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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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Protandim: Another Kind of Antioxidant

Four years ago I received an e-mail inquiry about Protandim. I had never heard of it; but I looked it up and wrote a quick, informal, somewhat snarky answer that got posted on the Internet. It got a lot of attention. Googling for Protandim now brings up my critique right after the Protandim website itself: that can’t be good for sales. Over the years, several e-mails and blog comments have informed me that I was wrong (usually offering testimonials or calling me closed-minded), and recently I’ve been getting inquiries asking if I’ve changed my mind now that a clinical study has been published. I haven’t.

Instead of providing antioxidants directly, Protandim is supposed to stimulate the body to produce its own antioxidants. The website tells us it is “the only supplement clinically proven to reduce oxidative stress by 40%, slowing down the rate of cell aging to the level of a 20 year old.” It provides “thousands of times more antioxidant power than any food or conventional antioxidant supplement.” It signals the body’s genes to produce the enzymes SOD (superoxide dismutase) and CAT (catalase) that act as catalysts to neutralize free radicals and are not “used up” like ingested antioxidants are. It “creates a cascade of your body’s natural catalytic antioxidants that are able to destroy millions of free radicals per second.” It raises the level of glutathione by 300%. Glutathione is good, apparently.

What is Protandim? It’s a combination of Milk thistle, Bacopa extract, Ashwagandha, Green tea extract, and Turmeric extract. I looked these up in the Natural Medicines Comprehensive Database. None of them is known to have any significant clinical benefit from antioxidant effects. Some of them are listed as “not enough information” to know if they are safe. One has estrogenic properties and more than one has known side effects and potential interactions with other drugs. The only one that even sounds remotely like it might have some pertinent data behind it is green tea. Green tea contains antioxidant catechins that are “thought to possibly have a protective effect against atherosclerosis and heart disease” and contains flavonoids that “might reduce lipoprotein oxidation; however benefits have not yet been described in humans.”

A Pubmed search for “Protandim” yielded only 3 studies: One in mice, one in cell cultures and one in humans. (more…)

Posted in: Herbs & Supplements

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Functional Medicine IV

When I started this series on Functional Medicine, David Gorski suggested looking at Mark Hyman’s web page, which I had seen months before, but thought did not reveal much. That was a wrong. It shows a lot, and I suggest bloggers et al review it.

So I decided on a fourth “functional medicine” (FM) installment, in search of what it FM really is. On the Mark Hyman web page and in his Public TV monolog fund-raiser,  Hyman follows a seven point outline of what he believes Fuctional Medicine (“FM”) is. If one follows the 7 “keys” as he writes, optimum health, “ultra-wellness” happens. Here are the points:

  1. Environmental inputs
  2. Inflammation
  3. Hormones
  4. Gut & digestive health
  5. Detoxification
  6. Energy/Mitochondria/Oxidative Stress
  7. Mind body

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Posted in: Energy Medicine, Herbs & Supplements, Science and Medicine

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Functional Medicine II

In searching for just what FM is, one has to in a way read between lines. Claiming to treat the “underlying cause” of a condition raises the usual straw man argument that modern medicine does not, which of course is untrue. It also implies that there are underlying causes known to them and not to straights. FM claims to treat chronic disease which FM claims is inadequately treated by medicine.  FM claims to be a more advanced approach both in conceptual thinking and in practical management. Such claims are on the face doubtful, but hard to disprove. The way to find out would be to analyze cases they manage and critique them.

I tried to see specific examples of treatments but the web page text book links were not working at the time. I understand others have seen the contents and perhaps can add some information.   I sense a difference between “CAM” and FM – at least among the MDs and DOs -  is that FMers tend to use methods and substances with some degree of scientific or biochemical rationale, even if not proved, moreso than many of the CAMers.  Many seem to practice both systems or do not distinguish between the two systems.  In order to get a sense of the degree to which FM is known, I requested from the web page the names of practitioners in a 50 mile radius of my home (near Palo Alto, Calif.). The names ranged from Santa Cruz (40 miles) to Berkeley (50) and San Francosco (40) and Marin County (Sausalito – 50 miles) The population of that area is about 5 million. They sent 46 names:   MD/DO  31 – (including a nephrologist formerly on the staff of my teaching hospital)   PhD 1   DC 8   Lac 3   ND 2   RN 1   Because I had become aware of FM only 1-2 years ago, I thought 46 was a relatively large number.  The Web page lists four text books published in the past few years. A manuscript of the first one is available on line for downloading (not functioning when I tried.) .  21st Century Medicine: A New Model for Medical Education and PracticeMonograph Set – Functional Medicine Clinical Monograph Set – CME Available Textbook of Functional Medicine Clinical Nutrition: A Functional ApproachAs mentioned, I could not activate the links to those books, and did not have time to get to them individually.  No authors were listed.

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Posted in: Basic Science, Health Fraud, Herbs & Supplements, Nutrition, Science and Medicine

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DSHEA: a travesty of a mockery of a sham

In 1994, Congress enacted the Dietary Supplement Health and Education Act (DSHEA). This act allows for the marketing and sales of “dietary supplements” with little or no regulation. This act is the work of folks like Tom Harkin (who took large contributions from Herbalife) and Orrin Hatch, whose state of Utah is home to many supplement companies.

DSHEA has a couple of very important consequences (aside from filling the pockets of supplement makers). (more…)

Posted in: Health Fraud, Herbs & Supplements, Politics and Regulation, Science and Medicine

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The Marshall Protocol

Revised 7/23/9 to correct an error.

While there are many taxonomies of alternative medicines, one thing almost all alternative therapies have in common is they are originally the de novo discovery of one lone individual. Working outside of the mainstream, they are the gadflies who see farther because those around them are midgets.

  • Hanneman conceives of homeopathy, the treatment of all disease.
  • Palmer conceives the cause of all disease and its treatment in chiropractic
  • Mikao Usui, while having a mid-life crisis, conceives Reiki.

Virgin births all. These pioneers boldly go where no man has gone before.

Others have been less acclaimed after seeking out new life. An example is Virginia Livingston, MD, the discoverer of the cause of all cancer (1). She discovered a bacterium, the cause of cancer, she called Progenitor cryptocides, which, unfortunately only she could grow. Her therapies include an autogenous ‘vaccine” made from your own urine, which will probably preclude widespread use even in alternative therapies circles. I wonder if Jenny would object to vaccines if there were naturally derived from the patients urine?

Discovering a new form of pathogenic microbiology that no one else can see or grow is not uncommon, since people seem to be unable to recognise artifact on slides, be it Oscillococcinum being seen by Joseph Roy 200 years ago or Virginia Livingston in the 1960s. Sometimes I regret the discovery of H. pylori as a cause of gastritis as it gives the alternative microbiologists a medical Galileo to point at. H. pylori is used as an example, erroneously, of a bacteria causing disease that was laughed at by the medical establishment (Parenthetically, as my flawed memory has it, while I was an Infectious Disease Fellow the data for H. pylori came trickling in. I remember discussing the papers with one of my attendings who was an expert in GI infections. We all thought it was an interesting hypothesis and waited further data with interest. I cannot remember anyone dismissing the idea out of hand with derisive laughter. But then, I remain convinced that infections are the cause of all disease, at least the diseases that matter).

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Posted in: Herbs & Supplements

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Functional Medicine (FM) What Is It?

Functional Medicine – What is it?

After extensive searching and examination, my answer is still – only the originators of “FM” know. Or, at least one must assume they know, because so far as I can see, I certainly see nothing that distinguishes “FM” from other descriptions of sectarian and “Complementary/Alternative Medicine” practices. A difference may lie in the advocates’ assumptions to have found some “imbalance” of body chemistry or physiology before applying one or more unproved methods or substances. From what I could determine, the “imbalance” or dysfunction is usually either imaginary or at least presumptive. And the general principles are so poorly defined as to allow practioners vast leeway to apply a host of unproven methods.

I figured there would be several ways to find out. One would be to read FM’s material – mainly what “they” placed on the Internet. Another would be to enter the system and find out as a patient or as a prospective practitioner what it is that “FM” claims to be. The third would be to listen to a practitioner or advocate on tape, disk, radio, etc.
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Posted in: Basic Science, Herbs & Supplements, Nutrition, Science and Medicine

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FDA Zicam Warning

On June 16th the FDA issued a warning advising consumers not to use Zicam Nasal Gel or Nasal Swabs because of reports that it can damage the sense of smell, a condition called anosmia. This event highlights some problems with current regulations of health products.

There have been 130 cases reported to the FDA of decreased sense of smell following the use of one of these Zicam products – sometimes after a single use, sometimes after repeated use.  All of these cases were reported by patients or their doctors; none were reported by the company, Matrixx Initiatives. According to reports, the FDA has asked Matrixx to turn over 800 consumer complaints regarding to Zicam. There is a 2007 law that requires company to report such complaints to the FDA, although the FDA has not said whether Matrixx violated this law.

Anosmia is a serious medical condition. The senses of smell is one of those things we take for granted until it is gone. People who lack a sense of smell cannot tell if milk has gone sour or if their food is bad. They cannot smell smoke to warn of a fire, nor can they smell a gas leak. The FDA fears that some of the cases of anosmia associated with Zicam use may be permanent.

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Posted in: Herbs & Supplements, Homeopathy, Politics and Regulation

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Risks Associated With Complementary And Alternative Medicine (CAM): A Brief Overview

Having grown up on a dairy farm, I am one of the least likely people to object to the deification of yogurt. However, as a critical thinker, I cannot help but resist the idea (promoted by some health sites) that probiotics are a reasonable alternative to chemotherapy in the treatment of colon cancer. And there are many other equally unhelpful claims being made all the time. Fish oil for ALS anyone?

What amazes me about the “cherry yoga” camp (as my friend Bob Stern likes to call it), is that they aggressively market CAM as “harmless” and “natural.” They point to the warning labels and informed consents associated with science-based medicines as evidence that the alternative must be safer. In reality, many alternative practices are less effective, and can carry serious risks (usually undisclosed to the patient). For your interest, I’ve gathered some examples of risks associated with common alternative practices that have been described by the CDC and in the medical literature:
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Posted in: Acupuncture, Chiropractic, Herbs & Supplements, Homeopathy

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