IN THE SHADOW OF MAN by Jane van Lawick-Goodall. 297 pages. Houghton Mifflin. “I saw a black shape hunched up on the ground. I hunched down myself . . . in the thick undergrowth. Then I heard a soft hoo to my right. I looked up and saw a large male directly overhead. All at once he uttered a long drawn-out wraaaai . . . one of the most savage sounds of the African forest … I forced myself to appear uninterested and busy, eating some roots from the ground. The end of the branch above me hit my head. With a stamping and slapping of the ground a black shape charged through the undergrowth … I expected to be torn to pieces. I do not know how long I crouched there before I realized that everything was still and silent again, save for the drip-drip of the raindrops.”

With this scene of primeval terror, a young Englishwoman named Jane Goodall began an intimacy with the chimpanzees in the rain forests of Tanzania that has lasted a decade and produced one of natural history’s most impressive field studies. In this book she has greatly expanded the preliminary report on her experiences, My Friends: The Wild Chimpanzees (1967); the photographs speak a volume in themselves. In the Shadow of Man should become an instant animal classic.

Scary Scrapes. Jane was 26 and a scientific nonentity when she began her work. Born in London in modest circumstances, she worked as a secretary when she arrived in Nairobi. Struck by her feeling for animals, Africa’s world renowned paleontologist, Dr. L.S.B. Leakey, wangled a grant and packed the young lady off to chase chimps. At first she could not get within 500 yards of her subjects. Real discoveries started, however, when a bold chimp she called David Graybeard strolled into her camp one day and began chewing on a palm nut. Lured by bananas, his friends followed. Jane in turn followed the band on its jungle journeys—sometimes, despite scary scrapes with leopards, she even stayed with them all night—and gathered impressive evidence that the chimpanzee has a far more complex life-style than anybody had supposed.

Like men, she quickly discovered, chimpanzees are technological animals. They chew leaves to make sponges, which they use to sop water out of hollow branches. They also strip grass stems to make long probes, which they use to fish tasty termites out of their mounds. Jane also found out that chimps, long considered vegetarians, also eat meat. Like primitive humans, they form hunting parties and carry out fairly intricate plans to capture young bush pigs, monkeys, baboons—and even, she reports, human babies.

Prodigies of imagination. Compared with the behavior of any species except man, the chimp’s social life is richly sophisticated. They have a wide range of intelligible expressions: fear, rage, hunger, shock, confusion, boredom, irritation, amusement, worry, pleading, mischief, tenderness, embarrassment—even a look of comic alarm that reminded Jane of refined English girls watching horror movies. The chimps also smile, hold hands, dance when it rains, play simple games and stage hugging-and-backslapping orgies when they discover a new fruit tree.

Status is important to both sexes, but among the males it seems to matter as much as food, perhaps more than sex. The struggle to achieve it calls forth prodigies of creative imagination. Mike, a low-ranking male of unremarkable physique, seized supreme power in his group by a stroke of genius. He grabbed a couple of empty kerosene cans from the author’s camp and then charged at the other males, bellowing ferociously and banging the cans together as he came. Appalled by the din, his rivals fled. Swaggering absurdly, Mike challenged Goliath, the dominant male, and in a drama of display and roaring counter-display he broke the older male’s nerve. After that, whenever the two met, they rushed up to each other like a couple of rival jocks and worked off their anxiety by hugging, slapping, grooming—and kissing each other on the neck. “Never, however,” the author reassures us, “have we seen anything that could be regarded as homosexuality in chimpanzees.”

On the whole, in fact, sex was the least serious problem in a chimpanzee’s relations. Total promiscuity was the rule, but now and then a male developed a platonic passion for a special female and followed her everywhere, whether or not she was in heat. Sometimes his feeling was returned, and in that case something like a chimpanzee marriage was made. At times sexual fidelity was a part of the contract. At the other extreme, one of the dominant males would sometimes try to assemble a harem. At the first opportunity, the females usually flew the coop.

A Model Mother. Most females were more interested in children than they were in males. Jane found that chimp mothers who made their babies get out on their own at an early age wound up with clinging, frightened children. Steady, loving and even indulgent mothers, in contrast, generally had happy, independent offspring. Flo, a perfectly hideous old chimp who for reasons beyond human imagination made all the males go ape at mating season, was a model mother when the study began. She played with her babies continually, picked them up at the first whimper, followed every slap with a squeeze and cleverly distracted her child when she saw misbehavior in the making; but as she grew older she became grandmotherly and spoiled one little chimp rotten. As he approached maturity, he was still a screaming ninny.

Unlike Sunday Darwins like Robert Ardrey (African Genesis), Jane van Lawick-Goodall does not press the homo-simian parallels or insist that psycho-cosmic mysteries can be solved by watching a bunch of monkeys in a tree. Yet the parallels are strong, and so is the reader’s temptation to see in the chimpanzee a hairy mirror of mankind. A woman as well as a scientist, Jane loves her subjects and makes the reader love them too—not as clever pets but as serious and struggling individuals. All the more painful, then, to be told that throughout Africa chimpanzees are being shot for the pot by natives and pursued by professional hunters who knock off the mothers and ship the babies to zoos and laboratories. To one who has read this book, the fact that people kill chimpanzees seems only slightly less sickening than the fact that people kill people

Although bonobos have been called pygmy chimpanzees, their behavior is very different from chimps. They are more peaceful and are led by the females, instead of males. Bonobos really like, uh, making love for the sake of making love. That’s really unique in the animal kingdom. They also use this peaceful activity for conflict resolution. They’ve even been called the hippies of the rain forest (Make Love, Not War!).

The last of the great apes to be discovered, the bonobo shares more of our DNA than any other animal on earth. (Some scientists argue that the chimpanzee is just as closely related since the two are so similar.) Sadly, the bonobo has been considered endangered by the IUCN Red List of Threatened Species since 1996.

We don’t really know how many bonobos exist today. They are scattered around in one of the largest rain forests in the world: the Congo basin. Estimates range from 5,000 to 50,000 with bonobos existing only in pockets of their original range. Surveys have shown that their numbers are declining. Learn more about the animals of the Congo basin at this World Wildlife Federation page.

Hunting is a major threat to bonobos. It’s difficult to imagine these creatures being smoked and sold in bushmeat markets, but that is happening very often. Habitat destruction is another big concern for the bonobo. Increasing human population and political instability of the Congo also make the future survival of the bonobo uncertain.

The Bonobo Conservation Initiative (BCI) is the only international organization dedicating itself solely to helping the bonobo. Among many other projects, BCI rescues bonobo orphans who’ve lost their moms to hunting. One of their major projects is the Bonobo Peace Forest, a place of conservation and research. You can read about all of BCI’s many projects here.

Help the bonobo.

While bonobos live only in the rain forest of the Congo (the second-largest in the world), anything that you do to help protect any rain forest helps endangered wildlife.

Several studies shed light on where aggression comes from and how it can be controlled
By Kristin Leutwyler

KISS AND MAKE UP: A female chimpanzee (right) kisses a dominant male with whom she has fought. After aggressive conflicts, monkeys usually make dramatic gestures of reconciliation that include hugging and kissing.

Science may never be able to explain in full such violent acts as the shooting at Columbine High School, which claimed 15 lives 15 months ago. But various studies¿some probing the evolutionary origins of aggression, and others, our conscious ability to control it¿are changing the ways in which researchers regard violence. Two papers review several recent lines of thought in the July 28 issue of Science.

One intriguing perceptual shift is coming from those who regularly observe our closest kin, the chimpanzees, and other monkeys. Indeed, primatologists are now suggesting that aggressive behavior be viewed as a normal means for competing and negotiating within groups, and not as a fundamentally antisocial instinct. This shift, they say, could lead to a better understanding of how aggression ends and can be kept under control among humans.

Although it is hard to look at violence as anything but an attempt to destroy community, Frans de Waal, the C. H. Candler Professor of Primate Behavior at Emory University, makes a compelling argument for seeing it as an integral part of any social network. Were aggressions truly antisocial acts, he points out, there would be no way to explain the fact that the overwhelming majority of attacks involve people who know one another well. And it wouldn’t explain the ways in which colonies of monkeys pick fights or make peace.

Primatologists first began to study aggression as a social phenomenon during the 1970s, when a curious incident was recorded at the Arnhem Zoo after a dominant male chimp attacked a female. The rest of the colony came to her aide, and then screamed and chased one another for a while. After a tense period of silence, the entire group began hooting, and during this chorus, two chimps embraced each other and kissed. When researchers reexamined the event, they realized that the two who had kissed were the very same two that had been fighting. Soon they found that most monkeys and apes make dramatic gestures of reconciliation after conflicts.

Additional research since then has shown that monkeys are actually more likely to seek contact with former opponents than with others, which indicates that they do not start a fight to alienate themselves from another individual but rather to renegotiate the terms of an ongoing relationship. And peacemaking, an important part of this negotiation, appears to be in part a learned skill. Of interest, de Waal notes, one of the best predictors of whether schoolchildren make peace is the level of positive contact they have had before a conflict erupts.

Accepting the idea that a cycle of violence and reconciliation provides a natural way of redefining the terms of relationships does not mean, of course, that it is the only way. And there can be no denying the fact that individuals have different thresholds for acting out. In an accompanying review to de Waal’s essay, Richard Davidson, Katherine Putnam and Christine Larson of the University of Wisconsin put forth the theory that a diminished ability to regulate negative emotions¿including fear, anger, distress and agitation¿can heavily predispose people to impulsive bursts of aggression.

FAMILY COURT: Rhesus monkeys frequently fight with relatives but maintain close bonds through reconciliations. Shown are two adult sisters, sitting to either side of their mother, making peace after having bitten each other.

The neural circuitry involved in quelling negative emotions appears to involve an inhibitory connection from part of the prefrontal cortex to the amygdala, and Davidson and his colleagues cite several lines of evidence as support. In rodents, for example, lesions to the prefrontal cortex render the animals much slower at eliminating aversive responses. Similar lesions in humans produce syndromes marked by impulsivity and aggression. And positron emission tomography (PET) scan studies have shown that murderers tend to have decreased glucose metabolism in the prefrontal cortex, as well as increased activity in parts of the amygdala.

Among 43 normal subjects, the authors tested individual variations in the circuit by first arousing negative emotion and then giving instructions to enhance, maintain or suppress that emotion (for details on the experiment, see sidebar.) They then measured the subjects’ tendencies to startle¿a reaction produced by the amygdala in response to negative emotion. As it turned out, subjects asked to suppress the negative emotion showed much lower “startle magnitudes” than those asked to maintain or enhance their feelings, meaning these people had successfully activated the circuit.

What’s more, the neuroscientists found in subsequent work that among people asked to suppress negative emotions during the experiment, those who were best able to dampen their startle response also showed greater electrical activity in the prefrontal scalp regions, suggesting that the prefrontal cortex was very likely playing its inhibitory part. And given how well the level of prefrontal activation predicted an individual’s ability to control negative emotion, it is conceivable that such testing might provide a way to screen for people at high risk for aggressive behavior.

The good news is that if such people can be identified, it might be possible to provide therapy. Davidson and his colleagues note that both genes and environment contribute to the development of this circuit regulating emotional control, and so interventions involving medication and psychosocial training could improve its functioning. Such treatment could not eliminate aggressive impulses, but it might insure that people at risk for becoming violent could better regulate those urges. And nurturing control and peacemaking skills may not rid society of violence, but it would be a valuable start.

Every Once In a While, We Need to be Stupid



By Olivier Pourquié, June 18, 2008, HHMI – Snakes, fish, chickens, and humans all begin life in much the same way. Early in their transformation from an amorphous blob of cells into a fully developed animal, growing cells pinch off into a string of identical segments destined to become individual vertebrae, which will later sprout blood vessels, peripheral nerves, and muscle. These repeated segments ensure that the rod-like spinal column can hunch, arch, and twist.

The segmentation process also helps establish some key differences in the body plans of different organisms: while humans have 33 vertebrae, frogs have 10 or fewer, and snakes can have more than 300.

Now, a team led by Howard Hughes Medical Institute researchers has uncovered the mechanism that guides vertebral development in the early embryo and makes sure each species ends up with the right number of vertebrae.

The team, led by Olivier Pourquié, an HHMI investigator at the Stowers Institute for Medical Research, reported its results on June 18, 2008, in an advanced online publication in the journal Nature.

“There is huge variability in the number of vertebrae among different animals, and virtually nothing [was] known about what controls this diversity,” said Pourquié. “What we do in the paper is provide an explanation.”

During development, vertebrate embryos grow from head to tail. As the body elongates, vertebral precursors known as somites, or segments, emerge from a group of immature cells called the presomitic mesoderm (PSM). These segments develop at regular intervals, much as a plant’s stem forms branches at regular intervals as it grows.

“The way the body of a human or mouse or any vertebrate forms is from a growth zone – like the tip of a shoot – which is called the tail bud. First you produce the head, then the neck, then the thorax, and so on, until the tail,” said Pourquié. The long chain of vertebrae that defines a snake’s body takes shape in about 23 days.

The regular emergence of segments from the PSM is driven by a cell signaling system known as a “clock and wavefront.” The clock is a simple set of signaling molecules that accumulate and disappear in rhythmic oscillations. Each time the clock molecules peak, a new vertebral segment is created.

Left to their own devices, the oscillating proteins would stay in one place, and create vertebrae one on top of another. But in developing embryos, the clock is whisked along the extending tail by another set of signaling molecules called the wavefront. It’s a bit like an ambulance roaring down the street with its siren blaring; when the ambulance stops, the siren just blares in place. But when the ambulance is moving, every time the siren peaks, it’s in a new place a little farther down the road. In the same way, every time the clock ticks, the wavefront has carried it a little further down the developing body to a new group of cells.

As a mouse or snake embryo begins to develop, the tailbud moves faster than the wavefront, leading to an increase of the PSM size. But then, probably due to a slowed down growth in the tail bud, the PSM starts to shrink. “The PSM shrinks until there is virtually no material left to make segments, and the process terminates,” said Pourquié. In mice, this happens after 65 segments have been produced. In snakes, over 300 segments are created before the PSM is exhausted.

Pourquié’s group discovered this segmentation clock several years ago, and he and others have been working to identify and explain how the components of the clock and wavefront work together. But until now, no one understood how different species produced different numbers of vertebrae. The snake, with its unusually high number of vertebrae, served as a good organism for Pourquié’s team to study.

“The most intuitive way to think about it would be to say that the oscillator is going to move for a longer time period” to create so many more segments, said Pourquié. “You’d imagine that in chickens, where there are around 50 segments, the oscillator would move for a defined time period. In snakes, the oscillator would move for six times as long.”

Pourquié’s group started out thinking that that was how snakes created all their myriad segments, but once they tracked the clock in a developing embryo, they rejected the idea. “What we see is that that is absolutely not the case,” he said. While it’s true that snake embryos take several times as long as chicken embryos to develop, in fact this is because the development proceeds several times more slowly than it does in chickens. In relative terms, the time that a chicken and a snake have to produce somites is not very different.

Pourquié and his group discovered that the way a developing snake gets around this is to speed up their clock relative to their development rate. They compared a developing snake embryo to those of chickens and found that, after taking into account the different paces of development, the snake’s clock ticks much faster relative to the movement of the wavefront, creating segments more often. They also compared the snake embryo to a lizard, because, said Pourquié, “lizards are like snakes in that they develop very slowly, but they produce many fewer somites than snakes.” The team found that, while the corn snake made a somite every 100 minutes or so, the lizard took four hours between somite formation.

Pourquié’s work on vertebrae development has already begun to have an impact on medicine. “We’re trying to investigate diseases that result from defects in the segmentation clock,” he said. Using their knowledge of how vertebrae develop, Pourquié’s group compiled a list of genes they suspected might be involved in human diseases that result when this processs goes awry. Using this technique, they identified a recessive mutation responsible for Jarcho Levin syndrome, a congenital defect that results in malformation of the spine and ribcage. “Now we’ve developed a genetic test to identify the mutation, and so it’s possible to do some genetic counseling,” said Pourquié.

-1.jpgWhen Olivier Pourquié looks at the amorphous shape of a mouse embryo, he sees more than a blob of cells. He sees a biological clock that turns on every 90 minutes, setting off the cascade of events that will create the individual segments making up the spine.

Starting at the head and moving toward the tail, the growing cells pinch off a string of identical segments destined to become individual vertebrae that sprout blood vessels, peripheral nerves, and muscle. In people, defects in this segmentation process can cause vertebra and rib deformities that worsen with growth and require intricate orthopedic surgery.

Pourquié studies the genetic and developmental mechanisms that control segmentation. Plants, fruit flies, fish, chickens, and people all use some sort of segmentation of the main body axis as the basic building blocks for their bodies. In vertebrates, the repeated parts ensure that the rod-like spinal column can hunch, arch, and twist.

In studies of the chicken embryo, Pourquié and his colleagues found the first evidence that a molecular clock precisely times the beginning of the development of each new segment. Every 90 minutes, a transcription factor turns on just as a new segment forms. In mouse embryos, which Pourquié also studies, a new segment forms every 120 minutes until 65 have been added along the spine. This work validated a concept based on a mathematical model involving an oscillator, proposed about 30 years ago to explain segmentation of the developing spine.

Subsequent work by Pourquié’s lab and others showed that the clockwork relies on feedback loops involving two key signaling pathways, Notch and Wnt. Pourquié and his colleagues showed that while the clock sets the pace for generating new segments, a traveling threshold of growth factors guides their spacing. Growth factors are churned out by the leading edge of cells forming the spine. The signal grows weaker as the molecules degrade and the cells making the factors move out of reach.

The molecular mechanisms underlying the clock oscillator and its role in development remain poorly understood. Pourquié plans to design fluorescent markers to visualize different genes acting at different times. He is beginning to apply microarray technology to identify new pathways in this cyclic process. And he has started a collaboration with researchers at Children’s Hospital in Boston to analyze the genetic basis of congenital scoliosis in people, which is rare but runs in families who are also more prone to sporadic spinal deformities well after birth.

Dr. Pourquié is also Investigator at the Stowers Institute for Medical Research and Adjunct Associate Professor of Anatomy and Cell Biology at Kansas University Medical School.


Olivier Pourquié wants to understand the genetic and developmental mechanisms that control segmentation in vertebrates, a striking feature of the early growth of embryos that has long been thought to be a key aspect of the basic design of many animals.

Umut Sarpel, MD; Bruce C. Vladeck, PhD; Celia M. Divino, MD; Paul E. Klotman, MD
Ann Surg. 2008;247(4):563-569. ©2008 Lippincott Williams & Wilkins
Posted 06/06/2008

Abstract and Introduction


The United States has the most expensive and complex healthcare system in the world. Despite the magnitude of funds spent on the system, Americans do not achieve the high standards of health seen in other developed countries. The current model of health insurance has failed to deliver efficient and effective healthcare. The administrative costs and lack of buying power that arise out of the existing multipayer system are at the root of the problem. The current system also directly contributes to the rising number of uninsured and underinsured Americans. This lack of insurance leads to poorer health outcomes, and a significant amount of money is lost into the system by paying for these complications. Experience from other countries suggests that tangible improvements can occur with conversion to a single-payer system. However, previous efforts at reform have stalled. There are many myths commonly held true by both patients and physicians. This inscrutability of the US healthcare system may be the major deterrent to its improvement. A discussion of these myths can lead to increased awareness of the inequality of our healthcare system and the possibilities for improvement.


Although most people readily agree that the US healthcare system is deeply troubled, there is little consensus on how to resolve its problems. The current system is so cumbersome and confusing that anything but the most superficial discussion seems to require an advanced knowledge of medicine and public policy. As a result, both patients and their physicians are alienated from trying to understand and improve the system. Debates about the plight of the uninsured and the rising costs of health insurance tend to end in an exasperated sigh of resignation to the status quo.

Our peculiar system of employment-based private insurance has been called an accident of history. During World War II, a wage freeze prevented employers from attracting workers by offering higher salaries. However, fringe benefits were not controlled and employers soon discovered that they could compete for workers by providing health insurance packages. This benefit was highly valued by wartime Americans and enrollment in insurance plans soared. Employers willingly participated in this new union because they received financial benefits from the tax-free status of health insurance. Job-linked health insurance gained momentum and evolved into the system that stands today.

Many of the problems encountered in the system are deeply interconnected with other complex issues. For example, it is hard to talk about the reason for the growing number of uninsured without also discussing the history of Medicare/Medicaid, funding for medical education, government lobbyists, and tort reform. These are worthy topics that cannot be addressed within the scope of this paper.

The goal of this article was to give physicians the groundwork to launch conversations about the US healthcare system. The format for this discussion has been adopted from Dr. Robert Lebow’s Health Care Meltdown: Confronting the Myths and Fixing Our Failing System.[1] Lebow identified many myths that are commonly held by both patients and physicians; for this discussion we have focused on 5 common misconceptions. The following myths are not intended to be an all-inclusive list of the woes of our healthcare system. However, they represent key and common misperceptions that are stumbling blocks on the path to improvement.

Perhaps it is important to state up front that this effort makes certain assumptions; it is understood that 1) members of a civilized society agree that there is an obligation to provide healthcare to those who need it, and that 2) there cannot be a tiered class system for access to healthcare, although people who are willing to spend more could have the option to do so. Our goal is simple: to spark discussion and focus attention to the issue of inequity of healthcare.

Myth 1: The US Healthcare System Is the Best in the World

This idea has been called the alpha myth because it is fundamentally the root of all other myths.[1] It is the straightforward belief that Americans have access to the highest quality healthcare available in the world. A different way to present this myth is to state that citizens in other countries experience long waits for healthcare, that they must rely on generalists, and that they suffer worse outcomes as a result.

This belief is widespread and well-entrenched in the American mindset. So it is perhaps surprising that in a 10-nation 1990 survey on the level of satisfaction with the national healthcare system, the United States ranked 10th.[2] These results were then reproduced a decade later.[3] Although Americans believe the US system is the best, clearly they are not as satisfied with the healthcare they receive as are citizens of other countries.

In fact, this disparity between perception and reality has been captured in several studies. In the year 2000, the World Health Organization (WHO) dedicated its annual World Health Report to a comparison of healthcare across the globe.[4] In this exhaustive analysis, American superiority was not borne out: the United States ranked 32nd for infant survival, 24th for life expectancy, and 54th for fairness. The fairness ranking was derived from a comparison of the individual financial contribution required with the quality of healthcare received. The current US system is known as a regressive system; that is, the poor pay relatively more for healthcare. In fact, the poorest fifth of Americans spend 18% of their income on healthcare, whereas the richest fifth of Americans spend about 3%.[5] In this type of regressive system, it is clear why about 50% of personal bankruptcies in the United States are related to medical bills.[6] Tragically, 75% of individuals declaring medical bankruptcy had medical insurance at the onset of their illness.[6] Overall, the WHO ranked the United States 37th in the world.

Similar results were found by the Commonwealth Fund in a recently released scorecard on the performance of the US health system.[7] Outcomes in the United States were compared against those achieved by top countries or the top 10% of US states, hospitals, or other providers. The scorecard evaluated multiple indicators of health outcomes, including mortality, life expectancy, and the prevalence of health conditions that limit the capacity of adults to work or children to learn. The average ratio score for the United States was a 69 out of a possible 100.[7] The United States ranked 15th out of 19 countries with respect to preventable deaths before the age of 75, with a death rate more than 40% higher than the benchmark countries of France, Japan, and Spain. The United States ranked last in infant mortality out of 23 industrialized countries, with rates more than double the benchmark countries of Iceland, Japan, and Finland. The United States tied for last on healthy life expectancy at age 60.[7]

Despite these mediocre results in objective parameters of health outcomes, the United States spends far more than any other country for its healthcare. In 2000 the United States spent 13% of its gross domestic product on national health expenditures.[8] The next highest spending countries were Germany at 10.6% and France at 9.5%. In a graph of life expectancy versus health spending per capita, the United States falls far off the curve, both spending more and gaining less than other countries.[4] Another example of this contradiction is seen in the outcome of patients on hemodialysis. Although there are more hemodialysis centers per capita in the United States,[9] when end-stage renal disease patients were matched for severity of disease in Canada and the United States, patients in the United States were less likely to receive a kidney transplant and also had a higher mortality rate while on hemodialysis.[10]

Myth 2: There Will Always Be a Certain Segment of the Population That Remains Uninsured

There is a general misconception that the uninsured are also unemployed, that they represent the marginalized section of society. Epidemiological studies clearly show that this is false: two-thirds of the nonelderly uninsured are employed.[11] And rather than representing an invisible minority, the number of uninsured persons is steadily growing. At last count, there were 46.6 million uninsured people in the United States,[12] but this number is projected to grow to 56 million by 2013.[13] It is notable that one-third of the recent increase in the number of uninsured adults occurred among those with incomes more than 200% of the federal poverty level, and about half the growth was among young adults ages 19 to 34.[14]

The reasons for the rising number of uninsured are many and complex. In part, the character of the US workforce has changed. From 1977 to 1998, there was a decrease in unionized factory jobs from 25% to 15%, with a concomitant rise in service or clerical work from 19% to 29%.[15] Members of unions receive insurance, whereas workers in the service industry typically have no health coverage. This shift in the workforce created a new rank of people, still employed but now without health insurance.

The single most influential factor in the rise of the uninsured has been the increasing cost of health insurance and the growing share that employers expect employees to absorb. In a system in which employment-based insurance is still the dominant mode, a smaller and smaller proportion of employers now offer health insurance to their employees at all.[16] Of those that do, most are increasing the amount that individual employees must contribute at a rate that is rising much faster than employees’ incomes. This cost-shifting to employees has had an especially significant effect on the coverage of dependents.[16] Finally, the growing cost of health insurance policies has essentially destroyed the market for individual self-purchased policies in most states.

Even for those with insurance, the growing share of expenses that must be covered out of pocket through deductibles and copayments is a mounting problem. Some health economists have recommended high out-of-pocket payments, as a means of deterring frivolous discretionary use of health services.[17] Judging by certain parameters, cost-sharing is effective. In the widely cited RAND Health Insurance Experiment, between 1975 and 1982 about 4000 patients in 6 cities around the United States were randomly enrolled into 1 of 4 test plans with varying amounts of cost-sharing. Those patients in plans with the largest deductible used 25% to 30% fewer medical services than patients with free care.[18] However, high-deductible plans also resulted in some lower health outcomes: poorer control of blood pressure, corrected vision, and oral hygiene.[18,19] In the subgroup of patients who were poor and sick, the subpar control of blood pressure increased the annual likelihood of death by 10%.[20] Thus, although total physician visits dropped, the financial deterrent did not differentiate between necessary and unnecessary visits. Patients who were unable to afford their copayment, despite the fact that they were insured, chose to forgo necessary visits and suffered a decline in health.[18]

An extraordinary demonstration of the effects of cost-sharing occurred when, in 1996, the province of Quebec instituted a 25% copayment for prescriptions that had previously been free to the elderly and those on welfare.[21] This new policy affected over 1 million Canadians. In the following year there was a reduction in the use of essential medications by 9% in the elderly and 14% in those on welfare (Figure 1). Adverse events rose 117% in the elderly and 97% in those on welfare. Emergency department visits rose 43% in the elderly and 78% in those on welfare.[21]

Figure 1.
Observed and predicted use of essential medication in the prepolicy and postpolicy periods. Reproduced with permission from Tamblyn et al.[21]

Those individuals who are officially insured, but still suffer from lack of healthcare, have been termed the under-insured. They may miss doctors’ appointments, leave prescriptions unfilled, or defer recommended laboratory tests. People without any insurance at all represent only the tip of the iceberg; there are far more individuals who are under-insured. Currently, there are an estimated 50 million individuals who are considered under-insured.[22] Meanwhile, the burden of cost-shifting continues to grow. Average yearly premiums have risen precipitously, at far greater rates than general inflation (Figure 2). [23] Rates of copayments and deductibles continue to rise markedly as well, creating increased burdens on family budgets. In the years 1996-1997 and 2001-2002, the average family’s out-of-pocket spending rose nearly twice as fast as did family income.[24]

Figure 2.
Cumulative changes in health insurance premiums, overall inflation, and workers’ earnings. Reproduced with permission from The Kaiser Family Foundation.

Cost-shifting may decrease initial healthcare spending up front, but it does not decrease the national healthcare expenditure.[21,25,26] The United States, for example, has both the highest insurance deductibles and the highest national healthcare expenditures in the world. As the number of under-insured grows due to the demands of cost-shifting, more and more people will be driven to give up their insurance completely.

Rather than comprising a static group of people, the number of uninsured is steadily rising, and this new generation of uninsured is made largely of people who are employed and have-or recently had-medical insurance. The current system of job-based insurance and cost-shifting are creating this dysfunctional environment.

Myth 3: The Uninsured Have Equal Access to Medical Care Through the Emergency Room

While admitting that the system is flawed, many people feel a sense of complacency, believing that the uninsured still have access to healthcare through emergency departments. Although inconvenient to obtain, the same quality of care is ostensibly available to the uninsured and the insured. Although this is true in theory, it is not realized in practice.

Multiple studies have shown that the uninsured receive less healthcare and have worse outcomes than the insured.[27,28] The Institute of Medicine reports that working-age Americans without health insurance are more likely to receive too little medical care and receive it too late; be sicker and die sooner; and receive poorer care when they are in the hospital, even for acute situations like a motor vehicle crash.[27] After adjusting for age, gender, smoking, and education, lack of insurance alone increases risk of death by 25%.[29]

This increase in mortality is independent of income level.[30,31] In other words, it is not being poor per se that leads to the adverse effects of being uninsured. The lack of insurance interrupts the patient-physician link, which is necessary to pursue good health. For example, diabetes cannot be cured but its effects on the body can be attenuated with strict glucose control and regular surveillance. In a study comparing insured and uninsured patients with diabetes, those lacking insurance had statistically lower rates of the recommended eye and foot examinations, vaccines, glycosylated hemoglobin screening, and checks of cholesterol level (Figure 3). [32] In patients with kidney failure, the uninsured start dialysis at a later stage of disease. Uninsured patients with HIV are less likely to receive effective drug therapy. The uninsured are screened less often for hypertension and are less likely to take blood pressure medication prescribed to them.[27]

Figure 3.
Diabetes management among insured and uninsured adults. Reproduced with permission from The Institute of Medicine.

The uninsured suffer poorer outcomes across surgical disciplines as well. Although the insured meet goals of 90% for cervical cancer screening, 70% for breast cancer screening, and 50% for colorectal cancer screening, a recent study shows that the uninsured fall well short of these goals, reporting 77%, 52%, and 29%, respectively.[31] As a result, uninsured people (or those with Medicaid) have more advanced cancers at the time of diagnosis and/or lower survival rates for breast cancer, colon cancer, cervical cancer, prostate cancer, and melanoma.[27,33,34] Patients without health insurance present more often with perforated appendicitis.[35] Individuals with ulcerative colitis and private insurance are more likely to undergo colectomy than their uninsured counterparts.[36] In a study of over 5000 patients with abdominal aortic aneurysms, those without medical insurance were significantly more likely than individuals with private insurance to suffer rupture.[37] There are a remarkable number of studies that draw a strong correlation between lack of insurance and poorer health.

Finally, the care administered to the uninsured in the emergency department setting is generally more costly to the national budget. When there is no preexisting patient-doctor relationship, the physician finds it more difficult to gauge a patient’s symptoms and to rely on follow-up. For example, a patient in the emergency room with mild pain on urination will undoubtedly be prescribed an antibiotic. This same patient, if seen in a generalist’s office, might be asked to leave a urine sample and will only be medicated if the culture confirms a urinary tract infection. Similarly, a patient with abdominal pain who might be observed with serial examinations will more likely undergo a computed tomography scan if seen first in the emergency department.

Relying on emergency rooms to provide primary healthcare for the uninsured is clearly a lose-lose situation. The patients themselves experience poorer health outcomes and lost wages, whereas the system suffers from the cost of overly conservative medical decisions.

Myth 4: A Free Market Is the Best Way to Get the Highest Quality Health Insurance for the Lowest Cost

Competition for goods and services generates maximum quality for minimal price. Policy makers often refer to this tenet when defending the multipayer system that exists in the United States. However, a free market only works when the consumer can use buying power to influence the price and quality of goods. In the current healthcare system, insurance is usually purchased by third parties (ie, employers), not by the consumer directly. Also, healthcare is not a discretionary desire; patients cannot delay purchase until prices drop. As a result, the consumer is not in charge of directing the market and thus there is no feedback loop to increase quality or reduce cost. The current system is not a free-market but is instead a for-profit system driven by private insurance providers who are immune to the checks and balances associated with the free-market ideal. This system, which has been in place for decades, has led to increases in healthcare expenditures, poorer health outcomes, and less choice in providers.

Despite the lack of market influence, many consumers still prefer private insurance companies over government-run programs. There is a pervasive belief that the government is fundamentally inefficient, and any private health insurance company will be better run than a public one. In truth, federal health insurance is much more cost-efficient than private insurance because of its ability to streamline costs. The existence of multiple private insurance companies increases the complexity of the system and administrative costs. At present, the US system is overrun by hundreds of for-profit insurance providers. Medicare’s administrative costs run less than 3%, whereas private insurance administrative costs are above 16% of budget (Figure 4). [38-40] These funds are spent on increasing revenue by aggressive marketing and billing, and decreasing losses with programs such as utilization reviews (labor-intensive patient chart surveys performed to monitor billing practices). This policy does save individual insurance companies money, but there is a substantial overhead involved in this labor-intensive process. Furthermore, there is no evidence that utilization reviews decrease the national healthcare expenditure, they merely shift the financial burden away from the individual company.[41] Private insurance companies vie to cut their own costs without regard to the effects on the national healthcare expenditures.

Figure 4.
Administrative cost as percent of benefits. Reproduced with permission from The Commonwealth Fund.

Other nations with single-payer systems, where only one agency provides insurance, demonstrate significantly lower administrative costs.[42] In the United States, the total administrative costs alone were over $100 billion in 2002.[38] Furthermore, administrative costs are the fastest-growing component of national healthcare expenditures.[39,40] The largest savings lie in decreasing the administrative costs of insurance companies, which are inseparable from a for-profit system.

Finally, because of the special nature of healthcare, even a functional free market system would not result in high quality medical care for all its consumers. There is no incentive in a profit-driven market to attend to low-yield issues such as mental healthcare, preventive care, and chronic illnesses. These fields of medicine are considered money sinks; although clinically important, they do not generate profit for insurance companies. As a result, these areas tend to be neglected. For example among the elderly, those in HMOs were more likely to suffer a decline in health over a 4-year period than those in a nonmanaged care plan (54% versus 28%).[43] In a profit-driven system, there is no mechanism for those without buying power to affect their care.

Myth 5: We Just Cannot Afford to Cover Everyone

This myth is founded on the belief that you have to pay more to get more; because the United States already spends too much on healthcare expenditures, the nation cannot afford to cover even more of its citizens. But clearly this logic cannot be entirely sound: every other industrialized nation in the world offers universal coverage, and all accomplish it with lower national health expenditures than the United States. Much of our nation’s healthcare money is spent on costs that arise directly from a multipayer system with limited coverage. It is vital to identify these spending sinks to find the funds that will provide for universal coverage. Painless cost control measures reduce costs without a resultant decrease in quality of care. Established targets for painless cost control include providing preventive care, training more generalists, controlling drug prices, decreasing unnecessary procedures, and reducing administrative costs in health insurance.

On average, Americans pay more for the same medications than do patients in other countries.[44,45] This disparity has been defended by the assertion that the United States supports the world by developing more new pharmaceuticals, and therefore these research costs result in higher drug prices. This altruistic rationalization is unfounded: combined, the European nations produce on average the same number of new pharmaceuticals per year as the United States.[1] Drug prices can be lowered by preventing pharmaceutical companies from advertising directly to the public, by increasing use of generic drugs, and by collective bargaining though a centralized healthcare system.

End-of-life extreme care is another area of financial inefficiency. Thirteen percent of Medicare’s total funds are spent on healthcare provided during the final 60 days of life. Although we pride ourselves on providing cutting-edge technology to our patients, there is clearly a point where technology no longer provides the best care for our patients’ needs. Lower-cost measures that increase the quality of remaining life should take precedence over high-cost measures that only extend quantity not quality of life.

Another potential method of cost-control lies in reducing the number of unnecessary medical procedures performed in the United States. The rate of coronary angioplasty in the United States is 300% the rate in Canada, with no associated increase in life expectancy. In 2002, 26% of all births in the United States were by cesarean section.[46] This rate is twice that seen in the next highest country.

Despite these figures, the cost problem in the United States is not solely a matter of overutilization. Other countries with far lower healthcare expenditures have longer hospital stays, perform more imaging, and prescribe more medications than the United States.[44,45] And so even more significant than overuse is overpricing. The United States spends more on healthcare without providing more services than other countries do. This suggests that the difference in spending is largely attributable to higher prices of goods and services: hospitals are more expensive and patients are treated more intensively.[9]

Higher prices for medical goods and services are generated by the incredible complexity of the US system. Whereas in other countries governments bargain directly with suppliers, in the US health system money flows from patients to providers through a vast network of middlemen. This highly fragmented system weakens buying power and results in overall higher prices of goods.

Real-life lessons on cost control can be gleaned from Taiwan’s experience. In 1995 Taiwan transitioned from a US-style system to a single-payer system with universal coverage, similar to the Canadian system. Before the switch in 1995, less than 60% of the population was insured. By 2001, 97% of the population had health coverage.[47] What is remarkable is that this marked expansion in coverage was accomplished with essentially no change in national healthcare expenditures.[47]

It is important to recognize that, in one form or another, we already pay for the health costs of the uninsured. The Institute of Medicine estimates that the value of covering the uninsured is $65 to $130 billion per year.[48] A substantial portion of the cost of universal coverage, approximately half, is already in the system and is being spent by the government on the healthcare costs of the uninsured.[49] It is a matter of redirecting funds to create the greatest good for the most people.


In the effort to ameliorate the problems with our healthcare system, recently several programs for reform have been launched. Although well intentioned, these proposals have limited ability to affect change. For example, employer-mandated plans, such as the one recently instituted in Massachusetts, require individuals to purchase private sector insurance coverage. Pretax dollars are used to purchase policies, and a small portion of the cost is covered by an employer contribution. Although this proposal forces individuals to purchase insurance (under fear of tax penalties), it does not guarantee the existence of affordable plans. Serious concerns exist over the long-term financial viability of the program. As enrollment costs continue to rise, insurance companies can give the illusion of affordability by excluding services. Forcing consumers to purchase stripped-down plans does little to improve the quality of healthcare.

Another attempt at reform is through the creation of health savings accounts. Individuals can shelter part of their income from taxes by making deposits in such accounts and using these funds toward medical bills. By definition such programs favor individuals who are in higher tax brackets since they have more to gain from diverting pretax dollars. Obviously, individuals in these higher tax strata are not the appropriate targets for healthcare reform.

Adding graduated increases in coverage, although politically more palatable, has largely failed to impact the lives of the uninsured. Incremental plans such as the State Children’s Health Insurance Program (SCHIP) are worthwhile but have failed to defray the ever-rising number of uninsured. Although SCHIP is responsible for a modest decrease in the number of uninsured children by 25% from 1996 to 2005, it has come at higher costs than anticipated.[50] The program is facing funding shortfalls in several states.

In the end, these paths at reform suffer from the same fatal flaw: they leave in place the existence of a multipayer, for-profit system. It is this infrastructure that is the Achilles’ heel of the United States healthcare system. The crux of effective reform is the development of a simple, streamlined system of universal coverage by a single-payer.

Financial savings and good patient care flow naturally from universal coverage by a single-payer. All individuals would have access to cost-saving preventive care through generalists. Fewer people would have to rely on inefficient and expensive emergency departments for their primary care. A single-payer system maintains the bargaining power necessary to contract with pharmaceutical companies to lower the costs of medications and biotechnology. In addition, evidence-based utilization standards could be defined to guide selection of medications and procedures.

The largest source of savings in reforming our system would come from cutting the administrative costs associated with multiple private insurance carriers. Competition between for-profit insurance companies drives cost-shifting and ever-increasing out-of-pocket payments for patients. As patients’ costs go up, more and more under-insured people are unable to afford healthcare. When many insurance carriers exist, they must compete for patients, and this competition is financed by massive administrative marketing costs. Many experts believe that universal coverage would likely pay for itself by creating a more efficient system.

Universal coverage and a single-payer plan could be created in different ways. Specific proposals have been published by various groups.[51] Universal coverage does not necessarily mean Medicare for all. Certainly, universal coverage could be provided by a single-payer government-run program as in Canada or the United Kingdom. Although this is the most straightforward approach, other countries have developed successful systems composed of private companies coupled with governmental organizations. For example, most of the German population receives its health insurance through sickness funds, which are nonprofit, closely regulated semiprivate organizations. The key is that these companies are required to cover a broad range of medical services and are prohibited from excluding individuals due to illness. Even in countries like Japan and Germany where health insurance is job-linked, times of unemployment, changes in workplace, and periods of self-employment do not create interruptions in healthcare coverage.

Finally, universal coverage and a single-payer plan do not exclude the option for purchasing additional private insurance. Supplemental insurance could exist that would cover nonessential medical care such as cosmetic surgery, private nursing, or even pay for expedited essential care. A new healthcare plan could be tailored to the preferences of the American population.

Myths have the ability to perpetuate themselves in the absence of supporting evidence. The myths concerning the state of the US healthcare system need to be actively dispelled-quickly. There are already overwhelming data showing the dangers of uninsurance and the benefits of universal coverage. There is no more deliberation that needs to be done. We must instead move on to making universal coverage a reality.

In the first use of a framework allowing submission of a single application to the two agencies, the FDA and the European Medicines Agency (EMEA) have worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or “biomarkers” found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity. The new biomarkers are KIM-1, Albumin, Total Protein, β2-microglobulin, Cystatin C, Clusterin, and Trefoil Factor-3. For decades, both FDA and EMEA have required drug companies to submit the results of two blood tests, called blood urea nitrogen (BUN) and serum creatinine, to evaluate renal toxicity. In addition to those tests, the FDA and EMEA will now consider results from the seven new tests as part of their respective drug review processes. Although a decision by the sponsor to collect information using the new tests is voluntary, if collected, it must be submitted to FDA. Development of the new biomarkers was led by the Predictive Safety Testing Consortium (PSTC), whose members include scientists from 16 pharmaceutical companies. The PSTC was organized and led by the Critical Path Institute, a nonprofit organization that works to support FDA research collaborations that improve the development of medical products. Researchers from Merck & Co., Whitehouse Station, N.J., and Novartis AG, Basel, Switzerland, identified the new biomarkers, tested them to prove their accuracy and usefulness, and then shared their findings with the other consortium members for further study. The consortium then submitted applications for use of the biomarkers to FDA and EMEA. The project is the first in which a group of drug companies has worked together to propose and qualify new safety tests and then present them jointly to the FDA and EMEA for consideration. The FDA and EMEA laid the groundwork for these specific joint-agency biomarker reviews in 2004 when they developed a framework called the Voluntary Exploratory Data Submission review process. The new process allowed the PSTC to submit a single biomarker data application to both regulatory agencies, and then to meet jointly with scientists from both agencies to discuss it in detail and to address additional scientific questions posed by the regulators. Each regulatory agency then reviewed the application separately and made independent decisions on use of the new biomarkers. FDA scientists believe that the seven new tests may provide important advantages over the BUN and creatinine tests. For example, in experiments using rats, the two traditional tests can only detect kidney damage a week after it has begun to occur. The new tests, however, are more sensitive and can detect cellular damage within hours. And while BUN and serum creatinine show that damage has occurred somewhere in the kidneys, the new tests can pinpoint which parts of the kidney have been affected. The seven new tests were developed and will be carried out initially in rats. These tests were selected because other studies have shown that identical biomarkers are produced in human kidney cells. While the FDA and EMEA will consider these biomarkers in rat studies initially, the PSTC has begun work to further qualify the biomarkers for use in human studies. If successful, the PSTC will present a new biomarker data application to the two agencies to seek acceptance of the human biomarkers.Beginning as the Division of Chemistry and then (after July 1901) the Bureau of Chemistry, the modern era of the FDA dates to 1906 with the passage of the Federal Food and Drugs Act, which added regulatory functions to the agency’s scientific mission.

For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.

Your toenails can tell you if you’re a candidate for heart disease sometime in the future. There’s a simple test that can predict your chances with almost 100% accuracy – and it all has to do with your 1) ___. Testing the level of 2) ___ in your toenail – whether or not you are a smoker – is a significant 3) ___ of possible coronary heart disease ahead. Non-smokers can also have high levels of nicotine in their bodies as a result of 4) ___ smoking. Toenail analysis has been tested on a group of 62,641 nurses who provided toenail clippings in 1982. Between 1984 and 1998, 905 of the nurses, developed coronary heart disease, and there was a direct 5) ___ to the levels of nicotine found in their toenails. Those who had the most nicotine also had a 3.4 times higher risk of heart disease, and each increase in the scale used to measure nicotine levels correlated to a 42% increased 6) ___. The analysis remained accurate even after the researchers adjusted for smokers and non-smokers. Analyzing the nicotine content of toenail clippings can also help gauge a woman’s heart disease risk. Toenail analysis could become a useful 7) ___ to identify high-risk individuals in the future, especially in circumstances when smoking history is not available or is subject to bias. Biomarkers of cigarette smoke exposure now used, such as the amount of 8) ___ (a nicotine breakdown product) in urine or saliva, only reflect exposure within the past few days. Because toenails grow 9) ___, they may offer a longer-term, more stable estimate of a person’s total level of 10) ___ to tobacco smoke. The women in the top fifth for toenail nicotine content were thinner, less active, heavier drinkers, and more likely to have high blood pressure or diabetes, as well as a 11) ___ history of heart attack, compared to those with less nicotine in their toenails. Also, the 905 women who had been diagnosed with heart disease had 12) ___ as much nicotine in their toenails, on average, as similar women without heart disease. After the researchers adjusted for other risk factors, they found that women in the top fifth for toenail nicotine had nearly four times the risk of heart disease compared to those in the bottom fifth. According to the authors, the findings suggest that measuring nicotine levels in the toenails “may improve the assessment of exposure and therefore our understanding of tobacco-related illnesses”. Source: American Journal of Epidemiology, 2008; 167: 1342-1348

ANSWERS: 1) toenails; 2) nicotine; 3) indicator; 4) passive; 5) match; 6) heart risk; 7) test; 8) cotinine; 9) slowly; 10) exposure; 11) family; 12) twice

Target Health Inc. has long been committed to being environmentally sensitive in our business practices. One approach is to provide a “paperless” environment for clinical research. We have already eliminated paper case report forms and paper queries with Target e*CRF®. Our latest PMA submission was done via eCOPY which eliminated one paper copy and an NDA submitted last year was fully paperless. Target Document® allows us to have a paperless Trial Master File and all faxes for projects are received directly into an eFax account and then uploaded directly into Target Document.

Please visit us at Booth 1261 at the Annual DIA Meeting in Boston. In addition to our full-service CRO capabilities, we will feature our paperless eClinical trial web-based toolbox including:

1. Target e*CRF® Version 1 with Batch Edit Checks
2. Target Document® – Paperless Trial Master File (TMF)
3. Target e*CTMS™ – Project Management Made Easy
4. Target Newsletter® – One Click Clinical Trial Information
5. Target e*CTR™ – eClinical Trial Record – Coming Soon

For more information about Target Health or any of our software tools for clinical research, please contact Dr. Jules T. Mitchel or Ms. Joyce Hays.

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