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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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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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Obesity, cancer, and chemotherapy

In medicine, particularly oncology, it’s often the little things that matter. Sometimes, however, the “little things” aren’t actually little; they just seem that way. I was reminded of this by a story that was circulating late last week in the national media, often under titles like “Obese cancer patients often shorted on chemo doses”, ”Are obese people with cancer getting chemotherapy doses too small for them?”, and “Obese Cancer Patients Not Getting Full Doses of Chemotherapy Drugs”. It’s also interesting to me because it stands in marked contrast to something I’ve written about a lot on this blog: The overtreatment of cancer. In this case, this story is about the undertreatment of cancer in patients who are obese, and it’s a problem that has definite adverse effects on an obese person’s odds of surviving cancer.

I’ve been aware of this issue for some time and had been thinking of blogging about it for at least three years. The reason is that the oncologist who is best known for sounding the alarm on this issue is Jennifer Griggs at the University of Michigan and, being local and all, I’ve seen her speak on the topic several times at local breast cancer conferences. Now that I work with a statewide breast cancer care quality improvement initiative, I’m becoming more aware of her work. Indeed, I was rather puzzled why this issue bubbled up enough to be reported widely on the national news last week when the Nature Clinical Oncology paper by Gary H. Lyman and Alex Sparreboom that drew attention to the issue was published in August, and the original American Society of Clinical Oncology (ASCO) guidelines were published last year. Whatever the reason this issue has been getting more attention, it’s a good thing.
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Posted in: Cancer

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Is U.S. cancer care “in crisis,” as the Institute of Medicine proclaims?

Americans love to fight, traditionally. All real Americans love the sting and clash of battle…When you, here, everyone of you, were kids, you all admired the champion marble player, the fastest runner, the toughest boxer, the big league ball players, and the All-American football players. Americans love a winner. Americans will not tolerate a loser.

General George S. Patton, Jr. was famous for his flamboyance and aggressiveness going on the attack, among other things. He was also known for a number of pithy quotes made throughout his lifetime, particularly during World War II, such as the one above in which he declared how much Americans love to fight. I sometimes wonder whether he was more correct in that assessment than he knew in that we seem to view almost everything through the lens of war and a crisis that calls for a war. In medicine, for instance, we have the “war on cancer” and the “war on obesity.” We have a propensity for likening problems and their solutions to war, where the goal is to destroy the enemy.

Similarly, but less dramatic (although only slightly so), we have various crises. Indeed, Americans seem to love to compare problems to crises as much as they love to compare them to war. Of course, the two are closely related, as a crisis of some sort is a necessary prelude to a war. We can argue about the definition of a “crisis,” but one thing is certain. No matter how one defines it the word “crisis” implies an urgent problem and further implies that something must be done now—or at least very soon—to prevent the catastrophic consequences of that problem, which usually involve a breakdown of a current system. It was with these thoughts in mind that I approached the Institute of Medicine (IOM) consensus report released last week, Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis. It’s a behemoth of a report, weighing in at 360 pages, and it does indeed paint a picture of some very serious problems in cancer care that should be addressed. It is subdued in that it doesn’t engage in that oh-so-American tendency to declare “war” on every problem, but is cancer care “in crisis”? Of that, I’m not so sure, but it’s definitely got problems. But, as I’ve said, the system’s had problems for a long time, as the IOM itself documented in its 1999 report Ensuring Quality of Cancer Care, which concluded that “for many Americans with cancer, there is a wide gulf between what could be construed as the ideal and the reality of their experience with cancer care.” The report also recommended steps to improve cancer care and the evidence base for cancer care, and to overcome barriers of access to high-quality cancer care. As the introduction to the current report states:
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Posted in: Cancer

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Another antivaccine zombie meme: polio vaccine and SV40 and cancer, oh, my!

Another antivaccine zombie meme: polio vaccine and SV40 and cancer, oh, my!

The Internet has produced a revolution with respect to information. Now, people anywhere, any time, can find almost any information that they want, as long as they have a connection to the global network and aren’t unfortunate enough to live in a country that heavily censors the Internet connections coming in. In addition, anyone any time can put his or her opinion out on the Internet and it might be read by people on the other side of the planet. For example, it continually amazes me that my blatherings here are read by people in Australia and New Zealand, as well as Europe and pretty much every other continent. Before the Internet, there was no way I would ever have achieved my current measure of minor celebrity status (and I do mean minor). Now, with enough good (I hope) writing and some links from some popular sources, and I can make my opinion known worldwide.

The dark side of this is that cranks can also make their opinions known worldwide, and, all too frequently, they are much better at it than skeptics are. For example, this very blog used a generic, vanilla WordPress template for the longest time, only updating it a few months ago. Meanwhile crank websites like NaturalNews.com are decked out in the latest, greatest web accoutrements, complete with video. One other problem with the democratization of information is that there now exist what I like to call “zombie memes.” In the world of quackery and pseudoscience, these are pseudoscientific claims on the Internet that never die, no matter how often they are refuted. Generally, such memes/claims pop up, make a fuss, are refuted, and then disappear. Then a few months (or even a year or two) later, something will happen to resurrect them. Maybe it’s a clueless mortician cremating the remains of such a zombie meme during a rainstorm and letting whatever it is that resurrected the dead meme in the first place permeate the soil of a graveyard of dead memes. Maybe it involved injecting a glowing fluid into the corpse of the meme. Who knows? Who cares that much? All I know is that these zombie memes keep popping up again and again as though they were new.

Re-animator-imagem

Now that the World Wide Web (at least as we know it, in its graphically browsable form) is approaching its twentieth birthday, we now have enough perspective to see these things. Steve Novella pointed out one zombie meme just the other day about the MMR, as did a certain person well known to this blog. Just yesterday I noticed another of these zombie memes arising from the dead yet again to feast on the brains of the living and thus make them cranks too. (At least, that is the goal of their continual resurrection.) This one popped up at that online repository of all things quackery, NaturalNews.com, in a post by Mike Adams himself entitled Merck vaccine developer admits vaccines routinely contain hidden cancer viruses derived from diseased monkeys. Other versions of this meme pop up from time to time with titles like CDC Admits 98 Million Americans Received Polio Vaccine In An 8-Year Span When It Was Contaminated With Cancer Virus.

Let’s dive in, shall we?
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Posted in: Vaccines

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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:
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Posted in: Cancer, Clinical Trials, Medical Ethics

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E-cigarettes: The growing popularity of an unregulated drug delivery device

This post is not about vaccines (for a change).

However, I deem it appropriate to mention that one of the topics that I blog most frequently about is vaccines and how the antivaccine movement pushes pseudoscience and quackery based on its apparently implacable hatred of vaccines. (You’ll see why very shortly.) It seems almost as long as my interest in the topic since I first noticed that the antivaccine movement acquired its very own celebrity spokesperson in Jenny McCarthy, who at least since 2007 has been promoting outrageous quackery and pseudoscience associated with her antivaccine views. To her, vaccines are chock full of “toxins” and all sorts of evil humors that will turn your child autistic in a heartbeat and in general “steal” your “real” child away from you the way she thinks vaccines “stole” her son Evan away from her. Indeed, among other “achievements,” she’s written multiple books about autism in which vaccines feature prominently as a cause, led a march on Washington to “green our vaccines” and has been the president of the antivaccine group Generation Rescue for the last few years. None of this stopped ABC from foolishly hiring her to join the regular cast on The View beginning in a few short weeks.

Because I occasionally check on what Jenny McCarthy is up to, I noticed a couple of weeks ago that she had been hired to be a celebrity spokesperson for blu™ e-cigarettes. Here she is, hawking the blu™ Starter Pack:

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Posted in: Cancer, Medical devices, Politics and Regulation, Public Health

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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.
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Posted in: Cancer, Clinical Trials, Politics and Regulation

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