Inside Walter Reed’s ‘Presidential Suite'

The Presidential Suite at Walter Reed National Military Medical Center, where President Trump spent the night, has both top-level medical care and some comforts of home for the ailing commander-in-chief.

The six-room suite includes an intensive care unit, a kitchen, a living room and a secure conference room in addition to the bedroom, which has a desk where the president can get some work done. There’s also a dining room with a crystal chandelier, according to The Daily Mail.

The entire suite, which is controlled by the White House, is outfitted with protective devices and communications gear to allow the president to work.

The first time that Trump wore a mask in public was on July 11, during a visit to Walter Reed to visit ailing troops at the facility.

Trump was admitted Friday evening after he announced he tested positive for the coronavirus. In a video he recorded before heading to the hospital 9 miles from the White House, he said he was “doing very well.” At 11:30 p.m., he tweeted, “Going well, I think! Thank you to all. LOVE!!!”

In addition to the rooms specifically for the president, the suite also includes an office for White House Chief of Staff Mark Meadows, and sleeping quarters for the White House physician to be present 24/7 during the president’s stay, NBC Washington reported.

The Medical Evaluation and Treatment Unit, also known as Ward 71, is on the south side of the sprawling 243-acre campus, which houses 88 buildings and has about 7,000 staff members.

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The VIP treatment ward at Walter Reed Army Medical Hospital, referred to there as Ward 71.

Tim Dillon-USA TODAY

Walter Reed National Military Medical Center was formed in 2011 with the combination of Walter Reed Army Medical Center and the National Naval Medical Center. It was named for Major Walter Reed, an Army researcher who helped prove that an earlier viral epidemic, yellow fever, was transmitted by mosquitoes, the Atlanta Journal Constitution reported.

https://nypost.com/2020/10/03/inside-walter-reeds-presidential-suite-where-trump-is-staying/

Bipartisan bill aims to create subscription-style model for bigger antibiotic market

Two senators recently introduced a bill that would establish a subscription-style payment model to expand the antibiotic market.

Sens. Michael Bennet, D-Colo., and Todd Young, R-Ind., introduced the Pasteur Act, which would create a subscription-style model that gives drugmakers upfront payments in exchange for unfettered access to their antibiotic supply. 

The bill was drafted to grow the antibiotic market by offering drugmakers incentives. Pharmaceutical companies have been reluctant to expand the antibiotic space because the drugs are usually most effective when taken only for a short amount of time, but the new legislation would allow drugmakers to make a sufficient profit without having to sell large quantities of antibiotics.

In their bill, the senators write that the subscription contracts will range from $750 million to $3 billion and be paid over 10 years or via patent exclusivity. They also outline that the contracts would require antibiotics to be available for free to patients with state health insurance, support appropriate use so the risk of antibiotic resistance is reduced, track resistance data and conduct post-marketing studies. 

https://www.beckershospitalreview.com/pharmacy/bipartisan-bill-aims-to-create-subscription-style-model-for-bigger-antibiotic-market.html

Trump's Coronavirus Diagnosis And Its Impact On The Stock Market

Markets traded lower on Friday after U.S. President Donald Trump tested positive for the coronavirus just one month ahead of the November election.

Trump and First Lady Melania Trump both tested positive shortly after top Trump aide Hope Hicks tested positive. Trump’s diagnosis comes just three days after his first debate with Democratic nominee Joe Biden. Early reports suggest Trump is experiencing “mild symptoms” but is in “good spirits.

Trump is 74 years old and overweight, placing him in two high-risk demographics.

Several analysts and market experts have weighed in on the impact Trump’s positive test could have on the market.

No Market Panic: Joseph Brusuelas, Chief Economist at RSM US LLP, said the initial market reaction suggests there is not a large-scale flight to safety asset classes on Friday.

“Rather, the initial knee-jerk reaction may stimulate volatility in equity and FX markets that is likely to subside in the coming days,” Brusuelas wrote.

The Barclays iPath Series B S&P 500 VIX Short-Term Futures ETN (BATS: VXX) traded higher by 4% on Friday.

Chris Zaccarelli, Chief Investment Officer for Independent Advisor Alliance, said Trump’s diagnosis overshadowed news that the U.S. unemployment rate has dropped below 8%.

“To the extent that government functions as normal, markets will be concerned, but not necessarily panic, however, this incident highlights how Covid-19 continues to be a threat to the economy and markets,” Zaccarelli said.

Peter Essele, Head of Portfolio Management for Commonwealth Financial Network, said it's reasonable to assume markets will be shaky in October given all the uncertainty surrounding the election and the pandemic.

“Investors should remain vigilant and consider some type of portfolio protection, as there remains a very real possibility that the market’s gains over the previous two quarters will steadily erode in the months ahead as we close out a year that many would like to forget,” Essele said.

Potential Silver Linings: Jamie Cox, Managing Partner for Harris Financial Group, said a positive test from Trump is not nearly as devastating for the market as it would have been back in March.

“Markets could have some unexpected reactions as this could break the log jam in current stimulus negotiations,” Cox said.

Bloomberg senior editor John Authers said Trump’s diagnosis may go a long way in convincing Americans who believed the coronavirus pandemic was a hoax.

“Negative news for the economy, because the chances of a significant relaxation in lockdown provisions.. have just been sharply reduced,” Authers said.

Jeff Buchbinder, Equity Strategist for LPL Financial, said defensive assets such as gold, the yen and Treasury bonds have been surprisingly calm in Friday morning trading.

“Markets appear to be increasingly pricing Joe Biden in as the favorite, and this news may not change that, but Trump could gain support from a quick recovery as UK Prime Minister Boris Johnson did during his battle with COVID-19,” Buchbinder said.

Benzinga’s Take: A positive test for President Trump is obviously bad news for the stock market and for every American. However, the market’s muted reaction likely has a lot to do with the timing of the diagnosis given the nation was already just a month away from a potential transfer of power.

https://www.benzinga.com/analyst-ratings/analyst-color/20/10/17756000/experts-react-to-trumps-coronavirus-diagnosis-and-its-impact-on-the-stock-market

Low infection rates could extend data readouts in large-scale COVID-19 trials

• Falling COVID-19 infection rates, especially among adults at least 55 years old, are good news/bad news for public health and vaccine developers. The negative implications of higher infection rates are self-evident for the overall population but are a narrowly defined positive for vaccine makers considering the shorter amount of time to accumulate enough events, i.e., cases of post-dose infections, to gauge efficacy. Lower infection rates are clearly preferred, again for obvious reasons, but extend the timeline in a vaccine trial since event accrual is slower. This is a major reason that late-stage vaccine trials recruit tens of thousands of participants. Event accrual is the tollgate for assessing efficacy, even preliminarily.
• Assuming the FDA's stated 50% minimum efficacy bar, Johnson & Johnson's (NYSE:JNJ) Phase 3 trial, ENSEMBLE, evaluating Ad26.COV2.S in 60K adults will require a minimum of 154 events. Likewise, Pfizer (NYSE:PFE)/BioNTech's (NASDAQ:BNTX) 44K-subject study of BNT162b2 will need 164 events (52% efficacy), AstraZeneca's (NASDAQ:AZN) 30K-subject study of AZD1222 will need 150 and Moderna's (NASDAQ:MRNA) 30K-subject trial of mRNA-1273 will need 151.
• Vaccine efficacy (VE) is calculated as: VE = 100 x (1 - IRR). IRR, the infection rate ratio, is the rate of confirmed COVID-19 infections in the vaccinated group divided by the rate of infections in the placebo group.  For example, if the infection rate in the test group was 0.1% compared to 1.0% in the control group, vaccine efficacy would be 90% [100 x (1 - (0.1%/1.0%)].
• A potential emergency use nod in the U.S. based on an interim analysis of less data will likely need a higher efficacy bar before a developer would proceed with an application considering the current public mood about rushing the vaccines to market without thorough vetting since there is no way to truncate the time required to thoroughly assess medium- and long-term safety and efficacy.
• J&J's study, launched last week, assumes 60% vaccine efficacy and a 1.4% infection rate in the placebo group during the first three months, dropping to 0.7% in month four and ~0.5% thereafter. Monitoring can start after half of the participants have at least two months' follow-up from the second shot, at least six cases of COVID-19 have been reported in subjects at least 60 years old and at least 20 moderate-to-severe/critical COVID-19 cases have occurred (at least five deemed severe/critical) (protocol, page 110). No interim analyses or efficacy monitoring will be done until these conditions are met. Monitoring for efficacy will be done at least once/week by independent committee until 154 events have been reported or the efficacy (statistical) boundaries have been met.
• The minimum number of events in Pfizer/BioNTech's study is also based on an assumed VE of 60%. 164 events will provide 90% power (statistical threshold) to demonstrate efficacy and an early end to the study (protocol, page 92). This would be achieved with 17,600 evaluable subjects in each arm or 21,999 vaccine recipients randomized 1:1 with placebo for a total sample size of 43,998 based on a 1.3% infection rate in the placebo group. As of September 28, enrollment was 35,469 including 24,289 participants who have received the second shot.
• Likewise, Moderna is basing the 151 events in its Phase 3 trial on an assumed VE of 60% (90% power) and a 0.75% six-month infection rate in the control arm (protocol, page 13). There are two interim analyses planned, after 35% and 70%, respectively, of the total targeted cases have been observed. As of September 25, 27,232 people have been enrolled including 15,454 who have received the second jab.
• All things considered, the chance of a U.S. emergency use nod before election day appears remote, but possible before year-end.
• https://seekingalpha.com/news/3618991-low-infection-rates-extend-data-readouts-in-large-scale-covidminus-19-trials
  

Next big move for Amazon, Apple & Google: Health insurance?

Google, Apple and Amazon have all moved into the healthcare space and are now eyeing the $6 trillion health insurance market, according to a new report from CB Insights.

Four trends to know:

1. Big tech companies have data and distribution platforms to reach insurance buyers digitally and can utilize information from smart home and wearable products for underwriting and claims, according to the report. Insurers are also transitioning data to the cloud and using artificial intelligence provided by big tech companies.

2. The big tech companies are currently distribution partners or digital enablers for insurance companies but they could break into the field if they own the data, analytics and distribution.

3. Forty-four percent of people surveyed by Capgemini said they would be willing to buy insurance from a big tech company.

4. Big tech companies may decide to become a licensed insurance broker or develop risk rating models for underwriting, according to the report. "Finding and servicing insurance customers on behalf of insurers would leverage big tech companies' established networks and could serve as an effective business model," the report concludes.

Here is a breakdown of partnerships and investments Google, Apple and Amazon have already made in the insurance industry.

Google

• Google invested $375 million in Oscar Health, owning 10 percent of the company in 2018.
• Google also made a nine-figure investment in Applied Services, a core insurance agency management software provider.
• Google's Verily formed a subsidiary health insurance company earlier this year with Swiss Re.

Amazon

• Amazon has partnerships with Geico and Allstate for Alexa skills that provide policy information and quotes for customers.
• Amazon is working with Cigna to access healthcare through Alexa.
• The company collaborated with Blue Cross Blue Shield of Massachusetts for members to access PillPack with the BCBS app.
• Amazon is also part of the collaboration that formed Haven, a self-managed health plan for employees.
• In April, the company asked 900,000 e-commerce sellers about current health insurance needs and pain points, setting the stage to offer employee health benefits to sellers.
• Amazon launched wearable Halo earlier this year and partnered with John Hancock's Vitality life insurance program for members to earn benefits and discounts through Halo use.

Apple

• Amazon focuses on personal health and wellness data through the Apple Watch, which now can record ECG and blood oxygen levels.
• Apple Watch and the new Apple Fitness+ focuses on healthy lifestyles, which have benefit for life and health insurers, according to CB Insights.
• Apple is a flagship partner in John Hancock's Vitality program and UnitedHealthcare's health plans

https://www.beckershospitalreview.com/healthcare-information-technology/the-next-big-move-for-amazon-apple-google-health-insurance.html

FDA OKs Combination Immunotherapy for First-Line Mesothelioma

The US Food and Drug Administration (FDA) has approved combination nivolumab (Opdivo, Bristol-Myers Squibb) and ipilimumab (Yervoy, Bristol-Myers Squibb) to be used as first-line treatment of adult patients with unresectable malignant pleural mesothelioma.

This is the first drug regimen to receive regulatory approval for mesothelioma in 16 years and only the second systemic therapy to be approved for this indication.

"Today's approval of nivolumab plus ipilimumab provides a new treatment that has demonstrated an improvement in overall survival for patients with malignant pleural mesothelioma," Richard Pazdur, MD, director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research, said in a statement.

"In 2004, FDA approved pemetrexed in combination with cisplatin for this indication, and now patients have an important, additional treatment option after more than a decade with only one FDA-approved drug regimen," Pazdur added.

Improved Overall Survival

The approval is based on efficacy results from the CheckMate 743 trial, which compared immunotherapy with a chemotherapy regimen in a cohort of more than 600 treatment-naïve patients (no systemic therapies) with unresectable mesothelioma. Patients were randomized 1:1 to nivolumab and ipilimumab for up to 2 years (n = 303) or 6 cycles of combination chemotherapy with cisplatin or carboplatin plus pemetrexed (n = 302).

The study results were initially presented during the presidential symposium of the World Congress on Lung Cancer 2020, as reported by Medscape Medical News.

The combined immunotherapy regimen was associated with a 26% improvement in overall survival. At 2 years, 41% of patients in the immunotherapy arm were still alive vs 27% in the chemotherapy group.

Overall, the trial demonstrated a statistically significant improvement in overall survival for patients who received nivolumab plus ipilimumab vs those treated with chemotherapy. Median overall survival was 18.1 months versus 14.1 months (Hazard ratio [HR], 0.74; P = .002).

Median progression-free survival per blinded independent central review was 6.8 months in the nivolumab plus ipilimumab arm and 7.2 months in the chemotherapy arm (HR, 1.0). The confirmed overall response rate was 40% vs 43% in the immunotherapy and chemotherapy arms, respectively.

Median response duration was 11.0 months in the nivolumab plus ipilimumab arm and 6.7 months in the chemotherapy arm. At 24 months, 32% of the immunotherapy patients were still experiencing a response compared with 8% of those in the chemotherapy arm.

The recommended doses for unresectable malignant pleural mesothelioma are nivolumab 360 mg every 3 weeks and ipilimumab 1 mg/kg every 6 weeks until disease progression or unacceptable toxicity, or up to 2 years in patients without disease progression.

The most common adverse reactions (incidence ≥ 20%) in patients receiving combination immunotherapy were fatigue, musculoskeletal pain, rash, diarrhea, dyspnea, nausea, decreased appetite, cough, and pruritus.

New Standard of Care?

The trial "met its primary endpoint of statistically improving overall survival for the experimental arm vs chemotherapy in a prespecified interim analysis," reported study author Paul Baas, MD, PhD, Netherlands Cancer Institute, Amsterdam, The Netherlands, at the time of its presentation.

He also suggested that it should therefore "be considered as a new standard of care."

https://www.medscape.com/viewarticle/938530