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CAM and the Law, Part 1: Introduction to the issues

When I write or talk about the scientific evidence against particular alternative medical approaches, I am frequently asked the question, “So, if it doesn’t work, why is it legal?” Believers in CAM ask this to show that there must be something to what they are promoting or, presumably, the government wouldn’t let them sell it. And skeptics raise the question often out of sheer incredulity that anyone would be allowed to make money selling a medical therapy that doesn’t work. It turns out that the answer to this question is a complex, multilayered story involving science, history, politics, religion, and culture. 

While we science types tend to be primarily interested in what is true and what isn’t, that is a sometimes surprisingly minor factor in the process of constructing laws and regulations concerning medicine. What I hope to do in this series of essays is look at some of the major themes involved in the regulation of medical practice, particularly as they relate to alternative medicine. I will begin by touching on some of the general philosophical and legal issues that have defined the debate among the politicians and lawyers responsible for shaping the legal environment in which medicine is practiced. The I will review some of the specific domains within this environment, including: medical licensure and scope-of-practice laws; malpractice law; FDA regulation of drugs, homeopathic remedies, and dietary supplements; truth-in-advertising law; and anti-trust law.

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Posted in: Legal, Politics and Regulation, Science and Medicine

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Answering a criticism of science-based medicine

Attacks on science-based medicine (SBM) come in many forms. There are the loony forms that we see daily from the anti-vaccine movement, quackery promoters like Mike Adams and Joe Mercola, those who engage in “quackademic medicine,” and postmodernists who view science as “just another narrative,” as valid as any other or even view science- and evidence-based medicine as “microfascism.” Sometimes, these complaints come from self-proclaimed champions of evidence-based medicine (EBM) who, their self-characterization otherwise, show signs of having a bit of a soft spot for the ol’ woo. Then sometimes there are thoughtful, serious criticisms of some of the assumptions that underlie SBM.

The criticism I am about to address tries to be one of these but ultimately fails because it attacks a straw man version of SBM.

True, the criticism of SBM I’m about to address does come from someone named Steve Simon, who vocally supports EBM but doesn’t like the the criticism of EBM implicit in the very creation of the concept of SBM. Simon has even written a very good deconstruction of postmodern attacks on evidence-based medicine (EBM) himself, as well as quite a few other good discussions of medicine and statistics. Unfortunately, in his criticism, Simon appears to have completely missed the point about the difference between SBM and EBM. As a result, his criticisms of SBM wind up being mostly the application of a flamethrower to a Burning Man-sized straw man representing what he thinks SBM to be. It makes for a fun fireworks show but is ultimately misdirected, a lot of heat but little light. For a bit of background, Simon’s post first piqued my curiosity because of its title, Is there something better than Evidence Based Medicine out there? The other reason that it caught my attention was the extreme naiveté revealed in the arguments used. In fact, Simon’s naiveté reminds me very much of my very own naiveté about three years ago.

Here’s the point where I tell you a secret about the very creation of this blog. Shortly after Steve Novella invited me to join, the founding members of SBM engaged in several e-mail frank and free-wheeling exchanges about what the blog should be like, what topics we wanted to cover, and what our philosophy should be. One of these exchanges was about the very nature of SBM and how it is distinguished from EBM, the latter of which I viewed as the best way to practice medicine. During that exchange, I made arguments that, in retrospect, were eerily similar to the ones by Simon that I’m about to address right now. Oh, how epic these arguments were! In retrospect, I can but shake my head at my own extreme naiveté, which I now see mirrored in Simon’s criticism of SBM. Yes, I was converted, so to speak (if you’ll forgive the religious terminology), which is why I see in Simon’s article a lot of my former self, at least in terms of how I used to view evidence in medicine.

The main gist of Simon’s complaint comes right at the beginning of his article:
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Posted in: Clinical Trials, Medical Academia, Science and Medicine

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Why science reporters should do their homework

One of the most significant medical advancements of the last few decades has been the use of cholesterol-lowering medications called statins.  These drugs, when used properly, have been shown over and over to lower the risk of heart attacks, strokes, and death.  But like all drugs, they have many effects, both those we like (preventing heart attacks) and those we don’t (in this case, rare liver and muscle problems); the latter we call “side-effects”.  Studies done on drugs before they hit the market can identify common side-effects, but it’s not until many more people are exposed for a long period of time that rare side-effects show up.

A recent Scientific American article wondered if one of these rare side-effects could be memory problems.  At first glance, the idea seems pretty improbable, but the SI article takes some sketchy anecdotes and runs with the idea, managing to cobble together an interesting hypothesis: (more…)

Posted in: Science and Medicine

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Fatigued by a Fake Disease

One of the realities of being a pharmacist is that we’re easily accessible. There’s no appointment necessary for consultation and advice at the pharmacy counter. Questions range from “Does this look infected?” (Yes) to “What should I do about this chest pain?” to more routine questions about conditions that can easily be self-treated. Part of the pharmacist’s role is triage — advising on conditions that can be self-managed, and making medical referrals when warranted. Among the most common questions I receive are related to stress and fatigue. Energy levels are are down, and patients want advice, and solutions. Some want a “quick fix,” believing that the right combination of B-vitamins are all that stand between them and unlimited energy. Others may ask if prescription drugs or caffeine tablets could help. Evaluating vague symptoms is a challenge. Many of us have busy lifestyles, and don’t get the sleep and exercise we need. We may compromise our diets in the interest of time and convenience. With some simple questions I might make a few basic lifestyle recommendations, talk about the evidence supporting supplements, and suggest physician follow-up if symptoms persist. Fatigue and stress may be part of life, but they’re also symptoms of serious medical conditions. But they can be hard to treat because they’re non-specific and may not be easily distinguishable from the fatigue of, well, life.

This same vague collection of symptoms is called something entirely different in the alternative health world. It’s branded “adrenal fatigue,” an invented condition that’s widely embraced as real among alternative health providers. There’s no evidence that adrenal fatigue actually exists. The public education arm of the Endocrine Society, representing 14,000 endocrinologists, recently issued the following advisory:

“Adrenal fatigue” is not a real medical condition. There are no scientific facts to support the theory that long-term mental, emotional, or physical stress drains the adrenal glands and causes many common symptoms.

Unequivocal words. But facts about adrenal fatigue neatly illustrate why a science-based approach is a consumer’s best protection against being diagnosed with a fake disease. (more…)

Posted in: Science and Medicine

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Blog Discussion with an SBM Critic

Over the last couple of days I have been engaged at NeuroLogica in a discussion with a fellow blogger, Marya Zilberberg who blogs at Healthcare, etc. Since the topic of discussion is science-based medicine I thought it appropriate to reproduce my two posts here, which contain links to her posts.

A Post-Modernist Response to Science-Based Medicine

I receive frequent commentary on my public writing, which is great. The feature that most distinguishes blogs is that they are conversations. So I am glad to see that science-based medicine (a term I coined) is getting targeted for criticism in other blogs. One blogger, Marya Zilberberg at Healthcare, etc., has written a series of posts responding to what she thinks is our position at Science-based medicine. What she has done, however, is make many of the logical fallacies typically committed in defense of unscientific medical modalities and framed them as one giant straw man.

She is partly responding to this article of mine on SBM (What’s the harm) in which I make the point that medicine is a risk vs benefit game. Ethical responsible medical practice involves interventions where there is at least the probability of doing more benefit than harm with proper informed consent, so the patient knows what those chances are. Using scientifically dubious treatments, where there is little or no chance of benefit, especially when they are overhyped, is therefore unethical. And further, the “harm” side of the equation needs to include all forms of harm, not just direct physical harm.

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Posted in: Science and Medicine

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Lies, damned lies, and…science-based medicine?

I realize that in the question-and-answer session after my talk at the Lorne Trottier Public Science Symposium a week ago I suggested in response to a man named Leon Maliniak, who monopolized the first part of what was already a too-brief Q&A session by expounding on the supposed genius of Royal Rife, that I would be doing a post about the Rife Machine soon. And so I probably will; such a post is long overdue at this blog, and I’m surprised that no one’s done one after nearly three years. However, as I arrived back home in the Detroit area Tuesday evening, I was greeted by an article that, I believe, requires a timely response. (No, it wasn’t this article, although responding to it might be amusing even though it’s a rant against me based on a post that is two and a half years old.) Rather, this time around, the article is in the most recent issue of The Atlantic and on the surface appears to be yet another indictment of science-based medicine, this time in the form of a hagiography of Greek researcher John Ioannidis. The article, trumpeted by Tara Parker-Pope, comes under the heading of “Brave Thinkers” and is entitled Lies, Damned Lies, and Medical Science. It is being promoted in news stories like this, where the story is spun as indicating that medical science is so flawed that even the cell-phone cancer data can’t be trusted:

Visit msnbc.com for breaking news, world news, and news about the economy

Let me mention two things before I delve into the meat of the article. First, these days I’m not nearly as enamored of The Atlantic as I used to be. I was a long-time subscriber (at least 20 years) until last fall, when The Atlantic published an article so egregiously bad on the H1N1 vaccine that our very own Mark Crislip decided to annotate it in his own inimitable fashion. That article was so awful that I decided not to renew my subscription; it is to my shame that I didn’t find the time to write a letter to The Atlantic explaining why. Fortunately, this article isn’t as bad (it’s a mixed bag, actually, making some good points and then undermining some of them by overreaching), although it does lay on the praise for Ioannidis and the attacks on SBM a bit thick. Be that as it may, clearly The Atlantic has developed a penchant for “brave maverick doctors” and using them to cast doubt on science-based medicine. Second, I actually happen to love John Ioannidis’ work, so much so that I’ve written about it at least twice over the last three years, including The life cycle of translational research and Does popularity lead to unreliability in scientific research?, where I introduced the topic using Ioannidis’ work. Indeed, I find nothing at all threatening to me as an advocate of science-based medicine in Ioannidis’ two most famous papers, Contradicted and Initially Stronger Effects in Highly Cited Clinical Research and Why Most Published Research Findings Are False. The conclusions of these papers to me are akin to concluding that water is wet and everybody dies. It is, however, quite good that Ioannidis is there to spell out these difficulties with SBM, because he tries to keep us honest.
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Posted in: Clinical Trials, Science and Medicine

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Influenza Vaccine Mandates

I have been involved in infection control and in what is now called quality for my career. Since infection control issues can occur in any department, my job involves being on numerous quality related committees (Medical Executive, Pharmacy and Therapeutics, etc) where I have witnessed or participated in what seems to be innumerable quality initiatives.

It always gripes my cookies when someone says “Get your own house in order,” because that is a person who evidently is arguing from ignorance. Since To Err is Human was published at the turn of the century, the hospital systems in Portland and across the country have invested significant time and money into quality improvement. Do a Pubmed on ‘Hand Hygiene Compliance’ in the last decade; there are over 400 references. Or ‘deep venous thrombosis prophylaxis’ — over 5,000 references. Or ‘ventilator associated pneumonia prevention’ — over 750 references. Pick a topic related to safety and quality and search the literature, and you will find a remarkable amount of research into the best ways to decrease morbidity and mortality in the hospital.

Hospitals, at least those in my city, take safety and quality very seriously, and by applying the results of these studies, there has been a marked decrease in mortality and morbidity in my institutions. Compared to historical controls, we estimate we have, in the last 2 years, prevented about 600 hospital acquired infections and over 200 deaths. (more…)

Posted in: Science and Medicine

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Heart disease: one of science-based medicine’s great successes

Sixty years ago, the world was full of miracles. Western Europe was recovering from the devastation of World War II, an agricultural revolution promised to banish the fear of starvation in large parts of the world, and the mythical Mad Men era gave Americans a taste of technology-dependent peace and prosperity unlike any in the past. Despite the technological progress that would soon send animals into space and return them relatively unharmed, Americans, and westerners in general, were still dying of heart disease at a frightening rate. If you, as a middle aged American, experienced chest pain and were lucky enough to make it to a hospital (about 20% of all sufferers would die immediately), you would probably be given nitroglycerin and morphine to control you pain, put on bed rest, and could expect to live a few more years, with limited physical activity.

Heart disease continues to be a top killer of Americans, but there has been a dramatic decline in heart disease mortality in the last 60 years, with age-specific mortality rates dropping 60%. Fewer people are developing heart disease, and those that have it are living longer. It is estimated that in 2000 alone, there were 341,745 fewer heart disease deaths than would have been expected if rates had remained unchanged.  This decline has not been driven by a renaissance of alternative medicine.  It has been driven by science.

The trend has been going on for many decades, and has been accelerating, although current trends in diabetes and obesity put us at risk for more overall cases of heart disease in the future. So what are we doing right? How have we managed to cut the death rate from heart disease so dramatically?
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Posted in: Science and Medicine

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The 2010 Lorne Trottier Public Science Symposium

I really have to give those guys at McGill University’s Office for Science and Society credit. They’re fast. Remember how I pointed out that I’ve been away at the Lorne Trottier Public Science Symposium? This year, the theme was Confronting Pseudoscience: A Call to Action, and I got to share the stage with Michael Shermer, Ben Goldacre, and, of course, our host, “Dr. Joe” Schwarcz. Sadly, I couldn’t stay to see The Amazing Randi do his thing yesterday evening, but at least I did get to have breakfast with him before I left.

In any case, the reason I have to hand it to Dr. Joe and his team at McGill is because they’ve already uploaded all the videos for symposium events. Here’s the main page with the videos (the 2010 Trottier Symposium occurred on October 17, 18, and 19), and here are the individual links:

And, because I can’t resist, here are some photos taken with various people’s cell phone cameras. First, we have a lovely poster of woo that I saw at the restaurant where we had lunch on Sunday and just had to snap a quick picture of:
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Posted in: Announcements, Science and Medicine, Science and the Media

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At the Lorne Trottier Symposium…

I have to apologize. There won’t be one of my usual epic posts this week. Fear not, however. I did get another SBM blogger to pinch hit for me in a post that will appear later today. I also had time to write a quick post announcing an initiative we here at SBM are planning for early November.

The reason for the rare occasion of my missing a week, of course, is that I’m participating in the 2010 Lorne Trottier Public Science Symposium in Montreal. Between all the travel, a two hour roundtable discussion featuring Michael Shermer, Ben Goldacre, and yours truly, among others, all organized by the McGill University’s Office for Science and Society. The event was videotaped, and a webcast of the event will be available, as will a webcast of our talks tomorrow. You can trust that I will certainly post links to them after they have been posted on the McGill website, in particular the symposium itself, so you can for yourselves see how much better speakers Michael Shermer and Ben Goldacre are when compared to me.

I’ll also be on the radio on CJAD AM 800 at 10 AM Monday morning with Michael Shermer and “Dr. Joe” Schwarcz to talk about pseudoscience in medicine and other areas.

Yes, I’m having a blast here, having had the opportunity at a leisurely dinner to discuss differences between the quackery situation in England compared to the U.S. and to meet Lorne Trottier. Now I have to fine tune my talk for tomorrow, and it’s late. Oh, well…

Posted in: Announcements, Science and Medicine, Science and the Media

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