Issues

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...

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...

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,...

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...

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...

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...

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. ...

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...

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,...

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. ...

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...

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...

For the more than 7 million Americans who inject insulin, Friday will mark an important anniversary: 38 years since the Food and Drug Administration (FDA) approved the use of human insulin synthesized in genetically engineered bacteria. This momentous event launched a revolutionary new era in pharmaceutical development, and, as the FDA medical reviewer of the product and the head of the evaluation team at the time, I had a front-row seat. To commemorate the event, I open a bottle of champagne every...

PRI's Dr. Henry Miller joins the John Batchelor Show to discuss the lateset updates on a coronavirus vaccine. Dr. Miller talks about President Donald Trump's treatment with remdisivir during his positive coronavirus diagnosis. Batchelor and Miller talk about the push by the American government decades ago to use advertising to influence the public to take the polio vaccine and what the government can do now to encourage everyone to take a COVID-19 one. Miller also breakdowns how effective a vaccine...

By Henry Miller, M.S., M.D. and Andrew Fillat Americans -- so desperate to end the need for masks, social distancing, and limited access to restaurants, salons, concerts, and schools -- will surely be clamoring for a vaccine as soon as it’s available. Or will they?  Recent polls suggest that only about 40% of Americans would take the vaccine. It is vital that this number be increased. But how? Let's explore this issue. There is widespread anticipation of vaccines to prevent COVID-19 infections so that...

The COVID-19 pandemic has intensified various political and economic flashpoints. From health care to housing, drug pricing to food pricing, the societal strain of the pandemic has renewed the urgency and raised the stakes for long-standing issues. The increasingly heated debate about the rules and regulations governing medical device servicing is an exemplar of this new reality. Although the dispute between independent aftermarket repair businesses and original equipment manufacturers (OEMs) isn’t new, it has shifted from auto repair, farm equipment, and...

A new brief released today by the Center for Medical Economics and Innovation at the nonpartisan Pacific Research Institute shows that counterfeit drugs put patients in harm’s way, hinder drug innovation, and lead to job losses. Proposals like drug importation or price controls, if implemented, would exacerbate the problem and result in more health and economic consequences. Click here to download the brief “Counterfeit drugs expose patients to potentially lethal contaminants, and may also increase public health risks by failing to effectively...

“Don’t Fight the Fed” is an old saying that advises business investors to align their choices with the actions of the Federal Reserve System, the U.S. central banking system which has several potent tools at its disposal to influence stock prices. When it comes to understanding and preventing the spread of infectious diseases, an analogous maxim might be, “don’t fight science,” or, more specifically, epidemiology. A pertinent example is the outbreak of COVID-19 among President Trump, First Lady Melania Trump, senior presidential advisor Hope...

Dr. Henry Miller and John Batchelor break down President Donald Trump's positive coronavirus diagnosis. Miller also looks at the different pillars that are in place to help reduce the spread of coronavirus in crowded areas. Miller also talks about the pending flu season, what the stress of more flu cases could mean for hospitals, and any changes the public should make to their health protocols. ...