.comment-link {margin-left:.6em;}

retired doc's thoughts

Thursday, December 03, 2009

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 .

Monday, November 30, 2009

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.

Thursday, November 26, 2009

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.

Saturday, November 21, 2009

Physicians and patients will both pay more attention to the USPSTF after medical care is "reformed"

Very newsworthy in recent days has been the publication of the latest recommendations from the USPSTF regarding mammograms. Surprising to many and shocking to some were the changes from earlier recommendations and the degree to which they differ from the widely disseminated and adhered to recommendations of the American Cancer Society.

Seemingly to allay some of the shock and likely backlash from those who fear and/or write about the "r" word (rationing) in regard to health care , HHS Secretary Sebelius told the country not to worry about their recommendations regarding women less than fifty and over seventy-five .She reassured everyone that- no these are not binding to Medicare or to any insurance company and for everyone to go along just as they had before and be sure to check with their physician about proper advice in that regard.

DrRich of The Covert Rationing Blog dug through goodness knows how many pages of HR 3962 and pulled out some very interesting, and to some of us, very alarming provisions. Go here to read what he found.
HR 3962 provisions, if they survive, will elevate the USPSTF to something much more than an advisory body and morph them in to an entity named TFCPS (Task Force on Clinical Preventive Services) and when they make an "A" or a "B" level recommendation that will become part of the essential package that will be required to be included the coverage of "qualified health plans".

But there is even more. Not just incorporating future recommendation of the TFCPS aka USPSTF the HHS Secretary will go back and use their previous recommendations as policy. Here is a quote from the bill as reported by DrRich;

All recommendations of the Preventive Services Task Force and the Task Force on Community Preventive Services, as in existence on the day before the date of the enactment of this Act, shall be considered to be recommendations of the Task Force on Clinical Preventive Services and the Task Force on Community Preventive Services, respectively, established under sections 3131 and 3132 of the Public Health Service Act, as added by subsection (a).” (Section 3171, page 1319).

Since all their current recommendation may become policy not only should the breast cancer/mammograms interest groups be very interested, so should others and they read through their 2009 set of recommendations here.

The American college of Radiology alertly recognized what clout the USPSTF is likely to have and recommend that the USPSTF change its stance (fat chance of that) and/or for whatever deliberative body there will be to be more "inclusive".

In regard to the more narrow issue of what lead the USPSTF folks to reach their conclusion, this analysis by Dr. John Goodman is worthy considering. Apparently the issue of false positives and the necessary and costly followup weighed fairly heavy in their calculus. ( Aside, warning biased anecdote to follow -- in the years when I recommended PSA screening, over a five year period 12 cancers were detected and another 6 patients were evaluated and no cancer was found.Interesting the false positive group all expressed relief that they did not have cancer a view that I have also observed in other patients who had a scare based on a lab test.) From what I have observed the false positive issue is larger in the eyes of those who write guidelines and they speak of anxiety but really are concerned over aggregate cost that accrues when false positives are further evaluated.

Dr. Mark J Perry, an economist from the University of Michigan, makes insightful comments here regarding this issue.In the world of HSA (Health Saving Accounts ),which are under assault in the senate health care bill, the pronouncements of the USPSTF would not be determinative and the individual patient could confer with her individual physician to decide when and if you get mammograms and the secretary of HHS would not be in charge.

Friday, November 20, 2009

Still more worries regarding clopidogel and PPIs

Previously on Retired Doc, I commented that first we were warned about a drug-drug interaction in which PPIs ( or at least omeprazole ) mitigated the therapeutic effect of clopidogrel in a clinically important way and then a randomized clinical may have failed to showed such a relationship.Now we need to worry again.

See here for comments about what the FDA is now saying about the combo of clopidogrel and omeprazole suggesting we need to dust of the H2 blockers rather than using the PPIs. Bad news for the PPIs but possibly good news for ticagrelor since it is, unlike clopidogrel, apparently not a prodrug and drug-drug interactions will be less likely.Then again look how long both Plavix and Prolosec were used before we had data sufficient to worry about that interaction.

Monday, November 16, 2009

Health care (insurance) bill has what in common with the Mafia?

I had promised myself (fingers crossed behind the back) not to comment further on the health insurance bill after reading the comments of Bill Clinton and Rahm Emanuel to the effect of let's pass something and worry about what later.

But, the title ( an offer you can't refuse) alone of this entry by Dr. Paul Hsieh is worth the price of admission.Also his review of how well Mass-care is working is well done and should be a cautionary tale but I am increasingly convinced it is not about what is in the bill but just that something gets passed and not about rational arguments pro and con but about what deals are made to get something passed.

Tuesday, November 10, 2009

Follow the money (or promise of it) to see why AMA and AARP support the health care bill(s)

See this article for one explanation for why AARP might support the current democratic health care "reform" bill. This is from the pen of Dick Morris and his assertion is that AARP in its role as an insurance broker will reap rewards from the bill(s) cutting funds to Medicare Advantage as a number of old folks will then need/want to buy medicare supplemental insurance for which AARP is a major broker.

How does this "follow the money rule" work for the AMA support of the bill(s)? Again Morris suggests a deal with the Obama administration , one in which AMA is promised that the dreaded and dreadful SGR annual cuts will be abolished. He does not spell out the evidence that such a deal was made and if so what was the deal.

Morris's article also tackles the relationship of the drug companies,insurance companies and medical device companies regarding their support or lack thereof and what they might or might not get out of it all.

'Follow the money" continues to be a very useful insight-generating rule or at least a hint as to what rocks to look under.