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The Mammogram Post-Mortem

The Mammogram Post Mortem
Steve Novella whimsically opined on a recent phone call that irrationality must convey a survival advantage for humans. I’m afraid he has a point.
It’s much easier to scare people than to reassure them, and we have a difficult time with objectivity in the face of a good story. In fact, our brains seem to be hard wired for bias – and we’re great at drawing subtle inferences from interactions, and making our observations fit preconceived notions. A few of us try to fight that urge, and we call ourselves scientists.
Given this context of human frailty, it’s rather unsurprising that the recent USPSTF mammogram guidelines resulted in a national media meltdown of epic proportions. Just for fun, and because David Gorski nudged me towards this topic, I’m going to review some of the key reasons why the drama was both predictable and preventable.  (And for an excellent, and more detailed review of the science behind the kerfuffle, David’s recent SBM article is required reading. http://www.sciencebasedmedicine.org/?p=1926 )
Preamble
In an effort to increase early detection of breast cancer, American women have been encouraged to get annual screening mammograms starting at age 40. Even though mammograms aren’t as sensitive and specific as we’d like, they’re the best screening test we have – and so with all the caveats and vagaries associated with what I’d call a “messy test,” we somehow collectively agreed that it was worth it to do them.
Now, given the life-threatening nature of breast cancer, it’s only natural that advocacy groups and professional societies want to do everything in their power to save women from it. So of course they threw all their weight behind improving compliance with screening mammograms, and spent millions on educating women about the importance of the test. Because, after all, there is no good alternative.
However, the downside of an imprecise test is the false positive results that require (in some cases) invasive studies to refute them.  And so this leaves us with 2 value judgments:  how many women is it acceptable to harm (albeit it mildly to moderately) in order to save one life? Roughly, the answer is a maximum of 250 over 10 years (I came up with that number from the data here: http://www.sciencebasedmedicine.org/?p=565 if as many as half of women receive a “false alarm” mammogram over a period of 10 years of testing, and half of those undergo an unnecessary biopsy). And second: how many tests are we willing to do (this is more-or-less an economic question) to save 1 life? The answer is roughly 1900.
So when the USPSTF took a fresh look at the risks and benefits of mammography and recommended against screening average risk women between 40-50 (and reducing mammogram frequency to every other year for those over 50), what they were saying is that they would rather injure fewer women and do fewer costly tests for the trade off of saving fewer lives. In fact, their answer was that they were willing to perform 1300 mammograms to save 1 life, not 1900 (as has been our standard of care).
This value judgment is actually not, in and of itself, earth shattering or irresponsible. But it’s the societal context into which this judgment was released that made all the difference.
1. Timing Is Everything: Or, why not to bring a party hat to a funeral
First of all, it’s almost amusing how bad the timing of the USPSTF guidelines really were. The country was in the midst of trying to pass our country’s first serious healthcare reform bill in decades (at least, the house reform bill was being voted upon the week that the USPSTF guidelines were released) and opponents of the bill had already expressed vehement concern about arbitrary government rationing of healthcare services.
What worse time could there have been to announce that a government agency is (against the commonly held views of the rest of the medical establishment) recommending reduction in frequency  of a life-saving screening test for women? The fact that the guidelines leader said she hadn’t thought about the greater context when she scheduled the press release is quite astonishing. On the one hand, I suppose it shows how disconnected from potential political bias the workgroup really is. On the other hand, it is violates Public Relations 101 so completely as to call into question the judgment of those making… er… judgments.
2. You Can’t Replace Something With Nothing: Or How To Take Scissors From A Baby
Let’s just say for a moment that we all agree that mammograms aren’t the greatest screening test for breast cancer. They’re rather expensive, and wasteful perhaps one might even argue that in a healthcare system with limited resources, one healthy woman’s screening test is another woman’s insulin.  But – it’s all we have. And they do save lives… occasionally.
Anyone who’s seen a child pick up something harmful realizes that the only way to take it from them without tears is to replace it with something harmless. You can’t just take away mammograms from women who have come to expect it, without offering them something more sensible. If there is nothing, then I’m afraid that discontinuing them will result in considerable outrage which you may or may not wish to engage. Given the size and power of the breast lobby – I’d say it’s pretty much political suicide.
3. Know Your Opposition: Or Don’t Bring A Knife To A Gun Fight
And that brings me to point #3. The breast cancer movement is one of the most powerful and successful disease fighting machines in the history of medicine. And bravo to all the women and men who made it such a visible disease. The amount of funding, research, and PR that this cancer gets is astounding – it dwarfs many other worthy diseases (like pancreatic cancer or lymphoma), and is a force to be reckoned with.
Which is why, before you undermine a cherished tenet of such a group, you take a long hard look at what you’re going to say… Because it will be shouted from the hilltops, scrutinized from every conceivable angle, and used to rally all of Hollywood, the medical establishment, and everyone in Washington to its cause. Yeah, you better be darn sure you’re “right” (whatever that means in this context) before attempting to promote a service cut back to this group.
4. Know Who You Are: Or Unilateral Decision Making Is Not A Great Idea – Especially For Government
And finally, it’s important not only to know who you’re dealing with, but to know your mission in society so you can be maximally effective. The US government exists to honor the will of the people and serve its citizens. The best way to do that is to listen to them carefully, engage in consensus-building, and try to be a good steward of resources. When government behaves in ways counter to our expectations, it provokes some legitimate negativity.
So, for example, when a small group of civil servants hole themselves up in a room to create guidelines that will potentially take preventive health services away from women – resulting in a larger number of deaths each year… and they don’t invite input from key stakeholders, and announce their views in the midst of a firestorm about “rationing”
In summary
The new USPSTF guidelines for mammogram screenings debacle serves as a perfect public relations case study in what not to do in advancing healthcare reform. It was the perfect storm of high profile subject, bad timing, poor argument preparation, and lack of back up planning. Though we could have had a rational discussion about the cost/benefit analysis of this particular screening test, what we got instead was the appearance of a unilateral rationing decision by an out-of-touch government organization, devaluing women to the point of death. Throw that chum in the water of human frailty and you’ll get the same result every time: a media feeding frenzy that makes you regret the moment that guideline development became a twinkle in your task force eye.

Steve Novella whimsically opined on a recent phone call that irrationality must convey a survival advantage for humans. I’m afraid he has a point.

It’s much easier to scare people than to reassure them, and we have a difficult time with objectivity in the face of a good story. In fact, our brains seem to be hard wired for bias – and we’re great at drawing subtle inferences from interactions, and making our observations fit preconceived notions. A few of us try to fight that urge, and we call ourselves scientists.

Given this context of human frailty, it’s rather unsurprising that the recent USPSTF mammogram guidelines resulted in a national media meltdown of epic proportions. Just for fun, and because David Gorski nudged me towards this topic, I’m going to review some of the key reasons why the drama was both predictable and preventable.  (And for an excellent, and more detailed review of the science behind the kerfuffle, David’s recent SBM article is required reading.)

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Posted in: Cancer, Public Health, Science and the Media

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The USPSTF recommendations for breast cancer screening: Not the final word

Preface: On issues such as this, I think it’s always good for me to emphasize my disclaimer, in particular:

Dr. Gorski must emphasize that the opinions expressed in his posts on Science-Based Medicine are his and his alone and that all writing for this blog is done on his own time and not in any capacity representing his place of employment. His views do not represent the opinions of his department, university, hospital, or cancer institute and should never be construed as such. Finally, his writings are meant as commentary only and are therefore not meant to be used as specific health care recommendations for individuals. Readers should consult their physicians for advice regarding specific health problems or issues that they might have.

Now, on to the post…

“Early detection saves lives.”

Remember how I started a post a year and a half ago starting out with just this statement? I did it because that is the default assumption and has been so for quite a while. It’s an eminently reasonable-sounding concept that just makes sense. As I pointed out a year and a half ago, though, the question of the benefits of the early detection of cancer is more complicated than you think. Indeed, I’ve written several posts since then on the topic of mammography and breast cancer, the most recent of which I posted a mere two weeks ago. As studies have been released and my thinking on screening for breast cancer has evolved, regular readers have had a front row seat. Through it all, I hope I’ve managed to convey some of the issues involved in screening for cancer and just how difficult they are. How to screen for breast cancer, at what age to begin screening, and how to balance the benefits, risks, and costs are controversial issues, and that controversy has bubbled up to the surface into the mainstream media and public consciousness over the last year or so.

This week, all I can say is, “Here we go again”; that is, between downing slugs of ibuprofen for the headaches some controversial new guidelines for breast cancer screening are causing many of us in the cancer field.
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Posted in: Cancer, Diagnostic tests & procedures, Politics and Regulation, Public Health

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Cancer prevention: The forgotten stepchild of cancer research?

The New York Times has been periodically running a series about the “40 years’ war” on cancer, with most articles by Gina Kolata. I’ve touched on this series before, liking some parts of it, while others not so much. In particular, I criticized an article one article that I thought to be so misguided about how the NIH grant system leads researchers to “play it safe” and how we could cure cancer if we could just fund “riskier” research that I had to write an extended screed about the misconceptions in the article. The latest installment, Medicines to Deter Some Cancers Are Not Taken, also by Kolata, is much better in that it discusses a problem at the heart of cancer, namely that we have developed drugs that can decrease the risk of specific cancers but they are not as widely used as they could be.

The first part of the article contrasts a seeming incongruity:

Many Americans do not think twice about taking medicines to prevent heart disease and stroke. But cancer is different. Much of what Americans do in the name of warding off cancer has not been shown to matter, and some things are actually harmful. Yet the few medicines proved to deter cancer are widely ignored.

Take prostate cancer, the second-most commonly diagnosed cancer in the United States, surpassed only by easily treated skin cancers. More than 192,000 cases of it will be diagnosed this year, and more than 27,000 men will die from it.

And, it turns out, there is a way to prevent many cases of prostate cancer. A large and rigorous study found that a generic drug, finasteride, costing about $2 a day, could prevent as many as 50,000 cases each year. Another study found that finasteride’s close cousin, dutasteride, about $3.50 a day, has the same effect.

This is indeed a contrast. Think about it. Millions of Americans take statins, for instance, to lower their cholesterol and thereby try to prevent the complications of elevated cholesterol, such as heart disease, vascular disease, and strokes. Yet, for at least two common cancers, there are proven effective drugs that will lower the risk of cancer considerably with a side effect profile at least as favorable as that of statins.
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The cancer screening kerfuffle erupts again: “Rethinking” screening for breast and prostate cancer

I see that the kerfuffle over screening for cancer has erupted again to the point where it’s found its way out of the rarified air of specialty journals to general medical journals and hence into the mainstream press.

Over the last couple of weeks, articles have appeared in newspapers such as the New York Times and Chicago Tribune, radio networks like NPR, and magazines such as TIME Magazine pointing out that a “rethinking” of routine screening for breast and prostate cancer is under way. The articles bear titles such as A Rethink On Prostate and Breast Cancer Screening, Cancer Society, in Shift, Has Concerns on Screenings, Cancers Can Vanish Without Treatment, but How?, Seniors face conflicting advice on cancer tests: Benefit-risk questions lead some to call for age cutoffs, and Rethinking the benefits of breast and prostate cancer screening. These articles were inspired by an editorial published in JAMA last month by Laura Esserman, Yiwey Shieh, and Ian Thompson entitled, appropriately enough, Rethinking Screening for Breast Cancer and Prostate Cancer. The article was a review and analysis of recent studies about the benefits of screening for breast and prostate cancer in asymptomatic populations and concluded that the benefits of large scale screening programs for breast cancer and prostate cancer tend to be oversold and that they come at a higher price than is usually acknowledged.

For regular readers of SBM, none of this should come as a major surprise, as I have been writing about just such issues for quite some time. Indeed, nearly a year and a half ago, I first wrote The early detection of cancer and improved survival: More complicated than most people think. and then followed it up with Early detection of cancer, part 2: Breast cancer and MRI. In these posts, I pointed out concepts such as lead time bias, length bias, and stage migration (a.k.a. the Will Rogers effect) that confound estimates of benefit due to screening. (Indeed, before you continue reading, I strongly suggest that you go back and read at least the first of the aforementioned two posts to review the concepts of lead time bias and length bias.) Several months later, I wrote an analysis of a fascinating study, entitling my post Do over one in five breast cancers detected by mammography alone really spontaneously regress? At the time, I was somewhat skeptical that the number of breast cancers detected by mammography that spontaneously regress was as high as 20%, but of late I’m becoming less skeptical that the number may be somewhere in that range. Even so, at the time I did not doubt that there likely is a proportion of breast cancers that do spontaneously regress and that that number is likely larger than I would have guessed before the study. Of course, the problem is that we do not currently have any way of figuring out which tumors detected by mammography will fall into the minority that do ultimately regress; so we are morally obligated to treat them all. My most recent foray into this topic was in July, when I analyzed another study that concluded that one in three breast cancers detected by screening are overdiagnosed and overtreated. That last post caused me the most angst, because women commented and wrote me asking me what to do, and I had to answer what I always answer: Follow the standard of care, which is yearly mammography over age 40. This data and these concerns have not yet altered that standard of care, and I am not going to change my practice or my general recommendations to women until a new consensus develops.
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Posted in: Cancer, Diagnostic tests & procedures, Public Health, Science and the Media

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Mainstreaming Science-Based Medicine: A Novel Approach

I have often mused about the difference between being right and being influential – especially in light of the relative success of the anti-vaccine movement. Despite the fact that there is no evidence for a link between vaccines and autism, celebrities like Jenny McCarthy have manufactured public mistrust in one of the safest, most cost effective means of combating disease known to humankind.

So if scientists are not persuading the public with appeals to carefully designed trials and factual data, how should they make their point? I’m not sure I have the full answer, but I think I might have struck a nerve with the public lately. I decided to try a novel approach to communicating my concerns about pseudoscience on the Internet – and presented 20 slides at 20 second intervals to a conference of ePatients in Philadelphia. I did it with powerful and humorous images, tied together with a long Limerick. Sound kooky? Maybe so… but it resonated, and was received with cheers and applause. Now that’s how we like science to be recognized! (more…)

Posted in: Cancer, Science and the Media

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Suzanne Somers’ Knockout: Dangerous misinformation about cancer (part 1)

If there’s one thing I’ve become utterly disgusted with in the time since I first became interested in science-based medicine as a concept, its promotion, and the refutation of quackery and medical pseudoscience, it’s empty-brained celebrities with an agenda. Be it from imbibing the atmosphere within the bubble of woo-friendly southern California or taking a crash course at the University of Google and, through the arrogance of ignorance, concluding that they know more than scientists who have devoted their lives to studying a problem, celebrities believing in and credulously promoting pseudoscience present a special problem because of the oversized soapboxes they command. Examples abound. There’s Bill Maher promoting anti-vaccine pseudoscience, germ theory denialism, and cancer quackery on his show Real Time with Bill Maher and getting the Richard Dawkins Award from the Atheist Alliance International in spite of his antiscience stances on vaccines and what he sneeringly calls “Western medicine.” Then there are, of course, the current public faces of the anti-vaccine movement, Jenny McCarthy and her boyfriend Jim Carrey, the former of whom thinks it’s just hunky dory (or at least doesn’t appear to be the least bit troubled) that her efforts are contributing to the return of vaccine-preventable infectious diseases because she apparently thinks that’s what it will take to make the pharmaceutical companies change their “shit” product (her words), and the latter of whom spreads conspiracy theories about vaccines and contempt on people suffering from restless leg syndrome. Finally, there’s the grand macher of celebrity woo promotion, Oprah Winfrey, who routinely promotes all manner of medical pseudoscience, be it “bioidentical” hormones, the myth that vaccines cause autism (even hiring Jenny McCarthy to do a blog and develop a talk show for her company Harpo Productions), or other nonsense, such as Christiane Northrup urging Oprah viewers to focus their qi to their vaginas for better sex.

Unfortunately, last week the latest celebrity know-nothing to promote health misinformation released a brand new book and has been all over the airwaves, including The Today Show, Larry King Live, and elsewhere promoting it. Yes, I’m talking about Suzanne Somers, formerly known for her testimonial of having “rejected chemotherapy and tamoxifen” for her breast cancer, as well as her promotion of “bioidentical hormones,” various exercise devices such as the Thighmaster and all manner of supplements. Her book is entitled Knockout: Interviews with Doctors Who Are Curing Cancer–And How to Prevent Getting It in the First Place. It is described on the Random House website thusly:
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Posted in: Book & movie reviews, Cancer, Science and the Media

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The “Iron Rule of Cancer”: The dangerous cancer quackery that is the “German New Medicine”

Given that I trained as a cancer surgeon, do laboratory and translational cancer research, and spend my clinical time taking care of breast cancer patients, not surprisingly one topic that gets me the most irritated and provokes a lot of my verbiage for SBM is cancer quackery. As I was perusing my list of posts the other day, it occurred to me that there’s one huge topic that in the more than a year and a half I’ve been blogging for SBM I’ve never covered. It’s a particularly pernicious and dangerous quackery. Indeed, it’s a quackery I mentioned during part of my talk at the Science-Based Medicine Conference, which Steve organized and where several SBM bloggers spoke the day before TAM7 started.

I’m referring to the dangerous and vile quackery known as the German New Medicine (Die Germanische Neue Medizin). Pioneered by Ryke Geerd Hamer, it is a quackery that claims lives. So what is this German New Medicine? Well, it appears to be a Theory of Everything Medical, and in particular everything having to do with cancer:

THE GERMAN NEW MEDICINE provides us with illuminating explanations about the origin, development and healing of both physical and mental disorders. In 1981, Dr. Hamer discovered that every DISEASE is caused by a shock experience that catches us completely off guard. He found that this shock not only occurs in the psyche but simultaneously in the brain and on the organ level. At the moment the unexpected trauma takes place the shock impacts a specific area in the brain causing a lesion that is clearly visible on a brain scan as a set of sharp concentric rings. With the impact the affected brain cells communicate the disturbance to the corresponding organ. Whether the organ responds with a tumor growth (cancer), with tissue degeneration, or with functional loss, is determined by the exact type of conflict shock. Based on the analysis of over 40,000 case studies Dr. Hamer is the first to provide scientific proof that cancer is not caused by a malfunctioning organism producing deadly cancer cells but is rather the result of an innate meaningful survival program that has been successfully practiced for millions of years. Since HEALING can only occur after the conflict has been resolved, the GNM-therapy focuses on identifying and resolving the original conflict. By understanding healing symptoms such as painful swelling, infections, fever, or inflammation in their psychological, biological and evolutionary context, we are able to liberate ourselves from the fear and panic that often come with the onset of an illness. Dr. Hamer’s findings offer a completely new understanding of so-called diseases. His scientific discoveries revolutionize entirely our view of medical conditions and their causes.

The German New Medicine presents a comprehensive system that allows us to understand what type of conflict causes the onset of a particular disease, how the disease manifests itself in the conflict active phase, what can be expected in the healing phase, and how all the developments are connected to the brain, verifiable with a brain scan.

The German New Medicine is a natural science, based on FIVE empirically disovered BIOLOGICAL LAWS that apply, in a strong scientific sense, to each and every case of disease of man and mammal.

The repository of quackery known as Mercola.com describes the “Five Biological Laws” of German New Medicine thusly:
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Posted in: Cancer, Health Fraud, Science and Medicine

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Bill Maher endorses cancer quackery

Over the last five years or so, I’ve often asked, “Is Bill Maher really that ignorant?” I’ve come to the conclusion that he is, and a couple of weeks ago laid out the evidence why right here on this very blog. (Lately Maher has been issuing Tweets that call people who get flu shots “idiots.”) Indeed, I even included in the post perhaps the most hilariously spot-on riposte to Maher’s crankery. This occurred when Maher proclaimed that he never gets the flu and wouldn’t get the flu on an airplane, which his guest Bob Costas to exclaim in exasperation, “Oh, come on, Superman!”

Bob Costas won my respect that day. My favorite part was when Maher looked at his guests, who were shifting in their seats, all embarrassed and unsure of what to say, and observed, “You all look at me as though I’m crazy.”

Why, yes, Bill, we do. Let’s put it this way. When Age of Autism likes you, you have a serious problem when it comes to being credible about medical science.

In that same post, I complained about Maher’s being awarded the Richard Dawkins Award by the Atheist Alliance International (AAI). I liken giving Bill Maher an award that lists “advocates increased scientific knowledge” anywhere in its criteria, not to mention being named after Richard Dawkins, to giving Jenny McCarthy an award for public health, given that, at least when it comes to medicine, Maher is anti-science to the core. Along the way, I’ve ruffled the feathers of some of both Dawkins’ and Maher’s fans.

I regret nothing.

Not only do I regret nothing, but on September 18, a mere two weeks before the AAI Convention, Maher provided me with more ammunition. In fact, this is probably the most blatant bit of crankery I’ve seen from Maher in a long time. Watch and learn. The “alternative medicine” nuttery begins at around the 0:50 mark:

Laetrile? Really? Laetrile?? How 1970s cancer quackery!
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Posted in: Cancer, Faith Healing & Spirituality, Health Fraud, Science and the Media, Vaccines

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Tom Harkin, NCCAM, health care reform, and a cancer treatment that is worse than useless

ResearchBlogging.orgPRELUDE: SOME BAD NEWS FOR ADVOCATES OF SCIENCE-BASED MEDICINE

It was a bad week for science-based medicine. It was a good week (sort of) for science-based medcine.

First the bad.

There has been a development that anyone who supports science in medicine and opposes quackery will likely find disturbing. Do you remember Senator Tom Harkin (D-IA)? We’ve written about him extensively over the last several months on this blog. First of all, he is the man most responsible for the creation of that government-sanctioned, government-funded bastion of pseudoscience, the National Center for Complementary and Alternative Medicine. He’s also one of the men most responsible for the Dietary Supplement Health and Education Act (DSHEA) of 1994, which has done more to protect the supplement industry from making dubious health claims than any other piece of federal legislation. More recently, Harkin has made a name for himself in the health care reform debate currently ongoing by inviting advocates of “integrative” medicine (IM), which in essence integrates quackery and the pseudoscientific with scientific medicine, to Capitol Hill as a means of trying to persuade his fellow legislators to include a CAM/IM version of “wellness” care as part of any bill that might pass this fall. In essence, he is trying to hijack any health care reform bill to include government sanction of unscientific medicine. Meanwhile, he has been chastising NCCAM because it hasn’t “validated” enough “alternative medicine” for his taste. (Actually, it’s validated none, because virtually none of it is likely to be valid.)

This is the man who, according to reports, will almost certainly be taking over the chair of the Senate Committee on Health, Education, Labor, and Pensions (HELP) after the death of its former chair, Senator Edward Kennedy. This committee is among the most important for government health policy and will be in the thick of the final negotiations and battles over any health care reform that may arise from Congress this fall.

The existence of powerful supporters of pseudoscience in the highest eschelons of government has real consequences. As I’ve described before, NCCAM, being based entirely on studying highly–even ridiculously implausible–notions about disease and how to treat it, has resulted in the infiltration of quackery into academia, where ideas once rightly dismissed as quackery are respectfully given deference and studied as though they were anything other than Tooth Fairy science, a process that Dr. R. W. Donnell has amusingly termed “quackademic medicine.” One result was the expenditure of $30 million on an unethical, poorly designed, and corrupt trial of chelation therapy for cardiovascular disease. Another result was an even more unethical trial of an even more scientifically implausible remedy for a deadly cancer. Although the fact that the trial was even done is a horror, at least last week we finally found out the results, which had been suppressed for nearly four years, namely that this protocol is not just useless, but worse than useless. It’s a Pyrrhic victory for science-based medicine and cold comfort to patients with pancreatic cancer who may have continued to use this protocol during those four years, but at least we finally know.

Let’s take a look at the study. But first, a little background.
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Posted in: Cancer, Clinical Trials, Politics and Regulation

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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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