Working in pharmacies where supplements are sold alongside traditional (over-the-counter) medications, I’m regularly astonished at the different perceptions consumers can have about the relative efficacy and safety of different types of products. Once, speaking with a customer about a medical condition she wanted to treat, I indicated that there were no effective non-prescription therapies — she needed to see a physician for access to an effective treatment by prescription — and I gestured behind the counter. “Back there?!” she pointed. “That’s where you keep the stuff that kills people! I want something natural!” Suggesting that my patients with heart disease or HIV had a somewhat different perspective, I tried (unsuccessfully) to talk her out of a questionable-looking supplement (Hint: avoid anything from a company with a P.O. box as a mailing address.) This appeal to nature, combined with a perception that natural products are safe, and conventional drugs are unsafe, is pervasive. (more…)
Posts Tagged CAM
This one crept up on me by surprise. You see, I recorded an interview with D.J. Grothe, President of the James Randi Educational Foundation and host of the podcast For Good Reason back in November. I wasn’t sure when it would appear. Well, it turns out that it popped up on my iTunes podcast feeds sometime over the last few days. (It’s been really busy at work, and I haven’t really been paying attention to podcasts–at least, not until yesterday.)
So, here it is. I haven’t listened to it all yet, but hopefully I explained myself well enough and did credit to my fellow SBM bloggers. DJ is a good interviewer, which means he presses his subjects a bit and sometimes gets them out of their comfort zone.
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.
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:
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”:
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.”
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.
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…)
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.
Laurie Edwards has a rare chronic disease called primary ciliary dyskinesia. Her symptoms are quite similar to those associated with cystic fibrosis, and her young life has been punctuated by numerous hospitalizations, physical limitations and the occasional near-death experience. She is a remarkably upbeat woman, and attributes her self confidence and optimistic outlook to her loving friends and family.
Laurie is part of the patient blogging community online. She reads physician blogs with interest, and wants to protect others like her from snake oil and misinformation. She recently interviewed me about my pro-science views for a new book that she’s writing. People like Laurie play a critical role in accurate health communication, and I welcome the chance to discuss science-based medicine with them. Here are some excerpts from our chat: (more…)