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“Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part I: Results)

ResearchBlogging.org

Review

One of the more bizarre and unpleasant “CAM” claims, but one taken very seriously at the NIH, at Columbia University, and on Capitol Hill, is the cancer “detoxification” regimen advocated by Dr. Nicholas Gonzalez:

Patients receive pancreatic enzymes orally every 4 hours and at meals daily on days 1-16, followed by 5 days of rest. Patients receive magnesium citrate and Papaya Plus with the pancreatic enzymes. Additionally, patients receive nutritional supplementation with vitamins, minerals, trace elements, and animal glandular products 4 times per day on days 1-16, followed by 5 days of rest. Courses repeat every 21 days until death despite relapse. Patients consume a moderate vegetarian metabolizer diet during the course of therapy, which excludes red meat, poultry, and white sugar. Coffee enemas are performed twice a day, along with skin brushing daily, skin cleansing once a week with castor oil during the first 6 months of therapy, and a salt and soda bath each week. Patients also undergo a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest.

Veteran SBM readers will recall that in the spring of 2008 I posted a series of essays* about this regimen and about the trial that compared it to standard treatment for subjects with cancer of the pancreas. The NIH had funded the trial, to be conducted under the auspices of Columbia, after arm-twisting by Rep. Dan Burton [R-IN], a powerful champion of quackery, and much to the delight of the “Harkinites.”

In the fall of 2008 I posted an addendum based on a little-known determination letter that the Office for Human Research Protections (OHRP) had sent to Columbia during the previous June. The letter revealed that the trial had been terminated in October, 2005, due to “pre-determined stopping criteria.” This demonstrated that Gonzalez’s regimen must have been found to be substantially worse than the current standard of care for cancer of the pancreas, as ineffective as that standard may be. I urge readers who require a review or an introduction to the topic to read that posting, which also considered why no formal report of the trial had yet been made available.

Now, finally, the formal report has been published online by the Journal of Clinical Oncology (JCO):

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Posted in: Cancer, Clinical Trials, Health Fraud, Herbs & Supplements, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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The price of cancer quackery

I don’t have much to add to this one, as it’s a tragic tale. Shadowfax, a blogging ER doc, relates to us what happens when cancer patients rely on quackery like the Gerson protocol instead of scientific medicine:

This was a young woman, barely out of her teens, who presented with a tumor in her distal femur, by the knee. This was not a new diagnosis — it had first been noted in January or so, and diagnosed as a Primary B-Cell Lymphoma. By now, the tumor was absolutely huge, and she came to the ER in agonizing pain. Her physical exam was just amazing. The poor thing’s knee (or more precisely, the area just above the knee) was entirely consumed by this massive, hard, immobile mass about the size of a soccer ball. She could not move the knee; it was frozen in a mid-flexed position. She hadn’t been able to walk for months. The lower leg was swollen and red due to blood clots, and the worst of the pain she was having seemed due to compression of the nerves passing behind the knee. It was like something you see out of the third world, or historic medical textbooks. I have never seen its like before.

So we got her pain managed, of course, and I sat down to talk to her and her family.

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Posted in: Cancer, Health Fraud, Medical Ethics

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If you’re sick, even the ridiculous can seem sublime

Let’s say you have cancer. And let’s say you’re really, really sick of having cancer. And let’s say that you’re also pretty tired of scans, chemo, radiation, hair loss, nausea. And let’s say you’re not really sick and tired of living, but actually pretty happy to be alive.

Finally, let’s say someone says that they can get rid of your cancer, without all of those pesky side-effects. It’s a win-win, no?

No.

It’s easy to believe in promises that are congruent with our wishes. That’s what makes human beings so easy to deceive. A case in point is the VIBE Machine, a discredited quackery device. This thing was marketed until about a year ago. Not surprisingly, Orac has written about this thing in his Friday Dose of Woo. Stephen Barrett, the King of Quack-Busters, has also tracked the sordid history of this rip-off. The device was recalled back in 2008, so this shouldn’t even be a story anymore, except that word of the device still circulates among cancer patients and their friends. The company’s website is down, which is good, but this thing is still out there.

At least one website is still promoting it in detail. The website is, needless to say, a whole lot of words that make no sense: (more…)

Posted in: Cancer, Health Fraud, Science and Medicine

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Are one in three breast cancers really overdiagnosed and overtreated?

ResearchBlogging.orgScreening for disease is a real pain. I was reminded of this by the publication of a study in BMJ the very day of the Science-Based Medicine Conference a week and a half ago. Unfortunately, between The Amaz!ng Meeting and other activities, I was too busy to give this study the attention it deserved last Monday. Given the media coverage of the study, which in essence tried to paint mammography screening for breast cancer as being either useless or doing more harm than good, I thought it was imperative for me still to write about it. Better late than never, and I was further prodded by an article that was published late last week in the New York Times about screening for cancer.

If there’s one aspect of medicine that causes more confusion among the public and even among physicians, I’d be hard-pressed to come up with one more contentious than screening for disease, be it cancer, heart disease, or whatever. The reason is that any screening test is by definition looking for disease in an asymptomatic population, which is very different from looking for a cause of a patient’s symptoms. In the latter case, the patient is already being troubled by something that is bothering him. There may or may not be a cause in the form of a disease or syndrome that is responsible for the symptoms, but the very existence of the symptoms clues the physician in that there may be something going on that requires treatment. The doctor can then narrow down range of possibilities for what may be the cause of the patient’s symptoms by taking a careful history and physical examination (which will by themselves most often lead to the diagnosis). Diagnostic tests, be they blood tests, X-rays, or other tests, then tend to be more confirmatory of the suspected diagnosis than the main evidence supporting a diagnosis.
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Posted in: Cancer, Clinical Trials, Diagnostic tests & procedures, Public Health, Science and Medicine, Science and the Media

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Cancer research: Going for the bunt versus swinging for the fences

A couple of weeks ago, our resident skeptical medical student Tim Kreider wrote an excellent article about an op-ed in NEWSWEEK by science correspondent Sharon Begley, in which he pointed out many misconceptions she had regarding basic science versus translational research, journal impact factors, and how journals actually determine what they will publish. Basically, her thesis rested on little more than a few anecdotes by scientists who didn’t get funded or published in journals with as high an impact factor as they thought they deserved, with no data, science, or statistics to tell us whether the scientists featured in her article were in fact representative of the general situation. Begley’s article caught flak from others, including Mike the Mad Biologist and our very own Steve Novella. Naturally, as the resident cancer surgeon and researcher, I had thought of weighing in, but other issues interested me more at the time.

In retrospect, I rather regret it, given that this issue crops up time and time again. In essence, it’s a variant of the lament that pops up in the press periodically, when science journalists look at survival rates for various cancers and ask why, after nearly 40 years, we haven’t yet won the war on cancer. Because of his youth, Tim probably hasn’t seen this issue crop up before, but, trust me, every couple of years or so it does. Begley’s article and the NYT article strike me as simply “Why are we losing the war on cancer?” 2009 edition.

Now the New York Times has given me an excuse both to revisit Begley’s article and discuss yesterday’s front page article in the NYT Grant System Leads Cancer Researchers to Play It Safe. Basically, they are variants of the same complaints I’ve heard time and time again. Now, don’t get me wrong. By no means am I saying that the current system that the NIH uses to determine which scientists get funded. Those who complain that the system is often too conservative have a point. The problem, all too often, however, is that the proposals for how to fix the problem are usually either never spelled out or rest on dubious assumptions about the nature of cancer research themselves.
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Posted in: Basic Science, Cancer, Medical Academia, Politics and Regulation

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Applying evolutionary principles to cancer treatment

ResearchBlogging.orgEDITOR’S NOTE: Unfortunately, this weekend, I was forced to get my slides together for the upcoming SBM Conference, plus editing a manuscript for resubmission, plus working on a manuscript that I should have submitted six months ago, plus reading over some grants, plus…well, you get the idea. What this means is that, alas, I didn’t have any time to prepare one of the new, long posts that you’ve come to love (or hate). Fortunately, there are a lot of other things I’ve written out there that can be rapidly adapted to SBM. For instance, what I am about to present now. Since I wrote this, I’ve thought of a couple of things that I should have said the first time (and was kicking myself for not having done so); so publishing an updated version here allows me to rectify those omissions.

A couple of weeks ago, there was a lot of hype about a study that hadn’t been released yet. Indeed, there was a story in Wired entitled To Survive Cancer, Live With It and an editorial by the study’s lead author in Nature entitled A change in strategy in the war on cancer. Not bad for a study that hadn’t been released yet. Intrepid medical and science blogger that I am, I waited until the actual study was published a week ago the June 1 episode of Cancer Research. It’s a clever study, but the hype over it was a bit overblown. For example:

For all the weapons deployed in the war on cancer, from chemicals to radiation to nanotechnology, the underlying strategy has remained the same: Detect and destroy, with no compromise given to the killer. But Robert Gatenby wants to strike a peace.

A mathematical oncologist at the Moffitt Cancer Center, Gatenby is part of a new generation of researchers who conceive of cancer as a dynamic, evolutionary system. According to his models, trying to wipe cancer out altogether actually makes it stronger by helping drug-resistant cells flourish. Rather than fighting cancer by trying to eradicate its every last cell, he suggests doctors might fare better by intentionally keeping tumors in a long-term stalemate.

Maybe I’m being a bit picky, but what annoys me about the news reports on this study is that the concept of turning cancer into a manageable chronic disease like diabetes or hypertension is not by any means a new idea. Remember, one of my major research interests is the inhibition of tumor angiogenesis. Consequently, I know that the late, great Judah Folkman first proposed the concept of using antiangiogenic therapy to turn cancer into a chronic disease at least as early as the mid-1990′s. The only difference is the strategy that he proposed. The idea had also been floating around for quite a while before that, although I honestly do not know who first came up with it.

But let’s see what Dr. Gatenby proposes. What makes it interesting is that his study actually looks at how scientists have applied evolutionary principles to cancer until recently, argues that we’ve been doing it wrong. He then proposes a way to use the evolutionary dynamics of applied ecology. He may well be on to something. First, here’s the problem:
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Posted in: Basic Science, Cancer, Science and Medicine

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The case of chemotherapy refusenik Daniel Hauser

I’ve written before about clinical trials as one place where “the rubber hits the road,” so to speak regarding the interface between science-based medicine and actual medical practice. Another critical place where an equal amount of rubber hits an equal amount of road is how the medical system and the law deal with the medical care of minors. In the vast majority of cases, parents take their children to physicians ostensibly practicing science-based medicine and, more or less, follow their advice. One of the more common areas where there is resistance to science-based medicine is, of course, the issue of vaccination, which I and other bloggers at SBM have written about extensively. Another issue, which has not yet been touched upon on this blog, is what to do about parents who refuse chemotherapy for their children with curable childhood cancers or children who refuse chemotherapy whose parents either agree with them or are unwilling to do the hard work of convincing their children that they must undergo therapy. Most often, the reason cited by such “chemotherapy refuseniks” is either religion or a desire to undergo “alternative” therapy rather than conventional therapy. One such case, a particularly high profile one, has been in the news over the last couple of weeks. In this post, I plan to discuss the case of Daniel Hauser, a 13-year-old boy from Minnesota with Hodgkin’s lymphoma who, after one round of chemotherapy, is currently refusing further therapy. This case ended up in court (as these cases often do) and led to a decision that is likely to satisfy no one (as these cases nearly always do).

Before I discuss Daniel’s case in more depth, however, let me make one thing clear. From my perspective, competent adults have the right to choose whatever treatment they wish–or to refuse treatment altogether–for virtually any condition. The sole exception that I can think of would be the case of a highly contagious infectious disease, where society has a right to prevent epidemics and, if necessary, quarantine someone who refuses treatment and refuses to avoid interaction with others. Note, however, that the right competent adults to choose whatever quackery they desire should in no way be construed to imply that quacks have any sort of “right” to provide them with quack treatments. The reason is that providing such treatments inherently involves making claims for them that are not supportable by science. In essence, selling such treatments involves fraud, even if the practitioner is a true believer and just as deluded about the efficacy of the woo he is selling as the person buying it is. Be that as it may, if a competent adult wants to refuse treatment and understands the consequences, then I will call him a fool if what he has is a potentially very curable disease like Hodgkin’s disease and chooses bogus (word choice intentional) alternative “cures” instead, but it’s his call.

However, from my perspective (and that of the law in most states) the key to such self-determination is that the person must be informed of and understand the consequences of his actions, and there are three components to this understanding. First, of course, is mental competence; i.e., no serious untreated mental illness that impairs a person’s ability to perceive reality can be present. Untreated schizophrenia, for example, can definitely interfere with a person’s ability to evaluate information. The second is the ability to understand the disease and what the consequences of treatment or doing nothing are. That is why adults with mental retardation severe enough to prevent them from understanding are in general not considered competent to make such decisions. Indeed, it is why parents are expected to act on the behalf of their normal children to make such decisions. Finally, there is informed consent. A person refusing treatment must be told the consequences of his refusal and acknowledge them. Whether he believes what he is told is another matter, but it is not up to physicians to force treatment on someone just because that person doesn’t believe what they tell him, as long as the first two conditions are met.

The conflict arises when a parent decides to pursue quackery for a life-threatening but potentially curable illness for a child or a child refuses therapy. It is on such occasions that society as represented by the state has a compelling interest in overriding the parent’s decision and making sure that the child gets the best science-based treatment available. It is also a situation when parental rights, rights of self-determination, and the legitimate interest of society in protecting children can all clash in a most chaotic and nasty manner. That is exactly what is at issue in the case of Daniel Hauser, as described in a news report of the testimony given in his case:
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Posted in: Cancer, Faith Healing & Spirituality, Medical Ethics, Science and the Media

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The Huffington Post‘s War on Medical Science: A Brief History

I realize that our fearless leader Steve Novella has already written about this topic twice. He has, as usual, done a bang-up job of describing how Arianna Huffington’s political news blog has become a haven for quackery, even going so far as to entitle his followup post The Huffington Post’s War on Science. And he’s absolutely right. The Huffington Post has waged a war on science, at least a war on science-based medicine, ever since its inception, a mere two weeks after which it was first noticed that anti-vaccine lunacy ruled the roost there. Because I’ve had experience with this topic since 2005, I thought I’d try to put some perspective on the issue, in order to show you just how pervasive pseudoscience has been (and for how long) at the blog whose name is often abbreviated as “HuffPo.”
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Posted in: Cancer, Health Fraud, Herbs & Supplements, Homeopathy, Politics and Regulation, Science and the Media, Vaccines

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Medical Propaganda Films

David Gorski suggested I expand on a comment I left recently on one of his November posts. His subject was the then new documentary movie, “A Beautiful Truth.“ “Truth” is about the Gerson method – the dietary deprivation cum coffee enema cancer treatment developed by Dr. Max Gerson, a refugeee from Germany I the 1930s. His daughter, Charlotte now runs the Gerson Institute in Tijuana, Mexico. Gerson is one of the models for the Gonzales method recently reviewed by Kim Atwood.

I had previously referred to the movie in a prior post (1) (but in a different context. Here I’ll explore the movie from a different angle – with its partners, propaganda documentaries.

David called my attention to “Truth” plus another by the same producer – with trailers on You Tube. When I watched the trailers last year I saw myself interviewed briefly, but could not recall being filmed, or even identify where the scene took place. I had to email Steve Barrett, also in the movie, who reminded me about filmmaker Steve Kroschel’s visits 2-3 years before, although neither did he have strong memory of the interview.
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Posted in: Cancer, Clinical Trials, Energy Medicine, Health Fraud, Herbs & Supplements, Nutrition, Science and Medicine, Science and the Media

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When Should We Call A Quack A Quack?

It is not uncommon for Science Based Medicine to receive complaints about the tone of our writing. Some people feel that it is indelicate to use the “q” word (for the uninitiated, “q” is for “quack”) when describing practitioners who promote disproven therapies with jubilant fervor. Others believe it unkind to lump “well meaning” alternative medicine experts in with those who are engaged in overtly illegal activities.

We are all affected by the tension between wanting to call a spade a spade and respecting our cultural need to be polite. Perhaps one of the clearest examples of this inner conflict is Orac’s Respectful Insolence blog. As the name implies, Orac is both thoughtful and brutally honest – he expresses our communal reticence to make waves, but follows up with a reasoned hostility that is quite understandable, given the circumstances described in each post. Respectful Insolence is fun to read because it is educational, persuasive, and expressive – and it captures how many of us feel about various forms of hucksterism. However, snake oil salesmen and their sympathizers are unlikely to enjoy the blog.

Here at Science Based Medicine, readers find a wide range of expression with a common commitment to science and reason. Just as physicians have different practice styles (some are more nurturing in temperament, others offer “tough love”) so too do we authors vary in tone. For those readers who favor one style over another – I hope you’ll find the voice that suits you and return regularly for more. Please don’t assume that one particular post is representative of the entire blog, and please don’t be offended by the legitimate exasperation of writers who have suffered through decades of observing swindlers swindle.
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Posted in: Cancer, Science and Medicine

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