The New York Times: Theranos Under Fire As U.S. Threatens Crippling Sanctions The Wall Street Journal: Regulators Propose Banning Theranos Founder Elizabeth Holmes For At Least Two Years Federal health regulators have proposed banning Theranos Inc. founder Elizabeth Holmes from the blood-testing business for at least two years after concluding that the company failed to fix what regulators have called major problems at its laboratory in California. In a letter dated March 18, the Centers for Medicare and Medicaid Services said it plans to revoke the California lab’s federal license and prohibit its owners, including Ms. Holmes and Theranos’s president, Sunny Balwani, from owning or running any other lab for at least two years. That would include the company’s only other lab, located in Arizona. (Carreyrou and Weaver, 4/13) Theranos has positioned itself as a cheaper, more efficient alternative to traditional medical tests. It claimed it could process up to 70 lab tests on just a few drops of blood. It is valued at more than $9 billion and has been billed as a classic industry disruptor. But in October 2015, a scathing report in the Wall Street Journal called much of its technology and testing methods into question. CMS’s concerns became public in January, after the agency conducted a routine survey of the lab and found five areas in which it fell short of compliance standards. Theranos responded and said it had addressed the issues, but in the March letter, CMS said it wasn’t adequate. (O’Brien, 4/13) Federal regulators have threatened a series of stiff sanctions against Theranos, the embattled blood-testing company, including closing down its flagship laboratory and potentially barring its chief executive from owning or operating its labs for two years. The sanctions, which have not been made final, were included in a strongly worded letter from officials from the Centers for Medicare and Medicaid Services. It is the latest blow to the credibility of Theranos and Elizabeth Holmes, its chief executive, who seemingly became a self-made billionaire by promising to upend the clinical testing industry. (Abelson and Pollack, 4/13) The Los Angeles Times: Federal Health Regulators Seek To Revoke License Of Theranos Blood-Testing Lab CNN Money: Theranos CEO In Jeopardy After Regulators Propose Ban In ‘Worst Case Scenario,’ Theranos Founder Could Face 2-Year Ban The Centers for Medicare & Medicaid Services offered harsh sanctions to the troubled blood-testing startup and its leadership in a March 18 letter, which The Wall Street Journal obtained. CMS is now reviewing Theranos’ response as to why those punishments should not be imposed. Theranos has responded to the letter and is waiting for the agency to finish reviewing the privately held company’s proposed solutions, Theranos spokeswoman Brooke Buchanan said. In the meantime, “CMS has not imposed any sanctions on Theranos or its executives,” and the sanctions proposed by the agency in its letter were “the worst-case scenario,” Buchanan said. The Centers for Medicare and Medicaid Services declined to comment, noting that the letter was not intended to be made public. (Peltz, 4/13) This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
The New York Times: Prominent Cancer Researcher Resigns From Dartmouth Amid Plagiarism Charges Cancer Researcher Resigns Following Plagiarism Investigation, But NEJM Refuses To Retract His Article Dr. H. Gilbert Welch disputes Dartmouth University’s findings that one of his published papers includes a plagiarized graph. Meanwhile, the New England Journal of Medicine’s decision to leave the article is angering some researchers. Stat: Turmoil Erupts Over Expulsion From Leading Evidence-Based Medicine Group In other health care personnel news — The New England Journal of Medicine is again refusing to retract an article co-authored by one of the country’s leading health policy scholars even after the researcher resigned his position this week following a misconduct finding last month. As STAT and Retraction Watch reported Thursday, Dr. H. Gilbert Welch resigned from his faculty position at Dartmouth following an internal investigation, which found that Welch had plagiarized material from a Dartmouth colleague and a researcher at another institution for a 2016 paper published in the venerable journal. The paper was an analysis of how breast cancer screening led to the overdiagnosis of tumors and unnecessary treatments. Welch disputes Dartmouth’s conclusions. (Oransky and Marcus, 9/14) Modern Healthcare: #MeToo Era Highlights Importance Of Emergency CEO Succession Plans Stat: NEJM Again Refuses To Retract Article Dartmouth Says Is Plagiarized One of the medical world’s most respected expert bodies is in turmoil as its annual meeting gets underway in Edinburgh, Scotland, after its governing board voted to expel a member. The Cochrane Collaboration, which reviews the scientific literature in areas of clinical research and produces widely cited analyses that help guide clinical practice, kicked out a member who has been an outspoken critic of certain vaccines and has blasted the profession of psychiatry for pushing unsafe drugs on unsuspecting patients. (Marcus and Oransky, 9/16) One of the country’s most influential researchers in cancer screening has resigned from his post at Dartmouth College, after a two-year internal investigation concluded he had plagiarized a graph included in a paper published in a prominent journal. The researcher, Dr. H. Gilbert Welch, has published widely on the risks of aggressive screening and over-diagnosis, including Op-Ed articles in The Times and several popular books. He disputed the university’s findings against him. (Carey, 9/14) Healthcare CEOs haven’t been bolting under the weight of #MeToo accusations at nearly the same rate as other industries, but the sector is not immune to surprise exits. Athenahealth co-founder and CEO Jonathan Bush, for example, left swiftly in June amid allegations of physical abuse and sexual harassment. But there are other reasons, too. The CEO of PinnacleHealth, currently UPMC Pinnacle, stepped down suddenly last year, reportedly to “seek an alternative career path.” In Ohio, Summa Health CEO Thomas Malone resigned last year, shortly after hundreds of physicians and staff members expressed displeasure with his leadership. (Bannow, 9/15) This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
And, in other news — Bloomberg: Big Pharma Lobby Group Spent Record Amount As Reform Push Grows The pharmaceutical industry’s leading trade group disclosed Tuesday that it had spent a record $27.5 million on lobbying in 2018, $1.4 million more than in 2009, when Congress and the White House created the Affordable Care Act, the health-care overhaul better known as Obamacare. The surge in spending by the Pharmaceutical Research and Manufacturers of America came as the industry failed to win a last-minute legislative fix that would have reduced its share of outlays in a popular Medicare program, and as it prepared for what could be its most challenging year in decades. (Allison, 1/22) Stat: PhRMA Spent A Record $27.5 Million On Lobbying In 2018 In Sign Of Increasing Threat Facing Industry, Big Pharma Spent A Record $27.5M On Lobbying In 2018 The lobbying numbers from the pharmaceutical industry’s leading trade group reflect an industry under fire from all sides over its pricing practices, as well as its efforts to roll back changes to a Medicare program. The changes is expected to cost drugmakers as much as $1.9 billion in 2019. Meanwhile, there’s a lot of money going toward influencing drug cost decisions, but it’s not always clear who is behind the groups ponying up the cash. Sen. Chuck Grassley (R-Iowa) is giving Republicans an early test on their commitment to lowering drug prices. Legislation sponsored by the Senate Finance Committee chairman and Democratic Sen. Amy Klobuchar (Minn.) would allow people to buy prescription drugs from approved pharmacies in Canada. The bill is reigniting a long-simmering debate about drug importation, a proposal strongly opposed by the powerful pharmaceutical lobby. (Weixel and Hellmann, 1/21) The tally, as detailed in lobbying filings posted online on Tuesday, far outstrips the group’s previous record-setting spend, when it dropped a little more than $25 million in 2009, as Congress was deep in the debate over the Affordable Care Act. It spent just shy of that figure again in 2017. The group’s eye-popping 2018 spending — sums that support some two dozen internal lobbyists as well as a crowd of external contractors — is a sign of the increasingly existential threat the drug industry faces in Washington. The Trump administration has ramped up its efforts to address high prescription drug prices with a flurry of new regulations, and congressional lawmakers also spent the last year turning up the volume on their own criticism of the industry’s practices. PhRMA represents most of the nation’s largest drug companies, including Johnson & Johnson, Pfizer, and Merck. (Florko, 1/22) The political war over prescription drug practices is spawning a frenzy of activity by outside lobbying groups, some with names that mask their ties to industry and one that has gone to great lengths to disguise its origins. The increase in advertising, advocacy and pressure tactics is aimed at thwarting some efforts to control drug costs proposed in the Democratic-controlled House, such as allowing Medicare to negotiate drug prices, as well as ideas pursued by the Trump administration to curb prices. (Rowland and Stein, 1/22) The Hill: Grassley To Test GOP On Lowering Drug Prices The Washington Post: Anonymous ‘Ghost Ship’ Is Among Groups Flooding Drug Pricing Debate This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
Both Reps. Dan Crenshaw of Texas and Pete Stauber of Minnesota have retreated from their campaign pledges on the issue — a sign, experts said, of both the political appeal of pledging to lower drug prices and the trepidation that comes with crossing the party line on a divisive issue. The political liability that comes with quickly abandoning a campaign-trail promise, too, could be substantial. (Facher, 5/24) Denver Post: Colorado Becomes First State In Nation To Cap Price Of Insulin This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription. Stat: These Republicans Campaigned On A Bold Drug-Pricing Pledge. Since They Won, They’ve Gone Silent President Trump’s new vow to cut off work with Democrats is threatening recent progress in bipartisan talks to lower drug prices. Staffers for the White House and Speaker Nancy Pelosi’s (D-Calif.) office have been in discussions for months about potential legislation to lower the cost of prescription drugs, and sources say the White House has expressed openness to some form of Medicare negotiating drug prices, a major Democratic goal that Trump supported during the 2016 campaign before backing off. (Sullivan, 5/24) The Hill: Trump-Pelosi Fight Threatens Drug Pricing Talks Diabetics in Colorado who use insulin to control their blood sugar levels won’t pay more than $100 per month for the drug starting in January thanks to a bill signed into law by Gov. Jared Polis on Wednesday. “Today, we will declare that the days of insulin price gouging are over in Colorado,” Polis said in his office as he signed the bill, according to CBS Denver. Insulin has been around for nearly a century, but the price that patients with Type 1 and Type 2 diabetes pay for the drug has doubled since 2012, according to the Healthcare Cost Institute. The cost of insulin can creep up toward $1,000 for those whose health care coverage requires significant cost-sharing. (Staver, 5/23) New GOP Lawmakers’ Silence After Campaigning On Drug Pricing Reveals Difficult Reality For Republicans Reps. Dan Crenshaw (R-Texas) and Pete Stauber (R-Minn.) both talked on the campaign trail about giving Medicare negotiating powers as a way to curb high drug prices. Now, in Congress, they appear to have backpedaled their positions. Meanwhile, the spat between President Donald Trump and House Speaker Nancy Pelosi jeopardizes a potential deal on drug pricing. And Colorado caps the costs of insulin.
Source: Charge Forward Tesla benefits from some of the most hardcore fans and owners in the world, some of whom act as evangelists for the brand.Now, those owners have gathered at Tesla’s Club Leadership Summit for their annual meeting. more…The post Tesla owners gathered at Club Leadership Summit for annual meeting appeared first on Electrek.
Source: Electric Vehicle News The New Tech Headache Formula E Teams Must Solve Formula E Will Not Award Best Efficiency Point This Season Nissan “Very Unhappy” About Formula E Driver’s Bid To Leave The Nissan e.dams Formula E squad has had “15-20” drivers get in contact about a possible seat for the 2018/19 season, says team boss Jean-Paul Driot. Author Liberty Access TechnologiesPosted on October 25, 2018Categories Electric Vehicle News Nissan had been expected to field Sebastien Buemi and Alexander Albon in FE’s fifth season, the Japanese manufacturer’s first since taking over from alliance partner Renault at the e.dams entry.More Formula E News But with Albon, who was signed to a three-year FE contract in July, now closing on a Toro Rosso F1 seat for 2019, Nissan will likely need a new driver to slot in alongside season two FE champion Buemi.When asked if Nissan was looking for a replacement for Albon as it negotiates his situation with Red Bull, Driot replied: “We are, we had so many drivers who rang during these two days, I couldn’t believe it.“Drivers who rang, who sent emails – if I give you the names you are going to be very astonished – incredible,” he told Motorsport.com.“I think at least 15-20 [got in contact].”Nissan replaced Albon for the final day of last week’s Valencia pre-season test with former DAMS Formula 2 racer Oliver Rowland.Driot confirmed that Rowland – the 2015 Formula Renault 3.5 champion – is in contention for the race seat.“Oliver is in consideration because we were thinking about him for the third driver anyway, and we know him well because he did Formula 2 with us the same year as [Charles] Leclerc was racing in Formula 2 [in 2017],” he said.“And he did well – he won three races and did poles – and we know him because he was in Renault 3.5.”Rowland completed 85 laps for Nissan during the third day of the test – including a 21-lap run that was the team’s longest stint of the week.“It was good – I just focused on race stuff,” Rowland explained to Motorsport.com.“It was fine – I got my head around that a little bit and just worked through the programme for the guys and Nissan really.“It was nice to get out in the wet – seemed pretty competitive. I didn’t really do any performance running in the [dry] afternoon, but it was good.“It’s really hard for me say [where Nissan is in FE’s competitive order], I haven’t been involved in any of the [private] tests.“But it seemed good and the pace seemed quite good – I don’t even know who is the best to compare to or anything like that.“But it was important for me to just try and understand as best I can with the car and also just give them the data and stuff they need.”Regarding the possibility of racing for Nissan in FE in season five, Rowland, said: “Obviously I came here and covered – super-subbed – for them again, a bit like I did with Nicholas Latifi at the start of the year [in F2 testing].“But let’s see – obviously I’d like to race in Formula E, so we’ll see what they come up with.”
EVs are proliferating, and their growing popularity has revealed security vulnerabilities that could slow the industry’s further growth. To combat these roadblocks, the DOE has granted Virginia Tech $3 million to improve charging network quality and security.Virginia Tech will work with researchers and manufacturers to both improve charging network security and streamline the charging experience, addressing such issues as privacy, charge time, cybersecurity and cyber-physical security.“We will work to protect the infrastructure for fast charging: controllers, converters and monitoring systems. In addition, we will address user privacy by using secure sensing and ‘smart’ defense systems,” said assistant professor Ryan Gerdes. “The process will deploy remote updates to address system vulnerability.”Virginia Tech partnered with IoT security provider OnBoard Security to improve charging unit cybersecurity and resilience while protecting user privacy by designing new software and charging architectures, the university reported.“EVs are vulnerable to attacks via charging stations that could lead to stolen personal and financial information, vehicle damage and attacks on the electrical grid,” said OnBoard Director of Research Jonathan Petit. “The grant will allow my research team, Virginia Tech and other partners to evaluate these attack vectors and recommend solutions.” Source: Electric Vehicles Magazine Source: Virginia Tech
Visual approximation pic.twitter.com/sMn3Pv476Y— Elon Musk (@elonmusk) October 12, 2018 Source: Electric Vehicle News In the sometimes-bizarre world of Tesla CEO Elon Musk, the absurd can become reality and does so on a regular basis. Typically, these instances are related to his particular sense of humor. Consider any number of the superfluous Easter eggs in the automaker’s vehicles or the stereos that “go to 11.” Need another example? How about his tunneling outfit, The Boring Company, selling 20,000 copies of “Not-A-Flamethrower?” We rest our case.Read also Elon Musk: “Ford Tried To Kill Sex” (w/video) Thanks!!! pic.twitter.com/cHKl6B2f9i— Taylor Harris (@AntVenom) April 20, 2018 That Dad-joke wit is making headlines again around his intention to produce something he’s calling Teslaquila. According to Automotive News, it’s gotten the attention of the tequila industry, which is very keen to protect the integrity of its product. According to the Tequila Regulatory Council (CRT), which makes its home in Mexico, naturally, “tequila” is a protected word and Teslaquila is too evocative of that fine alcoholic beverage. Perhaps we should back up for a second.Back on April 1st of this year (widely known as April Fools Day), Musk tweeted out (embedded below) a series of joking tweets about how Tesla had gone bankrupt and the co-founder had been found passed out surrounded by bottles of “Teslaquila.” Ha ha.In response to this, it was suggested by Twitter user @AntVenom (Taylor Harris) that Musk “make that happen.” Within days, a photo of a Teslaquila bottle appeared on Musk’s Instagram account, and shortly after that, Harris tweeted a picture of himself holding a similar (if not the same) bottle.Fast forward to mid-October and Musk tweets out (embedded below) “Teslaquila coming soon …” in response to a story that Tesla is seeking to trademark the awkward portmanteau. It’s hard to say whether the protestations of the CRT will interfere with the trademark effort. Originally submitted October 8, applications typically aren’t examined until three months after the filing date.While we wait to learn whether this novelty product becomes an actual thing that will eventually flood eBay for exorbitant amounts, we suggest that if the trademark is rejected, the company try again with the name Not Teslaquila. You’re welcome. Elon was found passed out against a Tesla Model 3, surrounded by “Teslaquilla” bottles, the tracks of dried tears still visible on his cheeks.This is not a forward-looking statement, because, obviously, what’s the point?Happy New Month! pic.twitter.com/YcouvFz6Y1— Elon Musk (@elonmusk) April 1, 2018 Workaholic Musk Camps Out On Gigafactory Roof For The Sake Of Model 3 Source: Automotive News Elon Musk’s Tesla Roadster Set To Enter Space On February 6 Author Liberty Access TechnologiesPosted on November 14, 2018Categories Electric Vehicle News OK. “Not-Teslaquila,” then. ***UPDATE: Elon Musk has responded to our story in a tweet (embedded) saying, “We will fight Big Tequila!”We will fight Big Tequila!— Elon Musk (@elonmusk) November 14, 2018
However, Tesla disagrees with this assessment. The automaker says the 70% claim is “off by a significant margin,” but stops short of saying what the actual sales figure was for October.Quoting Tesla:“This is wildly inaccurate. While we do not disclose regional or monthly sales numbers, these figures are off by a significant margin.”Poor sales for Tesla were expected due to the increase of import duty from the U.S. from an already insanely high 25% to a ludicrous 40%. That would explain why Tesla lowered prices and decided to absorb the higher taxes.After the prices were lowered, the Tesla stand at the 2018 Guangzhou Auto Show was flooded by consumers, many of which placed orders.Source: Reuters, CNBC Tesla Cuts Prices In China By 12-26% To Absorb Increase Of Import Duty Tesla Booth Flooded With Model 3 Buyers In China Tesla Model 3 Performance Pricing Announced For China Source: Electric Vehicle News Author Liberty Access TechnologiesPosted on November 27, 2018Categories Electric Vehicle News 40% import tax may have limited Tesla sales in China, but not by the claimed 70%.While general plug-in electric car sales in China are reaching all-time records in October, Tesla EV sales sank by 70% year-over-year, or so says Reuters.According to Reuters, which says it obtained sales results from China Passenger Car Association, Tesla sold only 211 electric cars last month in China. The automaker currently offers two models – S and X, while the Model 3 is expected in March.Tesla in China