Archive for Clinical Trials

When urgency to cure beats research ethics, bad things happen

Editor’s note: Just for your edification, here’s a “bonus” post. True, you might have seen this recently elsewhere, but it’s so appropriate for SBM that I couldn’t resist sharing it with those of you who might not read the other source where this was published recently. :-)

I’ve written a lot about Stanislaw Burzynski and what I consider to be his unethical use and abuse of clinical trials. Before that, I used to regularly write about Mark Geier and his unethical use and abuse of IRBs and clinical trials. Both doctors use their own IRBs stacked with their own cronies to rubberstamp scientifically and ethically dubious studies. Mark Geier got away with it for years. Stanislaw Burzynski got away with it for decades and, apparently, is still getting away with it to some extent. (His IRB is chaired by an old Baylor crony of his from the 1970s, and he has been cited for numerous problems with his IRBs.) I’d like to contrast how their unethical research, in which Mark Geier and his son David subjected autistic children to chemical castration with Lupron to decrease testosterone levels and allegedly make mercury easier to chelate (to them mercury was bound by testosterone, something that doesn’t happen under physiological conditions but requires organic solvents) and Stanislaw Burzynski administered an unproven cancer chemotherapy (antineoplastons) to hundreds of patients over the years and charged them for it, compares to a recent case in the news.

The case has been mentioned by PZ Myers. It happened that it involves the same sort of tumors that Stanislaw Burzynski claims to be able to cure, namely brain tumors. It happened at the University of California Davis (UC Davis) and involved two very prominent neurosurgeons there, a former head of the department Dr. J. Paul Muizelaar and Dr. Rudolph J. Schrot, who were found to have violated university’s faculty code of conduct with their experimental work. When you read this part of the story, you’ll shiver. At least, I did:

Posted in: Cancer, Clinical Trials, Medical Ethics

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Survey Says…

Surveys are evidently a popular way to get a paper published. Put “complementary alternative medicine survey” into Pubmed and get 2,353 hits. I would have trouble coming up with a hundred groups about whom I would be interested in their use of SCAMs, but I tend to be a lumper rather than a splitter. But if you want to know about SCAM use in chronic pain patients in one Singapore hospital, the information is available.

I am a survey magnet and a remarkable number of people send me dead tree and electronic surveys which I generally ignore. So people like me, those who ignore surveys (but support public television), are underrepresented in surveys. But evidently there is no group whose attitudes about SCAM are not amenable to analysis including my medical brethren, Infectious Disease doctors.

So I was understandably curious when I was sent a link to “Infectious Diseases Physicians’ Attitudes and Practices Related to Complementary and Integrative Medicine: Results of a National Survey“. The abstract makes it sound like my colleagues are a bunch of ignorant rubes who just fell off the turnip truck: (more…)

Posted in: Acupuncture, Clinical Trials, Critical Thinking, Homeopathy, Science and Medicine

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A Different Perspective: Placebo, SCAM, and Advertising

Summertime, time, time

Child, the living’s easy.

Fish are jumping out

And the handicap, Lord

Handicaps high, Lord so high

~ Janis Joplin

It is summer. Time for the kids and the outside, not the computer. What follows is a summertime blog entry, for which I admit to feeling guilty for the comparatively little time I have spent on it, but as I have said before, no dying patient has ever told me “Doc, I wish I had spent more time at work.”

Mt. Hood has been a constant feature to the east my entire life. The mountain, on a clear day at least, is Portland’s most impressive geologic feature. If you are in the right part of the city, you may see Mt. St. Helens or the tips of Jefferson, Adams and even Rainier, but Mt. Hood dominates. It is solitary mass of rock, (diminishing) ice and snow only 50 miles from where I live. I have spent uncountable hours hiking in the Mt. Hood wilderness. When I think of Mt. Hood, in my mind’s eye it is from the perspective of west Portland looking east.

Last week was our yearly summer vacation in Sunriver, just south of Bend Oregon on the eastern side of the cascades in the Oregon High Desert. Driving north/south on highway 97 puts Mt. Hood in a different perspective. From the high desert you can see the huge swaths of the Cascades: calderas, mountains, lava fields and cinder cones. You see Mt. Hood differently. Not a single mountain to the east, but part of a chain of recent and distant historical volcanic activity along the Rim of Fire. Photographs do not do the view of the Cascades justice from this vantage point.

The eastern view puts Mt. Hood in a broader geologic and time perspective. It is still the same Mt. Hood, but in a different context. Like running into a nurse outside of the hospital, you have to recalibrate the context in which you understand and know the person.

I have written on placebo, the placebo effect, and its relationship to SCAM. To my understanding the preponderance of literature indicates there is no placebo effect upon any objective medical problem, only a change in the patients perspective of the problem. (more…)

Posted in: Basic Science, Clinical Trials, Science and Medicine

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Integrative Medicine Invades the U.S. Military: Part Three

Nobody seems to know exactly how to define “integrative medicine” (“IM”) or to demonstrate what it does that is superior to the “conventional” kind. There is a lot of talk about addressing the “whole person” and not just the disease, patient-centeredness and the like, all of which are already aspects of conventional medicine. But, however defined, the central idea seems to be that if you incorporate complementary and alternative (CAM) into conventional medicine the practice of medicine will improve tremendously.

Despite not having any clear idea of what IM is, or does, the military, prestigious medical institutions, hospitals, and individuals practitioners are eager to imprint the integrative medicine brand firmly on their public images. Hence the Consortium of Academic Medical Centers for Integrative Medicine, a newly minted medical specialty in integrative medicine, societies devoted to integrative medicine practitioners, CME courses, conferences, and so on.

But – whoops! – proponents, in their overblown hype for IM, apparently didn’t give enough thought to the fact that there isn’t much of an evidence base for this loosely-defined but supposedly superior system. And – whoops again! – you can’t really research something unless you know what it is you are researching. These little oversights have brought about efforts to decide which of the competing definitions of integrative medicine should prevail and, whatever it is, whether there is any evidence of benefit for the patient. (more…)

Posted in: Acupuncture, Clinical Trials, Homeopathy, Legal, Politics and Regulation

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The difference between science-based medicine and CAM

“Alternative medicine,” so-called “complementary and alternative medicine” (CAM), or, as it’s become fashionable to call it, “integrative medicine” is a set of medical practices that are far more based on belief than science. As Mark Crislip so pointedly reminded us last week, CAM is far more akin to religion than science-based medicine (SBM). However, as I’ve discussed more times than I can remember over the years, both here and at my not-so-super-secret-other blog, CAM practitioners and advocates, despite practicing what is in reality mostly pseudoscience-based medicine, crave the imprimatur that science can provide, the respect that science has. That is why, no matter how scientifically implausible the treatment, CAM practitioners try to tart it up with science. I say “tart it up” because they aren’t really providing a scientific basis for their favored quackery. In reality, what they are doing is choosing science-y words and using them as explanations without actually demonstrating that these words have anything to do with how their favored CAM works.

A more important fundamental difference between CAM and real medicine is that CAM practices are not rejected based on evidence. Basically, they never go away. Take homeopathy, for example. (Please!) It’s the ultimate chameleon. Even 160 years ago, it was obvious from a scientific point of view that homeopathy was nonsense and that diluting something doesn’t make it stronger. When it became undeniable that this was the case, through the power of actually knowing Avogadro’s number, homeopaths were undeterred. They concocted amazing explanations of how homeopathy “works” by claiming that water has “memory.” It supposedly “remembers” the substances with which it’s been in contact and transmits that “information” to the patient. No one’s ever been able to explain to me why transmitting the “information” from a supposed memory of water is better than the information from the real drug or substance itself, but that’s just my old, nasty, dogmatic, reductionist, scientific nature being old, nasty, dogmatic, reductionist, and scientific. Then, of course, there’s the term “quantum,” which has been so widely abused by Deepak Chopra, his acolytes, and the CAM community in general, while the new CAM buzzword these days to explain why quackery “works” is epigenetics. Basically, whenever a proponent of alternative medicine uses the word “epigenetics” or “quantum” to explain how an alternative medicine treatment “works,” what he really means is, “It’s magic.” This is a near-universal truth, and even the most superficial probing of such justifications will virtually always reveal magical thinking combined with an utter ignorance of the science of quantum mechanics or epigenetics.

Posted in: Clinical Trials, Diagnostic tests & procedures, Homeopathy, Medical Academia

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Integrative Medicine Invades the U.S. Military: Part One

Integrative medicine proponents claim superiority over physicians practicing “conventional” medicine. (Which I will refer to as “medicine” so as not to buy into integrative medicine’s implied claim that medicine can be practiced with two separate standards.) While conceding that medicine is good for treating conditions like broken arms and heart attacks, physicians who purport to practice integrative medicine argue it ignores “the whole person, including all aspects of lifestyle.” Their vision of a new, improved practice of medicine “emphasizes the therapeutic relationship between practitioner and patient, is informed by evidence, and makes use of all appropriate therapies.””

But, as we know, the practice of medicine already takes into account “the whole person, including all aspects of lifestyle,” is “informed by evidence” and uses “all appropriate therapies.” This includes recommendations regarding diet, exercise, relaxation and vitamin and dietary supplement use, which are often erroneously labeled “CAM.” Medicine appears to be well aware of problems in the current model of health care delivery and is actively seeking ways to improve it. If integrative medical practitioners and their proponents were simply directing their time, energy and resources toward facilitating a better model for delivering health care I suppose no one would have any problem.

But they aren’t. They are claiming rights to an entirely new specialty in medicine. Proponents do this by advancing two dubious arguments. First, integrative medicine alone can deliver on this “whole person” model of care. Second, inclusion of alternative medicine is essential to good patient care.

From a consumer protection standpoint, I find integrative medicine troubling. Proponents are unfairly misrepresenting medical practice as inferior and offering themselves as the solution when there is no evidence that they can deliver on these claims. Unfortunately, despite this lack of evidence, integrative medicine has seized the imagination of public policy makers and legislative bodies. It is included in the Affordable Care Act and continues to metastasize throughout the military health care system, which together will soon control delivery of the vast majority of health care in this country.

Posted in: Acupuncture, Chiropractic, Clinical Trials, Energy Medicine, Legal, Politics and Regulation

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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.

Posted in: Cancer, Clinical Trials, Politics and Regulation

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


(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.)

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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