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Happy Valentine's Day

My valentine understood me back in the early days when I didn't even understand myself. She taught me everything I know and helped me feel safe. She tolerates me even when I'm really bouncy. She lets me curl up next to her and use her ear as a blanket. I wouldn't be the dog I am without her.
Thank you for being my big sister, Lulu. I love you.

love,
Uba




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Happy Halloween!

 




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Happy birthday to me! (44)

Hello and howdy. I usually describe myself as turning the "ripe old age of so-and-so" on my birthday posts, but I may need a new adjective as I'm solidly in my mid-40s, now (44). Perhaps "fermented." The birthday's come and gone without incident, although there were minor contemporaneous incidents:

Still in the math hole. It might be an infinite hole. Trying to get out. But I have improved my console fonts and ANSI color libraries and GPU programming skills, at least. I was very pleased that a recent release of NVIDIA drivers came with a brand new updated OpenCL, which I previously assumed had been abandoned like so many computer things that I become fond of. Kudos to whoever at NVIDIA pushed on this. I am making myself laugh privately to myself (well, no longer private now) by imagining someone who spells it out like an acronym, N-V-I D-I-A.

Also, like usual, I ran the Pittsburgh Great Race, a mostly-downhill 10k. No encumbrances this time. I've been in good shape this summer, but I got sick last month and it set me back a bit, so this wasn't a star performance. Still 43m22s is not too bad and I didn't push myself all that hard. Fewer minutes than years old.

The new GPU is mostly for math, but I wanted to try it out for its Intended Purpose, (N)Video Games. So I played through Far Cry 6, which was okay. I liked it better than 5, which among other things had a bunch of technical problems (this one was much smoother and more stable), but I probably should have read my review of that game before downloading, as I say something like "I should probably stop playing this series." Still slowly savoring Tears of The Kingdom, which remains great. I also started Return To Monkey Island. I loved the first two in this series, but couldn't get into the later sequels; of course I'm interested in giving this one a shot since it's made by the original designers (and I did like Thimbleweed Park). Too early to render a verdict, but I did like how they deftly handled the canonicity of the end of 2.

Then there's this: I think this is Taylor Swift wearing a homemade t-shirt of her "Pegicorn" (sometimes "Pegacorn"), a Unicorn-Pegasus hybrid. The text is in my font Action Jackson:


Taylor Swift Pegicorn (Action Jackson font)


You can also see this drawing/font at the beginning of the "Making of" video for You Belong With Me". I think she posted this to twitter in May 2009, but somehow I'm unable to find an archive of her tweets from this time (inconceivable??).




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Happy New Year 2024!

Hello and happy Honda-days, Toyota-thon, etc.!

It's the tail end of winter break here, and we did a little traveling to see family, etc.. But I've been keeping the calendar light so that I have plenty of time for projects. There are too many in the works simultaneously, which is a bad sign, but during break I made significant progress on all of them. I also added a new one, with the idea that it would be a "small hack" so that I'd be sure to have something for SIGBOVIK (not everything needs to be epic, right?). It already works, but now I'm in the midst of writing a PDF file generator, which is also a bad sign.

Now that I'm nearly done going in and out of my attic so much, it seemed like good timing to attend to the dangerously acrobatic way that I always get in, which is to stand at the very top of a ladder and then mantle up using the floor joists. It's not actually that dangerous even though the ladder demands that you Never Stand Above This Line (how am I supposed to stand in the attic then, ladder?!), but I regularly lose my phone out of my pocket in the last leg-swinging step, which is at least dangerous to the phone. Without belaboring the tale, I ended up "having" to go to Harbor Freight to invest in some suspiciously cheap tools like a set of black pipe threading dies, pipe wrenches, pipe cutter, and while I was there I got a new vise. Worried that the vise would be too easy to install, I wisely purchased carriage bolts with square necks, so I had to file down the mounting holes of this thing:


JPEG File


This provided a good occasion to listen to some albums in the basement and order some new files. It is now very firmly and satisfyingly bolted to that satisfyingly timeworn workbench. Not pictured is how I needed to grind down the bolts so that the cabinet door below could open and close again (I use this cabinet to store old vises).


Codename: Viseman


The only thing I have used the new vise for so far is to flatten one of the washers that was used to attach the old, crappy vise, so that I could weld that washer to the charging terminal on my Roomba so that it's able to charge again, so that I could vacuum up all the steel filings on my basement floor. Anyway, getting back now to the original task of making the entrance to the attic a similar amount of athletic but less fraught, I installed this pull-up bar:


workout


The only hard part of this was getting the pipe to be just the right length, and threaded, but I am now equipped to do such tasks.

Winter is also a time for hibernation. I played through The Talos Principle II. I really loved the first Talos Principle, which had no business being as good as it was (the team was mainly known for Serious Sam, an over-the-top first-person shooter). Talos is a puzzle game with a pretty interesting story and fairly thoughtful writing. The sequel is good and definitely worth playing if you liked the original. It has a bit of the "Portal 2" effect where they clearly had a bigger budget and wanted to add all this polish, but did miss some of what made the original magic along the way. As you know I love to play games "the wrong way," and so I'm always looking for ways to break the puzzles in this game. I felt like the first one let me get away with more hijinks, like you'd stack items to make your way up somewhere, and a third of the time it'd be a Star (expected for 100%), a third of the time it'd be an Easter egg (acknowledging your prowess), and a third of the time you'd just fall out of the map forever and have to reset (true victory). I did fall out of the level several times on this sequel, but it seemed to me that the puzzles were more tightly constrained. Then again, I watched the current world record speedruns and there's certainly a lot of hijinks possible, so maybe I'm just losing my edge! I also played through Party Hard. It's a "murder all the people in 2D" game very similar to the Hotline Miami games, and not as good, but its absurd mood and unfair chaotic difficulty did grow on me. Right now I am "playing" (the) Gnorp Apologue, an idle game that has its charms, but, well, it's an idle game and I think it is cruel to ever recommend those. It was written in Rust!




happy

why you should be happy

Today on Married To The Sea: why you should be happy


This RSS feed is brought to you by Drew and Natalie's podcast Garbage Brain University. Our new series Everything Is Real explores the world of cryptids, aliens, quantum physics, the occult, and more. If you use this RSS feed, please consider supporting us by becoming a patron. Patronage includes membership to our private Discord server and other bonus material non-patrons never see!




happy

Sunday Happy Hour

Apparently tomorrow is Monday.




happy

Happy Hour

Get happy.




happy

Happy Hour

 go




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Happy New Year?

As the new year brings in a new peak in COVID cases across the country, we all have a right to feel a little down in the dumps. One trend picked up by surveys earlier in the pandemic was a drop in self-reported happiness. Now, with a new year of General Social Survey data released, […]




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Happy Birthday, Harrison Ruffin Tyler!

November 9 is the 96th birthday of Harrison Ruffin Tyler, a retired chemical engineer and a historical preservationist who lives in Virginia. His claim to fame is that he is the grandson of U.S. President John Tyler, our tenth president who served in office from 1841 to 1845. That's like, 180 years ago. How is that possible?

President Tyler fathered 15 children. The thirteenth was Lyon Gardiner Tyler, born in 1853, when the former president was 63 years old. Lyon Gardiner Tyler had six children, the fifth being Harrison Ruffin Tyler, who was born in 1928 when his father was 75 years old. Therefore, a president who was born 234 years ago has a living grandchild today. 

Harrison Ruffin Tyler is also a descendant of Pocahontas and several other prominent figures from both the Revolutionary War and the Civil War. Happy Birthday, Mr. Tyler. -via Boing Boing

(Portrait of President Tyler from Wikimedia Commons)




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AI decodes oinks and grunts to keep pigs happy




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Beading + Quilting - a Happy Marriage!

It sure was a lovely surprise one day last fall when a representative from the Bead&Button Show called to ask if I would be interested in sending my beaded quilts for exhibition at the 2015 show in Milwaukee, WI.

Would I be interested? Of course I would!!! But since I'm more of a beader and don't have that many beaded quilts, I suggested they also contact my brother, Thom Atkins, who has made a mind-boggling number of beaded quilts in the last 10 years or so.

Brother-sister exhibition... how fun is that! You can see all 22 quilts in the Artisan Area of the Exhibition Hall if you're attending the show, May 27 - June 8. For those who can't make it, here are my quilts, the ones in the show. When you click on the first picture, you can see a slide show with full-size pictures.













It's really special how,in recent years, quilters are interested in beads, and beaders are playing with quilting, both finding ways to expand their creativity! And it's super fun to show with my bro!




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Wool Applique + Thread Embroidery + Beads = Happy Quilts!!!

Oh dear, busy me, four months since I've posted here. Lots of quilting, a little beading, some travels, and recently several sets of house guests have made "retirement" a bit of a joke. For now, since the La Conner Quilt Festival is just around the corner (October 2-4), my subject is one small exhibition on the first floor at the Museum, which is currently up, and will remain through the Festival.

Last year at the Festival (and again this year!) Sue Spargo taught workshops on her wool applique embroidery methods. Those of us who were lucky enough to get in were invited by the Museum to exhibit our finished pieces. These marvelous creations are the subject of this post. Uneven lighting makes it difficult to get good photos, so please forgive poor color or tone on some of these photos.

In case you are unfamiliar with Sue's work, below is an example of her work. Students in her class could choose to make chicks, circles, or flowers. Most chose the chicks. Eight of her students are showing their work in the current exhibit.

My vote for the most awesome-creative piece goes to Bunny Starbuck for She Has Flown the Coop! Here it is:

Having put my chicks all in neat rows similar to Sue's example, I find it amazing that Bunny's mind took the idea and made a whole different story of it... a coop full of chicks, with two in line on the roof ready to follow the one already in the air. Don't you just love the way the lines divide the space?!




Note Bunny's use of whispy yarn to suggest little chick feathers, her use of snaps for eyes, the one chick turned full front, the one with a bead-tassled braid and glasses, and the one with beaded loop fringe and a gathered yellow ribbon (?) yo-yo. I love them! I'm in awe, Bunny!

Below is Chicks on Parade by Dorie Benson. It's so fun the way they are so close together, with two of them going in a different direction, just as you might see in a little cluster of chicks. If you click the photo to enlarge it, you can see some of Dorie's excellent stitching and hand quilting!

The next one is Chicks by Glenys Baker, who not only did all 36 chicks but also made a second quilt featuring circles (shown further down). Awesome work, Glenys!

And next is Birds of a Feather Can Dance Together by Lorraine Jones. The fun of the title is matched by the fun of Lorraine's embellishments, including her border treatment. (You'll have to see this one in person, because the light from a table lamp, made the lower corner of the photo look terrible.)

I guess most of us like to "swim the other way," as you can see in the next piece, Chickadees, by Carrie Unick. I thought many of Corrie's embellishments were especially fun and creative, so I've also included a couple of detail photos.




Last of the chicks is my piece, simply named Chicks. It was so much fun, that I made another small piece (also in the exhibition), shown at the top of this post. Both are displayed in shadow-box type frames to protect them from dust and moth damage.

Glenys Baker, in one year, made not only a 36-chicks quilt (shown above), but also a 48-circles quilt, Circles. How she keeps thinking of new embellishment variations I can't imagine. Yet each of her circles is completely unique! Her choice of border fabrics is perfect for the quilt, complimenting the flow of color among the circles.


I love the fun color combinations and the way the beads enhance her embroidery on Nancy Anders' Bodacious Blooms, a joyful wall quilt if ever there was one! (Again, I couldn't quite get the color right in the photo, so you'll just have to go to the Museum to see it in person.)


The name of Roberta Roberts' flower quilt, Memories, invites us to look closely at the flower with three ladybugs. I don't know the story, but I can tell there is one here... and I love that. Her embellishments are varied and fun as well.



There you have it... 10 quilts by 8 students who learned some methods of wool applique and embroidery from Sue Spargo, last year at the La Conner Quilt Festival. I'm so grateful to be one of them!




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Merry Christmas and Happy New Year!

Dear Friends, At this special time of the year, RSS Ground team would like to send you its best greetings and wish you happy holidays. We express you our sincerest appreciation for being with RSS Ground. And we thank you for making our job enthralling and enjoyable. May God bless you and may the new […]

The post Merry Christmas and Happy New Year! appeared first on RSSground.com.



  • RSS Ground News

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Merry Christmas and Happy New Year!!!

May this Christmas be a fitting ending to a successful year for you. May the New Year bring fresh hopes and bright beginnings!

The post Merry Christmas and Happy New Year!!! appeared first on RSSground.com.



  • RSS Ground News

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Happy Thanksgiving 2020

Here comes another year of giving thanks to all our dear customers! Happy Thanksgiving to everyone celebrating. May you enjoy this wonderful occasion and have lots of fun in the whole year ahead. We will do our best to keep RSS Ground on the highest level and continue developing it according to your needs. Thank […]

The post Happy Thanksgiving 2020 appeared first on RSSground.com.




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Merry Christmas And Happy New Year!!!

Dear RSS Ground Users! We sincerely wish you happy holidays! May peace and prosperity always stay in your homes, May joy and happiness always follow you in your life. Merry Christmas and Happy New Year!

The post Merry Christmas And Happy New Year!!! appeared first on RSSground.com.



  • RSS Ground News

happy

Happy Halloween!

This time of the year there is an urge for holidays and amusement. Halloween is one of those best occasions to take a break from your daily routine and to fully enjoy this very special night of the year. We sincerely wish you a Happy Halloween and a great holiday season. Have fun and stay […]

The post Happy Halloween! appeared first on RSSground.com.




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Happy Thanksgiving and Black Friday Deal

We are taking this opportunity to say Thank You! We can’t express how much we appreciate you being a part of RSS Ground family. We hope our unique tools will continue to be useful to you for years to come. We usually never do this, but this time we would like to show our token […]

The post Happy Thanksgiving and Black Friday Deal appeared first on RSSground.com.




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Merry Christmas And Happy New Year!

Dear Friends, RSS Ground team wishes you Merry Christmas and Happy New Year! May all your current plans and projects be successful and bring you joy and happiness. We have a lot of exciting plans for 2022 and will continue developing our service to make your work online easier. Happy Holidays!

The post Merry Christmas And Happy New Year! appeared first on RSSground.com.




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Happy Halloween!

We are welcoming this holiday season! And they are coming for you. Our spooky scary-good updates are lurking out there, but there is no need to fear because we are always working to enhance your online experience. We have just added: IFTTT integration – ability to automate posting to many more destinations and collect more targeted […]

The post Happy Halloween! appeared first on RSSground.com.



  • RSS Ground News

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Happy Thanksgiving!

Traditionally, end of November is the time to be thankful, a time to remember and to embrace those who enrich our lives. Thanks to your active participation in our development process we continue to grow RSS Ground  service. This year we have added several powerful tools based on your feedback: Telegram Feeds and automated Poster, […]

The post Happy Thanksgiving! appeared first on RSSground.com.




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Merry Christmas And Happy New Year!

There is no perfect moment to take action for success, always strive to bring your ambition to life.  Wishing you great inspiration and success!

The post Merry Christmas And Happy New Year! appeared first on RSSground.com.



  • RSS Ground News

happy

A Time for Gratitude: Wishing Our Beloved RSS Ground Community a Happy Thanksgiving!

Dear RSS Ground Family, As the golden leaves of autumn usher in a season of warmth and gratitude, we pause to reflect on the journey we’ve shared. Thanksgiving isn’t just a holiday—it’s a heartfelt reminder of the importance of connection, community, and the spirit of giving thanks. Today, we extend our deepest appreciation to you, […]

The post A Time for Gratitude: Wishing Our Beloved RSS Ground Community a Happy Thanksgiving! appeared first on RSSground.com.



  • RSS Ground News

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Merry Christmas & Happy New Year!

The magic of the holiday season is upon us, and it’s the perfect time to reflect on the year that has flown by. Here at RSS Ground, we’ve been on an incredible journey, one that would not have been possible without you, our dedicated users. Your trust has empowered us to continuously enhance our offerings, […]

The post Merry Christmas & Happy New Year! appeared first on RSSground.com.



  • RSS Ground News

happy

Dear Life Kit: Is it a faux pas to create a 'happy graduation' registry for myself?

An NPR listener is graduating soon with her MBA. She wants to know if it's OK celebrate her achievement by asking loved ones to buy her gifts from a registry, similar to what people do for weddings.




happy

Make them happy

OM Guatemala distributes more than 1,000 pairs of shoes at local primary schools.




happy

News24 Business | More than 50% of unhappy medical scheme members win their case at regulator

Complaints about denied claims often concern the treatment the scheme will cover for a prescribed minimum benefit.




happy

Alumnus cultivates local film community, encourages creativity in Happy Valley

Alumnus Pablo Lopez works to give back to Penn State and State College through his role as film production manager for the Happy Valley Adventure Bureau.




happy

News24 Business | Exec pay: Shoprite forced to engage unhappy shareholders

Investors holding more than a quarter of Shoprite shares opposed its executive pay, requiring SA's largest retailer to address dissenting shareholders' concerns.




happy

Happy endings

“As I watched the ending scene (that lasted about three minutes) I thought about the “happy ending” notion,” says Ava. “Is it real or is it a fairy tale? A utopia created by Hollywood to give their viewers a false sense of hope in the reality of a broken world? And so, I said to myself: I believe in happy endings.”




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Secretary of State Jeff Bullock Wishes Delawareans A Happy Italian American Heritage Month

October is National Italian American Heritage Month, a month dedicated to celebrating the distinguished cultural contributions of Americans with Italian lineage. According to the United States Census Bureau, as of 2019, more than 16 million Americans of Italian descent reside in the United States, making up the seventh largest ethnic group in the country. “Italian […]



  • Department of State
  • News
  • Delaware Department of State

happy

Delaware Children Wish Smokey Bear Happy 80th Birthday at Dover Public Library

More than 100 Delawareans, from newborns to seniors, attended story time at the Dover Public Library to wish Smokey Bear a happy 80th birthday on August 9, which marks Smokey’s official birthday.




happy

Soweto Business Forum ‘excited and very happy’ after Gauteng suspends vendors’ trading at schools




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to make yourself happy and remarkably less disturbable

to make yourself happy and remarkably less disturbable




happy

Scientists ID 'Happy' Gene in Women

Title: Scientists ID 'Happy' Gene in Women
Category: Health News
Created: 8/29/2012 4:05:00 PM
Last Editorial Review: 8/30/2012 12:00:00 AM




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Unhappy at Work in Your 20s, Unhealthy in Your 40s?

Title: Unhappy at Work in Your 20s, Unhealthy in Your 40s?
Category: Health News
Created: 8/22/2016 12:00:00 AM
Last Editorial Review: 8/23/2016 12:00:00 AM




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Many Parents Not Happy With Later School Start Times

Title: Many Parents Not Happy With Later School Start Times
Category: Health News
Created: 8/29/2017 12:00:00 AM
Last Editorial Review: 8/29/2017 12:00:00 AM




happy

Goats Can Read Human Emotions, Prefer Happy Faces

Title: Goats Can Read Human Emotions, Prefer Happy Faces
Category: Health News
Created: 8/31/2018 12:00:00 AM
Last Editorial Review: 8/31/2018 12:00:00 AM




happy

When Robots Meet Cute: Maybe Happy Ending

“It might feel like 2064 on the surface, but in its nostalgic, rechargeable heart, the show parties like it’s 1999.”





happy

Google's AI Overview has no opt-out. That's making some people unhappy

Tech companies are force-feeding people AI on search engines and social media platforms and there's no way to opt out. Google search, considered the gateway to the internet, is especially frustrating.




happy

Strictly pro isn’t happy with BBC show’s treatment of Shayne Ward

‘You deserve something better!’ Ward’s partner Nancy Xu said of result




happy

'No happy paintings': Dozens of art works by Canadian war artist at Calgary exhibit

Bill MacDonnell's paintings are on display at the Military Museums in Calgary through Remembrance Day and into 2025.



  • News/Canada/Calgary

happy

Happy Martian New Year!

The Martian new year arrives with the Red Planet’s vernal equinox. Explaining why requires a deep dive into celestial mechanics and Earth’s calendrical history




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If Plan Sponsors Are So Unhappy with Their PBMs’ Transparency, Why Won’t They Change the Model?

A new survey of plan sponsors sheds light on their satisfaction with transparency at large and small pharmacy benefit managers (PBMs).

As you will see, clients remain slightly more satisfied with the perceived transparency of smaller PBMs compared with the Big Three PBMs—CVS Caremark, Express Scripts, and Optum Rx.

However, plan sponsors are dissatisfied with transparency about how both large and small PBMs make money. Smaller PBMs have an edge, but it’s narrower than you might think.

Perhaps PBMs’ clients are unable or unwilling to negotiate better deals, write more effective contracts, and switch to more satisfying relationships. Or maybe they don’t mind the current system, despite the challenges for patients. Some argue that transparency could swoop down to solve this problem. Riddle me this: Should we watch what plan sponsors say, or what they do?

Read on to see what you think of my arguments below. Then, click here to share your thoughts with the Drug Channels community.
Read more »
       




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Every Unhappy PREA Study is Unhappy in its Own Way

“Children are not small adults.” We invoke this saying, in a vague and hand-wavy manner, whenever we talk about the need to study drugs in pediatric populations. It’s an interesting idea, but it really cries out for further elaboration. If they’re not small adults, what are they? Are pediatric efficacy and safety totally uncorrelated with adult efficacy and safety? Or are children actually kind of like small adults in certain important ways?


Pediatric post-marketing studies have been completed for over 200 compounds in the years since BPCA (2002, offering a reward of 6 months extra market exclusivity/patent life to any drug conducting requested pediatric studies) and PREA (2007, giving FDA power to require pediatric studies) were enacted. I think it is fair to say that at this point, it would be nice to have some sort of comprehensive idea of how FDA views the risks associated with treating children with medications tested only on adults. Are they in general less efficacious? More? Is PK in children predictable from adult studies a reasonable percentage of the time, or does it need to be recharacterized with every drug?

Essentially, my point is that BPCA/PREA is a pretty crude tool: it is both too broad in setting what is basically a single standard for all new adult medications, and too vague as to what exactly that standard is.

In fact, a 2008 published review from FDA staffers and a 2012 Institute of Medicine report both show one clear trend: in a significant majority of cases, pediatric studies resulted in validating the adult medication in children, mostly with predictable dose and formulation adjustments (77 of 108 compounds (71%) in the FDA review, and 27 of 45 (60%) in the IOM review, had label changes that simply reflected that use of the drug was acceptable in younger patients).

So, it seems, most of the time, children are in fact not terribly unlike small adults.

But it’s also true that the percentages of studies that show lack of efficacy, or bring to light a new safety issue with the drug’s use in children, is well above zero. There is some extremely important information here.

To paraphrase John Wanamaker: we know that half our PREA studies are a waste of time; we just don’t know which half.

This would seem to me to be the highest regulatory priority – to be able to predict which new drugs will work as expected in children, and which may truly require further study. After a couple hundred compounds have gone through this process, we really ought to be better positioned to understand how certain pharmacological properties might increase or decrease the risks of drugs behaving differently than expected in children. Unfortunately, neither the FDA nor the IOM papers venture any hypotheses about this – both end up providing long lists of examples of certain points, but not providing any explanatory mechanisms that might enable us to engage in some predictive risk assessment.

While FDASIA did not advance PREA in terms of more rigorously defining the scope of pediatric requirements (or, better yet, requiring FDA to do so), it did address one lingering concern by requiring that FDA publish non-compliance letters for sponsors that do not meet their commitments. (PREA, like FDAAA, is a bit plagued by lingering suspicions that it’s widely ignored by industry.)

The first batch of letters and responses has been published, and it offers some early insights into the problems engendered by the nebulous nature of PREA and its implementation.

These examples, unfortunately, are still a bit opaque – we will need to wait on the FDA responses to the sponsors to see if some of the counter-claims are deemed credible. In addition, there are a few references to prior deferral requests, but the details of the request (and rationales for the subsequent FDA denials) do not appear to be publicly available. You can read FDA’s take on the new postings on their blog, or in the predictably excellent coverage from Alec Gaffney at RAPS.

Looking through the first 4 drugs publicly identified for noncompliance, the clear trend is that there is no trend. All these PREA requirements have been missed for dramatically different reasons.

Here’s a quick rundown of the drugs at issue – and, more interestingly, the sponsor responses:

1. Renvela - Genzyme (full response)

Genzyme appears to be laying responsibility for the delay firmly at FDA’s feet here, basically claiming that FDA continued to pile on new requirements over time:
Genzyme’s correspondence with the FDA regarding pediatric plans and design of this study began in 2006 and included a face to face meeting with FDA in May 2009. Genzyme submitted 8 revisions of the pediatric study design based on feedback from FDA including that received in 4 General Advice Letters. The Advice Letter dated February 17, 2011  contained further recommendations on the study design, yet still required the final clinical study report  by December 31, 2011.
This highlights one of PREA’s real problems: the requirements as specified in most drug approval letters are not specific enough to fully dictate the study protocol. Instead, there is a lot of back and forth between the sponsor and FDA, and it seems that FDA does not always fully account for their own contribution to delays in getting studies started.

2. Hectorol - Genzyme (full response)

In this one, Genzyme blames the FDA not for too much feedback, but for none at all:
On December 22, 2010, Genzyme submitted a revised pediatric development plan (Serial No. 212) which was intended to address FDA feedback and concerns that had been received to date. This submission included proposed protocol HECT05310. [...] At this time, Genzyme has not received feedback from the FDA on the protocol included in the December 22, 2010 submission.
If this is true, it appears extremely embarrassing for FDA. Have they really not provided feedback in over 2.5 years, and yet still sending noncompliance letters to the sponsor? It will be very interesting to see an FDA response to this.

3. Cleviprex – The Medicines Company (full response)

This is the only case where the pharma company appears to be clearly trying to game the system a bit. According to their response:
Recognizing that, due to circumstances beyond the company’s control, the pediatric assessment could not be completed by the due date, The Medicines Company notified FDA in September 2010, and sought an extension. At that time, it was FDA’s view that no extensions were available. Following the passage of FDASIA, which specifically authorizes deferral extensions, the company again sought a deferral extension in December 2012. 
So, after hearing that they had to move forward in 2010, the company promptly waited 2 years to ask for another extension. During that time, the letter seems to imply that they did not try to move the study forward at all, preferring to roll the dice and wait for changing laws to help them get out from under the obligation.

4. Twinject/Adrenaclick – Amedra (full response)

The details of this one are heavily redacted, but it may also be a bit of gamesmanship from the sponsor. After purchasing the injectors, Amedra asked for a deferral. When the deferral was denied, they simply asked for the requirements to be waived altogether. That seems backwards, but perhaps there's a good reason for that.

---

Clearly, 4 drugs is not a sufficient sample to say anything definitive, especially when we don't have FDA's take on the sponsor responses. However, it is interesting that these 4 cases seem to reflect an overall pattern with BCPA and PREA - results are scattershot and anecdotal. We could all clearly benefit from a more systematic assessment of why these trials work and why some of them don't, with a goal of someday soon abandoning one-size-fits-all regulation and focusing resources where they will do the most good.




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U.S. surprised, happy at SAARC observer offer



  • India-US relations

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C�r�monie de remise du Prix Happy City : AG2R LA MONDIALE, Nexity, Sodexo et SUEZ environnement r�compensent les meilleures initiatives en faveur du bien-�tre citoyen - Interview Jean Jou

Interview Jean Jouzel, Pr�sident du jury




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Happy Book Birthday to Gareth Hinds and Graceling the Graphic Novel!

Today, Gareth Hinds's beautiful graphic novel adaptation of Graceling hits stores. Join us for an event! Here's a link to all your options.