#carolina bloo

[dciyaoi]

A collection of corps hugs

[ardenl0ughty]

FULL NAME: Arden Loughty NICKNAME: Banks AGE: 26 DATE OF BIRTH: 09/14/1997 PLACE OF BIRTH: Santa Monica, California GENDER IDENTIFICATION: Female SEXUAL ORIENTATION: Bisexual RELATIONSHIP STATUS: Single NEIGHBORHOOD: Downtown OCCUPATION: Bartender WORKPLACE: Sunset Saloon POSITIVE TRAITS: Courteous, Authentic, Passionate NEGATIVE TRAITS: aggressive, impulsive, sarcastic LENGTH OF TIME IN HAVENRIDGE: 2 years FACE CLAIM: Phoebe Dynevor 

TRIGGER WARNING: physical abuse, drug abuse, alcohol, murder, miscarriage

Ardens mother was only 19 when she met her father in her hometown HavenRidge, North Carolina. Her father was 23 and on a vacation for the summer with his family, they had rented out a house for the three months of the season. Her mother was a bartender at Sunset Saloon and the regulars favorite. She was the kindest young lady you would ever meet, some would say, and with a smile that would have you thinking about it for hours even days after departing the bar. Two weeks of being on vacation Ardens father took it upon himself to enjoy sometime without his family and spend some exploring the town stumbling to the bar her mother was at. It was a quiet night, just the few locals there engaging in conversation with one another. The moment her father laid eyes on her mother, the connection was instant and her father did everything in his power to claim the beautiful bartender. Just only a month and a half into the summer, Ardens parents fell in love, or what she would call it now, lust. Her mother ended up getting pregnant not much longer resulting in her grandmother kicking her out, and with termination being out of the question she was left with no choice but to go back to California with Ardens father. Once moving there, the two of them ended up settling down and finding the perfect house to raise their beautiful perfect little dream girl.

On September 9th, 1997, Arden Maree Loughty was born with a smile just as bright as her mothers, some may say more. With just one look her mother instantly fell in love with what God had gifted her, she would call her Banks to remind her of back at home, and not long after her birth, her mother and father soon married. Life was going great, her father got a new job, one that would financially put the family on the rise, and her mom was set to stay at home and raise her. A couple years later, Ardens fourth birthday is coming up, her father was bringing in tons of money, and the relationship she had with her mother for just being a toddler was a bond that could never be broken. One night her father had come home reeking of alcohol, and constantly snorting his nose as if he was inhaling something through his nostrils. Ardens mother had immediately sent Arden to bed so she wouldn’t have to witness the actions that were to soon occur. From that night forward, whenever her dad would go out with friends, coworkers, any excuse for him to have a sip, he would come home, Arden would be sent to bed, and the beatings would start.

For years it lasted, and as Arden was growing up into a woman her father would soon start to pick at her when he could. At home Arden did what she was commanded by her father, upheld herself, and be the woman he wanted her to be. Secretly, she prayed for her mother, every night, she wrote out a different plan in her journal for the two of them to secretly escape back to where her mother was from, HavenRidge. She would quietly keep her journal under her mattress where she would never think for her father to look and continue on with life with a secret plastered all over her. Just like her mother, Arden falls in love with a boy behind her fathers back and with a sense of déjà vu, she ends up pregnant. She confided in her mom with the news and her mother knew the only shot they had at keeping this a secret from her father, was to escape. A week went by and as Arden was coming home from a 8 hour shift at their local bar, she walked into the house she shared with her parents to blood splattered across the room in every direction her eyes could lay on. From her bedroom she could hear the sobs coming from her father and Ardens heart instantly stopped, her chest got as tight as it ever had and she could feel the world spinning around as if she wasn’t there anymore and just looking above. Somehow she convinced herself to get up and to her bedroom she went, where she found her mattress flipped upside down, her journal lying face up and open, her father bent down on the ground with a gun in one hand and the other covering his face. Next thing she saw was her mothers lifeless body laying on the ground covered in a puddle of mud. Arden screamed unintentionally but alerting her father. From what she remembers, her father pleaded for her forgiveness, for gods forgiveness, and for the first time in her life saw remorse from her father right before he too, shot himself in the head.

After the biggest tragedy occurred in her life, Arden suffered a miscarriage, she broke up with her boyfriend, and constantly blamed herself for the murder of her mother. After years of therapy and reconnecting with her grandmother, Arden finally decided it was time for her to leave behind everything that occurred in California, and live out the dream she prayed for with her mother. Arden soon moved to HavenRidge and from there on she started to rebuild the life she had always wanted to live. She got a job bartending at the Sunset Saloon just like her mother once had and once recognized they brought her in as family, eventually letting her own the apartment right above. Arden promised she wouldn’t let the tragic events that occurred in her family change who she was ever again. She was going to live out the dream her mother wasn’t able to and she made a promise to that.   

Quick facts

She tries her best to be as polite as can be, but she tends to snap back at people.

Even though her grandma kicked her mother out, the two have since rekindled and that’s the only family she has left remaining.

She plans to open up her own bar one day in memory of her mother.

Even though her dad was an alcoholic, drinking doesn’t bother her seeing as her mothers job was a bartender growing up but sometimes she feels she may have inherited his drinking problem

She is very closed off to relationships which she hopes to grow out of.

She won’t talk about what happened to her mother or father, unless drinks are in her.

If shes not working a shift at the Saloon, you can catch her down at the pier with one of her favorite books in hand

She bought her grandmother a dog to keep her company which she goes over to help her with once a week for walks

[zeke-exiel]

@twiggenstein​

Zeke stood there fidgeting and shifting his weight from foot to foot, anxiety flaring up and down and he tried to keep himself calm.

“ Carolina, can I have a moment? ”

He moved his hand into his pocket, fetching something quickly before hastily hiding it behind his back; heart racing in his chest as he went through all the scenarios he had thought out of how this moment would transpire. Never would he think things would line up to such a day but it seemed like now or never.

“ The truth is, I haven’t given you your real Valentine’s Day present. we’ve been together for a while now and you’ve helped me through so much, and all I’ve been is a weight up until recently. But you’ve always pushed me to do better and been my anchor while I was lost at sea, so even though it’s long overdue... ”

The boy pulls out what was hidden, a roughly palm-sized chip glowing with a faint blue light that seemed to pulse and expand endlessly without any pattern, as if it housed a small nebula. “ I’d like to give you this. ”

[band-shenanigans]

July 20, 2018

So we were at the DCI Tour Of Champions thing and during the intermission we went over to see and say hi to our friends in the Bluecoats, and then afterwards we sat and watched Carolina Crown's warm up. We started walking back to the stadium when they finished their warm up. We could hear people chanting "bloooooo" but silly me thought they were booing (oops) and was like " wait, are they booing?" To which one of our friends replied with "no they're saying bloo" and that's when we were like 'oh shit' and realized that the Bluecoats were up next and I kid you not we dead fast sprinted back to the stadium. We made it back to our seats by the time they were setting up the props, so we didn't miss anything which is good.

-saxy bassoon

[cheap-pack-of-cigarettes]

song url tag🎵

tagged by @loveinbam thanks lovie🖤

Rules: spell out your url with song titles and tag ten people

C: can’t - got7

H: hit - seventeen

E: ever since new york - harry styles

A: almost (sweet music) - hozier

P: perfect - one direction

P: page - got7

A: alligator - monsta x

C: cheese & wine - dpr live

K: kiwi - harry styles

O: ooh la la la - exo

F: fire away - niall horan

C: carolina - harry styles

I: im the one - bloo

G: good years - zayn malik

A: all i wanna do - jay park

R: ready to run - one direction

E: eden - iz

T: two of us - louis tomlinson

T: twilight - ateez

E: endless love - colde

S: slow - liam payne

tagging: @bleusidemv @maddiekira @mastmagan @selectivelysalty @empressjiaer @hideinsideout @sevenpeaches

[shirlleycoyle]

A Controversial Autism Treatment Is About to Become a Very Big Business

When desperate parents are looking for medical treatment for their kids, especially their autistic kids, they often do two things: They look up information about a program at Duke University, and then, in short order, they go to GoFundMe. The fundraising site is full of pleas that often mirror each other, in essence saying: My child has one hope, and that hope is in stem cell and cord blood treatments.

This hope, though, is attached to treatments that are hotly disputed at best, unproven at worst, and often very expensive in either case. At Duke University’s Marcus Center for Cellular Cures, parents can enroll their children into a number of clinical trials that aim to study the effects of cells derived from umbilical cord blood on treating the effects of autism and brain injuries; adults can also participate in a trial testing whether cord blood can help them recover from ischemic strokes. And when parents can’t get their children into any of these clinical trials, particularly for autism, they often opt for what’s called the Expanded Access Program (EAP), in which they pay between $10,000 and $15,000 to get their kids a single infusion.

All of the trials use products derived from human umbilical cord blood, which is a source of stem cells as well as other types of cells. The autism trials are using a type of immune cells called monocytes, according to Dr. Joanne Kurtzberg, a well-respected Duke professor who’s conducting clinical trials into whether cord blood can help with autism, and who has been researching stem cells since the early ‘90s. (On ClinicalTrials.gov, however, these trials are listed as using mesenchymal stromal cells, which are a completely different type of cord blood cell.)

Now, a for-profit company called Cryo-Cell International with ties to Duke researchers has indicated that it plans to open clinics promoting these treatments, under a licensing agreement with the renowned North Carolina university. (Cryo-Cell acknowledged receiving a list of questions from Motherboard, but did not respond to any follow-up emails or respond to those questions before publication.) In their investor presentation, Cryo-Cell said they plan to become “an autonomous, vertically integrated cellular therapy company that will treat patients.”

Do you work for Duke University or Cryo-Cell? We would love to hear from you. Contact the reporter at anna.merlan@vice.com, or on Signal at 267-713-9832.

Duke and Cryo-Cell’s rush to monetize a procedure before it’s shown to have solid benefits has created concern, though, across the community of scientists, clinicians, and medical ethicists who study autism treatments.

The hope is that these cord blood infusions can improve some autism symptoms, like socialization and language, or decrease the inflammation that some parents and clinicians think might exacerbate autism symptoms. Early study results, however, haven’t been very promising. A large randomized clinical trial, the results of which were released in May 2020, showed that a single infusion of cord blood was not, in the words of the researchers, “associated with improved socialization skills or reduced autism symptoms.”

This is why Duke’s latest move comes as such a surprise: The university and Cryo-Cell have told investors that they’re planning to open a series of “infusion centers.” At these clinics, Cryo-Cell will use Duke’s technology and methods to offer cord blood treatments for $15,000 per infusion.

In an exuberant presentation for investors, Cryo-Cell said it estimates an annual revenue of $24 million per clinic; it hasn’t disclosed how many clinics it plans to open. At least one will reportedly open in Durham, North Carolina.

A student walks past Duke Chapel on the campus of Duke University in Durham, North Carolina, Monday, April 30, 2007. (Photo by Jim R. Bounds/Bloomberg via Getty Images)

The move follows a June 2020 announcement that Cryo-Cell had entered into an exclusive patent-option agreement with Duke, allowing it to manufacture and sell products based on patents from Dr. Joanne Kurtzberg.

Thus far, though, Duke’s trials have not shown any promising results for cord blood products as autism treatments, granting that the research is still far from over. The university told Motherboard, “Duke’s institutional position is that additional research is required and to encourage further study to provide definitive results.” (Many autistic self-advocates object to the idea that autism needs a “cure,” and elsewhere, autism research is beginning to shift away from that language and more toward early diagnosis for children and helping autistic adults lead fulfilling and fully supported lives.)

Kurtzberg's goal, she told Motherboard in email responses provided by Duke, "is to develop and evaluate treatments that will help improve social skills and the ability to communicate with others in children with autism.” For both cerebral palsy and autism, she added, “improvements are measured using well-established tests. Among some children with cerebral palsy, improvements have been measured in gross motor function. With autism, there have been measurable improvements in communications and executive function among some study participants.”

Alycia Halladay is the chief science officer at the Autism Science Foundation, which seeks to guide families into safe, evidence-based treatments for autism. “While stem cell therapies as medical intervention for the ASD are currently being rigorously studied at Duke, it is still too early to say they actually help those on the spectrum,” she told Motherboard. “Making the move at this time to sell this therapy to families across the world is irresponsible and dangerous. It shocks and surprises me that Duke University, an institution with a stellar academic reputation, would enter into an agreement to sell intellectual property for stem cells in autism, especially since Duke has enormous financial incentive to make this profitable for Cryo-Cell.”

“I was horrified when I first heard about the Duke program,” said Anne Borden King. She’s a Toronto-based science writer and the current chair of the Campaign Against Phony Autism Cures. She also hosts the podcast “Noncompliant,” about neurodiversity, where she’s frequently spoken critically about the Duke program.

Borden King has come to believe that Duke is leveraging its reputation to run a program that’s far from ethical. “When you see a university name on a project, you think everything must be on the up-and-up,” she said. “But that’s actually not a safe assumption. Money talks.”

The idea of using therapies derived from umbilical cord blood to treat serious disorders isn’t new, and neither is the controversy around it. There are small stem cell clinics across the world, from Mexico to Panama to the Caribbean, making a host of shaky claims about the benefits that stem cells from cord blood can provide, both autologous ones (stem cells that come from the patient themselves, taken from cord blood banked at birth) and allogeneic (stem cells that come from someone other than the patient). In the past decade, small stem cell clinics have also begun to dot the United States, mostly in strip malls and similarly downmarket locales, offering treatment for things like back pain.

Stem cell clinics started to bubble into the public awareness around 2010. At that point, said Paul Knopefler, “almost all of it was outside the United States. I had people asking me, ‘Should I go to the Caribbean?’”

Knoepfler is a professor at UC Davis in the Department of Cell Biology and Human Anatomy. For the last 11 years he’s also been one of the more widely-read experts on stem cell and related therapies, with a blog called The Niche. He’s watched as these treatments went from speculative to potential cash cows; one of the earliest clinics to get a flood of attention was Celltex, a Texas firm where former Gov. Rick Perry had experimental back surgery. (NBC reported in 2011 that Perry pushed a bill that would have benefited Celltex, and he joined its board of directors in 2016, after he was no longer governor but before he joined the Trump administration as energy secretary. Perry resigned from that position in 2017.)

In the early days, Knoepfler said, “it was a mixed bag in terms of the diseases that were on people’s minds: arthritis, orthopedic issues, ranging to things more concerning to me, like parents reaching out about kids with autism or cerebral palsy.”

In the mid 2000s, agreed Leigh Turner, “I was watching this entire marketplace come into existence before my eyes.” Turner is a bioethicist and a professor in the Department of Health, Society and Behavior at UC Irvine’s public health program, and he and Knoepfler released a study in 2016 showing a huge profusion of stem cell clinics across the United States, often marketing themselves as cures for orthopedic and sports medicine problems. What they found, Turner said, was “a growing number of companies in the U.S. that were selling purported stem cell treatments not licensed by the FDA, [and which had] no meaningful evidence of safety and efficacy.” He wrote a letter to the FDA about one such clinic, urging it to investigate, before realizing that looking at the field as a whole would be a better use of his time.

Umbilical cord blood and cord, collected from hospitals, are prepared for storage at the headquarters of the Polish umbilical cord blood bank PBKM/FamiCord on November 26, 2019 in Warsaw. – Poland has emerged as Europe's leader in stem cell storage, a billion-dollar global industry that is a key part of a new therapy that can treat leukaemia but also raises excessive hope in other patients. (Photo by Wojtek RADWANSKI / AFP) (Photo by WOJTEK RADWANSKI/AFP via Getty Images)

Though stem cell clinics have been around for years, the sheen of academic and scientific legitimacy bestowed by Duke onto experimental stem cell and cord blood treatments is very new indeed. And the combination of legitimate institutional backing, money, and the hopes of desperate parents is creating a combination that critics say is combustible and potentially very risky.

At Duke, Turner said, there are respected researchers like Kurtzberg, who have, as he put it, “a long period of actual research in stem cell transplantation and meaningful research in publications, credible clinical trials. These are actual individuals who are part of the broader scientific community. It’s not the veneer of science. I imagine there are cell manufacturing and cell processing techniques that are more robust than you’d get at a strip-mall stem cell clinic.”

But there are also some similarities between what Duke is doing and the work at smaller clinics, he added. “One of them is that, at the end of the day, there are many individuals paying out of pocket. It’s not just a clinical trial. Not covered by a public or private health insurer.”

Kurtzberg is also now the medical director at Cryo-Cell, a position she took on in 2018. (A Duke spokesperson confirmed that she’s still in that role. In response to a question about how the university manages potential conflicts of interest between Kurtzberg’s two roles, they told Motherboard: “All Duke faculty must observe conflict of interest guidelines that are closely monitored by the university. Dr. Kurtzberg has reported activities with companies, institutions, or organizations outside Duke University. Any potential conflicts of interest are reviewed and, when appropriate, managed by the individual and the university.”)

Kurtzberg, in email responses provided by Duke, said that her role at Cryo-Cell was the result of the company acquiring a cord blood bank called Cord:Use, which contracted with a blood bank she founded at Duke. “When Cryo-Cell bought Cord:Use, those functions and financial arrangements continued without change.” Her salary for that job, she said, “was paid directly to the Family Support Program for the Pediatric Transplant and Cellular Therapies” at Duke.

As the cord blood market has grown, autistic children—and their often desperate, always well-meaning parents—have since begun to comprise a core market for those therapies, even as the benefits of the treatments remain largely speculative. And as Business Insider’s Tom Porter reported in January, experts in the field say that the fly-by-night clinics in other countries are getting an unintended legitimacy boost from Duke. In GoFundMe appeals, parents talk about going to overseas clinics after being unable to get into Duke, or because they felt they saw promising results from a Duke infusion and wanted another. “We have researched hospitals outside of the United States and there is a reputable medical group performing the Stem Cell Therapy in Panama City, Panama,” reads one typical plea, from a desperate mother, asking for $20,000 to get her child there.

Autistic kids and their parents are already extremely vulnerable from the start, Borden King says, due to the sheer amount of misinformation and pseudoscience that’s directed their way. She began running the Campaign Against Phony Autism Cures three years ago, after her son received an autism diagnosis. “I started meeting all these parents in meetup groups who were doing phony cures and it really shocked me, just how much of it is out there, how many different scams,” she said. “How dangerous some of them are for kids. Things like feeding kids bleach, using chelation to remove so-called ‘vaccine injury,’ and so many other things.”

She began looking at the Duke program after seeing the results of the study released in May 2020, which showed that a single cord blood infusion wasn’t effective in reducing autism symptoms. (The study authors, Dr. Kurtzberg and her colleague Dr. Geraldine Dawson, did say, however, that a subgroup of children in the study without an intellectual disability showed some improvements in “language communication, ability to sustain attention measured via eye tracking, and increased alpha and beta EEG power, a measure of brain function,” as a press release from Duke put it.)

The results were unambiguous overall, in the view of experts in the field. “This is a uniquely solid study in this area so in my view there’s not much room for hedging bets like ‘Well, maybe trying things a little different will work’ anymore,” Paul Knoepfler wrote on The Niche. “The key data in the paper are in Table II (screenshot below) showing across the board that there is no benefit of cord blood for these patients.”

“The first thing that jumped out at me when I read Duke’s study was they reported kids having health issues during infusion, like severe allergic reactions—and also being agitated and upset by the procedure,” Borden King said. (Duke’s researchers said some children experienced “agitation during IV placement and infusion” and one child experienced an allergic reaction, which was immediately treated, but they characterized most of the adverse events seen during the study as “nonserious,” and that overall the infusions were “safe and well tolerated.”)

Duke told Motherboard that “‘Cures’ is an aspirational term, not a statement about the current standard of care.”

The second thing, Borden King added, was “Duke’s own conclusion that they didn’t find any benefit from the infusions. The third thing was that they were continuing with new studies of the same thing and running a pay-to-play [in the form of the EAP program]. I thought, why? Their own studies say no evidence of benefit and clear evidence of harm. Why are they continuing?” (Duke told Motherboard, “Further research is warranted to understand the basis for favorable responses in some study participants,” referring apparently to the subgroup of children without intellectual disabilities.)

There’s one main reason why Duke has been able to run so many clinical trials relating to stem cells: Bernie Marcus, the Home Depot founder. Marcus suffered from bronchiectasis, a condition where the lungs become damaged and clogged with mucus, and sought treatment from the Stem Cell Institute (STI) in Panama, according to a blog post on its website. STI is controversial, to put it lightly. The physician and science writer Dr. David Gorski, who writes frequently about pseudoscience, especially in autism treatments, has baldly referred to it as a “quack clinic,” noting that their website “advertises stem cells to treat autism, cerebral palsy, heart failure, multiple sclerosis, osteoarthritis, rheumatoid arthritis, spinal cord injury, and autoimmune diseases, complete with very little actual science but a whole lot of testimonials.”

Home Depot CEO Bernie Marcus poses for a portrait in a Home Depot store October 15, 1998. (Photo by Erik Lesser/Liaison)

Marcus felt that the treatment he received in Panama helped his condition; soon, per the STI blog post, he was bringing his wife down to Panama for treatment to help with her knee pain. His foundation, the Marcus Foundation, soon began donating millions of dollars to both STI and Duke for stem cell research. (The Marcus Foundation could not be reached for comment: the non-profit does not maintain any kind of public-facing website or social media presence, and a phone number for them does not allow callers to leave messages. Several messages to the organzation’s program director, Elisa Levy, were returned as undeliverable.)

Bernie Marcus’ efforts in this area led, in 2018, to the founding of the institution at Duke that bears his name: the sunnily named Marcus Center for Cellular Cures.

“I think [that name] is hugely problematic,” says Jeremy Snyder, a professor in the Faculty of Health Sciences at Simon Fraser University whose research focuses on public health ethics and medical tourism, among other topics. (He and Leigh Turner have released research about misleading stem cells claims in GoFundMe appeals and the ways platforms like GoFundMe can spread health misinformation across the web. “In general crowdfunding platforms, they appear to be do very little in terms of any way vetting crowdfunding campaigns, Turner told Motherboard. “It can be a dodgy cancer clinic in Germany or a stem cell clinic in the U.S. and GoFundMe takes a hands-off approach unless there’s a groundswell of media coverage.”)

“That’s a longstanding complaint,” Snyder says, of the Marcus Center’s incredibly optimistic name. “You’ll see this in the cancer realm quite a bit. Marketing divisions of large hospitals put out commercials and different marketing materials, and you get a lot of that misleading language, playing on these tropes of hope, fighting, cures.” The point of the research, he explained, isn’t necessarily to “cure” the participants. “It’s to find out if this thing even works. If you’re getting ahead of yourself and calling it a cure, that’s deeply unethical.” (Duke told Motherboard that “‘Cures’ is an aspirational term, not a statement about the current standard of care.”)

In email responses provided by Duke, Kurtzberg told Motherboard that monocytes “can modulate inflammation, especially in the brain. In cerebral palsy, these cells promote repair of myelin—particularly in the motor tracks, which is often damaged during injuries. We have published several papers regarding this, noting the unique properties of monocytes in cord blood.”

Autism, Kurtzberg added, “is more complicated because there are multiple etiologies causing this condition. In some instances, there is inflammation of the brain, and cord blood tissue appears to calm down that inflammation in animals and lab models. We are exploring whether cells in cord blood or in cord tissue, we’re not sure which, has the ability in certain patients to calm down that inflammation and improve symptoms.”

This theory, though, is not new. As journalist Brendan Bournell reported in an extensive investigation for Spectrum News in 2019, Kurtzberg and Geraldine Dawson led a Duke team that published results in 2017 suggesting that in a trial of 22 children, all between 2 and 5 years of age, 13 had shown improvement after a single infusion. But, as Bournell noted, “Without a control group, it is impossible to say whether the children would have improved anyway.” More importantly, he wrote, “A follow-up report found that those who improved showed increased connectivity in brain regions affected by autism, including the limbic system, but the researchers published no evidence to support their inflammation theory.”

As the years have passed, Turner, Knoepfler, and Snyder have all begun asking the same basic question about the Duke program: Why is an intervention that hasn’t shown much in the way of results not only still operational, but also charging participants a lot of money to get access to it?

“We can look at their own research,” Turner said. “They haven’t done a convincing job of demonstrating efficacy. So should people have to pay what can end up being substantial amounts of money?”

Knoepfler has questions, he said, about whether the FDA is “carefully monitoring” the Expanded Access Program at Duke, which it does have to approve, at least initially. “Are they still aware Duke and Cryo-Cell want to expand this greatly?” he asked. “Is the FDA aware of the fact that hundreds of kids have gotten infused and the plans could be for thousands more? That’s where I don't have a good sense. A lot of these things are hard to tease apart. There’s different confidentiality issues.”

One especially tricky thing, he added “is that Duke must have gotten what’s called an IND, or investigational new drug applications, for cord blood or stem cells related to cord blood. That’s the basis for running a clinical trial. And anything related to an IND, the FDA views as confidential.” Indeed, in investor documents, Cryo-Cell says plainly that it plans to administer stem cell infusions under the permissions granted by Duke and Kurtzberg’s IND approval. It has gotten, Cryo-Cell’s documents add, $5 million in startup funding from the Marcus Foundation.

The FDA did not answer specific and detailed questions about Cryo-Cell’s planned infusion centers, telling Motherboard, “As a general matter, FDA cannot comment on particular applications or investigational products.” But in order to charge patients for an investigational drug under an IND application, the agency added, “the sponsor must obtain prior written authorization from FDA in accordance with FDA regulations. When charging for individual patient expanded access [sic] to an investigational drug, a sponsor may recover only its direct costs associated with making the drug available to the patient. For individual patient expanded access, the sponsor may not charge for indirect costs, including administrative costs associated with providing an investigational drug.”

“Anything related to an [investigational new drug application], the FDA views as confidential.”

The FDA also told us that stem cell therapies and other similar treatments carry some innate risk, and essentially warned that the buyer should beware:

Stem cell therapies offer the potential to improve human health, but they also create potential inherent risks for patients because of the way they may be manipulated or administered. Unproven/unapproved stem cell therapies can be particularly unsafe and have led to serious infections, blindness, and death.  There are companies that are making unsubstantiated claims about the potential benefits of unproven cell therapies and their use in regenerative medicine, which is a disservice to those innovators who are working to develop safe and effective stem cell products, fully in keeping with our statues and regulations. Actions like this cast doubt across the entire field of regenerative medicine. We are concerned that people may use these unapproved products with a false sense of security about their safety and efficacy. Consumers should be cautious of any clinics, including regenerative medicine clinics, or health care providers, including physicians, chiropractors, or nurses, that advertise or offer any of these products.

The agency also said it has sent warning letters and “pursued enforcement actions for serious violations of the law” related to stem cell clinics. To date, a spokesperson wrote, it has sent “400 letters to manufacturers, clinics and health care providers, noting that it has come to our attention that they may be offering unapproved regenerative medicine products and that their activities may be subject to FDA regulation.”

In a recent blog post on The Niche, Knoepfler called on the FDA to freeze Duke’s EAP and closely examine its deal with Cryo-Cell. “The big-picture reason that I believe the agency should freeze this EAP is that it is not in the best interest of the children and their families,” he wrote. “I believe that Duke and Cryo-Cell may be too focused on ultimately profiting off of the EAP in the long run rather than just helping children.”

The science, he added, is simply not there. “Keep in mind,” he wrote, “there is no good evidence that cord blood can help kids with autism or CP. EAPs of this kind are supposed to have at least some quality data that is encouraging. I don’t see such data in this case.”

There’s also evidence that Cryo-Cell plans to extend these unproven treatments to COVID-19, which would both expand its market share and crowd an already cluttered marketplace of questionable treatments for the disease.

With funding from the Marcus Foundation, Duke is already running Phase 1 and 2 trials to see if mesenchymal stromal cells, which are also taken from cord blood, could help treat Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19. Those results are not expected until 2022, but as has become a pattern with Duke and Cryo-Cell’s partnership, they’re already selling investors on the idea: Cryo-Cell’s pitch deck to investors says there are “indications under current clinical study” that mesenchymal cells from cord tissue could be used against both autism and COVID-19. (The FDA told Motherboard the agency has not approved “any regenerative medicine products, including stem cell therapies, for the treatment of COVID-19, multiple sclerosis, or autism. The only stem cell–based products that are FDA-approved for use in the U.S. consist of blood-forming stem cells (hematopoietic progenitor cells) derived from cord blood.”)

Halladay, of the Autism Science Foundation, told Motherboard she has simple advice for families looking at these treatments for autistic kids. “Families should not consider this an established, evidence-based treatment,” she wrote in an email. “Families hearing about this plan by Cryo-Cell should be suspicious and turn to their doctor or clinical team for other potential treatments and treatment combinations. This may include not just for core autism symptoms but for debilitating mental health comorbidities as well.”

In the end, the issues here extend beyond just Duke, and even the world of stem cell research, Borden King argues, noting they touch on the very nature of scientific credibility itself.

“When people think of pseudoscience, they tend to think of things like a cheesy salesman selling fake pills online,” she said. “But in my work, I see quite a few examples of autism scammers hiding behind university credentials, building hype through a university. This all has a broader impact on the credibility of our universities, which are supposed to be grounded in science. Especially at this time, when we’re fighting a pandemic and we need clear boundaries around science versus pseudoscience, the impact of projects like this just really ripples out.”

A full statement from Duke University is below:

Researchers at Duke University have studied the use of cord blood cells for pediatric blood cancers and have explored potential therapeutic applications of these cells for neurological disorders in children arising from inborn errors of metabolism, traumatic brain injury, cerebral palsy, autism and neuroinflammatory conditions.

Duke researchers are active in conducting randomized controlled clinical trials evaluating cord blood cell therapies for these applications. Data from the studies are submitted for publication in peer reviewed journals and are rigorously assessed by the scientific community and the FDA. Much remains to be learned about how these cells affect the brain and about clinical outcomes, and Duke investigators are committed to ongoing research to close these gaps in knowledge.

For some children who do not qualify for clinical studies, but who have few other options for treatment of their conditions, the FDA has authorized Duke to offer cord blood cells through an expanded access protocol (EAP) monitored by the FDA.

In recent months, Duke has entered into a licensing agreement with Cryo-Cell International to provide regulatory information and other data that would help advance the company’s effort to develop a cell therapy program eligible for approval from the FDA. This licensing agreement does not grant Cryo-Cell the use of Duke’s EAP for the treatment of patients at Cryo-Cell, but will allow Cryo-Cell to develop its own cell therapy program.

Duke is committed to ensuring that scientific evidence guides the further study and use of these investigational therapies. As new findings provide additional insights, Duke will continue to evaluate how best to move forward, both with research and with FDA-approved clinical applications.

A Controversial Autism Treatment Is About to Become a Very Big Business syndicated from https://triviaqaweb.wordpress.com/feed/

[iilovedalone-blog]

sends every single shade of blue

NSFW Bloo Asks || Accepting

I will answer these, but I will be painfully brief just because of this.

Aqua: Top or bottom?

“Top.”

Azure: What’s your biggest turn-on?

“A good setting.”

Baby: Have you ever had sex with someone of the same gender?

“I only have sex with people of the same gender as me.”

Carolina: Have you ever had sex with someone of a different gender?

“No.”

Cerulean: What’s your biggest turn-off?

“Shitty music.”

Cyan: What’s your sexual orientation?

“I’m gay.”

Cobalt: Rough or soft?

“Depends on the person.”

Cornflower: Are you a virgin?

“No.”

Denim: Are you naturally submissive or dominant?

“Dominant.”

Electric: Do you prefer lingerie to regular underwear?

“Lingerie.”

Indigo: Do you like phone sex?

“It’s fine, I guess.”

Lapis: What’s your best fantasy?

“Getting fucked in a graveyard under the full moon. Obviously.”

Midnight: Are you into role-play?

“Depends. It can be kinda awkward.”

Oxford: Have you ever had sex with more than one person in a 24 hour period?

“Yes.”

Periwinkle: Do you use sex toys often?

“Yeah.”

Persian: Would you do public sex at all?

“Yes.”

Powder: Vanilla sex or spiced up?

“Depends on the person.”

Prussian: Confess a kink to me?

“Hair pulling? Uh... I guess leather gets me going?”

Royal: What’s your favourite position?

“I do like doggy style a lot.”

Sapphire: When was the last time you had sex?

“Last Saturday I think.”

Sky: Do you read smut/watch porn?

“Yeah.”

Teal: Where was the strangest place you ever had sex?

“An empty movie theatre.”

Tiffany: Would you/do you do sex work?

“Nah, I don’t think so.”

Turquoise: Have you ever taken part in group sex?

“I mean, I’ve been in a threesome? But nothing more than that yet.”

True: Do you remember your first time?

“Yeah.”

Ultramarine: Do you do/enjoy oral?

“I enjoy giving oral.”

Zaffre: Make up your own question!

“Why would someone send me all of these?”

“I don’t have an answer.”

[americanfreighttrucking]

China Open to Partial U.S. Trade Deal Despite Tech Blacklist

China Open to Partial U.S. Trade Deal Despite Tech Blacklist

(Bloomberg) — Terms of Trade is a daily newsletter that untangles a world embroiled in trade wars. Sign up here. China is still open to agreeing a partial trade deal with the U.S., an official with direct knowledge of the talks said, signaling that Beijing is focused on limiting the damage to the world’s second-largest economy.Negotiators heading to Washington for talks starting Thursday aren’t…

[nancyedimick]

The national government and the states: A paradox

An American flag in Means, Ky. ( Michael S. Williamson/The Washington Post)

A compendium of state taxing and spending data by the business website WalletHub, discussed at length in a terrific analysis by John Tierney over at the Atlantic, opens a pretty fascinating window on the state of American federalism at this point in time.

If you compute the amount of money paid to the national government in taxes by residents of each of the 50 states and compare it with the amount of money each state receives from the national government, 11 states receive more than $2 back for every dollar they send to Washington, D.C.: South Carolina, North Dakota, Florida, Louisiana, Alabama, Hawaii, Mississippi, New Mexico, Kentucky, West Virginia and Indiana (55 percent).

(States shown in bold type in the above list and subsequent lists voted for Trump in the last presidential election; the number displayed at the end of the list is the average percentage of the vote that went Trump’s way in the listed states.)

On the other side of the scale, these 14 states show a “deficit”; they receive less than $1 for each $1 paid in federal taxes: California, Massachusetts, Wyoming, Oklahoma, New Jersey, Utah, Colorado, New York, Kansas, Ohio, Nebraska, Illinois, Minnesota and Delaware (47.5 percent).

Similarly, using a somewhat more encompassing “dependency index” for each state, based not only on the amount of federal spending per capita in each state compared with every dollar paid in federal income taxes but also on (a) the percentage of a state’s annual revenue that comes from federal funding and (b) the number of federal employees per capita, show that these are the states that are the 10 most “dependent” on federal funding: Kentucky, Mississippi, New Mexico, Alabama, West Virginia, South Carolina, Montana, Tennessee, Maine and Indiana (57 percent).

And the least-dependent 10 are: New Hampshire, Connecticut, Massachusetts, Nevada, Kansas, California, Illinois, New Jersey, Minnesota and Delaware (42 percent).

It’s strange, and quite counterintuitive (to me, at least): The reddest states — the ones whose citizens consistently vote to dismantle significant portions of the federal government machinery — are the ones that receive the most benefit, financially speaking, from that federal government, while, correspondingly, the lower the financial benefit a state receives the more likely it is to vote blue. South Carolinians — who receive nearly $8 for every $1 they send to the feds — want less involvement by the federal government in their lives? Even though it means they’ll have to come up with that extra 7 bucks from some source other than the taxpayers in New York, California and Illinois?

I would have expected the relationship to run in the opposite direction, on the simple-minded theory that people vote with their pocketbooks. Obviously, there’s a lot more going on here, with many factors that play into a state’s voting patterns, and there’s also a fair bit of noise in the data, and there may be no simple explanation for what’s going on.

But regardless of the explanation for why the pattern exists, the fact that it does exist surely makes Ilya Somin’s argument — that “federalism can help save the failing ‘marriage’ between the red and blue states” — both more attractive and, I think, more plausible as a path forward:

A political union need not be as close a relationship as a marriage usually is. Red and blue America may not be able to spend some time completely apart. But they don’t have to do so many things together.

Today, the federal government has control over an extraordinarily wide range of issues, everything from health care to drug prohibition, to light bulbs and toilet flows. By decentralizing more power to the state and local level, or to the private sector, we can reduce the number of issues on which a one-size-fits-all decision has to be made. There will be less need to make painful compromises and concessions if each side can get their own way in their own state, locality, or private planned community.

A political family that doesn’t have to do so much together can be a happier family with fewer dangerous zero-sum conflicts. It may not be quite like a successful marriage. But perhaps a less intimate form of political relationship is precisely what we need. People who are too different to be good spouses might nonetheless make good friends or relatives – as long as they don’t have to do too many things together. Uncle Red and Cousin Blue might be a lot more likable if you didn’t have to worry about them controlling too many aspects of your life.

If South Carolinians and Nebraskans and Oklahomans want less “interference” from the federal government, it doesn’t take a great deal of imagination to think of the voters in California and New York and Illinois saying, “Fine — you go your way and we’ll go ours. You want to have a lousy health-care system, starve your public schools, open up more coal-fired plants without any regulatory supervision, prohibit your doctors from even mentioning the word ‘abortion,’ round up all your illegal immigrants and lower drinking water standards? Be our guest! Just don’t make us subsidize your lousy policies the way we have been up until now.”

This becomes an even more convincing argument — a no-brainer, even — when considering that the blue states:

contain nine of the 10 top-ranked universities in the country;

comprise nine of the 10 states with the highest median household income;

generate most of the technological innovation (measured by patent rates);

have higher average life expectancy

and so on.

It’s hard to imagine, given the degree of polarization we see around us, that we won’t be hearing more arguments from blue staters pointing in this very direction. See, for instance, Kevin Baker’s excellent open letter to red staters in the New Republic, suggesting that it’s time for “Bluexit” (pronounced, I believe, “Bloo-ksit”):

You want to organize the nation around your cherished principle of states’ rights—the idea that pretty much everything except the U.S. military and paper currency and the national anthem should be decided at the local level? Fine. We won’t formally secede, in the Civil War sense of the word. We’ll still be a part of the United States, at least on paper. But we’ll turn our back on the federal government in every way we can, just like you’ve been urging everyone to do for years, and devote our hard-earned resources to building up our own cities and states. We’ll turn Blue America into a world-class incubator for progressive programs and policies, a laboratory for a guaranteed income and a high-speed public rail system and free public universities. We’ll focus on getting our own house in order, while yours falls into disrepair and ruin.

It does require something of an ideological turn-around — blue staters are not usually associated with the idea of states’ rights and the advancement of true “federal”(as opposed to “national”) power. But the time sure seems ripe for such a move now.

Originally Found On: http://www.washingtonpost.com/news/volokh-conspiracy/wp/2017/03/28/the-national-government-and-the-states-a-paradox/

[wolfandpravato]

The national government and the states: A paradox

An American flag in Means, Ky. ( Michael S. Williamson/The Washington Post)

A compendium of state taxing and spending data by the business website WalletHub, discussed at length in a terrific analysis by John Tierney over at the Atlantic, opens a pretty fascinating window on the state of American federalism at this point in time.

If you compute the amount of money paid to the national government in taxes by residents of each of the 50 states and compare it with the amount of money each state receives from the national government, 11 states receive more than $2 back for every dollar they send to Washington, D.C.: South Carolina, North Dakota, Florida, Louisiana, Alabama, Hawaii, Mississippi, New Mexico, Kentucky, West Virginia and Indiana (55 percent).

(States shown in bold type in the above list and subsequent lists voted for Trump in the last presidential election; the number displayed at the end of the list is the average percentage of the vote that went Trump’s way in the listed states.)

On the other side of the scale, these 14 states show a “deficit”; they receive less than $1 for each $1 paid in federal taxes: California, Massachusetts, Wyoming, Oklahoma, New Jersey, Utah, Colorado, New York, Kansas, Ohio, Nebraska, Illinois, Minnesota and Delaware (47.5 percent).

Similarly, using a somewhat more encompassing “dependency index” for each state, based not only on the amount of federal spending per capita in each state compared with every dollar paid in federal income taxes but also on (a) the percentage of a state’s annual revenue that comes from federal funding and (b) the number of federal employees per capita, show that these are the states that are the 10 most “dependent” on federal funding: Kentucky, Mississippi, New Mexico, Alabama, West Virginia, South Carolina, Montana, Tennessee, Maine and Indiana (57 percent).

And the least-dependent 10 are: New Hampshire, Connecticut, Massachusetts, Nevada, Kansas, California, Illinois, New Jersey, Minnesota and Delaware (42 percent).

It’s strange, and quite counterintuitive (to me, at least): The reddest states — the ones whose citizens consistently vote to dismantle significant portions of the federal government machinery — are the ones that receive the most benefit, financially speaking, from that federal government, while, correspondingly, the lower the financial benefit a state receives the more likely it is to vote blue. South Carolinians — who receive nearly $8 for every $1 they send to the feds — want less involvement by the federal government in their lives? Even though it means they’ll have to come up with that extra 7 bucks from some source other than the taxpayers in New York, California and Illinois?

I would have expected the relationship to run in the opposite direction, on the simple-minded theory that people vote with their pocketbooks. Obviously, there’s a lot more going on here, with many factors that play into a state’s voting patterns, and there’s also a fair bit of noise in the data, and there may be no simple explanation for what’s going on.

But regardless of the explanation for why the pattern exists, the fact that it does exist surely makes Ilya Somin’s argument — that “federalism can help save the failing ‘marriage’ between the red and blue states” — both more attractive and, I think, more plausible as a path forward:

A political union need not be as close a relationship as a marriage usually is. Red and blue America may not be able to spend some time completely apart. But they don’t have to do so many things together.

Today, the federal government has control over an extraordinarily wide range of issues, everything from health care to drug prohibition, to light bulbs and toilet flows. By decentralizing more power to the state and local level, or to the private sector, we can reduce the number of issues on which a one-size-fits-all decision has to be made. There will be less need to make painful compromises and concessions if each side can get their own way in their own state, locality, or private planned community.

A political family that doesn’t have to do so much together can be a happier family with fewer dangerous zero-sum conflicts. It may not be quite like a successful marriage. But perhaps a less intimate form of political relationship is precisely what we need. People who are too different to be good spouses might nonetheless make good friends or relatives – as long as they don’t have to do too many things together. Uncle Red and Cousin Blue might be a lot more likable if you didn’t have to worry about them controlling too many aspects of your life.

If South Carolinians and Nebraskans and Oklahomans want less “interference” from the federal government, it doesn’t take a great deal of imagination to think of the voters in California and New York and Illinois saying, “Fine — you go your way and we’ll go ours. You want to have a lousy health-care system, starve your public schools, open up more coal-fired plants without any regulatory supervision, prohibit your doctors from even mentioning the word ‘abortion,’ round up all your illegal immigrants and lower drinking water standards? Be our guest! Just don’t make us subsidize your lousy policies the way we have been up until now.”

This becomes an even more convincing argument — a no-brainer, even — when considering that the blue states:

contain nine of the 10 top-ranked universities in the country;

comprise nine of the 10 states with the highest median household income;

generate most of the technological innovation (measured by patent rates);

have higher average life expectancy

and so on.

It’s hard to imagine, given the degree of polarization we see around us, that we won’t be hearing more arguments from blue staters pointing in this very direction. See, for instance, Kevin Baker’s excellent open letter to red staters in the New Republic, suggesting that it’s time for “Bluexit” (pronounced, I believe, “Bloo-ksit”):

You want to organize the nation around your cherished principle of states’ rights—the idea that pretty much everything except the U.S. military and paper currency and the national anthem should be decided at the local level? Fine. We won’t formally secede, in the Civil War sense of the word. We’ll still be a part of the United States, at least on paper. But we’ll turn our back on the federal government in every way we can, just like you’ve been urging everyone to do for years, and devote our hard-earned resources to building up our own cities and states. We’ll turn Blue America into a world-class incubator for progressive programs and policies, a laboratory for a guaranteed income and a high-speed public rail system and free public universities. We’ll focus on getting our own house in order, while yours falls into disrepair and ruin.

It does require something of an ideological turn-around — blue staters are not usually associated with the idea of states’ rights and the advancement of true “federal”(as opposed to “national”) power. But the time sure seems ripe for such a move now.

Originally Found On: http://www.washingtonpost.com/news/volokh-conspiracy/wp/2017/03/28/the-national-government-and-the-states-a-paradox/

[zeke-exiel]

@twiggenstein

A sole light in the otherwise dark room emitted from Zeke’s desk, the young man hunched over as he worked on the framework of his latest project; adjusting the magnification on his goggles slightly as he screwed, bolted, and soldered in small detail after small detail. 

Moving the eye wear to rest on top of his head revealed faintly glowing eyes starting to flicker as he lost concentration from lack of sleep, his body growing limp as his robotic hand started to get ahead of the other for a brief moment before that too gave in to exhaustion; his body giving way and falling down onto the desk with a thud, eyelids growing heavy as he stared at the blueprint sitting on the screen in front of him; some sort of computer chip with a ridiculous amount of detail and layers of technology even he wouldn’t understand without the help of his semblance.

Eyes weakly roll towards another screen to the side of the other, showing the schematics for his companion, Carolina, and an exposed core with a small almost hidden extra slot still yet to be filled. As the last of the light left his eyes the screens flickered to black and lids fluttered closed to finally rest.

Or so he should have, but moments later he shook and twitched on the hard surface as his fists clenched and unclenched repeatedly as his movements became more and more violent just as his dreams did; memories and fears flashing though his unconscious mind. After all this time he recognised that none of it was real, yet all he could do was writhe and mumble for help through gritted teeth.

“.....Carolina.......”

[zeke-exiel]

//My likes consist almost entirely of Carolina related stuff....

i think i have a problem This is the opposite of a problem

[zeke-exiel]

"Creator, I require an A.I. Please procure one for me so I may fulfill the prime directive to my fullest extent."

His chest tightened at the request; alarm bells blaring as he gave a look of concern and confusion to his creation.

“A-An AI? Fulfill the prime direct– Carolina what do you mean? What part of the prime directive has changed to require such a thing? I’m… fine!”

Even he wasn’t convinced by his own words as they came out of his mouth, and it’d be even more of a lie if he said that he hadn’t thought about the possibility of doing such a thing while he was running away.