The FDA and its regulation of genetic data purchased by Americans

Link here. The article is a detailed history of the company 23andMe, which offers individuals a way to get their personal genetic data. The company was growing and flourishing, providing data to its customers, until the FDA stepped in.

In 2009, the FDA started asking 23andme for evidence that the company’s products worked as advertised and wouldn’t harm customers. The agency was worried that people might take drastic medical measures on the basis of their test results, such as deciding to change the dosage of their medications without consulting a doctor or undergoing unnecessary surgery, such as a mastectomy, or treatment based on false positives. Regulators demanded evidence that the tests were accurate, and that customers were well informed what the results meant.

The next years were difficult ones for 23andme. It communicated with the agency on a few occasions and promised in January 2013 that data would be forthcoming. According to the FDA, it then ceased communicating with regulators entirely in May, even as it started a new advertising campaign. Fed up, the agency sent [Anne] Wojcicki [company CEO] a strongly worded warning letter on 22 November 2013 ordering her company to stop marketing its product.

It was a self-inflicted wound for the company. “There was a bit of arrogance,” says Richard Scheller, who was an executive at Genentech at the time. As a result, 23andme was forced to drastically cut its customer offerings, threatening its viability.

Wojcicki was stunned. “It became clear that we had pissed them off,” she says. “I really didn’t know that we had done so many things that angered them.”

Soon after the letter arrived, Wojcicki called Kathy Hibbs, a lawyer then working for Genomic Health, a gene-testing company in nearby Redwood City, California. “Can I get my whole company back in one year?” Wojcicki asked Hibbs.

“You can get it back, but it will take years,” Hibbs replied. And to get there, she counselled, Wojcicki would have to cooperate with regulators.

It was a tough adjustment for Wojcicki; she didn’t think that the FDA should be able to stop customers from learning their own genetic information. But Hibbs and others convinced her that capitulating to the FDA’s demands was the fastest way to rescue her company. [emphasis mine]

The FDA’s high and mighty attitude here really offends me. It appears that before and after their demands, nothing really changed. All that had happened was that a government agency took control of a private company’s operation, coming between it and its customers. Right now it limits the data that the company can release to its customers, the people that pay for the service in order to obtain their own genetic data.

In other words, the FDA doesn’t think ordinary people are smart enough to see their own data. If that doesn’t capture the arrogance of government, I don’t know what does.

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Astronomers discover ring around object beyond Neptune

Observations of the trans-Neptunian object Haumea has revealed that not only is is shaped like a football due to its fast rotation, it has a ring.

Haumea is an interesting object: it rotates around the Sun in an elliptic orbit which takes it 284 years to complete (it presently lies fifty times further from the Sun than the Earth), and it takes 3.9 hours to rotate around its axis, much less than any other body measuring more than a hundred kilometers long in the entire Solar System. This rotational speed causes it to flatten out, giving it an ellipsoid shape similar to a rugby ball. The recently published data reveal that Haumea measures 2.320 kilometers in its largest axis – almost the same as Pluto – but lacks the global atmosphere that Pluto has.

“One of the most interesting and unexpected findings was the discovery of a ring around Haumea. Until a few years ago we only knew of the existence of rings around the giant planets; then, recently, our team discovered that two small bodies situated between Jupiter and Neptune, belonging to a group called centaurs, have dense rings around them, which came as a big surprise. Now we have discovered that bodies even farther away than the centaurs, bigger and with very different general characteristics, can also have rings,” says Pablo Santos-Sanz, another member of the IAA-CSIC team.

The more we see of these distant objects beyond Neptune the more I suspect that they are going to be puffy, not very dense, and surrounded by miscellaneous objects. The gravity and environment that far from the Sun simply allows them to not coalesce as happened in the inner solar system.

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First discoveries from China’s FAST radio telescope

Astronomers using China’s new FAST radio telescope have announced its first discoveries, the identification of two pulsars,

The new pulsars PSR J1859-01 and PSR J1931-02, also referred to as FAST pulsar #1 and #2 (FP1 and FP2), were detected on August 22 and 25, and were confirmed by the Parkes telescope in Australia on September 10. “FP1 is a pulsar with a spin period of 1.83 second and an estimated distance of 16 thousand light-years, and FP2, is a pulsar with a spin period of 0.59 second and an estimated distance of 4,100 light years,” said Li Di, Deputy Chief Engineer of FAST Project at the National Astronomical Observatories (NAOC), on Tuesday.

FAST’s gigantic size will allow it to pinpoint many similar astronomical objects previously beyond the resolution of radio telescopes.

Note that there is still no word on whether China has found a scientist to head FAST operations.

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The mysterious dark splotches of Mars

The dark splotches of Mars

Cool image time! The image on the right, cropped and reduced in resolution to post here, shows one particular dark splotch in a region with several similar dark areas.

Geologists aren’t quite sure what to make of the dark splotch in the middle of this image, one of several similar dark splotches that extend east and west for over 100 kilometers. From measurements made in infrared, this and other dark splotches have what we call “high thermal inertia,” meaning that it heats up and cools down slowly. Scientists use thermal inertia to assess how rocky, sandy, or dusty a place is. A higher thermal inertia than the surrounding area means it’s less dusty.

The image below the fold shows at full resolution the area indicated by the white box. It provides me no clue as to the cause for the darker color. I think we can speculate all we want, but the truth is that we simply don’t have enough information. We need a closer look, including boots on the ground, to figure this out.
» Read more

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Sunspot update for September 2017

On Sunday NOAA posted its monthly update of the solar cycle, covering sunspot activity for September. That graph is posted below, with annotations.

September 2017 Solar Cycle graph

The graph above has been modified to show the predictions of the solar science community. The green curves show the community’s two original predictions from April 2007, with half the scientists predicting a very strong maximum and half predicting a weak one. The red curve is their revised May 2009 prediction.

Last month saw the strongest amount of sunspot activity in a year, thus helping to bring the pace in the decline of sunspot activity back towards the low prediction from April 2007. This also suggests that the ramp down to solar minimum will continue through 2019, with minimum not occurring before then, at the earliest. At the same time, the increase in sunspot activity seen in September seems to have eased in October, with the return of a blank Sun this past week.

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Mars Odyssey makes its first observations of Phobos

Sixteen years after entering Mars orbit Mars Odyssey finally made its first observations of the Martian moon Phobos last week.

Since Odyssey began orbiting the Red Planet in 2001, THEMIS has provided compositional and thermal-properties information from all over Mars, but never before imaged either Martian moon. The Sept. 29 observation was completed to validate that the spacecraft could safely do so, as the start of a possible series of observations of Phobos and Deimos in coming months.

In normal operating mode, Odyssey keeps the THEMIS camera pointed straight down as the spacecraft orbits Mars. In 2014, the spacecraft team at Lockheed Martin Space Systems, Denver; and NASA’s Jet Propulsion Laboratory, Pasadena, California; and the THEMIS team at Arizona State University, Tempe, developed procedures to rotate the spacecraft for upward-looking imaging of a comet passing near Mars. The teams have adapted those procedures for imaging the Martian moons.

The data from this particular observation is less significant than the fact that the spacecraft can now do it. Expect some new results about the Martian moons in the coming months.

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Nobel Prize for Physics awarded to three LIGO scientists

The 2017 Nobel Prize for Physics has been awarded to three scientists involved in the development of the Laser Interferometer Gravitational-wave Observatory (LIGO), which detected the first gravitational waves in 2015.

While some of the recent Nobel Prizes have been absurd (such as the Peace award to Obama), this award is absolutely deserved and appropriate. Until LIGO detected that gravitational wave they were merely a theory. The detection proved the theory to be real.

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Database of presumed human-caused earthquakes created

The uncertainty of science: Geologists have assembled a database of more than 700 earthquakes they think might have been caused by human activity.

The Human-Induced Earthquake Database, or HiQuake, contains 728 examples of earthquakes (or sequences of earthquakes) that may have been set off by humans over the past 149 years. Most of them were small, between magnitudes 3 and 4. But the list also includes several large, destructive earthquakes, such as the magnitude-7.8 quake in Nepal in April 2015, which one paper linked to groundwater pumping.

Miles Wilson, a hydrogeologist at Durham University, UK, and his colleagues describe the database in a paper set to be published on October 4 in Seismological Research Letters2. The scientists say that HiQuake is the biggest, most up-to-date public listing of human-caused quakes ever made. By bringing the data together in this way, they hope to highlight how diverse induced quakes can be — and help society to understand and manage the future risk.

Many of these quakes were likely caused by human activity. Many however might not have been. The jury is still out, as the article reluctantly admits near the end.

All possible instances of induced quakes were included “without regard to plausibility”, writes the team, because of the difficulty involved in deciding what constitutes absolute proof that an earthquake was caused by human activity. But that could mislead people about the real hazard from induced quakes, says Raphaël Grandin, a geophysicist at the Institute of Earth Physics in Paris. “When you put a dot in the database, and a scientific reference behind it, then you may lead the non-expert to think that the earthquake was caused by humans,” he says. Such a listing might hide scientific uncertainty, as with the Chinese quake: despite the paper linking it to reservoir filling, many seismologists do not believe it was triggered by human activity.

In other words, they included every quake that had the slightest suggestion it was connected to human activity, without noting the uncertainties. This makes this database to me somewhat suspect. Rather than identify the known reliable links between human activity and quakes in order to learn what causes them, this database seems more designed as a political propaganda tool aimed at limiting future human activity. It certainly doesn’t clarify our knowledge on this subject, but instead muddies the water significantly.

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Testing underwater interplanetary robots on the cheap

This article describing a test of an underwater robot by JPL scientists in the interior of a glacier warmed the cockles of my heart when I read this paragraph:

Klesh and Leicty’s recent expedition relied on a commercial grade submersible and a “homemade” glacial probe. The latter was built using off-the-shelf and 3-D printed parts. They did all their own wiring and programming.

NASA test projects like this are often gold-plated. I like how these scientists took a more practical approach, getting their data without spending a fortune in time and money. Moreover, they gained some engineering knowledge that can be applied practically in future probes, both here on Earth and on other planets.

Hat tip Jim Mallamace.

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Solar storm activates global aurora on Mars

The strong solar flare that occurred earlier this month was strong enough to activate a global aurora on Mars.

The solar event on Sept. 11, 2017 sparked a global aurora at Mars more than 25 times brighter than any previously seen by the MAVEN orbiter, which has been studying the Martian atmosphere’s interaction with the solar wind since 2014. It produced radiation levels on the surface more than double any previously measured by the Curiosity rover’s Radiation Assessment Detector, or RAD, since that mission’s landing in 2012. The high readings lasted more than two days.

Strangely, it occurred in conjunction with a spate of solar activity during what is usually a quiet period in the Sun’s 11-year sunspot and storm-activity cycle. This event was big enough to be detected at Earth too, even though Earth was on the opposite side of the Sun from Mars.

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Webb Space Telescope delayed again

NASA announced today that they are further delaying the launch of the James Webb Space Telescope from October 2018 to late spring 2019.

NASA’s James Webb Space Telescope now is planning to launch between March and June 2019 from French Guiana, following a schedule assessment of the remaining integration and test activities. Previously Webb was targeted to launch in October 2018. “The change in launch timing is not indicative of hardware or technical performance concerns,” said Thomas Zurbuchen, associate administrator for NASA’s Science Mission Directorate at Headquarters in Washington. “Rather, the integration of the various spacecraft elements is taking longer than expected.”

As part of an international agreement with the ESA (European Space Agency) to provide a desired launch window one year prior to launch, NASA recently performed a routine schedule assessment to ensure launch preparedness and determined a launch schedule change was necessary. The careful analysis took into account the remaining tasks that needed to be completed, the lessons learned from unique environmental testing of the telescope and science instruments at NASA’s Goddard Space Flight Center in Greenbelt, Maryland, and the current performance rates of integrating the spacecraft element.

Webb’s original launch date was supposed to be 2011, making its launch now verging on a decade late. The original budget for the telescope was supposed to be $1 billion. It is now expected to cost more than $9 billion. Like SLS/Orion, this project more resembles feather-bedding, providing NASA employees and the contractors involved a steady paycheck, regardless of whether they ever get anything done. In fact, both Webb and SLS/Orion seemed designed to encourage failure. The project never gets cancelled no matter what goes wrong. Instead, more money gets poured in.

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Hubble spots most distance active comet yet

Comet C/2017 K2

Using the Hubble Space Telescope astronomers have imaged a comet that is sublimating material at a distance from the Sun farther than any previously known comet, out beyond Saturn.

“K2 is so far from the Sun and so cold, we know for sure that the activity — all the fuzzy stuff making it look like a comet — is not produced, as in other comets, by the evaporation of water ice,” said lead researcher David Jewitt of the University of California, Los Angeles. “Instead, we think the activity is due to the sublimation [a solid changing directly into a gas] of super-volatiles as K2 makes its maiden entry into the solar system’s planetary zone. That’s why it’s special. This comet is so far away and so incredibly cold that water ice there is frozen like a rock.”

Based on the Hubble observations of K2’s coma, Jewitt suggests that sunlight is heating frozen volatile gases – such as oxygen, nitrogen, carbon dioxide, and carbon monoxide – that coat the comet’s frigid surface. These icy volatiles lift off from the comet and release dust, forming the coma. Past studies of the composition of comets near the Sun have revealed the same mixture of volatile ices.

The significance here is that by studying the comet’s activity scientists will be able to identify some of these volatile gases, which in turn will tell them something about the make-up of the outermost fringes of the solar system.

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Status of Arecibo radio observatory

It appears that, while Puerto Rico itself suffered devastating damage from Hurricane Maria, the Arecibo Observatory came through relatively unscathed.

The surface of the dish was largely unscathed, and the observatory’s most vulnerable component, the instrument platform suspended high above the dish by cables strung from three towers, each more than 80 meters tall, was still in place and seemed undamaged, says Schmelz. She is based at the Columbia, Maryland, headquarters of one of Arecibo’s operators, the Universities Space Research Association, and spoke with staff in Puerto Rico who first used a ham radio and then a single working satellite phone. But the roofs on some observatory buildings were blown off, the sinkhole under the dish was flooded, and other equipment was damaged by rain and fallen trees. Most significantly, a large portion of a 29-meter-long antenna—the 430-megahertz line feed used for studying the upper atmosphere—appears to have broken off and fallen from the platform into the dish. Mathews estimates a bill of several million dollars to replace the line feed alone.

Because of the significant infrastructure damage across the island, there will be significant delays in getting any of this fixed. Since the telescope is already being considered for shut down due to budget issues, these delays could lead to that shut down.

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One last image from Rosetta

Rosetta's last image

Engineers reviewing the last bits of telemetry that was transmitted back to Earth by Rosetta just before it crashed on Comet 67P/C-G have discovered one last image of the comet’s surface.

That image is on the right. It is slightly blurred because of the limitations of Rosetta’s camera at this short range, and the incompleteness of the data received.

The image covers an area about a meter across, with a resolution of about two millimeters per pixel.

I imagine this surface is relatively soft, since the gravity holding the comet together is so slight. If you wanted to dig down, you would find it easy digging.

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Gravitational waves from black hole collision detected

Three Earth gravitational wave observatories have detected the waves coming from the same collision of two black holes.

The collision was observed Aug. 14 at 10:30:43 a.m. Coordinated Universal Time (UTC) using the two National Science Foundation (NSF)-funded Laser Interferometer Gravitational-Wave Observatory (LIGO) detectors located in Livingston, Louisiana, and Hanford, Washington, and the Virgo detector, funded by CNRS and INFN and located near Pisa, Italy.

The detection by the LIGO Scientific Collaboration (LSC) and the Virgo collaboration is the first confirmed gravitational wave signal recorded by the Virgo detector.

Based on the data obtained, they estimate that the two black holes 25 and 31 times the mass of the Sun and are about 1.8 billion light years away.

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Dark energy might not exist

The uncertainty of science: A new model for the universe that omits dark energy produces a better fit to what is know than previous theories that included it.

The new theory, dubbed timescape cosmology, includes the known lumpiness of the universe, while the older traditional models that require dark energy do not.

Timescape cosmology has no dark energy. Instead, it includes variations in the effects of gravity caused by the lumpiness in the structure in the universe. Clocks carried by observers in galaxies differ from the clock that best describes average expansion once variations within the universe (known as “inhomogeneity” in the trade) becomes significant. Whether or not one infers accelerating expansion then depends crucially on the clock used. “Timescape cosmology gives a slightly better fit to the largest supernova data catalogue than Lambda Cold Dark Matter cosmology,” says Wiltshire.

He admits the statistical evidence is not yet strong enough to definitively rule in favour of one model over the other, and adds that future missions such as the European Space Agency’s Euclid spacecraft will have the power to distinguish between differing cosmology models.

Both models rely on a very weak data set, based on assumptions about Type 1a supernovae that are likely wrong. It is thus likely that neither explains anything, as neither really has a good picture of the actual universe.

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OSIRIS-REx looks at Earth

NASA has released the images that OSIRIS-REx took as it flew past Earth last week on its way to its 2018 rendezvous with the asteroid Bennu.

The image shows the Pacific Ocean from Australia to California. Its main significance it demonstrates that the spacecraft’s camera and pointing system is working perfectly.

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The kittens of Saturn’s rings

The scientists who used Cassini to identify about 60 transient clumps in Saturn’s rings have dubbed them “kittens” and have been naming them appropriately.

Saturn’s kittens are a group of small clumps and baby moons, or moonlets, that occupy the planet’s F ring. Like the rest of Saturn’s rings, this thin outer ring is made up of countless particles that range in size. When enough of those particles bump into one another and stick together, they aggregate into larger clumps — and become eligible for a kitten name.

So far, the list of Saturn’s kitten names includes several classics, like Fluffy, Garfield, Socks and Whiskers. These are unofficial nicknames for more-complicated (and less adorable) official titles like “Alpha Leonis Rev 9” (aka, Mittens). The technical names for these features come from events called stellar occultations, during which Cassini was able to detect the little clumps. In a stellar occultation, a star passes behind Saturn’s rings from Cassini’s point of view.

Most of these clumps will likely never be found again, so their unofficial kitten names are essentially just for fun.

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Scientists finally image SMART-1 lunar impact site

SMART-1 impact site

Eleven years after the European SMART-1 probe was sent crashing onto the Moon’s surface, scientists have finally identified in a Lunar Reconnaissance Orbiter image that crash site.

The image is shown on the right, reduced and cropped to post here.

The images show a linear gouge in the surface, about four metres wide and 20 metres long, cutting across a small pre-existing crater. At the far end, a faint fan of ejecta sprays out to the south. Foing said: “The high resolution LRO images show white ejecta, about seven metres across, from the first contact. A north-south channel has then been carved out by the SMART-1 spacecraft body, before its bouncing ricochet. We can make out three faint but distinct ejecta streams from the impact, about 40 metres long and separated by 20-degree angles.”

Stooke said: “Orbit tracking and the impact flash gave a good estimate of the impact location, and very close to that point was a very unusual small feature. It now seems that impacts of orbiting spacecraft, seen here from SMART-1, and also in the cases from GRAIL and LADEE, will form elongated craters, most of whose rather faint ejecta extends downrange”.

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