Drugmaker Created To Reduce Shortages And Prices Unveils Its First Products

Pharmacy technician Peggy Gillespie fills a syringe with an antibiotic at ProMedica Toledo Hospital in Toledo, Ohio, in January.

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Tony Dejak/AP

On Wednesday, Civica Rx, a nonprofit drug company founded last year by a consortium of hospitals and foundations, said it had entered an agreement with a Danish drugmaker to make available injected forms of vancomycin and daptomycin, two antibiotics that are often in short supply.

Civica Rx has plans to become an alternative source of generic drugs for hospitals and provide a steady supply of critical medicines at reasonable prices .

The company’s initial plan is to make 14 drugs and offer them to member health systems. The antibiotics are the first two that Civica Rx has publicly announced.

“Vancomycin is kind of the typical shortage drug because it’s generic and it’s an injectable and it’s critically needed,” says Erin Fox, a pharmacist who studies drug shortages at University of Utah Health, one of Civica Rx’s members. “But we just haven’t had a very good routine supply of it for a while now,” she explains. She also recently joined Civica Rx’s advisory board.

When the heavy-duty antibiotic vancomycin is in short supply, Dr. James Augustine, an emergency physician at Mercy Health hospitals in Cincinnati, gets worried.

“Vancomycin has been our last-ditch antibiotic for quite a few years,” Augustine says. “It is our go-to antibiotic for very, very sick people and those with resistant infections.”

Augustine collects information on drug shortages and shares it with other health care professional across the country. Shortages of key drug are a big and persistent problem for hospitals, he says.

“We have experienced shortages of most every drug,” he says. “It’s getting hard to keep track,” Augustine says. In a survey last year of emergency physicians, 9 in 10 had experienced a shortage in the previous month.

Shortages of vancomycin are a particular problem because it’s a powerful medicine that doesn’t have a good alternative, he says.

It’s unclear why vancomycin, which has been a generic for many years, has experienced shortages, says University of Utah’s Fox.

“Sometimes it’s just some kind of a supply constraint, or one company discontinuing production,” she says. “But we don’t always know the reasons for shortages. The companies won’t won’t tell us. In fact, pharma companies, while they’re required to report a shortage to the [Food and Drug Administration] FDA, they’re actually not required to provide the reason for that shortage to the FDA.”

Neither vancomycin, whose name comes from the same root as vanquish, nor daptomycin drug is on the FDA’s list of drugs in short supply, but they both are on another drug shortage list that Fox helps manage, along with the reasons why, if available. Drug giant Pfizer, for example, lists shortages for both drugs because of “manufacturing delays.”

Civica Rx won’t be making these drugs itself. Instead it has contracted with Danish drugmaker Xellia to make them with a Civica Rx label. Civica Rx’s member health systems currently include 800 hospitals across the country.

Fox says the real innovation here is a new kind of contract between drugmakers and hospitals.

“You can pretty much predict how much product you’re going to need at your hospital, and you can say, ‘Yep, I will purchase, say, 500 packages of this in a year,” she explains. “You would have to sign up for that and say, ‘I’m going to buy that,’ and if you don’t, the company still gets the money.”

That “guaranteed volume” for Civica Rx is supposed to help with the periodic shortages.

How much will the Civica Rx drugs cost? “Pricing will vary based on product,”company spokesperson Debbi Ford said in an email. She declined to provide specific prices.

Vancomycin “right now is a fairly reasonable price,” says Martin VanTrieste, Civica’s president and CEO. “However daptomycin is one of those high-priced drugs, and we’ll be able to bring [it at] a significantly lower price.”

VanTrieste says Civica’s pricing will be based on manufacturing costs, plus a “fair margin” for the drugmaker — in this case, Xellia. “Once we negotiate that price, we go back to our members and say, ‘I have vancomycin 1-gram vials I’m offering to you at “X” price. You want to opt in to purchase that product or opt out?’ “

Dr. James Augustine’s health system, Mercy Health, isn’t a Civica Rx member, although membership is open. It costs $300 per hospital bed to join, according to VanTrieste.

Augustine is encouraged by what Civica Rx is trying to do. “It’s a fabulous idea,” he says.

But the company’s existence underscores for him that up until now, generic drugmakers have failed patients and providers. “They have decided not to make a reliable source of these medicines available and where possible to jack up the prices to to incredible levels,” he said. “It’s disgusting.”

“We always support additional competition to the market,” said Rachel Schwartz, a spokesperson for the Association for Accessible Medicines, a trade group for generic drugmakers, in an email.

Civica Rx’s VanTrieste expects to be able to offer the two antibiotics to member health systems this summer.

That’s when the experiment to prevent drug shortages and bring down prices will be put to a real-world test.

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After 12 Seasons, ‘Big Bang’ Writers Bid Farewell To Their ‘Surrogate Family’

The characters in The Big Bang Theory were “outliers” who formed a “surrogate family,” says show co-creator Chuck Lorre. Above, Simon Helberg, left, Johnny Galecki, Kaley Cuoco, Jim Parsons and Kunal Nayyar.

Monty Brinton/CBS ©2007 CBS Broadcasting Inc.


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Monty Brinton/CBS ©2007 CBS Broadcasting Inc.

The hit TV show The Big Bang Theory is signing off after a 12 season run – and the show’s writers and creators aren’t quite ready to say goodbye. For more than a decade, the writers have pitched storylines and traded jabs from their creative space at Warner Bros. studios.

On their long conference table you’ll find Star Wars toys, e-mail about the structure of DNA, and the collected work of physicist Richard Feynman. There are Star Trek screensavers on the TV monitors.

The Big Bang Theory was always a show for and about geeks and nerds, and that’s why it’s worked, says executive producer Chuck Lorre: “The characters were outliers and felt somewhat disenfranchised from the world and clung to each other – they created a surrogate family,” Lorre explains. He’s proud that the show connected with viewers who didn’t always fit in. “This is for the rest of us who weren’t the king and queen of the prom,” he says.

Lorre co-created the show with Bill Prady, who long ago wrote computer software that he says was “sold in your neighborhood Radio Shack.” He talked with Lorre about how brilliant his coworkers were at programming — but how bad they could be interacting with people — women in particular.

Prady knew one programmer who could do amazing calculations in his head but couldn’t manage to tip the waiters in a restaurant. When he shared that story, Lorre said, “Hang on, I’ve never seen that guy on television.”

Lorre and Prady made their Big Bang protagonists scientists, not programmers: Sheldon (Jim Parsons), a fastidious genius and his best friend and fellow physicist Leonard (Johnny Galecki). The show also features their Caltech friends Raj (Kunal Nayyar), an astrophysicist scared of talking to women, and Howard (Simon Helberg) an astronaut with an overbearing mom. Sheldon eventually marries neurobiologist Amy (Mayim Bialik) and Leonard weds Penny (Kaley Cuoco), an aspiring actor turned pharmaceutical rep who started out as their neighbor.

The writers say one of their favorite moments was when Penny gifted Sheldon a napkin from the restaurant where she worked. It was autographed, “To Sheldon: Live Long and Prosper. Leonard Nimoy.”

When she apologizes for the napkin being dirty — “He wiped his mouth with it,” she explains — Sheldon gasps: “I possess the DNA of Leonard Nimoy!?”

Writer Steve Molaro says this scene was key to the evolution of the show. “That was the first truly electric moment,” he says. “You could just feel what we were doing vibrating.”

Bill Prady, front left, and Chuck Lorre, front right, are the co-creators of The Big Bang Theory.

Mike Yarish/© 2019 Warner Bros. Entertainment Inc.


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Mike Yarish/© 2019 Warner Bros. Entertainment Inc.

The writers say they also treasured quieter scenes — like the time Sheldon’s friends throw him a birthday party and he gets overwhelmed and Penny finds him in the bathroom. She tells Sheldon that years ago, she would never have been friends with someone like him, but now he’s one of her favorite people.

“If what you need is to spend your birthday in a bathroom, I’m happy to do it with you,” she tells him.

“But everyone will think I’m weird,” he says.

“Sweetie,” she responds, “You are weird.”

Over the years, the show has welcomed appropriately nerdy guest stars: Nobel laureates, astronauts, actors from Star Wars and Star Trek — even physicist Stephen Hawking. The writers took cues from the latest scientific breakthroughs and they regularly consulted with UCLA physicist David Saltzberg to make sure their scripts were scientifically plausible.

“Sometimes you just send him the script with big blank sections to be filled in with appropriate science so that we’re not ridiculed,” says Lorre.

Writer Steve Holland adds “sometimes, we say things to him like ‘Sheldon and Amy need to have a discovery that could be worthy of a Nobel Prize but [it] can’t be something anyone else has already thought of. So: go!”

Saltzberg came up with the fictitious theory of “Super Asymmetry,” which was sort of a riff on the real-life physics theory of Super Symmetry.

“Theoreticians love symmetrical equations, but the world around us is clearly asymmetrical,” Saltzberg says. “What theoretical physicists often do is create a theory with lots of symmetry, but then then break it, to explain our world. … The brilliance of Amy and Sheldon was to include asymmetry into their theory from the start.’

Saltzberg adds that he hopes a physicist watching the show would at least chuckle — and then think about it seriously. “As for details, I will need to read Amy and Sheldon’s publication very closely to tell you more,” he says.

Super Asymmetry may made-up, but in 2010, scientists did end up winning a Nobel Prize for research into “graphene” — a subject that was mentioned on a whiteboard in the background of The Big Bang Theory earlier that year. The prize-winning scientist cited the episode in his Nobel lecture.

Writer Dave Goetsch says he’ll miss generating show ideas from real world science. Stories would catch his eye on online and he’d say: “Oh that’s going to make an amazing episode.” He says he can’t bring himself to turn off his daily Google alert for physics news.

Most of writers have been together for 12 years, and many are now also executive producers of the show. Maria Ferrari says she’ll miss this writing team. “Most jobs, you go off and you write your scripts and then you come back and you punch it up together,” she says. “Here, we write it all together. That’s the only thing I feel like I know how to do: is write, in this room, for this show. It is so hard to leave it behind.”

Bill Prady gets emotional when he talks about how fans have connected with the show — and for him, it’s personal. “All of the people who have said that they see themselves in the show because they were outsiders and people who didn’t fit in — that was me,” he says.

No spoilers for the show’s emotional final episode — which airs Thursday on CBS — but no doubt it will end as it all began, with a Big Bang.

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Trump To Outline Immigration Plan That Would Overhaul Who’s Allowed Into The U.S.

President Trump tours a portion of the border wall between the United States and Mexico in Calexico, Calif., last month.

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President Trump is set to unveil an immigration plan that would vastly change who’s allowed into the United States.

Trump will present the plan in a speech from the White House Rose Garden Thursday afternoon. The plan, according to a senior administration official, includes six planks:

  • Securing the border: Finishing the border wall
  • Protecting American wages: Stemming the flow of low-wage labor
  • Attract and retain the best and brightest immigrants
  • Prioritize nuclear families: It would limit which family members can come to the country to children and spouses
  • Import labor for critical industries
  • Preserve humanitarian values: Keep asylum system, but limit it.

The formula currently for who comes to the country is 12% skill-based, 66% with ties to family members and 22% humanitarian, or asylum-seekers.

Trump would change that calculation to 57% skill, 33% family, 10% humanitarian.

The bottom-line politically, said the administration official, “We want to show country that Republicans are not against immigrants.”

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Guidance Reminder: On Abortion Procedures, Terminology & Rights

As we’ve covered the new abortion law in Georgia and legislation in Alabama, we’ve followed long-standing guidance very well. Thank you to all involved.

For those new to the subject, that guidance about abortion and related topics is collected in our Intranet “radio” style guide. We’ll attach it below.

One thing to keep in mind about this law and others like it: Proponents refer to it as a “fetal heartbeat” law. That is their term. It needs to be attributed to them if used and put in quotation marks if printed. We should not simply say the laws are about when a “fetal heartbeat” is detected. As we’ve reported, heartbeat activity can be detected “about six weeks into a pregnancy.” That’s at least a few weeks before an embryo is a fetus.

Here is the long-standing guidance:

ABORTION PROCEDURES & TERMINOLOGY: Use the term intact dilation and extraction to describe the procedure, or a procedure known medically as intact dilation and extraction; opponents call it partial-birth abortion. On the latter, it is necessary to point out that the term partial-birth is used by those opposed to the procedure; simply using the phrase so-called partial birth abortion is not sufficient without explaining who’s calling it that. Partial-birth is not a medical term and has no exact parallel in medical terminology; intact dilation and extraction is the closest description. Also, it is not correct to call these procedures RARE — it is not known how often they are performed. Nor is it accurate to use the phrase LATE TERM ABORTION. Though we initially believed this term carried less ideological baggage when compared with partial-birth, it still conveys the sense that the fetus is viable when the abortion is performed. It gives the impression that the abortion takes place in the 8th or 9th month. In fact, the procedure called intact dilation and extraction is performed most often in the 5th or 6th month — the second trimester — and the second trimester is not considered “late” pregnancy. Thus “late term” is not appropriate. As an alternative, call it a certain procedure performed after the first trimester of pregnancy and, subsequently, the procedure…. Also note:

NPR doesn’t use the term “abortion clinics.” We say instead, “medical or health clinics that perform abortions.” The point is to not to use abortion before the word clinic. The clinics perform other procedures and not just abortions.

Do not refer to murdered Dr George Tiller as an “Abortion Doctor.” Instead we should say Tiller operated a clinic where abortions are performed. We can also make reference to the fact that Tiller was a doctor who performed late abortions.

Here’s some additional guidance from Joe Neel, regarding the Unborn Victims of Violence Act:

The term “unborn” implies that there is a baby inside a pregnant woman, not a fetus. Babies are not babies until they are born. They’re fetuses. Incorrectly calling a fetus a “baby” or “the unborn” is part of the strategy used by antiabortion groups to shift language/legality/public opinion. Use “unborn” only when referring to the title of the bill (and after President Bush signs it, the Unborn Victims of Violence Law). Or qualify the use of “unborn” by saying “what anti-abortion groups call the ‘unborn’ victims of violence.” The most neutral language to refer to the death of a fetus during a crime is “fetal homicide.”

ABORTION RIGHTS:

On the air, we should use “abortion rights supporter(s)/advocate(s)” and “abortion rights opponent(s)” or derivations thereof (for example: “advocates of abortion rights”). It is acceptable to use the phrase “anti-abortion rights,” but do not use the term “pro-abortion rights”. Digital News will continue to use the AP style book for online content, which mirrors the revised NPR policy. Do not use “pro-life” and “pro-choice” in copy except when used in the name of a group. Of course, when the terms are used in an actuality they should remain.

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Auto Industry Waits (And Waits) To See If Trump Will Slap New Tariffs On Cars

New cars sit in a lot at the Auto Warehousing Co. near the Port of Richmond in Caliornia on May 24, 2018. President Trump has threatened to impose heavy tariffs on auto imports, but the White House has not announced a decision.

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Justin Sullivan/Getty Images

The Trump administration’s trade war with China continues to roil markets and draw headlines. But that’s not the only trade tension in town.

For more than a year, the White House has been weighing the possibility of imposing tariffs or quotas on cars and car parts imported from close allies in Europe and Japan.

The auto industry is united in opposition to the tariffs. But carmakers and auto suppliers may have to keep waiting to find out if their pleas have been heard.

While the administration faces a Saturday deadline on the question of tariffs, the White House is widely expected to opt for an extension rather than make an announcement one way or another.

The hypothetical auto tariffs would be enacted in the name of of national security, under the same “Section 232” authority that Trump used to impose tariffs on steel and aluminum.

Those tariffs have provided a boost to American steel and aluminum producers, while raising costs for the many American manufacturers who use the metals in their products.

Auto tariffs would be different, because the industry is so globally intertwined. Instead of helping some American companies and hurting others, Section 232 tariffs would raise costs for automakers and suppliers across the board. Hundreds of thousands of jobs would be lost, according to industry analyses, and that’s without even factoring in retaliatory tariffs.

“The entire industry is very much opposed to it,” says Ann Wilson, the senior vice president of government affairs for the Motor and Equipment Manufacturers Association.

Of course, the possibility of such tariffs may be used by the White House as a negotiation tactic — leverage to push for more favorable trade deals — without ever actually putting the tariffs in place. David Schwietert, interim CEO of the Auto Alliance, says if that’s the strategy, the goals may be laudable. But the tactic has costs, he says.

“This is having a chilling effect,” he says. “Just the near-term threat of even implementing such tariffs, let alone what would happen economically should they be imposed.”

The prolonged uncertainty inhibits investment and makes it hard for automakers to plan for the future, he says.

“The sooner it’s resolved, the better — not only for manufacturers but also for the economy,” Schwietert says.

An issue of national security?

So, how do car imports imperil national defense? Experts are skeptical, to say the least, that there’s any persuasive argument to be made. But no one knows exactly what the administration’s argument would be.

In February, the Commerce Department submitted a report on the topic, but it’s never been made public. Even Sen. Chuck Grassley, the Republican chairman of the Senate Finance Committee, hasn’t seen it — despite making multiple requests to the administration.

But it may not matter how robust the logic is. The president’s authority under Section 232 is broad, and historically, the courts and Congress have been reluctant to challenge determinations of national security.

Gary Hufbauer, a nonresident senior fellow at the Peterson Institute for International Economics, says the World Trade Organization has also been reluctant to challenge any trade policies claimed for reasons of national security.

As a result, “from President Trump’s standpoint the use of this section has been very attractive,” he says.

Before this administration, the law was rarely invoked. The president’s use of the section has raised some eyebrows in Congress, and a pending legal challenge argues that the law gives the president too much leeway.

Hufbauer notes that Section 232 is a Cold War-era statute.

“During wartime, Congress gives lots of power to the president,” he says. “At this time, when things are completely different and when we’re talking about … trade with allies, it’s very odd.”

When ‘buying American’ isn’t an option

Trump has repeatedly defended his trade policies by saying tariffs can be avoided by supporting U.S. manufacturers. But while auto tariffs would target imports, American companies would inevitably take a hit.

“There is no such thing as a U.S. vehicle,” says Ann Wilson of the Motor and Equipment Manufacturers Association. “All vehicles that you purchase in the United States … depend on a vibrant global marketplace.”

Cars are made up of thousands of parts, sourced from around the world. In some cases, parts pass back and forth across borders repeatedly.

Consider the seat in a new American-made vehicle. Inside that seat is an electronic sensor — one made by a foreign manufacturer, Wilson says.

The sensors will be imported into the U.S. and programmed. “Then after they’re programmed they are oftentimes sent abroad someplace else, to be put into a larger component,” Wilson says. “Then they’re brought back into the United States so that they could actually become part of that seat.”

All that happens before the seat ever makes it to an auto plant. Multiply this by the multitude of parts inside a car, and even the most American vehicle has been touched by part manufacturers around the world.

As a result, tariffs would raise costs for U.S. manufacturers as well as foreign rivals. And ultimately, the costs could be passed to consumers.

The precise impact depends on how exactly any tariffs would imposed, and which countries might get exemptions. An analysis by the Center for Automotive Research found very narrow tariffs would only increase car prices a few hundred dollars, while a broad tariff would make cars thousands of dollars more expensive: Imported car prices could go up $3,700, and cars made in the U.S. would go up $1,900.

Automakers have already been hurt by existing tariffs, including the steel and aluminum tariffs under Section 232 and the array of tariffs on Chinese goods.

But industry leaders say the specter of auto-specific tariffs is far more concerning.

“The potential [of] upwards of 25% tariffs on vehicles would make the steel and aluminum tariffs look really small,” says Schwietert, of the Auto Alliance.

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‘A Thousand Small Sanities’ Is A Lesson In Understanding Liberalism

Jostein Gaarder’s Sophie’s World was one of the most memorable books I read in my early teens. The brilliance of that book came from Gaarder’s ability to make complicated concepts easier for young minds to digest. Adam Gopnik’s A Thousand Small Sanities: The Moral Adventure of Liberalism does the same thing with liberalism — but for politically engaged adults.

Liberalism and liberals are under attack. In the current political landscape, the attack is coming from both right and left and rides a wave of events that threaten democracy and that have produced a mounting crisis of faith in liberal institutions while criticizing the core of liberal thought. A Thousand Small Sanities stands against this charge. By (re)defining liberalism, tracing its impact on history, society, and politics, and engaging with a mix of intellectuals, theorists, writers, and political figures such as Frederick Douglass, Bayard Rustin, John Stuart Mill, Robert D. Putnam, Michael de Montaigne, Adolf Hitler, Benjamin Disraeli, Philip Roth, George Eliot, Harriet Taylor, G.H. Lewes, Michel Houellebecq, and Jürgen Habermas, Gopnik demonstrates how liberalism is, more than a term for political centrism or the idea of free markets, a concerned, ever-expanding search for positive, inclusive changes at all social and political levels. Ultimately, by showing the impact it’s had in the past, Gopnik presents liberalism not only as a moral adventure but also as a necessity in an age of resurging autocracy and rampant bigotry.

Gopnik wants readers to understand liberalism. However, liberalism is many things. Throughout this book, he explores its history and explains its need, but he never loses sight of his main goal: making people understand what it is because understanding it is understanding the need for it. To achieve this, he defines and redefines liberalism in various ways, tying it to the human condition, to our growing set of problems, and to shifting political realities. He starts with simple, somewhat humorous statements like this: “Liberalism is our common practice of connection turned into a principle of pluralism, teenage texting raised to the power of law.” From then on, he complicates and simplifies the definition, adapts it to new problems, and gets to its humanist core:

“Liberalism is a fact-first philosophy with a feelings-first history. Liberal humanism is a whole, in which the humanism always precedes the liberalism. Powerful new feelings about a compassionate connection to other people, about community, have always been informally shared before they are crystallized into law. Social contacts precede the social contract. Understanding the emotional underpinnings of liberalism is essential to understanding its political project.”

One of the ideas at the center of this book is that liberalism’s main goal from a sociopolitical standpoint is reform — and that liberals “believe in the possibility of reform” and think of it as something that “is always going to be essential” and constantly required:

“The next reform is necessary not because we changed our views but because new kinds of cruelty are always coming into existence or into view. Our sights sharpen. Our circles of compassion enlarge. No sane society reaches a secure balance point. We always need change. The process of reform is never ending not because we are always searching for utopia but because as the growth of knowledge alters our conditions, we need new understandings to change out plans.”

As with any nonfiction book about big ideas with a political slant, A Thousand Small Sanities will cause much debate. It’s a startingly intelligent, passionate, well-researched manifesto, but contains so much that it’s impossible to engage with on only one level, or to agree or disagree with its entirety. In fact, while I agreed with most of the book, I found some issues. For example, Gopkin says it’s OK to let small things slide in order to focus on the bigger picture. Furthermore, he never engages with scholar and feminist critic Gayatri Chakravorty Spivak’s work, which would have enriched and complicated things wonderfully. And he defends freedom of speech and the proverbial “slippery slope” in a way reminiscent of those who make eloquent defenses of people like Jordan Peterson, Milo Yiannopoulos, and Alex Jones (none of whom Gopnik defends or even mentions, obviously).

If Sophie’s World was Gaarder teaching young readers about philosophy, A Thousand Small Sanities — which Gopnik writes for his teenage daughter (he refers to what he does in the book as “dad-splaining” in the acknowledgements) — is one of sharpest contemporary works teaching us about liberalism and convincingly framing it as one of the most powerful tools we have to change our current situation:

“Liberalism isn’t a political theory applied to life. It’s what we know about life applied to a political theory. That good change happens step by step, stone by stone, and bird by bird, that we advance in life by invisible thoroughfares and, feeling our way along in their darkness, awaken to find ourselves changed and, sometimes, improved.”

Whether readers agree with Gopnik or not, this is an important, timely book that should be required reading because it points to everything that’s wrong and then takes it a step further — a crucial step most others fail to take: It offers a viable solution.

Gabino Iglesias is an author, book reviewer and professor living in Austin, Texas. Find him on Twitter at @Gabino_Iglesias.

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