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Novartis AG Drug Certican® Approved by European Health Authorities to Prevent Organ Rejection in Adult Liver Transplant Patients
"As a leader in transplant medicine for 30 years, we have worked to develop the industry's broadest portfolio of transplant medications to meet varied needs of individual patients," said Tim Wright, Global Head of Development, Novartis Pharma. "This new indication for Certican reinforces our continued commitment to transplantation and further expands availability of this important treatment option to physicians and transplant patients throughout Europe."
The approval was based on the largest liver transplant study to date, which showed that Certican plus reduced tacrolimus led to similar efficacy and superior renal function versus tacrolimus alone at 12 months1,2. New 24-month data from this pivotal study will be presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, MA, USA, in November 20125.
"In clinical practice, our top priority is to prevent organ rejection post-transplant and to optimize renal outcomes for patients, with the goal of reducing long-term co-morbidities and mortality related to early post-transplant renal injury," said Faouzi Saliba, M.D., Associate Professor in Gastroenterology and Hepatology, Hôpital Paul Brousse, Villejuif, France. "With the approval of Certican, the first mTOR inhibitor for liver transplant patients which has shown benefit on renal function, the physician community now has a new treatment option to help meet the evolving needs of transplant patients in Europe."
A large registry study of nearly 70,000 patients who received a non-renal solid organ transplant between 1990 and 2000 showed that the incidence of chronic renal failure was greater in liver transplant recipients than in recipients of all other solid organ transplants, except intestinal transplants6. Calcineurin inhibitors (CNIs), such as tacrolimus, are part of the standard-of-care treatment regimen for immunosuppression in liver transplantation, but they can contribute to complications, including impaired renal function3,4. Certican works by binding to a protein called mTOR, and acts synergistically with CNIs, offering an opportunity to potentially lower CNI exposure7.
The US Food and Drug Administration has accepted a filing for RAD001 (everolimus) for the prophylaxis of organ rejection in adult patients receiving a liver transplant. A regulatory decision is expected by the end of 2012.
Pivotal Study Details: Certican Plus Reduced-Dose Tacrolimus
The approval was based on 12-month results from a Phase III, multicenter, open-label, randomized, controlled study conducted in 719 de novo liver transplant patients. Following liver transplantation and a 30-day run-in period with tacrolimus and corticosteroids (with or without mycophenolate mofetil), patients were randomized to one of three groups: everolimus (C0 3-8ng/mL) plus reduced-exposure tacrolimus (C0 3-5ng/mL) (n=245), everolimus (C0 6-10ng/mL) plus tacrolimus withdrawal at four months (n=231) or standard-exposure tacrolimus (C0 6-10ng/mL) only (control, n=243); all arms included corticosteroids for at least six months post-transplant. Enrollment into the everolimus plus tacrolimus withdrawal arm was prematurely halted due to a higher incidence of treated biopsy acute rejection (tBPAR) episodes and adverse events leading to treatment discontinuation (45 events), clustered around the time of tacrolimus elimination (at four months post randomization)1,2. The study protocol was amended at that time.
The main endpoints at 12 months included the composite efficacy failure rate (tBPAR, graft loss, or death) and its components, and renal function (assessed using glomerular filtration rate [eGFR] estimated by the four-variable Modification of Diet in Renal Disease [MDRD4] formula). Key safety endpoints also included the incidence of adverse events (AEs)1,2.
The composite efficacy failure rate in the everolimus plus reduced-exposure tacrolimus group was lower compared to the control group at month 12 (6.7% vs. 9.7%, respectively). The results showed non-inferiority (against the non-inferiority margin of 12%) with -3.0% [97.5 CI (-8.7%, 2.6%)] in favor of the everolimus plus reduced-exposure tacrolimus group. Everolimus plus reduced-exposure tacrolimus also demonstrated fewer and less severe episodes of tBPAR between randomization (Day 30±5) and month 12. Episodes of tBPAR in the everolimus plus reduced-exposure tacrolimus group were mild (graded =RAI 4-5) compared to nine episodes in the standard-exposure tacrolimus control group that were moderate (graded RAI 6-7) or severe (graded RAI 8-9). None of the graft losses in the everolimus plus reduced-exposure tacrolimus group (n=6) or the control group (n=3) were related to rejection. The incidence of death was comparable between treatment groups at 12 months and 24 months1,2.
At month 12, the incidence rates for AEs for everolimus plus reduced tacrolimus (94.7%) versus the tacrolimus control group (95.0%) were comparable1,2.
The original study protocol included two co-primary endpoints, which were composite efficacy failure and renal function measured by eGFR at 12 months after liver transplantation. Both co-primary endpoints were met. In the original study protocol, composite efficacy failure was defined as graft loss, death or lost-to-follow-up8.
About Certican (everolimus)
Everolimus is the most extensively studied immunosuppressant in solid organ transplantation with more than 10,000 transplant recipients enrolled in Novartis-sponsored clinical trials worldwide9. Under the trade name Certican®, it is approved in more than 90 countries to prevent organ rejection for renal and heart transplant patients, and is approved in the EU, Chile and Philippines to prevent organ rejection for liver transplant patients. In the US, under the trade name Zortress®, the drug is approved for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant.
Everolimus is also available from Novartis in different dosage strengths and for different uses in non-transplant patient populations under the brand names Afinitor® and Votubia®. It is also exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents.
Not all indications are available in every country. As an investigational compound, the safety and efficacy profile of everolimus has not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that everolimus will become commercially available for additional indications anywhere else in the world.
The foregoing release contains forward-looking statements that can be identified by terminology such as "commitment," "will," "expected," or similar expressions, or by express or implied discussions regarding potential future revenues from Certican. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Certican to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Certican will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Certican could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2011, the Group's continuing operations achieved net sales of USD 58.6 billion, while approximately USD 9.6 billion (USD 9.2 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Novartis Group companies employ approximately 127,000 full-time-equivalent associates and operate in more than 140 countries around the world.
For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.
1. Certican (everolimus) Prescribing Information.
2. Fung, J., Nevens, F., De Carlis, L., et al. Everolimus with Early Reduction or Elimination of Tacrolimus in 719 De Novo Liver Transplant Recipients: 12 Month Efficacy and Safety Results from H2304 Study. Presented at the American Transplant Congress; June 2-6, 2012; Boston, MA, USA. Poster 705.
3. McGuire B.M., Rosenthal P., Brown C.C., et al. Long-term Management of the Liver Transplant Patient: Recommendations for the Primary Care Doctor. Am J Transplant, 2009;9:1988–2003.
4. Venkataramanan, R., Shaw, L.M., Sarkozi, L., et al. Clinical Utility of Monitoring Tacrolimus Blood Concentrations in Liver Transplant Patients. J Clin Pharmacol, 2001;41:542-551.
5. Saliba, F., De Simone, P., Nevens, F., et al. Everolimus-Facilitated Reduction of Tacrolimus Provides Comparable Efficacy and Superior Renal Function Versus Standard Tacrolimus in De Novo Liver Transplant Recipients: 24-Month Results of a Randomized Trial. To be presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases; November 9-13, 2012; Boston, MA, USA. Presentation LB-5.
6. Ojo, A., Held, P., Port, F., et al. Chronic Renal Failure after Transplantation of a Nonrenal Organ. New Eng J Med, 2003;349:931-940.
7. Schuurman, HJ., Cottens, S., Fuchs, S., et al. SDZ RAD, A New Rapamycin Derivative: Synergism with Cyclosporine. Trans, 1997;64,1;32-35.
8. Saliba, F., De Simone, P., Nevens, F., et al. Efficacy and Safety of Everolimus with Early Reduction or Elimination of Tacrolimus in 719 De Novo Liver Transplant Recipients: 12 Month Results of a Phase III, Randomized, Controlled Study. Presented at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases; November 4-8, 2011; San Francisco, CA, USA. Poster LB-7.
9. Novartis Data on File: DSUR. July 2012.
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YOUNGSTOWN, Ohio (AP) - A 4-month-old in a playpen on her Ohio porch was critically injured when a neighbor's fireworks landed on her.
A witness told police a 10-year-old neighbor of the Youngstown baby kicked over a lit tubular firework, which shot into the playpen, burning the child.
The baby was flown to the burn unit at Akron Children's Hospital following the late Friday night accident.
The child's grandmother, Carol McCormick, injured her fingers rescuing the baby. She tells WFMJ-TV in Youngstown the child's entire face is burned.
A spokeswoman at Akron Children's Hospital could not immediately confirm the child's condition Monday.
Police are investigating.

subset: commoncrawl


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Itineraries can be tailor-made according to your preferences.
Each programme and tour is chosen with great care and experience, and we visit each venue personally to ensure a high standard in courses and accommodation.
There will be always amazing food, whether you are cooking with a Michelin-starred chef or preparing a feast with a local mamma in a farmhouse. For us, it's all about the experience. And it's not all luxury all the time. Rather, it's a mix that allows you to sample both a region's most refined cuisine and its most rustic traditions.
"One of the best courses I've done, cleverly structured so that your confidence really increases as the week progresses. It's great fun too." Jenny M, UK
"It completely surpassed my expectations. Best deal out there and absolutely excel-
lent course." Caryn P, California
"You gave us the very best Christmas present we could have had. It was was wonderful. Your enthusiasm, ambition and talents are amazing" Ros T, UK
"The entire experience was excellent, from the wine to the food, sunrise to sunset."
S. Dunsford, US
"It was definitely one of the most enjoyable, memorable vacations I have ever had. The location and the cooking course were even more incredible than I had dreamed they would be. Thanks so much!" Colleen K., California, US
|Map Legend
|Cooking courses. Wine tours. Culinary adventures.
|cooking courses
|wine tours
|cookery courses
|wine tasting


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FitzGerald Media needed a new logo design and created a contest on 99designs.
A winner was selected from 149 designs submitted by 55 freelance designers.
Looking for a top quality, inviting, and professional logo for TDM Consulting Group, which specializes in non-profits.
TDM Consulting Group
Our client is a small business start-up, TDM Consulting, which is a consulting group specializing in the non-profit sector. What we need for them is something clean that has an inviting feel and is not too corporate, but still reflects professionalism.
What we are looking for is a logo which symbolizes these aspects of the organization: teamwork, connection,
community, people.
TDM Consulting Group is all about connecting with
non-profits and helping them reach out to their communities to raise
involvement and awareness about their organizations, bringing them the
attention they deserve.
Like any logo, it will need to be represented on various medium including business cards, print pieces, and on the Web.
- "earth tones" notably an "earthy red" could be a choice for a primary color.
- style should be creative, clean, and inviting
- must be delivered in vector .ai or .eps
- busy designs
- cursive typeface
Find out how a design contest works or learn more about our logo design services.


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NEW YORK (Reuters Health) - Wastewater from cities and hospitals releases some antibiotic-resistant bacteria into the environment, according to a new French study.
And although wastewater treatment plants cut the number of bacteria overall, the treatment process boosts the proportion of bacteria resistant to some antibiotics, the research found.
The study focused on E. coli, a type of bacteria that commonly inhabits the intestines of many healthy animals, including humans, although certain strains can cause food poisoning.
Drug resistance among many types of bacteria, including E. coli, is a growing problem. Previously unaffected bacteria can pick up resistance genes from other bacteria that carry them, and resistance can also spread through food crops irrigated with affected water.
"These multi-drug resistant bacteria are now the most frequently isolated ones in French hospitals, and in many countries," said Xavier Bertrand, an author of the study and a microbiologist at Universite de Franche-Comte in Besancon, France.
Because E. coli commonly lives in the human digestive tract, the organism finds its way into wastewater, for example, when waste is flushed down the toilet.
"The extent to which the discharge of (antibiotic-resistant E. coli) into the environment contributes to its global spread remains uncertain," Bertrand wrote in an email to Reuters Health.
For the study, published in Clinical Infectious Diseases, Bertrand and his team collected and analyzed samples from 11 sites in the Besancon wastewater network. Two of the sites contained wastewater from university hospitals. Some of the other wastewater came from the city, while a fraction was from rainwater. No water in the study had been used in livestock farming. The samples were collected each week for 10 weeks.
The researchers found that all samples contained E. coli, and 96 percent contained antibiotic-resistant strains. The average number of individual E. coli bacteria found in the city wastewater was more than twice that in the hospital wastewater.
After wastewater had been treated to make it suitable for release back into the environment, the number of antibiotic-resistant E. coli dropped by 94 percent. But the proportion of resistant bacteria doubled during treatment: initially, 0.3 percent of E. coli carried a gene for resistance, whereas 0.6 percent did after treatment.
Although some towns, such as Wichita Falls, Texas, have turned to recycling wastewater due to an ongoing drought, experts said the new results likely don't mean much for people drinking water from American faucets.
That's because water in the U.S. undergoes myriad processes with the aim of eliminating bacteria and other contaminants. Furthermore, the U.S. has stringent limits for bacteria in treated wastewater, said John Scott Meschke, a microbiologist at the University of Washington in Seattle.
"We have a very good multi-barrier approach (to water purification and disinfection) in the U.S.," Meschke told Reuters Health.
Each wastewater treatment plant must meet specific standards, including for the number of bacteria and the amount of oxygen the water contains. Water cannot contain any E. coli in order to qualify as drinkable.
Still, the importance of wastewater as a source of antibiotic resistance remains to be seen.
"The immediate concern is the risk of bacteria carrying these genes within recreational water, such as lakes and rivers," not drinking water, Meschke said.
Infections in humans caused by resistant bacteria are more difficult and complicated to treat than infections caused by non-resistant bacteria.
The U.S. drinking water supply, Meschke said, is disinfected, so bacteria in tap water "is not something to worry about."
SOURCE: bit.ly/1ksBD98 Clinical Infectious Diseases, online May 1, 2014.


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2002 :: Scottish Champs, Fort William ...
Some weekend - some course! 16 hours driving but it was worth it. Fort William rules. Pictures from Saturday morning in Glencoe to Sunday evening battlescars. | Pics ©[stunts.org.uk] | Race report on-line here.
You are viewing the thumbnail index - click a pic to enlarge.
All images in this gallery are © [ gravity-slaves ] and may not be reproduced without permission.


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Cause under investigation
An early morning fire resulted in several area residents being displaced.
Don Crawford, assistant chief at the Kinston Department of Public Safety, said the fire began at 2:31 a.m. Thursday morning at 1307 Morningside Drive in a building of Highland Avenue Apartments.
�Upon arrival, crews found an apartment on the second floor with a kitchen fire,� he said. �There was heavy damage, but it was contained to the kitchen. Also, because of fighting the fire, there was water damage to the first floor apartment.�
Crawford said the residents of the second floor apartment stayed with some friends, while those on the first floor were provided lodging at West Park Inn overnight by the American Red Cross.
He said the cause of the fire is still under investigation.
Noah Clark can be reached at 252-559-1073 or email@example.com. Follow him on Twitter @nclark763.


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Alex Ferguson always seems to be angry at someone, and this week his ire was aimed at most of the media for the apparent reason that they published what he said.
Of course broadcasting something negative that Fergie has said has its consequences – he promptly spoke to no-one all week. Ridiculous over-reactions aside, it's only natural that he is this week's photoshop theme.
Considering there's been someone else in the news all week for the exact opposite of Ferguson's actions (i.e. spouting off every day) it seemed right to combine the two…
Plenty more here.


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AIMP3 comes with some nice features, for example an integrated graphic equalizer, the ability to adjust speed, tempo and pitch to name but a few.
I found the online radio feature a nice addition to the software when I tried the ShoutCast link was outdated, however the Icecast had plenty of choice.
As a free player this is on par with some of the best you can get.
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It's getting to that time of year again we we have to pause and reflect on our accomplishments (or lack thereof) during the year. Again.
A time to compare where we are, to where we should be, to where would like to be…
And as is usual for most of humanity, we will all most likely decide: Screw that, we'll try again next year.
Merry Christmas to all of you, and a very Happy New Year.


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Two-thirds of the world's land is turning to desert, thanks largely to the steak on your plate. That's the conventional wisdom, anyway.
For decades people have pointed to overgrazing by cattle as the main cause of desertification. When animals overgraze, they strip the land of native grasses, leading to erosion of the topsoil from wind and storms. These parched landscapes become incapable of supporting the livestock or wild animals that once lived there — a situation that has led to famine and conflict in developing nations around the globe.
But what if livestock could be used in a way that actually revitalizes landscapes and mitigates the impacts of climate change? It's a counterintuitive and controversial idea that has the environmental community buzzing.
The idea's unlikely champion is Allan Savory, a 77-year-old biologist, farmer, and former politician. In the 1950s, he was responsible for the slaughter of tens of thousands of wild African elephants. Like many ecologists of the time, Savory believed elephants were destroying the African savanna, and by thinning the herds the grasslands would rebound. So Savory persuaded the government of Rhodesia (today Zimbabwe) to cull more than 40,000 elephants, but the grasslands continued to wither.
Through this tragic experiment Savory unlocked what he believes is the key to saving grasslands and reversing desertification. Savory's method, known as holistic planned grazing, calls for managing livestock in ways that mimic the prehistoric herds that once roamed the earth, fortifying grasslands with the pounding of their hooves and nutrient-rich manure. The cattle's natural movement patterns and activities, Savory claims, spur the regrowth of carbon-sequestering grasslands. And if done on a large enough scale, these grasses could not only absorb enough carbon to offset the methane produced by livestock but also help combat climate change.
"There is no alternative to address the massive environmental malfunctioning over so much of the world that is desertifying," Savory said. "Only livestock properly managed can do what is required."
Savory, winner of the 2003 Banksia International Award and the 2010 Buckminster Fuller Challenge, runs the Savory Institute, a nonprofit dedicated to spreading the practice. But it wasn't until Savory's TED talk in February 2013 that this method attracted mainstream attention.
Planned grazing has its share of critics, with some claiming the practice doesn't scale well and others questioning the research supporting it. Savory has faced this criticism for decades but remains unfazed.
"To rectify the damaging ways of agriculture we have all the knowledge we need," he said. "And as more and more people adopt planned grazing practices, the tide is finally beginning to turn."


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|Paradise beachfront of peace & serenity in
With distinctive architecture and lush tropical gardens, Dhevan Dara Beach Villa - Kuiburi is a resort hotel in Polynesian style.
Guests at our hotel can enjoy a wide range of 5 star facilities in our studios , deluxe suites and villas, Relax on the Beach or The Bubble Pool Lounge.
Our hotel also has the spa "DARA LUXE"– a traditional Polynesian style spa offering rejuvenating massages and treatments.
From the South of Bangkok, it takes around 3 hours drive to reach Dhevan Dara Beach Villa – Kuiburi. The hotel site features 83 accommodation units of studios, Deluxe, Suites & Pool Villas – all with Polynesian design with air conditioning, cable TV, free toiletries and shower facilities, laundry service, free internet access – wifi available for guests throughout the residence.
Enjoy tasteful meal and chill at the beachfront restaurant , pool lounge which serve both Thai and International cuisine.
Revitalize your spirit in a large outdoor swimming pool, parallel to the beach .Relax at "DARA LUXE Spa & Health Club" in which offerings are based on the rituals of Harmony, Purity, Energy, and Bliss derived from traditional Polynesian healing philosophies. Dhevan Dara Beach Villa – Kuiburi offers free daily shuttle service as per resort's schedule to go to Hua Hin town and shopping area which takes only around 45 minutes from the resort. The hotel also offers many tour programs , water sports and other activities on your choices that will be provided with our warmest service.
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2 Bedrooms Pool VillaArea: 150 Sq.m. | Details: 2 Bedrooms (1 King Size & 1 Twin Bed) + 1 Living Room + Private Pool
3 Bedrooms Pool VillaArea: 150 Sq.m. | Details: 3 Bedrooms (1 Double Bed & 2 Twin Beds) + 1 Living Room + Private Pool
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Illusive Man as Cohaagen, Miranda as Lori, Liara as Melina. And Shepard as Quaid. This is the audio from Total Recall's 2012 trailer and visuals from the Mass Effect trilogy, by an outfit called Node Studios. They've done three other mashups of recognisable trailers since June; this is probably the best of the four.
Now, when the Mass Effect movie arrives, I'm gonna expect to see its trailer recut with video from Total Recall.


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When I made a batch of these cookies, half of them went to my office. People were curious - they aren't traditional chocolate chip or oatmeal cookies, and after one bite the most common response was "mmm." My supervisor felt better about eating them because they seemed healthy - you know, the pine nuts and almonds. Sure. But the first ingredient is butter, so don't let these cookies fool you. Enjoy!
Apricot and Nut Cookies with Amaretto Icing
Recipe courtesy Giada de Laurentiis
1/2 cup (1 stick) unsalted butter, at room temperature
1/2 cup plus 2 tablespoons sugar
1 teaspoon pure vanilla extract
1/4 teaspoon ground cinnamon
1/4 teaspoon fine sea salt
1 large egg
1 1/4 cups all-purpose flour
1/2 cup dried apricots, coarsely chopped
1/4 cup slivered almonds, toasted
2 tablespoons pine nuts, toasted
Icing: 1 3/4 cups confectioners' sugar 5 to 7 tablespoons almond flavored liqueur (recommended: Amaretto)
For the Cookies: In a large bowl, beat the butter, sugar, vanilla, cinnamon, and salt with an electric mixer until light and fluffy, about 2 minutes. Beat in the egg. Stir in the flour until just blended. Mix in the apricots, almonds, and pine nuts.
Transfer the dough to a sheet of plastic wrap and shape into a log, about 12-inches long and 1 1/2-inches in diameter. Wrap the dough in the plastic and refrigerate for 2 hours.
Preheat the oven to 350 degrees F. Line 2 heavy baking sheets with parchment paper.
Cut the dough log crosswise into 1/4 to 1/2 inch-thick slices. Transfer the cookies to the prepared baking sheets, spacing evenly apart. Bake until the cookies are golden around the edges, about 15 minutes. Transfer the cookies to a wire rack to cool completely before icing.
For the Icing: Place the confectioners' sugar in a medium mixing bowl. Gradually whisk in the almond flavored liqueur, until the mixture is of drizzling consistency.
Place the wire rack over a baking sheet. Using a spoon or fork, drizzle the cookies with the icing, allowing any excess icing to drip onto the baking sheet. Allow the icing to set before serving, about 30 minutes.


text: Floral Tulip Pendant Floral Tulip Pendant Floral Tulip Pendant Paua Shell Pendant £6.00 Quantity: at £6.00 each Add To Basket 2 in stock. Red Tulip Pendant Inlaid Paua shell Pendant 20mm. Chain - 18" trace chain. Natural Paua Shell Pendant. This jewellery is supplied in its own attactive gift box, with white velvet effect interior. Sustainably Sourced - We respect the environment and all our Jewellery only uses shell sourced in a sustainable way. All the shell used arises either from farmed sources or from harvesting natural resources for their food value Hypoallergenic - Our jewellery is finished in a high quality plate, meaning its not only hardwearing but also nickel, cadmium and lead compliant Paua Shell is a natural product, each piece of paua shell jewellery is unique. The colouring and swirls create unique patterns on each piece, no two are the same, photos are for illustration purposes only.


text:
[Funeral Program for Bishop Ernest Thomas Dixon, Jr., July 3, 1996]
Description: Funeral program for Bishop Ernest Thomas Dixon, Jr., born October 13, 1922 and died June 29, 1996. The ceremony was held July 3, 1996 at University United Methodist Church, officiated by Reverend Minerva G. Carcano, Dr. Freddie B. Dixon, Sr., Ms. Muriel Dixon, Bishop Alfred Norris, Ms. Virginia Orr, Bishop Raymond Owen, Reverend Mario Ruggia, Reverend Harold G. Sassman, Bishop F. Herbert Skeete, Reverend Jerry J. Smith, Dr. Stephen P. Wende, and Dr. Prenza L. Woods. Funeral arrangements were made through Sutton-Sutton Mortuary, Inc. and he was buried in Sales Cemetery in Edna, Texas.
Date: July 3, 1996
Partner: San Antonio Public Library


text:
Natural Capital in a Green Economy – From Regional Insights to a Global Partnership
Event Date:June 19, 2012 - 5:00pm
Location:JW Marriott Hotel | Rio de Janeiro.
On June 19, Worldwatch President Robert Engelman will participate on the panel: "Natural Capital in a Green Economy – From Regional Insights to a Global Partnership." Hosted by the Nordic Council of Ministers in cooperation with UNEP, the event will bring together a variety of international experts and policy-makers to explore what a "green" economy really means. Panelists will draw on concrete examples to discuss and debate the role of natural capital in a green economy.
Join us from 5:00 to 7:00 pm at:
The JW Marriott Hotel
Avenida Atlântica, 2600
Copacabana, Rio de Janeiro, Brazil
For further details, click here.


text:
Free Gallery Talks in English and Japanese
Gallery talks take place at 2 pm, Wednesday through Sunday, and are free with Museum admission. Talks are open to all individual visitors. As part of its First Friday and Second Sundays programs, the Museum also offers the 2 pm gallery talk in Japanese.
Group Visits
The Museum offers guided interactive tours for groups of all ages and abilities. Tours are conducted by Museum educators and explore select works in the Museum's collection and special exhibitions while introducing the life and vision of Isamu Noguchi. In keeping with Noguchi's interest in the visitor's personal experience of the Museum, groups will be encouraged to share their observations and interpretations throughout the course of the tour. Tours last approximately one hour and are available in English, Japanese and Spanish. A minimum of 10 people is required to comprise a group. For further information on Japanese Language Tours or visits for groups with special needs, see below. To schedule a visit, email [email protected] or call 718.204.7088, extension 203.
Japanese Language Tours
Japanese language tours are conducted by Museum Educators and offer visitors of all ages an intimate look at the Museum's permanent collection and temporary exhibitions. Tours are available Wednesday through Sunday, year-round and reservations are required. For further information, please email [email protected] or call 718.204.7088, extension 203.
Tours for Visitors with Special Needs
The Noguchi Museum is committed to enabling all visitors to experience the art and environment created by Isamu Noguchi. Guided tours and art workshops which are carefully designed to meet the needs of particular groups are available for groups of all ages. Planned in conjunction with the visiting group's coordinator, these programs provide appropriate and accessible entry points into Noguchi's art work using visual, verbal and tactile demonstrations and encourage participants to engage in meaningful dialogues within the Museum space.
Service animals are welcome in the Museum. The following services and programs are offered to provide as inclusive an environment as possible; to learn more about programs for visitors with special needs, or to book a tour, email [email protected] or call 718-204-7088, extension 203.
Blind or Partially Sighted Visitors
The Noguchi Museum is pleased to be able to offer guided Touch Tours of select works from the permanent collection for individuals and groups by appointment. These tours include explorations of original works of art, verbal description and tactile diagrams. We need at least three weeks advance notice to schedule a Touch Tour.
Hard of Hearing and Deaf
FM headsets for sound amplification are available for all group tours upon request. Sign language interpretation for all programs is available with 4 weeks advance notice. These services are free.
Tours for Visitors with Developmental Disabilities
The Noguchi Museum offers a 60 minute gallery tour or 90 minute gallery tour and a hands-on workshop for visitors with developmental disabilities. This is available for groups of any age.


text:
Showing Suppliers 1 - 20 of 24
D. F. Burnham & Co.
Address: 40750 Enterprise Drive, Sterling Heights, MI
Business Type: Distributor
Flow Control Systems
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Freer Tool & Supply
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Business Type: Distributor, Service
Grainger Industrial Supply
Business Type: Distributor
Description: Grainger helps customers save time and money by providing them the right products to keep their facilities up and running. Grainger's customers are 2.0 million businesses and institutions in 157 countries. While each customer has a unique facility to operate and a different problem to solve, our... (more)
Address: 1587 E. Whitcomb Ave. Branch 232, Madison Heights, MI
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H.O. Trerice Co.
Address: 12950 W. Eight Mile Road, Oak Park, MI
Business Type: Manufacturer


text:
Coconut Oil Chocolate Chip Cookies
Have you heard all the hype about Coconut Oil?
I finally decided to try it out, and bought the two-pack on Amazon. I have read that along with some health benefits, coconut oil can be used as a moisturizer or even in your hair. I love the smell of coconut, and this particular brand seems to get very good reviews (Nutiva's Cold-Pressed, Organic Extra-Virgin Coconut Oil). No, they're not paying me.
While I generally try to fry foods as little as possible, this oil is a fun alternative to my good old standby, olive oil. It does lend a slight coconut-y flavor to foods, but was very good in a chicken-broccoli-pineapple stir fry!
I started looking for other ways to use my new ingredient and found this delightfully yummy cookie recipe!
It made about 12 large chunky, chewy (dare I say decadent) cookies.
1/2 cup coconut oil
2 eggs
1 1/2 cups brown sugar
1/2 teaspoon salt
1 teaspoon baking powder
1/4 teaspon baking soda
1 tablespoon vanilla
1 3/4 cup flour
1 cup semisweet chocolate chips
1 cup white chocolate chips
- Preheat oven to 400 degrees.
- In an electric mixer, beat together coconut oil, eggs, and brown sugar until well mixed.
- Add remaining ingredients, mixing together just until all are incorporated.
- Use a 1/3 cup-measuring cup to form cookies on a cookie sheet.
- Bake for 9-11 minutes, or just until the outside of the cookies have browned.
- Remove to a wire rack to cool.


text:
Science fiction is full of amazing musical acts. If you could rock out with your cosmos out, which musical group from science fiction or fantasy would you want to jam with? We asked over at io9's Facebook group, and now we're putting together a poll.
Vote below for your favorite musical group from science fiction that you'd like to thrash with.
Oh, and for those of you who forgot Andromeda, the amazing band from that Buck Rogers episode, here they are:


text:
Famous San Francisco street to see summer closing
By TERRY COLLINS and MARCIO JOSE SANCHEZ
SAN FRANCISCO (AP) - San Francisco transit leaders will temporarily close a stretch of Lombard Street, a popular tourist spot that's known as the "Crookedest Street in The World."
On Tuesday, the city's Municipal Transportation Agency unanimously approved a pilot closure to vehicles on the oft-photographed, well-traveled curvy and winding thoroughfare for four consecutive weekends starting in late June and including the Fourth of July weekend during the busy summer tourist season. The vehicle closure does not apply to residents who live in the area.
About an average of 2,000 vehicles travel on the street each weekend day during that period, the city said.
The world famous scenic, hilly street in San Francisco's Russian Hill neighborhood been featured on TV, in movies- and even video games - is known for its one-block stretch of winding brick road that consists of eight sharp, hairpin turns. Attracting hundreds of thousands annually, tourists prefer to take snapshot panoramic views of the city at the top and then drive down the crooked street with flower gardens at every corner like it's an amusement park ride. It is perhaps the most popular tourist destination in San Francisco besides the iconic Golden Gate Bridge, the Cable Cars and Fisherman's Wharf.
The temporary closing idea came at the request of Supervisor Mark Farrell and a steady stream of complaints by some residents wanting to curb the street's chronic gridlock mostly due to curious tourists, especially during the summer.
"This will be a test to improve the safety for residents, pedestrians and motorists in the area," MTA spokesman Paul Rose said. "There are often a lot of people who come to either take pictures or drive down the street and it can cause lengthy delays."
Tourist Dylan Giordano, 21, of Los Angeles, agreed, as he took in the scenery Tuesday with his family visiting from Florida. "It's an insane amount of traffic and it must be difficult and obnoxious for the wealthy residents who live here and can't even get into their own driveway," said Giordano, who just graduated from the University of Southern California with his degree in Environmental and Urban Planning.
The city will evaluate what impact the temporary closure will have and may seek to shut down Lombard Street more often, Rose said. No permanent shutdown is being considered - yet.


text:
Laurie J. Goodyear, Ph.D.
Research Summary
The Effects of Exercise
It is well established that the performance of regular physical exercise results in numerous health benefits, including a reduced risk of developing type 2 diabetes. Physical exercise is also widely accepted as a clinically important modality to decrease blood glucose concentrations in patients with diabetes. Even a single session of exercise can lower blood glucose concentrations by stimulating glucose uptake into the muscles and making the muscles more sensitive to the effects of insulin. Regular physical exercise also has many additional health benefits important to people with diabetes including lowering blood pressure, improving lipid levels and lowering the risk of heart disease. Despite the profound clinical importance of the metabolic effects of exercise, until recently, there has been little focus on the underlying molecular mechanisms that mediate these responses.
Research in the Goodyear laboratory is focused on understanding the molecular mechanism by which physical exercise exerts beneficial effects on health. The rationale for this work stems from the well-established findings that the performance of regular physical exercise results in numerous health benefits, including a reduced risk of developing type 2 diabetes. Physical exercise is also widely accepted as a clinically important modality to decrease blood glucose concentrations in patients with diabetes, due largely to an increase in the rate of glucose transport into the contracting skeletal muscles and an increase in insulin sensitivity in the period following exercise. Despite the profound clinical importance of the metabolic effects of exercise, until recently, there has been little focus on the underlying molecular mechanisms that mediate these responses.
Specific goals of the work in the Goodyear laboratory include elucidating the mechanisms through which a single bout of physical exercise increases glucose transport in skeletal muscle and determining the mechanisms through which chronic exercise training improves overall metabolic homeostasis. Our work has shown that muscle contractile activity increases glucose transport in muscle through intracellular signal transduction mechanisms that are distinct from that of insulin. The putative signals have long been elusive, but in recent years we have identified the AMP-activated protein kinase (AMPK) as a mediator of insulin-independent glucose transport in skeletal muscle. These studies have contributed to worldwide interest in AMPK as a master regulator of metabolic and transcriptional functions in tissues and cells throughout the body. Furthermore, this work has led to intensive work in the pharmaceutical industry focused on the development of an AMPK activator as a novel drug target for the treatment of diabetes.
Although AMPK is a master regulator of skeletal muscle metabolism, our group has determined that AMPK is not necessary for many of the effects of exercise on skeletal muscle metabolism, including contraction-stimulated glucose transport. We have discovered that there are additional signaling systems that mediate the beneficial effects of exercise in skeletal muscle, and we are intensively studying these molecules. For example, we have determined that sucrose nonfermenting AMPK-related kinase (SNARK) mediates contraction-stimulated glucose transport in mouse skeletal muscle, and are currently investigating several other AMPK-related kinases. In other studies of glucose transport regulation we have developed a novel imaging system to elucidate the kinetics of contraction-induced GLUT4 translocation in skeletal muscle, and discovered that Myo1c, a protein implicated in GLUT4 translocation in adipocytes, is a novel mediator of insulin- and contraction-stimulated glucose uptake in skeletal muscle. In addition, we have published very novel data on the role of TC1D1, TC1D4, and CaMKII in the regulation of skeletal muscle metabolism.
Our laboratory has been at the forefront of research in skeletal muscle metabolism through the use of a combination of molecular and physiological approaches including contraction of rodent skeletal muscles in vitro and in situ, wheel cage training of animals, knockout and transgenic mice, overexpressing foreign proteins into adult rodent skeletal muscle using electroporation, whole body metabolic assessments, and methods to identify phosphorylation sites of endogenous skeletal muscle proteins using mass spectrometry.
In addition to studies focused on skeletal muscle, more recently, our laboratory has investigated adipose tissue function using a transplantation model. For one project, we have studied brown adipose tissue's function in energy expenditure and the effect of its transplantation on metabolism. In other work, we are investigating mechanisms through which chronic exercise training improves glucose homeostasis, focusing on the novel hypothesis that adaptations to adipose tissue improves glucose tolerance and insulin sensitivity. This ongoing work has identified numerous novel secreted proteins in adipose tissue which we are studying for putative effects on metabolism. All of these investigations should help define the molecular basis for the important adaptations that occur with exercise, and will have important ramifications for patients with metabolic and cardiovascular diseases.
General Projects
- Regulation of glucose transport in skeletal muscle
- Molecular signaling mechanisms regulating contraction-stimulated glucose metabolism in skeletal muscle
- The role of AMPK and AMPK-related kinases in skeletal muscle, heart and adipose tissue metabolism
- Mechanisms regulating the beneficial effects of exercise to improve whole body glucose homeostasis in people with diabetes
Laurie J. Goodyear is a Senior Investigator and Head of the Section on Integrative Physiology and Metabolism at the Joslin Diabetes Center and an Associate Professor in Medicine at Harvard Medical School. She is a graduate of Springfield College and the University of South Carolina, and obtained her Ph.D. degree in Cell Biology from the University of Vermont. She completed her postdoctoral research at Joslin in the lab of Dr. Robert J. Smith of the Metabolism Section. Dr. Goodyear has been the recipient of several awards including Career Development Awards from the American Diabetes Association and Juvenile Diabetes Foundation, a New Investigator Award from the American College of Sports Medicine, and the 2012 Edward F. Adolph Distinguished Lectureship of the American Physiological Society. She has served as Deputy Chair for the Biochemical Journal and an Associate Editor for Diabetes, and has served on several grant review committees for the National Institutes of Health. She has had the honor of giving over 75 invited lectures at national and international conferences.
Page last updated: September 19, 2019


text:
With the extreme heat that many of us have experienced over these last few days, many are grateful for the air conditioners in our home. Without it, the heat of summer would simply be too unbearable.
Many of us resort to our air conditioner unit for relief from this heat, until the unthinkable happens—it breaks! As unfortunate and scary as that is, many failures can be prevented with maintenance. Maintaining your air conditioner should never be neglected. Below are 3 tips to make sure your AC continues running smoothly.
1.) � Change the filter. This is perhaps the most simple and important step. A clogged air filter can drastically reduce the efficiency of your air conditioner. When dust, dirt, and debris clog your filter, air cannot flow through properly causing system inefficiency and/or failure. Generally, you want to change the filter every 3 to 6 months depending on air quality. Changing the filter will cause your HVAC unit to run more efficiently and last longer. See here for a complete list of filters that we offer.
2.) � Regular Maintenance. Checkups for your HVAC system will keep it running smoothly and efficiently. You can do it yourself, or you can call in a professional. Maintenance of your system should include checking the controls of the system, lubricating all moving parts, tightening all electrical connections and checking thermostat settings. You should also seal and insulate ducts as well. This is done to increase comfort levels in your home and improve your system's efficiency by 20% or more. The more efficient your system is, the longer it will last.
3.) � Install a programmable thermostat. This is an important step so your A/C doesn't have to run all day while you're away. Consider using the Honeywell FocusPro, which is easy to use, has precise comfort control and comes with a 5 year warranty. Programmable thermostats can save you almost $200 off heating and cooling costs every year.
Maintaining your air conditioner is important to say the least. A properly maintained air conditioner will allow you to beat the heat and stay cool in the comfort of your own home. Remember, changing your filter is one of the most important steps you can take to maintain your air conditioner. Click on the image below to view a video about the proper way to change your filter.


text:
Maher to Maddow: GWB not Watergate
Liberal comic Bill Maher continued to question MSNBC's coverage of New Jersey Gov. Chris Christie's bridge scandal, telling the network's Rachel Maddow, "It's not Watergate."
On his blog last week, Maher jokingly wrote that he was "going to start seeing other news organizations" following all of the coverage of the lane closures scandal plaguing the Republican governor.
Story Continued Below
"Look at yourself. You're turning into Fox News," Maher wrote. "Bridgegate has become your Benghazi, and this isn't easy to say, but you and I are no longer on the same news cycle. Sure, you read me the results of a recent Gallup poll, but you never really ask me how I'm feeling. It's not you, it's… Chris Christie."
"I just wonder if it is too much. That's all I was asking," Maher said Friday referring to the post on his HBO program "Real Time with Bill Maher."
Maddow, host of "The Rachel Maddow Show," defended the network's coverage.
"I am totally obsessed with the Christie story. Unapologetically. And will continue to be obsessed with it while amazing things in that story continue to happen," Maddow said.
"It may be more coverage than you want," Maddow said, but added that the bridge scandal is "just as good" as covering former Illinois Gov. Rod Blagojevich's corruption scandal.
While Maher said he's "still actually in love with MSNBC" and the story is worth covering, he also noted that for a lot of the programs on the network, the bridge scandal is the top story every night, two months after it first broke.
The late-night host also walked back his comparison of Benghazi.
"I should have said that, yes, this is not the same as Benghazi," Maher said. "Benghazi is nothing. There is no scandal there. This is an actual scandal, it's just that it's not Watergate. He's not the president. He's not even a guy who ever himself said he was going to be running for president."
Maher asked whether the lane closures were "really that bad" and whether the coverage would be the same if it involved Democratic governor not close to New York.
Maddow argued that there still wasn't an explanation for the closures and denied that she or the network were using the coverage to eliminate Christie's chances for running in 2016.
"It's not like we're not covering other things," Maddow said. "It's not every second of the day."


text:
Apple has posted a recruitment ad on its own site for a Software Engineering Manager specifically for the Apple TV team. It appears that Apple may be getting ready to move the Apple TV from the hobby stage into a full blown can't do without living room necessity. According to the ad, Apple is seeking someone to deliver the next generation features for Apple TV.
The Apple TV team is looking for an experienced engineering manager to help deliver the next generation features for Apple TV. Bring your creative energy and engineering discipline, and help us bring the Apple experience to the Living Room.
Lead a team of engineers working on exciting new features and functionality - Drive releases from initial concept to completion
Work closely with cross functional teams, representing Apple TV across Apple - Develop the engineering plan for upcoming projects
Communicate status to key stakeholders and senior management
The rumors surrounding the Apple TV platform are always circulating with many believing that Apple will release its own actual television set. Each year we are told by analysts that it will arrive and so far we are still waiting. The other rumor and the one that is more likely in my opinion, is the release of an Apple TV SDK (Software Development Kit). This would allow developers to start creating apps for the Apple TV and could open it up to a whole new market. It had already been rumored that an event was planned for April however that has since been dismissed as incorrect.
The other option would be for Apple to continue with its content partner agreements where they strike deals with YouTube, Vimeo, Hulu, major league sports, etc. on a channel-by-channel basis. Either way, the fact that Apple is publicly advertising for Software Managers to deliver the next generation features for the Apple TV and also calls it a "High Priority" is extremely interesting!
We may earn a commission for purchases using our links. Learn more.


text:
Erie County Pa has its fair share of paranormal places.
From hauntings , close encounters to UFOs, Bigfoot sightings and Bessie the lake monster, the county is full of high strangeness.
But one of the most mysterious places of supernatural legend in the county is the Vampire's Crypt that lies in The Erie Cemetery between 26th and 19th streets.
Now the cemetery has its share of unique tombs, Erie was a chief industrial town in the 1800s and the wealth of the city is evident in the many lavish personal mausoleums the cemetery holds.
But the Vampire's Crypt stands out from even the most lavish of tombs.
It is not because it is the most ornate, no on the contrary its fairly sparse-it even lacks a family name. But over the doorway is an ornate "V", that has given it its infamous name.
There are many stories of supernatural and odd experiences at the Crypt, and with this entry I am going to try something a little different, an animated video blog.
For more info on the Vampire's Crypt, it's background and other stories about the supernatural occurrences there read this article of mine on the Examiner: http://www.examiner.com/article/what-lurks-the-vampire-s-crypt and the full story in my book "Eerie Erie: Tales of the Unexplained from Northwestern Pennsylania" due August 2011 from The History Press!
Until Next Time,
Pastor Swope


text:
Darkroom/E6 development
Hey folks, we have successfully achieved E6 color development by hand using the chems Eric donated. This is a full 6 bath E6 kit (as opposed to E6 Rapid).
E6 "6 bath" steps[edit]
Following is the protocol we followed, it is a hybrid of the instructions on the box of chems and the 6 bath instructions on wikipedia. I will write down the exact chems we used and find a link for them next time I'm in the space. If you want a simpler process, consider E6 Rapid.
- 1st dev - 6 min @ 100.0°F
- water stop bath - 2 min @ 100.0°F
- reversal - 2 min @ 96-103°F
- 2nd dev - 6 min @ 96-103°F
- pre-bleach - 2 min @ 90-103°F
- bleach - 6 min @ 92-103°F
- water rinse @ 92-103°F
- fixer - 4 min @ 92-103°F
- water rinse @ 92-103°F (goes in fix-water jug)
- final rinse - 1 min @ 80-103°F (includes photo flo)
Color Development Equipment Checklist[edit]
- Large tub, translucent plastic preferred (think we have this)
- E6 chems (thanks Eric!)
- temp controller (see shopping list below)
- chem bottles, 1 qt x6 (see shopping list below)
- plastic reels, 35mm & 120 (ours are convertible)
- film tanks (check!)
- timer (check!)
- Darkroom (check!)
Most of this stuff is on the Darkroom resources page.
Kelly's Shopping list[edit]
- Temperature controller - $72.77
- Accordion chem bottles, 1qt - $4.99 (x6)
Total: $102.71
- Kelly - $20
- Subtotal: $80.71
- Rubin - $80.71
- Subtotal: $0
We have enough monies! Kelly is ordering stuff.
Development queue[edit]
Update: Kelly and MacKenzie mixed up a 1 liter batch of E6 chems on 8/14/11 and have developed 8 rolls in it since then. Feel free to book yourself some E6 time while the chems are still good! --Hurtstotouchfire 02:03, 23 August 2011 (UTC)
- Heroic 06:08, 8 August 2011 (UTC) - about eight rolls
- Various Velvia 50, Velvia 100, Digibase CR200, shot on the Big Island of Hawaii
Donating film[edit]
If you'd like to donate some slide film or $$ towards slide film that may be helpful for people who don't already have a backlog of E6 film to develop.
E6 examples and recommendations[edit]
If you're just looking for advice on what film to get, you can check out what other people have been shooting, above. Unfortunately slide film is a bit more expensive than color negative film, running about $8/roll for 36 exposures on 35mm. It's lovely though. I know that Joachim and Jas can probably provide more examples (links, guys?), but my flickr feed has a few shots which were E6 processed slide film. --Hurtstotouchfire 17:58, 24 June 2011 (UTC)
Here are some random shots on Velvia: [1] Heroic 06:11, 8 August 2011 (UTC)


text:
A husband and wife were killed and their adult son air-lifted following a single-vehicle wreck on U.S. 17 near Verona Thursday.
A husband and wife were killed and their adult son air-lifted following a single-vehicle wreck on U.S. 17 near Verona Thursday.
George Theodorakis, 70, and his wife, Betty Theodorakis, 71, of Lake Waccamaw in Columbus County died in the wreck; and their son, 40-year-old Michael Theodorakis, was air-lifted to New Hanover Regional Medical Center with significant injuries.
�This is a great loss to the Gator family,� East Columbus High School Principal Bobby Vaughan told The News Reporter of Whiteville. George and Michael were very dedicated fans, and they came to every game. They always carried themselves with Gator pride, and we're surely gonna miss them � our prayers go out to the family."
Sgt. R.E. Dudley with the North Carolina Highway Patrol said that excessive speed was not a factor, alcohol was not believed to be a factor and that they would need to wait on medical examiner�s results before determining if a medical condition was involved.
All three passengers were wearing their seat belts.
Dudley said that George Theodorakis was driving the 2005 Buick Park Avenue north on U.S. 17 near Murrill Hill Road when the vehicle started to skid and swerve to the right before it swerved back to the left, lost lateral stability and began to spin before entering the median.
The driver�s door hit a tree, Dudley said.
George and Betty Theodorakis, who were the front-seat passengers, were pronounced dead at the scene. Michael Theodorakis was the back-seat passenger. New Hanover Regional Medical Center Spokesperson Carolyn Fisher said late Thursday there was no new information to release on his condition.
Authorities believe the vehicle was traveling between 60 and 65 mph in the 55 mph zone at the time of the wreck.
Verona Volunteer Fire Department, N.C. Highway Patrol, and Onslow County EMS responded to the wreck, and had to use the Jaws of Life to remove the three from the vehicle.
U.S. 17 northbound was closed completely as workers responded to the wreck, and traffic was redirected to Murrill Hill Road until one lane north was reopened shortly after 1:30 p.m.


text:
I was born on the 20th of July 1988 in Duisburg (Germany). I love Star Trek, Stargate and the old 'Seaquest'. My favorite music is about Trance and House. My Skills reach from 2D art to 3D art and creating sounds. I have worked for Stardock on the Galactic Civilizations II Addons, Dark Avatar and Twilight of the Arnor. I have translated them together with my Team for the german publisher, Kalypso Media. I am leading a site for developers and modders, called I-mod Productions, providing several free services.
Only registered members can share their thoughts. So come on! Join the community today (totally free - or sign in with your social account on the right) and join in the conversation.


text:
I have heard a lot of arguments about this with some voices saying "it must be uk type approved" but I think in the end it is ok and actually you are legally ok using them.
Of course you need to be using the frequency you are licenced to and no more than the power limit. And pmr 446mhz at 5 watts is also a no as the limit is 500mw (a half watt)


text:
Teacher resources and professional development across the curriculum
Teacher professional development and classroom resources across the curriculum
Overview Video
This six-minute video introduces you to the Teaching Foreign Languages K-12 Workshop series and provides you with a virtual tour of the Web guide. Watch the video to familiarize yourself with what you will be doing as a participant in the workshop, or to launch a study group using the workshop.
<< Back
|Foreign Languages Workshop Home | © | About This Workshop | Glossary | Site Map
© Annenberg Foundation 2017. All rights reserved. Legal Policy


text:
By Chris Rees
When the FDA got together with the Oncologic Drugs Advisory Committee (ODAC) in early May to discuss whether to approve Aveo Pharmaceutical's (AVEO) Tivozanib for the treatment of renal cell carcinoma (RCC), it would be fair to say the FDA reception was not what AVEO was expecting.
After all, they were so sure of approval they had interviewed and hired sales staff and planned launch details, even down to deciding upon the kind of cars their sales reps would be driving. Instead, the FDA was merciless, ripping apart Aveo, Tivozanib, the phase 3 trial design and data, and just about everything and everyone involved in trying to bring this drug to market. People who witnessed the meeting described it as 'brutal' and 'scathing.' After a morning of spirit-wilting torture, and just a few minutes before the scheduled lunch break, the ODAC committee was asked to vote on a carefully worded question:
"Has the Applicant demonstrated a favorable benefit-to-risk evaluation for the treatment of renal cell carcinoma in an adequate and well-controlled trial?" The panel voted 13-1 that the answer to this question was no.
The show was over. The good guys had won; the guardians of our public health had done their job. Those suffering with terminal RCC would be protected from the potential dangers and ineffectiveness of Tivozanib. Maybe the FDA will give Tivozanib another chance if Aveo does a new trial and manages to come up with a better and more acceptable set of benefit-to-risk data. A new trial would likely take at least three years. In this scenario, Tivozanib would not be available until 2017. Between now and then, approximately 56,000 people will die from RCC in the U.S. alone.
To better understand what went wrong, we need to examine the two main components of FDA approval. These are progression-free survival (PFS) and overall survival (OS). For many years, the FDA has insisted PFS is the primary endpoint as it is considered to be more reliable and measurable, while OS is often harder to measure and often confounded by issues of crossover and the use of sequential therapy. For now, let's take the FDA at their word and explore PFS.
Progression- free survival (PFS) is the length of time a disease does not get worse (progress) while someone is taking, and after they have taken a drug. Let's take a look at the following PFS chart.
Source: Tenstocks.com, FDA/ODAC briefing document table 2.
All the drugs in the above chart were approved by the FDA based on the PFS shown. Tivozanib has not been approved. If the primary endpoint for approval was PFS, and the Tivo-1 phase 3 trial was designed to measure PFS, why won't the FDA approve Tivozanib when they approved all the others? After all, by using the FDA's own data, Tivozanib appears to be best in its class.
The use of RCC drugs in the first-line setting can offer cleaner data because the patients are treatment naïve. If Tivozanib is indeed the best in class, its supremacy should show up here too. The current accepted standard of care in RCC is Sunitinib—marketed by Pfizer (PFE) as Sutent—and Pazopanib —marketed by GlaxoSmithKline (GSK) as Votrient. They are considered the best available drugs for RCC. A look at treatment-naive data from various previous trials shows the same pattern of Tivozanib outperformance.
Source: Tenstocks.com, Aveo slide 5
There seems little doubt that when it comes to PFS, Tivozanib is the best in class. If the other drugs were approved based on PFS, Tivozanib clearly should be approved as well.
However, the FDA is now saying they have not changed the rules for approval and that PFS is still the primary endpoint, but OS is now the gold standard of endpoints. If you find this slightly confusing, join the club.
So, we move on to OS, the FDA's gold standard. Take a look at this OS chart:
Source: Tenstocks.com, FDA briefing document table 2.
Here again, we see an indicator of Tivozanib's supremacy. Again, realize all the drugs in the above chart have been approved based on the data shown—all except Tivozanib. This doesn't make logical, rational sense, does it? After all, PFS is clearly a predictor of OS, and OS is clearly a predictor of PFS. If a drug outperforms in both endpoints—primary and gold, as the FDA calls them—its performance confirms superiority over all other approved RCC drugs and it also confirms efficacy and safety.
The FDA does not think Tivozanib has demonstrated a favorable benefit-to-risk in an adequate and well-controlled trial. The biggest issue for the FDA was the OS result in Aveo's phase 3 Tivo-1 trial. The OS for Tivozanib came in at 28.8 months, as shown in the OS chart above. The problem was the Sorafenib comparator arm came in at 29.3 months. Sorafenib—marketed by Bayer (BAYRY) and Onyx Pharmaceuticals (ONXX) as Nexavar— outperformed Tivozanib.
This resulted in a hazard ratio (HR) of 1.25. The FDA has never approved a drug for RCC with an HR greater than 1. The difference between the two arms—28.8 versus 29.3—was not statistically significant, but the FDA decided the HR was. So, at Aveo's ODAC meeting, the FDA introduced a new endpoint for approval: The HR had to be less than 1.
When looking at the issue of HR in this case, it's important to note 61% of the patients who started on Sorafenib crossed over to Tivozanib upon progression. This meant the trial involved two active drugs against one. It was Sorafenib/Tivozanib versus Tivozanib alone.
Now, Tivozanib achieved PFS of 11.9 in this trial. Sorafenib reached a PFS of 9.1. However, in the Sorafenib arm, the 61% who crossed over and had sequential therapy on Tivozanib achieved an additional PFS of 8.4 months. If the 61% who crossed over in the comparator arm had a median PFS of 9.1 while on Sorafenib, then they had a total PFS of 17.5 months when combined with Tivozanib. Is it any wonder OS in the comparator arm was higher?
When it comes to approval, The FDA now states an HR of less than 1 favors the investigational drug and an HR greater than 1 does not. Here we have an HR of 1.25. Pazopanib was approved with an HR of .91 but it was compared to placebo and 54% crossed over to Pazopanib. So the comparison was 100% Pazopanib versus 54% Pazopanib. Sorafenib was also approved based on an OS of 17.8 months with an HR of .88 against placebo. Getting an HR of less than 1 is easy when you compare your drug to a placebo or a half dose of the same drug. Tivozanib was compared to an approved and effective drug and to Tivozanib.
Other RCC drugs, including standard of care Sunitinib, were approved based on comparison to IFNa, a minimally effective drug. Again an easy HR bar to clear.
Of all the drugs approved for RCC, only Axitinib—marketed by Pfizer (PFE) as Inlyta— was compared to a really active and approved RCC drug. Again, Sorafenib was used as the comparator. The HR came in at .97 but no crossover was allowed, so the comparison was straight Axitinib versus Sorafenib.
How would OS for Tivozanib versus Sorafenib look with no crossover? Look at this chart:
Source: FDA, Aveo slide OS-14
The OS trend favors Tivozanib.
If Aveo's RCC drug was negatively impacting OS, it would also show up in serum levels. Analysis of the OS data and serum levels show no indication of a higher incidence of death with higher serum levels of Tivozanib. Indeed, the most likely cause of death due to Tivozanib would likely come from hypertension, which is Tivozanib's main side effect.
Its incidence is higher with Tivozanib than with all other RCC drugs. But hypertension is also a marker of efficacy in RCC. A subgroup with hypertension in the Tivo-1 trial reached a PFS 18.3 months. This is yet another indicator of Tivozanib being the best-in-class RCC drug.
Essentially and importantly, Tivozanib is the first RCC drug to be compared to not one, but two active drugs, and its use, when combined with Sorafenib, achieved an OS of 29.3 months, the highest ever recorded in an RCC trial, and 28.8 months when used alone. Results such as this would just not be possible if Tivozanib was inferior to the other already approved drugs. In the case of Tivozanib, an HR of 1.25 demonstrates the effectiveness, not inferiority, of Aveo's cancer drug. Nevertheless, the FDA is insisting on using a comparative benchmark of HR=<1 as if Tivozanib had been compared to a placebo or IFNa.
In my opinion, the error Aveo made in the Tivo-1 trial was not doing a two-way crossover. Patients on both arms should have been able to cross over to the other drug upon progression. This would have balanced out the effects of two drugs versus one and the HR would almost certainly have been below 1.
In RCC, cancer drugs are used in sequence. When one drug ceases to work, patients are switched to another drug until progression and so on. Drug side effects also play a role. All RCC drugs are toxic and cause a wide range of adverse events. Some are better tolerated than others. Dosage often has to be reduced, interrupted or discontinued altogether, depending on the patient's ability to tolerate a particular drug. This is why having a wide range of options in the treatment of RCC is important. For a patient suffering with RCC, the more options the better.
At Aveo's FDA ODAC meeting, the single vote for approval of Tivozanib was from a patient advocate. Members of the public were also allowed to address the ODAC panel. One by one they offered heartbreaking testimony to the efficacy of and need for Tivozanib. They were doctors and nurses, caregivers and patients. Each had personal experience of RCC and some of them had been taking Tivozanib in trials. Of the nine people who spoke, eight of them pleaded for the approval of Tivozanib (the ninth suggested another trial may be needed).
According to an article in the Wall Street Journal, the FDA's cancer czar is Dr. Richard Pazdur. In the article, the co-founder of a group that wants patients to have wider access to cancer drugs calls Dr. Pazdur "a lethal disaster for cancer patients." Indeed, it was Dr. Pazdur who led the blistering attack on Aveo and Tivozanib at the FDA's ODAC meeting. He is quoted by the Wall Street Journal in a related interview as saying, "the major issues with the oncology drugs as mentioned before are efficacy, demonstration of efficacy, kind of like in the real-estate industry the mantra being location, location, location, in oncology it's efficacy, efficacy, efficacy."
He went on to say that "the reason why oncology drugs don't get approved is basically because they fail to demonstrate efficacy… A lot of the misconceptions people have revolve around their own misunderstanding of the field of statistics and whether or not a trial meets its primary endpoint and why that is important."
Okay. We're back to the primary endpoint. That's what is important. Tivozanib met its primary endpoint. So it should be approved, right? Dr. Pazdur again: "one does not want to see a potentially active drug not be available to the American public."
Neither do cancer patients, or their families and friends. But if the FDA doesn't approve Tivozanib, isn't that exactly what's happening here?
At Aveo's ODAC meeting, Dr. Pazdur, expressing his concern about Tivozanib said, "obviously overall survival is a much more important clinical endpoint than progression-free survival."
Yet, while at the ODAC meeting to discuss Axitinib, which was approved, he said "to say that we have to demonstrate an overall survival advantage from the last approved drug for any other new drug to be approved is a very high bar here and really is a comparative efficacy standard, which we do not have the legal authority to impose."
And then he said, "we have to be consistent with other sponsors, and we have a track record here that has ranged of six drugs that have been approved and six companies given advice with a PFS endpoint, so we can't hold one sponsor up to a higher standard than another sponsor; that's for sure."
So we go round and round on the FDA merry-go-round about what the approvable endpoint is and what it isn't. Meanwhile, there will be about 65,000 new cases of RCC this year in the US alone. About 14,000 Americans will die of RCC this year. In the Tivo-1 trial, after Sorafenib stopped working, Tivozanib halted disease progression for 8.4 months.
When the FDA is making life and death decisions for cancer patients, it's not the FDA or Dr. Pazdur that does the dying. If the FDA is so concerned about the Tivozanib OS data, a pragmatic, logical, sane and compassionate solution for all sides would be to approve Tivozanib for patients suffering with RCC and order post-approval monitoring of OS.
Tivozanib is also being studied for efficacy in liver, breast, colorectal and other cancers. Those in the cancer community who want to see this effective drug approved need to speak up now. When it comes to cancer, the dead don't talk. For cancer patients, that's the real endpoint.
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Cheer Small Pendant
History: This design was created from a dictionary published in the early 1900s.
Process: We have a huge library of vintage maps, dictionaries, and encyclopedias that we use to source the designs for our pendants. We print the map selection using the highest quality paper. The selection is then placed under domed glass and sealed before being bezel set into the pendant tray. After this process we pack your piece with love and send it on its way to you! All pieces are handmade at our studio in Atlanta, Georgia.
Dimensions: 1 inch diameter pendant, 24 inch chain
Materials: Sensitive skin safe zinc alloy, Glass. Lead and nickel free.
Care: Remove before showering, swimming, exercise, or any activity where the piece may come into contact with moisture.


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Yellow Pages have always been a great medium for advertising your electrical business to homeowners. Nothing beats the tangibility and completeness of a big, annual reference book—like CEE News' annual Buyers Guide, for instance. But these days it also pays to keep your business searchable online.
People like the speed and convenience of the Internet. Letting their fingers walk through the yellow pages used to be to the fastest way for customers to shop around. Now it's faster for them to click directly to your business. With so many aging houses and so many new homeowners needing quick fixes, it's a good bet to make your business easily retrievable through a good search engine, like Google. It's also good idea to post your phone number and e-mail address prominently on the site.
Googling around for an electrician here in the Kansas City area—using "electrician," "electrical contractor" and "Kansas City" as key search words—I was unable to find a firm right off the bat. (Please e-mail me at [email protected] if you think I slipped past your company somehow.) Preparing last month's Top 50 electrical contractors story, we were amazed to find that some of the nation's largest electrical contractors have bad, slow-moving Web sites that drive potential customers away. Speaking of driving and customers...
Fuel-cell power plants. I've said this before in this space, but it bears repeating: Fuel cells offer a tremendous opportunity for future-minded electrical contractors. The hydrogen-based technology may never be a viable option for mass-produced cars—or at least in time for me to buy a good, used fuel-cell car—but it's an excellent energy alternative for powering individual homes and commercial buildings. Though it's probably way too soon to give up entirely on hooking clients to the utility grid, it's a good idea to keep you eyes open for fuel-cell prospects down the road.
The new Big Eight. The Big Eight college football conference became the Big 12 a few years ago. The Big Eight accounting firms now number many more than eight—even with the imminent demise of Arthur Anderson. But, according to USA Today, there's a new big eight on the block—the eight big companies that still have Standard & Poor's AAA credit ratings. In the high-flying late 1990s, when even Barbra Streisand touted herself as a financial genius, plenty of companies maintained the triple-A rating. Now, many of these giant companies seem to be sinking in the sand of empty promises. For instance, The New York Times recently reported that the stocks of several large energy companies fell sharply as the industry was buffeted by fresh doubts about the continued viability of electricity trading. Curious thing about the new Big Eight: It seems to be comprised principally of companies that actually produce a tangible good or service, like successful electrical contractors do.
Reader's humor is uniform. Hey, contractors—our humor well is starting to run dry. Please send more funny stories. Over and over again, we've been getting new variations on the same two old jokes: "Let an electrician wire your shorts" and "how do you keep an apprentice busy for hours?" (Answer: Have him search for something that doesn't exist.) Please send more real-life stories. You can change names and locations to protect the guilty.
Days of wine and roses. Movies have always done a great job of showing the creepiness of public relations—from the corrupt columnist and sycophantic PR lackey of "The Sweet Smell of Success" to the oily, drunken pitchman of "Days of Wine and Roses." Of course, movie PR people sometimes pale in comparison to the insidiousness of real-life public relations. (Take the recent example of a smarmy Washington D.C. PR firm's idea to pitch American-way-values propaganda to the citizens of adversarial nations overseas—with Uncle Sam footing the bill.)
Here at CEE News, we maintain a great relationship with the PR firms. (We often tell them "thanks, but it's not really a good fit for us.") PR firms provide us with new product information and news leads that we pass on to you the reader. We also have a great relationship with people who sell CEE News ad space. (We don't tell them how the sell the magazine; they don't tell us how to fill it.) The trick for editors is drawing the line between good information and commercial puffery. The lines seem to be blurring in some magazines—or maybe they just look blurrier to my 44-year-old eyes.
We've noticed a trend toward trade magazines praising their industry manufacturers for no apparent reason—well, I guess advertiser money could be a reason. One national newsweekly (I won't say which, but it wasn't Time or Newsweek) recently ran an editorial criticizing the Food and Drug Administration's slowness to approve new drugs while praising pharmaceutical companies' speediness to invent new drugs. Opposite the editorial ran an ad spread for the American Pharmaceutical Association.
If you, the reader (with whom we should always maintain the best relationship), ever catch us crossing the line into the land of mercenary commercialism, please call us on it—literally. Or e-mail me at [email protected].


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Managing Habitat for Pollinators
Native pollinators clearly help with crop pollination, yet many agricultural areas lack the habitat necessary to support native pollinators. Proximity to natural or semi-natural land is often an important predictor of pollinator diversity in cropland. For agricultural areas that have lost native pollinators due to habitat modification or pesticide treatments, adjacent natural areas provide two valuable benefits. First, they are a source of pollinators for crop pollination. Second, they act as refugia for pollinators that can recolonize degraded agricultural areas. View in-depth guidelines for managing pollinators in natural areas.
Another valuable resource is the Yolo Natural Heritage Program (NCP/NCCP) Pollinator Conservation Strategy. Written by Xerces Society scientists, this first-of-its-kind conservation strategy summarizes the threats facing native bees and identifies conservation measures that can be taken within diverse landscapes, including agriculture, grasslands, woodlands, shrubland, riparian, and urban.
Management tools, such as grazing, fire, and mowing, can be used in a manner that benefits pollinators. The use of insecticides and herbicides can be harmful to pollinators; if they must be used, there are a few considerations to minimize their impact on pollinators.
Consider timing, duration and intensity
A diverse pollinator population requires adequate nectar and pollen sources from early spring to early fall, which makes seasonal timing a key consideration for an effective grazing plan. Management should be adjusted to maintain the majority of the floral resources throughout the seasons. Also, grazing should be avoided when butterfly larvae or adults are active, as it can result in direct mortality. Grazing periods should be short to allow for adequate recovery of the habitat. Herd sizes should be moderate to light.
While prescribed burning has a role to play in long-term maintenance of pollinator habitat, it can also have catastrophic impacts on pollinators. To minimize negative impacts, a single fire should not burn an entire area of pollinator habitat. Ideally, a program of rotational burning in which small sections—30 percent of a site or less—are burned every few years will ensure adequate colonization potential and refugia for insects.
Mowing can cause direct insect mortality, especially for egg or larval stages that can't avoid a mower. Ideally, mowing should occur in the fall or winter when flowers have died or are dormant. Mowing a mosaic of patches over several years is better than mowing an entire site all at once; no single area should be moved more than once a year.
While herbicides can be an important management tool, broadcast applications of non-selective herbicides can reduce important floral resources. To avoid herbicide damage to nontarget plants and associated pollinators, avoid broadcast spraying or pellet dispersal, which may kill large numbers of larval hostplants or adult forage plants. Instead, spot treat with a backpack sprayer, allowing for selective control.
Consider application method, product formulation, and timing
Insecticides used on forests, rangelands and farms can severely impact pollinator populations. In situations where insecticides must be used, it is best to avoid spraying when flowers are in bloom. Choose less harmful formulations—in general dusts and microencapsulated insecticides are the most dangerous formulations for bees, and aerial spraying is the most harmful method of application. Sprayed solutions and large granules tend to be less harmful to pollinators. Pay attention to the potential presence of butterfly hostplants in the management area and avoid spraying them.
Oregon State University, Washington State University and the University of Idaho Extension have developed a comprehensive guide, available as a pdf: How to Reduce Bee Poisoning from Pesticides.