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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...

December 10, 2020 Blog, Innovation

By Henry Miller, Shiv Sharma Much of the progress in medicine during the past half-century has involved expensive, high-tech diagnostic tests and therapies.  The trend in this direction worries health economists and politicians because it has the potential to send already-high healthcare costs into the stratosphere. However, in both medicine and dentistry, there is an important role as well for ingenious, low-tech, less expensive approaches to improved health and increased longevity. The FDA last year approved a high-tech gene therapy drug, Zolgensma, for a...

December 9, 2020 Briefs, Price and Costs

Tearing down drug “rebate walls” that increase patient costs and block access to cheaper and often more effective medications would increase competition, lower out-of-pocket costs, and improve health outcomes, finds a new brief released today by the Center for Medical Economics and Innovation at the nonpartisan Pacific Research Institute. Click to download the brief “America’s patients are harmed because they do not benefit from large, fast-growing rebates when purchasing their medicines,” writes the brief’s author, Dr. Wayne Winegarden, director of PRI’s Center...

December 7, 2020 Coronavirus-Alternate2

By John J. Cohrssen and Henry I. Miller, M.S., M.D. Relief from the scourge of COVID-19 in the United States may be in sight. Government and private sector initiatives should be able within months to provide enough safe, effective vaccines to begin to make a dent in COVID-19 cases, hospitalizations, and deaths. But for society to approach normalcy, people will need to be able to document that they are immune to COVID-19. Although vaccination is intended primarily to protect individuals against COVID-19...

December 3, 2020 Coronavirus - Alternate

It should be obvious by now that the adoption of measures to prevent the spread of coronavirus SARS-CoV-2, which causes COVID-19, has become politicized. Consider the presidential campaigns: President Donald Trump held large indoor rallies with mostly mask-less supporters, while President-elect Joe Biden seemed to have a mask sutured to his face and spent much of the campaign in isolation. Gallup surveys published in November show that partisanship remains the most significant driver of the public’s perceptions of the COVID-19 pandemic and...

November 25, 2020 Coronavirus - Alternate, Coronavirus-Alternate2, Issues, Multimedia

Dr. Henry Miller, PRI senior fellow in health care studies and former founding director of the FDA’s Office of Biotechnology, joins PRI's "Next Round" podcast with an update on efforts to develop vaccines and therapeutics to fight Covid-19.  He discusses how a transition between two presidential administrations will affect the work of the federal government in fighting Covid-19, whether a national mask mandate is a good idea, whether Governors like Gavin Newsom should initiate state-level reviews of potential vaccines, and...

November 25, 2020 Blog, Coronavirus-Alternate2, Innovation

By Henry I. Miller, M.S., M.D. and John J. Cohrssen The United States is one of the most seriously COVID-19-impacted countries, faring the worst among the ten most-affected countries worldwide, as measured by new cases. The pandemic threatens both American lives and the economy. Even more worrisome, as shown below in this figure, the situation is deteriorating. Two things about those trends are especially problematic: first, deaths are a lagging indicator, following chronologically behind cases and hospitalizations, so the death curve will continue upwards; and...

November 23, 2020 Coronavirus - Alternate

Shots Heard 'Round the World: Will Pfizer, Moderna Vaccines Start End of Pandemic? By Adam Smith, The Street The U.S. found itself this month both in the most dangerous stage of the Covid-19 pandemic to date, and in the most hopeful stage. Just as the daily case counts of new coronavirus infections surged toward 200,000, the developers of two different vaccines said their shots were around 95% effective at preventing development of full-blown Covid-19 in patients. . . . . . On the other hand,...

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 18, 2020 Coronavirus-Alternate2

By Henry Miller, M.S., M.D. and John J. Cohrssen Presumptive President-Elect Joe Biden’s transition organization has published an initial plan to “beat” the rapidly worsening Covid-19 pandemic. Though it is essential and not wholly unreasonable, some parts seem to have been highjacked by a political agenda that contains tangentially related issues. The plan’s sole focus should be on the difficult and complex problem of interrupting the runaway pandemic while maintaining a viable economy. It needs a sensible organizational structure to use the available...

November 17, 2020 Coronavirus - Alternate

The John Batchelor Show talks to PRI's Dr. Henry Miller about the effectiveness of a COVID-19 Pfizer vaccine compared to industry standards. Miller explains the baselines based on current vaccines and talks how a 90 percent effective vaccine could create herd immunity. Batchelor and Miller also talk about the logistics of storing, creating, and producing the vaccine including extreme cold storing requirements and a short shelf life. ...

November 17, 2020 Coronavirus-Alternate2

Dr. Henry Miller breaks down the latest announcement from Pfizer about a potential COVID-19 vaccine and look at the numbers around placebo and side-effects. Larson and Miller also talk about the impact of mild symptoms and what those could mean for at-risk Americans and those with co-morbidities and if the vaccine has "sterilizing immunity." Moderna has also announced a potential vaccine. Lars Larson National Podcast · Lars Larson National Podcast 11-10-20...

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 9, 2020 Coronavirus-Alternate2

Henry Miller, M.S., M.D., joins the John Batchelor Show to discuss an alleged mutation of COVID-19 in Europe. Miller explains the difference between flu or cold mutations and how these mutations to mink farms could jeopardize current novel coronavirus vaccines. Several of the mutations in Denmark and the Netherlands have moved directly from animal to human, according to the Wall Street Journal. ...

November 9, 2020 Coronavirus - Alternate

Dr. Henry Miller, M.S., M.D. talks about the impact of a pending vaccine in the United States. Miller also talks about continuing treatments like remdisivir, zinc, and other common treatments to help fight the COVID-19 and how they will play an important role as more vaccine are developed. Larson and Miller also talk about how COVID-19 has been found to impact the immune system and what hospitals and health care officials can do to lessen the impact of the coronavirus. Lars...

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...