Oracle’s Acquisition of Cerner: The Future of Healthcare

https://blogs.oracle.com/healthcare/post/oracle-acquisition-of-cerner-the-future-of-healthcare

Prioritizing outcomes in healthcare is long overdue and now within reach following Oracle’s acquisition of Cerner. To achieve more seamless, coordinated care, technology must play a greater role in reframing solutions for health and well-being around the world.

Combining Cerner’s clinical capabilities with Oracle’s enterprise platform, analytics, and automation expertise will change health and wellness in a way that simply hasn’t been possible before. We’ll provide secure and reliable solutions that deliver health insights and experiences to dramatically change how health is managed by patients, providers, and payors. The industry has never been riper for change.

Designing for people

Healthcare is innately personal; however, the industry often loses sight of the human side of health as delivering and understanding care has become increasingly disconnected and complex. Research reveals that doctors spend nearly twice as much time on administrative work as they do engaging with patients. If we replaced clinicians’ time spent performing administrative tasks with patient interactions, imagine how dramatically we could improve quality of care. Technology-induced administrative burden contributes to burnout, which has, in part, resulted in a workforce shortage and overshadowed the true benefits of healthcare technology. Clinicians didn’t enter medicine to spend half of their time conducting routine tasks and completing required documentation; they chose their profession to practice at the top of their license. We’re working to make this a reality, providing a toolset that supports clinical decision making and prioritizes the user experience.

For care delivery organizations, we’ll develop new cloud-enabled capabilities allowing providers to access the information they need, where and when they need it, on an interface that is easy to use. This will significantly reduce the time and effort required to find a patient’s information, even if the information is scattered across different providers or care settings. We’ll help people access and manage their own health information from wherever they are, so that they have a stronger voice in their care and can conduct more meaningful conversations with their providers. When successful, these improvements ultimately increase the value of healthcare and have the additional benefit of contributing data to population health insights.

Collaborative, interoperable care

In a complex and inefficient healthcare industry, interoperability is critical; but, it hasn’t been widely adopted between organizations. From the patient perspective, data silos limit patients’ empowerment and involvement in their health and well-being. It is vitally important that medical records are portable. Regardless of where someone receives care, their records should be accessible and unified. From a clinical perspective, interoperability ensures clinicians can properly review a patient’s entire medical history within their workflow and provide appropriate, contextual treatment.

recent survey shows a staggering 97% of healthcare executives have called for increased healthcare data interoperability, the lack of which inhibits digital transformation and innovation within organizations and throughout the broader industry. Oracle is committed to open APIs to ensure any authorized user can consume health data and insights. We know a closed system will not create connectivity and unification across the many existing players and systems. Creating more solutions without an open ecosystem commitment would only contribute to the problems we see today with fractured and siloed systems.

Oracle will harness the power of data to create a collaborative ecosystem where people, patients, providers, and payors can securely access clinical, operational, and financial data on the cloud. These efforts will break down data silos and provide open systems that talk to—and connect with—one another to generate actionable, scalable, and global insights previously unavailable. Industry fragmentation impacts both patients and providers, but Oracle has the power to aggregate data into a single source of truth to achieve better outcomes.

Improved efficiency across the system

While enhanced clinical systems will improve experiences bedside and lead to better public health outcomes, back-office operations must also be improved to drive true efficiency, reduce costs, and make the business of healthcare more predictable. Oracle’s Fusion application suite can create this bridge between the bedside and the back-office, enhancing employee experience (better retention, less administration), streamlining the supply chain (reduced shrinkage, better inventory management), and giving the executive a better understanding of the issues impacting their business (greater predictability and cost control).

Secure healthcare data

Unfortunately, we know that retail, finance, and health data are the most targeted in security breaches. Patient privacy and the security of health data, when left unaddressed, threaten what the information of health exchange is solely meant to protect­­: patient safety. It’s time to raise health data security to an unprecedented level of investment and focus.

Oracle is an industry leader in securely storing, processing, and analyzing large volumes of cloud-based data. We’ll continue to apply the same security-obsessed focus to healthcare as we do to all industries, ­allowing people, patients, providers, and payors to safely access insights that improve care and advance decision-making. Oracle has been trusted with some of the world’s most sensitive and regulated data for more than 44 years. For the financial services industry specifically, Oracle already serves customers in more than 140 countries and manages risk for 24 of the world’s 28 systemically important financial institutions (SIFIs).

Meeting the moment

While we already knew this industry was ready for change, the pandemic amplified and accelerated the world’s readiness to see that change. We aim to meet this moment leveraging the technology and expertise that have revolutionized other industries, as well as applying new innovations to transform these systems of record into systems of intelligence.

Combining our existing healthcare industry solutions—from clinical trials to health insurance payor solutions to public health analysis systems—with our acquisition of Cerner, we believe Oracle has a uniquely positioned opportunity to offer new solutions to a broken healthcare system. We plan to support the entire lifecycle of healthcare, going beyond traditional health IT to integrate our infrastructure, platform, and applications capabilities for a more fully connected operational, administrative, and clinical system. 

We are fully committed to the partnerships that will be instrumental to this journey. The technology and the world are ready for transformation. This is just the beginning.

Optum’s strategy for 2022 growth

Optum spent the last decade investing in significant growth, adding thousands of physicians to its network and purchasing ASC company Surgical Care Affiliates in 2017. Now the company is focusing more on its primary care network, data offerings and $115 billion pharmacy and medical care business line.

Optum, owned by UnitedHealth Group, has three divisions:

  • Optum Health, the healthcare provider division which includes physician groups and ambulatory surgery centers
  • Optum Insight, which houses the data analytics platforms designed to connect clinical, administrative and financial data
  • Optum Rx, a pharmacy benefits and care services business

Each division has a unique growth strategy focused on the patient and provider experience.

Provider growth
Optum Health now has 60,000 employed or aligned physicians and partners with 100 payers. Optum as a whole now works with 80 percent of health plans and 90 percent of hospitals and 90 percent of Fortune 100 companies.

Wyatt Decker, CEO of Optum Health, said in the 2021 earnings call in January that Optum Health is still a growth platform and the company will make investments to more deeply penetrate established markets. He expects Optum Health to deliver 8 percent to 10 percent margins annually going forward.

“Our approach strengthens the critical provider-patient relationship by empowering our primary care physicians with the latest information, insights and best practices to help them efficiently coordinate all patient care, manage referrals and identify higher-quality, lower-cost options,” the company said in its 2021 yearend highlights report.

ASCs certainly fit the high quality, low-cost care description, but Optum’s executives fell shy of mentioning whether the company would focus on growth in that sector during the 2021 earnings call.

Optum is also expanding its virtual care capabilities, focused on chronic care patients, and its behavioral health services. The company said it needs to add physicians, clinicians and technology to support patient care in those areas. Optum said it has its sights set on providing more whole-person, value-based care, scaling in new markets and having the key data insights to do it better than anyone else.

Value-based care
Last year, Optum and UnitedHealth Group’s health insurance business, UnitedHealthcare, worked together with external partners to grow in commercial and government payer markets, innovate and add 500,000 patients to their value-based contracts. Optum served 100 million patients, and 2 million of the patients were under fully accountable arrangements. Both companies also had a sharpened focus on the consumer experience.

“Taken together, these efforts helped us add more than $30 billion in revenue for the year, about $10 billion above our initial outlook,” said Andrew Witty, CEO of UnitedHealth Group, during the earnings call, as transcribed by The Motley Fool. “And you should expect similar growth in the year ahead. We see an even greater demand for integration to bring together the fragmented pieces of the health system, to harness the tremendous innovation occurring in the marketplace, to help better align the incentives for providers, payers and consumers, and to organize the system around value.”

Data and information
Optum Insights aims to continue growing by acquiring Change Healthcare, a healthcare data and technology company.

“The combination will advance our ability to create products and services that improve the delivery of healthcare and reduce the high costs and inefficiencies that plague the health system,” Optum claimed on its fact sheet about the transaction. “We will share these innovations broadly to benefit those who engage with the health system today and well into the future.”

The acquisition could make the episode of care more seamless for patients and reduce administrative burden for providers, as well as give payers a comprehensive view of the patient’s health outcomes with the potential to reduce cost. But it could also give Optum and UnitedHealth Group an unfair advantage over competitors, the Justice Department argued in a lawsuit filed in February.

“Across Optum, we operate with the highest ethical standards in protecting confidential data and information of our clients and adhere to the safeguards we have had in place for more than a decade to ensure data is accessed and used only for permissible purposes,” according to a statement on Optum’s website responding to the Justice Department’s lawsuit. “We will not be distracted by the DOJ’s complaint and will continue to honorably serve our clients and consumers and those that engage in the health system.”

5 new responsibilities for the beyond-finance CFO

https://www.cfodive.com/spons/5-new-responsibilities-for-the-beyond-finance-cfo/607630/

The Urgent Need to Redefine the Office of the CFO

For years, pioneering CFOs steadily extended their duties beyond the boundaries of the traditional finance and accounting function. Over the past year, an expanding set of beyond-finance activities – including those related to environmental, social and governance (ESG) matters; human capital reporting; cybersecurity; and supply chain management – have grown in importance for most finance groups. Traditional finance and accounting responsibilities remain core requirements for CFOs, even as they augment planning, analysis, forecasting and reporting processes to thrive in the cloud-based digital era. Protiviti’s latest global survey of CFOs and finance leaders shows that CFOs are refining their new and growing roles by addressing five key areas:

Accessing new data to drive success ­– The ability of CFOs and finance groups to address their expanding priorities depends on the quality and completeness of the data they access, secure, govern and use. Even the most powerful, cutting-edge tools will deliver subpar insights without optimal data inputs. In addition, more of the data finance uses to generate forward-looking business insights is sourced from producers outside of finance group and the organization. Many of these data producers lack expertise in disclosure controls and therefore need guidance from the finance organization.

Developing long-term strategies for protecting and leveraging data – From a data-protection perspective, CFOs are refining their calculations of cyber risk while benchmarking their organization’s data security and privacy spending and allocations. From a data-leveraging perspective, finance chiefs are creating and updating roadmaps for investments in robotic process automation, business intelligence tools, AI applications, other types of advanced automation, and the cloud technology that serves as a foundational enabler for these advanced finance tools. These investments are designed to satisfy the need for real-time finance insights and analysis among a mushrooming set of internal customers.

Applying financial expertise to ESG reporting – CFOs are mobilizing their team’s financial reporting expertise to address unfolding Human Capital and ESG reporting and disclosure requirements. Leading CFOs are consummating their role in this next-generation data collection activity while ensuring that the organization lays the groundwork to maximize the business value it derives from monitoring, managing and reporting all forms of ESG-related performance metrics.

Elevating and expanding forecasting – Finance groups are overhauling forecasting and planning processes to integrate new data inputs, from new sources, so that the insights the finance organization produces are more real-time in nature and relevant to more finance customers inside and outside the organization. Traditional key performance indicators (KPIs) are being supplemented by key business indicators (KBIs) to provide sharper forecasts and viewpoints. As major new sources of political, social, technological and business volatility arise in an unsteady post-COVID era, forecasting’s value to the organization continues to soar.

Investing in long-term talent strategies – Finance groups are refining their labor model to become more flexible and gain long-term access to cutting-edge skills and innovative thinking in the face of an ongoing and persistent finance and accounting talent crunch. CFOs also are recalibrating their flexible labor models and helping other parts of the organization develop a similar approach to ensure the entire future organization can skill and scale to operate at the right size and in the right manner.

Large health systems band together on monetize clinical data

https://mailchi.mp/41540f595c92/the-weekly-gist-february-12-2021?e=d1e747d2d8

Image result for monetizing clinical data
Fourteen of the nation’s largest health systems announced this week that they have joined together to form a new, for-profit data company aimed at aggregating and mining their clinical data. Called Truveta, the company will draw on the de-identified health records of millions of patients from thousands of care sites across 40 states, allowing researchers, physicians, biopharma companies, and others to draw insights aimed at “improving the lives of those they serve.” 

Health system participants include the multi-state Catholic systems CommonSpirit Health, Trinity Health, Providence, and Bon Secours Mercy, the for-profit system Tenet Healthcare, and a number of regional systems. The new company will be led by former Microsoft executive Terry Myerson, who has been working on the project since March of last year. As large technology companies like Amazon and Google continue to build out healthcare offerings, and national insurers like UnitedHealth Group and Aetna continue to grow their analytical capabilities based on physician, hospital, and pharmacy encounters, it’s surprising that hospital systems are only now mobilizing in a concerted way to monetize the clinical data they generate.

Like Civica, an earlier health system collaboration around pharmaceutical manufacturing, Truveta’s launch signals that large national and regional systems are waking up to the value of scale they’ve amassed over time, moving beyond pricing leverage to capture other benefits from the size of their clinical operations—and exploring non-merger partnerships to create value from collaboration. There will inevitably be questions about how patient data is used by Truveta and its eventual customers, but we believe the venture holds real promise for harnessing the power of massive clinical datasets to drive improvement in how care is delivered.

Centene’s $2.2B deal for Magellan adds focus on behavioral health

Dive Brief:

  • Centene has entered into a definitive agreement to acquire Phoenix, Arizona-based Magellan Health for $2.2 billion, or $95 per share, the payer said Monday. Magellan will operate independently under the Centene umbrella.
  • Executives said the combination will result in one of the nation’s largest behavioral health platforms as the two will provide behavioral services to about 41 million members in the U.S.
  • The deal also boosts Centene’s already established footprint in government sponsored health plans with the addition of 5.5 million lives and another 2.2 million to add to its pharmacy benefit management platform.

Dive Insight:

The deal is designed to boost Centene’s ability to market a “whole health” approach for its members. The COVID-19 pandemic has underscored the need to care for more than just a member’s physical health by also caring for their mental health, the company said Monday.

“This has become even more evident in light of the pandemic which has driven a dramatic rise in behavioral health needs,” Centene CEO Michael Neidorff said in statement. Both boards unanimously approved the deal.

Magellan Health provides managed care and pharmacy services for an array of clients that include health plans, unions and third-party administrators. Centene has been a client of Magellan’s in years past.

Magellan leans on analytics and other technologies in an attempt to improve health outcomes and lower costs. In addition to behavioral health, Magellan focuses on high-cost or complex patients for its clients. In its presentation to investors on Monday, Centene said 71% of total healthcare costs in the U.S. are spent on complex patients, illustrating the need for the deal.

For its healthcare management services, Magellan typically enters into risk-based contracts with its clients where it assumes all or a substantial portion of the risk in exchange for a per member, per month fee. Or, Magellan will enter into an administrative services only agreement in which it reviews utilization and claims administration and manages provider networks, according to its latest 10-Q filing.

The deal is expected to close in the second half of the year pending regulatory approvals. CEO Ken Fasola and other Magellan executives will continue their leadership roles.

Last year, Centene completed its blockbuster acquisition of rival WellCare, a $17 billion deal that catapulted the company to the fourth-largest insurer by membership when including Aetna, which is now part of CVS Health. The deal also doubled Centene’s Medicare Advantage footprint. Centene’s core business is Medicaid managed care and it is the largest insurer on the Affordable Care Act exchanges.

The COVID Tracking Project

https://covidtracking.com/data/charts/us-daily-positive

The public deserves the most complete data available about COVID-19 in the US. No official source is providing it, so we are.

Every day, our volunteers compile the latest numbers on tests, cases, hospitalizations, and patient outcomes from every US state and territory.

https://covidtracking.com/

Patchwork approach to contact tracing hampers national recovery

https://thehill.com/homenews/state-watch/514233-patchwork-approach-to-contact-tracing-hampers-national-recovery

Patchwork approach to contact tracing hampers national recovery | TheHill

A patchwork approach to contact tracing across state health departments is making it increasingly difficult to know where people are getting exposed to COVID-19.

While some states like Louisiana and Washington state publicly track detailed data related to COVID-19 cases in bars, camps, daycares, churches, worksites and restaurants, most states do not, creating obstacles to preventing future cases.

The extensive spread of the virus, combined with the country’s 50-state approach to pandemic response, has led to a dearth of information about where transmissions are occurring. Those shortcomings are in turn complicating efforts to safely open the economy and to understand the risks associated with certain activities and settings.

Experts know COVID-19 spreads in crowded indoor spaces, but more specifics could help state and local lawmakers strike a better balance between public health needs and those of the economy.

“If you want to take a more targeted approach to public health measures, the more information you have the better,” said Joshua Michaud, an associate director for global health policy at the Kaiser Family Foundation and an infectious disease epidemiologist.

“Rather than have a blunt, close-everything-down approach, you could be a bit more targeted and surgical about how you implement certain measures,” he added.

The Hill asked every state for information about the data they collect and share as part of their contact tracing programs, one of the main tools public health officials have to slow the spread of COVID-19.

Most states release information about outbreaks and cases at congregate settings like nursing homes, meatpacking plants, and prisons, which comprise the majority of cases. But there is less information publicly available about the numbers of cases or outbreaks tied to other settings commonly visited by people.

A handful of states including ArkansasColoradoKansasLouisianaMaryland, Michigan, Ohio, Rhode Island and Washington track and publicly release data on the settings where COVID-19 outbreaks are occurring, according to responses from state health departments.

For example, Louisiana has tied 468 cases to bars in the state, but most of the new cases in the past week have been tied to food processing plants.

In The Hill’s review of publicly available state data, other settings for COVID-19 transmission include restaurants, childcare centers, gyms, colleges and schools, churches, retailers, weddings and other private social events. It is not clear how widely those settings contributed to infections because widespread transmission of the virus means many people who get sick do not get interviewed by contact tracers — over the past week, there has been an average of 42,000 confirmed cases, though many more are likely going undetected.

State health departments in Idaho, Illinois, Massachusetts, Mississippi, Missouri, New Hampshire, North Carolina, South Carolina, Tennessee, Texas, Vermont, Virginia and West Virginia told The Hill they don’t track location data.

Utah tracks outbreaks and cases tied to workplaces and schools, but not restaurants or bars.

Arizona, California, Delaware, Indiana, Oregon and Pennsylvania track infection locations, but don’t release it to the public.

“The number of people getting COVID-19 from isolated, identifiable outbreaks, such as those in long term care facilities, is decreasing, and more people are contracting COVID-19 from being out and about in their community, such as when visiting restaurants and bars,” said Maggi Mumma, a spokeswoman for the Pennsylvania Department of Health.

Bars, indoor dining and gyms are still closed in most of New York and New Jersey, so there is no current data to track for those settings.

But the state health departments also don’t release data on outbreaks or cases tied to other settings like childcare or retail stores.

MinnesotaMontanaNorth Dakota and Wisconsin release the number of cases tied to outbreaks in the community but do not go into specifics about possible transmission sites.

For example, Minnesota lists nearly 7,000 cases as being tied to “community” exposure, but that includes settings like restaurants, bars and workspaces.

In Iowa, a state health department spokesperson said the agency is working on extracting and sharing this type of data on its website, while Maine would not say if they track by specific location.

The remaining state health departments did not respond to multiple requests for comment from The Hill and don’t have information about outbreaks or exposure settings on their websites.

Several states said local health departments may be tracking infection locations even if the state is not.

Experts said such a decentralized approach can miss outbreaks if local departments aren’t communicating with each other, meaning any data should be public.

“I do think it would be very valuable for states to make that information public,” said Crystal Watson, assistant professor at Johns Hopkins Bloomberg School of Public Health.

“It helps us collectively get a better understanding as policymakers, as people trying to help in the response. It can also help with personal decision making for people to understand … where it’s most dangerous to go related to getting infected,” Watson said.

The disparities between state health departments are partially due to a lack of federal guidance.

There are no federal requirements on the information contact tracers collect; guidelines vary from state to state, and sometimes from county to county.

Tracking data about where people are getting sick would allow states to take a “cluster busting” approach, experts said, by working backwards from confirmed cases to find where patients might have first contracted the disease, potentially stopping future outbreaks.

That approach requires a change in mindset for contact tracers, who typically focus on reaching close contacts of confirmed cases who might have been exposed to the virus. But research shows between 10 and 20 percent of people are responsible for about 80 percent of new infections, mostly through so-called super-spreader events.

“We know that the way this virus has transmitted is highly clustered groups and anytime you have settings where a lot of people are together in one place,” said Kaiser’s Michaud.

“Collecting good information on this — the cluster busting approach — is a good way to find out where your prevention efforts can have the best bang for your buck,” he said.

At the same time, some state programs are still not operating at full force and are struggling to keep up with widespread infections.

“I think that many parts of the country, especially outside of the Northeast … simply have too many cases to use contact tracing as the primary public health measure to control cases,”  said Stephen Kissler, a research fellow at the Harvard T.H. School of Public Health.

“It’s just not enough,” he said. “We just don’t have enough resources, and in a lot of these places enough contact tracers, to follow up on all of the cases.”

 

 

 

 

 

Convalescent Plasma: The Unanswered Questions

https://www.medpagetoday.com/infectiousdisease/covid19/88264?xid=fb_o&trw=no&fbclid=IwAR0F6xiRAQ7ngBz4pNozJ2VqWm0-UJqGdlQojfOeyXbPJjbAeYtGL8jbAiw

“The data don’t show anything useful”

Problems with the government’s rationale for authorizing use of convalescent plasma in COVID-19 patients go far beyond the dustup over the purported 35% survival benefit cited by top officials on Sunday, numerous researchers say.

That figure quickly came under fire, leading to an apology from Commissioner Stephen Hahn, MD — but that’s not the only criticism leveled at the FDA’s analysis of the available data.

Much of it came from the Mayo Clinic and FDA expanded access program (EAP), at this point published only as a preprint manuscript. Although a large number of patients were included, the study was observational only, with no untreated control group. That makes the findings merely hypothesis-generating, and can’t offer any firm conclusions.

That’s fine for issuing an emergency use authorization (EUA), but not so much for making claims about survival benefit, independent researchers said.

“It’s not even a question of overstating,” Adam Gaffney, MD, MPH, a critical care doctor and health policy researcher at Harvard Medical School, told MedPage Today. “You can’t state much at all when you don’t have a randomized controlled trial.”

“People have made a big deal of Hahn referring to relative versus absolute risk reduction, but I think that’s less of a big deal,” Gaffney said. “The biggest problem is that the data they are citing … is not randomized. That’s the source of all the problems.”

Hahn took heat for saying that a “35% improvement in survival is a pretty substantial clinical benefit” further explaining that of “100 people who are sick with COVID-19, 35 would have been saved because of the administration of plasma.”

Critics rapidly took to Twitter, stating that the interpretation was incorrect. Hahn was referring to relative risk reduction, not absolute risk reduction. Thus, calculating the number of lives saved — which isn’t something experts recommend doing based on observational data in the first place — would have translated to somewhere more in the ballpark of 5 out of 100.

Moreover, the “risk reduction” came from a comparison of patients treated with high-titer plasma versus those receiving lower-titer preparations. The study offered no basis for concluding how many patients may have been “saved” relative to standard care.

And the 35% reduction in that analysis was for 7-day mortality; the relative reduction at 30 days was only 23%.

Hahn’s recital of the 35% figure “was just PART of the error,” tweeted Vinay Prasad, MD, MPH, of the University of California San Francisco. “The entire comparison is flawed. It is not a suitable control. The data don’t show anything useful.”

“The much broader problem here is the lack of commitment to performing large, national randomized controlled trials,” Gaffney said. “We could have done it for convalescent plasma. Instead, we did the EAP. I understand why people wanted it, but now we don’t know [if convalescent plasma works]. We have a question mark instead of a period.”

Undermining Trust in FDA?

Critics have charged that serious mistakes like Hahn’s misstatement could undermine FDA’s credibility, especially as it faces challenging decisions about potentially approving a vaccine this fall.

“This is playing out in the context of a hyper-politicized moment,” Gaffney said. “It behooves everyone to be extremely cautious in speaking about these things to avoid the appearance of politicization.”

On CBS This Morning on Tuesday, Hahn addressed concerns about politicization by offering reassurance to the “American people that this decision was made based upon sound science and data.”

In response to questions about the timing of the EUA announcement — it came just a day after President Donald Trump tweeted allegations that the “deep state” was holding back access to COVID-19 treatments with Hahn’s Twitter handle cited, and a day before the Republican National Convention got underway — Hahn said the agency had been working on the application for 3 or 4 weeks and was waiting on additional validation data, which were received at the end of last week and over the weekend.

“We’re going to continue to get data and as we’ve done with any other authorization, we will update that decision as new data come,” Hahn said on the news program. His agency initially issued an EUA for hydroxychloroquine, for instance, but later revoked it when the negative randomized trial data became available.

Lack of Access to FDA’s Data Review

Whether the public will ever see the full convalescent plasma data underlying the EUA is another matter. The “Clinical Memorandum” issued as the evidence behind the FDA’s decision glossed over the statistical analysis conducted by the agency; in particular, it made no mention of the 35% relative reduction in deaths.

Another problem with that is the 35% figure’s source isn’t fully clear. Although the EAP preprint manuscript is the most obvious source, Gaffney noted that HHS Secretary Alex Azar said it referred to a subgroup of patients under age 80 who were not on a ventilator. That is not found in the publicly available data. He also pointed to a tweet by FDA spokesperson Emily Miller that contains an agency slide showing a 37% reduction in mortality for non-intubated patients age 80 or under treated within 72 hours who got high-titer convalescent plasma, compared with low-titer product. Neither of those figures is reflected in the EAP manuscript.

The FDA did not return a request by MedPage Today for the full summary of data reviewed by FDA and any independent statistical analysis done by the agency.

Shmuel Shoham, MD, of Johns Hopkins University in Baltimore, said during a press briefing organized by the Infectious Diseases Society of America that “enormous amounts of data have been generated” from the EAP, in which more than 70,000 patients have been treated.

“Some data have been reported in articles and at meetings, but that’s only part of what the FDA — this is their program — has access to,” he said. “The stuff in the public domain is only a fraction of the data they have collected.”

Shoham is on the scientific advisory board of the EAP and is involved in two convalescent plasma clinical trials at Johns Hopkins.

Gaffney said Mayo researchers and FDA reviewers have noted that physicians were blinded to the dose of antibody given in plasma infusions, which he described as a “pseudo-randomization effect. We could use that to make more causal inferences about the effectiveness of antibody titers.”

However, he said there were some significant differences between those who received high-titer versus low-titer antibody, including differences in P-to-F ratio (a measure of inhaled oxygen to blood oxygen) and in those with five or more severe risk factors, suggesting the low-titer group was sicker to begin with than the high-titer group.

Also, patients in the EAP received a variety of other treatments: about half got steroids and 40% were given remdesivir.

“This is why we do randomized controlled trials,” Gaffney said. “Without them it’s very difficult to ensure that the effect you see is the result of the drug, and not the result of patient characteristics.”

Is an Answer Forthcoming?

Several randomized controlled trials of convalescent plasma are underway in the U.S., but the big concern is that wider access to convalescent plasma will limit enrollment. Will clinicians recommend that their patients enroll in a trial in which they might receive placebo? Will patients agree?

For the Hopkins studies, the prevention trial has enrolled 25 people out of a goal of 500, and its outpatient trial has enrolled 50 people of its 600-patient goal.

Liise-anne Pirofski, MD, of Montefiore Medical Center in New York, started a study at the end of April, looking to enroll 300 people. She said the team enrolled the first 150 people quickly, but “then the pandemic began to wane in New York.” With subsequent funding from the NIH, the trial has managed to enroll 190 patients, and has now expanded to four additional sites: New York University, Yale, the University of Miami, and the University of Texas Houston.

Clifton Callaway, MD, PhD, of the University of Pittsburgh Medical Center and lead investigator on the C3PO trial looking at outpatient convalescent plasma, said he hopes the EUA doesn’t discourage participation.

“To the contrary, I believe it should reassure persons considering participation that the FDA feels that convalescent plasma is safe and potentially useful and that the FDA specifically comments: ‘Current data suggest the largest clinical benefit is associated with high-titer units of CCP administered early in the course of disease.’ Giving high-titer convalescent plasma earlier (before you are sick enough to be in the hospital) is exactly what C3PO is testing.”

In addition to determining whether earlier or prophylactic treatment works, Shoham said other unanswered questions include identifying whether other components in plasma are useful therapies and whether low-titer plasma can work at all.

“What everyone agrees on is that the gaps in knowledge that exist can best be addressed by high-quality randomized controlled trials,” he said.

Pirofski said the science and data should be the focus, “rather than the decision and what drove the decision…. I don’t think anyone knows what drove that decision other than the people in that room. Hopefully they know.”