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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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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, Diagnostic tests & procedures

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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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The sad saga of an Amish girl with a curable cancer whose parents are refusing chemotherapy in favor of “natural healing”

Over at my not-so-super secret other blog, one common type of story that I’ve blogged about has been that of the “chemotherapy refusenik.” It’s a topic I write about here not infrequently as well. People like Suzanne Somers and Chris Wark come to mind, mostly people who had effective surgical therapy for their cancers and then decided to forego adjuvant chemotherapy in favor of quackery. Not surprisingly, they attribute their having beaten cancer not to the surgery that saved them but to the woo du jour that they chose instead of chemotherapy, not understanding that such chemotherapy is not the cure; it only reduces the risk of recurrence after surgical extirpation of the tumor. What I haven’t discussed as much here as I have over there are cases of children with cancer whose parents refuse effective chemotherapy to treat their malignancy (other than Daniel Hauser). Because most childhood cancers are not treated with surgery, chemotherapy ± radiation therapy really is the primary therapeutic modality for most of them; so refusing it has a very high probability of resulting in the unnecessary death of a child. Generally pediatric cancers have an 80-90% five year survival, and recurrences after five years are rare, which, as I described recently, is an enormous improvement over 40 years ago.

Sadly, there have been many such cases, such as the aforementioned Daniel Hauser, Abraham Cherrix, Kate Wernecke, and Jacob Stieler. All of these are stories of children who were diagnosed with highly curable cancers who refused either chemotherapy or radiation therapy and were supported in that decision by their parents. Indeed, of these, Cherrix, Hauser, and Wernecke ran away with their parents to avoid chemotherapy. They all came back, but with different results. Hauser came back, started chemotherapy again, and is doing well. Cherrix ultimately came back, but the court made a deal with his parents that let him be treated by an “integrative medicine” doctors who treated him with low dose radiation and a bogus “immunotherapy.” As a result, several years later his tumor recurred, and he was last seen earlier this year asking for money for treatment. His battle in the courts in Virginia also inspired the passage of a supremely bad law that basically allows open season on teens for quackery. Wernecke disappeared when her parents refused radiation therapy after having undergone chemotherapy and took her for intravenous high dose vitamin C. In 2007, her cancer recurred, but the recurrence appeared to have been treated successfully. It’s not clear how much conventional therapy she had received, at least as of 2010, which was the last time I could find anything about her online.

The latest of these cases that has come to my attention is the case of a 10-year-old Amish girl from Medina County in Ohio named Sarah Hershberger, who developed T-cell lymphoblastic lymphoma, an aggressive form of lymphoma, underwent chemotherapy for a few weeks, and then decided she didn’t want it anymore. Her parents, convinced that the chemotherapy was killing her, instead of insisting that she undergo potentially curative therapy, which her doctors estimated to have an 85% chance of eliminating her cancer, refused to let undergo any further therapy. This led to a court case in which Akron Children’s Hospital (ACH) sued to obtain medical guardianship of the girl in order to make sure that she would undergo curative chemotherapy. The first ruling in the case in a Medina County court was for the parents. Then on appeal the 9th District Ohio Court of Appeals ordered Medina County Judge John Lohn to take another look at the case, ruling that he had failed to weigh adequately which course would best serve her interests — the decision of her parents to withhold treatment (at her request) or to appoint a limited guardian to make medical decisions, as proposed by Akron Children’s Hospital. Amazingly, Judge Lohn reiterated his previous ruling, finding that appointment of a guardian would interfere “with Sarah’s need and desire to be cared for by her loving parents” and stating that “the guardianship will not promote Sarah’s interests.” One month ago, Judge Lohn’s decision was reversed on appeal to the 9th District Ohio Court of Appeals, which caused everyone’s favorite quackery supporter to lose his mind in rage.

Since then the case has only gotten stranger, as hard as it is to believe. Indeed, it’s hard to know exactly what is going on, although discussing the case allows me to discuss a both the science and ethics of treating children with cancer using science-based modalities.
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Posted in: Cancer, Medical Ethics, Religion

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Full of Energy

Want to know what a craniosacral treatment is actually like? How about reiki? What about Eden energy medicine – do you even know what that is? Read on, because this past Sunday afternoon I experienced all three.

But first, the why and where. The local Healing Arts Alliance of the Big Bend (which is what they call the area of Florida I live in) held an information session for the public at our local library’s meeting room. Practitioners of about 10 different “healing arts” sat at a circle of folding tables chatting with visitors and handing out information. One even brought her diagnostic machine, which measures a person’s aura. (More on this later.) Some offered free samples of their treatments. It was a great opportunity for science-based medicine field work and I aimed to take full advantage.

The Alliance handed out a free booklet at the door listing local health care practitioners who:

. . . share a commitment to the whole person, patient-centered approach to health and wellness.

But, as the booklet explains,

[w]e do not endorse any specific method or system. Our member/practitioners are committed to a nonjudgmental collaboration and cooperative relationship . . .

This philosophy is indeed fortunate. If any of these practitioners endorsed a specific method, such as, say, the scientific method, it could lead to the judgment that what some of the others are saying is gobbledygook.

The booklet contains a helpful “Glossary of Holistic Health Terms,” which further serves to make the point that nonjudgmental collaboration is absolutely necessary to the cause. A few examples:

BioMat: This device delivers the highest vibrational resonance deep into all the tissues of the body using negative ions, amethyst, and Far-Infrared light to open the channels for intelligent cellular communication leading to DNA repair and total body wellness. Negative ions, found in abundance in nature, heighten alertness and mental energy, and decrease drowsiness. Amethyst enhances strength, stability and vigor. Far-Infrared light assists blood flow, helps release toxins and enlivens metabolism. Elevating temperature eliminates bacteria, heals and relaxes muscles, boosts immune system [sic], and promotes cardio fitness and healthy arteries.

Total body wellness is hard to beat. The one true cure, indeed! (more…)

Posted in: Cancer, Chiropractic, Energy Medicine, Health Fraud, Herbs & Supplements, Homeopathy

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Chemotherapy doesn’t work? Not so fast… (A lesson from history)

If there’s one medical treatment that proponents of “alternative medicine” love to hate, it’s chemotherapy. Rants against “poisoning” are a regular staple on “alternative health” websites, usually coupled with insinuations or outright accusations that the only reason oncologists administer chemotherapy is because of the “cancer industrial complex” in which big pharma profits massively from selling chemotherapeutic agents and oncologists and hospitals profit massively from administering them. Indeed, I’ve lost track of the number of such rants I’ve deconstructed over the years. Usually, they boil down to two claims: (1) that chemotherapy doesn’t work against cancer (or, as I’ve called it before, the “2% gambit“) and (2) that the only reason it’s given is because doctors are brainwashed in medical school or because of the profit motive or, of course, because of a combination of the two. Of course, the 2% gambit is based on a fallacious cherry picking of data and confusing primary versus adjuvant chemotherapy, and chemotherapy does actually work rather well for many malignancies, but none of this stops the flow of misinformation.

Misinformation and demonization aside, it is also important to realize that the term “chemotherapy,” which was originally coined by German chemist Paul Ehrlich, was originally intended to mean the use of chemicals to treat disease. By this definition, virtually any drug is “chemotherapy,” including antibiotics. Indeed, one could argue that by this expansive definition, even the herbal remedies that some alternative medicine practitioners like to use to treat cancer would be chemotherapy for the simple reason that they contain chemicals and are being used to treat disease. Granted, the expansive definition evolved over the years, and these days the term “chemotherapy” is rarely used to describe anything other than the cytotoxic chemotherapy of cancer that in the popular mind causes so many horrific side effects. But in reality virtually any drug used to treat cancer is chemotherapy, which is why I like to point out to fans of Stanislaw Burzynski that his antineoplastons, if they actually worked against cancer, would be rightly considered chemotherapy, every bit as much as cyclophosphamide, 5-fluorouracil, and other common chemotherapeutics.
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Posted in: Basic Science, Cancer, Clinical Trials, History

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Redefining cancer

Blogging is a rather immediate endeavor. Over the last nine years (nearly), I’ve lost track of how many times I saw something that I wanted to blog about but by the time I got around to it, it was no longer topical. Usually what happens is that my Dug the Dog tendencies take over, as I’m distracted by yet another squirrel, although sometimes there are just too many targets topics and too little time. Fortunately, however, sometimes the issue is resurrected, sometimes in a really dumb way, such that I have an excuse to correct my previous oversight. This is just such a time, and the manner in which the topic has been resurrected is every bit as dumb as the rant by the Food Babe that Mark Crislip so delightfully deconstructed last Friday. Unfortunately, for purposes of snark, I’m not Mark Crislip—but, then, who is?—but fortunately I am known elsewhere (and sometimes here) for being a bit “insolent.” So let’s dig in. We’ll start with the idiocy and then use that as a “teachable moment” about cancer biology. Funny how I manage to do that sort of thing so often.

Abuse of cancer science for political purposes

I realize that we at SBM are supposed to stay, for the most part, apolitical, but the idiocy that’s leading me to revisit a topic is unavoidably political because it involves using a profound misunderstanding of science for political ends. Specifically, I’m referring to the misuse of a legitimate scientific debate about cancer screening and diagnosis for purely political ends. First, however, for those not living in the US or my fellow citizens who might be blissfully unaware (in this case) of recent events, during the first half of October, our nation underwent what can only be described as a self-inflicted crisis that could have caused worldwide economic turmoil if it hadn’t been (sort of) resolved at the last minute. The reason for the crisis boiled down to the extreme resistance of some of our more radically conservative Representatives to the Patient Protection and Affordable Care Act, usually referred to as just the Affordable Care Act (ACA) or, colloquially, Obamacare. Normally when we write about Obamacare here on SBM, it’s to complain about how advocates of unscientific medicine and outright quackery have tried to piggyback their advocacy on the ACA in order to have health insurance plans sold through government exchanges cover modalities like naturopathy, chiropractic, and other so-called “complementary and alternative medicine” (CAM) or “integrative medicine.” In related posts, I’ve examined the evidence with respect to the relationship between health insurance and mortality and whether attacks on Medicaid as not improving the health of patients insured by it have any validity. (Let’s just say they are oversimplifications and distortions.)
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Posted in: Cancer, Diagnostic tests & procedures, Politics and Regulation, Science and the Media

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Yes, Chris beat cancer, but it wasn’t quackery that cured him

Editor’s note: Due to technical difficulties, SBM experienced considerable downtime yesterday. I therefore decided to delay publishing this post until now. Harriet’s normally scheduled Tuesday post will also appear later.

I like to think that one of the more important public services I provide here at Science-Based Medicine is my deconstructions of alternative cancer cure testimonials. After all, one of the most powerful marketing tools purveyors of cancer quackery have in their arsenal is a collection of stories of “real patients” with cancer who used their nostrums and are still alive and well. These sorts of analyses of alternative cancer cure testimonials began right near the very beginning of my not-so-super-secret other blog way back in 2004, metastasized—if you’ll excuse my use of the term—to SBM in 2008, and have continued intermittently to this very day, most recently with a bevy of posts showing why the testimonials of Stanislaw Burzynski’s patients do not constitute good evidence that he can cure cancers considered incurable by “standard” medicine. In other words, Burzynski’s “success stories” aren’t the slam-dunk evidence he and Eric Merola want you to believe them to be regarding the use of antineoplastons to cure brain cancers.

Sometimes, these patients who believe that alternative medicine somehow cured their cancers are so transformed, so energized, that they basically devote their lives to selling, in essence, their story, along with all the stuff they did to “cure” their cancer. I just came across one such person, a man by the name of Chris Wark, whose website and blog Chris Beat Cancer sells the idea that he beat his cancer with nutrition and “natural therapies” that he used to “heal himself.” All of this wouldn’t be quite so horrible—after all, there are lots of people who believe in woo and say so publicly—except that Wark is now also selling all sorts of misinformation about cancer, at $175 for a two hour phone consultation. Regular readers will recognize right away where Mr. Wark goes wrong in his story. Even so, I think it’s worthwhile to take a look because since discovering Mr. Wark’s site I’ve seen his name popping up all over the place promoting “natural” cures, and his site has become a repository of all sorts of “alternative cancer cure” testimonials, as well as credulously promotional material for quackery like Gerson therapy, the Beck protocol, and the Gonzalez protocol.

First, let’s take a look at Mr. Wark’s story. Since his story is so simple to deconstruct, I’ll then look at more of the material on his website. Right on the front page of Mr. Wark’s website, there is a brief blurb about him that reads:
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Posted in: Cancer

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Licensing Naturopaths: the triumph of politics over science

Naturopaths shouldn’t get too excited about having a special week in their honor. The U.S. House of Representatives gave watermelons a whole month. As between naturopathy and watermelons for my good health, I’ll go with the watermelons any day. You’ll soon understand why.

Today is not my usual blogging day. But when David Gorksi announced SBM’s celebration of Naturopathic Medicine Week, I volunteered an extra post to answer the question I am sure is on everyone’s mind: How in the heck do they get away with this stuff?

The answer lies in the creation of Naturopathic Medicine Week itself: politics. Just as Sen. Barbara Mikulski turned her credulous acceptance of naturopathy into a Senate Resolution and slipped it by her Senate colleagues, clueless legislators around the country are sponsoring bills to license naturopaths, in some cases as primary care physicians. And it’s not as if these legislators don’t know they are incorporating quackery into primary care. Practices such as naturopathic “organ repositioning” (an anatomical impossibility) and Mark Crislip noted, what little data there is suggests that naturopathic primary care is associated with worse outcomes. But evidence is not necessary in the political realm. And now the political process has given naturopaths an additional incentive for licensure. They argue that the Affordable Care Act mandates reimbursement for their services. (more…)

Posted in: Cancer, Energy Medicine, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation, Traditional Chinese Medicine

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