Tag: Election

 

The final 2020 presidential election debate



Donald Trump, Joe Biden are posing for a picture


© Getty Images


Donald Trump’s more sedate debate performance on Thursday night was a departure in tone from his chaotic performance weeks ago, but the President continued to cast his warped view of the world as truth.

In reality, Trump’s performance was riddled with false claims, on topics ranging from the coronavirus to foreign policy to immigration. And while former Vice President Joe Biden made some missteps and stretched the truth at times, his comments essentially hewed to the truth.

Trump came into the debate needing to clean up from his first performance and he clearly listened to his advisers who urged him to turn down the heat and stop his incessant interruptions. But the President relied heavily on the same rhetoric that fills his raucous rallies and Twitter feed, just set at a lower volume. His lies ranged from the political, like when he falsely claimed the coronavirus was “going away” or that a vaccine to end the pandemic was ready, to the personal, like when he falsely said Biden has “houses all over the place” or lied about Biden receiving millions of dollars from Russia. And his lies were clearly aimed at politically important issues, like health care, the economy and coronavirus, three topics that voters say are critical to them as they head to the ballot box.

Biden’s misstatements were more on the margins, like when he falsely claimed that he never said he opposed fracking, understated the number of people for whom Trump has granted clemency and made a misleading claim about health care coverage losses under Obamacare.

CNN’s team watched the second and final presidential debate. Here are the facts.

Coronavirus

Trump: Coronavirus is ‘going away’

Trump claimed the virus is going away. “We’re rounding the corner. It’s going away,” Trump said.

Facts First: This is false. The US coronavirus situation — as measured by newly confirmed cases, hospitalizations and the test positivity rate — is getting worse, not better. There is no basis for his vague claim that we are “rounding the corner.”

Trump has baselessly claimed for eight months that the virus would disappear or was currently disappearing.

Holmes Lybrand

Biden: An additional 200,000 Americans will die from Covid-19 by the end of the year

Biden said: “The expectation is we’ll have another 200,000 Americans dead the time between now and the end of the year.”

Facts First: This needs context.

One study published in October in the medical journal JAMA showed that there were more than 225,000 excess deaths in a five-month period at the start of the year as a result of the Covid-19 pandemic, compared to past years. (Excess deaths are the number of deaths beyond what historic numbers of deaths have been in a similar time period.) The study then predicted that the total number of excess deaths would likely be greater than 400,000. But as of Thursday evening, 223,000 Americans have lost their lives to Covid-19, according to data from Johns Hopkins University.

These are merely

On The Trail: A third coronavirus wave builds just before Election Day

A new wave of viral infections is washing over the nation just weeks before Election Day, putting a new spotlight on a crisis that has come to define President TrumpDonald John TrumpJudge rules to not release Russia probe documents over Trump tweets Trump and advisers considering firing FBI director after election: WaPo Obama to campaign for Biden in Florida MORE’s struggle for re-election.

For months, public health experts have warned of an increase in the number of cases that would accompany lower temperatures in the fall and winter. As people move inside more, they said, the coronavirus was likely to spread.

Those predictions have come true — earlier and more significantly than expected.

“We’re in a really precarious time,” said David Rubin, a pediatrician who runs the PolicyLab at the Children’s Hospital of Philadelphia, whose models show devolving situations across much of the nation. The pandemic “is accelerating, and it’s accelerating quickly. We’re now seeing hospitals exceeding capacity in the Upper Midwest, in Salt Lake, where hospitals are filling up, and it’s just mid-October.” 

The number of new coronavirus infections confirmed over the last week rose in 44 states compared to the week prior, according to The Hill’s analysis. Cases have declined for two or more consecutive weeks in just two states, California and Hawaii.

Several states now rank at the top of the worst outbreaks in the world. In North Dakota, where Gov. Doug Burgum (R) has resisted any new restrictions, the per capita infection rate last week was 711 per 100,000 residents — a rate more than twice as high as New York’s during its initial surge in April, and almost two times larger than the worst outbreaks in states like Arizona and Florida over the summer.

More than one in every 200 residents of South Dakota, and more than one in every 250 residents of Montana and Wisconsin, tested positive for the virus in just the past seven days. Texas recorded 36,000 new cases in the last week, while Illinois, California and Florida all reported more than 20,000 additional cases.

Case data show that more younger people are contracting the virus. While those younger people are less likely to be hospitalized or die, more infections will by nature lead to more people in the hospital. And those younger people, even asymptomatic ones, may become vectors who expose older and less healthy people with whom they come into contact.  

“What we know from the experience from the summer is that rising cases in younger people tends to be followed by a rise in cases among more vulnerable people,” said Rich Besser, a former director of the Centers for Disease Control and Prevention who now heads the Robert Wood Johnson Foundation. “If you look at the curves and the trends in America, they’re very concerning.”

Already, Wisconsin has opened an auxiliary field hospital to deal with surging demand for care. More than 80 percent of intensive care unit beds in Alabama, Kentucky and Rhode Island are occupied.

The Alliance for Regenerative Medicine Announces Election of 2021 Officers, Executive Committee, and Board of Directors

Washington, DC, Oct. 21, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — The Alliance for Regenerative Medicine (ARM), the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies, announced today the election of its 2021 Officers, Executive Committee, and Board of Directors.

The Executive Committee and Board of Directors oversee the formation and execution of ARM’s strategic priorities and focus areas over the coming year. The committee and board are subject to an annual re-election or rotation process, with nominations and approval by the ARM membership and current Board.

“We are pleased to welcome such an accomplished group of executives to the 2021 ARM board of directors,” said Janet Lambert, CEO of ARM. “As scientists, commercial leaders, and regulatory experts, the new members of the board will be instrumental in helping ARM and its members deliver transformative and potentially curative regenerative medicines to patients around the world.” 

ARM 2021 Officers:

Emile Nuwaysir, Ph.D. – President and CEO, BlueRock Therapeutics (Chairman)

Usman ‘Oz’ Azam, M.D. – President and CEO, Tmunity Therapeutics (Vice Chairman)

Amy Butler, Ph.D. – President, Biosciences, Thermo Fisher Scientific (Secretary)

Devyn Smith, Ph.D. – COO, Sigilon Therapeutics (Treasurer)

ARM 2021 Executive Committee:
*new to the Executive Committee for 2021

Usman ‘Oz’ Azam, M.D. – President and CEO, Tmunity Therapeutics

Amy Butler, Ph.D. – President, Biosciences, Thermo Fisher Scientific 

* Miguel Forte, M.D., Ph.D. – CEO, Bone Therapeutics

Claudia Mitchell, MBA, Ph.D. – SVP, Product and Portfolio Strategy, Astellas Pharma

Emile Nuwaysir, Ph.D. – President and CEO, BlueRock Therapeutics 

Bob Smith, MBA – SVP, Global Gene Therapy Business, Pfizer Inc.

Devyn Smith, Ph.D. – COO, Sigilon Therapeutics

* Arthur Tzianabos, Ph.D. – President and CEO, Homology Medicines

* Christopher Vann – COO, Autolus Therapeutics 

ARM 2021 Board of Directors:
*new to the Board for 2021

Usman ‘Oz’ Azam, M.D. – President and CEO, Tmunity Therapeutics

Ronald Bartek – Co-Founder and President, Friedreich’s Ataxia Research Alliance

Amy Butler, Ph.D. – President, Biosciences, Thermo Fisher Scientific

Bradley Campbell, MBA – President and COO, Amicus Therapeutics

Cindy Collins, MBA – President and CEO, Editas Medicine

* Maria Fardis, Ph.D., MBA – President and CEO, Iovance Biotherapeutics

Miguel Forte, M.D., Ph.D. – CEO, Bone Therapeutics

Jonathan Garen, M.S. – CBO, uniQure

* Bobby Gaspar, M.D., Ph.D. – CEO, Orchard Therapeutics

Michael Hunt, ACA – CFO, ReNeuron

Jerry Keybl, Ph.D. – Senior Director, Cell & Gene Therapy, MilliporeSigma

* Louise Rodino-Klapac, Ph.D. – SVP, Gene Therapy, Sarepta Therapeutics

Ann Lee, Ph.D. – SVP and Head of Cell Therapy Development & Operations, Bristol Myers Squibb

* Dave Lennon, Ph.D. – President, Novartis Gene Therapies

Bruce Levine, Ph.D. – Barbara and Edward Netter Professor in Cancer Gene Therapy, and Founding Director, Clinical Cell and Vaccine Production Facility, Department of Pathology and Laboratory Medicine, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania

John Maslowski, M.S. – President and CEO, Castle Creek Pharmaceuticals

Claudia Mitchell, MBA, Ph.D. – SVP, Product and Portfolio Strategy, Astellas Pharma

* Adora Ndu, PharmD,

Affordable Care Act: Trump keeps chipping away at Obamacare with only weeks until the election — and a Supreme Court hearing

The administration this week approved Georgia’s waiver request to provide Medicaid coverage to certain low-income residents if they work or participate in other qualifying activities for at least 80 hours a month. It’s the latest state to receive permission to require work as a condition of coverage, though implementation elsewhere has been halted by federal courts or state officials.

Also, the Centers for Medicare and Medicaid Services announced it had completed its review of Georgia’s more controversial request to make fundamental changes to the state’s Affordable Care Act exchange. The agency, which opened the door for states to create alternatives to Obamacare in 2018, is still finalizing the terms for approval.

The Peach State, which has the nation’s third highest uninsured rate at 13.4%, is the first to seek this enhanced power to reshape its individual market.

Georgia and federal officials say that these efforts will make coverage more available and affordable to residents, but consumer advocates say they are the latest attempts to undercut the law.

“It’s a road map of what they would allow were the ACA to be struck down and were they to win election again,” said Judy Solomon, senior fellow at the Center on Budget and Policy Priorities.

These moves come as health care takes center stage in the 2020 presidential campaign. Former Vice President Joe Biden’s campaign has hammered Trump for trying to take down the landmark health reform law and its protections for those with pre-existing conditions. Trump has repeatedly said he has a replacement plan that would continue those safeguards but has yet to produce one.
Also, Trump’s Justice Department is backing a coalition of Republican-led attorneys general, who argue that Obamacare’s individual mandate was rendered unconstitutional after Congress reduced the penalty for not having insurance to zero as part of the 2017 tax cut law. As a result, the entire health reform law must fall, they argue. The Supreme Court will hear oral arguments in the case on November 10.
The administration has pursued multiple avenues to overturn the Affordable Care Act in its first term. After efforts to repeal the law in Congress failed in 2017, officials started undermining it from within, including shortening the annual enrollment period to obtain coverage on the exchanges and slashing the budget for outreach and assistance. It also broadened the availability of alternative plans, primarily short-term health insurance policies that typically have lower premiums but are allowed to base coverage and premiums on people’s medical histories.
Also, officials took the unprecedented step in 2018 of allowing states to institute work requirements in Medicaid, a longtime Republican goal. However, the effort has been set aside by federal courts in four states, prompting the six others that had received approval (prior to Georgia) to stop implementation. Another eight states are awaiting permission from the Centers for Medicare and Medicaid Services.

What Georgia wants to do

Georgia is not looking to expand Medicaid under the Affordable Care Act. The waiver only applies to those earning up to

Pfizer says it will not have a coronavirus vaccine until late November, allaying fears of a rush for approval before Election Day

Chief executive Albert Bourla wrote in the letter that while the company projects it may have enough data to determine whether the vaccine is effective in October, there will not be sufficient safety follow-up to satisfy criteria laid out by the Food and Drug Administration until late November.

“A key point that I’d like to make clear is that effectiveness would satisfy only one of the three requirements and, alone, would not be enough for us to apply for approval for public use,” Bourla said. “Safety is, and will remain, our number one priority.”

The letter was welcomed by Eric Topol, a physician-scientist at Scripps Research Translational Institute who joined other experts in writing to Bourla in late September, asking the company not to seek authorization for a vaccine before late November. Topol recently had a virtual meeting with company executives to express his concerns and said he was frustrated they would not answer directly whether they would seek broader use of a vaccine before Nov. 3.

Bourla’s emphasis on having data in October “is what got many of us concerned, whether it was inadvertently playing into the political pressure or just because the incentives were aligned,” Topol said. “I thought [the letter] was very good. I wish it had been done potentially even earlier.”

Bourla made clear that while the company won’t seek approval until reaching the safety threshold, it could announce data on whether the vaccine candidate works before the election.

Pfizer’s trial will ultimately include 44,000 study subjects, with half receiving two shots of its experimental vaccine and the other half receiving placebo inoculations. Neither participants, study investigators nor company executives know who received a vaccine and who did not. But periodically throughout the trial, an independent committee is examining the data to see whether the vaccine is protecting participants from infection, as demonstrated by far fewer cases of covid-19, the disease caused by the virus, in those getting the shots than those receiving a placebo.

“In the spirit of candor, we will share any conclusive readout (positive or negative) with the public as soon as practical, usually a few days after the independent scientists notify us,” Bourla wrote.

The FDA in October issued guidance explaining the criteria for an emergency use authorization, saying a vaccine given to healthy people will be held to a higher standard than the typically low threshold that a medical product “may be effective” for emergency use. The agency put forth a requirement — despite White House objections — that vaccine candidates must have a minimum of two months of follow-up data on half of the participants in the study.

Pfizer will not have such data until the third week of November. Moderna, a biotechnology company, will not have enough safety data to apply for regulatory authorization until two days before Thanksgiving, according to spokesman Ray Jordan. Two other late-stage vaccine trials, from AstraZeneca and Johnson & Johnson, are paused because of potential safety concerns and have previously predicted readouts from their

Don’t Expect a COVID Vaccine before the Election

During a press conference in early September, President Donald Trump was asked when he thought a vaccine for COVID-19 might become available. His prediction was upbeat: “We’re going to have a vaccine very soon,” Trump said. “Maybe even before a very special day—you know what day I’m talking about.”

Trump was referring, of course, to the presidential election on November 3. But the odds of a vaccine materializing for public use before then appear slim. New drugs and vaccines ordinarily go through a lengthy review process prior to regulatory approval. Vaccines for COVID-19, however, are widely expected to be released under emergency use authorization (EUA) protocols, which allow for the sale of unapproved medical products during national health crises. On October 6 the White House agreed to new EUA guidelines that call on COVID-19 vaccine developers to monitor their phase III clinical trial subjects for at least two months for side effects and severe disease. The U.S. Food and Drug Administration, which administers EUAs, will host a widely anticipated meeting on October 22 to address standards for efficacy, safety and manufacturing of COVID-19 vaccines. But the FDA’s recommended two-month observation period puts a preelection vaccine approval out of reach.

EUAs could, however, make the first successful COVID-19 vaccines available to frontline workers by the start of 2021, although distribution in the general U.S. population will take longer, starting with elderly and other high-risk groups, and then younger healthier people who may not have access to them until late in the year, according to Paul Offit, a pediatrician and director of the Vaccine Education Center at Children’s Hospital of Philadelphia. The FDA has already granted hundreds of COVID-related EUAs for products such as diagnostic tests, medical devices and therapies—including for convalescent plasma and hydroxychloroquine (the latter was later revoked).

“All the COVID-19 vaccine developers are going for an EUA first,” says Eric Topol, a cardiologist and head of the Scripps Research Translational Institute in La Jolla, Calif., who has directed numerous multinational clinical trials (although none for vaccines). “It makes no sense to wait for formal licensure.”

Defining Success

Obtaining an EUA hinges on how independent reviewers judge a vaccine’s performance during periodic readouts of phase III clinical trial data. The trials are each enrolling tens of thousands of people and are also double-blinded—meaning that neither the subjects nor the experimenters know which participants got a vaccine versus a placebo. They were designed to continue until the number of symptomatic infections reaches 150 in the vaccinated and control groups combined. If a vaccine halves the risk of symptomatic infections among the vaccinated group, it will meet the FDA’s minimum bar for approval.

Reviewers examining the interim data readouts will be looking for better protection than that. Pfizer, which began a phase III trial for its vaccine on July 27, plans to conduct its first readout when the number of symptomatic cases reaches 32. The company expects that could happen this month, making it first in line for a potential EUA. Statistical