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Dr. Stanislaw Burzynski’s “personalized gene-targeted cancer therapy”: Can he do what he claims for cancer?

Last week, I wrote a magnum opus of a movie review of a movie about a physician and “researcher” named Stanislaw Burzynski, MD, PhD, founder of the Burzynski Clinic and Burzynski Research Institute in Houston. I refer you to my original post for details, but in brief Dr. Burzynski claimed in the 1970s to have made a major breakthrough in cancer therapy through his discovery of anticancer substances in the urine that he dubbed “antineoplastons,” which turned out to be mainly modified amino acids and peptides. Since the late 1970s, when he founded his clinic, Dr. Burzynski has been using antineoplastons to treat cancer. Over the last 25 years or so, he has opened a large number of phase I and phase II clinical trials with little or nothing to show for it in terms of convincing evidence of efficacy. Worse, as has been noted in a number of places, high doses of antineoplastons as sodium salts are required, doses so high that severe hypernatremia is a concern.

Although antineoplastons are the dubious cancer therapy upon which Dr. Burzynski built his fame, they aren’t the only thing he does. Despite the promotion of the Burzynski Clinic as using “nontoxic” therapies that “aren’t chemotherapy” by “natural medicine” cranks such as Joe Mercola and Mike Adams, Dr. Burzynski’s dirty little secrets, at least as far as the “alternative medicine” crowd goes, are that (1) despite all of the attempts of Dr. Burzynski and supporters to portray them otherwise antineoplastons are chemotherapy and (2) Dr. Burzynski uses a lot of conventional chemotherapy. In fact, from my perspective, it appears to me as though over the last few years Dr. Burzynski has pivoted. No longer are antineoplastons the center of attention at his clinic. Rather, these days, he appears to be selling something that he calls “personalized gene-targeted cancer therapy.” In fact, it’s right there in the first bullet point on his clinic’s webpage, underlined, even! Antineoplastons aren’t even listed until the third bullet point.

But what is “personalized gene-targeted cancer therapy,” according to Dr. Burzynski? Here is how it is described:
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Posted in: Basic Science, Cancer, Clinical Trials, Pharmaceuticals

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Stanislaw Burzynski: Bad medicine, a bad movie, and bad P.R.

And the Lord spake, saying, “First shalt thou take out the Holy Pin. Then shalt thou count to three, no more, no less. Three shall be the number thou shalt count, and the number of the counting shall be three. Four shalt thou not count, neither count thou two, excepting that thou then proceed to three. Five is right out. Once the number three, being the third number, be reached, then lobbest thou thy Holy Hand Grenade of Antioch towards thy foe, who, being naughty in my sight, shall snuff it.

Cleric from Monty Python and the Holy Grail

I’ve always wondered about the power of the number three. When it comes to quackery propaganda movies, certainly three seems to be the magic number. For example, The Greater Good, an anti-vaccine propaganda film, features three anecdotes, three children allegedly suffering from vaccine injury, and it interspersed its interviews with experts, both real (such as Dr. Paul Offit) and phony (such as Barbara Loe Fisher) with vignettes from these children’s stories interspersed between them in a highly biased manner. I have to wonder whether these cliches are taught in film school, given that they seem to be so common. Such were the thoughts running through my brain as I watched the latest medical propaganda film by writer/producer Eric Merola that’s floating around the blogosphere and the film circuit, Burzynski The Movie: Cancer Is Serious Business. In this movie, there are three testimonials, and, if anything, they are far more manipulative than even the testimonials featured in The Greater Good, because each of them are of the type that portrays doctors as sending a patient home to die; that is, until a “brave maverick doctor,” one Stanislaw R. Burzynski, MD, PhD, comes to the rescue with his unconventional and unproven therapy. The only difference is that this film counts testimonials up to the number three in the beginning as “proof” that Burzynski can cure cancer before lobbing the Holy Hand Grenade of Burzynski towards its foes in the hopes that, being naughty in the filmmaker’s sight, the FDA and Texas Medical Board will snuff it. Or, as a caption says right at very the beginning of the movie:

This is the story of a medical doctor and PhD biochemist who has discovered the genetic mechanism that can cure most human cancers. The opening 30 minutes of this film is designed to thoroughly establish this fact — so the viewer can fully appreciate the events that follow it.

It turns out that the grenade is a dud.
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Posted in: Basic Science, Cancer, Clinical Trials, Medical Ethics, Politics and Regulation, Science and the Media

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Chemotherapy doesn’t work? Not so fast…

“CHEMOTHERAPY DOESN’T WORK!!!!!”

“CHEMOTHERAPY IS POISON!!!!”

“CHEMOTHERAPY WILL KILL YOU!!!!”

I’ve lost count of how many times I’ve come across statements like the ones above, often in all caps, quite frequently with more than one exclamation point, on the websites of “natural healers,” purveyors of “alternative medicine.” In fact, if you Google “chemotherapy doesn’t work,” “chemotherapy is poison,” or “chemotherapy kills,” you’ll get thousands upon thousands of hits. In the case of “chemotherapy kills,” Google will even start autofilling it to read “chemotherapy kills more than it saves.” The vast majority of the hits from these searches usually come from websites hostile to science-based medicine. Examples include Mercola.com, the website of “alternative medicine entrepreneur” Dr. Joe Mercola and NaturalNews.com, the website of Mike Adams, where you will find cartoons like this one, which likens the administration of chemotherapy to a Nazi death camp:

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Posted in: Cancer, Science and Medicine

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Dummy Medicines, Dummy Doctors, and a Dummy Degree, Part 1: a Curious Editorial Choice for the New England Journal of Medicine

Background

This post concerns the recent article in the New England Journal of Medicine (NEJM) titled “Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma.” It was ably reviewed by Dr. Gorski on Monday, so I will merely summarize its findings: of the three interventions used—inhaled albuterol (a bronchodilator), a placebo inhaler designed to mimic albuterol, or ‘sham acupuncture’—only albuterol resulted in a clinically important improvement of bronchial airflow; for that outcome the two sham treatments were equivalent to “no intervention.” For all three interventions, however, self-reported improvements were substantial and were much greater than self-reported improvements after “no intervention.” In other words, dummy treatments made the subjects (report that they) feel better, whereas real medicine not only made them feel better but actually made them better.

Before proceeding, let me offer a couple of caveats. First, the word ”doctors” in the flippant title of this post refers mainly to two individuals: Daniel Moerman, PhD, the anthropologist who wrote the accompanying editorial, and Ted Kaptchuk, the Senior Author of the trial report. It does not refer to any of the other authors of the report. Second, I have no quarrel with the trial itself, which was quite good, or with the NEJM having published it, or even with most of the language in the article, save for the “spin” that Dr. Gorski has already discussed.

My quarrels are the same as those expressed by Drs. Gorski and Novella, and by all of us on the Placebo Panel at TAM. This post and the next will develop some of those points by considering the roles and opinions of Moerman and Kaptchuk, respectively.

A True Story

Late one night during the 1960s a friend and I, already in a cannabis-induced fog, wandered into a house that had been rented by one of his friends. There were about 8-10 ‘freaks’ there (the term was laudatory at the time); I didn’t know any of them. The air was thick with smoke of at least two varieties. After an uncertain interval I became aware of a guy who was having trouble breathing. He was sitting bolt upright in a chair, his hands on his knees, his mouth open, making wheezing sounds. He took short noisy breaths in, followed by what seemed to be very long breaths out, as though he was breathing through a straw. You could hear the wheezing in both directions. Others had also noticed that he was in distress; they tried to be helpful (“hey, man, ya want some water or somethin’?”), but he just shook his head. He couldn’t talk. My friend, who had asthma himself, announced that this guy was having an asthma attack and asked if he or anyone else had any asthma medicine. No one did.

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Posted in: Acupuncture, Cancer, Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Health Fraud, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Pharmaceuticals, Public Health, Science and Medicine, Science and the Media

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Hash Oil for Gliomas? What Would You Do?

A friend asked me to look at the evidence for hash oil as a treatment for glioma. His teenage daughter was recently diagnosed with brain cancer: a grade 3 anaplastic ependymoma. It recurred very rapidly after surgery and radiotherapy and the latest tissue diagnosis shows an aggressive grade IV glioma. Her prognosis is not good. No further attempts at curative therapy are indicated; the oncologist prescribed only palliative therapy with temozolomide. Her father, who had recently lost his wife to cancer (breast cancer metastatic to lungs and brain), was understandably devastated. As he puts it, he remains “focused on the belief that just maybe a cure can be found.” He stumbled on what he calls “earth-shattering news” regarding hash oil. He and his friends established a private wiki website which they are constantly updating with information about THC (tetrahydrocannabinol, the active ingredient in marijuana and hash) and other possible cancer cures: everything from curcumin to diet. He asked me to look at the information he has accumulated. He said

I hope to convince you in the same way I have done with my daughter’s GPs and her neuro-oncologist at BC Children’s Hospital.

The oncologist was not exactly convinced. He didn’t say he thought hash oil was likely to work; he only said it would be reasonable to try it as a complementary therapy. He said

the data published so far appears very preliminary, most of its potential effectiveness in vivo so far appears in colonic disease, having said that there doesn’t appear to be any obvious down side as a complementary therapy and may have synergistic effect, so may be reasonable as add on to temodal if she tolerates it

I wasn’t convinced either.

I will discuss two issues here:

  1. What does the evidence say about gliomas and hash oil?
  2. When is it reasonable to try an unproven treatment as a last resort?

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Posted in: Cancer, Herbs & Supplements

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Hope and hype in genomics and “personalized medicine”

“Personalized medicine.” You’ve probably heard the term. It’s a bit of a buzzword these days and refers to a vision of future medicine in which therapies are much more tightly tailored to individual patients than they currently are. That’s not to say that as physicians we haven’t practiced personalized medicine before; certainly we have. However it has only been in the last decade or so that our understanding of genomics, systems biology, and cell signaling have evolved to the point where the vision of personalized medicine based on each patient’s genome and biology might be achievable within my lifetime.

I was thinking about personalized medicine recently because of the confluence of several events. First, I remembered a post I wrote late last year about integrating patient values and experience into the decision process regarding treatment plans. Second, a couple of months ago, Skeptical Inquirer published an execrably nihilistic article by Dr. Reynold Spector in Skeptical Inquirer in which he declared personalized medicine to be one of his “seven deadly medical hypotheses,” even though he never actually demonstrated why it is deadly or that it’s even really a hypothesis. Come to think of it, with maybe–and I’m being very generous here–one exception, that pretty much describes all of Dr. Spector’s “seven deadly medical hypotheses”: Each is either not a hypothesis, not deadly, or is neither of the two. Third, this time last week I was attending the American Association for Cancer Research (AACR) meeting in Orlando. I don’t really like Orlando much (if you’re not into Disney and tourist traps, it’s not the greatest town to hang out in for four days), but I do love me some good cancer science. One thing that was immediately apparent to me from the first sessions on Sunday and perusing the educational sessions on Saturday was that currently the primary wave in cancer research is all about harnessing the advances in genomics, proteomics, metabolomics, and systems and computational biology, as well as the technologies such as next generation sequencing (NGS) techniques to understand the biology of each cancer and thereby target therapies more closely to what biological abnormalities drive each cancer. You can get an idea of this from the promotional video the AACR played between its plenary sessions:

Which is actually a fairly good short, optimistic version of my post Why haven’t we cured cancer yet? As I mentioned before, with this year being the 40th anniversary of the National Cancer Act, as December approaches expect a lot of articles and press stories asking that very question, and I’m sure this won’t be the last time I write about this this year.
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Posted in: Basic Science, Cancer, Clinical Trials, Diagnostic tests & procedures, Politics and Regulation

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The benefits and risks of folic acid supplementation

Could a vitamin with proven benefits in one group cause harm to another? That’s the growing concern with folic acid, the vitamin that dramatically reduces the risk of neural tube birth defects such a spina bifida. Studies designed to explore the possible benefits of folic acid for heart disease, stroke and cancer are giving out some worrying signs: At best, folic acid is ineffective, and at worst it may be increasing the risks of some cancers. So what does this say about routine supplementation for the typical healthy individual, and its overall risk and benefit?

Folate (vitamin B9) is an essential nutrient found green, leafy vegetables, broccoli, peas, corn, oranges, grains, cereals, and meats. Folate has important roles in the synthesis of DNA, and consequently cell division. Significant folate deficiency can lead to macrocytic anemia. Folic acid, a synthetic form of folate, is used in multivitamins supplements because it is better absorbed.

Folic acid’s benefits in pregnancy are well documented. Supplementation before conception, and in the first few weeks of pregnancy, significantly and substantially lower the risk of several different birth defects, including neural tube defects (NTDs). The neural tube is the embryonic precursor to the brain and spinal column. NTDs include very serious defects like spinal bifida and anencephaly, birth without part of the brain.

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Posted in: Clinical Trials, Epidemiology

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Ann Coulter says: Radiation is good for you!

Here at Science-Based Medicine, we try to be relatively apolitical. We might not always succeed, but in general our main concern is not so much with right-wing or left-wing politics, but rather with how prevailing government policies and regulation impact the delivery of medical care, in particular whether they tend to prevent, do nothing about, or promote the proliferation of non-science-based medical care. Consequently, when Kimball or I call for the disbanding of the National Center for Complementary and Alternative Medicine (NCCAM), it does not matter one whit to us who is President or which party controls Congress. All that matters is that we see NCCAM as a government entity that, through credulously studying many “alternative medicine” modalities, ends up inadvertently promoting them and providing them with the imprimatur of government approval. The same concept applies to state medical licensing boards licensing pseudoscientific modalities, such as naturopathy, acupuncture, and homeopathy. By regulating these “disciplines,” states also provide them with an unmerited mantle of respectability through their imprimatur of regulating them as professions, just like medicine and nursing.

As far as political views, although all of us have them and they occasionally even come to the fore in disagreements (remember when Wally Sampson occasionally clashed with others with differing political viewpoints?), we generally subsume them for purposes of the SBM blog experience into our advocacy for basing medicine on the best science available. Sometimes, however, when a pundit or politician makes claims that are either contrary to or distort science for ideological or political advantage, I feel the need to discuss those claims, sometimes even sarcastically. Such was the case last week, when Ann Coulter wrote a blisteringly ignorant column, entitled A Glowing Report on Radiation. She wrote this article in the wake of the fears arising in Japan and around the world of nuclear catastrophe due to the damage to the Fukushima nuclear power plant caused by the earthquake and tsunami that hit northern Japan on March 11. Coulter was subsequently interviewed by Fox News pundit Bill O’Reilly on The O’Reilly Factor on Thursday evening:

Yes, according to Coulter, radiation is good for you, just like toxic sludge! Even more amazing, in this video Bill O’Reilly actually comes across as the voice of reason, at least in comparison to Ann Coulter. He’s very skeptical of Coulter’s claims and even challenges her by saying, “So by your account we should all be heading towards the nuclear reactor.”

So, fellow SBM aficionados, is Coulter right? Are all those scientists warning about the dangers of even low-level radiation all wrong? Should we start hanging out in radioactive mine shafts, as Coulter mentions in her column (seriously) in order to boost our health and decrease our risk of cancer?

Not so fast, there, Ann. Here’s a hint: If Bill O’Reilly can lecture you on science and look more reasonable than you, you’re off the rails.
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Posted in: Cancer, Science and the Media

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Why haven’t we cured cancer yet?

Why haven’t we cured cancer yet?

If we can put a man on the moon, why can’t we cure cancer?

If we can harness the atom, why can’t we cure cancer?

How many times have you heard these questions, or variants thereof? How many times have you asked this question yourself? Sometimes, I even ask this question myself. Saturday was the two year anniversary of the death of my mother-in-law from a particularly nasty form of breast cancer, and, even though I am a breast cancer surgeon, I still wonder why there was nothing in the armamentarium of science-based medicine that could save her from a several month decline followed by an unpleasant death. That’s why, to me at least, the timing of the publication of a study examining the genome of prostate cancer that was published in Nature and summarized in this Science Daily news story was particularly apt. Performed as part of the National Cancer Institute’s Cancer Genome Project, the study undertook complete genome sequencing of seven advanced and aggressive prostate cancers. The results, as ERV put it, revealed what can be describe as a “train wreck.”

Personally, I’d describe it as looking as though someone threw a miniature grenade into the nucleus of a prostate epithelial cell. You’ll see what I mean shortly.

Of course, although that image does give you an idea of the chromosomal chaos in the heart of prostate cancer cells, it is inaccurate in that it implies a sudden explosion, after which the damage is done, and if there’s one thing we know about cancer it’s that in most cases it takes many years for a normal cell to progress to a cancer cell fully capable of metastasizing and killing its host. I’ve written in detail about the complexity of cancer before, of course, and have even pointed out before that when President Nixon launched the “war on cancer” 40 years ago scientists had no idea how difficult it would be. Indeed, before I discuss the current study, it’s probably useful to reiterate a bit why, in order to put the study in context.
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Posted in: Cancer, Science and Medicine

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Overdiagnosis

Dr. H. Gilbert Welch has written a new book Over-diagnosed: Making People Sick in the Pursuit of Health, with co-authors Lisa Schwartz and Steven Woloshin.  It identifies a serious problem, debunks medical misconceptions and contains words of wisdom.

We are healthier, but we are increasingly being told we are sick. We are labeled with diagnoses that may not mean anything to our health. People used to go to the doctor when they were sick, and diagnoses were based on symptoms. Today diagnoses are increasingly made on the basis of detected abnormalities in people who have no symptoms and might never have developed them. Overdiagnosis constitutes one of the biggest problems in modern medicine. Welch explains why and calls for a new paradigm to correct the problem. (more…)

Posted in: Book & movie reviews, Cancer, Diagnostic tests & procedures

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