Recently ProPublica and This American Life (TAL) released the results of an investigation into acetaminophen, the active ingredient in Tylenol. TAL devoted an entire episode to the issue, and ProPublica has published several stories on acetaminophen’s toxicity, how it can cause harm, and how it is regulated.
The investigation summarizes the key “Takeaways” as follows:
- 150 Americans die per year from accidental acetaminophen overdoses
- The safety margin (safe dose vs. toxic dose) with acetaminophen is small
- Both the FDA and the manufacturer, McNeil, have known about the toxicity for years
- For over 30 years the FDA has failed to implement measures to reduce the risk of harms it knew existed
- The manufacturer has taken steps to protect consumers but has also opposed other safety measures
While Tylenol is a single brand out of hundreds of prescription and non-prescription products that contain acetaminophen as an active ingredient, it is the brand most closely associated with the chemical. Amazingly for a drug that has no patent and lots of competition, Tylenol products are estimated to make up half of all non-prescription acetaminophen sales in the US, a testament to the power and effectiveness of marketing. (It’s also a clear refutation to alt-med arguments that unpatented products can’t be profitable, or aren’t of interest to the pharmaceutical industry.) While much of the focus of the investigation centers on the corporate behavior of Tylenol’s manufacturer, McNeil, (a division of Johnson & Johnson), it is important to keep in mind that no single company is responsible for acetaminophen sales and marketing. (more…)
First, my bias. I work in Portland and we have medical students, residents, and faculty who are DOs (Doctor of Osteopathy). Before he moved on to be a hospitalist my primary physician was a DO. From my experience there is no difference between an MD and a DO. In my world they are interchangeable. There are many more qualified applicants for medical education than positions in MD programs and some opt for a DO education. Osteopathy has a dark side.
As best I can determine from my colleagues, learning osteopathic manipulation (OM) is the price they pay to obtain an otherwise standard medical education. I have yet to see OM offered by any of my DO colleagues. It may be they know better than to offer such a modality around me given my ranty propensity for all things SCAM.
The literature would suggest that OM is left behind by most DOs upon graduation. DOs are not proud of their OM, and rarely invite them ‘round to dinner. It will be interesting to see if OM fades over time in DO school as the old time true believers die off and are supplanted by a generation of DOs trained with more traditional medical education.
OM, the small pseudoscientific aspect of DO medical school education, is a form of massage and manipulation invented in the 19th century with no basis in reality. OM postulates
the existence of a myofascial continuity – a tissue layer that interlinks all parts of the body. By manipulating the bones and muscles of a patient a practitioner is supposed to be able to diagnose and treat and variety of systemic human ailments.
Studies into the efficacy of OM find it to be ineffective for any process aside from low back pain (is there anything that does not help low back pain?), not surprising for a therapeutic intervention detached from reality. My purpose with this entry is not to review OM per se, which may be a good topic someday, but to focus on a specific application of OM. (more…)
Last week I posted a list of 30 rebuttals to many of the recurrent criticisms that are made by people who don’t like what we say on SBM. I thought #30 deserved its own post; this is it. At the end, I’ve added a few items to the original list.
What’s the harm in people trying CAM? Science-based medicine has been criticized for being too rigid and intolerant. Why do we insist on randomized placebo-controlled trials to prove that a treatment is safe and effective? Isn’t it enough that patients tell us they feel better? Isn’t that what we all want, for our patients to feel better? Even if the treatment only works as a placebo, isn’t that a good thing? What’s the harm in that?
The albuterol/placebo study
I would argue that we don’t just want our patients to think they are better, we want them to actually be better. A study that illustrates that principle has been discussed on this blog before, here and here.
A group of patients using an effective albuterol asthma inhaler was compared to 2 placebo groups (a placebo inhaler group and a sham acupuncture group), and to a group that got no treatment at all. Patients reported the same relief of symptoms with each of the two placebo controls as with the albuterol inhaler; all three groups reported feeling significantly better than the no-treatment group. It could be argued that placebos are an effective treatment for the subjective symptoms of asthma. (more…)
My first “real world” employment after completing residency was as a full-time newborn hospitalist in Houston. After spending 3 years in Space City, often rounding on as many as 30 newborn infants in the Level 1 and Level 2 units each day at the county hospital, I feel as if I’ve probably about seen it all when it comes to the nursery. I then left the babies behind while working as a pediatric hospitalist in Baton Rouge for four years, but now I’m back in the newborn business up here in Boston. While there have certainly been a few changes since 2009, many things remain exactly the same.
I help take care of a very vulnerable population in my current position: parents. Parents, in particular the young and first time variety, often approach parenting with a blank slate. Sure there is frequently a grandparent or four there for assistance, but the healthcare professionals working in the nursery are looked to for vital knowledge about how to care for the new arrival. Even some of the more experienced parents will still have questions, and most respect and follow the advice given during those first few days while at the hospital. These questions most commonly focus on topics such as feeding, vaccinations and vitamin supplementation, but I am regularly asked about a variety of routine parenting skills such as swaddling, and even baby “gear” like Angel monitors.
Parents love their children and want what is best for them, and they frequently express fear and anxiety over some of these topics. Love and fear are two powerful factors in the acceptance of pseudoscience and bad advice, which is why parents are set up to be fooled. Over the next few posts, I plan to cover some examples of newborn issues known to cause excessive parental anxiety and that sometimes lead to poor decisions, in large part because of bad information received from people who should know better.
First up is a concept that is well-known in the nursery, and strikes fear in the hearts of lactation consultants all over the world. I’m talking about nipple confusion. This is a concept that may seem silly to those unfamiliar with the world of parenting, but it is something that newborn doctors deal with daily and there is a great deal of controversy. Not “vaccines and autism” controversy unfortunately, but if after reading this post you find yourself feeling let down because I didn’t start with something sexier, take solace in the fact that winter is coming. (more…)
Savvy consumers have learned over the years that the primary goal of marketing is to create demand for a product or service. This has risen to the point of inventing problems that do not really exist just to sell a product that addresses the fake problem. Who knew that my social status could be destroyed by spotty glassware.
Better yet, if you can make people worry about a nonexistent problem, something that they were not previously aware of and don’t understand, they might buy your solution just to relieve their worry.
This type of “artificial demand” marketing can be very insidious when it occurs with medical products and services. The pharmaceutical industry has been accused of generating artificial demand for some of their drugs. For example, osteopenia is a relative decrease in bone density, but not enough to qualify for osteoporosis. Osteopenia is not really a disease, or even necessarily a mild version of osteoporosis, although it is a risk factor. Merck, however, was happy to broaden the market for its drug for osteoporosis and argue that patients with osteopenia should be treated also, even though the evidence really did not support this.
Sometimes the accusations are flat-out wrong. GSK has been accused of inventing restless leg syndrome (RLS) to sell a failed Parkinson’s drug. In fact the drugs used for RLS are successful Parkinson’s drugs. Further, I found references to RLS in neurology texts going back over 50 years, and there were even older references although not using the same name.
Some people don’t like what we have to say on Science-Based Medicine. Some attack specific points while others attack our whole approach. Every mention of complementary and alternative medicine (CAM) elicits protests in the Comments section from “true believer” users and practitioners of CAM. Every mention of a treatment that has been disproven or has not been properly tested elicits testimonials from people who claim to have experienced miraculous benefits from that treatment. In previous articles I have compiled the criticisms of what I wrote about Protandim and Isagenix. It’s instructive to read through them. We welcome rational and substantive criticism, but most of these comments are neither.
Our critics keep bringing up the same old memes, and it occurred to me that rather than try to answer them each time, it might be useful to list those criticisms and answer them here. In future, when the same points are raised, we could save time and effort by linking to this page and citing the reference number. I know this list is not comprehensive, and I hope our readers will point out anything I’ve omitted. Here are some of the criticisms we keep hearing:
1. Big Pharma is paying you to promote their products and discredit CAM.
No it isn’t. We are not Pharma shills. We are not paid anything for writing this blog. We do not get money from pharmaceutical companies. We do not accept gifts from drug companies. We do not get kickbacks for prescribing certain drugs. We have no incentive to favor drugs over other treatments. Incidentally, critics who prefer natural remedies to pharmaceuticals should note that many CAM diet supplements are sold by subsidiaries of Big Pharma. (more…)
The price of life is eternal vigilance. If you have severe food allergies, that is your reality. Every day, every meal, every bite. Eating is an intrinsic and essential part of what we do and who we are, so the idea that our bodies can rebel violently to everyday foods can be difficult to believe. But it’s real, and the numbers of the severely food allergic are growing. Frustratingly, we don’t know why. While recognized over 100 years ago, the social acknowledgment had lagged. That’s improved in the past decade. Food allergy prevention approaches are now a routine part of travel, school, sports, and the workplace. Peanuts on planes seem to have completely disappeared. The days of lunchbox peanut butter sandwiches are over, with many schools completely banning all peanut-containing products. It is the education system that seems to have become a ground zero for allergy programs and policies, where educators are challenged to ensure that schools are safe environments for all children, some of whom have long lists of food allergies. (more…)
Reality is one honey badger. It don’t care. About you, about your thoughts, about your needs, about your beliefs. You can reject reality and substitute your own, but reality will roll on, eventually crushing you even as you refuse to dodge it. The best you can hope for is to play by reality’s rules and use them to your benefit. Combined with a little luck (nothing quite as beneficial as being a white, middle class male in the US) you might have a reasonably healthy health.
The most reliable way to understand reality is science and the scientific method. Used wisely you may have a shot at minimizing morbidity and mortality. Deny or ignore it and reality don’t care. Reality will get us all.
We all have our biases, recognized and unrecognized. I often see the world in terms of infectious diseases. When I read Team of Rivals: The Political Genius of Abraham Lincoln I enjoyed the politics and personalities but I was struck by how people constantly died young of infectious diseases. We don’t see mortality in the young anymore for a variety of reasons: better nutrition, an understanding of the pathogenesis of disease, clean water, flush toilets and vaccines.
A deplorable article by Suzy Cohen on Huffington Post is titled “Feel Bad? It Could Be Lyme Unless Proven Otherwise.” It consists of irresponsible fear-mongering about a nonexistent disease. A science-based article would be titled “Feel Bad? It Couldn’t Be Chronic Lyme Disease Because CLD Is Nonexistent Until Proven Otherwise.”
People often attribute uncomfortable symptoms to aging, stress, or the “aches and pains of daily living,” especially if blood tests and body scans are normal. What if you have Lyme and don’t know it? If you’ve ever been for a walk in the woods, laid in the grass, live in or visited a Lyme-endemic area, or have a pet cat or dog, you may have exposed yourself to Lyme disease and associated co-infections. There is even the possibility of contracting Lyme if you were born to a mother who has been exposed. Tick born infections can also be transmitted from blood transfusions.
That pretty much covers everyone. Who hasn’t been for a walk in the woods, lain down on the lawn, or had a pet? (And incidentally, are there no editors or proofreaders at HuffPo who realize that the past participle of lie is lain and that infections are tick-borne, not tick born?) (more…)
I was the other day. I’ve been on vacation this week (staycation, actually, as I stayed at home and didn’t go on any trips); so you would think it would take a lot to depress me. Unfortunately, today is the last day of that vacation; so the thought of diving back into the fray trying to fund my lab. It didn’t help that I read Scott Gavura’s Thursday post how another once-proud academic medical center, the University of Toronto, is letting the Trojan horse that is “integrative medicine” into the halls of its medical school and school of pharmacy. As I frequently say, much to the annoyance of advocates of “complementary and alternative medicine” (CAM) and “integrative medicine,” what “integrative medicine” does is to “integrate” quackery with real medicine, which neither validates the quackery nor improves the real medicine. Or, as my good bud and fellow SBM blogger Mark Crislip so aptly put it:
If you integrate fantasy with reality, you do not instantiate reality. If you mix cow pie with apple pie, it does not make the cow pie taste better; it makes the apple pie worse.
Yes, I’ve been trying to come up with a quote that captures the essence of “integrative medicine” better than Mark’s quote. I’ve yet to succeed; so I steal his quote whenever I need to. It’s sort of the same way that I didn’t actually coin the term “quackademic medicine” to describe the infiltration of quackery into academic medicine. (Dr. R. W. Donnell did, as far as I’ve been able to ascertain.) However, I believe I’ve done more than anyone else to use and promote the term, both here and at my not-so-super-secret other blog. As I like to say say, mediocre bloggers borrow. Great bloggers steal.
Be that as it may, Scott’s post reminded me that I hadn’t looked much at quackademic medicine, at least not at the status of its infiltration into medical academia, in a while. Then I saw a review article entitled The Future of Integrative Medicine in The American Journal of Medicine by Victor S. Sierpina, MD, ABFM, ABIHM and James E. Dalen, MD, MPH. (Note that ABIHM stands for the American Board of Integrative Holistic Medicine and ABFM stands for the American Board of Family Medicine.). The article itself has no place in any self-respecting peer-reviewed medical journal, but there it is, much the same way that quackademic woo has been intermittently infiltrating the New England Journal of Medicine. The article itself is one massive apologia for integrative medicine. In fact, it’s useful to look at because it follows a script that virtually all such articles follow, with only relatively minor variations.