editor are published (right now, only one is), I might even blog about them.

In the meantime, I want to deal with criticism published in an unexpected place, albeit not by unexpected critics. The reason is that this criticism relies on a common straw man caricature of what we are saying when we advocate science-based medicine (SBM) that considers prior plausibility in determining what modalities to test in clinical trials and understands Bayesian thinking in which prior plausibility affects posterior plausibility that a “significant” result is not a false positive in contrast to the current evidence-based medicine (EBM) paradigm, which relegates basic science knowledge, even well-established principles of science that show that something like, say, homeopathy or reiki is impossible under the current understanding of physics, chemistry and biology, to the lowest rung on the EBM pyramid. It’s also a criticism that comes up frequently enough that, even though it’s been addressed before in various ways by various SBM bloggers, it’s worth revisiting from time to time. In this case, that’s particularly so because one of the two critics taking Steve and me to task is currently embroiled in a controversy about testing homeopathy for attention deficit hyperactivity disorder (ADHD) at the University of Toronto (more details on that later). Let’s just say, the criticism of Steve and me gives me an “in” to address a story that I thought had passed me by, and I intend to take it.
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Posted in: Clinical Trials, Energy Medicine, Homeopathy

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The Gerson protocol, cancer, and the death of Jess Ainscough, a.k.a. “The Wellness Warrior”

The Wellness Warrior website now redirects to this photo.

The Wellness Warrior website now redirects to this photo.

Less than four days ago, a young Australian woman died of a very rare type of cancer. Most of my American and probably many of my European readers have never heard of her, but in Australia she had become quite famous over the last seven years as a major proponent of “natural health.” Her name was Jess Ainscough, but, like a certain American woman who has become famous for promoting dubious science, she was better known by her “brand” name. That brand name was The Wellness Warrior.

I first encountered Ms. Ainscough about a year and a half ago and have been intermittently following her career ever since. I’ve even blogged about her three or four times during that period over at my not-so-super-secret other blog. However, for whatever reason, even though it was my intent to write about her here on Science-Based Medicine, I never got around to it. Her death prodded me to write now, because her tale is a cautionary one important enough that I believe there should be something written here about it. Given that, those of you who follow my cubical other self will find some of this post repetitive. However, think of it as the first opportunity I’ve had to tell the story from beginning to end, along with a major deconstruction of the Gerson protocol. (Yes, unfortunately the Gerson protocol figures heavily in this story.) It’s a story that has led to the deaths of at least two people, and whose harm to others is impossible to quantify, given that the reach of The Wellness Warrior was long, at least in Australia.
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Posted in: Cancer, Herbs & Supplements, History, Science and the Media

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The Hippocrates Health Institute: Cancer quackery finally under the spotlight, but will it matter?

This is a screenshot from the website of the Hippocrates Health Institute, showing its grounds.

This is a screenshot from the website of the Hippocrates Health Institute, showing how high end its grounds and facilities are.

I first came across Brian Clement, the proprietor of the Hippocrates Health Institute in West Palm Beach, Florida, a little more than a year ago based on the story of Stephanie O’Halloran. Ms. O’Halloran was—word choice unfortunately intentional—a 23-year-old mother of an 18 month old child from Ireland who was diagnosed with stage IV breast cancer in 2013, with metastases to her lymph nodes, liver, lung, and leg. Unfortunately for her, she found Brian Clement at the Hippocrates Health Institute, who gave her false hope with his claims that a raw vegan diet and wheatgrass can treat just about everything. Unfortunately, but not unexpectedly, Ms. O’Halloran died in June 2014, less than nine months after having been diagnosed with metastatic breast cancer.

I didn’t write about Stephanie O’Halloran at the time (at least not here), but I did write about Brian Clement and the Hippocrates Health Institute (HHI) twice over the last several months in the context of the cases of two 11-year-old Aboriginal girls in Canada with cancer, specifically lymphoblastic leukemia. One was —word choice again unfortunately intentional—named Makayla Sault and the other is referred to as “JJ” in news reports to protect her privacy in her parents’ legal proceedings to assert their right to use traditional medicine to treat their daughter’s cancer rather than curative chemotherapy, which was estimated to have a 75% chance of curing Makayla Sault and an 85% to 90% chance of curing JJ. Unfortunately, both girls and their parents fell under the spell of Brian Clement and his cancer quackery. The result was one unnecessarily dead girl (Makayla Sault, who died last month) and one likely to be dead by the end of this year or not much longer (JJ). Such is the price of cancer quackery. In this case, even more puzzlingly, these girls’ parents seemed quite content to conflate the quackery of Brian Clement, a white man practicing in Florida, with “traditional Aboriginal medicine,” the sort of practices they were claiming to have a right to.
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Posted in: Cancer, Health Fraud, Herbs & Supplements, Legal

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How not to report about vaccine safety issues, Toronto Star edition

This is the original headline of the Toronto Star's scientifically incompetent and fear mongering Gardasil story. It was later changed to "Families seek more transparency on HPV vaccine."

This is the original headline of the Toronto Star‘s scientifically incompetent and fear mongering Gardasil story. It was later changed to “Families seek more transparency on HPV vaccine.”

I remember it well, because several of my readers forwarded it to me not long after it appeared on the website of the Toronto Star: An eye-catching headline proclaiming a “wonder drug’s dark side,” that “wonder drug” being Gardasil, one of two vaccines against the human papilloma virus (HPV) designed to prevent cervical cancer by preventing infection with the HPV virus. The story’s caption blared:

Hundreds of thousands of teen girls in Canada have safely taken Gardasil, a vaccine shown to prevent HPV. But a Star investigation has found that since 2008 at least 60 Canadians have experienced debilitating illnesses after inoculation. Patients and parents say the incidents point to the importance of full disclosure of risks.

There was even a video that would have been right at home on a variety of antivaccine websites, such as Age of Autism, SafeMinds, or VaxTruth:

Indeed, the video above reminded me more than anything else, of a segment from the antivaccine “documentary” that functions as antivaccine propaganda, The Greater Good, which portrays as one of its vaccine “victims” Gabi Swank, a girl whose story is not unlike that of Kaitlyn Armstrong, the teen profiled by the Star. Both girls had a deterioration of their health that appears to have happened sometime after receiving Gardasil. Both attribute their health issues to Gardasil. Neither story was examined with even a modicum of skepticism or critical thinking. In fact, part of the reason I recognized immediately how bad the Star story was derives from my previous experience examining similar stories promoted by the particularly vociferous wing of the antivaccine movement that focuses on the perceived “evils” of Gardasil. That’s something we expect from an antivaccine propaganda film like The Greater Good. We expect better from investigative journalists like David Bruser and Jesse McLean. We don’t get it.

I had meant to blog about this incident because the Star story was such a horrendously bad story from a scientific perspective, but, blogging being what it is, other topics intruded and for some reason I never got back to this topic. Over the last 11 days, however, the criticism and inept responses kept percolating along, as you will see, involving a clueless editor who lashed out at critics, a public editor who just didn’t “get it,” and a newspaper that took far too long to admit that it had screwed up epically and only then after sliming its critics. Fortunately, an excellent analysis in the Los Angeles Times by Michael Hiltzik provided me with an “in” to do the post I had wanted to do before. How the Toronto Star wrote the story is an object lesson in how not to do a vaccine safety story, and how it responded to reasonable criticism was an even more pointed lesson in how not to deal with scientific critics.

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Posted in: Science and the Media, Vaccines

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The Food Babe’s war on “chemicals” heats up again

The Food Babe

[Note: This is an extra bonus post. Because The Food Babe has been in the news and I couldn’t wait until today, I discussed it at a certain not-so-super-secret blog. If you’ve read it before, it’s only somewhat modified and updated. If you haven’t, it’s new to you. Either way, feel free to comment. Completely new material by me will appear here in a scant few hours.]

It’s been a while since I’ve taken notice of Vani Hari, a.k.a. The Food Babe, the misguided “food safety” activist who sees chemicals, chemicals, chemicals everywhere and raises fears about them all, especially the ones that she can’t pronounce. The first time I took any significant notice of her was about a year ago, when she was making news for lobbying Subway to remove the “yoga mat chemical” azodicarbonamide from its bread, although I didn’t write about her here for a few months after that. As I explained at the time, azodicarbonamide is a chemical used in small amounts to mature bread dough, improve its handling properties, and produce a drier, more cohesive, and more pliable dough that holds together better during kneading by hand or machine. It is safe, breaks down during baking into small amounts of safe substances, and is only a hazard if you inhale it in powder form, where it can be a pulmonary irritant. Then, she made some astonishingly ignorant statements about beer, where she pulled the same routine, to the point where I labeled her tactics as the “appeal to yuckiness.” Basically, if something sounds yucky to her (such as isinglass, which is derived from the swim bladders of fish and is used in some beers to remove haziness and yeast byproducts), then it must be bad, either for you or just bad because it’s gross. It also turns out that The Food Babe makes quite a pretty penny spreading her ignorance and has become sought after to feature in various media appearances, such as magazine covers.

For the last few months I’ve been somewhat dreading February, because I knew Hari was poised to release her first book. As I described before, she has more than a fair amount of social media savvy and business acumen, which have allowed her to build the Food Babe brand rapidly and explains (to me at least) why she seemed to come out of nowhere on a trajectory to become as influential as Dr. Mehmet Oz. Her book, released this week, is called The Food Babe Way: Break Free from the Hidden Toxins in Your Food and Lose Weight, Look Years Younger, and Get Healthy in Just 21 Days! (Talk about ridiculously long subtitles!) You see, I knew that when it came time for Hari’s book to come out we’d be seeing a lot more of her, and unfortunately that’s what happened. As part of that publicity, Hari was featured in a fairly long feature article in The Atlantic by James Hamblin, The Food Babe: Enemy of Chemicals. It’s a relatively amusing title, to be sure, and there’s a lot that’s good about the article. Unfortunately, there’s also a lot that’s downright infuriating about it as well, the more so given that Hamblin is a physician and really should know better, but unfortunately in this piece he shows himself far more respectful of pseudoscience of the sort promoted by The Food Babe than a physician should be.
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Posted in: Nutrition, Science and the Media

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What do we do about politicians and physicians who promote antivaccine misinformation?

Given the ongoing (and increasing) measles outbreak linked initially to Disneyland, it’s hard for me not to revisit the topic from time to time. This time around, there are two issues I wish to discuss, one political and one that is a combination of medical and political. After all, it was just one week ago when New Jersey Governor Chris Christie stepped in it by advocating parental choice in vaccines, as if parents don’t already have a choice. He rapidly had to walk it back, and his ill-considered remarks were almost certainly not evidence that he is antivaccine. They are, however, evidence that he doesn’t understand that we do not have “forced vaccination” in this country (we have school vaccine mandates). Parents already have choice in 48 states, given that only two states (Mississippi and West Virginia) do not allow belief-based non-medical exemptions, be they religious exemptions, personal belief-exemptions, or both, to school vaccine mandates. It also came out that in 2009 while running for Governor, Christie met with Louise Kuo Habakus (who is antivaccine) and the NJ Coalition for Vaccine Choice, a very vocal NJ antivaccine coalition whose member organization list reads like a who’s who of the national antivaccine movement and includes Life Health Choices, the antivaccine organization founded by Habakus. He even wrote a letter promising that as governor he would stand with them in “their fight for greater parental involvement in vaccination decisions that affect their children.”

It’s also evidence that vaccine mandates are becoming even more politicized. Indeed, Senator Rand Paul, on the very same day, provided more such evidence when he claimed on a conservative talk radio show that he’s seen children with severe neurological problems after vaccination, the implication being that he believed these children’s problems were linked to vaccination. Later, in a testy exchange with a CNBC reporter, who asked him whether he had really said that he thought vaccines should be voluntary, Paul sarcastically replied, “I guess being for freedom would be unusual.” Later in the exchange, after repeating the same antivaccine talking points that he had related earlier in the day, he said, “The state doesn’t own the children. Parents own the children, and it is an issue of freedom.” You get the idea. He, too, ultimately had to back off a bit, famously showing himself getting vaccinated for hepatitis A, but given that Paul has had a long history of making similar comments, this was almost certainly strategic.
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Posted in: Politics and Regulation, Public Health, Religion, Vaccines

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Screening for disease in people without symptoms: The reality

One of the most contentious questions that come up in science-based medicine that we discuss on this blog is the issue of screening asymptomatic individuals for disease. The most common conditions screened for that we, at least, have discussed on this blog are cancers (e.g., mammography for breast cancer, prostate-specific antigen screening for prostate cancer, ultrasound screening for thyroid cancer), but screening goes beyond just cancer. In cancer, screening is a particularly-contentious issue. For example, by simply questioning whether mammography saves as many lives lost to breast cancer as advocates claim, one can find oneself coming under fire from some very powerful advocates of screening who view any questioning of mammography as an attempt to deny “life-saving” screening to women. That’s why I was very interested when I saw a blog post on The Gupta Guide that pointed me to a new systematic review by John Ioannidis and colleagues examining the value of screening as a general phenomenon, entitled “Does screening for disease save lives in asymptomatic adults? Systematic review of meta-analyses and randomized trials.”

Before I get into the study, let’s first review some of the key concepts behind screening asymptomatic individuals for disease. (If you’re familiar with these concepts, you can skip to the next section.) The act of screening for disease is based on a concept that makes intuitive sense to most people, including physicians, but might not be correct for many diseases. That concept is that early intervention is more likely to successfully prevent complications and death than later intervention. This concept is particularly strong in cancer, for obvious reasons. Compare, for example, a stage I breast cancer (less than 2 cm in diameter, no involvement of the lymph nodes under the arm, known as axillary lymph nodes) with a stage III cancer (e.g., a tumor measuring greater than 5 cm and/or having lots of axillary lymph nodes involved). Five year survival is much higher for treated stage I than for treated stage III, and, depending on the molecular characteristics, the stage I cancer might not even require chemotherapy and can be treated with breast conserving surgery (“lumpectomy” or partial mastectomy) far more frequently than the stage III cancer. So it seems intuitively true that it would be better to catch a breast cancer when it’s stage I rather than when it’s stage III.
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Posted in: Cancer, Clinical Trials, Epidemiology, Public Health

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An aboriginal girl dies of leukemia: Parental “rights” versus the right of a child to medical care

makayla-sault-v2

One topic that keeps recurring and obligating me to write about it consists of critically analyzing stories of children with cancer whose parents, either on their own or at the behest of their child, stop or refuse chemotherapy or other treatment. It is, sadly, a topic that I’ve been discussing for nearly a decade now, starting first on my not-so-super-secret other blog and continuing both there and here. Indeed, the first post I wrote about this problem was in November 2005, a fact that depressed me when I went back through the archives to find it because so little has changed since that time.

I was painfully reminded of this last week when stories started circulating in the media about the death of Makayla Sault, an Ojibwe girl and member of the New Credit First Nation in Ontario:

The entire community of New Credit is in mourning today, following the news of the passing of 11 year old Makayla Sault.

The child suffered a stroke on Sunday morning and was unable to recover. Friends and family from across the province travelled to New Credit First Nation today to offer condolences, share tears and pay their respects.

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Posted in: Cancer, Public Health, Religion, Science and the Media

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The Disneyland measles outbreak: “Dr. Bob” Sears says measles isn’t that bad, and an antivaccine activist invokes the Brady Bunch fallacy

Editor’s note: There is an extra special bonus guest post today in addition to my regular post. It’s by Paul Knoepfler, a stem cell biologist, and it’s about unregulated stem cell clinics. Be sure to check it out!


BradyBunch

Last week, I wrote about a rather impressive measles outbreak at the “happiest place on earth,” a.k.a. Disneyland. At the time I wrote that post, the outbreak, which had reached several states, had spread to 17 people. As I sat down to write this, I wasn’t actually sure that this topic needed another post, but then I saw this:

As the number of measles cases continues to rise in Southern California following an outbreak at Disneyland last month, about two dozen unvaccinated students at one Orange County high school have been forced to stay home after a classmate contracted the disease.

In a message to students and parents at Huntington Beach High School on Thursday, Pamela Kahn, health and wellness coordinator at the Orange County Department of Education, said that students “who do not have any documented [measles, mumps and rubella] immunizations will be excluded from attending school until January 29.”

Also, the number of confirmed measles cases has climbed to 52, 46 of them in southern California. In Orange County itself, there were 16 cases as of Friday, ten of them linked to Disneyland, the rest not, a finding that’s led health officials to conclude that “measles has become more widespread throughout the county.” Not surprisingly, health officials in Californian are warning that the number is likely to go higher still. In fact, it’s already happening as “satellite” outbreaks are being reported as children infected at Disneyland come home and infect others.
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Posted in: Science and the Media, Vaccines

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Say it ain’t so, Mickey! A holiday measles outbreak makes the happiest place in the world sad

disneyland

Last week, the self-proclaimed “happiest place on earth” wasn’t so happy.

One of the disadvantages of posting once a week is that, unless I muscle in on someone else’s day I can’t respond rapidly to stories that appear early. Of course the flip side of that is that if a story appears over the weekend it’s all mine, and, besides, I have my not-so-super-secret other blog to respond to issues that occur earlier in the week. Another advantage is that, if I do decide to write about something from earlier in the week, I have the advantage of time to think.

You’ve probably figured out that what I’m referring to is the latest measles outbreak. Not surprisingly, it happened in the Los Angeles area. Surprisingly (or perhaps not so much), it happened at Disneyland. I say “not surprisingly” because it’s been well-publicized over the last few years that there are pockets of low vaccine uptake and high personal belief exemptions in California, complete with measles and pertussis outbreaks. This is thanks to pockets of affluent, entitled parents full of the Dunning-Kruger effect who think that they can learn as much about vaccines and autism via Google University as pediatricians and researchers who have devoted their entire professional careers to studying them. Of course, these parents are also facilitated by pediatricians who cater to their fears, the most famous of whom is Dr. Bob Sears, whose The Vaccine Book is a very popular, reasonable-sounding (to parents not aware of the antivaccine tropes within) bit of antivax lite, but there is also our old buddy Dr. Jay Gordon and a host of others.

So what happened at Disneyland? On January 7, the California Department of Public Health confirmed seven measles cases:
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Posted in: Public Health, Vaccines

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