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.

Monday, November 09, 2009

The very best comment regarding HR 3962

I am not surprised that the comment was offered by DrRich on his blog Covert Rationing. Here is his entire commentary and here is the great quote by James Madison regarding which DrRich reminds us:

“It will be of little avail to the people, that the laws are made by men of their own choice, if the laws be so voluminous that they cannot be read, or so incoherent that they cannot be understood…”
- The Federalist #62

Will the house and senate bills raise insurance premiums and actually decrease coverage?

According to Harvard economist Martin Feldstein they may well. See his article here. Here is how that could work.

If the monetary fine for not having insurance is less than the premiums on available insurance AND a person can get insurance AFTER a medical condition occurs, a rational strategy would seem to be to not insure yourself , pay the fine and wait until you need insurance and then buy some. Is this really a major flaw in the Pelosi bill ? Will this be a flaw that will defeat some of the purported purposes of the legislation?

Economists are fond are saying that economics is largely about incentives.If Dr. Feldstein is reporting the facts of the bill accurately and unless the bill somehow repeals human nature , it appears that one of the purported aims of the "reform",namely to insure [almost]everyone will not be achieved. He argues further as to what might happen as the number of insured actually decline:

But as the number of those who are currently insured declines, a future Congress might respond by increasing subsidies to middle- and upper-income individuals to buy private insurance. More likely, it would subsidize a public insurance company--whether or not such a public option is in the initial law--just as it now subsidizes Medicare in a way that was not contemplated when the Medicare program was created.

So, it seems even if there is no public option provision enacted now the consequences of certain other provisions will make it come to pass later on anyway. So, it is a flaw or a clever ploy?

Monday, November 02, 2009

Tight control blood sugar- Pendulum swings back a bit

A recent systematic review by Kelly et al in the Annals of Internal Medicine tackled the issue of glucose control and cardiovascular disease risk in type 2 diabetes.(Annals of Internal Medicine,15 September,2009,vol 151, no 6 p 384.) The authors found by combining data from 28,000 patients from 5 large randomized trial that there was an approximate 10% decrease in the risk for coronary heart disease (largely from decrease in non-fatal myocardial infarctions) but no overall effect on cardiovascular or all cause mortality.The authors' take on the situation is that since there is no apparent benefit from tight control in terms of overall mortality or cardiovascular disease mortality and the risk of serious hypoglycemia is real that the emphasis should be on total risk reduction in terms of optimal control of blood pressure and cholesterol and use of aspirin because in part those maneuvers have been shown to significantly reduce cvd and all-cause mortality.

In the last year, three studies have been published which seem to dash the hopes of those who hoped for a significant decrease in cardiovascular risk by tighter glucose control. Two trials ( ADVANCE and VADT showed no decrease in CV events with tighter control and one trial has even worse news.The ACCORD trial found an increased risk for CV deaths and total mortality in the group treated with intensive glucose control.(more comment on that trial below)

I thought it would be a good time to reprint a commentary I previously made on that general theme.
The following is a slightly re-edited version of comments I made two years ago.

How many evening diner,CMEoid sessions included the chant, "treat to goal,treat to goal" in regard to blood sugar. As with LDl cholesterol-the goal just kept getting lower and lower.

The DPPT study seemed to provide very good evidence that the microvascular complications of type 1 diabetes could be significantly mitigated by "good"control of blood sugar.Later a follow up report from that landmark trial also provided some reasonable evidence that perhaps macrovascular disease could also be decreased.

Many had hoped that we could accomplish the same reduction in the complications of type 2 diabetes by a similar surge of intensive treatment aimed at bringing about near normoglycemia. Would that life and disease and managing disease were so simple.

The DPPT was a fairly simple trial. There were patients with a disease that seems fairly homogeneous and has relatively straightforward pathophysiology ,i.e insulin lack from the clinical beginning and the treatment intervention was simply more insulin. On the other hand, the UKPDS trial involved several treatment arms and greater heterogeneity of comorbid conditions in the subjects as well as more variation in the the tempo of the various pathophysiological disturbances and the fact that the pathophysiology of type 2 is much more complex than in type 1 and is still being worked out, as exemplified by the recent surge of interest in the role and therapeutic manipulation of the incretin family in type 2.

With trials with more complicated conditions and multiple treatment arms there is greater likelihood of chance and confounding and various biases clouding the results. Clouded results or not the UKPDS became a major element in the argument to treat to lower blood glucose value in type 2 diabetes. The results of the UKPDS were not earth moving but were encouraging. There was some decrease in blood vessel disease on retinal exam and some decrease in the rate of progression of urinary protein leak but no change in renal failure or blindness or clinical manifestations of macrovascular disease. The benefit in terms of reduction of retinal microvascular and perhaps renal disease was arguably balanced by an almost four fold increase in serious hypoglycemia episodes ( 0.6% per year versus 2.3%). The former effect was emphasized and the later effect was not in the 2002 position paper from the American diabetes Association from which a lot of the enthusiasm for tight control arose.
Now fast forward to the ACCORD trial . Here is the announcement of the cancellation of the intensive treatment arm of this large randomized trial. This was supposed to be the trial that would answer-among other questions- the question "can we decrease the macrovascular events associated with type 2 diabetes with intensive blood glucose control ?" Here the treatment goal was a HbA1C of less than 6 %, i.e. basically normal.

However,there were more overall deaths in the intensive treatment arm than in the standard treatment arm. Of those intensively treated about 1/2 had hemoglobin A1C values of less than 6.4 while in the standard treatment arm 1/2 had value less than 7.5. The mortality increase was certainly not what the investigators likely expected.The overall death rate was reported as 20% higher but there were actually fewer heart attacks in the intensive treatment arm but of those there was a higher mortality. So what is happening to cause increase mortality? The NIH announced their analysis so far has not determined what factor(s) are to blame.

Is this simply a matter of getting the glucose too low? Maybe, but an early report from the trial claimed that the excess mortality was not related to hypoglycemia although there were expectedly more hypoglycemia episodes in the intensive treatment group. Although rosiglitazone's role in the disappointing results has been battered back and forth the authors of the current Annals review comment that rosi was more commnly used in the intensive arm than in the control arm of ACCORD.

Dr. RW suggested that excessive insulin use may really be the culprit though not necessarily by precipitating hypoglycemia episodes but by fueling weight gain and the metabolic syndrome and insulin resistance. Other suggestions have been made,see here for references, including the stress placed on patients to achieve a difficult therapeutic goal and the theory that too rapid decrease in blood glucose might have played a role.

Various commentators have had their say regarding this trial and some have attempted to give it a bit better spin,but deaths are not a surrogate measure and the major observation of more deaths with intensive treatment may well shift the momentum of diabetic treatment from "lower is better" to "well maybe not too low" and maybe " not necessarily the same target for everyone". A number of doctor bribe programs (A.K.A. pay for performance ) are keyed to hemoglobin A1C levels .Will we see those third party payers whose interests are claimed to be in improving quality of care quickly revise their guidelines?

Physicians want better treatments for their patients and they want results of promising treatments to be true. That desire to do good for their patients coupled with big pharma funded hype often aided by a shinny veneer pasted on by academic and other thought leaders can really energize therapeutic exuberance that may have a much less robust evidentiary base that we were lead to believe.Treating to a goal or treating the numbers can make clinical life seem simpler, sometimes too simple. Of course, an A1C target was just to handy for guideline writers to ignore.

It is a good thing we quasi- codified all some things into guidelines and pay-for-compliance programs otherwise we might not have had a chance to use them before we decided there weren't really a great idea after all. I remember as house officers we used to talk about the patient dying but the electrolytes were in balance but in those days our actions were not guideline driven.

The plan to decrease cardiovascular disease morality by tight blood glucose control may not have been completely abandoned at this juncture but it is hard to locate statements as enthusiastic as the 2002 ADA position paper.

The 2006 ADA position paper offers an approach to use of the hemoglobin A1C that seems reasonable and
and allows for more nuanced clinical judgment, so do the October, 2009 recommendations of the ACCE/ACE (see here.) Here is a quotes from their recent publication emphasizing the increased risk for patients with a longer history of diabetes and implying that one size for the hemoglobin A1C may not really fit everyone.

".....the risk of cardiac events
and death is more common in patients with hypoglycemic
episodes (and especially severe hypoglycemia) and that
the benefit-to-risk ratio decreases progressively with the
duration of diabetes, such that the use of intensive therapy
may be at least relatively contraindicated in patients with
a duration of diabetes longer than 12 years (VADT) (17).
The ACCORD study (15) also suggested that excessively
rapid or aggressive adjustment of therapy may be associated
with increased risk. The A1C levels show an excellent
correlation with the mean glucose level, but this relationship
is also affected by several other factors, such as
hemoglobinopathies, hemolytic anemias, varying rates of
individual glycation, genetics, and the variabilities of different
laboratory methods."