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Posts Tagged Nicholas Gonzalez

Steve Jobs’ cancer and pushing the limits of science-based medicine

Editor’s note: There is an update to this post.

An Apple fanboy contemplates computers and mortality

I’m a bit of an Apple fanboy and admit it freely. My history with Apple products goes way back to the early 1980s, when one of my housemates at college had an Apple IIe, which I would sometimes use for writing, gaming, and various other applications. Indeed, I remember one of the first “bloody” battle games for the IIe. It was called The Bilestoad and involved either taking on the computer or another opponent with battle axes in combat that basically involved hacking each other’s limbs off, complete with chunky, low-resolution blood and gore. (You youngsters out there will be highly amused at the gameplay here.) Of course, it’s amazing that nothing’s changed when it comes to computer games except the quality of graphics. Be that as it may, this same roommate was one of the first students to get a hold of the new Macintosh when it was released in early 1984. I really liked it right from the start but only got to play with it occasionally for a few months. After using a Macintosh SE to do a research project during my last year of medical school, I have used the Macintosh platform more or less exclusively, and the first computer I purchased with my own money was a Mac LC back in 1990 or 1991. Today, I have multiple Apple products, including my MacBook Air, my iPhone, and my old school iPod Classic, among others. Oddly enough, I do not have an iPad, but that’s probably only a matter of time, awaiting software that lets me do actual work on it.

All of this is my typical long-winded way of explaining why I was immensely saddened when I learned of Steve Jobs’ death last week. Ever since speculation started to swirl about his health back 2004 and then again in 2008, capped off by the revelation that he had undergone a liver transplant for a rare form of pancreatic cancer in 2009, I feared the worst. Last week, the end finally came. However, there is much to learn relevant to the themes of this blog in examining the strange and unusual case of Steve Jobs. Now, after his death five days ago, which coincidentally came a mere day after the launch of iCloud and the iPhone 4S, it occurs to me that it would be worthwhile to try to synthesize what we know about Jobs’ battle with cancer and then to discuss the use (and misuse) of his story. Of course, this is a difficult thing to do because Jobs was notoriously secretive and I can only rely on what has been published in the media, some of which is conflicting and all of which lacks sufficient detail to come to any definite conclusions, but I will try, hoping that the upcoming release of his biography by Walter Isaacson in couple of weeks might answer some of the questions I still have remaining, given that Isaacson followed Jobs through his battle with cancer and was given unprecedented access to Jobs and those close to him.

In the meantime, I speculate. I hope my speculations are sufficiently educated as not to be shown to be completely wrong, but they are speculations nonetheless.
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Posted in: Cancer, Medical Ethics, Nutrition, Science and the Media, Surgical Procedures

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Of SBM and EBM Redux. Part II: Is it a Good Idea to test Highly Implausible Health Claims?

Review

This is the second post in a series* prompted by an essay by statistician Stephen Simon, who argued that Evidence-Based Medicine (EBM) is not lacking in the ways that we at Science-Based Medicine have argued. David Gorski responded here, and Prof. Simon responded to Dr. Gorski here. Between that response and the comments following Dr. Gorski’s post it became clear to me that a new round of discussion would be worth the effort.

Part I of this series provided ample evidence for EBM’s “scientific blind spot”: the EBM Levels of Evidence scheme and EBM’s most conspicuous exponents consistently fail to consider all of the evidence relevant to efficacy claims, choosing instead to rely almost exclusively on randomized, controlled trials (RCTs). The several quoted Cochrane abstracts, regarding homeopathy and Laetrile, suggest that in the EBM lexicon, “evidence” and “RCTs” are almost synonymous. Yet basic science or preliminary clinical studies provide evidence sufficient to refute some health claims (e.g., homeopathy and Laetrile), particularly those emanating from the social movement known by the euphemism “CAM.”

It’s remarkable to consider just how unremarkable that last sentence ought to be. EBM’s founders understood the proper role of the rigorous clinical trial: to be the final arbiter of any claim that had already demonstrated promise by all other criteria—basic science, animal studies, legitimate case series, small controlled trials, “expert opinion,” whatever (but not inexpert opinion). EBM’s founders knew that such pieces of evidence, promising though they may be, are insufficient because they “routinely lead to false positive conclusions about efficacy.” They must have assumed, even if they felt no need to articulate it, that claims lacking such promise were not part of the discussion. Nevertheless, the obvious point was somehow lost in the subsequent formalization of EBM methods, and seems to have been entirely forgotten just when it ought to have resurfaced: during the conception of the Center for Evidence-Based Medicine’s Introduction to Evidence-Based Complementary Medicine.

Thus, in 2000, the American Heart Journal (AHJ) could publish an unchallenged editorial arguing that Na2EDTA chelation “therapy” could not be ruled out as efficacious for atherosclerotic cardiovascular disease because it hadn’t yet been subjected to any large RCTs—never mind that there had been several small ones, and abundant additional evidence from basic science, case studies, and legal documents, all demonstrating that the treatment is both useless and dangerous. The well-powered RCT had somehow been transformed, for practical purposes, from the final arbiter of efficacy to the only arbiter. If preliminary evidence was no longer to have practical consequences, why bother with it at all? This was surely an example of what Prof. Simon calls “Poorly Implemented Evidence Based Medicine,” but one that was also implemented by the very EBM experts who ought to have recognized the fallacy.

There will be more evidence for these assertions as we proceed, but the main thrust of Part II is to begin to respond to this statement from Prof. Simon: “There is some societal value in testing therapies that are in wide use, even though there is no scientifically valid reason to believe that those therapies work.”

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Posted in: Chiropractic, Clinical Trials, Energy Medicine, Health Fraud, History, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Politics and Regulation, Science and Medicine

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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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My NCCAM Wish List

For a number of reasons, well-argued many times here on SBM, it would be beneficial to American citizens if the National Center for Complementary and Alternative Medicine (NCCAM) were abolished. This does not seem to be in the cards anytime soon. Here, then, are my suggestions for making the Center less dangerous and less of a marketing tool for pseudomedicine than it has been since its inception. Some suggestions might even make the Center somewhat useful. They are listed in order of priority. The Center should:

1. Abandon all unethical trials, beginning with the Trial to Assess Chelation Therapy (TACT, which is under the joint auspices of the NHLBI). This should be done in a very public manner. The reasons for abandoning the TACT, in summary, are as follows.

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Posted in: Medical Ethics, Politics and Regulation, Science and Medicine

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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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How not to win friends and influence people

BLOGGER’S NOTE: The incident described in this post is true, although somewhat embellished to protect the names and identities of the innocent, if you know what I mean. This conversation occurred a few years ago at a large national cancer meeting.

The question caught me by surprise.

While attending a large national cancer meeting, I was having brunch with a friend, a colleague with whom I used to work when I was doing laboratory research, someone whom I hadn’t seen in a long time. She and her husband had brought along two of their oldest and dearest friends, whom they had known for decades, as well as another of my former coworkers from my old lab. We were idly chatting away and eating, when one of the occupational hazards of being a doctor presented itself. Tthe conversation drifted to medical topics. And then it came.

“What do you think of Dr. Gonzalez?”

Ah, hell.
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Posted in: Cancer, Health Fraud, Science and the Media

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