Google expands to health tracking via smartphone cameras to monitor heart, respiration

 

Google Health developed a new feature to measure respiratory rate. Users place their head and upper torso in view of their phone’s front-facing camera and breathe normally to capture that measurement. (Google Health)

Google is stepping up its health-tracking game with a new tool to help consumers monitor key vital signs.

And while Google just closed a deal acquiring Fitbit, it says this new product doesn't need a wearable. 

Instead, Google Health, the tech giant’s health and wellness division, has added new features to its Google Fit app that enables users to take their pulse just by using their smart phone's camera.

“We’re working on ways to unlock the potential of everyday smart devices. We’re exploring how to leverage sensors that are becoming more ubiquitous to support health and wellness,” said Shwetak Patel, director of health technologies at Google Health, during a briefing with reporters Wednesday.

“There is a paradigm shift in health measurement. Our team of researchers, engineers, and clinicians are exploring how everyday devices and inexpensive sensors can give people the information and insights they need to take control of their health," he said.

The new features will be available in the Google Fit app for Pixel phones in the next month, with plans to expand to more Android devices, the company said.

The measurements aren’t meant for medical diagnosis or to evaluate medical conditions but can be useful for people using the Google Fit app to track and improve day-to-day wellness, Patel said. The health tracking tools do not provide any feedback based on users’ measurements.

Google Health developed a way to measure respiratory rate using a smartphone camera and a computer vision technique called optical flow to detect subtle movements in the chest. Users place their head and upper torso in view of their phone’s front-facing camera and breathe normally to capture that measurement, the company said.

To detect heart rate, Google Health uses smartphone cameras to detect subtle color changes in the fingertip that happen when freshly oxygenated blood flows from the heart through the body, a process called photoplethysmography (PPG). Users place their fingers on the rear-facing camera lens to measure heart rate.

Google also is exploring the ability to measure heart rate from color changes in the face.

With the aim of making the features work for as many users as possible, Google said it completed initial clinical validation with people of different health status, in different ambient lighting, different skin tones, as well different heart rate ranges, such as users sitting at rest and users elevating their heart rate by briefly exercising.

The company plans to share the results of these studies in a preprint publication in the coming weeks, and is seeking publication in a peer-reviewed journal, company officials said.

For the respiratory rate tracking feature, researchers examined its accuracy among healthy individuals as well as those with respiratory conditions that might impact measurement. Google Health’s algorithm is accurate within 1 breath per minute on average on both groups, said Jiening Zhan, technical lead at Google Health.

The heart rate measurement algorithm is accurate within 2% on average, Zhan said.

“We’re exploring a variety of sensors to bring to bear for health and wellness. The smartphone is a good starting point and we’re exploring other devices in our product lines,” Patel said.

Last month, Google closed its deal to buy fitness tracking giant Fitbit for $2.1 billion. It’s not clear how Google’s new health-monitoring features will fit into Fitbit’s business.

“We’re excited to collaborate with Fitbit and work on health and wellness. It’s still very early to figure out how we can align our efforts,” Patel said, noting that the acquisition closed just a few weeks ago.

The consumer-facing health monitoring market is crowded with smartwatches and wearables that can monitor steps taken, heart rate, sleep cycles, and blood oxygen levels. Compared to a Fitbit that can continuously track heart rate, Google’s health-tracking features require users to actively measure their vitals using the camera.

Patel said smartphones are more ubiquitous than wearables and the accessibility of phone cameras will help more people to monitor their health.

“Relatively few people in the U.S. actually have wearables. We know a lot of people in disadvantaged populations don’t have wearables and aren’t benefitting from health tracking. Equity is an important part of Google’s mission,” he said.

Currently, Google is focused on using the features for general health and wellness but there is the potential to use the technology as part of a medical device, which would require approval from the Food and Drug Administration.

“Work in the technology and research community suggests the technology might work for sick patients but there is not enough testing and validation. We’re definitely working on those use cases and are exploring that,” said Ming Jack Po, product management at Google Health, during the briefing with reporters.

https://www.fiercehealthcare.com/tech/google-pushes-into-health-tracking-using-smartphone-cameras-to-monitor-heart-respiratory-rates

McKinsey to pay $573M to 47 states, D.C. to settle role in opioid epidemic

 The major consulting firm McKinsey & Co. agreed to pay $573 million to 47 states and the District of Columbia to settle allegations over its role in the opioid epidemic.

The settlement announced Thursday is the latest against actors in the epidemic. A collection of states and localities reached a settlement with pharmaceutical manufacturer Mallinckrodt last year. The money from the McKinsey settlement will be used by states and localities to abate the opioid epidemic.

States charged that McKinsey contributed to the opioid crisis by promoting marketing schemes and consulting services for opioid manufacturers including Purdue Pharma, maker of the popular opioid Oxycontin for more than a decade.

“McKinsey & Company was a player in this unfolding opioids tragedy,” said California Attorney General Xavier Becerra in a statement. Becerra is Biden’s nominee to lead the Department of Health and Human Services.

California’s legal complaint said that McKinsey advised Purdue on the ways to maximize profits from opioids, including strategies on targeting high-volume prescribers and developed messaging to get physicians to prescribe more Oxycontin, according to a release from the attorney general.

“When states began to sue Purdue’s directors for their implementation of McKinsey’s marketing schemes, McKinsey partners began corresponding about deleting documents and e-mails related to their work for Purdue,” the release said.

The agreement calls for McKinsey to prepare a trove of internal documents on its work with Purdue Pharma. The firm also agreed to adopt a document retention plan and continue to investigate “allegations that two of its partners tried to destroy documents in response to investigations of Purdue Pharma,” the release said.

The consulting firm said in a statement that it deeply regrets "that we did not adequately acknowledge the tragic consequences of the epidemic unfolding in our communities. With this agreement, we hope to be part of the solution to the opioid crisis in the U.S."

This is the latest legal action over the opioid epidemic. Last December, the Department of Justice filed a lawsuit against Walmart and alleged the retail giant “unlawfully” distributed opioids at the height of the epidemic.

https://www.fiercehealthcare.com/payer/mckinsey-to-pay-573-million-to-47-states-and-d-c-to-settle-role-opioid-epidemic

23andMe to go public in $3.5B Branson SPAC deal

 23andMe is going public through a $3.5 billion deal spearheaded by Sir Richard Branson’s Virgin Group.

The consumer-focused genetic testing provider will be claimed by a special purpose acquisition company, or SPAC, launched by the multinational conglomerate: the descriptively dubbed VG Acquisition Corp. The cash-and-stock deal is set to close by the end of June, with plans to trade on the New York Stock Exchange under the ticker “ME.”

Branson and 23andMe co-founder and CEO Anne Wojcicki will each put in $25 million, through a $250 million round of private investments in the company’s public equity. When all is said and done, 23andMe expects to emerge with a cash balance approaching $984 million.

"Of the hundreds of companies we reviewed for our SPAC, 23andMe stands head and shoulders above the rest," Branson said. "As an early investor, I have seen 23andMe develop into a company with enormous growth potential.”

Today’s shareholders will end up owning 81% of the new company—which aims to use the proceeds to enter a new phase in its business, focused on providing personalized healthcare and therapeutics based on a person’s DNA, according to Wojcicki.

"We have always believed that healthcare needs to be driven by the consumer, and we have a huge opportunity to help personalize the entire experience at scale, allowing individuals to be more proactive about their health and wellness," she added.

The transaction includes gross proceeds from up to $509 million in cash held by VG Acquisition Corp.—which held its own $480 million IPO last October—plus the $250 million private placement of stock priced at $10 per share, where Branson and Wojcicki will be joined by funds managed by Fidelity, Altimeter Capital, Casdin Capital and Foresite Capital.

23andMe’s therapeutics development enterprise previously inked R&D deals with GlaxoSmithKline, as well as a January 2020 deal with Almirall, which gave the Spanish drugmaker the rights to a bispecific monoclonal antibody with potential in multiple inflammatory and dermatological conditions.

https://www.fiercebiotech.com/medtech/23andme-intertwines-branson-s-virgin-group-to-go-public-3-5b-spac-deal

Pfizer, J&J balk at shareholder push for COVID-19 vaccine pricing info

 What's the rationale behind COVID-19 vaccine and drug prices? You don’t have a need to know—or so say a couple of the leading contenders. 

Two major players in the pandemic fight, Pfizer and Johnson & Johnson, are urging the Securities and Exchange Commission (SEC) to forestall shareholder resolutions that would require them to disclose how they set prices on their COVID-19 vaccines.

Several not-for-profit groups are pushing the two companies—along with fellow pharmas Eli Lilly, Gilead, Merck & Co. and Regeneron—for information on their drug and vaccine pricing decisions, citing the federal money all have received, either for supplies, R&D or manufacturing scale-up. Or all three.

The Interfaith Center on Corporate Responsibility (ICCR) said in early December that it had filed shareholder proposals with all six of those companies. The goal of the ICCR according to its announcement was to “learn how the companies will price COVID medicine developed with public monies.”

In similarly-worded letters to the SEC, first reported by Newsweek, Pfizer and Johnson & Johnson both contend that they don't need to put those resolutions to a shareholder vote, saying their “ordinary business operations” should be exempt from shareholder oversight.

The U.S. government has awarded contracts that total more than $10 billion. Pfizer agreed to provide 200 million vaccines for $19.50 per dose, or $3.9 billion. Johnson & Johnson signed on for 100 million doses at $10 each. Nearly a year ago, Johnson & Johnson also won $465 million in federal funding for vaccine R&D—bringing its U.S. funding total to almost $1.5 billion. Regeneron agreed recently to a deal that could bring the company as much as $2.6 billion, depending on how quickly it can produce its antibody cocktail.

ICCR says Pfizer and J&J are making "unsubstantiated" arguments to avoid a shareholder vote on the pricing-information proposals. Access to COVID vaccines "transcends ordinary business," said Meg Jones-Monteiro, health equity director of the ICCR, a coalition of 300 faith communities and other organizations that use investments as levers for social change.

“It’s been proven in past SEC decisions that pricing and access is really a social policy issue," Jones-Monteiro said in an interview. "And in the context of COVID, it’s even more problematic that they’re using that as a reason to exclude this proposal from their proxy."

Both pharmaceutical companies also referred to the shareholder proposal as an attempt to “micromanage,” which Johnson & Johnson characterized as “probing too deeply into matters of a complex nature upon which shareholders, as a group, would not be in a position to make an informed judgment.”

But Jones-Monteiro says ICCR isn't asking for "specific algorithms" or details on how the companies determine pricing. She said she expects a decision from the SEC later this month.

“Our ask is: Have you taken into account the public investment?” she said. "Have you taken that into account and how have you taken it into account?’ When you look at the disclosures both companies have, they don’t reference that.”

Nicholas Lusiani of Oxfam America, a member of the ICCR, stated the case for the public interest group in its proposal announcement. The group doesn't just want info on the companies' rationale, but on what they'll do with the proceeds.

“We want to understand the extent to which any profits derived from the public investment will be reinvested to further critical scientific agenda versus, for example, to pay dividends to shareholders, which doesn’t advance the public health goals these public investments are intended to facilitate," Lusiani said.  

Jones-Monteiro said that there’s more to the public investment than the dollar amounts paid by the government. Consider the Pfizer and Moderna vaccines, both developed with the mRNA technology provided by the National Institutes of Health.   

“When you think about this concept of public support, it’s not just about the investment in R&D initially, but it’s also the technology that was developed with public support, public funding, academic support.” 

This isn't the first time ICCR has demanded sensitive information from top pharma companies. Most recently, the organization put forth proxy proposals that would force disclosures about executive pay. The resolutions, which went up for a vote at annual shareholder meetings, asked the drugmakers whether they use price increases to meet their sales goals, whether boards must approve price hikes and more. 

https://www.fiercepharma.com/pharma/pfizer-johnson-johnson-balk-at-shareholder-requests-for-vaccine-pricing-info

Could combining Pfizer's, AZ's COVID vaccines fill supply gaps? UK researchers aim to find out

 Given that the COVID-19 vaccines from Pfizer and AstraZeneca each require one dose, followed a few weeks later by a booster shot, could the two products be used interchangeably?

That’s the question researchers from the Oxford Vaccine Group have set out to answer with a new clinical trial designed to address a mounting problem: The demand for COVID vaccination in many locales around the world is far outstripping the supply.

Oxford’s 13-month study will recruit more than 800 volunteers in England, who will receive one of four different combinations of the vaccines. Half the participants will get two doses of the same vaccine, while the others will receive one dose of either the Pfizer or AstraZeneca vaccine, followed by a booster of the other company’s product.

The researchers will use blood samples taken at various intervals to monitor patients’ immune responses, while also recording any adverse reactions that occur. They believe the data they collect will help policymakers decide whether they can adopt mix-and-match strategies to address supply shortfalls and other logistical challenges, as well as the changing nature of the COVID-19 virus.

“If we do show that these vaccines can be used interchangeably in the same schedule this will greatly increase the flexibility of vaccine delivery, and could provide clues as to how to increase the breadth of protection against new virus strains,” said chief investigator Matthew Snape, associate professor at the University of Oxford, in a statement. AstraZeneca is partnered with Oxford in developing its shot.

“There are no data available on the interchangeability of Pfizer-BioNTech’s vaccine (BNT162b2) with other COVID-19 vaccines to complete the vaccination course,” a Pfizer spokesperson said in an emailed statement, adding that anyone who already received one dose of its vaccine should get the same shot as a booster.

AstraZeneca did not immediately respond to a request for comment from Fierce Pharma.

The Oxford trial is launching just days after AstraZeneca proposed a solution of its own to address the vaccine supply constraints. Last week, CEO Pascal Soriot told reporters that the European authorization of his company’s vaccine specifies that the booster shot can be given as long as 12 weeks after the initial dose.

In fact, data released earlier this week showed that when people received the second shot of AstraZeneca’s vaccine 12 weeks after the first, the efficacy rate was 82.4%, versus 54.9% in those who got the booster within six weeks.

Soriot suggested the data supported a strategy of using all available doses of AstraZeneca’s vaccine and not stockpiling any booster shots because the company should be able to fill any supply gaps within 12 weeks.

Pfizer and BioNTech, meanwhile, have brought in some support to ramp up the production of its mRNA vaccine. Last month, Novartis agreed to produce the Pfizer/BioNTech COVID shot at one of its Swiss manufacturing facilities starting in the second quarter. Deliveries of the vaccines produced there should start in the third quarter, Novartis said. That deal followed a similar agreement with French drugmaker Sanofi, which also has separate development deals with GlaxoSmithKline and Translate Bio.

Pfizer’s vaccine uses mRNA technology, while AstraZeneca’s is a modified viral vector, so the Oxford team hopes the new trial will also provide some clues as to how a combination of the two technologies might work against fast-spreading mutant strains of COVID-19.

Many COVID vaccine makers have launched their own investigations to try to determine just how effective their shots are against the new variants. Pfizer scientists, working with a team at the University of Texas, released a study showing the company’s vaccine could neutralize an engineered version of the mutant virus spreading through the U.K. and South Africa

But not everyone is convinced the data are conclusive. Evercore ISI told its clients last week that Pfizer’s analysis failed to include some of the mutations found in the South Africa coronavirus variant, making it a less-than-comprehensive study. SVB Leerink analysts griped that vaccine makers are testing their products against the new variants with assays that have not been adequately validated.

AstraZeneca isn’t taking any chances with the newly emerging COVID-19 strains. It is now working with Oxford to develop a next-generation version of its vaccine that’s designed to neutralize new variants and that could be available next fall, an executive said during a press briefing, according to Reuters.

https://www.fiercepharma.com/pharma/could-combining-pfizer-s-and-az-s-covid-19-vaccines-fill-supply-gaps-uk-researchers-set-out

Roche hit by $5.6B worst-case biosim assault as COVID-19 hurts new hit Ocrevus

 Before biosimilars to Herceptin, Avastin and Rituxan arrived in the U.S., Roche laid out an estimated range of potential damage to its business. By the look of its first post-biosim year, the company was hit with its worst-case scenario.

Biosimilars to the three cancer megablockbusters in the U.S., EU and Japan put a CHF 5.05 billion ($5.62 billion) dent in Roche’s top line in 2020, the company said Thursday. The worldwide loss was about CHF 5.7 billion.

“We’ve seen the worst that it can get—the impact was bigger than certainly our base case,” Roche’s pharma chief Bill Anderson said during a conference call with investors.

The U.S. market contributed a large share of the decline, especially given that Herceptin and Rituxan copycats had already been on the European market for some time. In the U.S., Avastin sales dropped 37% in 2020 to CHF 1.80 billion, Rituxan fell by 32% to CHF 2.86 billion, and Herceptin by 47% to CHF 1.36 billion.

The drop was also bigger than industry watchers had expected; none of the three drugs’ global sales met analysts’ consensus.

For 2021, the absolute reduction will be milder at roughly CHF 4.6 billion ($5.1 billion) globally, Anderson added. That may sound like a positive turn, but it’s much larger than the CHF 3.57 billion analysts at Jefferies had modeled, which they noted was already above consensus expectations.

It also looks more severe if we put this into the perspective of Roche’s historical forecast. By what Roche called a “conservative” erosion from biosims, the company had in 2019 projected a CHF 9.6 billion gap between 2018 and 2023 sales for the three drugs. Anderson’s numbers now indicate that the drugs will have crossed that threshold by 2021.

Roche has traditionally pointed to new drugs to back up its confidence that the company will grow through the biosimilar attack. But COVID-19 derailed that plan, at least for the pharma business, in 2020.

Multiple sclerosis drug Ocrevus dethroned Avastin as Roche’s best-selling drug beginning in the third quarter of 2020. But its 17% year-over-year annual growth was significantly slowed by COVID-19, which dragged its CHF 4.48 billion ($4.98 billion) haul below the Street’s consensus. The reported growth level was partially hurt by a strong Swiss franc; at constant currencies, Ocrevus’ increase amounted to 24%.

Ocrevus was attracting high levels of patients switching from another MS drug up to the first quarter of 2020. Then came the pandemic, and switching slowed dramatically, Anderson said. Because Ocrevus targets B cells and is injected by a healthcare professional, some existing patients became nervous about whether to get a dose out of concerns that the therapy might hurt their immune system’s strength against the novel coronavirus—or that going into a therapy center could increase their chance of infection.

In the third quarter, some of the patients who delayed their doses came back, Anderson said. But because Ocrevus is dosed every six months, the Q2 drop also extended to Q4. The rate of switching is still significantly below pre-pandemic levels—at 40% in October by Roche’s market research. So this cycle of quarterly sales fluctuations will probably continue for years to come, Anderson warned.

Whatever increases Ocrevus and other newer drugs such as Tecentriq and Hemlibra pulled off, they were not enough to turn Roche pharma’s 2020 into a sales-positive year. Overall, Roche’s pharma sales came in at CHF 44.53 billion ($49.53 billion) down by 8% year over year, or 2% at unchanged exchange rates.

https://www.fiercepharma.com/pharma/roche-hit-by-worst-case-scenario-biosim-assault-as-covid-19-hurts-new-king-ocrevus

WHO inspector 'has conflict of interest in Wuhan COVID probe'

 A prominent molecular biologist at Rutgers University claims that a member of the World Health Organization (WHO) team investigating the origins of COVID-19 in Wuhan has a conflict of interest, due to his ties with the Wuhan lab at the center of the inquest.

British zoologist and the president of EcoHealth Alliance Peter Daszak is the only individual to be part of both the WHO and The Lancet teams investigating the origins of the Wuhan coronavirus pandemic. However, he has long-term professional and financial ties with the Wuhan Institute of Virology (WIV), which represents a conflict of interest.

Richard H. Ebright is the Board of Governors Professor of Chemistry and Chemical Biology at Rutgers University, and Laboratory Director at the Waksman Institute of Microbiology. He told Taiwan News that Daszak is the contractor who funded the WIV's research on bat SARS-related coronaviruses, with subcontracts of $200 million in USAID funding and $7 million in NIH funding.

Ebright said that Daszak is a collaborator on the WIV research for bat SARS-related coronaviruses. He lamented that the WHO named Daszak as a member of its review team, and The Lancet named Daszak as the head of its review team. Ebright said this makes "it clear that WHO and Lancet reviews cannot be considered credible investigations."

In addition to the funding EcoHealth Alliance receives from USAID, NIH, and other agencies, which it funnels into the WIV, Ebright stated the firm received US$30 million from the US Department of Defense.

When asked whether Daszak had been involved in the controversial gain of function experiments on bat coronaviruses at the WIV, Ebright said: "Daszak has been a contractor, a collaborator, and a co-author on work at the WIV on construction and analysis of novel chimeric coronaviruses."

A report by Independent Science News and a search of U.S. government databases revealed that EcoHealth Alliance received US$39 million in funding from the Pentagon from 2013 to 2020. Adding another US$64.7 million from USAID, the report found that Daszak's "non-profit organization" has raked in over US$103 million from the U.S. government.

Since 2014, Daszak's organization has funneled some of this U.S. government funding into the WIV to carry out research on bat coronaviruses. In the first phase of research, which took place from 2014 to 2019, Daszak coordinated with Shi Zhengli (石正麗) — also known as "Bat Woman" — at the WIV to investigate and catalog bat coronaviruses across China. EcoHealth Alliance received US$3.7 million in funding from the NIH for this research, and 10 percent was channeled to the WIV, reported NPR.

Shi Zhengli (center) and Peter Daszak (far right). (Emerging Viruses Group photo)

The second phase, which started in 2019, involved gain-of-function (GoF) research on coronaviruses and chimeras in humanized mice from the lab of Ralph S. Baric of the University of North Carolina. In a video interview originally recorded on Dec. 9, 2019, Daszak mentioned the testing of modified coronaviruses on human cells and humanized mice in the WIV, just weeks before the first cases of COVID-19 were announced in the city of Wuhan, China.

Daszak has dismissed the possibility of a lab leak, insisting since the start of the pandemic it's a "conspiracy theory" — without providing evidence for his claim. A report by U.S. Right to Know alleges that emails released through freedom of information requests reveal that Daszak persuaded 26 prominent scientists to sign a statement published in The Lancet on Feb. 19 2020, claiming that any suggestions that COVID-19 was not of natural origin are "conspiracy theories."

Four signatories of The Lancet statement are employed by EcoHealth Alliance. Six scientists who signed the statement, including Daszak, now comprise half of The Lancet's panel investigating the origins of the virus.

Furthermore, Daszak in 2015 co-authored an article in the journal Nature titled, "Spillover and pandemic properties of zoonotic viruses with high host plasticity," in which he stated that zoonotic virus spillover from wildlife was "most frequent" in a number of settings and occupations, including "laboratory workers." He also warned that laboratories are one of the most dangerous settings for major spillover events.

"Among all high risk interfaces and hosts, only viruses transmitted to humans by contact with wild animals in the wildlife trade and in laboratories ... were more likely to have broader geographic reach," Daszak said.

Daszak's colleague, Shi Zhengli, in 2010 published a paper describing a scenario in which infected rodents led to a deadly virus being leaked from a Chinese lab. The paper, titled, "Hantavirus outbreak associated with laboratory rats in Yunnan, China," detailed an outbreak of hantavirus hemorrhagic fever with renal syndrome (HFRS) at a college in Kunming as the result of a lab leak in 2003.

Since the start of the pandemic, both Daszak and Shi have denied that a lab leak occurred at the WIV. However, over a year since the outbreak, Shi has yet to provide independent investigators with access to the WIV's database and laboratory records.

Daszak has yet to respond to a request to comment on allegations that he has a conflict of interest in the WHO and The Lancet investigations. The WIV has also yet to reply to questions about their experiments in 2019.

https://www.taiwannews.com.tw/en/news/4119101