No More Needles? Oral Flu Vaccine Tablet Shows Promise in Phase 2 Trial

Flu Vaccine Oral Tablet
Participants were successfully challenged intranasally with homologous A strain influenza virus 90-120 days after vaccination to see if they had developed any immunity,

An investigational H1 influenza oral tablet vaccine was found to provide similar protection against influenza as an injectable quadrivalent influenza vaccine (QIV) in a Phase 2 clinical trial. 

The trial participants were randomized to receive either a single dose of Vaxart oral tablet vaccine and a placebo intramuscular injection, a QIV injection plus a placebo tablet, or a double placebo. They were challenged intranasally with homologous A strain influenza virus 90–120 days after vaccination. Laboratory-confirmed homologous influenza A infections were compared among the groups.

Results showed that the tablet vaccine provided a 39% reduction in clinical disease relative to placebo, compared to a 27% reduction with injectable QIV. The tablet also demonstrated a safety profile similar to placebo.

“These results provide clinical proof-of-concept for Vaxart’s groundbreaking oral tablet vaccine technology,” said Wouter Latour, MD, MBA, CEO of Vaxart, in a press release. “A convenient and effective tablet vaccine could significantly increase current vaccination rates and generate important public health benefits for at-risk groups and the population as a whole.”

For more information visit Vaxart.com.

 

Click here to read the original article.

 

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JD Power Identifies Decline in Pharmacy Customer Satisfaction Driven by Escalating Prescription Drug Costs

by Michael Johnsen

 

The U.S. pharmacy industry, perennially one of the highest-scoring industries measured by J.D. Power, experienced notable declines in overall customer satisfaction this year, the research firm reported Tuesday.

According to the J.D. Power 2017 U.S. Pharmacy Study, decreases in satisfaction with both brick-and-mortar and mail order pharmacies were driven primarily by declines in satisfaction with cost.

“Pharmacies have historically earned very high marks for customer satisfaction, so any significant year-over-year decline is cause for closer investigation,” stated Rick Johnson, director of the Healthcare Practice at J.D. Power. “Consumer concerns about rising drug prices have likely affected perceptions of the cost for their retail prescriptions. The decrease in satisfaction with cost is the primary drag on overall customer satisfaction, creating a serious challenge for retailers.”

“Pharmacies have historically earned very high marks for customer satisfaction, so any significant year-over-year decline is cause for closer investigation.”

Decreases in satisfaction with brick-and-mortar pharmacies were driven by year-over-year declines in satisfaction with cost, which fell 27 index points to 789 (on a 1,000-point scale), and the in-store experience, a 14-point drop to 851.  Decreases in satisfaction with mail order pharmacies were driven by declines in satisfaction with cost (minus 49 to 787) and the prescription ordering process (minus 15 to 877).

This year’s study measured drug adherence levels across the different pharmacy channels for the first time, and found that 79% of customers who filled prescriptions through a brick-and-mortar pharmacy reported they always were adherent to their medications. This compares with 84% among mail order customers and 74% among specialty pharmacy customers. Customers who discussed a prescription with a pharmacist in a brick-and-mortar pharmacy at the time of pick-up had the highest overall levels of adherence.

Among all channels studied, supermarkets had the highest levels of overall customer satisfaction (859), followed by mail order (853); hospital or clinic (851); chain drug stores (849); specialty pharmacy (842); and mass merchandisers (839).

AmerisourceBergen’s Good Neighbor Pharmacy ranked highest overall among brick-and-mortar chain drug stores with a score of 889.  McKesson’s Health Mart (886) ranked second and Cardinal Health’s The Medicine Shoppe Pharmacy ranked third (879).

Sam’s Club ranked highestoverall among brick-and-mortar mass merchandisers with a score of 874. Fred’s (873) ranked second and Costco (875) ranked third. While CVS Pharmacy at Target placed fifth this year, it had the largest increase in satisfaction of any pharmacy from 2016 (+20).

Brookshire Grocery ranked highest overall among brick-and-mortar supermarkets with a score of 894. H-E-B (893) ranked second and BI-LO (891) ranked third.

Walgreens Specialty Pharmacy ranked highest among specialty pharmacies with a score of 853. BriovaRx (851) ranked second and CVS Specialty/CVS Caremark (840) ranked third.

 

Link to original article posted in Drug Store News

Food & Drug Administration Warns of Gastric Balloon Deaths

by Kristina Fiore

7 reports of death tied to gastric balloon obesity treatment since 2016

The FDA sent a letter to healthcare providers warning of reports of seven deaths with liquid-filled intragastric balloon systems used to treat obesity.

In five cases, the cause of death was unclear, but all occurred within a month or less of balloon placement, the agency said. In three of those cases, the patient died within one to three days of having the balloon inserted.

Four of these reports involved the Orbera Intragastric Balloon System from Apollo Endo Surgery, and one involved the ReShape Integrated Dual Balloon System by ReShape Medical.

The FDA noted that for these five cases it doesn’t know “the root cause” of the problem. It also can’t determine the incidence rate of patient death, nor could it “definitively attribute the deaths to the devices or the insertion procedures for these devices” — meaning they couldn’t tell if death was due to gastric or esophageal perforation, or to intestinal obstruction, or to some other cause.

Two additional reports of deaths in the same time period — since 2016 — were also noted in the FDA letter. One was related to gastric perforation with the Orbera Intragastric Balloon System and one to esophageal perforation with the ReShape device.

The FDA said it’s working with both companies to better understand what’s causing these issues, and to monitor potential complications of acute pancreatitis and spontaneous overinflation. It also emphasized that it had mandated ongoing post-approval studies for the devices.

Article originally appeared in MedPage Today

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Do you Really Need These Vitamin Supplements?

By  Dr. Manny

According to 2016 consumer survey data, 71% of U.S. adults take some type of dietary supplement. And the appeal of supplements is obvious. We know vitamins are necessary for health, so why not make sure we’re covering our bases?

The darker side of dietary supplements is that many of the alleged health benefits are coming straight from people who stand to make big money from vitamin sales, and the research doesn’t always agree with the claims of vitamin manufacturers and retailers.

Here’s a look at four vitamins you may want to think twice about taking.

1. Vitamin E

According to the National Institutes of Health, the recommended daily allowance (RDA) of vitamin E for adults is 15 mg (or 22.4 IU). RDAs are based on what will meet the nutritional needs of 97-98% of healthy people, but supplements are widely available from 200 to 1000 IU per pill. When it comes to vitamin E, the research is clear that you can have too much of a good thing. A large review of the research by John Hopkins University found that people who took more than 400 IU daily faced a 4-6% increased risk of death. Another large study found that, despite health claims to the contrary, vitamin E did not decrease prostate cancer risk in study participants. In fact, men who supplemented with vitamin E were slightly more likely to develop prostate cancer than men who didn’t use the supplement.

2. Vitamin C

Pricey vitamin C supplements marketed for the prevention and treatment of the common cold and the flu have popped up in every grocery store and drug store. They come as pills, lozenges, and powdered drinks and typically contain 500-1000mg of vitamin C, at least 5-10 times the RDA of vitamin C for adults. Some people use supplements daily to prevent colds, and others use high doses at the beginning of a cold to shorten its duration. But a review of the evidence shows that vitamin C only impacts the common cold in one way – if you’re already taking daily vitamin C, your colds may be a little bit shorter. Despite the claims of manufacturers, people who supplement daily don’t get fewer colds, and starting supplementation at the beginning of a cold doesn’t affect cold symptoms. If you choose to take a daily vitamin C supplement to shorten your colds, keep in mind that mega doses can contribute to kidney stones.

3. Vitamin A

Vitamin A can be toxic in large doses, causing symptoms like nausea, vomiting, and abdominal pain. Most cases of vitamin A toxicity occur in adults using mega doses of vitamins to treat illness or in children who accidentally ingest supplements, but researchers are now wondering if smaller supplemental doses of vitamin A can cause health problems too. The RDA for vitamin A for adults is 700-900 mcg, and an article published in The American Journal for Clinical Nutrition notes that just twice this amount has been connected to osteoporosis and hip fracture in people without other symptoms of toxicity.

4. Multivitamins

Seventy-five percent of Americans who take supplements take a multivitamin, making it the most popular dietary supplement in the US. Multivitamins are all different, but most contain a long list of vitamins and minerals, sometimes in amounts well over their recommended daily intakes. Over the last few years, study after study has challenged the alleged health benefits of multivitamins, but there have also been a few that show some health benefit. In a large study of older women, multivitamin use was associated with increased mortality. An eight-year study showed no protective effect against cardiovascular disease or mental decline but a slight protective effect against cataracts and cancer. And most recently, a 2016 study has contradicted previous research by showing a slight benefit for heart health. The research surrounding multivitamin supplements isn’t clear-cut, and it’s possible that not all adults benefit from them.

It’s important to consult with your doctor before taking a new supplement and to know that adding more fruits and vegetables to your diet is the most evidence-supported intervention you can make for your own health. Fruits and veggies can lower your risk of cardiovascular disease, cancer, diabetes, and high blood pressure without any dangerous side effects. And a cart full of produce is much more affordable than a cabinet full of supplements.

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Common antibiotics help patients recover from MRSA skin abscesses

National Institute of Allergy and Infectious Diseases-funded trial counters current thinking about treatment effectiveness.

MRSA – Methicillin-resistant Staphylococcus aureus bacteria are resistant to multiple antibiotics and commonly cause skin infections that can lead to more serious or life-threatening infection in other parts of the body. In new findings published in The New England Journal of Medicine, researchers found that two common, inexpensive antimicrobials can help patients heal from MRSA skin abscesses. The findings suggest that current treatment options for MRSA still have a role, even as scientists continue to search for new antimicrobial products. The research was funded by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health.

The study was conducted at hospitals across the United States and involved 796 children and adults with small, uncomplicated skin abscesses.  All patients had their abscesses opened and drained as part of standard MRSA treatment. The patients were then sorted into three groups, each of which received a different, ten-day oral treatment regimen. One group received clindamycin, a second group received trimethoprim-sulfamethoxazole (TMP-SMX), and the third group received placebo.

The group treated with clindamycin had an 81.7 percent cure rate, and the group that received TMP-SMX had an 84.6 percent cure rate. The placebo group had a 62.9 percent cure rate. According to the researchers, the findings contradict a commonly held belief that antimicrobial treatment is little better than doing nothing for MRSA skin infections. It corroborates the findings of another NIAID-funded study(link is external) demonstrating that TMP-SMX treatment resulted in better clinical outcomes than placebo for MRSA skin abscesses, and also upholds other findings(link is external) that both clindamycin and TMP-SMX are equally beneficial in treating MRSA skin infections.

The researchers note, however, that the side effects of clindamycin and TMP-SMX (including nausea, diarrhea, and possible new Clostridium difficile infections) can be severe. In addition, some strains of Staphylococcus are resistant to clindamycin. The authors recommend that healthcare providers weigh the risks, but not dismiss these antimicrobials out of hand as viable treatment options for MRSA skin abscesses.

Additional funding for the study was provided in part by NIH’s National Center for Advancing Translational Sciences.

Click here for a link to the National Institutes of Health article