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Tuesday, June 5, 2018

Facebook Confirms Data-Sharing Deals with Chinese Tech Firms


Facebook Inc. said Tuesday that it struck data partnerships with at least four Chinese electronics firms, including Huawei Technologies Co., a telecommunications-equipment maker that U.S. officials view as a potential tool for state-sponsored spying.
The four partnerships are among the roughly 60 that Facebook struck with device manufacturers starting in 2007 so they could recreate the Facebook service on their devices, a Facebook spokeswoman said. As of Tuesday, more than half of those partnerships have been wound down, the spokeswoman added.
The social-media company said it plans to wind down its data-sharing partnership with Huawei by the end of the week. It isn’t clear when Facebook will end partnerships with the three other companies: Lenovo Group Ltd., the world’s largest personal-computer maker; Oppo Electronics Corp., a smartphone maker; and Chinese electronics conglomerate TCL.
Facebook officials defended the decision to work with Huawei and said that no data belonging to Facebook users was saved on Huawei servers. Facebook had a manager and an engineer review the apps before they were deployed to ensure the data wasn’t saved on company servers, the Facebook spokeswoman said.
“Huawei is the third-largest mobile manufacturer globally and its devices are used by people all around the world, including in the United States,” Francisco Varela, vice president of mobile partnerships, said in a statement. “Facebook along with many other U.S. tech companies have worked with them and other Chinese manufacturers to integrate their services onto these phones.”
The New York Times earlier reported on Facebook’s device partnerships with companies like Apple Inc., Amazon.com Inc. and Microsoft Corp. After the Times article, several lawmakers said they felt they had been misled by Chief Executive Mark Zuckerberg, who testified in April that Facebook restricted data access to outsiders in 2015.
“Facebook’s integrations with Huawei, Lenovo, OPPO and TCL were controlled from the get go — and we approved the Facebook experiences these companies built,” Mr. Varela said. “Given the interest from Congress, we wanted to make clear that all the information from these integrations with Huawei was stored on the device, not on Huawei’s servers.”
The company is dealing with the fallout related to Cambridge Analytica, a research firm that had ties to President Donald Trump’s 2016 campaign and improperly obtained the data of 87 million Facebook users. The crisis sparked questions about Facebook’s lax oversight of its platform, an investigation by the Federal Trade Commission and two congressional appearances by Mr. Zuckerberg last month.
Facebook argues that the device partnerships are different from the data extended to third parties like academics and mobile apps. Facebook negotiated each device deal differently.
Still, lawmakers have raised several concerns about Facebook’s partnership with Huawei, the subject of a 2012 report by U.S. congressional investigators who said the company could be exploited to spy or harm the U.S. telecommunications network. Huawei makes telecom equipment and smartphones.
“The news that Facebook provided privileged access to Facebook’s API to Chinese device makers like Huawei and TCL raises legitimate concerns, and I look forward to learning more about how Facebook ensured that information about their users was not sent to Chinese servers,” Sen. Mark Warner said in a statement Tuesday, referring to the website’s application programming interface, or set of software-building tools.
It isn’t clear why Facebook continued to maintain a relationship with Huawei despite the U.S. government’s concerns. When asked, the Facebook spokeswoman said the company hasn’t seen nor does it suspect any misuse of Facebook user data.

Nurse practitioners increasingly fill gap in primary care delivery


  • With an ongoing physician shortage, primary care practices are increasingly turning to nurse practitioners and other interdisciplinary provider scenarios to fill the care delivery void, a new study in Health Affairs finds.
  • In 2016, NPs represented a quarter of the provider workforce in rural practices and 23% in nonrural practices — up from 17.6% and 15.9%, respectively, in 2008.
  • NPs were most prevalent in states with full scope-of-practice laws. However, the fastest growth was seen in states with reduced and restricted scopes of practice.

The Association of American Medical Colleges estimates a shortfall of as many as 105,000 doctors by 2030. In primary care, that number could reach 43,000. Meanwhile, the U.S. population is expected to grow by about 2.3 million people each year between now and 2030, according to U.S. Census Bureau data.
NPs are a potential way to mitigate the physician shortage while also improving care coordination and population health efforts.
In the face of these trends, the AAMC began pushing for higher medical school enrollment in the early 2000s — a drive that has seen both an increase in the number of medical schools and in matriculants. The group is also focused on interprofessional teamwork to increase the use of NPs and physician assistants.
Edward Salsberg, director of health workforce studies at George Washington University’s Health Workforce Institute, believes such a team approach can help solve the physician shortage problem. “While the number of new physicians is growing slowly, the number of NPs and PAs is growing very rapidly, as is a whole host of other professions,” he told Healthcare Dive via email earlier this year. “Making better use of the workforce we have through innovations in service delivery and modifications in scope of practice laws/regulations can help increase access, improve quality and constrain the growth in health care costs.”
According to the Health Affairs study, the number of NPs is rising annually, with 87% educated to provide primary care. “Policymakers could further encourage these trends by continuing to invest in NP education and training and by facilitating direct reimbursement for NP-delivered care,” the authors write.
They point to the Affordable Care Act’s Graduate Nurse Education Demonstration, which reimbursed five hospitals for the cost of training NPs in primary care. The pilot sunsets next month, with no plans for further funding. Direct reimbursement of NP services could also incentivize practices to use NPs at the top of their practice. “Both strategies can be accomplished in ways that benefit a variety of stakeholders, including patients,” the study says.

#ASCO18: AbbVie convinces analyst $6B ‘megablockbuster’ Rova-T is worthless



AbbVie $ABBV has managed to convince at least one prominent analyst that Rova-T is absolutely worthless, as the company’s vision of a $5 billion earner gradually dissolves.

Geoffrey Porges at Leerink took a look at AbbVie’s formal presentation of its Trinity trial data at ASCO and came away shaking his head. His conclusion:
The results shown in the presentation were even worse than we had feared, and although AbbVie’s stock sold off much more than the value of Rova- T after the announcement, we can’t help but regard the ongoing trials as largely fruitless exercises. Furthermore, the toxicity signal from the trial, along with the relatively marginal efficacy signal, justifies the complete elimination of all revenue associated with Rova-T from our company forecast and valuation for AbbVie.
There was a lot to dislike about the data, he says, including the high 34% discontinuation rate in the study; “49 or these 116 premature discontinuations were due to progressive disease, with the others being due to adverse events or other undisclosed reasons.”
For the primary endpoint over response rate, measured by change in the target lesion, of the 301 evaluable patients (presumably the other 38 patients were deceased or lost to follow up), the investigator-measured response rate was 18%, increasing modestly to 19.7% in the DLL3 high group.
As measured by the independent review board,  the response rate fell to 12.4% for the combined population, and 14.3% in the DLL3-high patients. And serious adverse events in the drug group ran high.
AbbVie paid $5.8 billion in cash for this drug, promising up to $4 billion more in milestones to acquire the little-known biotech unicorn Stemcentrx. And with money like that on the table, expectations were running high, fueling forecasts that the pharma company could get past the eventual loss of patent protection on Humira in style. AbbVie itself projected peak sales at $5 billion a year.
Porges’ conclusion: The drug and the class look dead on arrival at ASCO.
Ultimately it seems unlikely in our view that Rova-T, or perhaps any variant of DLL3 antibody-drug conjugate medicine, will come to market, at least while the profile looks the way it did in TRINITY.

‘Millions’ prescribed wrong dose of common drugs


According to updated calculations published this week, over 11 million people in the United States may have been given the wrong prescription for a range of commonly used drugs.
Scientists from the Stanford University School of Medicine in California recently investigated the reliability of so-called pooled cohort equations (PCEs).
These dry-sounding sums perform a pivotal role in the prescribing of drugs, including blood pressure medications, statins, and aspirin.
PCEs help doctors to determine each patient’s overall risk of stroke or heart attack.
Assessing cardiovascular risk helps to inform the physician about the exact level of medication that will be both effective and safe.
These equations are available as online web tools and smartphone apps, and they are even built into digital medical records.

Problems with PCEs

In recent years, some have called into question the accuracy of PCEs, asking whether the data that they rely on are outdated. If this were found to be the case, patients could potentially be at risk of taking dangerously high or ineffectively low doses of drugs.
Dr. Sanjay Basu, Ph.D., is an assistant professor of primary care outcomes research at Stanford. He set out to uncover whether PCEs should be improved. As he explains, “We found that there are probably at least two major ways to improve the 2013 equations.”
His findings were published this week in the journal Annals of Internal Medicine.
The first issue that Dr. Basu identified was one that had been discussed for some time: “[T]he data used to derive the equations could be updated.”
PCEs are based on various datasets, some of which are relatively old. For instance, one included information from people who were aged 30–62 in 1948.
Diet, lifestyle, health risks, and everything in-between have changed since those days. The study authors say that, because of the age of this information, people’s risks were being estimated at around 20 percent higher than they truly were.
Dr. Basu notes dryly that “relying on our grandparents’ data to make our treatment choices is probably not the best idea.”

Other issues unearthed

Another issue the researchers identified was the lack of African-Americans in the datasets. It is now known that cardiovascular risk is significantly higher in the African-American population.
So while many Americans were being recommended aggressive treatments that they may not have needed according to current guidelines, some Americans — particularly African-Americans — may have been given false reassurance and probably need to start treatment given our findings.”
Dr. Sanjay Basu, Ph.D.
To rectify these shortcomings, the researchers added new data to improve the PCEs’ accuracy. The data are currently maintained by the National Institutes of Health (NIH), and they have approved the new and updated equations.
Addressing the aged data was the first step, but there was a second issue to attend to. According to the researchers, some of the statistical methods behind the PCEs were also outdated. So, they brought them in line with current standards.
In the paper, the study authors explain, “We found that by revising the PCEs with new data and statistical methods, we could substantially improve the accuracy of cardiovascular disease risk estimates.”
As the PCEs guide medical decisions involving some of the most commonly used prescription drugs — such as aspirins, blood pressure medications, and statins — these changes could potentially save and extend thousands of lives.

NYU Langone to open new high-rise hospital with superstorm protection

When Hurricane Sandy caused destructive flooding along the East Coast in 2012, the New York University Langone Medical Center campus sustained significant damage.
Power was cut, health providers were forced to evacuate more than 300 patients, and officials had to not only renovate and weatherproof existing buildings but ensure their planned campus construction wouldn’t allow the campus to be impacted by flooding that way ever again.
The Kimmel Pavilion (NYU Langone)
Now, as NYU Langone prepares to open the 21-story Helen L. and Martin S. Kimmel Pavilion on the east side of Manhattan later this month, officials said they are not only marking the delivery of the final step of a long-planned upgrade to health services in the city: They have finished the final piece of the effort to protect against future superstorms.
“It completes that perimeter wall for us to protect that entire campus,” Vicki Match Suna, NYU Langone’s senior vice president and vice dean for real estate development and facilities, told FierceHealthcare.
The Kimmel Pavilion was the final phase of $6 billion campus plan, which included the creation of a new energy facility and science research building. Those projects were already well underway but needed a revamp after Sandy hit, Match Suna said. “We quickly had to reassess our campus plan in terms of resiliency for the future and very rapidly made a lot of changes to the design,” she said.

That involved changing plans such as moving much of the mechanical and electrical infrastructure up to the first floor, she said. A new protection wall that protects the campus from one end to the other has gates at every necessary break in the perimeter that can be shut when any kind of surge from the river is expected.
It’s one of the unique design features of the new 830,000-square-foot Kimmel Pavilion project, the largest and most extensive revitalization in NYU Langone Health’s history. The building officially opens June 24.
An operating room in the new building.
(NYU Langone)
Among its other features, the building includes 374 private inpatient rooms as well as outdoor landscaped gardens and roof terraces with views of the city.
The new Hassenfeld Children’s Hospital with two floors will be dedicated to 68 inpatient pediatric beds, When it opens, it will be the only pediatric inpatient facility in Manhattan with all private patient rooms, officials said. The 160,000-square-foot children’s hospital has its own designated building entrance on 34th Street and will include a pediatric intensive care unit, congenital cardiovascular unit, surgery services and a pediatric emergency department.
The pavilion will greatly increase the health system’s capacity for procedure-based volumes with 30 new operating rooms and image-guided labs, as well as acute care and critical care services in hematology/oncology, bone marrow and solid organ transplantation, Match Suna said. The health system’s bed count has not increased significantly because the new building is helping create private patient rooms while officials plan to renovate the existing NYU Langone Tisch Hospital, she said.
In January, NYU opened its 16-floor science building, which includes more than 365,000 square feet and 10 floors of laboratory space covering medical research such as neuroscience, the Institute for System Genetics, Institute for Computational Medicine, cardiology, endocrinology and rheumatology.
The Energy Building, which opened in May 2016, allows the campus to be more environmentally sustainable but also allows the health system to power its buildings and remain operational in the event of a utility power interruption, with two different sources of backup power for critical areas.

VBL Therapeutics gains after CEO comments on series of antibodies


In a statement, CEO of VBL Therapeutics, Dror Harats, M.D, said, “Our research has shown that MOSPD2 plays a key role in the regulation of cell motility.We have generated data indicating that MOSPD2 is required for directional movement, or chemotaxis, of tumor cells and certain immune cells, and therefore appears to play a central role in both oncology and inflammation. We continue to advance our exciting VB-600 series of antibodies as drug candidates for oncology and inflammatory indications.” Shares of VBL Therapeutics are up about 47% to $3.20 per share in after-hours trading.

Exact Sciences, Mayo ID liver cancer biomarker


Researchers at Exact Sciences Corp. (Nasdaq: EXAS) and Mayo Clinic announced significant progress toward developing a panel of novel, blood-based, DNA biomarkers that could accurately detect hepatocellular carcinoma (HCC), the most common cancer that originates in the liver.1 The researchers detailed their findings during a presentation today at Digestive Disease Week, the world’s largest gathering of gastroenterologists and scientists in the field.
The biomarker panel was shown to be 95 percent sensitive for detecting HCC across all stages. Sensitivity among patients with curable-stage disease was 91 percent. The panel has overall specificity of 93 percent, demonstrating its ability to discriminate between normal and diseased patients. Sensitivity and specificity are the most important statistical measures of a cancer detection test’s performance.
“These results are further validation of our advanced DNA technology and our multi-biomarker approach for the detection of the deadliest forms of cancer,” said Kevin Conroy, chairman and CEO of Exact Sciences. “We look forward to advancing this important research in early stage cancer with Mayo Clinic.”
HCC accounts for nearly 90 percent of all liver cancers and is the fastest-growing cause of cancer-related death in the United States.1 Mayo Clinic experts predict that liver and bile duct cancers will be the third-leading cause of cancer deaths in the United States by 2030 due, in part, to the obesity epidemic.2,3
Individuals diagnosed with cirrhosis have the greatest risk of developing HCC, and it is recommended that they undergo ultrasound and blood monitoring every six to 12 months. The three-year survival rate for patients regularly surveilled is approximately 60 percent, compared to approximately 30 percent for those who don’t undergo regular surveillance.4 When HCC is detected early and treated, patient survival rates improve significantly.1 Exact Sciences estimates that more than 3 million Americans are eligible for HCC surveillance.
“The potential of an accurate, non-invasive blood test that can identify early-stage disease is very exciting,” said John Kisiel, M.D., the gastroenterologist and assistant professor of medicine at Mayo Clinic Medical School who led the study. “This could potentially transform the way patients are monitored and lead to the identification of many more curable-stage tumors than we typically see today.”
Dr. Kisiel said the current options for monitoring at-risk patients are “sub-optimal.”
“We estimate that fewer than half of at-risk patients are tested regularly, and some estimates suggest the monitoring rate is less than 20 percent in primary care settings, where most people get their care,” Dr. Kisiel said.
Using DNA extracted from the blood samples of 244 people, including 95 diagnosed across all stages of HCC, 51 with cirrhosis, and 98 healthy volunteers, researchers tested the samples against 15 biomarkers to identify the combination of six biomarkers that yielded the most accurate detection of HCC.
“Now we must confirm the accuracy of the biomarkers we’ve studied for the detection of HCC,” Dr. Kisiel said. “We are seeking to apply this DNA assay technology to all cancers, and these findings are an important step toward that goal.”
Exact Sciences and Mayo Clinic have been collaborators since 2009. The collaboration previously yielded Cologuard, the stool-based, advanced-DNA screening test for colorectal cancer. The non-invasive test was approved by the U.S. Food and Drug Administration in 2014 and has been used by more than 1 million patients. Exact Sciences has identified biomarkers associated with 10 of the deadliest cancers and is advancing a pipeline of non-invasive diagnostic and screening tests based on those biomarkers.