HealthCommentary

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AMA Relieved

Posted on | June 25, 2015 | 2 Comments

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Steven J. Stack, MD President

“The American Medical Association (AMA) is relieved that today’s Supreme Court decision will allow millions of patients to continue accessing the health care they need and deserve.

“Physicians know that the uninsured live sicker and die younger so the AMA has been a leading voice in support of expanding health insurance access to ensure patients can get the care they require.

“The subsidies upheld today help patients afford health insurance so they can see a doctor when they need one and not have to wait until a small health problem becomes a crisis. The subsidies provide patients with peace of mind that they will not risk bankruptcy should they become seriously ill or injured and experience catastrophic health care costs.

“With this case now behind us, we hope our country can move forward and continue strengthening our nation’s health care system.”

Scientific Literacy – Critical in a Capitalistic, Free Society.

Posted on | June 24, 2015 | No Comments

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Mike Magee

This week the FDA announced that they are finally banning Trans Fats though food companies have three years to comply, which means three years to lobby for delay or repeal of the ruling.

Fundamental to the ineffectual delayed response has been purposeful confusion sown by the very organizations that invented these “foods” and portrayed them to an uncritical public as healthier than their natural alternatives.

This marketing challenge was made easier due to a rather fundamental and widespread level of illiteracy in America when it comes to basic chemistry. I tackled this issue, with respect to “Trans Fats” back in 2007, creating a video that helps explain what they are. You can view it HERE.

What are the basics you should know?

The Balanced Diet:

A balanced diet is about taking in the recommended portions of protein, carbohydrates and fats. The American Heart Association recommends that fats should make up 25% – 35% of our daily diet. The right combination of fats is critical to life. Fats are an important source of energy, they’re essential for growth and development, and they help regulate blood pressure, heart rate, blood clotting, nerve transmissions and temperature control.

What is a fat?

It’s mostly a chain of carbon and hydrogen atoms with a couple of oxygen atoms attached to the tail end. Carbon is the main player here, and because of the atomic structure of carbon, it is able to form four bonds to other structures. When you create a carbon straight chain you immediately fill 2 of the 4 spots for each carbon. That leaves two spots open.

Saturated Fat:

If you fill all the open spots with hydrogen, or saturate the structure with hydrogen, you’ve created a “saturated fat.”

Unsaturated Fat:

Dropping a couple of hydrogen atoms and using the extra spots to doubly connect two carbon atoms together creates what is called a “double bond.”  Because several hydrogen spaces have been evacuated, an “unsaturated fat” has been created. If the chain has only one double bond, it is a “monounsaturated fat.” If the chain has two or more double bonds, it’s a “polyunsaturated fat.”

Trans Fat:

Now, if you take an unsaturated fat with a double bond, heat it and add hydrogen, you can change the position of the hydrogen atoms at the double bond. Usually they are both on one side of the chain, but the chemical reaction causes one hydrogen to cross over to the other side of the chain so that the hydrogen atoms now sit across from each other. We call this a “trans fat,” because “trans” means across.

History of Trans Fats:

We first started making trans fats when concerns surfaced about the health effects of saturated fats in butter. By hydrogenating vegetable oil – that is, adding hydrogen atoms to create trans fats – we discovered that liquid vegetable oil turned solid and could be sold as sticks of  margarine. From the 1950s to the 1980s, we thought what we were doing was healthy. Tufts University nutrition professor Alice Lichtenstein has said that back then “anything was good if it decreased saturated fat consumption. But then studies began to question ‘trans fats’ too.”

Fats, Cholesterol, and Cardiovascular Disease:

Unsaturated fats, those with one or more double bonds, are good. They lower bad LDL cholesterol and raise good HDL cholesterol.  Trans-fats, those liquid-to-solid hydrogen creations, are the evil twin. They raise LDL cholesterol and lower HDL cholesterol. Unsaturated fats lower rates of heart attack and stroke. Trans fats raise them. Saturated fats with endless straight lines of carbon and hydrogen that we worried so much about in the past? Still bad, but not as bad as trans fats. Saturated fats raise LDL and HDL, but the net overall effect is more harmful than it is good.

Take-Away:

In our capitalistic, free society, lack of scientific literacy makes us vulnerable to those who would profit at the cost of our healthy futures. We have seen this story play out in many forms – tobacco, food, energy. Profiteers first deny, then confuse, then resist, then delay. It’s a long and painful process to reverse the harm they have done. They are by no means innocent. But if there is a take-away, it is this. We are responsible for knowledge acquisition. If we are lazy; if we are distracted; if we are not dogged in the pursuit of truth; we will (as we have in the past), pay for our errors.

Knowledge must be acquired and transferred. Having trouble visualizing the chemistry above. Check out this video, and pass it on.

For Health Commentary, I’m Mike Magee.

King v. Burwell – Thursday, 10 AM. Friday’s Question For Presidential Candidates: “What’s Your Plan Now?”

Posted on | June 14, 2015 | No Comments

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Mike Magee

According to the official blog of the Supreme Court of the United States, this Thursday at 10 AM, we can expect some decisions coming down in the much publicized case, King v. Burwell. But while many Americans have vaguely heard of the case, few understand exactly what the case is about, and what is at stake in the ultimate decision.

In a nutshell, the case, being funded by the libertarian think tank, Competitive Enterprise Institute, claims that the Internal Revenue Service exceeded the powers granted it by Congress through the Affordable Care Act (Obamacare) when it extended subsidies to help cover federally run insurance exchanges for low income Americans. In their literal reading of the law, subsidies were allowed to be granted only by state run exchanges.

Federal exchanges come into play when individual states decline to set up their own exchanges. (So far only 16 states and the District of Columbia have set up fully independent state exchanges.) Were the challenge to carry this week, subsidies would disappear in the 34 states without a state run exchange, leaving an estimated 5 million in those states in the lurch. What’s interesting is that the insurance companies in these states would still be required to provide the insurance, but the rates for unsubsidized individuals would rise and preclude participation by many. The pool of insured would shrink, broadly undermining the ACA itself.

Collapsing the program is the goal. Opponents of ACA haven’t be shy about trumpeting this, and the chorus has blared ever louder as the Presidential campaign gains steam. And while opinions vary on the value of ACA, all agree that undermining it now would be significantly disruptive, and carry with it a political cost.

This point was highlighted in the Commonwealth Fund survey released this week on the programs growing popularity. A rather remarkable 86% of Americans covered under the ACA through the exchanges or associated expanded Medicaid programs were “very” or “somewhat” satisfied with their insurance. More specifically, 91% were satisfied with the choice of doctors in the program; 77% found it easy to find a primary care doctor through the program; and 60% were able to get an appointment with the doctor within two weeks.

A second survey released by the Urban Institute last week found that fears, registered by ACA opponents, that the new insurance exchanges would result in a wholesale collapse of employer based insurance, did not prove to be true. In fact, the percentage of employees covered with health insurance provided by their employers has remained steady at 70%.

For a presidential hopeful who is opposed to the ACA, a ruling for CEI on Thursday may be met with muted cheers. Why? Because on Friday, he or she will have to figure out what to say to the millions of disenfranchised, formerly insured American citizens, and how to answer the question certain to be posed again and again on the campaign trail, “What’s your plan now?”

For Health Commentary, I’m Mike Magee

 

The Microbial Threat: Why The White House Is Engaged.

Posted on | June 7, 2015 | No Comments

president-obamaImage Credit:Medical Daily.com

Mike Magee

Infectious diseases are all the rage these days. Bird flu and MERS outbreaks are back in the news. Hepatitis C is pervasive in the Appalachian states, tick-borne Lyme disease is heading north and coliform bacteria is finding its way onto college toothbrushes in CT. Water is being boiled in Utah, Blue Bell ice cream comes laced with Listeria, and a common cat parasite, some say, may cause brain disorders in cat owners.

It’s no wonder that the White House is concerned about degrading our disease fighting weapons and promoting a strategy to limit the emergence of antibiotic-resistant bacteria.

Infectious microbes – tiny organisms that include bacteria and viruses – are living entities with a nearly unlimited ability to adapt. Microbes reproduce approximately every 30 minutes. This event allows constant mutation, migration, and adaptation of these organisms, which are the basic building blocks for some of the world’s most virulent diseases. The new forms that survive their predators, which include antibiotics and antivirals, go on to reproduce, multiply, and thrive. Staying one step ahead of these survivors requires surveillance, testing, and the redesigning of strategies through research, development, and distribution of new medicines and vaccines.

We develop antimicrobials in order to control symptoms, to destroy organisms, and to seek to eradicate diseases. With the development of new classes of antimicrobials in the 1950s and 60s, the scientific community prematurely thought it could claim victory over microbes. In fact, in the late 1960s, Surgeon General William H. Stewart stated it was “time to close the book on infectious diseases, declare the war against pestilence won, and shift national resources to such chronic problems as cancer and heart disease”.

Yet over a half-century later, we continue to struggle with highly recognizable foes like malaria, tuberculosis and HIV, and newcomers like SARS, Bird Flu, and MERS. Five distinct threats have emerged in our evolving battle with infectious diseases:

First, the resurgence of endemic diseases, especially in the developing world.

Second, a growing link between microbes and chronic diseases.

Third, drug-resistant microbes.

Fourth, new emerging infections, and fifth, the threat of bioterrorism.

With so many sources for trouble, it’s little wonder that infectious diseases remain a dominant cause of death worldwide. At the turn of this century, infectious diseases caused 26 percent of global deaths. Four million deaths were attributed to respiratory infections; 2.8 million to HIV/AIDS; 1.8 million to diarrhea; 1.6 million to TB; and 1.3 million to malaria.

Several factors have coalesced to make this an ideal time for an emergence of infectious diseases, according to the Institute of Medicine.

The microbes themselves have demonstrated truly remarkable genetic and biologic flexibility. We’re seeing changes in our physical environment, with global warming and weather patterns being favorable to microbes. Social, political, and economic factors, compounded by war and famine, have led to a breakdown in public health measures. Human behavior and activities bring people into contact with species of animals that harbor transmittable diseases. And finally, high speed travel and the threat of terrorism have the world on edge.

Infectious diseases are a critical concern for developing nations, but they are no less active in more developed countries, especially as they associate with an explosion of chronic diseases. In fact, the role of infectious diseases in the creation of chronic diseases is becoming increasingly well defined.

Clearly, greater investment in predictive science and preventive measures will be required if further pandemics are to be avoided. The Spanish Flu Pandemic in 1918 and 1919 killed nearly 50 million people worldwide. The 1957 to 1958 Asian Flu Pandemic and the 1968 to 1969 Hong Kong Flu claimed 1 million and 700,000, respectively. The progressive reduction in the number of deaths was primarily the result of effective antibiotics that controlled secondary bacterial infections.

Today, some believe another massive flu pandemic is conceivable because of the converging elements of a “perfect storm.” These elements include, first, the possible emergence of a strain of influenza that is non-responsive to existing vaccines. Second, the association of the virus with a highly resistant secondary bacterial infection. And third, extraordinarily fast proliferation under the radar screen due to the hyper-mobility of today’s traveler’s. Consider that in 1950 we had 200 million travelers worldwide. Fifty years later, this number increased seven fold to 1.4 billion, and ten years later, those numbers continue to swell. Charles Darwin said, “It is not the strongest of the species that survives, nor the most intelligent, but the one most responsive to change.”

The White House report not only acknowledges that o manage microbes we need to change faster than they do, but also, that we need to assure that the current weapons we possess to fight infectious diseases are not foolishly degraded by improper overuse. To review their findings and action steps, go HERE.

For Health Commentary, I’m Mike Magee.

The Class of ’65: Aging in Place.

Posted on | May 29, 2015 | No Comments

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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 | No Comments

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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.

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.

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