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.

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.

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.

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.

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.

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?

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."

The unintended (but not unexpected)consequences of the Baucus Bill

In a lengthy,somewhat complicated and IMO very reasonable analysis John Goodman plows through various scenarios that seem likely if/when the provisions of the Baucus bill take effect.Economics is largely about incentives and the bill is packed with incentives and penalties that companies and individuals will factor into their various decisions. In his commentary (see here) he takes the reader through a number of outcomes all of which have major consequences far beyond the feel-good purported aim of getting all ( well many) those folks out there some health insurance.

He discusses why there likely will be job loses, more contractor work,rising medical costs ( increased premiums,more out of pocket costs,unfunded state obligations), ultimately lower take home wages and harm to the middle class in a number of ways.Increased demand for care, no change in supply so wait times move higher and quality decreases even more . See here, for a NYT's commentary regarding the incentives and complications that will likely result from the Baucus bill's provisions.

Labeling and spin is important in political issues. The label "health care reform" implicitly promises the reader a change for the better. The current health care bill will change many things but little in Goodman's analysis or in the analysis offered in the NYT would be for the better. I have used the term health care deconstruction-reconstruction rather than reform.Reform is a word to spin whatever congress can cram into thousands of pages into a feel-good image.

Dr. Goodman's (PhD economics, Columbia) analysis seems to me on target about what is likely to happen after the bill's provisions go into effect. I would like to see an economist speculate on what strategies and tactics businesses in and outside of the health care complex will employ to minimize their loses and prepare as best they can for the several years down the road when the health care bill kicks in. One new growth industry is likely to be "consultants" who can advise business on how to live within the new health care environment.

Government run comparative effectiveness panel and regulatory capture - Fait Accompli?

Is the deck already stacked for a regulatory capture type scenario in regard to the government version of comparative effectiveness research panel? At least according to one bill it is. Read Dr. Roy Poses's account of what is in store and what sorts of folks will constitute the panel.

After noting that in the draft bill ( I don't know if there are provisions in other draft bills on not) that 6/25 of panel members will represent for-profit organizations , Dr. Poses continues:

We often discuss how clinical research sponsored by organizations with vested interest in the research turning out to favor their products or services may be manipulated to favor these interests, and sometimes suppressed if it does not. In the US, there are few unconflicted sources of sparse funds to support comparative effectiveness research.

...If the government is going to support comparative effectiveness research, it ought to make sure such research is not run by people with vested interests in the outcomes coming out a certain way.

"Making sure" that a government endeavor is not run or significantly influenced by interest groups may be not possible considering the strong, well practiced, very well funded lobbying capabilities of vested interests (Madison spoke of factions and hoped in vain that a republic versus a direct democracy would hold them at bay)) and the general inability ( or lack of desire) on the part of legislators to resist their efforts.

The composition of the CER panel is regulatory capture preemption at its best-writing into the bill a seat at the planning table for representatives of vested interests. Go to Dr. Poses commentary for details of the appointment and composition of the panel. Note this panel is not a government agency but it is appointed by government and its work product will greatly influence health care funding and ultimately decisions made by physicians and insurance companies.


"If the government is to tell big business men how to run their business, then don't you see that big business men have to get closer to the government even than they are now? Don't you see that they must capture the government, in order not to be restrained too much by it? Must capture the government? They have already captured it.".....Woodrow Wilson,1913

I welcome comments from those who expressed optimism and enthusiasm for government sponsored CER now that some of the details of how that will work are becoming available.

The "battle" over the public option-rope-a-dope or just a diversion

Mohamed Alli made the rope-a-dope (RAD) strategy famous by using it successfully against George Foreman and Joe Frazier. It consisted of leaning on the rope (and on the opponents) and covering the head and letting the opponent hit his arms and abdomen until they were exhausted and then Ali would take them out. (don't try this at home as it doesn't work that well for most other boxers).

More generally it has referred to a strategy whereby you make your enemies think you are losing and you are really not.

On to the public option. Many opponents believe that adoption of a public option will be the slippery road to government run health care and the single payer. We are seeing that the public option may not pass and that democrats are supposed to be fighting over it (the Republicans' dismal performance in the last election effectively disarmed them) and if it fails the country will be saved from government run health care. The inclusion of compulsory health insurance in all of the current bills already means government health care regardless of the outcome of the public option.

I maintain that adoption of employer and individual mandates and subsidies will constitute government medicine. Read Michael Cannon's essay on mandates (see here ) and the power implicit in the control over what type health insurance everyone must have and then see if you think the public option "controversy" really matters.

Maybe the public option contrived ruckus would be better characterized as Arnold Kling did :

... the debate over the "public option" in health reform also can be viewed as an exercise in symbolic politics and diversion. The point is to divert attention away from the bankruptcy of Medicare. (see here for his entire commentary)

And I would add diversion away from the mandates.

Health insurance mandates-An economist's argument that it is a bad idea

Much of the argument involving the health care deconstruction-reconstruction bills (misleadingly labeled as reform) that is reported and emphasized is the issue of the public option. A more fundamental issue, in my opinion, is found in the personal and employer mandates which seem to be slipping by with much less comment and discussion and concern than is warranted by the degree to which government will increase its control of every one's lives.Further,as has been so eloquently described and documented by Dr. Robert Higgs, once a government policy or program is put into place it almost never goes away or even pulls back a little bit.Public option or not the mandate (s) is/are a major government takeover of health care and a serious abrogation of individual freedom.

Tyler Cowen, a professor of economics at George Mason University, offers this detailed and cogent argument against the mandate from an economic point of view.Thomas Sowell talks about economic thinking as involving thinking "past stage one" and analyzing things not in terms of the hoped far results but in terms of the incentives and constraints that a given policy is likely to bring about. Cowen looks at the incentives that mandates and subsidies involve.

He points out that the mandate will result in lower wages, discusses "implicit marginal tax rate increase" and who will be hurt by that,the likelihood of "mandate creep", and the likelihood of continuing increasing cost of health care which will be exacerbated by the mandate. The issue of implicit marginal tax is discussed in detail here by another economist,Greg Mankiw from Harvard.

Cowen closes with these remarks:

We’re often told that America should copy the health care institutions of Western Europe. Yet we’re failing to copy the single most important lesson from those systems — namely, to put cost control first. Instead, we’re putting our foot on the gas pedal and ratcheting up the fiscal pressures on the system, in the hope that someday, somehow, it will all work out.

As it stands, we’re on the verge of enacting a policy that is due to explode, penalizing many of the very people that it was ostensibly designed to help.

The two economists speak of damage to the very groups the bills purport to help and collateral damage for most everyone else. I wonder how much effort has been made by the medical organizations (AMA, ACP and others)that seem to support much of what the current (five) bills contain to think past "stage one" and consider what incentives will be put into play under the rubric of reform.

Madison had it right when he said this over two hundred years ago:

"the old trick of turning every contingency into a resource for accumulating force in government." The massive increase in central government power, and control that these reform bills will bring about will happen with or without a public option.

Is medical fee for service the real villian or it is price controls?

I will argue that it is the price controls on the fees and not the fee-for-service (ffs) system per se.

The more popular argument is to the contrary. One example appeared recently in the NEJM,Oct 8,2009 edition in the "Perspective" section which featured a discussion about economics and health care reform. The comments of one of the participants seems typical. Dr. Elliot Fisher said in part ," Fee for service does not pay us to have long conversations with our patients.When we're feeling constrained, it is much harder for us to have the long conversation with patient with heart failure to see if we can manage them at home".

Fee for service once did pay us to have those longer conversations and offer longer history and physical exams when the fees were considered by the physicians to be adequate compensation . When I practiced in a fairly large group of internists ( circa the 1980s) most of us set aside one hour for new patients and 15-20 minutes for followup.Then CMS imposed wage and price controls and other third party payers typically followed the lead of CMS. This is the origin of the constraints of which Dr. Fisher speaks.

The price controls have worked as price controls have almost always everywhere.The quantify demanded increases, the quantity supplied decreases and quality of service diminishes.In econospeak, the demand curve slopes downwards and the supply curve slopes upwards.

FFS as currently constituted does not pay enough for physicians to spend the time previously spent with patients when fees were higher. To compensate physicians have decided to spend less time and thereby see more patients per day .Even with this, generally physician incomes are lower now than in the pre price control era when inflation is taken into account.

In these discussions, one jumps quickly to a fix-how to have a system that will rectify the defects of the flawed fee for service way of doing business, assuming away any argument counter to the assertion that FFS is to blame for the cost curve that is bent the wrong way.

One fix was suggested in the above referenced NEJM article-just pay one flat fee based somehow on a risk adjusted basis and on the quality and value of what they deliver. (as if quality and value are inherent characteristics such a weight or specific gravity) Enter from stage left the "accountable care organization", (ACO) which will save us from the FFS induced mess we are in now.

The ACO is the latest incarnation of a entity or mechanism that will do the wine for water trick for health care-improve quality and save money. Here is a brief discussion of the ACO from Kaiser Health News which, for some strange reason, reminded me of Will Roger's comment about boiling the oceans.

One of by two favorite EP cardiologist bloggers hit it solidly here when he said "

"Perhaps I'm too cynical, but I think the subliminal message coming from Washington so far is really this: doctors should be happy becoming salaried employees of larger health systems. This way, the government can pay the health system a bundled fee and the doctors can fight for their share of the kitty."

Health insurance in New York,study in the effects of community rating & guaranteed issue

This article in the Wall street Journal,Opinion, on line discusses how the mandating or community rating and guaranteed issue for health care insurance has worked out in New York state-in a word- badly.Here are two quotes from that article.

"A 2007 report by the respected Seattle-based actuarial consulting firm Milliman surveyed the damage. It noted that "by 1996 GI and CR requirements effectively eliminated the commercial individual indemnity market in New York." While the reforms were supposed to help keep insurance affordable, "premiums for the two [remaining] standard plans increased rapidly," with one researcher noting "insurers increased premium rates 35%-40% in this period."

Today, New York's private individual insurance market is among the nation's most expensive and highly regulated. New York City residents buying private, unsubsidized individual insurance coverage pay at least $9,036 a year for individual coverage and $26,460 for family coverage. New York's average premiums in the individual market are more than twice the national average, according to a 2007 eHealth Insurance survey."

OK, so it costs more , what about increasing the coverage?

"Today, 14% of New York's population lacks coverage, essentially the same as the national average of 15%"....."In 1994, about 4.5% (10.45 million) of the U.S. nonelderly population was covered by individual insurance. Today, that number has grown to 5.5% (14.35 million), a 20% increase."

The old saw about someone who continues to do the same thing and expect a different result is foolish may not apply to legislators. Maybe the Washington lawmakers know what will happen and believe the less than desirable results will move the U.S. closer to a single payer.

Article we really want to believe,ways to avoid dementia

Being physically and cognitively active and social engaged are suggested by this article as things you can do that might delay or even prevent dementia. Wouldn't it be nice to think so.The authors, writing in the Archives of Neurology, discuss other factors including diet and treatment of the usual suspect risk factors for vascular disease related dementia, such as treating cholesterol, BP etc.

I have blogged before about some of the observational studies that link higher levels of physical activity and protection from dementia.In that regard one has to mention "reverse causation". Do the seniors who have early dementia withdraw from various activities such as regular exercise? The Archive article does reference one interventional article which suggest benefits of exercise in folks who already have some cognitive decline.

Social engagement also seems to correlate with lower risk of dementia. But is a low level of social engagement merely an early sign of dementia rather than a modifiable risk factor?

In discussing exercise and brain function one has to at least mention the putative roles of two substances,ILGF and BDNF.

There some animal data suggesting that insulin-like growth factor I (ILGF) may have some neuroprotective effect and that exercise can increase ILGF levels.Also there is human data published from Japan linking lowered levels of ISGF to dementia and more carotid artery thickening.

Brain Derived Neurotrophic Factor (BDNF) as the name suggest is recognized as a substance capable, under certain conditions,of stimulating nerve cell growth and repair and exercise has been shown to increase levels of BNDF. Other animal data indicated that in rats the increased learning noted in exercising rats could be blocked by a substance (an immunoadhesin molecule) that inhibited BDNF uptake by the hippocampus.

In the early days of the jogging-aerobic craze ( that never went away- at least so far), runners would knowing say that they felt so good from running because of release of endorphins. Now runners can feel even more self satisfied by thinking about all those wonderful neurotrophic factors surging in their veins and brains and get all tingly as they envision benefits in terms of synaptic plasticity.

The Stabenow bill to abolish SGR,accounting trick and/or small payoff to the doctors?

Senator Debbie Stabenow has introduced a bill to abolish the dreaded SGR ( Sustainable growth rate) mechanism by which physician fees under Medicare were theoretically reduced every year to compensate for an overall increase in Medicare expenditures. "Theoretically" because typically at the last minute Congress responded to the annual humiliating begging of doctors to not really have the cut so none occurred. A 21% cut is due in January 2010. The bill will do away with the annual debacle of the only profession in the United States living under price controls coming to Washintton whinning and holding their breath until congress relented and did not enforce the reduction.

The Baucus bill ( or the vapor bill as skeptics call it) did not abolish the SGR and part of its alleged savings was to be the annual taking it out on the hides of doctors via SGR. This bill will also abolish those putative savings.Hence the reference in the title to the accounting trick. So one could vote for Baucus's savings with a wink knowing the savings would be vapor with the passage of Stabenow.

Of course, I favor doing away with the SGR;it was a terrible idea which was bound to self destruct or at least destroy medical practice as we once knew it.However, the basic price controls on physician's Medicare payments remains in place and periodically congress will threaten further cuts and off to Washington will the representatives of AMA,ACP,ACCP etc to to plead for more money.

Price controls almost always lead to 1)increased demand for the good or service,2) decreased supply of the good or service 3) poorer quality and 4) black markets. Since CMS put into place the price controls on physician's Medicare fees the first three have come to past and only number 4 is yet to be realized.The Stabenow bill, if passed,will help a little bit, but the problem remains.

Mayo Clinic's stand on Medicare and Medicaid-?Model for the country

This news item seems to show another side to Mayo Clinic who has received nothing but praise from some quarters regarding their reputation as a quality center who provides care for less.

From the news report:

Mayo announced late last week that its flagship facility in Rochester, Minn., will no longer accept Medicaid patients from Nebraska and Montana. The clinic draws patients from across the Midwest and West, but it will now accept Medicaid recipients only from Minnesota and the four states that border it. As it is, 5 percent of Mayo's patients in Rochester are on Medicaid, well below the average for other big teaching hospitals, and below the 29 percent rate at the other hospital in town.

The Washington Post article continues:

Separately, the Mayo branch in Arizona -- the third leg of the Mayo stool, with the Rochester clinic and one in Florida -- put out word a few days ago that under a two-year pilot program, it would no longer accept Medicare for patients seeking primary care at its Glendale facility. That facility, with 3,000 regular Medicare patients, will continue to see them for advanced care -- Mayo's specialty -- but those seeking primary care will need to pay an annual $250 fee, plus fees of $175 to $400 per visit.

I would not having good standing to criticize their refusing some Medicaid patients,I did the same thing in my practice as did most of my partners. I am puzzled how they can charge more to Medicare Patients seeking primary care.I thought if you "accepted" Medicare patients you agreed to their payment schedule and could not bill for the balance.

Mayo has been held up as a model for high quality, efficient health care but what sort of model is it that is moving to see fewer Medicare patients? What will their stance regarding the public option patients be (should there even be a public option)?

One more time, again,How is the Health Care refrom in Massachusetts working out?

How many times have we heard the refrain "If you are happy with your health care plan you can keep it"? Well, we'll see what happens with the national health care overhaul but the Massachusetts plan sounds a lot like what the current health "reform" bills pending in Congress offer and here is one story of how a family kept their old plan but had to pay a fine to do it.

They had the choice of going with the state plan or paying a fine because the plan their had (a plan from IBM from which the husband had retried) did not meet the requirements of an acceptable or approved plan ,such approval coming from the wise oversight of the state regulators.

Here is part of the story as told by the wife and quoted in the WSJ:

For the first two years of the mandate, our IBM health insurance was seen as acceptable in the eyes of the state. This year the rules changed. The state requires that health plans cap out-of-pocket expenses for individuals (not including monthly premiums) at $2,000 a year. Our plan's cap is $2,500.

Ten years ago, we had excellent coverage through a more gold-plated plan. But we found that it was no longer worth paying the premiums and scaled back to a more modest policy. Today, we pay about $300 a month for catastrophic care. If we went with the next step up in plans offered to us by IBM, our monthly premium would increase to $800. We simply don't need to pay that kind of money for the amount of health care we actually consume.

Nonetheless, we now owe the state an extra $1,000. Ironically, that's about the extra amount we would pay out-of-pocket under our current plan if both of us actually fell ill in the same year.

From the description of this couple's economic circumstances it seems clear than they are likely not earning over $250,000 a year.

Another campaign promise often repeated after the election was/is that there will be no increase in taxes for people earning less than $250.000/yr . I have commented before that in the Baucus bill there are provisions that in effect raise the marginal tax on folks quite a bit below the 250 k level. A Harvard economist takes up that issue here in his commentary entitled " Marginal Tax Rates from Health Reform".

The WSJ story family is not hammered by the type of implicit tax planned for those folks who attempt to move out of the lower level of earned income but the fine they pay is just as real.

The Institute of Medicine tell us that there are five criteria that should be used to judge the adequacy of a health care plan. Here is how the Massachusetts stacks up in that context as seen by a commentary in the Boston Globe by a Massachusetts physician.

Evidence based health care policy? an oxymoron?

If you consider the problem to be "some folks are unable to obtain health insurance"because of bad health, then you might want to pass a law to increase access to health insurance that 1) makes an insurance company take all comers ( guaranteed issue ) and 2) prohibits insurance companies from charging more for higher health risk policy holders (community rating ). How well that works out in states that have done those things is explained in this WSJ article.

The highlighted case in that of New York state which mandated these two magic bullets in 1993. Over a several year period the number of insured, non-elderly people with private ( not group) insurance decreased from 4.7% to 0.2% while states without these two insurance regulatory provisions increased a bit from 4.5 % to 5.5%. This seems to have happened because insurance companies raised the premiums to counteract potential losses brought about by these two provisions in their underwriting patterns and as premiums rose , fewer folks bought policies.

This would appear to conform with the economics 101 notion that as prices of a good or service increases (other things being equal) the quantity demand decreases.

To battle this pesky downward sloping demand curve policy makers might respond with a third provision-simply force every one to buy insurance ( individual mandate) and if they can't afford it give them a government subsidy to pay for the premium. By doing that it is hoped that by adding many more healthy folks to the insurance pool (hopefully many of the healthy young who still consider themselves to be bulletproof) the insurance companies would make up any loss brought about by the first 2 provisions.

We can now look at this quasi experiment as it played out in Massachusetts after it enacted all three provisions namely 1)guaranteed issue,2)community rating and 3)individual mandate which are important elements in the proposed health care reforms bill pending in Congress. The WSJ puts it this way in regard to the question did the mandate fix the problem:

The experience of Massachusetts, which implemented an individual mandate in 2007, suggests otherwise. Health-insurance premiums in the Bay State have risen significantly faster than the national average, according to the Commonwealth Fund, a nonprofit health foundation. At an average of $13,788, the state's family plans are now the nation's most expensive. Meanwhile, insurance companies are planning additional double-digit hikes, "prompting many employers to reduce benefits and shift additional costs to workers" according to the Boston Globe.

And health-care costs have continued to grow rapidly. According to a Rand Corporation study this year, the growth now exceeds state GDP by 8%. The Boston Globe recently reported that state health-insurance commissioners are now worried that medical spending could push both employers and patients into bankruptcy, and may even threaten the system's continued existence.

So higher premiums anyway and probably higher premiums in the future plus longer waits to see physicians and the concern that they program go broke.

Maine put into place a plan similar to some of the current proposed public options in 1993 under the interesting name "Dirigochoice" and as reported by the WSJ so far there has been little or no change in the percent of uninsured citizens (about 10%) and an increase in premiums.A recent report suggests the program is on life support and the tubes may be pulled.

When the canary in the coal mine,which was sent down to see the air was safe, keeled over, the proper response was not " well maybe it will be all right for the miners".That seems to be the thinking of many legislators, at least to the extent they actually believe their own rhetoric as they push to go national with something very similar to the Massachusetts Plan.

Health care "reform" will help the poor-maybe not

The blog "Diagnosis", which is one of three blogs connected the New Atlantis.com, offers a detailed analysis of the effect of a proposed health care bill ( the Baucus bill) on the level of poor people just above the lowest level. The author is James C. Capretta. See here for that commentary.

As Capretta explains as a family moves from the lowest category to the next ( slight higher) run of the economic income ladder they loose a major portion of the government subsidy which is offered to help pay for the the health insurance the government is forcing them to buy.Here is a quote from that article detailed what is in effect an "implicit marginal tax" of no small proportion:

"According to CBO, family coverage in 2016 is likely to cost about $14,400 under the so-called “silver option” in the health-care reform plan sponsored by Senate Finance Committee Chairman Max Baucus. In the Baucus plan, a family of four at the poverty line (about $24,000 in 2016) would have pay to about $1,400 toward coverage, with the federal government paying the other $13,000 on their behalf. In addition, the government would also provide $3,500 to reduce the family’s deductible and co-payment costs for health services. Thus, the new entitlement provided by the Baucus bill would be worth a whopping $16,500 for a family at the poverty line.

As incomes rise, however, the Baucus bill cuts the value of the entitlement. A family with an income at twice the poverty line, or $48,000 in 2016, would get $9,072 in federal assistance for coverage — still a substantial sum. But it’s $7,400 less than the family would get if they earned half as much. The Baucus plan thus imposes an implicit marginal tax rate of about 30 percent ($7,400/$24,000) on wages earned by families in this income range."

Of course,no one knows what the final bill will contain but the possibility of grotesque unintended consequences such as the one suggested by Mr. Capetta is a strong reason for there to be adequate time for all sides to know exactly what will be voted on and not have some massive hodgepodge of provisions rushed through Congress. The recent proposal to have whatever the bill turns out to be posted for 72 hours on the web is a step in the right direction but so far democratic party leadership is less than enthusiastic so passage is more than a bit problematic.

Blame it on the fat people and penalize them if they don't shape up

The health care crisis is increasingly being blamed on folks with bad health habits and particularly the obese. Nothing seems outside of the wake of destruction brought about by the "intentionally unhealthy", including -but not limited to-the health care cost curve that is bent in the wrong direction,the economic downturn and global warming.

Fortunately, we have wise, well informed senators who are going to do something about it. They will allow and seemingly encourage companies to use economic punishments on those employees with bad health habits. Junkfood Science tells us about here.

The notion that preventive (which is increasingly spelled preventative) medicine will save money seems so intuitively obvious that it is widely accepted in spite of little evidence that it is true and much to suggest it is not.See here for Charles Krauthammer's commentary of how prevention really does not save money.

There are a number of excellent commentaries and critiques of the evidence that claim to link obesity to most of what is wrong with the nation's health. Megan McArdle has much to say about that and here she discusses some of the aspects with Paul Campos, author of The Obesity Myth.Sandy Szwarc,in her blog Junkfood Science has an excellent series about the "Obesity Paradox".See here for the first of that series.

It is predictable that corporate human resource departments and others will jump on the idea of penalizing employees who are not team players and stubbornly refuse to meet such health goal targets as cholesterol , weight loss, participation in exercise programs.Some companies are already ahead of that curve even to the point of testing employees to see if they really have quite smoking.

A number of years ago I was consulting with the medical department of a large corporation who was hosting a vendor giving their pitch for a wellness program that was supposed to save on medical costs for this company which was self insured. At some point someone asked but if we keep the employees healthy longer won't we have the cost of paying folks their pensions for a longer time.

Another reason for internists to not participate in Medicare-Medicare Recovery Audits

The Medical Recovery Audits system has designated various contractors to execute this program to audit physician's practices searching for errors and overcharging.See here for CMS 's description of what is in store and what has happened so far with this program.

The auditors will use Part B claims data to identify what they will decide are underpayments and overpayments (don't expect to find a lot of those). Medical records will be "requested" from physicians. They will be looking for noncovered/unnecessary services,incorrect coding,insufficient documentation and duplication of services.

The auditors will be compensated on a contingency basis-the more problems they find the more money they make.This bounty hunting program will be costly to physicians even if they are not audited and even if no problems are found.The time spent preparing for a possible audit will be costly in office staff time and physician time taken away from the actual practice of medicine.

This is happening now and we can look forward to a new program proposed in the Baucus bill for penalties for "outlier physicians" in which the top 10% of "resource user" physicians will be penalized without regard to the patient mix or any other potential explanatory factor. Every year there will be some 10% penalized.

Meanwhile,none of the proposed health care deconstruction-reconstruction bills will do away with the draconian SGR with its built in ratcheting down of physician payments. The specter of ever decreasing Medicare payments, more auditing hassles and the overarching and recurrent uncertainty of what Congress and/or CMS will do next as well as the decreasing satisfaction of the officist practice of internal medicine makes me wonder why anyone would op to do training as a general internist.

We cannot trust drug company studies so we need a government panel,one that is not biased

I read the medical blog "The Last Psychiatrist" (TLP) regularly.Sometimes I think I understand it.I keep going back because at some level I just know he has a lot to say even if some(much) of it escapes me.

In this entry (see here) he takes on a recent commentary by Dr. Daniel Carlat.Dr Carlat gained some degree of name recognition when he renounced his lucrative life as a drug company paid speaker and has become an outspoken critic of many of the drug companies practices including those involving paid physician spokesmen.

TLP quotes Carlat making the point that people respond to incentives and with financial incentives at work how can you trust someone's analysis of the value of a given medication.How can you trust what a drug company's research or spokesman says?

Here is the passage from The Last Psychiatrist that really nails it: (my bolding)

This is the same error people make about the need for government intervention, e.g. that the "free markets" have failed and more regulation is obviously needed. Even if one were to agree on principle that people can't be trusted, the mistake is in forgetting that government is people. These people are subject to the same biases, cognitive errors and general prejudices as the guys at Goldman Sachs, albeit currently it in the opposite direction. We can argue that we prefer the government's biases, but one cannot argue that the government is less biased, self serving, or corruptible.

This may originally have been a country of laws, not men, but that's not the country most modern people want; they want to be able to alter the laws to suit the times. Fine, it's your country. But understand that if the laws are subordinate to men, then the enforcers of those laws will always have more power than you. Has anyone tried to get an anti-Depakote study published in J Clin Psych in the past decade?

It's excellent that Daniel Carlat thinks doctors like himself cannot be trusted to read and interpret their own studies, and that some other group of-- doctors? lawyers? what?-- with special bias-immunity rings need to be assembled to protect us. But those people are still people. This is why the NIH, with their incestuous grant reviewers, crazy politics and flavors of the decade philosophies is so dangerous-- they're just as biased as Pfizer except you think they are objective.

He captures the basic thoughts of the "Public Choice" school of thought. The people who comprise the government are just like the people not of the government in that they too are biased,self-serving and corruptible and respond to incentives and constraints just like everyone else.

His closing paragraph make it clear

People would do well to remember that at one point in our nation's history, "government" was George Bush. When you argue that government needs to be more involved, you are arguing that George Bush needs to be more involved. I do not trivialize this discussion by offering Barack Obama as an equivalent example of the government you want so desperately to supervise your lives.

See what Baucus bill has to offer in 2015 (just one little part)

A very grateful tip of the hat to Health Care Renewal for information about one of the things that lies in store after the next presidential election in regard to payment to the likely-to- be- far- fewer- physicians who are still seeing medicare patients. See here.

Page 80-81 of the Baucus bill has the following:

"Beginning in 2015, payment [under Medicare] would be reduced by five percent if an aggregation of the physician's resource use is at or above the 90th percentile of national utilization." Thus, in any year in which a particular doctor's average per-patient Medicare costs are in the top 10 percent in the nation, the feds will cut the doctor's payments by 5 percent."

The Washington Times (see here) has this to say:

This provision makes no account for the results of care, its quality or even its efficiency. It just says that if a doctor authorizes expensive care, no matter how successfully, the government will punish him by scrimping on what already is a low reimbursement rate for treating Medicare patients. The incentive, therefore, is for the doctor always to provide less care for his patients for fear of having his payments docked. And because no doctor will know who falls in the top 10 percent until year's end, or what total average costs will break the 10 percent threshold, the pressure will be intense to withhold care, and withhold care again, and then withhold it some more. Or at least to prescribe cheaper care, no matter how much less effective, in order to avoid the penalties.

This proposal is just another in the long list of "perverse incentives" that John Goodman speaks of here. This is another example of a situation in which the interests of the physician will be pitted against the best interest of the patient. In a way the proposed provision is blatantly straight forward; its aim is to save money and to do so without pretending that there will be an increase in quality plus there will always be 10% of docs who will have their fees reduced.

PPIs blunt effect of clopidogrel-yes they do,no they don't

Patients and physicians alike had to be a bit worried when this study suggested that PPIs decrease the efficacy of clopidogrel and could lead to more cardiovascular events. But the story continues and the results of the COGENT study discussed here said "no" : presumably offering some reassurance that the putative PPI inhibition of the desired beneficial pharmacological effect of clopidogrel is not really a problem.

What if the articles were published in reverse order?

Does the fact that COGENT was a randomized trial with placebo versus omeprazole in patients on clopidogrel and the Medco data study was more of a data dredge mean that we have no need to worry? Or does the fact that the COGENT trial was stopped ( the sponsor,Cogentus, filed for bankruptcy) before the planned number of patients were enrolled limit the power of the trial to find a real difference mean that we should question how much we should really be reassured? Can anyone tell me if the prematurely stopped COGENT trial was adequately powered to show a difference as great as that reported in the Medco study?

The villian is fee for service-of that we can all agree?

Health care costs too much and it will cost more and we are told that a major cause of this is the fee for service system (apparently obesity is the other cause) that rewards volume and not quality.So to bend the cost curve ( I presume they mean bend it downward),we must do away with physician fee for service and pay for quality. Quality is nebulous and floating and if Congress has its way the definition will be whatever the secretary of HHS says it.

What does this really mean?

I think Dr. Wes nails it cleanly here when he says"

"Perhaps I'm too cynical, but I think the subliminal message coming from Washington so far is really this: doctors should be happy becoming salaried employees of larger health systems. This way, the government can pay the health system a bundled fee and the doctors can fight for their share of the kitty."

The larger health care systems, the vertically integrated systems, that some allege will save us from the old-fashioned and very harmful fee for service is a topic that I spent some effort ranting about two years ago.
see here. Not only will it save money but it will further the ubergoal of social justice. Those systems offer a chance to employ the utilitarian ethics to the cost curve bending exercise.

Dr. Richard Cooper's views get aired on major economic blog

Arnold Kling is one of the economists whose blogs I have begun to read lately ( lately being since the stock market tanking in 2008 scared the heck out of me ) In this entry he gives well deserved blog time to the thoughts of Dr. Richard Cooper who- is among other things (quite a few other things)-an outspoken and well spoken critic of the Dartmouth studies on regional variation in Medicare expenditures, a study that Mr. Peter Orszag and others in the Obama administration seemed to have taken as gospel truth.

Dr. Cooper points out several flaws in the widely quoted Dartmouth studies and their conclusions and the purported remedies based on that work. I have blogged about Dr. Cooper's views before. He argues , in part, that just looking at Medicare expenditures, which is what Dartmouth did, gives a false impression of what is really going on. One should examine total costs and when one does a different picture emerges, one in which more expenditures does correlate with better outcomes which is certainly a conclusion more consistent with common experience.

So what do tires and a tariff on Chinese tires have to do with health care?

The United States has moved to impose a tariff on imported tires from China.See here for WSJ article.

With the stock market swoon of 2008 and dire predictions of another great depression blaring from just about every "news" source and while I watched some significant percent of my retirement assets drop, I morbidly began to try and educate myself about the great depression. One thing I learned was that tariffs are not a good thing from an economic point of view.

While admittedly much ( but not all ) of what I read was more to the Austrian and Monetarist economic sides of the aisle there seemed to be agreement about at least two factors that took a severe recession and made it great; monetary actions of the Federal Reserve in reducing the money supply and the Smoot-Hawley tariff.

As best I can tell, economists of almost every stripe agree that free trade is a good thing and tariffs are not. A tariff is a tax on imports. The following is a quote from a text book on Macroeconomics by Paul Krugman and Robin Wells. Dr. Krugman has made it very clear than he is not of the Austrian School of economics and seems to be more in agreement with at least some of what Keynes said.

[A tariff] raises the domestic price above the world price,leading to a fall in trade and domestic consumption and an increase in domestic production. Domestic producers and the government gain , but domestic consumer loses more than offset the gain leading to a dead weight loss. ("Dead weight loss" is a term of art in economic circles and you can read about here without a graph or here replete with a graph and cogent comments by a real economist-Dr.Mark Perry of University Of Michigan- who discusses the issue in the context of the recently imposed tariff.)

Since the President has access to a number of highly educated and intelligent economists who would, if asked, would be likely to tell him that from an economic of view a tariff is not a good thing to impose,it seems unlikely his actions are being done in a belief that it will the economy. Perhaps political motivations are more likely.What could that be?

The United Steelworkers union supports the action. Could the tariff move be another gift to the unions from which the Obama administration might reasonably expect support for their health care reconstruction plans, particularly in regard to putting pressure on the Blue Dog Democrats who may have reason to worry about reelection and whose vote may be crucial to the health care bill passage.

Is Roflumilast the next drug for obstructive lung disease?

The answer seems to be a firm "maybe".

Remember aminophylline.Once a mainstay in the treatment of asthma and COPD exacerbations as well for longer term therapy in the form of various oral preparations, it now generally considered a third line medications almost about as likely to be used as the 12th man on the NBA bench in a close game.

Interestingly, one of the purported ways that aminophylline was thought to exert a therapeutic effect was its inhibition of PDE3 and PDE4. Now a new drug, roflumilast, is being studied to treat obstructive pulmonary diseases is also a phosphodiesterase inhibitor.

Recently four phase 3 clinical trials were published in the Lancet.See here for a brief summary.

The four trials involved 4500 patients;two lasted six months and two for one year. A decrease in exacerbations was shown as was a slight increase in some parameters of lung function.These statistically significant outcomes occurred in patients who were already taking a long acting beta agonist or an anticholinergic ( Tiotropium). Nausea was the most common side effect.

Why are placebos thought to be getting stronger?

I read the blog Wired from time to time to make some slight attempt to keep up with really cool innovations and products in the land of the wired.In doing so I came across an excellent essay on placebos. See here .

Here is one sample from the article:

"Two comprehensive analyses of antidepressant trials have uncovered a dramatic increase in placebo response since the 1980s. One estimated that the so-called effect size (a measure of statistical significance) in placebo groups had nearly doubled over that time." [Unfortunately, no references are given in the article].

If the placebo effect is getting stronger, why would that be?

One thought is that the direct to consumer drug company advertising has had effect(s) greater than simply promoting sales for a given medication.Perhaps it could generate greater belief in the effectiveness of pills in general which has stirred up a greater expectation of something good happening to people who take medications.Drug company advertising is just one force pointing in that direction;so do the activities of various disease promotion organizations (some of which are thought by some cynics to really be put-up jobs by the drug companies) and the general trend that seems to make almost everything a medical problem.

The "expectation effect" is a topic of relevance to the placebo effect. A patient can expect the announced beneficial effect of a pill and this has been shown in some experimental settings to increase the release of endogenous opioids. This article from Scientific American gives some detail and background regarding this issue.Areas of the brain that deal with weighting of events and threats seem to be activated by placebo through this mechanism of anticipation. Some studies have indicated that subjects who sign up a drug study may experience beneficial effect even while they are put on the waiting list.

Harriet Hall offers a detailed discussion of various issues related to the placebo effect here in the May 20th 2009 issue of the blog "Skeptic".

She outlines 4 possible ways placebo might work;

1.Expectation
2.Motivation (folks want to get better and often sign up for clinical trials)
3.Conditioning ( maybe all of us have become somewhat conditioned to believing pills make us better is in no small measure due to the effect of drug company and disease promotion groups advertising )
4.release of feel good substances such as endogenous opioids.

Do resident work hour restrictions transform professionals to shift workers?

The answer according to Dr. John D. Rybock,from Johns Hopkins School of Medicine, is "yes". Dr. Rybock in a letter to the editor published in the August 27,2009 issue expresses the opinion that the duty-hour rules of 2003 have "taken away their(residents) control" and prevent them from making decisions that characterize a professional.

In regard to limiting work hours he says:
"We now force them to leave a patient with whose treatment they are intimately involved or to cease the observation of an instructive surgical procedure midstream.It did not take long for this system to produce residents who would either walk away when their time" had expired or else lie in order to violate the rules.Although we added "professionalism" as a training goal, we began giving our trainees the choice between abandoning a patient and lying."

As pointed out in another letter to the editor in the same issue of NEJM: It has now been six years since the implementation of the 2003 ACGME regulations and there still is no consensus or clear cut evidence on whether the work-duty hours changes have improved safety and the debate continues on the effect on residents' medical education.

I continue to be amazed at how much impact the pronouncements of the IOM have and how there seems to be so little questioning and criticism of their recommendations.The IOM recommendations regarding further limitation of work hours seems to be taken seriously by ACGME.

An editorial in the NEJM presented the voice of reason.(Blanchard,MS, et al, To nap or not to Nap.Residents' work hour revisted .NEJM 2009,360,2242-4). That editorial recommended careful studies on the impact on the new IOM recommendations regarding patient safety and other relevant end points before widespread implementation of further restrictions.

Closer and closer to a new oral anticoagulant (dabigatran)

Actually, there already is a new oral anticoagulant available in Europe and Canada at least for the application of clot prophylaxis in hip and knee surgery patients.Dabigatran is an oral direct thrombin inhibitor that is taken twice a day and requires no blood test monitoring .In Canada, the trade name is Pradax and in Europe,Pradaxa.


Data from the large RELY trial were presented in Barcelona in August 2009. Some details can be found here and the entire article is available on the NEJM web site for free.

18,000 patients with non-valvular atrial fibrillation were randomized into three groups:warfarin titrated to an INR of 2-3, dabigatran 110 mg twice a day and 150 mg twice a day.The lower dabigatran does was associated with a slightly lower rate of bleeding while the higher dose and warfarin had similar rates. With a median followup of 2 years there was no increase in abnormal liver function tests in either dabigatran group.

Liver function test is an important issue as an earlier another oral thrombin inhibitor (ximelagatran) was withdrawn from the market after it had been approved in several European countries because of liver problems.

One possible bump in the road to FDA approval is the finding of a small increase in heart attacks in both dabigatran groups. I can't guess how an anticoagulant could cause an increase in heart attacks but perhaps warfarin is better at reducing risk of myocardial infarctions. Even so, with the battles and bad press that the FDA has had in recent years with real or purported increase risk of myocardial infarctions with certain prescription drugs an anticipated 2010 approval might be overly optimistic.

Now for something complety different-we should spend more on health care

"We are not spending enough of health care" is the point made by economist Mark Perry (economist at the University of Michigan) and the WSJ. See here for Dr. Perry's blog and see here for the WSJ article by Craig Karpel.

Here are some snippets:

The 2.4 trillion spent on health care in the United States is not buried in the ground but paid to other Americans.One man's cost is another man's stream of income. This is a basic economic fact that we take for granted in every area except in health care. I believe Uwe Rheinhardt asked the question "Why is it good when someone buys a car but bad when they buy medicine?" I guess part of the answer maybe because so much of the latter is paid for by the government.

In the midst of what some have labeled "the great recession" while hundred of thousands of jobs were lost the health care section actually added jobs to the tune of 19,000 in July 2009.

About 400,000 non US residents came to the US for health care in 2008.

Economists Robert E. Hall and Charles Jones wrote the following in a 2007 article that examined the "optimal health care spending" in the U.S." (my bolding)

"Viewed from every angle, our results support the proposition that both historical and future increases in the health spending share are desirable. . . . [W]e believe it likely that maximizing social welfare in the United States will require the development of institutions that are consistent with spending 30 percent or more of GDP on health by the middle of the century." ( quote is from the WSJ article, I don't have the original citation)

Ambiguity in Legislative language in HR 3200 may be there for a reason

Everyone with any interest in the proposed health care legislation should go here to read DrRich's latest blog entry in which he tell us what the ambiguity in the house bill is really all about.

I have blogged briefly before on the ambiguity and cognitively impenetrable nature of HR 3200 and suggested that is was not due to ineptitude of the authors of the bill and their inability to clearly put in words what they were proposing. As DrRich points out it is ambiguous for a reason.

The reason is that the lack of meaning will be supplied by the rule making processes of the various government agencies and this will be an unending process as opposed to a one time rule setting.

Ambiguity is a topic that has been discussed from time to time in the law journals. See here for a recent article from the Stanford Law Review.

Legal scholars talk about the willful insertion of ambiguous language into statutes as opposed to the inadvertent insertion of ambiguity. The first category sometimes is used to effect a compromise between opposing factions of a legislative body.In other cases the lack of clarity leads to interpretation (or more accurately definition) by an administrative or regulatory agency which could be the real reason for the ambiguity at least in some instances.

If a proposed statute is so ambiguous that its meaning cannot be determined by careful reading of the statutory language then public support or public denunciation of the proposal will likely turn on the rhetorical expertise and the persuasive power of the opponents to fabricate catch phrases and sell them to the public.

In regard to house bill 3200 DrRich's point is that no one knows what the specific effects of passage will be because as written the bill is without operational meaning and that will be supplied by government technocrats after the bill is passed and signed into law.

Here is how Dr.Rich summarizes it:

"This is legislation designed to create a legal framework under which huge cadres of unelected, politically-appointed policy mavens and bureaucrats will determine - by publishing hundreds of thousands of pages of regulations, rules, and guidelines - what our new healthcare system will look like. And until those regulations and guidelines are actually created - and this “creation” will be a never-ending process rather than an act - anybody claiming to know the precise nature of our new healthcare system under HR 3200 is engaging in one of the following: lying, projecting one’s own wishful thinking, or extrapolating on the perceived behaviors and beliefs of those who (one surmises) will finally get to make up all the rules."

I can't say it any better than that.

Who benefits from the world class ambiguity of section 1233 of House Health Care bill ?

Does section 1233 ( of the current version of the House bill dealing with Health Care "reform") make end of life counseling mandatory or voluntary or does the section's multi-layered and seemingly un-dissectable ambiguity enable the Secretary of HHS to determine what it "really means"?

Dr.RW discusses aspects of this general issue here quoting two sources with significant insight content from Kathleen Parker and Wesley Smith. Smith's quote is particularly noteworthy;

The bill might not create punishments [ in regard to quality measurement that the Secretary may enact concerning physicians who fail to counsel] , but the regulations that would be created in the shadows outside the direct democratic process could.

So the question arises is the bill written is such a way as no one really knows what it means which in turn raises the question "Are the bill's authors (whoever they are) merely bad at statute composition and are unable to clearly delineate what is to become law or is the ambiguity really quite artfully, purposely inserted so that HHS technocrats can do pretty much what they want"?

In another posting Dr. RW offers this comment:

Although a good palliative care service can save an institution money its focus is on what's best for the individual patient. Sometimes those goals are in conflict, sometimes not, but an excellent palliative care team will manage the conflict appropriately by putting the individual patient first, no matter the impact on the medical commons. When an end of life counseling provision is part of a bill with a clear agenda to control costs some degree of skepticism is appropriate.

How many other sections of the House bill suffer (or benefit) from this same type of opaque wording?

One more time, so how is the Massachusetts health care plan working?

Here is one view offered by one of my favorite economists, Arnold Kling. Some proponents of certain elements of the administration's health care reform plan ( really the Democrats House of Representatives plan) amazingly claim that the plan for Mass-care is working just fine and would serve well as an example of what should be done on a national level

As Kling explains: ( the italics were added by me):

So, the reform is "working" by mandating a shift in compensation from take-home pay to health insurance ( i.e forcing employers to offer insurance) and by draining money from the Federal taxpayers ( yes, the federal government is bailing them out)

In sum, the plan costs much more than projected, waiting times for physician appointments have skyrocketed, and the Federal Government is having to help pay for it . Who will pay for the cost overruns if and when a similar plan is put into place for the entire country?