Overregulation of diagnostic testing has played a major role in delaying the U.S. response to the coronavirus outbreak. The existing rules have created a bottleneck in delivery of testing kits, slowing the process of detection of cases in Washington state for weeks, said a health policy expert.
“The problem is a holdover from the Obama administration,” Roger Klein, a physician, attorney, and health policy expert, told The Epoch Times.
“It’s not a rule. It’s not written down anywhere,” he said. “I don’t know if anybody in the Obama administration was even aware of it. This is a pretty obscure area.”
However, the Food and Drug Administration “got more assertive during the Obama administration and tried to get control over clinical laboratory testing” said Klein, who is also a former advisor to the FDA and former director of molecular pathology at Cleveland Clinic.
He noted that an FDA letter in 2016 during the Zika virus epidemic was good evidence for the agency’s practice. The agency sent a warning letter dated March 2016 to two hospitals in Houston asking them to get clearance and approval from the FDA for the test kits they had developed to detect the Zika virus….
Senate Minority Leader Chuck Schumer repeatedly criticized the president’s handling of the coronavirus response, urging him to expedite the approval of labs for testing.
“The United States is trailing countries around the world in our testing capacity,” Schumer said on March 11 on the Senate floor.
“I honestly don’t know why it has taken so long for the Trump administration to get a handle on testing, which is the most powerful tool in helping us respond to the spread of the virus.”
Trump blamed his predecessor, saying he had to overcome an Obama-era FDA regulation in order to more quickly provide diagnostic tests.
“The Obama administration made a decision on testing that turned out to be very detrimental to what we’re doing, and we undid that decision a few days ago so that the testing can take place in a much more accurate and rapid fashion,” Trump said at a meeting with airline executives on March 4 at the White House.
He was soon criticized by media for “falsely” claiming that he ended Obama-era rules.
“The president was right,” Klein said, adding that it wasn’t a regulation but a policy originated under Obama.
“I don’t know who initiated it, but I think it happened at the career level.”
To remove the barriers, the agency issued guidance on Feb. 29 expanding the number of laboratories eligible to provide testing. The agency said it would allow labs to create and use their own in-house tests immediately, without FDA review, as long as they completed an emergency use authorization (EUA) request within 15 days.
Robert Redfield, director of the Centers for Disease Control and Prevention, on March 4 at the White House meeting described the regulatory change made by the Trump administration.
“In the past, we used to be able to have laboratories that could develop what we call ‘laboratory-developed tests’ and then be able to apply them for clinical purposes. And in the previous administration, that became regulated so that now for someone to do that, they had to formally file with the FDA,” Redfield said.
And with recent changes, university labs and other labs in the country “can be fully engaged in developing laboratory diagnostics for the clinical arena,” he said.
There is an entire legal debate over whether the FDA should regulate lab-developed tests, according to experts.
“In my view, the hospital laboratories shouldn’t need to apply for EUAs,” Klein said.
He said the administration has taken the right step in providing regulatory relief, but there’s a further need to lighten the regulatory burden.
“The FDA doesn’t belong to this space,” he said. “The agency should not be involved in regulating these laboratories.”…
My question is whether the FDA should exist at all, given that it’s a hive of corporofascist intrigue. They still haven’t approved CBD for instance.
Even as VP Pence and CDC Director Robert Redfield said that up to 4 million tests would be distributed to labs across the country in the coming days, even as they admitted that only 5,000 Americans had been tested for the virus so far.
But as Politico reported last night, even as the Trump Administration plays catch up with distributing tests, its latest roadblock involves an inability to prepare samples for testing, creating uncertainty over the length of time for tests to produce results, which could also delay the response to the virus. The problem is related to something called “reagents”.
CDC Director Robert Redfield told Politico on Tuesday that he is “not confident” that US labs have an adequate stock of the “RNA extraction kits” needed to extract genetic material from any virus in a patient’s sample.
“The availability of those reagents is obviously being looked at,” he said, referring to the chemicals used for preparing samples. “I’m confident of the actual test that we have, but as people begin to operationalize the test, they realize there’s other things they need to do the test.”
The White House coronavirus task force is aware of the shortages and, as one official told Politico, the members are “working on it.” However, if the problem isn’t dealt with soon, all of those labs that have set up testing for the virus won’t be able to actually run their tests.
The growing scarcity of these “RNA extraction” kits is the latest trouble for US labs, which have struggled to implement widespread coronavirus testing in the seven weeks since the country diagnosed its first case. Epidemiologists and public health officials say that the delayed rollout, caused in part by a botched CDC test, has masked the scope of the U.S. outbreak and hobbled efforts to limit it.
If enough processing kits aren’t available, the risk that testing will be disrupted is “huge,” said Michael Mina, associate medical director of molecular diagnostics at Brigham and Women’s Hospital in Boston.
One company that makes these critical reagents said that its products are currently on back-order due to the enormous surge in demand.
Qiagen, a major supplier of the kits, confirmed that its product is backordered due to “the extraordinary pace” at which the world has increased coronavirus testing over the last few weeks….
Those ruling the healthcare industry have hijacked our health, but it’s not lost. The Rockefellers spearheaded the healthcare industry, policies, institutes, and eugenics over a century ago. From vaccine cocktails to fertility suppression and control over agriculture, it was a mad scientist’s dream. The Gates Foundation served to further these agendas, and before long, mankind became the greatest experiment. Bigger than that, was the need to control minds by way of perpetrating narratives that read like a heroic novel, with scientists and doctors ensuring ones health and wellbeing, creating the illusion of saviors for all of eternity. By no means did they want people being aware of their innate, natural healing abilities, our robust immune systems, the value of body, mind, and spirit, or taking a holistic approach to health. Flooding the markets with sugar was a surefire way to camouflage the necessity for nutrition. They have hijacked minds, and convinced man that their twisted scientific experiments were the way forward. But, man’s abilities to heal are not lost, they are merely stifled by the decades of brainwashing, fear mongering, and those who continue to rule the industry without accountability or oversight.
Recently, in South Dakota, Bill HB1235 to remove student vaccination requirements and allow parents to decide what medical interventions they wish for their children, was debated in an intense livestream. It was an historic, first-of-its-kind bill in the U.S. Unfortunately, it was voted down 10-2, for this year, but there was mention of the bill being brought back up in a summer study. Nonetheless, many incredible individuals fought for this, the audio is preserved, and it is a solid step in the right direction. We are gaining traction, and it has been witnessed through rallies and people speaking out all over the country – that safety concerns over vaccines need to be investigated STAT, and forcing mandatory injections of cocktails into our bodies and our children’s needs to be a choice, not law.
According to Lawrence Palevsky, a licensed pediatrician from New York City who spoke in support of the bill, he said that “science has changed,” and that “we are told with certainty that science has been done efficiently on vaccine safety, but yet if we read the ingredients in the vaccines, we will find that the ingredients have never been tested for injection of vaccines into human beings – children or adults.” He went on to say that “most of the ingredients are toxic and can enter the brain and lead to concerns that we are seeing in our children today. Our children have the highest number of chronic diseases of any country in the world.” He backed this up with the following statistics:
1 in 5 have learning disabilities
1 in 10 diagnosed with ADD or ADHD
1 in 11 diagnosed with asthma
1 in 12 with significant allergies
1 in 35 with autism
1 in 20 under the age of 5 with seizures
“Something is happening to the nervous system and the immune systems of our children, and the powers that be continue to insist that vaccine ingredients have nothing to do with these challenges that we are seeing in children,” Palevsky said. He continued to get into the science and falsehoods behind vaccines, and the human anatomy. It was a very compelling and informative statement – certainly worth a listen.
Dr. James Neuenschwander, from Ann Arbor, Michigan, a 30-year physician who is duly board certified in both emergency and integrative medicine, caring for chronically ill adults and children, blew the lid off the testing and safety issues surrounding vaccines. “With the exception of a small number of participants in one Gardasil trial, no vaccine has ever been subjected to a prelicensure, inert, placebo controlled trial. This is the gold standard of medicine. Without it, you don’t know what the side effects of your product are,” said Neuenschwander. He went on to state, “If vaccines were truly great at maintaining public health, we should have the healthiest infants and children in the entire world. We vaccinate more than any other industrialized nation in the entire world. But when we evaluate those outcomes, unfortunately, the opposite is true. Our pediatric rate of chronic diseases rose from 12% in 1986 up to over 50% in 2007. Mandates are a last ditch effort by a government to control its population. If vaccines were truly safe and effective, people would be lining up for them. There would be no reason to have mandates. If parents are not willing to accept a product for which there is no long term safety studies, they were poorly tested for approval, and have no liability, they should have that right.”
Kevin Barry, Former U.S. Attorney for southern district of New York, United Nations representative, author of a book called ‘Vaccine Whistleblower’ about fraud conducted by the CDC on vaccine studies, quoted from the Universal Declaration on Bioethics and Human Rights from 2005, which was unanimously adopted by 193 countries including the U.S. Based on its content, it is clear that mandatory and forced vaccines completely deny individual liberty, and goes against this entire declaration. ….
Joe Biden is once again celebrating after a big night on “Mini Tuesday.” The former vice-president won the popular vote in at least four of the six states on offer yesterday, putting him ahead of his last credible challenger, Bernie Sanders. At a rally in Philadelphia, he framed the contest as over, addressing the Vermont senator’s surrogates directly: “We need you, we want you, and there’s a place in our campaign for each of you. I want to thank Bernie Sanders and his supporters for their tireless energy and their passion,” he said. “We share a common goal, and together we’ll beat Donald Trump.”
Biden, a consummate Democratic insider, has received the wholehearted backing of the party’s establishment and the Democratic-aligned media. Yet his campaign is aware of his serious weaknesses both on his record and as a candidate. He has deliberately refrained from public or media appearances due to his propensity for making egregious errors. Democratic House Majority Whip Jim Clyburn suggested to NPR that the DNC should consider stepping in to “shut down” the contest, canceling any future debates in order to prevent Biden “getting himself into trouble;” something that could hurt the party come November.
This video shows that the autoworker says “this is not OK” in reference to Biden pointing his finger in his face, and Biden flips out and says “you want to take this outside?” pic.twitter.com/UN1Di19v0i
— abolish ICE abolish ICE abolish ICE abolish ICE ab (@OrganizingPower) March 10, 2020
Even as Clyburn was speaking, Biden was doing exactly what he feared. While making a publicity stop in Michigan, he was confronted by a union autoworker who challenged his stance on guns. An angry Biden immediately went on the attack. “You’re full of shit,” he said, while aggressively pointing at the man’s face and calling him a “horse’s ass.” After the autoworker asked him to stop behaving that way, Biden challenged him to a fight, telling him they should go outside.
While the video went viral online, corporate media did their best to sanitize it. MSNBC, for example, managed to cut out all of the above from the short confrontation, showing its viewers only a short clip where Biden lectures the man that he is pro-Second Amendment, also cutting out when he shushed his female colleague and threatened to slap the questioner. Host Andrea Mitchell then went on to attack the Sanders campaign for supposedly siding with Trump on the issue. The incident led many on social media to wonder aloud whether Twitter would flag MSNBC’s account as a purveyor of manipulated videos. Meanwhile, CNN editor-at-large Chris Cillizza spun the event as “probably a good thing for Biden.”…
Convicted rapist Harvey Weinstein purportedly suggested that Jennifer Aniston “should be killed” after wrongfully believing the actress was planning to report that he sexually assaulted her, writes The New York Times.
The publication cites sealed Manhattan Supreme Court documents made public ahead of Weinstein’s scheduled sentencing on 11 March for forcibly performing oral sex on former “Project Runway” production assistant Miriam Haleyi and third degree rape for an attack on hairstylist Jessica Mann.
The trove of unsealed documents is reported to contain emails penned by the former film producer upon learning that the National Enquirer was planning to publish a report based on allegations by “friends” star Jennifer Aniston that he sexually assaulted her.
On 31 October 2017, as the #MeToo allegations against Weinstein were gathering momentum, Sitrick public relations company executive Sallie Hofmeister, who was working as Weinstein’s spokeswoman, forwarded him an email from the Enquirer, according to the records.
“Not sure if you saw this one. Jennifer Aniston,” she wrote.
The email by the Enquirer said that “Jennifer confided to a friend that during the production of the 2005 movie ‘Derailed’ Weinstein sexually assaulted her by pressing up against her back in [sic] grabbing her buttocks.”
The Enquirer email went on to note:
“Through the years he would frequently stare at her cleavage/breast and move his mouth around making Jennifer uncomfortable… We also quote a source close to Jennifer who tells the Enquirer: ‘Harvey was infatuated with Jennifer Aniston — He had a massive crush on her and constantly talked about how hot she was.’”
According to cited records, after receiving the email, Weinstein responded to the spokeswoman with a message sent from his iPhone that read: “Jen Aniston should be killed.”
Weinstein allegations linked with Jennifer Aniston were never published by The Enquirer, as publicist Stephen Huvane, a spokesman for the actress, said:
“Jennifer has never been harassed or assaulted by Harvey Weinstein. He never got close enough to touch her and she has never been alone with him.” …
She may yet be killed, but probably not right away. This is the state of the pedocracy.
Humanitarian Joe was VP during the catastrophic (for libya and syria and the USA) obama administration. Somehow I doubt his intentions.
Presumably this is a shot at Trump. But epidemics of known R0 values are just a matter of mathematics. Who is responsible for advising the white house on this matter? Probably the CDC and/or NIH. Given the level of infiltration and betrayal within this administration (a reflection of Trump’s “outsider” status) this looks like a pre-election setup to me. But then again I’m a “conspiracy theorist” because I can see that transnational money interests are the only constituency that counts in washington or the WHO and the only news that counts in the perpetually incumbent media.
After weeks of exponentially rising death and suffering worldwide, with WHO’s major funding partner China perhaps having turned the corner, WHO Chief Tedros has finally decided to declare Covid-19 a Pandemic…
You would think at some point our liberal humanitarian medical establishment would connect the dots. Perhaps they’re afraid of being called racist. Or maybe they think there are too many black people in the world. Eugenics is so progressive.
In any case, apparently hospital buildings somehow “know” a woman’s skin color and act out their malevolence independently of the bias or blindness of medical researchers.
To examine within-hospital racial and ethnic disparities in severe maternal morbidity rates and determine whether they are associated with differences in types of medical insurance.
We conducted a population-based, cross-sectional study using linked 2010-2014 New York City discharge and birth certificate data sets (N=591,455 deliveries) to examine within-hospital black-white, Latina-white, and Medicaid-commercially insured differences in severe maternal morbidity. We used logistic regression to produce risk-adjusted rates of severe maternal morbidity for patients with commercial and Medicaid insurance and for black, Latina, and white patients within each hospital. We compared these within-hospital adjusted rates using paired t-tests and conditional logit models.
Severe maternal morbidity was higher among black and Latina women than white women (4.2% and 2.9% vs 1.5%, respectively, P<.001) and among women insured by Medicaid than those commercially insured (2.8% vs 2.0%, P<.001). Women insured by Medicaid compared with those with commercial insurance had similar risk for severe maternal morbidity within the same hospital (P=.54). In contrast, black women compared with white women had significantly higher risk for severe maternal morbidity within the same hospital (P<.001), as did Latina women (P<.001). Conditional logit analyses confirmed these findings, with black and Latina women compared with white women having higher risk for severe maternal morbidity (adjusted odds ratio [aOR] 1.52; 95% CI 1.46-1.62 and aOR 1.44; 95% CI 1.36-1.53, respectively) and women insured by Medicaid compared with those commercially insured having similar risk.
Within hospitals in New York City, black and Latina women are at higher risk of severe maternal morbidity than white women; this is not associated with differences in types of insurance.
Call someone by the wrong pronoun, or deny a biological male the right to use the women’s toilet and a person will feel the unbridled wrath of the Liberal inquisition. Ban an anti-war candidate in your own ranks, however, and that’s just par for course in the Democratic club.
‘Bad publicity is better than no publicity,’ as any marketer worth his salt understands. Yet Tulsi Gabbard, the anti-war, anti-interventionist Democratic presidential candidate, who should be the darling of every progressive, has virtually disappeared not only from the debate stage, but from the news cycle as well.
During Super Tuesday, the Iraq War veteran managed to pick up two delegates, which, under previous terms would have qualified her to participate, alongside Bernie Sanders and Joe Biden, in future Democratic debates on the road to the November elections. As predicted, however, the DNC changed the rules mid-game.
The DNC has banned the only woman left from the next Democrat debate. I don’t hear any complaints from the same women — Warren, Harris, Pelosi, et al — accusing “the country” of sexism.https://t.co/0DMVbMeLYp
— Mark R. Levin (@marklevinshow) March 7, 2020
Woman of color? Can we start talking about policies yet? Or if we have to be obsessed with race 24/7, can we start talking about the race of wealthy satanists who use every conceivable superficial characteristic to drive wedges between people in the name of combating institutional biases that they themselves cultivate for precisely that purpose?
BTW: if Tulsi is a woman of color I’m an eskimo. It doesn’t matter. Policies matter. It’s not nice to kill people in the service of empire no matter what your skin color is. Obama demonstrated just how superficial skin color can be. Tulsi is being excluded because of her politics, not her tokenized genetics.
Can we be grownups now?