The cost of the delivery of healthcare in this country always seems to be independent of traditional models of demand in practically any other market-based, for-profit operation. That is, instead of relying on the parameters of patient (consumer) satisfaction or dissatisfaction; further innovation fuels the development of costlier, more advanced technology seemingly designed to break the bank (in one way or another) the very entity it is supposed to benefit: the patient.

An editorial reprint in today’s Minneapolis-St. Paul paper of record, the Star Tribune, makes the case for the unintended costly consequences this very innovation has on the big picture with respect to healthcare delivery in the 2010s. It focuses on the use of nuclear diagnostics developed by the Mayo Clinic as a superfluous and disruptive innovation which does the patient-as-consumer no favors…while benefiting the institution at the hands of government abetting.

Proton beam therapy is a kind of radiation used to treat cancers. The particles are made of atomic nuclei rather than the usual X-rays, and theoretically can be focused more precisely on cancerous tissue, minimizing the danger to healthy tissue surrounding it. [...]

To generate sufficient revenue, proton beam facilities need to treat patients with other types of cancer. Consequently, they have been promoted for patients with lung, esophageal, breast, head and neck cancers.

But the biggest target by far has been prostate cancer, diagnosed in nearly a quarter of a million men each year. [...]

With Medicare reimbursement so generous, and patients and doctors eager for the latest technology, building new machines is sane, profitable business for hospitals like Mayo.

But it is crazy medicine and unsustainable public policy.

Maybe so, but the practice of medicine depends upon the richness of technologies in which parties not only compete toward developing paths of effective treatments for chronic diseases (like cancer, in this case), but also race to spur further research on the nature and behavior of disease. It is within this self-fulfilling prophecy of the cycle of medical education that knowledge moves forward — something the creators of publications like this one thrived upon. And, that’s a good thing. | LINK

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Sign of the times: social media’s use in increasing interaction among patients with dementia. A researcher, part of a team, is busy at work on a web-based app based upon Facebook for utilization among cognitively impaired elders. She states:

“We have already carried out some practical testing of other web-based communications systems. Among other things, we have tested a “digital diary” and a “scrapbook” containing personal photos, newspaper cuttings and information found online.”

What is both curious and puzzling at the same time regarding this research is that it is being conducted in Norway, of all places. Why not here in the good ol’ U.S. of A? Innovation of this type began and germinated here. Social media’s global function of “keeping one in the loop”, including the elderly, can not be understated in its potential in non-pharmacologic dementia research. Here’s to hoping it gains ground on these shores.

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For all of the policy posts here on Doctor Pundit, it is especially cool when we’re able to relay news based upon purely scientific discovery. It’s even more amazing if that discovery will lead to even more treatment avenues than previously expected or planned for. (I guess Pharma is taking note.)

Research into the pathophysiology of Alzheimer dementia (AD) continues at its earnest and deliberate pace. Each new genetic breakthrough finding gives greater insight in to previously known pathways into the development of the disorder. It’s been long known for the past 10 years, or so, that the altered tau protein hypothesis has been increasingly critical to the understanding of the progression of the disease after diagnosis. Consequently, drug development has focused on preventing or reversing the incidence of these and other proteins responsible for progression into the moderate phase of the disease.

Researchers at U Penn and in the United Kingdom have verified the existence of five new genes implicated in the very initial development in the pathology of AD. The findings are significant, as everything from laboratory testing based upon genomic information to sites of drug action can be gleaned from this discovery. All of this means that the initial development of disease is just as important to understanding how the disorder progresses.

The ADGC’s study, led by Gerard D. Schellenberg, Ph.D., at the University of Pennsylvania School of Medicine, involved researchers at 44 universities and research institutions in the U.S. The consortium analyzed genetic data from 11,000 AD patients and nearly the same number of elderly controls with no dementia. Three additional institutes contributed confirmatory data from new individuals, taking the total number of people analyzed in the study to over 54,000.

Amid all the fanfare of this news, it is important to note that we are no closer to obtaining information on the exact susceptibility of one for AD (remember apolipoprotein E?), but the breadth of information contained within this novel genetic discovery is enough to drive innovation in this sector of medical research.

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From JAMA: Over 20 percent of patients  who receive an AICD^[1] fall out of established guidelines, ultimately facing a higher risk of death than those who properly are not treated with such a medical device. Although the study, published in this week’s edition, is of a retrospective design, it still does provide compelling data on the use of such devices, tracked by a national registry mandated by the federal government.

When the Centers for Medicare & Medicaid Services announced their expanded coverage for ICD implantation for the primary prevention of sudden cardiac death in January 2005, the agency mandated that data on all such implants in Medicare beneficiaries be entered into a national ICD Registry.

Tracked patients who received a device also tended to be sicker, carrying more chronic cardiac disease and other illnesses at time of implantation.

[P]atients who received a non–evidence-based ICD were more likely to have heart failure, atrial fibrillation or flutter, ischemic heart disease, cerebrovascular disease, chronic lung disease, diabetes, and end-stage renal disease. In addition, patients who received a non–evidence-based ICD were more likely to belong to a racial minority group (other than black) and to receive a dual-chamber ICD.

Finally, those patients who were implanted most appropriately were those most likely to have had the procedure performed by electrophysiologists — cardiologists specifically trained in all things AICD. The rate of appropriateness was statistically significant among those with this level of certification as opposed to non-EPS trained cardiologists. In previous studies, researchers had examined underuse of the devices and found that many patients who could benefit from the defibrillators did not get them. This study, obviously, looks at the converse — and provides interesting results in the process. PDF LINK

1. Automatic Implantable Cardioverter-Defibrillator

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This is a surprise. Well, at least I wasn’t expecting this aspect of reform to initiate so quickly: five states will be awarded grants to fund tech infrastructure for the purpose of creating early insurance exchanges.  HHS, of course, is responsible for the project’s implementation. The hope is that a template will be created for the overall adoption of the exchanges by mid-decade, as the result of reform.

President Obama’s push for IT integration into all aspects of reform is at play here, as interested states competing for the lucrative grants will have to design seamless modes of technology foundations for the exchanges. The amount that the states will receive is yet to be determined, with the announcement of finalists and grant recipients by February ’11.

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Imagine never having to obtain a colonoscopy for the purpose of cancer prevention and screening. The push to research alternative methods to cancer detection and early treatment in the least invasive way possible has been a holy grail of sorts in this area of preventive medicine. The desire to diminish concerns for a less onerous way of undergoing such testing is matched only by the level of anxiety, embarrassment, and total discomfort it engenders in many patients.

A DNA-based stool screen is able to, at least, stratify patients who need a follow-up colonoscopic screen, sparing patients in whom results are negative from even undergoing the procedure. As stool passes abnormal (pre-cancerous) colon epithelial cells in its wall,^[1] it collects DNA matter which can be quantified by this test to give an accurate result of one’s cancer risk by its detection.

Colon cancer is the second most common cancer killer in the US, and it is hoped that this test is able to lower the cost per detection ratio drastically. Could a home version also be in the offing? The biotech company involved in the test’s development will ready FDA application in 2012. | LINK

1. The test looks for three genes that have been altered in a process called methylation.

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The FDA seems to be focused on cleaning house. A couple of issues the agency is focusing on — attacking the increasing levels of antibiotic resistance and the failure of once formidable agents to treat serious infectious disease, and boosting its regulatory tools. In the wake of multi-million dollar lawsuits, payouts, so-called fast-tracked drugs later pulled from the market, and oversight problems originally deemed preventable by the agency; the FDA is serious about making things right.

The U.S. Food and Drug administration plans to spend millions of dollars to update its tools for reviewing prescription drugs, medical devices and tracking food safety, according to a proposal released Wednesday by the agency’s leadership. [...] “We need new approaches, new collaborations and new ways to take advantage of 21st century technologies,” the FDA said in its white paper announcing the initiative. [...] Modernization is a key focus for the FDA’s leadership as the federal agency scrambles to keep pace with the scientific developments behind the latest drugs, devices and foods.

Good news, and recommended reading [PDF, 20 pp.] for anyone interested in innovations in regulatory methodolgies as it applies to the safety, approval, and oversight of pharmaceuticals, medical devices, and treatment applications of those regulated technologies.

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The huge drive to immunize the masses against threat of H1N1 in the 2009/10 influenza season (which the WHO has officially declared concluded) has created more than a watershed moment in 21st century public health response to a potential biological catastrophe, it has also touched off a political debate that’s just getting started. And it all has to do with authoritarian mandate of the vaccine for healthcare workers.

Contrary to popular thought, many healthcare workers do not receive the vaccine; in fact, approximately 40 percent of said workers actively refused [PDF link] the vaccine last year — during infection’s peak. This notion does not sit well with a couple of policy organizations — one academic and one medical. Both groups say mandatory influenza vaccine should be a condition of employment. The groups stress increased availability of the vaccine, a steadier supply of healthy workers to administer care in times of a crisis, and an overall decrease in the incidence of influenza-related deaths in already compromised inpatients with other medical problems.

Already, the state of New York is hard at work in developing regulatory actions for its public healthcare workers. | LINK

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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

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• Popular anticonvulsant (with a multitude of off-label pain uses) gains approval to go generic.
• A Web-based provider of care analytics has come up with a prostate cancer screen. The cynic in me says it’s a new look to an old unresolved problem.

Through a web-based tool, men enter the results of their PSA test history and personal information such as height, weight and health history. This information is compared with up to a million case studies and outcomes from other men with various prostate conditions. Finally, the system may suggest a medical detective process for doctors and their patients in their efforts to detect non-cancerous prostate conditions and improve prostate cancer screening, the company said.

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