Lab Soft News

Why Having A Pet Tends to Improve Your Heart Health

Bruce Friedman — 2013-05-20T14:35:30-04:00

There is a correlation between having a pet such as a dog or cat and an improved health status. Exactly how this works was the subject of a recent article (See: American Heart Association: Pets, especially dogs, are good for the heart). Below is an excerpt from it:

An animal companion may not just warm your heart, but also help you maintain a healthy heart....Pet ownership, particularly dog ownership, is probably associated with a decreased risk of heart disease," [said the] director of the cardiac care unit at Baylor College of Medicine....[T]here are 78.2 million owned dogs and 86.4 million owned cats in the United States. Thirty-nine percent of U.S. households have at least one dog, while 33 percent have at least one a cat. The AHA's committee reviewed previous research on how pets affect human health, and they found studies that showed owning a pet was associated with fewer heart disease risk factors and increased survival among patients. In particular, owning a dog was shown to reduce cardiovascular risk, perhaps because dog owners are more likely to engage in physical activities just by walking them. One study of over 5,200 adults showed that dog owners were more active than non-dog owners, and were 54 percent more likely to reach recommended levels of physical activity....[A cardiologist said that] "there are plausible psychological, sociological and physiological reasons to believe that pet ownership might actually have a causal role in decreasing cardiovascular risk." [He also] pointed out though if people buy a pet but sit around all day, smoke, eat whatever they want and don't monitor their blood pressure, heart benefits aren't likely."

So walking your dog improves one's health by providing an incentive to walk him around the block a few times a day. This probably won't help if the owner engages in other unhealthy habits. You all know what they are. I also believe that caring for a pet has unique psychological benefits such as relieving stress. These benefits have been shown to be more effective than ACE inhibitors in lowering blood pressure (see: Pet Dog or Cat Controls Blood Pressure Better than ACE Inhibitor):

[A professor of medicine] assessed the effect of social support on heart rate, blood pressure and renin reactivity in response to mental stress in a group of 48 stockbrokers, all of whom were being treated with lisinopril, an angiotensin converting enzyme (ACE) inhibitor used to treat hypertension. She found that in 24 participants selected at random to add a dog or cat to their treatment regimen, these cardiovascular measures remained significantly more stable during stressful situations than in 24 participants in the non-pet-owner group, who served as controls.

The bottom line is that rather than spending money on drugs and surgery for yourself, redirect it to the veterinary bills for your dog and cat. It's a better investment.

Epic Founder Faulkner Gives Hospital Executives Exactly What They Want

Bruce Friedman — 2013-05-17T14:02:18-04:00

Judith Faulkner, founder and CEO of Epic, is warming up to the media according to an interview in Forbes by Zina Moukheiber (see: An Interview With The Most Powerful Woman In Health Care). Here's the reason that she offers in the interview:

I’m recognizing that when we were small, we could stay under the radar, but now it’s harder. I get so many requests for interviews. If I talk to everyone, we can’t do our job with our customers and work on our software. It would be hard to stay focused.

Here's one of the many reactions to the piece by David Shaywitz, also of Forbes (see: Two Quick Reactions To Epic Faulkner Interview: SV Should Show Judy More Love; We Should Shouldn't Let Hospitals Off Hook)

Interoperability issues associated with Epic may reflect tacit preferences of hospital systems. Tory Wolff and I have discussed the interoperability challenges associated with Epic, and it’s potentially negative impact on the innovation ecosystem (see here and here). Faukner’s comments don’t particular assuage my concerns, but certainly highlight Epic’s laser-focus on delivering what customers want – and make no mistake, the customer isn’t the patient but the hospital. This is critical to appreciate. Thus, while it’s easy (and appropriate) to critique Epic for impeding data sharing, it’s probably also important to remember that if hospitals were all that keen to share data better, I suspect Epic would rapidly find a way to accomplish this. It’s almost as if Epic provides hospitals with plausible deniability. While it may be convenient to blame EMRs in general, and Epic in particular, for data access challenges, I suspect we also need to dig deeper, and hold hospital systems themselves far more – what’s the word? – accountable.

I couldn't agree with Shaywitz more. In fact, here's a quote from my note of September 14, 2011 (see: Judith Faulkner, EMR Interoperability, and Washington IT Politics)

Now comes a little secret that is not discussed much. Hospital CEOs and CIOs have little interest or enthusiasm for multivendor interoperability, either within their hospitals or hospital systems or across the outside hospital systems that they compete with. Customized interfaces between heterogeneous systems are a pain in the rear-end for the CIOs. They would thus rather have shrink-wrapped integration delivered by a vendor like Epic, the so-called "enterprise solution." Moreover, CEOs don't want to encourage broad patient and clinical data portability because it gives the payers (insurance companies and the federal government) a strategic advantage during negotiations about reimbursement.

So, when the feds raise the topic of interoperable EMR software, most hospital CEOs and CIOs will stand up and cheer. However, when they go out to purchase EMR software, they largely select Epic, particularly the larger ones that can afford it. Faulkner provides the non-interoperable product that they really want. She can also runs political interference for them. She donates generously to the Democratic party, she is tight with the Wisconsin congressional delegation, and takes no prisoners in her political feuds (see: Epic Flexes Its Political Muscle in Wisconsin with Boycott). And she can now try to block any inconvenient initiatives in the arise in the Health Information Technology Policy Committee.

Epic will provide some measure of interoperability to her hospital clients but slowly and most efficiently among Epic client hospitals. This is what her hospital clients want and this is what she will give to them. Here are the (slightly garbled) Epic "rules of the road" in terms of working with other HIT vendors, quoted from the Forbes interview:

We don’t let anyone write on top of our platform, come read our code and study our software. I worry about intellectual property at that point. With our customers, we make sure we have signed agreements. They know they have to respect our software. Customers can do it in a controlled environment, but not the whole world. You’ll see us do more and more of that.

Should Hospitals Develop Lab Formularies Like Those in the Pharmacy?

Bruce Friedman — 2013-05-16T20:14:13-04:00

I recently learned about the concept of a lab formulary, an analogue of the pharmacy formulary. The latter is a list of the stock drugs carried by the pharmacy in a hospital. Prescriptions for hospital patients can only be written by physicicans for the drugs listed in the formulary. The comparable notion on the lab side is that only tests contained in the lab formulary can be ordered by physicians. Here is an article that describes the concept in greater detail (see: Constructing A Lab Formulary). Below is an excerpt from it:

Given healthcare's increasing emphasis on cost control and quality measurement, laboratorians need to reconsider their roles within healthcare organizations. A lab that provides what appears to be a commodity service may be at risk of being marginalized at best or outsourced at worst. But a laboratory that plays a highly visible role in promoting high-quality clinical care can strengthen its status within a hospital or healthcare system. One approach worth considering is to think of the laboratory test menu as a "laboratory formulary" analogous to the drug formulary maintained by a hospital pharmacy. Despite what outsiders might think, the role of the hospital pharmacy goes far beyond simply stocking drugs and fulfilling orders. For one thing, it is not feasible to stock every drug in every formulation that a physician might order. For another, it would not be in patients' best interests for pharmacists to fulfill blindly all orders they receive.

...[T]he appropriate role of the laboratory professional goes far beyond simply maintaining analytic quality and fulfilling laboratory orders. It includes determining what test methodologies will be offered and in what forms, specifically point of care, in-house laboratory and referral laboratory. It also includes redirecting physicians when they order tests that the laboratory knows to be suboptimal....The stereotype of a lab professional, whether technologist, clinical lab scientist or pathologist, is one of an introvert who likes to hide away in the lab... But the stereotype still risks being self-fulfilling....As lab professionals find creative ways...to share diagnostic testing expertise with medical staffs, we, too, will see an increase in professional status. And more importantly, patients will benefit through more efficient and accurate diagnostic testing.

I have not heard any strident calls for the use of a lab formulary so perhaps I am stirring up controversy where none exists. One of the major drivers for the development of pharmacy formularies has been the need to switch physicians to the less expensive generic drugs to contain drug costs. If a particular generic drug is the only option available in a hospital, this goal can be more rapidly achieved. The ire prompted by such a shift from the clinicians is transferred from the pharmacist to the hospital pharmacy committee that maintains the formulary. Since there is no "generic equivalent" to lab tests, such a goal can't be used as an incentive for the development of a lab formulary.

I can envision that one major rationale for the development of a lab formulary: the desire to place some limits on the inappropriate ordering of expensive molecular and genomic tests. However, even the most expensive of these tests may be appropriate under the right circumstances. Rather than a blanket ban on such tests, it would seem more appropriate to publish the clinical criteria for the ordering of such tests and then require the approval of a pathologist when these clinical criteria are not met. In other words, publishing criteria for ordering expensive lab tests, and then enforcing them, would be a suitable substitute for a lab formulary.

The Institutionalization of Healthcare; Consequences of Big Medicine?

Bruce Friedman — 2013-05-15T19:13:10-04:00

I posted a note five days ago about how the cost of healthcare seems to be gradually declining (see: Decrease in Healthcare Costs May Persist as Economy Revives). A reader, Ajit Alles, responded with a comment that decreasing expenditures of health my result in a lower quality of care, which I responded to in another note (see: The Correlation between the Cost of Care and the Health of a Population). He has responded to this second note with the following comment:

As follow-up, I agree that we spend way too much on end of life care, but that won't be reduced without a cultural shift. People expect miracles from medicine based on what they hear on the news and see in TV dramas. We could spend less and get better results, but people have to first start accepting that modern healthcare has limitations, not the least of which is funding. The new push for genomic healthcare is a good example of unrealistic ideas being pushed for profit. If everyone thinks that they are going to get personalized gene targeted healthcare they are dreaming! I know I'm a curmudgeon in this regard, but we first need to have good basic healthcare before we get cadillac genomics....We in for-profit medicine must share the blame for pushing "new and improved" medicine that is unaffordable and only (marginally) benefits the few people who can afford it. I recently heard of a family that wants some genomic test done on their child with cancer. The test looks at sequence variation in multiple genes and provides a "report" of very limited utility since most of the variations have no specific treatment. The test costs about $25000 and is not covered by insurance ....The family can afford to pay for this so it's being done with the encouragement of the oncologist. There are others who peddle proteomics reports to desperate patients. Enough said. This is the road to ruin.

I would like to respond specifically to his suggestion that "[those of us] in for-profit medicine must share the blame for pushing new and improved medicine that is unaffordable and only (marginally) benefits the few people who can afford it." I agree that many providers participate in "for-profit" medicine. However, the nature of the healthcare enterprise is now changing to what has been called "Big Medicine" or "Big Med" (see: Physician Private Practice Declines; the Last Barrier to Emergence of "Big Medicine"; The Transition to "Big Med": Need for Emphasis on Standardization and Cost; Health Systems Use Their Regional Dominance to Muscle Insurance Companies). With the rapid decline of private physician practices, many of the key decisions about the future of healthcare will be made by the federal government, large hospital systems, health insurance companies, and Big Pharma. So while we indeed have a for-profit health system in this country, most of the resources will flow from institutions like the federal government and health insurance companies to large institutions like large hospital systems. The great majority of physicians will be hospital employees. I refer to this as the institutionalization of healthcare delivery. We need to better understand the consequences of this shift.

I think that this change will have a major effect on the incentives experienced by physicians. In previous notes, I have made the point that cancer patients receive better care if the treating oncologist is salaried and does not benefit directly from selecting the most expensive treatment. This idea becomes apparent, as one example, in the treatment of ovarian cancer patients where a private oncologist is incentivised to maximize revenue from patient "chair time" whereas salaried academic oncologists seem to be more inclined in select the preferable intraperitoneal infusion of chemotherapeutic agents (see: Patients with a Cancer Should Seek Treatment in Cancer Hospitals). This is the best therapy but complicated and with lengthy patient visits. Here's are a couple of additional articles about how oncologists are compensated for additional reading (see: Will the Sequester Cause Oncologists to Lose Money Prescribing Chemotherapy?; Who Pays Your Oncologist?).

For private oncologists, the so called "oncology concession" goes to their group practice and they themselves directly benefit financially from their clinical decisions (see: The Oncology Concession Under Attack by Health Insurance Companies). For a salaried oncologist, the "oncology concession" goes to the hospital whose executives may choose to pay their oncologists the internist market salary, retaining the difference. The hospital may then choose to reward its executives at a higher level for developing a bigger cancer center (see: Cancer Business Highly Remunerative for Sloan-Kettering Executives).

I believe that health system executives will be more highly compensated and physicians will be less so as a result of institutionalization. After all, it is the executives who are making macro compensation decision and it would be natural for them to reward themselves. Moreover, these same executives will also have critical decision-making power in terms of how "new and improved" medicine is delivered. I believe that most of decisions will be based on how such care is compensated by the various institutional payers.

Is Any Hospital Using the "Hybrid" Digital Pathology Business and Workflow Model?

Bruce Friedman — 2013-05-14T10:26:32-04:00

In a previous note, I discussed the hybrid teleradiology business model (see: Hybrid Model of On-Site and Remote Radiology for Enhanced Patient Workflow). In a nutshell, it works in the following way:

A radiology department at a 370-bed acute-care hospital in Carmichael, California, utilizes both its on-site radiologists and remote radiology ("nighthawk") consultants to improve the quality of care and workflow.
Cases are turfed to the outside consultants when the local radiology expertise is unavailable (e.g., neuroradiology), when the local number of radiologists is insufficient to handle the current case load, and during the night and weekends when the local radiology department is not fully staffed.

It occurred to me that this model would be ideal for smaller hospitals today who have deployed a digital pathology system or are interested in doing so. When outside consultation is required for a surgical pathology case, it could be scanned after primary review by the local pathologist. The volume of such cases would thus be small and a high-volume, high-throughput, expensive scanner would not be required. Moreover, such a surgical pathology consultation would require only an outside secondary opinion and thus, given my understanding of today's regulatory environment, would be acceptable to the FDA.

The Digital Pathology Association is planning a webinar next month focusing on the various business models that can be used to deploy digital pathology technology. Are there any readers of this blog who have successfully deployed such a hybrid model and wish to be considered as a faculty member for this upcoming webinar?

The Correlation between the Cost of Care and the Health of a Population

Bruce Friedman — 2013-05-13T19:43:41-04:00

In a recent note, I reported that the cost of healthcare in the U.S. was beginning to decline, perhaps due, in part, to reasons other than the drop in the economy (see: Decrease in Healthcare Costs May Persist as Economy Revives). A reader of Lab Soft News submitted the following comment in response to the post:

Costs are down, but has health taken a beating? If people are seeing less of their physicians are they then showing up sicker? Does this give us a healthier population?

I have come to believe that spending more on healthcare does not necessarily result in greater health for a population. The U.S. ranks 40th in life expectancy when compared to other countries according to a 2012 WHO study (see: List of countries by life expectancy). We also spend far more per capita and as a percentage of the GDP on healthcare than all other countries (see: List of countries by total health expenditure (PPP) per capita). I understand that are are other factors at play here such as the homogeneity of populations. Moreover, much of our per capita expenditures for healthcare also come in the form of end-of-life care which is expensive and doesn't always have a positive outcome for the patient (see: The Cost of End-of-Life Care). Here's a quote from the final section of this article:

Near the end of life, clinical priorities change and measures of care should be adjusted accordingly. When illness becomes irreversible, clinical deterioration may no longer justify escalation of care, so risk-adjusted cost analysis may become less relevant than better definition and proper attribution of overaggressive end-of-life care. To avoid desperate overtreatment, better implementation of palliative care is needed, and hospital investment in such services appears fruitful.

A substantial portion of our cost-of-care is related to chronic conditions which could be ameliorated by having patients taking more ownership of their health and introducing more preventive health measures (see: The Need for a Preventive Medicine Infrastructure in the U.S.). The Affordable Care Act (ACA; Obamacare) does earmark some funds for preventive medicine so we can hopefully look forward to some improvements in this aspect of healthcare (see: Preventive Care and the Affordable Care Act). This will require a substantial change in direction of providers away from disease and toward wellness.

The conclusion that can be drawn from all of this is that spending more on healthcare does not necessarily result in better health. Stated a another way, we can reduce our healthcare costs without having health "taking a beating."

Decrease in Healthcare Costs May Persist as Economy Revives

Bruce Friedman — 2013-05-10T13:52:16-04:00

One of the biggest challenges facing our economy is the cost of healthcare which has been rising for years as a percentage of GDP. Recently, however, health spending has been decreasing. There has been much speculation as to whether this slowdown is transient or lasting. A recent article addressed this topic (see: Slowdown in Health Costs’ Rise May Last as Economy Revives). Below is an excerpt from it:

One of the economic mysteries of the last few years has been the bigger-than-expected slowdown in health spending, a trend that promises to bolster wages and help close the wide federal deficit over the long term — but only if it persists. Major new studies...have concurred that at least some of the slowdown is unrelated to the recession, and might persist as the economy recovers. David M. Cutler...estimates that, given the dynamics of the slowdown, economists might be overestimating public health spending over the next decade by as much as $770 billion. Between 2009 and 2011, total health spending grew at the lowest annual pace in the last five decades, at just 3.9 percent a year, although rising out-of-pocket costs have hit millions of families. In contrast, between 2000 and 2007, those annual growth figures ranged between 6.2 and 9.7 percent, according to government figures. Data from the Altarum Institute... suggests that the low pace of growth has continued through 2012 and early 2013.

The studies...shed new light on the precise mix of factors that have led to the flattening-out. Economists concur that the deep recession and sluggish recovery are the main reasons for slowing growth in spending. During the recession, millions of Americans lost their jobs, and thus their insurance coverage; millions more struggling families were reluctant to see a physician or undergo a procedure. But the slowdown in health costs proved steeper than forecast. It also occurred in populations whose health spending was mostly sheltered from the economic gyrations, like Medicare patients. That led economists to surmise that other factors were at play. In new research, the Kaiser Family Foundation estimated that the recession accounted for about three-quarters of the lower spending trajectory, with the rest attributed to other factors not directly related to the economy....

Among other factors [contributing to the decline], the studies found that rising out-of-pocket payments had played a major role in the decline. The proportion of workers with employer-sponsored health insurance enrolled in a plan that required a deductible climbed to about three-quarters in 2012 from about half in 2006...Moreover, those deductibles — the amount a person needs to pay before insurance steps in to cover claims — have risen sharply. That exposes workers to a larger share of their own health costs, and generally forces them to spend less.

For many years, there has been speculation that exposing healthcare consumers to the true cost of care will cause them to be smarter shoppers. Here's the key quote for me from the article above: [Rising insurance deductibles] exposes workers to a larger share of their own health costs, and generally forces them to spend less. If demand for services continues to decline, providers, exposed to more competitive pressures, will theoretically begin to lower their prices for services. All of this is going to hurt healthcare consumers in the U.S. who are generally used to a high quality and abundant services and will squeal when their choices become more limited. However and as noted above, the cost of healthcare in the country is not sustainable in the long run. Here's another article on this same topic: Brakes on U.S. health spending go beyond the recession -studies.

Does Genomic Health Have Another Winner with Oncotype DX Prostate Cancer Test?

Bruce Friedman — 2013-05-08T20:46:16-04:00

Oncotype DX definitely produced a winner with its Breast Cancer Assay. Here are the results of the test according to the company web site:

33% [of tested patients] switched from chemotherapy + hormone therapy to hormone therapy alone based on a low Recurrence Score result
4% [of tested patients] switched from hormonal therapy only to chemotherapy + hormonal therapy based on a high Recurrence Score result

The company is now introducing a new assay for assessing the risk of biopsied prostate cancer (see: New Test Improves Assessment of Prostate Cancer Risk, Study Says). Here's an excerpt from a recent article discussing this new test:

A new test can help distinguish aggressive prostate cancer from less threatening ones, potentially saving many men from unneeded operations for tumors that would never hurt them, researchers are reporting....Results of a study assessing the test’s performance will be presented...at the annual meeting of the American Urological Association in San Diego....Still, some experts said it was too early to assess how accurate the test [developed by Genomic Health] really was and whether it would make a difference in men’s decisions. Insurers are going to want to know that before deciding to pay for the test...at a list price of $3,820....The new test, which is called the Oncotype DX Prostate Cancer Test, is one of more than a dozen coming to market that use advanced genetic methods to help better manage prostate cancer....[Genomic Health] already sells a similar test for breast cancer, also Oncotype DX, that is widely used to help women decide whether they can forgo chemotherapy after their tumor is surgically removed....

The test looks at the activity level of 17 genes in the biopsy sample and computes a score from 0 to 100 showing the risk that cancer is aggressive.To see how well the test worked, testing was performed on archived biopsy samples from 412 patients who had what was considered low or intermediate-risk cancer but then underwent surgery. In many such cases, the tumor, which can be closely studied after it is surgically removed, turns out to be more aggressive than thought based on the biopsy, which looks at only a tiny sample of the tumor.The researchers found that the Oncotype test predicted such unfavorable pathology more accurately than existing methods, which depend mainly on the Gleason score based on how the biopsy sample looks under the microscope. Genomic Health said that 26 percent of the samples were classified as very low risk by its test, compared to only 5 to 10 percent for the existing methods. In some cases, however, the new test showed the cancer to be more aggressive than the existing methods.

We'll see how all of this works out. The company certainly has momentum and experience on its side with its earlier breast cancer test. These two tests represent the first generation of tests for determining the genetic fingerprints of tumors deemed malignant by pathologists but which may act in varying ways clinically. There will be more of such tests in the future, each of which should be more accurate as the experience increases. The list price for the prostate cancer test is stiff but certainly worth it for the lucky patients who may be able to avoid the more aggressive surgery and chemotherapy regimens.

PAML Invests in CellNetix, a Provider of Esoteric AP Services

Bruce Friedman — 2013-05-07T21:09:01-04:00

PAML has invested in CellNetix, an esoteric anatomic pathology esoteric lab (see: Esoteric Anatomic Pathology Testing Is Goal of New Pact between PAML and CellNetix). Here are more details from this note in the Dark Daily:

[The] agreement calls for both parties to collaborate in offering esoteric and reference anatomic pathology services nationally. It is an effort to align their clinical laboratory and anatomic pathology services to the evolving needs of hospitals, physicians and other providers....The two companies ...stated that they entered into an agreement to work together to form a “jointly owned national Esoteric Anatomic Pathology reference laboratory offering." For anatomic pathologists across the nation, this new agreement is notable. Independent pathology laboratory companies and private pathology group practices are dealing with a series of serious hammer blows to reimbursement for key anatomic pathology procedures that have happened over the past 18 months. Facing significant declines to important sources of revenue, these pathology organizations are looking for effective business strategies they can use to sustain financial viability. As a response to the deterioration in reimbursement for anatomic pathology testing services, many experts predict that there will be a wave of acquisitions, mergers, and consolidation among anatomic pathology organizations.

Here is a description of the services offered by CellNetix copied from the company web site:

CellNetix is the largest and most comprehensive AP provider in the Pacific NW. Services include cytology, histology, fine needle aspiration (FNA) services, flow cytometry, immunohistochemistry, immunofluorescence, UroVysion, and molecular diagnostics. In our subspecialized case allocation process, cases arrive in the pathology laboratory and staff allocate these by subspecialty; breast cases to breast pathologists, gastroenterology (GI) cases to GI pathologists, genitourinary cases (GU) cases to GU pathologists...

PAML is owned by two health care systems: Providence Health & Services and Catholic Health Initiatives. CellNetix is a privately held laboratory that provides clinical and anatomic pathology services in Washington, Idaho, Oregon and Alaska (see: CellNetix to partner with Spokane's PAML laboratory).

Robert Michel of the Dark Daily is right on target with his observation: As a response to the deterioration in reimbursement for anatomic pathology testing services, many experts predict that there will be a wave of acquisitions, mergers, and consolidation among anatomic pathology organizations. It's logical for surgical pathology reference labs to seek to improve their bottom lines by acquiring labs performing tests such as flow cytometry, immunohistochemistry, immunofluorescence, and molecular diagnostics.

UPenn Medical School Establishes Biomedical Informatics Institute

Bruce Friedman — 2013-05-03T11:50:19-04:00

Medical schools are getting much more interested in developing more expertise in the field of bioinformatics. Here's an excerpt from an article about the development of a new bioinformatics center at the UPenn School of Medicine (see: Big data gets a home at University of Pennsylvania’s medical school):

University of Pennsylvania’s Perelman School of Medicine in Philadelphia has established a dedicated center for biomedical informatics, underscoring the expansion of big data from drug development to population health. The Institute for Biomedical Informatics will focus on improving patient care and the research that goes into personalized medicine, according to a statement from Penn Medicine....The institute will work in partnership with Children’s Hospital of Philadelphia and some schools at the university including the school of engineering and applied sciences, nursing and as well as veterinary medicine....[The] three associate directors [of the institute] are seasoned experts in one or more of the five domains of biomedical informatics: translational bioinformatics, clinical research informatics, clinical informatics, consumer health informatics and public health informatics.....[One of the directors] said some emerging areas of interest within biomedical informatics are personalized medicine, where diagnosis and treatment is linked to the patient’s genome; social and behavioral medicine, with a focus on reducing health disparities through improving access to quality health information; and telemedicine, where the functionality of healthcare practitioners is extended beyond the traditional clinic or hospital.

According to the article, the new institute will work with a very broad charter in five IT domains: (1) translational bioinformatics; (2) clinical research informatics; (3) clinical informatics (4) consumer health informatics; and (5) public health informatics. In a sense, the reference to translational bioinformatics is redundant. Translational bioinformatics forms a bridge between clinical research and clinical informatics. By stating that these latter two fields will be addressed, the translational component can probably be assumed. The reference to "big data" in the article headline adds little to the narrative -- the term "big data" has rapidly become a cliche.

For me, the most important terms in this article are "personalized medicine" and "drug development." These areas are where the major payoff will come for biomedical informatics institutes at UPenn and elsewhere. These two areas of interest are tightly linked. Genomic analysis of patients and their malignancies is now yielding new and more effective therapy choices. Precision/personalized medicine these days is all about cancer diagnosis and treatment (see: Bespoke (i.e, Customized) Cancer Treatment; Cancer "Cures" and the Media).

Unstated in the article, but extremely important for these bioinformatics centers, is the role that they will play in the development of the new clinical information systems and software that are required for the storage and analysis of the cancer genomic data and drug selection. There are currently no robust clinical "omics" systems for this purpose. The urgent need for them was described in a previous note (see: Hospital EHRs Inadequate for Big Data; Need for Specialized -Omics Systems).

Research that Transfusion of "Older" Blood May Be Harmful to Patients

Bruce Friedman — 2013-05-01T09:00:00-04:00

There was a time when I, in a previous incarnation as a blood banker, spent a lot of time thinking about the shelf life of blood and how to increase the utilization of blood in blood bank inventory. Hence, a recent article about this topic caught my eye, partly out of a sense of nostalgia (see: The Shelf Life of Donor Blood). Here is an excerpt from it:

For decades, the Food and Drug Administration has limited storage of refrigerated red blood cells to 42 days. But it has been clear for some time that stored blood degrades in various ways long before that six-week limit, and some research suggests that the changes may be harmful to patients who receive older blood. Now a study published in the journal Anesthesia & Analgesia has found that after even 21 days, the membranes of stored blood cells have stiffened, apparently the result of damage over time. That’s a problem because red blood cells are about the same diameter as small capillaries, and they have to change shape to get through.....“What we showed is that the cell membranes lose their flexibility,” said the lead author, Dr. Steven M. Frank....“That makes it more difficult for them to travel through.” The study also found that the older blood cells did not recover their flexibility after being transfused into patients, unlike certain other kinds of changes that blood cells undergo during storage. For example, nitric oxide, essential to keep blood vessels open, is depleted from cells after a few hours of storage, but is restored rapidly after transfusion. Still, researchers do not fully understand the importance of such findings to clinical practice. Even permanent changes in cell structure may not matter, according to [another expert]. “You constantly have blood cells that are getting old in your body, and they’re filtered out,” he said. “It may be that that same system harmlessly filters out these structurally abnormal blood cells.” Two large randomized clinical trials have been undertaken to clear up some of the uncertainties about stored red blood cells.....Dr. Richard J. Benjamin, chief medical officer at the Red Cross, said the two trials would provide important information. If older blood turns out to be less effective, he said, “there are a couple of ways we can respond.” “There are already better storage solutions in development that show drastically improved biochemistry parameters,” he said. “Is the next step to restrict the age of blood for vulnerable populations? ....” As the system works now, the newest blood goes to hospitals that do transfusions infrequently. This gives them time to store the blood safely until it is needed. But it leaves hospitals that use the most blood — trauma hospitals and academic medical centers — with the older blood.

Some highly esteemed hospitals now hold the view that most blood transfusions should be avoided. In short, they view blood transfusion with a jaundiced eye (see: Avoiding Blood Transfusion as a Hospital Quality and Cost-Savings Measure; The Value of a Restrictive Blood Transfusion Strategy for Hospitalized Patients). These hospitals are establishing policies to discourage transfusions on the basis of both cost and quality concerns. Such policies extend beyond the risk of transmitting infectious disease with the blood. I personally don't think that there will be a rapid drop in demand for blood regardless of the results of the two randomized clinical trials referred to in the excerpt above. It's often hard to get older physicians to accept new policies. Rather, I suspect that demand for blood may gradually level off and perhaps even go down slightly in the near future as these anti-transfusion policies extend beyond the few places where they have been already implemented.

Informed Patients as Micro-Experts; Web and Patient Education

Bruce Friedman — 2013-04-29T09:36:05-04:00

I have always been supportive of the opportunity that the web provides for patients to learning about their diseases, compare their experiences with other patients, and learn about new therapies. This has been called participatory medicine in the past (see: "Participatory Medicine" and Its Relationship to Clinical Lab Testing; Recruiting Office Patients into a Participatory Model of Healthcare Delivery; The Future of Healthcare and the Four P's: Preventive, Predictive, Personalized, Participatory). Below is an excerpt of an article discussing how new web patient resources are popping up that enable education and greater participation in care (see: A Former Google Exec Aims To Power A Patient Revolution):

Well-educated patients can have a valuable voice in drug development. More than that, patient empowerment is now a real force in changing medicine, she says....Information is power. If the hierarchy of doctors are the only ones that have that power, that puts patients at a disadvantage. The power dynamic as a partner, as someone who has a stake in it, is different....Smart Patients is building on the [Association of Cancer Online Resources] ACOR experience by using the Web to do things that a mailing list can’t. On ACOR, as on older Internet communities like mailing lists and message boards, conversations are siloed with little cross-communication. If you have kidney cancer, you interact with other people in the kidney cancer group. But Smart Patients will also show you messages from other groups if they’re relevant. For instance, a kidney cancer patient with bone metastases, Smart Patients might direct you to conversations going on about cabozantanib, a drug for bone metastases in other diseases being developed by Exelixis....It also contains a search engine for clinical trials that Zeiger hopes will be easier to use than the one on the government’s ClinicalTrials.gov site, and there can be individual discussions formed around each study. [A spokesperson for Smart Patients] points out that this does not mean that patients have to be experts in their disease. Instead, each can become a “micro-expert” about part of his or her disease, and the community can serve to pool that knowledge....[He] hopes that his community will be self-correcting, especially with so many other doctors and experts around.

I have been searching for years for a name to capture the idea that some patients become so knowledgable about their diseases, particularly rare ones, that they can sometimes approach the knowledge of the physicians caring for them. Prior terms such as informed or educated patient never seemed to capture the essence of this. However, the term micro-expert, used in the excerpt above, does seem highly descriptive. Here's a couple of links to articles that provide more ideas about the micro-expert patient: THE EXPERT PATIENT AND THE OPPORTUNITY FOR PHARMA; Examining the microexpert role to improve clinical trials. Look for the pharmaceutical industry to help drive the notion of the "informed" patient. They are harnessing web sites, often inappropriately, to help market their prescription drugs and also gain more knowledge about the efficacy and side effects of their drugs. They have been previously warned by the FDA about the misuse of social media for marketing purposes (see: Limitations Placed on Big Pharma Facebook Pages).

Bespoke (i.e, Customized) Cancer Treatment; Cancer "Cures" and the Media

Bruce Friedman — 2013-04-28T11:25:35-04:00

Patients with cancer need to seek the most sophisticated care that they can obtain these days, which is usually found in cancer centers and academic hospitals (see: Patients with a Cancer Should Seek Treatment in Cancer Hospitals). Not only is treatment in such centers usually state-of-the-art but they also provide ready access to the best diagnostic tests including genomic analysis of both the patient and the tumor. They also provide ready access to controlled clinical trials where new drugs are being evaluated. Here's an excerpt from a recent article about how cancer centers are racing to map patients' genes with a interesting comments included about cancer and the media (see: Cancer Centers Racing to Map Patients’ Genes):

...Kieran P. Holohan [is], a 45-year-old lawyer who received a diagnosis of acute myeloid leukemia in 2009. After his chemotherapy and the disease’s remission, his original doctor pushed him to have a bone-marrow transplant to prolong the remission. A friend from his rugby club, a geneticist, told him that “this has a lot to do with chromosomes,” he recalled, and sent him to a doctor at Weill Cornell, Gail J. Roboz. A relatively new laboratory test found that Mr. Holohan’s leukemia had a mutation that meant that his chances of survival would not necessarily improve with the risky transplant. So he opted for more chemotherapy, and his cancer is still in remission.“They didn’t go with a suit off the rack,” he said. “This was bespoke medicine.” His doctor is more cautious. “Unfortunately, cancer is cured three times a day in the media,” she said. But that does not mean that there might not be truly customized treatments for cancer 10 years down the line, she said.

For me, this quote was doubling interesting based on the following:

I have been tracking the various terms that have evolved over the past five years to describe the process by which a genomic profile of both a cancer patient and his tumor are characterized in order to select the most effective drug therapy. Such terms include personalized medicine, targeted therapy, precision medicine, and customized treatment. We can now add to the list bespoke medicine after the British term for a custom-made suit.
I also very much like the quote above: cancer is cured three times a day in the media. This is unfortunately true and a result of over-eager journalists reporting on a cancer therapy stories and oncologists and pathologists who are being interviewed and eager to trumpet their latest therapeutic and diagnostics successes.

An Explanation about How ACOs May Save Money

Bruce Friedman — 2013-04-25T12:28:26-04:00

I have never quite understood how accountable care organizations (ACOs) are supposed to reduce the cost of healthcare although many hospitals have been creating them, often with the help of consultants (see: Hospital Executives Search for the Formula for an Accountable Care Organization). I recently came across a clear explanation about how ACOs are designed to work (see: ACOs Won't Work According to Clayton Christensen in the WSJ). Below is an excerpt from the article (see: A Health Provider Finds Success in Keeping Hospital Beds Empty):

[T]he Affordable Care Act, President Obama’s health care law, has helped encourage a shift to [Advocate Health Care's] payment model. Such agreements were merely a theory four years ago. But an estimated 428 accountable-care organizations now cover four million Medicare enrollees and millions more people with private insurance. Under Advocate’s deal with Blue Cross Blue Shield, certain patients are assigned to the accountable care framework — about 380,000 — and their health costs are projected. If Advocate achieves savings below that amount while meeting explicit quality targets, it splits the money with the insurer. If not, its revenue is at risk. In some ways, accountable care resembles earlier efforts to control medical spending, including the health maintenance organizations that proliferated in the 1980s but fell out of favor, in part because they severely limited patients’ choices. But accountable care differs by giving doctors and hospitals a direct financial stake in saving money and a reason to invest in various programs of preventive care rather than relying exclusively on the fees they would normally earn from providing services....To help control costs, Advocate has hired scores of workers to coordinate care and keep an eye on the highest-cost patients, like those who are obese or have diabetes. It started providing doctors’ offices with report cards on their performance. Dozens of quality-control measures cover items as varied as blood pressure, rehospitalizations for asthma attacks or the use of expensive imaging machines....Advocate, a faith-based nonprofit, has an advantage over other health systems just jumping into what is more broadly known as “value-based care.” In the late 1990s, well before it forged its contract with Blue Cross Blue Shield, Advocate began taking steps to control costs and improve quality.

For me, it doesn't get any clearer than this. Advocate has a deal with Blue Cross Blue Shield encompassing a defined population of 380,000 patients for its ACO. Future healthcare costs for this group of patients are estimated. Advocate personnel then employ various preventive measures to reduce the healthcare costs of these patients while simultaneously maintaing the overall quality of care for them. If the costs experienced by the patients fall below the projected costs, the hospital system gets to split the savings with the health insurance company. Obviously, the Advocate personnel will seek to focus their preventive measures on the highest cost patients in the group such as those who are obese or have diabetes because this is where the greatest payoff lies. All of this makes perfect sense to me. Provide financial incentives to promote preventive care to at-risk patients.

I suspect that most hospital executives will be taking a hard look at their ACO options in the future and try to assess whether their best course of action is to embrace this approach or to continue business as usual. This would involve admitting more patients to the hospital, performing more surgical procedures, and not emphasizing preventive care. Remember that many such executives have large physical plants to maintain and employees on their payrolls. If preventive medicine begins to take hold and reduces hospital admissions, many cities may be overbedded. This could lead to the development of bedless hospitals, a concept discussed in a previous note (see: The Future of Healthcare: Virtual Physician Visits & Bedless Hospitals).

Cancer Tissue Acquisition and Genomic Testing in Integrated Diagnostic Centers

Bruce Friedman — 2013-04-23T20:52:46-04:00

In a recent article, Dr. Eric Topol discussed what he describes as the "cancer clinic of the future." However, much of his discussion was directed at tumor tissue specimen collection and genomic testing (see: Topol on the Cancer Clinic of the Future). Below is an excerpt from it:

So what is the cancer clinic of the future going to look like, because it's just starting to get developed today? For example, when we have an individual presenting for a new diagnosis of cancer, we have to move away from fine-needle aspiration and minimal tissue; we need real tissue to be able to process it properly. Not only do we need the formalin-fixed paraffin-embedded (FFPE) specimen, but we also need another type of FF -- that is, flash-frozen specimens so that we can then whole-genome sequence this tissue. Now, when that is done at the primary diagnosis and done within hours and analyzed with the appropriate software algorithms, we could get the driver mutations nailed within 24 hours from the diagnosis. This can set up remarkably precise therapy that can be given to the patient on the basis of that individual's tumor. There are no 2 different cancers that are the same anywhere. Just like there are no 2 individuals who have the same DNA, that's the same for a tumor. One of the issues that we have to confront is that there's a lot of intratumor heterogeneity. We need multiple samples to sequence from the tumor, and if there's already a metastatic lesion, we need a sample of that as well. Multiple sequencing, frozen tissue, genome-driven guided therapy ...is what we need. That's not what we have today, but that's where we can go in the future of cancer genomic medicine....We need much more tissue, and to use frozen tissue so that we don't have to bootstrap the FFPE...and only get a couple of hundred genes or coding elements, but in fact get a whole genome from the flash-frozen specimen. That's really important, and we have to move in that direction -- get more tissue in order to account for the heterogeneity that we know exists. And we have to do deep sequencing of that frozen tissue in order to get the driver mutations identified, and also be able to anticipate where relapses can occur downstream. That is precision therapy.

Here is what I think that Dr.Topol is asking for to facilitate accurate cancer genomics:

Abundant and multiple tumor tissue samples including metastatic lesions.
Fresh-frozen (FF) tissue for whole genome sequencing as well as formalin-fixed paraffin-embedded (FFPE) specimens.
Rapid genomic processing of multiple tissue samples to discover the driver mutations of the tumor in about 24 hours.

In a number of previous notes, I have proposed the establishment of integrated diagnostic centers which I have defined as physical or virtual centers staffed by pathologists and radiologists, including interventional radiologists (see: More on Integrated Diagnostic Centers; Trend or Lukewarm Idea?; Can Existing Breast Clinics Evolve into Integrated Diagnostic Centers?; Plan for the Evolution of Integrated Diagnostic Centers Beyond Breast Clinics; Multidisciplinary Diagnostic Teams and Integrated Diagnostic Centers). Most of my earlier notes were focused on the initial diagnosis of an unknown mass. Dr. Topol's discussion reminded me that part of the mission of such centers could also be directed to the collection of tissue for cancer genomics for previously diagnosed patients. The advantage of directing tissue acquisition and genomic processing for cancer patients to integrated diagnostic centers is that all all of the processes could be protocol-driven, ensuring better coordination of these activities and the most accurate results.

Hospital EHRs Inadequate for Big Data; Need for Specialized -Omics Systems

Bruce Friedman — 2013-04-22T17:10:59-04:00

The EHRs now being installed in hospitals, viewed as the key hospital information systems, are totally unable to mange the "big data" that is being generated as a byproduct of precision medicine. This was the conclusion in a viewpoint article in JAMA by Justin Starren and co-authors. (see: Electronic Health Records Upgrades Needed for Big Medical Data). Starren is chief of the Division of Health and Biomedical Informatics in the Department of Preventive Medicine at Northwestern University Feinberg School of Medicine. Here is an excerpt from an article describing their views:

Even as physicians across the nation transition to electronic health records, commonly known as EHRs, these data systems are not sophisticated enough to handle or store the amount of electronic information created by currently available medical technology, argue the authors of a new viewpoint published online in JAMA ( Crossing the Omic Chasm. A Time for Omic Ancillary Systems). According to the authors, this chasm will only continue to grow as “big data,” including next-generation genomic sequencing, becomes cheaper and more available to healthcare providers. As fields such as genomics, epigenomics, and proteomics advance, the ability to store large-scale raw data for future reference with patients is critical, and current EHRs are not up to the task. “EHRs are designed to facilitate day-to-day patient care,” says ...Starren....“EHRs are not designed to store large blocks of data that do not require rapid access, nor are they currently capable of integrating genomics clinical decision support.”When diagnostics tests create large amounts of data,...only a small portion of relevant information is transferred to a patient’s EHR....With the rise of genomics, epigenomics, proteomics, and metabolomics..., however, the data are different....We need dynamic systems that can reanalyze and reinterpret stored raw data as knowledge evolves, and can incorporate genomic clinical decision support.”....The authors propose dedicated ancillary storage systems as an interim solution to store and analyze raw omics data.“ This approach adds value by providing a location to store variants of unknown significance until enough knowledge emerges to move these variants into clinical practice,” says Starren....The authors note that large organizations like Northwestern will likely operate their own ancillary omics systems, while smaller practices may use reference laboratories. Genomics clinical decision support systems may be part of the omics ancillary system, they write, but the decision system can also be external to the organization.“The time for omics ancillary systems is now,” concludes Starren.

Starren and colleagues are right on target here. Large academic centers are spending hundreds of millions of dollars, or even billions in the case of Kaiser, on EHRs that merely replicate the paper medical records of the past. Little attention is being paid by hospital executives and chief medical officers to the need to access and analyze the "big data" that is generated in the -omics sciences. Cancer genotyping is already leading to radically new approaches to cancer treatment (see: Cancer Centers Racing to Map Patients’ Genes). They are also correct with their following statement: ...[L]arge [academic hospitals] will likely operate their own ancillary omics systems, while smaller practices may use reference laboratories. Most of the knowledge related to the storage and interrogation of -omics information has been developed on the research side of these academic centers and these scientists will lead the way to the development of specialized -omics systems. Starren suggests in his paper that some of the solutions will be developed by the eMERGE Network. Here's a description of this network from the web home page:

The Electronic Medical Records and Genomics (eMERGE) Network is a national consortium organized by NHGRI (National Human Genome Research Institute) to develop, disseminate, and apply approaches to research. It combines DNA biorepositories with electronic medical record (EMR) systems for large-scale, high-throughput genetic research with the ultimate goal of returning genomic testing results to patients in a clinical care setting. The Network is currently exploring more than a dozen phenotypes (with 13 additional electronic algorithms having already been published). Various models of returning clinical results have been implemented or planned for pilot at sites across the Network. Themes of bioinformatics, genomic medicine, privacy and community engagement are of particular relevance to eMERGE.

Unfortunately, the large academic centers are being so badly drained of resources to pay for their EHRs, there may not be enough left over to develop the necessary ancillary -omics systems.