FDA Relaxes Rules To Allow for More Ventilators, Finally
“The Food and Drug Administration (FDA) is easing up on some regulations so that ventilators can be manufactured and implemented more quickly to respond to the spread of COVID-19.”
Lone Candle
Champion of Truth
“The Food and Drug Administration (FDA) is easing up on some regulations so that ventilators can be manufactured and implemented more quickly to respond to the spread of COVID-19.”
“Unbeknownst to many Americans, we’ve been hurtling toward a worsened conflict with Iran for nearly two years now. The Trump administration has been quietly escalating against the country and its allies using a selection of counterterrorism laws, many of them passed after 9/11, that allowed it to act without going through Congress or the public. Former President Barack Obama, meanwhile, left a force in the region to counter the Islamic State that the Trump administration eventually pointed against the Islamic Republic.
Trump and his advisors objected to the violence carried out by Iran and its proxies across the Middle East. They also disliked Obama’s “nuclear deal,” which lifted U.S. economic sanctions on Iran in order to get international inspectors access to the country’s nuclear research program. So in 2018, the Trump administration replaced Obama’s deal with a campaign of sanctions aimed at forcing the Iranian government to change a range of foreign and domestic policies.”
“The single most important failure of the U.S. response to COVID-19, the disease caused by the novel coronavirus, has been the slow rollout of testing. This was an abject failure of bureaucracy. But it was also a failure of presidential leadership.
The countries that have had the most success in containing the outbreak, such as South Korea and Singapore, have done so through early, rapid, and widespread testing and contact tracing, followed by targeted quarantines. South Korea and the United States discovered initial cases of the coronavirus on the same day in January. Since then, some 290,000 people in South Korea have been tested and new daily cases have fallen from 909 to just 93. Despite a much larger population, the United States, tested just 60,000 people in the same period of time.”
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“Much of the failure to make mass testing available lies with the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). As a Wall Street Journal report makes clear, the CDC, which managed the development of the initial test kits, botched the job in just about every possible way: The CDC not only produced a faulty test that had to be retracted but adopted narrow testing criteria that meant many people with symptoms simply couldn’t be tested.
Perhaps most disastrously, as The Washington Post reports, federal health agencies initially declined to certify tests produced by private companies that were better suited for rapid mass testing anyway. This is despite the fact that experts, including the former head of the FDA, were publicly recommending that they do so as early as February 2.
The CDC was following its usual protocols, developing initial diagnostic tests on its own in order to maintain quality control, as it usually does. But that’s exactly the problem.”
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“But this was also a failure of political leadership, most notably from President Donald Trump. For weeks, Trump and senior White House officials actively downplayed the threat of the virus.
As late as February 25, National Economic Council adviser Larry Kudlow was offering assurances that the coronavirus was “contained” and that it was “pretty close to airtight.” Trump treated the virus with similar breeziness, suggesting that the virus was “going to disappear” and that while it might get worse, “nobody really knows.””
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“The problem here is obvious: Trump, who as the head of the executive branch oversees federal agencies such as the FDA, did not view the virus as a serious problem—and did not want others to view it that way either. That, in turn, translated into a downstream lack of urgency, which meant that critical aspects of the response were not prioritized. According to The Wall Street Journal, health officials who have examined the testing calamity have concluded that it was a result of both bureaucratic bumbling and a “broader failure of imagination,” in which Trump and other administration officials “appeared unable or unwilling to envision a crisis of the scale that has now emerged.”
The job of a president is to make decisions, set priorities, and convey clear information to both the public and the staff of the executive branch. This is especially important in a moment of crisis, when the executive is in charge of acting both quickly and with sound judgment. In this outbreak, Trump has failed on every count. Not only did he fail to see the threat even when it was apparent to experts, but he actively undermined preparedness by downplaying its significance far long after the problem was apparent, and by providing false and misleading information as the mitigation effort proceeded.”
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“The federal health bureaucracy deserves much of the blame for America’s faltering response to the coronavirus outbreak. But the president has made the fiasco worse.
The bureaucracy reports up to an executive, who is tasked with setting priorities and ensuring performance—and for taking responsibility when there are failures. Instead, Trump has inaccurately blamed the Obama administration for failures that occurred on Trump’s watch. (Indeed, under Barack Obama, diagnostic tests for swine flu were designed and approved in less than two weeks.) Asked whether any of this is his fault, the president rejected the idea, saying, “I don’t take responsibility at all.” Trump’s refusal to admit failures makes it more likely that he will repeat them, and that more Americans will pay the price.”
“If the policies and decisions above are worth tossing out in an emergency, maybe they ought to be sidelined during normal times too.
Situations like the 9/11 attacks and the coronavirus outbreak often open the door to naked power grabs whose terrible consequences stick around long after the events that inspired them (looking at you, TSA!). Governments rarely return power once they’ve amassed it. But if you listen carefully, you can hear them telling us what stuff they realize can be safely tossed. When the infection rates come down and the theaters and schools and everything else get back to normal, it may be tempting just to go back to the way we were. Resist the temptation: A lot of the rules we put up with every day are worth reevaluating, and not only during an emergency.”
https://www.yahoo.com/lifestyle/america-thirsting-over-boyfriend-andrew-203500245.html
https://www.politico.com/news/2020/03/22/minnesota-political-transformation-137289
“At the moderate end, among the media-skeptic pro-Trump crowd, the virus is real and it’s scary, but so are liberal overreach, open borders, government spending, breathless public-health fearmongering and criticism of Trump. At the extreme end, let’s call it Full QAnon, the outbreak is engineered by Chinese scientists, Big Pharma or criminal celebrities, and may or may not be real.”
“The Covid-19 crisis is exactly the kind of moment when we need our leaders to reassure and protect us most. Instead, recent reports suggest several United States senators responded by protecting themselves first, selling stock to avoid personal financial losses from a growing public health crisis that they knew, from confidential intelligence briefings, was probably going to be much worse than the public knew at the time.”
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“Should members of Congress even be permitted to trade securities or engage in significant outside business activities at all? I don’t think they should.”
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“This isn’t the first time that members of Congress have faced accusations that they misused information they learned on the job for their personal benefit. In November 2011, “60 Minutes” released an investigative report suggesting that several had engaged in extensive stock trading after learning secret details regarding the last financial crisis, in 2008-09. The problem was that while it looked and smelled like corruption, not everyone agreed that it violated federal securities laws.”
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“Members of Congress and their staffs learn a lot of information that the general public doesn’t know: They get briefings from others in government; they get selective information from large companies and trade associations. Congressional members are granted access to information precisely because they have the ability to influence outcomes, and they are entrusted to use their knowledge to make the best decisions for our country. Shouldn’t they then have a “duty” to not use the information they learn in their jobs for their own personal financial benefit?”
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“Why should we expect them to even be capable when making business decisions of separating what they know as a result of their governmental job and what they might otherwise know as private individuals?”
“Choosing to ban abortion in cases where rape caused pregnancy would be difficult to argue as biblically supported, as the Book of Numbers prescribes a potion that should cause sterility and perhaps even abortion as the enforced consequence of infidelity. As a result, it is hard to argue that the Bible always speaks out against abortion.”
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“All in all, the Bible does not speak as clearly about abortion as some politicians might wish. Where it does speak about pregnancy and abortion, the God-given character of human life is an important point of departure. On the one hand, there are passages that state how God has plans for some special human beings, his prophets, already during their stay in their mother’s womb. This implies that already at that stage God had selected them as the persons they would become. On the other hand, some passages indicate that human life was only thought to begin either at the moment the fetus was fully developed or even up to a month after the baby’s birth. It is therefore difficult to refer to anything like “the Bible’s teaching on abortion.” The Bible contains a diverse collection of views on the origin of human life. Any attempt to base a political strategy on the Bible should always indicate, for honesty’s sake, that such a “biblical view” is based on a conscious choice of passages and interpretations by each individual speaker.”