Innovation

On this page, you’ll find the Center’s analysis on how free-market policies can better balance the competing interests of medical innovation and competition. Here, you’ll find our research and commentary on such issues as patents, research and development spending, and reforms that will promote more robust competition.

By Henry Miller, M.S., M.D. and Kathleen Hefferon, Ph.D When was the last time you read an online magazine or newspaper, only to find yourself bombarded with shopping ads specifically targeted to your preferences and needs, seemingly by magic? How about the detection of fraud or the filtering of spam from your email inbox? Well, that was most likely the handiwork of "machine learning," a subset of artificial intelligence that uses computer algorithms that over time and multiple experiences, or iterations,...

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...

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 ....

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...

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...

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...

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...

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...

It's hard to find a silver lining in a pandemic. But one of the few may be the rapid rise of telemedicine. With people stuck at home, doctors retooled their practices to see patients via videoconference. Insurance companies and regulators expanded the number of services available via telemedicine—and made reimbursement for telehealth consultations on par with conventional in-person visits. The Federal Trade Commission has now called on officials at the Centers for Medicare & Medicaid Services (CMS)  to permanently extend the emergency...

The COVID-19 crisis has tested America’s health care system like no other event in recent memory. One irony during this pandemic is that America has actually experienced the promise of health care innovation in an important way, namely through telehealth. Telehealth allows patients to talk with their doctors online using videoconferencing platforms. Doctors can see patients, discuss their symptoms, order tests, and even prescribe medication. Earlier this spring, as the coronavirus was becoming a serious problem across the country, Congress temporarily suspended regulations...

Listen to Dr. Henry Miller, PRI senior fellow in health studies, discuss the move by the WHO to pause hydroxychloroquine trials for Coronavirus treatment on the nationally-syndicated Lars Larson Show. TheLarsLarsonShow · Dr. Henry Miller - WHO pauses hydroxychloroquine trials for Coronavirus treatment...

A COVID-19 Vaccine by January? Here’s Why It’s Possible But Not Likely By Christopher Curley The timeline to develop a safe, effective vaccine to fight a virus is typically counted in years — or even decades. But with the COVID-19 pandemic affecting millions around the world and killing hundreds of thousands of people, the race is on to produce a vaccine faster than ever before. President Donald Trump has said a vaccine could be available by January, which would be an unprecedented development cycle. But how realistic is that? Experts...

Medical innovations do not happen overnight. Whether it is gene therapies, new vaccines, or cutting-edge medical equipment, developing innovative medical products is a risky venture. It also takes time, lots of financial resources, and most importantly, human ingenuity. Developing new drugs, for instance, can take between 10 and 15 years. Now, more than ever, it is imperative that our regulatory framework encourages innovation and protects the intellectual property that makes innovation possible. Otherwise, the medical advancements we desperately need will cease....

How hydroxychloroquine toes the line between promise and 'happy talk' in the coronavirus fight By: Anjalee Khemlani After weeks of polarizing debate over the use of two generic anti-malarial drugs, hydroxychloroquine and chloroquine, the Food and Drug Administration this week warned they were not “safe and effective” when used on COVID-19 patients. However, the hydroxychloroquine debate is far from over, as the drug gets qualified support from others deeply involved in the war against the coronavirus, and is used to treat COVID-19 patients...

Covid-19 cases, hospitalizations and deaths are leveling off in hot spots like Seattle and New York. New infections should soon begin to decline, and many parts of the country will be able to start a phased return to “normal.” Yet without a vaccine, normality will look very different than it did before the pandemic. The medical community and the public are hungry for news about vaccines, but accounts of progress have been exaggerated. Anthony Fauci, director of the National Institute of...

Optimism is in short supply as the coronavirus pandemic grows deadlier by the day. COVID-19 has taken thousands of lives around the world and upended nearly every aspect of daily life. But there is at least one bright spot in this global public health emergency. That's the astounding speed with which private firms have begun tackling the problem. While federal regulators have exacerbated the crisis at seemingly every turn, private firms have rolled out promising new therapies and technologies that could...

As the United States ramps up rapid testing for the coronavirus, the results will surely show a sharp uptick in the number of cases of coronavirus-caused COVID-19. Those tested will learn whether they are infected, but, paradoxically, the public – and public health officials – will not know whether the overall results are encouraging or discouraging, because the rates of the coronavirus infectivity and mortality will remain poorly understood. The existing tests will not identify the potentially large numbers of people who were...

When President Trump met with drug-company executives at the White House on March 2, at the top of the agenda was the development of a vaccine to prevent COVID-19, the respiratory infection caused by the Wuhan coronavirus, SARS-CoV-2 (the World Health Organization’s designation for the virus). “We’ve asked them to accelerate” work, the president told reporters. As the coronavirus outbreak accelerates, with cases now found on every continent except Antarctica, and the world is hit with widespread social and economic disruption,...