It’s one thing for medical researchers to suspect an answer they set out to prove is within the scope of the methods by which they conduct the study. It’s quite another when the results of said study give a totally unexpected conclusion. This is perfectly illustrated in this week’s NEJM, in which investigators show that cardiologists are essentially inappropriately heading right for the high-cost (and apparently low-value) procedure known as the angiogram in attempting to diagnose coronary disease.

Out of almost 400 000 patients studied, investigators found that 4 out of every 10 patients who underwent this procedure (which involves invasive catheterization) had absolutely no findings of disease (blockages). Not exactly half, but you get the idea. Although it’s clear that these subspecialists must do a better job in stratifying the most appropriate patients for this procedure, what’s even more salient is the fact that coronary angiograms — being an invasive procedure — are not without risk. Their implementation carries an approximate risk of 1% of an acute coronary event (ie., heart attack), not to mention the amount of radiation exposure involved. | LINK

A major focus of President Obama’s healthcare reform initiatives included over $1B in funding for comparative effectiveness research — a discipline designed to study the most efficacious, efficient, and low-cost methods for healthcare delivery. Perhaps the most basic scenario is defined by the study of two different pharmacological therapies for the same problem. A trial published in this week’s JAMA states, however, that relatively few studies were devoted to this research modality, a cornerstone of Obama’s pledge to research better ways to deliver healthcare more cheaply. Only a third of 328 studies published in six top medical journals from June 2008 through September 2009 met the definition of comparative effectiveness, according to the investigators.

Naturally pharma companies aren’t invested in such matters, with the majority of funding for CE trials paid for by public sources. Typical pharma-financed trials are usually designed to show positive results. Although the need for unbiased, pure research is high given Obama’s admirable concern for such resource deployments, the road to drug research using such models is a long one filled with roadblocks — as long as Pharma has a stake. Perhaps a better way to ensure greater adoption of this initiative is not only to earmark a steady stream of federal funds targeted at comparative effectiveness research, but also to compare newer treatments with longstanding existing modes of treatments (pharma or otherwise) whenever possible.

RELATED: House bill concerning CE [PDF] | Senate bill [PDF]

The questions and lingering concerns surrounding the overuse of antibiotics is an age-old and well-worn conundrum for physicians and patients. Even the latter group, well-informed as consumers of healthcare, can agree that most acute upper respiratory infections are most often the result of viral infestations which play themselves out in spite of antimicrobial treatment.The decision to (over)use them in standard medical practice is often the point of debate, as physicians weigh factors such as patient satisfaction and lingering medical and health policy issues surrounding resistance.

Last year, this blog reported on these issues as background for a program in which some retail pharmacy chains were giving away for free antibiotics to patients with prescriptions from their physicians as a way of helping with affordability in the wake of the debate on reform. The CDC offered a statement promoting the responsibilities providers, pharmacists, and patients should consider in taking part in such a program.

Smaller chain pharmacies are trying to compete with the big boys, and in trying to earn store-brand loyalty among their (un- and underinsured) consumers, they are throwing free antiobiotics their way. Last week, the CDC sent out letters those several chain pharmacies that offer no-cost prescription antibiotics to low-income consumers urging them to promote responsible use of antibiotics.

While the program was essentially successful in its efforts to bridge the gap between affordable, accessible healthcare and patient responsibility, no one was really prepared for the massive policy decisions that would have to be made as the June ‘09 H1N1 pandemic loomed — after its initial discovery just one month after this initial Doctor Pundit posting.

It’s often said that the beleaguered emergency department (ED) is the initial point of care for many patients. In this current broken healthcare delivery system, that means an umbrella which “covers” the uninsured as well as those who are underinsured. The total cost for these points of acute care notwithstanding, how is the best way to explain new numbers out of the CDC this week?

The CDC’s National Center for Health Statistics reported the numbers in its annual summary of U.S. data on disease conditions, health behaviors and use of medical services. The scan figures are based on visits to roughly 500 hospitals and 3,000 doctor’s offices and outpatient clinics.

According to this survey data, the CDC says that the use of imaging modalities in the ED has quadrupled since the mid-1990s. Besides being just another point of confirmation of the origin of skyrocketing healthcare costs in this country, the heavy emphasis placed on tech will not abate anytime soon. Issues pertaining to defensive medicine, integration of such tech into ingrained training of new physicians, and the cost of using such technology within the medical device market are all good reasons to try to begin attacking this startling — yet, unsurprising — statistic. | LINK

What’s the healthiest county in the state in which you live? A new survey just published by the RWF finds what is essentially common knowledge in the healthcare policy blogosphere —  that persons in more rural counties fare worse than their urban counterparts with respect to decreases in healthcare access, increases in premature death, increases in hospital admissions for the treatment of highly preventable conditions, among other findings.

These findings should come as no surprise, because all (healthcare) politics is local, right? Here in Minnesota, research findings such as these take on an entirely prescient meaning — as our Governor is proposing enormous cuts in spending within the budget this cycle in order to balance it. The vast majority of those cuts are occurring in within the Dept. of Human Services, particularly its wholly funded General Assistance Medical Care public payer program. | LINK

• The Wellpoint saga continues…as well as the blame game for significant premium hikes.
• Study: alcohol + energy drinks (like Red Bull) = recipe for disaster.
• Has the H1N1 pandemic peaked?
• The first study of the anti-CSF prototypes for treatment/reversal of Alzheimer dementia is underway.

The trial will measure in the cerebrospinal fluid (CSF) and blood plasma of amnestic mild cognitively impaired (MCI) patients the biochemical changes that are associated with AD and correlate them with the pharmacokinetics of the drug and its metabolites.

• For California, the bleeding never ends. Today, Gov. Schwarzenegger releases his spending plan for 2010-11 which details even deeper cuts to its Dept. of Human Services.

Often referred to as the “bible” for the medical discipline of psychiatry, the Diagnostic and Statistical Manual of Mental Disorders, still in its fourth edition overall, is preparing for a makeover — its first since 1994. This was the reference that was the handbook for getting through psychiatric rotations in medical school and residency. Its focus is to provide criteria for diagnosing mental disorders. Incorrectly referred to as a “cookbook” by many, the manual actually stands as complementary to the myriad postulates and patient presentations often part of the challenging workup toward a clinical psychiatric diagnosis.

Scheduled for release in 2013, the fifth edition is now in its final stages of preparation. Starting today, a task force commissioned with proposals for the upcoming edition is now soliciting public comment on proposed changes — which include everything from the proper nomenclature for substance abuse to the increasingly necessary strict determination of the diagnosis of autism. | LINK

A year ago, this blog cited a study which detailed the difficulties cancer patients faced when navigating the byzantine nature of health plans which essentially made it difficult, if not impossible, to receive life-saving treatments. The paper [PDF] went on to describe the problems these patients would still face even when eligibility requirements for government assistance via Medicare or Medicaid were at least partially met.

Either through ignorance of policyholders’ plans limitations or via the inability for their out-of-pocket costs to cover the difference, cancer patients have continued to face significant challenges in accessing crucial care. The verdict may still be out on the finer points of President Obama’s goals for reform, but Insurance does not really seem to be waiting for his signature on legislation to react.

With respect to one insurer, news comes of a cancer patient’s current fight to obtain treatment oncologists thought could save his life. Relapsing neuroblastoma has sidelined a five year-old’s life right now; his insurer has refused a new treatment option it deems as expiremental — in spite of covering a cheaper treatment in 2007 that was also called such, resulting in a full remission. The child’s parents are suing the carrier.

Advocates for insurance reform have taken a backseat in the reform debate, which is not surprising. Although, Obama has described his reform plans are not a referendum on reform of Insurance in a strict sense, it is apparent that sound arguments based upon solutions in the way coverage is paid and delivered need to transcend the rather simple promise of non-discrimination based upon claims denials.

The increase is primarily for health programs in poor countries that will build on U.S.-funded efforts to combat AIDS. President Barack Obama’s budget boosts global health initiatives by almost 10 percent — expanding child and maternal health programs that coincide with AIDS relief programs in the world’s poorest countries.

The new global health initiative reiterated the administration’s pledge to put more than four million people on HIV/AIDS drug therapy and prevent more than 12 million new HIV infections by 2014.

AIDS/HIV continues to be a scourge worldwide, to say nothing of its prevalence here in the United States, as well as here in Minnesota — whose increases in incidence and prevalence should not only spur new efforts at education, but also at healthcare delivery with respect to this still-fatal virus. | LINK

All it took was an inch — as the GOP is going the whole mile, and then some. I’m talking about the stalemate in getting Obama’s reform bill passed. The election of Scott Brown to fill the seat once held by the legendary health reform stalwart Ted Kennedy seems to be only the beginning of an effort by the GOP to take over the parameters of what “reform” really means at this point.

The WaPo has an interesting analysis into the Democrats’ missteps leading to where the party finds itself today: a wounded warrior with very little to show in the way of valor in upholding Obama’s original plans for an overhaul.

Looking back, Obama and his congressional allies failed to appreciate the depth of frustration with Washington – people’s desire for health care legislation that would respond to their anxieties, not the clamor of interest groups.

There’s more. Some GOP lawmakers are upping the anti-reform rhetoric with fiesty language meant to energize its base and incite debate for their benefit. Invoking states’ rights arguments, a VA congressman calls reform measures at the hands of Democrats “mobster mandates”, and such issues “cross the line” as far as he’s concerned.

Del. Robert G. Marshall (R-13th District) has filed the “Virginia Health Care Freedom Act” (HB 10), which would “protect an individual’s right and power to participate or decline to participate in a health care system or plan,” according to a summary of the bill.

Mobsters and missteps. February is getting off to a rollicking start for the party that was supposed to have had a bill on Obama’s desk by now.

A nationwide clinical trial is underway to determine if a specialized drink is able to improve the neurocognitive deficits seen in Alzheimer dementia (AD). The tested concoction is being evaluated for its ability to provide improvement in the clinical domain of verbal recall. The trial is based upon a European study done in which 225 AD patients were randomized to take the nutritive drink or a placebo. Results were apparently encouraging^[1] enough to U.S. researchers to enroll patients at 40 sites across the U.S. in a double-blinded study. Should be interesting.

I guess you could call it a kind of Boost for dementia.

1. In that study, 225 patients with mild Alzheimer’s were divided into two groups. Some drank Souvenaid and the others sipped a non-medical drink every day for 12 weeks. Researchers found that the patients who drank Souvenaid improved in a delayed verbal recall task. [↩]

Pennsylvania’s Corrections Department is getting creative in the healthcare delivery to its aging prison population. With funding courtesy a grant from the National Institute of Nursing Research, the state will be bringing together the appropriate caregiving provider contingent to study the cheapest and most effective ways to deliver end of life (EOL) care. This pro-active move will likely be a point of reference as state budgets come under increasing pressure to provide this level of service to this patient population in the unique ”perfect storm” of declining state budgets devoted to healthcare delivery; exponential growth of geriatric populations/units in correctional facilities; and competition for federal healthcare dollars as the result of the Obama reform package (whenever that occurs).

The project will develop an intervention toolkit for use by staff at any prison in the country. [..] Prison workers, including health care professionals, chaplains, prison society volunteers and corrections officers, will provide information on current limitations, strengths, existing perceptions of end-of-life care among prison stakeholders and areas of care that bear improvement. Using the data collected, researchers will create a set of educational strategies for use by prison staff that they can tailor to fit individual prison’s needs.

The devotion of grant money to fund this type of research is appealing and compelling on many fronts — not the least of which is a shared national discourse which is sure to follow on such unique EOL care initiatives. | LINK

Higher copays mean a higher incidence of unnecessary acute care visits, thereby placing elderly patients at higher risk for significant medical problems if not caught earlier. This, according to a study just published in the NEJM. This trial sheds light on a phenomenon not adequately studied until now because of numerically inadequate elderly subjects for study and the absence of reliable Medicare claims data.

Patients affected were principally enrolled in Medicare Advantage (MA) plans whose premium copays increased.  They were compared to patient cohorts whose plans did not increase copay amounts for a 5 year period (2001-2006). The shifting of the cost of care burden to the patient resulted in the findings of almost 20 fewer annual outpatient visits per 100 enrollees in the year after the rise in copayments and 13 more annual inpatient days per 100 enrollees of MA.

Although study limitations were quite notable for the lack of randomization among specific medical diagnoses (non-randomized controlled mechanism); the use of primary care versus specialty care measurements; and the lack of the inclusion of the measurements of cost-shifting on future hospital visits — the basic take-home message is the same: increased out-of-pocket healthcare costs for ambulatory (office) visits for elderly patients mean decreased secondary prevention of adverse medical consequences and higher healthcare costs overall, owing to increased use of hospital services. | LINK