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Archive for Clinical Trials

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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Warts

As this is published I am finishing the last day of a 12 day stretch covering my partner while he is off trying to get MDRTB and typhoid fever.  He is in India. I may have to autoclave him when he returns before I let him in the hospital.  Double the work means double the fun, but free time goes down by the power.  Same thing happens with the kids.  If you have two kids, the work squares, three kids, the work cubes.  A linear change in one domain leads to exponential change in other domains.  I am sure that phenomena has a name that one of our readers will know.

I lack the mad typing skills of other contributors and it usually takes me at least a week to carefully construct the spelling errors and grammatical faux paux for which I am justly famous.  And then I have to come up with content to surround the faulty English.  This week I have little time and so a ‘fun’ post.

When I make rounds it is not unusual for people to ask questions about their health and their family.  I learned long ago to ask why they want an answer to a particular question so I do not inadvertently offend a colleague.  When I offend I like to be advertent.  Years ago I was asked what I thought of hyperbaric oxygen, and I replied that it is great for the bends but otherwise mostly serves to enrich the hyperbaric doctors.  Why do you ask?  I am the new director of the hyperbaric program, was the reply.  Open mouth and insert foot.

So recently a nurse asked me if duct tape would remove warts.  Wary, I asked why, and she showed me a huge wart on her hand.  I have used duct tape for many purposes; few home repairs cannot be (temporarily) accomplished with duct tape. But treating warts?  Do you use the tape as a way to yank the wart out by its roots?  Got me.  I gave my best Gallic shrug and went looking for information. (more…)

Posted in: Clinical Trials, Naturopathy

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Dr. Stanislaw Burzynski’s cancer “success” stories

The year 2012 was rung out and the year 2013 will be rung in by news that Eric Merola, propagandist for “brave maverick doctor” Stanislaw Burzynski who claims to have developed a cancer treatment far superior to current conventional science- and evidence-based cancer treatments, is releasing releasing a sequel to his wildly successful documentary (in the “alternative cancer” underground, that is) Burzynski The Movie: Cancer Is Serious Business. In fact, the sequel is coming out on DVD on March 5, and you can even preorder it now. I somehow doubt that Eric Merola will send me a screener DVD to review, but I did review the first movie because it easily falls into a genre that I like to refer to as medical propaganda movies, which are almost always made in support of dubious medical treatments. My mostly lame jokes about proposed titles aside (e.g., Burzynski II: Electric Boogaloo, Burzynski II: This Time It’s Peer-Reviewed, or even Burzynski II: Quack Harder), it’s very clear that in the wake of the Texas Medical Board’s decision to drop its case against Burzynski on a technicality, Burzynski and his very own Leni Riefenstahl named Eric Merola are planning on a huge publicity blitz, in which Burzynski will be portrayed as, yes, a “brave maverick doctor” whom “They” (as in the FDA, drug companies, and the Texas Medical Board, a.k.a “The Man”) tried to keep down but failed because he has The Natural Cure For Cancer “They” Don’t Want You Sheeple To Know About.

I come back to this again because Merola’s strategy for Burzynski II, as I pointed out, is going to involve “conversion stories” of oncologists who didn’t believe in Burzynski’s magic antineoplastons but do now, attacks on skeptics who have been critical of his work (like me), and, of course, testimonials for success stories. I don’t know how I missed this before, but what exactly that will mean in practice is actually spelled out pretty well in an installment of a video blog by a Burzynski patient named Hannah Bradley. Bradley became famous for her battle against a malignant brain tumor, her decision to go to the Burzynski Clinic, and the prodigious fundraising efforts of her partner Pete Cohen through their Team Hannah website and vlog. In this vlog, recorded on September 7, 2012, Pete and Hannah are happy because in their previous vlog of July 27, 2012, they reported that, after having received Dr. Burzynski’s antineoplaston treatment Hannah has had a “complete response,” and indeed the MRI scans shown in their movie, Hannah’s Anecdote, do appear to show just that (more on that later).

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

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Mouse Model of Sepsis Challenged

A recent study published in the Proceedings of the National Academy of Sciences calls into question the standard mouse model of sepsis, trauma, and infection. The research is an excellent example of how proper science investigates its own methods.

Mouse and other animal models are essential to biomedical research. The goal is to find a specific animal model of a human disease and then conduct preliminary research on the animal model in order to determine which research is promising enough to study in humans. There are also non-animal assays and “test tube” type research that is used to screen potential treatments, but scientists still prefer a good animal model.

It is also understood that animal models are imperfect – mice are not humans, after all. Animal research is therefore not a substitute for human research. I and other SBM authors have regularly criticized proponents of dubious treatments who make clinical claims based upon preliminary animal research. Until something is studied in humans, we cannot make any reliable claims about its safety and efficacy in people.

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Posted in: Clinical Trials, Science and Medicine

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Honey Boo Boo

My son has been coughing for several weeks, and the cough will probably persist for another 2 or 3 weeks. Coughs last a long time. Patients think a cough will go away in less than a week but in reality they are likely to last several weeks.

Coughs are a pain for the patient and an annoyance for the people around them. You never really know if the cougher in the row behind you has asthma,  a post infectious cough or  is actively spewing TB or influenza all over the airplane.  I learned from Clinton the importance of not inhaling, especially on airplanes.

I tend to leave most symptoms alone if the they are not life threatening or otherwise unbearable for the patient. Codeine is the only really good cough suppressant and none of the over the counter cough medications are effective.  I assume that coughing with infection, like diarrhea, is beneficial. Key to treating all infections is to physically remove it. Undrained pus doesn’t heal, and a good cough is the most efficient way I know to remove potential pathogens from the lungs.

If there are benefits to suppressing the cough associated with acute respiratory infections I can’t find any and we have all seen people who, because of inability to cough secondary to rib fractures, develop severe pneumonia.  As a resident I had an elderly male die of just such a series of unfortunate events.

I suffer from a mild form the the naturalistic fallacy. I tend to let normal physiologic processes run their course unimpeded as long as they pose no harm to the patient.  So I do not treat infectious coughs, in part because medications are not effective, in part there is no benefit  and in part because the medications that are effective, and those that are not, have side effects.  (more…)

Posted in: Clinical Trials, Herbs & Supplements, Science and Medicine

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