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Shift Leader
- Employer
- Greggs
- Location
- CM7 1RB, Braintree
- Salary
- £8.52 per hour
- Closing date
- 18 Mar 2019
View more
- Category
- Production & Manufacturing, Operatives, Butchers & Bakers, Retail
- Contract Type
- Full Time
Job Details
Shift Leader
Location: Essex, Braintree, GB, CM7 1RB
Company: Greggs Plc
Join the family
We believe in growing together – as a united team and working towards the achievement of our vision which is to be a winning brand in the food-on-the-go market. Greggs is a much loved and trusted brand with a strong traditional bakery heritage. Our people are what makes our business successful.
We aim to provide our people with a great place to work, where they feel valued by listening, developing and rewarding them.
Pay Rates
£8.52 per hour
Shift Pattern and Contracted Hours
We are looking for a permanent Shift Leader to join our Greggs Family in Braintree. If you're able to work 20 hours per week and are open to these hours including Weekend work (on a rotational basis), then our lovely Area Manager Dawn would love to hear from you and would be happy to discuss your availability at interview stage.
Job Description
Greggs Shift Leaders or Senior Team Members (as the role is known internally) are at the heart of the team supporting with the management of the shop at key times of the day.
You would be looking after the shop for a few hours a day, either at opening or closing time so your role is invaluable to your manager.
When opening the shop you'll be working with the team to ensure our much loved products are ready for our customers and the shop is set up to the highest standard. This is where your passion to deliver a fantastic shopping experience for our customers comes in.
A close down shift means getting the shop ready for the next day; cleaning, stock counting and cashing up. You'll have a natural flair for team work whilst enjoying a little extra responsibility.
You'll fit right into the Greggs family if you're not afraid of hard work and enjoy some fun at work. Some supervisory experience always comes in handy although not essential.
Everyone in our family values hard work, commitment and a flexible approach to working hours.
To be able to:
- Serve customers in a friendly, professional and efficient manner.
- Prepare a variety food items to the highest standards, in order to meet customer demand.
- Ensuring that all areas of the shop and food products are displayed in a clean, tidy and attractive manner.
- Seeking to maximise the sales and profitability of their store.
- Working collaboratively with their Shop Manager and other Team Members and providing managerial support to the shop management team.
• Our Greggs Employee Staff Discount Scheme is very generous, offering you up to 50% off our food
• Your holiday entitlement starts with 21 days, in addition to bank holidays, which increases with service up to a maximum of 30 days after 25 years' service. (Pro-rata for part time)
• After 6 months service you may be eligible for our profit share scheme where the company distributes 10% of its profits and allows you to share in the success of the business
• You will receive free life assurance after 1 years continuous service. This is a death in service benefit which provides a lump sum payment equal to one years' salary
• You will automatically join our Greggs pension scheme which is a fantastic way to save for your retirement and allows you to benefit from employer contributions and tax advantages
• Other benefits include:
- Share Save and Share Incentive Schemes
- Employee Assistance Programme
- Healthcare Plans
- Cycle to Work Scheme
Your Application
During the application process we'll keep in touch every step of the way. We know how big a decision it is for you to apply for a job. Once you do we'll work hard to keep you up to speed on how your application is progressing. With your help, we can make your application as quick and smooth as possible.
We believe in growing together – as a united team and working towards the achievement of our vision which is to be a winning brand in the food-on-the-go market. Greggs is a much loved and trusted brand with a strong traditional bakery heritage. Our people are what makes our business successful.
We aim to provide our people with a great place to work, where they feel valued by listening, developing and rewarding them.
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Granite Crystal Metallic Clearcoat 2022 Ram 1500 Classic Tradesman Crew Cab 4x4 4WD 8-Speed Automatic 3.6L V6 24V VVT 115V Auxiliary Power Outlet, 40/20/40 Split Bench Seat, ABS brakes, Anti-Spin Differential Rear Axle, Center Hub, Class IV Receiver Hitch, Cloth 40/20/40 Bench Seat, Cloth 40/20/40 Premium Bench Seat, Compass, Electronic Stability Control, Folding Flat Load Floor Storage, Front Armrest w/3 Cupholders, Front Center Seat Cushion Storage, Heated door mirrors, Heated Front Seats, Heated Steering Wheel, Interior Cold Weather Group, Leather Wrapped Steering Wheel, Low tire pressure warning, Manual Adjust Seats, ParkView Rear Back-Up Camera, Power 10-Way Driver Seat, Power Lumbar Adjust, Quick Order Package 29B Tradesman, Radio: Uconnect 3 w/5" Display, Rear 60/40 Split Folding Seat, Rear Folding Seat, Remote Start System, Remote USB Port - Charge Only, Security Alarm, Steering Wheel Mounted Audio Controls, Storage Tray, Traction control, Tradesman Package, Wheels: 20" x 8" Aluminum Chrome Clad. Price includes: $1825 - Bonus Cash 22CNA. Exp. 02/28/2023
The minute you walk through the doors and speak with our friendly none commissioned sales and service staff, you will come to realize how we became Chicagoland's "One Price" Chrysler Jeep Dodge Ram FIAT dealership since 1992. This has fueled our decision to continue to grow and maintain a level of service that most people have never experienced. In the spring of 2017, we finished our largest renovation to date, with our new state of the art showroom, offices, and car service center car service center, so that we may better serve our valued customers. With a more spacious showroom, five additional service bays, and more, we have the most customer-friendly dealership in the area. Check out our updated new cars deals and car service specials! We'll take care of your Chrysler, Jeep, Dodge, Ram repair needs and more!
One thing that has not and will not be changed, however, is our commitment to complete customer satisfaction. With the dedication from our staff, we have made it our mission to provide you with a more enjoyable car buying experience with our One Bottom Line Price and No Hassle sales approach. Our family values, honesty, and fair business practices help set us apart, and will continue to do so for the Bettenhausen family for generations to come. We are continuously seeking new ways in which we may better serve our customers. We invite you to come visit us today and experience the difference for yourself. We know that you will find that Bettenhausen is the best dealership in Chicagoland! Just ask someone who knows.
New vehicle pricing includes all offers and incentives. Tax, Title and Tags not included in vehicle prices shown and must be paid by the purchaser. While great effort is made to ensure the accuracy of the information on this site, errors do occur so please verify information with a customer service rep. This is easily done by calling us at 708-840-8678 or by visiting us at the dealership.
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15941 S. 94th Ave • Orland Park, IL 60462Get Directions

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A83, Rest-and-be-Thankful pass, near Arrochar, Argyll
Poster describing landslide (Adobe Acrobat PDF 1.74 MB)
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Except as stated above, BGS gives no warranty as to the quality or accuracy of the information or the medium on which it is provided or its suitability for any use. All implied conditions relating to the quality or suitability of the information and the medium, and all liabilities arising from the supply of the information (including any liability arising in negligence) are excluded to the fullest extent permitted by law.
BGS excludes all liability arising from any errors or omissions in any data provided by you or on your behalf and used to provide a BGS report.
Geological observations are made according to the prevailing understanding of the subject at the time. The quality of such observations may be affected by subsequent advances in knowledge, improved methods of interpretation, and better access to sampling locations.
Raw data may have been transcribed from analogue to digital format, or may have been acquired by means of automated measuring techniques. Although such processes are subjected to quality control to ensure reliability where possible, some raw data may have been processed without human intervention and may in consequence contain undetected errors.
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The most appropriate techniques for copying original records are used, but there may be some loss of detail and dimensional distortion when such records are copied.
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One Piece Closet
Ved Ceramica Sanitary is one of the leading names in the domain that you can consider for getting high-quality and industry-grade One Piece Closet In Vadodara at industry-leading prices. We offer our complete range under the brand name of Vedant Export Depot. Our offered range precisely manufactured, tested, packed and dispatched safely under strict watchfulness. We follow strict industry-norms on every stage and maintain the value of our brand.
Being one of the prominent One Piece Closet Manufacturers in Vadodara, we have a well-equipped manufacturing unit, advanced tools and technologies and a specialized team to handle all the processes in a definite manner. Our products have set their standards in the market and gained an appreciation for their quality and performance.
We are one of the noted One Piece Closet Exporters and Suppliers in Vadodara. You can also put your faith in us for timely delivery and round-the-clock support. Our experts are just a call away to support you.


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The Linux-based living room gaming announcements Valve co-founder Gabe Newell promised last week began today with the unveiling of SteamOS, a new Linux-based operating system focused on living room gaming.
"As we've been working on bringing Steam to the living room, we've come to the conclusion that the environment best suited to delivering value to customers is an operating system built around Steam itself," Valve wrote on a page announcing the upcoming OS. "SteamOS combines the rock-solid architecture of Linux with a gaming experience built for the big screen. It will be available soon as a free stand-alone operating system for living room machines."
Why a new OS? Valve says that with SteamOS, the company has "achieved significant performance increases in graphics processing, and we're now targeting audio performance and reductions in input latency at the operating system level." The Linux-based platform will also be freely licensable to hardware manufacturers, allowing a wide number of "Steam Box" living room PCs to germinate. Newell has previously called Windows 8 a "catastrophe" for the gaming market, so it's not at all surprising that his company decided to move forward with a more open option under its direct control.
With the vast majority of Steam's thousands of games currently designed to run only on Windows and/or Mac, compatibility is obviously a major concern with any Linux-based system. Valve says that "hundreds" of games are currently running on their new OS (presumably building off current Steam for Linux compatibility) and promises that the coming weeks will see many AAA game announcements with native SteamOS support in 2014 (when living room systems with SteamOS are expected to launch). The OS will also support the full Steam catalog through "in-home streaming," which presumably means remote play from an office PC to a living room TV over a home router.
SteamOS will be fully compatible with existing Steam functions like automatic game updates across machines, Steam Workshop add-ons and marketplaces, in-game chat and friends lists, family sharing across multiple accounts, and more, according to Valve. In addition, Valve says it's "working with many of the media services you know and love" to bring unspecified online music, TV, and movie services to the new OS.
This is one of the first concrete announcements regarding Valve's highly anticipated living room gaming plans since the introduction of "Big Picture" mode last September. Since then, there have been a number of hints and leaks surrounding the existence of "Steam Box" living-room-based gaming PCs, but very little in the way of official announcements.
Valve is currently teasing two more living room-centric announcements on a countdown page. The next bit of news is set to come Wednesday at 1pm Eastern Time.


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For media and entertainment companies with multiple locations, or a large number of employees working in the field or on location, providing reliable IT support can be complicated. But it is much easier to manage with the right tools.
5 Best Practices
- Simplify PC deployment. Rely on Lenovo services such as Advanced Deployment Services, which empowers users to setup and configure new devices while maintaining the integrity of your IT policies. The user launches a setup assistant wizard, answers a handful of easy questions, and in minutes the system is customized. Or First Boot Services, where we install your preferred software and drivers onto devices in our factory.
- Streamline endpoint device maintenance and patching. Intel® Active Management Technology enables remote out-of-band management to help you discover, repair and protect devices. Lenovo Vantage software guides users through PC setup, securing WiFi and updating software and drivers. Vantage also provides access to Lenovo Migration Assistant for seamless file and settings transfer from one PC to another.
- Implement cloud-based remote diagnostics and control. Take advantage of Windows 10 Pro mobile data management (MDM) features for diagnostics granularity and control. And Lenovo's global partnership with MobileIron® provides enterprise mobile management (EMM) that secures provisioning and simplifies endpoint device management.
Secure the user, the device and your data:
- User Authentication: Lenovo Match on Chip Fingerprint Reader (MoC FPR) stores biometric credentials on a separate chip. Intel® Authenticate provides a deep layer of silicon-based protection, which is stronger than software-based protection.
- Device Security: with features such as Smart USB Protection which blocks data transfer capability; a camera shutter that protects user privacy; and a chassis lock that prevents component theft.
- Data Protection: Lenovo Online Data Backup (OLDB) automatically secures business-critical information in the cloud. Full Drive Encryption (FDE) encrypts all data on hard drives.
- Enable effective collaboration. Solutions such as Lenovo Unified Workspace enable secure remote access, app and desktop services delivery and integration with cloud storage and file shares. Endpoint devices also need to have strong WiFi, possibly 4G connectivity, and features such as high-quality microphones and cameras for conferencing.


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White House says Obama supports women in combat
WASHINGTON (AP) ? The White House says President Barack Obama supports the Pentagon's decision to lift the ban on women serving in combat.
Press secretary Jay Carney told reporters Thursday that Obama favors expanding opportunities for women to serve in the armed forces. Carney also said Obama believes the country should continue to remove "unnecessary gender-based barriers to service."
Defense Secretary Leon Panetta is expected later Thursday to announce his decision to open more than 230,000 battlefront posts to women.
It will be up to the military service chiefs to recommend whether women should be excluded from any of those more demanding and deadly positions, such as Navy SEALs or the Army's Delta Force.


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November 8th, 2012
Romney's loss closes out 'Mormon moment'
By Dan Merica, CNN
Washington (CNN) – Mitt Romney's defeat appears to close out a years-long "Mormon moment," a period of national fascination with the Church of Jesus Christ of Latter-day Saints.
It has also provoked Mormon disappointment; Romney would have been first Latter-day Saint in the White House, culminating a decades-long process of growing Mormon acceptance and influence.
But prominent Mormons and religion experts say Mormons should be heartened that Romney's candidacy appeared to help mainstream the relatively young faith, which was founded in 1830 in upstate New York.
"Part of the Mormon moment was curiosity and much of that curiosity has been satisfied," said John Green, professor of political science at the University of Akron.
"There will always be people who disagree with them," Green said, "but the sense is that this community is part of the broad middle of American society."
As stories about the LDS Church graced the covers of magazines and front pages of newspapers, the church's press office was working overtime to answer questions from around the globe. A church that prefers to keep private became very public.
Election results raise questions about Christian right's power
"Without question there has been an increase in interest in the Church over the past several years," church spokesman Michael Purdy told CNN. "Although there have been exceptions, this attention has given people the opportunity to know who we are and what we believe."
It also meant more publicity for aspects of the church that many Mormons would prefer not dwell on, like the church's onetime practice of polygamy (the church banned the practice more than 100 years ago) and its denial of the priesthood to black members until the late 1970s.
But even the uncomfortable questions were good for the church, said Richard Bushman, a Mormon scholar who has served as a local Mormon leader.
"So long as those objections and criticisms were kept under wraps, they just sort of festered there," Bushman said. "Getting them out in the open where people could speak candidly, that in a way clears the atmosphere."
Coverage of Mormonism also led to some level of misinformation. One example: On the TV show "The View," on October 18, 2012, Whoopi Goldberg asked Ann Romney, Mitt Romney's wife, about how she would relate to soldiers.
Opinion: Moving on from elections as American rite
"As first lady, if you get the job, it's going to entail a lot of things, and one of those things is going to be talking to the mothers whose children are coming home in bags, you know, from wars," Goldberg said. "Now, I know - I believe that your religion doesn't allow you to go fight."
Goldberg was wrong. Mormons are actually known to enlist in the military at higher levels than others. "No, that's not correct," Ann Romney told Goldberg. "We have many, many members of our faith that are serving in armed services."
Purdy, the church spokesman, says such exchanges were ultimately beneficial.
"A good deal of misinformation has been replaced with a more accurate picture of the Church, its doctrines, and its members across the world," Purdy said. "That is a good thing for all involved and we look forward to these opportunities continuing."
But with Romney's loss, interest in Mormonism is expected to dwindle. Joanna Brooks, a well known Mormon blogger and author says it's only a matter of time until that interest returns.
CNN's Belief Blog: The faith angles behind the biggest stories
"There have been many Mormon moments, and there will be many more to come," she said. "Mormonism remains a vibrant and distinctive force on the American religious landscape, and as a young religion with a new global reach, the Mormon story is still unfolding."
The last Mormon moment, she said, was a good one: "This is a moment in which the nation proved that it was capable of having a discussion about candidates and platforms without openly subjecting either candidate to a religious test."
Though Romney's faith garnered plenty of coverage - from Time's cover story "The Mormon Identity," to New York Magazine's "Where is the Mormonism in Mitt Romney?," - neither the campaigns nor outside groups made much, if any, mention of it.
Romney's bid seemed to improve relations between Mormons and evangelical Christians, many of whom have long seen the LDS Church as a cult. In May, Romney spoke at Liberty University, founded by Jerry Falwell.
Follow the CNN Belief Blog on Twitter
Weeks before the election, too, the Rev. Billy Graham met with Romney for the first time and removed "Mormonism" from a section of his website devoted to cults.
"The Billy Graham business, for me that was symbolic that evangelicals instead of just dismissing Mormonism, (they) now need to talk a little more about what they mean," Bushman said.
According to exit polls on Tuesday, 79% of white evangelical Christians voted for Mitt Romney in 2012. That's an even higher share of the white evangelical vote than John McCain got in 2008, when he was the Republican presidential nominee.
"From the point of view of religious tolerance and acceptance, there were some really positive trends," Green said. "It does suggest that the path towards greater religious tolerance has continued."
Green raised the subject with his students after Tuesday's election. At the end of the conversation, Green said one non-Mormon student's comment encapsulated the strides Mormonism made in the last year.
"They aren't any stranger," the student joked, "than anyone else."
- CNN's Allison Brennan contributed to this report.
About this blog
The CNN Belief Blog covers the faith angles of the day's biggest stories, from breaking news to politics to entertainment, fostering a global conversation about the role of religion and belief in readers' lives. It's edited by CNN's Daniel Burke with contributions from Eric Marrapodi and CNN's worldwide news gathering team.


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Hot Online: 83-year-old survives Komodo dragon attack
Trending topic
An 83-year-old Indonesian woman fought off a Komodo dragon when the giant lizard attacked her as she was sitting outside her house. The lizard bit her wrist and held on, and the woman kicked it "with all my strength" until it let go, and she screamed for help.
Check this out
Michael Jordan has a custom golf cartthat you have to see to believe. The cart features North Carolina blue, has a Jordan logo on it, has special rims, a sunroof, speakers and more. Check it out at the link above.
Hot video: Reasons people are laughing at Reasons My Son is Crying blog
Reasons My Son is Crying is the hilarious blog of a father who explains what makes his sons cry. From not being able to eat Buzz Lightyear's head to being unhappy that the refrigerator door is shut, the blog is making waves, and getting laughs, especially among parents. Gillian Pensavalle has more.
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I found this delicious, easy to make, recipe in Jacqueline Bellefontaine's What's Cooking – Chocolate, I changed one ingredient (butter) to make it parve and it still tasted great, in fact these truffles disappeared in no time!
Italian Chocolate Truffles
Yields: 24 truffles
- 6 ounces dark chocolate
- 2 tbsp almond flavored liqueur (amaretto) or orange flavored liqueur
- 3 tbsp unsalted margarine
- 1/2 cup confectioners' sugar
- 1/2 cup ground almonds
- 1 3/4 ounces grated chocolate
- Melt the chocolate and the liqueur in a double boiler, stirring until combined.
- Add the margarine and stir until it has melted. Stir in the confectioners' sugar and the ground almonds
- Leave the mixture in a cool place until firm enough to roll about 24 balls.
- Place the grated chocolate on a plate and roll the truffles in the chocolate to coat them.
- Place the truffles in paper candy cases and chill.
Cook's Tip: These truffles will keep for about 2 weeks in a cool place.
Variation: For a dairy, sweeter, truffle use milk chocolate and sweet butter instead of dark chocolate and margarine. Dip the truffles into melted chocolate to finish, if desired.
Either variation goes great with coffee. Personally, I can't wait to make the dairy variation. These truffles could then become a great breakfast, or dairy lunch (or dairy dinner) treat.
Enjoy, gentle reader, enjoy!


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How much does MRI cost in Burlington, Iowa | Best rate: $250
MRI cost Burlington, Iowa
MRI scan costs in Burlington by insurance coverage & health care plans
|MRI study price w/o contrast
|Price range
|MRI cost for fully-insured patient (25% co-pay)
|$861 - $1,076
|MRI cost for high-deductible plan
|$3,442 - $4,303
|MRI cost for Medicare / Medicaid insurance (20% co-pay)
|$60 - $70
|MRI cost for a self-pay patient
|$250 - $406
Cash MRI price by city in Iowa
- Ankeny: $250-$9,808
- Bettendorf: $250-$2,269
- Burlington: $250-$4,303
- Clive: $250-$9,956
- Mason City: $250-$4,473
- Ottumwa: $337-$3,813
- Pleasant Hill: $250-$9,585
- West Des Moines: $250-$1,776
Insured MRI scan cost Burlington
At hospitals in Burlington, patients with health insurance can expect to pay a copay between $861 and $1,076, which is 25% of the total cost of the MRI scan procedure. To avoid additional charges, patients need to ensure the radiologist is also in-network, otherwise their fees will need to be paid in full. Also, if you haven't met your yearly deductible yet, you will be likely billed the full procedure list price ($3,442 - $4,303) and your insurance coverage will kick-in only after meeting the yearly deductible.
If your insurance plan has limited coverage for imaging procedures or high-deductible, you can use our patient asssist program to compare other insurance plans to rightsize your insurance coverage to meet your needs.
Medicare MRI scan cost Burlington
Medical & Medicare are the largest payers for healthcare in Burlington, so they negotiate the best rates. They can pay between $298 and $348 per scan, patients can expect to pay price ranges as little as $60 in copay . Keep in mind there is a high chance that doctors will deny an MRI scan referral, as Medicare only covers the cost of medical imaging in very selective cases.
High-deductible MRI scan cost Burlington
Almost 40% of all adult patients have high-deductible health plans, which means they need to meet their deductible of up to $13,000 per family before their insurance kicks-in. They can expect to pay the full price for the MRI scan ($3,442 - $4,303). For these patients, the best option is often to pay in cash.
Cash MRI cost Burlington
Self-pay patients can get a discount of up to 80% by using a service such as AffordableScan and can get an MRI scan for cash price as little as $250. Our partner testing facilities are able to use their excess capacity and pass the savings to our patients.
MRI scan costs by procedure type & body part in Iowa
- MRI scan of spine: $250 - $4,303
About MRI proceduresMRI scan is an image of internal body organs that radiologist look at to evaluate medical injuries. According to articles published in USA Today, the MRI scan medical procedure cost varies widely based on facility & location. There are about 3,000 hospitals with imaging centers, that need to pay for they expensive emergency departments, so they charge the insurance companies extra for their patients' use of imaging services. As of now the imaging procedure prices are about 10x what they are in Europe .
Tips for saving on MRI scan in Iowa
- Shop around for the best price (get a quote for facilities near you).
- Don't hesitate to ask for pricing infromation & compare prices for procedures with and without contrast.
- Look for facilities that work with a teleradiologist, those provide much better reading costs.
- Ask about all the fees - do they include the cost of the MRI scan and the cost of the radiologist reading?
- Take your doctor referral with you to another facility – your referral might be issued for one of the most expensive hospitals in the area.
- Use a patient concierge service such as AffordableScan to get a quote and schedule and appointment. We'll be happy to assist you.


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Iconic photo of counter-protester with misspelled sign is now 10 years old
Pat Cunningham
On March 23, 2003, the photo above, which has appeared on the Internet countless thousands of times in the past 10 years, was snapped outside a Boeing missile plant in St. Louis.
The guy with the misspelled sign was demonstrating against several hundred antiwar protesters a few days after the start of the U.S. conflict in Iraq. I read somewhere that his name is Sullivan and that he's from Decatur, Illinois. But the article did not include any other photo of him — so I have my doubts.
I have relatives named Moran, all of whom are doing just fine ...


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As a library school student or a recent graduate, it is all of our hopes that we're not getting this degree in vain. The job market however, cannot support all of us and we have to wonder how to keep the balance. Many people point to the library school programs and say that is where the change needs to happen. A couple months ago, Will Manley wrote a post about the growing divide between libraries and library schools and he asked his readers some very good questions, the main ones being "what value does the MLIS have? Is it just a union card?" Through reading the comments, it started to sound like some people just see the graduate degree is nothing more than a stepping stone to their dream library job. In some ways, I can see how this is true, most librarian positions do require that you have an MLS/MLIS. However, the bigger problem is not the "union card" idea, it's the current state of LIS education. This is an issue very dear to us at HackLibSchool. No library school program is perfect, but that is why this blog exists, to try and change what we don't like, to add to our curriculum.
It's hard to ignore this idea of the MLIS as just a union card for the job. Generally, we all have identified a few problems that seem to have de-valued this degree, and none of these should come as surprise. First issue being, lax acceptance rules; after all, higher education is also a business (read more about the numbers on Lauren's blog). The second point of contention is that library school is seen as too easy, but I personally believe there are plenty of things students can do if they feel this way. In the end, what we all see is a flooded market of graduates to fill the few jobs out there. These are hard times for everyone and libraries have been especially hit hard, but this is also a good time for things to change for the better. It's good that we identify problems in our field and especially in our education system. We should ask whose responsibility is it to address these issues? Should the American Library Association step in? It's hard to say, but by identifying what we think isn't working, we can start the process of changing what we don't like.
Let's take a step back for just a moment though. Library Research Service did a survey last May asking librarians, staff and students about the value of the MLIS to them. The results showed that 76% of the participants agreed or strongly agreed that their degree was worth the investment. This should really tell us that a good number of librarians out there see much value in their degree, that it can be more than just a "union card". There are many ways that we all can add value to our own education and what we walk away with in our job search. Joe Hardenbrook, who writes on Mr. Library Dude really summed it up well when he said "Library school is what you make of it." It doesn't matter really where you go to school, what really matters is how you use your time in school. That's where the value is. I have gotten so much from my degree so far, not only from the courses but from the extra curricular activities that I've become involved in.
The MLIS can be more than just a union card, but it's going to depend on the student to take it to the next level. If you are passionate about this field, then the activities that you take on while in school will eventually translate into things that can go on your resume. Even still, there are many questions and conversations that we as professionals should be consistently having. We need to be asking ourselves about the future of librarianship. We need to wonder if LIS education is headed in the right direction, or if it's truly preparing students for what libraries will need.
What changes do you want to see in library school education? Do you think think that your degree is valuable? How do we become the change that we want to see?
Categories: Big Picture


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In a night characterized by a rambling debate format, Mitt Romney came on strong and stated his message more forcefully than in recent weeks, while President Barack Obama seemed disinclined to engage. The candidates dwelled heavily on the words "middle class" at the University of Denver, and avoided major gaffes. Obama, who won a coin toss and started first, said he'd led the country through the worst economic crisis since the Great Depression and had created five million jobs over 30 months. But he spun quickly to criticizing Romney, saying the GOP nominee's budget plan — which does not specify which tax credits and exemptions he would cut — would cut taxes by $5 trillion, slashing taxes for the wealthy but DU Presidential Debate ultimately raising them on the middle class. This assumption is based on analyses of Romney's plan that assert there is no way to cut federal spending as much as he wants without cutting spending on Medicaid and Medicare but also eliminating tax breaks enjoyed by the middle class like mortgage interest deductions and child care tax credits. "Are we going to double-down on the top-down economic policies that helped to get us into this mess?" Obama asked. "Or do we embrace a new economic patriotism that says America does best when the middle class does best?" Romney fired back that Obama was continuously mispresenting his plan. Romney said he would not enact any tax cut that increased the deficit, especially a cut on high-income earners. "I know that you and your running mate keep saying that, and I know it's a popular thing to say with a lot of people, but it's just not the case," Romney said. "Look, I've got five boys. I'm used to people saying something that's not always true, but just keep on repeating it and ultimately hoping I'll believe it. "But that — that is not the case. All right? I will not reduce the taxes paid by high-income Americans." It was the first debate between Obama, the Democratic incumbent president, and Romney, the former governor of Massachusetts and Republican nominee for president. The debate at DU's Ritchie Center centered mostly on the economy, job creation and America's deficit. The debate was hosted by the Commission on Presidential Debates and moderated by PBS' Jim Lehrer, who started by asking the pair how they would create jobs. Mail ballots in Colorado go out Oct. 15, and an estimated 80 percent of voters will have cast their ballots by the November election. The debate also touched on the Affordable Care Act, the 2010 federal health care reform law that Romney referred to as "Obamacare," apologizing to the president for using that term, which some critics use derisively. Obama shrugged it off, saying, "I like it."
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Police: Connecticut man swallows cousin's ear lobe during fight
Police in Connecticut say a city man bit off his cousin's ear lobe and swallowed it during a fight over loud music.
Officers in Stamford charged 27-year-old Emilio Mendoza with first-degree assault and other crimes early Monday morning in connection with the attack on his cousin, 29-year-old Ruiz Clemente-Perez.
Clemente-Perez told police that he asked Mendoza to turn down his loud music because he had to work in the morning, but Mendoza started punching him in the head. During the brawl, Mendoza allegedly bit off part of Clemente-Perez's left ear and swallowed it.
Officers say Clemente-Perez was bleeding and missing part of his ear when they arrived. He also suffered a broken nose and fractured eye socket.
Mendoza is detained on $100,000 bail. It's unclear if he has a lawyer.


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Espace et Volume and Finstral together offer the most complete range of windows in Europe.
You don't buy windows off the shelf – windows are planned individually. The frame form, the colour, material and functions should all aim to match the architecture and furnishing style of the house. As a manufacturer, Finstral offers the greatest variety and freedom of design in Europe: practically every item in its range can be combined with everything else.


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Minivan destroyed after GPS leads driver onto MBTA tracks in Belmont
Woman, children escape vehicle stuck on tracks
A Belmont woman and two children escaped serious injury when a train slammed into their minivan after a GPS device led the driver onto MBTA train tracks Tuesday night.
The woman, who was not identified, was driving southbound on Brighton Street shortly before 9 p.m. using her GPS. Two children, ages 7 and 10, were inside the vehicle at the time.
Just before Hittenger Street, the GPS indicated for her to take a right-hand turn, police said.
Unfortunately the turn positioned her vehicle onto the railroad tracks. The woman tried to drive the minivan off the tracks, but was unsuccessful. She fled the vehicle with two minor children.
Shortly after, a MBTA Fitchburg bound commuter rail train struck the vehicle, leaving it in a mangled mess on the tracks.
The driver and children were not injured. There were about 70 passengers on the train at the time of the crash.
Last summer, a South Attleborough woman told police she was driving in Brookline when her GPS caused her to take a turn onto the Green Line trolley tracks. Her car got stuck on the tracks, but there were no trains in the area at the time.


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Customize your JAMA Network experience by selecting one or more topics from the list below.
Kesselheim AS, Myers JA, Avorn J. Characteristics of Clinical Trials to Support Approval of Orphan vs Nonorphan Drugs for Cancer. JAMA. 2011;305(22):2320–2326. doi:10.1001/jama.2011.769
© 2023
Author Affiliations: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Context The Orphan Drug Act incentivizes medication development for rare diseases, offering substantial financial benefits to the manufacturer. Orphan products constitute most new drug approvals in oncology, but safety and efficacy questions have emerged about some of these agents.
Objectives To define characteristics of orphan cancer drugs and their pivotal clinical trials and to compare these with nonorphan drugs.
Design and Setting We identified all new orphan and nonorphan drugs approved between 2004 and 2010 to treat cancer. We then collected data on key development variables from publicly available information on the US Food and Drug Administration's Web site and in the Code of Federal Regulations.
Main Outcome Measures We assessed clinical testing dates, approved indications, and regulatory characteristics (regular vs accelerated review, advisory committee review, postmarketing commitments). We then compared design features (randomization, blinding, primary end point) of pivotal trials supporting approval of orphan and nonorphan drugs and rates of adverse safety outcomes (deaths not attributed to disease progression, serious adverse events, dropouts) in pivotal trials.
Results Fifteen orphan and 12 nonorphan drugs were approved between January 1, 2004, and December 31, 2010. Pivotal trials of orphan drugs had smaller participant numbers (median, 96 [interquartile range {IQR}, 66-152] vs 290 [IQR, 185-394] patients exposed to the drug; P < .001) and were less likely to be randomized (30% vs 80%; P = .007). Orphan and nonorphan pivotal trials varied in their blinding (P = .04), with orphan trials less likely to be double-blind (4% vs 33%). Primary study outcomes also varied (P = .04), with orphan trials more likely to assess disease response (68% vs 27%) rather than overall survival (8% vs 27%). More treated patients had serious adverse events in trials of orphan drugs vs trials of nonorphan drugs (48% vs 36%; odds ratio, 1.72; 95% confidence interval, 1.02-2.92; P = .04).
Conclusion Compared with pivotal trials used to approve nonorphan cancer drugs, pivotal trials for recently approved orphan drugs for cancer were more likely to be smaller and to use nonrandomized, unblinded trial designs and surrogate end points to assess efficacy.
The Orphan Drug Act of 1983 provides special incentives to manufacturers who develop drugs to treat rare diseases (affecting <200 000 people in the United States), including grants to perform clinical trials, a 50% tax credit for clinical testing costs, and an exclusive right to market the drug for 7 years after regulatory approval.1 Orphan drug manufacturers also receive waivers of drug application fees and may be eligible for faster review by the US Food and Drug Administration (FDA).2 Through 2010, 362 orphan designations have led to approvals, with oncology representing the largest clinical subcategory.3
While the Orphan Drug Act has been lauded as highly effective policy making,4,5 there has been some debate about how its incentives are implemented. For example, a recent study suggested that the Orphan Drug Act encourages manufacturers to define subdivisions of nonrare conditions, such as subpopulations in whom existing therapies have failed or who have a more severe or progressed form of a disease.6 Recent developments have also raised concerns about the safety and efficacy of some approved orphan drugs. For example, gemtuzumab ozogamicin, an orphan drug approved in 2000 for acute myeloid leukemia, was removed from the market in 2010 when a confirmatory postmarketing trial (initiated in 2004) showed no improvement in outcome and a greater number of deaths in the gemtuzumab group.7 The drug was originally approved after an open-label study in 142 patients with no control group, using the surrogate end point of complete remission.8 In early 2010, the United Kingdom's National Institute for Clinical Excellence recommended against use of 2 orphan drugs also approved in the United States—nilotinib and dasatinib for chronic myelogenous leukemia—because evidence to support their effectiveness was "very poor" and their cost was "extremely high."9
The FDA must approve prescription drugs on the basis of adequate studies, which, according to the Code of Federal Regulations, requires a "design that permits a valid comparison with a control."10 However, such requirements may be relaxed at the discretion of the FDA,11 and orphan drugs are likely to qualify for lower approval standards because they are designed for small populations in which organization of controlled trials may be difficult.12,13 In 2009, Mitsumoto et al14 evaluated 3 characteristics—blinding, control groups, and randomization—in the pivotal clinical trials used to approve orphan drugs for neurological conditions and found that a substantial minority of trials for orphan drugs lacked these qualities.
We hypothesized that we would find similar differences in the basis of approval for newly approved orphan vs nonorphan drugs used in oncology. We also sought to identify whether those differences were associated with signals of safety concerns in the approved drugs. Therefore, we identified characteristics of the core preapproval clinical trials, as well as the efficacy and safety outcomes of the trials, for recently approved orphan and nonorphan cancer drugs.
We first identified the names of all new orphan drugs approved by the FDA to treat cancer-related indications between January 1, 2004, and December 31, 2010, a period when comprehensive data needed for this study were accessible. The cohort was derived from a public domain master list of all orphan product approvals and their approved indications published by the FDA Office of Orphan Product Development.15 We selected those indicated to treat a form of cancer, as defined in a complete cancer directory published by the National Cancer Institute.16
For a comparator group of drugs, we used the FDA Web site to identify all nonorphan drugs approved during the same period to treat cancer-related indications.17 For both groups, we excluded drugs already on the market that received a supplemental approval for a cancer-related condition during this period.
The FDA publishes summary reports of the basis of approval and makes them publicly available on the Drugs@FDA Web site. This document provides (1) an overview of the drug development process, including a description of the administrative characteristics of the FDA review and (2) a detailed description of clinical data collection. Data were collected independently by 2 of us (A.S.K. and J.A.M.), with differences reconciled by consensus.
First, we noted the characteristics of first approval mentioned in the FDA reports, including indication, dates, drug class, and alternative therapies available at the time of approval. We then extracted when possible the important administrative and drug development dates corresponding to the approval of the Investigational New Drug (IND) application (beginning of human trials), the orphan drug designation (if applicable), and the filing of the New Drug Application (NDA). Dates were checked for 17 products from drug-specific Determinations of Regulatory Review Period for Purposes of Patent Extension published in the Code of Federal Regulations. For 2 orphan drugs for which IND dates could not be located (decitabine and temsirolimus), we used the earliest reported date of communication with the FDA, while for 1 orphan drug (azacitidine) for which the original IND was reportedly set more than 30 years ago, we used the more recent date of initiation of contact between the FDA and the manufacturer regarding trials in the patient population for which the drug was approved. Next, we identified whether an FDA advisory committee was convened to consider the drug's efficacy and safety and whether the drug underwent regular or accelerated review. Finally, we noted postmarketing commitments required at the time of approval by examining the formal Letter of Approval for each drug (available on the FDA Web site) and a special database published by the FDA that lists all postmarketing requirements for approved drugs.18
We next focused on the trials leading to each drug's approval. The Clinical Review provides detailed information on the methods and results of the trial(s) deemed by the FDA to be most important in providing support for the indication(s) for which a drug is approved; these are usually labeled as "pivotal" trials. The Clinical Review also provides more limited information about so-called supportive studies that supplemented the efficacy data presented in the pivotal trials. In 1 case in which the Clinical Review provided a detailed report about a trial but did not specify whether it was pivotal or supportive (for the orphan drug dasatinib), we considered this trial to be pivotal. For all pivotal trials, we identified basic features of their design: whether participants were randomized, the extent of blinding (double-blind, single-blind, or open-label), the number of participants (defined as the number randomized to active treatment in randomized controlled trials and the total number of enrollees in single-group studies), and the existence (if any) of a comparator. The primary end point was recorded as relating to overall survival or 1 of 2 general types of surrogate end points recognized by the FDA: disease response (including hematological response, cytogenetic response, or change in tumor burden) or a temporal measure of disease progression (including time to tumor progression and progression-free survival). If trials included open-label extensions, we defined the features of the trial based on the controlled segment.
We also collected the results of pivotal trials, including reported rates of any serious adverse events, deaths not related to progression of disease, and dropouts due to adverse events. Although we sought to focus on pivotal trials, safety data were occasionally reported in aggregate with nonpivotal trials; if so, we adjusted the denominator accordingly. If any details were not extractable from the Clinical Review, we sought copies of published articles related to the pivotal studies and checked the data reported in that source. We were unable to identify rates of death for 1 trial of the nonorphan drug sunitinib and serious adverse events for the 2 trials of the orphan drug nilotinib.
We used the Fisher exact test to compare the distributions of categorical attributes (randomization, blinding, etc) between orphan and nonorphan trials and between orphan and nonorphan approval processes. A nonparametric Wilcoxon rank sum test was used to compare the development times and the number of patients treated with the study drug between orphan and nonorphan trials. To compare relative rates of serious adverse events, deaths, and dropouts, we used patient-level random-effects logistic regression models for each of these outcomes, with a random intercept for each trial and a fixed effect for orphan status. From these models, we estimated the odds ratio (OR) of a given trial characteristic comparing orphan trials with nonorphan trials.
We also used the Simes procedure (a modified Bonferroni correction) to test the null hypothesis of no differences between orphan and nonorphan approval characteristics.19 This procedure allows evidence to be combined across many hypothesis tests of varying type. Rejecting the null hypothesis at the .05 level of significance indicates that at least 1 of the individual differences tested is nonzero with a global type I error of .05. The statistical analysis was conducted using R software, version 2.12.2, with a 2-sided α = .05.20
Our sample included 15 orphan drugs (56%) and 12 nonorphan drugs (44%) approved to treat oncologic diseases (Table 1). Twenty-three (85%) were approved under an NDA, while 4 (15%) were approved under a Biologics Licensing Application. The indications covered 14 different general categories of cancer, led by renal cell carcinoma (5 drugs), acute lymphoblastic leukemia in pediatric and adult patients (3 drugs), myelodysplastic syndrome (3 drugs), breast cancer (3 drugs), and colorectal cancer (3 drugs). Among the drugs approved for renal cell cancer, 3 were orphan drugs and 2 were nonorphan drugs. Three of the orphan drugs (20%) and 5 nonorphan drugs (42%) were novel compounds not closely related to previously FDA-approved drugs, while 6 orphan drugs (40%) and 4 nonorphan drugs (33%) were approved for at least 1 condition with no alternative approved chemotherapeutic agents (Table 1).
The median total clinical testing phase (IND approval to NDA submission) for orphan drugs was 5.1 years (interquartile range [IQR], 4.5-7.0 years), shorter than that for nonorphan drugs (6.9 years [IQR, 6.5-8.0 years]), although it was not a statistically significant difference (P = .07). The median FDA review time—from submission of the NDA to final approval—was nearly identical: 6.2 months (IQR, 5.8-8.9 months) for orphan drugs and 6.1 months (IQR, 5.4-8.0 months) for nonorphan drugs (P = .45). The orphan drugs received their orphan designations a median of 2.4 years (IQR, 1.2-2.7 years) before the date of approval.
With regard to the FDA review process, 7 orphan drugs (47%) were reviewed by an FDA advisory committee compared with only 1 nonorphan drug (8%; P = .04). There was no difference in the distribution of usual vs accelerated review (P = .70): 5 (33%) of the orphan drugs and 2 (17%) of the nonorphan drugs underwent accelerated review, with 1 orphan and 1 nonorphan drug receiving both regular and accelerated review for different indications.
As reflected in documents made public by the FDA, all drugs except 1 (the orphan drug pemetrexed) were approved with postmarketing "commitments" and "recommendations" of various types, although the agency's capacity to require the completion of such studies is limited, especially for the years studied.21 For most drugs, the FDA asked manufacturers to complete a controlled trial assessing efficacy (including overall survival); we could not identify such requirements for 6 orphan drugs (40%) and 1 nonorphan drug (8%).
The FDA approvals for the 27 drugs in this sample were based on 38 pivotal and 19 supportive trials. Among the 38 pivotal trials, 23 were conducted for the 15 orphan drugs and 15 were conducted for the 12 nonorphan drugs. Pivotal trials for orphan drugs enrolled fewer patients exposed to the drug per study than those for nonorphan drugs (median, 96 [IQR, 66-152] vs 290 [IQR, 185-394]; P < .001). Table 2 presents the characteristics of these trials.
The pivotal trials on which approval of orphan drugs was based were significantly less likely to be randomized than the pivotal trials of nonorphan drugs (30% vs 80%; P = .007). Among the 7 orphan drug pivotal trials that were randomized, the drug was compared with an active comparator in 4, a placebo in 1, and supportive care in 2. Among the 12 randomized pivotal trials for nonorphan drugs, 7 included testing against an active comparator, 4 against a placebo, and 1 against supportive care.
Adequate masking (blinding) of study group assignment was significantly less common for orphan drug studies (P = .04). Of the 23 orphan drug pivotal trials, only 1 was double-blind (4%) and 1 was single-blind (4%). In contrast, 5 of 15 nonorphan drugs studies (33%) were double-blind.
The distributions of the primary outcomes studied also varied by orphan status (P = .04). Most pivotal trials of orphan drugs used a surrogate measure of disease response as the primary trial end point (17/23 [68%]), while pivotal trials for nonorphan drugs most commonly used a measure of disease progression (6/15 [40%]). In total, 21 of the 27 drugs (78%) were approved on the basis of data on surrogate end points; the exceptions were 4 nonorphan drugs—bevacizumab for advanced colorectal cancer, erlotinib for advanced non–small cell lung cancer, eribulin for advanced breast cancer, and cabazitaxel for advanced prostate cancer—and 2 orphan drugs: temsirolimus for advanced renal cell carcinoma and pemetrexed for malignant pleural mesothelioma. Further details of the pivotal studies of the orphan cancer drugs in our study are presented in the eTable.
Patients participating in preapproval studies of orphan drugs had a higher rate of serious adverse events than those in studies of nonorphan products. A total of 1358 serious adverse events were reported in 2806 treated patients in orphan drug pivotal trials (48%), significantly more than in nonorphan drug pivotal trials, where there were 1666 serious adverse events in 4621 patients (36%; OR, 1.72; 95% confidence interval [CI], 1.02-2.92; P = .04). There was a higher death rate among patients in the orphan drug studies, although the difference did not reach statistical significance (129/3105 [4.2%] vs 135/4534 [3.0%]; OR, 1.61; 95% CI, 0.89-2.91; P = .12). The proportion of dropouts (316/2940 [10.7%] vs 658/4745 [13.9%]; OR, 0.78; 95% CI, 0.51-1.20; P = .26) also did not differ significantly between the 2 cohorts.
Combining information from all the comparisons reported above, the Simes procedure rejects the null hypothesis of no differences between orphan and nonorphan drug approval characteristics (a P value is not available for this procedure).
A review of all new drug approvals from 2004 through 2010 in oncology reveals several important differences in the preapproval evaluation of orphan vs nonorphan drugs for patients with cancer. The Orphan Drug Act has made available considerable resources to encourage manufacturers to develop new drugs for rare conditions. In evaluating such products, the FDA has approved alternative trial designs that allowed most orphan cancer drugs to be approved on the basis of single-group, nonrandomized trials that enrolled comparatively small numbers of patients. These pivotal trials tended to be unblinded and relied on surrogate markers of disease response to assess efficacy. Perhaps because of more limited preapproval testing, drugs designated as orphan products had shorter clinical testing phases than nonorphan products, although this difference did not reach statistical significance.
There can be several reasons for approving some cancer drugs—including orphan drugs in particular—on the basis of trials with limitations in their design. Organizing a randomized clinical trial of a new cancer drug might not be feasible if the disease is exceedingly rare or might encounter resistance if a reasonable therapeutic alternative does not exist. Using surrogate end points for the pivotal trials leading to drug approval is a common practice in oncology,22 and many drugs approved on this basis remain useful and on the market.23 Preapproval trials that are single-group or that use surrogate end points can be completed and analyzed more rapidly than large randomized trials, which can expedite drug availability to patients with life-threatening disease.24 However, while the complexity of performing clinical trials in orphan populations should be acknowledged, methodological designs should still strive to include blinding25 and randomization,26 which are among the hallmarks of high-quality clinical trial design.
The higher frequency of nonblinded, nonrandomized trials of orphan drugs raises concerns about the robustness of the findings of such trials. While the FDA permitted surrogate end points to be the basis for approval of many of the orphan drugs (and some nonorphan drugs) in our study,27 these efficacy data can later turn out to be unfounded, as in the cases of gemtuzumab ozogamicin and the approval of bevacizumab for breast cancer.28 In addition, although both newly approved orphan and nonorphan cancer drugs in our sample were tested in relatively small numbers of patients prior to approval, we found a suggestion of safety concerns associated with the orphan drugs. No new drug's safety can be completely assessed on the basis of prospective clinical trials.29 The FDA has recently announced a commitment to comprehensive and timely follow-up testing and postmarketing surveillance of cancer drugs granted accelerated approval,30 and our findings support extending this policy to orphan drugs as well. Notably, manufacturers of orphan drugs receive substantial additional financial benefits during the drug development process, including tax breaks, additional market exclusivity, and research grants. One way to encourage timely completion of such studies would be to amend the Orphan Drug Act to withdraw exclusivity for drugs or require reimbursement of public grant funding if the required studies have not been satisfactorily completed after 3 years on the market.
Our study shines a light on other aspects of drug development and evaluation related to the Orphan Drug Act. First, while there are about 6000 unique rare diseases affecting about 25 million Americans,5 including many malignant conditions, most orphan drug innovation in our sample occurred for a limited number of diseases and drug classes (eg, tyrosine kinase inhibitors). These results suggest that the orphan drug incentives may not encourage transformative drug innovation that affects a diverse range of conditions. Furthermore, although patients benefit from having multiple treatment options, there may be less compelling justification for rapid approval of follow-on drugs, even if they treat a rare disease. It should be possible for orphan drugs that are not first-in-class compounds or that do not address an important unmet clinical need to be subjected to higher standards of clinical evaluation, more similar to that expected of nonorphan cancer drugs.
We found some variability in the way the orphan drug designation was applied. For example, drugs approved to treat advanced renal cell cancer were evaluated as both orphan and nonorphan products, even though disease prevalence has not changed substantially over the past decade.31 Sunitinib was approved to treat gastrointestinal stromal tumor as a nonorphan product, even though this is an extremely rare condition that would qualify for orphan drug status. Orphan designation occurred relatively late in the product life cycle for many drugs, well into the clinical testing phase. If a product was initially designed solely for a particular orphan disease, one might predict that orphan designation would occur close to the time of the initiation of clinical trials. One potential explanation is that manufacturers may delay the administrative mechanism required for orphan product designation until the early clinical results suggest that a product will be marketable. Another possibility is that manufacturers identify whether their product will be useful in an orphan disease relatively late in the process, which also leads to questions about the role of the statutory incentives in driving drug development.
This study has certain limitations. It is restricted to recently approved cancer drugs and so may not be generalizable to orphan drugs for other diseases. However, our results are consistent with the findings of Mitsumoto et al,14 who studied this question in neurology. In addition, our study is limited to pivotal trials and we did not examine the entire range of data presented to the FDA. For example, the FDA commonly evaluates the safety of cancer drugs under review by taking into account results from all phase 1 trials and experiences of patients who receive the product for compassionate use, neither of which were included in our analysis. We do not conclude that the FDA erred in its decision to approve any of the products in our sample.
Our results may also reflect that most orphan drugs in our sample relate to hematologic malignancies, for which the clinical trial designs observed and use of surrogate end points such as disease response may be appropriate, at least for initial evaluation of the drugs' efficacy.27 In nearly all circumstances, the design of pivotal studies for potential new cancer drugs is prospectively agreed on after discussions between the sponsoring pharmaceutical manufacturer and the FDA. Worse safety outcomes for orphan drugs may also be related to the patient population in which these drugs were tested, rather than the drugs themselves, although many orphan and nonorphan drugs in this sample were tested in patients with advanced disease who had received 1 or more prior chemotherapy regimens.
The Orphan Drug Act is widely regarded as a watershed piece of legislation that has helped spur the development of numerous useful drugs for rare medical conditions. However, given the limited evidentiary basis on which orphan cancer drugs are approved, the act may need to be amended so that its resources can be more selectively guided to first-in-class drugs or those that treat a condition for which no other treatments are available, and to ensure that orphan products are rigorously evaluated and closely followed up once they are approved.
Corresponding Author: Aaron S. Kesselheim, MD, JD, MPH, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, 1620 Tremont St, Ste 3030, Boston, MA 02120 (firstname.lastname@example.com).
Author Contributions: Dr Kesselheim had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Kesselheim, Avorn.
Acquisition of data: Kesselheim, Myers.
Analysis and interpretation of data: Kesselheim, Myers, Avorn.
Drafting of the manuscript: Kesselheim, Myers.
Critical revision of the manuscript for important intellectual content: Kesselheim, Avorn.
Statistical analysis: Myers.
Obtained funding: Kesselheim.
Study supervision: Avorn.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Funding/Support: Dr Kesselheim is supported by career development award K08HS18465-01 from the Agency for Healthcare Research and Quality and a Robert Wood Johnson Foundation Investigator Award in Health Policy Research.
Role of the Sponsor: The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; or preparation, review, or approval of the manuscript.
Additional Contributions: We thank Deborah Schrag, MD, MPH, Department of Medical Oncology, Steven Joffe, MD, MPH, Department of Pediatric Oncology, and James E. Bradner, MD, Department of Medical Oncology, all from Dana-Farber Cancer Institute, Boston, Massachusetts, for their comments on a previous draft. They received no compensation for their work.


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From "Me" To "We:" Communicating with Your HEALTHCARE Team
When you are dealing with an illness like PH, it is important to talk often and comfortably with your healthcare team. SPEAK UP to help the team understand your needs and discuss options; the PH team does not know what you are experiencing or what questions you have until you tell them. Empowered patients allow the PH team to partner with them in their care and know that taking charge of their health is an ongoing process. The following tips will make it easier for you and your team to cover everything you need to talk about during your appointments.
List and Prioritize Your Concerns: If you have several items, put them in order and group similar topics together. Don't put off the things that are really on your mind – bring them up right away!
Bring Information with You: Some PH teams suggest bringing all medications and supplements to your appointment. Others recommend you bring a list of everything you take. Find out your team's preference and try to meet their request. Have copies of your medical records, a current medication list, PH history, other recent health history and immunizations and remember to update them regularly. Don't forget to bring your insurance information and medical ID numbers, including contact names and phone numbers.
A helpful resource for managing this information is PHA's Empowered Patient Toolkit.
Consider Bringing a Family Member or Friend: Let your family member or friend know in advance what you want from them at your visit. Your companion can remind you what you planned to discuss with the doctor if you forget, take notes for you and help you remember what the doctor said.
Plan to Update the Team: Be honest with your healthcare team when you answer their questions. Provide points of reference; keep a journal or calendar of symptoms and issues and note the impact on your daily activities and what makes symptoms better or worse. If family or friends are with you, be sure to include them in the conversation and ask them to provide examples.
Your team may ask you how your life is going, as this may be useful medically. It's okay to ask family and friends to leave the room so you have some time alone to talk to your team. Let the doctor know about any major changes or stresses in your life, but don't forget to talk about the good things as well!
Ask Questions: If you don't ask questions, your team may assume you already know the answer or that you don't want more information. If you don't understand something, say so. You should not leave until you comprehend what is being communicated. If you have a family member or friend who helps you take medicine, make sure to sign a release and ask the team to talk to him or her. If you have a power of attorney and/or healthcare directive, carry a copy with your medical records and update them as appropriate.
When it comes to your treatment, instructions from your team are important. Tell them what you think the instructions are and let them know if they need to write them down. Ask about different treatment options. You will benefit most from a treatment when you know what is happening and are involved in making the decisions. Make sure you understand what your treatment involves and what it will or will not do. Ask for prescriptions to be renewed at your appointments. If you need to call your team for a prescription renewal, try to give them at least two weeks' notice.
Know when to call your team and when to head for the emergency room. Does your team want you to call with a 2-3 lb. weight gain over two days? What are your team's specific instructions related to the PH therapy you are on? If you wonder if your question is one you should ask your team, please call; they are there to help you and can talk through any issues you are having.
If You Go to the Emergency Room: Make sure to bring your prepared collection of medical information and contacts. While in the emergency room, ask questions if you don't understand tests or procedures that are being done. Make sure to notify your PH team on your way to the hospital even if your visit is not PH-related and contact them with an update after your visit.
Keep Contact Information Accessible: Always have your center's phone number available in your phone under DOCTOR, on your medical alert bracelet and in your medication box. Have a list of important phone numbers and an up-to-date medication list on your refrigerator; this is usually the first place EMS will look for it.
Always remember that you are your own best advocate. Communicating openly and honestly with your PH team is essential to your PH journey.
This article first appeared in Pathlight, Winter 2013. Written by Louise Durst, RN, Research Nurse and Study Coordinator, Mayo Clinic Medical Center, Rochester, Minn.


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This forum section is a read-only archive which contains old newsgroup posts. If you wish to post a query, please do so in one of our main forum sections (here). This way you will get a faster, better response from the members on Motherboard Point.
What does 10000 refer to, in "Sun Enterprise 10000 server"?
Discussion in 'Sun Hardware' started by qazmlp1209, Dec 1, 2006.
- Ask a Question


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3 Way Intersection Mighty Line Floor Sign, Industrial Strength, 12" Wide. Mighty Line safety floor signs are a great floor marking tool. Mighty Line floor signs are perfect solutions for 5s facilities, lean operations, and for warehouse safety.
Easy to Install
Your warehouse floor must be clean and dry. You can peel the liner back and stick it down by hand, or you can use our new Mighty Liner.
Withstands Forklift Traffic
Mighty Line floor tape has a beveled edge on both sides. These edges allow for industrial wheels to roll over without catching. The thickness of the tape allows it to stay on your floors for 3 years.
Easy To Remove
Cheaper floor tapes become expensive later on. Mighty Line floor tapes leave no residue. To remove, use a thin tool to get under the tape and pull the tape up in one piece. Mighty Line guarantees clean removal.
Easy to Keep Clean
Run your floor scrubber over the tape or mop it with a degreaser. Cleaning our tape as you clean your floor is encouraged. Avoid acids and standing water. Mighty Line has a very smooth surface that does not trap dirt.


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In this tutorial we'll take a look at making parametric tubes with threads using the coils feature in Fusion 360.
Learn Guide
CAD files on Prusa Printers
Fusion 360 Share Link
As 2022 starts, let's take some time to share our goals for CircuitPython in 2022. Just like past years (full summary 2019, 2020, and 2021), we'd like everyone in the CircuitPython community to contribute by posting their thoughts to some public place on the Internet. Here are a few ways to post: a video on YouTub, a post on the CircuitPython forum, a blog post on your site, a series of Tweets, a Gist on GitHub. We want to hear from you. When you post, please add #CircuitPython2022 and email email@example.com to let us know about your post so we can blog it up here.
Stop breadboarding and soldering – start making immediately! Adafruit's Circuit Playground is jam-packed with LEDs, sensors, buttons, alligator clip pads and more. Build projects with Circuit Playground in a few minutes with the drag-and-drop MakeCode programming site, learn computer science using the CS Discoveries class on code.org, jump into CircuitPython to learn Python and hardware together, TinyGO, or even use the Arduino IDE. Circuit Playground Express is the newest and best Circuit Playground board, with support for CircuitPython, MakeCode, and Arduino. It has a powerful processor, 10 NeoPixels, mini speaker, InfraRed receive and transmit, two buttons, a switch, 14 alligator clip pads, and lots of sensors: capacitive touch, IR proximity, temperature, light, motion and sound. A whole wide world of electronics and coding is waiting for you, and it fits in the palm of your hand.
Join 32,000+ makers on Adafruit's Discord channels and be part of the community! http://adafru.it/discord
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"The major cause of the Civil War is when slavery spread its ugly testicles across the West."
From Ignorance Is Blitz
Ignorance Is Blitz: Mangled Moments of History From Actual College Students. Compiled by Anders Henriksson. Workman, 155 pp., $6.95, paperback. Originally published as Non Campus Mentis.
By Janice Harayda
Zoroastrianism was founded by Zorro. The South succeeded from the Union. Joan of Arc was Noah's wife.
What a pity that SAT scores don't measure common sense. If they did, those of us who have taught college students might have seen far fewer lines like these on tests and term papers. And now comes Ignorance Is Blitz to show us that cultural illiteracy on campus is at once far more extensive — and more entertaining — than some of us knew from the students who solemnly told us that a fictional character founded a major religion or that the South "succeeded" from the Union.
After decades of teaching at a state college in West Virginia, Anders Henriksson has collected hundreds of his students' gaffes and supplemented them with others from professors at universities in the U.S. and Canada. Henriksson doesn't name most of the schools, and that's a mercy when the blunders include lines like:
"The P.L.O. is the airline of Israel."
"George Eliot was written by Silas Marner."
"Greek semen ruled the Agean [sic.]."
"The Berlin Mall was removed."
"Without the discovery of the flying buttock it would have been an impossible job to build the Gothic cathedral."
"John Huss refused to decant his ideas about the church and was therefore burned as a steak."
"The Civil Rights movement in the USA turned around the corner with Martin Luther Junior's famous 'If I Had a Hammer' speech."
In a postscript Henriksson blames some of the tragicomic errors on an overreliance on spell-checkers and on anxieties about test-taking. The causes of the problem go deeper than he allows and include a devaluation of history in schools and grade inflation that allows some students to do well even if they write, as one student in the book did, that "St. Teresa of Avila was a carmelized nun."
But the skimpy analysis in no way detracts from the hilarity found on nearly every page of Ignorance Is Blitz. Well ahead of the holiday season, this small-format humor book has emerged as of the year's best literary stocking stuffers. In the meantime some of its mangled lines could add levity to a tense election season. You're worried about problems with those butterfly ballots? America's students are here to remind you that it could be worse. There was a time when, as one of them put it, "Voting was done by ballad."
Best line: "The major cause of the Civil War is when slavery spread its ugly testicles across the West."
Worst line: "Machiavelli, who was often unemployed, wrote The Prince to get a job with Richard Nixon." One of the few lines that make you wonder if a student was pulling the teacher's leg.
Recommendation? A great gift for teachers, history lovers and, of course, some of those "actual college students" in the subtitle. Many high school students would also enjoy this book.
Editor: Ruth Sullivan
Published: January 2008 www.workman.com/products/9780761149491/. First published in 2001 under the title Non Campus Mentis. Portions of the material in the book appeared in The Wilson Quarterly.
© 2008 Janice Harayda. All rights reserved.


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As of September 2021, we have moved technical support to Robolink Help
Welcome to the Robolink Community forum!
You can post here to interact with others in the Robolink community. We're checking it weekly, and we'll respond to some messages. If you're looking for technical support, head over to Robolink Help.
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Movie review: 'Red Dawn' is a dismal remake
"Red Dawn" (D)
Just what we need for the Thanksgiving holiday: another pointless remake, and appropriately enough, "Red Dawn" is a turkey. Hold the stuffing. It's already loaded with byproducts.
You know, it's one thing to remake a good movie. It's quite another to Xerox a film that was a gobbler the first time around. At least the 1984 version featured a decent cast, including Patrick Swayze, Charlie Sheen, Ben Johnson, Harry Dean Stanton and Jennifer Grey. The remake features Chris Hemsworth ("Thor") and castaways from the Island of Misfit Thespians.
For a little background, the remake has been sitting on the shelf for awhile as its studio, MGM, dealt with some financial issues. Too bad the film didn't stay in mothballs. Rumor has it that the bad guys in this version were initially Chinese, but not wanting to alienate such a large market, the filmmakers decided to change the villains to North Koreans complete with CGI alterations. Easy target as the Kim Jong-un Fan Club has few members. So, repeat after me, the North Koreans are coming! The North Koreans are coming! Strikes fear into your heart, doesn't it?
In the original, a group of plucky teenagers fights to save the United States from the invading communists from Russia. In the remake, opening today, a group of plucky teenagers fights to save the United States from the invading communists from North Korea. Interchangeable commies. Hey, the only good Red is a dead Red, right? The original struck a chord during the Cold War and, besides, who doesn't want to root for plucky teenage underdogs? The remake may strike a chord, too, with its jingoistic hokum as the film wears the American flag on its sleeve, its pant leg and its boxer shorts. That the movie is preposterous is almost beside the point. As the movie's tagline says, "Welcome to the home of the brave." And the braindead.
The film opens with news footage featuring actual politicians providing a Cliff Notes version of global politics where North Korea is painted as the bogeyman. Hey, its leader is insane so an invasion is possible, right? And the invasion could be successful, right? Paratroopers land in Spokane and our only defense is a group of plucky teenagers? Don't ask, don't smell.
We then get introduced to our plucky teenagers. There's Matt Eckert (Josh Peck), who plays quarterback for his high school football team, the Wolverines. He thinks he can do it all by himself. Think he'll learn the value of teamwork by film's end? Then there's Jed Eckert (Hemsworth), Matt's older brother who just happens to be a Marine. Matt and Jed have issues. Think they'll get resolved by film's end? We also have Matt's girlfriend Erica (Isabel Lucas), who plays the stereotypical cheerleader, and Robert (Josh Hutcherson), who plays the stereotypical best friend. To boost its demographic reach, the film includes a black teen and two Hispanic teens. At the start of the invasion, the teens number around 12 – it's the Dirty Acne Dozen - but their numbers sadly decrease during the course of the film. Can you predict which ones will die? Will you care?
Anyway, Jed takes time out from the bloodshed to train the teens in warfare and transform them into a crack guerrilla fighting unit. Sure, that's possible.
The remainder of the film shows the plucky teenagers raising all kinds of heck with the North Koreans: shooting them, blowing them up, making them listen to Justin Bieber. As with a Michael Bay film, pay no attention to the plot, just watch the explosions.
And definitely don't listen to the dialogue. If the script's prose were any more purple, it would be an eggplant. "Even the tiniest flea can drive a big dog crazy," says Jed, who gets to utter most of the inane phrases. Later on, he proclaims, "We inherited our freedom. Now, it's time to fight for it!" All that's missing from these scenes is a playing of the Battle Hymn of the Republic.
For some added drama, Matt wants to rescue Erica from a North Korean prison. Think his actions will have consequences?
For the parents in the audience, the soundtrack adds a couple Creedence Clearwater Revival songs. Too bad it didn't include "Who'll Stop the Rain."
In between the gunfire and explosions, Jed finds time to rekindle a relationship with Toni (Adrianne Palicki). Why? Let us count the ways: to add another love interest for the female viewers who get dragged to this slop by their boyfriends, to present Jed's softer side so we care about him more and to pad the film's length.
This abomination was directed by first-timer Dan Bradley, a former stuntman, and penned by first-timer Jeremy Passmore and Carl Ellsworth. Yes, it's amateur hour and a half with no cliché left unused. Only the well-shot action scenes keep "Red Dawn" from being labeled cinematic manure.
The acting certainly doesn't help. Hemsworth is obviously slumming while Peck smiles and shouts a lot. Turnips demonstrate more emotion. Lucas and Palicki, meanwhile, get little to do except kiss their boyfriends, fire machine guns and blow things up. But she's always a woman to me.
Later in the film, the plucky teenagers steal a very important device from the North Koreans… and they never use it. Why? Well, either the filmmakers are idiots or they're planning a sequel. Or both. Maybe in the sequel, the plucky teenagers will vanquish the North Koreans and turn their attention to the nation that poses the real global threat to freedom, mom and apple pie: Liechtenstein. I can see the tagline now: "Let's lick Liechtenstein."
"Red Dawn" is rated PG-13 for sequences of intense war violence and action, and for language.


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Front Runners List: Click to see list completion progress by climbers that log their climbs using Peakbagger.com.
Compare Climbers: Click to compare ascents of up to 5 climbers working on this list.
The ten summits on this list are all in the eastern Olympic Mountains (visible across Puget Sound from Seattle) and also easily ascended as alpine scrambles, rather than serious climbs. They provide a good list of Olympic summits that lack the daunting climbing challenge of the range's higher peaks, and that are also more accessible from the Seattle area than the more remote Olympic wilderness.
= Peak with Rank #1 on List;   = Other Peaks
This page has been served 1118185 times since 2004-11-01.


text: One of my favorite bad jokes: "Why are French omelettes made with only one egg? Because in France, 'one egg' is un oeuf. " (I have a weakness for very bad jokes. ) Allow me to kill the joke with an explanation: oeuf is the French word for "egg. " Which makes it a particularly apt name for a nursery design company, especially one with French and American roots. When Sophie Demenge and Michael Ryan became parents, they realized there was no way for them to merge their own aesthetic tastes with a nursery outfitted according to their available options. So they created Oeuf, where they apply principles of clean, simple design to nursery necessities. Operating on the belief that babies don't really need too many items, they've dedicated themselves to producing safe, stylish essentials for a practical modern nursery.