Sunday, October 25, 2020
Tuesday, October 20, 2020
The BIDEN CRIME FAMILY'S Payoff Scheme | Rudy Giuliani's EXCLUSIVE Reaction •Oct 14, 2020
Many or most of the 220,000 deaths in the United States to date could have been prevented by widespread HCQ use that the FDA blocked.
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FDA obstruction: Patients die, while Trump gets the blame
In a recent Washington Post op-ed, seven former FDA commissioners claimed that the agency has lost credibility with the public, and they blamed it on President Trump.
Jumping on the same bandwagon, an editorial in the once-venerable New England Journal of Medicine accused the president of "failing at every step" to stop the COVID-19 pandemic, thus enabling more than 220,000 deaths to date.
In reality, these charges are driven by craven politics and Big Pharma conflicts of interest. They divert attention from the FDA’s despicable efforts to block access to effective and inexpensive generic medications. Foremost among these is hydroxychloroquine.
Let’s take this in steps.
First, who is bringing these charges? The seven commissioners include David Kessler — adviser for the Biden campaign; Scott Gottlieb — board of directors of Pfizer and consultant to many pharmaceutical companies; Mark McClellan — board of directors of Johnson & Johnson; Robert Califf — extensive ties with many of the largest pharmaceutical companies; Andrew von Eschenbach — board of directors of the biotech company BioTime and director of Viamet Pharmaceuticals; and Jane Henney — who has served on the board of directors of AstraZeneca.
Many of these companies manufacture patented COVID-19 vaccines and medications. These products are in direct competition with generic, low-cost drugs that FDA has been asked to approve for outpatient COVID-19 use, but that it has refused.
Not to be outdone, the New England Journal of Medicine editorial was led by Deputy Editor Lindsey Baden, who disclosed that he is involved in COVID-19 vaccine clinical trial work conducted in collaboration with the National Institutes of Health, COVID-19 Vaccine Prevention Network, and Crucell/Janssen, Moderna, the Gates Foundation, and the Ragon Institute.
Baden is also chair of the Antimicrobial Drug Advisory Committee of the FDA. Not only is Baden, because of his role with the FDA, motivated to deflect blame from the agency, but he appears to be incentivized financially to tilt the COVID-19 response away from inexpensive generic medications and toward patented and massively profitable vaccines.
The reality is that the FDA has undermined its own credibility, and it has done so brazenly in plain sight. No president was needed for that, as I’ll explain.
As background, one must understand that COVID-19 patients are typically hospitalized because they have developed a severe and life-threatening pneumonia, one that fills the lungs with inflammatory debris and causes abnormal blood clotting in the lungs and small blood vessels. This advanced and dangerous condition, often described as acute respiratory distress syndrome, or ARDS, is entirely different from early “outpatient” (that is, outside the hospital) manifestations of COVID-19, which typically consist of a self-limiting, flu-like illness. We are thus speaking of two very different groups of patients. This distinction between COVID-19 outpatient and inpatient, of course, is well known to the FDA.
And yet, on July 1, the FDA posted on its website a large, black-letter warning against using hydroxychloroquine, or HCQ, to treat outpatients: “FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting.” The FDA justified this warning — stated on the website, just beneath the warning itself — by referring to safety concerns among hospitalized patients.
The FDA does not mention the crucial distinction between evidence for outpatients and inpatients. It does not mention the large body of evidence that HCQ is safe when used in COVID-19 outpatients. It does not mention that HCQ is currently being used safely by millions of outpatients with lupus and other rheumatological conditions. Nor does the FDA mention that HCQ has been safely used worldwide by hundreds of millions of persons, equaling tens of billions of doses, over more than half a century.
And finally, the FDA does not mention that it has no data showing adverse events in outpatient use. In short, among relatively healthy outpatients, HCQ has amassed one of the deepest and most extensive safety records of any drug in history, and the FDA’s warning implication of general harm is an outright lie.
On Aug. 18, Republican Sens. Ron Johnson, Ted Cruz, and Mike Lee sent a letter to FDA Commissioner Stephen Hahn asking the FDA to justify its public warning. After a seven-week delay, the FDA gave a vacuous non-response that contained no data on outpatient adverse events. Yet, the black-letter warning remains on the FDA website. That warning has caused state medical and pharmacy licensing boards to block physicians and patients from obtaining HCQ, and it has caused large health systems, medical groups, individual doctors, and other care providers to shun HCQ altogether.
Why is this important? There is extensive evidence that HCQ, when used within the first five days of symptom onset, produces a sharp and statistically significant reduction in hospitalization and mortality. Seven controlled, well-conducted clinical studies show this: 636 outpatients in São Paulo, Brazil; 199 clinic patients in Marseille, France; 717 patients across a large HMO network in Brazil; 226 nursing-home patients in Marseille; 1,247 outpatients in New Jersey; 100 long-term care institution patients in Andorra (between France and Spain); and 7,892 patients across Saudi Arabia.
All of these studies pertain to the early treatment of high-risk outpatients, and all showed 50% or higher reductions in hospitalization or death. Not a single fatal cardiac arrhythmia attributable to the HCQ was reported among these thousands of patients. In addition, a new summary analysis of five randomized controlled trials has also shown a statistically significant outpatient benefit, proving the case.
The inability of COVID-19 outpatients to obtain prescriptions for HCQ — a medication that along with zinc, vitamin D, antibiotics, and likely steroids will almost certainly prevent them from hospitalization and death — stems entirely from FDA’s refusal to remove its fictional website warning, and its refusal to grant HCQ emergency use authorization in spite of the major evidence of benefit. That evidence is much stronger than that involved in the FDA’s approval of convalescent plasma, and especially of its approval of remdesivir, which has now been proven ineffective.
Many or most of the 220,000 deaths in the United States to date could have been prevented by widespread HCQ use that the FDA blocked. It is the FDA that is responsible for these deaths, not the president. It is sheer corrupt hypocrisy, and completely shameful, for past FDA commissioners and for a New England Journal of Medicine editor with ties to the FDA to accuse the president of what the FDA itself has done.
It is time to clean up this mess once and for all. The FDA must remove its black-box warning, approve the emergency use authorization for outpatient HCQ use, and let doctors get on with the work of saving lives.
Harvey Risch, M.D., Ph.D., is professor of epidemiology at Yale School of Public Health.
Thursday, October 15, 2020
Why Won't Joe Biden Repudiate Anti-Semitic Democrats?
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President Trump has fought anti-Semitism ‘everywhere and anywhere’ By Jackson Richman
President Trump has fought anti-Semitism ‘everywhere and anywhere’
(October 14, 2020 / JNS) Boris Epshteyn, a strategic advisor for U.S. President Donald Trump’s 2020 campaign, has been the campaign’s point person for Jewish outreach for a while now, though the “Jewish Voices for Trump” coalition only launched in September.
Lately, he has repeatedly called for his counterpart on the campaign of Democratic presidential nominee Joe Biden, Aaron Keyak, to debate him. However, the Biden campaign told JNS last month that Keyak will not do so.
Epshteyn, 38, and his wife, Lauren, have one son.
JNS talked with Epshteyn by phone on Oct. 7. The interview has been edited for brevity and clarity.
Q: Can you describe your background, especially where you are from and how your identity plays a role in the re-election campaign for U.S. President Donald Trump?
A: I’m originally from the former Soviet Union; I came here in 1993 from Moscow. We were Jewish refugees. I worked on the John McCain campaign, was a surrogate on the Mitt Romney campaign, then I was a supporter, then a surrogate and then senior advisor overseeing surrogate messaging on the 2016 Trump campaign. I was communications director for the inauguration, assistant communications director at the White House. I was the chief political commentator at Sinclair Broadcast Group, and now I’m the strategic advisor at the Trump campaign, and I’m the co-chair of “Jewish Voices for Trump.”
In terms of my Jewish background, it’s obviously extremely important to me, and I’m proud to be the point person for Jewish outreach for the Trump campaign and make it clear he is the most pro-Israel president in the history of this country. It’s definitely been promises made, promises kept.
On the international front and domestically, the president has fought anti-Semitism everywhere and anywhere. He’s enabled federal agencies to combat anti-Semitism as a hate crime. He has fought anti-Semitism on college campuses, classifying it as a violation of a hate crime under Title VI of the 1964 Civil Rights Act. We just saw the first settlement under such auspices between New York University and the U.S. Department of Education. The president also signed the 2017 JUST Act. He also signed the Never Again Education Act, which provides $10 million for education on the Holocaust for our younger generations.
Q: Why was the Jewish outreach effort only launched last month?
A: To be fair, while the official coalition was launched the day after the Abraham Accords were signed, we had been having events geared throughout the Jewish community, including back in May, when we commemorated the second anniversary of the move of the U.S. embassy to Jerusalem. So the campaign has been focusing on outreach to the Jewish community throughout its time. Meanwhile, we’ve put together the advisory board and did all the logistics around that. We rolled that out in September. But our outreach has been in place throughout the campaign and definitely throughout this year.
Q: Why didn’t the president condemn white nationalists during the first presidential debate?
A: He did.
Q: He said he was willing to, but didn’t actually do so.
A: You asked, let me answer. When [Fox News anchor and debate moderator] Chris Wallace asked him if he condemns white nationalists, Trump said, “Sure.” And did so repeatedly. However, the question was supposed to be, “Does Joe Biden condemn Antifa?” but that never ended up being asked of Joe Biden. And Joe Biden mentioned the Proud Boys. The president has come out and condemned the Proud Boys and white nationalists. People on the left attack the president for everything, and many of those in the media try to find some sort of hole somewhere to attack the president, but he’s been absolutely clear in his condemnation of white supremacists, white nationalists, the KKK and the Proud Boys.
If anybody out there thinks the president of the United States—he has a Jewish daughter, Jewish grandchildren, Jewish son-in-law, has had Jewish people surrounding him throughout his career in business and now has had Jewish people surrounding him in senior positions in his administration—is anything close to anti-Semitic, they’re absolutely kidding themselves. All they have to do is look at the facts.
Q: Most Jews vote Democratic and place numerous issues above that of the U.S.-Israel relationship. How can the Trump campaign increase its share of the Jewish vote? And how can it appeal to voters who like Trump’s pro-Israel accomplishments, but don’t like his temperament?
A: In terms of increasing the percentage, we’ve actually seen that improvement. The president got roughly 25 percent in 2016. He’s polling at 30 percent right now, and I do think there’s a hidden Trump voter in there—probably 5 percent to 10 percent—so I think the numbers are even better than that. If you look at Joe Biden, he’s way below what Hillary Clinton was in 2016. He’s coming in at about 67 percent right now, and if that were to hold through Election Day, it would be the lowest for any Democratic presidential candidate since Michael Dukakis in 1988, and we all know how that turned out.
So Jewish voters are moving towards President Trump. I think that’s going to continue, and I think the keys to do that are through events and discussions.
Q: What would a second Trump term mean for the Jewish community?
A: The continued support of Israel is obviously vital to the Jewish community. Continuing to fight against anti-Semitism is vital for the Jewish community. As long as President Trump is in office, Jewish Americans are safe from the rabid anti-Semitism of the far-left.
Q: If he wins a second term, how does the president plan to address growing anti-Semitism in the United States, not only on the far-left but also on the far-right?
A: The president has absolutely fought against anti-Semitism, and that’s what the executive order last year does. It doesn’t just fight anti-Semitism everywhere, not just the far-left. The president will continue to support the DOJ and the federal agencies in fighting anti-Semitism.
Q: In three sentences: Why should Jewish and pro-Israel voters cast their vote for Trump?
A: Combating anti-Semitism. Championing Israel. Making America great again.