Lab Soft News

Professional Services Divisions as Potential New Profit Centers for Pathology Vendors

In a recent note, I commented on the professional services division of Aperio as a relatively novel component of digital pathology companies (see: Emergence of a Professional Services Division at Aperio). Ole Eichhorn, the CTO of Aperio, emailed me the following comment to this note, which I quote with his permission:

One key point about having a professional services team is that [this approach requires] a relatively open system to build on....The professional services team is a sort of “third party for hire” that [Aperio's] customers can use to create interfaces, customize the product, and otherwise work with them to craft a tailored solution.  Our team builds onto existing interfaces and plug-in APIs at each point, they never modify our baseline code. Another point which won’t surprise you: most radiology PACS vendors have professional services teams and they’re an important part of their businesses.  I remember meeting with [a PACS vendor that told me that] 25% of their revenue came from professional services.

Lot's of interesting food for thought in this short passage. First of all and in order to develop a professional services unit, the product being offered by a vendor such a digital pathology system needs to have an open architecture. Put another way, you can't make money and serve customers modifying an unmodifiable product. He also make mention above of plug-in APIs, which can be defined in the following way in the Wikepedia: an application programming interface (API) is a set of routines, data structures, object classes and/or protocols provided by libraries and/or operating system services in order to support the building of application.

The second concept raised by Ole is that a professional services division works with a customer to develop new applications without altering the "baseline code." The product keeps improving using customer input but without modification of the core hardware/software, which must be sold to other customers. Compare this with the Epic EMR with most modifications generated by the centralized corporate R&D rather than by customers (see: Some Additional Insights into the Epic Corporate Culture). Improvement cycles for such products tend to be slower and they also tend to drift toward "vanilla" over time, making them easier to maintain.

Lastly, he makes mention of a PACS vendor with 25% of revenue derived from professional services. It seems to me that with this type of contribution to the bottom line, a professional services unit starts getting some "respect" within the company. Put another way, the links between it and the company marketing & sales unit become weaker. The professional services consulting division becomes empowered to turn to products and solutions outside the company if and when necessary to increase consulting sales. This, in turn, leads to a virtual circle or cycle, a feedback mechanism whereby the customer sees the consulting services offered by the company as more tied to quality improvements for them and generates even more business. The company products, I am sure, will always remain as the central focus on the solutions proposed by the professional services unit but with alterations at the margins, based on the special needs of the customer.

Training and Credentialing Standards Proposed for Surgeons Offering Robotic Surgery

Have you ever noticed billboards on your way to working placed by local hospitals bragging about their newly purchased robotic surgery device, da Vinci? I'll bet that the advertisement did not bother to mention that some of the surgeons operating in that hospital may not be qualified to use this expensive piece of equipment. Read on for an excerpt from a recent article on this topic (see: Medical societies push standards for robotic surgery):

Surgeons are increasingly turning to high-tech robotic equipment to operate on patients with prostate cancer and other conditions but some medical authorities worry about inadequate training and lax standards among practitioners. Doctors are opting for Intuitive Surgical's popular da Vinci Surgical System over conventional surgery, especially for removing the prostate gland, because it is less invasive and allows for greater precision. There were some 80,000 robotic prostatectomy procedures in the United States last year....The rate of failure for such surgeries is comparable to that of traditional surgeries but patients are more at risk if inexperienced surgeons use the robots....[A]n article in the September issue of the Journal of Urology...proposed instituting training standards for surgeons using the equipment. Currently, there is no credentialing system to evaluate a surgeon's competency and surgeons cannot practice on simulators before taking on live patients....[The author of the article], who said he has performed more than 500 robot-assisted surgeries, reckoned a surgeon must use the system at least 20 times before becoming familiar enough with the set-up and the procedure to do the surgery safely....[He] said that surgeons, not manufacturers, carry ultimate responsibility for proper training. Ben Gong, vice president of finance at Intuitive, agreed, saying that while the company is committed to training, it is not the manufacturer's responsibility to set standards.

My understanding of the da Vinci robotic surgery system is that it is certainly radically different than normal surgery and even from laparoscopic (minimally invasive) surgery. So now we are faced with a situation where "some 80,000 robotic prostatectomy procedures in the United States last year" and urological societies are only now considering whether to require some sort of formal training standards and credentialing for the equipment. How much damage may have already been done to patients by urologists who are inadequately trained on the equipment? Think of the hue and cry that would ensure if even a handful of patients were harmed by a new drug on the market, even after rigorous clinical trials. As most of the readers of this blog will understand, surgical techniques and instruments are not subjected to the same scrutiny as drugs when they first come on the market. It seems to me that "using" the da Vinci device only "20 times," as suggested above, would constitute only a minimal demonstration of competence, given that the term "using" can be broadly interpreted. But let's not quibble. It's time for some long-overdue consideration of this problem of the introduction of new surgical equipment and devices. Let's pay more attention to patient safety and physician training and less to the marketing opportunities of some new piece of equipment.

The Use of Procalcitonin to Reduce Inappropriate Antibiotic Usage in Respiratory Tract Infections

Serum procalcitonin levels have been shown in the past to be elevated with bacterial infections but not with viral infections. It's important for physicians to be able to distinguish between these two types of infections because antibiotics are often the treatment of choice in the former but ineffective in the latter. Appropriate use of antibiotics can reduce the cost of care and also the likelihood of the emergence of antibiotic-resistant bacterial strains. A recent article revealed some new findings in this area of inquiry (see: Procalcitonin measurement may help reduce antibiotics overuse for lower respiratory tract infections). Below is an excerpt from the article:

The use of guidelines for treatment of lower respiratory tract infections such as bronchitis and pneumonia determined by measurements of a chemical in the blood known as procalcitonin [PCT] resulted in lower rates of antibiotic use and associated adverse effects, and similar rates of adverse outcomes compared to standard guidelines, according to a study in the September 9 issue of JAMA....[C]linical signs and symptoms are unreliable in distinguishing viral from bacterial LRTI [lower respiratory tract infections], and that as many as 75 percent of patients with LRTI are treated with antibiotics despite the predominantly viral origin of their infection....The researchers found that “the rate of overall adverse outcomes was similar in the PCT and control groups ....The mean [average] duration of antibiotics exposure in the PCT vs. control groups was lower in all patients ...and in the subgroups of patients with community-acquired pneumonia, ..., exacerbation of chronic obstructive pulmonary disease..., and acute bronchitis....Antibiotic-associated adverse effects were less frequent in the PCT group."....PCT guidance will have substantial clinical and public health implications to reduce antibiotic exposure and associated risks of adverse effects and antibiotic resistance.

I have discussed the term comparative effectiveness in previous notes as well as the key role of clinical lab testing for monitoring the effectiveness of various therapies (see: The Inclusion of Molecular Diagnostic Testing in Comparative Effectiveness Studies; Moving Resources from the Therapeutic to the Diagnostic Silo; Biomarkers Used to Assess Treatment Efficacy). The use of procalcitonin in the manner described about is another good example of how lab tests can be used in this way in the health delivery system. Procalcitonin can also be used to diagnose septicemia in intensive care units for patients suffering traumatic injuries (see: Procalcitonin can also be used to diagnose septicemia in trauma intensive care units). This latter article makes reference to the semiquantitative PCT-Q test, which is highly specific but far less sensitive than the LUMItest PCT, also available from Brahms International. Point-of-care availability of one of them would be necessary for the test to be useful in the triage of LRTI. Twenty minutes is cited as the time required for test result availability in the JAMA article above.

Decision-Aids for Helping Consumers Make Informed Medical Decisions

Who is the best person to advise you on important medical decisions? Nearly everyone would respond to this question by citing their family physician. It turns out that this ain't necessarily so according to a recent article (see: Weighty Choices, in Patients’ Hands). Here are some of the details:

For patients [with serious diseases], the current health-policy debate comes down to a very personal issue: how to make ever-more-complex decisions when faced with multiple options, each with no clear advantage and with risks and harms that patients may value differently. Preliminary data from the National Survey of Medical Decisions, conducted by researchers at the University of Michigan, showed that doctors are more likely to discuss the advantages of treatments while giving short shrift to the disadvantages. The study also found that doctors often offer their opinion but much less frequently ask the patient’s own opinion....Though decision-aid programs cost money to deliver, they appear to save money in the long run. Studies show that when patients understand their choices and share in the decision-making process with their doctors, they tend to choose less-invasive and less-expensive treatments than they would have otherwise received. A number of states and policymakers in Washington are considering legislation that would provide funding to study the use of shared-decision-making programs and in some cases require such programs to be offered to patients as part of the informed-consent process. A growing number of hospitals, medical groups and health plans are using decision aids offered by the Foundation for Informed Medical Decision Making, which grew out of research at Dartmouth University, for conditions where there is no consensus as to the best course of treatment. The foundation offers decision aids for 23 diseases and conditions including breast and prostate cancer, knee surgery, end-of-life care and uterine fibroids. Health Dialog, its for-profit partner, provides the programs to health plans and employers reaching about 20 million beneficiaries. Using claims data, Health Dialog determines which patients might benefit from shared decision making, then reaches out to them by mail or phone to offer informational DVDs and telephone-coaching sessions to help make decisions.

I believe, as stated above, that physicians are more like to discuss the advantages and benefits of treatment than the disadvantages. In effect, they are trained to "sell" various treatments and therapies. After all, that is the business that they are in and all of them firmly believe in what they are "selling." Coupled with this, there is always the problem that surgeons like to operate and oncologists are trained to offer chemotherapy to nearly all of the patients who are referred to them. Some of these problems can be reduced by the use of multidisciplinary teams (MDTs) in cancer hospitals and breast clinics (see: The Value of "One-Stop" Breast Cancer Clinics Confirmed in the U.K.). One of the antidote to this problem is the well-informed patient and the web is one of the vehicles for educating healthcare consumers.

I think that it would be a bit of a stretch to suggest that all patients should make use of the "decision-aids" described above to help them navigate through complex medical decisions. The use of such products could seriously disrupt the critical patient-physician relationship. Obviously, health plans and employers, as described above, could mandate their use because they are paying the medical bills. The experience gained in these new approaches will be invaluable. Meanwhile, it would help if these "decision-aids" as well as supplemental educational materials could be made more broadly available on the web. In this way, motivated patients needing help in making significant medical decisions could have access to them in parallel with discussions with their personal physicians. Ideally, the advice obtained on the web would reinforce the same decisions arrived at in discussions with their physicians. If not and perhaps for some patients, these decision-aids could guide them in a better direction based on their individual needs.

Exercise and a Mediterranean Diet Lower the Risk of Alzheimer's Disease

In previous note, I presented data that showed a correlation between serum cholesterol levels and both ischemic dementia and Alzheimer's disease (see: Even Moderate Elevations of Cholesterol Predispose to the Two Types of Dementia). Now comes another article describing how exercise and a Mediterranean diet can provide protection from Alzheimer's (see: Exercise and Mediterranean-type diet combined associated with lower risk for Alzheimer's), Below is an excerpt from it:

Both being more physically active and adhering to a Mediterranean-type diet appears to be associated with reduced Alzheimer's risk, according to a...report in ...JAMA. While previous studies have only investigated the association between either physical activity or diet and Alzheimer's disease risk separately, this new research explored their combined association....A Mediterranean-type diet is typically characterized by high intake of fish, vegetables, legumes, fruits, cereals and monounsaturated fatty acids; relatively low intake of dairy products, meats and saturated fats; and moderate alcohol consumption. The study found that those subjects who were very physically active had a 33 percent risk reduction of Alzheimer's; those who adhered more strongly to a Mediterranean-type diet had a 40 percent risk reduction...."So it seemed that the more that they were doing in terms of both diet and exercise, the lower was their risk for the disease," said [the lead author]. [He] further noted that even low degrees of physical activity reported by these elderly study subjects seemed to be associated with having a protective effect against Alzheimer's

There are a number of good reasons to exercise and consume a healthy diet relating to cardiac health alone. Now apparently added to this list of the benefits of a healthy lifestyle is the possible avoidance of Alzheimer's disease. It has occurred to me on the basis of these two articles that Alzheimer's may correlate in some way with cerebral ischemia similar to ischemic dementia. The histopathologic changes associated with Alzheimer's may thus be the final common pathway of a number of insults, one of which is ischemia. Research has shown that various vascular risk factors do correlate with a greater risk of developing Alzheimer's disease. In one study, these factors were defined as high blood pressure, diabetes, hypertension, heart disease, and smoking. Diabetes and smoking by themselves were associated with the highest risk. People with three or more vascular risk factors had nearly three-and-one-half times the risk of developing Alzheimer’s as those with none of them.

Details Emerge About Ghost-Written Medical Articles for Wyeth

There appears to be few limits on what some pharmaceutical companies have been willing to attempt to influence the drug-prescribing habits of physicians. One company created a phony medical journal from scratch (see: Merck Creates Phony Peer-Reviewed Medical Journal to Dupe Physicians). We now learn some of the details about how another company commissioned a review article by a medical communications company and then used an academic physician as the lead author. This news appeared in the New York Times with details about how this was accomplished (see: Medical Papers by Ghostwriters Pushed Therapy). Below is an excerpt from the article:

Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known....In 1997, for example, DesignWrite, a medical communications company in Princeton, N.J., proposed to Wyeth a two-year plan that would include the preparation of about 30 articles for publication in medical journals.... Sometime in 2003, a DesignWrite employee wrote a 14-page outline of the article; the author was listed as “TBD” — to be decided. In July 2003, DesignWrite sent the outline to Dr. Gloria Bachmann, a professor of obstetrics and gynecology at the Robert Wood Johnson Medical School in New Brunswick, N.J. Dr. Bachmann responded in an e-mail message to DesignWrite: “Outline is excellent as written.” In September 2003, DesignWrite e-mailed Dr. Bachmann the first draft of the article. She also pronounced that “excellent” and added, “I only had one correction which I highlighted in red.” The article, a nearly verbatim copy of the DesignWrite draft, appeared in 2005 in The Journal of Reproductive Medicine, with Dr. Bachmann listed as the primary author. It described hormone drugs as the “gold standard” for treating hot flashes and was less enthusiastic about other therapies. The acknowledgments thanked several medical writers for their “editorial assistance,” not disclosing that those writers worked for DesignWrite, which charged Wyeth $25,000 to generate the article. Dr. Bachmann, who has 30 years of research and clinical experience in menopause, said she played a major role in the publication by lending her expertise. Her e-mail messages do not reflect contributions she may have made during phone calls and in-person meetings, she said. “There was a need for a review article and I said ‘Yes, I will review the draft and make sure it is accurate,’ ” Dr. Bachmann said in an interview Tuesday. “This is my work, this is what I believe, this is reflective of my view.”

It's not clear from the article how much compensation Dr. Bachmann received for allowing her name to be used in this way and/or in consulting fees from Wyeth. Interestingly enough, she indicates that the use of hormone replacement was "reflective" of her view of practice. I suspect that this is a true but somewhat irrelevant in terms of the issues at hand. It appears that she had little to do with the article for which she was credited as the lead author except to review the initial outline and subsequent drafts. This was certainly one facet of the problem. The second facet was that the employees of DesignWrite, who appear to have written the entire piece, were said to have been provided "editorial assistance." Hopefully, this case, and others like it, will cause medical journal editors to pay more attention to the authorship of all articles but particularly those where pharmaceutical companies may be working in the shadows. At the very least, we need a crisper definition for what constitutes primary authorship of an article. Is it sufficient to only review the work of other unspecified parties?

Even Moderate Elevations of Cholesterol Predispose to the Two Types of Dementia

Most people know about Alzheimer's disease but few are aware of the second most common cause of dementia, vascular dementia. That's probably because the latter condition is poorly understood and little discussed in the media. The name, however, provides a clue. The three most common mechanisms of vascular dementia are multiple brain cortical infarcts, a strategic single infarct, and small vessel disease (see: Vascular Dementia). There's now evidence that both types of dementia have a relationship to serum cholesterol and that even moderate levels of it in midlife can put you at risk (see: Study Shows Even Moderately Elevated Cholesterol Level Boosts Dementia Risk). Below is an excerpt from the article:

Elevated cholesterol levels in midlife – even levels considered only borderline elevated – significantly increase the risk of Alzheimer’s disease and vascular dementia later in life, according to a new study...(see: Midlife Serum Cholesterol and Increased Risk of Alzheimer’s and Vascular Dementia Three Decades Later).... Even borderline cholesterol levels (200 – 239 mg/dL) in midlife raised risk for late-life vascular dementia by nearly the same amount: 52 percent. Vascular dementia, the second most common form of dementia after Alzheimer’s disease, is a group of dementia syndromes caused by conditions affecting the blood supply to the brain. Scientists are still trying to pinpoint the genetic factors and lifestyle causes for Alzheimer’s disease....[T]his study is the largest long-term study with the most diverse population to examine the midlife cholesterol levels and late-life dementia. It is also the first study to look at borderline high cholesterol levels and vascular dementia, rather than just Alzheimer’s disease. “Our findings add to the existing body of evidence on a degree of overlap between two dementia types in terms of risk factors, symptoms and neuropathology,” said the study’s lead author....“Dementia and cardiovascular disease are common major health problems, share several risk factors and often occur simultaneously, interacting with one another. A holistic approach that addresses multiple major health problems simultaneously is needed to effectively manage these disorders.”

I found this article to fascinating. Many years ago, I asked my an internist friend whether it could be possible to take one's cholesterol level too low with statins, exercise, and dietary control. After all, cholesterol is a major component of cellular membranes. He said, "I'd advise anyone to try to lower it as much as possible." Now we learn, at least from the perspective of dementia and heart health, that this was sound advice. Although it's reasonable to assume that dementia and cardiovascular disease share multiple risk factors, I never had them strongly linked in my mind. However, they will remain bound together from now on. As a pathologist who has performed many autopsies, I am all too familiar with atherosclerotic plaques in the aorta, coronary arteries, and carotid arteries. Obviously, many of these patients had high cholesterol levels. In my experience, however, it was unusual to see smaller arteries with lipid deposits. However, there's still much to learn about the relationship between small vessel disease, dementia, and cholesterol levels. There's now another good reason to keep your cholesterol levels in good control.

Lecture Notes Available for Deloitte Webinar on Comparative Effectiveness

The term comparative effectiveness is much in the news these days, often in connection with discussions about healthcare reform. I have posted previous notes about it in addition to an allied concept, treatment efficacy. Comparative effectiveness, in my mind, is also a first cousin to evidence-based medicine (EBM). All of these concepts are associated with the need to treat patients in the most effective manner. They also relate to the important goal of compensating physicians for treatments that are likely to improve the health status of patients rather than on a fee-for-service basis.

A recent webinar by consultants from Deloitte on comparative effectiveness provided a very comprehensive view of the topic. Following the presentation, the firm provided a link to their PowerPoint presentation (see: Comparative Effectiveness: A Compelling Approach to Cost Control and Quality Improvement). Complimentary registration is required to view or download this file. The only "problem" with the presentation is that it is so comprehensive that it probably can't be absorbed at one sitting.

Slide #5 in the set is the healthcare reform pyramid covered here in previous blog note and which I like so much that I have used it some of my own lectures (see: A Look at Deloitte's Healthcare Reform Pyramid: A Strategy for Reducing Costs). I was also impressed with the distinction made between comparative efficacy and effectiveness in slide #11. Here is a list of the differences between the two  copied from that slide:

• Efficacy: (1) Performance under controlled or ideal conditions; (2) Question addressed: Is the intervention better than placebo or doing nothing; (3) Methods: Randomized, controlled clinical trials

• Effectiveness: (1) Performance under “real life” practice conditions; (2) Question addressed: Does this intervention achieve better health outcome in real-world situation; (3) Methods: “Real-world” clinical trials; observational studies

One of my criticisms of evidence-based medicine, covered in a previous note (see: Flaws in Evidence-Based Medicine), is its rigidity. Many of the EBM recommendations in the literature can't be applied by physicians in practice. The article quoted in this latter note calls for a more patient-centric and cost-efficient approach to patient care than EBM. The Deloitte definition for comparative efficacy and effectiveness suggests that, in the former, evidence flows from controlled clinical trials. The latter relates more to "real-world" clinical trials and observational studies. I am not sure whether comparative effectiveness research will prove to be useful in providing recommendations for physicians about the most effective treatments for their patients. My immediate concern is that the concepts of "real-world" clinical trials and observational studies will be difficult to define and may therefore be rejected by the academics who will be managing the comparative effectiveness studies and projects sponsored by the government.

CDC Releases On-Line Environmental Health Tracking System

The future of tethered personal health record (PHR) products, as in the case of HealthVault and Google Health, lies on the web. The term tethered here means that these electronic records have links to hospital and physician office EMRs such that data from them can be copied to the PHRs. Moreover, web-based PHRs also provide the opportunity to link to other valuable medical information resources on the web. For example, a consumer might highlight the name of a drug or disease in his or her personal health record and launch a search of trusted web resources to learn more about the topic. A recent article (see: CDC Launches Online Health Tracking Network) alerted me to another possibility -- tracking environmental exposures and chronic health conditions on the web. Below is an excerpt from the article:

The Environmental Health Tracking Network [of the CDC] is the first program available to the general public, as well as scientists and health professionals, that follows environmental exposures and chronic health conditions on the CDC's website....The online tool presents information about air and water pollutants and environmental health issues such as asthma, cancer, and heart disease in a single resource. By unifying the health demographic information in a single program, the CDC say it hopes to help scientists make a variety of environmental and health connections that heretofore couldn't be analyzed in one location....To further increase public awareness of the new tool, the CDC released a video advertisement for the Health Network on YouTube, stressing the correlations between environmental and personal health as well as the information now available through the CDC's website. Although 17 local and state health departments currently contribute to the online resource, the CDC hopes to expand the network to all 50 states and develop a complete national picture of public and environmental health....CDC officials said the resource has already had 73 success stories, in which information from the Web site has led to action to control potential illnesses from environmental exposure. The agency cited a Utah case in which a concerned citizen contacted the Utah Department of Health about what he thought was an unusual number of cancer cases in his neighborhood. Prior to the availability of the new software, a multi-year study would have been necessary to collect data. But through the Utah Tracking Program, officials were able to respond in less than a day, telling the man his local cancer rate was no higher than in the rest of the state, CDC officials said.

Bravo! What a great idea and effort on the part of the CDC scientists and public health officials. The home page of the Environmental Health Tracking Network features the following three categories: Environments, Health Effects, and Location. Under Health Effects are the following four categories: Asthma, Cancer, Childhood lead poisoning, and More health conditions. Clicking through Cancer and then Leukemia under Additional Links displays a page captioned Leukemia and the Environment. The site, even in this early stage, provides valuable data. The site is a little quirky and probably designed by an epidemiologist. Once you get the hang of it, you will find a treasure trove of useful health data.

A mash-up is a Web application that combines data or functionality from two or more sources into a single integrated application (see: Web-Based PHR Mash-Ups). The availability of the Environmental Health Tracking Network provides an early view of the potential for mash-ups linking our PHRs with other health resources on the web. For example and in this particular instance, the owner of a PHR could be automatically alerted to local environmental problems such as an outbreak of an infectious disease. Contrariwise, the CDC could use the national network of PHRs for reporting local outbreaks of conditions like flu or food-borne bacterial diseases. This would be similar to the syndromic surveillance systems being installed in hospital emergency departments and used in connection with bioterrorism monitoring.

The Transition from Pre-Diabetes to Diabetes Comes into Better Focus

More sophisticated use of medical diagnostics will enable the identification of diseases in earlier and earlier stages. For example, there are various types of pre-clinical manifestations of diabetes. One of them that is now well-recognized is the metabolic syndrome. A state of apparent wellness can co-exist with a predisposition to disease which can transition to a pre-disease and then to clinically overt disease (see: Predisposition to Disease and Pre-Disease on the Health Continuum). Pre-disease is frequently recognized by abnormal lab test results. A recent article provides some additional clues about the transition from pre-diabetes to diabetes (see: The trajectory of pre-diabetes comes into focus). Below is an excerpt from it with boldface emphasis mine:

[T]the Lancet [recently] published a study of 6,538 British civil servants who were followed for over 13 years....Five hundred and five of these subjects eventually developed diabetes (7.7% of the study population). Interestingly, when the measures of blood glucose and insulin resistance were examined for the people who developed diabetes and for the people who did not, they behaved quite differently. The people who did not develop diabetes during that 13 year period did not experience any increase in fasting blood glucose levels but they did experience a slow increase in their non-fasting glucose levels. Meanwhile, the people who did develop diabetes had higher values both for fasting blood glucose as well as the non-fasting glucose level....What this study shows is that the onset of type 2 diabetes can be divided into 2 stages. There is a long period of reasonably successful compensation where blood sugar levels are slowly rising but things are pretty much under control. During this period the pancreas is compensating for the metabolic problem by increasing insulin production. Then the patient enters into an unstable metabolic state which lasts from 3 – 5 years before diabetes onset. During this time, insulin secretion can no longer handle the metabolic deficit and blood glucose levels rise rapidly. The importance of this observation is that most people with pre-diabetes are identified after they have entered this unstable period of rapid deterioration. It is likely that if lifestyle changes were initiated during the more stable portion of the process, the results would have been vastly more successful....We need a study that looks at the costs of early identification and lifestyle modification in these people who are likely to develop type 2 diabetes a decade hence. Since the rate of increase in blood glucose levels was vastly different for people who develop diabetes from those who do not, it should not require a decade to figure out the answer.

On the basis of clinical studies such as this one, we are now beginning to better understand the transition from pre-diabetes to clinically overt disease. We are also getting clues about when intervention such as lifestyle changes can alter or prevent the onset of frank disease. This value of such studies is so obvious, one wonders why a number of them have not been performed prior to this time. I suspect the reason is that most medical researchers have had little interest in the past in studying pre-disease such as pre-diabetes. This may have been because there were few good therapeutic options available for pre-diabetes (see: Few Good Treatment Options for Pre-Diabetes and Metabolic Syndrome) or lifestyle interventions were not as well understood. At nay rate, my hope is that studies such as this one will peak the interest of younger physicians who will then begin to delve deeper into predictive/preventive medicine.