Does the medical profession deserve the Luddite label as DB suggests? The Dinosaur doesn’t think he does even though he is skeptical about the benefits of electronic medical records (EMRs). I’m not a Luddite—I’m a computerphile. I was one of the first kids on my block to go on line with medical searching, way back before the days of the World Wide Web. But I share much of Dinosaur’s skepticism. I place myself in the middle ground on this debate.
Let’s look at a couple of Dinosaur’s objections, which addressed some of the popular myths about EMRs. First, do they really improve legibility? That depends, of course, on the quality of the doctor’s handwriting, and whether or not the doctor dictates his/her notes. But Dinosaur makes an important point about readability problems inherent in EMRs which rings true in my own experience: computer template generated clinical notes have a very low signal to noise ratio. For the doctor the signal is clinical information. The noise consists of all the clinically useless clutter which serves no purpose but to keep the insurance coders happy. Template generated progress notes make it nigh unto impossible to communicate a doctor’s thinking or tell a patient’s story in a meaningful narrative form.
Do EMRs save time? There’s probably not an “evidence based” answer to this, but the overwhelming subjective experience seems to be that EMRs are a net consumer of time, at least for a year or two after implementation.
Do they improve reimbursement? Dinosaur addresses P4P and points out that any P4P rewards gained from EMRs are nominal. Do they improve E&M coding, thus improving reimbursement? The potential is certainly there. I’ve encountered software that prompts me to “add one more system to the review of systems and two more to the physical exam to code one level higher.” This ensures that the documentation will support the coding but is it ethical? If the patient has a cold does he/she need a complete system review? A great deal of template generated “documentation” appears gratuitous to me.
Do EMRs improve quality? Many studies report soft outcomes. An EMR may increase the rate of documentation of patients’ hemoglobin A1C levels from 75% to 83%, but what about error rates and clinical outcomes? Although EMRs may intercept certain types of errors they increase others. Data on hard clinical outcomes are sparse, but at least one study showed an increase in mortality related to computerized physician order entry.
How can this debate be resolved? The answer is “it depends”. In a MedGenMed Video Editorial last year opinion leader Robert Wachter, M.D. gave a sober assessment. He cautioned that Computer systems must be implemented carefully, with unforeseen consequences not only sought but anticipated. Systems should be launched on a pilot unit, and should be extensively vetted by user groups before going live. Staff must be educated, and swarms of real-time problem solvers should be immediately available after implementation. The computerization of healthcare will ultimately improve the quality, safety, and efficiency of care. But the road will be full of bumps and curves. It’s not a matter of “just doing it”.
Monday, April 30, 2007
The DocSurg is aggravated with the hospitalist movement
At my place of work surgeons and hospitalists enjoy a mutually respectful and beneficial relationship. So, I was surprised to read this rant from Aggravated DocSurg, a general surgeon and one of my favorite medical bloggers. He’s underwhelmed with the hospitalists who came to fill the vacuum in his community resulting from all the internists giving up hospital medicine. These hosptialists don’t provide him the help he needs. Consequently he’s having to “tune up” his surgical patients and manage their post operative medical complications. In short he’s functioning as a flea (a pejorative term for Internist) and, thanks to global surgical fees, not getting reimbursed for it.
He writes “How can a middle aged guy who has spent the last 19 years training and then working as a general surgeon be a flea underneath his scrubs? I am afraid that it is because the economics of medicine, and the lifestyle choices of (many) physicians, have foisted the hospitalist era upon us.” He laments that the hospitalist program at his institution is inefficient and that other surgeons he networks with across the country feel the same way. Citing several possible reasons for this he notes, concerning hospitalists “…but in my experience they are folks who did not flourish in the world of office practice seemingly due to an inability to address patient problems in a time efficient manner.” Ouch. He goes on with “Additionally, one of the unspoken problems with the hospitalist system is that many patients are so P.O.ed at not being able to see their ‘real’ doctor that they develop an intense animosity towards the hospitalists called in to see them....and then fire them.” Yikes. And finally “I manage a whole host of perioperative medical problems because I can now do it more expediently, more safely, and with a better degree of success than my patients could get the same care through the system that has been handed to us. When cardiac problems get out of my league, I call a cardiologist ---- just like the hospitalists do. Ditto for pulmonary issues.” Blistering.
What about the generalizability of DocSurg’s experience? He no doubt could provide a collection of anecdotes to back up his impressions, but these do not equal evidence. The evidence regarding the hospitalist movement right now is mixed. DB recently pointed out that there will be good hospitalists and not so good hospitalists. Moreover, from an organizational point of view there are good and not so good hospitalist programs. DocSurg has pointed out some quality concerns that hospitalist leaders need to address. I hope they’re tuned in.
Kevin weighs in here.
He writes “How can a middle aged guy who has spent the last 19 years training and then working as a general surgeon be a flea underneath his scrubs? I am afraid that it is because the economics of medicine, and the lifestyle choices of (many) physicians, have foisted the hospitalist era upon us.” He laments that the hospitalist program at his institution is inefficient and that other surgeons he networks with across the country feel the same way. Citing several possible reasons for this he notes, concerning hospitalists “…but in my experience they are folks who did not flourish in the world of office practice seemingly due to an inability to address patient problems in a time efficient manner.” Ouch. He goes on with “Additionally, one of the unspoken problems with the hospitalist system is that many patients are so P.O.ed at not being able to see their ‘real’ doctor that they develop an intense animosity towards the hospitalists called in to see them....and then fire them.” Yikes. And finally “I manage a whole host of perioperative medical problems because I can now do it more expediently, more safely, and with a better degree of success than my patients could get the same care through the system that has been handed to us. When cardiac problems get out of my league, I call a cardiologist ---- just like the hospitalists do. Ditto for pulmonary issues.” Blistering.
What about the generalizability of DocSurg’s experience? He no doubt could provide a collection of anecdotes to back up his impressions, but these do not equal evidence. The evidence regarding the hospitalist movement right now is mixed. DB recently pointed out that there will be good hospitalists and not so good hospitalists. Moreover, from an organizational point of view there are good and not so good hospitalist programs. DocSurg has pointed out some quality concerns that hospitalist leaders need to address. I hope they’re tuned in.
Kevin weighs in here.
Saturday, April 28, 2007
Canada’s health care is at least as good as in the U.S., and that’s evidence based!
The inaugural issue of Open Medicine published a systematic review of health outcomes in Canada and the U.S. which purported to show that “…although Canadian outcomes were more often superior to US outcomes than the reverse, neither the United States nor Canada can claim hegemony in terms of quality of medical care and the resultant patient-important outcomes.” This despite the fact, as the authors point out, that the U.S. spends nearly twice as much per capita on health care as Canada. At face value it doesn’t speak well for the U.S. free market model. Although several bloggers jumped on this sound bite uncritically it’s worth digging deeper.
First, the conflict of interest disclosure reads “Competing interests: None declared.” That may be literally true but it’s deceptive. No conflicts were declared but they certainly do exist. Not very open for an open medical journal, I’d say. It took some serious Googling on my part to find the conflicts.
What I found was that several of the authors are political activists and staunch advocates for the Canadian model. Co-author Steffie Woolhandler, for example, was profiled thusly in the New York Times: “Her plan is simple. Get rid of the private health insurance industry and abolish Medicaid, the government's health insurance program for the poor. In their stead, set up a national health insurance system that would cover all Americans by expanding Medicare, the old-style Medicare, to include everyone from birth to death.” A co-founder of Physicians for a National Health Program, (PNHP) she’s also on their speaker’s bureau and a board member of the organization. The John Goodman Health Blog had this to say about her: “Not if you're Steffie Woolhandler, who along with her husband, David Himmelstein, has spent years urging Americans to adopt Canada's healthcare system.” Himmelstein by the way is another of the co-authors of the paper. Kevin had a few choice words about an earlier Woolhandler study here.
Lead author Gordon Guyatt appears to have a similar conflict. He’s been a political candidate for the socialist-leaning New Democratic Party which advocates for government health care and the end of privatization. He was taken to task before for not declaring this obvious competing interest.
Another of the authors, Armine Yalnizyan, has been a vigorous advocate for the Canadian model as evidenced by these writings.
The methods session of the paper is no more open than the conflict of interest statement. We are told that “Interested readers can obtain the detailed protocol for this review from the corresponding author.” That’s right; you have to email the authors to get the search strategy. It would appear, though, that the search strategy was not predetermined; rather, it was “iterative”, almost as if they made it up as they went along. Then they culled the list of retrieved citations down from 4923 down to 38. We’re not told exactly how this was done or by whom, but it appears to have been a complicated procedure, and to the reader it’s somewhat mysterious.
Even if this review is valid it’s nothing new. No one is claiming that patients in the U.S. live longer. This paper, from where I sit, smacks of activism for single payer health care disguised as research.
First, the conflict of interest disclosure reads “Competing interests: None declared.” That may be literally true but it’s deceptive. No conflicts were declared but they certainly do exist. Not very open for an open medical journal, I’d say. It took some serious Googling on my part to find the conflicts.
What I found was that several of the authors are political activists and staunch advocates for the Canadian model. Co-author Steffie Woolhandler, for example, was profiled thusly in the New York Times: “Her plan is simple. Get rid of the private health insurance industry and abolish Medicaid, the government's health insurance program for the poor. In their stead, set up a national health insurance system that would cover all Americans by expanding Medicare, the old-style Medicare, to include everyone from birth to death.” A co-founder of Physicians for a National Health Program, (PNHP) she’s also on their speaker’s bureau and a board member of the organization. The John Goodman Health Blog had this to say about her: “Not if you're Steffie Woolhandler, who along with her husband, David Himmelstein, has spent years urging Americans to adopt Canada's healthcare system.” Himmelstein by the way is another of the co-authors of the paper. Kevin had a few choice words about an earlier Woolhandler study here.
Lead author Gordon Guyatt appears to have a similar conflict. He’s been a political candidate for the socialist-leaning New Democratic Party which advocates for government health care and the end of privatization. He was taken to task before for not declaring this obvious competing interest.
Another of the authors, Armine Yalnizyan, has been a vigorous advocate for the Canadian model as evidenced by these writings.
The methods session of the paper is no more open than the conflict of interest statement. We are told that “Interested readers can obtain the detailed protocol for this review from the corresponding author.” That’s right; you have to email the authors to get the search strategy. It would appear, though, that the search strategy was not predetermined; rather, it was “iterative”, almost as if they made it up as they went along. Then they culled the list of retrieved citations down from 4923 down to 38. We’re not told exactly how this was done or by whom, but it appears to have been a complicated procedure, and to the reader it’s somewhat mysterious.
Even if this review is valid it’s nothing new. No one is claiming that patients in the U.S. live longer. This paper, from where I sit, smacks of activism for single payer health care disguised as research.
Another resource for bloggers on fair use
Page 3.14, the editorial blog of Science Blogs, has started a continually updating post and comment thread about fair use with experts expected to weigh in. Add this to the list of resources.
New open access journal will increase the transparency of pharmaceutical industry studies
Wiley-Blackwell publishing has announced the launch of Archives of Drug Information. The journal will publish inconclusive and negative trials as well as positive trials.
C. Michael Stein, M.D. of Vanderbilt University School of Medicine, the editor of the new journal, was interviewed in the March 23 edition of the Vanderbilt Reporter.
“’The pharmaceutical industry is under a lot of pressure to publish information about the studies they perform,’ said Stein, professor of Medicine and Pharmacology, and associate director of the Division of Clinical Pharmacology. ‘But it's actually very difficult for them to do so because most scientific journals select the highest impact articles for publication, and many of the studies performed in drug development do not have a high scientific priority for medical journals.’
As a result, ‘whenever there are problems with a drug later on, there are often allegations that information was in some way hidden,’ he said.”
C. Michael Stein, M.D. of Vanderbilt University School of Medicine, the editor of the new journal, was interviewed in the March 23 edition of the Vanderbilt Reporter.
“’The pharmaceutical industry is under a lot of pressure to publish information about the studies they perform,’ said Stein, professor of Medicine and Pharmacology, and associate director of the Division of Clinical Pharmacology. ‘But it's actually very difficult for them to do so because most scientific journals select the highest impact articles for publication, and many of the studies performed in drug development do not have a high scientific priority for medical journals.’
As a result, ‘whenever there are problems with a drug later on, there are often allegations that information was in some way hidden,’ he said.”
Inflamatory abdominal aortic aneurysm
It accounts for about 5%-10% of all abdominal aortic aneurysms and is under appreciated. Its unique clinical features, including its association with retroperitoneal fibrosis, are reviewed in Grand Rounds at the Johns Hopkins Bayview Medical Center.
Thursday, April 26, 2007
What did we learn today about fair use?
Science blogger Shelley Batts got into a little tiff with Wiley publishers over reproducing a figure from a Wiley journal in one of her blog posts, raising all sorts of questions about fair use. The blogosphere responded with an avalanche of posts and emails, overwhelmingly in Shelley’s favor. Today Shelley reports a happy resolution. The publisher issued an apology of sorts and gave Shelley written permission to use the figure. What is not clear from the publisher’s response is whether it was really OK with them that she used the figure without permission in the first place. The fair use question was thus dodged.
What can we learn from the many blog posts and comment threads that ensued? I haven’t read them all. From what I’ve seen so far, while most commenters, with varying levels of expertise, seem to think Shelley was within the bounds of fair use, the concept is fuzzy and if you really want a final answer you would have to test the legal waters and see what a judge would say. But, needless to say, the issue was thoroughly hashed out and those interested might want to bookmark a few of these threads for reference. One commenter pointed to this web site devoted to the issue.
On a side note, Drug Monkey ended his post on this subject with an expression of disgust over the reactionary nature of the scientific blogosphere: This is not a “win”. This is a “loss” in which the blogos look like emotional nutcases willing to go ballistic before all the facts are in and/or considered rationally. That may be okay for the political ranters but surely scientific bloggers can do a bit better? Indeed. Let’s leave the caterwauling to the political bloggers.
What can we learn from the many blog posts and comment threads that ensued? I haven’t read them all. From what I’ve seen so far, while most commenters, with varying levels of expertise, seem to think Shelley was within the bounds of fair use, the concept is fuzzy and if you really want a final answer you would have to test the legal waters and see what a judge would say. But, needless to say, the issue was thoroughly hashed out and those interested might want to bookmark a few of these threads for reference. One commenter pointed to this web site devoted to the issue.
On a side note, Drug Monkey ended his post on this subject with an expression of disgust over the reactionary nature of the scientific blogosphere: This is not a “win”. This is a “loss” in which the blogos look like emotional nutcases willing to go ballistic before all the facts are in and/or considered rationally. That may be okay for the political ranters but surely scientific bloggers can do a bit better? Indeed. Let’s leave the caterwauling to the political bloggers.
Medical and surgical treatment of peripheral vascular disease
A concise review in American Family Physician.
Prescription drug deaths soar in Tennessee
They exceed illicit drug deaths and nearly equal murders according to this article in the Tennessean. Narcotic pain relievers are the major culprits and leading the list, of course, is methadone.
Wednesday, April 25, 2007
What’s fair use?
An Orac post and the ensuing comment thread examine the case of another Science Blogger who reproduced a figure in her report on a paper from a Wiley Interscience nutrition journal. (BTW, Wiley journals are very closed access—as closed as they come, as in locked up tighter than a drum).
Within a day of her report she received a letter from Wiley demanding that the figure be removed, and threatening legal action. As Orac asks, isn’t the inclusion of the figure, with its appropriate attribution and its use for the purpose of criticism, an example of fair use? And doesn’t the “amount and substantiality” of the reproduced content (one figure---it’s not as if she reproduced the whole thing) fall within the boundaries of fair use?
This should be of great interest to bloggers, who do this sort of thing a lot. As this gets passed around the blogosphere the reaction is likely to be overwhelmingly negative. Let’s hope some experts weigh in and let’s hope Wiley notices.
Within a day of her report she received a letter from Wiley demanding that the figure be removed, and threatening legal action. As Orac asks, isn’t the inclusion of the figure, with its appropriate attribution and its use for the purpose of criticism, an example of fair use? And doesn’t the “amount and substantiality” of the reproduced content (one figure---it’s not as if she reproduced the whole thing) fall within the boundaries of fair use?
This should be of great interest to bloggers, who do this sort of thing a lot. As this gets passed around the blogosphere the reaction is likely to be overwhelmingly negative. Let’s hope some experts weigh in and let’s hope Wiley notices.
I’ve been away and computerless for the last few days
So today I surveyed some of the medical blogs for recent interesting posts and these (in no particular order) caught my eye:
Retired Doc comments about Joint Commission’s recent decision to change the four hour antibiotic rule for pneumonia treatment to six hours. They just don’t get it. (The updated and recently published guidelines promulgated jointly by the ATS and the IDSA have eliminated all specific timing recommendations for the administration of initial antibiotic doses, citing the potential for abuse of antibiotics and flaws in the evidence upon which the original four hour rule was based. “Guideline concordant therapy” for community acquired pneumonia should include the administration of antibiotics as soon as possible, and in most cases in the ER, but no longer incorporates rigid time rules).
DB cites a clinical vignette from the New York Times presented by columnist and Yale internist Lisa Sanders, M.D. The patient, who presented to the ER with abdominal pain, hypotension and profound bradycardia was ultimately “cured” by the urology resident. The sequence of events was that this patient, despite a lack of prior urinary symptoms, was in acute urinary retention which led to renal failure, hyperkalemia and, consequently, depression of cardiac function. The case is instructional and interesting on several levels. Could application of the Prostate Symptom Score have averted the crisis? Although it’s an intriguiging question, Dr. Sanders’s self flagellation seems unwarranted.
The Patient’s Doctor has a couple of items concerning Wal-Mart, headquartered just down the street from where I sit. The Washington Post reports Wal-Mart’s plan to open 400 in-store clinics. IHealthBeat reports on remarks by Wal-Mart’s CEO on the role of business in transforming U.S. healthcare.
The Dinosaur presented a case puzzler here, and the solution here. One commenter was partially correct and everyone else missed it a mile. The patient had an uncommon presentation of a common disease (peptic ulcer). The lesson? Perhaps it’s the old saw (that I think I remember once reading in Cliff Meador’s Little Book of Doctors’ Rules) that you can not diagnose that which is not in your differential diagnosis, assuming you generated one in the first place. Or maybe that it’s occasionally appropriate to order an imaging study without a focused clinical question, other than just to “see what’s going on.”
For a little gallows humor here are some politically incorrect mnemonics being kicked around at the Student Doctor Forum (via Kevin).
The blogosphere was screaming after the U.S. Supreme Court decision to uphold the Partial-Birth Abortion Ban Act of 2003, even calling it shameful and incomprehensible, apparently so incomprehensible that no medical blogs I could find provided a link to the original document. For those interested and who think they can comprehend the nuances, it’s here.
Retired Doc comments about Joint Commission’s recent decision to change the four hour antibiotic rule for pneumonia treatment to six hours. They just don’t get it. (The updated and recently published guidelines promulgated jointly by the ATS and the IDSA have eliminated all specific timing recommendations for the administration of initial antibiotic doses, citing the potential for abuse of antibiotics and flaws in the evidence upon which the original four hour rule was based. “Guideline concordant therapy” for community acquired pneumonia should include the administration of antibiotics as soon as possible, and in most cases in the ER, but no longer incorporates rigid time rules).
DB cites a clinical vignette from the New York Times presented by columnist and Yale internist Lisa Sanders, M.D. The patient, who presented to the ER with abdominal pain, hypotension and profound bradycardia was ultimately “cured” by the urology resident. The sequence of events was that this patient, despite a lack of prior urinary symptoms, was in acute urinary retention which led to renal failure, hyperkalemia and, consequently, depression of cardiac function. The case is instructional and interesting on several levels. Could application of the Prostate Symptom Score have averted the crisis? Although it’s an intriguiging question, Dr. Sanders’s self flagellation seems unwarranted.
The Patient’s Doctor has a couple of items concerning Wal-Mart, headquartered just down the street from where I sit. The Washington Post reports Wal-Mart’s plan to open 400 in-store clinics. IHealthBeat reports on remarks by Wal-Mart’s CEO on the role of business in transforming U.S. healthcare.
The Dinosaur presented a case puzzler here, and the solution here. One commenter was partially correct and everyone else missed it a mile. The patient had an uncommon presentation of a common disease (peptic ulcer). The lesson? Perhaps it’s the old saw (that I think I remember once reading in Cliff Meador’s Little Book of Doctors’ Rules) that you can not diagnose that which is not in your differential diagnosis, assuming you generated one in the first place. Or maybe that it’s occasionally appropriate to order an imaging study without a focused clinical question, other than just to “see what’s going on.”
For a little gallows humor here are some politically incorrect mnemonics being kicked around at the Student Doctor Forum (via Kevin).
The blogosphere was screaming after the U.S. Supreme Court decision to uphold the Partial-Birth Abortion Ban Act of 2003, even calling it shameful and incomprehensible, apparently so incomprehensible that no medical blogs I could find provided a link to the original document. For those interested and who think they can comprehend the nuances, it’s here.
Thursday, April 19, 2007
Simplistic thinking about conflicts of interest
I’ve commented before about simplistic and one sided thinking concerning conflicts of interest in the medical profession. Medical Progress Today has published a symposium which takes a more skeptical, nuanced look at the issue. The introduction says this: “The fiduciary standards companies owe their shareholders are surely compatible with producing the highest quality products and research possible given existing technologies. Companies that made products that routinely harmed patients or produced deceptive marketing materials for physicians would find themselves punished by investors, physicians, courts and regulators in very short order.” Drug company marketing is biased and yes, there are potential conflicts of interest, but in the final analysis they have an interest in good patient outcomes. I’ll be covering some of the individual articles in this series in future posts.
Interview with Michael Crichton
Crichton was interviewed at The Daily Ablution. Here’s a snippet of what he had to say about the global warming debate: Any departure from environmental orthodoxy is marked by ad hominem attack, vigorous spread of false information, claims of criminality and mental derangement, and general nastiness. Apparently this is one area where reasonable people cannot disagree.
There’s much more, as well as this link to his web site.
There’s much more, as well as this link to his web site.
Critical illness in morbidly obese patients
This topic was recently reviewed in Critical Care Medicine. (Via Medscape).
Wednesday, April 18, 2007
Hypocrisy about direct to consumer advertising
If you’re a health care professional who likes to rail against direct to consumer advertising by drug companies do you market your services to consumers or remain silent when the hospital or clinic where you work does the same thing? I wrote about this problem last month and the Dinosaur weighed in the other day saying Medical marketing is bullshit; even more so than direct-to-consumer pharma advertising. He’s right!
Tuesday, April 17, 2007
More on NSAIDs and cardiovascular risk
The portrayal of COX-2 inhibiting NSAIDs as cardiotoxic and older NSAIDs as safe is simplistic and irresponsible, as I demonstrated here. Now there’s this study, published ahead of print in the Annals of Rheumatic Disease on line, suggesting that ibuprofen is associated with higher cardiovascular risk, over 8 fold in high risk aspirin users, than the COX-2 inhibitor lumiracoxib.
Sunday, April 15, 2007
Addressing conflicts of interest that matter
Mention conflict of interest in medicine and the knee jerk response is likely to be a diatribe about drug company gifts to doctors. This selective outrage is misdirected. Drug company gifts, though ubiquitous, are modest these days, and any potential conflicts of interest they create for doctors are trivial in comparison to other conflicts in day to day professional life, especially compensation incentives.
Physician compensation plans in the U.S. are varied and complex but almost all, with perhaps the notable exception of the V.A.’s, contain financial incentives that can influence practice patterns and clinical decisions. This NEJM Career Center article on compensation plans notes (italics mine) “’Compensation plans in the 1990s were very complicated, and included such things as participation in the group and patient satisfaction, which involved very complex formulas. Today, they [models] are moving back to a focus on productivity, efficiency, and the amount of dollars a physician brings in’”. Though these positive cost incentives are the norm today the negative incentives of capitation common in the managed care era still prevail in some regions according to the NEJM report. Both types of incentive can influence clinical practice away form what’s best for patients and away from the dictates of evidence based medicine.
The effects of compensation in clinical practice are more pervasive than those of drug company gifts because they go beyond drug prescribing. Pressure to see more patients in less time as well as incentives to overuse ancillaries and do more procedures all have potential to harm patients.
What is the evidence that compensation incentives influence doctors? Jason Shafrin, the blogger at Healthcare Economist, discusses his recent paper on physician compensation here (h/t to Kevin). The post contains a link to the actual draft of the paper, which reviews previous research linking compensation plans to physician behavior and presents new data showing that switching from capitation to fee-for-service compensation increases surgery rates by 155%! Now that represents a lot of surgery. Think of all the pens and lunches that could be funded by those extra fees!
What’s a doctor to do? There’s no pat answer in the real world. We’re not all alike, and not equally susceptible to perverse incentives. Most of us would strive to adhere to first principles. Patients come first. But there are some who take a more radical position. The folks at No Free Lunch apparently believe that the only way to deal with conflicts of interest is to avoid them altogether. By selectively addressing drug company gifts they are focusing on the easiest conflict to avoid. It costs virtually nothing. But any consistent application of the avoidance principle must also take into account the conflicts inherent in compensation incentives. Avoidance of such conflicts is possible, but often at great personal sacrifice. Those doctors who sign the No Free Lunch pledge to avoid conflicts of interest should consider this cost and be willing to disclose their compensation incentives.
Physician compensation plans in the U.S. are varied and complex but almost all, with perhaps the notable exception of the V.A.’s, contain financial incentives that can influence practice patterns and clinical decisions. This NEJM Career Center article on compensation plans notes (italics mine) “’Compensation plans in the 1990s were very complicated, and included such things as participation in the group and patient satisfaction, which involved very complex formulas. Today, they [models] are moving back to a focus on productivity, efficiency, and the amount of dollars a physician brings in’”. Though these positive cost incentives are the norm today the negative incentives of capitation common in the managed care era still prevail in some regions according to the NEJM report. Both types of incentive can influence clinical practice away form what’s best for patients and away from the dictates of evidence based medicine.
The effects of compensation in clinical practice are more pervasive than those of drug company gifts because they go beyond drug prescribing. Pressure to see more patients in less time as well as incentives to overuse ancillaries and do more procedures all have potential to harm patients.
What is the evidence that compensation incentives influence doctors? Jason Shafrin, the blogger at Healthcare Economist, discusses his recent paper on physician compensation here (h/t to Kevin). The post contains a link to the actual draft of the paper, which reviews previous research linking compensation plans to physician behavior and presents new data showing that switching from capitation to fee-for-service compensation increases surgery rates by 155%! Now that represents a lot of surgery. Think of all the pens and lunches that could be funded by those extra fees!
What’s a doctor to do? There’s no pat answer in the real world. We’re not all alike, and not equally susceptible to perverse incentives. Most of us would strive to adhere to first principles. Patients come first. But there are some who take a more radical position. The folks at No Free Lunch apparently believe that the only way to deal with conflicts of interest is to avoid them altogether. By selectively addressing drug company gifts they are focusing on the easiest conflict to avoid. It costs virtually nothing. But any consistent application of the avoidance principle must also take into account the conflicts inherent in compensation incentives. Avoidance of such conflicts is possible, but often at great personal sacrifice. Those doctors who sign the No Free Lunch pledge to avoid conflicts of interest should consider this cost and be willing to disclose their compensation incentives.
We (doctors) don’t know Jack
----according to this Medscape Video Editorial by Linda Casebeer, PhD. But there’s hope that online CME can help. She cites (as yet unpublished) data showing that it improves decision accuracy, and offers some tips for on line searching.
Thursday, April 12, 2007
Evidence based woo
The National Center for Complementary and Alternative Medicine, which I will henceforth refer to as the National Center for the Promotion of Pseudoscience (NCPP), has just released a study claiming that Tai Chi boosts immunity against HVZ (Shingles) virus. There’s something in this paper to make all the alties happy. The anti vaccination crowd will be excited to learn that Tai Chi worked as well as vaccination. For the integrative medicine enthusiasts there was the finding that Tai Chi combined with vaccination worked better than either treatment alone.
If you ignore the obvious problem of biologic implausibility (the “mechanism” of Tai Chi is said to be the unblocking of the flow of the vital energy Qi along the body’s meridians) the paper appears sound at first glance. With its prospective randomized design, p values and prestigious institutional representation (UCLA and UCSD) it has all the trappings of science. But the ever diligent Orac, in contrast to the sound bite style of the popular media and much of the blogosphere, looked beyond the abstract and, digging deep into the methods section of the paper, discovered that this study proved nothing whatsoever about the effect of Tai Chi on the immune system. Because the control subjects merely “sat on their behinds in a class” the study suggests only that exercise might boost immunity. As Orac points out, to prove any unique effect of Tai Chi a comparison group treated with conventional exercise at a comparable aerobic level, or Tai Chi exercises with the “wrong moves” (a valid Tai Chi placebo for most subjects unschooled in the ways of woo) would have been necessary.
That is a patently obvious, huge, huge design flaw! Why was this study conceived in this way and why was it accepted for publication? Orac suggests a significant conflict of interest: woo is sexy these days, it sells, and it gets funded.
If you ignore the obvious problem of biologic implausibility (the “mechanism” of Tai Chi is said to be the unblocking of the flow of the vital energy Qi along the body’s meridians) the paper appears sound at first glance. With its prospective randomized design, p values and prestigious institutional representation (UCLA and UCSD) it has all the trappings of science. But the ever diligent Orac, in contrast to the sound bite style of the popular media and much of the blogosphere, looked beyond the abstract and, digging deep into the methods section of the paper, discovered that this study proved nothing whatsoever about the effect of Tai Chi on the immune system. Because the control subjects merely “sat on their behinds in a class” the study suggests only that exercise might boost immunity. As Orac points out, to prove any unique effect of Tai Chi a comparison group treated with conventional exercise at a comparable aerobic level, or Tai Chi exercises with the “wrong moves” (a valid Tai Chi placebo for most subjects unschooled in the ways of woo) would have been necessary.
That is a patently obvious, huge, huge design flaw! Why was this study conceived in this way and why was it accepted for publication? Orac suggests a significant conflict of interest: woo is sexy these days, it sells, and it gets funded.
Wednesday, April 11, 2007
Public Citizen: Celebrex ad “dangerous and misleading”
After a long moratorium, Pfizer resumed television advertisements for Celebrex last week. The Public Citizen Health Research Group, declaring the ad “dangerous and misleading”, is petitioning the FDA to ban the spot, which you can view here. Decide for yourself whether it’s misleading or dangerous. The Public Citizen letter also strikes me as a little misleading. The ad, the essential messages of which are that “Celebrex is an option” and “get your doctor’s advice,” makes cautious claims.
The ad points out that all NSAIDS are now required by the FDA to carry the same cardiovascular warning. Public Citizen believes this statement is misleading, claiming that the cardiovascular risks of COX-2 inhibitors exceed those of traditional NSAIDS. The Pfizer ad makes no claim about the safety of COX-2 inhibitors relative to other NSAIDS, but merely states that the notion that traditional NSAIDS are free of cardiovascular risk is “not clear.”
Public Citizen cites this BMJ meta-analysis which found no difference in cardiovascular risk between COX-2’s and older generation NSAIDS overall with the singular exception of naproxen which was associated with lower risk. The Public Citizen letter emphasized the difference in naproxen but neglected to mention the overall equivalency in risk between COX-2’s and older generation NSAIDS. The letter also conspicuously neglected to mention this large study in the European Heart Journal showing that the risk of MI was equally increased by COX-2’s and older generation NSAIDS.
We knew about the adverse cardio-renal effects of NSAIDS long before the COX-2 inhibitors. Although the COX-2’s arrived with a claim of increased GI tolerability there was no claim, by the drug companies or anyone else, of improved cardiovascular safety. In fact, substantial medical literature raised early concerns about cardiovascular risks. If the pharmaceutical industry concealed information about adverse cardiovascular events they should be held accountable. Nevertheless there were plenty of warnings, published in peer reviewed medical journals for all to see, about adverse cardio-renal effects of COX-2’s. Had these warnings been heeded there would have been far fewer prescriptions for Vioxx in patients with increased cardiovascular risk, the very patients in whom the absolute risk of cardiovascular harm was higher, and we might have avoided the Vioxx debacle.
It’s not fair to pick on the COX-2’s. All NSAIDS are problematic. I confess, I hate NSAIDS, old and new, and have for years. As an internist who treats many patients with cardiovascular risk factors and renal disease they are a class of drugs I love to hate.
The ad points out that all NSAIDS are now required by the FDA to carry the same cardiovascular warning. Public Citizen believes this statement is misleading, claiming that the cardiovascular risks of COX-2 inhibitors exceed those of traditional NSAIDS. The Pfizer ad makes no claim about the safety of COX-2 inhibitors relative to other NSAIDS, but merely states that the notion that traditional NSAIDS are free of cardiovascular risk is “not clear.”
Public Citizen cites this BMJ meta-analysis which found no difference in cardiovascular risk between COX-2’s and older generation NSAIDS overall with the singular exception of naproxen which was associated with lower risk. The Public Citizen letter emphasized the difference in naproxen but neglected to mention the overall equivalency in risk between COX-2’s and older generation NSAIDS. The letter also conspicuously neglected to mention this large study in the European Heart Journal showing that the risk of MI was equally increased by COX-2’s and older generation NSAIDS.
We knew about the adverse cardio-renal effects of NSAIDS long before the COX-2 inhibitors. Although the COX-2’s arrived with a claim of increased GI tolerability there was no claim, by the drug companies or anyone else, of improved cardiovascular safety. In fact, substantial medical literature raised early concerns about cardiovascular risks. If the pharmaceutical industry concealed information about adverse cardiovascular events they should be held accountable. Nevertheless there were plenty of warnings, published in peer reviewed medical journals for all to see, about adverse cardio-renal effects of COX-2’s. Had these warnings been heeded there would have been far fewer prescriptions for Vioxx in patients with increased cardiovascular risk, the very patients in whom the absolute risk of cardiovascular harm was higher, and we might have avoided the Vioxx debacle.
It’s not fair to pick on the COX-2’s. All NSAIDS are problematic. I confess, I hate NSAIDS, old and new, and have for years. As an internist who treats many patients with cardiovascular risk factors and renal disease they are a class of drugs I love to hate.
Tuesday, April 10, 2007
We haven’t always embraced woo
In fact, our love and affection for quackery is a relatively recent development. As I’ve pointed out before Franz Mesmer, thoroughly discredited in the eighteenth century for his magnetic energy woo, might be on faculty at a medical school in today’s climate. Snake oil salesman John R. Brinkley, virtually run out of the country in 1930, would be making millions doing infomercials today.
As recently as 1959, as illustrated in this video from the Internet Archive (hat tip to the Health Fraud List) we were not afraid to use the Q word.
As recently as 1959, as illustrated in this video from the Internet Archive (hat tip to the Health Fraud List) we were not afraid to use the Q word.
Intensive glycemic control in patients undergoing cardiac surgery
It may be worthwhile in the post operative period but not intraoperatively according to this single center study in Annals of Internal Medicine.
Diabetic foot disorders
As a hospitalist I wind up getting involved in the care of diabetic foot problems much more than I ever anticipated. Internal Medicine World Report has a little blurb based on an interview with John M. Guirini, DPM, of the Joslin Diabetes Center.
According to Dr Giurini, “There is no one person who can take care of diabetic foot problems by him or herself. It involves the cooperation of a foot and ankle surgeon, a visiting nurse, an endocrinologist, and sometimes a vascular surgeon and infectious disease specialist.” Trying to take care of these problems on their own, “from soup to nuts” is “probably one of the worst things that physicians can do,” he warns.
A world of information about the diabetic foot can be found in the newly released guidelines of the American College of Foot and Ankle Surgeons.
According to Dr Giurini, “There is no one person who can take care of diabetic foot problems by him or herself. It involves the cooperation of a foot and ankle surgeon, a visiting nurse, an endocrinologist, and sometimes a vascular surgeon and infectious disease specialist.” Trying to take care of these problems on their own, “from soup to nuts” is “probably one of the worst things that physicians can do,” he warns.
A world of information about the diabetic foot can be found in the newly released guidelines of the American College of Foot and Ankle Surgeons.
Thursday, April 05, 2007
It has a certain symmetry to it
China is moving from traditional TCM to Western evidence based medicine while the U.S. increasingly embraces woo, observes Orac.
Backlash against drug reps gathering momentum
Kevin MD linked this from CNN. The public relations campaign against drug company to doctor promotions seems to be effective. More and more doctors---in some regions up to 50% according to the CNN piece---are saying no to drug reps.
The most publicized effect is the massive laying off of drug reps. Less well appreciated is the increase in direct to consumer advertising that is bound to occur as drug companies divert their marketing resources. I guess the lay consumers are supposed to be better information filters than those morally bankrupt, self-deceptive doctors.
The most publicized effect is the massive laying off of drug reps. Less well appreciated is the increase in direct to consumer advertising that is bound to occur as drug companies divert their marketing resources. I guess the lay consumers are supposed to be better information filters than those morally bankrupt, self-deceptive doctors.
Tuesday, April 03, 2007
Contraindicated prescribing claims two more casualties: Permax and Zelnorm
According to Pharm Aid contraindicated prescribing is responsible for the withdrawal of these two drugs from the market. You can bet the trial lawyers are interested and they’ll be going after the drug companies, not the doctors. The drug companies will also take the public relations hit. Contraindicated prescribing not only causes direct harm to patients but also, by causing good drugs to be yanked, deprives many patients of beneficial therapies.
I’ve previously blogged this very point here and here and discussed it in the Medscape Roundtable here.
I’ve previously blogged this very point here and here and discussed it in the Medscape Roundtable here.
Monday, April 02, 2007
Review of medical Web 2.0 applications from BMC Medical Education
The Patient’s Doctor points us to a BMC Medical Education review of medical blogs, wikis and podcasts which outlines the principles, advantages and disadvantages of web 2.0 applications and cites numerous examples.
Among those mentioned:
Clinical Cases and Images
Flu Wiki
Ganfyd
Johns Hopkins Medicine Podcasts
Cardiovascular Multimedia Information Network Podcasts
Among those mentioned:
Clinical Cases and Images
Flu Wiki
Ganfyd
Johns Hopkins Medicine Podcasts
Cardiovascular Multimedia Information Network Podcasts
Sunday, April 01, 2007
Doctors, do you know you’re morally bankrupt?
No Free Lunch is an organization concerned with pharmaceutical companies and their influence on the medical profession. They believe scientific evidence, rather than industry promotion, should guide clinical practice. Most of us would agree with that. The problem, though, arises with what the blogger at Pharm Aid considers to be a paternalistic position which assumes that doctors, because they can be “bought” with a slice of pizza or a free pen, are morally bankrupt. That radical idea, proclaimed by a vocal minority, has been subject to little in the way of critical examination. Maybe that’s because its purveyors are more interested in spreading hype than examining evidence and its opponents don’t take it seriously. In any case it’s an increasingly visible public perception as illustrated by New York Times articles cited by Pharm Aid here and here.
The “paternalists”, notes Pharm Aid, argue that because doctors are morally bankrupt their judgment can’t be trusted unless they are shielded from the pharmaceutical industry. Such shielding may take the form of an institutional ban on drug company lunches or a self imposed ban such as the No Free Lunch pledge. The pledge is purported to publicly separate those doctors who base their practice on evidence from those who base it on promotion by posting a web listing of doctors who signed on. It’s as if the true test of evidence based medicine is whether or not a doctor takes the pledge. Absurd though the notion seems there’s been little effort to challenge it.
The web listing of No Free Lunch pledge adherents has yet to appear on line despite having been promised on the site for several years. One wonders if more than a small handful of doctors has taken the pledge. Indeed on close examination very few practicing physicians, at least in the United States, could honestly sign the pledge because of this requirement: “to avoid conflicts of interest in my practice….” That pretty well disqualifies most doctors who practice medicine for a living. Depending on our compensation model most of us practice under either positive or negative financial incentives. These incentives influence the types and numbers of patients we see, the procedures we do, the tests we order and our referral patterns. Compared to the measly drug company pens, note pads and lunches these conflicts are much more powerful. They’re about real money and they impact each and every patient encounter.
Conflicts of interest are pervasive in medical practice and take many forms. Those inherent in doctors’ interactions with drug companies are small in the grand scope of things. If the paternalists are really interested in conflicts that matter why do they focus selectively on the pharmaceutical companies?
Regarding No Free Lunch, Pharm Aid writes: “This organization urges physicians to avoid any interaction with pharmaceutical companies, including pens, lunches, etc. However, their disdain of drug companies doesn’t seem to apply to anyone else (including insurance companies) trying to influence their physician’s prescribing patterns, the diagnostic tests they order and the medical procedures they perform.”
Are we morally bankrupt as a profession? Perhaps. And if we think holding ourselves at arms length from the pharmaceutical companies will cure our moral turpitude we are also profoundly self-deceptive.
The “paternalists”, notes Pharm Aid, argue that because doctors are morally bankrupt their judgment can’t be trusted unless they are shielded from the pharmaceutical industry. Such shielding may take the form of an institutional ban on drug company lunches or a self imposed ban such as the No Free Lunch pledge. The pledge is purported to publicly separate those doctors who base their practice on evidence from those who base it on promotion by posting a web listing of doctors who signed on. It’s as if the true test of evidence based medicine is whether or not a doctor takes the pledge. Absurd though the notion seems there’s been little effort to challenge it.
The web listing of No Free Lunch pledge adherents has yet to appear on line despite having been promised on the site for several years. One wonders if more than a small handful of doctors has taken the pledge. Indeed on close examination very few practicing physicians, at least in the United States, could honestly sign the pledge because of this requirement: “to avoid conflicts of interest in my practice….” That pretty well disqualifies most doctors who practice medicine for a living. Depending on our compensation model most of us practice under either positive or negative financial incentives. These incentives influence the types and numbers of patients we see, the procedures we do, the tests we order and our referral patterns. Compared to the measly drug company pens, note pads and lunches these conflicts are much more powerful. They’re about real money and they impact each and every patient encounter.
Conflicts of interest are pervasive in medical practice and take many forms. Those inherent in doctors’ interactions with drug companies are small in the grand scope of things. If the paternalists are really interested in conflicts that matter why do they focus selectively on the pharmaceutical companies?
Regarding No Free Lunch, Pharm Aid writes: “This organization urges physicians to avoid any interaction with pharmaceutical companies, including pens, lunches, etc. However, their disdain of drug companies doesn’t seem to apply to anyone else (including insurance companies) trying to influence their physician’s prescribing patterns, the diagnostic tests they order and the medical procedures they perform.”
Are we morally bankrupt as a profession? Perhaps. And if we think holding ourselves at arms length from the pharmaceutical companies will cure our moral turpitude we are also profoundly self-deceptive.
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