Coronavirus

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January 12, 2021 Coronavirus

By Monday afternoon, of 25.5 million COVID-19 vaccine doses distributed across the United States, just 9 million had actually been administered to patients. That's well short of the government's goal of inoculating 20 million people by the end of 2020. Perhaps we shouldn't be surprised. Government-controlled markets are notoriously inefficient and subject to waste, fraud, and abuse. In this case, tragically, the consequences are deadly. Inexplicably, the government is moving with no real sense of urgency. In December in New York City, vaccinations effectively weren't...

January 6, 2021 Coronavirus

Dr. Henry Miller, M.S., M.D., joints the nationally-syndicated Lars Larson Show based out of Portland, Oregon, to discuss the latest issues with the production and distribution of the COVID-19 vaccine. Dr. Miller's interview begins at the 47:00 minute mark. Miller talks about his disappointment with the vaccine distribution, but also says that it wasn't entirely unexpected. When you put distribution on the states and farther down the chain, your going to have issues. Miller also says that the timing of the...

December 16, 2020 Coronavirus, Coronavirus - Alternate, Innovation

By Henry I. Miller, M.S., M.D. and John J. Cohrssen Few could have imagined a year ago that by now our world would be so profoundly changed by a pandemic that has killed more than 300,000 Americans; been confirmed in over 16 million; gone undiagnosed in scores of millions more; and caused debilitating, persisting symptoms in many who have “recovered.” Certainly, no credible drug manufacturer would have claimed that a new vaccine for this emerging infectious disease could go through all...

December 15, 2020 Coronavirus, Coronavirus - Alternate, Innovation

To the editor of the Wall Street Journal: Your editorial contains the statement: "There's no evidence that a three-week review is needed." You know this how, exactly? Has anyone at the Journal seen the data (which run to hundreds of thousands of pages)? Has anyone at the Journal ever seen, let alone touched, an application for approval of a drug or vaccine? I have. As an FDA reviewer, I found extraordinary complexity, and sometimes shortcomings or inconsistencies, in many submissions ....

December 15, 2020 Coronavirus, CoronaVirusSlide3, Innovation

Public Health And Economic Growth Are Two Sides Of The Same Coin Vaccination of high-risk groups against SARS-CoV-2, the virus that causes COVID-19, has begun in earnest – and not a moment too soon because the trends in the United States are moving in the wrong direction. On December 13, records were set for 7-day averages of daily cases ((211,494), the number of people hospitalized (106,656), and daily deaths (2,427); and with the Christmas and New Year’s holidays approaching, we can expect worsening...

November 23, 2020 Coronavirus

Dr. Henry Miller joins the John Batchelor Show for his weekly conversation about the coronavirus and COVID-19 vaccine. Miller and Batchelor discuss the Pfizer declaration for an emergency track and approval with the FDA to begin distributing a vaccine for treatment against the novel coronavirus. Miller shares his 15 years of experience at the FDA including the precedent that all applications and decisions are made with incomplete data when it comes to vaccines and that an approval by the FDA...

November 20, 2020 Coronavirus

We are in the midst of a pandemic of historic proportions. COVID-19 has killed more than a quarter of a million Americans, caused pain and suffering to many more, damaged a thriving economy, and caused great public anxiety. And it promises to get worse before it gets better. The numbers of cases, the percentage of positive test results, and hospitalizations are all trending upwards. That bodes particularly ill as the Thanksgiving and Christmas holidays approach, tempting many of us into high-risk situations. Relief...

November 16, 2020 Coronavirus

By Andrew Fillat and Henry Miller, M.S., M.D. The announcement last week by Pfizer that its COVID-19 vaccine has been shown in large-scale clinical trials to be more than 90% effective at preventing symptomatic infection has been much in the news. [After this article was posted, biotechnology firm Moderna, Inc., announced that its vaccine was 94.5% effective.] It is especially welcome news, given the skyrocketing numbers of COVID-19 cases, percentage of positive tests, and hospitalizations in much of the nation. However, to state the obvious,...

November 3, 2020 Blog, Coronavirus

President Trump’s COVID-19 recovery has thrust into the spotlight the possibilities of novel, experimental therapies for this potentially deadly disease.  During his stay at Walter Reed National Military Medical Center, he was treated with at least three drugs that have since received substantial attention in the media: the anti-viral remdesivir, the glucocorticoid steroid dexamethasone, and the monoclonal antibody cocktail REGN-COV2. While evidence suggests these drugs may be effective (and remdesivir just received full marketing approval from the FDA), there are other potential game-changers...

September 17, 2020 Coronavirus

There is widespread anticipation of the availability of vaccines to prevent COVID-19 infections so that Americans can get their lives back to some semblance of normal. Some four dozen vaccines, made with a variety of technology platforms, are now in clinical trials; nine are in large-scale safety/efficacy testing. Several of the more promising development programs have been accelerated by a White House crash program, “Operation Warp Speed,” which was launched in May. It was no secret that there would be intense pressure...

September 17, 2020 Coronavirus

Dr. Henry Miller and Lars Larson talk about who could be eligible for an early vaccine and what data could tell us about how effective the vaccine will be on different age groups. Miller also talks about having insufficient data on vaccine clinical testing for seniors or those more at risk of COVID-19 due to those not involved in the study and sheltering at home. Miller and Larson also discuss concerns from health experts like Dr. Anthony Fauci about the coming...

September 14, 2020 Coronavirus

Title: Here’s what you need to know about clinical trials as drug makers push forward with coronavirus vaccine studies By: Jaimy Lee Whether you’re new to investing in pharmaceutical or biotechnology companies or simply paying close attention to the race to develop a COVID-19 vaccine, questions may have occurred about how clinical trials work — here’s what you need to know to understand the process. The first thing is that we’ve never seen vaccines developed as quickly as what is happening right now....

September 9, 2020 Coronavirus

Dr. Henry Miller and Lars Larson talk about the latest in progress in the search for a vaccine for the coronavirus pandemic, including the recent news that AstraZeneca has paused their third-stage clinical trial for a COVID-19 vaccine due to an illness to a participant. Miller talks about how the review process works when it comes to assessing the safety of a vaccine in the clinical trial phase. Dr. Miller's segment begins at the 47:00-minute mark. Lars Larson National Podcast · Lars...

September 8, 2020 Coronavirus

There is widespread anticipation of the availability of vaccines to prevent COVID-19 infections so that Americans can get their lives back to some semblance of normal. About four dozen, made with a variety of technology platforms, are now in clinical trials, nine in large-scale safety/efficacy testing. It was hardly a secret that there would be intense pressure on the FDA from a White House desperate for good news to provide an “October Surprise” in the form of a vaccine approval before...

September 8, 2020 Coronavirus

There is widespread anticipation of vaccines to prevent COVID-19 infections so that Americans can get their lives back to some semblance of normal. About four dozen, made with a variety of technology platforms, are now in clinical trials, nine in large-scale safety/efficacy testing. Vaccines have also assumed unprecedented political importance. The Washington Post reported on Sunday: “President Trump is so fixated on finding a vaccine for the novel coronavirus that in meetings about the U.S. pandemic response, little else captures his attention, according to administration...

September 2, 2020 Coronavirus

Nearly three dozen attorneys general are attempting a legal act of theft. This month, attorneys general from 31 states, American Samoa, Guam and the District of Columbia sent a letter to the heads of the U.S. Department of Health and Human Services, the National Institutes of Health and the Food and Drug Administration asking the federal government to revoke Gilead Sciences ’ patent for remdesivir, an antiviral drug shown to reduce mortality in patients with Covid-19. The attorneys general effectively assert...

August 31, 2020 Coronavirus

While discussing many pandemic-related issues with friends and colleagues, we were reminded of the quip of journalist and satirist H.L. Mencken: “For every complex problem, there is an answer that is clear, simple, and wrong.” As we battle the SARS-CoV-2 virus, and the illness it causes, COVID-19, the “fog of war” continues on both the medical and epidemiological fronts. On the public health side, different studies, especially those that involve modeling, seem to reach conflicting, or at least ambiguous, conclusions. And...

August 28, 2020 Coronavirus

There is widespread anticipation of the availability of vaccines to prevent COVID-19 infections so that Americans can get their lives back to some semblance of normal.  Some three dozen vaccines, made with a variety of technology platforms, are now in clinical trials. Several of the more promising development programs have been accelerated by a White House crash program, “Operation Warp Speed,” which was launched in May. It was no secret that there would be intense pressure on the FDA from a White House...

August 26, 2020 Blog, Coronavirus

The newest tool to fight coronavirus could be coming soon to your neighborhood retailer. This month, Walgreens announced it will partner with Village MD to open primary care clinics in 500 to 700 stores over the next five years. The drug chain is joining the likes of Walmart, CVS and Amazon to bring retail health clinics to the masses. By increasing the supply of care available to consumers, these new clinics will help lead to lower prices throughout the rest of the...

August 24, 2020 Coronavirus

Dr. Henry Miller, M.S., M.D., joins the John Batchelor Show for his regular update on the coronavirus pandemic and COVID-19 impact on how an eventual vaccine would be distributed. Miller talks about a recent op-ed he wrote that details the dilemma vaccine makers and the government face when it comes time to distribute a COVID-19 vaccine first by breaking down different populations that need access to the vaccine first. Batchelor and Miller also talk about the impact of the election year...