If you're a parent of a child who is having or has had recurrent ear infections, and I can answer yes on both counts, you have no doubt heard of tubes that can be placed in your child's ears to prevent infections so those tedious bottles of suspiciously flavored antibiotic solutions can presumably be jettisoned.  As Rick and I reveal on PodMed this week, recurrent ear infections in children are a BIG problem, providing the number one condition requiring medical treatment in children under the age of five years in the United States.  So what happens when you go ahead with the devices, known as tympanostomy tubes as well as a number of other names, and your child still gets ear infections????  That's the subject of a study in the New England Journal of Medicine this week, and it provides us with some good news regarding management.

Two hundred thirty children ranging in age from 1 to 10 years, all of whom had tympanostomy tubes placed but still developed ear infections, known in the parlance as otorrhea, were enrolled in this trial.  One-third were assigned to observation only, one-third to oral amoxicillin–clavulanate suspension, and the final third to a topical solution of hydrocortisone–bacitracin–colistin eardrops.  Regimens included  hydrocortisone–bacitracin–colistin eardrops, administered as five drops, three times daily, in the discharging ear or ears for 7 days, oral amoxicillin–clavulanate suspension (30 mg of amoxicillin and 7.5 mg of clavulanate per kilogram of body weight per day, divided into three daily doses administered orally for 7 days), or observation for 2 weeks.

Parents were asked to keep a diary of medication adherence, complications or adverse events for two weeks, and any ear-related symptoms for six months.  The study physician visited the child at home (study conducted in the Netherlands)  at 2 weeks and 6 months, examined the child's ears and collected the parents' diaries and questionnaires.  The study results indicate the clear superiority of the topical treatment to both oral antibiotics and observation in providing the shortest duration of otorrhea (4 days versus 5 days versus 12 days, respectively).  At 2 weeks of follow-up, 5% of children treated with the topical solution, 44% of those who received the oral antibiotics, and 55% of those randomized to observation remained symptomatic. As Rick and I opine on PodMed, the topical treatment avoids systemic side effects of oral antibiotic treatment such as diarrhea, as well as reducing the potential for developing antibiotic-resistant organisms.  Clearly, topical treatment will also reduce parental stress resulting from dealing with a child with a symptomatic ear infection, so sounds like a win-win to us. Could such a strategy be expanded to include additional populations of children with ear infections?  That's outside the scope of this study but seems worth consideration.

Other topics this week include the use a common antidepressant to treat agitation in Alzheimer's disease in JAMA, ablation therapy for atrial fibrillation in the same journal, and how to treat arteriovenous malformations found incidentally.  Until next week, y'all live well.

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Alcoholism is a huge source of disability and death in our world, as everyone knows. Survey data seem to conclude that about 10% of males and about 3% of females engage in heavy alcohol use, with 10.5% of males and 5.1% of females meeting the criteria for alcohol dependance or abuse in the past year.  Now, as Rick and I discuss on PodMed this week, a complicated study in the Lancet combining economic data with population studies supports the idea that raising the base price of alcoholic beverages would favorably affect alcohol consumption in the group that is most negatively impacted by such consumption: low income people.  Let's examine the study.

The authors employed the Sheffield Alcohol Policy Model, version 2.6, a UK-based database utilizing income and socioeconomic subgroup analysis of alcohol purchase and consumption preferences. Price, type, and place of purchase/consumption were included, as was stratification based on moderate, hazardous and harmful consumers of alcoholic beverages. Moderates were defined as those who consumed less than or equal to 21 units of alcoholic drinks per week for men and 14 for women, hazardous consumed 21 to 50 for men and 14 to 35 for women, and harmful consumed more than 50 among the men and more than 35 among women. A unit of alcohol was calculated as 8 gm or 10 ml of pure ethanol, which of course is not how these beverages are sold, so calculations must be made accordingly. These latter three frequency groups were further categorized into three income groups.  The groups were concomitantly analyzed against rates of morbidity and mortality when a baseline price of 0.45 British pounds ($0.75 US) per unit was imposed on all alcohol sales.

Why was this study done at all, since previous analyses have already estimated that price constraints would disproportionately impact the heaviest drinkers?  What is unique about this study is its use of health data to compel the argument, in light of the fact that the lowest socioeconomic groups bear the biggest brunt of the deleterious consequences of alcohol consumption on both economic and health outcomes. So what did it calculate?

All groups in this analysis immediately reduced consumption when a price floor was established. Those who drank moderately were least impacted, with the greatest change seen in the harmful drinker group, in the lowest income bracket.  Yawn.  But here's the compelling data: persons in the lowest income group would accrue almost 82% of the total reduction in premature death and an increase of over 87% of the quality-adjusted life years of the entire analysis.  Wow!  That's a lot of life saved. As I opine to Rick in the podcast, this model seems to me to be a lot like the one for cigarettes, where increasing price points drive down use, especially among those least able to afford it.  While not usually a fan of the adage that the ends justify the means, in this case such a strategy seems quite supportable and legislators should take note and employ same.  Revenues collected could be diverted to treatment programs thus creating even more benefit to society at large.  A win-win.

Other topics this week include the impact of number of doses of the HPV vaccine received on genital warts in JAMA, a possible treatment for restless legs syndrome in NEJM, and the risk of end-stage renal disease in live kidney donors, also in JAMA.  Until next week, y'all live well.

 

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Traffic fatalities for children have declined by almost fifty percent, the newest data just crunched by the CDC and reported in Morbidity and Mortality Weekly Report (MMWR) establishes.  Good news indeed! Rick and I agree on PodMed this week.  It's always so wonderful when a somewhat tedious practice results in such a dramatic reduction in that hard endpoint of death, and especially death in children.  I say somewhat tedious because as anyone who's reading this probably already knows, kids don't much like car seats of any ilk, and are likely to protest in whichever way they can when buckled into them.  Yet the data is irrefutable and provides a compelling argument to enforce existing law and expand it further, as this paper clearly demonstrates that we have a ways to go.  Let's examine the numbers more closely.

The CDC analyzed data regarding traffic fatalities in the 0-12 year old set from 2002 through 2011.  Deaths per age category and restrained versus unrestrained were also broken out, with children younger than one year of age, one to three years of age, 4 to 7 year-olds, and 8-12 year olds comprising the categories.Data from 2009-2010 was also further stratified with regard to ethnicity, with sufficient numbers to permit reporting for non-Hispanic whites, African Americans, and Hispanics.  The age groups were used that correspond to recommended forms of restraint categories, such as infant seat or booster seat.

The good news is that during this time period, deaths in motor vehicle accidents declined by 43% for all age groups.  Per age category, motor vehicle death rates decreased significantly among children aged <1 year by 45%, 1–3 years by 44%, 4–7 years by 43%, and 8–12 years by 41%. However, of the children who died as a result of motor vehicle accidents, 33% were unrestrained.

Ethnicity was also an important factor in this analysis. Black children had a significantly higher proportion of unrestrained child deaths compared with white children for those aged 1–3 years (47% versus 20%), 4–7 years (46% versus 26%), and for all children aged 0–12 years combined (45% versus 26%).  Hispanic children also had a significantly higher proportion of unrestrained child deaths compared with white children for those aged 4–7 years (50% versus 26%), 8–12 years (55% versus 33%), and 0–12 years (46% versus 26%). As Rick opines in the podcast, this clearly points to the need for culturally sensitive education to inform black and Hispanic parents on the need to provide age-appropriate restraints for their children when they are passengers in motor vehicles.

Another issue worth consideration emerged from this analysis. Only two states in the US, Tennessee and Wyoming, have laws that mandate use of booster seats among older children until they reach the age of 8 years, although children aged 8–12 years had the highest proportion of unrestrained child deaths (45%), based on known restraint use.  Clearly this points to the need to enact laws mandating use of age and size-appropriate restraints for everyone riding in or on a motor vehicle.  As I comment to Rick in the podcast, we've had great national success with seat belt use by adults, and the same should be enacted for children of all ages.

Other topics this week include no help for slowing cognitive decline with tight control of risk conditions in people with diabetes in JAMA Internal Medicine, a new type of medication for post-herpetic neuralgia  and a novel flu virus in the Lancet.  Until next week, y'all live well.

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Chances are excellent that you've probably taken an NSAID, a nonsteroidal anti-inflammatory medication, and you're in good company.  Almost everyone has taken one of this class of pain relievers at least once, and if survey data are to be believed, at any one time about a quarter of adults in the United States use these medications once per week or more.  That's a lot of NSIAD use, and it's worth reviewing that this class would include aspirin, ibuprofen, and naproxen, available over the counter (OTC) domestically and in many countries around the world.  How do these drugs compare with another major player in the OTC pain reliever world, acetaminophen or paracetamol?  Their mechanisms of action are different: NSAIDs work by inhibiting both cyclooxygenase-1 and 2, abbreviated COX-1 and COX-2, both enzymes, and thereby down regulating the production of thromboxanes and prostaglandins, which are involved in inflammation and pain.  Acetaminophen inhibits only COX-2, as does the prescription pain reliever celecoxib. As such these latter two may result in less gastrointestinal bleeding.  So what's the issue Rick and I discuss on PodMed this week?  The FDA has issued a report on the cardiovascular risk represented by NSAIDs, and since so many people are taking them, it's worth taking a look at the report.

The most recent data cited in the report is a meta-analysis of  280 placebo-controlled and 474 active-controlled NSAID trials, representing about 200,000 subjects in many comparisons and study designs. Sixty-eight percent of subjects were female, and 79% Caucasian, with a mean age of 61 years. Most people taking the medications had osteoarthritis (63%), with the next most common condition rheumatoid arthritis (20%). Lots of other data regarding comorbidities, concomitant use of gastroprotective medications or more than one NSAID was also examined when available.  The conclusion of the analysis was that use of these drugs did increase the risk of a vascular event by three in a thousand person years of treatment, with one fatal event. Ibuprofen was associated with a two-fold increased risk in major coronary events but not a statistically significant increase in major vascular events. Naproxen was not associated with major vascular events or vascular death, to which I quipped to Rick that I wish I had purchased stock in Naprosen prior to this report's release.

Gastrointestinal bleeds were also assessed and surprise!  were higher in the ibuprofen group.  Here's the take home as far as I'm concerned:  if you said to me as a patient in chronic pain that I had a very small but real increased risk for stroke and heart attack when I took NSAIDs or COX-2 inhibitors, and I juxtaposed that against daily pain relief, I would chose the small risk every time.  Rick responds to that with the current belle of the ball idea, "shared decision making."  He opines that this is one ideal time to educate the patient on both risks and benefits, ideally tailored to their specific situation, and then stand back and let the patient decide.  My own view of shared decision making is less sanguine, but I do agree that fair or not, its time has come and this may be the perfect illustration of when it should be used.

Other topics this week include a look at childhood obesity in the US in NEJM, the implications of the new cholesterol screening guidelines in Annals of Internal Medicine, and evaluating the potential for child abuse in fractures, in Pediatrics.  Until next week, y'all live well.

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When thinking of ways you'd really like to avoid ending up in life, Rick and I agree on PodMed this week that developing Alzheimer's disease is close to the top of the list, in such salubrious company as ALS and locked in syndrome, and we're in abundant company.  Small wonder then, that research on Alzheimer's disease continues at a blistering pace on every aspect of the disease, with two papers representing four studies published in the New England Journal of Medicine this week on the use of antibodies against amyloid and their potential for helping folks with the disease.  Sigh.  That just about says it all with regard to these two drugs, at least in those disease stages in which they were tested.

Solanezumab and bapineuzumab are the names of these humanized mouse antibodies against beta-amyloid, with the former tested for its ability to reduce beta-amyloid in both plasma and cerebrospinal fluid, while the latter was assessed with regard to its ability to reduce beta-amyloid as seen with PET imaging as well as measurement of tau in the cerebrospinal fluid.  Patients enrolled in the former 2 trials were 55 years of age or older, had been diagnosed with mild to moderate Alzheimer's disease (AD) but without evidence of depression.  Subjects were randomized to 400mg of solanezumab received via IV infusion once every 4 weeks for a period of 18 months or placebo, with over 2000 people enrolled in these two studies. In the latter two trials involving bapineuzumab they also enrolled a couple of thousand folks with mild to moderate AD, aged 50 to 88 years.  They received either 0.5 or 1.0 mg per kilogram of the antibody or placebo via IV every 13 weeks for up to six infusions. Unfortunately neither drug had any impact on the cognitive and functional outcome measures used in these studies.  One group in the bapineuzumab study did show a reduction in CSF tau protein.  As I suggested at the outset, sigh.  While there are multiple reasons why antibody-mediated removal of beta-amyloid in people with mild to moderate AD might not work, it is disappointing. And it calls into question the hypothesis that accumulation of beta-amyloid is the key to the pathology of AD at all.  As has been suggested by others much more expert in this field than me, beta-amyloid may be a mere bystander in this arena and may only have utility as a surrogate for some other process that is so far, undefined.  Clearly, however, as the number of people who are projected to develop AD in the next couple of decades burgeons, as we are constantly refining ways to keep them alive longer, and the sheer number of healthcare providers who are needed to take care of these folks is projected to be huge while the supply is too small, we are headed for a train wreck.  For the moment I will cite Constantine Lyketsos, an AD expert here at Johns Hopkins, who says that while waiting for an effective treatment or preventative, make healthy choices with regard to diet and exercise, don't smoke, and stay socially engaged.

Other topics this week include risks of off-hours heart attack in the BMJ, MS and vitamin D levels in JAMA Neurology, and access to firearms, homicide and suicide in Annals of Internal Medicine.  Until next week, y'all live well. And for those who want to get automatic updates on their smartphone or other device of the podcast, here's the new link so  you can update:

https://itunes.apple.com/us/podcast/johns-hopkins-medicine-media/id792911349?mt=2

Happy listening!

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Gestational diabetes (GD) is the term used to describe diabetes that develops during pregnancy, and it's a big problem, as Rick and I discuss on PodMed this week.  According to these new recommendations from the United States Preventive Services Task Force, or USPSTF, published in Annals of Internal Medicine, about 240,000 pregnant women are affected by gestational diabetes each year in the United States, or about 7% of all births. Okay, so what's the harm in a little elevated blood sugar during pregnancy?  Turns out that preeclampsia, macrosomia and consequent difficulties during delivery, and low blood sugar in the infant all occur much more frequently in women with GD. Longer term risks are also present; our former colleague and diabetes expert Christopher Saudek, here at Johns Hopkins, was fond of identifying GD as "diabetes unmasked," referring to the probability that a woman who developed GD was much more likely to manifest frank diabetes later in life.  Indeed, the USPSTF places that probability at 15 to 60% within five to fifteen years of delivery.  And of course we are well aware of the many negative health consequences of long term diabetes.

As is their wont, the USPSTF took a look at all of the literature relative to GD, crunched the numbers and came up with these modified recommendations, which haven't been updated since 2008. All pregnant women are now recommended to undergo screening for the condition after 24 weeks of gestation.  This does not apply to women previously diagnosed with either type 1 or type 2 diabetes. The panel concluded that there is insufficient evidence to recommend screening before 24 weeks, and that the risk of harm to mother or fetus from screening is minimal.

The type of screening recommended is the oral glucose challenge test, to which I respond, yuck!  Women are not required to fast prior to consuming 50g of glucose in a very sugary drink.  Blood is taken at 1 hour following consumption and plasma glucose levels measured. If this generally exceeds 130mg/dL a second test is advised where a bit more glucose is consumed and more than one assessment of plasma glucose made, the so-called oral glucose tolerance test.  The diagnosis of gestational diabetes is made when 2 or more of these values fall above the threshold.

What then?  First recommendations, as for almost anyone with a new diagnosis of diabetes, involve diet and lifestyle, including increased moderate exercise.  Diabetes educators and nutritionists should be brought in and monitoring of blood glucose employed.  If these interventions prove inadequate then medications may be added. Clearly the fetus must be monitored and delivery plans considered if fetal growth is accelerated.  And finally, women who develop GD should be educated that they've received a red flag with regard to their risk for developing frank diabetes and should consider interventions such as weight loss and increased exercise as well as dietary modifications to avoid this or at least stave it off as long as possible.

Other topics this week include a new medication for genital herpes simplex in NEJM, and two from the BMJ: a small risk for pulmonary hypertension in the infant for women who take SSRIs in late pregnancy, and endovascular versus open repair for ruptured abdominal aortic aneurysm.  Until next week, y'all live well.

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If you're at risk to develop diabetes, and in these days of increasing body mass and sedentary lifestyle, who isn't? perhaps you'd prefer a switch to what's morphed into a 'Mediterranean diet,' from your normal pattern of consumption rather than hiring a former Marine as a personal trainer or going on a prolonged juice fast. That's one interpretation of a study Rick and I discuss on PodMed this week, published in Annals of Internal Medicine.  And as we quip, we'd be happy to ship out to the Mediterranean to consume same as we're enduring some rather frigid weather right now on the east coast of the US, but what do investigators do in this study?

The study enrolled over 3500 men and women at risk for the development of cardiovascular disease in Spain, with this particular study representing a subgroup analysis.  The study took place from October 2003 to December 2010, with an average follow up of 4.1 years. Participants were randomly assigned to one of three dietary groups: a Mediterranean diet supplemented with extra-virgin olive oil (EVOO), the same diet supplemented by nuts, and a control group who simply received dietary advice on low-fat consumption. Study subjects were also stratified with regard to age, sex, and study site. No weight loss or physical activity interventions were employed. It should be noted that the Mediterranean diet is actually fairly high in fat consumption, with about 35-40% of calories from fat, largely vegetable in origin. Dairy products are limited, and moderate alcohol consumption, particularly red wine, is typical.  Tomato-based sauces and garlic figure prominently.

One of my favorite aspects of the trial was that subjects were provided with either EVOO, nuts, including hazelnuts, walnuts and almonds, or nonfood items associated with shopping or cooking, depending on which group they were assigned to.  Wow!  Anyone who's taken a look at the price of EVOO lately might consider that supplement a powerful inducement to entering and completing the study.  All subjects met with a dietician and competed diet questionnaires at 3 month intervals. Among the many assessments performed at study enrollment was the absence of diabetes.

During the follow up period, 273 participants developed diabetes, 80 of whom were in the EVOO dietary group, 92 in the nut supplementation group, and 101 in the low-fat advice group.  Crunching the numbers leads to the conclusion that the Mediterranean diet groups experienced an overall 30% reduction in their risk of developing diabetes over the study period compared with the control group, with the group consuming the EVOO faring best.  There was no weight loss seen in any group, which as I comment to Rick in the podcast, calls into question the idea that increased BMI alone is the culprit when it comes to the rampant development of type 2 diabetes worldwide.  Clearly this is also good news for folks who aren't willing to endure Draconian measures to either lose weight or increasing physical activity, but are willing to make chances to their diet.  As we opine, however, results are no carte blanche with regard to increasing BMI, as it remains associated with many other health issues including cardiovascular disease, osteoarthritis and cancer.

Other topics this week include a novel device for overcoming obstructive sleep apnea in NEJM, and an entire issue of which we highlight two studies on cigarette smoking in JAMA.  Until next week, y'all live well.

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Those of us at a certain age , including Rick and me, recall the 1990s craze for vitamin E.  At the time studies concluded that vitamin E supplements could stave off dementia, and every neurologist I knew was downing the capsules in the fervent hope that the horror of developing dementia would be avoided.  Then came a slew of studies that attempted to utilize the vitamin for cancer and cardiovascular disease prevention.  Not only did these studies turn out to be disappointing, some of them actually indicated that vitamin E might increase the risk for certain conditions, notably prostate cancer. Just like every other vitamin, mineral, trace element or supplement craze before it, this one too dropped off the map.  Now, as we discuss on PodMed this week, it's bacccckkkkkkk.  JAMA reports a study where folks with established dementia were randomized to high dose vitamin E alone, in combination with memantine, memantine alone, or placebo.  Guess what?  Those who took the vitamin E alone slowed down the progression of their condition by six months.

The study population was culled from 14 Veteran's Administration medical centers, so it was largely male. All 613 participants who enrolled in the study in had mild to moderate Alzheimer's disease and were followed for 6 months to 4 years. At enrollment they were randomized to 2000 IU of alpha-tocopherol per day, 20 mg of memantine daily, the combination, or placebo. The primary outcome measure was the  Alzheimer’s Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) Inventory score, but other cognitive, functional and neuropsychiatric measures were also employed, as was an assessment of caregiver involvement.

Besides the delay in progression of symptoms of dementia, the need for increased caregiver involvement was also lowest in the group receiving vitamin E alone.  There was no benefit to memantine either alone or in combination, although the memantine receiving groups did have an increased risk of "infections or infestations(!)" No deleterious side effects from vitamin E were noted.

Well, what do we make of this?  Constantine Lyketsos, an Alzheimer's disease expert at Johns Hopkins, says he is persuaded by this study and will suggest vitamin E supplements to his patients with mild to moderate AD.  The caveat of course is that he will only recommend this intervention in those with mild to moderate disease.  This study, and the studies before it, do not establish a benefit for those in earlier stages of dementia, nor do they even intimate a role for vitamin E with regard to prevention.  What seems clear from this study as well as emerging data from many others is that there is a course of progression of AD where one intervention may be helpful but isn't at another point, and that seems to be the case with many other disease states as well. So for all of us who believe we're not demented yet, and really don't want to be, vitamin E supplementation isn't the ticket.  Sigh.

Other topics this week include driving distractions and car mishaps in NEJM, mammography statistics in JAMA Internal Medicine, and the global effects of smoking, also in NEJM.  Until next week, y'all live well.

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Are you familiar with your meniscus? Or menisci, to be more precise?  The term most often refers to the two pieces of cartilage sandwiched between the femur and the tibia inside your knee joint, and for some they are troublesome indeed. That's because they are prone to tear, either traumatically or as a result of wear and tear, and the usual method for dealing with that is to arthroscopically clean up the frayed parts, often in conjunction with or following other types of management such as steroid injections, physical therapy, and weight loss. Now comes a study published in the New England Journal of Medicine that Rick and I discuss on PodMed this week showing no benefit to surgery.  As I rather sarcastically remark to Rick, surprise!

The study took place in Finland, where such studies can be undertaken because there's less threat of litigation, in a modest 146 patients. All of the subjects were between 35 and 65 years of age, had no evidence of osteoarthritis in the knee joint, but did have symptoms consistent with a tear in the medical meniscus, and who did not respond over three months duration to conservative conventional treatment. MRI was performed on all participants to confirm the presence of a tear; final confirmation was performed at arthroscopy.  At arthroscopy, patients were randomized to either partial meniscectomy or elaborate sham surgery, completely simulating the meniscectomy without actually removing tissue.  Patients were blinded to their assignment, as were all providers outside of the surgeon and OR staff.

Study subjects were followed for 12 months with a primary outcome measure of knee pain and a couple of other measures, including quality of life.  Here's what the authors write, "Although marked improvement from baseline to 12 months was seen in the three primary outcomes in both study groups, there were no significant between-group differences in the change from baseline to 12 months in any of these measures." Well.  Guess that sums it up nicely, and fits well with much of the data from numerous studies demonstrating clearly that surgical interventions for a variety of conditions are not superior to time in pain reduction or improving function.  The caveat must be emphasized however, that all subjects in this study underwent a graded exercise program following their procedure and this no doubt improved function and stabilization of the knee joint.

A few statistics are worth repeating here:  partial arthroscopic meniscectomy is the most common orthopedic procedure performed in the United States, with an annual outlay of direct medical costs of approximately $4 billion dollars.  In this era of cost containment the procedure is clearly worth scrutinizing for efficacy.  As with so many conditions people develop, prevention is also worth a close look: would more regular physical activity and weight control reduce the number of folks who would develop this condition to begin with? For now, Rick and I agree, it's worth advocating for the 'tincture of time.'

Other topics this week include eating nuts during pregnancy in JAMA Pediatrics, BRCA screening recommendations in Annals of Internal Medicine, and dietary supplements and liver disease, in the New York Times.  Until next week, y'all live well.

 

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What makes a soap 'antibacterial' and are there any benefits conferred by such a product that are underpinned by evidence?  Moreover, are the ingredients of such a product more of a health risk than the bugs they supposedly dispatch?  Those are just a few of the questions the FDA is pondering regarding soaps marketed to consumers as 'antibacterial,' and as Rick and I discuss on PodMed this week, precipitated our first foray into discussing something not based on a study and completely lacking evidence.  Hmmm. New trend, anyone?

Here's the story:  this week the FDA announced a proposed rule that will require manufacturers to provide data that demonstrate both safety and efficacy in reducing harmful bacteria with products labeled as antibacterial.  Right now there is no evidence at all that such products are superior to plain old soap and water in reducing bacterial load or specific harmful species.  Moreover, the ingredients contained in these soaps and body washes available over the counter include triclosan and triclocarban, two chemicals that may have harmful effects on people, especially when they are used long-term.  Triclosan has been shown in animal studies to alter hormonal regulation and may also promote the development of antibiotic resistant bacterial species. Triclocarban is also suspected of affecting the action of testosterone.  Right now, both of these ingredients can be found in a range of consumer-directed products, including clothing, kitchenware, furniture, cosmetics and toothpaste, in addition to body washes and soaps.  Thus the range of exposures could be vast and the time period prolonged.

What specifically is the FDA proposing to do?  A new standard for laboratory testing that directly tests the ability of a product to reduce infection rates will be employed.  The agency is also working with the EPA to gather and integrate research data relative to triclosan with regard to risks related to exposure, especially as they occur over time. The FDA is also encouraging consumers and anyone else with an interest in this issue, including clinicians and scientists, to weigh in during the comment period for the new rule, which extends for 180 days. Okay, what about the rest of the madding crowd?

Rick suggests that for now, consumers read the labels of products they buy or have on hand around the house and see if triclosan or triclocarban are among the ingredients, and then make a decision about whether the risks of exposure are acceptable.  Certainly there seems to be no acute, immediate risk but if long term risks are a personal concern, dispose of the product.  The FDA and Rick and I all advocate for the pronounced ability of handwashing to reduce infection and contamination risk, however, so replacing your antibacterial product is encouraged if it keeps you washing your hands.   For anyone who reads the labels of produces used in hospitals or healthcare facilities, it's important to note that the proposed rule does not apply to products designed to be used in these settings.

Other topics this week include panning multivitamins in Annals of Internal Medicine, new recommendations for defining and managing high blood pressure from the 8th Joint National Committee, and calcium channels blockers and clarithromycin and acute kidney injury in JAMA.  A very Merry Christmas to all, and y'all live well.

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