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Being Right Versus Being Influential

On May 9th I had the pleasure of lecturing to an audience of critical thinkers at the NYC Skeptics meeting. The topic of discussion was pseudoscience on the Internet – and I spent about 50 minutes talking about all the misleading health information and websites available to (and frequented by) patients. The common denominator for most of these well-intentioned but misguided efforts is a fundamental lack of understanding of the scientific method, and the myriad ways that humans can fool ourselves into perceiving a cause and effect relationship between unrelated phenomena.

But most importantly, we had the chance to touch upon a theme that has been troubling me greatly over the past couple of years: the rise in influence of those untrained in science on matters of medicine. I have been astonished by the ability of “thought leaders” like Jenny McCarthy to gain a broad platform of influence (i.e. Oprah Winfrey’s TV network) despite her obviously flawed beliefs about the pathophysiology of autism. Why is it so hard to find a medical voice of reason in mainstream media?

The answer is probably related to two issues: first, good science makes bad television, and second, physicians are going about PR and communications in the wrong way. We are taught to put emotions aside as we carefully weigh evidence to get to the bottom of things. But we are not taught to reinfuse the subject with emotion once we’ve come to an impartial consensus. Instead, we tend to bicker about statistical analyses, and alienate John Q. Public with what appears to him as academic minutiae and hair-splitting.

I’m not sure what we can or should offer in place of our “business as usual” behavior – but I’ve noticed that being right isn’t the same as being influential. I wonder how we can better advance the cause of science (for the sake of public health at a minimum) to an audience drawn more to passion than to substance?

I would really enjoy your input, dear readers, because I’m at a loss as to what we should do next to reach people in our current culture, and with new communications platforms. What would you recommend?

*This blog post was originally published at Science-Based Medicine*

Is IV Sedation Over-Used?

We criticize alternative medicine for not being evidence-based, and they criticize conventional medicine in turn, saying that much of what conventional medicine does is not based on evidence either. Sometimes that criticism is justified. I have run across a conventional practice that I suspect began because it sounded like a good idea, but that never was adequately tested and is not carefully thought out for individual patients.

I recently had a bone marrow aspiration. The written instructions said not to eat or drink for 6 hours before the procedure, to bring someone to drive me home, and to expect an IV. I suspected from these instructions that they were planning to use IV sedation, and I was right.

I questioned the need for sedation. I am prejudiced about bone marrow aspirations. I observed several and did one myself during my internship. When I had finished, the patient asked me when I was going to start. We did the procedure at the patient’s bedside in a multi-bed ward with no sedation, only local anesthesia. So my prejudice was that the procedure was no big deal and was not terribly painful.

I can imagine that some patients may be terrified by the idea of a needle going into their bone and may want to be sedated and not remember the experience. But I was not anxious about it, and I saw no need for the fentanyl and Versed they wanted to give me. I figured it would only prolong my time in the hospital, produce amnesia, expose me to a small risk of adverse effects, and leave me groggy; so I asked to opt out. They readily agreed – although they did keep asking me if I was really sure I didn’t want it. They would not have offered the option of no sedation if I had not known to ask.

The pathologist doing the procedure told me the injection of local anesthetic into the skin was the most painful part of the procedure. He was wrong. It was the ONLY painful part of the procedure. The penetration of bone and the aspiration of marrow produced only a pressure sensation.

This study reported that 85% of non-sedated patients had intense pain. I find that hard to believe, based on my personal experience and the experience of the pathologist that the local anesthetic was the worst part of the procedure. I wonder if those patients were anxious and were expecting intense pain. At any rate, I think giving me IV sedation would have been the wrong thing to do.

I had a similar experience with an excisional breast biopsy. They offered me general or local anesthesia and I chose local as presumably the safer option. Then they said they would use IV sedation along with the local. I asked why. They said to relieve anxiety. I told them I wasn’t anxious so if that was the only reason for sedation, I didn’t want it. I finally prevailed. I was comfortable, alert, had a good time chatting with the anesthesiologist, and was able to leave the recovery room much sooner than sedated patients.

I’m not saying that IV sedation is not indicated for some patients, but I am convinced it was not indicated for me. Has it become a knee-jerk reflex to sedate everyone as a general principle? Why? To avoid complaints and keep patients more cooperative during procedures? Are we paternalistically deciding that it is better if the patients don’t remember the procedure? I wonder: if minor procedures are not remembered, might the mystery increase anxiety and fear of the unknown for future procedures? We must ask seriously whether IV sedation is done more for the patient’s benefit or the doctor’s. The answer will vary with the procedure and the patient.

Rather than sedating every patient, why not use some judgment? Even if the patient is anxious, perhaps a non-drug option could relieve that anxiety without risking the side effects of drugs. Surely some anxiety is due to fear of the unknown. Would it help to show patients a video of someone comfortably undergoing the procedure without sedation, with an explanation of exactly what was happening? Would simple reassurance or personal attention from a patient advocate be helpful? Worth looking into? I think so.

Doctors are frequently accused of prescribing unnecessary drugs out of habit or reflex. I suggest that IV sedation for minor procedures is an example of over-prescription that is based more on custom than on good evidence.

*This blog post was originally published at Science Based Medicine.*

Book Review: Triumph Of The Heart, The Story Of Statins

Triumph of the Heart, as its name does not suggest, is about science. The book’s author, Jie Jack Li, is a medicinal chemist who meticulously reviews the history relevant to the discovery of lipid-lowering drugs. He spares no details, even recounting the amusing quarrels and quirks of the scientists engaged in the “apocryphal showdowns” leading to the manufacture of cholesterol in a laboratory.

The personalities of the various scientists and Nobel laureates described in the book are highly entertaining. From beating one another with umbrellas, to insisting on wearing blue clothing only, to egos so large and unappealing as to empty an entire academic center of all its promising young recruits, one has the distinct impression that brilliance does not go hand-in-hand with grace.

That being said, each of these scientists did seem to share a common approach to research: carefully testing hypotheses, repeating peer study results to confirm them, and patiently exploring complex biochemical pathways over periods of decades. The physicians, physicists, and chemists showed an incredible ability to doggedly pursue answers to specific questions – understanding that the results might influence human health. But even more importantly, they were each willing to invest their careers in analysis that may never lead to anything more than a dead end. In fact, the book is full of examples of great ideas, developed over decades, that did not lead to a marketable drug. In some cases the research was halted due to lack of efficacy, in others political forces or personal whims influenced the course.

What strikes me about the scientists described in Triumph of the Heart, is how rare it is nowadays for people to have the sort of patience required for laboratory work. In an age where kids suffer from iPhone and video game addictions, young adults expect a relaxed work environment with high salaries and no accountability, and adults are flummoxed by stores that are not open 24 hours… who has time for the hard work of science? Even The Onion, my favorite spoof newspaper, mocks modern attention spans calling science “hard.”

Triumph of the Heart is about much more than the discovery and development of statins. It traces the historical development of the first antibiotics, pain medicines, diuretics, and steroids, the rise, fall and merger of drug companies, patent wars, the unethical conduct of some researchers, and the financial pressures that shaped the industry, both in the U.S. and abroad. Other than Mr. Li’s inability to resist his chemist’s urge to delve into advanced concepts in organic chemistry (around mid-book) as a physician I found Triumph of the Heart to be quite interesting, and well researched.

The most important take away, however, is that science is about hard work, attention to detail, innovative thinking, advanced analytic skills, serendipity, and the patience of Job. Triumph of the Heart reminds us all what good science is about, and how life-saving discoveries are made.

Acupuncture Doesn’t Work, Believers Ignore Evidence

steve_bwThe primary goal of science-based medicine (SBM) is to connect the practice of medicine to the best currently available science. This is similar to evidence-based medicine (EBM), although we quibble about the relative roles of evidence vs prior plausibility. In a recent survey 86% of Americans said they thought that science education was “absolutely essential” or “very important” to the healthcare system. So there seems to be general agreement that science is a good way to determine which treatments are safe and work and which ones are not safe or don’t work.

The need for SBM also stems from an understanding of human frailty – there are a host of psychological effects and intellectual pitfalls that tend to lead us to wrong conclusions.  Even the smartest and best-meaning among us can be lead astray by the failure to recognize a subtle error in logic or perception. In fact, coming to a reliable conclusion is hard work, and is always a work in progress.

There are also huge pressures at work that value things other than just the most effective healthcare. Industry, for example, is often motivated by profit. Institutions and health care providers may be motivated by the desire for prestige in addition to profits. Insurance companies are motivated by cost savings. Everyone is motivated by a desire to have the best health possible – we all want treatments that work safely, often more so than the desire to be logical or consistent. And often personal or institutional ideology comes into play – we want health care to validate our belief systems.

These conflicting motives create a disconnect in the minds and behaviors of many people. They pay lip service to science-based medicine, but are good at making juicy rationalizations to justify what they want to be true rather than what the science supports. We all do this to some degree – but, in my opinion, complementary and alternative medicine (CAM) is a cultural institution that is built upon these rationalizations.  It is formalized illogic and anti-science conceals as science under a mountain of rationalizations.

Some recent news items and reports dealing with acupuncture demonstrate this disconnect quite well.

The BMJ

The British Medical Journal (BMJ) recently published a review of acupuncture studies in the treatment of chronic pain. Like most other reviews of acupuncture studies, the authors were not impressed. They concluded:

A small analgesic effect of acupuncture was found, which seems to lack clinical relevance and cannot be clearly distinguished from bias. Whether needling at acupuncture points, or at any site, reduces pain independently of the psychological impact of the treatment ritual is unclear.

After decades of study and hundred of clinical trials, this remains the state of acupuncture research.  The best studies continue to show an unclear effect, which cannot be separated from bias – which of course is the point of clinical trials. In other words, the signal cannot be separated from the noise. The most parsimonious interpretation of this fact is that there is no significant signal – acupuncture does not work.

But supporters of acupuncture prefer to go through a litany of rationalizations rather than acknowledge that simple fact (more on this later).

It was also recently announced that the BMJ group will be adding a new journal: BMJ Acupuncture. That’s right, an entire journal dedicated to studying (read “promoting”) acupuncture.  The press release notes:

Acupuncture in Medicine is a quarterly title, which aims to build the evidence base for acupuncture.

I thought the purpose of research was to discover if a treatment works, not to build a case for it.

BMJ is a strange journal – it is generally of high quality but seems to have a blind spot for certain CAM modalities, like acupuncture. While it will publish critical reviews, like the one above, it also has published some low quality positive reviews – such as this one of acupuncture and IVF (in vitro fertilization).  The review glosses over the disparity in study quality and location. Other reviews published around the same time showed no effect from acupuncture in IVF.

And the best individual studies to date show no effect. In fact, the most recent study showed that the placebo acupuncture group had slightly higher pregnancy rates by some measures than the acupuncture group (while other measures showed no difference). Again – the most parsimonious interpretation of this study is the null hypothesis – acupuncture does not work in IVF. But proponents twisted themselves into logical pretzels and offered up the astounding rationalization that placebo acupuncture must have some real effect.

To be clear, I am not against journals that specialize in one area, or practitioners that specialize in one form of treatment. Specialization is essential to deal with the modern complexity of medicine. However, we must recognize the significant risk of specialization – and that is the fallacy that is often summarized as follows: if your only tool is a hammer then every problem will look like a nail. It is unlikely that a journal or practitioner dedicated to acupuncture will ever reach the conclusion that acupuncture is a dead end and science-based medicine should move on. As an extension of this, specialty journals and specialist should follow well-established modalities. Forming a specialty journal dedicated to an unproven and dubious modality is problematic, to say the least.

More Rationalizations

A recent Washington Post article observes in its headline: “Millions embrace acupuncture, despite thin evidence.” It seems this reporter, Ellen Edwards, has grasped the essential disconnect, although she does not sufficiently explore an answer to the implied question – why? Why do so many accept acupuncture despite an enduring absence of scientific evidence? Ironically, the press has much to do with it. They are often complicit in misrepresenting the facts, and abetting the rationalizations that are necessary for those who should know better to continue to promote acupuncture despite the lack of evidence.

Some professional organizations are also complicit. The article notes, for example:

The American Medical Association takes no position specifically on acupuncture; the AMA groups it with other alternative treatments, saying “there is little evidence to confirm the safety or efficacy of most alternative therapies.” It says “well-designed, stringently controlled research” is needed to evaluate its efficacy.

Now, the AMA is not the best place to go for position papers on specific scientific questions in medicine. But if they are going to bother having any position, it should be better informed. They say that research is needed, giving the impression that there isn’t already a large body of research to inform out opinion about whether acupuncture works or not.

The notion that more research is needed is one of the most common rationalizations. That allows someone to put off forever concluding that their pet modality does not work – simply make the case for more research, which is easy to make sound like it’s a good idea. And of course anyone against more research must be closed-minded.  For example, the story relates (standard disclaimer – I am aware that experts are often quoted out of context by journalists, so keep that in mind, but for the purposes of this post I will take the quotes at face value):

In 2007, NCCAM spent about $9.1 million on acupuncture research. While more is planned, Brent Bauer, an internist at the Mayo Clinic and director of its complementary and alternative medicine program, said the research is in its “toddlerhood.”

Nice touch – “toddlerhood.”  That’s just a cute way of saying that more research is needed and you can comfortably ignore any current negative research. If the assessment were fair, then it could be justified. But we have already had several fairly sophisticated placebo-acupuncture controlled trials. This represents reasonably mature clinical research. I suspect
Bauer just does not like the fact that these best studies (like the IVF study above) are generally negative. I wonder – if these studies were positive would he still think they were imature and could be ignored?

Linda Lee, a gastroenterologist who is director of Johns Hopkins’s new Integrative Medicine and Digestive Center, is quoted as saying:

“We have this double standard. We are completely comfortable using pharmacological therapies that have not been subjected to clinical trials for the purposes we use them, but we are super suspicious of alternative therapies that haven’t been tested with randomized placebo trials. From a research point of view, I understand the criticism. But we physicians are in the healing business, and we have to go beyond the pharmacological solutions to understand the whole person,” she said. “Acupuncturists start with the whole person.”

Ah – the “holistic” gambit.  This is just another rationalization to distract people from the uncomfortable fact, that she acknowledged. From a “research point of view” means “I understand that the best quality scientific evidence is negative.” And “we..are in the healing business” means “but I want to believe in this anyway.”

The double standard is also an incredible claim, because the opposite is true. SBM advocates want a single standard. What Dr. Lee is actually referring to is prior plausibility – scientific practitioners are more accepting of treatments that are biologically plausible, and are appropriately skeptical of treatments that are extremely implausible.  It is also a tu quoque fallacy – we advocate high standards of science for all treatments, even plausible ones. If some doctors uses drugs unscientifically, that does not justify chucking science whenever it conflicts with our beliefs and desires.

It is, in fact, the CAM proponents who want a double standard. Imagine if after hundreds of studies the best a drug could do for any indication is a weak effect that is likely just placebo – the signal cannot be separated from the noise. Imagine  a pharmaceutical company making the exact same rationalizations to put its failed drug on the market anyway that acupuncture proponents make for acupuncture.

The article concludes, as most do, with a positive anecdote from a believer – Elise Feingold:

“I decided to leave my science brain aside,” she said. “I felt it had helped other people, and it might help me. I don’t know how it works, but it’s got 4,000 years of Chinese medicine behind it.”

She begins with what amounts to saying that anecdotal evidence is more compelling that rigorous science. This, of course, makes no sense. The whole point of scientific rigor is for evidence to be more objective and reliable – to control for any many variables as possible. Anecdotes are unreliable because they do not control for any variables. Proponents of acupuncture are happy to cite scientific evidence when they think it supports their beliefs, but then will chuck science in favor of low quality anecdotes as needed.

Feingold finishes with the commonplace appeal to antiquity.  The premise of this argument is that a treatment that has no real effect could not survive for thousands of years. History proves that this premise is false (see blood letting), and it also profoundly underestimates the human capacity for self-deception and therefore the need for scientific controls.

Conclusion

There is still no compelling evidence that there is any real effect to acupuncture.  It didn’t have to turn out that way, but that is the way the scientific chips fell. The treatment also lacks plausibility (although I usually point out that something is happening, unlike homeopathy, and so there is the physical possibility of an effect), and in medicine you only get two strikes. No evidence and no plausibility means that you’re out.

But the disconnect continues. Proponents keep pretending that there is compelling evidence, or it has not been properly studied yet, or it does not have to be studied because historical anecdotes are enough – whichever argument suits the moment. Meanwhile the media keep breathlessly telling us that acupuncture is gaining ground, while the evidence is standing still.

The premise of SBM is that support and resources should follow scientific support. In the world of CAM, however, support follows belief, and the science seems to be an afterthought or, worse, an obstacle.

**This post was originally published at Science Based Medicine.**

Announcing The Science-Based Medicine Conference

My colleagues and I will be holding a Science-Based Medicine conference on Thursday, July 9th. This is an all-day conference covering topics of science and medicine. The conference is designed for both a professional and general audience.

The conference will be at the Southpoint Casino and Hotel in Las Vegas, Nevada. It is also part of The Amazing Meeting 7 (TAM7) which is run by the James Randi Educational Foundation (JREF). You can register for the conference either separately or packaged with TAM7.  You can register for both here.

Physicians can earn 6 hours of category 1 CME credits for attending the conference.

Below is the list of speakers and the titles of their talks, and below that is the bio for each speaker.

Topics:
Introduction to Science-Based Medicine (Steven Novella, MD)
Case studies in cancer quackery: Testimonials, anecdotes, and pseudoscience (David H. Gorski, MD. PhD)
A Scientific Critique of Chiropractic (Harriet Hall, MD)
Why Evidence-Based Medicine is not yet Science-Based Medicine (Kimball Atwood, MD)
Lyme: From the IDSA to the ILAD to the ABA (Mark Crislip, MD)
Online Health & Social Media: The Good, The Bad, and The Ugly (Val Jones, MD)
Conclusion (Steven Novella, MD)

Speakers:

Steven Novella, MD
Dr. Novella is an academic clinical neurologist at Yale University School of Medicine. He is the president and co-founder of the New England Skeptical Society. He is also the host and producer of the popular weekly science podcast, The Skeptics’ Guide to the Universe. He authors NeuroLogicaBlog and contributes to several other science blogs: The Rogues Gallery, SkepticBlog, and Science-Based Medicine, of which he is also the founding editor.

David H. Gorski, MD, PhD
Dr. Gorski is an Associate Professor of Surgery Division of Surgical Oncology, Wayne State University School of Medicine, Detroit, MI. He is also the Program Leader, Breast Cancer Biology Program, Barbara Ann Karmanos Cancer Institute. His cancer research has been funded by the NIH, ASCO, and the Breast Cancer Research Foundation. He is a long-time science blogger who regularly tackles issues related to science and medicine. He is the associated editor of Science-Based Medicine.

Harriet Hall, MD
Dr. Hall is a retired family physician. She spent 20 years in the Air Force as a flight surgeon and family physician and retired as a full colonel. Also known as “The SkepDoc” from her column in Skeptic magazine, she has written extensively about alternative medicine. She is an editor of The Scientific Review of Alternative Medicine and the Science-Based Medicine blog, is an advisor to Quackwatch, and is a contributing editor to both Skeptic and Skeptical Inquirer magazines. Her website is www.skepdoc.info.

Kimball Atwood, MD
Dr. Atwood is a practicing anesthesiologist who is also board-certified in internal medicine. He has been interested in pseudoscience for years. He was a member of the Massachusetts Special Commission on Complementary and Alternative Medical Practitioners, and subsequently wrote its Minority Report opposing licensure for naturopaths. He is an associate editor of the Scientific Review of Alternative Medicine and co-editor of Naturowatch. He is particularly concerned with implausible claims being promoted, tacitly or otherwise, by medical schools and government. He is also dubious about the ethics of human trials of such claims.

Mark Crislip, MD
Dr. Crislip has been a practicing Infectious Disease specialist in Portland, Oregon since 1990. He is Chief of Infectious Diseases for Legacy Health System.
He is responsible for the Quackcast, a skeptical review of Supplements, Complementary and Alternative Medicine, The Persilflagers Annotated Compendium of Infectious Disease Facts, Dogma and Opinion a guide to Infectious Diseases, the Persifalgers Puscast, a podcast review of Infectious Diseases, and Rubor, Dolor, Calor, Tumor, an infectious disease blog.

Val Jones, MD
Dr. Jones is the CEO of Better Health, LLC, a medical blogging network, and VP of Strategic Partnerships at MedPage Today, an online health news source for healthcare professionals. She has been the Senior Medical Director for Revolution Health, and the founding editor of Clinical Nutrition & Obesity, a peer-reviewed e-section of the online Medscape medical journal. Dr. Jones volunteers once a week as a rehabilitation medicine physician at Walter Reed Army Medical Center.

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