Section 10320 of PPACA,let me be perfectly clear

Section 10320 of PPACA says the following with my bolding:

An 18-member “Independent Payment Advisory Board” [Sec. 10320(b)] is given the duty, on January 15, 2015 and every two years thereafter, with regard to private health care, to make “recommendations to slow the growth in national health expenditures . . . that the Secretary [of Health and Human Services] or other Federal agencies can implement administratively” [Section 10320(a)(5)(o)(1)(A)]. In turn, the Secretary of Health and Human Services is empowered to impose “quality” AND “efficiency” measures [Section 10304] on health care providers (including hospices, ambulatory surgical centers, rehabilitation facilities, home health agencies, physicians and hospitals) [Section 3014(a) adding Social Security Act Section 1890(b)(7)(B)(I)] which must report on their compliance.

Note the words, "impose" and "must report",how advisory is that?

If that paragraph would not encourage an older physician to plan retirement for 2014, I don't know what would.

Note who is covered-everyone.There may be a loophole for some things but this essentially puts all practitioners, hospitals and all in between at the mercy of whatever the IPAB says and the Secretary of HHS wants to do, imposition wise.

The IPAB is what the IMAB morphs into in 2015. Remember we were reassured that the IPAB will give advice and not control the practice of medicine. What it changes into will have incredible power of what physicians have to do and what they can't do.

The next time you hear a proponent of the health care bill dismiss the charge that is a take-over of medical care, refer them to that section.

Ironic example of the unintended consequences of the health care bill

Could the Congress in their rush to pass something they could call health care reform backfire in a small way? Maybe so. See this from the NYT. The bill may disallow the current members of Congress from their current health care coverage and more likely will not allow new members ( those not elected yet) from enjoying the coverage their plan offers.

Then again surely Congress could fix this by more legislation or some other procedural slight of hand.Interestingly, the section of the bill that is at issue seems to be worded in such a muddled up way as to make it unclear how to enforce it if at all.

The Congressional Research Office (see here for who they are) seem to exist in part to help congress figure out actually what they pass really means was unable to do so in this instance so badly constructed was this section of the bill. If they could not get the section of the bill that directly affected them right........

The CRO said this in a 8,100 word memo.

“This omission, [ how to resolve ambiguities in the statute] whether intentional or inadvertent, raises questions regarding interpretation and implementation that cannot be definitively resolved by the Congressional Research Service,” the report says. “The statute does not appear to be self-executing, but rather seems to require an administrating or implementing authority that is not specifically provided for by the statutory text.”

I guess the CRO will have lots to do if and when they attempt to see what sense the rest of the 2100 page bill makes.

Transactional politics,the public good,social justice and the health care bill

A recent commentary by Bob Doherty,lobbyist for the American College of Physicians (ACP), included remarks critical of what some consider a growing trend in world of national politics and legislation,a phenomenon described as "transactional politics". These remarks appear as part of a reply to and a defense against some comments that he has received on his blog from internists who have expressed dissatisfaction with the ACP position of support for the recently passed health care bill.

Transactional politics ( "TP" for short) essentially means the horse trading that goes on with one group promising to do this for someone if someone does that for them. We are talking about getting votes to favor one group or another by promising something, such promise usually to involve voting .Basically vote for me and I will do this (give you health care,give you clean air, whatever).

Some have contrasted TP with another concept with the same initials , "transformational politics" which means the situation in which one acts to further the general good even if they may have to make some sacrifices themselves. In general, progressives typically believe, or claim at least,that they act in the public good so they are frequently transforming or trying to at least.

Doherty defends the ACP and their role in the health care debate by saying while the bill doesn't contain everything that physicians (including the ACP leadership) want but after all they are not a labor union and their motives include not only the interests of the physicians but of the patient and the common good. In short, they are acting in the public good. So while we didn't get everything we wanted we acted in the public interest and for the common good, with the implied contrast with other groups who lobby for their own focused self interest.

He quotes from the ACP's mission statement:

the principal goal is "To advocate responsible positions on individual health and on public policy relating to health care for the benefit of the public, our patients, the medical profession, and our members."

The message seems to be that the ACP is not engaging in transaction politics but they are working for the benefit of the public. I wonder what qualifies the ACP to make that claim while some other lobbyists are just doing venal transactional politics?

When is the last time a politician or a lobbyist favored a bill that he did not characterize as being in the public good or public interest.The words "public good" have largely replaced the words "God's Will" in the discourse surrounding advocacy for or against one thing or another. Preachers on both sides of the Civil War assured their congregations that God was on their side. Now policy advocates and opponents both seem to implicitly claim that they are blessed with some unique insight analogous to the divine knowledge that allowed the clergy to reassure their flock of the righteousness of the their cause. The thing about a gratuitous assertion is that it can be contradicted with a gratuitous denial with equal lack of need for evidence.

Whether a given policy position is for the public good is in the eyes of the claimants.

Mr. Doherty then quoted the Charter on Professionalism ,a statement by the ACP ( and other groups as well) on what modern medical ethics should be:

The Charter states that "the medical profession must promote justice in the health care system, including the fair distribution of health care resources" and "A commitment to equity entails the promotion of public health and preventive medicine, as well as public advocacy on the part of each physician, without concern for the self-interest of the physician or the profession." ( my bolding ,his use of italics)

Justice in the sense of the above quote would seem to mean social justice or distributive justice, a viewpoint that looks to equality of outcome not necessarily solely to the equality of opportunity. A number of medical bloggers, including me, have written about social justice in the context that the claim of advocacy for social justice is a necessary arrow in the quill of the ethical physician. See here. I reject the assertion that social justice is the justice that ethical physicians must adhere to. More than that, my assertion is that a mixed fidelity to the patient and to some general societal good or welfare may destroy the very essence of the traditional physician-patient relationship,the fiduciary responsibility to the patient.

Several years ago, I asked "Can the traditional medical ethical prime directive of placing the individual patient's interest first survive in a financial environment in which physician autonomy is greatly diminished and income for most physicians is controlled by third party payers?"

Before that , Dr. Edmund D. Pellegrino, whose credentials in the field of medical ethics are not likely to be questioned, asked in 1995 (JAMA,May 24/31,1995,Vol 273,no 20,) " Is medical ethics a social, historical, or economic artifact?Or are there some universal , enduring principles?

I maintain that the Charter on Professionalism answered that question in the negative.

The ACP, ABIM and the European Federation of Internal Medicine joined forces to formulate what was called the New Professionalism in which physicians were told that they had an ethical obligation to strive for Social Justice. This joint effort of re-doing medical ethics by several medical organizations was said to be necessary as the "old ethic" needed to be revised to align itself with the new economic environment in which physicians now lived and "medicine's commitment to the patient was being challenged by external forces of change within our society...

So, the ACP and others declared that the old ethic had to be revised. Yet, in a recent exchange between Dr. Richard Fogoros and Dr. Virginia Hood who represented ACP , Dr Hood seemed to maintain that really there was no conflict at all between the individual patient's well fare and the good of the herd and all the new professionalism did was to tell docs to just practice good medicine. At least, that was Dr. Fogoros's take on the non-debate, a view with which I agree. See here for details of that exchange, The issue is the conflict between the individual and society and that ACP leaders may have chosen not to fight that battle again having declared victory.

So the defense which the ACP's advocate choose to construct to justify their support of the health care bill consisted of:

1.We supported it because the bill did contain several items consistent with ACP mission and goals (e.g. providing health insurance for millions of previously uninsured citizens)
2.ACP will continue to fight for other things important to physicians ( e.g., repeal of the SGR compensation cuts)
3.ACP's lobbying effort is not your typical lobby effort but rather their proposals are also in the public interest.
4.Physicians have an ethical duty to promote social justice which many believe this bill accomplishes.

Arguments 1 and 2 hold water.More folks will be insured and the ACP has advocated greater access for years. I have no doubt they will continue to advocate a more reasonable compensation system for CMS and for malpractice tort reform.

However, Argument 3 is no more that a gratuitous assertion and argument 4 relies on the assumption that social justice is the only concept of justice appropriate to the modern day physician and that the concept of social justice actually has substantive meaning.

I have no reason to believe other than that the leadership of the ACP is populated by conscientious, well intended physicians who are dedicated to their profession and have given the matter of their advocacy for medical policies much thoughtful consideration and believe they are doing the right thing.

Acceptance of the social justice concept and the imperative to work for that end is likely part of the world vision of at least some ( most?) of the ACP leadership. To the extent that health care bill presents a victory for proponents of social justice, the actions of the ACP are consistent with their expressed core beliefs.

Physicians whose views can be characterized as progressive may be pleased with the bill, warts and all, while for libertarians and conservatives, not so much.The reaction of many physicians in opposition to the health care bill provides some evidence that the progressive view is not shared by all.

Which is more frightening , Section 10320 of the PPACA or Section 2713?

Actually two other sections are candidates as well; they are Sections 4105 and 4106.

To review- 10320 is the section that gives the Secretary of HHS the authority and power and mandate to issue rules and regulations to limit the growth of private medical spending. See here for my concern about that.

The other three sections outline the broad reach of recommendations that will be made by the USPSTF . It is worse that it sounds because it will also encompasses previous recommendations the group made (except for the recent mammogram recommendation because folks got upset about that before the health care bill was passed and the HHS Secretary did some quick damage control)

DrRich discussed the power that the USPHSTF will have over our ( "our" referring those of us having any kind of health insurance) health care insurance coverage. See here.

Section 2713 establishes that the recommendations made by the USPSTF regarding preventive services will determine what will be covered by private insurance. Section 4105 does the same for Medicare and 4106 for Medicaid.

Remember the outcry when the USPHSTF issued guidelines regarding breast cancer screening that were widely perceived as being counter to what advice had been pounded into women's heads for the last quite a few years. Government officials,including the Secretary of HHS, quickly reassured the country that this panels was not issuing official government mandates just offering advice and that women should confer with their physician and see what they both agree is best for them. Well, with the passage of the health care bill that all changes because the government will have the power to determine what insurance policies have to cover and I fear what they cannot.

Yet another government entity emerges from the health care bill

H/T to Dr RW (see here) for alerting me to the Center for Medicare and Medicaid Innovation (CMMI) which joins the list of mechanisms by which more control of medical practice is given to certain federal entities .

Here is the legislative language of the amendment that sets up of the power of the CMMI.I do not know to what extent, if any, the final bill altered the amendment's wording.

This- much like my favorite Section 10320- seems to not be getting that much attention . See here. A Google search (4/11/2010) kept bringing up this reference which in turn quotes the CG Weekly, whose content seems largely gated.

Again, only time will tell what this organization will bring about but from what I can read preservation of fee for service and independent practices is not what they will strive to preserve.

The basic, pervasive indeterminacy of the health care bill ( i.e. we do not know exactly what forms the power given to federal agencies will take and the devil really will be in the details) is one of the most important reasons for opposition to the bill .

Massashusetts government has to order health insurers to offer policies

Let us look one more time at how Obama care in miniature is working out in Massachusetts. See here for details as the latest series of events plays out three years after a health care plan was instituted in Massachusetts.

Non-profit insurers in that state had lost money in 2009 and requested a rate hike which was denied by the authorities in Massachusetts and at the old rates refused to offer policies. No problem- the state simply ordered them to offer policies.At this writing ( 4/10/2010)the matter is in court.

Actually, we will probably get more looks as the Mass mess really derails.

The Health care bill- No one knows what it will do but don't worry

Here are two interesting quotes regarding the health care bill.

The first from Nancy Pelosi , see here.

"But we have to pass the bill so that you can find out what is in it".

The second is from the Senior VP of Governmental Affairs and Public Policy for the American College of Physicians, Robert Doherty He writes a blog called "The ACP Advocate Blog by Bob Doherty".

He began a recent blog commentary with the following sentence:

Well you don't. Neither do I, and for that matter, nor does anyone else.

The reader soon realizes that this attention-getting lead sentence is in reference to what the effect(s) of the recently passed health care bill ( now known as PPACA) will be.

While Ms. Pelosi's statement seems at first analysis just to make no sense at all but maybe it makes more sense that it seems at first. On the other hand, Mr Doherty' offers are a candid,thoughtful assessment that concluded that the bill is so complex,and I would add currently in many regards indeterminate, that no one can known for sure what the consequences will be.

I agree. Further there are many sections of the bill that delegate much authority to political appointees ( e.g. the Secretary of HHS) to make rules and regulations that will have extreme broad effects on peoples lives . We cannot comment on what the outcomes of these decisions because we will know what they are until they are made.

Doherty continues:

Yet the honest, truthful answer is that neither side can really have all that much confidence in their assessments of the law's impact. If they were honest with themselves, and with us, they would acknowledge that there is a tremendous degree of uncertainty about how the PPACA will work in practice. Some elements of the law, like how it will provide access to health insurance coverage, can be assessed with greater confidence than, say, the long-term impact on health care costs and the federal budget deficit.

Again, I agree. Neither side can know the law's impact. In my opinion, one can rationally oppose a bill solely on the grounds that its effects and impact are not known. Can you say Pig in a poke"? On the other hand, I am puzzled how one can advocate for a bill given the knowledge that its effects are unknown. I am puzzled by the argument that support for it is based on a belief that the legislation is in the public interest if the face of admitted ignorance of the bill's effect. Of course the bill will provide health insurance coverage for millions of the previously uninsured but is that provision so important that it trumps all possible negatives. Apparently so it the eyes of at least some of its supporters.

Maybe Speaker Pelosi was right after all. We have to pass the bill AND wait and see what the bureaucrats do with the incredible powers delegated to them to really see what it is the bill.

This video seems an appropriate closing.

So how does the Obama health care bill "provide" health care for almost everyobody?

Ignoring for a moment the millions of U.S. citizens who are not covered by the Obama health care bill, how will those who are now ( well, in a few years) eligible for health care actually get their care ? The answer- two ways, 1) through the current (though modified) private health insurance industry by the simple ( actually the details are anything but simple) expedient of making those who can afford insurance it to buy and subsidies for those who cannot and 2)making more folks eligible for Medicaid.

This is the same (OK, currently modified, so new and improved) private insurance industry that was so vilified in the run up to the bill's passage but we are led to believe that through wise regulation these powerful and evil snakes in the grass will be defanged, such defangation accomplished by not allowing different rate premiums for different risks and by disallowing rescission ( aka, an insurance company dropping the patient when they get sick).

The second mechanism is increased in enrollment in a plan that virtually no one says is a good way to get health care.Good luck finding a physician who accepts Medicaid patients as millions are made eligible.

Well, maybe these are not the absolutely best ways to go about it but we told we must not let the perfect be the enemy of the good but at least we can feel good about the fact that this bill will save us money and we have been told by the president that without it the country will go bankrupt.

There are few instances where anything like controlled experiments occur in the world of economics but we can look at how things have worked out so far in Massachusetts where a very similar plan has been in place for the last three years. Here is an assessment of that from a new publication not known for its anti-government bias.

The bottom line is it that the Mass plan costs multiples of what the purported projections were ( as did the projections for Medicare) and waiting times to see physicians is the highest in the country, that in a state with many more per capita docs than most.

So with Massachusetts as a model ( or canary in the coal mine) how could anyone expect the Obama bill to save money and save the country from bankruptcy. One way was the hokey- pokey accounting shenanigans that prevailed in congress. By that I mean the CBO had to count the saving from a 21% cut in Medicare payments to doctors while legislators played a wink wink nudge nudge game promising to some of the more easily fooled medical organizations to eliminate those cuts in a separate bill. Bait and switch written very large.

With a plan as sound as the above would suggest, it is no wonder that the president has launched a campaign to educate the populace about the virtues of the plan .Currently the tactic appears to be to talk so much that ultimately everyone will just give in so that he will stop talking about it. Even the Washington Post seems to taken back a bit by his verbal excess. See here.

More "well thought out" parts of the massive health care bill deserve worry

The many parts of the health care bill are a marvel to contemplate and as the 2000 plus pages are deciphered there will be much to be considered.

Here is one that has received a bit more commentary than my current favorite worry,section 10320. See here for my fears about 10320.

Jason Shafin, Phd in economics, discussed the CLASS act in the above hyperlink. Class stands for Community Living Assistance Services and Support Act . This is a Long Term Care (LTC) program whose benefits seem grossly inadequate to pay for a nursing home but admittedly might help a bit.Funding for it precedes the years when payouts occur, part of the wink-wink-nudge-nudge accounting that achieved the veneer and illusion of "cost saving" of this landmark bill.

This is a voluntary program that may be offered by employers and applicants cannot be denied coverage. There are some interesting tricks in the program that Dr. Shafin warns us about. The default position regarding employees is that they are signed up unless they opt out.I suppose this the so-called libertarian paternalism at work. But, if you drop out after you figure out you are in it, you then have a penalty to pay if you decide you really want it after you get older and realize you might need it and sign up for the plan again. Not sure how paternalistic that is, maybe some type of tough love.

Section 10320 of health care bill-reason to be afraid

Section 10320 of the health care bill changes the focus and greatly enhance the influence of the IMAB.Again h/t to DrRick. The phrase "greatly enhanced" does not begin to capture the enormity of what that change could be.

The IMAB ( Independent Medicare Advisory Board) has been characterized as a rather benign entity merely existed to make suggestions regarding how to improve Medicare and benefit everyone over 65. But things seem to get really interesting in 2014. The initials changes to IPAB or the Independent Payment Advisory Board.

The title of section 10320 is illuminating ;“Expansion Of The Scope Of, And Additional Improvements To, The Independent Medicare Advisory Board.”


"Improvements" are in the eye of the beholder but in what way is the scope expanded? The board is directed to periodically (every 2 years) to submit recommendations to slow the growth in national health expenditures for private (non-Federal) health care programs.,such recommendations to be implemented administratively by the HHS Secretary and/or other such Federal agency heads.

Is it even possible for a federal agency to control private health care expenditures? Does this mean that the HHS secretary, a political appointee, could deny what would otherwise be a lawful contractual relationship between a person and an insurance company? For example HHS could write regulations forbidding an insurance company from paying for a brain MRI in a patient over 65. Having control of insurance coverage is a powerful tool that has now been taken over by the federal government.

Would the power of HHS extend to control private ( non insurance related) activities between a patient and a physician? It is easy to imagine how that could happen. Simply issue a regulation (aka edict) that disallows a physician who receives CMS funds from taking part in any private financial arrangements with a patient.

Does the creation of the IPAB make it possible for a government appointed administrator basically determine if health care in this country will go the way of Great Britain or Canada, with "allowed"private care in the former and not in the latter.

Here is more detail on 10320 and how it activities morph further as times goes by, e.g taking GNP into its calculus to control national (public and private) health care costs.

This topic deserves far more discussion and recognition by the public and by the medical profession. It deserved much more discussion before it was passed.When you Google "section 10320" and my earlier blog entry shows up on the first page of hits (as of 4.4.2010), you know that this needs more widespread discussion.

Here is a letter sent from dozens of health related organizations opposing the creation of the IPAB.


Interestedly, absent from the list are the AMA and ACP.

Could the Independent Medicare Advisory Board pave the way to an exclusive single payer?

I have written before that perhaps the worst part of the Obama health care redo is the incredible delegation of wide- almost unlimited- powers to a political appointee ( the secretary of HHS).

Scrutiny of the behemoth legislation by Dr. Fogoros (AKA DrRick of the Covert Rationing Blog) Rationing) has brought to light that fact that in 2015 the Independent Medicare Advisory Board morphs into an entity named the Independent Payment Advisory Board. See here for details as provided by Dr.Rick.

This is much more than a change in initials from IMAB to IPAB. It give the HHAS secretary authority to somehow issue administrative rules that will somehow limit private medical expenditure.

From DrRick:

Section 10320 changes the name of the Immutables from the Independent Medicare Advisory Board to the Independent Payment Advisory Board. It directs the Immutables (and now readers will understand why DrRich has resorted to this more descriptive name), at least every two years, to “submit to Congress and the President recommendations to slow the growth in national health expenditures” for private (non-Federal) healthcare programs. Furthermore, it allows that these “recommendations” may be implemented by the Secretary of HHS or other Federal agencies administratively.

Does this administrative power pave the way to limit what an individual might pay on his own for health care?

It need not but it could. The HHS czar could decree according to Section 10320 that no insurance plan could include coverage for something or other ( perhaps screening colonoscopy for folks over 65) and leave it at that. OR HHS could decree that no practitioner would receives Medicare/Medicare funds or payments for an insurance policy obtained from an exchange could enter into any financial relationship with a patient outside of that which is expressly provided by the plan. In other words more like Great Britain or more like Canada. I wonder how many House members who were herded into voting for the bill realized that much of the future of health care for millions of folks would be determined by a political appointee?

If you agree with many folks that the passage of the health care bill was an abuse of power (see Here),wait until we see what 2015 and the Department of HHS have to offer.

Health care "reform:,wouldn't it be nice to think so?

A recent commentary by Sheldon Richman has so many insights into what the health care bill offers,will offer and as to what it means that it must be read in its entirety. See here. All I can add is "amen".

Here are some of the major issues he raises.

Richman tell us that what "everyone" is provided with is not insurance at all

OPR [ stands for the Obama-Pelosi-Reid bill ] will directly subvert what is left of the insurance market and indirectly subvert what is left of the medical market. Insurance is about pooling risk in the face of an uncertain future. But OPR requires that insurance companies cover people without taking risk or even certainty (preexisting conditions) into consideration. There are no grounds for calling this insurance. Rather, it is welfare mixed with prepayment for future services. (Not that the insurers are complaining; it’s a price they’ll gladly pay for the captive customers that the mandate will deliver.)

Remember "fast,good and cheap" , pick any two. There is something similar with OPR, but I think you can pick only any one.

Adding insult to injury, OPR falsely promises that we can have government-subsidized consumption of medical services, lower prices, and freedom of choice at the same time. In fact, those three things cannot coexist. Subsidies will boost consumption, which will raise prices. If government is serious about lowering prices, it will have to curtail consumption, that is, limit freedom of choice, explicitly through rationing or implicitly through price controls and standards of practice.

And perhaps most important is that fact that no one really knows what is in the bill because much that will come out of the legislation is undefined and is to be determined by the Secretary of HHS and other panel and bureau heads.

Finally, OPR puts another nail in the coffin of government transparency. Regardless of how much or little government (if any) people want, they should at least be able to see and understand what it is up to and how much it costs them personally. In every way OPR flouts this principle. The law’s 2,700 pages of impenetrable “English” was read in its entirety by few if anyone. But that only begins to describe the offense. The law leaves much to be defined in the future by government departments, boards, and commissions. Hundreds of rules and regulations have yet to be written – and who do you think will be right there offering counsel as the new insurance rules are formulated? The same insurance companies whom last week were said to be the devil incarnate. (And Organized Medicine and Big Pharma too.) That’s how the Washington game is played. And we’re the losers.

I agree,organized medicine (at least the AMA and ACP) were on hand to "offer council" but while Pharma may have made out OK ( I say" may" because all of the fall out has not begun to fall ) organized medicine,IMHO, didn't get much to show for their lobbying efforts.The small dollops to physicians are more illusory than real and a very small price to approve giving massive power to the Secretary of HHS.

Compulsory medical insurance -but not until after the next presidential election

Front load some of the benefits, back load the costs and the compulsions, put them all together in a behemoth sized bill of mind boggling complexity and ambiguity and voila you have health care reform reform passed with 2 or 3 votes to spare. Here is cogent discussion of why the bill is so long and so complex when a few pages could have described a plan to give subsidies to those too poor to purchase health insurance. Could it be more than just a health care bill?

Apparently Senator Baucus thinks the health care bill may serve at least other or perhaps more important purpose.See here for that story. Here is what he is quoted as saying:

"Too often, much of late, the last couple three years, the mal-distribution of income in American is gone up way too much, the wealthy are getting way, way too wealthy and the middle income class is left behind," "Wages have not kept up with increased income of the highest income in America. This legislation will have the effect of addressing that mal-distribution of income in America."

Vice-President, Joe Biden, however says no, It is just being fair.See here

To the extent that Baucus has corrected characterized the legislation there are those who would believe that social justice has been well served as it is always said to be when wealth is redistributed.To those folks I submit the following commentary by the economist D.W.MacKensie

While we cannot be sure about the details of future changes in government regulations or programs, economic theory indicates that these costs rise over time. Ideally, legislators pursue what some people term ‘social justice’ through redistribution. The term social justice lacks any objective meaning. People have different opinions as to what constitutes a fair redistribution of wealth, and there is no objective criterion for determining whose version of social justice is correct. No one can comprehend all the factors that would have to enter into an actual estimate of ‘socially just’ income distribution. Claims of social justice are at best based on narrow and incomplete value judgments, and at worst completely arbitrary opinions. Since social justice has no meaning, the pursuit of this goal inevitably degenerates into power struggles among interest groups.

"Power struggles by special interests groups" is a concept not typically taught in high school civics class.

As business realize Obamacare will cost them,congress will demand what?

Henry Waxman appears angry (see here ) that CEOs of corporations dare tell the public that they will loose money from Obamacare and will haul them before tv cameras in a hearing room and ...

I suppose he might challenge them saying that how dare they know more about their own financial bottom line that the policy wonks who allege great savings for all.Surely folks who run businesses do not know more about their business than a government staffer who knows little or none of the particulars of the costs and other elements of a given business enterprise. It just gets better and better.

at least one country does its part for the earth and celebrates earth hour every night

Earth hour,"celebrated" each March 27 (see here for details) has come and gone for this year. Celebrants will not have wait another year for this joyous occasion.At lest one country observes this ritual every night.See here.

So who will do well and who will not as the Medical Care "reform" is enacted

A recent poll of U.S. physicians was published in the NEJM,(see here).About 46% of primary care physicians indicated they would leave practice or at least seriously consider leaving practice if some version the Senate health care bill becomes law.

The law will increase the number of patients covered under Medicaid and if big cuts occur in the Medicare Advantage there will be an increase in the number of folks moving to regular Medicare.We will have a situation in which there will be more patients trying to obtain care from fewer physicians. Those physicians remaining in the Medicare/Medicare treating group will be faced with increasing regulations and controls and ultimately further decreases in payments as the approximately $500 million in projected "savings" in Medicare payments play out. This in turn is likely to spral down with more physicians "going Galt".

Waiting lists , shortages and decreased quality likely will result. In Massachusetts with its version of what is to come nationally there are much longer wait times for physician visits even in spite of the very high per capita number of docs in that state.

Having health insurance is not equivalent to receiving health care. Who typically gets the goods or services that are in short supply due to government controls, the well to-do and well connected or the poor and less well connected? Either through accessing retainer practices ( it will take a while to outlaw them) or other means of getting to the front of the line or getting care out of the country the richer and more connected will , as always do much better. Those who will not are some the same folks who are the alleged beneficiaries of this deconstruction/reconstruction of health care.

Just a few reasons why meta-analysis may sometimes not advance our knowledge or understanding

Dr. David Rind in his blog "Evidence in Medicine" tackles an issue that has bothered me for some time.See here.That issue is, in the form of a question, is " are meta-analyses (MAs) really helpful" or not. I have questioned whether MAs should sit as high as they do on the generally accepted hierarchy of evidence based medicine. See here for my overly lengthy comments on why MA should not share the pinnacle position on the evidence based medicine hierarchy with randomized clinical trials and why the hierarchy scheme itself is flawed.

In his commentary he lists some of the reasons why they may be neither helpful nor productive of new insights. He is not saying MAs are never helpful ( and neither am I) and in fact takes the position that a recent MA regarding statins and diabetes does provide useful information .

Why may MAs sometimes not be very useful. Here are some of the reasons Rind lists and some others:

From Dr. Rind's commentary

1) Frequently... meta-analyses are either driven by the single large RCT that everyone would have cited anyway or, worse, a number of small, poorly-performed RCTs are combined with a moderate-sized, well-performed RCT and alter the results away from what was likely the best estimate of reality: the results of the well-performed RCT.

Sculpturing the numbers from several small, poorly done RCTs is no guarantee of discovering the clinical truth and may well give credence to some bad ideas.

3.MAs authored by folks with little or not subject matter expertise cannot or do not put the issues in a context that would have born of actual experience.

4.MAs that lump apples and peaches. I am reminded of one MA that looked at all thrombolytics. You don't write an order for "a thrombolytic" you write for a specific one.

5.Remembering that a meta-analysis is really an observational study in which the observed entities are trials,there is a real risk that the investigators might pre-screen the trails and in a post hoc fashion devise inclusion or exclusion criteria that would stack the deck to favor a conclusion that they already "knew was right".

So far carotid endarterectomy looks better than carotid stenting

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

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

The authors offered this closing sentence:


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

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

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

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

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


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

Why is the Avandia issue being raised again?

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

Any thoughts?

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

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

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

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

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

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

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

I will shamelessly repeat what I wrote earlier:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


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

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

More counterpoints to the Dartmouth Atlas data

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

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

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

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

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

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

Will long term endurance exercise prevent your telomeres from shortening?

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

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

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

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

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

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

Is everyone talking about the same health care bill?

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

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

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

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

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

It seems very likely than warfarin's days are numbered

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

What do we really know about Tamiflu and flu?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Diminishing returns on heart attack treatment innovation leads to new targets

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

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

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

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

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

Why not? Is it simply the mathematics involved?

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

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