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Gottlieb predicts “a lot of death and disease” before end of the year as COVID cases rise

Washington — With the number of confirmed coronavirus cases continuing to rise in states across the country, Dr. Scott Gottlieb, the former commissioner of the Food and Drug Administration, warned that there is going to be “a lot of death and disease” from now until the end of 2020.

“We’re in a difficult situation heading into the fall,” Gottlieb said Sunday on “Face the Nation.” “I think the only caveat is in terms of us being better prepared for this wave, is that we have dramatically improved clinical care in hospitals. So I think we’re going to have better outcomes overall, but we’re still going to have a lot of death and disease between now and the end of the year.”

There have been more than 7.7 million confirmed cases of the coronavirus in the U.S., and 15 states have a positivity rate above 10%. Forty states have an expanding epidemic, Gottlieb said, and hospitalizations are also rising.

In looking ahead to how the country will fare in the weeks ahead, Gottlieb predicted the U.S. is “going to face a difficult fall and winter.”

“What we thought might be just a bump after Labor Day clearly is a resurgence in a virus heading into the fall and the winter,” he said. “You’re seeing cases build across the entire country.”

The coronavirus swept through the halls of the White House this month, as President Trump, first lady Melania Trump and at least two dozen people in the president’s orbit have tested positive for COVID-19. Mr. Trump spent three days at Walter Reed National Military Medical Center receiving treatment for the coronavirus, which included a dose of Regeneron’s antibody cocktail, which he has since heralded as a “cure” for the virus.

On Saturday, White House physician Dr. Sean Conley said the president is “no longer considered a transmission risk to others,” but did not specify whether Mr. Trump has tested negative for the coronavirus.

Gottlieb, however, said the president will likely not test negative for “a period of time.”

“We know that people continue to shed virus for a long period of time, but that’s dead virus,” he said. “It’s a virus that doesn’t grow in a culture, can’t really pass on the infection. There are indications that the president’s no longer infectious.”

Gottlieb added it’s safe to assume Mr. Trump is no longer contagious, as he has been symptom-free for several days and has not had a fever for more than 24 hours.

“I think the question now is, has his health been restored?” he said. “And we know that a lot of patients have lingering effects from COVID.”

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Deaths could approach 400,000 by February, model predicts

The US coronavirus death toll could almost double to about 400,000 by February, an influential model predicts.



a person standing on a sidewalk: People walk through Times Square near Broadway and an empty theater district on October 9, 2020 in New York City. (Photo by Spencer Platt/Getty Images)


© Spencer Platt/Getty Images)
People walk through Times Square near Broadway and an empty theater district on October 9, 2020 in New York City. (Photo by Spencer Platt/Getty Images)

This comes as the country reports the highest number of daily Covid-19 infections in almost two months, with experts offering grim outlooks if Americans don’t take precautions.

The latest forecast projects 394,693 US coronavirus deaths by February 1, 2021. That’s about 181,000 additional lives lost beyond the current US death toll of 213,860, according to data from Johns Hopkins University.

The model, from the Institute for Health Metrics and Evaluation at the University of Washington School of Medicine, projects that daily deaths in the US will peak at about 2,300 in mid-January.

For comparison, Friday’s US death toll was 990, according to Johns Hopkins.

The new projections are based on current conditions. If the US eases social distancing mandates, the number of deaths could be 502,852 by February 1, the model says.

Masks make a difference, experts say. If 95% of people in the US wore them, the model projects, 79,000 fewer lives would be lost by February 1, and daily deaths would peak at less than 1,400.

Globally, the model predicts that 2,488,346 people will die from coronavirus by February 1. The model shows that if 95% of people around the world wore masks, more than three-quarters of a million lives would be saved by that date.

US cases highest since August

Johns Hopkins reported a total of 57,420 new US cases on Friday.

That is the most reported cases in a single day since August 14, when there were 64,601 new cases, the data show.

Friday’s surge of 57,420 cases marks the third consecutive day of 50,000+ reported cases in the US, Johns Hopkins says. The last time the US reported three consecutive days of more than 50,000 cases was also in mid-August.

Now Florida, which over the summer became the country’s hotspot, is “ripe for another large outbreak,” an infectious disease expert told CNN. Late last month, the state cleared the way for bars and restaurants to fully reopen and this week reported more than 6,000 cases over a two day-period.

“What they’ve done is opened up everything as if nothing had ever happened there, and you and I could be talking probably in eight to 10 weeks, and I will likely bet that Florida will be a house on fire,” Michael Osterholm, the director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told CNN Friday.

White House Coronavirus Task Force coordinator Dr. Deborah Birx also cautioned Friday of “early suggestions” of alarming trends in the Northeast, urging residents to take action and help prevent the spread before the virus takes off again.

“The actions this time have to happen at the personal level, in our private homes, rather than just the public spaces,”

Kansas health chief predicts bigger COVID-19 spikes to come

TOPEKA, Kan. (AP) — The top public health official in Kansas said Wednesday that the state has yet to see its biggest wave of coronavirus cases, suggesting the pandemic could spawn an average of 800 or even 900 new cases a day in coming months.

Dr. Lee Norman, the head of the state Department of Health and Environment, said Kansas is likely to surpass the record numbers of new confirmed and probable cases it has recently seen. The state had an average of 646 new cases a day for the seven days ending Wednesday, second only to the 667 cases per day for the seven days ending Monday.

While the state’s most populous counties have continued to generate hundreds of new cases every week, rural areas also have been seeing spikes. And health department data released Wednesday showed that outbreaks have returned to the state’s prison system.

The health department said Kansas saw 1,120 new confirmed and probable cases since Monday, an increase of 1.9%, bringing the total to 59,729. Norman said he thinks the state will see cases level off at the current daily increases, then “take off” for a “second wave.”


Norman said the likelihood of larger numbers demonstrates the need for continued “vigilance” in wearing masks and social distancing. He said efforts in March and April that included a statewide stay-at-home order and the closing of K-12 schools, cut down on the numbers of new cases but, “we would prefer not to go down that road again.”

“We have a long ways to go,” Norman said during a Statehouse news conference. “That really brings up, focuses on, why we need a vaccine.”

The number of coronavirus cases is thought to be higher because people can be infected without feeling ill and because of limited testing early in the pandemic. Norman said he believes Kansas is “close” to having its actual number of cases represent 3% to 5% of its population — from 87,000 to 145,000 cases.

For most people, the new coronavirus causes mild or moderate symptoms, such as fever and cough that clear up in two to three weeks. For some, especially older adults and people with existing health problems, it can cause more severe illness and death.

In Kansas, COVID-19-related deaths continue to represent about 1.1% of the number of reported cases.

The state health department reported 41 new COVID-19-related deaths since Monday, bringing the total to 678. However, the department said 21 of those occurred earlier this year and were reported after officials examined death certificates.

The health department also reported that there are active clusters of five or more cases in four prisons and an inmate work-release program in Wichita. They account for 244 cases within the past 14 days.

The health department said the prison in Hutchinson has had 85 active cases in the past two weeks and the state’s prison mental health center in Larned has had 79.

The state saw a massive outbreak at its prison in Lansing earlier this

High TMB Predicts Response to Pembrolizumab

Tissue tumor mutation burden (tTMB) has been under study for some time as a biomarker that could predict which patients are most likely to respond to immunotherapy.

In June, it was approved by the US Food and Drug Administration as a biomarker for pembrolizumab (Keytruda) use in patients with advanced cancers who have progressed on prior therapy.

Now the data supporting that approval have been published in Lancet Oncology.

They come from analysis of outcomes from 790 patients who participated in the phase 2 KEYNOTE-158 study of treatment with pembrolizumab in 10 tumor-type-specific groups.

The results show better responses in patients who had a high tissue TMB (≥10 mutations per megabase), which was found in 102 (13%) of the 790 participants.

The majority of these patients (87%) did not have high tTBM.

Of the 102 patients with high tTMB, 29% achieved an objective response to pembrolizumab compared with 6% in the non-tTMB-high group. In addition, the median duration of response was not reached in the tTMB-high group vs 33.1 months in the non-tTMB-high group.

An expert not involved with the study was enthusiastic about the results.

“This gives clinicians treating patients with any metastatic solid tumor the possibility of offering immunotherapy with pembrolizumab to those whose tumors have a TMB greater than 10 mutations per megabase,” said Matthew R. Zibelman, MD, assistant professor, Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.

“The real win here is not for clinicians but for the patients who may get access to this drug with an opportunity for a meaningful response, ” he said.

TMB is essentially a measurement of the number of somatic mutations within a tumor and defined as the total number of somatic mutations per coding area of a tumor genome, he explained.

“Currently, its use as a predictive marker to choose treatment remains investigational in most clinical settings,” Zibelman told Medscape Medical News. “This testing is becoming standard in most commercially available next-generation sequencing platforms offered, and has been looked at as a potential biomarker in several tumors, including non-small cell lung cancer and melanoma,” he added.

Zibelman suggested that the results should now be implemented into clinical practice. “Testing should be offered to all patients with metastatic solid tumors, particularly those without prior approvals for immunotherapy agents specific to their indication,” he said.

“Clear Advantage”

“The higher the TMB, the greater the number of neoantigens expressed by the tumor, enhancing the probability of cancer cells being recognized by the immune system. This simple but captivating rationale likely underlies the clear advantage from pembrolizumab treatment found for patients with tTMB-high tumors, in terms of objective response and duration of response,” writes Melissa Bersanelli, MD, Medical Oncology Unit, University Hospital of Parma, Italy, in an accompanying editorial.

The authors showed the usefulness of tTMB status even in tumors that are well known to be poorly immunogenic, such as small cell lung cancer, she noted.

However, in this setting of rare tumors where there are few viable options and limited