October, 23 2020, 12:00am EDT
FDA's COVID-19 Vaccine Emergency Use Authorization Would Rely on Seriously Deficient Vaccination Data
Sidney Wolfe Testifies Before FDA COVID-19 Vaccine Committee
WASHINGTON
The U.S. Food and Drug Administration recently increased some requirements for granting an Emergency Use Authorization (EUA) for a COVID-19 vaccine, but serious deficiencies remain, Sidney Wolfe, founder of Public Citizen's Health Research Group, said in testimony Thursday before the agency's Vaccines and Related Biological Products Advisory Committee. The hearing followed a protest outside of the U.S. Department of Health and Human Services building where activists demanded a safe, effective, accessible and free COVID-19 vaccine.
Public confidence in a COVID-19 vaccine continues to wane, and rushing a vaccine through an EUA without complete Phase 3 safety and efficacy data, which could take months to complete, would further undermine public confidence.
Wolfe asked the committee, "Based on incomplete Phase 3 trials, will your advisory committee have enough confidence, despite all this missing data, to recommend authorizing a vaccine, for use in tens of millions of people, when an EUA is requested? The gap between completed Phase 3 trials needed for approval and the current EUA standard, allowing half of Phase 3 trial participants to be followed for less than two months after vaccination does not engender confidence. Saving time by a faster but riskier data-deficient EUA pathway will surely be outweighed by further loss in public confidence in an incompletely tested, vaccine, accompanied by decreased willingness to be vaccinated."
Public Citizen is a nonprofit consumer advocacy organization that champions the public interest in the halls of power. We defend democracy, resist corporate power and work to ensure that government works for the people - not for big corporations. Founded in 1971, we now have 500,000 members and supporters throughout the country.
(202) 588-1000LATEST NEWS
'The Next Recession Starts Here': Trump Team Weighs Abolishing Bank Regulators
The president-elect's advisers are reportedly discussing plans to shrink or eliminate key bank watchdogs, including the Federal Deposit Insurance Corporation.
Dec 13, 2024
President-elect Donald Trump and his advisers are reportedly considering plans to weaken—or abolish altogether—top bank regulators, including the Federal Deposit Insurance Corporation and Office of the Comptroller of the Currency.
The Wall Street Journalreported Thursday that members of Trump's transition team and the new Elon Musk-led Department of Government Efficiency have asked nominees under consideration to head the FDIC and OCC if the bank watchdogs could be eliminated and have their functions absorbed by the Treasury Department, which is set to be run by a billionaire hedge fund manager and crypto enthusiast.
"Bank executives are optimistic President-elect Donald Trump will ease a host of regulations on capital cushions and consumer protections, as well as scrutiny of consolidation in the industry," the Journal reported. "But FDIC deposit insurance is considered near sacred. Any move that threatened to undermine even the perception of deposit insurance could quickly ripple through banks and in a crisis might compound customer fears."
The Trump team's internal and fluid discussions about the fate of the key bank regulators broadly aligns with Project 2025's proposal to "merge the Office of the Comptroller of the Currency, the Federal Deposit Insurance Corporation, the National Credit Union Administration, and the Federal Reserve's non-monetary supervisory and regulatory functions."
The FDIC, which is primarily funded by bank insurance premiums, was established during the Great Depression to restore public trust in the nation's banking system, and the agency played a central role in navigating the 2023 bank failures that threatened a systemic crisis.
Observers warned that gutting the FDIC and OCC could catalyze another economic meltdown.
"The next recession starts here," tech journalist Jacob Silverman warned in response to the Journal's reporting.
Eric Rauchway, a historian of the New Deal, wrote that "even Milton Friedman appreciated the FDIC," underscoring the extreme nature of the incoming Trump administration's deregulatory ambitions.
Musk, the world's wealthiest man, is also pushing for the elimination of the Consumer Financial Protection Bureau, an agency established in the wake of the 2008 financial crisis.
The Journal noted Thursday that "Rep. Andy Barr, a Republican from Kentucky and Trump ally on the House Financial Services Committee, has backed the plan to eliminate or drastically alter the CFPB and said he wants to get rid of what he calls 'one-size-fits-all' regulation for banks."
Barr has received millions of dollars in campaign donations from the financial sector and "introduced many pieces of pro-industry legislation, including significant rollbacks of protections stemming from the 2008 financial crisis," according to the watchdog group Accountable.US.
Keep ReadingShow Less
UN Chief Warns of Israel's Syria Invasion and Land Seizures
United Nations Secretary-General António Guterres stressed the "urgent need" for Israel to "de-escalate violence on all fronts."
Dec 12, 2024
United Nations Secretary-General António Guterres said Thursday that he is "deeply concerned" by Israel's "recent and extensive violations of Syria's sovereignty and territorial integrity," including a ground invasion and airstrikes carried out by the Israel Defense Forces in the war-torn Mideastern nation.
Guterres "is particularly concerned over the hundreds of Israeli airstrikes on several locations in Syria" and has stressed the "urgent need to de-escalate violence on all fronts throughout the country," said U.N. spokesperson Stephane Dujarric.
Israel claims its invasion and bombardment of Syria—which come as the United States and Turkey have also violated Syrian sovereignty with air and ground attacks—are meant to create a security buffer along the countries' shared border in the wake of last week's fall of former Syrian President Bashar al-Assad and amid the IDF's ongoing assault on Gaza, which has killed or wounded more than 162,000 Palestinians and is the subject of an International Court of Justice genocide case.
While Israel argues that its invasion of Syria does not violate a 1974 armistice agreement between the two countries because the Assad dynasty no longer rules the neighboring nation, Dujarric said Guterres maintains that Israel must uphold its obligations under the deal, "including by ending all unauthorized presence in the area of separation and refraining from any action that would undermine the cease-fire and stability in Golan."
Israel conquered the western two-thirds of the Golan Heights in 1967 and has illegally occupied it ever since, annexing the seized lands in 1981.
Other countries including France, Russia, and Saudi Arabia have criticized Israel's invasion, while the United States defended the move.
"The Syrian army abandoned its positions in the area... which potentially creates a vacuum that could have been filled by terrorist organizations," U.S. State Department spokesperson Matthew Miller said at a press briefing earlier this week. "Israel has said that these actions are temporary to defend its borders. These are not permanent actions... We support all sides upholding the 1974 disengagement agreement."
Keep ReadingShow Less
Sanders Says 'Political Movement,' Not Murder, Is the Path to Medicare for All
"Killing people is not the way we're going to reform our healthcare system," he said. "The way we're going to reform our healthcare system is having people come together."
Dec 12, 2024
Addressing the assassination of UnitedHealthcare CEO Brian Thompson and conversations it has sparked about the country's for-profit system, longtime Medicare for All advocate Sen. Bernie Sanders on Wednesday condemned the murder and stressed that getting to universal coverage will require a movement challenging corporate money in politics.
"Look, when we talk about the healthcare crisis, in my view, and I think the view of a majority of Americans, the current system is broken, it is dysfunctional, it is cruel, and it is wildly inefficient—far too expensive," said Sanders (I-Vt.), whose position is backed up by various polls.
"The reason we have not joined virtually every other major country on Earth in guaranteeing healthcare to all people as a human right is the political power and financial power of the insurance industry and drug companies," he told Jacobin. "It will take a political revolution in this country to get Congress to say, 'You know what, we're here to represent ordinary people, to provide quality care to ordinary people as a human right,' and not to worry about the profits of insurance and drug companies."
Asked about Thompson's alleged killer—26-year-old Luigi Mangione, whose reported manifesto railed against the nation's expensive healthcare system and low life expectancy—Sanders said: "You don't kill people. It's abhorrent. I condemn it wholeheartedly. It was a terrible act. But what it did show online is that many, many people are furious at the health insurance companies who make huge profits denying them and their families the healthcare that they desperately need."
"What you're seeing, the outpouring of anger at the insurance companies, is a reflection of how people feel about the current healthcare system."
"What you're seeing, the outpouring of anger at the insurance companies, is a reflection of how people feel about the current healthcare system," he continued, noting the tens of thousands of Americans who die each year because they can't get to a doctor.
"Killing people is not the way we're going to reform our healthcare system," Sanders added. "The way we're going to reform our healthcare system is having people come together and understanding that it is the right of every American to be able to walk into a doctor's office when they need to and not have to take out their wallet."
"The way we're going to bring about the kind of fundamental changes we need in healthcare is, in fact, by a political movement which understands the government has got to represent all of us, not just the 1%," the senator told Jacobin.
The 83-year-old Vermonter, who was just reelected to what he says is likely his last six-year term, is an Independent but caucuses with Democrats and sought their presidential nomination in 2016 and 2020. He has urged the Democratic Party to recognize why some working-class voters have abandoned it since Republicans won the White House and both chambers of Congress last month. A refusal to take on insurance and drug companies and overhaul the healthcare system, he argues, is one reason.
Sanders—one of the few members of Congress who regularly talks about Medicare for All—isn't alone in suggesting that unsympathetic responses to Thompson's murder can be explained by a privatized healthcare system that fails so many people.
In addition to highlighting Sanders' interview on social media, Congressman Ro Khanna (D-Calif.) pointed out to Business Insider on Wednesday that "you've got thousands of people that are sharing their stories of frustration" in the wake of Thompson's death.
Khanna—a co-sponsor of the Medicare for All Act, led in the House of Representatives by Congressional Progressive Caucus Chair Pramila Jayapal (D-Wash.)—made the case that you can recognize those stories without accepting the assassination.
"You condemn the murder of an insurance executive who was a father of two kids," he said. "At the same time, you say there's obviously an outpouring behavior of people whose claims are being denied, and we need to reform the system."
Two other Medicare for All advocates, Reps. Maxwell Frost (D-Fla.) and Alexandria Ocasio-Cortez (D-N.Y.), also made clear to Business Insider that they oppose Thompson's murder but understand some of the responses to it.
"Of course, we don't want to see the chaos that vigilantism presents," said Ocasio-Cortez. "We also don't want to see the extreme suffering that millions of Americans confront when your life changes overnight from a horrific diagnosis, and people are led to just some of the worst, not just health events, but the worst financial events of their and their family's lives."
Sen. Elizabeth Warren (D-Mass.)—a co-sponsor of Sanders' Medicare for All Act—similarly toldHuffPost in a Tuesday interview, "The visceral response from people across this country who feel cheated, ripped off, and threatened by the vile practices of their insurance companies should be a warning to everyone in the healthcare system."
"Violence is never the answer, but people can be pushed only so far," she continued. "This is a warning that if you push people hard enough, they lose faith in the ability of their government to make change, lose faith in the ability of the people who are providing the healthcare to make change, and start to take matters into their own hands in ways that will ultimately be a threat to everyone."
After facing some criticism for those comments, Warren added Wednesday: "Violence is never the answer. Period... I should have been much clearer that there is never a justification for murder."
Keep ReadingShow Less
Most Popular