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.

Last week, both New York and Kansas granted nurse practitioners the freedom to practice independently, without the supervision of a physician. The Empire State and the Sunflower State are now the 25th and 26th states to roll back "scope-of-practice" restrictions on NPs. This trend is worth celebrating. The shortage of primary care doctors in the United States is already at crisis levels, particularly in rural areas. Empowering NPs, physician assistants, and pharmacists to treat people independently could expand the supply of health care virtually overnight — at...

Nearly 84 million Americans live in “primary-care health professional shortage areas” — places that don’t have enough primary-care physicians to meet patient need. That includes over 7.8 million patients living here in California. Even in the face of this shortage, only 25 states grant the right of “full practice” to nurse practitioners, or NPs, who could immediately address this problem. In the remaining states, “scope-of-practice” laws prevent NPs from evaluating patients, ordering and interpreting diagnostic tests and managing treatments. States with such...

“That morning I squeezed every orange and it felt like a wet sponge – I knew I lost the whole crop,” said Natalia Derevianko, a small farmer in the tiny Florida town of Archer, somewhere in the void between Orlando and Tallahassee.   Florida’s peninsular climate offers farmers an opportunity to grow high-value fruit crops in the winter months when much of the rest of the country is blanketed in snow. On Jan. 30, this season’s valuable crop of citrus, peaches, and avocados was...

By Henry Miller and Kathleen Hefferon Much of the world is preoccupied with the ongoing coronavirus pandemic, but there are other global challenges, including climate change, food security, and degradation of the environment. Interestingly, and perhaps ironically, there is some good news regarding the latter three from a recent breakthrough in microbiology.   Plants depend upon beneficial interactions between roots and root-associated microorganisms for growth promotion, disease suppression, and nutrient availability. Crops require nitrogen to grow, and although there is an abundance of...

Gene editing, which allows precise edits to the genome, has been widely used for a variety of applications in laboratories worldwide since its discovery a decade ago. It has tremendous potential: Researchers hope to use it to alter human genes to eliminate diseases; improve the characteristics of plants; resist pathogens; and more. The two scientists who discovered the iconic gene editing technology, the CRISPR-Cas9 system, were awarded the 2020 Nobel Prize in Chemistry. In spite of the fact that gene editing is...

Earlier this month, the Biden administration bought 10 million courses of Pfizer's new COVID-19 pill, Paxlovid. Thanks to the Food and Drug Administration, however, it may be months before anyone can take it, as the agency hasn't yet offered up a timetable for approving it. Its inaction will almost certainly result in scores of preventable deaths. In clinical trials, Paxlovid proved nearly 90% effective at preventing hospitalization and death. The results were so promising, Pfizer ended its trial of the drug early. It would have been...

Millions of Americans may soon be able to hear a bit easier. The Food and Drug Administration just announced a new rule that would permit over-the-counter sales of hearing aids. Regulators are soliciting comments from the public. This move to liberalize the market for hearing aids is an unmitigated piece of good news. It recognizes that patients should have greater control over the care they receive, and it promises to increase competition in the market for hearing aids, saving consumers money...

Dr. Henry Miller talks to the nationally-syndicated Lars Larson Show based out of Oregon about innovations in artificially constructed organs and tissue that could be used to make up for the shortage of organ transplants. Miller also talks about the use of genetically-engineered animals, and the regulatory issues with the FDA, to develop organs for transplant into humans. Lars Larson National Podcast · Lars Larson National Podcast 09-28-21...

Modern medicine has produced many kinds of high-tech miracles, among them gene therapy to correct malfunctioning genes, electrical stimulation devices to restore significant function after traumatic spinal cord injury, and surgery performed by robots. Another medical area that desperately needs breakthroughs is transplantation of solid organs. We are making progress but are not quite there. Currently, donor organs — from a living donor or cadaver — must match the recipient's tissue type and size, and often, they are not perfect. By one estimate, approximately half of...

The study of genetics has always been an attempt to understand our biologically determined fate. Many of us know of families with a predisposition to maladies like heart disease or breast cancer. There are many kinds of interventions that can modulate the effects of our genetic endowment, whether directly (as in highly sophisticated gene therapy for genetic diseases) or pharmaceutical treatments, such as human growth hormone for growth hormone deficiency. But even when such targeted interventions aren't possible, we can modulate...

It’s time for your annual physical. You make an appointment with your doctor and mark the date on your calendar. But when the day arrives, you don’t set aside two to three hours or wait for a nurse to call your name in a sterile doctor’s office. You log onto your laptop from the comfort of your living room. The process takes less than 30 minutes. For many Americans, this was a reality amid the pandemic, when lots of care was delivered...

Reforms to the U.S. drug pricing environment are required, but to improve patients’ health outcomes, reforms must be grounded in a comprehensive understanding of the current drug pricing system. Otherwise, policymakers will make things worse, not better. Unfortunately, a March 2021 report by the Government Accountability Office (GAO) fails to live up to this goal. The title of the report, U.S. Prices for Selected Brand Drugs Were Higher on Average than Prices in Australia, Canada, and France, appears to confirm the narrative that U.S. patients...

On April 13th, citing "an abundance of caution," after the appearance of a few rare blood clots in the brain (cerebral venous sinus thrombosis, or CVST) following administration of the Johnson & Johnson COVID-19 vaccine, the FDA announced a "pause" in its administration. Regulators reversed course just ten days later, after confirming that the incidence of that adverse reaction was, indeed, extremely low, and that the benefits of receiving the vaccine overwhelmingly outweighed the risks. The decision to pause was precipitated...

This week, lawmakers in the House and Senate introduced bills that could preserve access to telehealth for Medicare and Medicaid beneficiaries beyond the pandemic. The House measure would allow Medicare beneficiaries to continue receiving “audio-only” remote care — that is, by phone. The Senate bill would direct the federal government to come up with a list of telehealth services that state Medicaid and the Children’s Health Insurance Program should cover. This sustained enthusiasm for telehealth is great for patients. State and federal officials relaxed...

[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column width="2/3"][vc_column_text css=".vc_custom_1621192674245{padding-right: 40px !important;}"]DOWNLOAD THE PDF In October 2019, the Center for Medical Economics and Innovation at the Pacific Research Institute released its second study documenting the savings potential enabled by biosimilars. Biosimilars are medicines manufactured in, or derived from, biological sources that are developed to be similar to FDA-approved reference products. Biosimilars are approved to compete in nine biologic drug classes in the U.S., and are available in seven of these drug...

By Henry Miller, M.S., M.D. and Andrew I. Fillat Sometimes the sheer stupidity, posturing, and lack of insight by policymakers are breathtaking. As a form of virtue signaling, the Biden administration has just announced U.S. support at the World Health Organization (under TRIPS, the Agreement on Trade-Related Aspects of Intellectual Property Rights) for waivers of patents on COVID-19 vaccines. Patents are widely misunderstood. They do not so much permit the holder to do something; rather, they prohibit others from copying the patented “invention,” and, thereby, can...

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...