Although I’m one of the few non-clinicians writing here at SBM, I think about clinical trials a great deal – especially this week.
First, our colleague, Dr. David Gorski, had a superb analysis and highly-commented post on The Atlantic story by David H. Freedman about the work of John Ioannadis – more accurately, on Freedman’s misinterpretation of Ioannadis’s work and Dr. Gorski’s comments. While too rich to distill to one line, Dr. Gorski’s post struck me in that we who study the scientific basis of medicine actually change our minds when new data become available. That is a GoodThing – I want my physician to guide my care based on the latest data that challenges or proves incorrect previously held assumptions. However, this concept is not well-appreciated in a society that speaks in absolutes (broadly, not just with regard to medicine), expecting benefits with no assumption of risk or sacrifice in reaping those benefits. Indeed, the fact that we change our minds, evolving and refining disease prevention and treatment approaches, is how science and medicine move forward.
Then, I had the opportunity to hear an excellent talk on pharmaceutical bioethics by Ross E. McKinney, Jr., MD, Director of the Trent Center for Humanities, Bioethics, and History of Medicine at Duke University School of Medicine. McKinney is a pediatrics infectious disease specialist who led and published landmark Phase I and Phase II trials zidovudine (AZT) for pediatric AIDS patients. While he continues working in this realm, McKinney also studies clinical research ethics, conflicts of interest, and informed consent. I was absolutely fascinated and refreshed by hearing from an expert who while describing and citing major ethical lapses in our system of drug development is also willing to propose solutions and do the hard thinking required for us to maximize the benefits we derive from pharmaceuticals while minimizing unethical behavior.
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…)
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.
A salesman is demonstrating a new product at a sports store in the local mall. He has a customer stand with his arms extended horizontally to the sides; he presses down on an arm and the customer starts to fall over. Then he puts a bracelet on the customer and repeats the test; this time he is apparently unable to make the customer lose his balance. He has the customer turn his head as far as he can without the bracelet, and shows that he can turn his head a few degrees more after he puts on the bracelet. (Try this yourself: if you turn your head, wait a couple of seconds and try again, you will always be able to turn it further on the second trial). He similarly shows that the customer is stronger when he wears the bracelet. The customer and the onlookers are mightily impressed by the demonstration, by the salesman’s testimonials, and by the endorsements of famous athletes: they buy the bracelets to improve their athletic performance.
These so-called energy bracelets (also pendants and cards) allegedly contain a hologram embedded with frequencies that react positively with your body’s energy field to improve your balance, strength, flexibility, energy, and sports performance; and they also offer all sorts of other benefits (such as helping horses and birds and relieving menstrual cramps and headaches). The claims and the language on their websites are so blatantly pseudoscientific it’s hard to believe anyone would fall for them. Here are just a few examples from the Power Balance website:
- We react with frequency because we are a frequency.
- Your body’s energy field likes things that are good for it.
- Why Holograms? We use holograms because they are composed of Mylar—a polyester film used for imprinting music, movies, pictures, and other data. Thus, it was a natural fit.
- A primitive form of this technology was discovered when someone, somewhere along the line, picked up a rock and felt something that reacted positively with his body.
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:
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.
Tonight (Friday Night) we will be moving SBM to a new faster host. This will improve the performance of SBM, which has been sluggish recently, and give us the ability to increase our resources as needed as SBM continues to grow.
Comments posted between Friday night and approximately Sunday morning may be lost in the gap as the location of the new servers propagates through the internet. The site will be up throghout this process, but comments may be lost during this period. We are making the move over the weekend because that is when traffic is lowest. SBM should be fully functional by Monday morning, and in any case I will update this post when it appears that the move is complete.
Thanks for your patience.
The SBM move is now complete. If you are seeing this addendum then you are pointing to the new host. Performance seems much better already, but we will be closely monitoring it to keep performance optimal.
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…)
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?
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:
In my group practice, the Yale Medical Group, drug-company sponsored lunches and similar events have been banned. This is part of a trend, at least within academic medicine, to create some distance between physicians and pharmaceutical companies, or at least their marketing divisions. The justifications for this are several, and are all reasonable. One reason is the appearance of being too cozy, which compromises the role of academic physicians as independent experts.
But the primary reason is the belief that “detailing” by pharmaceutical sales representatives has a negative effect on the prescribing habits of physicians. There is reason to believe this may be the case because of cases of bad behavior on the part of pharmaceutical marketing divisions – ghost writing white papers, for example. The concern, backed by evidence, is that pharmaceutical companies introduce spin and bias into the information they provide to physicians, whether though CME, detailing, literature, or sponsored lectures. Even when the information itself is not massaged, it is cherry picked, so in the end physicians are not getting a thorough and unbiased assessment of the facts.
The FDA does heavily regulate the marketing of information about pharmaceuticals, but marketers are very clever about exploiting loopholes and seem to be one step ahead of the regulators.
On the other hand there are those who argue that physicians can handle access to information and they are equipped to take it with a grain of salt and put it into context. Certainly most physicians I speak to believe this about themselves. Further, information provided by pharmaceutical companies may actually improve prescribing habits if it makes physicians aware of new products on the market and new information about the drugs they prescribe. The information itself is FDA approved (or at least should be), even if it is selective and wrapped in spin.