YCLOAK

Fentanyl, a highly dangerous painkiller at the heart of the U.S. opioid epidemic, has been overprescribed by doctors, according to a report Tuesday that accused health authorities and manufacturers of being too lax in their oversight.   

The drug is a synthetic opioid up to 100 times more powerful than morphine and which is largely sold on the black market.

But it is prescribed in certain cases of cancer under what are supposed to be very tight restrictions, in the form of lozenges, lollipops or sprays under the tongue. It is supposed to be used only on cancer patients for whom other opioid painkillers have been insufficient.

The report in Journal of the American Medical Association, or JAMA, said that this was not the case, however.

The investigation, carried out by experts from Johns Hopkins University, said that of the thousands of patients who had been prescribed fentanyl, between a third and half of them should never have received the drug.

One doctor in five did not know that fentanyl was only supposed to be used by opioid-tolerant cancer patients, the researchers found.

As a result, it has been wrongly prescribed for far less serious conditions like lower back pain or chronic headaches.

“The drug can kill you,” said one of the authors of the report Caleb Alexander, co-director at the Center for Drug Safety and Effectiveness at Johns Hopkins.

“There’s no question that individuals have died from inappropriate prescribing of these products,” he said.

“The whole point of this program was to prevent exactly the use that commonly occurs,” he said of fentanyl, which has become the deadliest drug in an epidemic that killed 70,000 people in the United States in 2016.

The team of researchers battled for four and a half years to get 5,000 pages of documents on the fentanyl program from the FDA.

Legally, doctors are allowed to prescribe a drug for an ailment other than the one it is indicated for. The role of the FDA is to regulate the laboratories that make the drugs, not the doctors.

But as part of their oversight responsibility, manufacturers “were supposed to monitor and potentially disenroll prescribers who violated the terms of the program. And yet not a single prescriber was identified and disenrolled,” said Alexander.

An FDA spokesperson said the agency shared the concerns raised in the report.

“The FDA will soon be sharing planned next steps … to make sure the program is working to mitigate the risks of these medicines and that they’re prescribed only to opioid-tolerant patients,” the spokesperson said.
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A scientist who raised early alarms about climate change and popularized the term “global warming” has died. Wallace Smith Broecker was 87.

 

The longtime Columbia University professor and researcher died Monday at a New York City hospital, according to a spokesman for the university’s Lamont-Doherty Earth Observatory. Kevin Krajick said Broecker had been ailing in recent months.

 

Broecker brought “global warming” into common use with a 1975 article that correctly predicted rising carbon dioxide levels in the atmosphere would lead to pronounced warming. He later became the first person to recognize what he called the Ocean Conveyor Belt, a global network of currents affecting everything from air temperature to rain patterns.

 

“Wally was unique, brilliant and combative,” said Princeton University professor Michael Oppenheimer. “He wasn’t fooled by the cooling of the 1970s. He saw clearly the unprecedented warming now playing out and made his views clear, even when few were willing to listen.”

 

In the Ocean Conveyor Belt, cold, salty water in the North Atlantic sinks, working like a plunger to drive an ocean current from near North America to Europe. Warm surface waters borne by this current help keep Europe’s climate mild.

 

Otherwise, he said, Europe would be a deep freeze, with average winter temperatures dropping by 20 degrees Fahrenheit or more and London feeling more like Spitsbergen, Norway, which is 600 miles north of the Arctic Circle.

 

Broecker said his studies suggested that the conveyor is the “Achilles heel of the climate system” and a fragile phenomenon that can change rapidly for reasons not understood. It would take only a slight rise in temperature to keep water from sinking in the North Atlantic, he said, and that would bring the conveyor to a halt. Broecker said it is possible that warming caused by the buildup of greenhouse gases could be enough to affect the ocean currents dramatically.

“Broecker single-handedly popularized the notion that this could lead to a dramatic climate change ‘tipping point’ and, more generally, Broecker helped communicate to the public and policymakers the potential for abrupt climate changes and unwelcome ‘surprises’ as a result of climate change,” said Penn State professor Michael Mann.

 

In 1984, Broecker told a House subcommittee that the buildup of greenhouse gases warranted a “bold, new national effort aimed at understanding the operation of the realms of the atmosphere, oceans, ice and terrestrial biosphere.”

 

“We live in a climate system that can jump abruptly from one state to another,” Broecker told the Associated Press in 1997. By dumping into the atmosphere huge amounts of greenhouse gases, such as carbon dioxide from the burning of fossil fuels, “we are conducting an experiment that could have devastating effects.”

 

“We’re playing with an angry beast — a climate system that has been shown to be very sensitive,” he said.

 

Broecker received the National Medal of Science in 1996 and was a member of the National Academy of Science. He also served a stint as the research coordinator for Biosphere 2, an experimental living environment turned research lab.

 

Broecker was born in Chicago in 1931 and grew up in suburban Oak Park.

 

He joined Columbia’s faculty in 1959, spending most of his time at the university’s laboratory in Palisades, New York. He was known in science circles as the “Grandfather of Climate Science” and the “Dean of Climate Scientists.”

 

“His discoveries were fundamental to interpreting Earth’s climate history,” said Oppenheimer. “No scientist was more stimulating to engage with: he was an instigator in a good way, willing to press unpopular ideas, like lofting particles to offset climate change. But it was always a two-way conversation, never dull, always educational. I’ll miss him.”
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The great white shark, one of the most fearsome predators in the world’s oceans in both fact and fiction, is a formidable creature — right down to its genes.

Scientists on Monday said they have decoded the genome of Earth’s largest predatory fish, detecting numerous genetic traits that help explain its remarkable evolutionary success, including molecular adaptations to enhance wound healing as well as genomic stability such as DNA repair and DNA damage tolerance.

The great white shark, whose scientific name is Carcharodon carcharias, boasts a very large genome, 1-1/2 times bigger than the human genome.

In theory, large genomes with a lot of repeated DNA, like this shark possesses, and its large body size should promote a high incidence of genome instability, with much more DNA and many more cells seemingly vulnerable as targets for damage through an accumulation of routine mutations.

Just the opposite seems to be the case for this shark, thanks to adaptations in genes involved in preserving genome integrity.

“This knowledge, in addition to providing understanding into how sharks work at their most fundamental level — their genes — may also be useful in downstream applications to human medicine to combat cancers and age-related diseases that result from genome instability,” said Mahmood Shivji, director of the Save Our Seas Foundation Shark Research Center and Guy Harvey Research Institute at Nova Southeastern University in Florida.

This species, star of the 1975 Hollywood blockbuster “Jaws” and its multiple sequels, roams the world’s oceans, primarily in cool coastal waters.

Gray with a white underbelly and torpedo-shaped body, it can reach 20 feet (6 meters) long, weigh 7,000 pounds (3.18 tons) and dive to nearly 4,000 feet (1,200 meters) deep. It uses its mouthful of large, serrated teeth to rip into prey including fish, seals and dolphins, swallowing mouth-sized chunks of flesh whole.

Sharks are an evolutionary success story, thriving for more than 400 million years. Our species appeared roughly 300,000 years ago.

The great white shark also displayed genetic adaptations in several genes that play fundamental roles in wound healing. For example, a key gene involved in producing a major component of blood clots was found to have undergone adaptations.

“These adaptations and enrichments of essential wound-healing genes may underlie the ability of sharks to heal from wounds so efficiently,” said Cornell University’s Michael Stanhope, co-leader of the research published in the Proceedings of the National Academy of Sciences.
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For nearly two decades, Vancouver, the epicenter of Canada’s increasingly deadly drug epidemic, has embraced an initiative that was once dismissed as a reckless experiment but has since won over some of its fiercest critics: a walk-in facility where addicts can inject heroin under the watch of medical professionals.

Allowed as an exemption under Canada’s drug laws, Insite operates out of a storefront in the drug- and crime-ridden neighborhood of Downtown Eastside. Inside is a quiet, spacious “injection room” with 12 booths where addicts can shoot up their own drugs using freely supplied clean needles and tourniquets.

Nurses keep watch from a nearby station. And in case of an overdose, a medical team is on hand to administer naloxone, the overdose-reversing drug.In the center’s 16-year history, not a single user has died of an overdose.

Now, as a deadly opioid epidemic wrecks American communities, Philadelphia, a city with over 1,100 overdose deaths last year and one of the most active heroin markets in the country, wants to be the first in the nation to adopt the Canadian model.

The mayor and the district attorney have endorsed the initiative. A former governor of Pennsylvania has incorporated a nonprofit organization called Safehouse to run the facility. And advocates have scouted locations with an eye on Kensington, an impoverished neighborhood that has borne the brunt of opioid-related deaths in recent years.

But the plan faces stiff opposition from federal prosecutors who say it violates a law against setting up facilities for illegal drug use. To prevent the facility from opening, William McSwain, the U.S. attorney for the Eastern District of Pennsylvania, last week asked a federal judge to declare the site illegal under a 1986 “crack house statute.”

“Normalizing the use of deadly drugs like heroin and fentanyl is not the answer to solving the epidemic,” McSwain told reporters.

Worth trying

McSwain wants advocates to change the laws not break them. But supporters of the project say changing the laws takes time and the time to embrace a concept with a proven track record of saving lives is now.

“All of these [facilities] have had a similar result: they’ve lowered the number of overdoses associated with the immediate area,” said Jose Benitez, a co-founder of Safehouse and executive director of Prevention Point, a needle exchange program. “We see the same thing happening in Philadelphia.

With more than 800 daily visits, Insite is the busiest facility of its kind in the world.In the 16 years since it opened its doors, Insite has recorded more than 1,000 overdoses, many potentially fatal without intervention. But not a single one has resulted in death. What’s more, researchers have found Insite users are more likely to seek out treatment.

“There are people who say that Insite sets a bad example and supports the initiation of drugs, but in fact what we found was that people who used Insite were more likely to stop using drugs,” said M-J Milloy, a research scientist at the British Columbia Center on Substance Use.

Milloy was part of a multiyear scientific evaluation of Insite mandated by the government of Canada. Among the study’s key findings: a 35 percent drop in overdose fatalities in the surrounding community.

He said scientists also examined whether the facility can encourage drug use and degrade the quality of life in the surrounding communities, as critics have claimed. They found the criticisms “to be wholly lacking in empiric support,” he added.

“There is a scientific consensus that these facilities can have important benefits, not only on the health and well-being of the clientele who use them, but also, indeed, in the surrounding community itself,” Milloy said.

“Based on our research, we believe Insite and other injection facilities to be important interventions that should be considered by any city or setting which is dealing with the negative consequences of injection drug use,” he added.

But Insite has not been without its critics who have questioned the scientific research. These critics say that while Insite has prevented overdose deaths, it has not led to a reduction in crime or drug use in the community.

The facility was designed as a three-year scientific experiment, but it has been allowed to operate indefinitely after a landmark ruling by Canada’s Supreme Court in 2011.

US cities interested

Inspired by the Insite’s success, nearly a dozen American cities and counties battling an opioid epidemic have taken up the idea in an apparent violation of federal law. In several cities, including New York, San Francisco and Seattle, local governments have worked out concrete plans for injection facilities, but it remains unclear if they can surmount opposition from federal and state authorities.

The controversy not only has pitted cities against the federal government but also localities against their state governments.

In California, the state Legislature last year passed a bill that would have allowed the city of San Francisco to operate a safe injection site on a pilot basis. But then-Governor Jerry Brown, a Democrat, vetoed the bill, citing the threat of federal prosecution.

Two state lawmakers reintroduced the bill recently, and current Governor Gavin Newsom, also a Democrat, has said he is “very, very open” to the idea.

Philadelphia, a storied Northeast city with a population of 1.6 million, has been hit especially hard by the opioid epidemic. Overdose deaths have more than doubled in the past five years.

Two years ago, Mayor Jim Kenney set up a task force to study the drug addiction scourge and make recommendations. Task force members traveled to Vancouver, to visit Insite, and Seattle, to learn about its plans to offer safe injection services out of a van. Among other recommendations, the task force suggested that the city explore a safe injection site on a pilot basis.

That led Ronda Goldfein, executive director of AIDS Law Project of Pennsylvania, and Benitez to set up Safehouse and enlist former Governor Ed Rendell’s support. Rendell, who as mayor of Philadelphia in the 1990s allowed the city’s first needle exchange program, agreed to incorporate Safehouse and sit on its board.

A study commissioned by the task force estimated that the opening of a safe injection site could potentially avert between 24 and 76 opioid overdose deaths each year.

“There are people who fear that we’re somehow promoting drug use, but there’s evidence from these facilities worldwide that they don’t encourage drug use,” Thomas Farley, the city’s health commissioner who sits on the board of Safehouse, told VOA last year. Many “people have an immediate negative reaction, but the evidence is quite strong that they have a real positive effect on users and in the neighborhoods,” he added.

Federal government hurdles

Unlike some other states, Pennsylvania doesn’t have a law against setting up a facility for drug use, and Safehouse is not seeking public funding. For those reasons, the initiative does not face state opposition, Goldfein said.

“Our biggest impediment is not the state government but the federal government,” Goldfein said, adding that the state governor has indicated that he won’t take any steps against the planned facility.

The federal opposition was long coming. In an op-ed in The New York Times last August, Deputy Attorney General Rod Rosenstein wrote that safe injection sites were illegal and he threatened “swift and aggressive action” against cities and counties opening them.

Goldfein said the site’s primary purpose is to prevent overdose deaths, not facilitate drug use, which would be illegal under federal law.

“We’re opening up a facility for the purpose of saving lives and for the secondary purpose of getting people into treatment,” she said. “That is a completely different intent from the reasoning behind crack house laws.”

Safehouse has 30 days to file its response to the federal complaint. The case is being closely watched by other cities and counties considering safe injection facilities.

If the federal judge hearing the case rules in Safehouse’s favor, “it will certainly be an important piece of information for other jurisdictions to go forward with,” Goldfein said.

Meanwhile, in Philadelphia, not everyone is convinced that an injection facility run by Safehouse is a good idea. David Oh, a Philadelphia City Councilman At-Large, said the center could spell trouble for the city.

“We’re the largest, poor big city in America with a lot of poverty issues, job issues and education issues,” said Oh, a Republican. “We’re inviting people to come live in our city and do their drugs here, and we’re going to service and provide for them, and the communities are trying to exist and don’t want them there.”
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A team of Australian paleontologists and volunteers has saved a once-in a lifetime fossil discovery from devastating floods in Queensland state.

The dinosaur tracks give a rare insight into an ancient world.  Found on an outback farm near the Queensland town of Winton, 1,100 kms from Brisbane, they are estimated to be almost 100 million years old.

The footprints are stamped into a large slab of sandstone rock, and were made by a sauropod, a giant creature with a long neck and tail, and by two smaller dinosaurs.  Some of the footprints are up to a meter wide and come from the Cretaceous period.  

Scientists were alerted to the danger posed to this remarkable collection when it was partly damaged by severe flooding last year.

For three weeks scientists and volunteers worked to carefully dig up and relocate the dinosaur tracks.   

They are being stored at the Australian Age of Dinosaurs museum in Winton, where they will eventually go on display.

David Elliott is the museum’s executive chairman.

“We really want to preserve the integrity of the tracks.  We do not want to just tear them up and go and lock them on the ground somewhere.  You know, they have to be done a certain way.  We cannot just leave it here because that is, you know, [a] find of a lifetime.”

Dinosaur tracks are rare in Australia.

Steve Poropat, a paleontologist at Swinburne University in Melbourne says the footprints were saved from recent monsoonal flooding in Queensland.

“The imperative was to get those soft footprints out of the ground because they just would not have lasted in another flood now that they have been fully exposed.  To get it all out of the ground, to make sure that it is safe from future floods is fantastic,” he said. 

Monsoonal rains in Queensland have caused chaos, flooding hundreds of homes and drowning several hundred thousand livestock.  Officials said it was a one-in-100-year event, and they have warned it could take years to rebuild the local cattle industry.

As the floodwaters recede on land, they are polluting parts of the Great Barrier Reef.  Experts say plumes of polluted water are stretching up to 60 kms from the coast, putting more pressure on coral that has suffered mass bleaching in recent years.  When ocean temperatures increase, corals can expel the algae that live in their tissues causing the coral to turn completely white.

The Great Barrier Reef is Australia’s greatest natural treasure and stretches 2,300 kms down Australia’s northeast coastline.
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Being surrounded by wild animals, feeding them and taking care of their little ones this is exactly what Tiffany Soechting wanted to do all her life. Anush Avetisyan met with the woman who is the human “mom” to the 500 animals that live on her family’s wildlife preserve in Texas.
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The ancient world of dinosaurs was a strange and dangerous place. Many of the animals that roamed the earth during the Cretaceous period 140 million years ago were all teeth and claws and spines. But even among all this natural weaponry, the Bajadasaurus stood out. VOA’s Kevin Enochs gives us a look.
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Nearly a year in space put astronaut Scott Kelly’s immune system on high alert and changed the activity of some of his genes compared with those of his Earth-bound identical twin, researchers said Friday. 

 

Scientists don’t know if the changes were good or bad, but results from a unique NASA twins study are raising new questions for doctors as the space agency aims to send people to Mars.  

 

Tests of the genetic doubles gave scientists an opportunity, not available before, to track details of human biology, such as how an astronaut’s genes turn on and off in space differently than at home. One puzzling change announced Friday at a science conference: Kelly’s immune system was hyperactivated. 

 

“It’s as if the body is reacting to this alien environment,” somewhat like the way a body would react with “a mysterious organism” inside, said geneticist Christopher Mason of New York’s Weill Cornell Medical College, who helped lead the study. He said doctors were now looking for that in other astronauts. 

 

Longtime research

Since the beginning of space exploration, NASA has studied the toll on astronauts’ bodies, such as bone loss that requires exercise to counter. Typically they’re in space about six months at a time. Kelly, who lived on the International Space Station, spent 340 days in space and set a U.S. record. 

 

“I’ve never felt completely normal in space,” the now-retired Kelly said in an email to The Associated Press, citing the usual congestion from shifting fluid, headaches and difficulty concentrating from extra carbon dioxide, and digestive complaints from microgravity. 

 

But this study was a unique dive into the molecular level, with former astronaut Mark Kelly, Scott’s twin, on the ground for comparison. Full results haven’t yet been published, but researchers presented some findings Friday at a meeting of the American Association for the Advancement of Science. 

​’Gene expression’

A number of genes connected to the immune system became hyperactive, Mason said. It’s not a change in DNA but in what’s called “gene expression,” how genes turn off and on and increase or decrease their production of proteins. Mason also spotted a spike in the bloodstream of another marker that primes the immune system. Yet at the same time, Kelly’s blood showed fewer of another cell type that’s an early defense against viruses. 

 

It’s not a surprise that gene activity would change in space — it changes in response to all kinds of stress. 

 

“You can see the body adapting to the change in its environment,” Mason said. 

 

The good news: Almost everything returned to normal shortly after Kelly got back on Earth in March 2016. Those immune-related genes, however, “seemed to have this memory or this need to almost be on high alert” even six months later, Mason said. 

 

“On the whole it’s encouraging,” said Craig Kundrot, who heads space life and science research for NASA. “There are no major new warning signs. We are seeing changes that we didn’t necessarily anticipate,” but they don’t know if those changes are consequential. 

Russian experience

 

From four Russians living in space for more than a year, NASA already knew prolonged time off Earth is possible, Kundrot said, adding, “We also aim for more than just possible. We want our astronauts to do more than just survive.” 

 

Ultimately, the twins study gives NASA a catalog of things to monitor on future missions to see if other astronauts react the same way. Astronauts on future missions will be able to do some of this testing in space instead of freezing samples for scientists back home, Mason said.  

Immune issues sound familiar to Dr. Jerry Linenger, an American astronaut who spent more than four months on the Russian space station Mir. He said he was never sick in orbit, but once he came back to Earth, “I was probably more sick than I was in my life.” 

 

Astronauts launch into orbit with their own germs and get exposed to their crewmates’ germs, and then after a week with nothing else new in the “very sterile environment” of a space station, “your immune system is really not challenged,” Linenger said. 

 

A human mission to Mars, which NASA hopes to launch in the 2030s, will take 30 months, including time on the surface, Kundrot said. 

Radiation exposure

 

Radiation is a top concern. The mission would expose astronauts to galactic cosmic radiation levels higher than NASA’s own safety standard. It’s “just a little bit over,” he said.  

 

On Earth and even on the space station, Earth’s magnetic field shields astronauts from lots of radiation. There would be no such shielding on the way to Mars and back, but tunnels or dirt-covered habitats could help a bit on Mars, Kundrot said. 

 

Kelly, who turns 55 next week, said he’d go to Mars. He said a trip that long “wouldn’t be worse than what I experienced. Possibly better. I think the big physical challenge, radiation aside, will be a mission where you are in space for years.”  
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