So far carotid endarterectomy looks better than carotid stenting

"So far" here means according to the results of the interim analysis of the International Carotid Stenting Study (ICSS) surgery looks better. This trial has enrolled 1713 with symptomatic carotid artery stenosis to either endarterectomy or stenting with the major outcome of interest to be the three year outcome of fatal or disabling stroke.

The interim analysis focused on the 3 month comparison of the rate of stroke,death and procedural myocardial infarction in the two groups.The endarterectomy group experienced 27 such events versus 34 in the stenting group or 8.5 % versus 5.2%.

The authors offered this closing sentence:


Completion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.

A earlier trial ( see here) in France also demonstrated the apparent superiority of surgery over carotid stenting.This was the EVa-3s trial which was stopped early for reasons of futility and safety.

For what it is worth the latest Medical Knowledge Self-Assessment Program MKSAP 15 says this about symptomatic ,severe (greater than 70%), carotid artery stenosis:

"carotid endarterectomy is still considered the gold standard..". (One may wonder why a retired internist is still ordering and reading MKSAP)

If I had to decide today in regard to my own neck I would opt for surgery .Of course, I live in an area populated with a large number of excellent, well experienced vascular surgeons and hospitals in which a lot of vascular surgery is performed.


ADDENDUM: (2/26/2010 1:00pm CST)
On the other hand maybe things might be a bit different in North American.The CREST trial results were just reported and seemingly stenting fares better but still not better than endarterectomy overall. Are American stentists more adept? Is comparative effectiveness research (CER) easy or what?

Why is the Avandia issue being raised again?

Dr.Mintz offers a good re-review of the literature behind the controversy regarding rosiglitazone (Avandia).
Avandia has been in the news again. See here. Dr. Mnitz says there is nothing new regarding data accumulation or analysis. So why are we hearing about it again. Why are Senators Grassley and Baucus stirring the pot again?

Any thoughts?

If medical care costs "too much" easy fix is price controls?

The Massachusetts health care plan facing costs greatly in excess of previously advertised ( fantasied?) cost projections can be fixed, according to a proposal by the governor of Mass. The answer is government controlled prices.See here for a new report on that development.

Wage and price controls predictably leads to several things:
poor quality, shortages and black markets.

The Medicare price controls have lead to the first two in regard to primary care.See here for an earlier rant on how price controls has worked out in regard to Medicare.

Statins in drinking water? not quite yet, but CRP for lots of folks?

The JUPITER trial was a great boost for Crestor and the use of the hs CRP and now the FDA gives approval for wider use of at least one statin.See here for FDA information. Dr. Mintz,as is often the case, offers his thoughtful insights to this issue here.

It has been a while since JUPITER was completed so if you want a review and a very detailed discussion of many of the related issues go here to read what DrRich had to say.

I will shamelessly repeat what I wrote earlier:

"You can talk about the fact that Jupiter was terminated prematurely, you can talk about relative risk versus absolute risk reduction and Crestor effect versus class effect but in the end here is the way things seems to work. When you have a large randomized clinical trial that demonstrates a benefit for a given medication and when many well known medical thought leaders endorse it and when it is then approved by the FDA you know that guidelines will be written and quality rule driven medical practitioners will follow and many patients will take the medication and likely insurance companies will pay for some or all of it.So in this case many folks will have their hs-crp checked and they will be prescribed Crestor ( a few will be given lower price statin cousins) and there will be- for a while- talk about crp at parties."

Enactment of Comparative Effectiveness Research -Libertarian Parternalism or Orszag type coercion

An excellent commentary by Dr. Jerome Groopman can be found here . It which offers a very thoughtful analysis of a number of issues related to comparative effectiveness research (CER) and what comes next.

He tells a narrative of two highly placed Obama administration players who views are seemingly widely divergent in regard to how to implement findings from clinical research; Cass Sunstein and Peter Orszag.

Sustein would "nudge" us along to do what is best for us while Orszag would implement, for example, the findings of comparative effectiveness research (CER) with " aggressive promulgation of standards and changes in financial and other incentives", the later approach finding a statutory home in the Senate health care bill but not the House bill.

Sustein and his collaborator Richard Thaler have brought to the current trendy universe of discourse and commentary the notion of "libertarian paternalism" (LP) replete with the concept of "Choice architect" and "nudging folks" to make the right decision in areas wherein their ignorance, cognitive limitations and lack of will power cloud their minds so that they do not do what in the view of the architects is the action which really is in their best interests. Basically the LP camp seems to say we ( the experts ) know what is best for you and we will in various not- really- coercive ways gently push you in the right direction. The more traditional progressive view, as exemplified by Orszag, is we know what is right and we,if necessary, will summon the force of law to make you do it.

Groopman favors the LP view and adduces persuasive evidence to the argument that a number of the so-called best practices and quality measures have been simply very bad ideas with bad consequences and I would add monuments to the hypertrophied hubris of those architects.These fiascoes include the now notorious 4 hour rule for pneumonia,fountain of youth estrogen movement,very tight blood sugar control for critically ill patients, and relatively tight glucose control for ambulatory patients,statins for dialysis patients and I would add:beta blockers for almost everyone pre op.Other quality measures have been shown to have no effect one way or the other.

Goopman, in a David Hume-like argument, turns the notion of the cognitive biases that limit the non-expert humans back on the experts pointing out the obvious that they too may fall victim to the same biases, such as overconfidence, the focusing illusion and confirmation bias and that they tend to " overestimate [their] ability to analyze information, make accurate estimates and project outcomes". He even admits that he was subject to some of those foibles in what turned out to be an over-zealous push for Erythropoiesis-stimulating agents, in cancer patients.

Dr. Goopman then offers what I believe is a profound insight in regard to expert panel's "best practices".They may often fail to recognize and distinguish between those practices that can be standardized and not significantly altered by the particulars of the individual patient and those that those practices that must be altered to the individual patient. A check list to prevent infection when an IV catheter is inserted exemplifies the former and issuing a dictum that all ambulatory patients with diabetes should be treated to a given Hb AIc is an example of the latter.What blood sugar target level is optimal may vary not only between individual patients but also may vary often time with the same patient and the one size for everyone is a recipe for trouble.

To the extent they actually believe their own rhetoric both Obama and Orszag demonstrate a naive view of science and medical research. They speak of simply "finding out what works and what doesn't" seemingly ignorant of the fact that so often what we "determine" today from clinical research is contradicted tomorrow and how very difficult it can be to find out what is best or even define "best"Science offers provisional conclusions subject to refutation.It is often not a matter of what works and what does not but more often a trade off between various approaches each with its own set of benefits and dangers.

Dr. Groopman hopes that the Sunstein approach will be used- preferring nudging to coercion. Given a binary choice I would opt for nudging as well However, some have suggested that notion of libertarian paternalism is an oxymoron and some have raised a slippery slope concern see here for one discussion of those issues.Nudging might gradually morph into regular traditional coercive paternalism. I am reminded of the "third party experts" who profess to know what is best for you better than you do and Thomas Sowell's comments in that regard.See here to see and hear Sowell on that issue.

Interesting new term-"Insurance free medicine" That may be what we need.

Go here to read a very interesting and thoughtful commentary by an academic internist whose thoughts I have quoted before.Dr Matthew Mintz suggests a new term, "Insurance free medicine" which I agree is a useful way to encompass several other terms and to reference modes of medical practice that have evolved to escape the increasingly intolerable world of primary care dominated by insurance companies and CMS. Here I refer to both family practice and internal medicine. do not have enough information about current day pediatric practice to comment meaningfully in regard to the current status of that aspect of primary care.))

Insurance free medicine would cover practice arrangements that are now called the following:
concierge medicine,retainer medicine,cash only medicine and boutique medicine.

I would sign up today if I could find an internist in my area offering insurance only medicine.

Toronto ACP meeting to offer mini-courses in minor surgery-what is that about?

I recently received a copy of the advance program for the April 2010 scientific meeting of the American College of Physicians (ACP). On page 38 we find a list of mini-courses in "Clinical Skills in Procedures". These include: skin biopsy and cryosurgery,suturing skills, and my favorite,"toenail removal" about which they state :

"Learn the indications for toenail removal. Using a realistic model and actual surgical instruments ( I guess as opposed to fake instruments),practice a digital block,wedge resection and removal of an ingrown toenail and wound care."

I am puzzled as to the intent of the ACP planners in offering this course. Do they intend that an internist whose post medical school training to my knowledge does not involve the development of surgical skills offer this procedure in his office with only several hours of instruction/practice as his qualifications? Do they believe that one serves his patient well by having an under trained physician perform a surgical procedure?

Should the planners of this course develop a painful ingrown toenail who would seek out for treatment: a general surgeon, an orthopedic foot surgeon, a podiatrist or an internist who took a course at the ACP meeting? I am reminded of this Monty Python skit of a job counseling interview in which the applicant's sole quality for lion taming was a hat that said 'Lion Tamer".

I have written before as has Dr RW (see here and here for his comments and here for mine) on what seems to me to be an identity crisis in internal medicine evidence for which is found in the more recent editions of MKSAP as well as the annual scientific meeting wherein the planners seem to be trying hard to make internists more like family practice physicians. The general internal medicine section of MKSAP had many sections removed from typical or traditional internist's training and areas of expertise such as diagnosis and treatment of corneal abrasions and detailed evaluations of uterine bleeding to name just two. A suturing skills mini-course practicing on pig's feet is part of the "why can't internists be more like family practitioners ?" movement, one that I believe does not enhance internist's patients' care nor the public or self image of internists.

If Mayo Clinic loses money on Medicare , what will the "average" internist do?

While the AMA and the ACP seemingly see better things ahead ( I assume they do because of their support for a bill whose particulars still remain a secret) after passage of the final health insurance deconstruction-reconstruction bill, the prestigious Mayo Clinic has seen fit to restrict Medicare patients because they loose money on their care.

Mayo's primary care physicians will only see Medicare patients at its Arizona facility if they agree to pay a $ 1500 annual fee. The Rochester mother ship facility has announced it will see Medicaid patients only from certain states.

Dr. Toni Brayer, author of the blog Everythinghealth, in her Jan 6,2010 on line issue of the ACP Internist tells her readers she has the same problem.Because of other sources of income she plans to continues to care for her Medicare patients but how many other internists will continue to choose to eat that economic loss. How many can afford to?

According to Dr. Brayer, Mayo clinic looses $ 840 million on Medicare patients' care and that about 70% of hospitals loose money on Medicare patients.

The issue is much bigger than Mayo's decision. Many physicians are not accepting new Medicare patients. The Texas Medical Association has reported that their survey of primary care physician indicates only 38% of Texas primary care docs are accepting new Medicare patients.

The incredibly arrogant purposeful secrecy and what has been described as "cash for caucus" of what the legislative process has descended to, makes it impossible to know what is planned to alleviate the problem of primary care docs not being financially able to treat Medicare patients. I share Dr. Wes's indignation at the failure of the leadership of major medical organizations when he states:

We see this as our professional membership leaders failed to ask about the details of the health bills ( my bolding) before them nor inquired about the potential flaws inherent to comparative effectiveness research promulgated on large, unfiltered populations. Rather, our representatives capitulated and mollified themselves with platitudes.

Here is what a recent commentary in the Boston Globe said in regard to the growing disconnect between primary care physician and Medicare-Medicaid patients and the Senate health bill;

The Centers for Medicare and Medicaid Services, a branch of the US Department of Health and Human Services, estimated last month that the Senate bill would squeeze $493 billion out of Medicare over the next 10 years. As a result, it cautioned, “providers for whom Medicare constitutes a substantive portion of their business could find it difficult to remain profitable and . . . might end their participation in the program (possibly jeopardizing access to care for beneficiaries).’’ In short, the Democratic understanding of health care reform - more government power to set prices, combined with reduced freedom for individuals - will make medical care harder to come by: an Economics 101 lesson in the pitfalls of price controls.

With many millions ( no, Virginia there will not be "universal coverage, still about 23 million will not be insured) more added to the medically insured population, with no meaningful relief in the wage-price controls on physician's fees from CMS and numerous hints in the bills of a heavier and more obtuse administration thumb on medical care details it seems inevitable that more and more physicians, unlike Dr. Brayer, will just shrug.

Why does the AMA support senate and House health insurance bills?

Several blogs have taken up the issue of the AMA 's support of the health insurance bills currently sliding behind the scenes through Congress. Here is a newspaper article that makes the case for a theme that is found in a number of blogs.

Essentially the charge is that the AMA supports the bill because of the fees it receives for what is described as a monopoly of the insurance billing codes (the CPT codes ). Linda Gorman explains it here.

Apparently HCFA and the AMA reached an agreement with the AMA to use AMA's copyrighted CPT Codes (Current Procedural Terminology codes) for Medicare billing purposes. AMA does not report income from their CPT business separately but estimates suggest something in the range of $ 70 million per year,not a large number by today's standards but significantly more than AMA receives from dues. (Only about 15% of physicians now belong to AMA)

The 1983 HCFA-AMA pact originally precluded the use of other codes for purposes of physician outpatient fees for Medicare and Medicaid.A 1997 Ninth Circuit finding that the AMA was misusing a copyright lliminated the exclusivity but by that time the CPT was the industry standard.

Dr. J.J. Rohack had this to say in reply to Gorman's commentary :

This democratic forum of grassroots physicians and medical students directed the AMA in 1983 to have Reagan Administration recognize CPT as the standard for physician coding. At the time, physicians struggled to cope with the multiple code sets used by third party payers, including the government. AMA brought calm to this chaos by securing a physician-driven standard used to describe medical services.


SERMO, the online physician social network, has become very critical of AMA's role in CPT and in fact has severed an earlier working agreement with AMA. See here for comments from SERMO's founder, Dr. Daniel Palestrant.

The AMA has received CPT fees for a number of years, why now have they reversed earlier opposition to universal health care plans? What exactly is the alleged link between the two? I do not claim the two are not related but I am having trouble seeing exactly how that works. I ask my handful of readers for their input.

More counterpoints to the Dartmouth Atlas data

This article from the journal Circulation provides data and analysis that at least suggests that the sweeping conclusions of the Dartmouth group may not tell all of the story. h/t to this entry by the Buckeye Surgeon.

The widely quoted publications of the Dartmouth group that studied the regional variations in Medicare patient death rates have been condensed to a simple recipe to solve at least some of the country's medical problems-let's all be more like the Mayo Clinic and the implication that spending more money necessarily translates into poorer health care.

The Circulation studied looked at the outcomes of Medicare patients in 6 California teaching hospitals.Here is the conclusion of the study's authors:

Conclusions— California teaching hospitals that used more resources caring for patients hospitalized for heart failure had lower mortality rates. Focusing only on expired individuals may overlook mortality variation as well as associations between greater resource use and lower mortality. Reporting values without identifying significant differences may result in incorrect assumption of true differences.

It is only in the context of the hype generated with the Dartmouth studies that one would be surprised that spending more resources on sick patients might actually improve their outcome.It is obviously true at the extreme-if we spend no money at all good outcomes would be unlikely. Within some of the health care "reform" rhetoric we hear the theme that spending more money is necessarily bad and wasteful. Spending more can be wasteful but often it is not. It is an empirical question and very context dependent- not one determined by reference to first principles.

I have written before abut Dr. Richard Cooper's critique and criticism of the Atlas studies.See here for some details of Dr. Cooper's arguments and comments by the economist, Arnold Kling.

Will long term endurance exercise prevent your telomeres from shortening?

I hope so and here is some evidence suggesting long term endurance exercise may mitigate the aging process which is part seems to be due to one's "chromosomes shortening". I had written earlier about claims that vitamin D has a similar effect.

This is not the first such article making this type association. This article by La Rocca et al in Circulation demonstrated longer leukocyte telomere length (LTL) in older endurance exercisers and correlated LTL with aerobic capacity and an index of endothelial dilatation.

An interesting study published in the Archive of Internal Medicine which in part involved study of twins showed that the inactive twin had shorter telomeres that the more active sibling. A companion editorial offered the appropriate caveats which might serve to mitigate any undue exuberance forthcoming from overly smug ,older long time runners:

A great deal of research has been done on telomere length in the past few years, and exactly what it is telling us is still being argued. Cross-sectional studies show that telomeres in humans are shorter at older ages and telomere length is shorter in peripheral white blood cells in a variety of chronic diseases. However, although shorter telomere length has been associated with cell senescence, its direct effect on organ function is not well documented, and telomere length in postmitotic cells has not been related to life span in the experimental animal in which it has been extensively studied, Caenorhabditis elegans.

Yeah, I know you shouldn't get carried away by surrogate makers. Further, this study of older Chinese found no such relationship.

So, I continue to run as long as I can even if the effect on telomeres really means little or nothing because after each run I seem reassured that I am not really that old yet (the marked reduction in running speed notwithstanding) as irrational as that belief is.

Is everyone talking about the same health care bill?

Apparently John Goodman on one hand and the American Medical Association and the American College of Physicians on the other are interpreting the thousand of pages of almost impossible to decipher verbiage in vastly different ways.

Here is what Dr. Goodman thinks is the key "accomplishment" of the bill.See here for his entire posting and consider the reasons he lists as to why the nationalizing of health insurance is what it is all about.

Nationalizing health insurance. For the first time ever, the federal government will tell you what kind of insurance you must buy and (effectively) where you will buy it and what price you will pay. You will not be allowed to buy better, cheaper insurance that is more suitable for your and your family’s needs — even if an insurer is willing in principle to sell it to you.

Don’t underestimate the importance of this accomplishment. Nationalization is the abiding, overriding, everlasting, immutable, unending, permanent, unchanging goal of the political left. There is no other there, there. There is no other beef. All else is sound and fury signifying things that are way down the priority list.

Nationalizing the health insurance industry will also politicize it.With the shameless performance of the Senators and the bribes involved in the health care bill passage fresh on our minds, that is a frightening thought.

It seems very likely than warfarin's days are numbered

The oral, direct thrombin inhibitor, ximilagatran for a while seemed to be poised to be the replacement for warfarin. Early trials indicated its efficacy and safety (at least in terms of bleeding risks) but its further advancement was stymied and ultimately blocked by the observation of what proven to be a unacceptably high level of abnormal liver function test abnormalities.(Direct thrombin inhibitors (DTIs) block thrombin from cleaving fibrinogen to fibrin.)

However, its descendant, dabigatran has successfully made its way through two large randomized clinical trials and seems to be at least as efficacious and at least as safe (in terms of bleeding risks at and no major signals of other adverse effects) and will probably emerge as the long sought after replacement to warfarin.

First dabigatran looked good (in some outcomes better than warfarin and in others, "not inferior") in the RELY trial which studied its use in high risk patients with atrial fibrillation. Next the RE-COVER trial (this is not to be confused with the RECOVER (without the hyphen) trial) compared dabigatran with warfarin in patients with deep vein thrombosis and found similar good results.

So far,dabigatran seems as efficacious and safe as warfarin in atrial fibrillation and in DVT and does not require frequent blood test monitoring nor frequent dose adjustments.

Still there are concerns and questions. Dabigatran is given twice a day so the compliance issue has to be considered. Further,in RELY two doses were tested. At the 150 mg twice a there were fewer strokes so that dose seems more efficacious. At the 110 mg dose there were fewer instance of hemorrhage, so the lower dose seem safer. The 150 mg twice a day dose was used in the RE-COVER dvt trial so that dose may become the one generally used.

Dabigatran is approved in the EU for prophylaxis in total hip and total knee replacements and also in Canada.
2010 will probably see its approval in the U.S, fifty years or more after warfarin was approved.

Will CRP(c-reactive protein) become a cocktail dinner conversation?

The answer to the title question is "probably yes" if the FDA concurs with the recent recommendation of its advisory committee in regard to a "new" indication for rosuvastatin (Crestor).

Dr. Matthew Mintz gives his thoughtful analysis of the panel's decision ( see here) and,in general, he seems to support the decision of the panel. The panel basically approved rosuvastatin for patients with normal LDLs and an elevated hs-CRP (high sensitivity CRP).

As has been pointed out (see here for Sandy Szwarc's detailed comments and critique on the study (Jupiter) that lead to the panel's decision) a very large number of people would be "eligible" for this new indication.I believe her comments contain several important counter-points to the avalanche of glowing comments from well known "thought leaders" that came quickly on the heels of the publication of Jupiter in the NEJM and should be read by someone before planning to check everyone's CRP and treat those eligible folks with CRPs of over 2.Although, I'll bet that the media blitz and specialty society guideline publicity that will blare forth if and when the FDA gives final approval will overwhelm any suggestion by a physician that we might give the matter a little thought before we prescribe Crestor because of an elevated CRP.

A 2009 article by Dr. Erica Spatz concluded " JUPITER’s findings have the potential to impact treatment recommendations for 20% of middle-aged to elderly adults, thus increasing the proportion of this segment of the population with an indication for statin therapy to nearly 80%."

That 80% of middle-aged and elderly should be on a statin is ,to put it mildly, mind boggling.

One comment by a FDA panel member caught my eye-that the increases of new onset diabetes in the Jupiter trial was a "class effect" meaning that all statins tend to do that. For the number of patients for whom I recommended statins I did not see fit to warn them about an increased risk of diabetes. I was not aware of any. In fact, the West of Scotland study (WOSCOPS) found a 30% reduction in the onset of new diabetes in the pravastatin treatment arm. JUPITER had reported the opposite namely that there were 3% new diabetes cases in the treatment arm versus 2.4% in the placebo group. Further, Rajpathak published a meta-analysis of six statin trials that demonstrated a slight increase if the WOSCOPS data were excluded but no difference in onset of diabetes when that data were included. ( I never did understand why they would want to exclude the Scotland study anyway but...) So, if it is a class effect it must be a rather small one and I would worry more about muscle toxicity related side effects in the newly enlarged pool of older eligible patients.

So much has been written,just in the medical blog world,that I won't try and summarize all of the gleeful announcements of a really big breakthrough or the more somber critiques. But if you read only one commentary this one by DrRich would be worthwhile.

You can talk about the fact that Jupiter was terminated prematurely, you can talk about relative risk versus absolute risk reduction and Crestor effect versus class effect but in the end here is the way things seems to work. When you have a large randomized clinical trial that demonstrates a benefit for a given medication and when many well known medical thought leaders endorse it and when it is then approved by the FDA you know that guidelines will be written and quality rule driven medical practitioners will follow and many patients will take the medication and likely insurance companies will pay for some or all of it.So in this case many folks will have their hs-crp checked and they will be prescribed Crestor ( a few will be given lower price statin cousins) and there will be- for a while- talk about crp at parties.

My first prediction for the new year: Look for a surge of CME-oid meetings and articles on the value of CRP for cardiac risk assessment and as basis for statin therapy.Yes, we have heard about CRP for quite a while but soon we will probably have the blessing of the FDA and things will really take off.

What do we really know about Tamiflu and flu?

The latest word ( but likely not the last) on the use of the neuraminidase inhibitors (Tamiflu and Relenza) comes from the Evidence Based Medicine epicenter, The Cochrane review) and can be found here.

The article in the BMJ did not go unnoticed by Dr. Howard Brody who correctly recognized that there was more there than simply a lack of definitive data about the role of Tamiflu. See here for his blog comments regarding that series of events in the broader context of an integrity crisis in medical research which I believe is part of an even broader context of "How the heck do we know what is correct in medical research publications".

An ingrained as Tamiflu is in the current medical thinking about management of flu (and anything that looks like flu) I doubt the BMJ article will have any significant impact on the sales of the drug. I bet that sometime in the near future we will see a meta-analysis to counter the analysis from Cochrane.

Will the senate Health care reconstruction bill cover acupuncture and bee pollen? Maybe

The answer seems to be "maybe" because while there is no specific mention of bee pollen ( no, I have not read the entire bill to be sure there is in fact no mention of bees) there is the issue of interpretation of the "non-discrimination provision which is discussed here. (h/t to John Goodman).The hyperlink cited also has a link to the bill itself)

The provision at issue states that insurers shall not discriminate against any health care provider that is licensed by the state. Many states do license "providers" who are,to be politically correct,alternative medicine practitioners. So does it follow that insurers will have to pay for whatever brand of woo dished out by certain alternative woo providers as long as they are licensed by the state?

The alternative medicine lobby along with the lobbyists for supplements would seem to be happy with the senate bill and both Senator Harry Reid and Senator Harkin also with Senator Hatch seem supportive of both interests according to the LA Times article referenced above.

How many more gems of silliness and special interest provisions will turn up in the compromise bill once the Senate passes something?

Maybe we should worry more about Lemierre Syndrome than rheumatic fever given a sore throat in adolescents

An important and perhaps a paradigm shifting article is found in the Dec 1,2009 issue of the Annals of Internal Medicine by Dr.Robert Centor. See here for the abstract.For the full article subscription required or wait 6 months.

For the past many decades medical students have been taught to be wary of the possibility of the later development of rheumatic fever in a sore throat patient and that possibility is one reason for treatment of beta strep sore throats,suppurative complication being the other.

The various treatment algorithms are based on the concern about beta strep infection but Centor warns us that a different bacteria may pose a greater risk in one age group, one that seemingly is not considered in the usual treatment guidelines.

Dr Centor puts forth a good argument that in the age group 15-24 years an equally important concern (perhaps a greater concern) is that the pharyngitis is due to Fusobacterium necrophurum and if so there is a real risk of the subsequent development of something called Lemierre syndrome . This is a potentially life threatening condition in which there is bacteremia and a suppurative thrombophebitits of the internal jugular vein. While rheumatic fever and patients with rheumatic heart disease were common when I trained in the late sixties and early seventies, can anyone remember the last case of rheumatic fever that they saw?

A clinical pearl is that typically worsening clinical symptoms with neck swelling in a 15-24 year old may signal the condition. Treatment for a beta-strep negative patient in whom you suspect F. necrophorum is with penicillin or a cephalosporin and not the ever popular macrolides. With bacteremia the recommended treatment is penicillin plus metronidazole or clindamycin alone.

Robert Centor has studied and written extensively on the topic of pharyngitis for a number of years he should be listened to and hopefully his article in this widely read journal will have some impact. Any bacteria with "necro" in its name should be taken seriously. Go here to his blog to read some of his comments on this issue.

Diminishing returns on heart attack treatment innovation leads to new targets

JAMA offers this excellent commentary on the topic of diminishing returns in reducing mortality in the treatment of myocardial infarction by further therapeutic innovations.We have come a long way but to go much further in terms of mortality reduction becomes progressively more difficult and this can be expressed both in terms of cost of the clinical trial and the number needed to enroll in clinical trials.

How far have we come? Consider ISIS 2 and the subsequent innovations in the treatment of acute myocardial infarction.

ISIS2 was published in 1988 and demonstrated that the combination of aspirin and streptokinase decreased the 35 day mortality from acute myocardial infarction from 13.2 % ( in the control group) to 8 % in the treatment arm.This is a five percent absolute reduction and about a 20% decrease in relative risk.

Over the next decade or two we saw the introduction of TPA ,and angioplasty and then coronary artery stents and drugs to inhibit the platelets and the mortality rate dropped to around 4%.In some more recent trials the mortality rate of acute MI is actually closer to 2%.

The authors assert that ...it is a mathematical truism that , given the diminished control rate,future innovations can never match the benefits already realized (at least in terms of case fatality).
( by "control rate" the authors mean the rate of death in an control group as it would be constituted today with the current standard of care)

Why not? Is it simply the mathematics involved?

They explain that the mortality reduction by successive trials with a constant relative risk reduction can be characterized by a declining exponential function for mortality and an increasing exponential function for the sample size necessary to show the effect. (Their mathematical argument seems reasonable to me but I'll admit I am easy to fool with that type of thing)

The argument continues that if larger and larger sample sizes will be required then the use of surrogate measures and combined end points increasingly come into play.Also those planning clinical trials will turn to the use of control groups with higher rates of mortality as can be found in less developed countries and utilize non-inferiority trials.It does seem we have be seeing more and more of these type trials particularly trials with combined end points .

Excellent new blog on "evidence" and medicine

A new medical blog named simply "Evidence" has appeared recently and it is definitely worth reading. The author identifies himself as an academic primary care physician named David Rind.


The following quote was worth the price of admission to the author's latest commentary:

There is no path from evidence to understanding that does not rely on expert interpretation, and, ultimately, no mechanical measure of sufficient evidence or proof outside of what counts as proof to those patients and providers who must make decisions.

Addendum: I neglected to give a link.Here it is.

Proposed Senate Health care bill shows us how regulatory capture can really work

If you thought the inclusion of industry representatives on the government proposed "CER panel" illustrated regulatory capture, you, of course, were right. But it gets even worse, much worse. Go here to read about it on Health Care Renewal as Dr. Roy Poses explains how bad it is.He also references a NEJM commentary on that subject which should be widely read and discussed and might give some pause to those who seem to assume that the purported intent of legislation and the likely consequences are the same thing.

Here is the essence of this new outrage.I am quoting from Poses's blog entry.

The Finance Committee bill also includes language requested by industry lobbyists (pages 1138–1139) that threatens to withdraw federal funding for 5 years from any investigator who publishes a report on research funded by the proposed institute that is not within the bounds of and entirely consistent with the evidence.' Determinations regarding such consistency would be made by the newly created research entity, which would have industry involvement both in its governance and in study design. To allow scientists — and their institutions, which receive the support for the conduct of research — to be punished for the publication of work that is not approved by this entity is essentially to cede authority over the dissemination of government-funded research to a body that is at least partially controlled by persons with a potential commercial interest in its outcome.

Comparative effectiveness research in the ideal and what it may turn into with the passage of this provision have as much in common as a warm puppy and a hot dog.