Sunday, February 22, 2015

Uncertain Health in an Insecure World – 24

 “For the Want of Money, Suffer Little Children”

There is no lack of will at the World Health Organization (WHO). The WHO has more than the will – it has a global plan of action to reduce the >3 million annual child deaths from environmentally-related diseases.

The WHO’s breakdown of diseases killing children, largely transmitted by infectious vectors in under- and undeveloped countries, is 1 million deaths from acute respiratory illnesses, 1.3 million from diarrheal conditions related to contaminated water & poor sanitation, and 0.8 million from malaria. Right now, children in Pakistan’s drought-stricken Tharparkar district are suffering malnutrition and starvation, and dying from pneumonia and diarrhea.

Our increasingly wired world is also harming the environment, and children.

The U.S. Environmental Protection Agency estimates that 2.5 million tons of non-compostable computer, monitor, mobile device, T.V. and peripherals waste are generated annually (~66 pounds per American). 70 million annual tons of worldwide ‘e-waste’ production contribute to kidney and neurological diseases, and cause genetic damage. Groundwater flowing through e-waste landfills (”leachate”) carries away trace elements like cadmium, lead, beryllium, PBDE’s and mercury into drinking water. 

Dismantling 1.5 million pounds of junked computers per year causes 70% of children in Guiyu township of China’s Guangdong Province to have excess lead in their blood, of which 82% have lead poisoning. Only one-quarter of U.S. e-waste is recycled. Even this e-waste is often illegally dumped in far off places like the Agbogbloshie region of Ghana in West Africa, where children scavenging gold, silver or copper for cyber-criminals are exposed to these toxins.

Low oil prices make consumer goods cheaper, and low gas prices make driving more affordable… both at the expense of children’s health.

The B.B.C. recently reported that a 10% fall in oil prices produces a 0.1% increase in Europe’s economic output. Despite the broadly based consumer bounce from >7 months of lower oil and gas prices, calls are growing to ban petroleum-based microplastics contaminating Europe’s marine ecosystems and seafood, and to eliminate noxious non re-cycleable foam containers used in American fast food take-out cartons. And notwithstanding lower gas prices, a recent King’s College London study showed that just 30 minutes of exposure to vehicle traffic pollutants among children walking to school stunts their lung growth.

Pre-natal and childhood exposure to volatile organic chemicals concerns environmental health scientists and international policy makers.

Pre-natal maternal phthalate ester exposure affects neurodevelopment and behaviors in 8-year old Taiwanese children. Polybrominated diphenyl ethers (PBDEs), now banned flame retardants applied onto numerous products & materials, are migrating to contaminate soil, wastewater, microbiota and foodstuffs. PBDE’s have adverse effects on adult thyroid hormones and fertility, and are shown to lower the I.Q.’s of North American and European children. Studies show that preconception parental exposure to 63 known persistent organic pollutants (POPs) adversely affects the birth size of offspring.

What the world lacks is a sustainable financing plan to impact these shocking child mortality statistics. For example, the 34 countries’ adopting a 15-year malaria elimination target would require US$8.5 billion in sustained financing through 2030.

A recent WHO meeting in Geneva, co-convened by Canada and Norway, brought stakeholders in women’s and children’s health together to discuss how to ensure global accountability in the post-2015 era. Building upon prior scientific momentum and independent Expert Review Group (iERG) recommendations for accountability, a growing focus of this movement is its relationship to a global financing strategy. 

In parallel, the 3rd progress report of the United Nations Environment Programme (UNEP) described the criticality of sustainable financial systems by which global markets could more effectively price environmental resources, fostering so-called environmental social governance (ESG). In the absence of effective ESG-based financial controls or market levers, the imputed value of natural capital stocks such as clean air, productive soils and abundant potable water is now falling in 116 of 140 countries around the world.

The WHO, with a 2014-15 budget of US3.98 billion (twice that of 1998-99), cannot do it all.

Despite extensive compelling research such as that highlighted above, there is still no comprehensive public financing regime and/or private sector intervention designed to positively impact long-term global environmental health.  

Absent that, millions of children continue to die on this complex, money-driven global environmental health battlefield.

In the Square or on the front lines, we must march toward the sound of battle, with victory being sustainable ESG funding that saves innocent children’s lives.

Wednesday, February 11, 2015

Uncertain Health in an Insecure World – 23

“The Buggy-man Cometh”

A recent study about the microbes that populate the subterranean world that is the New York City Subway showed that 5.5 million daily travelers are surrounded by DNA fragments of 637 diverse bacteria, viruses and fungi, including pseudomonas, anthrax, enterococcus and (yes!) bubonic plague.

So the ‘buggers’ are inside the gates, in sci-fi Ender’s Game speak.

Surprisingly, 48% of the microbes discovered had DNA that was unmatched to any known organism. Some 12% of the bacteria could potentially cause human diseases, and 27% of samples were from antibiotic-resistant bacteria. Despite common fears of catching viral infections in public places, only 0.032% of New York Subway DNA was viral. One subway station flooded in October 2012 by Hurricane Sandy had a microbiota characteristic of the cold water Atlantic Ocean.

In a move that would please the pro-open access Bill & Melinda Gates Foundation (see Post #16), the authors published their research on the Subway Microbiome in the on-line journal Cell Systems.

1958 Nobel Prize for Medicine winner Joshua Lederberg is credited with coining the term microbiome, the “microorganisms that share our body space…” In fact, microbial organisms (mostly living in our gut) outnumber human body cells 10-to-1! Collectively, an entire human microbiome weighs approximately 200 grams, or 7 ounces. Americans are collectively colonized by 10,000 microbial species with 8 million unique genes.

Why is it that we’re suddenly so keen to understand the human microbiome?

The art of the possible is involved.

In 2001, the Human Genome Project estimated that the cost to sequence a single human genome was US$100 million. The most recent 2013 cost-estimate dropped to just US$5,671. High technology has enabled the exploding field of “metagenomics”, spawning the Human Microbiome Project (HMP). Until recently funded by the U.S. National Institutes of Health (NIH) Common Fund, the HMP comprised only 2% of the total NIH budget in 2006. 

Despite >15 years squarely on the global scientific map, at the 2013 NIH Human Microbiome Science meeting attended by leaders in the field, co-host Dr. Owen White (also the HMP lead on large data management & data sharing) chastised his colleagues for repeatedly referring to the “gaps” in their HMP-enabling technologies. Said Owen, “I came here to be schooled, no kidding, on the specific obstacles to really getting science done”. He left the meeting wanting, it appears. 

HMP now has international partners in Canada, Korea, Australia and Europe.

Their research shows that important immunogenic micro-organisms are passed from mother to child during vaginal births. This is important health protection is lost in a Cesarian section, possibly predisposing C-section babies to emerging global chronic illnesses like asthma, diabetes, celiac disease and obesity (see post #10).

Agribusinesses that fatten cattle and other livestock with nontherapeutic drugs (see post #19) are also shifting the gut microbiomes of those eating these antibiotic-modified foods. Underfed people in rural Malawi, Burkina Faso and the Amazon have greater gut microbial diversity than urban Europeans, but still die younger and suffer more diarrheal intestinal illnesses.

Start-up spawn of the same Big Pharma companies that brought us multi-drug antibiotic resistant bugs like methicillin-resistant staph aureus (MRSA) see their future profitability tied to microbiome-modulating drugs for difficult-to-treat inflammatory bowel diseases (i.e., ulcerative colitis), obesity (i.e., metabolic syndrome), etc.

HMP scientists continue to warn of the complexity of the big data generated by their microbiome research… of analytic data “gaps” that confound their observations (see post #18).But for most of us, the simplest things, like eating bifidus regularis-laden yogurt, remains the only real-life microbiome building intervention available.

An average 165 pound human has approximately 350 times more cell-based than microbiome DNA. It's good that enabling metagenomics technology can now explore the significance of these bugs to human health.

That said, the developed world's scientific and Pharma R&D's laser-like attention to this potential druggable target feels like a public research funding and for-profit boondoggle. This is especially true when the global one trillion dollar drug bill, 50% of which is expended in the U.S., will likely never benefit the less developed, under-served people of the world.

We in the Square are all for the advancement of science, and see the benefits of bio-medical research on global human health. But for the moment... please pass the yogurt.

Thursday, February 5, 2015

Uncertain Health in an Insecure World – 22

“80-20 Rules of 21st Century Global Health”

The Pareto Principle was described in 1906 by economist Vilfredo Pareto, when he reported that 80% of the land in Italy was owned by 20% of the population. Also an avid gardener, Pareto had previously observed that 20% of the pea pods in his garden contained 80% of the peas. The business version of his Law of the Vital Few, The 80-20 Rule, states that 20% of customers create 80% of total sales. Complex mathematics & probability theory (the Pareto Distribution) explain this seemingly simple rule.
Question: Does Pareto’s 20th century principle impact 21st century global health?

The World Innovation Summit for Health (WISH) is a global health care community dedicated to evidence-based ideas & practices. WISH and others estimate that the social determinants of health account for 80% of global health. The World Health Organization (WHO) reports that such “unavoidable inequities” (i.e., socioeconomic status, education, environment, employment, food access, etc.) vary greatly across the globe. WHO also recognizes that where people are born, grow up, live, work and age – the “social gradient” – exerts a complex but unquestioned cumulative impact on global health.

In 2013, a U.S. biopharmaceutical research group reported that 80% of rare diseases, some 7,000 diseases affecting <200,000 citizens each, are of genetic origin. Approximately half of rare diseases affect children. In 2014, the U.S. FDA called for policy change for rare disease therapeutics in children, because 80% of new drug approval (NDA) requests contained no pediatric information.
In 2013, the U.S. FDA approved 13 orphan drugs for rare diseases, while Pharma reported >450 medicines & vaccines in their pipelines. 

Complex new pharmaceuticals (biologicals, immunotherapies, etc.) make up a growing segment of the new drug development marketplace. Increasingly, these new drugs are delivered in a home care setting, often self-administered, and requiring a higher level of customer support services from Pharma’s so-called ‘health storefront’.

Per IMS Institute for Healthcare Informatics 2011 data, 80% of prescriptions dispensed by U.S. pharmacy chains are for less costly “generic” drugs. Switzerland’s Alliance-Boots GmbH and U.S. Walgreens Co. will complete their merger in early 2015, largely in response to the increasingly complex retail pharmacy & pharmaceutical global marketplace. Generics are the volume-based horse pulling in profits at Walgreen-Boots-Alliance (WBA).

WBA’s highly sophisticated 21st century business model anticipates many market trends, including what might be considered as invasive use of personal health information (PHI) & lifestyle information – either knowingly supplied by patients via on-line tools &/or mobile apps, or extracted from ‘big data’ activity monitors such as Google. WBA have analyzed market sector growth in the affluent world, finding a 10-13% annual growth in specialty medicine use (i.e., ‘specials’) consistent with an explosion of interest in personalized (a.k.a. precision) medicine (PM).

But non-generic medicine R&D is really expensive. 

Many “ethical” (i.e., non-generic) Pharma companies’ post-blockbuster era profit models imagine future ‘gap’ care in the home from drugs like Herceptin™ for HERS-2 positive breast cancer. While these PM drugs and biologicals are relatively expensive compared to generics, their home delivery could bend the ever-growing costs of health care compared to hospital or clinic drug administration.

The Kaiser Family Foundation Health Research & Education Trust (HRET) reports that between 2003 and 2013, U.S. employer contributions to family health care insurance premiums of non-elderly insured (covered) workers increased 80%.

Why is that?

Eighty percent (80%) of Americans still die in hospital. Of the 70% of total health care costs incurred by the elderly, 80% occur in the final month of life for a combination of acute plus end-of-life care. Obviously, this care model adds massively to health insurance premiums and to the public cost of health care. Non-physician health care aides (a.k.a. personal support workers) now provide 80% of health care to the Canadian elderly in senior’s homes and facilities (1/3rd of whom have dementia, or “brain failure”; See post #9).

These trends reflect growing 21st century developed world momentum towards more accessible, personalized, lower-cost home health care for a variety of medical conditions & patient cohorts.

Answer: None of these 80-20 associations speak directly to a Pareto Principle influence on 21st century health.
It is intriguing to imagine that some fundamental truth about health and health care could be connected, however indirectly, to a rule of thumb or a mathematical certainty.

However, this exercise convinces me that despite our medical bent towards empiricism, much of what goes on in health and health care is akin to Brownian motion – replete with data misses & manipulations, random non-causal associations, and irreproducible models.

Such nihilism aside, the complexity & rapid pace of change that define 21st century global health and health care are often plainly unfair, and certainly feel unprincipled.

We seek answers to explain this complexity!

And those of us in the Square doing the hard math continue our quest for the rules.