Lab Soft News

Informed Patients as Micro-Experts; Web and Patient Education

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

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

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

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

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.

The Other Real Threat to Intel; Better Utilization of its Chips

I, like many other people with an IT interest, have been closely following the decline in PC sales (see: The Shift from PCs to Tablets; Most iPads Stay in the Living Room). On the face of it, this shift would seem not to bode well for chip manufacturers like Intel. However and simultaneously, the server business is booming with the proliferation of web users and more attention to cloud computing. Christopher Mims addressed this scenmario in a recent article (see: The (other) real threat to Intel’s business: You’re making better use of its products), Below is an excerpt from it:

...Well, the PC is dying, and that’s been devastating to [Intel's] revenue. But that misses an important point: Intel’s server business is doing well. It’s the only part of the company that’s both growing and contributing materially to the bottom line. Intel estimates that, for example, for every 120 tablets sold, someone has to buy a new server to deliver content and apps to those devices....So even though people are buying fewer PCs with Intel chips in them, they’re buying devices that require more servers, most of which have Intel chips in them. Why, then, isn’t the explosion of mobile offsetting the contraction in Intel’s business?

Multiplexing is a term from electronics and signal processing, and it describes, for example, the process of carrying several phone conversations on a single telephone wire. In general, multiplexing is applied to situations in which, with a little ingenuity, an expensive resource can be shared. In 2011, economists applied the term multiplexing to the business model of Netflix, which at the time was still sending out a lot of DVDs by mail. The obvious secret to Netflix’s business model at the time was that a single shared resource—a DVD of a hot new Hollywood blockbuster, for example—could be re-used again and again as it rotated between customers.

Zipcar, Netflix, AirBnB and several other companies all have essentially the same business model: Use the internet and information technology to squeeze as much use as possible out of an expensive, previously under-utilized resource....And now consider the “cloud.” Cloud computing is just a way to put as many microprocessors as possible into a single building, where they are fed computing tasks that use as much of their capacity as possible. That’s multiplexing. What the cloud is gradually doing is replacing all those expensive chips in people’s personal computers, where they spend most of the time switched off or idling, with a smaller number of chips in data centers that can be used at full blast pretty much all the time. When we stream videos or edit online documents, most of the processing it requires isn’t being done on the devices we’re using, but in the cloud.

This is great for consumers—more efficiency leads to lower costs and increased capabilities—and bad for Intel. Every transistor it rolls out is being used more effectively than ever. We have found a way to take the expensive resource the company produces and share it as much as possible. And the less powerful chips that still reside in our mobile devices? For the most part, Intel isn’t in that business, even though it very much wants to be. This, as much as the “death of the PC,” is the horns of Intel’s dilemma.

In essence, Mims presents some of the consequences as multiplexing meets the cloud. Here is the story in truncated form: (1) pack as many microprocessors as possible into a room; (2) rent out the computing power of that room to other businesses; and (3) the cost of a previously expensive resource like microprocessors and even demand for them ratchets down. There is decreased demand for Intel's microprocessors because each one of them is being used by these new technologies (multiplexing and the cloud) to its maximum capability by customers. The use of tablets and mobile phones is growing but Intel missed our on most of this less-powerful-chip business, perhaps because of its lack of understanding of disruptive innovation.

Welcome to the World of Pseudo-Academia: Pathology-2013

A recent article detailed a conference and journal scam that is being foisted on gullible academics in search of publications and lecture appearances, probably to pad their CVs (see: Scientific Articles Accepted (Personal Checks, Too). Here is an excerpt from the article from the NYT. I am only quoting part of it so link to it for more details.

[Some] scientists [have recently] stumbled into a parallel world of pseudo-academia, complete with prestigiously titled conferences and journals that sponsor them. Many of the journals and meetings have names that are nearly identical to those of established, well-known publications and events....The number of these journals and conferences has exploded in recent years as scientific publishing has shifted from a traditional business model for professional societies and organizations built almost entirely on subscription revenues to open access, which relies on authors or their backers to pay for the publication of papers online, where anyone can read them....The phenomenon has caught the attention of Nature, one of the most competitive and well-regarded scientific journals. In a news report published recently, the journal noted “the rise of questionable operators” and explored whether it was better to blacklist them or to create a “white list” of those open-access journals that meet certain standards..... [A research librarian] estimates that there are as many as 4,000 predatory journals today, at least 25 percent of the total number of open-access journals....One of the most prolific publishers on Beall’s list, Srinubabu Gedela, the director of the Omics Group, has about 250 journals and charges authors as much as $2,700 per paper. Dr. Gedela, who lists a Ph.D. from Andhra University in India, says on his Web site that he “learnt to devise wonders in biotechnology.

As luck would have it, the same day that this NYT article was published, I myself received an email invitation to speak at Pathology-2013, a "conference" hosted by Dr. Gedala's Omics Group. Here is an excerpt from it copied verbatim:

We are inviting you to avail the speaker opportunity at the 2nd International Conference and Exhibition on Pathology (Pathology-2013). This conference will be held on August 05-07, 2013 at Embassy Suites Las Vegas, USA. The main theme of the conference is “To Stimulate the Technology in Pathology for Scientific Excellence.” Pathology-2013 is Supported by Journal of Clinical and Experimental Pathology and Journal of Plant Pathology and Microbiology. Pathology-2013 is designed to offer comprehensive sessions like Anatomic Pathology, Pathology Immunohistochemistry, Surgical Pathology and Laboratory Medicine, Pathology and Parasitology, Pathology of Gastrointestinal Tract, Osteopathy and Dermatopathology, Pathology of Chronic Disease, Forensic Pathology, Clinical Pathology and Diagnostic Tools, Advanced Diagnostics Modalities, Areas of Current Research in Pathology, Plant Pathology and Disease Management; which would lay a platform for the interaction between experts around the world and aims in accelerating scientific discoveries.

Here's a quote from the Pathology-2013 conference web site: Pathology-2013 is comprised of 12 tracks and 77 sessions designed to offer comprehensive sessions that address current issues in the field of Pathology. So that no human pathologist would leave the conference disappointed for lack of coverage of plant pathology, the topic is covered in Track 10. Here's a link to the twenty different conferences that the Omics Group has planned for this year. The only way that I can describe this conference enterprise, putting aside the journals, is comprehensively audacious. Do registrants actually show up at these conferences or is the audience just faculty members?  Aside from some grammatical slips and the misstep into plant pathology for Pathology-2013, the web content does have a semi-authentic feel. The biggest clue, of course, is the grandiosity of it all. It seems to be an example of pseudo-academia writ large.

Hospitals Need to Expand Cloud Services Starting with Radiology Images

I began raising exploring cloud computing in healthcare in early 2008 (see: Cloud Computing in Healthcare: Key Questions to Ask; Finally, A Clear Definition for Cloud Computing). It looks like we are finally seeing some movement toward this technology some five years later (see: Where Do You Keep All Those Images?). Here is an excerpt from an article in the WSJ on the subject:

Health-care providers are starting to embrace the fast-growing area of technology known as cloud services, the model of shared computing in which data is stored on remote servers that hospitals can access via desktop, tablet or smartphone. Instead of big capital investments in their own storage, they are paying a relatively modest upfront charge and monthly usage fees for cloud services. About 15% of health-care systems in the U.S. are using cloud-based storage for images, according to consulting firm Accenture, which estimates that more than half of the country's health systems will use cloud storage for medical imaging in the next three years. The need for storage is immense and growing rapidly. About 600 million imaging procedures are performed each year by health-care providers in the U.S., including CT scans, X-rays, ultrasounds and MRIs....Hospitals generally are required by law to keep images for seven years, but many keep them longer. They also retain backup copies as part of disaster-recovery planning and to comply with the federal health-care privacy law. As a result, image archives are increasing by as much as 40% annually, according to AT&T. Marketers of cloud services say that by allowing health-care providers to store, view and share patient medical images expeditiously over a secure network, they can help doctors make diagnoses faster, reduce the need for duplicate images and protect patients from the extra radiation exposure of having another CT scan because an original can't be found....[An industry expert]....says that despite the advantages of cloud storage, privacy and security concerns have been a barrier to adoption. At present, most providers store recent images in-house, while older images may be shipped to an off-premises data center. In contrast, [he] says, cloud-storage vendors have multiple storage sites, and the provider "doesn't know where the data is sitting and doesn't have direct oversight into who is looking at it. "Vendors have started to provide customers with assurances that they are in compliance with security standards and patient-privacy laws, he says, and the advantages of cloud storage are likely to be increasingly persuasive, especially on the cost side. "With the cloud you have more recurring costs you can finance out of operating funds, as opposed to digging into your capital fund, and you have way less responsibility for maintaining, upgrading and protecting all this hardware every few years,"....

Here's a key quote from the excerpt above: Vendors have started to provide [hospital] customers with assurances that they are in compliance with security standards and patient-privacy laws, he says, and the advantages of cloud storage are likely to be increasingly persuasive, especially on the cost side. Hospital IT personnel have a high level of concern about safety and privacy issues. If they receive proof from cloud vendors and consultants that these concerns can be addressed, they will be more likely to move their data to the cloud. Moreover, hospitals are now under intense pressure to reduce costs and cloud storage is much less expensive than local storage and, for many, operating funds may be easier to acquire than capital funds.

As I noted in a previous note, hospital CIOs will not be using cloud storage for most clinical information without the cooperation and approval of their EHR vendors (see: Google Launches Renewed Effort in Cloud Computing; Reaction in Hospitals). This is unlikely for the following reason, quoting from this note:

There is no possible advantage for these vendors in bringing a third party cloud computing vendor into their relationship with hospitals. If they were to offer a "remote hosting option," they themselves would provide it (Comments about Cerner's Remote Hospital Option (RHO)).

However and as emphasized in the WSJ article above, the major current storage problem in hospitals is located in the radiology departments and their PACSs; these systems are not supplied by the EHR vendors. Therefore, radiology would be a good place to start testing the functionality and value proposition of cloud storage. Accenture, quoted in the excerpt above, is rolling out a new platform to manage hybrid clouds for radiology departments and predicts wide adoption of the technology by the speciality in three years (see: Accenture Rolls Out New Platform To Manage Hybrid Clouds).

Counting White Blood Cells with a Portable Flow Cytometry Device

I closely track the development of devices that will enable lab testing in a mini-lab or even a home setting previously that is now only available in hospitals or physician offices. I do this for two reasons: (1) I believe that patients and healthcare consumers should assume more responsibility for their own health; and (2) healthcare providers need to move the locus of much of their delivery to alternative care sites in order to provide cheaper, faster, and better care (see: The Future of Healthcare: Virtual Physician Visits & Bedless Hospitals). Hence, a recent article about an experimental devices for counting white blood cells caught my eye (see: Counting white blood cells at home). Below is an excerpt from it:

White blood cells, or leukocytes, are the immune system's warriors. So when an infection or disease attacks the body, the system typically responds by sending more white blood cells into the fray. This means that checking the number of these cells is a relatively easy way to detect and monitor such conditions. Currently, most white blood cell counts are performed with large-scale equipment in central clinical laboratories. If a physician collects blood samples from a patient in the office -- usually requiring a full vial of blood for each test -- it can take days to get the results. But now engineers at the California Institute of Technology..., working with a collaborator from the Jerusalem-based company LeukoDx, have developed a portable device to count white blood cells that needs less than a pinprick's worth of blood and takes just minutes to run.....The prototype device is able to count all five subtypes of white blood cells within a sample. It provides an accurate differential of the four major subtypes....The entire new system fits in a small suitcase...and could easily be made into a handheld device, the engineers say....[The device] detection assay...uses three dyes to stain white blood cells so that they emit light, or fluoresce, brightly in response to laser light. Blood samples are treated with this dye assay before measurement in the new device. The first dye binds strongly to the DNA found in the nucleus of white blood cells, making it simple to distinguish between white blood cells and the red blood cells that surround and outnumber them. The other two dyes help differentiate between the subtypes. The heart of the new device is ...[a] small [channel] to ensure that only one white blood cell at a time can flow through the detection region. The stained blood sample flows through this microfluidic channel to the detection region, where it is illuminated with a laser, causing it to fluoresce.....Thanks to the dye assay, the white blood cell subtypes emit characteristic amounts of red and green light. Therefore, by determining the intensity of the emissions for each detected cell, the device can generate highly accurate differential white blood cell counts.

I understand that only an early prototype is being described above. However, the idea of providing patients with ready access to WBC counts is very interesting. Here's a short quote from the LeukoDx web site: This groundbreaking technology has a wide range of potential applications, from early sepsis detection and monitoring, to HIV/AIDS monitoring and beyond. I am sure that an instrument like this will require some training; hence my reference above to a mini-lab in addition to perhaps home testing. I have always believed that the walk-in clinics that are popping up all over within drug stores or in strip malls should have some basic lab testing capabilities. When this flow-cytometry-based WBC analyzer is ready for prime time, it would be a suitable addition for such facilities.

NFL Physician Says Diagnosis of "Chronic Traumatic Encephalopathy" Lacks Validity

I have been closely following the topic of chronic traumatic encephalopathy (CTE) because of the evolving diagnostic aspects of the disease and also because of the large stakes involved with regard to the NFL and college football. I think that I already know how this story is going to turn out. Neurologists, pathologists, and radiologists are going to develop tests and imaging procedures that will provide earlier evidence of concussive injury for both amateur and professional football players. This will result in many players having to sit on the bench for longer periods of time after such injuries. This will cause some fans and league owners a lot of anxiety. Meanwhile, the NFL will do whatever it can to delay the development of faster and more accurate CTE diagnostic tools. One facet of this story was revealed in a recent newspaper article an excerpt of which is shown below (see: N.F.L. Doctor Says Disease Is Overstated):

When a government agency [NIOSH] prepared a workplace safety fact sheet based on a study of degenerative brain disease in retired N.F.L. players, the organization invited several people to comment on a draft. This seems too much like when tobacco companies denied the link between cancer and cigarettes. According to a memorandum obtained by The New York Times, most of the reviewers suggested simplifying the fact sheet so that players without a scientific background could better understand the findings. But one response stood out: a doctor on the N.F.L.’s head, neck and spine committee asked that a mention of chronic traumatic encephalopathy, or C.T.E., be removed....[T]he [NFL] has expressed skepticism about the possibility of a link between on-field head injuries and C.T.E., a sentiment captured in the league doctor’s request to the federal safety agency. The doctor, who was not named in the internal memo, said references to C.T.E. should be removed because it was “not fully understood” and because it was not listed on the death certificates of the retired players in the study and thus lacked “epidemiological validity.” He suggested that traumatic brain injury, or T.B.I., be used instead because it “may accomplish what you want to say in more established medical terms.” Researchers from the National Institute for Occupational Safety and Health, which wrote the fact sheet, rejected the league doctor’s proposed change. Independent medical experts said such a request was inappropriate and not in line with prevailing research.....But [a neurologist] said the [NFL] doctor was correct in wanting to include a reference to traumatic brain injury. T.B.I. is a clinical diagnosis that can be identified in living patients, [he] said, while C.T.E. is a pathological diagnosis that so far can be found only through autopsies....."I’m agreeing with the [NIOSH] study, but we just have to be more careful to make clear that C.T.E. is a pathological diagnosis and T.B.I. is a clinical diagnosis.”....The medical experts also expressed dismay that an N.F.L. doctor would point to the death certificates of former players in the study. C.T.E. is often diagnosed months after death, when brain samples are examined. 

To summarize, an NFL-salaried physician requested that the term chronic traumatic encephalopathy (CTE) in a National Institute for Occupational Safety and Health (NIOSH) report be replaced with the more non-specific diagnosis of traumatic brain injury (TBI). He said that the former term was not well understood and lacked "epidemiologic validity" because it was not listed on the death certificates of retired NFL players who had undergone autopsies. He is thus drawing a distinction between a clinical diagnosis such as TBI that is diagnosed in living patients and the pathological entity of CTE that is being confirmed with tissue examination at the time of autopsy.

It's true that, given the current state of the art, that traumatic brain injury (TBI) is a more general term than chronic traumatic encephalopathy (CTE). However, the latter is gaining favor as more cases are studied post-mortem. That's the way that things work in medicine. So this reaction to the use of terms in the NIOSH report is hair-splitting designed mainly to buy time. I suspect that as CTE becomes better defined and rapidly diagnosable, more attention will be paid to protecting the heads of players and the nature of professional football will need to be greatly modified.