April 9, 2019

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Business April 9, 2019

Opioid Maker Charged With Fraud In Marketing Drug As Less Prone To Abuse

Susan Stevens shows off a prescription for Suboxone her daughter filled the day before she died at her home in Lewisville, N.C. March 11.

Eamon Queeney/The Washington Post/Getty Images

Federal prosecutors late Tuesday charged British drug maker Indivior with felony fraud and conspiracy for its marketing of opioid products including Suboxone. The company allegedly created a “nationwide scheme” in the U.S. designed to convince doctors and government insurance providers their patented opioid medications are safer and less prone to abuse than cheaper generic alternatives.

“The indictment alleges that, rather than marketing its opioid-addiction drug responsibly, Indivior promoted it with a disregard for the truth about its safety and despite known risks of diversion and abuse,” said Assistant Attorney General Jody Hunt in a statement.

Federal prosecutors claim Indivior bilked Medicare, Medicaid and other health care providers out of billions of dollars as they paid for a more expensive version of the drug, believing it to be safer. The criminal charges, filed in the western district of Virginia, stem from a joint investigation that included the U.S. Food and Drug Administration, Virginia’s state attorney general office, and other agencies.

The company issued a statement denying any wrongdoing. “Key allegations made by the Justice Department are contradicted by the government’s own scientific agencies,” Indivior said on Tuesday, adding that the firm “will contest this case vigorously and we look forward to the full facts coming out in court.”

At the heart of the 28-count indictment is Indivior’s effort, beginning in 2007, to popularize a new method of delivering its Suboxone medication, which is used to treat patients suffering from opioid dependency. With a cheaper generic tablet form of the drug expected to go on sale, the company developed a dissolvable film that could be placed under the tongue, describing the new delivery system as “less abusable” with a “lower risk.”

Prosecutors now say the company knew the dissolvable film version of Suboxone was potentially more dangerous, more susceptible to abuse, and included a higher risk that children might be exposed to the drug. The firm also developed a program that allegedly connected opioid-dependent patients with doctors who prescribed Suboxone “in high doses and in suspect circumstances.”

Federal prosecutors say if Indivior is found guilty, the company should forfeit at least $3 billion in penalties. In its response, Indivior said the company acted responsibly and has played a crucial role responding the deadly opioid epidemic. The firm also says it tried to negotiate a settlement before the charges were filed.

“We are extremely disappointed in this action by the Justice Department, which is wholly unsupported by either the facts or the law,” Indivior’s statement said.

This indictment marks an escalation in what has already emerged as a dangerous year for major drugmakers and distributors entangled in the opioid crisis. According to the U.S. Centers for Disease Control and Prevention, prescription opioid overdoses have killed more than 200,000 Americans over the last 20 years.

Companies including Purdue Pharma, Johnson & Johnson and CVS face a wave of civil lawsuits in state courts around the country. They stem from claims that Big Pharma accelerated the opioid crisis by aggressively marketing prescription painkillers and other opioid medications. The next major trial is set to begin next month in Oklahoma.

Federal prosecutors have successfully pursued criminal charges against opioid manufacturers in the past. In 2007, Purdue Pharma and three of its executives pleaded guilty and paid more than $600 million in fines and other charges after the company falsely claimed its Oxycontin medication was less addictive than other opioid painkillers.

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Sports April 9, 2019

Scrutiny Continues For Santa Anita Race Track After 23 Thoroughbreds Die In 3 Months

The famed Santa Anita racetrack in southern California is under scrutiny after a spike in thoroughbred deaths. Santa Anita hosted its biggest race day of the year this past weekend.



AILSA CHANG, HOST:

Santa Anita Park in Southern California has been out of the headlines for a few days. That’s welcome news at the famous horse racing track. Over the past three months, 23 thoroughbreds have died, mostly due to injuries from racing or training. The track was shut down for most of March, but it was open this past weekend for a major event. Still, the scrutiny from Congress to the LA County district attorney continues. And as NPR’s Tom Goldman reports, throughout the racing industry, there’s concern the future of the sport is at stake.

TOM GOLDMAN, BYLINE: Santa Anita is nicknamed the Great Race Place, and Saturday, it was easy to see why.

UNIDENTIFIED ANNOUNCER #1: And Lemoona’s in the back.

GOLDMAN: From the grandstand along the stretch, a visual feast – a bright blue California sky, the San Gabriel Mountains, muscular thoroughbreds rumbling by on the dirt track.

(SOUNDBITE OF MUSIC)

GOLDMAN: Beneath this festive scene, though, there was anxiety among those connected to the track. Their mantra had been just get through Saturday. Meaning, after 23 thoroughbred deaths, Santa Anita certainly didn’t want another, not on a day when a national TV network would broadcast the Santa Anita Derby, a big prep race for the Kentucky Derby next month. This was jockey Joel Rosario after he rode in one of the day’s early races.

JOEL ROSARIO: You know, just hopefully everything, you know, go nice and smooth and then, you know, we don’t have any, you know, any problem, you know.

GOLDMAN: Steve Bazela was among the 30,000-plus paying and gambling customers on this day. He’s been coming to Santa Anita since the 1960s, and he certainly didn’t want to see what he saw just a week before – the catastrophic injury to a thoroughbred named Arms Runner, the most recent to die.

STEVE BAZELA: All you got to do is see that once or twice in your life, and it changes you. I saw a horse break down at the finish line about eight years ago here. I just literally walked to the parking lot I was so upset. I mean, they give you everything they got.

GOLDMAN: It changes you, but you’re back.

BAZELA: Yeah.

GOLDMAN: You still love this sport.

BAZELA: Oh, I love it.

GOLDMAN: How’d it change you, then?

BAZELA: It just makes you more aware.

UNIDENTIFIED ANNOUNCER #2: And they’re off in the Santa Anita Derby.

GOLDMAN: The big race didn’t disappoint. Horses trained by Hall of Famer Bob Baffert finished 1-2 and qualified for the Kentucky Derby. Baffert, the face of horse racing in this country, was thrilled and grateful for the fans who turned out and saw an entire day of injury-free racing.

BOB BAFFERT: We needed a lift. I know I did.

GOLDMAN: Catastrophic injuries happen in horse racing, but these spikes in deaths are not the norm, which is why Baffert warned against overreacting.

BAFFERT: You don’t have to burn the house down just because the pipes are bad, you know? And so, you know, we’re going to work through this, but I really think the weather really caused a lot of this.

GOLDMAN: He’s not wrong. In January and February, Southern California got a ton of rain. It affected the multilayer dirt track at Santa Anita and posed a potential risk to the massive horses who need those layers just right in order to protect their legs. But Dr. Rick Arthur says you can’t just blame the rain.

RICK ARTHUR: Frankly, we shouldn’t have run on some of the days that we had a bad track.

GOLDMAN: Arthur is an equine veterinary specialist who’s been based at Santa Anita for more than four decades.

ARTHUR: And some of the days when the track wasn’t as good as it should have been, trainers shouldn’t have trained their horses.

GOLDMAN: Those decisions, Arthur says, are driven by a reality that goes beyond Santa Anita to many of this country’s racetracks, where the focus, he says, is more on economics than on horses. That, he says, is horse racing’s real problem.

ARTHUR: Racing has become more competitive over a period of time. Horses are worked faster, and there’s fewer horses to fit the slots that are available, so there’s more pressure on the horses to race more frequently.

GOLDMAN: Getting the horse racing industry – track managers, owners, trainers – to buy into less racing and resting horses more, that’s going to take a culture change, Arthur says. But he adds, if that doesn’t happen and horses keep dying at higher rates, there’s a unanimous belief in what will happen.

ARTHUR: If we don’t make racing safer, I don’t think the public’s going to allow us to continue the sport.

(CHEERING)

GOLDMAN: There’ve been nine straight days of racing and training at Santa Anita without a horse dying. Considering the last three months, that’s a big deal. The weather now is warm, and Arthur says the track is in great condition. The group that owns Santa Anita has implemented new rules regulating medication – always a controversial issue in horse racing. Also more veterinarians have been dispatched to observe training sessions.

Even the industry’s harshest critic, People for the Ethical Treatment of Animals, praises the ownership group’s action. But PETA is now turning its attention to Churchill Downs, home of the Kentucky Derby. In a statement yesterday, PETA said, quote, “Kentucky is on notice. Churchill Downs has the second-worst death rate for horses in the country.” The organization says change is overdue, and it needs to come now. Tom Goldman, NPR News.

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Health April 9, 2019

Porcupine Barbs For Better Wound Healing


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At first, the idea of using porcupine quills to patch up wounds sounds torturous. But, taking inspiration from the spiky rodent, researchers have begun to work on a new type of surgical staple that may be less damaging — and less painful — than current staples.

Worldwide, surgeons perform more than 4 million operations annually, usually using sutures and staples to close wounds. Yet these traditional tools designed to aid healing can create their own problems.

“We’ve been using sutures and staples for decades, and they’ve been incredibly useful,” says Jeff Karp, a bioengineer at Brigham and Women’s Hospital in Boston and professor of medicine at Harvard Medical School. “But there are challenges in terms of placing them for minimally invasive procedures.”

Surgical staples are faster to insert than sutures, which require a needle and thread, he explains. But current staples, made of metal, tear tissue on the way in and cause more damage when bent to stay in place.

The quill tip in this finger has microscopic, backward-facing barbs that make the quill hard to remove. Bioengineers think the same sort of barbs could help keep dissolvable medical staples in place until a wound heals.

Josh Cassidy/KQED


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Josh Cassidy/KQED

Karp and his team have been searching for new ways to hold tissue together.

One brainstorming session led to a discussion of a porcupine and its quill.

The North American porcupine appears cute, but it has more than 30,000 menacing quills covering much of its body, each one hollow and 2 to 3 inches long. The slow-moving herbivore uses the quills as a last-resort defense against predators.

The quills are actually specialized hairs that mostly lie flat against the animal’s body. Only when threatened will the porcupine erect them. And, contrary to a common myth, porcupines don’t shoot the quills out from their bodies.

“The wonderful thing about porcupines is that they seem to feel secure,” saidUldis Roze, emeritus biology professor at Queens College, City University of New York. “They feel like they’re not in danger, and they’re sweet.”

When the porcupine is relaxed, its other hairs and fur hide most of the quills.

When threatened, the adult porcupine displays three types of warnings before lashing out, according to Roze’s book The North American Porcupine. First, the contrasting black and white pattern of the animal’s quills and other hairs — known as aposematic coloration — is a visual warning signal. A unique pungent odor and ominous teeth are further clues that dogs, mountain lions and other potential predators should stay away.

The North American porcupine has a cute face, but it has upward of 30,000 menacing quills covering much of its body. The slow-moving herbivore uses them as a last-resort defense against predators.

Lindsay Wildlife Experience


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Lindsay Wildlife Experience

If that doesn’t work, a porcupine will use its powerful, spiky tail to slap at the aggressor. Each quill is held in place by its own special structure in the porcupine’s skin. Direct physical contact with a predator causes the porcupine’s skin to release the quill.

Quills from North American porcupines pack a hidden punch: microscopic, backward-facing barbs.

Covering just the needlelike tip of the quills, the barbs make removing a quill difficult, because they flare out when pulled in a direction opposite to the way they went in.

That means that if a predator gets quilled, the quill might never come out. When scientists examine the skulls of deceased mountain lions, Roze says, they often find the tips of porcupine quills embedded in the lions’ jaw bones

“The mountain lion just accepts it,” said Roze. “It’s part of the work of killing a porcupine.”

Of course, that mountain lion’s days of porcupine feasting may end forever if the quills keep it from eating or end up in the cat’s vulnerable internal organs.

This image from a scanning electron microscope homes in on the tiny barbs on the tip of a porcupine quill.

Courtesy of Woo Kyung Cho


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Courtesy of Woo Kyung Cho

Still, a quill passing through the body is far from painless — it’s excruciating — as Roze knows from personal experience. He was once quilled in his bicep while up in a tree, trying to catch a porcupine.

Despite his wife’s suggestion afterward that he immediately seek medical care, he waited two harrowing days. By that time, the quill had traveled in one direction and cleanly exited his lower arm. He kept the quill as a souvenir.

The quill’s barbs eased its penetration into his flesh. They also helped drive the quill in deeper, until it exited (though it would have been stopped by a harder material, such as bone).

It was the barbs that most interested Karp. He and his teamran experiments comparing a barbed quill to a barbless quill, measuring the forces required to insert and remove barbed spears.

In contrast to a barbless quill or a surgical staple — which tear the tissue and create gaps that are susceptible to infection — the barbed quill’s design means it does minimal damage on the way in, the researchers found.

Left: A microscopic image compares the size of a North American porcupine’s quill tip with the tip of a narrow, 18-gauge needle. Right: In a live porcupine, the partially hidden quills usually lay flat along the herbivore’s body, amidst other hairs, until and unless called into action.

Josh Cassidy/KQED


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Josh Cassidy/KQED

A new type of medical staple that had two barbed tips would require much less effort to place, Karp figures, and the gripping power of the barbs would hold it in position without needing to bend the staple.

Karp says he anticipates making the new staples out of biodegradable material so they will fully dissolve over time without having to be removed.

The challenge now is to re-create the full barb’s shape.

“Nature has designs that humans can’t achieve yet, at least at large scale,” Karp says. “Large-scale manufacturing is a human problem.”

But if the right technologies become available, he estimates that human testing of porcupine quill-inspired tools could begin in two to five years.

“This could be an enabler for smaller incisions to be made in a large number of surgeries,” Karp says. That would be good news for both surgeons and patients.

This post and video were produced by our friends at Deep Look, a wildlife video series from KQED and PBS Digital Studios that explores “the unseen at the very edge of our visible world.” KQED’s Josh Cassidy is the lead producer and cinematographer for Deep Look. Laura Shields works as an intern for the series.

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