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Archive for November, 2013

USA Today versus Stanislaw Burzynski

This is an SBM public service announcement—with blogging! Think of it as a bonus post, and don’t forget to read Mark Crislip’s regular biweekly offering, as it’s about an article in Skeptical Inquirer that particularly irritated him—and me, as well. Because, as we all know, the world needs more Mark Crislip.

I’ve made no secret of how much I despise Stanislaw Burzynski, the self-proclaimed cancer doctor and medical researcher who has been treating patients with an unproven, unapproved chemotherapeutic agent since 1977, seemingly slithering around, under, over, and past all attempts to investigate him and shut him down. Indeed, just type his name in the search box of this blog, and you will see copious evidence of my disdain for the man. Over 37 years, Burzynski has become a hero to the cancer quackery industry, touted as the man who can cure incurable cancers that science-based medicine can’t, even though his treatment, antineoplastons, allegedly peptides isolated from blood and urine that normally keep cancer in check in healthy people, are by any reasonable definition chemotherapy. Indeed, they are toxic, with a number of side effects reported, the most common and dangerous of which being life-threatening hypernatremia (elevated sodium levels in the blood). All you have to do is to type Burzynski’s name into the search box of this blog, and you’ll find copious documentation of the abuses of patients, science, and clinical trials perpetrated by Stanislaw Burzynski and the cult of personality that has evolved around him. He’s even acquired his very own film propagandist, a credulous fellow named Eric Merola, who has made two astoundingly bad documentaries that are nothing more than unabashed hagiographies of the brave maverick doctor curing cancer where no one else can. They’re chock full of misinformation, pseudoscience, spin, and obvious emotional manipulation, and the first one at least, was very popular.

For the longest time, I’ve been hoping that major mainstream news organizations would take this story on. It’s happened from time to time, but until 2013 it hadn’t happened in a long time. Earlier this year, the BBC featured Burzynski in an episode of its long-running series Panorama. It was a mixed bag that took the fairly easy path of making it all about the patients and never really delved into what I believe to be the central mystery of the four-decade-long Stanislaw Burzynski story, and that’s how he’s managed to keep his medical license and register clinical trials right up until 2012. That was a disappointment, although much of the rest of the Panorama episode was very good. He still has his medical license, but as I’ve pointed out several times, the FDA placed a partial clinical hold on Burzynski’s antineoplaston phase II clinical trials back in the summer of 2012. A partial clinical hold means that no new patients could be enrolled, but patients already on them could continue to receive treatment. In 2012, apparently a child died on antineoplastons, and so a partial clinical hold was placed on the trials involving children. That clinical hold was extended to adults in January 2012, with much wailing and gnashing of teeth among Burzynski apologists, as the FDA investigated between January and March. We now know the results of that investigation, but we never knew much about how that partial clinical hold came about.

Now, thanks to Liz Szabo at USA Toda, we know from her article “Doctor accused of selling false hope to families“:
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Posted in: Cancer, Clinical Trials, Science and the Media

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Irritated by the Skeptical Inquirer. Again.

I have a confession. I have been interested in issues skeptical since high school when I came across a copy of the Zetetic at Powells. In the pre-digital era I had a complete library of Zetetic-Skeptical Inquirers (SI) that a decade ago was tossed in the recycle bin along with a similar collection of MacWorlds. I have been interested in skepticism a long time and, here is my confession, I no longer find much of the subject matter covered by SI all that interesting. Even big ticket topics like the existence of God are uninteresting. It is not that the topics are not important, they are, and each generation has to relearn why Bigfoot or haunted houses or UFO’s are nonsense. But for me it is a large serving of been-there, done-that.

So while I subscribe to SI, it is more from a sense of obligation to support institutions I think are important than from an expectation that I will be either educated by the content or entertained by the style of the writers. I usually skim the magazine while accomplishing tasks that do not require my full attention probably because SI is the only magazine I still receive in dead tree format, the rest of my life being digital.

So I ran across “Taking our medicine: What hope for skepticism in healthcare?” by Kenneth W. Krause and after skimming it I was irritated. So I read it again and I was more irritated, which is often a good sign. But I could not quite put a finger on what it was. So I read it again and then went for a walk and thought about it.

All the facts were fine. I had no issue with the content of the article. It was the adjectives that irritated me. And the essay was, from my perspective, incomplete. It was like reading a relationship/birth control article by the Pope. Sure, he knows the facts of the situation, but not being an active participant in the process and with an agenda to promote, vital information will be missing or distorted. (more…)

Posted in: Random Thoughts Cause I Can, Science and Medicine, Science and the Media

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Journal of the American Dental Association Falls for Tooth Fairy Science

The Tooth Fairy

The Tooth Fairy

Another venerable scientific journal has fallen prey to “alternative” medicine research. The Journal of the American Dental Association (JADA) has joined the New England Journal of Medicine and Annals of Internal Medicine, among others, with its publication of “A pilot study of a chiropractic intervention for management of chronic myofascial temporomandibular disorder,” in the October, 2013, issue.

And what “chiropractic intervention” is this? The Activator Method Chiropractic Technique (AMCT) as taught by Activators Methods International (AMI), which also conveniently sells its own line of Activator Instruments. (Practice-building seminar DVDs sold separately.)

What is this Activator Method? In short, it is a method of detecting and correcting subluxations (the chiropractic version, not the medical one). Thus, the underlying premise of this study was that subluxations could cause myofascial temporomandibular disorder (TMD) pain and that finding and vanquishing these subluxations could bring about pain relief.

Now, as regular readers of this blog know, vertebral subluxations are a figment of the chiropractic imagination. They do not exist, as we have pointed out many, many, many times. And here is where alternative medicine has it all over conventional medicine and dentistry. In alternative medicine, once you invent a non-existent condition you can proceed to invent all sorts of diagnostic techniques and remedies to treat patients with this condition. The AMCT is a perfect example of this. Conventional medicine and dentistry, on the other hand, are saddled with the scientific method, biological plausibility, having to discard therapies when studies no longer support their use, and all sorts of other persnickety limitations.
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Posted in: Chiropractic, Clinical Trials, Dentistry, Legal, Politics and Regulation

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The Nuances of Informed Consent

Modern medical ethics are built upon the concept of informed consent. This is not, however, as straightforward a concept as it may seem.

Physicians and health care providers have a duty to provide informed consent to their patients or their patients’ guardians, which means that they have to inform them appropriately about the risks and benefits of their recommendations and interventions. This includes informing them about the risks of not treating an illness.

This principle is, in turn, based largely upon the principle of autonomy – people have the right to control their own lives, and one cannot have control without information.

This is all simple enough, but where it becomes tricky is in deciding how much information to give patients, and how to present it. (more…)

Posted in: Critical Thinking, Medical Ethics, Science and Medicine

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Colonoscopy and Other Colorectal Cancer Screening Options: An Update

When I wrote about colonoscopy in 2010, colonoscopy was thought to be the best screening test for colorectal cancer because it could visualize the entire colon and could remove adenomas that were precursors of cancer. But only fecal occult blood testing (FOBT) and sigmoidoscopy had been proven to decrease colorectal cancer incidence and mortality (by 16% and 28%, respectively). Observational evidence suggested that colonoscopy would reduce the incidence and the number of deaths from colorectal cancer, but there were no randomized controlled trials, and the reduction in incidence of cancer after colonoscopy screening seemed to be restricted to left-sided colon cancers, which didn’t make sense.

We still don’t have any randomized controlled trials of colonoscopy, but a 2013 case-control study from Germany compared patients with and without colorectal cancer and found that those who reported having had a colonoscopy were less likely to develop colon cancer for up to 10 years after the procedure. And now two studies published in the New England Journal of Medicine in September 2013 have shed more light on the subject.
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Posted in: Cancer

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Revealed by the FDA: The results of the most recent inspection of the Burzynski Clinic

After posting the talks that Bob Blaskiewicz and I gave at TAM this year, I realized that it’s been a while since I’ve written about the topic of those talks, namely Stanislaw Burzynski, the Houston cancer doctor who inexplicably has been permitted to continue to administer an unproven cancer treatment to children with deadly brain cancers for nearly 37 years now. Beginning in 1977, when he left Baylor College of Medicine and opened up the Burzynski Clinic, Burzynski has administered a cancer therapy that he calls antineoplastons to patients. After nearly four decades and several dozen phase II clinical trials started, he has never published a completed phase II trial. The only evidence he’s published consists mainly of cell culture studies, case reports, and couple of preliminary reports of his phase II clinical trials. Of course, Burzynski’s lawyer, Richard Jaffe, even dismissively admitted that these clinical trials are designed solely to allow Burzynski to keep giving antineoplastons.

So Burzynski operated from the late 1990s until summer 2012, charging exorbitant “case management” fees to enroll patients in his clinical trials, working with a credulous filmmaker who wanted to make a movie about him—twice—and flouting regulations designed to protect human subjects involved in clinical trials. Meanwhile, he branched out to “personalized gene-targeted cancer therapy,” which he promoted through Suzanne Somers; to AminoCare, which is basically antineoplastons sold as an antiaging nostrum (or, as Burzynski puts it, a “genetic solution to aging“); and to selling an orphan drug as a “prodrug” for antineoplastons.

So what happened in the summer of 2012? Apparently, there was a treatment-related death of a child, which led the FDA to issue a partial clinical hold on the Burzynski Clinic that prevented him from enrolling any new children on his clinical trials, although he could keep treating existing patients and enroll new adult patients. That partial clinical hold was extended to adults in January 2013, at which time the FDA arrived at the Burzynski Clinic to investigate. It was an event that was included at the tail end of Eric Merola’s second propaganda film about Stanislaw Burzynski and represented as, in essence, jackbooted fascists trying to keep the cure for cancer from The People. None of this stops credulous reporters from writing misleading articles with titles like Young mother with brain cancer given just a year to live BEATS the disease and gets married after having controversial treatment in the US, which is a story about Laura Hymas, a woman whose good fortune is most likely not due to Burzynski. Not long before that, there was another credulous article featuring another Burzynski patient, Hannah Bradley, as one of four patients treated for cancer with alternative therapies who are allegedly doing well. Again, Hannah Bradley’s good fortune is highly unlikely to be due to Burzynski’s nostrums.

All of this is why those of us who follow Burzynski have been waiting with the proverbial bated breath to find out what the FDA concluded. Just before the government shutdown the first shoe dropped, when the FDA released a warning letter to the Burzynski Research Institute (BRI). Then last week, the second shoe dropped, when the FDA released the original forms describing its findings regarding the inspection. The findings are, to put it mildly, damning in the extreme. In fact, now, more than ever, I wonder how on earth Burzynski has been allowed to continue to run clinical trials—or even practice—for so long. The findings include massive deficiencies in the Burzynski institutional review board (IRB), the committee responsible for making sure that regulations designed to protect human subjects in research are adhered to.
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Posted in: Cancer, Clinical Trials, Medical Ethics, Politics and Regulation

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Medical cranks: Why we fight

Never let it be said that I can’t match Mark Crislip in shameless self-promotion. The world might indeed need more Mark Crislip™, but I like to think that it needs a bit more David Gorski, too. So, in that spirit, here are the videos, recently released by the James Randi Educational Foundation, of Bob Blaskiewicz, myself, and some key SBM players that you’ve come to know and love. The first video is my talk at The Amazing Meeting in July about Stanislaw Burzynski, MD, PhD. It’s entitled Why We Fight (Part I): Stanislaw Burzynski Versus Science-Based Medicine. The second video is Bob Blaskiewicz, of Skeptical Humanities and The Other Burzynski Patient Group, It’s entitled, appropriately enough, Why We Fight (Part II): It’s All About the Patients. The third video is of the panel that followed to discuss Medical Cranks and Quacks. Enjoy!

Oh, and consider it a bit of a taste of what’s to come tomorrow…and don’t forget to pay attention to Bob Blaskiewicz’s plea at the end of his talk to contact him if you’re interested in becoming active. At TAM, he had a sign-up sheet that he discussed at around 21:06 in the video. Online, just mosey on over to The Other Burzynski Patient Group and contact Bob Blaskiewicz. We will very likely be asking you to help very soon.

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

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Because the world needs more Mark CrislipTM

Should anyone be in Ashland, Oregon the afternoon of Sunday the 10th of November, and is sober after an afternoon of watching the NFL,  I will be giving a talk on Supplementary, Complementary and Alternative Medicine Myths.  Sponsored by the Jefferson Center, details on their website.

For those in the Portland, Oregon area, I will be giving same talk on Monday November 18th.

7:00 PM
Portland State University
Science Bld. 1 – Room 107

Although the Patriots-Panthers game may be more exciting.

Sponsored by Oregonians for Science and Reason and the PSU Department of Physics.

Both talks are free.

Posted in: Announcements

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Separating Fact from Fiction in Pediatric Medicine: Infant Teething

Teething is one of the most common sources of parental concern in the world of pediatric medicine. All children go through it, typically starting at about 6 months of age, and the current list of signs and symptoms attributed to the eruption of teeth in infants is long and varied, with most if not all of them inaccurate if not highly suspect. And although teething as a concept may seem rather commonplace, it is an entity with an interesting history and a frequent impetus for exposing young children to ineffective and even risky treatments.

What is teething?

Simply put, teething occurs when a tooth nears completion of its journey into the oral cavity, a journey which begins early in fetal development. The tooth erupts though the gum, often preceded by a small lump. Occasionally there can be a larger eruption cyst, and the area may appear somewhat bluish and swollen from bleeding into the tissue, but this is uncommon. The most widely accepted duration of a bout of teething is a roughly 8 day period, with tooth emergence generally felt to occur on day 5. The whole process usually takes about two years, with an average of one tooth emerging each month until the full complement of 20 baby teeth are present. (more…)

Posted in: Science and Medicine

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New concerns about the safety and quality of herbal supplements

If there is one aspect of “alternative” medicine that both critics and fans should agree on, it’s that products should be manufactured to high standards. What’s on the label should accurately describe what’s in the bottle. Product quality standards are essential, whether you’re using herbs or drugs. And when it comes to ensuring the products we buy are of high quality, we’re all effectively reliant on regulation to protect us. As a pharmacist, I can’t personally verify that each tablet in your prescription contains the active ingredient on the label. I am dependent on a supply chain that may stretch around the world. While the product manufacturer may be reputable, it’s only a regulator that can realistically verify and enforce production to strict quality standards. The same cannot be said for products like supplements and herbs which are regulated differently than drugs, and held to different, and in some cases, weaker standards. A weak regulatory framework, which doesn’t hold manufacturers to account, would be expected to result in a product of lower quality. And that’s exactly what you see when you look at supplements on the market today.

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Posted in: Herbs & Supplements, Science and Medicine

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