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.

Pfizer’s current research on a potential blockbuster anti-Alzheimer drug is currently back to drawing-board status. According to the pharma company

[T]he drug, called Dimebon, had shown virtually no effect after six months in treating the cognitive decline or behavioral problems associated with Alzheimer’s when compared with a placebo.

Apparently, Wall Street has been watching the results of this Phase I study; the verdict is still out on whether Pfizer will continue to fund the research for this agent — designed to work better and longer at inhibiting some of the most distressing symptoms related to the disease. | LINK

A safety review of GSK’s Avandia, under fire and intense scrutiny for its role in the possible development of cardiac adverse effects is nearing completion. In spite of the continued negative press, the pharma company has issued a thirty page rebuttal [PDF] of the Senate Finance Committee’s report alleging those safety issues.

The pharma company faces an uphill battle. In the wake of 24-hour, always on news cycles which seemingly filter only stories of negative sensationalism, it should be taking its damage control cues from Toyota these days.

Among the report’s most “glaring omissions” is its lack of discussion about the final results of the ADOPT, DREAM, or RECORD trials, the company said in a release. It said data from these three trials were reviewed by an FDA advisory committee in 2007 that voted overwhelmingly to keep rosiglitazone on the market.

Perhaps, but the issue now is that GSK chose to keep this information from the meta analysis of these trials from prescribers and patients, according to the Cleveland clinic physician responsible for bringing this data to the forefront. | LINK

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

• Vanderbilt University (my undergrad alma mater) has announced that it has access to a special blood test that can predict a patient’s risk for heart disease. Using genomic factors, along with the patient’s age, history of stable chest pain, and gender — the assay (dubbed Corus CAD) offers a non-invasive alternative in stratifying coronary disease risk.
  

  The test was developed as a part of a new medical field called genomic medicine, which enables doctors to further personalize patient care based on the unique genomic makeup of individual patients — an important factor for many visiting the doctor. For this reason, the blood test interests many physicians.

  Count me among those interested.

• On a more dour note, there is renewed interest in the recall of rosiglitazone (Avandia), the Glaxo drug with known associations in causing cardiac disease and risk of death; confidential studies via officials in the FDA are recommending the drug’s withdrawal from the market, potentially leaving Pfizer’s pioglitazone (Actos) as the only market alternative in this class to treat diabetes mellitus, type 2.
  

  The company has faced criticism that it has known about the heart-attack risks associated with Avandia for years. Glaxo added a “black-box” warning to Avandia in November 2007 that says the drug can cause or exacerbate congestive heart failure. The company has also faced accusations that it attempted to intimidate scientists and doctors outside the company who raised questions about the safety of Avandia. The company has said that it didn’t try to intimidate anyone.

You know the path toward any sensible healthcare reform is dead when Pharma’s chief lobbyist is prepared to step down. Former Louisiana congressman and PhRMA head, Billy Tauzin — who brokered a deal with the Obama admin to forge forward Pharma’s role in reform efforts — will be calling it quits in June.

You may be wondering why would one of the industry’s most loquacious and opinionated frontmen who could have shepherded his position as long as he wanted has decided to abandon the post. Perceived pressure. Pressure that was sure to mount against him as a complicit player in reform on the Democrats’ terms. But something funny happened on the way to Obama’s Oval Office desk for signature — the reform bill’s chances took a decidedly different turn with the election of Scott Brown to Teddy Kennedy’s long-held Mass. senate seat.

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• 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.

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.

You just have to hand it to Minnesota and its spirit of rugged self-determination. Its citizen individualism and desire to pioneer are just a couple of the qualities that are part of the state’s storied history as innovator and trendsetter. The concept of managed care as a healthcare delivery ideal had some of its roots in Minnesota, a concept going back over 35 years. Designed as a way to create a balance between providers and payments for services rendered, it has evolved — for better or worse — into a system upon which today’s healthcare marketplace has codified current business practices. That is, the very dynamic which has given the current President of the United States such a strong (though somewhat misguided) desire to overhaul the way healthcare is delivered in this country.

Pharma, Insurance, and the physician are the core triptych at which so much in the debate to reform healthcare is directed. Many primary care physicians feel as though they are at the epicenter of this reform morass, and many are left feeling dismayed over why they chose medicine as a profession at all. For many family docs, for example, navigating the complexities of day-to-day practice; feeling the pressure of seeing enough patients to justify employment in many manage care systems; and dealing with Insurance and public payers in order to simply get paid are essentially too much for them to deal with. Attrition from the profession usually results.

Imagine the self-determination of one Minnesota family physician — an employee of a primary care group in the Twin Cities for decades — when he simply could not “take it any more”. With actions that can at once be described as both narcissistic and noble, this doc decided to go it alone and get Insurance out of the mix altogether. Armed with $80 000 and a desire to accept only cash, he’s jumping into uncharted territory in 21st century healthcare delivery and going back to the pre-managed care days of Dr. Marcus Welby — and he’s doing it in one of the most heavily-penetrated managed care states in the country. The spirit of Minnesota innovation shines again, at least for one physician. | LINK

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. [↩]

Given time, anything can be politicized. Take the hysteria surrounding influenza A. Seems as though, since 9/11, the issue of mass casualties — be it via any cause — has, as a matter of policy, become a staple political topic among many policy organizations, governments, lawmakers, think tanks — you name it. With the formation of the Department of Homeland Security, protecting this country against the real or perceived threat of terrorism has become a necessary, yet arduous task, on the road toward providing and maintaining its national security. Military might is understood; in fact it is one of the exemptions President Obama seeks to the spending freeze he’ll announce at the SOTU address on Wednesday.

The spectre of biological warfare is another issue.

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