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Now that Burzynski has gotten off in 2012, Burzynski The Movie will spawn a sequel in 2013

About a year ago, I became interested in a physician named Stanislaw Burzynski who has been treating cancer with compounds that he calls “antineoplastons” for over three decades without, in my opinion, ever having ever produced any compelling evidence that antineoplastons have significant anticancer activity. Although I had been vaguely aware of Burzynski and his activities, it was the first time that I had looked into them in a big way.

Having found very few skeptical, science-based takes on Burzynski and having noted that the Quackwatch entries on Burzynski (1, 2, 3) were hopelessly out of date, I wrote a trilogy of posts about him, starting with a review of an execrably bad movie made by a simultaneously credulous yet cynical independent writer, producer, and director named Eric Merola whose primary business, appropriately enough, is mainly marketing. The movie was Burzynski The Movie: Cancer Is A Serious Business, a “documentary” (and I’m being polite here) that I characterized at the time as a bad movie and bad P.R. In brief, I saw this movie as a hagiography, a propaganda film so ham-fisted that, if she were still alive, it would easily simultaneously make Leni Riefenstahl blush at its blatantness and feel nauseated how truly awful it was from a strictly film making standpoint. It was also chock full of highly dubious science, in particular Burzynski’s latest venture, which is to sell “personalized gene-targeted cancer therapy” similarly lacking in oncological insight, so much so that I observed at the time that it was as though Dr. Burzynski read a book called Personalized Cancer Therapy for Dummies and decided he is an expert in genomics-based tailoring of targeted therapies to individual cancer patients. Finally, I completed the trilogy by pointing out that lately Burzynski has been rebranding an orphan drug that showed mild to moderate promise as an anticancer therapy.
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Posted in: Book & movie reviews, Cancer, Clinical Trials

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Journal of Clinical Oncology editorial: “Compelling” evidence acupuncture “may be” effective for cancer related fatigue

Journal of Clinical Oncology (JCO) is a high impact journal (JIF > 16)  that advertises itself as a “must read” for oncologists. Some cutting edge RCTs evaluating chemo and hormonal therapies have appeared there. But a past blog post gave dramatic examples of pseudoscience and plain nonsense to be found in JCO concerning psychoneuroimmunology (PNI) and, increasingly, integrative medicine and even integrations of integrative medicine and PNI. The prestige of JCO has made it a major focus for efforts to secure respectability and third-party payments for CAM treatments by promoting their scientific status and effectiveness.

Once articles are published in JCO, authors can escape critical commentary by simply refusing to respond, taking advantage of an editorial policy that requires a response in order for critical commentaries to be published. An author’s refusal to respond means criticism cannot be published.

Some of the most outrageous incursions of woo science into JCO are accompanied by editorials that enjoy further relaxation of any editorial restraint  and peer review. Accompanying editorials are a form of privileged access publishing, often written by reviewers who have strongly recommended the article for publication, and having their own PNI and CAM studies to promote with citation in JCO.

Because of strict space limitations, controversial statements can simply be declared, rather than elaborated in arguments in which holes could be poked. A faux authority is created. Once claims make it into JCO, their sources are forgotten and only the appearance a “must read,” high impact journal is remembered. A shoddy form of scholarship becomes possible in which JCO can be cited for statements that would be recognized as ridiculous if accompanied by a citation of the origin in a CAM journal. And what readers track down and examine original sources for numbered citations, anyway?
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Posted in: Acupuncture, Cancer, Clinical Trials, Energy Medicine, Neuroscience/Mental Health, Traditional Chinese Medicine

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A holiday round in the mammography debate

There are times when the best-laid blogging plans of mice and men often go awry, and this isn’t always a bad thing. As the day on which so many Americans indulge in mass consumption of tryptophan-laden meat in order to give thanks approached, I had tentatively planned on doing an update on Stanislaw Burzynski, given that he appears to have slithered away from justice yet again. Then what to my wondering eyes should appear in my e-mail in box but news of a study that practically grabbed me by my collars, shook me, and demanded that I blog about it. As if to emphasize the point, suddenly e-mails started appearing by people who had seen stories about the study and, for reasons that I still can’t figure out after all these years, were interested on my take on the study. Yes, I realize that I’m a breast cancer surgeon and therefore considered an expert on the topic of the study, mammography. I also realize that I’ve written about it a few times before. Even so, it never ceases to amaze me, even after all these years, that anyone gives a rodential posterior about what I think. Then I started getting a couple of e-mails from people at work, and I knew that Burzynski had to wait or that he would be relegated to my not-so-secret other blog (I haven’t decided yet).

As is my usual habit, I’ll set the study up by citing how it’s being spun in the press. My local home town paper seems as good a place to begin as any, even though the story was reprinted from USA Today. The title of its coverage was Many women receiving unnecessary breast cancer treatment, study shows, with the article released the day before the study came out in the New England Journal of Medicine:
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Posted in: Cancer, Diagnostic tests & procedures, Public Health

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True Informed Consent Is Elusive

Most of us would agree that doctors should not treat patients without their consent, except in special cases like emergency care for an unconscious patient.  It’s not enough for doctors to ask “Is it OK with you if I do this?” They should get informed consent from patients who understand the facts, the odds of success, and the risk/benefit ratio of treatments. The ethical principle of autonomy requires that they accept or reject treatment based on a true understanding of their situation and on their personal philosophy. Numerous studies have suggested that patients are giving consent based on misconceptions. There is a failure of communication: doctors are not doing a good job of providing accurate information and/or patients are failing to process that information. I suspect it is a combination of both.

An article in The New England Journal of Medicine reports that while the great majority of patients with advanced lung cancer and colorectal cancer agree to chemotherapy, most of them have unreasonable expectations about its benefits. For some cancers chemotherapy can be curative, but for metastatic lung or colorectal cancer it can’t. For these patients, chemotherapy is only used to prolong life by a modest amount or to provide palliation of symptoms. Patients were asked questions like “After talking with your doctors about chemotherapy, how likely did you think it was that chemotherapy would… help you live longer, cure your cancer, or help you with problems you were having because of your cancer?” A whopping 69% of lung cancer patients and 81% of colorectal cancer patients believed it was likely to cure their cancer, and most of these thought it was very likely. (more…)

Posted in: Cancer, Medical Ethics, Pharmaceuticals

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Mouse “avatars”: New predictors of response to chemotherapy?

Over the years, I’ve written a lot about “personalized medicine, mainly in the context of how the breakthroughs in genomic medicine and data pouring in from the Cancer Genome Atlas is providing the raw information necessary for developing truly personalized cancer therapy. The problem, of course, is analyzing it and figuring out how to apply it. Another problem, of course, is developing the necessary targeted drugs to attack the pathways that are identified as being dysregulated in cancer cells. Oh, and there’s that pesky evolution of resistance to antitumor therapies. Indeed, most recently, the Cancer Genome Atlas is bearing fruit in breast cancer (a study that I’ve been meaning to blog about).

One problem with modeling the pathways based on next generation sequencing data and expression profiling is testing whether therapies predicted to work from these analyses actually do work without actually testing potentially toxic drugs on patients. Cell culture is notoriously unreliable as a predictor. However, there is another way that’s intriguing. Unfortunately, as intriguing as it is, it has numerous problems, and, unfortunately, it’s being prematurely marketed to patients. Although I had heard of this technique as a research tool before, I learned about its marketing to patients when I came across an article by Andrew Pollack in the New York Times entitled Seeking Cures, Patients Enlist Mice Stand-Ins. Basically, it’s about a trend in science and among patients to use custom, “personalized’ mouse xenograft models in order to do “personalized” therapy:
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Posted in: Basic Science, Cancer, Clinical Trials, Diagnostic tests & procedures

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Antivaccine versus anti-GMO: Different goals, same methods

Countering ideologically motivated bad science, pseudoscience, misinformation, and lies is one of the main purposes of this blog. Specifically, we try to combat such misinformation in medicine; elsewhere Steve and I, as well as some of our other “partners in crime” combat other forms of pseudoscience. During the nearly five year existence of this blog, we’ve covered a lot of topics in medicine that tend to be prone to pseudoscience and quackery. Oddly enough, there’s one topic that we haven’t really written much about at all, and that’s genetically modified organisms (GMOs). GMOs, as you know, are proliferating, and it’s quite worth discussing the potential and risks of this new technology, just as it is worthwhile to discuss the potential benefits versus the risks of any new technology that can impact our health, not to mention the health of the planet. Unfortunately, GMOs have become a huge political issue, and, I would argue, they have become just as prone to pseudoscience, misinformation, and bad science as vaccines, with a radical group of anti-GMO activists who are as anti-science as any antivaccinationist or quack.

Leave it to that quackery promoter to rule all quackery promoters, Mike Adams, to give me just the opportunity to show you what I mean. Over the last couple of weeks, Mike has been in a fine lather about GMOs, with multiple posts with titles such as The GMO debate is over; GM crops must be immediately outlawed; Monsanto halted from threatening humanity and The evil of Monsanto and GMOs explained: Bad technology, endless greed and the destruction of humanity. In other words, it’s a series of post with Adams’ typical hyperbole. If you were to believe him, GMOs are the product of a plot by Satan, Monsanto, big pharma, and the government, and he’s not sure which one of these is the most evil of the bunch.
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Posted in: Cancer, Genetically modified organisms (GMOs), Politics and Regulation, Public Health

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Frightening Breast Cancer Patients with Bad Science

No Time to Waste: Avoidant Coping Style Scrambles Circadian Rhythms in Breast Cancer Patients, warned the headline of an article in Clinical Psychiatry News. The article went on to claim

Even in the earliest days following a diagnosis of breast cancer, maladaptive coping styles are associated with a disruption in circadian rhythms –which are proven in metastatic disease to be a prognostic indicator of mortality. The surprising finding… holds potentially profound implications for the timing and tailoring of psychosocial interventions in newly diagnosed patients.

And it invoked psychoneuroimmunology for an authoritative sounding warning to breast cancer patients:

The fact that circadian disruption was significant in a subset of patients a mean 19 [sic] days after diagnosis suggests that there may be no time to waste in identifying and treating potentially maladaptive coping responses that could impact not only their adjustment, but also their prognosis.

Women who are diagnosed with breast cancer, enroll yourself immediately in a stress reduction program or support group, if you want to stem the progression of your disease and prolong your life! If you have metastatic disease, maybe you can blame your “maladaptive coping,” your inept handling of the days and weeks immediately after your diagnosis. Such frightening messages to women who are vulnerable because they have just received their diagnosis should require high standards before being released. This article reeks of hype and distortion, starting with its emotional title, No Time to Waste and “Scrambles Circadian Rhythms,” continuing with claims of “profound implications for the timing of psychosocial interventions,” and ending with an exhortation to breast cancer patients that “early breast cancer patients certainly warrant paying closer attention to coping from Day 1.”

The issue is not just skewered science, because  the article contains information that is easily misunderstood without a proper context. Breast cancer patients are urged to take get psychosocial intervention under the threat that if they do not, they are missing an opportunity to control the progression of their disease. This is an example of the irresponsible nonsense that I have been complaining in the past two blogs. There is simply no evidence that psychological interventions can slow progression of cancer or extend life. Claims to the contrary serve to burden cancer patients with an unrealistic responsibility for the outcome of their medical condition. Patients who experience progression to a terminal condition are provided with an irrational sense that they are to blame because they did not take the right steps, namely avail themselves of effective psychological interventions. This article implies that breast cancer patients with an unfavorable course have brought it on themselves by getting too stressed out.

It’s not clear whether journalist Betsy Bates Freed, PsyD. actually interviewed the authors of the study on which the story is based. Media coverage often offers direct quotes that appear to have been obtained directly from authors when they actually come from the scientific article.  In this particular case, Freed provides a highly speculative direct quote that “circadian cycles regulate tumor growth” as if it came directly from the mouth of the lead author of the study. For the record, there is some evidence of an association between circadian rhythms and progression of metastatic breast cancer, but it is not clear that it is causal or  affects”regulation” or in what direction any causal arrows run. Importantly, such findings have not been replicated with early breast cancer patients.

Clinical Psychiatry News is not some dubious CAM website, but an Elsevier published monthly newspaper with an advisory editorial board with recognizable scientist and clinician psychiatrists. It has largely free web access because of pharmaceutical company support. One has to question what editorial control over content is exerted before releasing articles like No Time to Waste.
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Posted in: Cancer, Neuroscience/Mental Health

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Is shameless self-promotion of your science a good idea?

As part of my ongoing effort to make sure that I never run out of blogging material, I subscribe to a number of quack e-mail newsletters. In fact, sometimes I think I’ve probably overdone it. Every day, I get several notices and pleas from various wretched hives of scum and quackery, such as NaturalNews.com, Mercola.com, and various antivaccine websites. I think of it as my way of keeping my finger on the pulse of the antiscience and pseudoscience wing of medicine, but I must admit that I don’t really read them all, but they do allow me to know what the quacks are selling and what new arguments they’re coming up with without actually going to each of their websites. I can then judge by the headlines and the blurbs included in the e-mails whether I think it’s worth it to go to the website itself and, of course, whether the topic might represent fodder for a good blog post. I will admit that not all the sites I monitor are as loony as the Health Ranger’s. In fact, I monitor the blogs and websites of the National Center for Complementary and Alternative Medicine (NCCAM), various naturopath organizations, and the like in order to learn of the “respectable” arguments being used to tout various nostrums.
Sometimes—albeit rarely—I even learn about some interesting new science.

One of the most common themes (besides antivaccine hysteria, claims that diet can prevent 95% of all cancers, etc.) tends to be one of a variety of pitches for various “cures” of serious diseases like cancer and heart disease that “they” don’t want you to know about; i.e., the Kevin Trudeau gambit. Who this “they” is can range from doctors to pharmaceutical companies to universities to the government, but the central message is that someone out there doesn’t want you to know The Truth. A variation of this sort of appeal is the claim that there is a promising new therapy, a cure even, usually natural, that is languishing somewhere because it can’t be patented, because pharmaceutical companies would lose money if it were ever validated and brought into clinical use, or because it goes against current medical dogma. It doesn’t even have to be natural. After all, dichloroacetate (DCA) is not exactly “natural.” After it was shown to have promise in animal models, a pesticide salesman named Jim Tassano sold DCA bought from chemical companies to desperate cancer patients from a website that claimed to be selling it only for pets with cancer, a ruse that fooled no one. Yet the “natural treatment” crowd embraced it whole-heartedly because it looked as though sellers of DCA were sticking it to The Man.
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Posted in: Basic Science, Cancer, Clinical Trials

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Alternative medicine use and breast cancer (2012 update)

[Editor's note: It's a holiday here in the U.S.; consequently, here is a "rerun" from my other super not-so-secret other blog. It's not a complete rerun. I've tweaked it a bit. If you don't read my other blog, it's new to you. If you do, it's partially new to you. See you all next week with brand spankin' new material. It also (Ih hope) complement's Scott's excellent post from Thursday discussing the same issue and the same paper, but from a different perspective.]

As a cancer surgeon specializing in breast cancer, I have a particularly intense dislike reserved for cancer quacks, which I have a hard time containing at times when I see instances of such quackery applied to women with breast cancer. I make no apologies. These women are, after all, the type of patients I spend all my clinical time taking care of and to whose disease my research has been directed for the last 13 years or so. That’s why I keep revisiting the topic time and time again. Unfortunately, over the years, when it comes to this topic there’s been a depressing amount of blogging material. Indeed, Scott Gavura took a bite out of this particularly rotten apple just a few days ago. Even though he handled the discussion quite well, I thought it would be worthwhile for a breast cancer clinician to take a look. Our perspectives are, after all, different, and this is an issue that, from my perpective, almost can’t be discussed too often.

One question that comes up again and again is, “What’s the harm?” Basically, this question boils down to asking what, specifically, is the downside of choosing quackery over science-based medicine. In the case of breast cancer, the answer is: plenty. The price of foregoing effective therapy can be death; that almost goes without saying. In fact, it can be a horrific and painful death. It is, after all, cancer that we’re talking about. Aside from that, however, the question frequently comes up just how much a woman decreases her odds of survival by avoiding conventional therapy and choosing quackery. It’s actually a pretty hard question to answer. The reason is simple. It’s a very difficult topic to study because we as physicians have ethics. We can’t do a randomized trial assigning women to treatment or no treatment, treatment or quacke treatment, and then see which group lives longer and by how much. If a person can’t see how unethical that would be without my having to explain it, that person is probably beyond explanations. (As an aside, I can’t help but point out that a randomized trial of not vaccinating versus vaccinating is unethical for exactly the same reason; physicians can’t knowingly assign subjects to a group where he knows they will suffer harm. There has to be clinical equipoise.) There’s no doubt that foregoing effective treatment causes great harm.
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Posted in: Cancer, Clinical Trials, Health Fraud

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Questioning Whether Psychotherapy and Support Groups Extend the Lives of Cancer Patients

What a wonderful world it would be if  cancer patients could  extend their survival time by mobilizing their immune systems by eating the right foods, practicing yoga, and venting their emotions in a support group. The idea that patients can enlist their immune systems to fight the progression of cancer is deeply entrenched in psychosomatic medicine and the imagination of the lay public, and evidence to the contrary has been sometimes bitterly resisted. Of course, cancer patients can use psychological techniques to relieve stress or find emotional relief in support groups and thereby improve the quality  of their lives. But the prospect of being able to improve the quality of life pales in comparison to the promise of being able actually to extend life.

The hope that psychosocial intervention extends lives attracts philanthropic contributions to cancer centers and justifies research programs to determine just how psychological processes affect cancer. It is a lot easier to obtain funding if we promise to slow progression of  cancer than if we merely claim to offer patients solace and support or to be study ways to reduce stress and improve emotional well-being.

No mechanism by which the mind can alter the course of cancer has been convincingly demonstrated. But the jury was still out until the late 2000s, when well-resourced, carefully designed trials — with survival as the primary endpoint — repeatedly failed to show that psychological interventions were effective. My colleagues and I asked at the 2006 European Health Psychology Conference whether we could “Bury the Idea…” that psychotherapy could extend lives of cancer patients, and this was followed by our systematic review of the available data, “The Conflict Between Hope and Evidence.” Investigators who had undertaken ambitious, well-designed trials to test the efficacy of psychosocial interventions echoed with “Letting Go of Hope” and “Time to Move on.” For some of us, to make claims in earshot of cancer patients that we could extend their lives with psychotherapy was perpetuating a cruel hoax.

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Posted in: Cancer, Science and Medicine

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