The Class of ’65: Aging in Place.

Posted on | May 29, 2015 | Comments Off on The Class of ’65: Aging in Place.

Mike Magee

This weekend, I’ll be joining classmates for a 50th reunion of our high school. A half century ago, 1965, in the epicenter of a turbulent American decade, we graduated together. On the whole, our group has been pretty resilient, facing a range of challenges, including for many of my classmates, Vietnam. From the discussions in the lead-up to the event, it seems the group has aged well.

This reminded me of a quote by Donna Shalala, Commissioner of Health and Human Services at the turn of the 20th Century, who said: “We want life not only to be long, but good. This will be one of the central challenges of the 21st Century: to make dignity and comfort for the elderly as much a part of our national consciousness as education and safety are for our children.”(1)

Since then we have been in a scientific and social service race against the very real challenges of aging demographics. We’ve embraced a two-pronged strategy. The first arm has been prevention and health maintenance, intended to help elders maintain vitality and independence for as long as possible, by aggressively addressing those conditions that lead to disability and institutionalization. The second arm, which is complimentary to the first, has been the creation of new environments which actively manage the changes and disabilities that come with advanced age.

Long-term care is part of the natural fabric of life. It is fundamentally different than acute care in that it integrates health services and supports for daily living. The explosive growth of the long-term care industry simply reflects the numbers, with a projected doubling of the over-65s and tripling of the over-85s in the next 50 years.(2,3). During this period, the number requiring long-term care is projected to grow from under 10 million to 24 million.(4).

Of course, the big question is “independence”. What is it that causes individuals to require this support? The need for long-term care is measured by the limitation in capacity to perform certain basic functions or activities called “activities of daily living,” or ADLs. ADLs include bathing, dressing, getting in and out of bed, eating, toileting, and moving about. There are other activities, called “instrumental activities of daily living,” or IADLs, such as getting out, driving, preparing meals, shopping, maintaining a home, using a phone, managing finances and taking medications, which are critical and require help if absent, though not on the level of absent ADLs.

Early studies showed that 97 percent of nursing home patients had ADL limitations.(4). By age 85, the need for help was not at all unusual. Studies in the past have shown that some 35 percent needed assistance with walking, 31 percent with bathing, 22 percent with getting in and out of bed, 17 percent with dressing, 14 percent with toileting, and 4 percent with eating.

Most of those requiring long-term care prefer to “age in place,” in their own home and community, in familiar settings. And most do just that. They’re able to do that mostly because family and friends lend a hand.

The primary challenge for providing long-term care support for 4th and 5th generation Americans has fallen predominantly on 3rd generation female family members. As Jim Furman, president of the National Council on Aging has noted, “We mistakenly define long-term care problems as medical concerns rather than disability concerns. The care needs of most frail older people are primarily supportive: for example, help them move from here to there, help them eat and dress, and help them keep track of their medicine.”

The race against the aging juggernaut, then, is about science, about independence, and about “aging in place.” Long-term care is rapidly evolving with a primary focus on dignity, personal autonomy, support for caregivers, and personal resilience.

What are the major trends in long-term care? First, less institutionalized care. Nursing homes are being reserved for the most severely impaired. Second, more reliance on home care and community-based alternatives. Day care options, blended services, “assisted living,” and care for the caregiver programs all signal a shift in emphasis that presages a shift in finances. Third, these environments will feature more choices, greater use of supportive new life-assist technologies, a greater emphasis on prevention, and the opportunity for shared learning and community-based strategic planning.

For most of my classmates this weekend, I expect the challenges above will still seem far away. But time flies. A half century has passed in the wink of an eye.

For Health Commentary, I’m Mike Magee

References:

1.Shalala D. The United States Special Committee on Aging. Long Term Care for the 21st Century: A Common Sense Proposal to Support Family Caregivers. Testimony before the United States Special Committee on Aging: March 23, 1999.

2.The Long Term Care Workforce: Can the Crisis Be Fixed? Leading Age. http://www.leadingage.org/uploadedFiles/Content/About/Center_for_Applied_Research/Center_for_Applied_Research_Initiatives/LTC_Workforce_Commission_Report.pdf

3.The Growing Population of Persons Age 65 and Over: 1990 to 2050. Source: Cheeseman J. Population projections of the United States by Age, Sex, Race, and Hispanic Origin: 1995 to 2050. Current Population Reports. Washington DC: US Department of Commerce, Economics and Statistics Administration, US Bureau of the Census; February 1996. Publication No. P25-1130;12.

4. 1994 Green Book. Overview of Entitlement Programs. Committee on Ways and Means, US House of Representatives. Washington DC; July 15, 1994. [Appendix B: Health Status, Insurance, Expenditures of the Elderly, and Background].

Suicides in Black Boys and America’s “More Perfect Union”.

Posted on | May 22, 2015 | Comments Off on Suicides in Black Boys and America’s “More Perfect Union”.

Mike Magee

The results broadcast in a JAMA report this week on childhood suicides so shocked the researchers that they doubled back to check their facts. The shocker was that suicides in black boys, which had always been markedly less common than in white boys, had suddenly reversed the historic trend.

Specifically, the study on children from age 5 through 11 between 1993 and 2012, which was validated through a number of different data lenses, found that suicides in whites had dropped from 1.96 per million to 1.31 per million; and that the rates in blacks had increased from 1.78 per million to 3.47 per million. Death rates from guns stayed stable in blacks, but declined in whites. And deaths from hanging and suffocation increased in blacks.

The JAMA study heavily focused its discussions on prevention in ages 5 to 11, even though suicides are fifty times more common in ages 12 through 18. Their reasoning was that “upstream protection” through preventive programming and enlightened policy should result in declines throughout adolescence.

The study also reflects on possible causes for the increase rates in young black boys (black girls did not experience a statistically significant increase). The various issues raised included “disproportionate exposure to violence and stress”, “aggressive school discipline”, “early onset of puberty” which can be associated with depression and impulsive aggression”, changes in “social support and religiosity”, and less likelihood of seeking mental health services. But none of these factors are new, and the “experts” seem as uncertain as the rest of us about causation.

Any reasonable list would have to include societal based threats to young black males, understandably reinforced by their concerned parents on a daily basis. (“Don’t run.”) Also, for both blacks and whites, the management of gender identity and sexual orientation issues, known to surface from the earliest years of life, can trap a child inside himself, and corrode hopefulness and visions for an optimistic future. It has been well established that mismanagement of these issues can have profound mental health repercussions, whether as a result of personal, cultural or religious strictures.

Not directly related, but still very worthy of consideration, is the thoughful editorial of Charles Blow this week in the New York Times, titled “Underaffiliated and Underrepresented”. In it, Blow explores the tough language used to identify the mostly peaceful black protesters in Ferguson, MO (“thugs”), versus the romanticized terms used to define the armed and dangerous Waco, NV, biker club members who turned on each other and killed nine. As he says, “The words ‘outlaw’ and ‘biker’ while pejorative to some, still evoke a certain romanticism in the American ethos. They conjure an image of individualism, adventure and virility.” For young black boys, there is nothing romantic about the higher than normal suspension rates of elementary and middle school black kids. Already the most progressive schools are rethinking their “too tough to fail” policies which have translated into “too quick to bail on our children” in high risk areas.

The truth is, that when it comes to kids, and mental health, and dream fulfillment – words matter; communication matters; safety matters; open communication matters; fears matter; personal identities matter; hopefulness matters; fairness matters; peace matters. And all children’s lives matter. We collectively need to address this issue. In doing so, we will not only be following the directive suggested in Matthew 25:40 (“The King will reply, ‘Truly I tell you, whatever you did for one of the least of these brothers and sisters of mine, you did for me.”), but also take another step in the direction of Lincoln’s “more perfect union.”

For Health Commentary, I’m Mike Magee.

Category: Uncategorized

Note to FDA: Get On-Label Use Right, Before Liberalizing Off-Label Use.

Posted on | May 9, 2015 | 4 Comments

Mike Magee

“At my own medical center we have banned pharmaceutical reps from coming because we don’t think they are a good source of information. You don’t ask the barber if you need a haircut.”

Dr. Rita Redberg, editor, JAMA Internal Medicine.

What Dr. Redberg is protesting is the possibility of liberalizing the prohibition on pharmaceutical reps discussing off-label use of their drugs. This is the latest in a series of moves designed to advance the commercial interests of pharmaceutical companies. They are banking on historically weak checks and balances between the FDA, pharmaceutical companies, and the academic leaders who are now entrenched in both camps, and profiting at every turn of the coin.

The idea of liberalizing off-label use, at a time when on-label use, and its risk/benefit ratio, is questionable at best, seems to many critics to be unwise in the extreme. This is the result of a government and corporate financed system of research that is non-transparent, riddled with inconsistencies, and geared toward quick approvals.

Consider some of the current issues whose origins trace back to two decades of liberalizing legislation supported by corporate, governmental and academic leaders.

1. Companies are supposed to register all trials (to ensure transparency of trials that yield both positive and negative results, and avoid cherrie picking just positive studies). But registries are not yet routinely enforced.

2. Journals have agreed not to publish articles that derive from non-registry studies. But some continue to do so.

3. Universities and their ethic committees continue to pass through corporate contracts that allow companies total control of data, and veto power over publication of results.

4. Databases in the hands of the FDA, on specific product studies, are very difficult to access by the public. This means that the information originally submitted for drug approval (which is often incomplete and skewed toward approval) is now presented by the FDA in a format that involves the use of non-searchable systems, lacking executive summaries and obvious indexes.

5. Laws do not exist that compel companies to publish all data derived from drug studies.

6. Many academic physician bodies, individuals and institutions, who now share licensing rights and patents for the discoveries from which new products are derived, are neutral or complicit in maintaining a system of non-transparency.

7. Industry advocacy organizations like the Medical Information Working Group (which includes Pfizer Inc, Sanofi, Novartis AG, Johnson & Johnson, Eli Lilly and Co and GlaxoSmithKline Plc), actively lobby to create a more liberal regulatory environment for the medical-pharmaceutical-industrial complex. The group expended $420,000 in 2014.

And the list goes on. The point is that the checks and balances between FDA and industry are at an historically weak level after two decades of chipping away at boundaries designed to protect consumers rather than foster commercialism.

Now the industry sponsored organization, supported by K-Street litigators and lobbyists, have designed a convenient First Amendment argument to justify market extension of heavily marketed products of varying value (like statins for everyone, or SSRI’s for sadness/don’t worry about suicide ideation). Extended off-label use (which could include pediatric use) in areas where there is neither proof of efficacy or safety, would be to reward current weaknesses in on-label use that remain to be resolved.

The words of Cleveland Clinic’s Steven Nissen ring true to me. “If off-label marketing is allowed then drugs will come to be used for a wide variety of conditions…You take away those checks and balances and it’s the wild, wild west.”

Before the FDA considers liberalizing off-label marketing, it should be able to demonstrate that the weaknesses in current clinical research design, execution and public transparency that support the approval of on-label therapies have been optimally resolved.

For Health Commentary, I’m Mike Magee.

Category: consumer safety, FDA, pharmaceuticals
Tags: clinical research > consumer drug safety > FDA > off-label marketing

Medicare Part D Transparency: Are We Healthier or Simply Poorer?

Posted on | May 1, 2015 | 2 Comments

Mike Magee

This has been a week focused on drugs – not illegal drugs, prescription drugs. If you like health policy, and you like controversy, pharmaceuticals is the place to be.

On the one side you find Americans, with all their ills, real and imagined, hoping for a “miracle cure”, a quick fix that avoids the hard work of prevention or behavioral change; something that will rescue them from terrible and poorly understood conditions like cancer, or autoimmune diseases, or autism, or…. The answer they say is more discoveries, and their voice is amplified by pharmaceutical companies, and their funded patient groups, that make urgent pleas for faster drug approvals that tip the balance toward risk and away from benefit, and deliver extended patent protection, and expanded profitability.

On the other side of the equation, you find skeptical health professionals, consumers, and health economists, who see an industry that has managed to amass billions and billions of dollars by over-marketing products with marginal benefits for conditions whose basic science understanding is far from complete. They preach caution, restraint, less liberal treatment criteria, reasonable risk management, and the economics of prevention.

In such high stake battles, where literally billions of dollars are at stake, opportunists with expansive organizations, financial and legal resources, and fiscal incentives tend to prevail. In the wake of the Thalidomide disaster, with the subsequent Kefauver-Harris Amendments, 20 years of caution, and claims of a “drug lag” compared to approvals in Europe (reinforced by a nasty recession), laid the stage for three decades of liberalization and expansion of drug approvals in the US. But this movement required opportunism to become a reality. It was the fear, stigma, death and human suffering associated with HIV/AIDS, worsened by a Reagan administration stuck in denial, that brought all forces into alignment.

Since that time, over now three decades, we have seen progressive waves of enhanced FDA drug approval, as well as a shift to generics (many now marketed by their brand company parents), which now constitute nearly 90% of all prescriptions filled in the US. A brief list of the enabling legislation would include: Orphan Drugs Act – 1983, Hatch – Waxman Act – 1984, Priority Review – 1992, Prescription Drug User Fee Act -1992, Accelerated Approval – 1993, FDA Modernization Act – 1997, Fast track – 1988, Public Health Security and Bioterrorism Preparedness and Response Act – 2002, FDA Amendments Act – 2007. Add to this now the Century Cures Act, which is currently before Congress and is raising more than a few eyebrows.

Under the multiple, current, easement programs, approximately 1/3 of all recently approved products, made it to the market under the auspices of these exemption programs that sped up pass through and usually attached additional financial rewards to the sponsoring company, either directly or as a result of patent extentions. Where, in the late 1970’s, pharmaceutical advocates decried “drug lags”, now over 60% of new drug approvals occur first in the US.

This weeks release of the Medicare Part D prescription database begins to ask some uncomfortable questions of the “Medical-Pharmaceutical-Industrial Complex”. To begin with, the results show a peculiar non-alignment between the ten most prescribed drugs and the ten drugs generating the most cost to Medicare. Over a million prescribers generated prescriptions for 36 million elder Americans that cost the government and its’ Medicare program $103 billion in 2013 for over 3000 different drugs. The ten most prescribed drugs were all generics, with the most expensive coming in with a government bill of $911 million. Six of the ten were for either cholesterol control or hypertension. Now, let’s contrast that with the ten most expensive drugs – all brand named. Their cost – $19 billion.

Now, you must be thinking, of course, these are for incredible breakthroughs, modern day miracles, hard-fought discovery victories, deserving of our dollars. But uncomfortable, this is generally not the case. In the generic category, we have 4 high blood pressure meds, 2 cholesterol meds, 1 diabetes med, 1 thyroid med, 1 pain med, and 1 acid reflux med. In the wildly expensive brand med category, we have 1 acid reflux med (ranked #1 at $2.5 billion), 1 cholesterol med, 2 diabetes meds, 2 breathing meds, 2 psychiatric meds, and 1 cancer med(ranked #10 at $1.3 billion).

If we dig just a bit deeper, it gets interesting. Let’s start with expensive brand #1, Nexium, sold by AstraZeneca, and generating top cost honors to Medicare Part D at $2.5 billion. For that investment, this rather poorly differentiated (read “Me-Too”) drug treated about 1.5 million seniors, roughly a quarter of those treated by its’ close generic cousin, omeprazole (formerly Prilosec), which made it only to #6 on the generic list, and treated 6.4 million recipients at a cost of only $643 million, roughly 1/4 of the Nexium spend. Just to emphasize: they treated 4 times more patients at 1/4 of the cost.

Then consider Abilify. It’s primarily approved for the treatment of schizophrenia and bipolar disorder, but ranked #4 on the brand list generating $2.1 billion for its Japanese maker, Otsuka Pharmaceutical. Who knew there were so many schizophrenic, bi-polar adults? Scratch the surface of the Abilify website and you’ll find this suggestion: “Use as an add-on treatment for adults with depression when an antidepressant alone is not enough.” Wonder why all your nursing home seniors are falling out of their hospital beds, fracturing hips, or lying somnolent and unintended across America. Look no farther than Abilify.

But there are bigger questions here, and I’d like to cue up just one or two:

1. Has the liberalization of our indications for chronic disease management of conditions like high cholesterol and hypertension paralleled the liberalization of the FDA approval for new drugs?

2. Having given up the right to negotiate best prices for Medicare Part D drugs, should we at least be able to avoid “Me-Too” varieties that are so clearly wasting taxpayer dollars?

3. Have the large number of new drugs granted fast through-put by the FDA actually made us healthier, or simpler poorer?

For Health Commentary, I’m Mike Magee.

Category: health policy
Tags: cost of Medicare Part D > FDA drug approval > FDA legislation > Medicare Part D > Part D prescriptions > physician prescriptions to senior > Prescription database

A Message From “Paul From The Pocono’s”.

Posted on | April 24, 2015 | 1 Comment

Paul Boggia

Mike Magee

My brother-in-law, Paul, is visiting this weekend. He’s the director of the Main Street Counseling Center in Stroudsburg, PA. If you go to his site, you will find a Mission Statement which says, in part, “It is our belief that with the powerful healing combination of hope, compassion, and clinical expertise, every person who enters the Main Street Counseling Center can undergo a truly genuine, life-transforming, healing experience.” The site also says that they have attempted to create an environment “designed to foster a sense of peace and tranquility as you will experience the moment you enter.”

The Center does great work for a wide range of kids, adults, and families, many of whom struggle with very limited resources. I know this because I have been there. And much of the credit for creating this haven of peace goes to Paul. And much of the credit for making Paul who he is goes to my mother-in-law, June Davis Muller.

June Davis Muller

This week marked the 10th anniversary of her death, and without prompting, our daughter Meredith remembered her grandmother on her site, Homegrown Friends. Here is what she said:

“Today is the 10th anniversary of my Grandmother’s death. June Muller (the woman my little Charlotte June is named after) was remarkable to say the least. In her early 40s my Grandmother lost her husband leaving her to care for 10 children ages 1-14 by herself. She was a fighter, and yet a vision of peace. When so many people were telling her to split up her children and put them in various homes she kept every one together. She welcomed the poorest, loneliest people into her home on Christmas, despite the fact that she barely had enough for her own family. My grandmother understood that true wealth is found in your heart.”

“She could stretch a roast chicken to feed a week’s worth of hungry mouths (something I now do weekly). When I was 14 and really questioning organized religion I asked her if she thought I would go to Hell if I didn’t believe in religion. Without skipping a beat she said ‘No, but I think you’re dumb.’ Kinda loved her for that. My Grandmother’s faith in religion was endless.”

“She was incredibly intelligent graduating as salutatorian (probably missing valedictorian because she was a woman) and an amazing actress.”

“The last words she spoke to my mom and her sisters before she died were ‘Love and Laughter’. I can’t think of a better ending and mantra to remember my Grandmother by.”

Paul loves the US Postal Service. We get mail from him often, sometimes more than once a week. He always signs his postcards and notes, “Love, Brother Paul” or “Love, Paul from the Pocono’s”. We love getting mail from Paul.

This week he sent me an article, “How a garden can teach you creativity, spirituality and more”, written by William Hageman of the Chicago Tribune, and reprinted in the Pocono Record. It included an interview with gardening author, Fran Sorin, who wrote “Digging Deep: Unearthing Your Creative Roots Through Gardening”.

Paul sent me the article because he knows I love to garden – so does he. Sorin’s mantra is: “Play with dirt. Play with ides. Play with possibilities – every single day of your life.”

Hageman asked her why everyone doesn’t garden. Her response: “We are so disconnected from nature. There has been this profound impact of technology. And people are afraid to let their kids go out. We spend 90% of our time indoors. I saw a recent study of American parents, and the three biggest concerns for their kids were grades, bullying, and a lack of connection to nature. There is nothing like being on your knees, in the soil, digging deep.”

“What has your garden taught you?” asks the interviewer. “Patience, humility, connection, playfulness…I think you can take nature and learn everything from it.”

By the way, my mother-in-law’s home was always filled with plants.

For Health Commentary, I’m Mike Magee.

Category: happiness, Health Choices, prevention
Tags: creative gardening > fran sorin > gardening > healthy living > meditation > peace. > spirituality > william heageman

Is My Brain Growing As I Age?

Posted on | April 18, 2015 | Comments Off on Is My Brain Growing As I Age?

Mike Magee

Because my father and his sister developed Alzheimer’s disease in their late 70’s, and because they were subjected to a prolonged and painful decline, and finally death, as a result of the disease, my ten brothers and sisters (ranging in age now from the mid-fifties to the early seventies) have been particularly focused on our own brain health. As we learned this past week from the Institute of Medicine’s landmark report, Cognitive Aging: Progress in Understanding and Opportunities for Action, we are not alone. In an AARP report in 2012, 87% of responding members listed staying “mentally sharp” as a top concern.

In the preface to the report, the authors take the time in the opening paragraph to emphasize that the topic of cognitive aging is complex – specifically, the aging brain both gains and loses, and those dynamic changes are individually specific. In their words, “Cognitive functioning in older adults can improve in some areas, such as those related to wisdom and experience, and they can decline in others, such as memory, attention, and speed of processing. Individuals vary widely in the specific cognitive changes that occur with age, in the nature and extent of cognitive aging, as well as in the ways these changes affect daily life.”

The report is both long and broad, touching on a wide range of public policy areas. But what can the individual take away from all this?

A Few Obvious Takeaways:

1. All brains age, both in humans and other species. But all brains do not age the same way.

2. Neuronal death is not a significant feature in brain aging, but it is in neurodegenerative diseases like Alzheimer’s. In fact, some areas of the brain actually show increased functionality as they age.

3. Our basic science understanding of the brain leaves much to be desired. The report admits that this organ, and its alterations with age, is “only now beginning to be understood biologically, yet clearly involves structural and functional brain changes.”

4. Brains like prevention. Specifically, the steps we take to maintain cardio-vascular health and general health – like diet, exercise, sleep, human contact, fresh air – are well appreciated by the brain, and appear to enhance its’ functions. Overmedication – very bad idea!

5. Societies and population health strategies help build and maintain strong brains. Specifically, genetics, culture, environment and social determinants like education, housing, and transportation can help or hurt.

How Am I Doing?

Clearly keeping mentally and physically active; staying engaged with extended family and friends; and ensuring that your physical environment supports both movement and safety all make sense. As for measuring the up’s and down’s of your own brain function, it seems like the science is pretty primative at this point. That would seem to indicate that nearly all of the the supplements and devices that claim to “save your brainpower” are likely bogus.

My Favorite Message?

I like that the aging brain is growing in “wisdom and experience”. Add to this peacefulness, contentment, faith and security, and most of us might actually rejoice in getting older.

For Health Commentary, I’m Mike Magee

Category: brain, neuroscience, public health
Tags: AARP > aging > aging brain > alzheimer's > Brain health > cognition > IOM

Today is National Health Decisions Day!

Posted on | April 16, 2015 | Comments Off on Today is National Health Decisions Day!

Today is National Health Decisions Day!

As the organization’s website says, “A key goal of NHDD is to demystify healthcare decision-making and make the topic of advance care planning inescapable. On NHDD, no one in the U.S. should be able to open a paper, watch TV, view the internet, see a physician or lawyer, or go to a healthcare facility without being confronted with the topic of advance care planning. Among other things, NHDD helps people understand that advance healthcare decision-making includes much more than living wills; it is a process that should focus first on conversation and choosing an agent.”
If you or a member of your family hasn’t taken the time to prepare a living will or advanced directive, today is the perfect day to act. Se how easy it can be.” Press Here.

Category: Advanced Directive, Living Will
Tags: Advanced Directives > living will

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