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Tuesday, January 1, 2019

In Screening for Suicide Risk, Facebook Takes On Tricky Public Health Role


A police officer on the late shift in an Ohio town recently received an unusual call from Facebook.
Earlier that day, a local woman wrote a Facebook post saying she was walking home and intended to kill herself when she got there, according to a police report on the case. Facebook called to warn the Police Department about the suicide threat.
The officer who took the call quickly located the woman, but she denied having suicidal thoughts, the police report said. Even so, the officer believed she might harm herself and told the woman that she must go to a hospital — either voluntarily or in police custody. He ultimately drove her to a hospital for a mental health work-up, an evaluation prompted by Facebook’s intervention. (The New York Times withheld some details of the case for privacy reasons.)
Police stations from Massachusetts to Mumbai have received similar alerts from Facebook over the last 18 months as part of what is most likely the world’s largest suicide threat screening and alert program. The social network ramped up the effort after several people live-streamed their suicides on Facebook Live in early 2017. It now utilizes both algorithms and user reports to flag possible suicide threats.
Facebook’s rise as a global arbiter of mental distress puts the social network in a tricky position at a time when it is under investigation for privacy lapses by regulators in the United States, Canada and the European Union — as well as facing heightened scrutiny for failing to respond quickly to election interference and ethnic hatred campaignson its site. Even as Facebook’s chief executive, Mark Zuckerberg, has apologized for improper harvesting of user data, the company grappled last month with fresh revelations about special data-sharing deals with tech companies.

The anti-suicide campaign gives Facebook an opportunity to frame its work as a good news story. Suicide is the second-leading cause of death among people ages 15 to 29 worldwide, according to the World Health Organization. Some mental health experts and police officials said Facebook had aided officers in locating and stopping people who were clearly about to harm themselves.
Facebook has computer algorithms that scan the posts, comments and videos of users in the United States and other countries for indications of immediate suicide risk. When a post is flagged, by the technology or a concerned user, it moves to human reviewers at the company, who are empowered to call local law enforcement.
“In the last year, we’ve helped first responders quickly reach around 3,500 people globally who needed help,” Mr. Zuckerberg wrote in a November post about the efforts.
But other mental health experts said Facebook’s calls to the police could also cause harm — such as unintentionally precipitating suicide, compelling nonsuicidal people to undergo psychiatric evaluations, or prompting arrests or shootings.
And, they said, it is unclear whether the company’s approach is accurate, effective or safe. Facebook said that, for privacy reasons, it did not track the outcomes of its calls to the police. And it has not disclosed exactly how its reviewers decide whether to call emergency responders. Facebook, critics said, has assumed the authority of a public health agency while protecting its process as if it were a corporate secret.
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Facebook posted a description in September of how its computer algorithms scan and score certain user posts, comments and videos for indications of immediate suicide risk.CreditFacebook
“It’s hard to know what Facebook is actually picking up on, what they are actually acting on, and are they giving the appropriate response to the appropriate risk,” said Dr. John Torous, director of the digital psychiatry division at Beth Israel Deaconess Medical Center in Boston. “It’s black box medicine.”
Facebook said it worked with suicide prevention experts to develop a comprehensive program to quickly connect users in distress with friends and send them contact information for help lines. It said experts also helped train dedicated Facebook teams, who have experience in law enforcement and crisis response, to review the most urgent cases. Those reviewers contact emergency services only in a minority of cases, when users appear at imminent risk of serious self-harm, the company said.
“While our efforts are not perfect, we have decided to err on the side of providing people who need help with resources as soon as possible,” Emily Cain, a Facebook spokeswoman, said in a statement.
In a September post, Facebook described how it had developed a pattern recognition system to automatically score certain user posts and comments for likelihood of suicidal thoughts. The system automatically escalates high-scoring posts, as well as posts submitted by concerned users, to specially trained reviewers.
“Facebook has always been way ahead of the pack,” said John Draper, director of the National Suicide Prevention Lifeline, “not only in suicide prevention, but in taking an extra step toward innovation and engaging us with really intelligent and forward-thinking approaches.” (Vibrant Emotional Health, the nonprofit group administering the Lifeline, has advised and received funding from Facebook.)
Facebook said its suicide risk scoring system worked worldwide in English, Spanish, Portuguese and Arabic — except for in the European Union, where data protection laws restrict the collection of personal details like health information. There is no way of opting out, short of not posting on, or deleting, your Facebook account.
A review of four police reports, obtained by The Times under Freedom of Information Act requests, suggests that Facebook’s approach has had mixed results. Except for the Ohio case, police departments redacted the names of the people flagged by Facebook.

In one case in May, a Facebook representative helped police officers in Rock Hill, S.C., locate a man who was streaming a suicide attempt on Facebook Live. On a recording of the call to the police station, the Facebook representative described the background in the video — trees, a street sign — to a police operator and provided the latitude and longitude of the man’s phone.
The Police Department credited Facebook with helping officers track down the man, who tried to flee and was taken to a hospital.
“Two people called the police that night, but they couldn’t tell us where he was,” said Courtney Davis, a Rock Hill police telecommunications operator, who fielded the call from Facebook. “Facebook could.”
The Police Department in Mashpee, Mass., had a different experience. Just before 5:16 a.m. on Aug. 23, 2017, a Mashpee police dispatcher received a call from a neighboring Police Department about a man who was streaming his suicide on Facebook Live. Officers arrived at the man’s home a few minutes later, but by the time they got to him, he no longer had a pulse, according to police records.
At 6:09 a.m., the report said, a Facebook representative called to alert the police to the suicide threat.
Scott W. Carline, chief of the Mashpee Police Department, declined to comment. But he said of Facebook, “I’d like to see them improve upon the suicide prevention tools they have in place to identify warning signs that could potentially become fatal.”
Facebook’s Ms. Cain said that, in some cases, help unfortunately did not arrive in time. “We really feel for those people and their loved ones when that occurs,” she said.

The fourth case, in May 2017, involved a teenager in Macon, Ga., who was streaming a suicide attempt. Facebook called the police after officers had already found the teenager at her home, a spokeswoman for the Bibb County sheriff’s office said. The teen survived the attempt.
Some health researchers are also trying to predict suicide risk, but they are using more transparent methodology and collecting evidence on the results.
The Department of Veterans Affairs has developed a suicide risk prediction program that uses A.I. to scan veterans’ medical records for certain medicines and illnesses. If the system identifies a veteran as high risk, the V.A. offers mental health appointments and other services. Preliminary findings from a V.A. study reported fewer deaths over all among veterans in the program compared with nonparticipating veterans.
In a forthcoming article in a Yale law journal, Mason Marks, a health law scholar, argues that Facebook’s suicide risk scoring software, along with its calls to the police that may lead to mandatory psychiatric evaluations, constitutes the practice of medicine. He says government agencies should regulate the program, requiring Facebook to produce safety and effectiveness evidence.
“In this climate in which trust in Facebook is really eroding, it concerns me that Facebook is just saying, ‘Trust us here,’” said Mr. Marks, a fellow at Yale Law School and New York University School of Law.
Facebook’s Ms. Cain disagreed that the program amounted to health screening. “These are complex issues,” she said, “which is why we have been working closely with experts.”

Investing Into R&D Pays off for Some of Biotech’s Biggest Companies


The biotech industry is an ever-changing and evolving one. Companies need to invest a good portion of their budget into research and development if they wish to stay competitive. PwC recently came out with the latest version of their annual R&D spending report, and while there is a lot of interesting information to digest in this report, there are a few companies in particular that stand out in the field of biotechnology.
1. Roche
Having spent $11.8 billion in 2017 and now $10.8 billion in 2018, Roche takes the number one spot in the report for pharmaceutical and biotechnology companies. This heavy investment into research and development would appear to be paying off, as well.
Roche recently launched the first IVD pan-TRK immunohistochemistry assay, which is an in vitro diagnostic that will be used for analytical studies. It is capable of detecting tropomyosin receptor kinase (TRK) proteins in cancer. It is designed to measure the prevalence of TRK in tumor tissue and identify both wild-type and chimeric fusion proteins.

There are some kinds of rare cancers that are largely defined by TRK proteins, such as juvenile breast cancer and infantile fibrosarcoma, and this assay holds a lot of promise for aiding researchers who are studying cancers such as these.
The company that spent the second-most amount of money on R&D in 2018 was Johnson & Johnson with $10.6 billion, up from the $9.1 billion they spent in 2017, an increase of $1.5 billion. In comparison, their revenue has gone up by $4.6 billion over this same time span.
One example of their R&D products is the HELIOSTAR Multi-electrode Radiofrequency Balloon Ablation Catheter, which has recently been used to treat an atrial fibrillation patient in a clinical study. The device has 10 electrodes and is capable of achieving pulmonary vein isolation with one application of RF energy.
“This new balloon catheter is unique because it conforms to any pulmonary vein anatomy and allows me to control electrodes individually to deliver tailored energy when ablating around pulmonary veins,” said Dr. Rodney Horton, who is one of the cardiac electrophysiologists working on the study.
With an R&D budget of $10.2 billion in 2018, Merck takes the third place in the report. Notably, out of the top five biotech companies in this report, Merck had the highest R&D intensity (R&D expenditure as a percentage of revenue) at 25.4%.
This level of focus into R&D has had many benefits for Merck, as they have had numerous accomplishments regarding the development of new treatments. Recently, Merck began filing in the US for their Ebola vaccine that was given Breakthrough Therapy Designation by the FDA in 2016, and which Merck hopes will be able to help combat breakouts of Zaire ebolavirus.
Their Ebola vaccine is only one of Merck’s new treatments that have recently achieved some progress towards making it to market. The FDA also gave Merck approval for their PD-1 inhibitor Keytruda as a treatment for hepatocellular carcinoma. Blockbuster drug Keytruda has already been shown to be more effective than chemotherapy in some types of cancer, such as esophageal cancer.
Coming in at number four, Novartis invested $8.5 billion in 2018, which is $1.1 billion less than what it was the year prior. Even though they are spending less on R&D than in 2017, Novartis is still making great strides in developing new treatments. Most recently, their treatment for B-cell acute lymphoblastic leukemia, marketed as Kymriah, has shown a durable effect in blood cancer studies.
However, Novartis has recently decided to reevaluate their R&D pipeline, resulting in theabandonment of approximately 20% of their research projects, focusing on what they consider to be their core of treatments. It remains to be seen how this will pay off for them in 2019.
5. Pfizer
Finally, taking the fifth spot in the report is Pfizer with an R&D budget of $7.7 billion. This was down slightly from their 2017 budget of $7.9 billion.
Like the other companies mentioned in the report, Pfizer has plenty of new things coming down their R&D pipeline. Recently, Pfizer has received FDA approval for their acute myeloid leukemia (AML) treatment. This treatment, marketed as DAURISMO, has shown positive results when paired with low-dose chemotherapy and is intended for patients who are not able to undergo intensive chemotherapy. It is also being studied for its use in combination with other common therapies for treating AML.

How Automation Will Bring BioPharma Research Into the 21st Century


Look around you, technology is everywhere – it’s in your pocket, on your wrist, in your ears. As technology advances, more of it becomes automated. While some manufacturing industries have long utilized automation throughout their processes and product production, the biopharma industry is comparatively behind the times. Although most biopharma companies (and some academic labs) use liquid-handling robotics to automate parts of their processes, such as high-throughput screenings, robotics have not been utilized to its full potential through the entire process to improve productivity and product quality. How can automation be fully utilized to accelerate science?
The Impact of Automation
Automation uses robots and computers to monitor and perform experiments as well as process and analyze data. Some may think this will end up replacing scientists, resulting in job losses, but others believe automation will be very helpful for multiple reasons. Automation will free up scientists’ time, allowing them to spend much less time on grunt work in the lab and focus on experimental design and data interpretation, the crux of innovation.

“Basically, if you’re a biologist you spend all of your time moving tiny amounts of liquid around from vial to vial by hand with a little micro-pipette or you have a robot that does it for you,” saidWill Canine, co-founder of OpenTrons, a U.S. company making affordable liquid-handling robotics for biologists.
By having robots perform experiments more quickly than if they were performed by hand, the scientists will increase their productivity and be able to answer experimental questions faster. Automation will also increase the accuracy and reproducibility of results, something the science community is currently grappling with. A survey in Nature of about 1,500 scientists reported that more than 70 percent failed to reproduce other scientist’s experiments and more than 50 percent failed to reproduce even their own experiments.
Automation can improve the quality of products given to patients, such as stem cells, and clinical analysis, such as microbiology and pathology. As personalized medicine becomes increasingly common, so does the need for process optimization and regulatory compliance. Ensuring product integrity with no contamination is especially important in manufacturing patient-specific drugs. Automation allows for increased productivity, accuracy, and speed while making small batches of drugs.
Automation Type and Affordability
Liquid-handling systems and pipetting robots have been around for a while. Unfortunately, they often come with a large price tag (typically over $100,000), making them too expensive for most labs. In addition to their larger physical size, such systems also tend to require trained personnel to program and operate them.
More recently, companies have begun selling low-cost liquid-handling robots that can be controlled through a web browser, where researchers can download previously created protocols to either use directly or modify. One company, OpenTrons, offers a personal pipetting robot starting at $4,000.
Buying the automated instruments is just the first step – they must be controlled by software. When scientists run into limitations in the currently available automation software, they can gain full control over their instruments through a novel software platform called Antha created by Synthase, a London-based company. Antha is a software interface that allows scientists to create new protocols and automate lab equipment more specifically.
Instruments all use their own unique software and collect data in various formats. Facilitating communication between instruments will create a smoother workflow. One company, Riffyn, is doing just that. They provide cloud-based data organization, from experimental design to collecting data from multiple instruments into one location.
While automation is possible for some simpler experiments, more complex experiments may not be as feasible to automate.
“I have a hard time believing that a centralized automated lab will give you the freedom and flexibility to experiment with all the parameters you need to do some innovation,” said Roger Chen, an associate at the San Francisco investment firm AlphaTech Ventures.
However, automated instruments are not the complete picture; data is another piece of the puzzle. Converting data from handwritten notebooks to electronic records allows for easy querying and searching to find answers, rather than manually flipping through research notebooks.
Automating data collection and backing up data to the cloud will also facilitate easy management and analysis of large data sets. This is increasingly important in the big data era, where enormous amounts of data, such as whole genome sequences and high-throughput screens, are being collected. Various companies, such as BioBright, are offering automated data collection and cloud storage.
While automation seems to be the way of the future, figuring out the nuances of applying automation to more lab experiments and data management will be the hurdles to bringing lab science into the 21st century.

Are China’s CRISPR Clinical Trials Running off the Rails?


One of the biggest stories of 2018 was He Jiankui, a researcher at the Southern University of Science and Technology of China in Shenzhen, announcing he had used CRISPR gene editing to modify the CCR5 gene in human embryos. He conducted the procedure in the context of in vitro fertilization for seven couples. One of those couples gave birth to a set of twins. A later announcement indicated there was another pregnancy.
The news was met with global condemnation for violating moral and ethical standards. The Chinese government, Southern University, Rice University in the U.S., and the U.S. National Institutes of Health (NIH) launched investigations.

Follow-up investigations by the Wall Street Journal suggest that He Jiankui’s story may be just the tip of the iceberg of sloppy and unmonitored clinical trials using CRISPR in China. WSJ cites clinical trials in China where the researchers and physicians lost contact with patients whose DNA had been altered, and in a separate case, an Indian man who was treated with CRISPR for cancer improved but died from a heart attack and stroke, despite having no history of cardiovascular disease. The Chinese physicians involved apparently did not investigate his death.
However, in light of He Jiankui’s international scandal, China’s health authorities appear to be cracking down on some of this research. Three physicians involved with CRISPR clinical trials in China told the WSJ that the government science and health ministries had contacted them recently asking for information concerning their ongoing trials. WSJ writes, “Unlike in the U.S., no federal body is overseeing these trials in China, meaning standards vary across experiments.”
Although China appears to be ahead in terms of clinical trials using CRISPR, there are ongoing trials in Europe and the U.S. CRISPR Therapeutics began treating patients with beta-thalassemia in Europe earlier this year. In October, the U.S. Food and Drug Administration (FDA) lifted a clinical hold and accepted the Investigational New Drug (NDA) application of its CRISPR-based gene edited product, CTX001, for sickle cell disease. In the U.S., there is only one trial, which is at the University of Pennsylvania for melanoma, sarcoma, and multiple myeloma.
One significant difference between these trials and what He Jiankui did was the European and U.S. trials treat a disease in adult patients for which there is a clear medical need. In He Jiankui’s trial, he modified the CCR5 gene in the embryos in order to potentially make them less susceptible to HIV infection. The fathers of all seven couples have under-control HIV infections. As such, there was little likelihood of the children being infected. In addition, any changes made to their embryo DNA affects their germlines, meaning if they decide to have children someday, they will pass those changes onto their offspring. Also, research is still early and not all side effects are understood, notably off-target effects, where the gene editing effects areas of the genome besides the target areas.
Researchers associated with the discovery of CRISPR expressed concern about the lack of clinical follow-up in the Chinese studies. Jennifer Doudna, a professor at the University of California, Berkeley, one of the inventors of CRISPR, told WSJ, “Since we do not fully understand the human genome and are still developing knowledge of CRISPR-Cas technology, we need to monitor the intended and unintended consequences over the lifespan of patients.”
Beijing science and health officials have declared that implanting a CRISPR-modified embryo into a human is illegal. Using the technique to modify the DNA of adults isn’t illegal in China or the U.S., but U.S. researchers have generally erred on the side of caution. For example, the WSJreports that the University of Pennsylvania took two years to receive clearance to go ahead with the trial from the FDA and its institutional review board. Additional laboratory tests were requested and the consent agreements between the patients and the university received additional scrutiny.
“Even then,” WSJ reports, “the university struggled to recruit patients for months afterward because the requirements were so stringent.”
Part of the U.S. trial includes following the patients for 15 years.
China, however, only requires that a hospital’s ethics committee approve the trials. Which is at least why, as of January 2018, there were about a dozen CRISPR-based clinical trials publicly announced in China. At that time, about 86 adults had been known to have been treated using CRISPR gene editing. Most were involved in trials by Anhui Kedgene Biotechnology.
Mandy Zhou, founder of Kedgene, told WSJ that one trial didn’t finish as planned and they had lost touch with one of the treated patients. Another Kedgene trial was performed at the Anhui Provincial Hospital. It involved 18 patients, many who have died as their cancer grew. The China science ministry asked for a report this month, the first time they had requested information. Reportedly, none of the deaths were related to the gene editing, although no data is available to verify that.
In a third Kedge clinical trial, at least 19 out of 21 patients treated this year have died. Wu Shixiuof the Hangzhou Cancer Hospital told the WSJ none of the deaths were related to the use of CRISPR, although no details were provided.
“Any death in any clinical trial must be fully investigated,” Doudna told WSJ, adding she is concerned “about reckless applications of genome editing that put the safety of patients at risk, damages the public’s acceptance of CRISPR technology, and could trigger a range of negative but permanent unintended consequences.”

Smith & Nephew downgraded to Neutral from Overweight at JPMorgan


JPMorgan analyst David Adlington downgraded Smith & Nephew to Neutral and lowered his price target for the shares to GBP 14.77 from GBP 14.87. The analyst sees a more balanced risk/reward following the recent performance of the shares.

Biogen raised prices on MS drugs meaningfully today, says Piper Jaffray


Biogen raised prices on MS drugs meaningfully today, says Piper Jaffray According to Kluwer Health, Biogen took “meaningful” price increases across its multiple sclerosis franchise effective January 1, 2019, Piper Jaffray analyst Christopher Raymond tells investors in a research note titled “Starts The New Year Off With Spate of Price Increases.” The timing and magnitudes of the increases are consistent with Biogen’s established pattern, adds the analyst. Raymond, however, finds the company’s increases this year notable, “especially in an environment of increasing drug pricing scrutiny on both the political and policy front.” Biogen took a price increase of 6% for Tecfidera, 3.5% for Tysabri and 2% each for Avonex and Plegridy, he explains. Given President Trump’s Drug Pricing Blueprint and his willingness to call out individual companies for price increases, the analyst thinks some investors will be surprised by Biogen’s 2019 increases. He remains a buyer of Biogen shares with an Overweight rating and $400 price target. The stock closed Monday up $7.40 to $300.92.

Prices on hundreds of drugs rise to ring in the new year


Pharmaceutical companies are ringing in the new year by raising the price of hundreds of drugs, with Allergan PLC setting the pace with increases of nearly 10% on more than two dozen products, according to a new analysis.
Many companies’ increases are relatively modest this year, amid growing public and political pressure on the industry over prices. Yet a few are particularly high, including on some generics, the cheaper alternative to branded accounting for nine out of 10 prescriptions filled in the U.S. Overall, price increases, including recently restored price increases from Pfizer Inc. PFE, +1.61% , continue to exceed inflation.
More than three dozen drug makers raised the prices on hundreds of medicines in the U.S. on Tuesday, according to an analysis from Rx Savings Solutions, which sells software to help employers and health plans choose the least-expensive medicines. The average increase was 6.3%, according to the analysis, including increases on different doses for the same drug.
Allergan AGN, +0.65% confirmed the increases cited in the analysis, saying it raised the price of 51 products — 27 by about 9.5% and another 24 by about 4.9%. The increases covered more than half of its portfolio, from an extended-release version of its Alzheimer’s drug Namenda to dry-eye treatment Restasis. Of the companies analyzed, Allergan had the most increases of more than 9%.
Chief Executive Brent Saunders had announced in 2016 that Allergan would limit itself to one price rise a year on its medicines, and keep those increases under 10% as part of a “social contract” with patients. Allergan said Tuesday that it is “committed to responsible pricing principles” outlined in that pledge. Allergan applied price increases just below 10% on some of its products also at the start of 2017 and 2018.