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Are we really a "health"care society?

2/16/2017

 
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Childhood obesity rates have more than tripled in the past 30 years, an alarming public health development that is contributing about $150 billion a year to the overall cost of U.S. health care.
Almost one in five children aged six to eleven are seriously overweight, making them highly vulnerable to heart disease, diabetes and other serious illnesses.

​At the same time, Congress and the Department of Agriculture are spending more than $1.28 billion annually to subsidize the crops that are used as additives in manufacturing cookies, candies, soda pop and other highly popular junk food that arguably are among the primary contributors to childhood obesity. The sweet, fatty and calorie-rich Hostess Twinkies alone contain 14 ingredients made with highly subsidized processed ingredients, including corn syrup, high fructose corn syrup, corn starch and vegetable shortening--How Billions In Tax Dollars Subsidize The Junk Food Industry

Between 1995 and 2014, the US has spent $94, 349,576,890 subsidizing corn. That is $94 billion dollars my friends.

There are similar trends in soybeans and wheat. But investments in health top out at 1.8 billion for diabetes in 2016.

​There is no similar trend in spending for fresh fruit and vegetables--the sources of nutrition and health we are encouraged to include several times per day.
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The American Diabetes Association Applauds Major Funding Increase for Diabetes

The Consolidated Appropriations Act for Fiscal Year 2016 increased discretionary funding for the National Institute of Diabetes and Digestive and Kidney Diseases to $1.818 billion, an increase of over $68 million compared to FY2015. This robust funding will allow the institute to expand promising research toward improved treatments and move us closer to a cure for diabetes. 

The legislation also provided significantly increased funding of $170.129 million for the Division of Diabetes Translation at the Centers for Disease Control and Prevention (CDC). The $30 million funding increase will help the agency better carry out its mission to reduce the preventable burden of diabetes. 

Last, the spending bill doubled funding for the CDC’s National Diabetes Prevention Program to $20 million. This increased funding will allow more individuals with prediabetes to access evidence-based community prevention programs that can help lower their risk for developing type 2 diabetes.
Why is this a problem? I noticed a trend in the percentage of adults with diabetes. The CDC data is clear. Start with 1995 and what do you notice? The heat map on the far right of the image is quite informative.
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The story of our health, our populations, and disease needs a 360 perspective. Context is everything.

More to do, more to know, more to manage

1/18/2017

 
Coordinated Learning to Improve Evidence-based care: A model for Continuing Education for the New Healthcare Environment has created a much needed energized base in continuing education. On one hand, the industry as a whole is slow to respond to the evolving needs of healthcare providers outside of the watchful and financial resources of industry funded CME. On the other hand, many have debated the role of a Pharma company dictating how to evolve the CME framework. The article and framework is spearheaded by Genentech. Basically, if you hope to be funded, you will need to follow their articulated framework--drink the kool-aid so to speak--not necessarily a bad thing.

My clients seem to fall into two camps. How do I follow the model or how can I create a model beyond TELMS that addresses many of the key points? I am not going to debate the model but I will weigh in on the vagueness of "how" these mechanisms can be implemented beyond the narrow scope of the article. Let me cast a wide net and share a bit of what I find problematic regarding claims to "Improve awareness, convert information, demonstrate engagement, and substantiate partnerships". I don't have the answer--I would at least like to create an important dialogue.

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Medical education as a whole is data poor. The quality of data collection and analysis by even CME industry leaders is laughable. Look. I am not trying to be confrontational or combative. Each time I post a critical review of the learning healthcare system I create a diaspora. That is all well and good. If you choose to join me in trying to make sense of what we can accomplish with strong and concise objectives, I welcome you. If you are a medical education company reporting learning outcomes, no matter how far up the food chain you think you are--I have seen your data, reports, and post-activity deliverables. Maybe not by you, but I assure you, your clients or colleagues are looking for guidance--especially when they are handed a low quality output and made to defend the spend to their finance committee.

The data is compelling, confusing, and potentially influenced by industry and financial interests on a global scale. I am going to use T2D as an example. Lately I have been working with Oncology data but there is a whole other level of complexity there.

Data on food nutrition, food policy, consensus data, and clinical patient databases are informative when discussing chronic diseases--specifically Type II Diabetes. The short audio below sets the tone from the preventative perspective. You don't need me to tell you healthcare costs are unsustainable. There are limits to out-innovating our biology. We need stronger and more robust policies upstream from disease.
Added Sugar Intake and Cardiovascular Diseases Mortality Among US Adults provides an analysis of National Health and Nutrition Examination Survey Data.
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Continuing medical education laments about inviting voices outside of the bubble to the conversation about improving health outcomes through better education for providers. I agree. TELMS lacks the instructional granularity to guide toward data sources to add a full dimensional perspective on disease. A much needed guidance for healthcare providers responsible for the future outcomes of the healthcare they deliver.
The Expanded Learning Model for Systems (TELMS), offers a framework for designing, implementing, and evaluating learning solutions that move both HCPs and patients through a series of learning stages to enable them to adopt evidence-based behaviors informed by quality and performance indicators, and which will help CE stakeholders to demonstrate how such changes lead to improvements in care coordination and quality of care.
A total 360 degree look at care must include the cost and financial perspectives. The new administration has hinted at allowing cost to become part of care considerations. You will need to learn how to follow the dollar. Commercial companies typically follow the lead of Centers for Medicare and Medicaid.
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Many times we write about available interventions focused specifically on mechanism of action and potentially side-effect profiles--especially if those might be differentiators. If you rely on clinical literature, you will need to turn a keen eye on competitors selected in clinical trials. Will Cardiovascular Outcomes Data on Newer Diabetes Drugs Bury the Older Agents? is a timely article in JAMA Internal Medicine.
Although the FDA has traditionally focused on the safety and efficacy of drugs relative to placebo, there are abundant good reasons for the agency to push industry and other study sponsors to use active controls in type 2 diabetes studies. The major clinical role of the new drugs is as alternative treatments, not as therapies for patients who otherwise would not be treated with drugs.
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 I also like to look at Investor Reports accessible on the internet. We hear about "Innovation" being stifled if we lower drug costs.

Shouldn't the drug pipeline show investments in innovation? How about record amounts of shareholder dividends or stock buy backs? When you neglect to look at data and understand the "patient/return on investment" of shareholder argument you become a PR machine--not an informed voice or part of the broader discussion of change in healthcare.

What if I told you that many companies create revenue by cycling profits back to shareholders instead of capital investments like R&D? Obviously pharmaceutical companies are heterogeneous and have different practices and incentives but the demand for greater transparency is a bit ill-informed and ignorant. They are already transparent--If you know where to look.


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I highlight Novo-Nordisk only because Victoza tops the list in physician renumeration. It also tops a few other lists if you investigate quarterly trends in FDA Adverse Event Database (FAERS) data reported by Druginformer.
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-The industry affiliated model, TELMS highlights the cognitive overload of 27000 articles published every week but neglects the role of industry or low quality and poor statistical design of the large majority. Many decisions at the point of care are incentivized based on dubious claims or over-medicalization. We could do more by empowering providers with tools to improve numeracy.

Here is a brief snapshot of industry influence from a Virtual Expert Roundtable where a panel of experts will "discuss strategies to set appropriate HbA1c targets, how to select guideline-based therapies, and how to engage and motivate patients to be fully invested in their treatment program to reach their HbA1c goals."

​Here are the industry payments to expert #1:
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The website Open Payment Data reported $272,023.63 in total general payments.

Industry payments to expert #2:
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Open Payment Data reported $118,498.46 total in general payments.

Industry payment to expert #3:
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Open Payment Data reported $96,317.25 total in general payments. I am not here to demonize anyone but an educational program where the 3 "experts" are being paid ~ half of a million dollars by industry--is not trivial. 
Pharmaceutical Industry–Sponsored Meals and Physician Prescribing Patterns for Medicare Beneficiaries  demonstrates an association (not causal) with increased brand-name prescribing following industry-sponsored meals. 
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Addressing Unmet Basic Resource Needs as Part of Chronic Cardiometabolic Disease Management is an article describing social correlates of health. Discussions of basic resource needs as an interventional strategy are effective in directing care.
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Intensive Treatment and Severe Hypoglycemia Among Adults With Type 2 Diabetes helps to demonstrate the benefits or limits of treatment intensification in patients that do not benefit. The risk of hypoglycemia almost doubles in highly clinically complex patients.
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Join us at the Medical Affairs and Scientific Communications Forum. I will discuss "Data Talks, People Mumble"--new ways of presenting data in healthcare and medicine.
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Upstream solutions to poor downstream outcomes

10/24/2016

 
The table below summarizes the evidence supporting a systematic update of the 2008 U.S. Preventative Services Task Force (USPSTF) review on Type 2 diabetes in adults. You can scroll down on the right side of the document to see all the evidence (of varying quality). The actual update was published at the close of 2015. 

I attend a lot of health policy and health system improvement conferences either in person or by remote access. So far, the focus is far downstream of the trigger. Have you spent time reading about social determinants of health? The data is strongest for prevention. Why is so much money directed "downstream"?

Jeff Iliff is a neuroscientist part of a team discovering the "glymphatic system"...An interesting listen if you ever considered how the brain moves waste across that relatively impermeable blood-brain barrier.

As a nation we watch the documentaries about how food policy impacts our options at the grocery store--and the quality of our health. Let's face it. There can be an argument made for the influence of zip code vs. genetic code as a determinant or correlate of health outcomes in the US. 

​Are you involved with the Patient-Centered Outcomes Research Institute (PCORI)? Today was day 1 of the Improving Healthcare Systems October Advisory Panel. There are many working diligently to improve patient outcomes but a common thread is a lack of high-quality initiatives for funding. Please join the discussions.

How a national food policy could save millions of American lives-- Mark Bittman, Michael Pollan, Ricardo Salvador and Olivier De Schutter

Mark Bittman
Michael Pollan
Ricardo Salvador
Olivier De Schutter
The food system and the diet it’s created have caused incalculable damage to the health of our people and our land, water and air. If a foreign power were to do such harm, we’d regard it as a threat to national security, if not an act of war, and the government would formulate a comprehensive plan and marshal resources to combat it. (The administration even named an Ebola czar to respond to a disease that threatens few Americans.)

​So when hundreds of thousands of annual deaths are preventable — as the deaths from the chronic diseases linked to the modern American way of eating surely are — preventing those needless deaths is a national priority.
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Professor Tyrone Hayes discusses hormone disruptors and the downstream health consequences being played out without our consent or awareness.
Maptitude GIS and Mapping software simplifies the integration of population health data into many publically available datasets. Data & Donuts made a choice to invest in integrating population and community level data into disease state analyses. The ability to include Maptitude data in our Tableau Data Visualizations means more data informed insights for our collaborative projects.

​Here are a few mapping examples from the public sphere demonstrating how a focused data strategy can expand the perspective of a story, business objective, or targeted research question. Click image for more details.

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This final example from Vitality Institute describes a landmark study examining a connection between workforce health and the health of the surrounding communities.
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What's in your data?
Thoughtful discussions about content development and outcomes analytics that apply the principles and frameworks of health policy and economics to persistent and perplexing health and health care problems...

The data-chiatrist is in...

6/12/2016

 
I am not a statistician. I am a consumer of statistics courses from undergraduate, graduate, and post-graduate studies. I possess a theoretical grasp of numeracy that still allows a never-ending pipeline of questions and scientific inquiry.

I am unable to think of one post-graduate course that hasn't become out-dated. A dusty PhD in an obscure biological subspecialty may gain entry but my expertise in population genetics would be a relic--if I wan't continually learning...

I have mentioned the fire-hose of data and information--let's try to find a story in the numbers.
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Observation is a skill. Discovering what is present and also what is absent requires focus, objectivity, and awareness. Van Gogh, The Starry Night. 1889 can be viewed at Museum of Modern Art in New York City.

I like to use art as an interdisciplinary tool when working with clinical data and numeracy. I notice colleagues don't want to raise their hands to admit they don't understand hazard ratios or calculating number needed to treat (NNT)--but will scrunch up their faces and ask questions about what they observe in art.

We can often look at works of art and create a story. If I was to describe the picture above to you and help you "see" it too, what should I say? Should the information be factual and objective or subjective? Would that influence how you visualized the facts?

Cardiovascular Mortality in Patients With Type 2 Diabetes and Recent Acute Coronary Syndromes From the EXAMINE Trial

RESULTS Rates of CV death were 4.1% for alogliptin and 4.9% for placebo (hazard ratio [HR] 0.85; 95% CI 0.66, 1.10). A total of 736 patients (13.7%) experienced a first nonfatal CV event (5.9% MI, 1.1% stroke, 3.0% HHF, and 3.8% UA). Compared with patients not experiencing a nonfatal event, the adjusted HR (95% CI) for death was 3.12 after MI (2.13, 4.58; P < 0.0001) 4.96 after HHF (3.29, 7.47; P < 0.0001), 3.08 after stroke (1.29, 7.37; P = 0.011), and 1.66 after UA (0.81, 3.37; P = 0.164). Mortality rates after a nonfatal event were comparable for alogliptin and placebo.
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CONCLUSIONS In patients with type 2 diabetes and a recent ACS, the risk of CV death was higher after a postrandomization, nonfatal CV event, particularly heart failure, compared with those who did not experience a CV event. The risk of CV death was similar between alogliptin and placebo.
What is the story?
​stay tuned...

Beyond A1C—Why Quality of Life Matters

6/11/2016

 
From the press office in New Orleans 76th American Diabetes Association Sessions

 
​New Orleans (June 11, 2016) – Health-related quality of life (HRQOL) is an important area of investigation that has gained increasing recognition and is a critical element of diabetes research, treatment and care, according to experts at the Symposium, “Beyond A1C—Why Quality of Life Matters,” presented on June 11, 2016, during the American Diabetes Association’s 76th Scientific Sessions®, June 10-14, 2016, at the Ernest N. Morial Convention Center in New Orleans. 
 
Treating People, Not Numbers: Assessing Health-Related Quality of Life (HRQOL)
Diabetes treatment and care often focuses on measurable goals, such as maintaining target blood glucose levels. “It’s important, however, for healthcare providers and investigators to also take into account patients’ quality of life (QOL), which is more difficult to measure, yet can greatly impact outcomes,” said Lawrence Fisher, PhD, Professor Emeritus, Department of Family and Community Medicine at the University of California, San Francisco, in his presentation, “Quality of Life, Issues of Conceptualization and Measurement.”
 
“Using blood glucose numbers or improved glycemic control as outcome measures is too limited,” continued Fisher. “Patient quality of life can be a better predictor of mortality and morbidity than some biologic measures.”
 
It is critical that a comprehensive HRQOL assessment is incorporated into the structure of trials—to measure at baseline and at intervals that correspond and complement the study’s treatment protocol. “Patients provide a perspective that investigators can often miss. Early and continuous patient feedback is crucial for us to develop and employ the most effective strategies that can improve QOL and biologic outcome measures.”
 
All outcomes will not be achieved at the same pace, noted Fisher. For example, changes in glycemic control, behavior and quality of life are unlikely to occur simultaneously. “The introduction of a continuous glucose monitor might lead in the short term to improvements in glycemic control. However, the initial data overload can be very distressing for patients, so changes in quality of life might not become apparent until far later in comparison to changes in blood glucose levels.”
 
”We must consider patient experience feedback and quality of life data to be as important as biologic outcomes,” Fisher concluded.
 
Questionnaires Measure Quality of Life for People with Type 1 Diabetes and Their Caregivers
“Questionnaires for people with type 1 diabetes and their caregivers should soon provide a better means of measuring quality of life across the course of their lives, from early childhood through late adulthood,” said Marisa E. Hilliard, PhD, Assistant Professor of Pediatrics, Baylor College of Medicine, Texas Children’s Hospital, in her presentation, “Developing a Measure of Diabetes Health-related Quality of Life Across the Lifespan—Preliminary Qualitative Findings.”
 
Hilliard and her team are currently conducting a mixed-methods study—interviewing people with type 1 diabetes and their caregivers (parents and partners) in order to better understand the quality of life issues they experience at different points in life. 
The interviews have informed the research team’s development of new patient-reported outcome measures of diabetes-related quality of life, which will be validated across the United States this year. The new measures will be able to inform and improve patient-centered research and care. 
 
“People with diabetes are more than their glycemic control data,” she said. “The day-to-day experiences of living with and managing type 1 diabetes need to be better understood and addressed in clinical research and practice. Developed from the personal stories of people with diabetes and their family members, we hope the new patient-reported outcome measures we are developing will advance our ability to prioritize quality of life in clinical research and care. It is equally as important as glycemic control to the overall health and well-being of people with diabetes and their families.”
 
“Several themes have emerged from an analysis of the interviews conducted to-date,” said Hilliard, such as “worries about life with diabetes, challenges of managing diabetes care expenses, and the importance of supportive communication among family members and health care providers. We have learned quite a bit from how people told their stories and what they emphasized. For example, we were pleased to hear so many of our participants talking about the ’silver linings‘ of life with diabetes, their strategies to manage the burdens of diabetes, and their gratitude for the pace of technology advances and for the strong support of the diabetes community.”
 
 “By creating a suite of QOL measures that extend across the lifespan and can be used with both people with diabetes and their caregivers, we anticipate the measures will allow for consistent, longitudinal and outcomes research that can more accurately evaluate the impact of treatments and therapies on everyday life,” she said. “This will help bring to market new intervention approaches that meet more of the needs of people with and impacted by diabetes.”
 
Look AHEAD: Modest Weight Loss Yields Long-Term Quality of Life Benefits
Modest weight loss can significantly improve quality of life for middle-aged and older adults with type 2 diabetes, yielding benefits such as greater ease in performing daily tasks, reduced pain, greater mobility and a better state of mind, according to a review of findings from the Look AHEAD study. The analysis, “Quality of Life Findings from the Look AHEAD Study,” will be presented by Gareth R. Dutton, PhD, Associate Professor of Medicine, University of Alabama Division of Preventive Medicine.
 
The National Institute of Health-funded Look AHEAD (Action for Health in Diabetes) trial () was designed to test whether intensive lifestyle intervention (ILI)—healthy eating and increased physical activity—for weight loss could reduce the occurrence of cardiovascular disease, stroke and cardiovascular-related deaths in obese and overweight patients with type 2 diabetes. While the intervention yielded no reduction in the rate of cardiovascular events, it did achieve other benefits including improved quality of life. The trial included 5,145 adults from 16 clinical centers across the country, ages 45 to 75, with type 2 diabetes and a body mass index (BMI) greater than 25. Patient accrual was terminated after 11 years, when conclusions indicated the study’s primary outcome of reducing cardiovascular events would not be achieved. At that time, median follow-up for patients was 9.6 years. 
 
Study participants were randomly assigned to ILI (n=2,570) or standard of care diabetes support and education (the control group, n=2,575). The ILI group achieved significantly greater weight loss than the control group, with a mean weight loss of 6 percent at the end of the study, compared to 3.5 percent in the control group. Patients in the ILI group experienced significant QOL improvements, such as improved physical function and mobility (defined as the ability to get around and perform daily functions without pain or other limitations).
 
In addition, the ILI group experienced a 48 percent lower risk of loss of mobility, with 12.3 percent (308 of 2,514 patients) of those in the ILI group experiencing severe mobility-related disability after one year, compared to 18.9 percent (474 of 2,502 patients) in the control group. After four years, 20.6 percent (n=517) of the ILI group experienced severe mobility-related disability, compared to 26.2 percent (n=656) of those in the control group. Participants in the ILI group were also 15 percent less likely to experience elevated symptoms of depression eight years following the initiation of treatment.
 
Both groups experienced decreased physical function over time. The ILI group, however, demonstrated an initial significant improvement in functioning during the first year of treatment and continued to report better physical function during the following 8 years of the trial. This suggests that modest weight loss may help to mitigate deteriorations in physical function and QOL that typically occur with aging.  
 
“It is notable that some of the quality of life benefits—physical functioning and depressive symptoms—were still present nearly a decade after individuals began treatment for weight loss,” said Dutton. “These long-term benefits were also preserved even when there was some degree of weight regain.”  
 
“The results highlight the need to consider a variety of benefits for patients with type 2 diabetes who are able to lose a modest amount of weight,” said Dutton. “Many of the outcomes we measured, including physical functioning, mobility and depressive symptoms, are very important to patients who are understandably interested in maximizing their quality of life and maintaining their independence for as long as possible.”
 
Dutton’s review includes data previously published in Diabetes Care, the New England Journal of Medicine, and the Archives of Internal Medicine.-- mkirkwood@diabetes.org


  • Impact of Intensive Lifestyle Intervention on Depression and Health-Related Quality of Life in Type 2 Diabetes: The Look AHEAD Trial
  • Lifestyle Change and Mobility in Obese Adults with Type 2 Diabetes
  • Impact of a weight management program on health-related quality of life in overweight adults with type 2 diabetes

​

T2 diabetes: the underlying cause...

6/11/2016

 
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I unofficially transitioned from a medical writer for hire, to a journalist curious about the intersection of health policy, health economics, clinical medicine and research. Unable to pick a favorite genre I slowly learned the impossibility of pulling on too many individual strings. The story was and is complex.

The most valuable lessons I learned were in the audience of policy meetings at the Brookings Insititution, National Press Club, and the White House. Discussions (often heated) about health economics and outcomes research led by the formal medical director of CMS at an advisory council meeting were eye opening. Once you learn--you can't go back. I can't pretend that diabetes is just diabetes and a pill or injection is the answer.

I recently approached the mic at a session sponsored by the Johns Hopkins Institute for Basic Biomedical Sciences. Weighty Matters: Recent Advances in Metabolism, Obesity and Diabetes Research was targeted to journalists. Except there was limited or no data. No skill session on how to evaluate clinical data. I asked about a bariatric procedure and the risk of malabsorption of nutrients if indeed the digestive tract was abbreviated. You could hear crickets.

​My goal is to unpack the science. If we understand the evidence--both what we know and don't know--better decisions will be made. Better articles, education, and recommendations for patients at the point of care.
Recommending gastric bypass as a national solution for our diabetes epidemic is bad medicine and bad economics.-- Mark Hyman, MD
I was scheduled to attend the 76th Scientific Sessions of the American Diabetes Association. Professionally I was filled with anticipation. It is no trivial matter to be granted media access as a digital media professional, a.k.a. blogger. I had to submit analytics from my web traffic, share data regarding site visitors and pages viewed etc. and be open to having the content reviewed and considered.

I was in...

I did not attend. I will be staying up-to-date and writing about the sessions but not with my peers in a fully-staffed press room. Sometimes the personal over-rides the professional and you have to face the reality of the situation. A few client projects escalated requiring close oversight. I have been at conferences trying to juggle phone conversations, go-to-meetings, and deadlines and it isn't pretty.

I made a tough call. Tough because I thrive for the live connection. Access is my secret sauce and I use it liberally.

Lucky for me, I have been thinking about writing more specifically about diabetes. What a perfect time to slow down and create a narrative. But first, we need context. A level set of sorts to set the stage for how we think about clinical evidence. We also need to consider how we utilize surrogate measures to determine clinical efficacy and safety in clinical trials and what that means for the real world population (outside of a controlled clinical trial).
The figure below, highlights a comparison between agencies and their acceptance of surrogates --red for non-accepted surrogates, green for accepted surrogates. 

Comparison of international agencies: concerns with surrogate outcomes. Y axis: Drug submission. X axis: Agency. *No: no (e2) = implicit no “evidence 2”; no (ref) = implicit no “reference”; no (e) = explicit no “evidence 1”; no (e1 + e2) = explicit no “evidence 1” and implicit no “evidence 2”; Yes: yes (e1) = implicit yes “evidence 1”; yes (e2) = implicit yes “evidence 2”; yes (used) = implicit yes “used before”; yes (ref) = implicit yes “reference”; yes (e) = explicit yes; Not identified: N/S = no statement; N/A = not applicable; Red shades = negative statements of surrogate acceptability; Green shade = positive statement of surrogate acceptability; HbA1c = hemoglobin A1c; 6MWD = 6 minute walk distance; composite = histology, virology, serology; SVR = sustained virological response; CDR = Common Drug Review; HC = Health Canada; FDA = Food and Drug Administration; EMA = European Medicines Agency; NICE = National Institute for Health and Clinical Excellence; PBS = Pharmaceutical Benefit Scheme; SMC = Scottish Medicines Consortium.v
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Surrogate outcomes are defined as a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that measures directly how a patient feels, functions or survives, and that is expected to predict the effect of the therapy.

Surrogates are often biomarkers such as hemoglobin A1C [HbA1c], blood pressure, lipid levels, etc. Surrogate outcomes are used in clinical trials for reasons of efficiency and practicality; they can be measured with fewer patients, less invasiveness and a shorter observation period.

Where surrogate outcomes have validated links with final endpoints, their use can greatly facilitate clinical research. However, in the absence of validated links, there can be uncertainty about patient benefit; and even where the epidemiologic basis is sound, long-term safety and other unanticipated issues may predominate.

For example, while blood pressure is conclusively linked to cardiovascular morbidity and mortality, antihypertensive drugs do not necessarily reduce morbidity or mortality as expected.-- Surrogate outcomes: experiences at the Common Drug Review
I am not suggesting that I have any answers. But I do have a lot of questions. I field dozens of calls within medical education about writing need assessments for diabetes funding of interventions. Everybody wants to do what they have always done. "Hey, write about this class of drugs because the funder is <<insert pharma>>". No thank you. There is too much to lose.

Looking at a therapeutic area pipe-line and deciding what the gaps should be is like locking the barn door after the cows have wandered off. You need to look at the data--be open to the bounty of freely available datasets. Be open to making a difference. Let's figure it out together... moo.


2016 Banting Medal for Scientific Achievement

I continue to be puzzled by the quote by ADA--"The numbers associated with diabetes make a strong case for devoting more resources to finding a cure."

The statistics (at least to me) point to need for population health interventions and prevention strategies. Health costs are unsustainable and the diversion of funds looking for cures downstream of deleterious social correlates leaves me gobsmacked.


Thoughtful discussions about content development and outcomes analytics that apply the principles and frameworks of health policy and economics to persistent and perplexing health and health care problems...

​Stay-tuned @graphemeconsult

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    Why diabetes?

    Context is everything. Chronic diseases share common pathways -- metabolic derangements are seen in Alzheimer's Disease and a variety of other disease pathways.

    ​Time to create a narrative...

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