GET READY: A STAR WILL PASS PRETTY CLOSE TO THE SUN IN JUST 1.3 MILLION YEARS

GET READY: A STAR WILL PASS PRETTY CLOSE TO THE SUN IN JUST 1.3 MILLION YEARS

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Jun 4, 2018

Not long ago I wrote about a pair of dim red dwarfs in a binary systemcalled WISE J072003.20-084651.2 (or, more colloquially, Scholz’s Star) that passed fairly close to the Sun about 70,000 years ago. The exact distance isn’t easy to pin down, but it was likely just under a light-year. Close as stars go, though still too far to be visible to any humans banging rocks together back then. It’s possible it did affect comets in the outer solar system, though.

But that’s all in the past. What about the future?

In 1999, using data from the Hipparcos satellite (which observed the positions and motions of over 100,000 stars), astronomers found that the star Gliese 710 (or just Gl 710 for (barely more) short) will give us a pretty close shave in about 1.4 million years. Since that first prediction came out the distance estimate has been refined, and the most recent gives a pass at about 0.2 light-years. Given that it’s currently 62 light-years away, this means it’s headed nearly directly at us!

The Hipparcos data are good, but the new satellite Gaia is far more precise. Using this better dataset, a different team of astronomers looked at Gliese 710 and confirmed the older results. While exact data is hard to get — Gliese 710’s trajectory being so aligned toward us means that its sideways motion is small and hard to measure — their best fit to the data indicates it will pass us at a mere 0.163 light-years in about 1.28 million years.

That’s pretty dang close. Right now, the closest star to the Sun is Proxima Centauri at about 4.2 light-years (and it’s a red dwarf so dim you need a telescope to see it). As close as this pass will be, it’s not anywhere near close enough to affect the inner planets much — it’ll be over 10,000 times farther from Earth than the Sun is — but that does put it in the middle of the Oort Cloud, the vast repository of icy bodies out past Neptune. It’s entirely possible this will cause a great disturbance in the gravitational force out there, and send lots of these iceballs toward the Sun. As they get close they will start to warm, the ice will turn into a gas, and they will become comets.

Not to alarm you, but there could be planetary impacts from these comets… but I have to assume that by this time over a million years in the future, we’ll either a) be able to easily push them out of the way or 2) if we can’t then we’re in no position to complain about it.

I find this fascinating. Gl 710 is an orange dwarf, a star with about 0.6 times the mass of the Sun, and only about 4% as bright (the amount of energy a star emits depends very strongly on its mass). Still, at that distance it’ll shine in the sky pretty brightly, reaching a magnitude of about -2.5. Dimmer than Venus, but still about as bright as Jupiter gets, and the color of it should be stunning. It’ll be the brightest object in the sky outside the solar system by quite a bit.

I rather envy those future humans, seeing such a thing in their sky. I hope that if we are still around, and still recognizably human, someone in that distant future will wonder when we first knew that Gl 710 would become our nearest neighbor. Perhaps too they’ll find that we discovered it back in the dim dark ages of our species when humans had barely left our world for the first time, but when we did, we looked to the heavens and mapped its motion.

That’s a fine legacy.

 

 

Posted, but not written by, Louis Sheehan

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This Octopus’s Dreams (Maybe) Were Written All Over Its Body

 

This Octopus’s Dreams (Maybe) Were Written All Over Its Body

Octopuses are known for their astonishing ability to rapidly shift their skin color and texture, to hide from predators, to sneak up on prey and to communicate with each other.But what exactly is going on when octopuses change color in their sleep?

Footage that recently circulated on Twitter offered a rare glimpse of a Caribbean two-spot octopus (Octopus hummelincki) sleeping out in the open in its well-lit aquarium. And as it snoozed, the cephalopod’s skin color changed dramatically, from light to dark and back to light again. [8 Crazy Facts About Octopuses]

The video was captured in October 2017 at Butterfly Pavilion, a nonprofit invertebrate zoo in Westminster, Colorado. Rebecca Otey, then a science and conservation intern for the zoo, shot the footage and shared it on YouTube on Feb. 16, 2018.

At the start of the clip, the napping octopus was a pearly-white color. But as it slumbered, dark patterns that pulsed with the animal’s breath appeared on its skin. Then, a flood of dark color washed over its body, slowly fading back to white.

Color changes like these are caused by the octopus’s chromatophores, which are specialized pigment cells that expand or contract to alter colors and patterns on its body. Two other types of cells, iridophores and leucophores, are thought to detect the colors that the octopus’s skin then matches. Without them, octopuses likely couldn’t recognize those hues — because octopuses are colorblind, Sara Stevens, an aquarist with Butterfly Pavilion, told Live Science.

“The exact processes of how they match colors is still not fully understood, though it’s being very thoroughly studied,” Stevens said. “But current research suggests that the actual cells themselves can match colors.”

Cephalopods typically activate their camouflage superpowers in response to changing conditions around them. So, does this resting octopus’s color display mean that it’s dreaming about a threat? Research into cephalopod sleep and dreaming has grown over the years, but even so, there isn’t yet enough evidence to say for sure if they dream the way that people do, according to Stevens.

“It’s been hypothesized that octopus species can exhibit something very similar to REM cycles in humans — but the jury’s still out on whether they’re achieving REM sleep,” Stevens said.

Unlike humans (or any vertebrates), octopuses don’t have a centralized brain. Instead, they have multiple “brains” — bundles of neurons — distributed in their limbs. This unusual nervous system lends octopuses precise control over their color-changing cells; however, that ability may not be entirely under their control all the time, Stevens said.

“But there are no definitive answers to the questions: Are they dreaming? and What do they dream about?” she added.

 

Posted, but not written by, Louis Sheehan

 

 

 

 

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I want you to Panic

Think we should be at school? Today’s climate strike is the biggest lesson of all

We are among the young people striking against climate change in every corner of the globe – adults should join us too

Schoolchildren take part in a nationwide student climate march in George Square on February 15, 2019 in Glasgow.
 ‘This movement had to happen, we didn’t have a choice.’ Photograph: Jeff J Mitchell/Getty Images

It started in front of the Swedish parliament, on 20 August – a regular school day. Greta Thunberg sat with her painted sign and some homemade flyers. This was the first school climate strike. Fridays wouldn’t be regular schooldays any longer. The rest of us, and many more alongside us, picked it up in Australia, Germany, Belgium, Switzerland, New Zealand, Uganda. Today the climate strike will take place all around the world.

This movement had to happen, we didn’t have a choice. We knew there was a climate crisis. Not just because forests in Sweden or in the US had been on fire; because of alternating floods and drought in Germany and Australia; because of the collapse of alpine faces due to melting permafrost and other climate changes. We knew, because everything we read and watched screamed out to us that something was very wrong.

That first day of refusing to go to school was spent alone, but since then a movement of climate strikers has swept the globe. Today young people in more than 100 countries will walk out of class to demand action on the greatest threat humankind has ever faced.

These strikes are happening today – from Washington DC to Moscow, Tromsø to Invercargill, Beirut to Jerusalem, and Shanghai to Mumbai – because politicians have failed us. We’ve seen years of negotiations, pathetic deals on climate change, fossil fuel companies being given free rein to carve open our lands, drill beneath our soils and burn away our futures for their profit. We’ve seen fracking, deep sea drilling and coalmining continue. Politicians have known the truth about climate change and they’ve willingly handed over our future to profiteers whose search for quick cash threatens our very existence.

This movement had to happen, we didn’t have a choice. Last year’s UN Intergovernmental Panel on Climate Change’s special report on global warming could not have been clearer about the extreme dangers of going beyond 1.5C of global warming. To have any chance of avoiding that extreme danger emissions must drop rapidly – so that by the time we will be in our mid- and late-20s we are living in a transformed world.

‘I want you to panic’: 16-year-old issues climate warning at Davos – video

The students who are striking in cities, towns and villages around the world are uniting behind the science. We are only asking that our leaders to do the same.

If those in power today don’t act, it will be our generation who will live through their failure. Those who are under 20 now could be around to see 2080, and face the prospect of a world that has warmed by up to 4C. The effects of such warming would be utterly devastating. Rivers would flood, storms would wreak havoc on coastal communities and coral reefs would be eliminated. Melting polar ice caps would lead to dramatically higher sea levels, flooding coastal areas. Places on Earth will become uninhabitable.

Scientists have also shown us that burning fossil fuels is “the world’s most significant threat to children’s health”. Nine out of every 10 children around the world are breathing dangerous air. Our lives are being compromised before we are born. Toxic particles from exhaust fumes pass through the lungs of pregnant women and accumulate in the placenta. The risk of premature birth, low birth weight and cognitive dysfunction this causes is a public health catastrophe. Pollution from diesel vehicles is stunting the growth of our lungs, leaving us damaged for life. Toxic air from burning fossil fuels is choking not only our lungs but our hopes and dreams.

And the worst effects of climate change are disproportionately felt by our most vulnerable communities. This is not just about cutting down emissions, but about equity – the system we have right now is failing us, working only for the rich few. The luxury so few of us enjoy in the global north is based on the suffering of people in the global south.

We have watched as politicians fumble, playing a political game rather than facing the facts that the solutions we need cannot be found within the current system. They don’t want to face the facts – we need to change the system if we are to try to act on the climate crisis.

This movement had to happen, we didn’t have a choice. The vast majority of climate strikers taking action today aren’t allowed to vote. Imagine for a second what that feels like. Despite watching the climate crisis unfold, despite knowing the facts, we aren’t allowed to have a say in who makes the decisions about climate change. And then ask yourself this: wouldn’t you go on strike too, if you thought doing so could help protect your own future?

So today we walk out of school, we quit our college lessons, and we take to the streets to say enough is enough. Some adults say we shouldn’t be walking out of classes – that we should be “getting an education”. We think organising against an existential threat – and figuring out how to make our voices heard – is teaching us some important lessons.

Thousands of UK students strike over climate change – video

Other adults keep saying: “We owe it to the young people to give them hope.” But we don’t want your hope. We don’t want you to be hopeful. We want you to panic and we want you to take action. We want you to join us.

We’ve relied on adults to make the right decisions to ensure that there is a future for the next generation – surely we don’t have all the answers. But what we do know is that we need to keep fossil fuels in the ground, phase out subsidies for dirty energy production, seriously invest in renewables and start asking difficult questions about how we structure our economies and who is set to win and who is set to lose.

And we are no longer alone. Tens of thousands of scientists from around the world have released statementsin support of the strikes by children. The scientists have been very clear about what we need to do to tackle climate change. We are uniting behind the scientists. We are only asking that our leaders do the same.

It is so important that this happens now. The kind of changes that need to happen mean everyone recognising that this is a crisis and committing to radical transformations. We strongly believe that we can fight off the most damaging effects of climate change – but we have to act now.

There is no grey area when it comes to survival. There’s no less bad option. That’s why young people are striking in every corner of the globe, and it’s why we are asking that older people join us on the streets too. When our house is burning we cannot just leave it to the children to pour water on the flames – we need the grownups to take responsibility for sparking the blaze in the first place. So for once, we’re asking grownups to follow our lead: we can’t wait any longer.

This movement had to happen. And now, you adults have a choice.

 Greta Thunberg is a youth climate strike leader in Sweden, Anna Taylor in the UK, Luisa Neubauer in Germany, Kyra Gantois, Anuna De Wever and Adélaïde Charlier in Belgium, Holly Gillibrand in Scotland, and Alexandria Villasenor in USA

 

 

Posted, but not written by, Louis Sheehan

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Hidden FDA reports detail harm caused by scores of medical devices

 

Hidden FDA reports detail harm caused by scores of medical devices

The Food and Drug Administration has let companies file reports of injuries and malfunctions outside a widely scrutinized public database

Mark Levering, now 62, was in a medically induced coma and had several surgeries after a surgical stapler malfunctioned during a Feb. 17, 2018, liver surgery. His wife, Doris Levering, said in a deposition that he did not open his eyes after the initial surgery until March 13. [Courtesy of Doris Levering]

Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up.

Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences.

Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special “exemption” allowing them to file reports of malfunctions in a database hidden from doctors and from public view.

“I don’t want to sound overdramatic here, but it seemed like a cover-up,” said Kwazneski, who practiced in Pasco County, Fla., from 2016 through earlier this year.

The FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions, a Kaiser Health News investigation shows. Since 2016, at least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could put patients in jeopardy.

Deaths must still be reported in MAUDE. But the hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA, many implanted in patients or used in countless surgeries. They have included surgical staplers, balloon pumps snaked into vessels to improve circulation and mechanical breathing machines.

After Dr. Douglas Kwazneski witnessed a surgical stapler malfunction, he surveyed leading surgeons and discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. (Kendra Stanley-Mills for KHN) After Dr. Douglas Kwazneski witnessed a surgical stapler malfunction, he surveyed leading surgeons and discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. (Kendra Stanley-Mills for KHN)

An FDA official said that the program is for issues that are “well-known and well-documented with the FDA” and that it was reformed in 2017 as a new voluntary summary reporting program was put in place for up to 5,600 devices.

Yet the program, in all its iterations, has been so obscure that it is unknown to many of the doctors and engineers dedicated to improving device safety. Even a former FDA commissioner said he knew nothing of the program.

KHN pored over reams of public records for oblique references to reporting exemptions. After months of questions to the FDA, the agency confirmed the existence of reporting-exemption programs and thousands of never-before-acknowledged instances of malfunctions or harm.

Amid the blackout in information about device risks, patients have been injured, hundreds of times in some cases, lawsuits and FDA records show.

“The public has a right to know about this,” said Dr. S. Lori Brown, a former FDA official who accessed the data for her research. She said doctors relying just on the public reports — and unaware that many incidents may be omitted — can easily reach the wrong conclusion about the safety record of a particular device.

The FDA has also opened additional — and equally obscure — pathways for device makers to report thousands of injuries brought to light by lawsuits or even deaths that appear in private registries that medical societies use to track patients. Those exemptions apply to risky and controversial products, including pelvic mesh and devices implanted in the heart. FDA spokeswoman Deborah Kotz confirmed that the “registry exemption” was created without any public notice or regulations. “Any device manufacturer can request an exemption from its reporting requirements,” she said in an email.

Agency records provided to KHN show that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017 alone.

Alison Hunt, another FDA spokeswoman, said the majority of device makers’ “exemptions” were revoked that year as a program took shape that requires a “placeholder” report to be filed publicly.

More than a million reports of malfunctions or harm spanning about 15 years remain in a database accessible only to the FDA. But with the agency’s new transparency push, the public may find a public report and submit a Freedom of Information Act request to get information about incidents. A response can take up to two years.

The long-standing exemption program “has allowed the FDA to more efficiently review adverse events … and take action when warranted without sacrificing the quality of our review or the information we receive,” Hunt said in an email.

Madris Tomes (Courtesy of Madris Tomes) Madris Tomes (Courtesy of Madris Tomes)

To those outside the agency, though, the exceptions to the reporting rules are troubling. They strike Madris Tomes, a former FDA manager, as the agency surrendering some of the strongest oversight and transparency powers it wields.

“The FDA is basically giving away its authority over device manufacturers,” said Tomes, who now runs Device Events, a website that makes FDA device data user-friendly. “If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices.”

Doctors, like Kwazneski, who have turned to the public data to gauge the risks of surgical staplers have seen little. He wrote about the “unacknowledged” problem of stapler malfunctions in a 2013 article in the journal Surgical Endoscopy. In 2016, while reports of 84 stapler injuries or malfunctions were openly submitted, nearly 10,000 malfunction reports were included in the hidden database, according to the FDA.

Device maker Medtronic, which owns stapler maker Covidien, has been described as the market leader in surgical staplers. A company spokesman said that the firm has used reporting exemptions to file stapler-related reports through July 2017. Ethicon, the other major stapler maker, said it has not.

The public database shows that Medtronic has reported more than 250 deaths related to staplers or staples since 2001.

Mark Levering, 62, nearly lost his life after a stapler malfunction early last year, according to a lawsuit filed by his family. His surgeon has testified that a surgical stapler misfired during his liver surgery at ProMedica Toledo Hospital.

Staff performed CPR for 22 minutes while surgeons rushed to suture the severed vein. He emerged from a coma unable to walk or consistently recognize his wife and son. The surgeon, hospital and device maker Covidien have denied allegations of wrongdoing in an ongoing legal case.

Told of the reporting “exemption” for surgical staplers, his wife, Doris Levering, was incredulous.

“Why would this information not be made available to doctors? The true information — I mean the actual numbers …” she said. “People’s lives are at stake. Mark’s life will never be the same.”

The Stapler Problem

The sheer number of malfunctions made surgical staplers an easy pick for the new alternative summary reporting program at its inception nearly 20 years ago, according to Larry Kessler, a former FDA official and now a University of Washington health services professor.

Surgical staplers have a unique ability to help — or harm — patients. The device is designed to cut and seal tissues or vessels quickly, often during minimally invasive surgeries. When it fails to seal a major blood vessel, medical staff can quickly shift into “code blue” mode to rescue a patient from bleeding to death.

The severity of some of the injuries caught former FDA official Brown’s attention in the early years of its reporting exemption. Her 2004 article on stapler mishaps, published in the Journal of the American College of Surgeons, accounts for one of the few places in public records where an FDA authority mentions the “alternative summary” program. She found that in the first 28 months of filing to the hidden database, stapler makers filed more than 5,100 reports of malfunctions or injuries.

She also noted that the publicly reported 112 stapler-related deaths in patients aged 22 to 91 from 1994 to 2001 were a “reason for concern.”

In the public data filed since, it would appear that the staplers rarely misfire. In 2011, only 18 injury or malfunction reports were filed publicly. Last year, the number was 79.

Lawsuits detail how quickly a stapler failure can turn a smooth surgery into a catastrophe.

In Michigan, Eugene Snook’s surgeon was in the process of removing part of his lung when he cut but couldn’t seal a major vessel due to a “stapler malfunction,” the surgeon said in sworn court testimony. Snook, then 59, had no detectable blood pressure for four minutes during the 2012 surgery.

The damage to Snook’s artery was so great, his surgeon decided to remove his lung completely, medical records filed in court say. Snook sued stapler maker Covidien, which in court records said there was no proof the stapler was unsafe when it left Covidien’s control and also that the surgeon used it improperly. The case reached a confidential settlement in 2017.

Phil Levering (left) says his father, Mark Levering, used to have a calm demeanor but now exhibits signs of aggression due to a brain injury he suffered after a surgery gone wrong. Phil Levering (left) says his father, Mark Levering, used to have a calm demeanor but now exhibits signs of aggression due to a brain injury he suffered after a surgery gone wrong.

Another surgeon attempting to remove a benign liver growth from April Strange, 33, in 2013, testified that a stapler malfunction caused the woman to bleed to death. Strange, of central Illinois, left behind a husband and two daughters, then 6 and 8.

The stapler was thrown out after surgery, court records say. Covidien argued in court records that Ryan Strange couldn’t prove that the stapler had a specific defect.

Covidien reached an agreement to settle the family’s claims for $250,000, part of a larger settlement in the case.

Doctors initially thought Mark Levering had liver cancer. So when the diagnosis came back as an abscess that needed to be surgically removed last February, it came as a relief to his wife, Doris Levering.

That relief turned to dread the day of surgery. The procedure was supposed to last two hours, she said. But the surgery hit a snag when the stapler “misfired,” according to the surgeon, causing so much bleeding that the minimally invasive procedure was converted to an open procedure so the doctor could suture the vein.

Levering underwent CPR for 22 minutes. A code blue was called, a nurse testified. Levering lost 3 quarts of blood — about half the blood in his body. He was put on life support and would remain in a coma for weeks.

After Levering reopened his eyes, it was clear that the man who used to tend to stray cats and enjoy dinner out with his family was gone. Levering could no longer walk, comb his hair or recognize the letters of the alphabet.

Doris Levering holds a photograph of her and her husband predating his surgery. Levering says it’s clear that the man who used to tend to stray cats and enjoy dinner out with his family is gone. “People’s lives are at stake. Mark’s life will never be the same,” she says. Doris Levering holds a photograph of her and her husband predating his surgery. Levering says it’s clear that the man who used to tend to stray cats and enjoy dinner out with his family is gone. “People’s lives are at stake. Mark’s life will never be the same,” she says.

Doris and Mark Levering have sued the doctor, hospital and surgical stapler maker, alleging that the device caused Mark’s bleeding and brain injury. The surgeon has acknowledged in sworn testimony that the stapler malfunctioned, but denied other wrongdoing. The hospital said in a legal filing that its actions were “prudent, proper” and “lawful.”

Covidien denies any defect with the stapler or that it caused Levering’s injuries. A spokesman for parent company Medtronic declined to comment further on any lawsuit but said that “we always make patient safety our top priority” and that the company complies with FDA requirements.

But in 2018, with the reporting exemption gone, a spike of reports emerged for Covidien’s staples — not to be confused with staplers. While Medtronic reported 1,000 staple malfunctions or injuries in 2015, the number soared to 11,000 for 2018.

Rolling Out The Program

The alternative summary reporting program started two decades ago with a simple goal: to cut down on redundant paperwork, according to officials who were at the FDA at the time.

Kessler, the former FDA official, said the program took shape after scandals over under-reporting of device problems spurred changes allowing criminal penalties against device companies.

Soon, thousands of injury and malfunction reports poured into the agency each month, with about 15 staff members dedicated to reviewing them, Kessler said. Many reports were so similar that reviewing them individually was “mind-numbing.” Kessler went to the FDA’s legal department and to device manufacturers to propose a solution.

Device makers would be able to seek a special “exemption” to avoid reporting certain complications to the public database. The manufacturers would instead send the FDA a spreadsheet of injury or malfunctions each quarter, half-year or year.

That way, Kessler said, reviewers could quickly look for new problems or spikes in known issues. When the program launched in 2000, the list of exempted devices was made public and only a few devices were involved, Kessler said.

“I don’t know why it’s not [made public] now,” he said. “I’m surprised about that.”

Starting in September, KHN filed Freedom of Information Act requests for “exemption” agreements and reports for several medical devices. Health and Human Services officials denied an appeal to provide some of the records quickly, concluding there was no “compelling need” for haste. For one request, the records were estimated to arrive in 22 months.

The FDA did provide some top-level data. It shows that from 2014 through 2017, the overall number of alternative summary reports filed by device makers rose from 431,000 to 481,000.

The FDA declined to provide a complete list of “about 100” devices that have been granted reporting exemptions over the years, but confirmed that exemptions have been used for mechanical breathing machines and balloon pumps, known as intra-aortic balloon pumps, inserted in the vessels of people with circulation problems.

An FDA spokeswoman said “alternative summary” exemptions remain in place for pacemaker electrodes and implantable defibrillators.

Matthew Baretich, a biomedical engineer in the Denver area, said he helps several area health systems analyze device-related patient injuries and make equipment-purchasing decisions.

He said he regularly scans the FDA’s public device-injury reports. Asked about “alternative summary” reports, he said, “I’ve got to tell you, that’s a new term to me.”

Bruce Barkalow, president of a Michigan-based biomedical engineering firm, said he’s the guy government officials, attorneys or device makers call if someone gets a pacemaker and dies in the shower three days later.

In an interview, he said he was not aware of the reports, either. He said they may appear to the FDA to be a “nothing burger,” but the data would be meaningful to his forensic investigations.

The ECRI Institute, a nonprofit leader in medical device safety, declined to provide an engineer for an interview. Educating hospital leaders and health providers, the institute issues an annual “Top 10” in medical technology hazards. Its tagline: “Separating fact from fiction in healthcare.”

Among the institute’s “top medical device subject matter experts,” spokeswoman Laurie Menyo said in an email, “none of them had any familiarity with FDA’s Alternative Summary Reporting Program.”

Even Dr. Robert Califf, former FDA deputy commissioner and commissioner from 2015 to 2017, said in an interview that he was unaware of the program. “Never heard anything about it,” he said. “It’s interesting.”

Companies that get the exemptions tend to be very “tight-lipped” about them, said Christine Posin, a former device firm manager and consultant to device companies.

The relative secrecy around the program can give them an advantage, she said. For instance, sales representatives can print out only the public reports of device problems, ignoring what’s buried elsewhere.

That creates a business opportunity to persuade a doctor to try a different device. “‘We have a good product that does the same thing,’” Posin said a sales representative might tell a physician.

Exemptions Multiply

The FDA has spent millions, convened experts and pledged to improve its work in device safety in recent years. All the while, it has quietly opened new avenues for the makers of controversial and risky devices to file injury and even death reports with little public review.

Pelvic mesh is one example. The fabric-like device has long been used to hold up pelvic organs in women experiencing organ prolapse. In 2011, the FDA issued a “safety communication” saying “serious complications” like pain or infection were “not rare.”

The agency soon reclassified the device, ordered safety studies and saw most mesh makers remove the device from the market.

Behind closed doors, though, the agency has since granted pelvic mesh makers a special exemption from reporting injuries to the public, according to the FDA and mesh makers who were asked about the practices.

Under what the FDA calls the “litigation complaint summary reporting” exemption, device makers can file a single placeholder “injury” report. Attached to the summary report, device makers have sent the FDA a spreadsheet with as many as 1,175 reports of patient injuries, based on allegations in lawsuits.

To someone tallying the overall number of injuries related to pelvic mesh, the report would appear as a single injury. It would take a sharp eye to find the summary report and a special request — taking up to two years to be filled — to get the details on the 1,175 cases submitted directly to the FDA.

According to the FDA, in 2017 alone, eight mesh makers used their exemptions to send nearly 12,000 injury reports to the FDA.

Dr. M. Tom Margolis, a urogynecologist in the San Francisco Bay Area and an expert medical witness for those who are suing mesh makers, said a program that might hinder doctors relying on open FDA data to assess the risks of mesh is “horrible” and “unethical.”

“We need to know the good and the bad,” said Margolis, who treats patients in his urogynecology practice. “If you’re trying to hide complications from me, well that’s … wrong, my God, it’s heinous.”

The FDA issued the same kind of exemption to the makers of da Vinci surgical robots months after Johns Hopkins University School of Medicine researchers pointed out that the company was filing a notably small number of injury reports in the public database. Johns Hopkins professor Dr. Marty Makary noted in 2013 that the handful of reports sent to the FDA at the time were signs of a “haphazard” system that is “not independent and not transparent.”

Within months, the FDA allowed the makers of the robots to file a single report, noting that a spreadsheet sent straight to the FDA summarizes about 1,400 injuries alleged in lawsuits, with some injuries dating to 2004. Since then, the device maker has reported smaller batches of 99 and 130 injuries at a time.

Homa Alemzadeh (Courtesy of Homa Alemzadeh) Homa Alemzadeh (Courtesy of Homa Alemzadeh)

“This is very frustrating,” said Homa Alemzadeh, an assistant professor of computer engineering at the University of Virginia who is working with MAUDE data to create software to identify errors in real time or before they happen in surgeries performed by robots. She said she was not aware of the reporting exemption.

Under another reporting exemption, the FDA is allowing device makers to report hundreds of death cases in spreadsheets sent directly to the agency.

Under the “registry exemption,” device makers can summarize what they learn from registries that tend to be held by specialty medical societies, and track the use of a certain kind of device, according to FDA spokeswoman Kotz.

Kotz said the data in registries often falls short of the level of detail that the FDA seeks for the more thorough death reports that device makers are required to file.

Device makers filing such reports include Edwards Lifesciences, which makes the Sapien 3 valve that’s snaked through a vessel and implanted in the heart. Some hail the device as a breakthrough for saving patients from the trauma of open-heart surgery to replace a valve. Others raise concerns over limited data showing how long the valve will last in the body.

The summary reports offer potential patients few answers. Such reports document as many as 297 deaths or 1,800 injuries in a single filing, with virtually no detail readily available to the public. In all, Edwards filed more than 1,800 Sapien 3 valve patient deaths as summaries since 2016.

Edwards spokeswoman Sarah Huoh said in an email that the FDA mandated the tracking of every patient who has the valve in the registry to provide “comprehensive evidence for device safety.”

“The approval of alternative reporting protects against duplicate reports coming from multiple sources,” Huoh said.

Another device, the MitraClip, is used to attach two flaps in the heart that are allowing blood to flow backward. The device has been controversial with some scientists saying it is crucial for a certain subset of patients, and others pointing to the harm it can cause to the heart.

The FDA has allowed Abbott Vascular, which makes the MitraClip, to report as many as 347 deaths or 1,000 injuries in a single filing, also shipping the details straight to the agency, FDA records show.

An Abbott spokesman said in an email that the company has done clinical trials with thousands of patients to establish the MitraClip’s safety. He said the exemption was granted because data in the registry was stripped of patient identifiers, making it hard to know whether the company would be filing redundant reports to the FDA.

Last year, the FDA finalized regulations for yet another summary reporting program. Under the newest system, device makers do not have to seek an exemption or notify the FDA that they’ll be filing a public summary report in MAUDE.

Michael Carome (Courtesy of Mike Carome) Michael Carome (Courtesy of Mike Carome)

The FDA has deemed the makers of more than 5,600 types of devices eligible to file “voluntary malfunction summary reports.” Among them are some of the riskiest devices the agency oversees, including cardiac stents, leadless pacemakers and mechanical heart valves. The growing cadre of exceptions to the injury- and death-reporting rules strikes Dr. Michael Carome, director of the Public Citizen Health Research Group, as a retreat by the FDA from making crucial information available for researchers and patients.

“It’s just another example of a flawed oversight system,” he said, “bent toward making it easier for industry rather than making protection of public health the primary goal.”

California Healthline reporter and producer Heidi de Marco contributed to this report.

Kaiser Health News (KHN) is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

 

 

Posted, but not written by, Louis Sheehan

 

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Physicists May Have Found a Way to ‘Untangle’ Information Trapped in a Black Hole

Physicists May Have Found a Way to ‘Untangle’ Information Trapped in a Black Hole

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Physicists May Have Found a Way to 'Untangle' Information Trapped in a Black Hole

Credit: Shutterstock

Black holes are gravitational monsters, squeezing gas and dust down to a microscopic point like great cosmic trash compactors. Modern physics dictates that, after being consumed, information about this matter should be forever lost to the universe. But a new experiment suggests that there might be a way to use quantum mechanics to gain some insight into the interior of a black hole.

“In quantum physics, information cannot possibly be lost,” Kevin Landsman, a physics graduate student at the Joint Quantum Institute (JQI) at the University of Maryland in College Park, told Live Science. “Instead, information can be hidden, or scrambled” among subatomic, inextricably linked particles.

Landsman and his co-authors showed that they could measure when and how quickly information was scrambled inside a simplified model of a black hole, providing a potential peek into the otherwise impenetrable entities. The findings, which appear today (March 6) in the journalNature, could also help in the development of quantum computers. [Stephen Hawking’s Most Far-Out Ideas About Black Holes]

Black holes are infinitely dense, infinitely small objects formed from the collapse of a giant, dead star that went supernova. Because of their massive gravitational pull, they suck in surrounding material, which disappears behind what’s known as their event horizon — the point past which nothing, including light, can escape.

In the 1970s, the famous theoretical physicist Stephen Hawking proved that black holes can shrink over their lifetimes. According to the laws of quantum mechanics — the rules that dictate the behavior of subatomic particles at tiny scales — pairs of particles spontaneously pop into existence just outside a black hole’s event horizon. One of these particles then falls into the black hole while the other is propelled outward, stealing a tiny smidgeon of energy in the process. Over extremely long timescales, enough energy is pilfered that the black hole will evaporate, a process known as Hawking radiation, as Live Science has previously reported.

But there’s a conundrum hiding in the black hole’s infinitely dense heart. Quantum mechanics says that information about a particle — its mass, momentum, temperature and so on — can never be destroyed. The rules of relativity simultaneously state that a particle that has zoomed past a black hole’s event horizon has joined with the infinitely dense crush at the black hole’s center, meaning that no information about it can ever be retrieved again. Attempts to resolve these incompatible physical requirements have been unsuccessful to date; theorists who have worked on the problem call the dilemma the black hole information paradox.

In their new experiment, Landsman and his colleagues showed how to get some relief for this issue using the outward-flying particle in a Hawking radiation pair. Because it is entangled with its infalling partner, meaning its state is inextricably linked to that of its partner, measuring the properties of one can provide important details about the other.

“One can recover the information dropped into the black hole by doing a massive quantum calculation on these outgoing [particles],” Norman Yao, a physicist at the University of California, Berkeley, and member of the team, said in a statement.

The particles inside a black hole have had all their information quantum-mechanically “scrambled.” That is, their information has been chaotically mixed together in a way that should make it impossible to ever extricate. But an entangled particle that gets jumbled up in this system could potentially pass information to its partner.

Doing this for a real-world black hole is hopelessly complicated (and besides, black holes are hard to come by in physics labs). So the group created a quantum computer that performed calculations using entangled quantum bits, or qubits — the basic unit of information used in quantum computing. They then set up a simple model using three atomic nuclei of the element Ytterbium, which were all entangled with each other.

Using another external qubit, the physicists were able to tell when particles in the three-particle system became scrambled and could measure how scrambled they became. More importantly, their calculations showed that the particles were specifically scrambled with each other rather with other particles in the environment, Raphael Bousso, a UC Berkeley theoretical physicist who was not involved in the work, told Live Science.

“It’s a wonderful accomplishment,” he added. “It turns out that distinguishing which of these things is actually happening to your quantum system is a very difficult problem.”

The results show how studies of black holes are leading to experiments that can probe small subtleties in quantum mechanics, Bousso said, which could become helpful in the development of future quantum-computing mechanisms.

 

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Aliens Might Shoot Lasers at Black Holes to Travel the Galaxy By Rafi Letzter, Staff Writer | March 15, 2019 11:18am ET

An astronomer at Columbia University has a new guess about how hypothetical alien civilizations might be invisibly navigating our galaxy: Firing lasers at binary black holes (twin black holes that orbit each other).

The idea is a futuristic upgrade of a technique NASA has used for decades.

Right now, spacecraft already navigate our solar system using gravity wells as slingshots. The spacecraft itself enters orbit around a planet, flings itself as close as possible to a planet or moon to pick up speed, and then uses that added energy to travel even faster toward its next destination. In doing so, it saps away a tiny fraction of the planet’s momentum through space — though the effect is so minimal it’s pretty much impossible to notice. [9 Strange, Scientific Reasons We Haven’t Found Aliens Yet]

The same basic principles operate in the the intense gravity wells around black holes, which bend not only the paths of solid objects, but light itself. If a photon, or a light particle, enters a particular region in the vicinity of a black hole, it will do one partial circuit around the black hole and get flung back in exactly the same direction. Physicists call those regions “gravitational mirrors” and the photons they fling back “boomerang photons.”

Boomerang photons already move at the speed of light, so they don’t pick up any speed from their trips around black holes. But they do pick up energy. That energy takes the form of increased wavelength of the light, and the individual photon “packets” carry more energy than they had when they entered the mirror.

That comes at a cost to the black hole, sapping some of its momentum.

In a paper published in the preprint journal arXiv on March 11, David Kipping, the Columbia astronomer, proposed that an interstellar spacecraft could fire a laser at the gravity mirror of a fast-moving black hole in a binary black hole system. When the newly energized photons from the laser whipped back around, it could re-absorb them, and convert all that extra energy into momentum — before firing the photons back at the mirror again.

This system, which Kipping termed the “halo drive,” has a big advantage over more traditional lightsails: It doesn’t require a massive fuel source. Current lightsail proposals require more energy to accelerate the space shuttle to “relativistic” speeds (meaning a significant fraction of light speed) than humanity has produced in its entire history.

With a halo drive, all that energy could just be sapped from a black hole, rather than generated from a fuel source.

Halo drives would have limits — at a certain point the spacecraft would be moving so quickly away from the black hole s that it wouldn’t absorb enough light energy to add additional speed. It’s possible to solve this problem by moving the laser off the spaceship and onto a nearby planet, he noted, and just precisely aiming the laser so it emerges from the black hole’s gravity well to hit the spaceship. But without re-absorbing the laser light that planet would have to burn fuel to generate new beams constantly, and would eventually dwindle away.

A civilization might be using a system like this to navigate the Milky Way right now, Kipping wrote. There are certainly enough black holes out there. If so, that civilization might be sapping so much momentum from black holes that it would be messing with their orbits, and we could possibly detect the signs of alien civilization from the eccentric orbits of binary black holes.

And if no other civilizations are out there doing this, he added, perhaps humanity could be the first.

Author Bio


Rafi Letzter

Rafi Letzter, Staff Writer
Rafi joined Live Science in 2017. He has a bachelor’s degree in journalism from Northwestern University’s Medill School of journalism. You can find his past science reporting at Inverse, Business Insider and Popular Science, and his past photojournalism on the Flash90 wire service and in the pages of The Courier Post of southern New Jersey.

Posted but not written by Louis Sheehan
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Cars are killing us. Within 10 years, we must phase them out

It’s the last straw. Parked outside the hospital doors is a minibus with its engine running. The driver is playing on his mobile phone. The fumes are blowing into the atrium. I step up to his window and ask him to turn the engine off. He does so, grumpily. Then I notice he’s wearing a health service uniform. I walk through the atrium, down a corridor and into the cancer department (not for cancer this time, but to talk about reconstructive surgery). I look around the huge waiting room and wonder how many of the people sitting here might be ill as a result of air pollution. I think of people in other departments: children with asthma attacks, patients being treated for road injuries, or suffering from a lifetime of inactivity, as wheels replaced their feet. And I’m struck by the amazing variety of ways in which cars have ruined our lives.

Let’s abandon this disastrous experiment, recognise that this 19th-century technology is now doing more harm than good, and plan our way out of it. Let’s set a target to cut the use of cars by 90% over the next decade.

Yes, the car is still useful – for a few people it’s essential. It would make a good servant. But it has become our master, and it spoils everything it touches. It now presents us with a series of emergencies that demand an emergency response.

Why we should be paying more for parking – video explainer

One of these emergencies is familiar to every hospital. Pollution now kills three times as many people worldwide as Aids, tuberculosis and malaria combined. Remember the claims at the start of this century, projected so noisily by the billionaire press: that public money would be better spent on preventing communicable disease than on preventing climate breakdown? It turns out that the health dividend from phasing out fossil fuels is likely to have been much bigger. (Of course, there was nothing stopping us from spending money on both: it was a false dilemma.) Burning fossil fuels, according to a recent paper, is now “the world’s most significant threat to children’s health”.

In other sectors, greenhouse gas emissions have fallen sharply. But transport emissions in the UK have declined by only 2% since 1990. The government’s legally binding target is an 80% cut by 2050, though even this, the science now tells us, is hopelessly inadequate. Transport, mostly because of our obsession with the private car, is now the major factor driving us towards climate breakdown, in this and many other nations.

The number of people killed on the roads was falling steadily in the UK until 2010, at which point the decline suddenly ended. Why? Because, while fewer drivers and passengers are dying, the number of pedestrians killed has risen by 11%. In the US, it’s even worse: a 51% rise in the annual death rate of pedestrians since 2009. There seem to be two reasons: drivers distracted by their mobile phones, and a switch from ordinary cars to sports-utility vehicles. As SUVs are higher and heavier, they are more likely to kill the people they hit. Driving an SUV in an urban area is an antisocial act.

There are also subtler and more pervasive effects. Traffic mutes community, as the noise, danger and pollution in busy streets drive people indoors. The places in which children could play and adults could sit and talk are reserved instead for parking. Engine noise, a great but scarcely acknowledged cause of stress and illness, fills our lives. As we jostle to secure our road space, as we swear and shake our fists at other drivers, pedestrians and cyclists, as we grumble about speed limits and traffic calming, cars change us, enhancing our sense of threat and competition, cutting us off from each other.

New roads carve up the countryside, dispelling peace, creating a penumbra of noise, pollution and ugliness. Their effects spread for many miles. The deposition of reactive nitrogen from car exhaust (among other factors) changes the living systems even of remote fastnesses. In Snowdonia, it is dropped at the rate of 24kg per hectare per year, radically altering plant communities. Wars are fought to keep down the cost of driving: hundreds of thousands died in Iraq partly for this purpose. The earth is reamed with the mines required to manufacture cars and the oil wells needed to power them, and poisoned by the spills and tailings.

A switch to electric cars addresses only some of these issues. Already, beautiful places are being wrecked by an electric vehicle resource rush. Lithium mining, for example, is now poisoning rivers and depleting groundwater from Tibet to Bolivia. They still require a vast expenditure of energy and space. They still need tyres, whose manufacture and disposal (tyres are too complex to recycle) is a massive environmental blight.

We are told that cars are about freedom of choice. But every aspect of this assault on our lives is assisted by state planning and subsidy. Roads are built to accommodate projected traffic, which then grows to fill the new capacity. Streets are modelled to maximise the flow of cars. Pedestrians and cyclists are squeezed by planners into narrow and often dangerous spaces – the afterthoughts of urban design. If we paid for residential street parking at market rates for land, renting the 12m2 a car requires would cost around £3,000 a year in the richer parts of Britain. The chaos on our roads is a planned chaos.

Transport should be planned, but with entirely different aims: to maximise its social benefits, while minimising harm. This means a wholesale switch towards electric mass transit, safe and separate bike lanes and broad pavements, accompanied by a steady closure of the conditions that allow cars to rampage through our lives. In some places, and for some purposes, using cars is unavoidable. But for the great majority of journeys they can easily be substituted, as you can see in Amsterdam, Pontevedra and Copenhagen. We could almost eliminate them from our cities.

In this age of multiple emergencies – climate chaos, pollution, social alienation – we should remember that technologies exist to serve us, not to dominate us. It is time to drive the car out of our lives.

 George Monbiot is a Guardian columnist

 

Posted, but  not written by, Louis Sheehan

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