OP-ED

flying cadeucii88.2 % of all statistics are made up on the spot
- Victor Reeves

There’s a growing movement in medicine in general and imaging in particular which wishes to attach a number to everything.

It no longer suffices to say: “you’re at moderate risk for pulmonary embolism (PE).”

We must quantify our qualification.

Either by an interval. “Your chances of PE are between 15 and 45 %.”

Or, preferably, a point estimate. “You have a 15 % chance of PE.”

If we can throw a decimal point, even better. “You have a 15.2 % chance of PE.”

The rationale is that numbers empower patients to make a more informed choice, optimizing patient-centered medicine and improving outcomes.

Sounds reasonable enough. Although I find it difficult to believe that patients will have this conversation with their physicians.

“Thank god doctor my risk of PE is 15.1 % not 15.2 %. Otherwise I’d be in real trouble.”

What’s the allure of precision? Let’s understand certain terms: risk and uncertainty; prediction and prophesy.

By certainty I mean one hundred percent certainty. Opposite of certainty is uncertainty. Frank Knight, the economist, divided uncertainty to Knightian risk and Knightian uncertainty (1).

What’s Knightian risk?

If you toss a double-headed coin you’re certain of heads. If you toss a coin with head on one and tail on the other side, chance of a head is 50 %, assuming it’s a fair coin toss. Although you don’t know for certain that the toss will yield head or tail, you do know for certain that the chance of a head is 50 %. This can be verified by multiple tosses.

Continue reading “The Quantified Doctor”

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US Healthcare is sick and getting sicker, and while its chaotic complexity suggests to many that it will need to fail big before it can be rebuilt, some simple rules may help to get it back on track. As this the time of year when many of us prepare to send our children on grandchildren off to school in the hopes that they will learn what they need to succeed, I thought we could revisit the lessons of Kindergarten and their application to healthcare. The following list, initially from “ALL I REALLY NEED TO KNOW I LEARNED IN KINDERGARTEN” by Robert Fulghum.  has been adapted (read ‘man-handled’) for applicability to US healthcare. You’ll find the original list here:  http://www.robertfulghum.com/

  • Share everything – In healthcare, this means share ALL the data, all the information, all the acquired wisdom. Interoperable systems are essential. Price transparency is the right side of history. Automated, coordinated, connected systems are essential.  Healthcare is too much of a team sport not to share all that we know, so that we can quickly understand what works, what doesn’t, and what it’s all going to cost.
  • Play fair – It isn’t fair when decisions are made without a person’s input.  It isn’t fair that a patient should bear the risks, the pain, the scars and the costs without having unfettered access to all the relevant information. Shared decision making is part of playing fair in a world where healthcare is meant to happen for patients and with patients, but not to patients.
  • Put things back where you found them. Except for things like an infected appendix or a malignant growth, this continues to make great sense.  And as we go about transforming healthcare, we must recognize that wholesale, sweeping changes are easier to envision than execute.  While progress requires change those changes that align with / enhance / expedite existing workflows will be easiest to achieve.
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Screen Shot 2014-08-28 at 11.38.01 AMIn the past few years, we’ve seen headline after headline marveling at the advancements of medical technology. From wearable tech and micro sensors to 3D printing and health-oriented apps, it’s evident that technology and medicine have merged into an industry that’s pushing healthcare to a new level.

Yet many in the health tech industry are also voicing concerns about government regulators and their standards for healthcare technology. Some have even gone as far as accusing the FDA of “stifling” the creativity of healthcare tech and hindering the value these devices and apps could bring to the public.

In early 2014, legislation was introduced in an attempt to redesign the regulatory framework for certain types of technologies and lessen the FDA’s control over this growing industry. But are the FDA’s standards and actions so bad?

I’m in the tech field myself, and while I’ve heard many arguments against the FDA’s regulations, I strongly feel that it’s completely within its rights as a regulatory agency to place limits on medical technology. The FDA’s standards are put in place to protect consumers and to correct disingenuous manufacturer claims — an alarmingly frequent trend in today’s digital world.

Continue reading “Are Federal Regulations Stifling Disruptive Healthcare Technologies in the US?”

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Screen Shot 2014-08-22 at 9.26.00 AMThis week a host of organizations responded to a Senate Finance Committee request for feedback on how to better use healthcare data.

The inquiry is timely, given the widespread frustration providers have with health information technology (HIT), and electronic health records (EHR) systems in particular. This frustration stems from many HIT/EHR systems are locked in proprietary systems. This hinders technology’s ability to connect and exchange information freely between disparate systems, devices and sensors along the care continuum, thus undermining the overall goal of using HIT to improve efficiencies and reduce costs.

An example illustrates the point. Because HIT systems don’t work together, most hospitals use nurses to manually double check input from disparate “smart” devices. For instance, an infusion pump reports the level of pain medication being administered to a patient, as does the EHR. But these numbers sometimes don’t match, and must be double checked by at least two nurses to confirm the right dosing. Not only is this a step back for efficiency, but it’s also another manual process that has the potential to create errors and patient safety issues.

There are also economic consequences of data fragmentation. According to the Office of the National Coordinator (ONC), U.S. providers are spending $8 billion a year due to the lack of interoperability.

To address this problem and reduce the unnecessary fragmentation of healthcare data, it’s time to require the use of open and secure applications programming interfaces (APIs).

In April, a group of America’s leading scientists, named JASON, published a report that found the current lack of interoperability among HIT data sources is a major impediment to the exchange of health information. They recommended that EHR vendors be required to develop and implement APIs that support health data architecture. The recommendation was also endorsed by the President’s Council of Advisors on Science and Technology (PCAST) in May. Requiring open APIs as a foundational standard for healthcare data would reverse the current legacy of locked systems and enable the real-time exchange of information in EHR systems to reduce costs and improve patient safety.

Continue reading “An Open Letter on Open Healthcare Data”

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Screen Shot 2014-08-21 at 11.45.17 AM“The patient is the one with the disease.”  This medical aphorism, often quoted as rule number four from Samuel Shem’s 1978 novel, The House of God, has probably been around as long as medicine itself.  Its point is that doctors need to learn to accept their own vulnerability and fallibility before they can devote themselves fully to the care of their patients.  And so long as medicine was built on the relationship between two parties, patients and doctors, the rule worked reasonably well.

More recently, however, the party is being transformed into a crowd.  A third player is increasingly encroaching on the doctor-patient relationship, and more and more doctors are beginning to suspect that it may be the vector of much of contemporary healthcare’s pathology.  Who is the third party?  Its precise identity is often difficult to pin down, but its seat in the doctor’s office and at the patient’s bedside is often occupied by a hospital, a health insurer, or a government agency.

This third party usually does not see individual patients.  Instead it sees aggregates, such as rates of mortality, disease incidence, and the utilization rates of particular tests, procedures, and pharmaceuticals.  It tends to be particularly interested in parameters such as efficiency, safety, cost, and revenue.  Because it is largely blind to individuals, however, its risk of developing certain disorders is dramatically increased.  And when it falls ill, both patients and doctors suffer.

Before patients and doctors can respond effectively to such pathologies, they must first recognize that they exist.  One of the first steps in recognizing a disorder is applying a name to it, and one physician who has taken up this challenge is Adam Ratner, MD, one of the founders of the San Antonio-based non-profit, The Patient Institute.  Ratner, who has been struggling to clarify the nature of these pathologies for many years, believes that healthcare is in the midst of an unrecognized epidemic.

Continue reading “Is the Patient the One With the Disease?”

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John Haughom MD whiteWe need to design a system of health care that optimally meets the country’s needs while also being affordable and socially acceptable. Clinicians should be at the center of this debate if care delivery is to be designed in a way that puts quality of care before financial gain.

This challenge is too important to be left to politicians and policymakers. There is an urgent need for clinicians to step up, lead the debate and design a new future for health care. Placing professional responsibility for health outcomes in the hands of clinicians, rather than bureaucrats or insurance companies with vested interests, must be an ambition for all of us. We need to find the formula that meets the needs of the patients and communities we serve. A sincere collective effort by committed clinicians to design an effective system will lead to a health care system that has a democratic mandate and the appropriate focus on optimizing the outcomes patients and society need.

As clinicians enter the debate, they should keep three things in mind.

Promote the leadership role of clinicians

We need to help politicians and policymakers recognize the role of clinical leaders in shaping a transformed but effective health care system. Clinicians must redefine the debate so that it focuses first and foremost on patients and health outcomes. Cost effective care can and should be a byproduct of optimal care. Accomplishing this will provide a strong common purpose for efforts to address the challenges of designing outcome-based funding structures and improving access to care.

Continue reading “A Time For Revolutionary Thinking”

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Screen Shot 2014-08-12 at 5.37.18 PMThe much awaited WHO ethics advisory group on the use of experimental drugs to combat Ebola has issued its statement.  While a start it is no more than a baby step.

The advisory panel did decide that they found the case for using experimental drugs in African populations ethical.  While they did not say much about why they reached this conclusion it seems valid in that when facing a deadly plague the overwhelming majority of people infected would want a drug, even one that has barely been tested, to try to save themselves or a family member.  In reaching this conclusion the committee puts to rest the argument that experimental drugs could not go to Africans at all or ought to go to Americans or Europeans first in order to avoid the charge of exploitation.  In a plague that kills 90% of its African victims complaints about unwarranted exploitative research seem a bit ridiculous even against a long history of misuse and abuse of poor desperate persons in poor African nations.

The committee did not say a good deal more other than that informed consent and choice ought to be respected.  This is far less helpful.

Continue reading “Why the WHO ethics advisory group is a start but hardly sufficient”

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Screen Shot 2014-08-01 at 9.42.53 PMMany doctors are frustrated by pressures to practice a faster and more impersonal brand of medicine, but some are actually doing something about it.  I recently spoke with one such doctor, Tom O’Connor, MD, who practices general internal medicine in central Connecticut.  He and his partner, Paul Guardino, MD, believe they were the first US physicians to begin building a fully concierge medical practice the day they completed training.  In the concierge model, their practice collects an annual fee of several thousand dollars from each patient, enabling better access, more personalized care, and even house calls.

But the real story about physicians such as O’Connor is not that they are opting for a different model of financing their practices.  Instead it is the unmistakable sense of excitement with which they talk about the way they care for patients – an attitude that has become noticeably rarer in recent years.  Says O’Connor, “I have been practicing medicine for nearly ten years this way, and I am happier than ever.”  His enthusiasm stems largely from the fact that, unlike most physicians, he is not employed by a hospital or a large practice group.  Instead, he works for himself.  He is his own boss.

Of course, the idea of doctors running their own practice is not a new one.  For much of the 20th century, most physicians were self-employed, and many operated in solo practice.  Today’s trend away from physician self-employment is driven by a number of factors, including increasingly complex and costly regulation of medical practice by government and insurance companies, the failure of medical schools and residencies to prepare physicians to manage their practices, and big financial incentives for hospitals and health systems to buy medical practices in order to capture patient referrals.

Enter a new breed of physician that includes O’Connor.  He did not want someone else telling him who he could care for, what tests and medications he could order, or how long he could spend with each patient.  In his practice, he and his partner – the doctors who actually see the patients every day – make such decisions themselves.  He sees all his own patients, whether in the office, the nursing home, the hospital, or at home – wherever care needs to be provided.  They do not go to walk-in clinics and they are not cared for by teams of hospitalists.  O’Connor is their doctor in every context.

Continue reading “Doctors Who Take Medicine Into Their Own Hands”

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Screen Shot 2014-07-31 at 8.57.28 AMPresident Obama has spent a lot of time defending his health law, but he appears to us to be quite ill-equipped to actually talk about health. In fact, it’s the just about the only thing he doesn’t talk about. He’s talked insurance, web sites, and funneling even more money to medical care providers. He’s talked about deadlines. He’s talked about glitches. The shocking lack of official communication about  what should be the central message of any drive to make Americans healthier should tell us something.

In point of fact, no American leader since John F. Kennedy has had the courage to implore us to work for our own better health. He wrote in 1961 in Sports Illustrated:

“Thus, in a very real and immediate sense, our growing softness, our increasing lack of physical fitness, is a menace to our security…if our bodies grow soft and inactive, if we fail to encourage physical development and prowess, we will undermine our capacity for thought, for work and for the use of those skills vital to an expanding and complex America. Thus, the physical fitness of our citizens is a vital prerequisite to America‘s realization of its full potential as a nation, and to the opportunity of each individual citizen to make full and fruitful use of his capacities.”

By JFK’s clear, powerful, and time-tested standard, we are a disaster. We have no leader on health. Nobody.

If the Forest Service has Smokey Bear and local law enforcement agencies have McGruff the Crime Dog, where is our fearless leader who makes doing healthy things cool, interesting, and desirable?

Doing healthy things is not cool, and until it becomes cooler than doing unhealthy things, we are delivering to ourselves and our kids a future of misery and entrapment in a medical care system that regards us and them as widgets in its revenue cycle.

Ask any kid on any playground who’s their role model for living a healthy life, who’s teaching them the value of eating smartly, exercising, and managing their stressors, and you’ll get a blank stare For example, standard medical advice is that electronic gaming is bad and is a major contributor to inactivity and declining health in our children. But, gaming is here to stay, and we don’t see how professional finger-wagging gets kids to make better choices. Who’s their enlightened leader to tell them that getting up and getting fit will make them even better gamers? Nobody. Leaders meet their followers where their “heads” are and craft messages that connect and inspire action.

Continue reading “Ask Not What Your Government Can Do For You: JFK Speaks to Us About Health”

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It was 1970. I was in my laboratory at the NIH sequencing a murine myeloma protein in order to define the structure of its antibody combining region. Studies of protein conformation were at the cutting edge of science then; enthusiasm abounded. But it was clear to me that this work, in all its scientific elegance, had little to do with treating myeloma or anything else in mice or man. The reason for all the painstaking effort was the joy of pushing back the frontier of ignorance, even if only a bit. No one could foresee clinical utility then, nor would any become apparent for decades. Today such monoclonal antibodies are widely used to treat many diseases, sometimes with efficacy that justifies the costliness.

Genomics is in a bigger hurry.

Thanks to 40 years of breakthroughs, many earning Nobel Prizes, the chromosome carrying the defective gene underlying a genetic disease, Huntington’s disease, was identified in 1983 and the gene sequenced a decade later. In short order, defective genes underlying a number of single-gene diseases were defined: cystic fibrosis, hemophilia, and others. We all wait with baited breath for these elegant insights to transform into primary treatments for single allele genetic diseases. Attempts to transfect patients with normal genes are encouraging but barely so; it has proved difficult to get the right gene to stay in the right cells. Likewise, directly modifying the abnormal genetic apparatus is still largely just promising. The fallback remains working downstream from the genetic apparatus, replacing or modifying the defective products of many of these pathogenetic genes.  Nonetheless, optimism regarding modifying the genetic apparatus itself is rational as is ever more boldness on the part of molecular biologists.

Continue reading “Hyping Cancer Genotyping”

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