Parkland Teens Teach “Positive Leadership”!

Posted on | February 28, 2018 | Comments Off on Parkland Teens Teach “Positive Leadership”!

nbcnewyork.com

Mike Magee

At this time of year my wife and I always try to see the movies nominated for an Academy Award. Recently we saw Darkest Hour, up for Best Picture as well as a Best Actor nod to Gary Oldman in his role as Winston Churchill. The film begins with Dunkirk and the historic private flotilla evacuation which Churchill directed as his advisers were defining the move as a hopeless cause and insisting that Britain’s only option was to surrender to the overwhelming German forces.

As I viewed those opening scenes, I couldn’t help but be reminded of a the maritime evacuation of Manhattan Island on 9/11 – 300,000 evacuated by mostly private vessels responding to a Coast Guard call for “All Available Boats” – documented in a book by the same name. But it was not only the vessels and rescues that drew the comparison but Oldman’s performance itself which reminded me that in times of crisis, such as the recent Parkland shootings, leaders must emerge who are unafraid and determined to guide us through to safer shores.

We are currently being challenged by destructive change and negative predatory leadership. Change is one of the few human conditions that can simultaneously support two diametrically opposed human emotions, fear and exploration. Change is the critical lever in leadership. Pull it one way and you create a positive leader. Pull it the other and you create a negative leader.

Negative leaders are short-term thinkers who use fear as a currency to herd people together and move them in whatever direction suits their needs. It is a short term, successful strategy, but suffers from a critical weakness, and that is that heightening fear causes people to retrench, reinforcing old beliefs and behaviors, naturally segregating segments of society, reinforcing silos and resisting change. In the short and medium term, fear can hold a population in place, even as the world around them continues to change. But the inability to evolve, to stay in step with or ahead of a changing world, insures that negative leaders will eventually fail.

In contrast, positive leaders like the Parkland high school students view change as exploration, and lead with vision rather than fear. Their view is longer term and they reach out across the divide. Rather than segregate, they congregate. Rather than build walls and silos they build islands of common stewardship.

As the Parkland shooting and its aftermath well illustrated this week, Americans currently live in fear. Why should this level of fear concern us? Well first, fear is the currency of negative leaders, and they are more likely to emerge and succeed in a fearful environment. Second, fear undermines trust, and trust is the fabric of a civic society. Third, fear clearly has short and long term mental health implications. Fourth, fear accumulates, especially in those who are already fearful. Post 9/11 studies showed clearly that fear biased women and minorities. Finally, fear obstructs vision, actively discouraging imagination, innovation and hopefulness. In compromising our wonder and inventiveness, fear fundamentally alters our collective future.

The Parkland teens, with their family’s support, and the coalescent of high schoolers across the nation this week have taught us all a thing or two about how to manage fear. First, they have identified, nurtured, and advanced individuals with the values and temperament to become tomorrow’s positive leaders. Second, they have incorporated fear management into their academic curriculum. Third, they reinforced the value that human beings should never remain silent in the face of evil. Forth, they have honored the ties between individual, family, community, and society; and in the process personalized and individualized their efforts in a manner that honors diversity and respects cultures. Fifth, in confronting the NRA, they have embodied the belief that judgment is at least as important as decisiveness, and that militarizing America is a poor judgment which ensures faulty decisions under stress.

People are basically good, but they are not perfect. People are basically kind, but when afraid they may act unpredictably. People are basically loving, but when misled respond with hatred and contempt. People are people. That is why we must continue to devote as much time and energy to the preparation for peace as you do for the preparation for war. For our homeland will never be secure if fear has so weakened the fabric of our society that we lose the capacity to be human and humane toward each.

#2018 Election.

Health Reform – Is This a 1960s Moment?

Posted on | February 12, 2018 | 1 Comment

Mike Magee

Quietly rising out of the ashes of the Republican led campaign to “repeal and replace” the Affordable Care Act, are pragmatic efforts, not focused on “if”, but focused on “how” and “when” the U.S. will join all other developed nations and provide all of her citizens with affordable, high-quality care.

Last week, a new bipartisan coalition led by Obama-era health policy guru, Andy Slavitt, and former Republican senator, Bill Frist, called the “United States of Care”, was announced. A consensus building effort featuring early listening tours, policy papers from the University of Pennsylvania, and a commitment to long-lasting solutions, did lay out four “musts” including: 1) universal (”every American without exception”), 2) high quality, 3) efficient (which included affordable for all, and sustainable for the country financially), and 4) equitable (no exclusions of coverage).

Grounded in optimism and consensus building, the “United States of Care” believes they can “redefine the goal in human, not political terms.” They make sure to tip their hat to American exceptionalists at the center of the Medical-Industrial Complex by stating that, “America leads the world in so much of health care. We drive world class research and…scientific innovation…that the rest of the world benefits from.” And “we have a highly trained clinical workforce that is the envy of the world.”

Of course, whether those innovations and skills deliver full human potential for all Americans or simply profitability for the entitled remain richly debated. But to their credit, they say straight up that we have real problems – vulnerability, limits on access, and unaffordability – which translate into “living in fear.” Bill Frist writes, “Our patient is the United States health care system, and it is very sick.”

If there is good news, most agree it comes in two forms: 1) There is ample money on the table if only it can be efficiently redirected. 2) Individual states, unleashed by Obamacare inducements, are in an experimenting mood. It is at these states that Slavitt and Frist and cohorts are targeting their listening tour with a subheading “Galvanizing Public Opinion and Taking the Conversation to the States.”

Institutional partner, U Penn, has added granularity in a white paper of its own. Opening with the fact that 28 million of our citizens continue to lack insurance coverage, they emphasize that coverage = access to 5 critical realms; primary care, preventive care, chronic illness treatment, medications, and surgery. (Left unaddressed is whether too much of any of these things might make you sicker rather than healthier.)

The paper then analyzes five states that have had a go at universal coverage including MA, VT, CO, NV, CA. In general, they all were focused on closing the “coverage gap”. But they had multiple other objectives as well including: cost-control, stabilzation of state insurance markets, and more choice of plans.

The analysis demonstrates that there are multiple pathways that lead to universality, just as there are many ways to undermine solidarity including: 1) Lack of clarity on financing, 2) Lack of clarity on long term sustainability, 3) Private sector fears of price controls and job loss, 4) Unclear federal government support for state-based solutions, and 5) Proposals that suggest drastic tax increases.

There is a certain amount of déjà vu to the “Can’t we all just get along?” model of health reform. After all, the AMA and allies used “Red Scare” tactics, fighting tooth and nail in the late ‘50’s and early ‘60’s to block progress in health coverage. Their main strategy (coordinated with other members of the Medical-Industrial Complex) was to feign cooperation and offer voluntary policy pablum, while at the same time hiring GE’s Ronald Reagan to mobilize letter-writing doctors wives and rent the Madison Square Garden for a rebuttal speech to JFK’s appeal for expansion of health care.

At the end of the day, it was LBJ pulling Wilbur Mills strings, that carried the day and rammed Medicare and Medicaid through. Once there, American seniors couldn’t quite figure out how they ever managed to live without it.

Now those very same Americans, and their children and grandchildren, hold the strings to our futures – with the 2018 election just 10 months away.

Category: health care reform
Tags: Andy Slavitt > bill frist > health finances > health reform > LBJ Medicare > United States of Care > universal health care > university of pennsylvania

Health Coverage “Black Eye” Needs a #MeToo Wake-Up Call.

Posted on | February 10, 2018 | 2 Comments

Mike Magee

It came as no surprise to #MeToo’ers across the nation that Gen. John Kelly expressed “shock” about Rob Porter’s eye-blackening abuse of his first wife, of which he was informed months before; any more than they were taken aback that Mike Pence fell back on his now well-worn defense, “This is the first I’ve heard of it.”

Their complicity is obvious to them and each of us. In Porter’s second wife, Jennie Willoughby’s haunting post describing her experience, she well describes her hostage status with these words, “Everyone loved him. People commented all the time how lucky I was. Strangers complimented him to me every time we went out. But in my home, the abuse was insidious. The threats were personal. The terror was real. And yet I stayed.”

Arguably, wives Colbie Holderness and Jennie Willoughby thought they had done enough when they warned FBI agents who were completing an investigation for Porter’s security clearance. But we likely must thank the #MeToo movement for providing them enough courage to speak up when the system failed, knowing that now their stories will be believed.

But Willoughby’s “Why I Stayed” post points to a larger problem – an institutional problem – which remains for #MeToo and all of us to address. Porter like Pence and Kelly and others lied convincingly and selectively, leaving Willoughby on the institutional out’s. In her words, “Friends and clergy didn’t believe me. And so I stayed.” A portion of our most autocratic leaders in and out of the government have been nurtured by a culture whose institutions are more than comfortable with gender abuse on a grand larger scale.

Consider the American health care system. Over the past three decades, death during pregnancy in America has increased from 7 per 100,000 live births to 18 per 100,000 live births. In the 2015 global rankings, the U.S. ranked 9th in economic status, 16th in education, 61st in maternal health, 42nd in childhood wellbeing, and 89th in female political status.

Back in 1998, when Viagra was released, and without a great deal of effort secured insurance reimbursement far and wide, the American College of Obstetrics and Gynecology went to the mat on gender bias, noting that 1 in 3 pregnancies was unintended, and demonstrating that reimbursement for contraception was still largely absent across America. Within a month, 2.4 million federal employees received contraceptive coverage.

With the passage of the Affordable Care Act, women thought the issue of contraceptive coverage had been finally resolved. The law mandated that all insurers provide contraceptives as part of their plans. The provision enjoyed the support of 77% of women and 64% of men. But the Catholic Bishops Association sent a small group of elderly chaste women, the Little Sisters of the Poor, to the bar to argue that the two page escape clause, designed by the Obama administration to skirt the issue, and allow Catholic institutions to house such coverage with a independent third party, was too onerous, stating that the signing would be morally tantamount to condoning contraception.

In 2017, a tenured department chair at Mount St. Mary’s college in Maryland prepared to leave her teaching post after more than a decade. Part of what led to her decision was the action taken in 2014 by college president, Tom Powell, in the service of his most influential Board member, Archbishop William Lori. At the time, Powell informed college employees that the coverage of contraception, which existed in the current agnostic employee health plan, would happily disappear if the Little Sisters prevailed.

In words and tone as seemingly benign as if they came out of Mike Pence’s own mouth, Powell said, “The whole issue about providing health care to society…that’s great. Health care is a good thing. It’s a funny thing for us to be fighting about health care. Nobody wants to be people’s life police.” With appropriate legal remedies, he said, “Then we’re not actually buying it….and let them use their own judgement.”

As #MeToo has revealed, the assault on women in America is real and pervasive. Believe it! The personal demons of Rob Porter reached deeply into the sacred space of the Oval Office. But he was not alone but in the company of Donald Trump, Mike Pence, John Kelly….and by extension, Tom Powell, William Lori, and countless other well entrenched mostly male leaders determined to maintain an edifice of gender bias and abuse.

Jennie Willoughby’s final sentence in her post reads, “In the end, who is the real victim of his choices?” I would answer, “America and her institutions.”

#MeToo2018.

Category: birth control, contraception, women, women's health

Hiding In America’s “Deep Poverty Problem” is Health Care.

Posted on | February 8, 2018 | Comments Off on Hiding In America’s “Deep Poverty Problem” is Health Care.

Mike Magee

Angus Deaton, the Princeton professor and Nobel Laureate who documented the tie between America’s raging prescription opioid epidemic and the first multi-year decline in U.S. life expectancy in our history, has done it again.

This time it’s America’s poor in a New York Times Op-ed title “The U.S. Can No Longer Hide From Its Deep Poverty Problem.” In the piece he reviews the findings of the U.N.’s Professor Philip Alston’s extensive December, 2017 report on poverty and human rights in the U.S. What he discovered is that over 40 million people (12.7% of the population) live in poverty in the U.S., and the number is growing in part because of our inequitable health care system.

As he says, “Americans can expect to live shorter and sicker lives, compared to people living in any other rich democracy.” Some of the bulleted finds are so crazy as to be unbelievable like:

* U.S. infant mortality rates in 2013 were the highest in the developed world.

*12 million Americans live with a neglected parasitic infection.

* The U.S. has the highest prevalence of obesity in the developed world.

*In access to clean water and safe sanitation, we rank 36th in the world.

* We have the highest incarceration rate in the world – that includes Cuba, Russia, and everyone else. 11 million are admitted to local jails each year. In total, 3/4 of a million are currently incarcerated with 2/3rds awaiting trial.

* Our youth poverty rate is a startling 25%, compared to 14% for OECD nations. Child poverty is greatest in three southern states – 30% in Mississippi and New Mexico, and 29% in Louisiana.

* We have the highest income inequality rate of all Western nations.

* Only 56% of our citizens voted in our last Presidential election. 64% of our voting age adults were registered to vote compared to 91% in Canada and the UK, 96% in Sweden, and 99% in Japan.

* 8 million more whites are poor in America than are African Americans living in poverty. 31% of poor children are White, 24% and Black, and 36% are Hispanic.

* In 1980, the top 1% in Europe controlled 10% of the wealth. They now control 12%. In the U.S., during the same period, the top 1% went from controlling 10% of the wealth to 20%.

* Between 2010 and 2014, as a result of medical outlays, an additional 1.5% of total income has been transferred from poor to rich.

* 7 million Americans making more than 150% of the poverty line ($31,000 for a family of three) dropped below the poverty line after paying medical costs between 2010 and 2014. Over half of them ended up below 50% of the poverty level.

How can America walk back poverty? The quickest and most effective way is by now obvious to most: institute nationwide universal health coverage.

Category: poverty, soial services and health
Tags: Angus Deaton > medical bankrupcy > Philip Alston > poverty > poverty and human rights > Social determinants of health

Majority Favor ACA by 8%.

Posted on | January 26, 2018 | Comments Off on Majority Favor ACA by 8%.

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Category: Uncategorized

Health Care Poverty – An American Phenomenon.

Posted on | January 25, 2018 | 3 Comments

Mike Magee

With great fanfare this week, the CEOs of Amazon, JPMorgan Chase, and Berkshire Hathaway announced that they were creating a healthcare company “free from profit making incentives and constraints.” Pledging to provide their combined 1.1 million employees with “simplified, high-quality and transparent healthcare at a reasonable cost” by “harnessing technology”, their move is more about parochial cost control and segmented solutions for the “have’s” than addressing fundamental inequities for the “have-not’s”.

For stark contrast, a recent report by Professor Philip Alston, UN Special Rapporteur, on growing poverty and absence of solidarity in America, approaches the problem from the other end. Alston writes, “instead of realizing its founders’ admirable commitments, today’s United States has proved itself to be exceptional in far more problematic ways that are shockingly at odds with its immense wealth and its founding commitment to human rights.”

By whatever measure you choose – the Stanford Center on Inequality and Poverty rankings, the OECD comparisons of 37 developed nations, or the World Income Inequality Database – the U.S. owns the bottom and continues to decline. Of special concern are American youth, 25% percent of whom fall under the poverty line compared to an average 14% across all other OCED nations.

In health care, we are a walking contradiction. One of the wealthiest nations on Earth, we manage to live shorter and sicker lives than everyone else. One in every eight Americans now lives in poverty, and half of those fulfill the definition of “extreme poverty”. Over ½ a million citizens are now homeless.

Over the past three decades, wages have stagnated for the bottom 50% of Americans, while earnings for the top 1% have increased by 205%, and earnings for the top .001% have increased 636%.

These disparity figures decline further if you factor in the medical outlays of the poor and the rich. A recent analysis found that “medical outlays effectively redistributed about 1.37% of total income from poorer to richer individuals.”

Half of all uninsured people have trouble paying medical bills, and 20% of all insured do as well. In the past few years, health costs have sent an additional 7 million Americans into poverty, in part because health insurance deductibles have increased fourfold between 2006 and 2017. 90% now pay in excess of $1,300 individually and $2,600 per family in deductibles. The new poor are sicker than ever before as well, because of care avoidance and because they lack the resources for basic services.

Even as utilization of both outpatient and inpatient services and therapies have declined in the past two years, spending has increased, not decreased, as a result of aggressive corporate pricing. For example, while hospital admissions declined by 13%, spending has risen 8% over the past 5 years. That was a bargain compared to drug prices. Spending there rose 27% over the past 5 years despite decreased utilization across all classes of drugs.

Not surprisingly, a majority of Americans (66%) now cite the cost of health insurance as a major stressor in their lives. It’s enough to make you sick! And yet, that is good news for American investors in the Medical-Industrial Complex, which now accounts for 1/5^th of our economy.

What Jeff Bezos, Jamie Dimon, and Warren Buffett fail to realize is that treating health care as a business challenge and opportunity in the immediate post-WWII period was this nation’s “original health care sin.” Tinkering at the edges will have little, if any, impact. What is required now is a well thought-out, universal approach to coverage that shares risk and benefit for all of our citizens, and provides a pathway to health for all Americans.

Category: healt reform, health care reform, Health Financing
Tags: disparity in health care > income disparity > Philip Alston > poverty in America > US health reform > warren buffett

Medical Device Regulation – FDA’s Weakest Link

Posted on | January 22, 2018 | 1 Comment

Bjork-Shiley heart valve

Mike Magee

Most Americans remain unaware that in the eyes of the FDA not all therapies are considered equal when it comes to regulatory approval and oversight. Drugs are one thing, but medical devices are quite another.

As we’ve seen with drug approvals, over the 20th century, organized review and oversight of the efficacy and safety of America’s medicines tightened in response to tragedies like the infection of children from tetanus-tainted diphtheria vaccine in 1901, the poisoning death of over 100 children from sulfanilamide elixir in 1938, and the fetal deformities associated with thalidomide use in pregnant women in 1961.

In response to all of the above, a relatively stringent and formal review process, somewhat liberalized over time with “fast-tracks” and “abbreviated reviews”, created a level of confidence in American medicines. Most citizens assume that a similarly stringent process exists for approval and oversight of medical devices. But they assume this at their own risk.

In fact, even the most high-risk implantable devices are often approved after a single clinical research trial, and most of these are not randomized, controlled or blinded trials. Some 15% of approved devices created by this $150 billion dollar industry in the U.S. are eventually removed from the market, but often not removed from the patients in whom they were implanted. Unlike drugs, devices often remain for a lifetime, subjecting their subjects to continued risk and worry.

Such was dramatically the case with the Bjork-Shiley heart valve co-invented by American engineer Donald Shiley and Swedish heart surgeon Viking Bjorg in 1971. It’s basket design with metal carbon-coated disc held in place by two welded struts was seen as a technological improvement and implanted in 55,000 patients around the world from 1979 to 1986 before being pulled off the market. By then the company had been purchased by Pfizer in 1979.

The problem? A design defect led to the fracture of the anchoring struts releasing the discs from their housings in over 400 patients and resulting in nearly 300 sudden deaths. This left behind some $500 million in liability for Pfizer to deal with, which was nothing compared to the remarkable burden for remaining patients and families left to weigh the risks versus the benefits of having their potentially deadly heart values replaced.

The FDA regulatory framework at the time for medical devices was still relatively new. Like other FDA regulation, it was the product of a tragedy. In 1970, Dr. Hugh J. Davis sold his invention, a small fish like implantable uterine device which dragged a porous multifilament string, to the A.H.Robins Company. In 1971, it went to market as an IUD that would be a safer alternative to birth control pills considered high-risk at the time. Called the Dalkon Shield, it was implanted in 2.8 million women. But within five years, its association with infection, septic abortions and death was irrefutably established and linked to its’ mutifilament tail. Within the decade, there were 300,000 lawsuits and A.H. Robins went bankrupt.

In response to the public outcry, Congress passed the 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act, and for the first time required testing and approval of “medical devices.” The loose system they put in place had to deal with the fact that all the devices in use at the time had never been independently analyzed or approved. They were effectively grandfathered in.

All new products were placed in one of three classes. Class I included low risk devices like tongue depressors or forceps. Class II devices were “cousins” to other devices already in use like joint replacement devices and electrocardiographs. And Class III were new devices which appeared to carry some risk like pacemakers or heart replacement valves. Class I and II required quick and inexpensive premarket review, little extra documentation, and simple “premarket notification”. Product enhancements could be filed when they occurred or at annual reviews. Class III required that manufacturers provide some kind of evidence that the product was safe and effective, but this often came from scientific reviews that were less than rigorous and often anecdotal. In return the company received a “premarket approval.”

Liberalization of the process occurred in the years that followed with two tracts created for new product approval: 1) “premarket approval” requiring clinical testing and inspections, or 2) the 510(k) process requiring affirmation that the new device is essentially similar to a device already on the market. User fees range from around $200,000 for “premarket approval” versus around $4000 for the 510(k) tract.

Equivalency can be in the eye of the beholder. For example, the ObTape Vaginal Sling for operative repair of female stress continence sailed through on a 510(k) approval in 2003 based on the manufacturer’s contention that it was substantially equivalent to support tapes manufactured by J&J and American Medical Systems already in use. But when adverse reports of encapsulation and expelling of the material with infection began to surface in 2004, it became clear that the ObTape was made of a dense material poorly incorporated by biologic tissues while the comparators were porous materials that allowed for vessel in-growth. In 2006, the product was withdrawn. In a bizarre twist, the ObTape creators had argued that the product was unique enough to support their patent application on the one hand, but essentially similar enough to existing products to allow 510(k) approval on the other hand.

As might be expected, the use of the less expensive and faster 510(k) route proliferated, and the FDA, poorly staffed and funded to support a rigorous regulatory process, did little to obstruct abuse. The net effect was that 113 approved devices had to be recalled between 2005 and 2009 because of serious complications or death. Roughly 4 out of 5 of these had avoided vigorous review. In 2010, 500 million individual devices were recalled nationwide, and a review by the Institute of Medicine found the approval process ”flawed based on its legislative foundation” and that the FDA lacked a “integrated premarket and post-market regulatory framework.”

Historic problems from infection plagued duodenoscopes, to knee pad implants rejected thrice for 510(k) approval but pushed over the finish line after direct appeals by New Jersey’s two senators, to Cyberonics vagus nerve stimulators to treat severe epilepsy which failed to stop convulsions but killed patients by stopping their hearts, continued to occur. And legal redress “checks and balances” are limited. A Supreme Court ruling in 2008 extended pre-emption protection to manufacturers of high-risk devices that cleared the premarket approval process.

Critics claim that the situation is getting worse, not better. The 21st Century Cures Act, which dramatically drew the support of Joe Biden in the wake of his son Beau’s cancer death, was also loaded with FDA changes that further liberalized approval of medical devices including the use of “data summaries” and “real world observational studies” to support device approval.

New devices appeared in multitudes. Let’s take for example the case of pacemakers. Approximately 400,000 Americans have them implanted each year, with 80% over 65 and 20% over 80 years old. In 1984, there were 56 heart conditions for which the American College of Cardiology approved a pacemaker as treatment. Twenty-five years later, that list had bulged to 88 conditions. Only 5% of those indications were backed by double-blind studies. Some 60% of the approved indications were based on recommendations from a 17 member expert government panel. 11 of those 17 were on the payroll of medical device makers.

One real world issue not covered by the 21st Century Cures Act legislation was the fact that medical devices are fundamentally different than pharmaceuticals in one important respect. If a drug is pulled from the market, a patient can stop the drug and it will eventually clear from the system in a relatively short period of time. In contrast, many devices either cannot be safely removed, or their removal comes at great risk.

When Pfizer finally settled its’ Shiley Heart Valve claims with a $500 million settlement, roughly 1/3 of that payment supported a fund that allowed patients to consult with their cardiologists and deliberate what to do next. Those who chose inaction accepted the uncertainty and lifelong dread that at any moment the struts on their valves might give way, and that sudden death would follow. This pressing reality – the potential irreversibility of harm – has been somewhat lost in the continuing debate over regulation of medical devices.

Category: Medical Devices
Tags: FDA regulation > medical device industry > medical devices > Shiley heart valve

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