Saturday, January 31, 2015

Uncertain Health in an Insecure World – 21

“Expectations of Health Privacy – Paradise Lost?”

There is nothing more injurious to the human psyche than a violation of personal privacy.

Humans in most countries and cultures value privacy, linked to the shame and humiliation that we all feel, rightly or wrongly, when others see what we are “willing to do only if no one else is watching”. It resides deep in our primitive hind brains. Privacy is so important that its loss in Paradise is of biblical proportions in the world's Abrahamic religions.

Every digital world citizen should listen to reporter Glenn Greenwald’s October 2014 TEDGlobal talk titled “Why Privacy Matters”. Greenwald plumbs the deeply held human privacy instinct in the face of recent data revelations by Edward Snowden and others. Whether WIKI leaked to the press, posted on YouTube, or whispered in a hospital hallway, such violations are deeply hurtful, and have very real consequences for many victims.

Greenwald’s TED talk touches lightly on health privacy issues (“… things to hide”), but zeroes in on the pernicious role of personal big data sharing and for-profit data redistribution platforms such as Facebook and Google. We’ll see how these connect in frightening ways shortly… 

But some health privacy background might help.

In medicine and other health professions, caregivers are sworn to maintain the confidentiality of their patients’ medical stories and records. Patients rightfully expect that what they tell their doctor, psychologist, dentist and nurse will not be shared with others unless there is an absolute medical necessity tied to their well-being.

In addition to these accepted oaths and norms of health professional conduct, health information privacy laws have emerged in most developed world jurisdictions in the past twenty years. These laws codify the rights of patients to privacy under most circumstances, and provide civil and criminal penalties for violations, whether unintentional or malicious. 

The original intention of laws such as the U.S. Health Insurance Portability and Accountability Act - (HIPAA, or Kennedy-Kassebaum Act) of 1996 was primarily to prevent health insurance companies from denying continuing coverage to those moving from state to state, due to their unapproved covert discovery in medical records of pre-existing medical conditions. Such conditions were commonly used as a reason to deny health insurance coverage & benefits, which still remains a real risk despite laws like HIPAA.

Over the past two decades, driven by the desire of public and private health insurers to better manage the costs and paths of care, the electronic medical record (EMR) has emerged as the new reality within modern health care systems. These EMR’s, largely designed for the expensive inpatient hospital care setting, are being rapidly on-boarded at hospitals and clinics to track utilization costs that are the basis for reimbursement to health care systems and doctors. The emergence of alternative payment models – pay for good performance and penalties for poor quality (like <30 day hospital re-admissions) – are now an accepted cost of doing business in the health care sectors of many developed world countries.
Of course, when hundreds of thousands of people (i.e. EMR “approved users”) enter, access and transfer health information into and through massive databases that are controlled and managed by “custodians” – two common problems emerge. The first problem fulfills the garbage in-garbage out adage, reflecting the degradation of data over time due to serial un-reconciled problems with EMR data entry errors, care complexity, software & operating system updates, and inpatient-outpatient system interoperability. Users interfacing with these EMR’s express their frustration and helplessness; eventual system performance failures ensue. 

The second problem is the risk to privacy associated with the churning of such patient data through health systems, insurance companies, and governmental agencies. These entities have appropriately strict risk management rules to mitigate their exposure to loss of privacy problems & penalties. Unfortunately, these rules and laws are subject to human error and foibles. The stolen clinical trial investigator laptop computer with unencrypted patient data is the poster child for personal health information (PHI) loss, and a sentinel event for system failure. The lure of personalized or precision medicine tied to one’s genetic make-up, is highly leveraged on the capacity of big data managers and analytics to safely and securely manage de-identified PHI (see post #18).

Recent revelations are even more disturbing!

On January 24, 2015, the Associated Press (AP) reported that the U.S. website enrolling patients in Obamacare insurance plans was “… quietly sending consumers’ personal data to private companies that specialize in advertising and analyzing Internet data for performance and marketing”. Read – Google, Twitter and Facebook!!!

That same day in a New York Times Op.Talk piece by Anna North, privacy law professor Woodrow Hartzog queried, “Are third party recipients of this information allowed to share with other people? Are they under an obligation to keep from trying to re-identify that (PHI) information?” 

In the days ensuing, the Obama Administration argued that “private sector tools” were essential to standing up a consumer-focused ‘Window Shopping’ feature on the once-failing web site. Amid a public outcry over privacy, the Obama Administration then relented by scaling back public-private information sharing and adding more layers of data encryption.

Do you feel more secure after this health privacy asteroid near-miss?

Privacy is reflexive… a core bodily function… likely breathing air, or swallowing food.

Let's be serious about protecting ourselves from abuses, wherever they lurk in the Square.

Sunday, January 25, 2015

Uncertain Health in an Insecure World – 20

“crISIS in the Caliphate”

What is the health status of the ISIS- or ISIL-controlled territories… the pan-Islamic Caliphate?

Islam is practiced in nearly all the countries of the world. The Pew Research Center reports that 23% of the world’s population is Muslim – 1.8 billion people, up from 1.6 billion in 2010. Islamic rituals such as ablution, praying five times daily towards Mecca, Halal dietary restrictions, fasting, modesty in the presence of the opposite sex, male circumcision and other practices may complicate health care, and could potentially affect Muslim patient outcomes in Western delivery systems.

There is no fundamental schism between Islam and Judaism – both are peaceful religions. The degree to which individuals and communities follow the rules & regulations of these religions – observance – creates different expectations for health care. Despite long-standing geopolitical differences & related military conflicts that exceed the scope of this medium, with some nuances, much of what Islam requires of observant Muslims also applies to observant Jews seeking health care.

Health care professionals are universally committed to culturally sensitive & compassionate care of all people, whatever their religious beliefs or observances. The act of caring for others is revered in Islam, as a manifestation of love for Allah and Muhammad. Muslim doctors may or may not choose to follow the Hippocratic Oath. Unlike modern Western medicine, Islamic health care stresses holistic approaches and well-being (Tawheed, or Oneness of Allah) through meditation and prayer.

But what does health care look like in ISIL-controlled territories of the emerging “Islamic State”?

Of course, there’s the trauma and death of combatants and collateral civilians. While statistically shocking, this mortality and morbidity – combatants killed-in-action (KIA) and civilian casualties – is almost taken for granted in 24/7 news cycle and official governmental reporting. In the fog of war and the related diaspora of refugees, KIA and casualty counts are hard for agencies on the ground or abroad to verify. The U.S. military claimed to have killed 4,000 ISIL combatants, only to have the Viet Nam War veteran and U.S. Secretary of Defense Chuck Hagel promptly refute the accuracy of such 30,000 foot fly-over body counts.

A lack of precise, real-time human health impact information is not unique to this global hot spot.

In countries surrounding the “Islamic State”, health workers are routinely caring for ISIL militants. A Mersin, Turkey hospital nurse was recently quoted as saying, “We treat them, and they go on to decapitate people”. She noted that Syrian refugees often identify themselves to hospital workers as Bashar al-Assad regime “opposition members”, only to be later revealed as ISIL fighters and commanders. Ironic to most, ISIL is currently holding hostage at least 46 Turkish citizens.

Should wounded terrorists receive health care consistent with the Geneva Convention? Should public taxes in neighboring countries pay for militants to recover from their war wounds, returning them to the battlefield? Did sleeper cell terrorists in Western Europe receive publicly funded health care?

Provocative questions! My answers are ‘Yes’… ‘No’… and ‘Probably’.

One of the first foreign hostages beheaded by ISIL in September 2014 was British medic David Haynes. The recently expired ISIL deadline for the Japanese government to pay $200M to prevent the brutal decapitation of two of its nationals (at least one of whom is now dead) creates a moral and policy dilemma – this unprecedented ransom could save two innocent lives, or be used for humanitarian aid and health care needs of hundreds of thousands at home or abroad.

Last week, U.S. Secretary of State John Kerry, another Viet Nam War veteran who protested American military atrocities in the 1970’s, chastised a left-wing women’s anti-war protest group (CODEPINK), telling them that ISIL is, “killing and raping and mutilating women”. It’s hard to definitively prove this Kerry rhetoric. But in response to CODEPINK hecklers, Kerry went on to correctly state about ISIL that, “They’re not offering health care of any kind.

Unlike some militant (a.k.a. terrorist?) groups like the political wing of Hamas in the Gaza Strip & West Bank, ISIL’s ballooning budget from stolen oil sales and ransoms does not support basic health care in the territories under its military control. ISIL operates no field hospitals.  ISIL lays siege to refugee field hospitals such as the one in Kobani, Syria. ISIL car-bombs field hospitals such as one in Atmeh, Syria. In fact, the ebb & flow of wounded fighters at field hospitals in Syria, Iraq and northern Yemen has made them favored targets for suicide bombings and reprisal attacks. 

The dramatic images of lifesaving aerial drops to desperate Yazidi refugees on Mount Sinjar in northwest Iraq have faded. But these and other displaced people still require mobile and refugee camp-based primary care & mental health services. Ironically, countries like Canada and France provided millions of dollars in humanitarian and health care aid to the ISIL-controlled regions in the months preceding the deadly ISIL-inspired lone wolf and sleeper cell attacks in Ottawa and Paris.

Despite foreign aid, the people of the Syrian Arab Republic are more than four years into a WHO-declared public health crisis. Children of Syria and Iraq are the most vulnerable. Disruptions in basic public health services like vaccination have prompted reemergence of measles & polio, and a severe depletion of medicines to treat childhood cancer. UNICEF’s Executive Director, Anthony Lake, recently stated that “Millions of children inside Syria and across the region are witnessing their past and their futures disappear amidst the rubble and destruction of this prolonged conflict.” Theirs is becoming a “lost generation”.

ISIL is clearly a threat to global security, and is destabilizing the health of millions.

Until we in the Square view this unhealthy Caliphate as our concern, this crISIS will continue to rake the region, and impact health for all of the 7.1 billion people around the globe.

Monday, January 19, 2015

Uncertain Health in an Insecure World – 19

Oil Price Shocks & Global Health – "Don’t Bring Me Down”

Oil prices are the world’s most volatile and geo-politically manipulated commodity.

In 1979, the overthrow of the Shah of Iran and the ascension of Ayatollah Khomeni quickly doubled global crude oil prices to a peak of US$39.50 per barrel.

Fast forward thirty-six years… On January 16, 2015, the spot market price of West Texas Intermediate (WTI) crude oil closed at a shocking low of US$48.69 per barrel!

A generation of oil exploration, gulf wars, climate change and global health crises later, the price of oil is less than $10 per barrel different… How can that be?

In late November 2014, Saudi Arabia’s oil minister Ali Al-Naimi said what his analysts had been signaling for weeks – high-priced oil production from shale and tar sands needed a market-based trimming. By December 31, 2014 the price of crude oil had cratered by -46%, to US$53.27 per barrel. Other notable Saudi-OPEC instigated oil price shocks followed price peaks in 1986 (falling -41% to US$15.04 per barrel over seven years), and again in 2008 (falling -55% to US$53.48 per barrel in just six months).

Like you, in January I gladly pumped gas into my car for less than US$3.00 per gallon for the first time since 2008, when then WHO Director-General Dr. Margaret Chan said, “We face a fuel crisis, a food crisis, a severe financial crisis, and a climate that has begun to change in ominous ways. All of these crises have global causes and global consequences. All have profound, and profoundly unfair, consequences for health…. The health sector had no say when the policies responsible for these crises were made. But health bears the brunt.”

I then drove 800 miles up the U.S. east coast listening to economic spinmeisters on the radio touting the benefits of falling crude oil prices on consumer prices and manufacturing costs.

What is the Uncertain Health in an Insecure World point, you ask?

The direct and indirect effects of irrational peaks and precipitous shocks in oil prices on global health may be less obvious than 2014’s other sentinel events, but are far more serious than Ebola (despite 8,429 deaths), the flu (and the 23% effective vaccine) and global warming (when the average temperature was +1.24oF higher than the 20-year average).

In rich countries, health care has been characterized as a “luxury good”, more readily purchasable as personal incomes and national standards of living rise. A 2013 study by Massachusetts Institute of Technology and University of Chicago economists analyzed the continual post-WWII rise in national health care spending as a percentage of GDP (tripling in the U.S., and rapidly growing in O.E.C.D. countries) in relationship to household incomes, market prices of oil, and local oil reserves. Their clever analysis of the elasticity of demand for health care purchases showed that rising income was unlikely to be the major driver of rising health care costs as a percentage of GDP.

What, then, is the cause?

Oil price shocks permanently damage personal income, and exert an unhealthy impact on public health spending in both oil-rich countries and oil-less jurisdictions.

As noted in Lancet at the time of the 2008 oil price shock, under-nutrition (mostly in poor countries) results in 35% of global child mortality and 11% of global disease burden. In 2009, the United Nations counted 1.02 billion undernourished people. Oil scarcity impacts food production quantity and pricing – oil is necessary for farm machinery, pesticide production, food transportation, etc. Sustainable agriculture & land ethics guru Fred Kirschenmann predicted that the end of cheap energy would force the redesign of the global food economy.

Massive global public health shocks are inevitable during this bio-fuel vulnerable food economy transition.

Increasingly expensive oil extraction from shale and tar sands – what the Saudis are currently pushing down on – inevitably drives up the cost of industrial food production, negatively impacting food security. Food insecurity has significant public health consequences. In 2010, the World Bank projected that a 35% food price increase would add 80 million undernourished people worldwide. This is well within the range of historical bio-fuel production related oil pricing peaks and shocks.

With the global population projected to exceed 9 billion by 2050, food insecurity will only worsen.
Jeff Lynne follows the 1979 Electric Light Orchestra (ELO) lyric, “Don’t bring me down”, with a strange word “….Brrruce!” Lynne’s original follow-on lyric was actually “….Groos!”, a Bavarian greeting that band members heard while recording their album in Munich. But the universally misheard mondegreen of “….Brrruce!” stuck in the final version of this ELO hit.

So, thirty-six years later, people hear what they want to… in music, and about oil shocks.

But in the Square, we are not so easily fooled by spinmeisters.

We understand that oil price shocks are bad for global health, even if the gas we pump is cheaper.

A wave of the honorable minister's oil wealthy hand bodes ill health.

Sunday, January 11, 2015

Uncertain Health in an Insecure World – 18

“Big Data, Analytics and The Emperor’s Clothes”

The brave new digital world makes measuring everything, yes everything, possible.

My Fitbit tells me if I slept soundly, after walking >10,000 steps during the day. The iCloud tells me that I’m out of new photo storage capacity, encouraging me to purchase more. I’ve already forgotten my login password to the electronic medical record (EMR) that I used in 2014, but faxes of my patients’ test results follow me everywhere.

This is progress, right?

Whether you’re a digital native, migrant or alien, what most of the world experiences of big data can be classified as “the tail wagging the dog.” The password protected entry of our vital signs (age, height, weight, etc.), PIN’s and patient information into secure databases serves a system that is supposed to benefit the users of services (i.e., us).

But does this really serve us?
The real value of big data resides in the capacity of information systems to predict a failure before it actually happens. If big data could foretell a bad night’s sleep, prevent incipient disease, or avert an airplane crash, then that would indeed be powerful.

But for big data to reach the level of useful predictive power, sophisticated analytics are needed.

Pattern recognition that predicts failure (or success) is the forte of high-speed computing. While IBM’s Watson can win TV’s ‘Jeopardy’ on the basis of massive random access memory, it is the analysis of complex chess move scenarios (i.e., modeling) that predisposes Watson to beat chess masters >95% of the time.
Software is necessary to detect problematic conditions early, and to predict bad outcomes that system operators could then use to mitigate harm, to their own platforms or to us. Familiarity is comfortable to humans. Software programs also recognize familiar patterns, giving them a beneficent “pass”. But until data patterns suggest that a predefined negative threshold or boundary has been crossed, it concludes that nothing is wrong.

Failure, like icebergs, loves to lurk below the surface of such familiarity.

Variability in data quality is the enemy of big data usefulness, and the nemesis of analytics. When U.K. patients fill in EQ-5D forms or record outcome measures (PROM’s) after inpatient hip or hernia surgery, the related cost-effectiveness and cost-utility of these procedures varies greatly across NHS hospitals, even after adjusting for case-mix index (CMI).

The “garbage in, garbage out” adage is applicable.

 Health care systems in the developed world collect gobs of data for reasons usually related to rational health care service delivery (administrative databases), and to the process & outcomes of health care (patient databases). Both types of big data sets should ideally provide health systems with insights into achieving the triple aims of patient access, sustainability (cost control) and care quality. Increasingly, health care payers (purchasers) require timely system performance data capture & submission before making payments to hospitals and caregivers (providers).

The purchaser-provider split remains a gulf, and costs are still rising in most health care jurisdictions.

For years, such central health care databases and the diverse EMR’s used in the field have underpinned triple aim aspirations of health care systems where insurance coverage is legislated and access is ±assured. But the successes (and failures) of these big data systems have mostly related to protecting patient privacy, assuring insurance portability, and measuring compliance with care guidelines & pathways.

The hoped-for benefits of big data to triple aim success (i.e., to us) remain largely unfulfilled.

A 2012 survey by MIT Sloan Management Review and SAS Institute Inc. of 2,500 big data users in 24 diverse industries, including Kaiser Permanente, revealed that the analytics revolution was incomplete. Only 11% of respondents were analytical innovators, while 29% were analytically challenged. Unlike in the data mining companies of Silicon Valley, with an estimated market cap of US$41.5 billion by 2018, the emerging field of data science has yet to produce tangible ROI in the health care sector.

To us, the possible is always alluring.

But in reality, the analytics revolution is not now… not yet.

The Emperor of Big Data was just spotted walking through the Square… sadly, without any clothes.


Friday, January 2, 2015

Uncertain Health in an Insecure World – 17

“Children Are Not Small Adults”

Dr. Peter Moore so titled his 1998 Lancet article about the under-regulation of prescription drugs for children. Children are classified as “vulnerable individuals” in many countries.

But until quite recently, the actual scope of that vulnerability within developed country health care systems has been under-appreciated.

What exactly has been threatening the world’s most vulnerable patient cohort – our children?

Over the past decade, clear evidence has emerged about the risks related to the paucity and poor process of pediatric clinical drug trials.

A 2008 Lancet review of 7-years of pediatric clinical trials data showed that only 2% (13/740) of research trials involving children had an independent data safety & monitoring committee.

A 2008 PLOS Medicine article reported that over half of the drugs used in hospitalized children are either used off-label (“compassionate” use) or are unlicensed for use in children. Drug dosing & pharmacological effectiveness in children is often incorrectly extrapolated from adult drug trials.

In 2010, Dr. John Ioannidis, Stanford University disease prevention advisor to countries around the world, was named a ‘brave thinker’ by The Atlantic magazine, after calling for better reporting of the ‘harms’ to children participating in pediatric drug trials.  

A 2012 Pediatrics study showed that despite the high burden of childhood diseases (59.9%), only 12% (292/2440) of all clinical trials involve pediatric populations. Existing pediatric trials are usually restricted to cancer drugs and vaccine development, and are most frequently funded by governments or non-for-profits. Lucrative adult drug trials are more often corporately funded by ‘Big Pharma’. 

In November 2014, Dr. Martin Offringa of Toronto Sick Kids Hospital acknowledged that these "failures are now on the table, rather than under the table..."

To those of us more familiar with adult drug and medical intervention trials, all of this information is frankly shocking!

The overdue global response to these mounting concerns has been impressive.

International experts are actively mobilizing effective pediatric clinical research networks:
•        StaR Child Health Network (est. 2012) – U.S., Canadian, Australian, European and Asian experts aid in the development of standards for the design, conduct and reporting of pediatric trials.

•        Eunice Kennedy Shriver National Institute of Child Health & Human Development Pediatrics Trials Network (est. 2012) – now operational in the U.S., and actively seeking global partners.

•        Global Research in Pediatrics (GRIP, est. 2011) – a European Union (EU)-funded pediatrics clinical trial resource for on-line tools and expertise in pharmacology, trial sample size calculations, data safety & monitoring committee creation linking >1,000 GRIP institutions worldwide.

•        National Institute for Health Research medicines for children research network (MCRN, est. 2006) – guides U.K. researchers in designing better pediatric clinical trial information leaflets; MCRN now actively involves children and young people in this process.

So - has this child-unfriendly clinical drug trials riptide turned?

No - not completely.

However - greater global medical community awareness of the need to reduce the risks & harms to vulnerable children from poorly designed clinical trials is now properly front & center.

And with these small steps, sick children may soon run more safely in The Square.