HealthCommentary

Exploring Human Potential

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.

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

Posted on | May 1, 2015 | 2 Comments

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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.

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

Posted on | April 24, 2015 | No Comments

paulPaul 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.

Is My Brain Growing As I Age?

Posted on | April 18, 2015 | No Comments

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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

 

Today is National Health Decisions Day!

Posted on | April 16, 2015 | No Comments

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.

The Planetary Patient “Where the wind comes sweeping down the plain.”

Posted on | April 10, 2015 | No Comments

source:https://www.youtube.com/watch?v=mrDVzbeDzRk

Mike Magee

Hugh Jackman in 1998, in the film version of the Broadway classic, Oklahoma, sings “We know we belong to the land, and the land we belong to is grand….you’re doing fine Oklahoma, Oklahoma OK.”

But as this week’s The New Yorker article, Weather Underground, suggests, not so much these days. Okie endurance and chance mythology is legendary. But as the Dust Bowl revealed in the 1930’s, burying your science head in the sand carries some serious risks. But the modern day risk isn’t tied to the Agriculture sector. It’s tied to the Energy sector.

Mary Fallin, the state’s two term Republican governor, and former two term Congresswoman, recently combined the state’s Secretary of the Environment and their Secretary of Energy positions. That tells you about all you need to know about the state’s feelings toward their current drill based economy.

The state’s Energy Resources Board says that 1 in every 5 jobs is tied to the oil and gas industry. That the rush toward fracking and natural gas has yielded wealth is indisputable. But distributing that wealth equitably is another story. A quarter of the state’s children live below the poverty level, and the state ranks 46th in overall health measures.

The mismanagement of human health in the state has now spread to the planetary patient. Up until 2008, when widespread fracking began, the state experienced 1 or 2 magnitude 3.0+ earthquakes a year. In 2009, there were 20. Five years later, they registered 585.

The United States Geological Survey has traced the problem not to fracking, which does cause earthquakes, but almost all are less than magnitude 3.o. The problem, they say “with virtual certainty”, is the result of deep, contaminated-water, disposal wells that often penetrate the Earth’s basement rock.

This effect is an “unintended consequence” of required safe disposal of mountains of brackish, chemically contaminated water, produced by the fracking process.  In Oklahoma, they’re pulling up 10 barrels of the stuff for every barrel of oil retrieved. And it has to go somewhere.

Now the state does maintain the Oklahoma Geological Survey. It is part of the Oklahoma University College of Earth and Energy, sitting on the campus that also houses the ConocoPhillips School of Geology and Geophysics. Rival Oklahoma State University has a school for geology as well, the Boone Pickens School of Geology.  At O.U., competing interests are balanced by their long-term university president, David Boren, a former U.S. senator. He also sits on the Board of local oil company, Continental Resources.

The people of Oklahoma are getting a bit nervous, as more and more of their homes shake to the foundations. 3639 magnitude 3.0+ quakes have been recorded now from 2009 to 2014. And what makes it worse is that, for a portion of the citizens whose houses are quivering, they don’t own the mineral rights on the very fragile land they live on. In the past, a land owner could refuse to let the drillers onto their land. But in the past few years, in some counties, those rules have been quietly changed.

In October, 2013, the U.S. Geological Survey issued a press release stating that the chances of a magnitude 5.5+ earthquake in Oklahoma had “significantly increased”. This in the state with “flowers on the prairie where the June bugs zoom, plenty of air and plenty of room; plenty of room to swing a rope, plenty of heart and plenty of hope.”

Economics can’t be denied. And health is certainly a function of social determinants, which lag poorly where poverty and income disparities rule. But of equal concern is the Planetary Patient, which in equal measures with economics, has and will continue to impact individual and population health.

For HealthCommentary, I’m Mike Magee.

Brookings Invitation

Posted on | March 30, 2015 | No Comments

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Assessing the Affordable Care Act’s efficacy, implementation, and policy implications five years later.

Tuesday, April 14, 2015, 9:00 AM — 12:00 PM (EST) 
The Brookings Institution, Falk Auditorium, 1775 Massachusetts Avenue, NW
Washington, DC  20036

RSVP Attend        RSVP Webcast

The Patient Protection and Affordable Care Act, most commonly known as the Affordable Care Act (ACA), is one of the most important pieces of legislation enacted into law and implemented by the federal government in a generation. The ACA is also one of the most complex and comprehensive efforts to reform the American health care system and reduce costs. Now that the ACA is five years old, how successful has the law been in meeting its primary goals? What has been its efficacy in transforming American health care? What have been the major outcomes and unintended consequences? And what might the future hold for this law, given today’s political environment and a pending, major U.S. Supreme Court decision that could determine the ACA’s fate?

On April 14, Governance Studies at Brookings will host a forum to examine the ACA five years after its passage. This forum is the sixth annual A. Alfred Taubman Forum on Public Policy, which will convene leaders from academia, the media, and government to explore the far-reaching implications of the ACA. Discussion will focus on the law’s successes and failures as the most consequential piece of health care legislation in recent history.

9:00 AM — A new way of covering the uninsured – how the ACA has changed American health care & the reverberations to come
Moderator: Darrell West, Douglas Dillon Chair and Vice President and Director, 
Governance Studies, The Brookings Institution   
Andrew Slavitt, Acting Administrator, Centers for Medicare and Medicaid Services 
Department of Health and Human Services

10:00 AM — Examining the ACA’s implementation, successes, and failures and efforts to modernize health care delivery
Moderator: Elaine Kamarck, Founding Director and Senior Fellow, Center for Effective Public Management, The Brookings Institution
Eric Patashnik, Professor, Public Policy and Politics, University of Virginia
Kavita Patel, Managing Director, Clinical Transformation, Center for Health Policy;
Fellow, Economic Studies, The Brookings Institution

11:00 AM — Has the ACA succeeded in bending the health care cost curve?
Moderator: Alice Rivlin, Leonard D. Schaeffer Chair in Health Policy Studies and Director, Center for Health Policy; Senior Fellow, Economic Studies, The Brookings Institution
Steven Brill, Founder, Brill Journalism Enterprises, LLC; Author, American’s Bitter Pill: Money, Politics, Back-Room Deals, and the Fight to Fix Our Broken Healthcare System
Jean Moody-Williams, Deputy Director, Center for Clinical Standards and Quality,
Centers for Medicare and Medicaid Services, Department of Health and Human Services

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