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Friday, February 5, 2021

Pfizer withdraws application for emergency use of its COVID-19 vaccine in India

 Pfizer Inc has withdrawn an application for emergency-use authorization of its COVID-19 vaccine in India that it has developed with Germany’s BioNTech, the company told Reuters on Friday.

The U.S. company, which was the first drugmaker to apply for emergency use authorization of its COVID-19 vaccine in India, had a meeting with the country’s drugs regulator on Wednesday and the decision was made after that, the company said.

“Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time,” it said in a statement to Reuters.

“Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future.”

Pfizer had sought authorisation for its vaccine in India late last year, but the government in January approved two much cheaper shots - one from Oxford University/AstraZeneca and another developed at home by Bharat Biotech with the Indian Council of Medical Research. Both companies had applied for approval of their vaccines after Pfizer.

India’s Central Drugs Standard Control Organisation had declined to accept Pfizer’s request for approval without a small local trial on the vaccine’s safety and immunogenicity for Indians, Reuters has reported.

Indian health officials say they generally ask for so-called bridging trials to determine if a vaccine is safe and generates an immune response in its citizens whose genetic makeup can be different from people in Western nations. There are, however, provisions under India’s New Drugs and Clinical Trial Rules, 2019, to waive such trials in certain conditions.

Pfizer earlier told Reuters its application was supported by data from a global study that showed an overall efficacy rate of 95% with no vaccine-related, serious safety concerns.

https://www.reuters.com/article/health-coronavirus-india-pfizer/exclusive-pfizer-withdraws-application-for-emergency-use-of-its-covid-19-vaccine-in-india-idUSL4N2KB1NZ

Palihapitiya-backed Clover Health gets notice of SEC probe

 Chamath Palihapitiya-backed Clover Health Investments said Friday it received a notice of investigation from the Securities and Exchange Commission and that it intends to cooperate.

Clover, however, pushed back against a critical report from short-selling specialist Hindenburg Research, saying some claims in the report were “completely untrue.”

On Thursday, Hindenburg published a scathing report that called Clover Health a “broken business,” sending the insurance firm’s shares down more than 12%, their biggest daily percentage drop in four months. Shares of Clover rose more than 3.5% in premarket trading Friday after the company published its response. Hindenburg, which has a history of publishing short-selling research, said Thursday it does not hold a position in Clover.

Hindenburg also said Clover was under investigation from the Department of Justice and that the investigation was not disclosed to investors. In its response to the Hindenburg report, Clover said it has received inquiries from the DOJ but did not believe the inquiries were material to its investors. The company characterized the DOJ inquiries as standard practice since Clover works with the Medicare system.

Clover said it decided it did not need to disclose the DOJ inquiries after consultation with its lawyers. The company did not say what the DOJ’s inquiries were about. On the SEC side, Clover said it received the letter from the agency on Thursday following the publication of Hindenburg’s report. The company said it was unware of any investigations outside of the letter from the SEC it received Thursday.

The DOJ on Thursday declined to comment on any potential investigations or inquiries related to Clover. The SEC declined to comment on Friday.

In addition to the alleged investigations, Clover responded to Hindenburg’s critique of a separate company that shares investors and governance with Clover called Seek Insurance. Hindenburg alleged Seek Insurance, a site designed to help people find Medicare plans, doesn’t disclose its relationship to Clover even though its website characterizes itself as an unbiased platform for choosing a health plan. Clover said in its response that Seek Insurance is an affiliate of Clover, but is still independent start-up.

Clover also said Seek’s website would be updated soon with more information, and published a breakdown of the plans Seek customers choose. According to Clover, 13.5% of Seek customers chose a Clover plan, behind CVS/Aetna (17%), Humana (20%) and Cigna (20%).

Finally, Clover addressed Hindenburg’s allegations that the company’s software prompts doctors to charge the Medicare system more than necessary, a practice called “upcoding.” Hindenburg said Clover’s software encourages upcoding with “irrelevant diagnoses” to “deceive” and charge the Medicare system more. Clover denied those allegations in its response, and said doctors receive a flat payment for office visit, and that it’s up to the doctor to choose the diagnosis.

You can read all of Clover’s lengthy, point-by-point response to Hindenburg here.

https://www.cnbc.com/2021/02/05/chamath-palihapitiya-backed-clover-health-gets-notice-of-sec-investigation.html

Merck KGaA to boost lipid supply to vaccine maker BioNTech

 Germany’s Merck KGaA said on Friday it would boost its supply of lipids, a key ingredient in messenger RNA COVID-19 vaccines, to biotech firm BioNTech.

“Merck, in close collaboration with BioNTech, will significantly accelerate the supply of urgently needed lipids and increase the amount of lipid delivery towards the end of 2021,” Merck said in a statement.

Lipids, mainly in the form of lipid nanoparticles, are used to encapsulate and protect messenger RNA molecules to help them reach the designated cells in the human body.

https://www.reuters.com/article/merck-biontech-lipids/merck-kgaa-to-boost-lipid-supply-to-vaccine-maker-biontech-idUSFWN2KA1OP

Thursday, February 4, 2021

Op-Ed: Do 'Lockdowns' Work? — And, if so, how much?

 In response to the COVID-19 pandemic, there have been thousands of specific policies instituted around the globe. At times, restrictions have been big and bold. Recently, the city of Perth, Australia, was placed in "lockdown" after a single case of SARS-CoV-2. Other restrictions have been focused: removing swings from playgrounds, capping the number of dining guests, or limiting the time for meals (90 minutes). One Toronto suburb closed outdoor ice-skating rinks, toboggan hills, and dog parks. The sheer variety of restrictions meant to curb the spread of SARS-CoV-2 raises an important question: which ones work? And how big are their effects?

I suspect that for many restrictions -- perhaps even most restrictions -- we will never know. We will never know, for instance, if removing the rim from a basketball hoop or closing a toboggan hill slowed SARS-CoV-2 where these strategies were deployed. For larger interventions -- mandatory business closure and stay at home orders, colloquially called "lockdowns" -- we may someday have a scientific consensus as to whether and to what degree this practice changes viral spread, but I believe that day is years away. Here, I wish to highlight challenges with understanding these interventions.

Challenges with identifying the effect of lockdowns

Already some studies have yielded mixed results. One analysis has found that mandatory business closure and stay-at-home orders were not associated with a reduction in infections. Another analysis did find a reduction. Both have limitations. Allow me to highlight some challenges that most research on this topic will face.

First, lockdown is not expected to yield immediate results. One has to account for the typical lag before an effect can realistically show up, but this introduces analytic flexibility. Should we look for effects 7 days later, or 5 or 15? If we look too soon, we might get the wrong idea. An intervention that slows viral spread may appear to lead to viral spread, because we deployed it on the upslope (reverse-causation). Alternatively, if we lag the analysis too much, we might see the impact of other interventions or the natural shape of the pandemic curve.

Second, places often institute multiple restrictions concurrently, alongside powerful media messages to the public. In other words, was it the business closure that helped, the fact the nightly news scared people, or was it another restriction that occurred at the time of (or close to) the business closure that changed outcomes?

Third, there are many ways to define "lockdown"; many regions, municipalities, or countries to include or exclude; many ways to model the data; and many investigators who will probe the dataset. Put this together, the range of "answers" is certain to vary widely. A team from Edmonton, Alberta, defining lockdown as all business closures of more than 3 days, and looking at the county level data for 12 countries might get a different "answer" than a group from Boston defining lockdown as any nonessential business closure, and looking at national data from 82 countries. Already we see a hint of the variety of answers that may be generated. In the long term, I am hopeful that somewhere in this sea of data, there may be a natural experiment that analysts can take advantage of to provide some clarity.

'Lockdown' is not like an aspirin

Fourth, restrictions might be even more complicated. A lockdown is not like an aspirin. It may not exert the same effect every time it is deployed. Lockdowns might have different effects based on the case rate. Lockdowns might help when cases are just a handful, as in Perth, in an effort to drive them to zero. Or lockdowns might only work when case rates are modest (1 case per 10,000 residents). Alternatively, lockdowns might work when case rates are brisk (1 per 1,000 residents). Perhaps lockdowns work in none of these cases, or just the first and second scenario. In other words, the effect of lockdowns may depend on the rate or absolute number of cases, or many other biologic factors (e.g., population density).

Fifth, the same lockdown in the same location with the same enforcement may have diminishing effects. If people are feeling a sense of purpose and camaraderie, there may be a positive effect, but if those same people feel distrustful or fatigued, there may be a negative one. Lockdowns depend on the buy-in of the populace. The desire to isolate yourself wanes over time. What worked in April might not work in November.

Sixth, lockdowns might have different effects based on the culture of the region, the practices of bordering nations, household density, or the political climate. What works in Norway might not work in the U.S. What works in New Zealand might not work in Canada.

Seven, lockdowns depend on media coverage. Previously I alluded to the fact that it will be challenging to separate the effect of lockdown policies from the fact that the media coverage of COVID naturally encourages people to hunker down. Here, consider that lockdowns might work better when media coverage is lax, but less so when it is frenetic. Because in the latter case, the additional people who change behavior due to the mandate may be few.

Eight, lockdowns depend on specific behaviors that drive spread. In a region where daily interactions are driving spread, lockdowns may work. In a region where all spread occurs in a meat processing plant, the same lockdown may have no effect if the plant remains in operation.

These considerations are just a few of the methodologic challenges with figuring out whether lockdowns work. And they do not even touch the harder question of: what are the complete effects of lockdown? What is the effect of restrictions on educational, mental health, cardiovascular, and other societal outcomes? And, when do these occur?

Finally, I must mention that some may frame this entire discussion differently. They may start with the premise that the goal of policies is to separate people to prevent spread, and consider lockdowns alongside all other measures. I support research efforts to examine the question in this manner as well.

I wish this discussion captured all the complexity to lockdowns, but there is one more factor that must be considered. In cancer medicine, methotrexate is an effective drug, but you often have to give leucovorin to overcome the devastating side effects. Similarly, a lockdown might have one set of effects in a nation with a strong social safety net, or strong unemployment insurance, and a different set of effects in a nation with a tattered safety net, and no unemployment insurance. Resources are the antidote to lockdown, and resources are not evenly distributed or deployed. All studies of lockdowns should account for varying resources.

This discussion has just been about one class of restriction or rule, but what about closing playgrounds, or removing swings, or closing ice rinks, or the many other specific policies implemented. For some of these interventions, I believe the plausibility is low. It is unlikely -- on the face of it -- that closing playgrounds will substantively curb viral spread, and these have met fierce opposition. A future society may look back critically on many of these policies. For many other policies, we may never know whether they helped or hurt.

Pundits need humility

When I think about the past year, and the thousands of interventions we deployed to combat the coronavirus, I am saddened to know we will end with very little idea of which specific interventions helped, which hurt, and which were neutral. Imagine you ran a multi-trillion-dollar study and you didn't get any answer at all.

Going forward, we must be more thoughtful in applying restrictions. Municipalities should avoid throwing the kitchen sink at once. Implementing things in sequence, with time between policies, can help disentangle which policies help and which do not.

Coordinated action can help. If 20 municipalities work together, and 10 try a set of some interventions and 10 others try different ones, we may start to learn which work, and to what degree. Repeating this experiment is the path to knowledge.

Next, with restrictions must come resources. Each policy meant to curb the spread of the virus may have harmful side effects. These harms must be measured and documented. Right now, we know little about how restrictions affect people, particularly poor and vulnerable ones. Resources can be applied to mitigate these harms. Folks concerned with the downsides of lockdown should not be demonized, ostracized, and marginalized. We must engage with them.

Pundits must have humility. Each day on Twitter, I see doctors, epidemiologists, or policy experts definitively proclaim what we ought to do. These comments often prompt fierce backlash from folks equally confident that these interventions hurt. The truth is there is massive uncertainty and being honest about that might make for more productive conversations and compromise.

Lastly, policymakers must be upfront with the public as to the goals of intervention and under what circumstances the restrictions can be relaxed. Specific benchmarks for when and how policies are deployed and when they can be eased must be posted for public view in advance of deployment.

Finally, we must not confuse matters of science with matters of morality. Most people want to minimize suffering and death, and disagreements are about how to do so, not the goal. Whether and to what degree restrictions work and under what circumstances is a set of scientific questions. Let me be the first to admit that I simply do not know the answers. Moreover, I believe the real answers will take years to emerge. As is often the case in life, distance brings wisdom.

Vinay Prasad, MD, MPH, is a hematologist-oncologist and associate professor of medicine at the University of California San Francisco, and author of Malignant: How Bad Policy and Bad Evidence Harm People With CancerThe views expressed above are his own and not his institution's.

https://www.medpagetoday.com/blogs/vinay-prasad/91054

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