Dec 31 2010
I have been in Infectious Diseases for almost 25 years. I have two major jobs: I see inpatient consults and I chair the Infection Control program. I have been involved in quality improvement, especially as it relates to hospital acquired infections, for my entire career. It has been an interesting quarter century. Year after year we have driven down infection rates and other kinds of mortality and morbidity in hospitalized patients. Everyone recognizes that medicine is difficult and dangerous and its biggest problem is medicine is practiced by humans, who, I would venture to observe, are prone to mistakes and any number of cognitive errors.
It has not been a easy journey. People hate change and there has not always been certainty as to the best options to choose to solve a problem, a problem that continues today. For example, how best to treat a patient with potential methicillin resistant Staphylococcus aureus colonization (MRSA). Should we screen everyone? Screen high risk patients? Surgical patients? Do we decolonize, with the long term consequence of accelerating antibiotic resistance? Do we place everyone with MRSA in isolation, with the known decrease in care that patients in isolation may have? Everything we do has potential downsides and unintended consequences. No good deed ever goes unpunished.
When I was a resident every PVC (preventricular contractions) in cardiac patents was suppressed as we thought PVC’s were the sentinel event that led to ventricular tachycardia and death. So patients received IV lidocaine and we often sent patients home on quinidine or other antiarrhythmics. Subsequent studies demonstrated that antiarrhythmics may have killed more people than they saved, and doctors no longer suppress every PVC in the ICU. Medicine changes, one hopes for the better, offering old geezers like me the opportunity to ‘reminisce’ about the old days, when I tied an onion to my belt, which was the style at the time. Now, to take the ferry cost a nickel, and in those days, nickels had pictures of bumblebees on ‘em. Give me five bees for a quarter, you’d say. Now where were we? Oh yeah: the important thing was I had an onion on my belt, which was the style at the time.
Sorry. I digress. A couple of months ago I had a patient with severe malaria that needed IV quinidine (the dextrorotatory diastereoisomer of quinine, but that is obvious) and there was none in the pharmacy; we had to get some shipped in by our dealer, er, distributor. In medicine, if it discovered that what was thought to be a beneficial intervention turns out to cause more harm than good, the intervention is abandoned.
When To Err is Human was published, it caused quite a brouhaha. Depending on whose numbers you want to believe, 44 to 98 thousand Americans died each year from medical errors. I did not have issues with the numbers. There are about 5700 hospitals in the US, so that would be about one death every month and a half. Knowing what I did about infections and other complications in the hospital, that did not seem like an unreasonable estimate. A bit high, perhaps, but in the ballpark of my understanding of reality.
That is old data, and no longer applicable. Due, in part, to To Err is Human, the last decade has led to innumerable studies evaluating the causes of infections and complications in hospitals and the best approaches to decrease them. My institutions have invested huge time and effort to implement these quality improvements with great success.
When I started in Infection Control, the infection data was considered protected. The thought was that institutions would be more likely to collect and evaluate data about infections if there were not discoverable by lawyers. The downside was, as I was informed, if I informed anyone about the data, it would no longer be protected, and the institutions would be open to expensive lawsuits. This century my institutions are much more transparent about disseminating information about our practice. I thought I would have a conniption the first time I saw the infection data for the ICU posted in the ICU for all too see. It turns out, like so many deeply held convictions, that keeping the data protected was a bad idea. Transparency has not led to an increase in lawsuits but it has led to a decline in all manner of hospital associated complications. Our staff takes a great deal of pride in their work. They took the data as a personal affront and worked to improve all aspects of patient care. When they saw harm potentially occurring, practice changed for the better.
So there are three reactions to new data in medicine that demonstrates that a given medical practice may cause harm.
First, the data and the conclusions are challenged, as they should be. All studies are open to analysis and improvement. In medicine we continuously try to improve care, and that requires good information.
Second, further studies are done to confirm and refine the problem and other studies are done to see how practice can be improved.
The third is practice change, which is often slower than we like. But change we do. I am old enough that I often bore the residents with how it used to be in the old days. Medicine today is drastically different than 20 years ago, and many logs better.
The most impressive example of improvement in the last 20 years is hand hygiene. Hand washing adherence 20 years ago was an embarrassment. Part of the problem was the time it took to wash hands; I have heard that if a nurse spent her time appropriately washing her hands, 80% of his shift would be spent at the sink.
Alcohol foam changed that. When we introduced the foam in the hospital, even when compliance was only 20%, we had a 50% drop in hospital infections, and as compliance has increased to 90 to 95%, the infections had a parallel decline. And the effects of alcohol foam improved once I discovered it was not a po agent, to be used like Cheez Whiz. Our biggest problem now is fall prevention. Most falls occur when the patient doesn’t want to bother the nurse and, in the process of moving about the room without help, falls. We are investigating ways to remove gravity from the hospital.
The threshold for changing and abandoning a therapy can be very small. Last century there was a drug called trovafloxacin that caused several hundred cases of hepatitis and a half a dozen deaths when it was being prescribed at a rate of 300,000 new prescriptions a month. Hepatitis was an extremely unusual complication, but the small risk was not worth the potential benefits since there were equally efficacious alternatives.
Compare and contrast medicine and alt med.
Most alt med interventions are, of course, based on eternal truths that cannot be improved or changed. They are often immune to reality induced change. Studies that confirm their eternal truth are always accepted. Studies that show harm or lack of efficacy? Not so much.
Certainly, when complications of alternative medicines are published the data is up for discussion. That is good and as it should be. But that is where the similarities with medicine ends.
There is an ongoing issue of safety in the two most invasive alternative interventions: acupuncture and chiropractic.
There were two reviews concerning chiropractic safety published recently. Safety of chiropractic interventions: a systematic review, which found
A total of 376 potential relevant articles were identified, 330 of which were discarded after abstract or complete article analysis. The search identified 46 articles that included data concerning adverse events: 1 randomized controlled trial, 2 case-control studies, 7 prospective studies, 12 surveys, 3 retrospective studies, and 115 case reports. Most of the adverse events reported were benign and transitory, however, there are reports of complications that were life threatening, such as arterial dissection, myelopathy, vertebral disc extrusion, and epidural hematoma. The frequency of adverse events varied between 33% and 60.9%, and the frequency of serious adverse events varied between 5 strokes/100,000 manipulations to 1.46 serious adverse events/10,000,000 manipulations and 2.68 deaths/10,000,000 manipulations.
CONCLUSION: There is no robust data concerning the incidence or prevalence of adverse reactions after chiropractic. Further investigations are urgently needed to assess definite conclusions regarding this issue.
That is impressive complication rates, although the authors suggest the data to support the rates are not robust, for an intervention that only has at best proven efficacy for low back pain and safer alternatives. Also published recently was Deaths after chiropractic: a review of published cases.
Twenty six fatalities were published in the medical literature and many more might have remained unpublished. The alleged pathology usually was a vascular accident involving the dissection of a vertebral artery.
That is about three times the number of deaths from trovafloxacin, an excellent antibiotic that we abandoned in the U.S. as too dangerous. Of course, we have safer alternatives with equal efficacy.
Also recently published was Acupuncture-related adverse events: a systematic review of the Chinese literature which found
that in total reported on 479 cases of adverse events after acupuncture. Fourteen patients died. Acupuncture-related adverse events were classified into three categories: traumatic, infectious and “other”. The most frequent adverse events were pneumothorax, fainting, subarachnoid haemorrhage and infection, while the most serious ones were cardiovascular injuries, subarachnoid haemorrhage, pneumothorax and recurrent cerebral haemorrhage.
Based on the reported complications of the two interventions, if they were a medical therapy regulated in a manner similar to medications and medical devices, they would certainly have, at a minimum, a black box warning and, in the case of chiropractic, no longer be used. Especially as there are no good indications for chiropractic or acupuncture.
What you do not see in the medical literature or the chiropractic blogs is any concern that harm may be done and investigations into changes in practice that could minimize the morbidity and mortality.
Two essay that show zero interest in considering that chiropractic could potentially cause harm, the latter including the argument that it is real doctors that kill people and in comparison out ‘an order of magnitude greater than the side-effects attributed to spinal manipulation.’ See. If you kill small numbers of people, it is not important. Safety only matters when you kill people in large numbers. In the risk/benefit calculus of medicine, an intervention that has no benefit should cause no harm.
If there are concerns in the chiropractic community expressed about these complications, I can’t find them. If there is to improve chiropractic care, I can’t find it. If there is any quality/safety research being done, please rub my nose in it. I would love to know and those involved or aware of such research should trumpet the results for all to read. All the literature and letters to the editor I can find concerns denying there is a problem at all.
At least I could find concerns in the acupuncture literature : ‘A single injury – let alone a fatality – caused by acupuncture is one too many.” Exactly right. If you are practicing prescientific magic, it should have a mortality and morbidity of zero. Again if there is ongoing research into improving the safety of acupuncture, I cannot find it either.
Both seem far more interested in the messenger (Dr. Ernst) and his malevolent intent rather than the message.
It is, I think, a key difference between medicine and its ‘alternatives’. The former takes safety and quality seriously and strives constantly with research and its application to improve care. The alternatives? Nope. Not yet. And probably never.
Addendum. This may be the last post of 2010. I would like to say on behalf of myself and the other authors of SBM (who can disagree in the comments if they desire): Happy New Year. Enjoy 2011 since the world will end in 2012. With one exception, we have a wonderful group of readers and commenters and at times I learn more from the comments that I do preparing my posts. Stay healthy, my friends.
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