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Of SBM and EBM Redux. Part IV, Continued: More Cochrane and a little Bayes

OK, I admit that I pulled a fast one. I never finished the last post as promised, so here it is.

Cochrane Continued

In the last post I alluded to the 2006 Cochrane Laetrile review, the conclusion of which was:

This systematic review has clearly identified the need for randomised or controlled clinical trials assessing the effectiveness of Laetrile or amygdalin for cancer treatment.

I’d previously asserted that this conclusion “stand[s] the rationale for RCTs on its head,” because a rigorous, disconfirming case series had long ago put the matter to rest. Later I reported that Edzard Ernst, one of the Cochrane authors, had changed his mind, writing, “Would I argue for more Laetrile studies? NO.” That in itself is a reason for optimism, but Dr. Ernst is such an exception among “CAM” researchers that it almost seemed not to count.

Until recently, however, I’d only seen the abstract of the Cochrane Laetrile review. Now I’ve read the entire review, and there’s a very pleasant surprise in it (Professor Simon, take notice). In a section labeled “Feedback” is this letter from another Cochrane reviewer, which was apparently added in August of 2006, well before I voiced my own objections:

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Posted in: Clinical Trials, Homeopathy, Medical Academia, Science and Medicine

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Topical NSAIDs

I have a mental basket of drugs that I suspect may be placebos. In that basket were the topical versions of non-steroidal anti-inflammatory drugs (NSAIDs). When the first products were commercially marketed over a decade ago, I found the clinical evidence unconvincing, and I suspected that the modestly positive effects were probably due to simply rubbing the affected area, or possibly due to the effects of the cream or vehicle itself. Frankly, I didn’t think these products worked. So when I recently noticed a topical NSAID appear for sale as an over-the-counter treatment for muscle aches and pains (seemingly only in Canada, for now), I was confident it would make a good case study in bad science.

It’s not that I’m partial to the oral NSAIDs. Yes, they’re among the most versatile, and probably most well-loved drugs in our modern medicine cabinet. They offer good pain control, reduce inflammation and can eliminate fever. We start using it in our sick and feverish infants, through childhood and adulthood for the aches and pains of modern life, and into our later years for the treatment of degenerative disease like osteoarthritis, which affects pretty much everyone as we age. An astonishing 17 million Americans use NSAIDs on a daily basis, and this number is expected to grow as the population ages. In the running groups I frequent, ibuprofen has the affectionate nickname “Vitamin I”, where it’s perceived as an essential ingredient for dealing with the consequences of training.

But NSAIDs have a long list of side effects. Not only do they cause stomach ulcers and bleeding by damaging the gastrointestinal mucosa, there are heart risks, too. It was the arrival (and departure) of the drugs Bextra and Vioxx that led to documentation of the potential for cardiovascular toxicity. And now there’s data to suggest that these effects are not limited to the “COX-2” drugs – almost all NSAIDs, including the old standbys we have used for years, seem capable of raising the risks of heart attacks and strokes.

So despite my initial skepticism, I took another look at the topical NSAIDs. The data were not what I expected.

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Posted in: Pharmaceuticals, Science and Medicine

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Skepticism versus nihilism about cancer and science-based medicine

Last Friday, Mark Crislip posted an excellent deconstruction of a very disappointing article that appeared in the most recent issue of Skeptical Inquirer, the flagship publication of the Committee for Skeptical Inquiry (CSI). I say “disappointing,” because I was disappointed to see SI (Skeptical Inquirer, not Sports Illustrated) publish such a biased, poorly thought out article, apparently for the sake of controversy. I’m a subscriber myself, and in general enjoy reading the magazine, although of late I must admit that I don’t always read each issue cover to cover the way I used to do. Between work, grant writing, blogging, and other activities, my outside reading, even of publications I like, has declined. Perhaps SI will soon find itself off my reading list. Be that as it may, I couldn’t miss the article that so irritated Mark, because it irritated me as well. There it was, emblazoned prominently on the cover of the March/April 2011 issue: Seven Deadly Medical Hypotheses. I flipped through the issue to the article to find out that this little gem was written by someone named Reynold Spector, MD. A tinge of familiarity going through my brain, I tried to think where I had heard that name before.

And then I remembered.

Dr. Spector, it turns out, first got on my nerves about a year ago, when he wrote an article for the January/February 2010 issue of SI entitled The War on Cancer: A Progress Report for Skeptics. I remember at that time being irritated by the article and wanting to pen a discussion of the points raised but don’t recall why I never actually did. It was probably a combination of the fact that SI doesn’t publish its articles online until some months have passed after the paper version has been released and perhaps my laziness about having to manually transcribe with my own fingers any passages of text that I might want to cite. By the time the article was available online, I forgot about it and never came back to it–until now. I should therefore, right here, right now, publicly thank Mark (and, of course, Dr. Spector) for providing me the opportunity to revisit that article in the context of piling on, so to speak, Dr. Spector’s most recent article. After all, Deadly Hypothesis Seven (as Dr. Spector so cheesily put it) is:

From a cancer patient population and public health perspective, cancer chemotherapy (chemo) has been a major medical advance.

Dr. Spector then takes this opportunity to cite copiously from his 2010 article, sprinkling “(Spector, 2010)” throughout the text like powdered sugar on a cupcake. There’s the opening I needed to justify revisiting an article that’s more than a year old! And what fantastic timing, too, hot on the heals of my post from a couple of weeks ago entitled Why haven’t we cured cancer yet?
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Posted in: Cancer, Science and Medicine, Science and the Media

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An ICD Code for the Running Piglets!

… animals are divided into (a) those that belong to the emperor; (b) embalmed ones; (c) those that are trained; (d) suckling pigs; (e) mermaids; (f) fabulous ones; (g) stray dogs; (h) those that are included in this classification; (i) those that tremble as if they were mad; (j) innumerable ones; (k) those drawn with a very fine camel’s-hair brush; (l) etcetera; (m) those that have just broken the flower vase; (n) those that at a distance resemble flies.

— Jorge Luis Borges (1899–1986)1

Not too long ago, I came across a disease taxonomy proposed by a certain East-West Medical Research Institute (EWMRI), that includes the kind of fantastic afflictions — such as “running piglet” disorder — fit for the best Borgesian list.

This obscure institute, located at Kyung Hee University in Seoul, Korea, is one of the 800 WHO Collaborating Centres designated to carry out various activities in support of the Organization’s programs. With the collaboration of China, Japan, Vietnam, Australia, and the US, this center is working to incorporate medieval Asian disease nomenclature to the 11th version of the International Classification of Disease (ICD-11).
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Posted in: Acupuncture, Basic Science, Science and Medicine

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Deadly Indeed

There are sources of information I inclined to accept with minimal questioning.  I do not have time to examine everything in excruciating detail, and like most people, use intellectual short cuts to get through the day.  If it comes from Clinical Infectious Diseases or the NEJM, I am inclined to accept the conclusions without a great deal of analysis, especially for non-infectious disease articles.  Infectious disease publications I have to read more closely; its part of passing as an expert.

Outside of medicine, I am predisposed to accepting at face value many of the articles in Skeptic and Skeptical Inquirer. They are trusted sources.  Some topics, like haunted house or Big Foot investigations, I barely skim. After all these years, I doubt there will be any new insights into the subject.  Other topics, depending on my interest, I may read more carefully.

I  often read longer articles  many times.  First a quick skim to see if it offers anything of interest.  If it does, then I may read it carefully.

This months Skeptical Inquirer had an article called  Seven Deadly Medical Hypotheses by Reynold Spector.  Just seeing the title and knowing the magazine, I was primed to accept the content at face value.  I enjoy a well reasoned, thoughtful rant. I relish a clever diatribe, even if I do not agree with the topic.   So I gave it a quick skim.  I was discomfited.  My first gut check was ick.  But I was uncertain why.  So I read it slowly and carefully, and still ick.  But why? (more…)

Posted in: Epidemiology, Science and Medicine, Science and the Media

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Supreme Court Saves Nation’s Immunization Program

The Supreme Court of the United States made a ruling the other day that has profound implications for the health of millions of children. Since October 12, 2010, The Court has been quietly deliberating the case of Bruesewitz v. Wyeth, inc. The case centers on Russell and Robalee Bruesewitz’s allegation that their 18 year old daughter, Hannah, was irreversibly injured by a DTP vaccine she received when she was 6 months old. What is important about this case is not the allegation itself (I will discuss its merits, or lack thereof, in a moment), but the ramifications the ruling has for the future of childhood immunization in this country. The Supreme Court’s ruling against the Bruesewitz’s and in favor of the U.S. vaccination program was the right one, and safeguards our children from the irrationality of the anti-vaccine movement. Some important background is necessary here to understand why this is so.

Prior to the development of effective vaccines, diphtheria, tetanus, and pertussis were common diseases, terrifyingly familiar to all parents. Death records from Massachusetts during the latter half of the 1800’s indicate that diphtheria caused 3-10% of all deaths. In the first part of the 20th century, these dreaded organisms still caused illness in hundreds of thousands of people each year in the United States. These are devastating diseases which, if not resulting in death, often produced severe and permanent damage to those afflicted. In the 1920’s, vaccines against each of these scourges were finally developed, and in the mid 1940’s the combined DTP vaccine was introduced. The vaccines were so effective that cases of these deadly infections were practically eliminated. Today, few parents know the terror once routinely wrought by these pathogens.

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Posted in: Legal, Science and Medicine, Vaccines

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Dr. Oz, you’re not helping diabetics

Dr. Mehmet Oz is one of America’s most influential doctors.  Just ask him.  He has a TV show and everything.  And in the past, much of his advice had been practical and mundane, the same advice you might hear from your own (perhaps less charismatic) physician.  But lately, he’s been giving out frankly bizarre medical opinions.  Not all of Oz’s recommendations are over-the-top strange, but even some of his less-bizarre stuff is hyperbolic to the point of being—in my opinion—deceptive.  Let’s explore one example close to my heart, diabetes.  As an internist, one of my most important tasks is the prevention and treatment of diabetes.  I know something about it.  As a heart surgeon, Dr. Oz deals with one of the most serious complications of diabetes, coronary heard disease, so he must know a bit about it as well.

So I was a bit surprised to learn from his website that I’ve  been going after diabetes the wrong way.  Unknown to me is the “prevention powerhouse” of coffee and vinegar.  He recommends heavy consumption of these miracle foods to prevent diabetes and to help the liver and cholesterol, whatever that means.  Reading this, two questions come to mind (a few more, really, but two that we will focus on): is this plausible, and is this true?
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Posted in: Science and Medicine, Science and the Media

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Critique of “Risk of Brain Tumors from Wireless Phone Use”

Following my recent critique here of the book Disconnect by Devra Davis, about the purported dangers of cell phones to health, David Gorski asked me to comment on a recently published “review article” on the same subject. The article is entitled “Risk of Brain Tumors from Wireless Phone Use” by Dubey et al [1] published in the J. Comput Assist Tomography. At the outset, the same question occurred to both of us: what is a “review article” about cell phones and brain tumors doing in a highly technical journal dedicated to CT scans and CT imaging? While we are both still guessing about the answer to this question, we agreed that the article itself is a hodge-podge of irrational analysis.

As you might surmise, Dubey and his Indian co-authors come to the conclusion that “that the current standard of exposure to microwave during mobile phone use is not safe for long-term exposure and needs to be revised.” But within the conclusion there is also the following: “There is no credible evidence from the Environmental Health and Safety Office (I presume in India) about the cause of cancer or brain tumors with the use of cell phones. It is illogical to believe that evidence of unusual brain tumors is only because of hundred’s of millions of people using cell phones worldwide.” What?! These are opposite and contradictory statements. The main body of the article includes a lot more instances of such inconsistency.

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Posted in: Clinical Trials, Epidemiology, Science and Medicine

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Why haven’t we cured cancer yet?

Why haven’t we cured cancer yet?

If we can put a man on the moon, why can’t we cure cancer?

If we can harness the atom, why can’t we cure cancer?

How many times have you heard these questions, or variants thereof? How many times have you asked this question yourself? Sometimes, I even ask this question myself. Saturday was the two year anniversary of the death of my mother-in-law from a particularly nasty form of breast cancer, and, even though I am a breast cancer surgeon, I still wonder why there was nothing in the armamentarium of science-based medicine that could save her from a several month decline followed by an unpleasant death. That’s why, to me at least, the timing of the publication of a study examining the genome of prostate cancer that was published in Nature and summarized in this Science Daily news story was particularly apt. Performed as part of the National Cancer Institute’s Cancer Genome Project, the study undertook complete genome sequencing of seven advanced and aggressive prostate cancers. The results, as ERV put it, revealed what can be describe as a “train wreck.”

Personally, I’d describe it as looking as though someone threw a miniature grenade into the nucleus of a prostate epithelial cell. You’ll see what I mean shortly.

Of course, although that image does give you an idea of the chromosomal chaos in the heart of prostate cancer cells, it is inaccurate in that it implies a sudden explosion, after which the damage is done, and if there’s one thing we know about cancer it’s that in most cases it takes many years for a normal cell to progress to a cancer cell fully capable of metastasizing and killing its host. I’ve written in detail about the complexity of cancer before, of course, and have even pointed out before that when President Nixon launched the “war on cancer” 40 years ago scientists had no idea how difficult it would be. Indeed, before I discuss the current study, it’s probably useful to reiterate a bit why, in order to put the study in context.
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Posted in: Cancer, Science and Medicine

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Of SBM and EBM Redux. Part IV: More Cochrane and a little Bayes

NB: This is a partial posting; I was up all night ‘on-call’ and too tired to continue. I’ll post the rest of the essay later…

Review

This is the fourth and final part of a series-within-a-series* inspired by statistician Steve Simon. Professor Simon had challenged the view, held by several bloggers here at SBM, that Evidence-Based Medicine (EBM) has been mostly inadequate to the task of reaching definitive conclusions about highly implausible medical claims. In Part I, I reiterated a fundamental problem with EBM, reflected in its Levels of Evidence scheme, that although it correctly recognizes basic science and other pre-clinical evidence as insufficient bases for introducing novel treatments into practice, it fails to acknowledge that they are necessary bases. I explained the difference between “plausibility” and “knowing the mechanism.”

I showed, with several examples, that in the EBM lexicon the word “evidence” refers almost exclusively to the results of clinical trials: thus, when faced with equivocal or no clinical trials of some highly implausible claim, EBM practitioners typically declare that there is “not enough evidence” to either accept or reject the claim, and call for more trials—although in many cases there is abundant evidence, other than clinical trials, that conclusively refutes the claim. I rejected Prof. Simon’s assertion that we at SBM want to “give (EBM) a new label,” making the point that we only want it to live up to its current label by considering all the evidence. I doubted Prof. Simon’s contention that “people within EBM (are) working both formally and informally to replace the rigid hierarchy with something that places each research study in context.”

In Part II I responded to the widely held assertion, also held by Prof. Simon, that there is “societal value in testing (highly implausible) therapies that are in wide use.” I made it clear that I don’t oppose simple tests of basic claims, such as the Emily Rosa experiment, but I noted that EBM reviewers, including those employed by the Cochrane Collaboration, typically ignore such tests. I wrote that I oppose large efficacy trials and public funding of such trials. I argued that the popularity gambit has resulted in human subjects being exposed to dangerous and unethical trials, and I quoted language from ethics treatises specifically contradicting the assertion that popularity justifies such trials. Finally, I showed that the alleged popularity of most “CAM” methods—as irrelevant as it may be to the question of human studies ethics—has been greatly exaggerated.

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