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The “Gonzalez Trial” for Pancreatic Cancer: Outcome Revealed

A Review

Dr. Lipson’s “detoxification” post on Thanksgiving Day and Dr. Gorski’s recent post about “Gerson Therapy” were timely, because last weekend I noticed something that I should have noticed months ago. Before delivering the punch line, let me remind you, Dear Reader, of the nature of the topic. The regimen advocated by Nicholas Gonzalez is a variation of a “detoxification” treatment for cancer that has been around, in one form or another, for more than 50 years (“Gerson Therapy” is another example).† Here is the National Cancer Institute’s (NCI) description:

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.

As unlikely as it may seem, in 1999 American taxpayers began paying for people with cancer of the pancreas to be subjected to that regimen, in a trial sponsored by the National Center for Complementary and Alternative Medicine (NCCAM) and the NCI, conducted under the auspices of Columbia University. Gonzalez provided the treatments. A few months ago I presented a multi-part treatise on the “Gonzalez regimen” and the trial. It demonstrated that all evidence, from basic science to clinical, including the case series that supposedly provided the justification for the trial, had failed to support any real promise (the case series had previously been considered by reader Dr. Peter Moran, who also found them wanting).

It showed that the impetus for the trial, as has been true for other regrettable trials of implausible health claims, can be traced not to science but to the reactionary politics of anti-intellectual populism: initially to Laetrile and to the “Harkinites,” and more recently to the Honorable Dan Burton (R-IN). It reported that there were major problems with the Gonzalez trial from the outset, and that for at least one subject the regimen was more torture than therapy. It reported that for unclear reasons the trial had come to a halt a couple of years ago, and that it appeared that there would never be a report of its findings.

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Posted in: Cancer, Clinical Trials, Medical Academia, Medical Ethics, Politics and Regulation

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The (Not-So-)Beautiful (Un)Truth about the Gerson protocol and cancer quackery

Note added by editor: The complete movie is now available on YouTube:

The Beautiful Truth

Although this blog is about medicine, specifically the scientific basis of medicine and threats to the scientific basis of medicine regardless of the source, several of us also have an interest in other forms of pseudoscience and threats to other branches of science. One branch of science that is, not surprisingly, critical to medicine is the science of biology, and the organizing theory of biology is the theory of evolution, which was first reported by Charles Darwin and subsequently synthesized with the developing science of genetics in the early 20th century and then with our increasing knowledge of molecular biology, genomics, and proteonomics whose rise ushered us into the 21st century. However, the implications of evolution, namely that humans and apes both evolved from a common ancestor and that humans, for all their belief of being different and superior to animals, are in fact related to animals in the great chain of life going all the way back to single-celled organisms, does not go down well with certain religious fundamentalists, particularly Christian fundamentalists. Whereas I (and I daresay several of my cobloggers) find the interconnectedness of life, including humans, implied by Darwin’s theory to be beautiful and uplifting, many fundamentalists see it as a profound threat to their world view. Consequently, they have attacked the theory of evolution at every turn and tried to insert creationism, particularly the latest incarnation of creationism known as “intelligent design,” into science classes as an “alternative” to “Darwinism.” The manner in which they torture science, logic, and reason to try to cast doubt on a theory that is every bit as rock solid in terms of massive quantities of experimental and observational evidence to support it as any other theory in science, if not more so, is legendary and well documented at blogs such as The Panda’s Thumb and websites such as Talk Origins.

Although one day I plan on writing about how insights from evolutionary theory have led to deeper understandings of human disease and strategies to improve human health in the future, this time I want to concentrate on the similarities in techniques of spreading disinformation between creationists and purveyors of unscientific medical “treatments.” For background, first, you need to be aware of a movie that was released in April. The movie, Expelled!: No Intelligence Allowed was released. Starring Ben Stein at his most unctuous sporting a bullhorn and styling himself as a conservative, buttoned-down version of Angus Young through his choice of apparel in its promotional material, the movie’s main theme is that any academic who “questioned Darwinism” is “expelled” from academia. The basic idea is that “intelligent design” creationism is being “suppressed” by biologists who just can’t accept the thought of the existence of a “designer” (i.e., God). Indeed, the movie goes so far as to equate biologists and scientists who accept the theory of evolution as the best current explanation for the diversity of life to Hitler and the Nazis and their “suppression” of “alternatives” (word choice intentional) to “Darwinism” to Nazi and Stalinist persecution of dissidents and perceived threats to the regime. The movie even features a sequence where Ben Stein visits Dachau and Auschwitz, as though to imply that biologists are busy firing up the ovens for the Brave Maverick Scientists who “dissent from Darwin.”

These Brave Maverick Scientists are a lot like the Brave Maverick Doctors who champion unscientific medicine. After all, Kevin Trudeau has made a cottage industry and sold millions of books based on the claim that there are “natural cures” that “they” (as in doctors, pharmaceutical companies, and the government) don’t want you to know about and that as a consequence the full forces of these groups are being marshalled to “suppress” them and “persecute” the Brave Maverick Doctors who dare to question the “orthodoxy” of “allopathic medicine,” up to and including claims of “Nazi”-like suppression. (Just read those repositories of quackery NaturalNews.com and Whale.to if you don’t believe me.) For the “alternative medicine” movement, it’s all there, in websites, blogs, and books. But one thing that the movement pushing unscientific treatments has lacked, and that’s a movie to call its own, a movie to spread the same message.

That is, until now.

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Posted in: Cancer, Dentistry, Health Fraud, Science and the Media

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Vitamin Cocktail with a Meme Twist (Supplement my gimlet with a dash of dissonance)

A trail of recent reports is trying to tell us something. But are we listening, and are “they” listening? If so, does it mean the same to “them” as it does to us?

The report trail is telling us that multiple vitamins fail as preventatives against cardiovascular disease, cancer, or even for anything other than for dietary vitamin deficiency. And that is what we were saying in the first place – forty and more years ago.

Here is a partial list of these recent reports –  followed by an odd turn

Vitamins E and C were ineffective in preventing `cardiovascular disease in men. Sesso HD, Buring JE, Christen WG et al. JAMA, 2008;300 (Physicians’ Health Study II, mong 14,641 male physicians. [...] The study participants were randomized to receive 400 IU of vitamin E every other day or a placebo and 500 mg of vitamin C daily or a placebo.

B Vitamins (B12, B6, folate) May Not Reduce Cardiovascular Events For Coronary Artery Disease Patients Ebbing M, et al, JAMA 2008, Aug 20 — In a large clinical trial involving patients with coronary artery disease, use of B vitamins B6, B12, folate was not effective for preventing death or cardiovascular events. Patients were randomly assigned to one of four groups receiving a daily oral dose of one of the following treatments: folic acid, 0.8mg, plus vitamin B12 , 0.4mg, plus vitamin B6 , 40mg (n= 772); folic acid plus vitamin B12 (n = 772); vitamin B6 alone (n = 772); or placebo (n = 780).The study was stopped early because of concerns among the participants about preliminary results from another similar Norwegian study suggesting no benefits from the treatment and an increased risk of cancer from the B vitamins. Daily supplementation combination that included folic acid and vitamin B6 and B12 had no significant effect on the overall risk of cancer, including breast cancer, among women at high risk of cardiovascular disease. Zhang M et al, JAMA 2008 Nov. 5.

Certain Vitamin Supplements May Increase Lung Cancer Risk, Especially In Smokers. November 11, 2008, from American Thoracic Society. March of the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine.

Selenium and vitamin E supplements, taken either alone or together, did not prevent prostate cancer; these results came from initial, independent review of study data from the Selenium and Vitamin E Cancer Prevention Trial (SELECT), funded by the National Cancer Institute. (publication  Feb. 1 in the Journal of Clinical Oncology.)

These reports, along with those showing inefficacy of vitamin E in CV prevention and others, all in recent months, dovetail on more reported over the past decade. Now for the dissonance. A popular Web portal posted a brief questionnaire following one of last week’s reports. It asked readers to answer if they took vitamins regularly, infrequently, or not at all.
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Posted in: Cancer, Clinical Trials, Health Fraud, Herbs & Supplements, Nutrition, Politics and Regulation

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“Urban Zen” and homeopathy at Beth Israel Medical Center, or: Dr. Gorski destroys his chances of ever being invited to join the faculty at BIMC or the Albert Einstein College of Medicine

I guess I never really wanted to work in Manhattan anyway. At least, that’s what I keep telling myself.

I mean, why on earth would I want to? What’s the attraction? Living in the heart of it all, all those shows and all those amazing cultural activities, all those world-class restaurants? Being close to Boston, Philadelphia, and other cool East Coast cities, which are all just a quick Acela train ride away? Who cares about those things, anyway?

Apparently I don’t, because I’m about to destroy my chances of working at what has been considered one of the premiere academic hospitals in New York City, specifically Beth Israel Medical Center, an academic affiliate of the Albert Einstein College of Medicine. It’s possible for me to have been ignored when I first included the Albert Einstein College of Medicine and its affliated Continuum Center for Health & Healing in my roll call of shame as a medical center that has not just added woo to its offerings, but actively embraced it. At the time I originally discovered it, though, its offerings seemed limited to fairly mild woo, the usual stuff like acupuncture, what I like to call “gateway modalities” that centers embrace first because they’re relatively tame and commonplace. All too commonly, though, dabbling in gateway modalities leads to the “hard stuff,” outright quackery with zero scientific basis like homeopathy, reflexology, and craniosacral therapy. Such is the pathway an academic medical center follows when it degenerates from science-based medicine to what Dr. R. W. famously dubbed “quackademic medicine,” usually driven by a few famous true believers, which, alas, is exactly what happened at fearless leader Steve Novella’s institution of Yale, thanks to Dr. David Katz and his “more fluid concept of evidence.”

In any case, last week, I realized that I’ve been completely neglecting the aforementioned roll call of shame. Perusing it, I now realize that it’s been over five months since I did a significant update to it. You just know that, given the rate of infiltration of unscientific medical practices into medical academia as seemingly respectable treatment modalities that there must be at least several new additions to this roll of shame. Alas, even today, having been shamed myself by the realization of my failure to keep the list updated, I’m not going to do the full update and revamping that the Roll Call of Quackademic Medicine cries out for. However, that doesn’t mean I can’t do a piecemeal addition here and there. That doesn’t mean I can’t point out new additions as they pop up, even if it takes me a while to find the time to give the list the facelift it cries out for. It doesn’t mean I can’t call out hospitals like Beth Israel when they fall into woo, especially when they dive into quackademic medicine in a big way for cancer patients.
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Posted in: Cancer, Homeopathy, Medical Academia, Science and the Media

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Vitamin C strikes (out) again

I didn’t think I’d be revisiting this topic again so soon. After all, I wrote one of my characteristic magnum opuses (opi?) less than two months ago, when I asked whether a recent animal study had vindicated Linus Pauling’s belief that high dose vitamin C is a highly effective cancer treatment. After that tsunami of verbiage that can only be exceeded by my fellow blogger Dr. Atwood when he’s on a roll doing a multipart deconstruction of some woo or other, I thought it would be best to give it a rest for a while. I guess less than two months will have to be enough.

The reason struck me as I was perusing the very latest issue of Cancer Research, hot off the presses October 1. As I did so, it didn’t take me long to come across an article from the Memorial-Sloan Kettering Cancer Center and the Herbert Irving Comprehensive Cancer Center at Columbia entitled Vitamin C Antagonizes the Cytotoxic Effects of Antineoplastic Drugs, whose first author is Dr. Mark Heaney.

Once more into the fray!
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Posted in: Basic Science, Cancer, Herbs & Supplements, Nutrition

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“Patient-Centered Care” and the Society for Integrative Oncology

Should Medical Journals Inform Readers if a Book Reviewer can’t be Objective?

At the end of last week’s post I suggested that book reviewer Donald Abrams and the New England Journal of Medicine had withheld information useful for evaluating Abrams’ review: that he is the Secretary/Treasurer of the Society for Integrative Oncology (SIO), the organization of which Lorenzo Cohen, the first editor of the book that Abrams reviewed,* is President. I also promised to look at material from the book and from the Society’s website in order to discover “data that will allow even the most conventional oncologists to appreciate [the value of 'integrative' methods].”

There is little question that Abrams and Cohen know each other, or at least that Abrams couldn’t have been expected to write an entirely objective review of Cohen’s book. Abrams is the Program Chair for the Society’s upcoming 5th International Conference, sponsored by the American Cancer Society. He and Cohen will be sharing the stage for the “Intro/Welcome.” Does it matter that most NEJM readers wouldn’t have learned of this association by reading the review? Probably not, in the case of readers who are well-versed in the misleading language of “CAM.”

I believe that most readers of medical journals are not so sophisticated. Otherwise, how could it have been so easy for “CAM” literature to seep through the usual evaluative filters, not only in medical schools and government but in the editorial boardrooms of prestigious journals? For anyone from the Journal who might be following this thread, Dr. Sampson’s satirical but deadly serious account of “how we did it” is obligatory reading.

Do “Integrative Oncology” Methods have Value?

Now let’s take a look at what Dr. Cohen’s book and the SIO are up to. The book’s introduction and table of contents are available on Amazon.com. The introduction contains the usual, misleading assertions and falsehoods that are ubiquitous in “CAM” promotions. I’ve added a few hyperlinks:

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Posted in: Book & movie reviews, Cancer, Energy Medicine, Medical Ethics

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The New England Journal of Medicine Disappoints

On July 31 of this year, a collective groan could be heard emanating from critics of pseudomedicine. The causative factors (which is medical bombast for “the cause”) were two book reviews published in the usually staid New England Journal of Medicine (NEJM):

Integrative Oncology: Incorporating Complementary Medicine into Conventional Cancer Care

Edited by Lorenzo Cohen and Maurie Markman. 216 pp., illustrated. Totowa, NJ, Humana Press, 2008. $79.95. ISBN 978-1-58829-869-0.
Reviewed by Donald I. Abrams

Alternative Medicine? A History

By Roberta Bivins. 238 pp., illustrated. New York, Oxford University Press, 2008. $35. ISBN 978-0-19-921887-5.
Reviewed by Teresa L. Schraeder

The Wooification of Medical Journals

I’ll review the reviews, but first let’s consider why their presence in the NEJM is so disturbing. The NEJM is the most widely read and cited medical journal in the world. Among American journals, the top three are usually reckoned to be the NEJM, the Journal of the American Medical Association (JAMA) and, at least for internists, the Annals of Internal Medicine (Ann Int Med). The extent to which each journal has sacrificed its integrity for the promotion of the recent wave of pseudomedicine has varied among the three: the NEJM rarely and, for the most part, unwittingly; JAMA famously in 1998 and occasionally since; and the Ann Int Med repeatedly and embarrassingly, most notably with a series of puff pieces on “CAM” that spanned several years and violated the Annals’ own policies regarding funding disclosures by authors and editors.

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Posted in: Book & movie reviews, Cancer, Medical Academia

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High dose vitamin C and cancer: Has Linus Pauling been vindicated?

ResearchBlogging.orgTHE ZOMBIE RISES AGAIN

Vitamin C as a treatment for cancer is back in the news again.

I’m not surprised. This is one therapy favored by advocates of “alternative” medicine that keeps popping up periodically (seemingly every couple of years or so). This latest bit of news has turned up almost right on time after the last time there was a push for rehabilitating vitamin C as a cancer cure a couple of years ago. Back in the spring of 2006, there were two studies published (more on them later) which were touted by the “complementary and alternative medicine” (CAM) crowd as evidence that Linus Pauling was supposedly vindicated. A little less than two weeks ago, an animal study was published suggesting that high-dose intravenous vitamin C had antitumor activity in mouse models. A couple of weeks prior, there had also been published a phase I clinical trial that showed that megadoses of IV ascorbate were safe and well-tolerated in cancer patients if they were appropriately screened for renal disease. Given the latest studies of this particular modality against cancer, it seemed like an opportune time for me to examine this new evidence and ask the question: Has Linus Pauling been vindicated?

I’ll cut to the chase. The short answer is: Not really, with the qualification that it depends on what you mean by “vindicated.” The long answer follows.
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Posted in: Basic Science, Cancer, Clinical Trials, Nutrition, Science and the Media

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The Orange Man

The first thing that struck me about him was that he was orange.

It was not a shade of orange I had ever ever encountered before in a patient. It was a yellowish orange, an almost artificial-looking color. At first I wondered if he was suffering from liver failure with jaundice, but this orange was just not the right shade of yellow for jaundice, and his sclerae were not yellow. I also considered whether he was suffering from renal failure, but the orange color of his skin didn’t quite match the rather coppery color that some patients suffering from longstanding renal failure necessitating dialysis sometimes acquire. I was puzzled. His chart said that he was being admitted for surgery for rectal cancer. So I sent the intern in to get the story, do the history and physical, and get him all plugged in for his bowel prep. Believe it or not, there was actually a time when it was not all that uncommon for patients to come into the hospital the night before major abdominal surgery in order to undergo a preoperative bowel prep, rather than being forced by their insurance companies to undergo the torture of drinking four liters of the purgative known as Go-Lytely–a misnomer, if ever there was one!–at home and spending the next several hours having to rush periodically to the toilet, waiting in vain for the liquid exploding out of their hind end to run clear.
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Posted in: Cancer, Clinical Trials, Science and Medicine, Surgical Procedures

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Cell phones and cancer again, or: Oh, no! My cell phone’s going to give me cancer!

Before I start into the meat of this post, I feel the need to emphasize, as strongly as I can, four things:

  1. I do not receive any funding from the telecommunications industry in general, or wireless phone companies in particular. None at all. In other words, I’m not in the pocket of “big mobile” any more than I am in the pocket of big pharma.
  2. I don’t own any stock in telecommunications companies, other than as parts of mutual funds in which my retirement funds are invested that purchase shares in many, many different companies, some of which may or may not be telecommunications companies. (I should probably go and look at the list.)
  3. None of my friends or family work for cell phone companies.
  4. I don’t have a dog in this hunt. I really don’t.

I say this because these are the most common accusations I hear whenever I venture into this particular topic area, and I thought I’d just clear that up right away in order (hopefully) to preempt any similar comments after this post. Indeed, one of the favorite retorts to anyone who criticizes fearmongering about cell phones is to try to insinuate that that person is only doing so because he or she is in the pocket of industry, and I’ve been at the receiving end of such claims. Unfortunately, I’m sure someone will probably show his or her lack of reading comprehension and post one of those very criticisms of me. It’s almost inevitable. Even though posting such disclaimers never works against the “pharma shill” gambit when I write about vaccines or dubious cancer cures, nonetheless hope springs eternal.

Now that that obligatory unpleasantness is out of the way, let me move on to say that I’m very puzzled about something that happened last week.

I know that being puzzled isn’t particularly unusual for me. Indeed, I’m frequently puzzled about a great many things. I can’t figure out how, for example, anyone with the slightest bit of reason or critical thinking ability can believe that homeopathy is anything other than water treated with, in essence, magical spells accompanied by shaking or do anything other than laugh when informed what homeopathy really is and how it supposedly “works.” I can’t figure out how anyone can look at the mass of interlocking evidence from multiple different scientific specialties supporting evolution and reject still reject one of the most powerful scientific theories ever to spring from the human mind, deciding instead that creationism or its bastard offspring, “intelligent design” creationism is anything more than pure religion or rank religion-inspired pseudoscience. I can’t figure out why American Idol or Survivor is so amazingly popular.

And I can’t figure out why on earth the University of Pittsburgh Cancer Center released this warning about cell phones last week:

PITTSBURGH July 24, 2008, 07:13 am ET · The head of a prominent cancer research institute issued an unprecedented warning to his faculty and staff Wednesday: Limit cell phone use because of the possible risk of cancer.

The warning from Dr. Ronald B. Herberman, director of the University of Pittsburgh Cancer Institute, is contrary to numerous studies that don’t find a link between cancer and cell phone use, and a public lack of worry by the U.S. Food and Drug Administration.

Herberman is basing his alarm on early unpublished data. He says it takes too long to get answers from science and he believes people should take action now — especially when it comes to children.

“Really at the heart of my concern is that we shouldn’t wait for a definitive study to come out, but err on the side of being safe rather than sorry later,” Herberman said.

Dr. Herberman is a highly respected cancer center director whom I’ve in general thought well of, and the University of Pittsburgh Cancer Institute is a highly respected cancer center. I know a few people there, and in the past I’ve worked closely with two surgeons who trained there. One in particular remains my collaborator, even though I’ve moved on from the institution where we were once partners.

That’s why I can’t help but wonder just what on earth Dr. Herberman was smoking when he decided to issue this warning, given my general respect for the University of Pittsburgh to the point where I once even tried to land a faculty position there. His announcement strikes me as being rash in the extreme, especially given that its text even admits outright that the published data at present do not appear to support a link between cell phone use and brain tumors. Consequently, I conclude that this is alarmism that, I suspect, even a prominent blogger known to be somewhat receptive to the claim that cell phones cause brain tumors (Revere) would have a hard time supporting, because it goes far beyond the published evidence and is based on “early unpublished data.” Scaring the nation based on “early unpublished data” that can’t be examined by the entire medical and scientific community is generally not a good idea. That’s why I’ve been asking over the last few days: Why on earth did Dr. Herberman do it?
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Posted in: Cancer, Public Health, Science and Medicine, Science and the Media

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