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Archive for 2012

## Fun With Statistics

Statistics is the essential foundation for science-based medicine.  Unfortunately, it’s a confusing subject that invites errors and misunderstandings.  We non-statisticians could all benefit from learning more about statistics as well as trying to get a better understanding of just how much we don’t know. Most of us are not going to read a statistics textbook, but the book Dicing with Death: Chance, Risk, and Health by Stephen Senn is an excellent place to start or continue our education. Statistics can be misused to lie with numbers, but when used properly it is the indispensable discipline that allows scientists:

…to translate information into knowledge. It tells us how to evaluate evidence, how to design experiments, how to turn data into decisions, how much credence should be given to whom to what and why, how to reckon chances and when to take them.

Senn covers the whole field of statistics, including Bayesian vs. frequentist approaches, significance tests, life tables, survival analysis, the problematic but still useful meta-analysis, prior probability, likelihood, coefficients of correlation, the generalizability of results, multivariate analysis, ethics, equipoise, and a multitude of other useful topics. He includes biographical notes about the often rather curious statisticians who developed the discipline. And while he includes some mathematics out of necessity, he helpfully stars the more technical sections and chapters so they can be skipped by readers who find mathematics painful. The book is full of examples from real-life medical applications, and it is funny enough to hold the reader’s interest. (more…)

Posted in: Book & movie reviews, Science and Medicine

## 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science-based takes on Burzynski and having noted that the Quackwatch entries on Burzynski (1, 2, 3) were hopelessly out of date, I wrote a trilogy of posts about him, starting with a review of an execrably bad movie made by a simultaneously credulous yet cynical independent writer,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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## Down the Virtual Rabbit Hole: Kangan water®

The interwebs are more than a series of tubes, it has the power of endless distraction and tangents, a series of clickable rabbit holes that can drag you deeper and deeper into the alternative universes that are parallel with our own. One moment you can be on Science Based Medicine, grounded on the terra firma of reality, and then with a click of the mouse you can lose your way in the electronic warren.

It started as an advertisement on a skeptical website, perhaps SBM, perhaps not. The entrances to rabbit holes are Hogwartian in nature, never being in the same place twice. It is how I remember it.

Google serves up ads based on what their algorithm perceives as the content of the website. The algorithm lacks a certain, shall we say, nuance, and fails to understand that advertisements suggesting training in homeopathy or the promoting the practice of chiropractic may not have a close relationship to the content of Science Based Medicine. Still the ad did intrigue me, as it mentioned that the practitioner was Oregon’s only MD Acupuncturist. So I clicked. (more…)

## Oregon Naturopaths v. Evidence-Based Medicine

Like every state, Oregon is struggling with the unsustainable costs of taxpayer-funded health care programs. In an attempt to tame this beast, Oregon recently established a system of coordinated care organizations, or CCOs, to (as the name suggests) coordinate medical, mental health, and dental care for residents enrolled in Oregon Health Plan, the state’s Medicaid program. The new system requires supervision of this coordinated effort by the participant’s primary care physician (PCP). Not one of the 15 newly-minted CCOs has credentialed a naturopath as a PCP even though naturopaths are licensed as such by the state. Needless to say, the naturopaths are not pleased by this development.

The big stumbling block appears to be the state’s requirement that CCOs practice evidence-based medicine as a cost control measure. Unfortunately for naturopaths, evidence-based medicine is not their strong suit. Apparently scientific plausibility is not much of a concern either.

As one chief medical officer of a CCO explained in a news report,

We have an obligation to the state and to the community that the providers on our panel will deliver the evidence-based care required by the Oregon Health Plan. . . . We need to make sure that all of the providers who are empanelled meet those basic standards of care.

## 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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## Homeopathic Vaccines Revisited

One of the core fictions of “complementary” or “integrative” medicine is that they are primarily offered in addition to science-based medicine and only to fill gaps in what SBM can offer. The original marketing label used to promote treatments that are not adequately supported by evidence , “alternative medicine,” was a bit more accurate in that at least it acknowledged that such treatments were being offered instead of SBM (the fiction being that they are a viable alternative, rather than just health fraud and pseudoscience). The switch to “complementary” and “integrative” did not reflect an evolving philosophy or practice, just an evolving marketing strategy.

Today proponents are likely to reassure the right people – journalists, regulators, and academics – that their offerings are not meant to replace proven therapies, but to complement them (the best of both worlds). (Mark Crislip is fond of pointing out that this is like mixing cow pie with apple pie. It doesn’t make the cow pie palatable, but it does ruin the apple pie.) However, behind closed doors practitioners of unscientific medicine generally prescribe their favorite pseudoscience instead of science-based treatments.

For example, Alice Tuff from Sense about Science investigated 10 homeopathic clinics in the UK.

In the consultations, Alice explained that she was planning to join a 10-week truck tour through Central and Southern Africa and that the anti-malarial drugs her doctor had prescribed made her feel queasy.

The results – all 10 homeopathy clinics offered homeopathic treatments for malaria protection, and none of them suggested this be done in addition to standard treatment. None of them referred Alice back to her medical doctor for further advice (in which case she could have been offered science-based alternative malaria treatments that she may have tolerated better). Only two homeopaths took a personal medical history.

Posted in: Homeopathy

## Ecstasy for PTSD: Not Ready for Prime Time

Hundreds of desperate combat veterans with Post-Traumatic Stress Disorder (PTSD) are reportedly seeking experimental treatment with an illegal drug from a husband-wife team in South Carolina. The Bonhoefers recently published a study showing that adding MDMA (ecstasy, the party drug) to psychotherapy was effective in eliminating or greatly reducing the symptoms of refractory PTSD. It was widely covered in the media, for instance in this article in the NY Times. It was only a small preliminary study, and the treatment is not yet ready for prime time; but media reports have sparked enthusiasm not justified by the evidence. (more…)

Posted in: Clinical Trials, Neuroscience/Mental Health

## 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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## Chiropractic “Research” on Tourette Syndrome: The Trouble with Case Reports…..

I can think of few conditions with clinical features more ideal for establishing a pattern of abuse at the hands of practitioners of so-called alternative medicine than Tourette syndrome. Tourette syndrome (TS), which first manifests itself in early childhood in the overwhelming majority of patients, is a neurological disorder with infamous motor and vocal manifestations and a troubled past. Historically the condition was blamed on everything from emotional disturbances to outright faking to demon possession. But over the past few decades it has increasingly been recognized as a primarily organic disorder caused by negative genetic and environmental influences on areas in the brain which control movement and behavior.

I have a particular interest in Tourette syndrome, not just because I am a pediatrician but because I was diagnosed with the disorder at the age of seven. I have been lucky in that my symptoms, after a few rocky years in middle school and early high school, have been fairly mild. It is obvious to most people that I have a movement disorder, but it has never impacted my ability to function in society and succeed in my chosen profession of pediatric medicine. In fact, I often think of my Tourette’s as a positive aspect of my life, believing that it helped shape who I am as a person. I feel that it has helped instill in me positive personality attributes that are beneficial in the practice of medicine, such as empathy and compassion.

Patients that would have been institutionalized a hundred years ago, or worse as you go farther back in time, are now treated based on scientific advances in neuroscience and pharmacology, typically very successfully — that is if they manage to avoid involvement with quacks and charlatans. A 2009 survey of TS patients, or parents of patients with TS, revealed that nearly two thirds partake in alternative therapies with no proven benefit.

## Bad Pharma: A Manifesto to Fix the Pharmaceutical Industry

“There is no medicine without medicines” write Ben Goldacre in his new book Bad Pharma. To Goldacre, an author, journalist and physician, this cause is personal. The title, a reference to both his first book, Bad Science, as well as the pharmaceutical industry’s nickname Big Pharma, is a bit of a misnomer. While the focus is pharmaceutical companies and their actions, there are a number of enablers in the health care system – medical journals, regulators, and even medical professionals, all of whom have put the industry’s needs ahead of good medicine. According to Goldacre, the damage is pervasive and deep, right to the roots of modern medicine. These problems know no borders, and affect us all. Despite the different health care systems that exist worldwide, we all depend on for-profit pharmaceutical companies to develop and market new medicines. These companies collectively wield enormous clout, due in part to the remarkable success of medicines over the past several decades. The global pharmaceutical market will probably top \$1 trillion (yes, 12 zeros) this year. And Goldacre argues the industry is not only compromised, it is broken. And over 400 pages, he defends the following paragraph:

Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in a drug’s life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion. In their forty years of practice after leaving medical school, doctors hear about what works ad hoc, from sales reps, colleagues and journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are, too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it’s not in anyone’s financial interest to conduct any trials at all. These are ongoing problems, and although people have claimed to fix many of them, for the most party they have failed; so all of these programs persist, but worse than ever, because now people can pretend that everything is fine after all.

We all have our own biases, and I should disclose mine. I’m a pharmacist who has seen HIV go from a death sentence to a chronic disease, thanks to newly developed drugs. I’ve watched cancers like leukemias be effectively cured, thanks to medication. And I’m amazed that surgeries like double-lung transplants, impossible in the past, are now a reality, thanks in part to drug treatments. Yet I’ve also spent more than a decade reviewing the efficacy and safety of prescriptions drugs. Regrettably few are truly innovative. Many are approved with lingering questions about long-term safety and effectiveness. The value some offer can be questionable. I’ve also seen tremendous harms caused by drugs – from individual patients who have suffered horrible adverse drug reactions to population-level disasters like the Vioxx (COX-2) debacle. And I haven’t ignored the countless fines levied on pharmaceutical companies for bad, and sometimes even criminal, behavior. With its repeated capacity for self-sabotage, the pharmaceutical industry is its own worst enemy. My colleagues who work in the pharmaceutical industry agree. They’re smart, honest people that genuinely want to help get good treatments to patients. They’re embarrassed by what they see. So while I have no doubts about the astonishing track record of innovative new drugs that have transformed medicine, I also have no illusions that drug companies always behave in ways that support science-based medicine. And I think there is the potential for the industry to do much better. So how do we get this? (more…)

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