Lab Soft News

The Challenge of Creating a True Longitudinal Health Record

iTriage is an app that runs on the iPhone and provides some of the following functionalities (see: Physicians Using an iPhone Application to Triage Their Patients):

• Information on thousands of symptoms, diseases and medical procedures
• A nationwide directory of hospitals, urgent care, retail clinics, pharmacies and physicians
• Help negotiating medical bills through an iTriage partnership with ...claims adjudication organizations
• Emergency Room wait times for hospitals in select parts of the country

Apparently one of the founders of the company is now moving in the direction of of integration and support by the device for Google Health, a PHR, according to John Moore who blogs over at Chilmark Research (see: Consumer Challenge: Creating a Longitudinal Record). Below is an excerpt from the note:

While Chilmark applauds iTriage and Peter [Hudson] for continuing to extend the functionality of their platform to now address consumers’ mobile access to their PHR, in this case Google Health, .... Peter has not addressed the real issue here, how do we, as a society, create the systems necessary that will allow a consumer to easily aggregate their health data to create a truly longitudinal record that they can securely tap via their iTriage app, or some other mechanism, regardless of location, when needed. And therein lies the rub – those systems do not exist. We are dealing with point-to-point access, point-to-point data retrieval, a complicated, convoluted process that frankly most consumers will not bother with. Ever the optimist, Chilmark firmly believes there may be a solution tucked within the billions that will be spent to digitize the healthcare sector: The Health Information Exchange (HIE).

John highlights in the note a critical aspect of EMRs that is often neglected -- the difficult pursuit of the longitudinal record. Simply put, the longitudinal record consists of the aggregated medical records of an individual across time or, put another way, a life-long record of a patient's care. Up to this point, most EMRs lump the records for a single episode of care such as an inpatient stay. If a patient has multiple inpatient episodes within a single health system, that institution's EMR can usually aggregate records across them.

The challenge is that we Americans tend to frequently move to different cities and receive care from a broad set of healthcare providers and systems. Each of them probably uses a different brand of EMR. As John points out above, most of our hospital information systems are designed to move data "point-to-point" and we lack a central clearing house for healthcare data across multiple providers. The HIE may serve this purpose in the future.

I made reference to the idea of a "an electronic clearinghouse" for clinical data on a much smaller scale in a previous note about comparative effectiveness research (CER) (see: The Inclusion of Molecular Diagnostic Testing in Comparative Effectiveness Studies). The key points are listed below.

For the sake of efficiency, let me distill from this article the key recommendations made by AMP [Association for Molecular Pathology] retarding all comparative effectiveness research (CER) going forward:

• Development of a model process for CER regarding clinical laboratory tests
• Creation of an electronic clearinghouse for information on CER projects 
• Development and adoption of standards for the collection and storage of data from genetic testing laboratories

Comments About Mergers and Acquisitions by Healthcare Software Companies

I have never quite understood the logic of some of the M&A's over past years by lab and medical software vendors. In some cases, Vendor A purchased Vendor B mainly to acquire the Vendor B client list. The apparent goal of A was to convert these clients, in time, to its LIS software. The scenario frequently did not work out in this way with the Vendor B lab clients hunkering down on their aging but familiar software and draining the resources of Vendor A to support it. Forcing the issue by sun-setting the B software only infuriated them more, causing them, in time, to flee into the arms of another vendor. John Moore who blogs over at Chilmark Research recently addressed the topic of acquisitions in relationship to healthcare reform (see: Healthcare Reform, Payment Models & Acquisitions). He launches his note with the following comment:

AllScripts’ acquisition  last week of Eclipsys. NextGen, a traditional ambulatory EHR vendor whose parent, Quality Systems Inc. acquired Sphere Health Systems and Opus Healthcare Solutions to target rural acute care facilities.

He followed this up with the following predictions about the future:

Looking to the future, one has to wonder what will be the fate of those who remain in either ...the acute or ambulatory [healthcare software sectors]. Our quick assessment of a few of the ambulatory vendors…

athenahealth: athenaclinicals is new to the market and the company has an opportunity to tap its existing customer base. Short-term, they’ll stay independent but likely to be acquired in 3-5 years.

eClinicalWorks: Fiercely independent and will likely attempt to pursue a strategy similar to EPIC’s and grow organically and stay independent. Will make some niche app acquisitions where needed to accelerate time to market

It's interesting that he groups together eClinicalWorks and Epic. The first has a very strong position in the office EMR sector and the second serves as the EMR of choice for many large health systems. Both are privately held, relieving the founders of the need to please the  financial analysts nor dress up their quarterly earnings. John describes them as fiercely independent and pursuing an organic growth strategy. By this I think that he means that they can add features/functions that are desired by their customer base, all of whom operate on the same, supportable software platform.There is no requirement to "integrate" heterogeneous systems.

What fascinates me about Epic is that an enormous hospital system like Kaiser would invest billions of dollars in software developed and maintained by a company that is privately held and thus controlled by a small circle of insiders. Theoretically, Epic could make changes to its business plan or product line that were not in the best interests of Kaiser. Alternatively, Epic could founder in a number of ways if something happened to micro-manager Judith Faulkner. Someone recently told me not to worry about such matters and that he was confident that there was a succession plan in place for Faulkner at Epic. I will assume that this is the case but I do wonder what such a plan would look like in order to provide sufficient assurances to the hospital executives whose jobs could be at risk due to the Epic relationship.

Putting Some Numbers to Digital Pathology Adoption Trends by Pathologists

I recently posted two guest blog notes by Steve Potts, Ph.D., focusing on the more rapid adoption of digital pathology by veterinary pathologists than MD pathologists (see: Veterinary Pathologists Adopting Digital Pathology Faster than MDs; Reasons Why DVM Pathologists Are Adopting Digital Pathology Faster Than MD Pathologists). Coincidentally, an article has just been published in Laboratory Economics entitled Adoption Trends in Digital Pathology (Volume 5, No. 6, June 2010) that provides survey data on this topic. I copy it in its entirety below.

Nearly everyone agrees that digital imaging will play a big role in pathology in the future. Academic medical centers, commercial labs and large independent pathology labs are rapidly installing digital pathology systems. But its use in reimbursable clinical diagnostics is currently limited. Twenty-two percent of pathology groups and labs currently have a digital imaging system in place, according to LE’s Digital Pathology Trends Survey conducted in June. Ten-percent plan to add a system within 12 months and another 10% within the next 12-to-24 months.

Today, education and training is the most common use for labs using digital pathology. The biggest barrier to more clinical use is the cost of scanning digital slides, which don’t eliminate the need to first prepare glass slides. Among surveyed labs using digital pathology, 72% are using it for education and/or training, according to LE’s Digital Pathology Trends Survey. Sixty-three percent use it for second opinions and/or consultations, and 62% for quantitative immunohistochemistry for HER2 scoring. In terms of market share, 44% of digital pathology users have an Aperio system; BioImagene has a 16% share; Ventana, 9%; and Olympus, 8%. Other vendors have a combined 23% share, including Nikon, Leica Microsystems and Dmetrix.

More than half of surveyed labs without digital pathology cited “too expensive” as a barrier to adoption. Another 36% said traditional pathology/microscope works fine and 23% had LIS integration concerns. Only 15% said digital pathology systems were too slow and only 3% had concerns about image resolution. Meanwhile, Amanda Lowe, principal of Digital Pathology Consultants...believes the limited menu of FDA-cleared tests is a bigger issue than our survey suggests. “There’s no doubt that if the FDA would ‘gold stamp’ digital pathology on the clinical diagnostic end, it would help significantly,” she says.

In an email to me, Jondavid Klipp, the founder and editor of Laboratory Economics provides additional information about this trend: Roughly 500 commercial labs, pathology groups and academic medical centers have a digital pathology system/scanner in place. Digital pathology utilization for clinical diagnostics in United States is extremely limited, currently less than 1% of all slides.

One of the drivers for adoption of digital pathology by veterinary pathologists, emphasized by Steve Potts in his guest blogs, was that many of them work for pharmaceutical companies. They are thus heavily involved in drug toxicology studies as part of basic research studies and clinical trials. In such settings, global image networks have been established by these companies for sharing and storing animal and human whole slide tissue images. It is thus readily apparent that a far more convincing business case can be made for the deployment of digital pathology systems in Big Pharma than can be made for a pathology group working in, say, a mid-size community hospital. Note the barriers to adoption cited by the pathologists above. Here's a quote from Steve's first note:

Nearly all of the top 15 pharmaceutical companies have completed multisite-integration with digital pathology. The result of such conversions is that a pathologist working in one location can access slides at any other one or participate in an informal peer review or pathology working group.

FDA Shelves IVDMIA Regulatory Initiative; Will Focus on Laboratory Developed Tests

I have posted a number of notes about IVDMIAs (in-vitro diagnostic multivariate index assays), a term that was coined by the FDA to refer to panels of biomarkers plus a computer algorithm that is used to analyze the set of test results. The agency is now dropping the idea of issuing a final guidance on IVDMIAs and focusing more broadly on the agency's role in ensuring the safety and efficacy of all laboratory-developed tests (LDTs) (see: FDA Shelves IVDMIA Final Guidelines in Order to Focus on Overall LDT Regulation). Below is an excerpt from this article:

The FDA said in a Federal Register notice...that due to "public health concerns, … it is time to reconsider its policy of enforcement discretion over LDTs."....In a meeting scheduled for July 19-20 in Washington, DC, the agency will invite stakeholder input on its regulation of LDTs. After the July meeting and a subsequent comment period ending Aug. 15, the agency is planning to develop guidelines for public comment and "phase in" the regulatory framework outlined in the guidance over time. FDA's move to regulate all LDTs in a risk-based manner comes after industry stakeholders and advisory groups argued that the agency's selective regulatory approach to regulate only a subset of high-risk LDTs — IVDMIAs — led only to more confusion and created an uneven playing field. In December 2008, Genentech petitioned the FDA to take make its in vitro diagnostics regulations more consistent by extending its oversight over LDTs in a risk-based manner. The HHS Secretary's Advisory Committee on Genetics, Health, and Society issued a report in 2008, recommending much the same. The agency's public meeting on LDTs comes three years after the agency convened stakeholders to discuss its regulatory approach for IVDMIAs, lab-developed multiplex tests that employ mathematical algorithms to interpret a person's molecular-based risk for disease or likelihood of response to a drug.

That highly contentious meeting led to a second draft guidance on the topic that satisfied few players in industry. Along the way, FDA never finalized its IVDMIA guidance, but as the industry eagerly awaited more clarity on the topic from FDA, agency officials have issued conflicting timelines for when a final guidance may come out. Now, in light of the regulatory uproar surrounding the direct-to-consumer marketing of genetic tests [see: FDA Cracks Down on Consumer-Oriented Genetic Testing Web Sites], it seems FDA is dropping its work on an final IVDMIA guidance in order to clarify its broader regulatory authority over all LDTs, an authority the agency says it has, but hasn't exercised since the implementation of the Medical Device Amendments of 1976. The FDA has practiced enforcement discretion over the majority of LDTs, which are assays developed and analyzed at laboratories that have been accredited under...Clinical Laboratory Improvement Amendment [CLIA]. Although laboratories are certified to develop and analyze these tests, the assays themselves do not hold 510(k) clearance or a premarket approval from the FDA.

I don't have much to add to this -- the article is largely self-explanatory. In summary, after working on its IVDMIA policy for some three years, the FDA is integrating this discussion into the large issue of LDTs. You may better recognize by the slang term of home-brew tests. This controversy has simmered for years. I discovered an article on the web from 1992 on this same topic (see: Threat to 'home brew' products angers labs - Food and Drug Administration draft policy guide). This expanded discussion by the FDA will, no doubt, also encompass genomic/genetic testing. As noted above, all of this brouhaha boils down to the following question: what regulatory authority does the FDA hold over all LDTs.

Reasons Why DVM Pathologists Are Adopting Digital Pathology Faster Than MD Pathologists

This is the second portion of guest blog note written by Steve Potts, PhD. The first was posted yesterday (see: Veterinary Pathologists Adopting Digital Pathology Faster than MDs). Steve is the CEO of Flagship Biosciences, a pathologist-owned CRO and provider of digital pathology services in the pharmaceutical and medical device industries.

I would propose the following reasons why the adoption of digital pathology among DVM pathologists is faster than among their MD counterparts:

• Veterinary pathologists have benefited from the development of a strategic, forward-looking vision by pathologists working in executive management at the various pharmaceutical companies. These individuals are required to manage studies generating hundreds, if not thousands, of slides each and requiring review by pathologists within groups and across groups. Many of the multi-site implementations of digital pathology have been driven by top-down decision-making on the basis of careful planning and ROI calculations by these executives. In short, the decisions to adopt digital pathology have not been made casually or informally.
• Quantitative data has always been a powerful driver in pharmaceutical research. Because the cost to bring a drug compound to market is measured in hundreds of millions of dollars, strategic go/no-go decisions are generally based on such quantitative data (e.g. real numbers on beta cell mass changes for a proposed diabetes compound or objective vascular changes for an anti-angiogenic compound). Digital pathology delivers the requisite quantitative information for the industry.
• Numerous pathologist-led committees have developed standards for imaging in the veterinary pathology societies, including ACVP, and STP, and PhRMA. This leadership in standards has provided strong incentives for the rank-and-file DVM pathologists to adopt the technology.
• A small core group of veterinary pathologists have provided leadership in identifying new applications for digital technology and subsequently demonstrated them to their peers in conference settings. Some examples include Bob Dunstan from Biogen Idec, Frank Voelker with preclinical image analysis from Novartis and Flagship Biosciences, David Young with companion diagnostics at OSI Pharmaceuticals, Sam Machotka from Merck with preclinical workflow requirements, and Gary Knutsen of Systems Pathology with automated toxicity screening.
• Veterinary pathologists, particularly at pharma companies, have benefited from some talented informatics leaders within their companies who have planned and delivered successful global deployments of digital pathology systems. Even, or maybe especially, in companies ranging up to 100,000 employees, a single person leading these efforts has made the difference. Examples of such leaders and presentations include Jim Deeds from Novartis, Xiaoyou Ying from Sanofi-Aventis, and Beverly Maleeff from GSK.
• Broad conversion to the technology will require a substantial time commitment and most MD pathologists are already challenged by their current daily work commitments. What is required now is a broad swath of MD pathologists coming on-line and demonstrating that digital pathology is an important technical component for the practice of the field. When this tipping point occurs, many more of them will be able to replicate the earlier digital footsteps of their veterinary pathologist colleagues

Veterinary Pathologists Adopting Digital Pathology Faster than MDs

This is a guest blog note written by Steve Potts, PhD. Steve is the CEO of Flagship Biosciences, a pathologist-owned CRO and provider of digital pathology services in the pharmaceutical and medical device industries.

There are approximately 1,200 board-certified veterinary pathologists in the U.S. working in a variety of settings including veterinary schools, clinics, pharmaceutical companies, governmental agencies, and contract research organizations (CROs). Approximately 500 veterinary pathologists work in the U.S. pharmaceutical industry with a consistent industry average of about one pathologist per one billion dollars in annual company revenue. I have had the privilege of working closely with many of these veterinary pathologists for the last three years after working for a large reference laboratory that employs hundreds of MD pathologists.

My work with both MD and DVM pathologists has lead me to the following observation: DVM pathologists are "going digital" faster than their MD colleagues. Nearly all of the top 15 pharmaceutical companies have completed multisite-integration with digital pathology. The result of such conversions is that a pathologist working in one location can access slides at any other one or participate in an informal peer review or pathology working group. Veterinary pathologists have proposed GLP [Good Laboratory Practice] standards and agreed on the requirements required of digital pathology vendors in order to meet the FDA compliance guidelines in preclinical testing. The regulations imposed on preclinical toxicology testing prior to first-use in human trials are more strict than clinical trial regulations. Despite this, veterinary pathologists are well prepared for the use of digital slides in these assessments.

A group called VIPER (Virtual Imaging in Peer Reviews) has been organized to propose digital pathology validation procedures for peer reviews, a key part of preclinical testing. The VIPER group is composed of veterinary pathologists from one CRO, a half dozen pharma's , and a medical device company. Some of the leading toxicologic pathology government organizations like the NIEHS, NCTR, and a leading government pathology support organization, EPL, were early adopters of whole slide scanners. The first two Aperio digital pathology customers were both veterinary schools. A number of digital pathology image analysis blogs have been launched by veterinary pathologists and many veterinary pathologists at pharmaceutical companies are beginning to adopt quantitative analysis as a part of their job description.

This is not to say that all segments of veterinary pathology are adopting digital pathology. The primary "read" in preclinical pharma studies is still performed with a microscope for reasons of speed, workflow, and regulatory uncertainty. Clinical veterinary diagnostics are also performed almost entirely with glass slides. While quantitative image analysis is growing quickly in the field, only a small subset of veterinary pathologists have acquired the training and experience and made the time investment necessary to manage their own image analyses.

To contrast the situation in veterinary pathology with healthcare, I would ask the following question: How many of the largest 15 hospital systems use digital slides, and if so, to what extent? Rather than belabor this point, let’s ask the following question: Why are veterinary pathologists adopting the technology more quickly? As usual, the easy answers are probably wrong. One response might be that veterinary pathologists have lower regulatory hurdles. However and as already mentioned, the 21 CFR, Part 11 guidelines that govern pharmaceutical electronic processes are more strict for preclinical veterinary testing than clinical trials for humans. A second easy answer is also wrong: There is more money in pharma pathology than in hospital pathology testing. Salaries of veterinary pathologists are highest in pharma companies and yet these are at best one third to one-half of those that their MD colleagues earn. Stay tuned for what I think are the correct answers to this overarching question.

To be continued tomorrow with the second portion of this guest blog in which Steve presents his arguments why the veterinary pathologists are "going digital" faster than their MD colleagues.

Baby-Boomer Doctors and Nurses Near Retirement; Implications for Healthcare Reform

One of the many challenges we are facing in the clinical lab industry is a shortage of medical technologists as well as an aging of this group (see: Comments on the Medical Technologist Shortage). This aging phenomenon is not restricted to med techs but also applies to baby-boomer doctors and nurses as well, according to a recent article (see: Retirements by baby-boomer doctors, nurses could strain overhaul). Below is an excerpt from the article

Since the passage of the health-care law in March, much has been said about the coming swarm of millions of retiring baby boomers and the strain they will put on the nation's health-care system. That's only half the problem. Overlooked in the conversation is a particular group of boomers: doctors and nurses who are itching to call it quits. Health-care economists and other experts say retirements in that group over the next 10 to 15 years will greatly weaken the health-care workforce and leave many Americans who are newly insured under the new legislation without much hope of finding a doctor or nurse. Nearly 40 percent of doctors are 55 or older....Included in that group are doctors whose specialties will be the pillars of providing care in 2014, when the overhaul kicks in; family medicine and general practitioners (37 percent); general surgeons (42 percent); pediatrics (33 percent), and internal medicine and pediatrics (35 percent). About a third of the much larger nursing workforce is 50 or older, and about 55 percent expressed an intention to retire in the next 10 years.... New registered nurses are flowing from colleges, but not enough to replace the number planning to leave the profession. "Moving into the future, we see a very large shortage of nurses, about 300,000," said ...a nurse and health-care economist....In an article for the Journal of the American Medical Association, [experts] predicted that there will be at least 100,000 fewer doctors in the workplace than the 1.1 million the federal government projects will be needed in 2020 under the health-care overhaul....Although the [American Association of Family Practitioners] supported the health-care overhaul, it thinks the law does not go far enough to address the workforce shortages projected for the coming decade. Reform will add demand on top of shortages already projected, and as a result the health-care workforce might not be attractive. According to the American Association of Colleges of Nursing, 75 percent of nurses said in a survey they think the shortage "presents a major problem for the quality of their work life, the quality of patient care, and the amount of time that nurses can spend with patients."

I am sure that many of you have picked up a prescription lately at one of the chain retail pharmacies. The staffing model in these stores is that a single, well-paid pharmacist oversees a large group of pharmacy technicians. These latter personnel handle all of the routine prescription transactions including most telephone calls. A similar staffing model is used for inpatient hospital care with registered nurses overseeing squads of LPNs and nursing aides. A recent article in the NYT discussed how the innovative Geisinger Health System, functioning as a health insurer, is paying to staff physician offices with nurses. These nurses focus on patients with chronic diseases with the goal of saving money by avoiding expensive inpatient care (see: A Health Insurer Pays More to Save). I have been an advocate of using nurse clinicians as replacement for PCPs in most office and ambulatory care settings (see: Have PCPs Become Obsolete?). Here is a passage from that note:

I believe that most of the common ailments seen in an office practice can and should be addressed by physician's assistants and nurse clinicians, the latter being defined as a registered nurse who has received special training and can perform many of the duties of a physician....[T]his will include the following: [any task]  that can be reduced to a guideline, a template, or treatment algorithm. The job description of PCPs should be to solve...complexity and clinical conundrums....PCPs should manage the critical first steps in the diagnosis of complex disease prior to referring patients to medical specialists. The care of complex chronic diseases should also be the responsibility of the PCP.

I can't argue with the idea of training more physicians and nurses, particularly given the fact that healthcare reform will provide access to the healthcare system of an increased number of patients. However, I also think that it's inevitable that there will be greater emphasis on the use of physician, nurse, and pharmacist extenders. I have recently commented on the emerging types of such personnel such as patient coaches, nurse information triage[ists], and patient navigators (see: Yet Another Type of Healthcare Professional Who Focuses on Patient Support).

Red Cross Fined, Again, by FDA for Unsafe Blood Collection and Manufacturing

I posted a note in September, 2006. about the American Red Cross being fined $4.2M by the FDA under the terms of a 2003 court settlement on top of a previous fine of $5.7M (see: Red Cross Blood Program Fined $4.2 Million by the FDA). The relationship between the two organizations doesn't appear to have not gotten any better since then -- this time a whopping fine $16M is being levied against the ARC (see: FDA Again Fines American Red Cross for Blood Safety Lapses; This Time $16 Million). The FDA's web site provides additional official details. Below is an excerpt from the first story:

The American Red Cross will have to pay $16.18 million in federal fines because of a failure to comply with safe practices dealing with collection and manufacturing of blood products, including red cells, plasma, and platelets, the U.S. Food and Drug Administration announced late yesterday....The fines include $9.79 million for mismanagement of certain blood products and $6.39 million for violations of Good Manufacturing Practice standards. The American Red Cross processes 43% of the nation's blood supply, or about 6.5 million units, which are turned into 9.5 million blood products used by patients each year....In a response posted on its website last night, the America Red Cross said it is "disappointed that the FDA believed it necessary to fine us for prior violations dating back several years. The FDA also acknowledged no evidence that the Red Cross violations endangered any patients....The Red Cross is fully committed to meeting all FDA standards, and we have made significant progress over the past two years in improving our regulatory compliance by our implementation of system-wide changes to our operations....It's important to understand that many of the incidents cited by the FDA in the October 2009 notification occurred prior to the improvements made by the Red Cross. In fact, 98% of the events identified by the FDA took place in 2008 and before. The recalls cited represent 0.0775 percent of our blood products, which is less than one-tenth of one percent of our total number of blood products produced,"....In the FDA's statement, the agency said that FDA officials notified the ARC last October that federal inspections in 2008 and 2009 discovered violations, such as failure to identify manufacturing problems and failure to adequately investigate those problems. 

These are fines and bad publicity that would put many healthcare businesses out of business. If a pharmaceutical company were involved, the news would probably be on the front page of most newspapers. But the ARC keeps rolling, providing 43% of the nation's blood supply. Here is a very good example of "too big to fail" outside of the financial sector. Why doesn't the ARC stake steps to avoid these recurring fines? First of all, it doesn't need to -- it can pay the fines and there is generally no public outcry that forces them to modify their systems and procedures. Secondly, it's a large bureaucratic organization and would have trouble changing its culture and operating procedures even if it wanted to. The span of these violations goes back at least seven years.

The spin put on this news of the new fine by the ARC is interesting. First of all, it says that this is mostly old news but the FDA responds that there were violations discovered in 2008 and 2009. Secondly and in relation to the scope of the problem, it calculates, to four decimal places, the percentage of blood products involved (0.0775%). Then, for the slower among us, it spells out that this is "less than one-tenth of one percent of our total number of blood products produced." What the ARC don't stipulate is that, given the fact that the organization processes 6.5 million units per year, the math works out to about 520 suspect units and certainly a larger number of blood components. Blood collection and blood transfusion is an unforgiving branch of medicine and all personnel and organizations involved must strive for zero errors. At least from the perspective of the FDA, the American Red Cross appears to be far from this goal.

Yet Another Type of Healthcare Professional Who Focuses on Patient Support

I have been developing a list of of new types of healthcare professionals who interact directly with patients. Here's how it currently stands: coach, counselor, telephone booster, and nurse-information-triage(ist) (see: The Emerging and Expanding Role of Counselors in Healthcare; Telephone Calls and Emails as Key Components of Primary Care). To this list, we can now add patient navigator (see: Patient Navigators: A Different Viewpoint), Quoted below is an opinion piece by an oncologist, Dr. Barbara McAneny, who reacts to a previous article in the Journal of Oncology Practice that advocated the use of patient navigators in physician office settings:

The authors suggested that patient navigators would be a valuable addition to any practice and described their use in several settings. If we are not careful, we may be witnessing the birth of a new allied health provider. Practices today cannot afford additional staff providing unreimbursed services, but this is only one of the reasons I am bothered by the navigator trend....It is crucial to have another friendly set of ears present to help the patient recall the discussion. I feel this role is best played by a family member, loved one, or close friend, not a stranger assigned as the patient navigator. The untrained friend or family member may get details wrong.... It is the job of oncologists to educate patients and families at their levels and to realize that emotional reactions are part of patients' hardwiring. We can set up another appointment, take the time to overcome that barrier, or provide the patient and friend or family member with written materials. Abdicating this function to a patient navigator will work only if the navigator has sufficient medical training and specific qualifications. The services provided by navigators become expensive quickly and are not reimbursable, adding to the already burdensome overhead of oncology practices. If we were to decide to employ patient navigators, how many patients could one navigator navigate?....The other aspect of patient navigation involves helping patients get all the appointments, tests, procedures, and information needed and ensuring that the insurance companies pay for all of these....This is the part of patient navigation I find most alarming. We have created such an inefficient system that we need to invent a new medical specialist to help us cope with it. If our system necessitates navigators, we need a new system.

I must admit that I find myself generally sympathetic to the concept of a patient navigator working in the office of an oncologist. Ideally, and as emphasized in Dr. McAneny's comments, the role of sympathetic patient advocate is best filled by a relative or friend of the patient. However, not all patients understand this need or have ready access to such people. Therefore, having a member of the office staff who can function as a patient advocate and second set of ears strikes me as an advantage. Now you may well ask at this point, why do you not consider physicians themselves as the key and sufficient patient advocates? My response is that I believe many, if not most, oncologists view their goal as treating cancer patients, often with chemotherapy. How much latitude is there in an oncology practice for a patient who does not want to be treated at all or does not place the same value as the oncologist on extending his or her live by a couple of months.

The general tone of Dr. McAneny's comments is somewhat imperious. She is distressed by "the birth of a new allied health provider." She concedes that "emotional reactions are part of patients' hardwiring." She also appears to be overly concerned that the "services provided by navigators become expensive quickly and are not reimbursable." Finally and perhaps most inappropriately, she suggests that the need for patient navigators is based on our "inefficient system." Although I would not doubt that this is frequently the case when scheduling new appointments, lab tests, and imaging procedures, I also believe that the need for the new patient intermediaries discussed above is largely the result of the complexity and aloofness of modern care, particularly for cancer patients.

Can We Reduce the Number of Preventable Deaths Occurring Yearly in the U.S.?

We need to place greater emphasis on wellness and preventive medicine in our lives and healthcare system (see: Wellness, Preventive Medicine, and the Classic Disease Model). The goal of such an approach is to prevent diseases before they strike and thus both improve the quality of life of Americans and also reduce our healthcare costs. Luckily, the recent healthcare reform legislation funds various preventive medicine initiatives (see: Some Encouraging News About New Federal Funding for Preventive Medicine Initiatives).

It is commonly stated that we are in the midst of a chronic disease epidemic (see: Seeking Solutions to the Chronic Disease Epidemic) with increasing incidence of obesity (see: Obesity as a Cause of Death Recorded on Death Certificates) and diabetes (see: The Staggering Cost of Treating Diabetes). Increasing attention is being paid to the lifestyle diseases (see: Seeking the Correct Definition for a "Lifestyle Disease") that are the result of both choices made by individuals such as diet or lack of exercise. On a larger population basis, lifestyle diseases can also be defined to include diseases of old-age as well as exposure to pollutants in a particular country. Needless to say, there are various conditions embedded in our chronic disease epidemic such as hypertension and abnormal lipid profiles that can be easily screened for and are amenable to medical treatment.

One of the ways in which to understand the effects the preventive medicine and wellness movement is to measure changes in the number of preventable deaths. A recent article in the NEJM by Drs. Murray and Frenk included the following passage about this topic  (see: Ranking 37th — Measuring the Performance of the U.S. Health Care System):

Given the vast number of preventable deaths associated with smoking (465,000 per year), hypertension (395,000), obesity (216,000), physical inactivity (191,000), high blood glucose levels (190,000), high levels of low-density lipoprotein cholesterol (113,000), and other dietary risk factors, there are huge opportunities to enact policies that could make a substantial difference in health system performance — and in the population's health.  More investments that are targeted at promoting proven strategies  — including tobacco taxation and smoking-cessation programs, screening and treatment for high cholesterol and blood pressure, banning of trans fat, creating incentives for people to engage  in physical activity, and subsidizing the cost of consumption  of n–3 fatty acids — could dramatically reduce mortality and enhance the performance of the U.S. health care system.

If we add up the numbers above for preventable deaths per year in the U.S., we arrive at the staggering number of 1,570,000. Assuming that the U.S. population is about 309,500,000, this constitutes about .5% of the population dying each year of preventable causes. We all know how to address some of these problems: better and broader health screening programs; enhanced public health education programs; sin taxes such as those on cigarettes, liquor, and even soda pop (see: State Taxes on Soda Pop Gain Momentum; Does the End Justify the Means?); and greater access to our health system to promote earlier treatment of disease. We also certainly need to pay more attention to the dietary habits of most Americans (see: Proposed Dietary Guidelines Take Aim at Obesity, registration required).

For me, one of the key question in this discussion is how much involvement in the lives of Americans can be justified in the pursuit of the certainly appropriate goal of reducing the number of preventable deaths in this country?