GLG News by Glen McDaniel, MS, MBA

Implications: Baby boomers are rapidly aging. According to Census Bureau by 2010 there will be 77 million people aged 55 and older; a number which will grow to a whopping 98 million by 2020. This aging population, living longer with chronic illnesses and more demanding of cafeteria-type service will drive the demand for medical services and more medical real estate into the forseeable future.

Analysis:

 There are several factors at work here. Baby boomers aging and  living longer will need medical care for years to come. Many will be treated for chronic illnesses (which are even now more treatable than previously) while others will be seeking to stay well as long as possible.

Boomers have the reputation of being more demanding in terms of service, quality and convenience. Therefore, medical offices will, for instance, be built in suburbs closer to homes for convenience. Many will be equipped with more conveniences and be more plush and comfortable; as well as less sterile and "clinical". There will be an increasing demand for many, many comfortable facilities. This demand relative to supply will drive up rents in a space where medical rent already exceeds that of  general office space failry significantly.

Constant threats of reduced reimbursement from Medicare will have minimal impact on the appetite for medical care as many boomers will be prepared to pay out of pocket for more cafeteria-style medical services.

Both construction and renovations should continue to grow in an attempt to keep pace with demand. Healthcare REITs should do very well and be a good investment in this climate.

Implications:  Hypercholesterolemia has an established link with a risk of cardiac events and there has been a push to screen high risk population for early intervention in an effort to reduce the incidence of heart attacks and strokes, for example. However to suggest any benefit from screening babies is to misunderstand the science and is immediately suspect in my view. Such a measure if adopted would increase healthcare costs and cause undue worry for parents, with no corresponding ability to mitigate the risk they are now told exists.

Analysis: First this is a meta-analysis of several studies and does not carry the same weight as a well constructed scientific study. There has been an ever increasing number of neonatal screening tests based on the fact that there is some corresponding identified intervention that can be done.  Whether it's for thyroid disease, PKU, sickle cell or any other neonatal screen; the information is always used to do something useful and to mitigate any likely sequelae.

In this case, testing babies at 15 months would at best indicate a familial tendency for hypercholesterolemia. The pattern of inheritance is autosomal recessive, so both parents would then have to be tested and the one with the high cholesterol (presuming there is one) would be the "culprit". What then? If the concern is high cholesterol, why not screen the parents directly rather than use the child as a surrogate? What treatment would the child undergo? There are no studies I could find in which children younger than 13 were routinely place don statins. As for diet; well ALL kids should be taught to have  healthy diet anyway.

Implications: Recently there has been a rash of takeover of publicly owned nursing homes by private equity firms flush with cash. There is a concomitant suspicion now that quality is being compromised systematically in these institutions in order to maximize profits. It's important to ascertain if this is so. If it is, there could be a whole new rash of regulations geared towards acquisitions and/or the nursing home industry.

Analysis: Skilled nursing facilities (SNFs) are a growth industry -as the population ages, more and more beds are needed. The model of the SNF is quite different from the hospital. There are certainly short term residents being treated for wounds, receiving IV medications, being given physical rehabilitation etc. But for the most part resident conditions are chronic and long term. Patrients are basically stable and are in the institution for extended periods. Visits by doctors are less frequent and nurse patient ratios are much lower (1 nurse has more patients than in a hospital). Much of the routine care is delivered by less skilled, lower paid assistive personnel.

Medicare reimbursement to SNFs has decreased in recent years so operators often claim "where hospitals look at margins in dollars, we look at cents!". Successful operators have certainly learned some tricks of the trade to stay viable, but they are always looking for opportunities such as that offered by equity firms. Recently equity firms have made some profitable takeovers; sometimes in all-cash transactions. The shareholders of publicly traded SNFs often receive premiums of 15-20% on their stocks in a takeover.

The equity firms on the other hand see a growth industry with great census, the possibility to realize healthy margins by putting into place operational efficiencies. Sounds like a good investment. Sounds like a real win/win situation.

How lean are these operational "efficiencies" though?  There have been a rash of complaints directed at nursing homes acquired by private equity firms that have been accused of reducing staff to a dangerous level, removing basic safety/quality measures to save money and so on. This article about Habana health Care in Tampa, FL is a classic example

Implications: Many lower income families depend on the SCHIP program administered by individual states to pay for healthcare. Republicans see this as just another entitlement program while Democrats see it as an essential way of making sure children have access to the basics in healthcare. This veto might be based more on political than financial (and certainly medical) grounds.

Analysis: This morning  President Bush vetoed legislation authorizing extension of the SCHIP program. The bill on his  desk seeks to authorize an additional $34.7 billion over 5 years to cover an additional 10 million children. The veto was not a surprise since the White House had proudly threatened veto for weeks now.

There is bound to be  a huge outcry from Children's advocacy groups, some healthcare workers, states and Democrats in Congress. The Democrats see this as a callous move, plus political fodder to use in 2008.  The President and his supporters see this as a sneaky way to move towards government healthcare. That socialized medicine fear overrides all other considerations. Cost is an issue certainly, but is defensible when put into context that 1 day of funding the Iraq war cost $300m which would cover 246, 000 under SCHIP. Also the Democrats proposed  to fund the increase through a tobacco tax. Not such a bad thing; right? Not if it means socialized medicine, counter some Republicans.

Several Republicans have joined the Democrats in voting for this bill which is supported by approximately 70% of Americans according to several polls. They are also concerned that a vote against children's healthcare could well cost them votes in 08. However there is not enough votes in the House to override the veto.

The concern I have is that this veto is being driven more by ideology and "sticking to the script" than by real fiscal concerns. Note the mad federal spending in the last 4-6 years. The implications will be political for sure, but what will be the medical fallout? That's the bigger concern to me.

Implications: Diabetes continues to be a global problem with hefty costs in dollars, death and disability.  Over the years treatment has not varied much-exercise, diet and use of insulin- and the problem continues to grow. If bariatric surgery shows amelioration of diabetes (if "cure" is too strong a worrd),  then surgery should  be considered a legitimate option in some cases.

Analysis: The incidence of diabetes is increasing with growing physical inactivity and obesity worldwide. Diabetes and its sequalae like amputations, blindness, ESRD and so on cause the healthcare system dearly. A diabetic is several times more likely to use the healthcare system on an ongoing basis (including inappropriate use of the ED)  than individuals with any other primary diagnosis. Treatment for diabetes has been pretty constant with minor tweaks such as closer monitoring, and the type and delivery system for insulin. Even identification of "bad food" has run the gamut and come back full circle. So it makes sense to consider other viable options.

In the overwhelming majority of cases-something like 80% to 90% of  diabetics who undergo bariatric surgery- there is a great amelioration of diabetic symptoms, reduction or total freedom from insulin or oral meds.

One colleague I contacted indicated that his hospital charges between $25000 and $35000 for each bariatric surgery. Such incremental revenue could prove very attractive in an industry always seeking additional revenue.

I have heard stories about hyperthyroidism and osteoporosis developing post bariatric surgery. But the benefits certainly outweigh the risks in this case, I think.

Those of us in healthcare are critical of anything seen as a quick fix. However -along with commonsense practices like regular exercise, a healthy diet, continued management of other health issues- bariatric surgery should eb considered adjunctive therapy for treating diabetes.

Implications: It is important to look closely at the new niche called Concierge Medicine. It is obviously created out of  a special need and will prove lucrative for physicians who choose to go that route. But there are larger questions of access and ethics of exclusivity/ One has to consider whether this provides better care, better service, or simply convenience.  All who provide and use healthcare ought to be interested in this trend and be prepared to weigh in as more physicians  pursue this model

Analysis: Concierge medicine is known by a variety of names, all indicating its exclusivity- boutique medicine, executive health medicine and even retainer-based medicine.

There is the hassle-factor. Physicians are fed up with the hassles of practicing medicine under the current model. Reimbursement has decreased from public and private payors, paperwork has increased, it's a hassle to file claims, the overall cost of doing business constantly increases. Coupled with these hassles are the fact that as  docs see more patients their social and family life suffer, and they often feel they are not giving good care because of the volume of patients they are forced to see in a typical day. Concierge medicine is tempting because it addresses, in their mind, almost all of these downsides of the current traditional practice. By limiting their patient population and charging a set fee of between $1000 and $20, 000 per year, they can have a nice income with fewer hassles!

Patients like the idea of ready access on short notice to a doctor who spends more time per visit and also helps them to navigate the healthcare system. There are often nice "extras" like physicals, spa-like decors in offices, house calls, networking and the like. For those who can afford it, what's there not to like?

However, there are questions about the ethics of access, equal quality of care and the like. Concierge physicians argue there is nothing wrong with paying extra for better "service". I wonder. Our society is rife with examples of 2 levels of service whether it's a celebrity hiring a high profile attorney while Joe-Blow gets a public defender, or choosing a  an exclusive private school for your child over an urban public school. This raises wider questions of healthcare as a right and the role of "the market" in addressing social and ethical  dilemmas.

Then there are contractual issues. Some like legislators in Washington state suggest concierge physicians should be subject to insurance regulation since they offer a service for a set premium just like insurance companies do. Contractually, patients must be very clear what's covered and what's not. What are the physician's obligations? What if a physician goes out of practice or fails to be available when needed? What if the patient becomes dissatisfied with the physician at some point? What if the patient requires a service outside the physician's scope?

If I were a physician I might well be tempted to go this route, but I would be concerned with maintaining my clinical competency and also my social obligation. But that's a personal construct.

Like everyone else, I watch this trend with interest.

Implications: The recent changes in leadership in the LTAC space is significant and suggests a tightening of operations. It is important to monitor the overall long term space as well as follow who goes where.  The changes are not insignificant, but may not be as ominous as they appear on the surface. Investors might want to monitor the sector performance closely for the next year or so.

Analysis: The article  announces the resignation of long term space veteran Earl Reed III from Life Care Holdings, Plano TX. Reed whose career started at Vencor (now Kindred) included a stint at Allegro Group a healthcare consulting company in Louisville, KY. When LifeCare was taken over by the Carlyle Group, a private equity firm, they wisely chose Reed because of his knowledge and management style. Now Reed has decided it's time to leave LifeCare and return to Allegro.

Reed is just the latest of several C-level executives leaving their jobs at LTAC companies. In late July Regency Hospital Company's founder and CEO Rod Laughlin announced he'd be concentrating on external relationships and growing the company, but stepping down as CEO. Regency is looking for a new president and CEO . Just weeks before that Regency's CFO left the company. Mike Cress resigned from Cornerstone Healthcare Group -an Austin based long term care company- earlier this year, supposedly to start his own consulting company.

Long term care companies are all facing challenges due to recent CMS regulatory changes and reduced reimbursement. Many have squeezed as much a as they can out of operational expenses and are not as successful as they would like in increasing revenue from non-CMS sources. Bad debt, census and cost of capital are all challenges that are reflected in lowered performance of several "former stars" in the LTAC space.

The re-shuffling of C-level executives might be just routine moves, but I suspect it's more significant. Some might be bailing before their company's challenge gets worse. Those interested in this space should monitor the situation closely for further changes before  coming to any firm conclusions.

Implications: - Some studies show that medical errors continue to increase despite an intense focus on this issue over the last recent years. This decision by CMS should bring even more attention to this whole area of patient safety and error prevention - There will need to be increased documentation to "prove" that an infection, for example, was present at admission or was not preventible or forseeable. This might increase the cost of delivering care. - The debate will continue  as to what is preventible - MCOs and other payers might well jump on the bandwagon and start parsing what is considered "allowable"  

Analysis: I addressed this same issue in a previous post on May 30, 2007 titled "Medicare should not pay for unsafe care".


Just about everyone in healthcare will agree that the goal should be to provide safe care, with as few errors or mishaps as possible. In principle it is a sound rationale NOT to pay for errors, or even for increased length of stay and increased costs to RECOVER from errors. The major cause of unintended increased length of stay (LOS) in the typical hospital stay is healthcare acquired infections (HAI). The general theory is that these nosocomial infections are ALL preventible. Are they?

I predict that hospitals and physicians will be placed in the defensive mode of over-documenting just to prove that they don't OWN an infection or other expensive patient condition , or that a certain complication or comorbidity could not be REASONABLY foreseen and prevented.

There will be lots of confusion and fingerpointing as payers try NOT to pay and providers try to get as much reimbursement as possible.
As I said in that May 5 post "The only concern I have is how CMS will ascertain and quantify what is considered preventible. While many scenarios are pretty clear, how do you decide definitively in each case whether or not the patient was admitted with MRSA  that "flared" during hospitalization; or which hospital "owns" a line infection if a patient is transferred with an IV then becomes septic?

In principle, everyone should benefit from this CMS decision. Providers will theoretically practice more safe, judicious care, paying attention to things like positive patient ID and infection control procedures. The patient will benefit from safer care.  But (much as I hate the over-used expression) I have to say it: "the devil is in the details"

Implications: Congress is looking at making cuts to Medicare especially the privately administered Medicare Advantage plans. America's Health Insurance Plans (AHIP) the advocacy group is concerned solely with preserving the healthy margins enjoyed by its members, while Congress is interested in reducing Medicare spending at all costs. Where is the patient in all this?

Analysis:  There is no doubt that this government -like most before it- has been concerned with reducing Medicare spending even as demands on the government program continue to grow. Gaining particular scrutiny is Medicare Advantage, the privately administered HMO-like Medicare plans. The concept sounds great in principle-greater access, more consumer choice, improved services etc. However the reality has been more harsh.


While the plans-especially the private fee for service (PFFS) variety -cost the government more than regular Medicare and the plan administrators line their pockets with healthy margins , patients dont always benefit.

In recent testimony before the House Ways and Means Committee, the AMA claimed their own study showed that patients on the Medicare Advantage received fewer benefits or end up being denied for more services than those under regular Medicare. Further, doctors often get paid less than they would under regular Medicare for the same service. Medicare has a huge price tag (an estimated $77billion will be spent on Medicare Advantage alone this year). Under PFFS plans alone there are over 1.3 million enrollees in 47 plans at a price tag of over $13billion. It is no wonder AHIP wants to campaign for continued payments at the current level!!

Congress is concerned with the overall price tag to the taxpayer, reports of unethical advertising, lax control and almost no oversight by CMS. Plus there is the traditional historical and continuing suspicion about Medicare fraud and uncontrolled spending.

AHIP might be reaching into its deep pockets to run highpriced advertising campaigns, but the motivation has nothing to do with patient care and everything to do with the profit motive. With Congress on one side and groups like AHIP on the other the patient is bound to get squeezed.

Implications: Siemens, a German company, known for medical diagnostic equipment such as imaging devices is acquiring Dade-Behring to expand its portfolio into the clinical lab science diagnostic area. As predicted in a post I did on February 28, we will be seeing more "fully diagnostic" companies combining the full range of diagnostic tools under one umbrella.  Stand alone clinical lab companies are all ripe for acquisition right now.

Analysis: Companies that have  been known for providing invitro diagnostics -eg GE and Siemens - are in an acquisitive mood right now and pursuing a deliberate strategy to control the "whole diagnostic" arena. They want to combine imaging, IT and clinical lab diagnostics for example under one umbrella. Clinical lab companies have a mixed history of financial performance and even those that have done well (or emerged successfully from bankruptcy) might find it hard to compete against the looming giants.

The planned Dade/Siemens merger costing an estimated $7billion should take place in early 2008 and will catapult the new company to the number 1 position worldwide in the diagnostic industry. The GE-Abbott merger announced earlier this year has fallen through because of so-called "complexities" of resolving international licensure and intellectual property issues. That setback does not temper the acquisitive fervor of GE. Nor does it make Abbott comfortable since they will then be third or 4th in the diagnostic market if they stand alone.

Siemens merged with DPC and Bayer under the umbrella of Siemens Medical Solutions (SMS) to form the first full service diagnostics company. Now, the Dade acquisition. Dade brings a long history of good customer service, innovation and a  worldwide presence. Siemens is known for efficiency and IT expertise. This should be an interesting partnership.

Local clinical laboratory customers might well be concerned about any possible change in customer service, innovation and nd responsiveness. However, from a business point of view, this merger makes perfect sense. Another prediction: we have not seen the end of mergers in this space.

Implications: Mini clinics will continue to operate in retail establishments for the forseeable future.  They have raised several concerns, so the company that addresses these concerns while providing the convenience will be rewarded with above average market share.

Analysis: Mini clinics are the direct products of a clear gap in the traditional health care delivery system. People fully satisfied with their provider's ability, responsiveness and access will not choose a miniclinic!

There is absolutely no doubt that these clinics provide a great service to a busy, impatient population willing to pay for convenience. The delivery model raises some concerns though; for example the practitioner is usually a nurse practitioner or physician assistant, not a physician. Will clinics act ethically and legally only within their scope? What if someone delays treatment for serious illness by going to a clinic instead of the ED? These are legitimate concerns.


Minute Clinic seems to be addressing some of these concerns-
- They use a software driven protocol of clinical practice guidelines and algorithms
- Some conditions are immediately ruled "too complex" and refered elsewhere, such as an ED
-Software automatically prepares appropriate prescriptions and patient education material based on documented assessments.
- Significant information is sent to the patient's primary care physician. Of course this might simply annoy some physicians if  they view this contact as an "afterthought" or if they are confronted with an abnormal finding, they now feel pressured to address
- They have an MD on call
-They dont accept patients under 18 months of age.

It appears Minute Clinic is doing something well. It will be interesting to see how well they fare compared to their competitors.

Implications: Retail clinics were born out of a gap between what patients want and what doctors were able to provide.  We cannot fight the trend by critisizing it. While clinics have their role, they do not replace more traditional delivery systems and patients should be educated accordingly.

Analysis:  Baby boomers are a  special bunch. We are the most educated, active (as in "not passive") demanding group in American history. We are also increasingly taking care of aging parents -at least overseeing their healthcare. We have more money, little time and less patience.

Traditionally healthcare has been doled out like a candy.Patients accepted whatever was handed to them by "experts" in terms of access, quality, schedule and so on. Boomers have said "No more!" With a busy schedule and more work/play balance they dont want to wait a week to see their primary care doctor, or spend  6 hours in an ED for flu-like symptoms. This is where retail clinics come in. They are merely filling a need that exists.

Retail chains have seen an economic opening where people can shop and take care of minor illnesses at the same time. Customers can shop,  see a practitioner for a minor illness, and fill their prescription all under one roof and be back home in a 1/3 of the time they'd spend in an ED. Retailers are counting on increased traffic and sales for those who visit the clinic. The clinics will benefit even from casual shoppers. Low cost is very attractive even to those of lower income, or those who are uninsured.

Most of the care in retail clinics are delivered by physician extenders like nurse practitioners and physician assistants (based on community practice and state law).  Such practitioners can act by protocol and treat minor illness as well as provide physicals, vaccinations and the like. They cannot replace a hospital, an ED or a primary care doctor. If they want to avoid litigation they would be wise to assess and immediately refer patients who are more complex than their scope allows.

Organizations like AMA too often have knee-jerk defensive reactions to any thing they perceive as power-sharing. The reality is that the healthcare system CREATED retail clinics by default. The best reaction is to 1. educate patients as to the role of the retail clinic 2. work with local clinics so they refer complex patients to you 3. try to be more accessible and accommodating in your own practice so that patients are not forced to choose retail clinics over you.

In the long term we are bound to see retail clinics continue to grow and they will try to distinguish themselves and capture market share by offering "extras" to separate themselves from the pack.

This is one area of healthcare to watch closely, folks.

Implications: Medical errors and nosocomial infections continue to be on the radar despite several years of heightened attention and regulatory prodding. There has been no requirement or incentive to document how much of each patient's cost is due to avoidable errors or complications. It makes sense that Medicare and other payers should not have to pay for the "mistakes" of caregivers.  Most healthcare organizations, patients and caregivers alike should agree with this development in principle. Like with most bureaucratic policies, however, the devil will be in the details.

Analysis:  AHRQ's patient safety index (PSI) increased 8% between 2003 and 2005, demonstrating that overall patient safety has not increased much in recent years.

Implications: Increasingly patients are being hit with higher out of pocket costs and it is a sad, unfair reality that patients might have to balance necessary treatment against the financial burden they might incur. Doctors have  a role in educating patients on the cost of alternative treatments offered. The problem is that for many modalities, physicians are no more aware of out-of-pocket than patients are.

Analysis: In most hospitals and other healthcare settings, the pharmacy produces a "cost per dose"  cheat sheet, so doctors can know which drugs are most expensive to the institution, basically. Generally the meds that cost institutions most will also be more expensive for patients who need such drugs for maintenance. In a PPS scenario it makes good sense for the institution to mitigate their cost per patient by prodding physicians to choose less costly drugs whenever possible. Some institutions even restrict or monitor the ease of ordering more expensive medications. The physician and patient together must then balance efficacy against cost.

The same transparent situation does not exist for non-medication modalities like diagnostic tests and procedures. These are generally weighed in terms of necessity, alternatives available, safety and so on. It is the rare physician, in my experience, who chooses options based on cost to the patient. A huge part of the reason is that the information is not readily available to the physician. Complicating that reality is the fact that many patients concentrate (understandably) on which modality will get to the diagnosis or treatment-not the relative costs of the choices available.

The party who has the greatest  stake here is the patient and to some degree CFOs/CEOs of PPS-reimbursed institutions. Patients might have to become more aggressive and militant in demanding out of pocket costs  of various options available before proceeding with a choice. This is all part of  a new concentration on price transparency. In reality, it is a difficult choice when faced with "this procedure is our best option at getting to a diagnosis, but you do have less optimal choices that cost less".

This is not a simple matter, but if physicians were provided with more cost information, they might choose a CT scan over an MRI, for example, in some cases where it is shown that the CT is the more cost effective and sufficient for the differential diagnosis presented.

Implications: This report raises more questions than answers. It is important because it suggests more work be done in several areas 1. A full scale study, not just a meta-analysis is needed. Also what are the risks of related drugs like Actos? 2. The Feds need to get serious about creating a robust, responsible FDA; an agency responsive to concerns, less trusting and less beholden to pharmaceutical companies. It needs to mandate more of a "trust but verify" approach 3. Another close look at the entire approval process including guidelines for R&D done overseas

Analysis: The NEJM article raises concerns, but does not suggest definitively what should be done. Exhaustive conclusions cannot be drawn for a meta-analysis performed on one drug. Physicians and patients jointly need to decide what measures to take going forward.

The spotlight is again on the FDA and how it conducts its approval process. What should be its role in following up on drugs once they hit the marketplace?
 
I have discussed the Avandia issue elsewhere on the blog so I will not repeat the same concerns here. Instead I would like to point out another concern not addressed previously.

Glaxo has expanded its R&D into China, in addition to operations in India and Croatia. This is not unique to Glaxo as many manufacturers are seeking out foreign countries as a source of cheap labor, more relaxed standards and finally potentially huge markets. Countries like China are also known for loose patent protection.

One concern, not often addressed, is that several foreign countries are racially homogeneous and it is not known how drug developers will adress the pharmacogenomics. Will the FDA require proof of efficacy and risks in various  genetic or racial groups? It seems the issues we have with approval of drugs will only be magnified if R&D is being increasingly conducted overseas.

There are many concerns, many questions. The only known factor right now is that Glaxo will lose some market share since Avandia is so popular among doctors and patients alike.

Implications:

Analysis:  Pharmaceutical companies have long claimed the high price of drugs is due to the need to recoup the cost of years(and millions of dollars) of R&D. Of course, hefty advertising aimed at doctors and directly to patients add to the cost of bringing drugs to market.

In that sort of climate poor patients and poor countries are deprived of vital drugs. Therefore it is very important when deals like these can be brokered. Partnerships such as these brokered by the Clinton Foundation means everyone is happy- the drug companies get market share, patients get crucial drugs they could not otherwise afford. In addition as competition among companies increases, consumers may be the beneficiaries of a lower price break.

It is to be expected that pharmaceutical companies will examine their sales and marketing strategies for other meds as well eg drugs for other chronic diseases like diabetes, CHF, CVD etc. Drug companies will seek out consortiums as much as consortiums seek out companies.

UNITAID and CHAI have demonstrated the wisdom of competitive bidding in a free market.

Implications: The idea of medical tourism is not entirely new, but has become an increasing trend largely for cost reasons. Many patients equate quality of care with "US-equivalent" or even "US-associated". Interestingly the JCAHO which accredits US hospitals and programs has been expanding its scope internationally to take advantage of just such a perception.  Patients may benefit from the JCAHO push, no matter what JCAHO's motives. 

Analysis:  Patients have long gone overseas to have some procedures done in order to recuperate in a luxurious climate and also for secrecy reasons- a tuck here and there, and the neighbors (or friends working at the local hospital) need never know. Recently the trend has increased because of cost factors. Americans can often get procedures performed (sometimes by US-trained doctors) at a fraction of what the cost would be here in the US. Some patients find that they can have more of a "cafeteria-style" choice than they would be allowed in the US.

Most Americans feel more re-assured if the foreign clinic/hospital has some American connection -e.g. run by US citizens, procedures performed by US trained doctors, facility US-accredited etc. The JCAHO and its subsidiary Joint Commision International (JCI) has established a presence overseas, largely to take advantage of this desire for "American-approved" hospitals overseas. This is a wide open market so the JCAHO has established offices in France, Italy, Singapore and United Arab Emirates. This is a very lucragtive undertaking for the cash-rich JCAHO, based in Illinois.

Recently JCAHO and JCI joined forces with WHO to promote Patient Safety worldwide. This emphasis on patient safety has , of course, been a concern here in the US for several years. WHO selecting JCAHO as its partner in addressing this problem worldwide is another feather in the cap of JCAHO.

As of this writing there is no plan for implementing the 9 Patient Safety Solutions which are all common-sense, well- proven procedures. We can expect to see more foreign healtcare organizations use the services of JCAHO/JCI in meeting these standards. Many will pay the substantial fee required to mee full JCAHO accreditation. It is hoped that patients (not just JCAHO) will benefit from this collaboration and JCAHO's reach into medical tourism.

Implications:   Abbott's new FreeStle meter does offer some good features, but it will be difficult for them to break through in a crowded market. Abbott needs to launch an adverising campaign to push the product even as it provides education as to how to best use the meter. Clinicians and Diabetes Educators need to help consumers make an informed decision.

Analysis: When Abbott sold its main diagnostic and point of care (POC) arms to GE recently, it made sure to hold on to its lucrative diabetes care business for good reason. This is an area for huge profits and significant market share, potentially.

This new meter is attractive because it meets several requirements for being dubbed user-friendly :

1. small sample-only 0.3 microliters
2. choice of several alternative testing sites-less painful than the usual finger tips
3. ease of use- few, simple steps, limited calibration, automatic sample detection to avoid premature analysis or recurrent analysis errors. Users do not want to be bothered with the nuances of complicated testing available in a clinical lab-nor should they have to!

Abbott makes a big deal of the fact that the Free Style Lite uses glucose dehydrogenase (GDH) to detect glucose in blood through an enzymatic , "coulometric" method. However, that also means it is prone to interference from several non-glucose molecules in the sample of some patients. Patients on immunoglobulins and peritoneal dialysis, for example, are subject to having maltose or breakdown products in their blood. GDH will cause false elevation in the presence of maltose, xylose, galactose etc. These patients will get a falsely high glucose reading on this meter.

So, while Abbott touts the GDH method as a "plus" because it's unaffected by oxygen in the sample, in my view it's a drawback for many patients.  In my hospital career, I have known diabetic patients on PD.

There is no doubt Abbott will be trying to maximize its margin in the businesses it retains post-GE. However it is up to the educated consumer  to use caution in thinking "newer is automatically better".

Physicians, nurses and Diabetic Educators should understand the limitations of this meter and counsel patients accordingly.

Implications: The approval of this new drug is very good news as long as it's used per approved indications. This drug is new in a real way since it has  a novel mode of action. It's exciting that it has a short course; and since it's topical it can be prescribed even to young kids who have a difficult time swallowing pills. It contributes to the arsenal in fighting a fairly common and annoying infection among kids in schools, day care centers etc.

Analysis: Altabax (retapamulin) belongs to a new class of antibacterials called the pleuromutilins. They have a novel course of action in that they bind to the 50S subunit of the bacterial ribosome, thereby inhibiting protein synthesis. A novel mode of action minimizes the chance of bacterial resistance -at least for awhile.

The fact that it's topical makes it very attractive for use in young kids who have  a hard time swallowing or who find medicine unpalatable. This is the exact population prone to impetigo for which the drug is approved. Of course, it can be prescribed for aduts as well. It should be recalled that impetigo is cause mostly by Staph aureus and Strep pyogenes, so doctors should resist the temptation to prescribe Altabax for every skin irritation or infection. Such a practice will delay more effective, appropriate treatment and serves to speed the development of bacterial resistance.

Most topical antibacterials have to be used for much longer- as  much as three times a day, and as long as 12 days in some cases. Altabax  can be used twice daily for 5 days. That's also good news.

Glaxo Smith Kline should see good reception and healthy sales in the market place for their new drug.

Implications: It was hardly surprising that this court upheld a ban on late term abortions. While it is true that the legal system reflects the values of society, it is becoming more diffuclt to separate legal decisions from political decisions. Judges increasingly tend to vote their political beliefs in favor of law or precedence. Implications: how will women, political scientsts and physicians react to this ruling?

Analysis: The Supreme Court upheld a ban on late term abortion which abortion opponents call "partial birth abortion". It is interesting the Court rejected a 2000 Nebraska law that would ban late term abortions. The opinion in that case given by the Court is that the law was too nartrow becuase it did not have an exception for the health of the mother. The majority in that case included all the dissenters in this case, plus the then-Justice Sandra Day O'Connor. With the departure of the moderate swing-vote O'Connor, the majority flipped.

Late-term abortion is a procedure endorsed by the College of Obstetrics and Gynecology in the (rare) cases in which it is the only option to preserve life. The ruling is significant in that the Court is outlawing a medical procedure completely. It will be interesting to hear the views of physicians on this issue.