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Archive for Clinical Trials

BBC Panorama investigates Stanislaw Burzynski

Last week, I reviewed a long-expected (and, to some extent, long-dreaded) documentary by Eric Merola, a filmmaker whose talent is inversely proportional to his yen for conspiracy, pseudoscience, and quackery. Through a quirk of fate that couldn’t have worked out better if I had planned it myself, a long-expected investigation of the Burzynski Clinic by the BBC aired on its venerable news program Panorama last Monday. It was entitled, appropriately enough, Cancer: Hope for Sale? Ever since learning that the BBC was working on this back in January or February, skeptics have been looking forward to it with a mixture of anticipation and dread, anticipation because we expected that the Panorama crew would “get it” (in the interests of full disclosure, I will mention that I was interviewed over the phone by a Panorama producer and exchanged e-mails to answer questions and suggestions), but a bit of dread because we feared the bane of all news reporting on issues of science and medicine: false balance.

So now that the report was finally aired, how was it? You can either watch it on iPlayer (if you’re in the UK) or on YouTube (if you’re not, assuming it’s still there):

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

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New Developments in Acupuncture: Turtles and Motion-Style Treatments

Note: Lest you think that SBM is becoming “turtles all the way down,”   let me apologize for the duplication and explain that I had already written this right before I read Mark Crislip’s Turtle Agony article on Friday.   My focus is different, and turtles were only a small part of my article, so I decided to leave the turtles in. If you prefer to avoid a turtle overdose, you can just skip the Turtlepuncture section and go on to the Motion Style Acupuncture section. They are clearly labeled for your convenience.

The “science” of acupuncture trudges ever onward without really getting anywhere. New developments include a report of turtlepuncture  and a study about treating low back pain with a new kind of “motion style” acupuncture using passive or active movement while the needles are in place. I found the first amusing and the second unconvincing.

Turtlepuncture 

Turtle Acupuncture

A group of Ridley sea turtles were rescued after being stranded during a cold spell that left them hypothermic and unable to function. In addition to the usual rescue and rehabilitation efforts, two of the turtles, Dexter and Fletcher Moon, were treated with acupuncture. It was intended to  “decrease inflammation and swelling on their front flippers, restore a full range of motion on those limbs and help the animals regain their appetites.” It allegedly worked: their appetite and the use of their limbs improved. But without any controlled observations, this is only an anecdotal report and means very little. They might have recovered just as well without the treatment, for all we know.

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Posted in: Acupuncture, Clinical Trials, Veterinary medicine

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Stanislaw Burzynski: A deceptive propaganda movie versus an upcoming news report

Well, I’ve finally seen it, and it was even worse than I had feared.

After having heard of Eric Merola’s plan to make a sequel to his 2010 propaganda “documentary” about Stanislaw Burzynski, Burzynski The Movie: Cancer Is Serious Business, which I labeled a bad movie, bad medicine, and bad PR, I’ve finally actually seen the finished product, such as it is. Of course, during the months between when Eric Merola first offered me an “opportunity” to appear in the sequel based on my intense criticism of Burzynski’s science, abuse of the clinical trials process, and human subjects research ethics during the last 18 months or so, there has been intense speculation about what this movie would contain, particularly given how Merola’s publicity campaign involved demonizing skeptics, now rechristened by Merola as “The Skeptics,” a shadowy cabal of people apparently dedicated (according to Merola) to protecting big pharma and making sure that patients with deadly cancers don’t have access to Burzynski’s magic peptides, presumably cackling all the way to the bank to cash those big pharma checks.
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Posted in: Cancer, Clinical Trials, Science and the Media

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Whack em hard/Whack em once and Stroke

There is no satisfaction in hanging a man who does not object to it.
~ George Bernard Shaw

I work in a 5-hospital system and many of us practice at several hospitals. The residents rotate through at least three of the hospitals and the peripatetic nature of health care allows word of curious cases to percolate through the system.  My current resident mentioned that there was a case of a vertebral artery dissection in a young female shortly after chiropractic neck manipulation.

Man, that’s awful. Is she doing OK?

Evidently there were no permanent neurologic sequelae. She dodged that bullet. Or perhaps that noose, as I once calculated that the force of a neck crack is about 40% that of hanging by the neck and it has the same pathologic changes if it goes wrong. Every time I see a death in the movie where the neck is twisted to break it, I think chiropractic, although some tolerate it better than others.

I have not written on CNS events related to chiropractic since 2008, although the topic has been covered by Dr. Hall.  I still suspect that occasionally there is a perfect storm of bad luck, the forces are perfectly aligned in a susceptible patient and they get an embolic stroke or a vertebral artery tear.
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Posted in: Chiropractic, Clinical Trials

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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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