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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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“Hard science” and medical school

One of the recurring themes of this blog, not surprisingly given its name, is the proper role of science in medicine. As Dr. Novella has made clear from the very beginning, we advocate science-based medicine (SBM), which is what evidence-based medicine (EBM) should be. SBM tries to overcome the shortcomings of EBM by taking into account all the evidence, both scientific and clinical, in deciding what therapies work, what therapies don’t work, and why. To recap, a major part of our thesis is that EBM, although a step forward over prior dogma-based medical models, ultimately falls short of making medicine as effective as it can be. As currently practiced, EBM appears to worship clinical trial evidence above all else and nearly completely ignores basic science considerations, relegating them to the lowest form of evidence, lower than even small case series. This blind spot has directly contributed to the infiltration of quackery into academic medicine and so-called EBM because in the cases of ridiculously improbable modalities like homeopathy and reiki, deficiencies in how clinical trials are conducted and analyzed can make it appear that these modalities might actually have efficacy.

Given this thesis, if there’s one aspect of medical education that I consider to be paramount, at least when it comes to understanding how to analyze and apply all the evidence, both basic science and clinical, it’s a firm grounding in the scientific method. Unfortunately, in medical school there is very little, if any, concentration on the scientific method. In fact, one thing that shocked me when I first entered what is one of the best medical schools in the U.S., the University of Michigan, was just how “practical” the science taught to us as students was. It was very much a “just the facts, ma’am,” sort of presentation, with little, if any, emphasis on how those scientific facts were discovered. Indeed, before I entered medical school, I had taken graduate level biochemistry courses for a whole year. This was some truly hard core stuff. Unfortunately, I couldn’t get out of taking medical school biochemistry my first year, but taking the course was illuminating. The contrast was marked in that in medical school there was very little in the way of mechanistic detail, but there was a whole lot of memorization. The same was true in nearly all the other classes we took in the first two years. True, for anatomy it’s pretty hard not to have to engage in a lot of rote memorization, but the same shouldn’t necessarily be true of physiology and pharmacology, for example. It was, though.

Over time, I came to realize that there was no easy answer to correcting this problem, because medical school is far more akin to a trade school than a science training school, and the question of how much science and in what form it should be taught are difficult questions that go to the heart of medical education and what it means to be a good physician. Clearly, I believe that, among other things, a good physician must use science-based practice, but how does medical education achieve that? That’s one reason why I’m both appalled and intrigued by a program at the Mt. Sinai School of Medicine for humanities majors to enter medical school without all the hard sciences. It’s a program that was written up in the New York Times last Wednesday in an article entitled Getting Into Med School Without Hard Sciences, and whose results were published in Medical Academia under the title Challenging Traditional Premedical Requirements as Predictors of Success in Medical School: The Mount Sinai School of Medicine Humanities and Medicine Program.

Let’s first take a look at how the NYT described the program:
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Posted in: Medical Academia, Science and Medicine

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New CMS Chief Donald Berwick: a Trojan Horse for Quackery?

NB: I posted this on Health Care Renewal a couple of days ago, figuring that Dr. Gorski’s post would suffice for the SBM readership (he and I had discussed the topic while at TAM8 last week). But Managing Editor Gorski has asked me to repost it here, which I’m happy to do. I am especially pleased to demonstrate that I am capable of writing a shorter post than is Dr. Gorski. 😉

On July 7, President Obama appointed Dr. Donald Berwick as Administrator of the Centers for Medicare and Medicaid Services (CMS). Dr. Berwick, a pediatrician, is well known as the CEO of the non-profit Institute for Healthcare Improvement (IHI), which “exists to close the enormous gap between the health care we have and the health care we should have — a gap so large in the US that the Institute of Medicine (IOM) in 2001 called it a ‘quality chasm’.” Dr. Berwick was one of the authors of that IOM report. His IHI has been a major player in the patient safety movement, most notably with its “100,000 Lives Campaign” and, more recently, its “5 Million Lives Campaign.”

Berwick’s CMS gig is a “recess appointment”: it was made during the Senate’s July 4th recess period, without a formal confirmation hearing—although such a hearing must take place before the end of this Senate term, if he is to remain in the position. A recent story suggested that Obama had made the recess appointment in order to avoid a reprise of “last year’s divisive health care debate.” The president had originally nominated Berwick for the position in April, and Republicans have opposed “Berwick’s views on rationing of care,” claiming that he “would deny needed care based on cost.”

A “Patient-Centered Extremist”

If there is a problem with the appointment, it is likely to be roughly the opposite of what Republicans might suppose: Dr. Berwick is a self-described “Patient-Centered Extremist.” He favors letting patients have the last word in decisions about their care even if that means, for example, choosing to have unnecessary and expensive hi-tech studies. In an article for Health Affairs published about a year ago, he explicitly argued against the “professionally dominant view of quality of health care”:

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Posted in: Health Fraud, Homeopathy, Medical Ethics, Politics and Regulation, Science and Medicine, Science and the Media

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CAM on campus: Ethics

In a previous post I described a lecture given by a faculty member to first-year medical students on my campus introducing us to integrative medicine (IM). Here I describe his lecture to the second-year class on legal and ethical aspects of complementary and alternative medicine (CAM).

Dr. P began his lecture by describing CAM using the now-familiar NCCAM classification. He gave the NCCAM definition of CAM as “a group of diverse medical and healthcare systems, practices, and products that are not presently considered to be part of conventional medicine.” To illustrate how this definition can lead to surprises, he asked us if the therapeutic use of maggots is CAM or conventional. Although it sounds rather CAM-ish, maggot therapy is used at some surgical centers for wound debridement, he told us, and therefore is part of “conventional medicine.”

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Posted in: Medical Academia, Medical Ethics, Science and Medicine

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Looking for quackademic medicine in all the wrong places

One advantage of having a blog is that I can sometimes tap into the knowledge of my readers to help me out. As many readers know, a few of the SBM bloggers (myself included) will be appearing at the Northeast Conference on Science and Skepticism (NECSS) on Saturday, April 17. Since the topic of our panel discussion is going to be the infiltration of quackademic medicine into medical academia, I thought that now would be a very good time for me to update my list of medical schools and academic medical centers in the U.S. and Canada that have embraced (or at least decided to tolerate) quackademic medicine in their midst. After all, the list is over two years old and hasn’t been updated.

My list is long past due for an update, and I want to post that update right here, either right before or right after NECSS. But I need your help. Please peruse the previous roll of shame. Then either post here in the comments or e-mail to me any examples of quackademic medical programs in the U.S. and Canada (I’ll leave Europe to others better qualified to deal with it) that I may have missed. Equally important, if there are programs I listed before that no longer peddle woo, let me know that too, so that I can investigate and decide if I should remove the program from my list.

I’m particularly interested in the most egregious examples (although your submitting all examples is greatly appreciated). Yoga and meditation don’t bother me that much, for example. Neither do dietary studies, because diet and exercise are science-based medicine that have all too often been coopted by purveyors of woo. Homeopathy and reiki, on the other hand, do bother me. A lot. I’m also particularly interested in educational programs in CAM that are funded by the National Center for Complementary and Alternative Medicine (NCCAM).

Please help me construct the definitive list of academic programs in the U.S. and Canada that have adopted quackademic medicine.

Posted in: Announcements, Medical Academia

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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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A temporary reprieve from legislative madness

While doctor visits for influenza-like illnesses seem to be trending downward again, and “swine flu” is becoming old news, I’d like to draw attention to an H1N1 story that has received very little coverage by the mainstream media.

Doctors in several states can now protect their most vulnerable patients from the H1N1 virus without worrying about breaking the law. In order to save lives, several states have announced emergency waivers of their own inane public health laws, which ban the use of thimerosal-containing vaccines for pregnant women and young children.

Legislators in California, New York, Illinois, Missouri, Iowa, Delaware, and Washington state have enacted these science-ignoring laws in response to pressures from the anti-vaccine lobby and fear-struck constituents. Except for minor differences, each state’s law is essentially the same, so I will focus on the one from my state of New York.

New York State Public Health Law §2112 became effective on July 1, 2008. It prohibits the administration of vaccines containing more than trace amounts of thimerosal to woman who know they are pregnant, and to children under the age of 3. The term “trace amounts” is defined by this law as 0.625 micrograms of mercury per 0.25 mL dose of influenza vaccine for children under 3, or 0.5 micrograms per 0.5 mL dose of all other vaccines for children under 3 and pregnant women. Because thimerosal (and thus, mercury) exists only in multi-dose vials of the influenza vaccines (both seasonal and novel H1N1), this law really only applies to these vaccines. The mercury concentration of the influenza vaccines is 25 micrograms per 0.5 mL, which therefore makes their use illegal. Unfortunately, the only form of the H1N1 vaccine initially distributed, and that could be used for young children and pregnant women, was the thimerosal-containing form. The thimerosal-free vaccine was the last to ship, and in low supply, and the nasal spray is a live-virus vaccine, not approved for use in pregnancy or children under 2. That meant, without a waiver of the thimerosal ban, these groups could not be vaccinated.
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Posted in: Politics and Regulation, Public Health, Science and Medicine, Vaccines

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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 III

Let’s look at one example.

A unknown number of Functional Medicine adherents broadcast call-in programs on radio stations. One FM physician, a Dr. “D” in Northern California graduated from UC Davis School of Medicine (Central California’s Sacramento Valley.) I find her program fascinating, requiring some attentive listening.

Dr. D’s recommendations for people’s complaints and conditions are often complex, a chimera of standard explanations and therapies, but painted with a variety of views that are anything but standard. The problem I found was that some of each answer was rational – especially the logic of her differential diagnosis – but suddenly spun out into space with unfamiliar methods or some recognizable as one component or another of sectarianism. Some answers had no relationship to the problem at hand, but seemed to be plucked out of a firmament of independent ideas, theories, ideologies, and personal anecdotes – a medical Separate Reality.

One can be carried along by an answer that sounds on surface reasonable because of the confidence and the delivery’s vocal tone. Her voice is medium-low, sort of a mezzo or contralto. It’s a voice ideal for advice; confidence oozes. Some of her separate reality recommendations she precedes with a biochemical or physiological explanation, so the shifting from standard to “separate reality” grids goes so smoothly, the usual recognizable red flags may not spring up.

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Posted in: 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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