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Archive for Clinical Trials

Stanislaw Burzynski: The Early Years, part 1

It’s been a week now since I got back from TAM, where Bob Blaskiewicz and I tag-teamed a talk about a man who has become a frequent topic of this blog, namely Stanislaw Burzynski. I’ve been meaning to come back to the topic of Burzynski, but from a different angle. There hasn’t been much in the way of news lately other than the release of Eric Merola‘s most recent propaganda “documentary,” Burzynski: Cancer Is A Serious Business, Part 2, but, believe it or not, there remain lots of loose ends that I haven’t covered. This time around, the angle is this: How did Burzynski get his start? His is a story that goes back over 46 years, and in the beginning he seemed to be a promising young academic physician and a perfectly respectable researcher. So what happened? How did he evolve from a seemingly idealistic young Polish physician to what he has been for many years now?

I started to think about this when I was writing my post about “alternative cancer cures” circa 1979, because one of the three articles written by Gary Null and various coauthors that appeared in Penthouse magazine in the fall that year, The Suppression of Cancer Cures, was dedicated primarily to Stanislaw Burzynski and his “antineoplastons,” which at the time were new news, so to speak. However, Null’s article, even though it was contemporaneous with Burzynski’s having recently struck out on his own and started his own clinic, didn’t reveal everything that I was interested in learning. Actually, the more I read, the more I realize that no source really reveals everything that I want to know about that time period in the 1970s and early 1980s that produced the Stanislaw Burzynski that we know and don’t love today. Available sources all tend to be either pro-Burzynski, Burzynski himself, or vague in the extreme about what happened. Fortunately, my research for my TAM talk will serve multiple purposes. Since the talk was so brief and required me to cover 40+ years of history in a mere 20 minutes, there was a lot left out. I hate to let all that research go to waste; so I’m going to use it for an intermittent series of blog posts.
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Posted in: Cancer, Clinical Trials, Politics and Regulation

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Do clinical trials work? It depends on what you mean by “work”

Introduction

(Skip to the next section if you want to miss the self-referential blather about TAM.)

As I write this, I’m winging my way home from TAM, crammed uncomfortably—very uncomfortably—in a window seat in steerage—I mean, coach). I had been thinking of just rerunning a post and having done with it, sleeping the flight away, to arrive tanned, rested, and ready to continue the battle against pseudoscience and quackery at home, but this seat is just too damned uncomfortable. So I might as well use the three and a half hours or so left on this flight to write something. If this post ends abruptly, it will be because I’ve run out of time and a flight attendant is telling me to shut down my computer in those cloyingly polite but simultaneously imperious voices that they all seem to have.

I had thought of simply recounting the adventures of the SBM crew who did make it out to TAM to give talks at workshops and the main stage and to be on panels, but that seems too easy. Even easier, I could simply post my slides online. But, no, how on earth can I reasonably expect Mark Crislip to post while he’s at TAM if I’m too frikkin’ lazy to follow suit? I’m supposed to lead by example, right, even if what comes out is nearly as riddled with spelling and grammar errors (not to mention the occasional incoherent sentence) as a Mark Crislip post? Example or not, lazy or not, I would be remiss if, before delving into the topic of today’s post, I didn’t praise my fellow SBM bloggers who were with me, namely Steve Novella, Harriet Hall, and Mark Crislip, for their excellent talks and insightful analysis. Ditto Bob Blaskiewicz, with whom I tag-teamed a talk on everybody’s favorite cancer “researcher” and doctor, Stanislaw Burzynski. It’ll be fun to see the reaction of Eric Merola and all the other Burzynski sycophants, toadies, and lackeys when Bob’s and my talks finally hit YouTube. Sadly, we’ll have to wait several weeks for that. (Hmmm. Maybe I will post those slides later this week.)
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Posted in: Cancer, Clinical Trials

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Homeopathy Ramblings

There needs to be a SCAM index, some quantitative tool, a formula for ranking the SCAMs, so one SCAM could reign supreme, to be definitely declared the the goofiest of all SCAMs. Perhaps (number of adherents)x(number of Pubmed publications)x(age of SCAM) all divided by a plausibility factor.

Homeopathy would win and any SCAM index that did not rank homeopathy at number one would have to put up a very convincing argument indeed that their formula was not somehow fundamentally flawed.1

For first time readers, homeopathy is based on several fictions, totally divorced from reality, made up in the 1800′s.

The first law,2 with less reality than Joe Abercrombie’s, is, “similia similibus curentur,” or “let like be cured by like”. Substances which cause specific symptoms can be used to cure diseases which cause the same symptoms.  If like cures like, I am uncertain what moonlight, one of many fanciful homeopathic nostrums, would cure. Lycanthropy? (more…)

Posted in: Clinical Trials, Homeopathy

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Coenzyme Q10 for heart failure: The hype and the science

Could a product sold as a dietary supplement really be delivering the benefits that advocates have claimed for decades? That’s what you might be wondering about coenzyme Q10, following recent stories like:

What’s caused all the excitement about CoQ10 is the Q-SYMBIO trial, more properly called “The effect of coenzyme Q10 on morbidity and mortality in chronic heart failure”, presented at the European Society of Cardiology conference last month. I’d normally wait for the full article to come out, and will review it if possible at that time, but the results are too interesting to ignore so I’ll dive into the study and the reaction – which is equally as interesting for advocates of science-based medicine. (more…)

Posted in: Clinical Trials, Herbs & Supplements

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Two Viewpoints

Most of what I read professionally is directed towards reality-based medicine. I spend my professional energies thinking about the application of reality to killing various and sundry microscopic pathogens.

The conceptual framework I use, and that used by others in medicine, does not concern itself with the application of the Supplements, Complementary and Alternative Medicines that occupy the attention of this blog. In acute care medicine SCAMs are of virtually no importance yet the approaches we need to take with patients and medicine are, with slight changes in emphasis, as applicable to SCAMs as real medicine. You need to remember, however, that the topic is not necessarily based in known reality.

Two viewpoints in JAMA caught my attention this month, both more thoughtful and reasoned than I am probably capable of. While focused on the application of reality-based medical practice, they apply to the topics of SBM as well. (more…)

Posted in: Clinical Trials, Medical Ethics, Science and Medicine

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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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