Pence’s office says he did not attend swearing-in due to CDC guidelines

Asked why Pence did not attend the ceremony, the official said in a statement: “As has been the case, the vice president has been adhering to the CDC guidelines for essential personnel.”

The decision comes days after five Pence aides, including his bodyman and Marc Short, his chief of staff, tested positive for coronavirus.

In the wake of the cases among his staff, Pence has insisted on maintaining an aggressive campaign schedule — a decision which runs counter to the CDC’s guidelines recommending individuals self-quarantine in the event of close contact with a person who has tested positive for coronavirus.

And though Pence has been heeding the guidelines at the events himself, he continues to host campaign events that actively ignore CDC guidelines on mask usage and social distancing among his supporters.

So far, Pence and second lady Karen Pence have continued to test negative for the virus. But Pence’s decision to continue to travel, given that he leads the White House’s coronavirus task force, has drawn scrutiny.

The administration official underscored that Pence is taking precautions on the road, saying that the vice president “has been wearing a mask on the helicopter, airplane, off the plane and onto the stage, in his cabin.”

Pence skips public health recommended self-quarantine but does change plans after staff outbreak

The official also noted that Pence’s regional media interviews have been canceled and during rallies, “When he removes his mask on stage he is greater than 20 feet from the audience.”

A person familiar with the vice president’s plans previously told CNN that the team traveling with Pence is slimmed down. Pence will also nix any rope lines or greetings with supporters at the events.

The White House has defended Pence’s continued travel and work as part of his duties as an essential worker. And while that may apply to his work in his official capacity as vice president and head of the coronavirus task force, it’s not clear how continuing to campaign falls under those duties.

The vice president has also been inconsistent in his adherence to the CDC’s guidelines.

Pence returned to Washington, DC, from the campaign trail in order to be available in case a tie-breaker was needed for Barrett’s confirmation vote. Democrats discouraged the vice president from coming near Capitol Hill for the vote.

Prior to the cases among his staff, a maskless Pence has been a frequent sight on the campaign trail.

But Monday night’s White House event for Barrett marked one of the first times the White House has implemented social distancing protocols and mandated mask-wearing.
The event came a month after a White House Rose Garden event to announce Barrett’s nomination — which has been labeled by public health experts as a coronavirus superspreader event. Attendees sat outdoors, shoulder-to-shoulder during the event, infrequently wore masks and were generally not practicing social distancing.

At least a dozen people who were at the announcement in late September confirmed they had contracted the coronavirus shortly after their attendance.

CNN’s Sarah Westwood and Daniella Diaz contributed to this report.

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Consensus Guidelines Address Inpatient Diabetes Technology

A new consensus statement offers detailed guidelines for inpatient use of continuous glucose monitors (CGM) and automated insulin delivery (AID) systems.

Aimed at clinicians, researchers, and hospital administrators, the open-access document was recently published by a multidisciplinary international panel of 24 experts in the Journal of Diabetes Science and Technology.

The statement includes 77 separate recommendations under five headings: 1) continued use of CGM by patients already using them at home, 2) initiation of CGM in hospital, 3) continuation of AID systems in hospital by patients already using them at home, 4) logistics and hands-on care of hospitalized patients using CGM and AID systems, and 5) data management of CGM and AID systems in hospital.

“This is the most comprehensive and up-to-date guideline on the use of diabetes technology in the hospital now,” lead author Rodolfo J. Galindo, MD, told Medscape Medical News in an interview.

“Overall, most experts believe that CGM and AID have the potential to overcome the current limitations of glycemic monitoring in the hospital to improve patient outcomes but we need research, first to get the approval and second to get widespread use,” said Galindo, medical chair of the hospital diabetes taskforce at Emory Healthcare System, Atlanta, Georgia. 

COVID-19 Changed Everything

The guideline is an update of a 2017 statement on hospital use of CGM. The new guideine adds AID systems — sometimes referred to as an artificial pancreas, which combines a CGM and insulin pump and uses an algorithm to guide insulin delivery — and is the first to be developed during the COVID-19 era.

The update had been planned prior to the pandemic, but the actual panel meeting took place in April 2020, after the US Food and Drug Administration allowed inpatient use of CGM despite lack of official approval.

“COVID-19 changed everything…We had to be more specific about how to implement CGM in these patients. The standard of care is hourly point-of-care glucose monitoring in the [ICU], and at least every 4 hours outside the ICU. With limited [personal protective equipment] and the burden on nursing it was unachievable,” Galindo explained.

In June 2020, Galindo and other guideline authors developed a COVID-19-specific document (also open-access), which goes more into detail about CGM and how to implement in-hospital use during the pandemic.

The current consensus guideline “provides a high-level review of the evidence by experts,” Galindo added.

Recommendations Cover Different Technologies and Hospital Settings

The panel “strongly” advises that hospital providers consult with an inpatient diabetes team, if available, to help manage patients already using CGM prior to admission. Among other recommendations, they list several situations in which CGM data should not be relied upon for management decisions, including severe hyper- or hypoglycemia, diabetic ketoacidosis, or in patients with skin infections near the sensor site.

The panel also call for more research into outcomes for CGM continuation in the hospital and optimal implementation of both CGM and point-of-care glucose testing. For hospitals, strong recommendations include developing standard CGM data reports and

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New guidelines address rise in opioid use during pregnancy

Opioid use in pregnancy has prompted new guidance from the American Academy of Pediatrics, aimed at improving care for women and newborns affected by their mothers’ drug use.

The number of affected women and infants has increased in recent years but they often don’t get effective treatment, and the pandemic may be worsening that problem, said Dr. Stephen Patrick, lead author of the academy report released Monday.

“While we have been talking about the opioid crisis for years, pregnant women and their newborns seldom make it to the top of the heap. Infants are receiving variable care and not getting connected to services,” said Patrick, a Vanderbilt University pediatrician.


The academy’s report says pregnant women should have access to opioid medication to treat opioid misuse. Two opioids, buprenorphine and methadone, are effective treatments but pregnant women often face stigma in using them and doctors who prescribe them are scarce.

The academy says hospitals should written protocols for assessing and treating opioid-affected newborns. Many don’t and practices vary widely.

Breastfeeding and other practices that promote bonding should be encouraged, and parent education and referral to services for affected newborns should be provided, the academy says. Its recommendations echo guidance from other medical groups and the U.S. government.

“This is a substantial public health problem that is still lacking solutions,” Patrick said.

According to the federal Centers for Disease Control and Prevention, 7% of U.S. women reported in 2019 that they had used prescription opioids during pregnancy. One in 5 of those women reported misusing the drugs while pregnant.

Some infants born to these women develop symptoms of opioid withdrawal, including tremors, fussiness and diarrhea.

By some U.S. estimates, nearly 80 affected infants are diagnosed every day on and the numbers have tripled in recent years.

Patrick has done research suggesting that these infants may be at risk for developmental delays, but says it’s possible those findings reflect use of alcohol or other drugs during pregnancy, poor prenatal care or stress.

“Getting into treatment may be getting even harder” because of the pandemic, he said. “There’s so much going on in the world that that issues involving opioid use are flying under the radar.”

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Follow AP Medical Writer Lindsey Tanner at @LindseyTanner.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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RNA COVID Vaccines; Down Syndrome Guidelines: It’s TTHealthWatch!

TTHealthWatch is a weekly podcast from Texas Tech. In it, Elizabeth Tracey, director of electronic media for Johns Hopkins Medicine, and Rick Lange, MD, president of the Texas Tech University Health Sciences Center in El Paso, look at the top medical stories of the week. A transcript of the podcast is below the summary.

This week’s topics include two RNA SARS-CoV2 vaccines, an inactivated vaccine, a look at who’s willing to be vaccinated, and guidelines for managing Down syndrome manifestations.

Program notes:

1:06 RNA vaccines

2:00 Similar immune responses young or old

3:00 Inactivated virus

3:10 Vaccine hesitancy

4:10 Vaccine attributes multiple

5:12 Suggests ways to address hesitancy

6:13 Rigorously tested even for an EUA

6:41 An inactivated viral vaccine

7:42 Inactivated vaccines must be made properly

8:44 Not a narrow vaccine

9:12 Guidelines for managing Down syndrome manifestations

10:13 Literature survey

11:12 Congenital heart disease common

12:45 End

Transcript:

Elizabeth Tracey: When a SARS-CoV-2 vaccine comes across the transom, will you take it?

Rick Lange: Report on a promising inactivated whole-virion COVID vaccine.

Elizabeth: What’s the best care for people with Down syndrome?

Rick: And the safety and immunogenicity of two RNA-based COVID vaccines.

Elizabeth: That’s what we’re talking about this week on TT HealthWatch, your weekly look at the medical headlines from Texas Tech University Health Sciences Center in El Paso. I’m Elizabeth Tracey, a Baltimore-based medical journalist.

Rick: And I’m Rick Lange, president of Texas Tech University Health Sciences Center in El Paso, where I’m also dean of the Paul L. Foster School of Medicine.

Elizabeth: And right now in the nation’s hotspot, I would say, relative to battling COVID-19. How’s it going?

Rick: You know, it’s really tough here. I think we have the highest number of cases per capita across the U.S. and increasing. It’s a really tough time in El Paso right now, so some of the stuff we’re talking about is very relevant.

Elizabeth: Yeah. Let’s turn, then, to… why don’t you talk about the first vaccine candidate that you’d like to illustrate?

Rick: Okay. This is a report from Pfizer and a company called BioNTech that is one of those vaccines that’s in phase III trials, so this is the initial report of their phase I and phase II trials. BioNTech and Pfizer launched a coordinated program to compare four RNA-based COVID-19 vaccine candidates. They did it in Germany initially and then brought it to the U.S.

This is a report on two of those RNA-based vaccines and how they decided for one over the other. I’m going to call them B1 and B2, because that’s what they call them. B1 is a RNA vaccine directed towards the receptor-binding domain. They took three of these domains and actually bound them together, which could be more antigenic, and the B2 was they took the whole spike protein.

They tested these in individuals 18 to 55 and those 65 to 85, and they did multiple different doses of these. What they discovered is

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Innovative Medicines Canada Responds to Release of Patented Medicine Prices Review Board’s (PMPRB) Final Guidelines

Press release content from Accesswire. The AP news staff was not involved in its creation.

OTTAWA, ON / ACCESSWIRE / October 23, 2020 / Innovative Medicines Canada (IMC) issued the following statement today in response to the release of PMPRB’s final Guidelines:

“For the last five years we have raised concerns about the negative impact PMPRB’s amendments to the Patented Medicines Guidelines and Regulations will have on Canadian patients. The final Guidelines released today do nothing to relieve those concerns.

“If implemented, they will have a negative impact on Canadian patients. Specifically, innovative new medicines will not launch in Canada, depriving patients of potentially life-changing new treatments; we will see further reductions in the number of clinical trials in this country; and our life sciences sector will lose out on critical investments.

“The height of a global public health crisis is the worst possible time to implement regulatory changes that will have such a direct and negative impact on Canadian patients. This is made even worse because the Guidelines released today are the result of an inadequate consultation process that largely ignored the significant concerns raised by industry, patients, researchers and others.

“Fortunately, there is still time to find a better path. Our members remain committed to their offer to work with government on a solution that meets their important public policy objectives, without undermining Canadians’ access to new medicines, or driving away investment.

“In the meantime, we will continue to ask that Health Canada delay the January 01, 2021 implementation of the final PMPRB Guidelines until after the COVID-19 crisis is passed. At this time our collective focus should only be on the discovery, development and delivery of COVID-19 medicines to treat those infected by the virus, and vaccines to halt its spread.”

About Innovative Medicines Canada

Innovative Medicines Canada is the national voice of Canada’s innovative pharmaceutical industry. We advocate for policies that enable the discovery, development and commercialization of innovative medicines and vaccines that improve the lives of all Canadians. We support our members’ commitment to being valued partners in the Canadian healthcare system.

For further information:

Samantha Thompson

Media Relations

Telephone: 613-790-4555

E-mail:

SOURCE: Innovative Medicines Canada

View source version on accesswire.com:

https://www.accesswire.com/611988/Innovative-Medicines-Canada-Responds-to-Release-of-Patented-Medicine-Prices-Review-Boards-PMPRB-Final-Guidelines

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Guidelines for approving a coronavirus vaccine will be the focus of FDA advisers meeting Thursday

The vaccine advisory committee, meeting remotely in an all-day session, will not review a specific vaccine because no company has applied for the FDA’s imprimatur. Rather, the group will provide views on the FDA’s standards governing whether a vaccine is sufficiently safe and effective to warrant an emergency use authorization. It will also weigh in on the conduct of clinical trials once a vaccine is cleared and monitoring safety on an ongoing basis.

Even a general discussion is an important milestone, especially after protracted political melodrama involving the vaccine review process, experts said.

“The visual of scientists sitting around the table carefully discussing what a safe and effective vaccine might look like is an important moment for the FDA,” said Jason L. Schwartz, assistant professor of health policy and management at the Yale School of Public Health. “For months, all the FDA could do was offer promises about how science would guide its decisions on the vaccine. This shows how that will happen as data begins to come in.”

The panel will offer the agency advice for navigating the “extraordinary and unprecedented steps” of clearing a vaccine on an emergency basis, said M. Miles Braun, former director of the FDA’s division of epidemiology and an adjunct professor at the Georgetown University School of Medicine, during a media briefing Wednesday. FDA officials will want to know they are “on firm ground, and not missing any issues,” Braun said.

The FDA has said it will hold additional advisory committee meetings to consider applications from vaccine makers, which could begin arriving as soon as mid-November.

The panel, called the Vaccines and Related Biological Products Advisory Committee, is made up mostly of academic experts in infectious diseases, immunology and biostatistics. Some members recused themselves because they work at hospitals where coronavirus vaccine trials are being conducted or are involved in the trials. They were replaced by temporary members, including Arnold Monto, a University of Michigan epidemiologist who will serve as committee chairman, according to documents on the FDA website.

The FDA on Wednesday posted the topics it wants to discuss with the committee, including the effects of vaccines in specific populations. One of the most complicated questions centers on how to continue clinical trials after a vaccine is authorized. Should participants who received the placebo be notified and allowed to get the vaccine? If so, will that hurt the trial’s ability to collect useful data on an ongoing basis, and how can that be mitigated?

The FDA has used advisory committees for decades to bulk up its expertise and win buy-in from the public and outside scientists on its decisions. The FDA is not required to take advice from the panels but often does. The vaccine committee is expected to play an especially important role given the political pressure exerted by the White House on the FDA in recent weeks and months.

The White House held up the guidance, but the FDA circumvented the blockade by publishing it as part of briefing materials provided

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CDC updates its guidelines for close Covid-19 contact after prison guard gets infected

The US Centers for Disease Control and Prevention has updated its definition of a close contact with a Covid-19 patient to include multiple, brief exposures, after a Vermont prison worker appears to have been infected that way, CDC Director Dr. Robert Redfield said Wednesday.



a man and a woman sitting on a bench: People gather on the pier at the Pacific Ocean on the first day of the Labor Day weekend amid a heatwave on September 5, 2020 in Santa Monica, California.


© Mario Tama/Getty Images
People gather on the pier at the Pacific Ocean on the first day of the Labor Day weekend amid a heatwave on September 5, 2020 in Santa Monica, California.

The new definition includes exposures adding up to a total of 15 minutes spent six feet or closer to an infected person. Previously, the CDC defined a close contact as 15 minutes of continuous exposure to an infected individual.

The agency changed the definition after a report from Vermont of a corrections officer who became infected after several brief interactions with coronavirus-positive inmates — none of them lasting 15 minutes, but adding up over time.

The corrections officer never spent much time with any particular inmate, but opened and closed cell doors, collected soiled linen, opened doors to shower and recreation rooms for inmates, conducted health checks and dispensed medication, Julia Pringle, a CDC officer working with the Vermont Department of Health, and colleagues reported.

The six inmates had no symptoms and had traveled from out-of-state facilities while they were awaiting coronavirus test results, Pringle’s team reported in the CDC’s weekly report, the MMWR.

His 22 short encounters added up to about 17 minutes of total exposure, the team calculated.

The data suggests at least one of the six inmates transmitted the virus to the officer during one of these brief encounters. The six inmates wore microfiber cloth masks for some, but not all interactions with the officer. “During all interactions, the correctional officer wore a microfiber cloth mask, gown, and eye protection (goggles),” the team wrote.

Redfield said it’s an example of real-world science informing policy. The CDC has now updated its definition of what constitutes a close contact.

“As we get more data and understand the science of Covid, we are going to incorporate that in our recommendations,” Redfield said at a news conference held at CDC headquarters in Atlanta.

“Originally, contact that was considered to be high risk for potential exposure to Covid was someone within six feet for more than 15 minutes,” Redfield added.

The new data is being incorporated into recommendations, he said.

“In an MMWR published today, CDC and Vermont health officials found that multiple, short and non-consecutive exposures to persons confirmed to have COVID-19 led to transmission,” the CDC said in a statement.

“The CDC website now defines a close contact as someone who was within 6 feet of an infected person for a total of 15 minutes or more over a 24-hour period. Previous language defined a close contact as someone who spent at least 15 minutes within 6 feet of a confirmed case.”

The website notes that this is not an exact science

“Factors to consider when defining close contact include proximity (closer

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DVIDS – News – Aerospace Medicine Implements Return to Flight Duty Status Guidelines for Aircrew Affected by COVID-19


As much of the military works to maintain readiness in the face of the Coronavirus (COVID-19), Aerospace medicine providers are working to implement a guideline with a set of return to flight duty status protocols. The guideline describes how Service members who are in a ‘down’ flight status may safely return to an ‘up’ flight status after close contact or contracting COVID-19.

These protocols were developed in response to Navy and Marine Corps Aerospace Medicine COVID-19 cases and are promulgated to synchronize the community’s approach to medical evaluation when returning aircrew to flight duty status. The protocols within the guideline are reviewed biweekly to incorporate the most updated national guidelines and current published research.

“The return to flight duty status guideline is critical to maintaining operational readiness amongst our aircrew and return them safely to the cockpit,” said CDR Allen Hoffman, Branch Head of Aerospace Medicine Programs at the U.S. Navy Bureau of Medicine and Surgery.

These protocols provide a basic framework for our squadron flight surgeons who will also use their sound clinical judgement when comprehensively evaluating each patient. The guideline details step by step how aircrew can return to flight duty status if they are determined to have contracted the virus or had close contact with someone who has contracted COVID-19.

“There are important clinical criteria for aerospace providers to follow if aircrew contracts COVID-19. For example, it is imperative that the provider follow-up with the infected individual once they have recovered to determine if they have optimal respiratory function and returned to a the physical fitness level necessary to safely operate in the flight environment,” said CDR Hoffman.

To know whether affected aircrew are able to safely operate an aircraft, they must meet set physical standards during a series of tests, including a physical exercise tolerance test. Some of those tests help determine if there are still any remaining functionally limiting damage caused by COVID-19.

“The medical evaluation and information in the guidance will ensure our aircrew are ready to fly after contracting COVID-19. Their health and safety is our first and foremost mission in supporting the warfighter,” said CDR Hoffman.

The official guidance will be published in the Naval Aerospace Medical Institute’s, Aerospace Reference and Waiver Guide by mid-November.

Navy Medicine is a global health care network of 63,000 personnel that provide health care support to the U.S. Navy, Marine Corps, their families and veterans in high operational tempo environments, at expeditionary medical facilities, medical treatment facilities, hospitals, clinics, hospital ships and research units around the world.

For more information about Navy Medicine, visit www.med.navy.mil





Date Taken: 10.20.2020
Date Posted: 10.20.2020 15:19
Story ID: 381341
Location: FALLS CHURCH, VA, US 




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