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Antidepressants Bad for Babies


Recently, two studies reported that selective serotonin reuptake inhibitors (SSRIs), a common class of antidepressant medication, increase the risk for congenital malformations and developmental disorders among children when taken by mothers during pregnancy.

The first study, published in Obstetrics and Gynecology, evaluated more than half of a million offspring over 11 years. Of these, just over 1% of the children were exposed to an SSRI during the first trimester of pregnancy. The study provided evidence for a two- to four-fold increased risk of cardiac and neural tube defects with specific SSRIs. Fetal alcohol spectrum disorders were also 10 times more likely in children exposed to an SSRI during pregnancy.

The risk of cardiac abnormalities in children exposed to SSRIs during pregnancy has been shown in many other studies over the last 15 years, with varying degrees of significance. Overall, the absolute risk of abnormalities associated with SSRIs is still very small. Other studies have reported neurobehavioral disorders, bleeding abnormalities, craniosynostosis, and abdominal malformations associated with prenatal SSRI exposure.

The second recent study reported a link between SSRI exposure during pregnancy and an increased risk of autism. This study, published in the Archives of General Psychiatry, found a two- to three-fold increase in autism spectrum disorders among children exposed to SSRIs during pregnancy. The risk was highest when SSRI exposure occurred during the first trimester of pregnancy. The study cannot prove cause and effect, and a link between a family history of depression and autism has already been established. SSRI exposure may have less to do with the development of autism than the genetic predisposition to depression and autism. This study was small, and its results should be interpreted cautiously. In both of the recent studies, the authors caution women not to change their mental health treatment plans without speaking to their physician.

In general, it is prudent to avoid unnecessary exposure to medication or other potentially harmful chemicals or products during pregnancy. And, the overall safety profile of SSRIs during pregnancy is questionable. But, SSRIs are also very effective antidepressants. This class of drugs should not be removed from a mother’s possible treatment options if she requires intervention for prenatal depressive disorders. In other words, don’t throw the proverbial baby out with the bath water.

Studies like the ones published recently might cause unwarranted alarm and prevent mothers from seeking mental health care during pregnancy. Clinicians should be vigilant to confirm a diagnosis of depression during pregnancy and communicate openly with mothers about the benefits, risks, and alternatives of treatment options. Ideally, every pregnancy ends with a healthy baby and a healthy mom. Mental health is a large piece of the puzzle for new moms and moms-to-be and the physical and psychological risks associated with depression during and after pregnancy might be worse than the risks of congenital malformations or developmental disorders to the fetus.



Colic and Probiotics – A Cure for the Crying?

Colic is a syndrome that appears in up to 20% of infants. It is generally defined by a set of criteria in which a baby between the ages of 2 weeks and 16 weeks cries inconsolably for at least 3 hours a day for at least 3 days a week, lasting at least 3 weeks. Colic has no defined etiology, and no effective treatments. But, any parent who has suffered through a baby with colic would be willing to try almost any remedy to soothe a crying baby.

While colic poses no direct threat to an infant, it can have significant consequences to the child and the family. To the baby himself, colic may lead to poor growth and development if normal sleep and feeding is interrupted. For the family as well, colic causes severe emotional distress, and babies with colic are at increased risk for abuse and shaken baby syndrome owing to parents’ frustrations. Over the years, everything from diet modifications for the infant (or mother, if baby is breast-fed) to gas-relieving medications to motion and sound machines to reducing stimuli altogether have been recommended in an effort to quell the cries of the infant, but nothing has proved effective. Until now, that is.

A new study published in the Journal of Pediatrics is among the first to report the effectiveness of a treatment for colic after a randomized, placebo-controlled, double-blind study. The authors report that the probiotic Lactobacillus reuteri significantly reduced crying time among infants with colic, compared to placebo. The subjects included 50 exclusively breast-fed infants, and were administered either L. reuteri or placebo daily for 21 days. At baseline, average crying times were 370 minutes/day for the L. reuteri group and 300 minutes/day for the placebo group. At the end of the 3 week study, crying times were significantly reduced to 35 minutes/day in the intervention group and 90 minutes/day in the placebo group. Even by day 7, the number of babies whose crying time had reduced by 50% from baseline was significantly higher among infants receiving L. reuteri than those receiving placebo. No adverse effects were reported among the infants, nor were any differences in weight gain, stool frequency, or incidence of constipation or regurgitation.

This is not the first study to show that probiotics might be helpful in reducing colic symptoms, but previous studies were not blinded or placebo-controlled. The mechanism behind the effectiveness of L. reuteri in reducing colic symptoms is unknown. Likely, it involves restoring normal gut flora and motility and reducing pain perception. Replication of the results among larger populations of infants will help define the mechanism. Several clinical trials involving L. reuteri and other strains of probiotics are underway worldwide, and the results are much anticipated among parents and pediatricians.

First and foremost, a diagnosis of colic should come after other medical or feeding problems have been ruled out. Continued reassurance of the parents until the colic resolves is often the only valuable management for colic. It is hard to imagine through the days and nights of incessant crying that there is nothing truly wrong with a baby, or that the parents are not doing something wrong, but colic will resolve without long-term effects on the baby or family. (Other than painful memories of sleepless days and nights.)

For families with a colicky infant, a reduction in crying times like seen in the study could prove to be a life-saver. But, colic is self-resolving, and it is difficult to say for certain that the infants did not outgrow the syndrome during the study period, or that some other intervention made a difference in symptoms. Still, desperate parents will try anything that is safe to treat their baby’s colic. Probiotics are safe, do not pose a risk of drugs interactions or adverse effects, and should be further explored as a treatment for infant colic.


Can You Compare Different Health Systems?

The effectiveness of different approaches to funding and running health systems is often hotly debated, with every viewpoint seemingly able to marshal facts in support of their case. In effect, health statistics have become every bit as politicized as criminal justice. With the current political focus on the limited reforms introduced into the US system by the Obama administration, accurate information is critical and in short supply.

So lets start with some comparative data courtesy of the Organisation for Economic Co-operation and Development (OECD).

In 2007, US health expenditure was estimated to be $7,290 per head leading to an average life expectancy of 78.05 and an infant mortality rate of 6.7 per 1000 live births. In comparison, Sweden spent $3,323 per capita, leading to life expectancy of 80.95 and infant mortality rates of 2.5 per 1000.

Life expectancy and infant mortality are used by the OECD as outcome measures as they are held to reflect the effectiveness of the overall public health system for the complete population.

If correct, the largely privatized US system dependent on individual insurance payments is more expensive (by a factor of 2) and far less effective than a system funded by taxation with access relatively free for the actual user. If true (and the figures are correct and available) then the clear implication is that the US system is both expensive and ineffective (at least for the population as a whole).

However, a more fundamental question is to ask if the methodology and the comparative usage is correct? For example, an early attempt by the World Health Organization (WHO) in the 1990s to prepare such comparisons was withdrawn after US complaints specifically about the methodology adopted.

So, what are the underlying problems in trying to compare different approaches to public health?

In effect, there are three related to the underlying data and an overarching issue about presentation. In terms of data gathering:

1) Measuring expenditure on health is not simple. Even those systems that rely mainly on state provision also raise money directly from users (such as prescription charges) and usually have a parallel private provision (and of course individuals can take out their own health insurance). In a system such as the US, actually identifying all the various strands of health expenditure is particularly complex. Furthermore health expenditure is not just spending on primary and secondary health care it can include public health initiatives around disease prevention and wider health advice (obesity, alcohol, diet). In effect, deciding just how much a given state is spending on health care is never easy;

2) If measuring expenditure is complex, measuring outcomes is even more so. The variety of perfectly valid indicators is overwhelming and each give different information. The data above cites two, based around infant mortality and longevity as these are often used as proxies for the overall health of the population. The World Health Organization, after its initial battering by the US administration, has started to rely on the concept ‘years of healthy life’ for such comparisons. Even without looking at the indicator in any detail that immediately raises the question how something as judgmental as ‘healthy life’ can be consistently measured;

3) The final problem is that each country has a different demographic profile and, in consequence, different health needs. The simplest example is that the elderly and the very young need the most health care. However, even this is not a sufficient adjustment to allow for comparisons (i.e. to start to answer the question does this country spend enough, as well to ask questions about efficiency of expenditure). For example, the health demands of a given population aged between 60-70 will vary due to differences in diet, consumption of alcohol, use of tobacco and level of physical activity undertaken in earlier years. On the other hand, a state with a large immigrant population (typically in their 20s-30s) will appear to do well on outcome measures regardless of actual expenditure, as this group are usually the healthiest sub-section of any human population.

All this leads to one final problem in comparing health outcomes. If all these figures are aggregated to give a simple single figure, as the WHO tried to do in the late 1990s, then that process of aggregation can be flawed. How can different measures, collected on different bases be combined? On the other hand, presenting users and policy makers with a sea of unaggregated numbers will invariably lead to a focus on those that most closely support their existing beliefs.

Given the importance of the current US debate on methods of health funding, these issues are not abstract. If a debate as to the merits of individual funded healthcare in comparison to socially funded models is to be conducted properly, a key element has to be to compare both levels of expenditure and health outcomes.


The NeuroSocial Network

Social neuroscience is a rapidly growing discipline that examines the relationship between the brain and social behavior. The “social brain hypothesis” posits that, over evolutionary time, living in large, social groups favored the physical growth of brain regions important for social behavior. In non-human primates, some evidence indicates that the size of the amygdala is related to social behavior. Little is known, however, about this relationship in humans. A provocative new study finds that the volume of a key component of the social brain, the amygdala, is directly related to the size and complexity of social networks in adult humans.

A research team headed by Lisa F. Barrett, Ph.D., Distinguished Professor of Psychology at Northeastern University, used brain imaging to study the relationship between the volume of the amygdala and social network size and complexity in both males and females.

To investigate, the researchers recruited 58 healthy adults (22 women and 36 men, aged 19-83 years, with average age of 53) with normal intelligence and no major mental disorders to participate in the study. Each participant underwent magnetic resonance imaging (MRI) in order to assess the volume of multiple brain regions, including the amygdala (important for emotions such as fear) and the hippocampus (important for learning and memory). Importantly, head size was corrected for in the measurement of each participant’s brain volume. In addition, the researchers used two versions of a questionnaire called the Social Network Index to evaluate the size (reflected by the total number of contacts), as well as the complexity (reflected by the number of different groups that contacts belong to), of each participant’s social network. Subsequently, the research team used advanced statistical methods to evaluate the relationship between the volume of different brain regions and social network size and complexity.

In a study published in a recent issue of Nature Neuroscience, the research team reports that people having larger and more complex social networks have larger amygdala volumes. These results persisted even when biological (such as age and amygdalae on different sides of the brain) and social (such as life satisfaction and perceived social support) factors were taken into account. Importantly, the volume of the hippocampus (measured for purposes of comparison) was not related to either the size or complexity of social networks. Further analyses also demonstrated a similar lack of relationship between the size of additional brain regions and social network variables. Amygdala volume was not related to other social variables, such as life satisfaction or perceived social support. These results demonstrate the specificity of the relationship between amygdala volume and social network parameters. Interestingly, when the participants were considered separately by age and sex, the relationship between amygdala volume and social networks was less pronounced in older participants, as well as in males (regardless of age).

This study is the first to report that the volume of the amygdala is related to social network variables within a single species. The researchers suggest that this phenomenon may have served, in evolutionary time, to facilitate greater social intelligence in order to accommodate the demands of an increasingly complex social life. It should be noted, however, that the results merely indicate a correlation; that is, people who have greater amygdala volumes have larger social networks, but it is unknown whether having greater amygdala volume leads to having a larger and more complex social network, or vice versa. Dr. Barrett said “it is probably a little of both.”

Imaging studies of amygdala volume as related to social behavior have mostly been conducted in individuals with autism or psychopathy/antisocial personality and have yielded variable results. Even in normal humans lacking any such disorders, the exact relationship between amygdala volume and social functioning has remained somewhat elusive. So, is a bigger amygdala better? The answer remains to be definitely determined. However, a bigger amygdala is likely to be better equipped to accommodate more social information from more people in more contexts. In this sense, a bigger amygdala may facilitate greater social intelligence.

The research findings have potential significance for a growing body of literature suggesting that emotional memories in the amygdala can be rewired during a process known as “reconsolidation” (during which time old memories can be updated with new information) in order to help people suffering from post-traumatic stress disorder. “We hope to be able to discover how abnormalities in the amygdala and related brain regions may impair social behavior in psychiatric and neurological conditions,” said Dr. Barrett.



Health Care Market Equilibrium in a Changing Environment

Strategic market planning has always been a challenge in the rapidly changing health care industry. Both internal factors of unpredictability and external market threats create waves of instability in the health care market industry. For health care consumers, this often means fluctuating health care costs and unpredictable care availability. For health care providers, this means decreased health care payments, rising costs per patient and a stressed health care workforce.

Some of the factors that drive the health care industry, such as aging and chronic illness, are quite predictable. These predictable factors shape the majority of private health care industry strategic thinking. Health care consumers directly feel the impact of these predictable changes over time. As consumers age, health care becomes more expensive in both terms of premium payments and amount of care required.

The predictable changes within the health care industry aren’t the ones that threaten true market equilibrium- rather; it’s the unpredictable market threats that cost consumers and providers big time. A unique challenge of health care market equilibrium is the rate at which unpredicted market threats emerge. The highly enmeshed relationship between health care providers and payers ensures that small changes within the market create ripple effects across the entire health care industry.

Unpredictable market threats can be as simple as a recalled medicine or unanticipated side effects of a popular drug. Another market threat (which initially may be seen as positive) could be a new piece of technology that redefines treatment for a particular illness or diagnosis methodology. Such market threats sweep instantaneously across an entire industry and stress both financing and market viability.

A recent example of an unpredictable market threat is the FDA’s discovery of toxic side effects of Vioxx, a popular painkiller, after market approval. Admittedly, over 50,000 patients may have died or had complications due to the FDA’s lapse in proper labeling for Vioxx. This discovery stressed the prescription medication market and changed requirements of drug providers that stressed FDA authority and raised costs across the entire health care industry.

Today’s changing health care environment has several primary threats that stress both consumers and providers. The most pressing threats against health care market equilibrium are regional malpractice crises, rapidly changing government regulations, decreasing insurance reimbursement levels and regional provider shortages.

As a result of the turbulent health care industry market threats, many health care insurers have opted to play the defensive line when it comes to insurance. Health care industry professionals match their current understanding market trends to their own goals and business strategy. Changing the rules of competition within the industry also drives disequilibrium that can both help or harm the health care industry consumer. As a result, defensive health care industry players raise premiums for consumers across the board, deny coverage to perceived high-risk consumers and cut reimbursement to providers.

Increasing government regulations further compound today’s changing health care industry market. In the short term, guaranteed care threatens to increase consumer cost if preventative care is not adequately followed by the consumer market. In the long term, guaranteed care will actually stabilize market costs as health care will spread across the continuum of whole life care, rather than just during periods of employment or illness.

Health care consumers are often forced to ride the abrupt changes and threats to the industry with increased costs and less availability to care. Conservative approaches to healthcare, such as ensuring adequate preventative care, can cut costs drastically and safeguard consumers from sudden shifts in costs. Upcoming changes to malpractice legislation and guaranteed care will also help stabilize the health care industry in the long-term strategic market.


Antidepressants – Who’s Prescribing What

Antidepressant medications are among the most commonly prescribed drugs in the United States – one of the top three, depending on who is counting — owing to a dramatic rise in antidepressant use in the last 10 to 15 years. A new health policy report finds, however, that this increase in antidepressant use is driven by nonpsychiatrist healthcare providers, often without a diagnosis of depression.

The report was recently published in Health Affairs. The authors analyzed data from the National Ambulatory Medical Care Surveys conducted by the Centers for Disease Control and Prevention, which summarize outpatient medical care practices, between 1996 and 2007. Overall, four out of five providers who prescribed antidepressants were not psychiatrists; most of them were primary care physicians. Antidepressants were prescribed in 9.3% of visits to primary care physicians, compared to 3.6% of visits to other nonpsychiatrist providers.

A worrisome finding, according to the authors, is that the proportion of antidepressants prescribed by nonpsychiatrists without a psychiatric diagnosis was 6.4% (increased from 2.5% in 1996). This proportion was highest among primary care physicians, accounting for 7.1% of antidepressant prescribing (up from 3.1%). Among other nonpsychiatrists, the proportion of antidepressants prescribed without a diagnosis was 5.8% (increased from 1.9%). Overall, the proportion of physician visits that resulted in an antidepressant prescription and a psychiatric diagnosis increased only slightly from 1.7% to 2.4%.

The most likely patients to receive antidepressants were non-Hispanic white women over the age of 50 with private health insurance or Medicare coverage. These women were also more likely to have chronic health conditions, including diabetes, high blood pressure, heart disease, excessive fatigue, headaches, nonspecific pain, or trouble sleeping.

A similar study reported that nearly 3 out of every 100 people in the United States received outpatient treatment for depression in 2007, increased from 2.3 people per 100 in 1998. Of these people, 75.3% were treated with an antidepressant, only slightly increased from 73.8% in 1998. At the same time, the proportion of people receiving psychotherapy decreased from 53.6% to 43.1%. Overall, data indicates that more than 10% of children, adolescents, and adults in the United States – roughly 27 million people — are receiving treatment with an antidepressant, with or without a diagnosis of depression.

One driving force of the increase in antidepressant use — other than excessive direct-to-consumer marketing — is the increased acceptance of antidepressant use among Americans. They stigma attached to mental health treatment is decreasing, particularly when it comes to less severe conditions. Many people view antidepressants as little more than enhancers of well-being. Also, some antidepressants are approved for nonpsychiatric conditions, including premenstrual dysphoric disorder, smoking cessation, diabetic neuropathic pain, chronic musculoskeletal pain, and fibromyalgia.

The authors of the current study do not intend to imply that antidepressant prescribing by nonpsychiatrist providers is inappropriate. But, the results do beg the question of who is prescribing what, and why? Antidepressants may not be effective for many of the conditions for which they are prescribed. Simply, more prescriber education and collaborative care might avoid unnecessary prescriptions and promote more appropriate treatments, like psychotherapy, exercise, and other lifestyle or behavioral changes.

Primary care physicians are in a tough spot today. They have too many patients and too little time to spend with them. Primary care physicians lack extensive training in specialized fields of medicine, and, without funding, reimbursement, or referral capabilities, are forced to do their best to take care of their patients, often with little support from other healthcare providers, insurance  companies, or the patients themselves. A paradox related to the findings of these studies is that a large number of patients with mental health disorders still do not receive treatment for their conditions, because primary care physicians are not able to diagnoses their signs and symptoms.  Improved awareness of appropriate prescribing on the part of physicians and patients and increased collaboration with more specialized healthcare providers will lead to better treatment outcomes for mental health disorders.



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