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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
November 16, 2013

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Treating Obstructive Sleep Apnea in Patients with Resistant Hypertension
What Agent Is Best for Managing Acute Hypertensive Emergency in Pregnancy?
Depression in Menopausal Women Frequently Abates in First Years After
   Menstruation Stops
Too Much Sun Is Not the Only Risk Factor at That Tiki Bar
Do Gastric Acid–Suppressing Drugs Increase Risk for Community-Acquired Pneumonia?
ACE-Inhibitor/ARB Combination to Curtail Diabetic Neuropathy Seen As Risky
What Explains High Ovarian Cancer Mortality in Black Women?
Drug Resistance Might Complicate Herpes Simplex Keratitis
Bariatric Surgery Linked to Increased Risk of Pre-term Delivery
Lipid-Modifying Therapy: A New Paradigm
Most Pharmacy Groups Oppose the Rescheduling Hydrocodone Combinations
Guidelines for Assessment of Cardiovascular Risk
President Allows One-Year Extension for Canceled Insurance Plans
Implantable Device Approved for Epilepsy

MM: This article caught my eye due to the similar response we frequently see with the HCG Metabolic Syndrome Protocol. It is not uncommon for people with a history of sleep apnea to see a reversal of that situation when engaging in the HCG protocol. Additionally, it is quite common to see a decrease in both systolic and diastolic blood pressure in many of these patients.
Chest 2013 Nov; 144:1487
Treating Obstructive Sleep Apnea in Patients with Resistant Hypertension
In a randomized trial, continuous positive airway pressure lowered daytime ambulatory blood pressure.
Many patients with resistant hypertension have obstructive sleep apnea (OSA). To determine whether treating OSA improves blood pressure (BP) in such patients, researchers in Brazil randomized 40 patients with resistant hypertension and OSA to receive medical treatment alone or medical treatment plus continuous positive airway pressure (CPAP). All patients had inadequately controlled BP (mean, 162/97 mm Hg) despite taking at least three antihypertensive drugs, and all had apnea/hypopnea indexes ≥15 per hour (mean, 29/hour). Twenty-four-hour ambulatory BP monitoring at 6 months (compared with baseline) showed that mean daytime systolic and diastolic BP increased by 3 mm Hg and 2 mm Hg, respectively, in the control group and decreased by 7 mm Hg and 5 mm Hg in the CPAP group — both differences were significant. No differences in nocturnal BP were noted between groups. Antihypertensive drug regimens were not changed during follow-up. CPAP was used an average of 6 hours nightly.
COMMENT: According to the authors, this is the first randomized trial in which the effect of obstructive sleep apnea treatment on resistant hypertension was examined specifically. Although the results are promising, follow-up was relatively brief, the study was small, and adherence to continuous positive airway pressure was higher than we usually observe in practice. Why the effect was limited to daytime blood pressure is unclear.
CITATION(S): Pedrosa RP et al. Effects of OSA treatment on BP in patients with resistant hypertension: A randomized trial. Chest 2013 Nov; 144:1487.
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MM: Nifedipine seems to be another drug that we can feel comfortable giving during pregnancy. It is inexpensive and easy to administer. It seems obvious that we would want to avoid any medications during a pregnancy but when they are absolutely necessary and potentially life-saving, it is good to know what can be in our arsenal.
Obstet Gynecol 2013 Nov; 122:1057
What Agent Is Best for Managing Acute Hypertensive Emergency in Pregnancy?
Oral nifedipine lowered blood pressure more quickly than did intravenous labetalol.
Hypertensive disorders affect as many as 10% of pregnancies worldwide. Largely because of safety concerns, hydralazine use has declined whereas labetalol and nifedipine have emerged as the most commonly used medications for hypertensive crisis during pregnancy. Researchers at one hospital in India conducted a randomized, double-blind trial to compare these two agents for their ability to lower blood pressure (BP) rapidly during an acute hypertensive emergency in pregnancy. Sixty pregnant women (age range, 18–45; ≥24 weeks' gestation; BP ≥160/110 mm Hg) were randomized to oral nifedipine plus intravenous placebo or intravenous labetalol plus oral placebo. After 20 minutes, if BP remained above 150/100, another dose was administered for up to five cycles. Nifedipine doses were constant (10 mg) for all cycles, while labetalol doses escalated from 20 mg to a maximum of 80 mg.
Median time to achieve the targeted BP of 150/100 was 40 minutes (2 doses) for nifedipine, versus 60 minutes (3 doses) for labetalol (P=0.008). Mean maternal heart rate increased significantly in the nifedipine group to 97±10.3 beats per minute; however, maternal and neonatal outcomes were similar in both groups, and no participants in either group experienced hypotension.
Comment: Although this study's sample size was small, the results provide additional reasons to consider nifedipine as an alternative to labetalol. In addition to its more rapid effect on blood pressure, nifedipine permits an easy dosing schedule, can be administered orally, and is readily available and cost-efficient (and therefore well suited for use in resource-poor settings). Concerns about the tocolytic effects of nifedipine and the safety of coadministration with magnesium sulfate should be laid to rest by results of this and other studies (e.g., AJOG 2005; 193:153).
Citation(s): Shekhar S et al. Oral nifedipine or intravenous labetalol for hypertensive emergency in pregnancy: A randomized controlled trial. Obstet Gynecol 2013 Nov; 122:1057.
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MM: During menopause there is a change in the balance of the hormones estrogen, progesterone and testosterone. Many women are sensitive to these changes. Sometimes the changes are abrupt and other times these changes are extremely gradual. In any case, each person's response is different. Although exogenous hormone supplementation (BHRT) is frequently helpful (about 75% of the time) that is not always the case. It may simply be an eventual stabilization of the hormones and their subsequent balancing at a lower, yet relatively balanced level that eliminates some of the "estrogen dominant" or "progesterone missing" symptoms associated with menopause.
Depression in Menopausal Women Frequently Abates in First Years After Menstruation Stops
By Amy Orciari Herman
Many women who develop depression during the menopausal transition become depression-free within a couple of years of their final menstrual period, according to a JAMA Psychiatry study.
Some 200 women were followed from the premenopausal period through menopause, with depression assessments performed regularly throughout the study.
Overall, high depression scores were significantly more common in the 10 years before the final menstrual period and significantly less common in the 8 years afterward. Among women with histories of depression before the study, 50%-65% had high depression scores in the years before the final menstrual period, while only 35% had high scores in the years afterward. Among women without depression histories, the corresponding numbers were 10%-30% before and 0%-15% after.
The authors conclude that women without depression histories "may have a low risk of depressive symptoms after the second postmenopausal year and benefit from short-term hormone therapy or short-term treatments with antidepressants."
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MM: For years dermatologists have been insistent that sun exposure is the culprit causing skin cancer. I wonder if those same doctors who refuse to expose themselves or their patients to the sun will soon become teetotalers?
Cancer Causes Control 2013 Oct 31
Too Much Sun Is Not the Only Risk Factor at That Tiki Bar
Type of alcohol and the amount consumed were among the risk factors linked to development of melanoma and nonmelanoma skin cancers.
Some study results have linked alcohol consumption with skin cancer risk. However, many of the prior analyses did not adjust for confounding factors. In Women's Health Initiative Observational Study, researchers recently found an increased risk for both melanoma and nonmelanoma skin cancer among alcohol drinkers, with links to the amount and type of alcohol consumed.
Among 59,575 white, postmenopausal women followed prospectively for a mean of 10.2 years, 532 cases of physician-diagnosed malignant melanoma (MM) and 9593 cases of self-reported nonmelanoma skin cancer (NMSC) were reported. Using Cox proportional hazards models and logistic regression techniques, the researchers found a significant relationship between amount of alcohol consumed and occurrence of both MM and NMSC. Compared with nondrinkers, those who consumed 7 or more drinks per week had a heightened hazard of MM (hazard ratio, 1.64; P=0.0013) and increased risk for NMSC (odds ratio, 1.23; P<0.0001). Higher lifetime alcohol consumption and a preference for white wine or hard liquor were also associated with increased occurrence of MM and NMSC compared with nondrinkers.
Comment: This large cohort analysis is the latest in a series of studies that have found a low but increased risk for nonmelanoma skin cancers and melanoma among drinkers. Drinkers may be more apt than nondrinkers to engage in higher-risk behavior, such as tanning and sunscreen neglect. The level of risk is significantly heightened but low enough that it would be hard to show a reduction in skin cancer risk with alcohol cessation. Nevertheless, I would recommend including skin cancer among the health hazards associated with heavy drinking when counseling patients.
Citation(s): Kubo JT et al. Alcohol consumption and risk of melanoma and non-melanoma skin cancer in the Women's Health Initiative. Cancer Causes Control 2013 Oct 31; [e-pub ahead of print].
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MM: Different studies will continue to yield different results. I never completely bought into the PPI causes CAP data. I do continue to be convinced that PPI's contribute to dysbiosis of the gut, osteoporosis, mineral deficiencies, and their associated maladies such as muscle pain, cramping and malabsorption.
Gut 2013 Jul 15
Do Gastric Acid–Suppressing Drugs Increase Risk for Community-Acquired Pneumonia?
Contrary to previous observational study findings, no association was observed.
Results of observational studies suggest an elevated risk for hospitalization for community-acquired pneumonia (CAP) in patients using proton-pump inhibitors (PPIs). The hypothesis is that the alteration of gastric pH leads to diminished bactericidal protection and, consequently, increased risk for infection. However, as the patients in those studies were often taking PPIs for gastroesophageal reflux disease (GERD), which itself is an independent risk factor for CAP, the results may have been biased toward a positive association due to uncontrolled confounding.
In the current study, investigators specifically selected patients who were prescribed PPIs for a non-GERD indication — prevention of complications associated with use of nonsteroidal anti-inflammatory drugs (NSAIDs) — in order to minimize potential bias. They identified eight cohorts of new users of NSAIDS from population-based Canadian databases and used propensity scores to estimate the odds of acquiring CAP at 6 months. A fixed effects model was used to estimate the impact across databases.
Of 4,238,504 new users of NSAIDs, 96,870 (2.3%) used a concomitant PPI. The cumulative 6-month incidence of CAP did not differ between PPI users (0.17%) and nonusers (0.12%). The cumulative 6-month incidence also did not differ between users of histamine-2 receptor antagonists (0.16%) and nonusers (0.12%).
Comment: This study's patient population was specifically chosen to minimize confounding from gastroesophageal reflux disease–related pneumonia risk. These findings should refute the global proposition that gastric acid inhibitors are associated with an increased risk for community-acquired pneumonia. Moreover, the lack of association observed for both proton-pump inhibitors and the less-potent histamine-2 receptor antagonists suggests that potency of gastric acid suppression does not affect the risk for CAP.
Citation(s): Filion KB et al. Proton pump inhibitors and the risk of hospitalisation for community-acquired pneumonia: Replicated cohort studies with meta-analysis. Gut 2013 Jul 15; [e-pub ahead of print].
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MM: This is a great example of how a little bit is good but a lot more can cause harm. ACE inhibitors have long been used for patients with renal problems but adding the similar class of antihypertensives ARB's to them appears to cause more harm than good.
ACE-Inhibitor/ARB Combination to Curtail Diabetic Neuropathy Seen As Risky
By Joe Elia
In patients with diabetic nephropathy, dual blockade of the renin-angiotensin system is associated with more harm than benefit, a New England Journal of Medicine study finds.
Veterans Affairs researchers randomized roughly 1450 patients with type 2 diabetes and albuminuria to either monotherapy with an angiotensin-receptor blocker (losartan) or dual blockade with losartan plus an angiotensin-converting-enzyme inhibitor (lisinopril).
The therapies had similar effects on slowing the decline in glomerular filtration rates. However, the trial was stopped when the rate of acute kidney injury requiring hospitalization was 1.7 times higher and that of hyperkalemia 2.8 times higher among the dual-therapy group. Dual therapy had no added beneficial effect on mortality or cardiovascular events.
Despite the hope that dual blockade would enhance renal protection in type 2 diabetes, an editorialist concludes that its use "cannot currently be recommended."
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Obstet Gynecol 2013 Nov; 122:1025
What Explains High Ovarian Cancer Mortality in Black Women?
MD Analysis of national data points to incomplete treatment.
In recent decades, 5-year survival in women with advanced ovarian cancer (stages III and IV) has risen in white women but fallen in black women. Some have attributed this inconsistency to more-advanced disease at presentation in black women. Investigators used Medicare and federal cancer surveillance data to assess whether this racial discrepancy results from differential probability of receiving guideline-recommended treatment (cytoreductive surgery plus ≥6 cycles of systemic therapy; termed “complete care” in this study).
Of 4695 patients aged ≥66 and insured by Medicare, 5% were black and the rest were white. Black women were more likely than whites to present with stage IV disease and higher comorbidity scores. Treatment in black women was more likely to be incomplete (46% vs. 32%; P<0.001), and this disparity persisted after controlling for age, comorbidity, stage, and tumor characteristics. In all, 28% of black women versus 18% of white women underwent surgery only (P<0.001); likelihood of surgery followed by ≤5 chemotherapy cycles was similar by race (18% and 14%, respectively). Although black women were more likely to die (hazard ratio, 1.27; 95% confidence interval, 1.10–1.46), all women who received complete treatment were less likely to die than those who did not, regardless of race (HR, 0.32; 95% CI, 0.30–0.34).
Comment: These findings show that black–white survival disparities in advanced ovarian cancer reflect treatment differences, with black women less likely to receive any chemotherapy after surgery. The investigators were unable to assess the extent to which not receiving chemotherapy was explained by the patient's refusal or the physician's judgment (perhaps because of greater comorbidity), although others have reported that, in the setting of breast cancer, black women were less likely to be familiar with the benefits of adjuvant chemotherapy and more likely not to trust the healthcare system (J Clin Oncol 2009; 27:5160). The specific factors determining incomplete treatment in black women are yet to be determined, but it seems clear that consistent receipt of recommended therapy whenever possible would narrow black–white survival disparities.
Citation(s): Howell EA et al. Racial disparities in the treatment of advanced epithelial ovarian cancer. Obstet Gynecol 2013 Nov; 122:1025.

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MM: It makes a lot of sense that anti-virals should have a similar end game to antibiotics when it comes to drug resistance. Prophylaxis with intent to kill a micro-organism or virus simply does not work. It's a better approach to do all that is possible to strengthen the immune system and reserve the "anti-" drugs for acute or life-saving situations.
J Infect Dis 2013 Nov 1; 208:1359
Drug Resistance Might Complicate Herpes Simplex Keratitis
Prolonged use of acyclovir and its derivatives for prophylaxis is a risk for resistance, even in immunocompetent patients.
Abigail Zuger, MDHerpes simplex virus (HSV) keratitis is treated routinely with oral acyclovir and its derivatives, and, as in other herpes infections, frequency of recurrences can be reduced by using these agents as prophylaxis. However, studies have suggested that immunocompetent patients with keratitis (unlike immunocompetent patients with genital or oral HSV infections) might develop drug-resistant disease when prophylaxis is used long term.
Among 78 Dutch patients with HSV keratitis followed for a median of 17.6 years, 8 had uniformly resistant viral isolates on sequential testing during recurrences, and 27 had resistant isolates identified at least once. Among patients who did not receive prophylaxis, drug susceptibility did not change appreciably over time, whereas for those who did receive prophylaxis, longer duration of prophylaxis was associated with significantly higher risk for drug resistance. On multivariate analysis, longer duration of recurrent disease and longer-term acyclovir prophylaxis were independent predictors of drug-resistant viral isolates.
Comment: Why should drug resistance be a problem in keratitis when it occurs so rarely in other herpes simplex virus infections in immunocompetent patients? Probably because the cornea is a locally immunodeficient site. Editorialists call for cautious long-term use of acyclovir or valacyclovir prophylaxis in patients with keratitis, because once HSV becomes acyclovir-resistant, use of parenteral toxic agents is almost unavoidable.
Citation(s): van Velzen M et al. Acyclovir prophylaxis predisposes to antiviral-resistant recurrent herpetic keratitis. J Infect Dis 2013 Nov 1; 208:1359.
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MM: It's interesting that if a woman is obese and loses weight she may have a better chance of getting pregnant but after that it seems that the method of weight loss and any subsequent vitamin or mineral absorption deficiency may have a detrimental effect on being able to go full term.That is one of the inherent dangers of bariatric surgery. Of the patients who have used the HCG Metabolic Syndrome Protocol, and have successfully been able to get pregnant, virtually all have gone full term.
Bariatric Surgery Linked to Increased Risk of Pre-term Delivery
By Amy Orciari Herman
Pregnant women who've previously undergone bariatric surgery are at increased risk for delivering prematurely and having a small-for-gestational-age infant, according to a BMJ study.
Using national Swedish registries, researchers matched some 2500 singleton births after bariatric surgery to 12,500 control births by maternal age, parity, and early-pregnancy BMI. Delivery before 37 weeks' gestation occurred significantly more often among bariatric patients than controls (10% vs. 6%), as did small-for-gestational-age births (5% vs. 3%). Large-for-gestational age infants were less common after bariatric surgery (4% vs. 7%).
The increased risks for preterm delivery and small-for-gestational age infants appeared limited to bariatric patients with early-pregnancy BMIs below 35.
The researchers conclude: "Pregnant women with a history of bariatric surgery should be regarded as a risk group and be counseled about the increased risk of preterm birth and intrauterine growth restriction." And Allison Bryant, an OB/GYN with NEJM Journal Watch, calls the findings "notable," adding that "future studies should explore how changes in weight after surgery and during pregnancy may mediate these effects."
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J Am Coll Cardiol 2013 Nov 12
Lipid-Modifying Therapy: A New Paradigm
An ACC/AHA guideline abandons treatment to specific LDL cholesterol targets.
Sponsoring organization: American College of Cardiology/American Heart Association (ACC/AHA)
Target Population: Primary care providers, cardiologists
Background and Objective: To guide clinicians in treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults.
Key points:

— High-intensity statin therapies are atorvastatin (40–80 mg) or rosuvastatin (Crestor; 20–40 mg). Moderate-intensity statin therapies include atorvastatin (10–20 mg), rosuvastatin (5–10 mg), simvastatin (20–40 mg), pravastatin (40–80 mg), and several others.
— With few exceptions, use of lipid-modifying drugs other than statins is discouraged.
— Ten-year ASCVD risk — which includes both coronary events and stroke — is determined using online calculators that can be accessed through the AHA and ACC websites.
For further discussion of the new risk-assessment tool, see NEJM JW Gen Med Nov 12 2013.
— Lifestyle modification is recommended for all patients, regardless of cholesterol-lowering drug therapy.
What's Changed:
This guideline is designed explicitly to replace the widely used ATP3 guideline from the National Heart, Lung, and Blood Institutes, last updated in 2004. The obvious major change is that clinicians now are directed to initiate either moderate-intensity or high-intensity statin therapy for patients who fall into the four aforementioned categories, without titration to a specific LDL cholesterol target. Measuring lipids during follow-up of drug-treated patients is done to assess adherence to treatment and not to see whether a specific LDL cholesterol target has been achieved.
Comment: This guideline represents a paradigm shift for most clinicians and patients. The rationale for abandoning LDL cholesterol targets is that randomized trials showing benefits of statins generally have examined fixed-dose statin therapy, rather than titrated therapy, to achieve pre-specified LDL cholesterol goals. Additionally, some drugs that “improve” the lipid profile (a surrogate endpoint) do not improve clinical outcomes, and statins are thought to exert benefit through pleiotropic effects apart from LDL cholesterol–lowering. The 7.5% risk threshold for primary prevention was selected based on analyses suggesting that benefit from treatment emerges at this threshold. The guideline writers do acknowledge that some patients do not tolerate statins (and might require treatment with lower doses) and that patient preferences for drug therapy should be discussed, particularly in primary prevention. However, the authors do not discuss drug costs: For some patients, the out-of-pocket cost of a high-intensity statin (including generic atorvastatin), compared with the cost for generic simvastatin or pravastatin, is a problem. An essay published last year, entitled “Three reasons to abandon low-density lipoprotein targets,” is a concise and readable analysis of the perspective embodied by this new guideline. (Circ Cardiovasc Qual Outcomes 2012; 5:2).
Citation(s): Stone NJ et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2013 Nov 12; [e-pub ahead of print]
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Most Pharmacy Groups Oppose the Rescheduling Hydrocodone Combinations
The FDA has recommended rescheduling of hydrocodone combination products from Schedule III to Schedule II. The following pharmacy organizations are opposing the rescheduling of hydrocodone combination products:

The letter sent to the FDA included statements such as:
"While we appreciate the efforts of the FDA to address the serious issue of prescription drug abuse, we believe rescheduling hydrocodone is not the solution."
"Rescheduling will have a profoundly negative impact on patients who legitimately need these medications and a negligible impact on drug abuse."
According to the November 11 letter, rescheduling hydrocodone would create serious barriers to patient access such as the inability to refill products in Schedule II; new burdens for an already overtaxed healthcare system; and new requirements for pharmacies, including the provision of additional secure storage, recordkeeping, and inventory management.
Supporting the rescheduling is:
American Society of Health-System Pharmacists (ASHP)
ASHP sent a November 5 letter to the HHS Secretary supporting hydrocodone rescheduling. According to statements made on APhA's website (November 12, 2013), an ASHP news release stated:
"ASHP called concerns regarding recordkeeping and security processes resulting from rescheduling 'valid,' but believes that they are outweighed by the public health benefit arising from increased control of drugs with high abuse potential."
APhA's website also stated that ASHP:
"also countered concerns that the inability to prescribe refills would have a broad impact on patient access."
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J Am Coll Cardiol 2013 Nov 12
Guidelines for Assessment of Cardiovascular Risk
A new global risk assessment tool makes its debut, and nontraditional risk factors take a back seat.
Sponsoring Organizations: American College of Cardiology, American Heart Association
Target Population: Primary care providers, cardiologists
Background and Objective: The ACC/AHA Task Force based these recommendations on a comprehensive report from an Expert Work Group convened by the National Heart, Lung, and Blood Institute. The Work Group was asked to (1) develop an approach to quantitative risk assessment for cardiovascular disease that could be used to guide care; and (2) address key questions in risk assessment using systematic review methods.
Key Points:

What's Changed:
This document supplants guidelines published by the ACC/AHA in 2010 (NEJM JW Cardiol Feb 9 2011). Notable changes from the previous guidelines include the endorsement of a specific model for global risk assessment and a diminution of the role of CIMT measurement.
Comment: These guidelines introduce new equations for assessing the 10-year (and also lifetime) risk for a first cardiovascular event. Calculators are available in downloadable form online and are relatively easy to use. Links to the equations are included in treatment algorithms contained in concomitantly released guidelines for management of cholesterol for primary prevention (NEJM JW Gen Med Nov 12 2013.
Citation(s): Goff DC Jr et al. 2013 ACC/AHA guidelines on the assessment of cardiovascular risk: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2013 Nov 12; [e-pub ahead of print]. (http://content.onlinejacc.org/article.aspx?articleid=1770220
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President Allows One-Year Extension for Canceled Insurance Plans
By Joe Elia
Mounting political pressure has forced the White House to change course and allow people a one-year extension on canceled healthcare plans that don't meet the requirements of the Affordable Care Act.
"Insurers can extend current plans that would otherwise be canceled into 2014," President Obama said at a news conference. Old plans would not be available to those currently without coverage, the New York Times reports.
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Implantable Device Approved for Epilepsy
By Kelly Young
The FDA has approved the RNS Stimulator to help reduce the number of seizures in patients with epilepsy who have not responded to drugs. The neurostimulator is implanted within the skull.
An FDA official explained that the device detects abnormal electrical activity and responds with stimulation that's intended to normalize activity and prevent seizures.
In a randomized study, 3 months after the device was turned on, patients experienced a 34% median reduction in seizures, compared with 19% in patients whose devices were turned off.
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