Yesterday, President Obama finally entered the debate about the national debt with a proposal to reduce US government borrowing by $4 trillion over the next 12 years. The proposal called for higher taxes on rich folks as well as deep cuts in military and domestic spending, including Medicare and Medicaid.

But unlike an earlier proposal by Representative Paul Ryan (R-Wisconsin), the Big O’s plan did not include making fundamental changes to the 2 US health entitlement programs, nor did it scale back the primary objective of the health reform law passed last year (the Affordable Care Act, or ACA), which is to provide health-care coverage for millions of uninsured Americans.

“We don’t have to choose between a future of spiraling debt and one where we forfeit investments in our people and our country,” he said. “To meet our fiscal challenge, we will need to make reforms. We will all need to make sacrifices. But we do not have to sacrifice the America we believe in. And as long as I’m president, we won’t.”

Ryan’s plan calls for Medicare beneficiaries to select from a pool of private insurance programs, and for the feds to pay a fixed amount of premium funds to the insurer chosen by each beneficiary. Additional costs would have to be borne by the beneficiary.

The president’s plan calls for $480 billion in cuts to Medicare and Medicaid by 2023, and a beefed-up role for the Independent Payment Advisory Board (IPAB), the new independent panel formed by the ACA as a watchdog against health cost escalations.

Responding to the Ryan proposal, Obama said, “Let me be absolutely clear: I will preserve these healthcare programs as a promise we make to each other in this society. I will not allow Medicare to become a voucher program that leaves seniors at the mercy of the insurance industry, with a shrinking benefit to pay for rising costs.”

The cornerstone of Obama’s proposal was a provision that empowers the IPAB to make cost reduction recommendations to Congress in the event that Medicare costs grow faster than the per-capita Gross Domestic Product plus 1%. The provision requires that these recommendations must not impede beneficiaries’ access to appropriate services. Now, Congress wouldn’t have to follow the advice from the IPAB. It could institute its own solution so long as it achieved the target reductions. In the event that Congress failed to act however, the Secretary of HHS would be required to develop and implement a plan that hit the target.

A second part of Obama’s proposal called for creating a single matching rate for all Medicaid program spending that “rewards states for efficiency and automatically increases if a recession forces enrollment and state costs to rise.”

A third part, sure to enrage Big Pharma and Biotech, would “limit excessive payments for prescription drugs by leveraging Medicare’s purchasing power,” according to White House officials. The plan also calls for making generic biological available more quickly and banning “pay for delay” agreements between Big Pharma and generics manufacturers that delay the introduction of generic drugs and biologicals.

And of course, there was the obligatory hand-wave in the direction of reducing fraud and abuse by Medicare and Medicaid providers…an initiative that has been underway for almost as long as the entitlement programs have been operational.

Many of these plans had been presented last year by the bipartisan Simpson-Bowles deficit reduction commission that had been appointed by Obama more than a year ago.

The use of Motrin, Aleve and other non-steroidal anti-inflammatory drugs (NSAIDS) is associated with erectile dysfunction, according to a study by scientists affiliated with Kaiser Permanente.

The apparent link surprised the scientists. They had hypothesized that the commonly used pain-killers would actually reduce the risk of erectile dysfunction since NSAIDS protect against heart disease, which has in turn been linked to the troubling condition.

To reach their surprising conclusion, Steven Jacobsen and colleagues used data from Kaiser’s HealthConnect EHR, an associated pharmacy database, and self-reports about NSAID use and erectile dysfunction from an ethnically diverse population of 80,966 men between the ages of 45 and 69.

After controlling for age, ethnicity, race, body mass index, diabetes, smoking status, hypertension, high cholesterol and coronary artery disease, the scientists found that men who used NSAIDS at least 3 times per day for at least 3 months were 2.4 times more likely to experience erectile dysfunction than those who did not consume them on a regular basis. The link persisted across all age categories.

Remarkable in its own right was the finding that overall, 29% of the men in the study reported some level of erectile dysfunction.

The authors emphasized that their findings do not prove that NSAID use causes erectile dysfunction. For example, the study findings could have been confounded by factors not considered by the scientists (such as subclinical disease or the severity of the comorbid conditions that were studied), and the chance that NSAID use was actually an indicator for other conditions that caused erectile dysfunction.

In addition, the scientists recognized that their study had some limitations. These included an inability to temporally link NSAID use and the development of ED, and possible selection bias.

As a result, they cautioned men against discontinuing NSAIDs based solely on the findings of their study. “There are many proven benefits of non steroidals in preventing heart disease and for other conditions. People shouldn’t stop taking them based on this observational study. However, if a man is taking this class of drugs and has ED, it’s worth a discussion with his doctor,” Jacobsen said in an interview.

The write-up appears in the Journal of Urology.

Other than a prolonged tantrum perhaps, nothing upsets the normal give-and-take between parent and child more than a child who is running a fever. Mild temperature elevations are usually a benign, physiologic response to a mild viral infection. Yet many well-meaning parents give their kids medicine for no other reason than to keep the temperature down. As if treating the fever was the same thing as treating the virus.

Now, a task force from the American Academy of Pediatrics has advised physicians and parents that a fever, in and of itself, should not be a cause for concern, and that parents should not bother  treating low-grade fevers in kids unless they are demonstrably uncomfortable because of the fever.

In short, parents should try to keep kids comfortable rather than reducing their temperature to a pre-determined number.
 
The viruses that cause most fevers typically last just a few days and cause no harm. And although febrile seizures do occur, the group says anti-fever medicine don’t necessarily prevent them.

“There is no evidence that fever itself worsens the course of an illness or that it causes long-term neurologic complications,” the report stated. In fact, fever is one mechanism by which the body fights viral infections. It slows growth and reproduction of the germs that typically cause fever and enhances neutrophil and T-lymphocyte production, for example.

According to the report, nearly half of all parents believe (incorrectly) that a temperature less than 100.4 degrees constitutes a fever, and nearly 25% would give antipyretics to their children for temperatures less than 100. And nearly 85% of parents would awaken a sleeping child if it was time to administer a dose of anti-fever medicine.

That’s unwise. “If they’re sleeping, let them sleep,” Henry Farrar, an emergency room pediatrician and report co-author said in an interview.

The AAP report doesn’t recommend a specific temperature that should prompt a call to the physician. Its main conclusion is that parents and physicians should look at the entire range of a kid’s symptoms (presumably to detect a more serious illness) and not just the temperature.

If it becomes necessary to reduce a high fever in kids, the report suggests that combining acetaminophen in alternating doses may be more effective than using either one alone, although this technique risks increasing the frequency of adverse effects associated with the drugs.

The report also cautions that many OTC medicines contain antipyretics, and this needs to be accounted for in properly dosing kids with anti-fever medications.

“Appropriate counseling on the management of fever begins by helping parents understand that fever, in and of itself, is not known to endanger a generally healthy child,” the report concluded.

Millions of people watch YouTube videos depicting teens injuring and cutting themselves, according to a new study. The authors conclude that the videos may serve to legitimize the behaviors as acceptable, even normal.

To assess the scope and accessibility of self-injury videos on the Internet, Stephen Lewis of the University of Guelph, and colleagues searched YouTube for keywords like “self-harm,” and “self-injury.”

They found that the top 100 most frequently viewed videos were watched more than 2.3 million times. Ninety-five percent of the viewers were female. Their average age was 25, although Lewis’ group suspects their actual average age was lower, since some YouTube viewers provide restricted content only to older viewers.

Typically, the videos contained graphic images of cutting, embedding and burning. Many of the videos contained statements of despair or images of sad or crying people. About 42% of the videos neither encouraged nor discouraged self-injury. An additional 26% denounced the behavior, while 23% gave a mixed message and 7% actually encouraged people to perform the depicted behavior.

Most of the videos contained no warnings or viewing restrictions. Viewers tended to rate these videos highly (an average score of 4.61 out of 5). Self-harm videos were identified as “favorites” over 12,000 times.

“Nonsuicidal self-injury videos on YouTube may foster normalization of nonsuicidal self-injury and may reinforce the behavior through regular viewing,” wrote the authors. “This may have triggering-like consequences for those who have enacted nonsuicidal self-injury repetitively and for youth who have just started to self-injure and who may come across these videos.”

Scientists have reported elsewhere that the incidence of nonsuicidal self-injury is between 14-24% among children, teens, and young adults. Six to seven percent of adolescents say they do it regularly. The behavior is thought to be a risk factor for maladaptive socialization and various psychiatric illnesses. Although the behavior isn’t intended to be suicidal, scientists believe that the distress it provokes can trigger suicidal ideation or suicide. And of course, the behavior can lead to accidental suicides as well.

For more information on this topic, please see HelpGuide.org. Lewis’ write-up appears in Pediatrics.

Energy drinks represent the fastest growing segment of beverage sales in the US, with revenues predicted to surpass $9 billion this year. Children, teens and young adults consume at least half of all energy drinks.

Is there a problem with this? Perhaps so, according to the results of a new study. Many energy drinks contain high levels of unregulated ingredients and therefore could pose a health risk to the younger folks who consume them so avidly.

To review the effects and adverse consequences of energy drink consumption among children, adolescents, and young adults, Sara Seifert, of the University of Miami, and colleagues searched PubMed and Google for an assortment of terms including “energy drink,” “sports drink,” “guarana,” “caffeine,” “taurine,” “diabetes,” and “poison control center.” They reviewed the articles they found as well as manufacturer Web sites for product information.

The review suggested that 30-50% of young people consume energy drinks in the US, although there is considerable variation in the types of drinks consumed and the frequency with which they are consumed.

The adverse consequences of energy drink consumption, as documented by the scientists’ review, can be divided into 3 categories: caffeine overdoses, organ system dysfunction and interactions with drugs. Let’s review these briefly:

Caffeine Overdoses
Nearly half of the 5,448 caffeine overdoses in 2007 involved people who were 19 years old or less, the scientists reported. They weren’t able to determine which cases were caused by the consumption of energy drinks, but suggested that it is substantial.

Energy drinks typically contain between 70-80 mg of caffeine per 8-oz. serving, or about 3 times as much as is found in most cola drinks. Since energy drinks are classified as dietary supplements rather than food, producers aren’t required to specify the caffeine content on the label, or the amounts of other ingredients which could add more caffeine.

Caffeine is the primary active ingredient in most energy drinks, but other ingredients like kola nuts, guarana, cocoa and yerba mate can significantly increase overall caffeine content.

For example each gram of guarana adds 40 to 80 mg of caffeine to the drink, not to mention small amounts of the stimulants theophylline and theobromine.

Organ System Dysfunction
Seifert’s literature review revealed a long list of physiologic problems and symptoms that have been attributed to energy drinks. These included diabetes, cardiac arrhythmias, hypertension, rhabdomyolysis, kidney and liver damage, behavioral and mood disorders and seizures.

The scientists found that kids with baseline health problems (including liver or kidney disease, cardiovascular disease, behavioral problems and hyperthyroidism) were at particularly high risk for complications from energy drinks.

Deaths attributed to energy drinks have been documented in Germany and Ireland.

Drug Interactions
Seifert’s group said that energy drinks containing vinpocetine, 5-hydroxytryptophan, ginseng, L-carnitine and yohimbine were particularly likely to cause adverse drug reactions, though they didn’t provide much data on how often these events actually happened.

“Energy drinks have no therapeutic benefit, and many ingredients are…not regulated,” Seifert’s group concluded. “Both the known and unknown pharmacology of various ingredients, combined with reports of toxicity, suggest that these drinks may put some children at risk for serious adverse health effects.”

The write-up appears in Pediatrics.

Aerobic exercise reduces the risk of cardiovascular disease, stroke and diabetes…and it may improve memory in elderly adults as well, a new study has found.

The study was carried out by Arthur Kramer of the University of Illinois Urbana-Champaign, and colleagues.

The scientists knew that as people age, a part of the brain known as the hippocampus shrinks by 1-2% per year. They also knew that this phenomenon is associated with impaired memory and an increased risk for dementia. In addition, they were aware of previous studies which had shown that (1)the hippocampus is larger in physically fit adults, (2)aerobic exercise increases blood flow to the hippocampus, and that (3)in animals, aerobic exercise reduces the loss of hippocampal volume and preserves memory.

It remained for Kramer’s group to determine whether aerobic exercise could reverse age-related shrinkage of the hippocampus in humans.

To study the matter, the scientists randomized 120 men and women in their mid-60s to either a program involving walking 3 times-a-week for a year, or to a stretching (non-aerobic) program. The first group walked around a track for 40 minutes per session.  All participants gave blood samples and underwent spatial memory tests and MRI scans at study onset, halfway through the study, and at the end of the study.

The scientists found that the aerobic exercisers had a 2% increase in hippocampal volume, whereas the control (stretching) group lost 1.4% of their hippocampal volume. In addition, the aerobic exercisers performed better on spatial memory exercises at the end of the study. They also had increased blood levels of BDNF, a chemical that is synthesized in the brain and is involved with memory and learning.

The findings “clearly indicate that aerobic exercise is neuroprotective and that starting an exercise regimen later in life is not futile for either enhancing cognition or augmenting brain volume,” the researchers wrote.

“Loss of hippocampal volume in late adulthood is not inevitable and can be reversed with moderate-intensity exercise.”

The write-up appears in the Proceedings of the National Academy of Sciences.

School-aged kids that get more sleep—even if it’s “catch-up” sleep on weekends—are less likely to be obese and have metabolic abnormalities, according to the results of a new study.

To reach these conclusions, David Gozal of the University of Chicago, and colleagues monitored sleep patterns for one week using wrist actigraphs in 308 children who were between 4 and 10 years old. In a subset of these kids, the researchers also obtained fasting blood levels of glucose, lipids, insulin, and C-reactive protein.
 
Overall, the kids averaged about 8 hours of sack-time per night, far less than the 9-10 hours pediatricians recommend for this age group.

More importantly, the subset of the kids who got the least amount of sleep and also the most night-to-night variability in sleep duration were 4.4 times more likely to be obese than those who got the most sleep. Kids in the former category were more also more likely to have abnormal blood levels of insulin, low-density lipoprotein, and C-reactive protein.
 
Kids who “caught-up” on sleep on weekends did better than those who didn’t, according to Gozal’s group. Although they were more than twice as likely to be obese as those who achieved high levels of sleep without the need for “catch-up,” they were still far less likely to be obese.

“In other words, the longer and more-stable sleep duration is, the less likely a child is to manifest (obesity and) metabolic dysfunction,” the researchers wrote.

Of course, the correlations demonstrated in this study don’t prove causal links between sleep duration and weight or metabolism function, nor do they prove that sleep-deprived kids could benefit by getting more shut-eye. Even so, the scientists mentioned that sleep deprivation could be linked to obesity via scientifically proven alterations in the physiology of appetite-controlling substances like ghrelin and leptin.

In addition to its possible benefit on weight and metabolism, “optimal sleep is associated with better attention, better ability to learn, and better memory,” Gozal added in an interview.

The authors recommended that the parents should be informed about the relation between longer, more consistent sleep and its potential impact on obesity and metabolic abnormalities.

The write-up appears in Pediatrics.

Scientists have confirmed that regular physical activity is associated with a lower risk of cardiovascular disease, dementia, all-cause disability and other health problems. However, few studies have looked at the possible association between time spent sitting and mortality. The two are not exact opposites, since a person who gets a good 30-minute work-out every day and then sits in front of a computer screen for 8 hours has high levels of both physical activity and sedentary behavior.

A new study by Emmanuel Stamatakis and colleagues at University College London has addressed the gap, and the results suggest that too much time spent in front of a computer or the TV increases the risk cardiovascular events and all-cause mortality, even in people also happen to engage in regular exercise.

To reach these troubling conclusions, Stamatakis’ group reviewed data from 4,500 respondents to the Scottish Health Survey of 2003. Participants were 35 years old or older, and were followed for at least 4 years.

Respondents were asked describe the time spent per day engaged in screen-based entertainment (like watching TV or surfing the Internet).

After adjusting for age, gender, BMI, ethnicity, social class, cigarette smoking and other factors, Stamatakis’ group determined that cardiovascular risk was about 50% higher among respondents who engaged in screen-based entertainment for two or more hours per day. They also found that all-cause mortality was more than twice as high among those who engaged in four or more hours of the same.

Importantly, when the scientists adjusted their analysis to account for physical activity, they found no appreciable reduction of the risk associated with sedentary behavior.

In an effort to study physiological mechanisms underlying the link between excessive sedentary behavior and cardiovascular risk, Stamatakis’ team looked at a subset of respondents for whom blood test results were available.

They found, rather surprisingly, that a combination of C-reactive protein (a non-specific measure of inflammation in the body), HDL (good) cholesterol and BMI explained only about 25% of the relationship.

“Further experimental studies will be required to determine the exact mechanisms accounting for increased cardiovascular disease risk during prolonged inactivity in humans,” Stamatakis’ team concluded.

The scientists’ findings are consistent with the few earlier studies that have addressed the matter, including this one.

The write-up appears in the Journal of the American College of Cardiology.

Hot flashes are a common symptom of menopause. Lasting from two to 30 minutes per episode, they usually begin with a sensation of intense heat on the face or chest which then spreads to other parts of the body. This sensation is often associated with sweating and tachycardia.

Not all women experience hot flashes, and for many others the symptoms amount to little more than a minor annoyance. But for some, hot flashes are down right debilitating. They have been known to precipitate fainting, for example. Some women experience several dozen hot flashes per day, and each one is severe enough to interrupt sleep or force them to cease normal activities until it subsides.
 
Hormone replacement therapy works like a charm for nearly all affected women, but it has fallen out of favor in the last decade or so, after scientists showed the therapy increased the risk of cardiovascular disease and breast cancer, among other things.

Women who suffer debilitating hot flashes, and the physicians who treat them will thus be heartened to learn that the antidepressant Lexapro reduces the frequency and severity of hot flash symptoms.

That’s the conclusion reached by Ellen Freeman and colleagues at the University of Pennsylvania, who recently published their findings in JAMA.

To reach this conclusion, Freeman’s team randomized 205 healthy menopausal women to receive either Lexapro or a placebo. Each volunteer reported experiencing at least 28 hot flashes per week. As a group, they averaged 9.8 hot flashes per day before the study began.

Women who didn’t have a favorable response after 4 weeks had their dose doubled from one pill to two (for those receiving Lexapro, this meant doubling the dose from 10mg to 20 mg).

After the 8-week study, women who took Lexapro reported experiencing 5.3 hot flashes per day, a 47% drop from baseline levels. Interestingly, the women who took placebo saw their hot flashes drop by 33%, to 6.4 per day, a finding that was significant in its own right.

In addition, Lexapro rendered the hot flashes less bothersome. Women in the Lexapro group said the severity of their hot flashes dropped by 0.6 on a 4-point scale, which compared favorably to the 0.4 point drop reported by women who received placebo.

Freemen’s group suggested that their findings were impressive enough for the drug to be given consideration as a first-line treatment for hot flashes. They cautioned however that the sizable placebo effect suggests “the importance of nondrug factors in clinical care and the potential for nonmedical approaches as other possible therapies for reduction of hot flashes.”

Still, the results of this study suggest Lexapro isn’t nearly as effective as hormone replacement therapy, which eradicates the symptoms in fully 95% of women. What is more, scientists have little knowledge about the long-term effects of Lexapro on healthy, non-depressed women, or what might happen when the drug is withdrawn.

“Will these women become depressed; will they have withdrawal problems?”wondered Wulf Utian, in an email to MedPageToday responding to Freeman’s report. “We simply do not know, and until such time as there is adequate safety information, I would advise clinicians to tread carefully before prescribing, and women to be cautious,” added Utian, who is the former executive director of the North American Menopause Society.

When the so-called “atypical antipsychotic” drugs became available for the treatment of schizophrenia, physicians began prescribing them like crazy because they did not cause debilitating extrapyramidal side effects like their predecessors. As we described previously, relentless and occasionally unscrupulous marketing campaigns by drug makers also drove utilization of the newer agents.

Unfortunately, the atypical agents turned out to have a nasty side-effect profile of their own. They promote obesity and diabetes, increase the risk of cardiovascular events, precipitate tics and increase mortality in elderly patients with dementia, among other things.

The weight gain/diabetes problem is particularly severe in children—a demographic in which these agents are rarely indicated. In one study for example, the drugs caused youths between the ages of 4 and 19 to gain between 10 and 19 pounds on average in just 11 weeks.

What’s New?
Recently, G. Caleb Alexander and colleagues at the University of Chicago reviewed historical trends in the use of atypical antipsychotics and published their findings in Pharmacoepidemiology and Drug Safety. It’s a largely confirmatory study, and the picture they paint is not pretty.

Caleb’s team queried nationally representative data from IMS Health’s National Disease and Therapeutic Index to characterize prescribing behavior for antipsychotic drugs in outpatient settings.

They found that overall, antipsychotic use (including atypical antipsychotic and first-generation agents) nearly tripled from 6.2 million treatment visits in 1995 to 16.7 million visits in 2008. For children, the number of treatment visits involving an antipsychotic increased 8-fold, from 0.3 million in 1995 to 2.4 million in 2005. And as expected, the scientists documented a tectonic shift in prescribing patterns: in 1995, 84% of the prescriptions for antipsychotic agents were for first-generation agents, whereas  by 2008, 93% of them were for atypical agents.

As physicians prescribed fewer first-generation agents, they tended to use them more specifically for schizophrenia, the indication for which they were initially approved by the FDA (30% in 1995 vs 48% 2008). On the other hand, the prescribing tsunami for atypical agents was accompanied by a three-fold increase in prescriptions for bipolar disease (10 to 34%) and a marked cut in their use for schizophrenia (56 to 23%). the now infrequently used typical agents.

On the cost side, the total cost of typical antipsychotics—which are now available in generic form–was $0.6 billion in the US in 2008, whereas that for atypical drugs was $9.9 billion.

Overall, antipsychotic use for non-FDA approved indications rose from 4.4 million visits in 1995 to 9.0 million in 2008. The scientists estimated the cost associated with off-label use of these drugs to be $6.0 billion in 2008, alone.

These trends occurred even though scientists have yet to prove that the atypical agents offer a clear advantage over their older congeners, when both efficacy and side-effects are considered, Caleb’s group said.

“Recent trials failing to demonstrate clinically significant differences in the effectiveness of these two classes in schizophrenia raise the question of whether typical antipsychotics should be reconsidered as a first line therapy, given that the superiority of atypical agents has yet to be established,” they wrote.

“Our results…suggest a substantial exposure to therapies for clinical indications that have not received regulatory scrutiny and where the evidence base is uncertain.”

Wonderful.