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Saturday, March 1, 2014

This is brilliant

Bohemian Polypharmacy


Excellent. Pay it forward. Interesting: two years ago tomorrow I wrote a post citing on of the books mentioned in this video during the exit crawl ("Overdiagnosed").

I'm really tired today. It took me almost 17 hours to get home from MCO. Layin' low, hangin' with my dogs, watchin' movies, drinking some Italian red, just fixed a big salad...

Nonetheless:

APROPOS


I read this book a number of years ago. It's now out on Kindle, and, because I'd bought the print edition I just got the eBook version for $2.99.
PREFACE TO THE PAPERBACK EDITION
 When Overdo$ed America was first published, I expected the book to generate immediate excitement. After all, the book exposes many of the drug companies’ well-kept secrets, such as the misrepresentation of their own research on Vioxx and Celebrex in our most respected medical journals and the pushing of cholesterol-lowering drugs on millions of Americans, unsupported by the scientific evidence. I had spent nearly three years documenting the undue influence of the drug and other medical industries on American health care and was sure that the response to my findings would be explosive.

During the first week after publication the silence was deafening. Maybe doctors were not ready to accept that much of the “scientific evidence” upon which they base their medical decisions is more like infomercials than disciplined science. Maybe the American public was not ready to swallow this bitter, but critically important, pill.

Then, just one week after the book hit the stores, Merck stunned the medical world with its announcement that it was withdrawing its $ 2.5 billion a year arthritis remedy Vioxx from the market. This was the biggest drug recall ever( about one out of ten American adults had taken Vioxx in the previous five years.

Initially Merck was credited with acting responsibly and decisively when it learned that its blockbuster drug doubled the risk of serious cardiovascular problems in a study designed to determine whether Vioxx reduces the recurrence of non-cancerous polyps of the colon. But the real news was not that Merck had done the right thing in September 2004 (which it had). Rather it was that American doctors had prescribed $ 7 billion worth of Vioxx, causing an estimated tens of thousands of heart attacks and deaths, after both Merck and the FDA had become aware (in 2000) that Vioxx was significantly more dangerous and no more effective than an older and far less costly anti-inflammatory drug, naproxen (Aleve).

Suddenly it was as if the waters had parted or the code of silence lifted. Americans wanted to know how a non-essential drug that turned out to be so dangerous had become so widely used. The media responded. Instead of being ignored, I was invited to explain to millions of Americans how this had happened on NBC’s Today show, CNN’s American Morning, Lou Dobbs Tonight, and on all the other major networks.

In the following three months an unprecedented string of drug company failures and embarrassments came to light. Just one week after the Vioxx recall, Americans learned that half of our supply of flu vaccine, 46 million doses, would not be arriving as planned from a manufacturing plant in Liverpool, England. The plant, which sends 90 percent of the flu vaccine it makes to the United States, had been abruptly shut down. Bacterial contamination of four million doses of flu vaccine was the initial sign of trouble, but the underlying problem was the inadequacy of the manufacturing safety systems. With most of the flu vaccine being produced in this plant headed for the United States, one might assume that the FDA had been actively monitoring the safety of these imported medicines-especially given its oft-expressed concern about the potential danger to individual citizens of importing drugs from abroad. But it wasn’t the FDA that shut down the plant in England. In fact, FDA officials were taken by surprise when they were informed that the British drug authorities had shut the plant down to protect Americans from unsafe flu vaccine being produced by an American company’s plant in the United Kingdom. This debacle was an accident that had been waiting to happen, at least in part the result of having transferred more than one thousand FDA employees into the department that approves new drugs (like Vioxx) and out of the department that oversees drug safety (like inspecting manufacturing plants).

This was not all. The following week the FDA issued a strong warning about the use of antidepressants in young patients: “Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents.” British drug authorities had mandated a similar warning a year and a half earlier, based upon the same information that had been available to the FDA. Eight months before the warning was issued in the United States, an FDA Advisory Committee met to discuss the potential danger of these drugs. But the FDA’s own epidemiologist, who had been heading up this investigation, was removed from the agenda and not allowed to present his report.

Although the six studies involving young patients that had been published in medical journals showed that antidepressants are safe and effective, nine studies showing just the opposite had not been published. Doctors, trusting their medical journals, were being misled. Instead of taking protective action based on a clear and present danger, the FDA asked an independent panel of researchers to review the data. When the outside experts agreed with its own, the FDA belatedly mandated the highest level of caution: a “black box warning” on the drug label and a patient information sheet to accompany the medication. In other words, the drug companies had maintained sales of largely ineffective drugs by not publishing results from their own studies showing that the new antidepressants increase suicidal behavior in youngsters, thus leaving doctors uninformed about these negative studies. When confronted with this situation, the FDA’s reaction was first to protect the drug companies rather than our children. (This brings to mind the maxim that the best measure of a society is how it treats its most vulnerable members.)

This rapid-fire series of events may have brought us to a watershed in American medicine, dispelling the illusion that what’s good for the drug companies is good for Americans and helping us to understand that we are not getting commensurate value for the enormous cost of our health care. Probably the greatest cause for optimism is the Senate Finance Committee hearing called by Sen. Grassley (R-Iowa) to investigate whether the FDA and Merck had adequately monitored the safety of Vioxx. Americans were given the opportunity to witness academic researchers and public employees describing how drug companies wield influence and suppress information. Most of the senators on the committee appeared to care deeply about protecting Americans from the unnecessary dangers of potentially harmful drugs and seemed to understand that the FDA is not now providing adequate monitoring of drug safety.

As the litany of previously undisclosed risks of some of our most widely used drugs grows ever longer, most of the attention is being focused on the FDA. Certainly reform at the FDA is necessary to improve the safety and effectiveness of our medical care, but this is in no way sufficient to achieve all our goals. Like a dentist not drilling all the way to the bottom of a cavity, we are still not getting to the bottom of the problem, and anything less is going to squander this extraordinary opportunity.
The over-use of Vioxx, Celebrex, and cholesterol-lowering drugs in adults, and antidepressants in children and adolescents all show that at the heart of the crisis in American medicine is a crisis in the quality of our medical knowledge. As you will learn in the pages to follow, the corruption of that knowledge extends far beyond the reach of the FDA. Overdo $ed America tells this story without protecting any of the vested interests, which is how we need to approach the crisis in American medicine if we truly want to restore its broken promise.
Yeah. I am reminded of my recent intense study of Bunge's "Medical Philosophy":

Ten percent of the health budget of the prosperous nations is spent on medical drugs. About $ 100 billion per year are invested worldwide in drug research and development. However, almost the entirety of this task is being performed in universities and state research institutes such as the National Institutes of Health, at taxpayers’ expense. But only 10% of this budget is devoted to studying drugs to treat diseases typical of the underdeveloped nations: parasitoses of various kinds, tuberculosis, malaria, Chagas disease, and dengue fever. There are, then, two pharmacopeias: one for the rich and another for the poor.

Still, there has been sensational progress, to the point that most of us have come to believe the formula a pill for every ill [emphasis mine -BG]. Consequently, selling medical drugs has become as lucrative as selling arms or narcotics. But this success has not made friends for either pharmacology or the pharma industry. On the contrary, we are witnessing a cultural backlash — the indignation caused by the disproportionate price of medical drugs and the reluctance of Big Pharma to manufacture generics (at one-third the price of brand names) has been compounded by the resentment that scientific and technological advancements provoke among those who are left behind for lack of a modern education. This second motive explains why the enemies of science are concentrated in churches and humanities departments.

Reaction against cultural innovation is not new. The ancient Mediterranean world was destroyed not only by barbarian invaders, but also by the destructive frenzy of the masses that had been left outside the official culture; they adopted exotic religions, like Christianity and Mithraism, that were hostile to learning and the arts; the seventeenth-century Witch Craze followed in the wake of the Scientific Revolution; the idealist philosophies of Kant and Hegel reacted against the materialism and scientism of the radical wing of the French Enlightenment; psychoanalysis, intuitionism, phenomenology, existentialism, linguistic philosophy, and dogmatic Marxism became popular at the same time that atomic physics, chemistry, pharmacology, neuroscience, evolutionary biology, and other new and rigorous disciplines flourished.

The laggards demonized the science that they could not understand or that contradicted their unexamined beliefs. And they were often joined by self-styled leftists incapable of distinguishing knowledge from its misuses; by those who imagined that medicine is just a tool of the pharmaceutical industry; and by those who wish to judge science with political criteria instead of engaging in the much harder task of thinking and doing politics with the help of science.

Bunge, Mario (2013-05-30). Medical Philosophy:Conceptual Issues in Medicine (Kindle Locations 2038-2055). World Scientific Publishing Co Pte Ltd. Kindle Edition.
Interesting. Let's further triangulate. As I've written before (Jan 21st), "Socioeconomic determinants of health" turn out to be much more significant than have historically been credited. So, let's add to that dismal stew the following:

Preface
Never before in human history has the gap between the scientific and economic potential for better health for all and the reality of avoidable premature death been greater. In the past, babies died in infancy, women in childbirth, workers from injuries or occupational diseases, and people of all ages from epidemics of infectious disease exacerbated by inadequate nutrition, contaminated water, and poor sanitation. For the most part, the world lacked the resources and the understanding to eliminate these problems. As societies developed; as science, technology, and medicine advanced; and as people organized to improve their standards of living, more and more of the world’s population attained the living conditions that support better health and longer lives.


Today, the world still confronts the global health challenges of the last century. Epidemics of malaria, HIV infection, tuberculosis, and other communicable diseases still threaten well-being and economic development in many poor countries. More than a billion people live in urban slums where the average lifespan can be 35 years, half of that in better-off places where residents have certain access to adequate nutrition, clean water, and sanitation.

Now new threats have emerged. Deaths from chronic conditions like heart disease, cancer, diabetes, and stroke have surged, today accounting for more than 60 percent of the world’s deaths. Injuries have become the leading cause of death for young people around the world. Everywhere, from the wealthiest nations like the United States to the poorest countries in Africa, Asia, and Latin America, the proportion of deaths from these causes of death are growing. These premature deaths and preventable illnesses and injuries impose new suffering on individuals, families, and communities. They burden economies and taxpayers and jeopardize the improvements in health brought about by the public health advances of the previous two centuries.

Alarmingly, these new epidemics are not the result of the poverty and squalid living conditions that caused illness and death in the past, even though chronic disease and injuries afflict the poor much more than the rich. Nor are they the result of ignorance and inadequate science. For the most part, we understand the causes of these illnesses and injuries enough to prevent them. What we lack is the political will to implement the needed preventive measures. Even worse, in some cases the growing health burden is the result of new science and technology, which have been used to promote profit rather than prevent illness. These new epidemics of chronic diseases and injuries are instead the consequence of what most people thought were the remedies for poverty-related ill health: economic growth, better standards of living, and more comfortable lifestyles.

While many factors contributed to this global health transformation, Lethal but Legal focuses on what I consider to be most important and most easily modifiable cause: the triumph of a political and economic system that promotes consumption at the expense of human health. In this book, I describe how this system has enabled industries like alcohol, automobiles, firearms, food and beverages, pharmaceuticals, and tobacco— pillars of the global consumer economy— to develop products and practices that have become the dominant cause of premature death and preventable illness and injuries. This system was born in the United States and has now spread around the world.


In a global economy that focuses relentlessly on profit, enhancing the bottom line of a few hundred corporations and the income of their investors has become more important than realizing the potential for good health that the world’s growing wealth and the advances in science, technology, and medicine have enabled. This tension between private accumulation and public well-being is not new. But in the twenty-first century, it has come to shape our economy and politics in ways that profoundly threaten democracy, human well-being, and the environment that supports life. Paradoxically, the increasing concentration of power in the small number of the world’s multinational corporations also presents new opportunities to create another healthier and more just future.

In Lethal but Legal, I argue that, for the United Sates and the world to achieve their articulated goals of better health for all and a more equal distribution of advances in health, we will need to redesign the system that has evolved to promote consumption at the expense of well-being. Succeeding in this task will require taking on the world’s most powerful corporations and their allies. Only the na├»ve or foolish would underestimate the enormity of this challenge. But neither nature, human evolution, nor fate created the new burdens of chronic diseases and injuries. Rather, it was human decisions, made in corporate boardrooms, advertising and lobbying firms, and legislative and judicial chambers.

In the last few decades, the directors of a few hundred corporations have changed the world to suit their needs, and as a result set the stage for the twenty-first– century epidemics. Surely the world’s people, supported by social movements, honest governments, health professionals, and scientists can take back our health, as we have done so many times before when special interests challenged human well-being.
As I've said, I always read the Amazon reviews before I buy. This one was rather compelling.

Again, one might ask: what the heck does any of this have to do with Health IT?

Seriously? I know; to the likes of my former REC ED, it's "beyond your scope."

Do I have to spell it out?

Data. Big Data. Coming from all points north, south, east, and west, ongoing out of our EHRs and HIEs. We'll be mining (carefully, scientifically, one hopes) for the gamut -- the gamut -- of causal relationships, productively inferential connections that go well beyond the confines of the episodic 30 minute 99213 visit and the usual CQM Quadrant 3 crap. Inclusive -- critically, if we are to make real, sustainable progress -- of the socioeconomic/political determinants of health. And, that inescapably goes to the nurturing of "just culture" and "the long view," and the breadth of difficulty that such implies.

We have a Triple Aim to attend to. Assiduously. It could not be more important.
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SUNDAY UPDATE:
INTERESTING ARTICLE WHEREIN I COMMENTED

See Harvard Business Review blog, "
Every Leader Needs a Challenger in Chief"

My $0.02:

Great post. Sustained improvement requires effective leadership. And, effective leadership requires the moral authority that is EARNED by gaining the respect and trust of everyone who is expected to and needs to follow. In the healthcare space in particular we (ironically) continue to have a prevalent delusion that technology (e.g., Health IT and ever-more information-rich clinical science) and "process improvement" ("Lean," "Six Sigma") will be our saviors, all while doing little to mitigate the all too prevalent "bully culture" that begets the enervating stresses the author alludes to. You can't really do productive "critical thinking" in an organizational culture where one speaks truth to power at one's peril. And, this reality, in healthcare, is fundamentally a patient safety issue.

apropos, I am studying MacCoby's excellent books on Leadership at the moment. e.g.,

"Emotional intelligence is about self-control and empathy, but personality intelligence goes beyond that to understanding the emotions that people experience in the context of the values that drive behavior. This is the basis for emotional competency, the ability to sense negative emotions and then stimulate positive feelings. Traditional spiritual and philosophical writers used the metaphor of the heart to describe thinking that integrates feeling with logic. The head alone is good for mathematics, science, and crafts, but without a developed heart, one is never sure of what is true in human affairs. Recent neuroscience provides support for this, showing that when the brain is cut off from centers of emotion, people can still do analysis but lose the ability to reason and make judgments."

"To develop your heart, recognize that both figuratively as well as literally the heart is a muscle. Without exercise, it won't get strong. Overly protected, it's easily hurt. There's a term for a person with a weak heart and a strong sense of guilt: a bleeding heart, typically someone who doesn't understand others but wants to help the underdog. When the object of these good intentions isn't grateful, the bleeding heart feels taken in. There is also a term for a person who has silenced the listening heart, a hard-hearted person. Hard-hearted leaders rule by fear."

Maccoby, Michael; Norman, Clifford L.; Norman, C. Jane; Margolies, Richard (2013-07-29). Transforming Health Care Leadership: A Systems Guide to Improve Patient Care, Decrease Costs, and Improve Population Health (Kindle Locations 3353-3361). Wiley. Kindle Edition.

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ERRATUM
T63622A (Toxic effect of contact with other jellyfish, intentional self-harm, initial encounter), V9542XA (Forced landing of spacecraft injuring occupant, initial encounter), V9733XA (Sucked into jet engine, initial encounter), and V80731A (Occupant of animal-drawn vehicle injured in collision with streetcar, initial encounter).
LOL. See Code Chaos: Another nightmare for doctors, courtesy of the federal government
“I’m very nervous about whether once we flip that switch on October 1 this is all going to work,” says William Harvey, an assistant professor of medicine and the clinical director of the Division of Rheumatology at Tufts Medical Center in Boston.
KatrinaCare.gov 2.0, 2014 Release?
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CODA

To the anonymous troll who posted the gratuitous, insulting comment directed at me and my late daughter, your comment has been deleted and you are now blocked. Sadly, I've had to enable comments moderation. I will not put up with inflammatory, off-topic asshattery.
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More to come...

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