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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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The complexity of cancer: A science-based view

Last week I participated in a panel discussion at NECSS with John Snyder, Kimball Atwood, and Steve Novella, who reported on the conference last Monday. What I mentioned to some of the attendees is that I had managed to combine NECSS with a yearly ritual that I seldom miss, namely the yearly meeting of the American Association for Cancer Research (AACR) meeting. There are two huge cancer meetings every year, AACR and the annual meeting of the American Society for Clinical Oncology (ASCO). AACR is the meeting dedicated to basic and translational research; ASCO, as the word “clinical” in its name implies, is devoted mainly to clinical research. Personally, being a translational researcher myself and a surgeon, I tend to prefer the AACR meeting over ASCO, not because ASCO isn’t valuable, but mainly because ASCO tends to be devoted mostly to medical oncology and chemotherapy, which are not what I do as a surgeon. Each meeting draws between 10,000 to 15,000 or even more clinicians and researchers dedicated to the eradication of cancer.

Having taken the Acela train from the NECSS meeting in New York straight to Washington, DC for the AACR meeting, I couldn’t help but think a bit about the juxtaposition of our discussion of the infiltration of quackademic medicine into medical academia with the hard core science being discussed at AACR. One session in particular at AACR highlighted what is one of the most significant differences between science-based medicine and the various forms of “alternative” medicine that we discuss here on SBM on such a regular basis. That difference, quite simply put, is the difference between the simple and the complex. “Alternative” medicine supporters often scoff at practitioners of science-based oncology, asking why we don’t have a “cure for cancer” yet—as if cancer were a single disease!—or why we haven’t made much more progress since President Richard Nixon declared “war on cancer” back in 1971. One part of the answer is that cancer is incredibly complicated. Not only is it not a single disease, but each variety of cancer is in and of itself incredibly complicated as well. To steal from Douglas Adams, cancer is complicated. You just won’t believe how vastly, hugely, mind-bogglingly complicated it is. I mean, you may think algebra is complicated, but that’s just peanuts to cancer.
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Posted in: Cancer

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