Amazon Expands Push Into Health Care With Online Pharmacy

Amazon Expands Push Into Health Care With Online Pharmacy - BloombergSource: Bloomberg, by Angelica LaVito and Matt Day Inc. unveiled its biggest push into selling prescription drugs with the launch of a digital pharmacy and discounts for paying U.S. Prime members that sent shock waves through shares of drugstore chains and distributors.

The e-commerce giant on Tuesday unveiled Amazon Pharmacy, a section of its retail website and mobile application that lets people order medication. Shoppers can pay using their health insurance. Prime members who don’t use their insurance are eligible for discounts on generic and brand-name drugs on Amazon’s site or at about 50,000 participating pharmacies.

Amazon’s new offering comes more than two years after its $753 million acquisition of PillPack, an online pharmacy known for organizing prescriptions into packets. This expansion puts the Seattle-based e-commerce company into more direct competition with pharmacy giants CVS Health Corp. and Walgreens Boots Alliance Inc., the two largest chains in the U.S.

CVS shares fell as much as 8.5% in early trading in New York, while Walgreens Boots dropped as much as 10.3%. GoodRx Holdings, a digital prescription-drug platform, fell 15% at 9:55 a.m. Drug distributor Cardinal Health Inc. lost as much as 9%, and rival McKesson Corp. slid as much as 6.8%.

The move also helps Amazon compete with Walmart Inc. and other big-box stores that already sell prescription drugs.

Analysts have long expected Amazon to dive deeper into health care in a bet the company can bring its digital real estate and logistical prowess to bear on a roughly $4 trillion industry in the U.S. with a reputation for inefficiency. The company rattled drug retailers with its PillPack acquisition, but Amazon has been slow to integrate the online pharmacy startup into its offerings.

The announcement Tuesday marks the first time that shoppers can order prescription drugs directly on Amazon. Previously, they were redirected to PillPack’s website. An integrated pharmacy removes one of the few gaps in Amazon’s offerings compared with major big box and grocery rivals, some of whom have long filled shoppers’ prescriptions in the same stores where they sold flat-screen televisions or cans of soup.

The discounts are a clear play for people who pay for their medications with cash, whether they are uninsured or are looking to save money. Strong demand for transparency and better deals have helped fuel the rise of discount card programs like GoodRx Holdings Inc. Amazon will display both the price when using insurance and the price without. Infusing transparency into a system that has been frustratingly opaque for consumers could alter the supply chain.

“We designed Amazon Pharmacy to put customers first – bringing Amazon’s customer obsession to an industry that can be inconvenient and confusing,” said TJ Parker, vice president of Amazon Pharmacy and co-founder of PillPack.

Amazon’s push comes as consumers are shunning stores and ordering more items online, a trend the coronavirus pandemic has accelerated. With consumer behavior shifting, chain drugstores have already started rethinking their strategies. CVS acquired health insurer Aetna for $68 billion in 2018 and is adding more health services to its stores. Walgreens is dabbling with numerous partnerships to add items like groceries and mobile phones to its stores.

Amazon could find it difficult to quickly pry away customers from pharmacy chains. For many consumers, asking doctors to steer recurring prescriptions elsewhere is cumbersome, especially for those who rely on insurance to pay for their medication.

In some cases, such a switch might also require an office visit — at a time when Americans have been steering clear of the doctor’s office out of concerns about the pandemic. And the ubiquity of the biggest pharmacy chains means most consumers have one nearby, and shopping at them is an ingrained habit.

Amazon’s entry into a market doesn’t guarantee its dominance. Drugstores have long insisted that patients prefer to talk to their pharmacist at the counter, an experience Amazon will try to recreate digitally.

Amazon Chief Executive Officer Jeff Bezos has positioned Prime, Amazon’s paid membership program, at the center of the company’s efforts to create loyal customers. What was originally an unlimited shipping program has grown in recent years to include video streaming, games and digital storage, and discounts at Amazon-owned Whole Foods Market.

Who Will Be The First To Get COVID-19 Vaccines?

Source: Associated Press

Who will be the first to get COVID-19 vaccines?

No decision has been made, but the consensus among many experts in the U.S. and globally is that health care workers should be first, said Sema Sgaier of the Surgo Foundation, a nonprofit group working on vaccine allocation issues.

An expert panel advising the U.S. Centers for Disease Control and Prevention is also considering giving high priority to workers in essential industries, people with certain medical conditions and people age 65 and older.

Once a vaccine gets a green light from the Food and Drug Administration, the panel will look at clinical trial data on side effects and how people of various ages, ethnicities and health statuses responded. That will determine the panel’s recommendations to the CDC on how to prioritize shots.

State officials are expected to follow the CDC’s guidance as they distribute the first vaccines.

Vaccine supplies will be limited at first. There won’t be enough to protect everyone, yet getting the shots to the right people could change the course of the pandemic.

Many other questions about distribution remain unanswered, Sgaier noted, such as whether to distribute shots equally across the country, or to focus on areas that are hot spots.

Pfizer To Start Pilot Delivery Program For Its COVID-19 Vaccine In Four U.S. States


Source: Reuters, by Staff

Pfizer Inc PFE.N has launched a pilot delivery program for its experimental COVID-19 vaccine in four U.S. states, as the U.S. drugmaker seeks to address distribution challenges facing its ultra-cold storage requirements.

Pfizer’s vaccine, which was shown to be more than 90% effective in preventing COVID-19 based on initial data, must be shipped and stored at -70 degrees Celsius (minus 94°F), significantly below the standard for vaccines of 2-8 degrees Celsius (36-46°F).

“We are hopeful that results from this vaccine delivery pilot will serve as the model for other U.S. states and international governments, as they prepare to implement effective COVID-19 vaccine programs,” Pfizer said in a statement on Monday.

It picked Rhode Island, Texas, New Mexico, and Tennessee for the program after taking into account their differences in overall size, diversity of populations, immunization infrastructure, and need to reach individuals in varied urban and rural settings.

The four states will not receive vaccine doses earlier than other states by virtue of the pilot, nor will they receive any differential consideration, Pfizer said.

The company expects to have enough safety data on the vaccine from the ongoing large scale late-stage trials by the third week of November before proceeding to apply for emergency use authorization (EUA).

Pfizer and its partner BioNTech SE 22UAy.F have a $1.95 billion deal to supply 100 million doses of the vaccine to the U.S. government, which has an option to acquire up to an additional 500 million doses.

Earlier on Monday, rival Moderna Inc MRNA.O said its experimental vaccine was 94.5% effective in preventing COVID-19 based on interim data from a late-stage trial, boosting hopes that vaccines against the disease may be ready for use soon.

Both the Pfizer and Moderna vaccines use a new technology called synthetic messenger RNA to activate the immune system against the virus.

20 Million Americans Could Receive COVID-19 Vaccine In December

U.S. President Donald Trump walks up to speak in the Rose Garden.

Source: Politico, by Sarah Owermohle

Roughly 20 million people could be vaccinated against the coronavirus in December, the head of the Trump administration’s vaccine and drug accelerator said Friday.

Americans can expect that about 25 to 30 million people could be vaccinated each month afterward, said Moncef Slaoui, co-lead of Operation Warp Speed, during a Rose Garden event with President Donald Trump and other top health officials.
That timeline depends on the Food and Drug Administration authorizing the emergency use of one or more vaccines — which could happen in a matter of weeks, Slaoui noted.

Pfizer announced promising data this week suggesting its vaccine is more than 90 percent effective, and has said it will apply to FDA later this month. Moderna, which is working closely with the National Institutes of Health, is preparing to announce its own efficacy data in a matter of days. An emergency-use application could soon follow, Slaoui said.

Gen. Gustave Perna, Operation Warp Speed’s chief operating officer, said that the government would begin vaccination within 24 hours after a shot secures emergency authorization.

But while manufacturers have developed coronavirus vaccines in record speed, and dozens more are still in the pipeline, Slaoui’s projections mean it will likely take months just for first-priority groups such as health care workers and the elderly to get a shot.

Both the Pfizer and Moderna vaccines are given as two doses, effectively cutting in half the government’s initial order of 100 million doses from each of the those manufacturers.

But Slaoui added that there could be more authorized vaccines in the spring, boosting chances for more people to get vaccinated. Four vaccines, including the Pfizer and Moderna shots, are now in late-stage U.S. trials, and at least one other company plans to start such a study this month.

“We may be able to immunize a larger number of Americans on an ongoing basis, per month,” Slaoui said after name-checking other promising candidates from AstraZeneca and Johnson & Johnson.
The government has not yet released a comprehensive plan to distribute any coronavirus vaccines, including how it will handle logistics for shots that need to be shipped in below-freezing temperatures and outreach to skeptical communities.

Because of the real-world challenges of vaccine distribution and supply, federal health officials including CDC Director Robert Redfield project that broad access will not be a possibility until summer 2021.

Moderna’s Coronavirus Vaccine Is 94.5% Effective, According To Company Data

Don't expect a coronavirus vaccine before December, experts caution

Source: CNN Health, by Elizabeth Cohen

The Moderna vaccine is 94.5% effective against coronavirus, according to early data released Monday by the company, making it the second vaccine in the United States to have a stunningly high success rate.

“These are obviously very exciting results,” said Dr. Anthony Fauci, the nation’s top infectious disease doctor. “It’s just as good as it gets — 94.5% is truly outstanding.”

Moderna heard its results on a call Sunday afternoon with members of the Data Safety and Monitoring Board, an independent panel analyzing Moderna’s clinical trial data.

“It was one of the greatest moments in my life and my career. It is absolutely amazing to be able to develop this vaccine and see the ability to prevent symptomatic disease with such high efficacy,” said Dr. Tal Zacks, Moderna’s chief medical officer.

Vaccinations could begin in the second half of December, Fauci said. Vaccinations are expected to begin with high-risk groups and to be available for the rest of the population next spring.

Unexpectedly high efficacy rates

Last week, Pfizer announced that early data show its vaccine is more than 90% effective against the disease.

In Moderna’s trial, 15,000 study participants were given a placebo, which is a shot of saline that has no effect. Over several months, 90 of them developed Covid-19, with 11 developing severe forms of the disease.

Another 15,000 participants were given the vaccine, and only five of them developed Covid-19. None of the five became severely ill.

The company says its vaccine did not have any serious side effects. A small percentage of those who received it experienced symptoms such as body aches and headaches.

Moderna plans to apply to the US Food and Drug Administration for authorization of its vaccine soon after it accumulates more safety data later this month.

Fauci says he expects the first Covid-19 vaccinations to begin “towards the latter part of December, rather than the early part of December.”

Initially, there won’t be enough vaccine for everyone. The highest priority groups, which include health care workers, the elderly, and people with underlying medical conditions, will get the vaccine first.

“I think that everybody else will start to get vaccinated towards the end of April,” Fauci said. “And that will go into May, June, July. It will take a couple of months to do.”

A new vaccine technology

Pfizer’s and Moderna’s vaccines have similar results because they use the same technique to activate the body’s immune system.

The vaccines deliver messenger RNA, or mRNA, which is a genetic recipe for making the spikes that sit atop the coronavirus. Once injected, the body’s immune system makes antibodies to the spikes. If a vaccinated person is later exposed to the coronavirus, those antibodies should stand at the ready to attack the virus.

No vaccine currently on the market uses mRNA.

“There has always been skepticism about mRNA — it’s brand new and would it work?” Fauci said. “What we saw in the trials is there was no real safety concern, and the efficacy is quite impressive. We saw nearly identical results [with Pfizer and Moderna] and it almost really validates the mRNA platform.”

Research on mRNA began many years before the current pandemic. Fauci’s agency, the National Institute of Allergy and Infectious Diseases, has collaborated with Moderna on the development of its vaccine.

Both vaccines are given in two doses several weeks apart.

Practical advantages of Moderna’s vaccine

While the two vaccines appear to have very similar safety and efficacy profiles, Moderna’s vaccine has a significant practical advantage over Pfizer’s.

Pfizer’s vaccine has to be kept at minus 75 degrees Celsius. No other vaccine in the US needs to be kept that cold, and doctors’ offices and pharmacies do not have freezers that go that low.

Moderna’s vaccine can be kept at minus 20 degrees Celsius. Other vaccines, such as the one against chickenpox, need to be kept at that temperature.

That means Moderna’s vaccine can be kept in “a readily available freezer that is available in most doctors’ offices and pharmacies,” Zacks said. “We leverage infrastructure that already exists for other marketed vaccines.”

Another advantage of Moderna’s vaccine is that it can be kept for 30 days in the refrigerator, the company announced Monday. Pfizer’s vaccine can last only five days in the refrigerator.

Pfizer’s Coronavirus Vaccine Is More Than 90 Percent Effective In First Analysis, Company Reports

Source: The Washington Post, by Carolyn Y. Johnson

A front-runner coronavirus vaccine developed by drug giant Pfizer and German biotechnology firm BioNTech was more than 90 percent effective at protecting people compared with a placebo saline shot, according to an interim analysis by an independent data monitoring committee that met Sunday.

The analysis of the ongoing trial provides a decisive initial glimpse of the real-world performance of one of the four coronavirus vaccines in the last stages of testing in the United States. It is the strongest signal yet that the unprecedented quest to develop a vaccine that could help bring the pandemic to an end might succeed, breaking every scientific speed record.

“I would say it’s a historical moment. Something like this has never happened before. First of all, the world was faced with such a terrible situation, the pandemic, and being able in such a short time to go through what usually takes many years,” Kathrin Jansen, head of vaccine research and development at Pfizer, said in an interview. “Hearing that at the interim analysis we are over 90 percent effective — it was almost stunning to hear.”

In Pfizer’s 44,000-person trial, there have so far been 94 cases of covid-19, the disease caused by the virus, in people who were not previously infected. Fewer than nine of those cases were among people who received two shots of the vaccine, a strong indication of efficacy. The study defined a case as someone with a positive test result and at least one symptom.

The company’s shares closed up nearly 8 percent. The data is not yet published or peer-reviewed.

The data committee noted no serious safety concerns. Jansen said the side-effect profile of the vaccine was similar to what was reported in an earlier study. That included pain at the injection site and fatigue, chills and fever — which occurred more frequently in younger trial participants than in adults over age 65.

“The results are really quite good, I mean extraordinary,” said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, adding that they might bode well for a vaccine being developed by biotech firm Moderna and his institute that uses a similar technology, “which gives you hope we might even have two vaccines.”

Fauci said he had spoken with Pfizer chief executive Albert Bourla about the results, but had not yet reviewed the individual data.

The rapid surge of coronavirus infections in the cooler months, while devastating for the country, means the trial is rushing toward completion faster than company executives anticipated. With more people being exposed to the virus amid the surge, testing the vaccine becomes easier — and faster.

The race for a vaccine had become inextricably tied to election-year politics, and for months, outside experts had worried that Pfizer’s vaccine might be an “October surprise” pushed prematurely through the regulatory process. In the end, the data arrived nearly a week after the election, and shortly after the race was called for President-elect Joe Biden.

President Trump called Bourla to ask about the vaccine over the summer, and previously accused regulators of a “political hit job” for slowing down a vaccine. He celebrated the news Monday morning on Twitter: “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!”

The post-election announcement was questioned by Donald Trump Jr., who suggested on Twitter that the timing was “nefarious.” But the meeting of Pfizer’s independent data committee, which reviewed the results, did not happen until Sunday afternoon, days after regulators approved a modification to its trial protocol to ensure the first look at data would have more cases than originally planned.

“For us, the Election Day was always an artificial day. We were not working with the election as a timeline,” Bourla said on CNBC. “The only pressure we feel is the pressure of the billions of people hoping on our vaccine. And we are going to follow the speed of science, so science spoke.”

Pfizer and BioNTech said they plan to submit an application for emergency authorization from the Food and Drug Administration after the third week of November, when they will have two months of safety follow-up data on half of the participants in their trial, along with data on their manufacturing process. The agency will hold an external advisory committee meeting, and review of the data could take a few weeks. The first doses of vaccine might be available in December.

The vaccine requires two doses, given three weeks apart. Pfizer and BioNTech are working around-the-clock to scale up production, in hopes of having 50 million doses — enough for 25 million people to receive both shots — by the end of the year, and 1.3 billion doses in 2021.

The vaccine will initially be available only to selected groups, likely to include health-care workers and other people at high risk of severe disease. After regulators authorize a vaccine, a Centers for Disease Control and Prevention advisory committee will make formal recommendations for who should receive it first. The trial will continue until it reaches its endpoint of 164 cases of covid-19.

Vaccine development typically takes many years, even decades. But the coronavirus vaccines have been a rare success story in the response to the virus, able to move forward because of a flourishing of new vaccine technologies, a backbone of prior work on emerging pathogens and a mentality that rarely exists in the world of vaccine development — of governments and companies willing to devote nearly unlimited resources to make sure that a vaccine succeeds.

Outside experts said crucial details of the data need to be examined: How did the vaccine perform in high-risk populations, such as elderly people? Were the cases of disease mostly mild, or did the vaccine also prevent severe disease? Will the effectiveness hold up as the trial moves toward completion? How long will protection last? What do detailed safety data show? Does the vaccine reduce the contagiousness of people without symptoms?

Paul A. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said the data look “encouraging.” The trial’s faster-than-expected progress to 94 cases, he said, was “the upside of having a virus that’s out of control.”

David Benkeser, a biostatistician at Emory University Rollins School of Public Health, said in an email that he was still digesting the news.

“It looks to be an incredibly promising result,” Benkeser wrote, noting that the two biggest questions are how long the effect lasts and how well the vaccine works to prevent severe cases of covid-19. “Both will still require more data to get a definitive answer, but for now, I think this is really good news.”

Natalie E. Dean, a biostatistics expert at the University of Florida, said that 90 percent efficacy was better than most had dared to expect from the first vaccine. And the decision to wait to examine the data until there were more cases of covid-19 in the trial “increases confidence and excitement” in the early result, even though she questioned the use of a news release to provide data.

Dean cautioned that despite the excitement, difficult tasks lie ahead: It will be essential to prioritize the limited doses to those at highest risk and to acknowledge that the extensive ultra- cold storage requirements of the vaccine, which must be chilled to minus-70 degrees Celsius, will limit the immediate impact.

If a vaccine goes into broader use, it will open debates about how to conduct trials of future coronavirus vaccines, raising questions about whether it is ethical to give a placebo to volunteers when a highly effective vaccine exists. Dean said she had recently attended a five-hour World Health Organization meeting that grappled with that issue.

“Whatever happens with this one product, it is not going to immediately have 8 billion doses,” Dean said. “I’m sensitive to the potential success of one product interfering with others. We’re going to need all of these, we’re going to need multiple products to meet global need.”

The final effectiveness of the Pfizer vaccine may waver as the trial continues, but it appears to be far above the minimum threshold set by regulators, requiring it be at least 50 percent effective. The FDA has also set forth a requirement for five severe cases of the disease in the placebo group, but Jansen said that to preserve the integrity of the trial, Pfizer’s scientists remain blind to the details of the cases at this time.

The vaccine uses a new technology never before deployed in an approved medical product. Each injection contains lipid nanoparticles — fat bubbles — that surround a strip of genetic material called messenger RNA. The genetic material carries the blueprint for the distinctive spiky protein that studs the coronavirus surface. After being injected into a person’s arm, the fat capsule delivers its payload to the body’s cells, and the messenger RNA instructs those cells to build the spike protein, effectively teaching the immune system how to recognize and block the coronavirus.

Pfizer’s early signal is encouraging not just for messenger RNA, Fauci said, but as a proof of concept that vaccine candidates that present the spike protein — the approach being pursued by essentially all the major candidates — can succeed.

Pfizer, unlike its competitors, did not join Operation Warp Speed, the government initiative designed to erase the financial risk of vaccine and therapeutics development by providing upfront funding to companies and helping coordinate the trials. Instead, Pfizer plowed $2 billion of its own money into the project and then struck a $1.95 billion contract with the U.S. government to provide 100 million doses, contingent on the vaccine being effective.

Its trial initially had a more aggressive design than other late-stage studies in the United States, allowing earlier and more frequent peeks at the data. That raised concern from outside scientists that the company might seek authorization of its vaccine when there were only 32 cases among participants.

The FDA shared those concerns, according to Jansen, and urged the company to wait to do its first data look until there were more cases. Pfizer scientists were initially concerned it would take too long to reach that milestone, particularly as it appeared the pandemic might be coming under control in late summer, thus depriving the study of potentially infected participants. But Pfizer scientists amended their protocol to wait to look at the data until they reached 62 cases as the virus began to surge, and they completed that paperwork last week.

“We saw that huge upswing, we realized that maybe we should listen and come back to the suggestion of the FDA to have more cases,” Jansen said. “It just shows you the enormous uptick right now of the pandemic, that certainly it took us by surprise — how quickly it really went.”

Once the independent data committee met Sunday, there were 94 cases in the trial — meaning the study is more than halfway done. Bourla said on CNBC that he believes the trial could reach its final endpoint before the end of the month.

Verily’s COVID Testing Program Halted in San Francisco and Oakland

Is The Bay Area's 'Unprecedented' Lockdown The First Of Many? | Kaiser  Health News

Source: Kaiser Health News, by Jenny Gold and Rachana Pradhan

Amid fanfare in March, California officials celebrated the launch of a multimillion-dollar contract with Verily — Google’s health-focused sister company — that they said would vastly expand COVID testing among the state’s impoverished and underserved communities.

But seven months later, San Francisco and Alameda counties — two of the state’s most populous — have severed ties with the company’s testing sites amid concerns about patients’ data privacy and complaints that funding intended to boost testing in low-income Black and Latino neighborhoods instead was benefiting higher-income residents in other communities.

San Francisco and Alameda are among at least 28 counties, including Los Angeles, where California has paid Verily to boost testing capacity through contracts collectively worth $55 million, according to a spokesperson for the California Governor’s Office of Emergency Services. About half of them have received COVID tests through six mobile units that travel among rural areas.

Gov. Gavin Newsom has heralded the investment as a game changer in addressing persistent inequities in access to COVID testing across the state that tend to fall along lines of ethnicity and income. The goal, he said in April, touting six new Verily testing sites, was to “make sure we’re truly testing California broadly defined, not just parts of California and those that somehow have the privilege of getting ahead of the line.”

Yet the roadblocks for getting underrepresented populations to use the program soon became apparent to Alameda County officials. In a June letter to California Secretary of Health Mark Ghaly, Oakland Mayor Libby Schaaf and other members of the county’s COVID-19 Racial Disparities Task Force raised numerous concerns about the Verily protocols.

Among their complaints: People signing up for a test through Verily had to do so online, using an existing or newly created Gmail account; the sign-ups were offered only in English or Spanish; and participants were asked to provide sensitive personal information, including their home address and whether they were managing chronic health conditions such as diabetes, obesity or congestive heart failure, which could expose their data to third-party use.

“It is critical in this crisis that we continue to build trust between government and healthcare providers and vulnerable communities,” the task force members wrote.

Verily had two sites in Alameda County, and one was shuttered by May. The second, located at an Oakland church, closed in August and is set to reopen using a different testing vendor. Alameda County testing director Dr. Jocelyn Freeman Garrick said that while the Verily sites helped the county reach testing goals in terms of raw numbers, they were phased out because of long wait times of a week or more for results, and because the tests were not reaching the residents in greatest need.

Verily does not manufacture the COVID tests used at its California sites. It contracts with major corporations such as Quest Diagnostics and Thermo Fisher Scientific to provide the test kits and perform the lab work. What Verily provides is a digital platform where people are screened for symptoms, schedule testing appointments at participating sites and check back for test results.

Dr. Noha Aboelata is CEO of Roots Community Health Center, an East Oakland clinic that serves mostly African Americans and is one of the original Verily sites in Oakland. Her experience with Verily is best described as a tale of two lines.

In May, Aboelata worked with Verily to establish a walk-up site at her clinic, rather than the drive-thru model the company typically uses. There would be two lines: one for people who scheduled their appointments through Verily’s online portal; and a second for people who had not preregistered with Verily. Roots would staff both lines, and Verily would supply test kits and personal protective equipment including masks, which were “like gold” at the time, Aboelata said.

Problems emerged almost immediately, she said. People were suspicious of the requirement that they sign up with a Gmail account, and the request for personal information, such as health status and risk factors. “You don’t necessarily want to share that with Google,” Aboelata said.

Then there was the language in the privacy policy that allows for sharing data with third parties. “That always is going to raise suspicion and concern in our community,” she said.

The people who ended up in the Verily-registered line, she said, tended to be white and to come from wealthier ZIP codes outside East Oakland. And because Verily never changed the website language describing Roots as a drive-thru site, many were angry at having to walk up.

“We had people coming from all over the Bay Area who were frustrated that they had to park in Oakland, where they had probably never been and didn’t seem to want to be,” she said. “They were creating quite a scene, and some were saying, ‘I want to talk to the manager.’” She had to ask a few people to leave. “One of them was saying, ‘This is so Oakland, and I hope you all get the virus.’ It was pretty awful.”

The Roots line for clients who did not register through Verily, on the other hand, was made up mostly of people of color from the community who long had come to the clinic for medical care, she said.

When Aboelata looked at the data, the disparities were obvious: 12.9% of people tested in the non-Verily line were positive for COVID-19, while just 1.5% of people tested in the Verily-registered line were positive. For Aboelata, it was clear that the two lines were testing two entirely different populations.

After just six days of testing, Aboelata asked Verily to leave.

“From where we sit, this is an old story,” she said. “Corporations that are not really invested in the community come helicoptering in, bearing gifts, but what they’re taking away is much more valuable.” That thing of value, Aboelata believes, is the data Verily requests from everyone who signs up for a test.

In San Francisco, Verily mobile testing clinics have also been sidelined. County officials declined to provide an explanation. However, multiple people with knowledge of the testing efforts said the Verily registration process proved chaotic for homeless people and others in the Tenderloin district, one of the city’s poorest neighborhoods.

Kenneth Kim, clinical director of Glide, an outreach center that helped run the Tenderloin site, said many homeless residents coming in for testing had Gmail accounts, as Verily required, but could not remember their passwords. When staffers at the testing site tried to help them retrieve their passwords, they found that Google’s two-factor authentication process required users to have the same phone number as when they signed up, which few of the homeless participants did.

Dr. Jonathan Fuchs, who leads San Francisco County’s testing strategy at the Department of Public Health, confirmed that the partnership with Verily was “currently on hold.” He declined to provide further details.

In response to questions, Verily spokesperson Kathleen Parkes said the program requires users to register with Gmail accounts because Google’s authentication procedures safeguard sensitive data and protect “against unknown individuals sending or receiving information with serious consequences for health or well-being.” Conversations with San Francisco and Alameda remain “active,” Parkes said. The company did not respond to specific questions about the testing disparities cited by community leaders.

Verily’s role in COVID-19 testing has been shadowed by controversy since President Donald Trump told reporters at a Rose Garden news conference in March that “Google” was developing a screening website and testing tool. “Google has 1,700 engineers working on this right now,” he said. “They’ve made tremendous progress.”

At the time, COVID tests were in short supply and Trump was under pressure to increase capacity as infections ballooned in California, New York and other states. But Google was not building such a website. Instead, Verily, another Alphabet Inc. subsidiary focused on life sciences, was in the early stages of developing a website to help triage people in need of COVID testing, Google clarified in a tweet. It planned to unveil a pilot program in two Bay Area counties.

Days later, Newsom announced a California partnership with Verily that so far has paid the company $55 million to establish both mobile and brick-and-mortar testing sites. In addition, Verily has partnered with Rite Aid to manage testing at approximately 300 sites in multiple states under a $122.6 million federal contract between the pharmacy chain and the U.S. Department of Health and Human Services. California’s Verily contracts are in place through Nov. 30; the HHS contract is set to expire in January.

Participants in the Verily initiative sign an authorization form that says their information can be shared with multiple third parties involved in the testing program, including unnamed contractors and state and federal health authorities.

“While the form tells you that Verily may share data with ‘entities that assist with the testing program,’ it doesn’t say who those entities are. If one of those unnamed and unknown entities violates your privacy by misusing your data, you have no way to know and no way to hold them accountable,” said Lee Tien, senior staff attorney for the Electronic Frontier Foundation, a nonprofit that advocates for digital privacy.

The policy states Verily will not use the data collected for its own research or meld it with other Google products without the user’s permission. But it notes participants may be invited to share their data for such research, and the testing portal prominently features links inviting participants to sign up for other Verily research.

In California, as of Oct. 8, the Verily sites had processed an average of 1,583 patient samples per day over the prior seven days, according to the California Department of Public Health. Verily, the state health department and Alameda County all declined requests to provide race and ethnicity data by testing site.

Dr. Kim Rhoads, a UCSF professor and former colorectal surgeon who leads a COVID testing project for Black communities, said Aboelata’s experience with Verily is emblematic of widespread racial disparities in the testing and treatment of COVID-19. “We can’t keep talking about the consequences being unintended,” Rhoads said. “We are six months into this pandemic and anyone who is surprised by the repetitive findings of inequity in testing, the spread of virus and COVID-19 mortality just isn’t paying attention.”

In an interview, Ghaly, California’s health secretary, said he believed the state’s partnerships with Verily and other companies continue to be a national model for addressing problems with testing disparities, including setting up venues for minority and rural populations. For example, in counties in northern parts of the state, sometimes the only regular testing available was through mobile testing set up under the program, he said.

“I think there’s lots of success and lots of lessons learned and we continue to apply them,” Ghaly said. “Until the entire effort is completed, I always look at where we are as part success and part opportunity to keep learning.”

In a September response to the Oakland COVID-19 disparities task force, Ghaly outlined several actions the state had taken or would take in response to the concerns, including having Verily update its platform to include additional languages and work with testing vendors on alternative methods for data collection to address privacy concerns.

“Some of the things we learned specifically in our experience in Alameda and other parts of the Bay Area is language matters,” Ghaly told KHN.

After working with the homeless for 25 years, Dr. Margot Kushel, director of the UCSF Benioff Homelessness and Housing Initiative, said she wasn’t surprised to learn some community leaders ran into problems with Verily.

“It turns out that in public health, the highest-tech solution is usually not the right one,” she said. To bring COVID cases down, she explained, requires a “laser focus” on the highest-risk communities. And people in those communities often don’t want to turn over the protected information Verily asks for, whether because of fears about their immigration status or a history of mistrust of the medical establishment and policing.

“You can imagine a million and a half reasons why people would distrust it,” Kushel said. “The very structure of this is set up to fail. And by failing the communities who need it most, we fail everybody.”

PwC: Mental Health, Telehealth Sectors Spur Robust Deal Activity Despite COVID-19

PwC: Mental health, telehealth sectors spur robust deal activity despite  COVID-19 | FierceHealthcare

Source: Fierce Healthcare, by Robert King

Even though the COVID-19 pandemic continues to roil the healthcare landscape financially, mergers and acquisitions remain robust thanks to heavy interest in the mental health and telehealth sectors, one expert says.

Providers have faced major declines in patient volume since the onset of the pandemic. But experts at the firm PwC say financial constraints haven’t cooled deals in the healthcare space.

“This is an interesting recession with a tremendous amount of liquidity in markets,” said Manoj Mahenthiran, head of the private equity sector practice at PwC, in an interview with Fierce Healthcare. “What we are still seeing is that for the right assets, prices really haven’t gone down.”

A prior report from PwC released in July found that the number of deals among provider and payer industries declined in the first half of the year by 21% compared to the same period in 2019.

But there has been a major shift among certain sectors of the healthcare industry.

One of the hottest sectors is in behavioral health that has taken advantage of new flexibilities for telehealth.

“This whole pandemic has shone a spotlight on some of the mental health issues in the country that may have been taboo in the past,” Mahenthiran said.

Digital behavioral health startups raised $588 million in funding in the first half of this year, according to a report from venture capital fund Rock Health. That was on top of the record $5.4 billion in startup funding for digital health investments overall, the report found.

Investors are still very interested in the telehealth space even though there is uncertainty over what the regulatory outlook will be after the COVID-19 pandemic.

The Centers for Medicare & Medicaid Services gave more flexibility for providers to get Medicare reimbursement from telehealth, and providers embraced the technology to grant access for patients afraid of going to an office or hospital due to the pandemic.

But those flexibilities last through the COVID-19 public health emergency, which was recently extended.

“There is apprehension on what will this post-COVID environment look like and what will happen with reimbursements,” Mahenthiran said of investors in telehealth. “If things are delivered over this medium versus the office medium for sure that is definitely something that weighs on a lot of PE funds that are thinking about entering this space.”

But he countered that the popularity of telehealth will outweigh any changes in reimbursement rates.

“Their view so far is that the volume growth is going to far outweigh any such rate reductions,” Mahenthiran said. “It is definitely part of the calculus.”

FDA Approves First COVID-19 Drug: Antiviral Remdesivir

FDA approves first COVID-19 drug: antiviral remdesivirSource: Associated Press, by Marilynn Marchione

U.S. regulators on Thursday approved the first drug to treat COVID-19: remdesivir, an antiviral medicine given to hospitalized patients through an IV.

The drug, which California-based Gilead Sciences Inc. is calling Veklury, cut the time to recovery by five days — from 15 days to 10 on average — in a large study led by the U.S. National Institutes of Health.

It had been authorized for use on an emergency basis since spring, and now becomes the first drug to win full Food and Drug Administration approval for treating COVID-19. President Donald Trump received it when he was sickened earlier this month.

Veklury is approved for people at least 12 years old and weighing at least 88 pounds (40 kilograms) who are hospitalized for a coronavirus infection. For patients younger than 12, the FDA will still allow the drug’s use in certain cases under its previous emergency authorization.

The drug works by inhibiting a substance the virus uses to make copies of itself. Certain kidney and liver tests are required before starting patients on it to ensure it’s safe for them and to monitor for any possible side effects. And the label warns against using it with the malaria drug hydroxychloroquine, because that can curb its effectiveness.

“We now have enough knowledge and a growing set of tools to help fight COVID-19,” Gilead’s chief medical officer, Dr. Merdad Parsey, said in a statement.

The drug is either approved or has temporary authorization in about 50 countries, he noted.

Its price has been controversial, given that no studies have found it improves survival. Last week, a large study led by the World Health Organization found the drug did not help hospitalized COVID-19 patients, but that study did not include a placebo group and was less rigorous than previous ones that found a benefit. The FDA’s approval statement noted that, besides the NIH-led one, two other studies found the drug beneficial.

Gilead charges $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries, and $3,120 for patients with private insurance. The amount that patients pay out of pocket depends on insurance, income and other factors.

So far, only steroids such as dexamethasone have been shown to cut the risk of dying of COVID-19. The FDA also has given emergency authorization to using the blood of survivors, and two companies are currently seeking similar authorization for experimental antibody drugs.

Medicare And Medicaid To Cover Early COVID Vaccine

A nurse prepares to administer a flu vaccination shot to a woman at a free clinic held at a local library in Lakewood, California.

Source: Politico, by Dan Diamond and Adam Cancryn

The Trump administration this week will announce a plan to cover the out-of-pocket costs of Covid-19 vaccines for millions of Americans who receive Medicare or Medicaid, said four people with knowledge of the pending announcement.

Under the planned rule, Medicare and Medicaid will now cover vaccines that receive emergency use authorization from the Food and Drug Administration, the people said, which is a change from current policy. The regulations, which have been under development for weeks, are likely to be announced by the Centers for Medicare and Medicaid Services on Tuesday or Wednesday.

At least two Covid-19 vaccine developers have said they plan to apply for an emergency use authorization before the end of the year.

The administration is “working to ensure that no American has to pay for the vaccine,” said one official. The administration’s planned rule also will address other Covid-19-related issues, like expanding flexibility for Medicaid patients seeking care for the coronavirus, two people familiar with the plan said.

CMS did not respond to a request for comment about the plan or how it would pay for the cost of vaccines for the roughly 120 million Americans who receive health coverage through Medicare and Medicaid.

CMS Administrator Seema Verma teased the announcement earlier this month in remarks at the HLTH virtual conference.

“I think we’ve figured out a path forward,” Verma said on Oct. 13. “It was very clear that Congress wants to make sure that Medicare beneficiaries have this vaccine and that there isn’t any cost-sharing.”

“And so, stay tuned, you’ll see more from the agency on this very shortly,” Verma added.

Congress in March sought to mandate free coronavirus vaccine coverage as part of a broader Covid-19 relief bill. But under its current rules, the Medicare program doesn’t cover the cost of drugs authorized under emergency use designations — leaving millions of Americans at risk of facing expenses tied to the vaccine.

The Trump administration later determined that it could not fix the loophole through an executive order, setting off a scramble within the health department to find alternative solutions.

Earlier this month, the administration struck a deal with CVS and Walgreens to administer an eventual vaccine with no out-of-pocket costs to seniors and health workers in long-term care facilities. Yet that arrangement only covered a narrow slice of the nation’s more than 60 million Medicare enrollees.

Last Updated 11/18/2020

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