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Archive for Clinical Trials

Antibiotics for Low Back Pain

Low back pain is a particularly frustrating condition that is common, poorly understood, and difficult to treat. Could a long course of antibiotics be the answer for some patients? A recent study from Denmark suggests that it might be:  “Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy” by Albert, Sorensen, Christensen and Manniche.  Is this a crazy idea like long-term antibiotics for “chronic Lyme disease” or will it pan out like antibiotic eradication of H. pylori in patients with ulcers? Time will tell. This was a rigorous, well-done study, but we can never rely on the results of a single study until it is replicated or confirmed elsewhere.
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Posted in: Clinical Trials, Pharmaceuticals

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The deceptive rebranding of aspects of science-based medicine as “alternative” by naturopaths continues apace

That naturopathy is a veritable cornucopia of quackery mixed with the odd sensible, science-based suggestion here and there is not in doubt, at least not to supporters of science-based medicine (SBM). However, what naturopaths are very good at doing is representing their pseudoscience as somehow being scientific and thus on par with conventional SBM. So how do they accomplish this? Certainly, it’s not through the validation of any of the cornucopia of pseudoscience and quackery that naturopaths apply to their patients as though picking “one from column A and one from column B” from a proverbial Chinese menu of woo. Naturopaths’ favored modalities include homeopathy (which remains to this day an integral part of naturopathy that all naturopaths are taught), acupuncture and traditional Chinese medicine (TCM), “detoxification” practices (a key precept of a lot of naturopathy) such as juicing, enemas, and chelation therapy, and the various other quack modalities that make up the practice of naturopathy. Treatments like these (especially homeopathy, whose precepts would require a massive rewriting of the laws of physics and chemistry for it to work) have not been and almost certainly cannot ever be scientifically validated with an evidence base of the quality and quantity supporting SBM.

So, instead naturopaths play a very clever game. In all fairness, naturopaths are not the only practitioners of so-called “complementary and alternative medicine” (CAM) or “integrative medicine” who play this game, but from my observations they appear to be the most talented at it. Their skill at obfuscating the line between SBM and naturopathy is evidenced by the success they have had in state legislatures in expanding their scope of practice, most recently in Colorado, where, if there is not a groundswell of support urging the Governor to veto SB-215 (or, as Jann Bellamy aptly called it, the quack full employment act), consumer protections against quackery in Colorado will be laid waste. At the same time, there is a naturopath licensing act (HB-1111) sitting on the Governor’s desk as well that would license naturopaths and give them the path to mandatory reimbursement from insurance companies. Instructions to write to the Governor opposing both bills can be found here and here; they would be disastrous for efforts to keep full vaccination in Colorado. A direct link to write the Governor can be found here.
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Posted in: Clinical Trials, Homeopathy, Naturopathy, Nutrition, Science and the Media

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Undermining the regulation of stem cell therapies in Italy: A warning for the future?

Stem cells are magical.

At least, if you listen to what docs and “practitioners” who run stem cell clinics in various parts of the world, usually where regulation is lax and money from First World clientele is much sought after, that’s what you could easily come to believe. Unfortunately, it’s not just Third World countries in which “stem cell clinics” have proliferated. For instance, they are not nearly uncommon enough in Europe. The example that is most troubling right now is Italy, and the reason is that there is currently a law being considered that would greatly weaken the regulation of stem cell therapies, so much so that on Friday I saw something that’s fairly rare: a major scientific journal published a pointed editorial about this new law. Specifically EMBO Journal published a commentary by an international group of scientists warning about the path that the government of Italy is considering entitled Regulation of stem cell therapies under attack in Europe: for whom the bell tolls.

Stem cell quackery is a very popular form of quackery these days because, well, stem cells are so magical-seeming. You can now find stem cell treatments offered for autism (one of which, offered at a clinic in Costa Rica, I’ve discussed before and involves injecting “stem cells” into the cerebrospinal fluid of autistic children for a cool $15,000). Kent Heckenlively, the man who took his daughter to the aforementioned Costa Rica clinic for this treatment, is not alone in subjecting his autistic child to such unproven uses of stem cells. Just a couple of months ago, a broadcast journalist in the Philippines named Karen Davila took her autistic son to the Villa Medica Clinic in Germany, which offers variants of stem cell therapy. One is known as “fresh cell therapy” and involves harvesting cells from lamb fetuses and injecting them into the patient. The other is called fat stem cell repair therapy, which is claimed to involve harvesting fat from the patient’s abdomen or thigh and then isolating “stem cells” from them to be injected back into the patient’s body.
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Posted in: Basic Science, Clinical Trials, Legal, Medical Ethics, Politics and Regulation

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Eric Merola’s conspiracy-mongering and more of Dr. Stanislaw Burzynski’s cancer “success” stories

About a month ago, Eric Merola screened his second movie about “brave maverick doctor” Stanislaw Burzynski, Burzynski: Cancer Is A Serious Business, Part 2 (henceforth referred to as “Burzynski II”), a screening that Brian Thompson and an unnamed colleague from the James Randi Educational Foundation (JREF) attended, took notes, and even managed to ask a question. At the time, I took advantage of Brian’s awesome commentary about his experience on the JREF Swift Blog, his copious notes, and my read on Eric Merola’s trailers for the movie, what he said in the first movie, and his own promotional material to write about how Merola dishonestly demonizes what he refers to as “The Skeptics” (i.e., us) and five major misconceptions about Burzynski, cancer, and skeptics promoted in Burzynski II, all with a heapin’ helpin’ of conspiracy mongering. In this post, I will delve into a little more detail about the fundamental intellectual dishonesty behind Eric Merola’s conspiracy mongering and discuss two of the cases being used to “prove” that Burzynski can cure cancer, mainly because they are appearing along with Merola on the publicity trail. Merola himself, thankfully (I guess) has allowed me to do this by posting an edited version of that original Q&A to YouTube:

In particular, note how everything I said in my previous post about what went on at the Q&A is verified, and, in fact, you now have the details. I will try to mention the specific time points to refer to as I go along. Also note that there is a segment at about the 47:45 mark in which JREF’s Brian Thompson (blurred out but still recognizable) speaks with the husband of one of Burzynski’s patients that is worth watching and that I will briefly discuss further into this post.
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Posted in: Cancer, Clinical Trials, Science and the Media

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Cranberry, the alt-med zombie

If there’s a characteristic that’s common among proponents of alternative medicine, it’s tenacity. The willingness to stick with an idea, no matter the evidence, must give one a certain clarity. The naturalistic fallacy is often the foundation. Natural is good, synthetic is bad, no matter the evidence. In some cases, in spite of the evidence. How one deals with contradictory evidence is an effective tool to differentiate between medicine and alternative medicine – given sufficient convincing evidence, medicine changes its practices. The same can’t be said for alternative medicine, where few treatments are ever discarded. Otherwise practices like homeopathy, acupuncture, reiki, and chiropractic would have disappeared long ago. It’s also why disproven products continue to have occasional resurgences in interest. Cranberry is one. It has been touted as a treatment and a preventative for urinary tract infections for years.  And it doesn’t seem to work – not well, and not reliably, if you look at all the trials. And that’s being generous, considering the poor quality of the evidence with its inherent biases. I know a dead parrot when I see one. Yet its advocates, mainly manufacturers (is there a Big Cran?) keep insisting it’s alive, supported by the occasional positive report that appears. With a new systematic review and meta-analysis that declares it’s effective, it’s time to update our review. (more…)

Posted in: Clinical Trials, Herbs & Supplements

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More shameless self-promotion that is, I hope, at least entertaining

Three weeks ago, I gave a talk to the National Capital Area Skeptics at the National Science Foundation in Arlington, VA. The topic was one near and dear to my heart, namely quackademic medicine.

I was informed the other day that the video had finally been posted. Unfortunately, there were some problems with the sound in a couple of places, which our intrepid NCAS video editor did his best to fix. Overall, however, the sound quality seems decent. The video even includes the Q&A session. In case you’re interested, the guy who asks the question about mercury in vaccines and autism is Paul Offit’s very own stalker Jake Crosby. I feel honored to think that Jake now apparently lumps me in the same category as Paul Offit, whom I admire greatly. Enjoy.

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

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Behold the spin! What a new survey of placebo prescribing really tells us

One of the recurring topics here at SBM is the idea of the placebo: What it is, what it isn’t, and how it complicates our evaluation of the scientific evidence. One my earliest lessons after I started following this blog (I was a reader long before I was a writer) was that I didn’t understand placebos well enough to even describe them correctly. Importantly, there is no single “placebo effect”. They are “placebo effects”, a range of variables that can include natural variation in the condition being studied, psychological factors and subjective effects reported by patients, as well as observer bias by researchers studying a condition. All of these, when evaluated in clinical trials, produce non-specific background noise that needs to be removed from the analysis. Consequently, we compare between the active treatment and the placebo to determine if there are an incremental benefits, to which we apply statistical tests to determine the likelihood that the differences between the intervention and the placebo groups are real. Removed from the observational nature of the clinical trial, we can’t expect the observed “placebo effects” to persist, as they’re partially a consequence of the trial itself. A more detailed review of placebos is a post in and of itself, so I’ll refer you to resources that describe why placebo effects are plural, that placebo effects are subjective rather than objective and there is no persuasive evidence to suggest that placebo effects offer any health benefits. What’s most important is the understanding that placebo effects are a measurement artifact, not a therapeutic effect.

Placebo effects are regular topics within in SBM posts because an understanding of placebo effects is essential to evaluating the evidence supporting (so-called) complementary and alternative medicine, or CAM. As better quality research increasingly confirms that the effects from CAM are largely, if not completely, attributable to placebo effects, we’ve seen the promoters of CAM shifting tactics. No longer able to honestly claim that CAM has therapeutic effects, “treatments” such as acupuncture or homeopathy are increasingly promoted as strategies that”harness the power of placebo” without all the pesky costs or side effects of real medical interventions. But this is simply special pleading from purveyors and promoters. Unable to wish away the well-conducted trials that show them to be indistinguishable from placebos, they instead are spinning placebo effects as meaningful and worthy of pursuit – ideally with your favourite CAM therapy. Again, I’ll refer you to posts by David Gorski and Steven Novella who offer a more detailed description of how negative results can be spun to look positive. Because CAM’s effects are indistinguishable from placebo, we should not invest time and resources into pursuing them – we should instead focus on finding treatments that are demonstrably superior to placebo.

But what if physicians are already using placebos widely in practice? Setting aside the ethical issues for now, widespread placebo usage might suggest that physicians believe that placebos are effective treatments. And that’s the impression you may have had if you skimmed the medical headlines last week:

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Posted in: Clinical Trials, Epidemiology, Science and Medicine

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Burzynski: Cancer Is A Serious Business, Part 2: Like the first Burzynski movie, only more so?

Film producer Eric Merola seems to think that there is a conspiracy of skeptics (whom he calls The Skeptics) who are fanatically hell-bent on harassing his hero, Brave Maverick Doctor Stanislaw Burzynski. According to his latest film Burzynski: Cancer Is A Serious Business, Part 2 (henceforth referred to as Burzynski II, to distinguish it from part 1, to which I will refer as Burzynski I), there is a shadowy cabal of Skeptics out there just waiting to swoop down on any Burzynski supporter who has the temerity to Tweet support for him, any cancer patient being treated by Burzynski who Tweets or blogs about it, and any cancer patient even thinking about going to the Burzynski Clinic. I know this because he’s made it very clear in the promotional materials of his movie that that’s what he thinks and that skeptics were going to be the main target of his “film making” in his latest hagiography devoted to Stanislaw Burzynski. Very clear indeed. And, given how ham-fisted he was in his conspiracy mongering in Burzynski I, I’d be lying if I didn’t admit that I was at least a little concerned, because Merola made an explicit promise to “name names.” So were some other skeptics. After all, Merola isn’t exactly known for intellectual honesty (or even talent) in film making. We expected a heavy duty sliming, and curiosity (not to mention concern over our reputations) made us very—shall we say?—curious about what Merola was going to say about us.

So it was with great interest that I learned that Burzynski II was going to be screened at a film festival in San Luis Obispo last weekend. Its DVD release having been delayed from March 5 to July 1, I had thought that my curiosity about the contents of the movie would probably have to wait, and it will, at least as far as seeing the movie. A review of the movie suggested dark insinuations about Burzynski critics abounded, but that was not enough. Fortunately, a small posse of skeptics, lead by the intrepid Brian Thompson, made posthaste for San Luis Obispo. When the reports and copious handwritten notes in perfect encoded reptilian script came back, however, I was faced with a problem. How does one review or discuss a movie second-hand? How does one report on a movie that one hasn’t seen, about which one has to trust the powers of observation (and not to mention the note taking capabilities) of someone else, no matter how well briefed beforehand about what to look for? I decided that there was only one thing to do, and that’s just to go ahead and do it. I realize that there are likely huge swaths of information missing, but I definitely got a flavor of the movie from Brian’s detailed account plus discussions, and a definite idea of how it is going to be promoted from what was reported to have been said during the Q&A. Then I’ll discuss each of these points, thus inflating the rather thin observations I have from our Skeptics into a real post. Unfortunately, more detail from me will have to wait until the official release of the movie, or until such a time as Merola tries to bring the movie to somewhere in my neck of the woods. (Wouldn’t that be amusing?)

So here are the five things I learned (secondhand) from the Burzynski II screening, thanks to The Skeptics.
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Posted in: Cancer, Clinical Trials, Science and the Media

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Acupuncture and Allergic Rhinitis: Another Opportunity for Intellectual Sterility

You need to keep an open mind.

A common suggestion offered to naysayers of nonsense.

The usual retort concerns not letting one’s brain fall out.

Evaluating SCAM’s is less about having an open mind and more about having standards, a conceptual framework that is used to interpret and analyze new information. One of the benefits of writing and reading topics covered by science-based medicine (SBM) is it has clarified and sharpened the ideas by which I understand the world. Those concepts were nicely summed up by Steve Novella at Neurologica, and I reproduce them here, slightly modified. They should be on stone tablets, not quite commandants, but strong suggestions. The 8 strong suggestions somehow doesn’t cut it however. (more…)

Posted in: Acupuncture, Clinical Trials, Science and Medicine

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Dr. Stanislaw Burzynski’s cancer “success” stories update: Why is the release of the Burzynski sequel being delayed?

It’s no secret that I happen to be on several mailing lists of groups or doctors whose dedication to science is—shall we say?—questionable. Of course, the reason I join such mailing lists is to keep my finger on the pulse of pseudoscience, so to speak. Between such lists and strategically selected Google Alerts (the latter of which appear to be failing me these days), I’m usually aware of potential blogging material fast on selected topics that have become my bailiwick on this blog. So it was that I became aware on Saturday of a development regarding the movie about Stanislaw Burzynski that was going to be released direct to DVD this week.

I wrote about this “documentary” a couple of weeks ago, because it had become pretty clear that a significant part of the movie will be dedicated to a PR counterattack (more like a smear job) on skeptics who have been critical of Burzynski, criticism that apparently goaded him to use a rather unhinged individual by the name of Marc Stephens to threaten skeptical bloggers who had written posts critical of Burzynski’s science (more appropriately, his lack of science), and his proclivity for charging patients huge amounts of money to be in clinical trials, a practice that is in general considered at best questionable. The brouhaha in the blogosphere led me to pay attention to Burzynski in a way that I hadn’t before. Sure, I had heard of him, but I hadn’t really delved deeply into his claims. That situation was rectified in late 2011, as I reviewed the first propaganda movie made about Burzynski by Eric Merola, Burzynski The Movie: Cancer Is Serious Business. As I delved deeper, I learned that Burzynski’s evidence for the anticancer efficacy of his “antineoplaston therapy” doesn’t hold up; that his “personalized gene-targeted cancer therapy” is anything but personalized or gene-targeted; and that he’s using an orphan drug now in what appears to me to be a strategy to bypass restrictions on his use of antineoplastons that he agreed to in a consent agreement with the Texas Attorney General back in 1998 that allow him only to use these drugs as part of a valid clinical trial.

So I awaited the approach of this week with a mixture of anticipation and trepidation; anticipation because I wanted to see what sort of bizarre new conspiracy theories (or new twists on old conspiracy theories) that Merola could weave, and trepidation because I don’t know how badly Merola will trash me (and people I know) in his movie and such attacks could cause me difficulties. Suffice to say, it looked very much as though Merola was going to resurrect Jake Crosby’s scurrilous attacks against me from three years ago. So it was with great surprise that I read this e-mail on Saturday morning, sent to the Burzynski Movie mailing list:

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Posted in: Cancer, Clinical Trials, Science and the Media

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