Albert Provocateur: November 2008

Not Your Mother's Common Cold

In an ideal world, big business would have a heart, and bottom lines and profit margins would play backseat to the overall good of community and fellow man. A reality check convinces us of the entirely opposite, and nowhere is this more true than in the for-profit pharmaceutical industry, where marketing of popular cholesterol-lowering, antidepressant, heartburn, or erectile dysfunction medications can net thousands of dollars per year of treatment. So, it’s no wonder that tropical diseases in poor nations of the world are unarmed Davids on a field of pharmaceutical Goliaths. Infectious diseases like tuberculosis, malaria, trypanosomiasis, leishmaniosis, and schistosomiasis, which are as bad as they sound, are of little or no priority on a pharmaceutical company’s agenda, as any gains made in the expensive research and development arena to come up with new and efficacious medications to combat them, cannot be offset by sales receipts from the resource-poor, healthcare-deprived, developing nations that stand to benefit most from the new drugs. Therefore, it comes as no surprise that of the 1,393 new pharmaceuticals developed between 1975 and 1999, only 16 specifically targeted diseases endemic to tropical and/or underdeveloped areas.
The problem is clear. Now, what has the U.S., as moral champion and outspoken political leader of the free world, done to lead by example, in this area of grave international calamity, that risks even greater repercussions for peaceful and warlike nations alike, due to the looming threat of bioterrorism? The Food and Drug Administration (FDA) took the lead in September 2008, by implementing its Amendments Act of 2007, which called for the issuing of “vouchers,” to accelerate FDA regulatory review of new, prospectively lucrative drugs, to those pharmaceutical companies also willing to develop new drugs targeting tropical and/or infectious diseases, on a “1-for-1,” “tit-for-tat” basis. A policy of that nature is in keeping with current social, economic, political, and public health trends to rely on financial incentives to achieve socially desirable outcomes. A policy of that nature, while developed with the best of intentions on the part of the FDA, neither guarantees that pharmaceutical companies will, indeed, implement research and development on drugs destined for geographically isolated and impoverished nations, nor lacks the “teeth” necessary to force distribution of those drugs once they have been developed.
Critics of review vouchers abound, and their arguments against the employment of such incentives run the gamut from uncertainty that a drug company will have a potentially profitable medication in its research and development pipeline to make a voucher worthwhile to the fact that traditionally it has been small drug companies that develop and distribute medications for neglected diseases, and it is precisely those small companies that usually do not develop “blockbuster” drugs that make the voucher system lucrative and attractive. Furthermore, were the latter to be the case, collusion between large and small pharmaceutical companies might lead to “deals” of dubious transparency, with vouchers and voucher rights being sold (which is legal) to the highest bidder, and patent and intellectual property rights dictating restraint in sales of needed pharmaceuticals to nations ill-equipped financially to afford them. “Cash and carry” is the name of the game, and countries financially “strapped” would be left to fend for themselves, and face possible epidemics of infectious disease with underdeveloped health care systems lacking the latest pharmaceutical formulations in those regards. Were that not enough, speedy FDA review, via vouchers, of new drugs might just be bad policy, leading to poor decision-making, consideration of drugs with very little or no clinical urgency or practicality, and inadequate consideration, testing, and clinical trials in order to rush to market. We might, in effect, be opening a veritable Pandora’s Box of not only disease, but also of its treatment.
To guard against this, and to place critical pharmaceuticals in the hands, minds, and bodies of those who most need them, a revamping or perhaps a complete revision of the voucher system from the ground up might be necessary. One proposal has been to set up independent health funds, financed by wealthier nations and overseen by international public health groups, to compensate drug companies for development of medications against ills far greater than “your mother’s common cold” in poorer nations, and then continue to reward those companies for appropriate implementation of successful treatment programs. Another idea might be for governments to work with nonprofit organizations to first develop new drugs, and then license them to pharmaceutical companies for production, distribution, and eventual earnings.
While convinced that patents and intellectual property are the “stuff” of capitalism, we must also admit that such models are neither sound nor efficacious when the lives of the poor and destitute hang in the balance. A voucher system, conceived of with the best of intentions, nonetheless places a price on that, namely human life, which we have been taught has none. Perhaps it is the job of public health to open eyes and close pocketbooks.

© 2008, Albert M. Balesh, M.D. All rights reserved.

Mental Hell-th

Hell on earth does, indeed, exist. Just ask products of a system that deinstitutionalized, with the best of intentions, the mentally ill back in the 1960s, in order to provide what was thought to be better care in the community, rather than in state-run asylums with the horrors they engendered in the minds of those who oversaw them in previous decades. The movement toward treatment of the mentally ill in the community was further buttressed by Academy Award-winning films, like One Flew Over the Cuckoo’s Nest, in the 1970s. The cycle has now become vicious today, however, and it begins with mental health agencies, child protective services, special education, juvenile justice, residential treatment centers, therapy sessions, psychological evaluations, medication management, psychiatric hospitalizations, and a plethora of other mental health services in youth, and proceeds through a repetitive waxing and waning of criminal activities and incarcerations. It appears that the mentally ill, from “modest beginnings” in their youth, are destined to reach the “big show” in our nation’s state prisons and local jails, if something is not done to create alternative mental health facilities and institutions. The numbers are staggering. More than half of all prison and jail inmates have a mental health problem of some kind, with the prevalence of mental disorders in the criminal justice system outstripping its rate in the general population by three times. To make matters worse, as many as 40 percent of people in the U.S. with mental illnesses are not receiving treatment, which “fast-tracks” them into lives of crime and eventual incarceration in state and local criminal justice facilities, where only about one-third of them will receive adequate mental health treatment. The bottom line: inmates with mental health issues released into the public domain with few “people skills,” with the inability to live self-sufficiently, and with overriding mental health deficiencies ranging from schizophrenia and bipolar disorder, to depression and acute psychosis from drug abuse, will most likely fall victim to recidivism and land once again in detention facilities, due to an utter lack of innate structure and responsibility that would enable them to live freely in society.
So, we must pose the question of why the U.S. criminal justice system has become what state mental institutions of yore once were? Obviously, when the latter facilities were closed, the “slack” had to be picked up somewhere by someone. It had never dawned on the public, our state legislatures and federal government, and communities across the nation that many “criminal” offenders, who, in reality, were victims of unrecognized or perhaps even ignored acute and/or chronic mental illnesses, would repeatedly recycle through state prison or local jail systems, draining precious dollars from state and federal coffers already stretched thin. Police officers in communities across the nation had not been trained adequately to recognize mental illness, district courts had remained nearsighted and continued to sentence offenders with mental illnesses to jails instead of treatment services, mental health courts had not existed to date, government had failed its responsibility to help the weakest links in our population chain and those who could not help themselves, funding for mental health services had continued to remain scarce, and community corrections and mental health providers had failed to collaborate with one another. All that has changed now, as mental health services, even now in times of financial shortfalls, contribute to re-entry of offenders from prison back into the community, via a series of evidence-based practices and programs.
While criminal recidivism and repeat incarceration have been reduced and continue to show signs of slow, progressive decline, the picture is not completely rosy. Money, as always, is the name of the game, and, while treatment of mental disorders constitutes greater than 6 percent of all health care spending, public health care financing for treatment and prevention of mental illnesses and for housing, employment, and other community services available to ex-incarceration populations falls substantially short of the ideal, or even the minimally adequate.
As states like New Mexico and Oregon vie for new, innovative approaches to financing community and mental health services, such as mental health call centers, transitional housing of freed offenders until gainful employment can be found, law enforcement street supervision programs, and mental health services in the jails themselves, the gap between mental health services and the criminal justice system continues to widen, although to a lesser degree than in the past.
While the descent into “mental hell-th” has been temporarily halted for many misdiagnosed “criminals,” without further availability of state and federal funding to mental health treatment and rehabilitative services, a further fall from grace and transformation of the sick role into hardened criminality is envisioned.

© 2008, Albert M. Balesh, M.D. All rights reserved.

Healthcare Reform Fit for Donkeys and Elephants

Whether you are a donkey (Democrat), an elephant (Republican), or something in-between, we all stand to lose in this election year if we blindly follow the lead of U.S. presidential candidates who would convince us that universal health insurance for all is affordable, easily accomplished, and without risk of paralysis of an already fragile healthcare infrastructure, as well as embark on something far more sinister, the financial collapse of a government stretched to limits untested in the past. We go to the polls on November 4, 2008, and, exercising the trite for the sake of the message, never have the stakes of our nation’s health been so high. Both presidential candidates, Sen. John McCain and Sen. Barack Obama, would have us believe that their respective health insurance “fix-its” would extend coverage to our 46 million uninsured and guarantee continued “smooth-sailing” for the three-fifths of us who rely on employer-sponsored health insurance to stem tides ranging from the common cold to brain tumors. Unfortunately, reading between the lines and a closer look at their proposals leave us with either a bad taste in our mouths or holes in our pockets. So, with the limited space available here, let’s dissect the McCain and Obama plans, and leave a clearer field than does the college biology student who disembowels his or her first fetal pig.
Barack Obama’s vision for health insurance would cover the legions of uninsured, maintain a certain status quo of employer-sponsored health insurance, reduce waste by increasing the efficiency of healthcare delivery, and put a health insurance savings of $2,500 in the pockets of beleaguered U.S. families. Sounds good, right? What could possibly be wrong with a plan that calls for a “play-or-pay” policy that rewards employers who contribute substantially to the cost of their employees’ health plans and penalizes, via taxation, those who do not? Is their any argument to a voice that calls for a national health plan, with benefits comparable to those enjoyed by members of Congress, with premium rates equitable for all, and without prejudice for preexisting health conditions? The popularity of such a plan among America’s financially hard-pressed is obvious, until the price tag is examined closely. Sen. Obama’s adherence to a policy that slows spending growth and provides affordable healthcare to America’s masses, including the poor and the dwindling middle class, bridges the healthcare divide. Yet, in an atmosphere of projected increasing healthcare costs and diminished employment-based health insurance, the biggest losers stand to be those who have the most to gain, as they will most assuredly be the parties targeted to finance the pipedream of the “donkey.”
If that were not bad enough, John McCain presents an altogether diametrically opposed vision and solution to America’s health insurance crisis, that has us begging for more (as we are tempted by the specter of lower taxes), as we are violently thrown over the table. Sen. McCain’s plan would decapitate employer-sponsored health insurance, increase reckless and unrestrained competition in the individual health insurance market, and do nothing to lower the numbers of our nation’s uninsured and lessen the toll they take on the national safety net system. The McCain plan is no less a pipedream than that of Sen. Obama, with the former resurrecting obsolete ideas of tax credits for individuals and families that don’t keep pace with the raising costs of premiums, association health plans (AHPs) that operate on behalf of their membership, only to “cherry-pick” and exclude the unhealthy, free-market insurance that would undermine care for the chronically ill, which is notoriously expensive, and, finally, greater reliance on state high-risk pools, which vary enormously from state to state in the amount of funding they make available to the sickest of all Americans. So, as the old proverb goes, while the “elephant never forgets,” it certainly does not dote on creatures smaller (or considered lesser) than itself.
Whether we choose the “blank check” of the donkey or the egotistical capitalism of the “larger-than-life” elephant, we must recognize that symbols do not do justice to the “animals” they represent. When men behave as animals, and work ceaselessly for the benefit of a chosen few or of small-interest groups instead of the greater good, then all of us and all of society suffers, and public health per se takes two giant steps back.

Healthcare Reform Fit for Donkeys and Elephants

Whether you are a donkey (Democrat), an elephant (Republican), or something in-between, we all stand to lose in this election year if we blindly follow the lead of U.S. presidential candidates who would convince us that universal health insurance for all is affordable, easily accomplished, and without risk of paralysis of an already fragile healthcare infrastructure, as well as embark on something far more sinister, the financial collapse of a government stretched to limits untested in the past. We go to the polls on November 4, 2008, and, exercising the trite for the sake of the message, never have the stakes of our nation’s health been so high. Both presidential candidates, Sen. John McCain and Sen. Barack Obama, would have us believe that their respective health insurance “fix-its” would extend coverage to our 46 million uninsured and guarantee continued “smooth-sailing” for the three-fifths of us who rely on employer-sponsored health insurance to stem tides ranging from the common cold to brain tumors. Unfortunately, reading between the lines and a closer look at their proposals leave us with either a bad taste in our mouths or holes in our pockets. So, with the limited space available here, let’s dissect the McCain and Obama plans, and leave a clearer field than does the college biology student who disembowels his or her first fetal pig.
Barack Obama’s vision for health insurance would cover the legions of uninsured, maintain a certain status quo of employer-sponsored health insurance, reduce waste by increasing the efficiency of healthcare delivery, and put a health insurance savings of $2,500 in the pockets of beleaguered U.S. families. Sounds good, right? What could possibly be wrong with a plan that calls for a “play-or-pay” policy that rewards employers who contribute substantially to the cost of their employees’ health plans and penalizes, via taxation, those who do not? Is their any argument to a voice that calls for a national health plan, with benefits comparable to those enjoyed by members of Congress, with premium rates equitable for all, and without prejudice for preexisting health conditions? The popularity of such a plan among America’s financially hard-pressed is obvious, until the price tag is examined closely. Sen. Obama’s adherence to a policy that slows spending growth and provides affordable healthcare to America’s masses, including the poor and the dwindling middle class, bridges the healthcare divide. Yet, in an atmosphere of projected increasing healthcare costs and diminished employment-based health insurance, the biggest losers stand to be those who have the most to gain, as they will most assuredly be the parties targeted to finance the pipedream of the “donkey.”
If that were not bad enough, John McCain presents an altogether diametrically opposed vision and solution to America’s health insurance crisis, that has us begging for more (as we are tempted by the specter of lower taxes), as we are violently thrown over the table. Sen. McCain’s plan would decapitate employer-sponsored health insurance, increase reckless and unrestrained competition in the individual health insurance market, and do nothing to lower the numbers of our nation’s uninsured and lessen the toll they take on the national safety net system. The McCain plan is no less a pipedream than that of Sen. Obama, with the former resurrecting obsolete ideas of tax credits for individuals and families that don’t keep pace with the raising costs of premiums, association health plans (AHPs) that operate on behalf of their membership, only to “cherry-pick” and exclude the unhealthy, free-market insurance that would undermine care for the chronically ill, which is notoriously expensive, and, finally, greater reliance on state high-risk pools, which vary enormously from state to state in the amount of funding they make available to the sickest of all Americans. So, as the old proverb goes, while the “elephant never forgets,” it certainly does not dote on creatures smaller (or considered lesser) than itself.
Whether we choose the “blank check” of the donkey or the egotistical capitalism of the “larger-than-life” elephant, we must recognize that symbols do not do justice to the “animals” they represent. When men behave as animals, and work ceaselessly for the benefit of a chosen few or of small-interest groups instead of the greater good, then all of us and all of society suffers, and public health per se takes two giant steps back.

Emerging Emergency

Instead of just owning up to our responsibilities, and demonstrating a touch of compassion for our fellow man, we, as Americans, choose instead to skirt the issue of health care for our nation’s uninsured, and implement half-way measures that give progressive momentum to an already snowballing effect. Now, it’s the turn of U.S. emergency departments (EDs) to shoulder the burden, the debt, and, if unsuccessful, the blame for the lack of primary care afforded to our legions of U.S. citizens, resident aliens, and even “illegals.” We are told that EDs are the only U.S. health care entities federally vested and mandated by law, specifically the Emergency Medical Treatment and Labor Act (EMTALA) of 1986, to screen and stabilize all who seek emergency medical care. Coverage of emergency health services by EDs cannot be denied to anyone in the U.S., and, yet, EDs currently find themselves strapped with an entire series of logistic and financial limitations that render delivery of such coverage tenuous, at best. The over-one million ED visits per year, coupled with hospital closures, in-patient downsizing, the elimination of some EDs by mergers and closures, an aging population, the increasing prevalence of complex medical problems, and the lack of qualified emergency physicians and nurses makes ED crowding the status quo and a quotidian reminder of the failure of the core safety net system, as conceived of and implemented today. If that were not enough, ED crowding is the catalyst for a cascade of subsequent adverse repercussions on ED infrastructure and patient treatment, ranging from compromised quality of care, shorter patient-practitioner interaction, lengthy waiting times, and high stress levels to ambulance diversion, ambulance gridlock, “boarding” (with EDs forced to hold patients for hours), and disaster unpreparedness.
So, with the previously well-oiled gears of the ED machinery nearly grinding to a halt in the current U.S. health care climate, with its greater than 42 million uninsured residents, we are left with the dilemma of what would be required to return EDs to their position of preeminence as vital, and perhaps even cost-effective, elements of the core safety net system. That, however, might be the wrong tack to take, and perhaps the question should be one of whether EDs should play any role at all in primary care of the uninsured and the socially and financially indigent. Perhaps some form of universal health insurance should be mandated to pick up the slack and eventually bear the entire brunt of health care coverage for U.S. citizens and legal residents, whether they be rich, poor, privately or publicly insured, or not. Universal health insurance might be the only truly socially equitable option available, but at what cost to U.S. taxpayers, in what timeframe for implementation, and weighed down with what concessions to the political, industrial, pharmaceutical, social, and other lobbying powers that be?
The so-called experts have been tossing around the idea of universal health insurance for years now, with no luck at consolidating a consensus on what a workable form of such insurance might entail. While no clear trail is currently being blazed, it has become evident that EDs, for their part, are expensive, unable to connect with the community and social resources, and perhaps ill-equipped to deal with chronic management on a large scale. They should not be counted out, however. EDs, or portions of them, might be restructured into 24-h walk-in primary care centers, “social triage” centers, and entry points for later channeling into other branches and components of a community safety network. In that light, they may be “down,” due to their high cost of care, but they are certainly not “out” for the count, and may actually become cost-effective in the framework of a primary care network that would employ them as a triage and starting point that would pass off patients with chronic management issues to a primary care focal point facility, thus alleviating or draining some of the overcrowding inherent in EDs, and contributing “new blood” to a primary health care system in dire need of additional manpower and facilities.
Who knows? With a little well-directed help from EDs, the emerging emergency might even submerge!

Statin Island?

No, that was not a misspelling, but a reference to the isolation and island mentality felt by many parents, as proclamations from on-high come down from the mount to tell us how to raise our children, and what is good for them. At one time, we thought we were the best judges of our own flesh and blood, and, now, organizations like the American Academy of Pediatrics (AAP) have usurped that God-given role. What are we talking about here? Hypercholesterolemia, or high blood cholesterol, in children. Why is this such a big deal? Because the AAP is now advocating pharmacologic treatment of high cholesterol in children, in order to head-off and reduce the risk of cardiovascular disease later in life. First it was Ritalin in children with Attention Deficit Hyperactivity Disorder (ADHD), then it was untested childhood vaccinations to interdict a legion of infectious diseases, and now it is even more and earlier pharmacologic therapy with drugs commonly known in layman’s jargon as statins, and more technically, as 3-hydroxy-3-methyl-glutaryl coenzyme A (HMG-CoA) reductase inhibitors. The latter intervene to block a crucial step in the synthesis of cholesterol in the liver. While they have been shown to be safe, and their side effects reasonable in adults (namely, muscle pain and an elevation of liver enzymes known as serum aminotransferases in the blood, a possible sign of liver damage), the effects of statins in children are virgin territory, if you’ll excuse the pun. Also, as cholesterol plays a key role in the brain, accounting for 25% of the total cholesterol stores in the body, and as at 8 years of age, a child’s brain is in a dynamic state of growth, development, and flux, pharmacologic therapy with statins at an early age may result in the opening of a neurologic Pandora’s box, whose long-term effects on the youth of the world may not only be devastating, but also not evident for years to come. That is why popular press and the media have been so eager to jump on this issue.
Let’s step back a bit, however. Hasn’t obesity been declared and coded as a disease of late, instead of a condition or a mere state of being? Hasn’t childhood obesity reached epidemic proportions in the U.S. and many parts of the world, with the prevalence of pediatric obesity tripling in the last 25 years and with the majority of some minority-group adolescents being overweight or obese? If that is, indeed, the case, and we believe it is, doesn’t the end justify the means? If increasing body weight in childhood is associated with cardiovascular risk in adulthood, as well as a plethora of other maladies in adolescence and adulthood, including type 2 diabetes mellitus, known to result in a complication cascade resulting in renal failure requiring dialysis, limb amputations, and even death before 30 years of age, perhaps we should not begrudge some clinicians, doctors of pharmacy, and public health professionals a proverbial stab in the dark. Risks and benefits will need to be weighed, as well as cost-effectiveness, and that will require time, further research, and unemotional objectivity. At this point in time, it is a little premature to say how this is going to go. Also, while pharmaceutical companies would be all too happy to include childhood statins in their cluster bombing of the television airwaves, along with the marketing of other “adult” drugs to children, their parents, and their educators, perhaps clinical and public health care expenditures would be better directed at lifestyle modification, via improved diet, increased exercise, and legal action to curtail fast-food advertising and to improve fast-food offerings. The stage is set for a long, drawn-out battle, with the AAP, pharmaceutical companies, and their political allies pitted against some pediatricians, public health professionals, school boards, nutritionists, kinesiologists, preventionists, and good old Mom and Dad.
With the new 2008 AAP recommendations on hypercholesterolemia calling for statins as first-line agents, an 8-year minimum age for pharmacotherapy, and a low-density lipoprotein (LDL, “bad cholesterol”) level of ≥ 130 mg per deciliter if diabetes mellitus is present, the walls are slowly closing in. No man is an island, however, even if drug companies would have us believe that our children and adolescents could better spend their time and health on a “statin island.” Only time will tell if island breezes prevail.

Albert Provocateur

Tuesday, November 11, 2008

Not Your Mother's Common Cold

Monday, November 10, 2008

Mental Hell-th

Sunday, November 09, 2008

Healthcare Reform Fit for Donkeys and Elephants

Healthcare Reform Fit for Donkeys and Elephants

Saturday, November 08, 2008

Emerging Emergency

Thursday, November 06, 2008

Statin Island?

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