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Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 2

NB: If you haven’t yet read Part 1 of this blog, please do so now; Part 2 will not summarize it.

At the end of Part 1, I wrote:

We do not need formal statistics or a new, randomized trial with a larger sample size to justify dismissing the Gonzalez regimen.

In his editorial for the JCO, Mark Levine made a different argument:

Can it be concluded that [the] study proves that enzyme therapy is markedly inferior? On the basis of the study design, my answer is no. It is not possible to make a silk purse out of a sow’s ear.

That conclusion may be correct in the EBM sense, but it misses the crucial point of why the trial was (ostensibly) done: to determine, once and for all, whether there was anything to the near-miraculous claims that proponents had made for a highly implausible “detoxification” regimen for cancer of the pancreas. Gonzalez himself had admitted at the trial’s inception that nothing short of an outcome matching the hype would do:

DR. GONZALEZ: It’s set up as a survival study. We’re looking at survival.

SPEAKER: Do you have an idea of what you’re looking for?

DR. GONZALEZ: Well, Jeff [Jeffrey White, the director of the Office of Cancer Complementary and Alternative Medicine at the NCI—KA] and I were just talking a couple weeks ago. You know, to get any kind of data that would be beyond criticism is—-always be criticism, but at least three times.

You would want in the successful group to be three times — the median to be three times out from the lesser successful groups.

So, for example, if the average survival with chemo, which we suspect will be 5 months, you would want my therapy to be at least — the median survival to be at least 15, 16, 17 months, as it was in the pilot study.

We’re looking for a median survival three times out from the chemo group to be significant.

Recall that the median survival in the Gonzalez arm eventually turned out to be 4.3 months.

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

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Nine Breakthroughs and a Breakdown

In his new book Breakthrough! How the 10 Greatest Discoveries in Medicine Saved Millions and Changed Our View of the World Jon Queijo describes what he believes are the 10 greatest discoveries. 9 of them are uncontroversial discoveries that have been on other top-10 lists, but his 10th choice is one that no other list of top discoveries has ever included. He realizes that, and even admits in his introduction that a former editor of The New England Journal of Medicine refused to review his book because there is no such thing as alternative medicine, only treatments that work and treatments that don’t. But he “respectfully disagrees.”

Hippocrates’ discovery that disease had natural causes, sanitation, germ theory, anesthesia, X-rays, vaccines, antibiotics, genetics, and treatments for mental disorders are all worthy candidates for the list. But Queijo ludicrously lists the “rediscovery of alternative medicine” as the tenth “great discovery.” He presents no evidence (because there is no evidence) that alternative medicine has “saved millions” or that it has saved anyone. He doesn’t realize that alternative medicine represents a betrayal of exactly the kind of rigorous scientific thinking and testing that led to all the other discoveries. His list of ten breakthroughs is actually a list of 9 breakthroughs and one breakdown. (more…)

Posted in: Book & movie reviews, History, Science and Medicine

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Energy Healing In Maryland

I had an interesting conversation with a reporter today. She called me to get a “medical/skeptical” counterpoint for an article she is preparing on energy healing. Although I don’t know if she’ll faithfully represent what I had to say, we had an entertaining exchange and so I decided to capture the essence of it here. I’m curious to see which parts of our conversation remain in her final article, due out on February 19th. (Stay tuned for that).

Apparently a local hospital in Maryland is now offering nurse-guided therapeutic touch and Reiki healing for inpatients. She decided to interview the practitioners involved, and turned to me for comment. I did not have the benefit of preparing in advance or having references handy – so I gave it my best shot. I’d be interested to know how you might have responded differently.

1. Is there any scientific evidence that energy healing works? (more…)

Posted in: Energy Medicine, Science and the Media

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Be careful what you wish for, Dr. Dossey, you just might get it

If there’s one thing about the so-called “complementary and alternative medicine” (CAM) movement that I’ve emphasized time and time again, it’s that its adherents have a definite love-hate relationship with science. They hate it because it is the single greatest threat to their beliefs system and the pseudoscience that underlies it. At the same time, they crave the legitimacy that science confers. They crave it not because they have any great love for science. Quite the contrary. It is simply that they recognize that science actually delivers the goods. Of course, they believe that they deliver the goods too, but they come to this belief not through science but rather through all the cognitive shortcomings and biases to which humans are prone, such as confusing correlation with causation, confirmation bias, not recognizing regression to the mean, and being fooled by the placebo effect. Whether it’s through a misunderstanding of science or less innocent reasons, they go to great lengths to torture it into superficially appearing to support their claims through a combination of cherry-picking of studies that seem to support them and misrepresenting ones that don’t, discussions of which abound right here in this very blog.

The other thing I’ve emphasized about the CAM movement is that, even more than scientific credibility, they crave legitimacy. To them, however, science is but one pathway to legitimacy, because, unlike practitioners of science-based medicine, they are more than willing to bypass science to obtain the legitimacy–or at least the appearance of the legitimacy–they so crave. If it means doing an end run around science by trying to hijack the Obama health insurance reform bill that is currently being negotiated to resolve the differences between the Senate and House versions, so be it. Indeed, earlier this year, I described how Senator Tom Harkin has tried to promote CAM through the National Center for Complementary and Alternative Medicine (NCCAM) and trying to insert provisions into the bill that would mandate that government-subsidized insurance exchanges pay for CAM. Meanwhile, prominent CAM advocates have been carpet-bombing the media with dubious arguments in support of CAM, as in when Deepak Chopra, Rustum Roy, Dean Ornish, and Andrew Weil teamed up in different combinations to promote the idea that CAM is all about “prevention” and that science-based medicine, in all its reductionistic evil, is nothing more than pushing pills.

They’re at it again.
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Posted in: Energy Medicine, Herbs & Supplements, Homeopathy, Medical Academia, Neuroscience/Mental Health, Politics and Regulation

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Medical Fun with Christmas Carols

Warning: If you are offended by humor that depends on psychiatric and medical diagnoses, read no further.

Disclaimer: Before anyone complains (and in this age of exaggerated political correctness, someone surely will), let me make it clear that I mean no disrespect to people suffering from the illnesses mentioned below. I have the greatest empathy for sick people, and I have encountered several of these conditions in my own family and have actually experienced four of them myself. Humor about them doesn’t offend me, and I hope it will not offend you. Also, my mention of Christmas and Hanukkah songs is not intended to endorse any religious belief.

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After a year of serious talk about mostly discouraging things, I thought it was time for a totally frivolous post to cheer us up with a little holiday humor. A friend sent me a list of “Christmas Carols for the Psych Ward.” I thought they were funny, and I’ve copied the best of them below. I’ve added a few of my own for other medical diagnoses, and then I added several about complementary and alternative medicine. (more…)

Posted in: Humor

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All Medicines Are Poison!

That’s the title of a new book  by Melvin H. Kirschner, M.D. When I first saw the title, I expected a polemic against conventional medicine. The first line of the Preface reassured me: “Everything we do has a risk-benefit ratio.” Dr. Kirschner took the title from his first pharmacology lecture in medical school. The professor said “I am here to teach you how to poison people.” After a pause, he added, “without killing them, of course.” 

He meant that any medicine that has effects has side effects, that the poison is in the dose, and that we must weigh the benefits of any treatment against the risks. Dr. Kirschner has no beef with scientific medicine. He does have a lot of other beefs, mainly with the health insurance industry, the pharmaceutical industry, and alternative medicine. (more…)

Posted in: Book & movie reviews, Pharmaceuticals

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“Oh, come on, Superman!” (Part II): Bill Maher meets Kryptonite over vaccines and “Western medicine”

It’s rather amazing how sometimes the best laid plans of mice and men (and bloggers) come to naught. I had planned on doing a followup post to my previous post about the cancer quackery known as the German New Medicine by discussing a particularly nasty French variant of it. Unfortunately (or fortunately, depending upon your point of view), events conspired to move my blogging ire towards another target, particularly since I had addressed this isse before. Specifically, I’m talking about 2009 Recipient of the Richard Dawkins Award, comedian and HBO talk show host Bill Maher.

As you may recall, about a month ago, I wrote a rather long post (par for the course for me, I know) detailing ad nauseam how Bill Maher not only embraces germ theory denialism, anti-vaccine nonsense, and alternative medicine, in particular his apparent belief that “aggregate toxicity” or the typical unnamed “toxins” that alternative medicine mavens are so fond of blaming most disease on or, as Maher likes to call it, the “poisons” that we are eating and otherwise exposed to every day, but has been preaching this pseudoscience since at least 2005. Maher then followed this up a mere week before receiving his award named after a famous scientist with a hideously irrational promotion of cancer quackery. At that point, I thought I was done with the topic, at least as far as this particular blog goes (others know that elsewhere I’ve not been so quiet). At least, I had intended not to deal with this again on SBM.

Unfortunately, Bill Maher had other ideas. This is the perfect description for how I felt having to blog about this again:

Yes, it fits, particularly after Maher Tweeted to his fans:

If u get a swine flu shot ur an idiot.

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Posted in: Politics and Regulation, Science and the Media, Vaccines

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Double-Talk And Paternalism

One of the more frustrating things about practitioners who promote unsafe and scientifically discredited medical practices is their tendency to change their message for different audiences. One day they’ll tell you that they espouse only evidence-based practices and the next they’ll be promoting snake oil. This double talk is hard to combat, since to disprove them one would essentially have to provide a video of their contradictory remarks.

One day I participated in a series of business meetings with a CAM practitioner in attendance (he was an MD who graduated from UCSF). During one meeting he boldly proclaimed his support of scientifically rigorous research, and praised the Cochrane Collaborative’s efforts to provide systematic reviews of the evidence (or lack thereof) for various practices.

Several hours later we were sitting together in another meeting in which I objected to the publication of a consumer article that would assist parents of children with autism in finding a DAN! practitioner who could provide chelation therapy to their children. I explained that there was no evidence for the efficacy of such treatments, and plenty of evidence for their harm (including the death of at least one child that I’d read about in the news). I suggested that an article describing these dangers might be in order, but that an article encouraging chelation use for autism was simply unethical and I would not allow it to be published.

Instead of agreeing with me, the CAM MD suggested that I was being “narrow” and that I should allow consumers to “explore all their options.” I was stunned. This was the same person who had just said that he fully supported scientific inquiry. So I asked him how he could say that he supported evidence-based medicine, and then turn around and ignore evidence at will – even at the peril of human life.

His response dumbfounded me:

“I am just as comfortable practicing within an evidence-based framework as I am outside it.”
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Posted in: Public Health, Science and Medicine

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Differences Of Opinion

After my fairly recent awakening from shruggieness  (i.e. a condition in which one is largely unaware of or uninterested in CAM) I decided to discuss my concerns about pseudoscience with my friends. One particular friend is a nationally recognized physician who believes in the importance of accurate health information and the promotion of science. However, he sees no urgent need to warn people against snake oil, and so long as it’s correctly labeled he doesn’t seem to mind it co-existing with scientific alternatives.

My friend and I had dinner a few weeks ago, and our conversation was both animated and disappointing. I somehow felt inadequate in conveying my objections (both ethical and scientific) to the promotion of pseudoscience. My best explanations were met with cheerful rebuttals, and while not intellectually convincing to me, those retorts satisfied my friend just fine. I guess the bottom line was that he was more interested in maintaining his position than reconsidering it… and so it left me feeling rather frustrated and a little sad.
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Posted in: Science and Medicine

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Primary care challenge

In this space we’ve read about the efforts of “alternative” practitioners such as naturopaths to gain the moniker “primary care provider”.  I’ve been wondering a bit about this.  I’m a primary care physician.  Specialists in internal medicine, pediatrics, and family medicine provide the bulk of primary care in the U.S. They attend a 4-year medical school, complete a 3-4 year residency, take their specialty board, and then work as experts in the screening, prevention, diagnosis, and treatment of common diseases.

So, what I’d like to do is give you a typical scenario from an internal medicine or family medicine practice.  It’s a simple one, one you might see on Step II of the USMLE boards or on a shelf exam for an internal medicine rotation.  I’d like to offer alternative practioners, especially naturopaths, an opportunity to show how they would approach the clinical scenario so that we can see what kind of primary care they provide.

Yes, every patient and every situation is different, but there are some general ways to approach health and disease based on the evidence.
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Posted in: Health Fraud, Science and Medicine

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