• High-Potency Statins Associated with Acute Kidney Injury
• Walking and Running Can Provide Comparable Heart Benefits
• Autism and C-Reactive Protein Levels During Pregnancy
• Pfizer Voluntarily Recalls Levoxyl
• Medication Study Shows Antibiotic Overuse
• A Surprising Outcome in a Staph Vaccine Trial
• Does Clarithromycin Use Lead to CV Events?
• Pharma Sales Reps Rarely Tell Doctors About Drugs' Side Effects
• Low-Fat Milk Might Not Have Intended Effect in Preschoolers
• Bacterial Digestion of Red Meat Frees Compound Associated with Atherosclerosis
• Kids Who Eat Throughout the Day Weigh Less
• At Hysterectomy for Benign Indications, Best to Leave the Ovaries In
• Morning-Sickness Pill Bendectin Back on the Market with a New Name
• Doxylamine and Pyridoxine for Nausea and Vomiting of Pregnancy: Together Again at Last
• Judge Orders FDA to Remove Age Restriction from OTC Sales of Morning-After Pill
• Da Vinci Surgical Robots Under Scrutiny
• Insulin Infusion Pumps Recalled Over False Alarms
• Prostate Cancer Screening: One More Take
• Intermittent Androgen Deprivation Therapy for Metastatic Prostate Cancer?
• New Bird Flu Claims 6 Lives in China, CDC Issues Advisory to U.S. Clinicians
MM: The distressing aspect of this data is the near universal recommendation by hospital protocol of statin use upon admittance. It is almost as if they are considered without adverse effects and it is obvious this not the case. On the home front (non-hospitalized patients) natural products such as our Cholesterol Health used with Fish Oil or Krill Oil has demonstrated outstanding results on cholesterol and lipid levels without adverse effects.
BMJ 2013 Mar 19; 346:f880
High-Potency Statins Associated with Acute Kidney Injury
Risk is greatest during the first 4 months of treatment.
Several reports have suggested that statins occasionally affect kidney function, but this association requires confirmation. In this retrospective analysis, investigators used administrative databases in Canada, the U.K., and the U.S. to assess the association between new statin use and acute kidney injury (AKI) in 2 million people between 1997 and 2008. They compared high-potency statins (
10-mg rosuvastatin, 
20-mg atorvastatin, and 
40-mg simvastatin) with low-potency statins to eliminate confounding by indication (i.e., patients to whom statins are prescribed are more likely to have multiple comorbidities), and they used propensity scores to adjust further for differences between high- and low-potency users. Overall, 33% received high-potency statins.
During the first 120 days of treatment, 4700 patients without chronic kidney disease (CKD) and 1900 patients with CKD were hospitalized for AKI. Among patients without CKD, those started on high-potency statins were 34% more likely to be hospitalized within 120 days than those who began treatment with low-potency statins. Between 120 days and 2 years, the increased risk was smaller (10%–15%) but still significant. Among patients with CKD, high-potency statin use was associated with a nonsignificant 10% higher risk for AKI hospitalization.
Comment: In this study, new high-potency statin use was associated with elevated risk for hospitalization for AKI. If the association is valid, potential mechanisms mentioned by the authors include rhabdomyolysis, suppression of coenzyme Q10 production, and pleiotropic effects of statins. The authors acknowledge that absolute risk is small: Roughly 1700 patients without CKD would have to be treated for 120 days to cause one additional hospitalization for AKI. Nonetheless, clinicians should prescribe the lowest effective statin dose of statins to avoid this and other possible complications.
— Paul S. Mueller, MD, MPH, FACP Published in Journal Watch General Medicine April 11, 2013
Citation(s): Dormuth CR et al. Use of high potency statins and rates of admission for acute kidney injury: Multicenter, retrospective observational analysis of administrative databases. BMJ 2013 Mar 19; 346:f880.
(http://dx.doi.org/10.1136/bmj.f880)
http://www.ncbi.nlm.nih.gov/pubmed/23511950?dopt=Abstract
http://www.bmj.com/content/346/bmj.f880
Top of Page
Walking and Running Can Provide Comparable Heart Benefits
By Amy Orciari Herman
Similar total energy expenditures, either from walking or running, offer comparable heart benefits, according to a study in Arteriosclerosis, Thrombosis, and Vascular Biology.
Researchers followed some 33,000 runners and 16,000 walkers for roughly 6 years. Overall, runners had lower risks for incident hypertension, hypercholesterolemia, and diabetes. However, when runners and walkers expended equivalent amounts of energy during their exercise regimens, coronary risk reductions were comparable between the groups.
The researchers conclude: "Our results suggest similar benefit for similar energy expenditures. These results should be used to encourage physical activity in general, regardless of its intensity." They add, however, that because runners averaged more than twice the energy expenditure of walkers, promoting more vigorous exercise might lead to greater health benefits.
http://atvb.ahajournals.org/content/early/2013/04/04/ATVBAHA.112.300878.abstract
Top of Page
MM: One of the interesting aspects of this article is the recommendation that pregnant moms should avoid infections during pregnancy. We have long stated that pregnant women need to take 5000-10,000IU daily of Vitamin D3. This approach not only helps to strengthen developing bones of the fetus but in all likelihood reduces the risk of both inflammation and infection. Therefore, there is even more reason to maintain this level of supplementation during pregnancy.
Mol Psychiatry 2013 Jan 22
Autism and C-Reactive Protein Levels During Pregnancy
Autism may have an infectious etiology; would early treatment of maternal infections lower autism risk?
Heritability of autism has been estimated at 50% to 70% (Mol Psychiatry 2013; 18:137), which suggests a nongenetic, environmental pathogenesis or gene–environment factors such as immune mechanisms. (For example, maternal levels of tumor necrosis factor α and interleukin 6 [IL-6] differ between autism and normal offspring.) These researchers used data from Finnish birth and autism registries to examine C-reactive protein (CRP) levels from maternal sera in the first and second trimesters. CRP is an acute phase reactant stimulated by IL-6.
Registry data from 1987 included 1.2 million births and 1132 children with autism who were followed through 2007. Researchers validated the registry autism diagnoses with comprehensive interview diagnoses on 80 cases; agreement between the two methods was 96%. Individuals with autism were matched to controls (in each group, 677 subjects with available maternal sera). On multiple covariates, autism participants were similar to those who were not included.
Analyses adjusted for many covariates (e.g., birth weight, gestational age at blood draw, parental ages and psychiatric histories, socioeconomic status). Group comparisons between the highest and lowest CRP quintiles and deciles showed that the highest levels were associated with increased autism risks of 40% and 80%, respectively.
Comment: These findings must be considered cautiously: Confidence intervals were wide, and the lower limits were barely above 1.0 (the marker of no significant differences between groups). Nevertheless, physicians should encourage pregnant patients to do everything reasonable to avoid infection during pregnancy. This is especially important for schizophrenia patients whose offspring are already at higher risk for autism. Whether early treatment of infection will lower the risk is not yet known.
— Barbara Geller, MD Published in Journal Watch Psychiatry March 18, 2013
Citation(s): Brown AS et al. Elevated maternal C-reactive protein and autism in a national birth cohort. Mol Psychiatry 2013 Jan 22; [e-pub ahead of print].
(http://dx.doi.org/10.1038/mp.2012.197)
Top of Page
Pfizer Voluntarily Recalls Levoxyl
King Pharmaceuticals, a wholly owned subsidiary of Pfizer, has initiated a voluntary recall of Levoxyl (levothyroxine sodium). The recall was initiated after learning of complaints from pharmacists and patients of an uncharacteristic odor coming from Levoxyl bottles. It was determined that the odor was caused by an oxygen-absorbing canister added to 100- and 1000-tablet pharmacy bottles to enhance the stability of the product. The company stated that the odor is not likely to cause any adverse health consequences.
http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=810051&topic=410
Top of Page
Medication Study Shows Antibiotic Overuse
U.S. physicians are prescribing enough antibiotics to provide them to 4 out of 5 Americans every year. Overuse is one reason for the development of resistance. There is no consensus on an appropriate level of antibiotic prescribing, but some experts said the new study's results are disturbing and that rates are probably excessive even in the states with the lowest antibiotic prescription levels.
http://hosted.ap.org/dynamic/stories/U/US_MED_ANTIBIOTIC_PRESCRIPTIONS?SITE=
AP&SECTION=HOME&TEMPLATE=DEFAULT&CTIME=2013-04-10-18-13-14
Top of Page
JAMA 2013 Apr 3; 309:1368
A Surprising Outcome in a Staph Vaccine Trial
Patients who received an investigational Staphylococcus aureus vaccine before cardiothoracic surgery showed significantly increased rates of postoperative multiorgan failure and death from staphylococcal infections.
Given increasing problems with antibiotic resistance in Staphylococcus aureus, new approaches to prevent staphylococcal infections are needed. In recent studies, a novel vaccine candidate (V710) based on a highly conserved S. aureus iron surface determinant was found to be protective in animal studies and highly immunogenic after a single dose in healthy volunteers. Now, in a manufacturer-sponsored, multinational, multicenter, phase IIb/III trial, researchers have assessed the vaccine's efficacy and safety in preventing serious S. aureus infections in adults who were about to undergo cardiothoracic surgery.
A total of 7983 participants had been vaccinated with either V710 or placebo when the data safety monitoring committee recommended study termination. The V710 vaccine was immunogenic and did induce increased levels of antistaphylococcal antibodies with opsonophagocytic activity. However, the incidence of the S. aureus bacteremia and deep surgical site infections was similar between vaccine and placebo recipients, and the incidence of postoperative multiorgan failure was significantly increased in vaccine recipients. In addition, the mortality rate among patients who developed a postoperative S. aureus infection was significantly higher for vaccine recipients than for placebo recipients.
Comment: The authors note that this study does not establish a causal relationship between the V710 vaccine and worse clinical outcomes in patients with staphylococcal infections, and a clear mechanism for such an effect is not clear. However, paradoxical reactions leading to more-severe clinical disease have been seen previously with other vaccines. The present findings highlight the need for a much deeper understanding of the humoral and cellular immune response to S. aureus before a safe and effective staphylococcal vaccine can be developed.
— Richard T. Ellison III, MD Published in Journal Watch Infectious Diseases April 10, 2013
Citation(s): Fowler VG Jr et al. Effect of an investigational vaccine for preventing Staphylococcus aureus infections after cardiothoracic surgery: A randomized trial. JAMA 2013 Apr 3; 309:1368.
http://www.ncbi.nlm.nih.gov/pubmed/23549582?dopt=Abstract
Top of Page
BMJ 2013 Mar 22; 346:f1235
Does Clarithromycin Use Lead to CV Events?
In patients with COPD or pneumonia, clarithromycin was associated with prolonged excess risk for adverse cardiovascular events.
Use of the macrolide antibiotics erythromycin and azithromycin has been associated with increased risk for cardiovascular (CV) death (JW Gen Med Sep 21 2004 and JW Gen Med May 22 2012). In this prospective analysis of data from 3000 patients hospitalized with acute exacerbation of chronic obstructive pulmonary disease (COPD) or community-acquired pneumonia (CAP), U.K. investigators determined whether use of another macrolide, clarithromycin, is associated with CV risk.
During 1 year of follow-up, 20% of COPD patients and 10% of CAP patients were hospitalized for adverse CV events (e.g., acute coronary syndrome, arrhythmia). Adjusted analysis showed that, compared with non-use, clarithromycin use in the COPD group was associated with significantly increased risk for CV events (hazard ratio [HR], 1.5), acute coronary syndrome (HR, 1.7), and CV mortality (HR, 1.5), but not for all-cause mortality. Clarithromycin use in the CAP group was associated with increased risk for CV events (HR, 1.7), but not for acute coronary syndrome, CV mortality, or all-cause mortality. Increased CV risk was noted only when clarithromycin use exceeded 7 days; however, increased risk was present months after the clarithromycin course had ended. Beta-lactams and doxycycline were not associated with increased CV risk.
Comment: Clarithromycin use was associated with prolonged excess risk for adverse cardiovascular events in patients with chronic obstructive pulmonary disease exacerbations and community-acquired pneumonia. Notably, the number-needed-to-harm was only 8 in the COPD group and 11 in the CAP group. Because increased CV risk persisted after the antibiotic course had been completed, the authors speculate that clarithromycin may activate macrophages, leading to an inflammatory cascade, plaque rupture, and adverse CV events; QT prolongation would not explain the persistent effect.
— Paul S. Mueller, MD, MPH, FACP Published in Journal Watch General Medicine April 9, 2013
Citation(s): Schembri S et al. Cardiovascular events after clarithromycin use in lower respiratory tract infections: Analysis of two prospective cohort studies. BMJ 2013 Mar 22; 346:f1235.
(http://dx.doi.org/10.1136/bmj.f1235)
http://www.ncbi.nlm.nih.gov/pubmed/23525864?dopt=Abstract
Top of Page
Pharma Sales Reps Rarely Tell Doctors About Drugs' Side Effects
By Amy Orciari Herman
Pharmaceutical representatives rarely mention the adverse events associated with a drug during sales visits to physicians' offices, according to a prospective study in the Journal of General Internal Medicine.
Some 250 physicians in Canada, France, and the U.S. reported on their experiences with nearly 1700 drug sales visits. Nearly half of all visits were for drugs that carried black-box warnings, but pharmaceutical reps mentioned serious adverse events only about 5% of the time. Despite this disparity, the providers said the quality of the scientific information they received was good or excellent over 50% of the time, and they were willing to prescribe the drug nearly two thirds of the time.
The researchers question "whether current approaches to regulation of sales representatives adequately protect patient health."
http://link.springer.com/article/10.1007/s11606-013-2411-7
Top of Page
MM: This is surprising data when it is initially presented but when you think about it, fat consumption staves off hunger for a longer time that does carbohydrate consumption. So, a little may go a long way. The bottom line is that a balanced diet that is rich with real foods is the best option. An appropriate amount of fat, protein, fiber and carbohydrates are the best approach to an overall healthy diet. To reach these goals we will often need assistance. Mark Drugs and our team of health professionals can guide you through these challenges.
Arch Dis Child 2013 Mar 18
Low-Fat Milk Might Not Have Intended Effect in Preschoolers
Preschoolers who drank low-fat milk were more likely to be overweight than those who drank whole milk.
To combat obesity in preschoolers, the American Academy of Pediatrics recommends low-fat milk (1% or skim milk) rather than 2% or whole milk for children ages 
2 years. Is this practice effective? Researchers prospectively studied the association between milk-fat consumption and weight in a nationally representative birth cohort of 7450 2-year-olds and 8300 4-year-olds.
Most children drank 2% or whole milk at ages 2 and 4 years (86% and 81%, respectively). Body mass index (BMI) z scores were significantly higher among low-fat milk drinkers than among 2% or whole-milk drinkers across all race, ethnic, and socioeconomic subgroups. In multivariable analysis, both 2-year-olds and 4-year olds who drank low-fat milk were more likely to be overweight (odds ratios, 1.64 and 1.63, respectively) or obese (ORs, 1.57 and 1.65) than children who drank 2% or whole milk. Among children who drank the same type of milk at ages 2 and 4 years (low-fat milk, 250 children; 2% or whole milk, 4900 children), the two groups had similar increases in BMI z scores from ages 2 to 4 years. However, normal-weight 2-year-olds who drank low-fat milk were significantly more likely to be overweight or obese by age 4 than their counterparts who drank 2% or whole-milk (adjusted OR, 1.57).
Comment: In this observational study of preschoolers, the counterintuitive association between low-fat milk consumption and overweight and obesity might reflect that parents of overweight children were more likely to serve their children low-fat milk. But among children followed longitudinally, low-fat milk did not decrease rates of overweight and obesity at age 4 years. Milk with greater fat content might suppress a child's appetite for other calorie-dense foods. I agree with the authors' recommendation to emphasize other preventive practices (e.g., reducing screen time and sugar-sweetened beverages) at preschool preventive health visits rather than milk choice.
— Cornelius W. Van Niel, MD Published in Journal Watch Pediatrics and Adolescent Medicine April 10, 2013
Citation(s): Scharf RJ et al. Longitudinal evaluation of milk type consumed and weight status in preschoolers. Arch Dis Child 2013 Mar 18; [e-pub ahead of print].
(http://dx.doi.org/10.1136/archdischild-2012-302941)
Top of Page
Bacterial Digestion of Red Meat Frees Compound Associated with Atherosclerosis
By Joe Elia
Patients may ask about a new study that could explain how red meat consumption might contribute to heart disease. The study, published in Nature Medicine, found that the metabolism of carnitine (a trimethylamine abundant in red meat) by gut bacteria leads to the formation of a compound associated with cholesterol transport and atherogenesis.
The compound, trimethylamine-N-oxide, or TMAO, was found to be plentiful in the blood of meat eaters, but not vegans. When meat eaters had their gut bacteria suppressed with antibiotics, their levels of TMAO did not rise after eating carnitine.
The researchers noted that increasing plasma carnitine levels were associated with increased risks for prevalent and incident cardiovascular disease, but only among those who also had high TMAO levels.
In a New York Times account, the study's senior author raised concern over the amount of carnitine in some energy drinks and bodybuilding supplements, calling the implications "scary, especially for our kids."
http://www.nature.com/nm/journal/vaop/ncurrent/full/nm.3145.html
http://www.nytimes.com/2013/04/08/health/study-points-to-new-culprit-in-heart-disease.html?_r=0
Top of Page
Kids Who Eat Throughout the Day Weigh Less
By Amy Orciari Herman
The more frequently that children eat throughout the day, the less likely they are to be overweight or obese, according to a meta-analysis in Pediatrics.
Researchers examined data from 11 observational studies comprising nearly 19,000 children and adolescents aged 2 to 19 years. Overall, those who ate most often were 22% less likely to be overweight or obese than those who ate least often. In analyses stratified by sex, the benefit of frequent eating remained significant in boys but not girls; the researchers note, however, that the analysis among girls was underpowered. Total caloric intake was not provided.
"The beneficial effect of increased eating frequency on insulin metabolism may be a potential biological mechanism," the researchers propose. They call for clinical trials to confirm their findings.
http://pediatrics.aappublications.org/content/early/2013/04/03/peds.2012-3241.abstract
Top of Page
Obstet Gynecol 2013 Apr; 121:709
At Hysterectomy for Benign Indications, Best to Leave the Ovaries In
Bilateral oophorectomy is associated with higher all-cause mortality; the good news is that ovarian conservation is increasingly common.
Routine bilateral oophorectomy (BO) at hysterectomy may be more harmful than beneficial (JW Womens Health May 7 2009). Now, Nurses' Health Study (NHS) investigators have conducted an updated analysis of posthysterectomy follow-up extended to 28 years in >30,000 participants.
Among women who underwent hysterectomy for benign indications, 17% of those with BO and 13% of those with ovarian conservation had died. BO was associated with lower risk for death from ovarian cancer and (if performed before age 47.5) breast cancer. However — regardless of age at surgery — BO did not lower risk for death from other causes (i.e., coronary heart disease, stroke, and lung and colorectal cancer) or all-cause mortality. For women younger than 50 at surgery, BO was associated with significantly higher all-cause mortality in those who had never used estrogen therapy (ET; hazard ratio, 1.4), but not in past or current ET users.
In another study, researchers analyzed data from 15% of U.S. hospital discharges to assess recent trends in ovarian conservation at hysterectomy for benign indications. Among >750,000 women who underwent hysterectomies from 2000 to 2010, ovarian conservation was performed in 54%. This practice was more common in younger women (74% of women younger than 40) than in older women (31% of those aged 60–64). Overall rates of ovarian conservation rose throughout the study period.
Comment: These updated Nurses' Health Study findings substantiate the view that, except in women with mutations that raise risk for ovarian cancer (i.e., BRCA and Lynch), bilateral oophorectomy should not be performed at hysterectomy for benign indications. In addition, unless they have specific contraindications, women who undergo BO before age 50 should be encouraged to use estrogen therapy. The NHS authors point out that, in the post-Women's Health Initiative climate, performing BO before age 50 and then prescribing ET is not prudent, given that women are currently reluctant to use ET and clinicians are reluctant to prescribe it. In this light, it's particularly encouraging that more U.S. gynecologists are practicing ovarian conservation.
— Andrew M. Kaunitz, MD Published in Journal Watch Women's Health April 11, 2013
Citation(s): Parker WH et al. Long-term mortality associated with oophorectomy compared with ovarian conservation in the Nurses' Health Study. Obstet Gynecol 2013 Apr; 121:709.
(http://dx.doi.org/10.1097/AOG.0b013e3182864350)
Perera HK et al. Variation in ovarian conservation in women undergoing hysterectomy for benign indications. Obstet Gynecol 2013 Apr; 121:717.
(http://dx.doi.org/10.1097/AOG.0b013e3182887a47)
Top of Page
MM: I was recently at a wedding and a young woman who was sitting next to me and was in her 2nd trimester was having terrible nausea. She had flown in from England and was absolutely miserable. I asked her if she had ever used acupressure for her nausea and she responded that she had not but was willing to try. I held her wrists and applied firm pressure over both pulse points. Within seconds her nausea had abated and she was able to enjoy the rest of the day. My point is that we will frequently resort to drugs as a first line treatment when there may be safer and effective treatments that can be used first. Acupressure is a simple, effective and FREE treatment for nausea. Try it before using Diclegis(R). It may be useful and is certainly at no risk for any side effects.
Morning-Sickness Pill Bendectin Back on the Market with a New Name
By Amy Orciari Herman
The combination of doxylamine succinate and pyridoxine hydrochloride has once again been approved to treat nausea and vomiting in pregnancy, the FDA has announced. The drug, to be marketed as Diclegis, was previously sold under the name Bendectin.
Bendectin was voluntarily pulled from the market in 1983 over concerns about birth defects; those concerns later proved to be unfounded.
The new approval was based on a randomized trial in which Diclegis outperformed placebo among some 260 pregnant women. In addition, says the FDA, epidemiologic studies show that the drug does not harm the fetus.
Severe sleepiness can occur with Diclegis, so patients should not drive, operate heavy machinery, or perform other activities that require mental alertness while taking the drug.
Clinicians should reassess a patient's continued need for Diclegis as the pregnancy progresses, the FDA advises.
Top of Page
Am J Obstet Gynecol 2010 Dec; 203:571.e1
Doxylamine and Pyridoxine for Nausea and Vomiting of Pregnancy: Together Again at Last
New combined formulation is effective and well-tolerated.
Nausea and vomiting of pregnancy (NVP) is common and can be debilitating. The combination of doxylamine succinate and pyridoxine hydrochloride (Bendectin) was voluntarily discontinued in 1983 by the manufacturer because of alleged birth defects in offspring of users. These claims were subsequently shown to be unfounded and the litigations were rejected, but no product has since been FDA-approved for NVP. Now, investigators have conducted a randomized controlled trial, sponsored by a different manufacturer, to assess efficacy of a new delayed-release formulation of the same two agents (Diclectin). Two hundred and eighty women with pregnancies of 7 to 14 weeks' gestation and NVP that was resistant to dietary and lifestyle management were randomized to receive placebo or Diclectin (10 mg of each agent; dosages were escalated as needed). The primary outcome was improvement as measured with a 15-point pregnancy emesis scale to assess symptoms and quality of life.
Diclectin, compared with placebo, was associated with greater improvements in emesis scores (change from baseline, –4.8 vs. –3.9; P=0.006) and quality of life, with a trend toward fewer missed days of work in the Diclectin group. Substantially more women in the Diclectin group (49% vs. 33%, P=0.009) asked to continue using their assigned treatment at the end of the 15-day trial period. Adverse events did not differ between groups.
Comment: The discontinuation (which was not based on definitive safety concerns) of an effective tool in the battle against nausea and vomiting of pregnancy was followed by a marked rise in hospitalizations for this condition. Taken together with previous findings supporting Diclectin's safety, these data, which offer compelling evidence of the efficacy and tolerability of a new formulation of an old pair of agents, should reassure patients, providers, epidemiologists, litigators, and regulatory agencies alike.
— Allison Bryant, MD, MPH Published in Journal Watch Women's Health January 6, 2011
Citation(s): Koren G et al. Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: A randomized placebo controlled trial. Am J Obstet Gynecol 2010 Dec; 203:571.e1.
http://www.ncbi.nlm.nih.gov/pubmed/20843504?dopt=Abstract
Top of Page
Judge Orders FDA to Remove Age Restriction from OTC Sales of
Morning-After Pill
By Joe Elia
A federal judge has ordered that the age restriction be removed from over-the-counter sales of Plan B One-Step (levonorgestrel) and its generic versions, the New York Times reported on Friday.
Sales of the so-called "morning-after" emergency contraceptive pill without a prescription have been restricted to those aged 17 and older. In late 2011, the FDA recommended dropping all age restrictions, but the Secretary of Health and Human Services overruled the agency. In his order on Friday, the judge called HHS's action "politically motivated, scientifically unjustified, and contrary to agency precedent."
In a December 2012 letter to HHS, several medical organizations asked that the age restriction be removed.
The judge ordered removal of the restriction within 30 days. It's not known whether the Obama administration will appeal.
http://www.nytimes.com/2013/04/06/health/judge-orders-fda-to-make-morning-after-pill-available-over-the-counter-for-all-ages.html
http://www.acog.org/About_ACOG/~/media/News%20Releases/20121207Release.pdf
Top of Page
Da Vinci Surgical Robots Under Scrutiny
By Kelly Young
The da Vinci robotic surgery system is under scrutiny following reports of five fatalities since last year, the Associated Press reports.
The FDA is investigating an increase in reported problems during da Vinci surgeries, which can include prostate removal, heart valve repair, and organ transplants. Earlier in 2013, the agency began surveying surgeons who use da Vinci because of the rise in the number of problems.
The increase could be attributed to wider use of the robots in surgery, the AP says. In 2012, there were 367,000 da Vinci robot surgeries, compared with 114,000 in 2008. The increase could also be related to more awareness by doctors and hospitals of the need to report problems.
The AP highlights several incidents that occurred on the operating table, including a robot hand that wouldn't release tissue during colorectal surgery and a robotic arm that hit a patient in the face during a hysterectomy.
http://news.yahoo.com/robot-hot-among-surgeons-fda-taking-fresh-look-174350045.html
Top of Page
Insulin Infusion Pumps Recalled Over False Alarms
By Amy Orciari Herman
Animas Corporation has issued a Class I recall of all of its 2020 Insulin Infusion Pumps that were manufactured between March and November 2012 because of the potential for false alarms that, ultimately, could lead to unintended insulin delivery.
The FDA says the false alarms may read "loss of prime," "occlusion," or "no cartridge detected," and the pump may prompt patients to take a series of steps to clear the warning. If patients fail to disconnect the pump from their bodies during these steps (per the product's safety instructions), insulin may be delivered unintentionally, putting them at risk for severe hypoglycemia. In addition, a software "limitation" will prevent the pump from working past 2015.
Animas notified customers of the recall in a letter dated January 3, 2013. People still using the recalled pump should call 877-280-2339 for a free replacement.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/
ucm346788.htm
Top of Page
Ann Intern Med 2013 Apr 9
Prostate Cancer Screening: One More Take
The American College of Physicians has issued guidance for clinicians.
The American College of Physicians (ACP) has issued a new publication on prostate cancer screening, focusing mainly on prostate-specific antigen (PSA) testing. The statement begins with a synopsis of four published guidelines — those of the U.S. Preventive Task Force, American Cancer Society, American Urologic Association, and American College of Preventive Medicine — and ends with two "Guidance Statements." Along the way, the authors briefly review the evidence for and against screening, and list ten talking points for use in discussions between clinicians and patients.
In the first guidance statement, ACP recommends that clinicians "inform men between the age of 50 and 69 years about the limited potential benefits and substantial harms of screening for prostate cancer," and that clinicians "should not screen for prostate cancer . . . in patients who do not express a clear preference for screening." In the second statement, ACP recommends against screening "in average-risk men under the age of 50 years, men over the age of 69 years, or men with a life expectancy of less than 10 to 15 years." The ten talking points (presented in a convenient figure) blend qualitative and quantitative interpretations of the natural history and epidemiology of prostate cancer as well as the potential outcomes of PSA screening.
Comment: This publication is one of the more user-friendly summaries of the key issues in prostate cancer screening. As I interpret it, the tone of the article is somewhat anti-screening; but the authors nevertheless believe that men should be offered screening in a context that allows for detailed discussion. Therein lies a dilemma for clinicians: Full and unbiased discussion of the relevant material — in a way that patients will understand and that balances all the complexities — can be so time-consuming that it simply won't happen in most clinical settings. Whether online or printed decision aids for patients are adequate substitutes for face-to-face clinical encounters is not addressed.
— Allan S. Brett, MD Published in Journal Watch General Medicine April 11, 2013
Citation(s): Qaseem A et al. Screening for prostate cancer: A guidance statement from the Clinical Guidelines Committee of the American College of Physicians. Ann Intern Med 2013 Apr 9; [e-pub ahead of print].
(http://annals.org/article.aspx?articleid=1676183)
Top of Page
N Engl J Med 2013 Apr 4; 368:1314
Intermittent Androgen Deprivation Therapy for Metastatic Prostate Cancer?
A randomized study failed to show that intermittent therapy was noninferior to continuous therapy with respect to survival.
Androgen deprivation therapy (ADT) for initial management of patients with metastatic prostate cancer has been the standard of care for more than 70 years. The dramatic rise in patients diagnosed with prostate cancer, following the advent of prostate-specific antigen (PSA) testing in the late 1980s, increased the ranks of those who underwent prostate surgery and radiotherapy and those who were ultimately found to have biochemical PSA failure. Many patients subsequently received ADT, often in the nonmetastatic setting, and were exposed to prolonged testosterone suppression, which unmasked such issues as increased risks for osteoporosis and metabolic syndrome. Thus, the intermittent use of ADT, to allow recovery of sexual function and to decrease other side effects such as hot flashes and weight gain, became a popular, albeit non-data-driven strategy.
Now, investigators from multiple U.S. cooperative groups have conducted a randomized trial involving 3040 patients with hormone-sensitive metastatic prostate cancer to test whether intermittent therapy is noninferior to continuous therapy with respect to survival and whether quality of life differed between patients assigned to either treatment 3 months after randomization. All patients received a luteinizing hormone–releasing hormone analogue and an antiandrogen agent for 7 months. Patients whose PSA level fell to 
4 ng/mL were randomized to continuous ADT (765 patients) or intermittent ADT (770 patients). Patients were stratified according to a several factors, including performance status, prior hormone therapy, and extent of the disease. For those randomized to intermittent therapy, ADT was resumed when the PSA level rose to 20 ng/mL or sooner in patients who developed symptoms.
Median survival was 3.7 years for all patients after initiation of ADT and 1.7 years for patients whose PSA did not fall below 4 ng/mL and who were not randomized. Compared with continuous therapy, intermittent therapy was associated with better erectile function and mental health at 3 months, but not thereafter. At median follow-up of 9.8 years, median survival was 5.1 years in the intermittent-therapy group and 5.8 years in the continuous-therapy group (hazard ratio for death, 1.10; 90% confidence interval, 0.99 to 1.23).
Comment: These results failed to show that intermittent therapy was noninferior to continuous therapy with respect to survival. The authors note that the confidence interval for survival exceeded the upper boundary for noninferiority, meaning that for men managed with intermittent therapy, significant inferiority (a 20% greater risk for death) could not be ruled out, as too few events had occurred. For physicians and patients considering intermittent therapy for metastatic disease, these findings provide a cautionary note. However, as in all choices, an individual's own assessment of risks versus benefits will likely drive the final decision.
— Robert Dreicer, MD, MS, FACP Published in Journal Watch Oncology and Hematology April 3, 2013
Citation(s): Hussain M et al. Intermittent versus continuous androgen deprivation in prostate cancer. N Engl J Med 2013 Apr 4; 368:1314.
(http://dx.doi.org/10.1056/NEJMoa1212299)
Top of Page
New Bird Flu Claims 6 Lives in China, CDC Issues Advisory to U.S. Clinicians
By Amy Orciari Herman
The novel avian influenza virus H7N9 has infected 21 people in China, claiming six lives, according to an update from the World Health Organization.
Thus far, there's "no evidence of ongoing human-to-human transmission," the WHO reports.
On Friday, the CDC issued an advisory "to inform clinicians and public health specialists throughout the U.S. of what is happening and what they should do if they have a suspected case in a traveler who is returning from China in terms of testing, infection control and care," the agency's Thomas Frieden said. The CDC has developed a test that may be used to screen ill travelers returning from China for H7N9 infection.
No travel advisories have yet been issued.
http://www.who.int/csr/don/2013_04_07/en/index.html
Top of Page
