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Boost Your Immune System?

This post is a wee bit of a cheat in that it is a rewrite of a Quackcast, but I have three lectures and board certification in the near future, so sometimes you have to cook the wolf.

What does that mean: boost the immune system? Most people apparently think that the immune system is like a muscle, and by working it, giving it supplements and vitamins,  the immune system will become stronger. Bigger. More impressive, bulging like Mr. Universe’s  bicep. That’s the body part I am thinking about. What they are boosting is vague, on par with chi/qi or innate intelligence. They never really say what is being boosted.

The other popular phrase is “support”.  A product supports prostate health, or breast health or supports the immune system.  It sounds like the immune system is sagging against gravity due to age and needs a lift.

The immune system, if you are otherwise healthy, cannot be boosted, and doing those things you learned in Kindergarten health  (reasonable diet, exercise and sleep), will provide the immune system all the boosting or  support it needs.
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CAM and Fibromyalgia

ResearchBlogging.orgOne of the common themes regarding alternative medicine is the reversal of normal scientific thinking. In science, we must generally accept that we will fail to validate many of our hypotheses. Each of these failures moves us closer to the truth. In alternative medicine, hypotheses function more as fixed beliefs, and there is no study that can invalidate them. No matter how many times a hypothesis fails, the worst that happens is a call for more research.

Sometimes this is the sinister and cynical intent of an alternative practitioner—refuse to let go of a belief or risk having to learn real medicine. Often, though, there are flaws in our way of thinking about data that interfere with our ability to understand them.

This week, the New York Times had a piece on alternative therapies for fibromyalgia. First a little background.
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We’re Back

As you can see, Science-Based Medicine is now back online and fully functional. We have moved to a new host and a faster dedicated server. It seems that our problem was just that we outgrew our previous host.

Sorry for the inconvenience and thank you for your patience. We will now resume our usual schedule of postings.

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SBM Problems

As many of you have probably noticed, the science-based medicine site has been having connection problems for the last week, and was in fact down for most of Friday. We are actively working on the problem and hopefully will have it fixed soon. The site is functioning now, but remains very slow.

Thanks for your patience, and sorry for any inconvenience.

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“Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part II: Loose Ends)

Last week I discussed the dismal results of the “Gonzalez Trial” for cancer of the pancreas,* as reported in an article recently posted on the website of the Journal of Clinical Oncology. I promised that this week I’d discuss “troubling information, both stated and unstated [in the report],” and also some ethical issues. More has come to light in the past few days, including Nicholas Gonzalez’s own voluminous, angry response to the JCO article. I’ll comment upon that below, but first a brief review.

The trial was begun in 1999 under the auspices of Columbia University, after Rep. Dan Burton had pressured NCI Director Richard Klausner to fund it. It was originally conceived as a randomized, controlled trial comparing the “Gonzalez Regimen” to standard chemotherapy for cancer of the pancreas. In the first year, however, only 2 subjects had been accrued, purportedly because those seeking Gonzalez’s treatment were not willing to risk random assignment to the chemotherapy arm. In 2000, the protocol was changed to a “prospective, cohort study” to allow potential subjects to choose which treatment they would follow. Gonzalez himself was to provide the ‘enzyme’ treatments.

After that there was little public information about the trial for several years, other than a few determination letters from the Office of Human Research Protections and a frightening account of the experience of one subject treated by Gonzalez. By 2006 or so, those of us who pay attention to creeping pseudomedicine in the academy were wondering what had become of it. About a year ago we found out: the trial had been quietly “terminated” in 2005 after it met “pre-determined stopping criteria.” As explained here, that meant that the Gonzalez group had not fared well.

Four years after the trial’s ‘termination,’ the report was finally published: The Gonzalez cohort had not only fared much worse than the cohort that received chemotherapy, but it had fared worse than a comparable group of historical controls. Here, again, is the survival graph from the JCO paper:

Snapshot 2009-09-11 16-16-15

The Gonzalez group had also fared much worse in ‘quality of life’ scores, which included a measure of pain.

Now let’s read between the lines. Forgive me for taking shortcuts; I’m a little pressed for time. (more…)

Posted in: Clinical Trials, Health Fraud, Herbs & Supplements, Medical Academia, Medical Ethics, Science and Medicine, Science and the Media

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Kevin Trudeau’s Legal Trouble

Kevin Trudeau has made millions of dollars selling dubious medical products. He started his snake-oil salesman career selling coral calcium through infomercials. Trudeau claimed that this magical form of calcium could cure cancer and whatever ails you. The Federal Trade Commission (FTC) investigated Trudeau, who was making millions off his claims, and found that he was being, let us say, less than honest. As a result the FTC banned Trudeau from selling health products through infomercials.

But Trudeau is tenacious and creative – an innovator. Prior to getting into infomercials he was small time – he was convicted for writing bad checks and credit card fraud and spent some time in prison. I always find it interesting that convicted con-artists seem to hit upon such well-guarded secrets. Dennis Lee claims to have found the secret of limitless energy, if only he were not attacked by Big Oil and a corrupt government. Kevin Trudeau claims to have found the cures for just about everything, but The Man is trying to shut him down.

Undeterred by the FTC ban, Trudeau decided that even though he could not sell health products he could sell information – that was protected under free speech – so he started selling books through infomercial, including Natural Cures They Don’t Want You To Know About. Trudeau claimed he went from writing bad checks to discovering not only hundreds of natural cures but uncovering a government and Big Medicine conspiracy to keep this vital information from the public.

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Posted in: Politics and Regulation, Public Health, Science and Medicine

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Applying Rigorous Science to Messy Medicine

The PowerPoint presentation that I gave at the Skeptic’s Toolbox workshop at the University of Oregon on August 7, 2009 is up on their website with the complete text of what I said. The theme of the workshop was scientific method. The title of my talk is “Tooth Fairy Science and Other Pitfalls: Applying Rigorous Science to Messy Medicine.” Click here for the link. It covers a lot of things that are pertinent to the subjects we discuss on this blog, and I thought some of our readers might enjoy it. I put in a lot of information and some good cartoons. Note: this was a talk to the general public, not an academic presentation, and it does not include citations or references.

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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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Integrative Obfuscation

The marketing of so-called CAM or integrative medicine continues. These terms are just that – marketing. They are otherwise vacuous, even deceptive, and meant only to conceal the naked fact that most medical interventions that hide under the CAM/integrative umbrella lack plausibility or credible evidence that they actually work.

Medicine that works is simply “medicine” – everything else needs marketing.

Last week in the British Medicine Journal (BMJ) Hugh MacPherson, David Peters, and Catherine Zollman wrote a very telling editorial entitled Closing the evidence gap in integrative medicine, which Edzard Ernst has rightly characterized “a masterpiece in obfuscation.”

The essence of the editorial can be boiled down to this – proponents of integrative medicine are disappointed that scientific research has not validated their failed modalities. Therefore they want to weaken the rules of evidence so that they can get the results they desire.

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Before you trust that blog…

Doug Bremner has a blog. That blog stinks.

Bremner is an apparently well-regarded psychiatrist, and takes a refreshing look at the influence of industry not just on pharmaceuticals but on the conduct of science itself. His outspoken views have led to attempts to squelch his academic freedoms. But his sometimes-heroic record does not excuse dangerous idiocy.

I can understand how wading into the cesspool that is conflict of interest can leave one cynical. But cynicism and suspicion turned up to “11″ is no longer bravery—it’s crankery. It’s not his snarkiness that burns—it’s his inability to separate his biases from the facts.

It’s not like the pharmaceutical industry doesn’t deserve to be taken to the wood shed. Examples of unethical and downright immoral practices abound, such as ghost-writing, fake journals, and a host of other sins. But the industry has also helped develop a most remarkable pharmacopeia which saves and improves countless lives. There is good, and there is bad. And telling the two apart, well, that makes all the difference.

He tends to go for headlines that hit hard, but miss the point entirely. Examples:

  • Angioplasty Found to be Useless Waste of Money: he cites a journal article which he says concluded that “not useful for patients with stable coronary artery disease (CAD). ” His title would be accurate if angioplasty were used only in stable CAD—it is not.
  • Should I Take Aspirin or Put a Gun To My Head?: here, he sort of gets the difference between primary and secondary prevention, but not really. He also likes to admit that the data contradict his conclusion but he’s nice enough to say, “screw the data”:

    Although technically the risk of stomach bleeding is outweighed by the heart benefits of aspirin (which can only be shown when large numbers of patients are studied), in terms of what that means to you the differences are clinically meaningless.

  • This Just In: Breast Cancer Screening Essentially Useless: yes, Doug, breast cancer screening doesn’t benefit everyone equally. For example, the prevalence of breast cancers in men is low enough that recommending it for you would be stupid—like your article.

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