Wednesday, February 25, 2009

Still More on comparative clinical effectiveness and the role of government

A number of medical bloggers have offered their opinions regarding the inclusion of "stimulus money" for a federal CER (comparative effectiveness research) unit . A particularly well balanced view is presented here by Dr. Val who has obviously spend some time and effort in trying to understand exactly what has passed and offers some thoughts about what it all might mean.

It seems like a major influence in this undertaking will be forthcoming from our colleagues at the Institute of Medicine (IOM) whose reports ring like pronouncements floating above the level of criticism and discussion that ordinarily pertains to comments by most other folks. They apparently will be given one million dollars to prepare a report indicating on what areas the early efforts at CER should focus. This will give some people at the IOM considerable clout since there are endless issues that could be addressed but for the limits of time, money and manpower so what gets studied is what it is all about. So the locus of lobbying and influence may shift for a while to this non-governmental organization.

DrRich offers his view on CER here. Among other insightful comments he tears into comments from the ACP that they will not countenance rationing,which some fear may result from the decisions issued by the federal CER group:

"The ACP seems to be delusional. Despite the ACP’s new protestation that they will not countenance healthcare rationing, this organization is one of the chief signatories of the recently updated version of medical ethics, updated to honor the “new realities” of the 21st century, which explicitly recognizes physicians’ inability to fully advocate for their individual patients in today’s healthcare system, and which therefore gives them permission to ration healthcare at the bedside in order to meet the demands of our larger society. (
As DrRich has argued, this new version of medical ethics fundamentally wrecks medicine as a true profession.) So for the ACP to come out at this time foresquare against rationing seems somewhat hollow."

Also ringing hollow to me are comments that the results of the CER studies will not be used to limit care. Although verbiage from government sources denies that will occur regarding government funded programs(and if we can't trust the government who can we trust) as Dr. Val points out isn't it likely that private insurers will pounce on results that can be used to save them money.

Dr.RW expresses his view on CER here and in this typically strong and well researched posting Dr. RW shows us why the premise that we don't already have have CER is just plain incorrect as he lists case after case of useful CER that was done without the federal goverment's largess.

Dr. Robert Centor,whose views are always worth considering seriously,offers a more optimistic take here. I hope he is right and the new federal agency can do better than the ad for chiropractors that NCCAM published and that I commented on here. KevinMD also expresses a positive view of the fed funded CER effort seemingly surprising himself that he agrees with Paul Krugman in that regard.

Tuesday, February 24, 2009

NIH publication looks like ad for chiropractors

This month I received in the mail a copy of NIH Medline Plus and was attracted to the article on CAM. The publication is also available online. Go here for what looks to me a lot like an advertisement for chiropractors rather than the unbiased scientific assessment which we should expect from the NIH and our taxes and what some medical bloggers expect will come forth from the federal CER group who is recently the recipient of part of the stimulus package.

The article does reference a clinical trial which apparently showed some benefit for folks with low back pain from what I consider to be basically physical therapy done by a chiropractor but the glossy page seems to imply more than that.We are told that "even super fit athletes, like marathoner Scimonelli (his picture is above the text) can benefit from CAM treatment for conditions such as low back pain."Note it says "conditions such as.." implying there are other conditions that can benefit from CAM.

This message is set out from NCCAM (National Center for Complementary and Alternative Medicine) who proudly announces it is now ten years old. There is a timeline heralded as a decade of progress. Go here to see what the tax payers received for that ten years of government spending. Tell me again why we expect great things from the government in regard to comparative effectiveness research.

Thursday, February 19, 2009

A positive article in WSJ about concierge docs

The Wall Street Journal published a positive article on concierge medicine.See here. I do not yet have a concierge type physician only because I have not yet found one in my area.

We can only hope that the powers that be and the forces that influence the powers that be will not manage to pass legislation to outlaw the practice or influence insurance regulators to assume jurisdiction over their practices. See here for details on the efforts of the Maryland Insurance Commission to do just that.

Wednesday, February 18, 2009

"Health care associated pneumonia" looks like a concept here to stay

The article from the Jan. 6,2009 issue of the Annals of Internal Medicine provides outcome data from 55 hospitals in Italy that offers more validation to the concept of Health care associated pneumonia (HCA pneumonia) as a "distinct subset" of pneumonia, which had been proposed in 2005 by the American Thoracic Society.

HCA pneumonia is pneumonia occurring in patients who have had association with the health care system as in residence in a nursing home care or treatment at a dialysis clinics or hospitalizations in the recent past.Basically,these are patients who present more acutely ill with the lung infection often superimposed on various chronic illnesses and who have a higher incidence of certain microbes, namely staph aureus and various gram negative bacteria.Compared with community acquired pneumonia there are longer hospital stays and a higher mortality which is really what is expected when chronically ill patients develop pneumonia.

The American Thoracic Society's guidelines for HCA can be found here.

Monday, February 16, 2009

Advocates of "Medical Homes" find little cheer in coordinated care study

A recently published study of 15 coordinated care programs found little evidence of benefit,no cost saving and no change in various "adherence" measures. A detailed discussion of the JAMA article can be found here at Junkfood Science.The JAMA article can be found here.

The notion that if we could educate patients better and interact with them more closely to encourage adherence to recommended care then costs would fall and quality of care would increase has been advocated by several professional organizations and policy wonks and disease management companies. The Balanced Budget Act of 1997 mandated that the Secretary of HHS study coordination of care programs in the Medicare setting. The JAMA article is the result of one such large study. Coordination of care is a major element in the Medical Home concept.Basically these coordinated care programs consisted mainly of educational activities by nurses and monitoring (usually by telephone calls) of patient adherence to medical care recommendations.

The negative results here remind me of a earlier publication investigating the similar results of a disease management program that I discussed several years ago.

Friday, February 13, 2009

Government funded comparative effectiveness project-mechanism for rationing or,boon to special interests or neither

To some,the allocation of 1 billion dollars to a government project to evaluate comparative effectiveness represents a danger, the specter of a mechanism to ration care and cut costs, and cast a big brother eye of physicians' practices glossed over with the veneer of scientific research. Others fear the capture of the government mechanism to further the special interests of various interested parties, such as drug and medical equipment companies. and to provide third party payers a rationale to limit payments.Others see the potential for unbiased, transparent research that could lead to better information for practicing physicians and a resultant improvement in medical care.

Dr. Roy Poses offers a thoughtful discussion of these issues here.

George Will talks about the Council of comparative effectiveness research (CER) here.

It is hard to ignore the possibility that at least one of the reasons for the existence of the council of CER might be to save money and limit Medicare expenditure-even if indirectly- as illustrated in this quote from Will's commentary.

The stimulus legislation would create a council for Comparative Effectiveness Research. This is about medicine but not about healing the economy. The CER would identify (this is language from the draft report on the legislation) medical "items, procedures, and interventions" that it deems insufficiently effective or excessively expensive. They "will no longer be prescribed" by federal health programs. The next secretary of health and human services, Tom Daschle, ( Written before Daschle declined the nomination) has advocated a "Federal Health Board" similar to the CER, whose recommendations "would have teeth Congress could restrict the tax exclusion for health insurance to "insurance that complies with the Board's recommendation." The CER, which would dramatically advance government control -- and rationing -- of health care, should be thoroughly debated, not stealthily created in the name of "stimulus."

Bob Doherty, The American College of Physicians' man in Washington, expresses the opinion that rationing is not the reason behind the bill and that it is really about "giving physicians and patients transparent and evidence based information to make their decisions."

That conclusion seems inconsistent with Will's quoting from the language of the bill ,although there is some doubt about exactly what the actual wording is, see below . Doherty argues further that the assertion that the council's decisions will lead to micromanagement of medical care as stated in a Wall Street Journal commentary found here cannot be true because the ACP favors the project. (There must be more to his argument that it seems-is he not simply saying it will not lead to micromanagement because the ACP says it won't).

In a second related posting, Doherty charges that the bill is mis-characterized in the widely read and quoted Bloomberg article by Betsy McCaughsey.He asserts that the bill does not create or empower the agency to make decisions to limit care,will not monitor physician's care nor mandate appropriate therapy. I wonder if CMS might find the CER's findings useful in their activities to control costs.

Another aspect of the CER matter is the issue of regulatory capture which I talked about here.

To muddy the waters even more, see this notice by Media Matters that asserts that the language of the bill does not in fact actually say federal health program will not pay for certain programs based on the CER analysis. We will have to wait a bit to clarify exactly what the bill says.

To the extent that the bill reflects the views expressed in Daschle's book on health care, cost containment will be on the table.See here for some comments about what his views are on that subject. Yes, I know Daschle won't be the health czar but will the views of the health wonks that wrote (or at least helped write) his book prevail.

Tuesday, February 10, 2009

Will A national coordinator of health information technology jump start the economy?

The first I read about the post of National Coordinator of Health Information technology (NCHIT) as being part of the stimulus package was in this commentary by Betsy McCaughey.

Reference to the relevant sections of the bill can be found in McCaughey's article in Bloomberg. including a description of the duties and powers of this office as outlined in one version of the House stimulus bill. Actually, this office already exists as shown here ,it is the expansion of a program headed by this office that is contained in the House Bill and so far seems to escaped much scrutiny.

The provisions as described by Ms.McCaughey,if accurately depicted, should be of concern to anyone old enough to be a member of AARP as it looks like the old folks will get screwed first. My attempts to verify Ms. McCaughey's comments by referring to the bill's language itself have not been successful. There are hundreds of pages of the type dense statutory prose that send the reader back and forth to various internal references.I will repeat some of her comments regarding the bill with the caveat that they are her comments and I have not been able to confirm their accuracy.

One new bureaucracy, the National Coordinator of Health Information Technology, will monitor treatments to make sure your doctor is doing what the federal government deems appropriate and cost effective. The goal is to reduce costs and “guide” your doctor’s decisions (442, 446). These provisions in the stimulus bill are virtually identical to what Daschle prescribed in his 2008 book, “Critical: What We Can Do About the Health-Care Crisis.” According to Daschle, doctors have to give up autonomy and “learn to operate less like solo practitioners.” .......

Hospitals and doctors that are not “meaningful users” of the new system will face penalties. “Meaningful user” isn’t defined in the bill. That will be left to the HHS secretary, who will be empowered to impose “more stringent measures of meaningful use over time” (511, 518, 540-541)

What penalties will deter your doctor from going beyond the electronically delivered protocols when your condition is atypical or you need an experimental treatment? The vagueness is intentional. In his book, Daschle proposed an appointed body with vast powers to make the “tough” decisions elected politicians won’t make.

It looks like Mr. Daschle,though no longer to be the czar of health care reform, will leave his imprint in the language of the bill which according to the Bloomberg article resonates with the ideas and plans outlined in the former senator's book.

MedInformaticsMD writing on the blog HealthCare Renewal also quotes the Bloomberg article but expresses in convincing detail another issue with the plan. That issue , simply put is that when governments have attempted to pull off an IT system of that complexity is that they will very likely screw it really badly and may never finish and he gives examples.

Whether it be considered as a Trojan horse to sneak in socialized medicine,a gigantic boondoggle that will have never ending cost overruns and myriad unintended consequences,or an important circuit in the electrified apparatus to jump start the economy, many would feel better about it if it could approached in the open with public comment and committee hearings rather than being rushed past Congress with warnings of the dire consequences of delay.

Monday, February 09, 2009

Lobbyists, including health care representatives,flood Washington on a pork hunt

Those who believed the claims that pork barrel legislation and special interest pleading would become things of the past will be disappointed in the events playing out as the current stimulus bill percolates through the Washington sausage factory.

The thousands of lobbyists (registered and unregistered influence peddlers) are pushing each other out of the way as this hurriedly prepared gigantic spending bill is being assembled. This bill is considered to be a great opportunity to insert provisions that groups may have had on their wish lists for some time. The concrete lobbyists are battling with the asphalt lobbyists over whether money should go mainly to repair work or new construction projects while the solar energy folks compete with the geo-thermal business interests for government favors,just to mention two contests of the many that are underway.

A Forbes article had this to say:

...Lobbyists for virtually every conceivable interest have tried shaping the measure, lured by its enormous size and scope, its must-pass status and a sense that budget pressures will make federal dollars scarcer in legislation later this year.

"This is a bill that's got just about as much room as you need," said Steve Verdier, top lobbyist for the Independent Community Bankers of America, which successfully supported expanded tax credits for home buyers and other provisions it said would help create jobs. "So if you've got some ideas you've been trying to push for a number of years, this is certainly the vehicle you want to use."

Various health care interests are well represented and in the game . Here is one news story of the lobby efforts for the Hospice business. The Biotech sector is asking for money for research claiming that with the credit crunch investment firms are no longer supplying some of the funds they typically rely upon for certain research projects.See here for a detailed discussion of what tactics the CAM (complementary integrative medicine) forces are using to get their feet into the doors of the health care reform funding,a key element of which appears to be coopting the preventive medicine angle.

This item suggest that there is money to made in the medical technology and computerized medical records provision of the stimulus bill and big players are interested.

This article outlines some of the conflicts involved in the electronic medical records issues and some of the players concerned with protection of patient data privacy and says in part:

Lobbyists for insurers, drug benefit managers and others in the health industry are mobilizing a campaign to persuade Congress that overly stringent privacy protections would frustrate the potential benefits of digital records.

The 20 billion dollar "jump start" of the health IT is a large enough slice for a number of interests to send their lobbyists to secure what they can get. I wonder though if the really big prize in will be the opportunity to data mine. Think of it, everyone's medical records on line somewhere, medications, procures, history,insurance data.Clearly the privacy issue mentioned above is critical and an issue of that important should not be part of legislation that is hurried through congress on the winds of rhetoric claims that delay will turn "crisis into catastrophe".Shoot, ready, aim is not the way to go.The British experience with their NHS IT adventure should give us some pause.

If you feel some reassurance that HIPAA will be protective, it is instructive to look into the lobbying origins of what the law was all about in the beginning. In spite of its veneer of privacy protection it was not about protecting patient privacy and facilitating medical insurance portability. A strong case can be made that it was driven by the health insurance lobby to obtain a federal law to give broad access to patient records and to facilitate insurance claims processing. That was achieved and the rest can be considered either collateral damage or incidental benefit. I am afraid of the collateral damage,unintended consequences and intended benefit to special interests that are all likely to occur as the health care IT bill is hastily put together under the watchful and helpful eyes of the relevant interested "stake holders".

Friday, February 06, 2009

Normal Weight Obesity joins normal blood pressure hypertension and others

It has been well recognized for a while that an elevated body mass index (BMI) does not necessary mean that a person has too much fat. Men and women with well developed muscles may have an elevated BMI and still have a low percentage of body fat. Look at any NBA game and you can see poster guys for that.

The BMI as an indicator of body fat also can also fail at the lower end. As humans age , often weight may not change but body composition does, with muscle mass decreasing and body fat increasing so that you may not gain weight but have a high percentage of body fat. Sarcopenia, or muscle loss, is a major element of old age fragility and so far the only way shown to mitigate that is resistance exercise.Aerobic exercise does not seem to help mitigate the apparently inexorable loss of the fast twitch muscle fibers whose loss is most marked in the age related decline in strength.

Nomal weight obesity (NWO) is a recently minted term that is meant to refer to the condition in which the BMI is in the generally accepted normal range but by some (perhaps less than widely accepted) standard of percentage of body fat, the person is deemed to have "too much". Hence they suffer (well, we haven't really shown yet that they suffer) from NWO. My term would be too much fat (TMF) because we have used BMI to operationally define obesity (as bad an indicator as it may be) and some may think we have at least the appearance of a contradiction in terms. People with this entity may be the some of the same people we used to call flabby.

Researchers from Mayo Clinic have published an article that correlates this NWO with risk for the metabolic syndrome. (You may remember this entity as something perhaps no longer believed in by endocrinologists but still by cardiologists. See here for comments regarding that schism). So, it appears that NWO or TMF would be a risk factor for a risk factor (metabolic syndrome) which is a risk factor for heart disease and diabetes, just to name two.

Tip of hat to Dr. Michel Accad's blog Alertandoriented for alerting me to this "novel" risk factor. Here is a press release for the May0 Clinic article.

The Mayo clinic researchers recommend that a shift from focusing on BMI and perhaps monitoring percentage of body fat or least waist measurements since the "real" definition of obesity is too much fat.

from CDC show that 35% of American are obese (as defined by BMI >= 30. Using NHANES data from 2003-2004 we see that 66% of Americans are either overweight or obese.That leaves 34% with a normal BMI but Mayo docs tell us about half of those are really obese after all leaving something around 17-20% of us who do not have too much fat. We now know that there are fat people that don't even look fat., a secret epidemic of fat people who don't look fat. (OK, some of them probably have a bulging tummy).A nation of reverse Lake Wobegon, where most everyone is worse than average.

There are new risk factors cropping up all the time. Risk and pre-risk and proto-risk abound. The cardiologist Dr. Thomas Giles, remarked that we are all pre-dead. Prompt and massive public health funding is the only answer,maybe as part of the stimulus package.

Thursday, February 05, 2009

Britain's NHS computer system said to be on verge of failure

See here for a news item and commentary about what seems to be shaping up as a giant governmental boondoggle in Great Britain, their computerization of their medical system.

We are repeatedly told that an electronic medical records system and more prevention will save much money greatly increase quality of care and possibly save the U.S. health care system in the process.The above quoted article could serve to disabuse the thoughtful about the metaphysical certainty of saving the country's health with computers and this great posting by DrRich might cast some doubt on the thesis that prevention will save money.

Can we believe guidelines formulated by "expert panels"

The blog, California Medicine Man, written by Dr. John S. Ford, expresses concerns about the recommendations that flow in ever increasing numbers from panels of experts. He expresses some of the same thoughts I have had for some time. My spider antenna quivers when I see a supplemental issue of a journal devoted to a specific topic which contain a panel's recommendation for a given therapy.

He mentions a 2007 supplement to The American Journal of Medicine that discusses hyponatremia and specifically treatment with a new class of medicines that I have briefly blogged about before .

I previously wrote in regard to this particular supplement:

The supplement is sponsored by the drug company that makes conivaptan ( trade name Vaprisol).This is an antagonist to renal vasopressin receptors and is a member of the "vaptan family" which so far has three other members. Vaprisol is approved by the FDA for treatment of euvolemic and more recently hypervolemic hyponatremia and is given IV. It is contraindicated in hypovolemic hyponatremia wherein further volume depletion from the ensuing aquaresis could be disastrous.

The way things work is that when a drug company assembles a "panel" to make recommendations about one of its products and pays to have the results published, usually the opinions tend to be somewhat favorable as was the case with this publication. I have no experience with any of the vaptans but I would be very interested in what the hospitalists (or any of the die hard internists who still treat people in the hospital) bloggers have to say about the role of vaptans in hyponatremic states.

However, as interesting as this new medication may be and as useful as it may or may not be, Dr. Ford's major point was :

The problem is that even before checking out this particular drug's usefulness, I'm already starting from a position of mistrust. With such an undeniable "appearance of impropriety" how can I truly rely on these experts to give me the unvarnished truth? It's one thing to report hard facts. It's something entirely different to render an opinion which is what a guideline is.

Ten years ago, we did not know about medical ghost writing and all the other subtle and so not so subtle techniques used by drug companies to influence physician's behavior but now we do and we cannot go back to an early era of relative innocence and less critical reading of whatever is written about medications and guidelines. From one point of view it is a good thing that physicians have had to become much more critical and skeptical about what we told and that applies to guidelines and not just those apparently encouraged by certain drug company interests. On the other hand, it is so much easier to just do what the experts tell us to.

Tuesday, February 03, 2009

American College of Physicians recommends against fighting with specialists over Medicare money

I have been a bit critical of some of ACP's positions and proposals but this time I agree. See here for a news item on their stance on food fighting and a rather long series of comments.

For a tactical point of view, ACP may have weight and influence disadvantages with professional associations of surgeons and some other specialists and might loose anyway. Sometimes proponents of taking money away from the "procedurists" to give to the primary care physicians actually say the procedure docs make "too much money" and their income should be limited. The wage and price controls imposed by CMS in 1990 has caused many problems for health care not the least of which is a shortage of primary care physicians.Extend that process and target specialists and we will likely see shortages for non primary care docs as well. For that matter, would we have physician groups going to Washington and begging for more money if there were not wage and price controls in Medicare?

Yes, it is true that the procedure docs have fared less badly as CMS has turned the cost control screws and the procedure doc dominated RUC has played no small role in that but to argue that they haven't been screwed enough and to limit their income will push things along so that everybody's ship will sink.

Monday, February 02, 2009

Tom Daschle history with lobbying firm damages credibility as future head of HHS

Tom Daschle has held a position as "policy advisor" with a prominent Washington law firm with well known lobbying activities.

The Washington Law firm, Alston and Bird, has a number of clients in the health care industry. See here for some details and here for a list of health care clients which include CVS Caremark, several drug companies and the American Orthotic and Prosthetic Association. The lobbying targets included HHS, FDA,CMS ( Medicare and Medicaid) and CDC.

Mr.Daschle was not a registered lobbyist in his position at Alston and Bird but was characterized as a " special public policy advisor" so an argument can be ( and has been) raised by the administration that since Mr. Daschle was not technically designated as lobbyist his appointment would violate no policy or promises regarding a lobbyist free administration.Even so, the administration says Mr. Daschle will recuse himself from any HHS work that might conflict with any previous activity he may have had while at Alston.

His wife is a lobbyist whose firm, Baker Donelson, has worked with Schering-Plough in efforts to extend patent rights for one of its medications. ( Will Mr.Daschle recuse himself also based on his wife's lobby activities?) At this writing she may have left that firm to set up her own lobbying firm and she was best known for her lobbying expertise in the aviation industries not in health care matters.

Moreover, Daschle's chief of staff at HHS will be Mark B. Childress and he did official lobbying work for another Washington Law firm, (Foley Hoag). Administration spokesmen have indicated that Mr. Childress will recuse himself from matters at HHS that he previously dealt with in his former lobbying life. See here for some details.

The list goes on. The nominee for the post of Deputy secretary of HHS is Bill Corr, who has also has been a registered lobbyist with some activity in health related activities.See here for details on that nomination. It is promised that he too will recuse himself should an issue arise at HHS for which he has a lobbying history.

It seems that whatever issue will be on the table at HHS there will be a lot of recusal going on.

The Public Citizen blog "Becoming 44" expressed their doubt of Daschle's suitability for the HHS post this way:

...the assurance that Daschle will recuse himself from any work presenting a conflict is hard to digest. He would, if formally nominated and confirmed, be the leader of the entire enterprise.

While we do not know which specific Alston health care clients Daschle worked for, it is highly likely that many of them would be affected by the regulatory decisions made by the director of HHS.

Daschle is also an advocate of the proposed Federal Medical Board and will play a dual role being the point man for President Obama's plans for health care change about which I have blogged before. Whatever concerns one may have regarding Daschle's appointment to HHS would apply to his role as architect of what appears to be a very powerful governmental body whose decisions may well have considerable impact on everyone's medical care and on the financial bottom line of many organizations, a list of which include many of the clients of Alston and Bird.