Author: Pacific Research Institute
COVID-19’s ‘Unknown Unknowns’ Are What Should Worry Us
By Henry Miller and Melissa Hart We're learning more every day about the SARS-CoV-2 virus, but it will likely present surprises. The best strategy is still to prevent new infections. Donald Rumsfeld, the two-time secretary of defense (Gerald Ford and George W. Bush administrations), is perhaps best remembered for a response he gave to a question during a 2002 news conference: As we know, there are known knowns; there are things we know we know. We also know there are known unknowns; that is...
Wayne Winegarden Discusses Prescription Drug Prices on Scripps National News
Watch PRI’s Wayne Winegarden, director of our Center for Medical Economics and Innovation, discuss efforts by the Federal Trade Commission to considering ordering large pharmacy benefits managers to study the competitive impact of contractual provisions, reimbursement adjustments, and other practices affecting drug prices on Scripps National News. https://youtu.be/DQsjKM44ScQ...
Wayne Winegarden Discusses 340B Hospital Study on AM 1590 in Boone, IA
Listen to Dr. Wayne Winegarden, director of PRI’s Center for Medical Economics and Innovation, discuss his recent 340B hospital study on AM 1590, KWBG Radio in Boone, IA. [audio mp3="https://medecon.org/wp-content/uploads/2022/02/Wayne-Winegarden-PRI-340B-Study-012522.mp3"][/audio]...
Nitrogen-Fixing Bacteria Are the Latest Genetic Engineering Breakthrough
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...
Opinion: The bioengineered food label is not expected to have any benefits to human health or the environment
By Henry I. Miller and Drew L. Kershen It's no secret that Congress sometimes does things – including creating laws – that make little sense and that are contrary to the public interest. One of the most egregious of those laws has just taken effect. The subject – labeling of foods that have been "genetically modified," or "bioengineered" — is somewhat obscure, but the measure, in the form of a Department of Agriculture regulation that was mandated by the law — affects...
The FDA needs reform. Biden’s nominee is not the person to do it
By Henry I. Miller, M.S., M.D. and Jeff Stier When President Joe Biden nominated Obama-era Food and Drug Administration Commissioner Dr. Robert Califf to return to his old post, he made what is widely seen as a safe, if uninspired, choice. Califf is a distinguished cardiologist and clinical trial specialist, but the day-to-day regulatory decision-making happens at the organizational levels below the commissioner. The FDA, a huge and critically important but dysfunctional organization, now needs a bold, clear-thinking reformer, but Califf, the...
The Biden administration should make promising anti-viral medications widely available to as many Americans as possible.
By Henry I. Miller, M.S., M.D. and John J. Cohrssen Earlier this week, President Biden outlined new steps to confront the growing spread of Covid-19 from the new, more infectious Omicron variant, which, in only a few weeks, has soared from virtually nonexistent to 73 percent of all new cases. Unfortunately, Biden’s plan failed to include what could be the most important action of all: an all-out effort to make safe and effective anti-viral Covid-19 pills available—two of which have now...
Wayne Winegarden Talks Biosimilar Price Benefits
Wayne Winegarden, PhD, Discusses the Value of an Interchangeable Designation for Adalimumab Biosimilars December 19, 2021 Skylar Jeremias The Center for Biosimilars® interviewed Wayne Winegarden, PhD, senior fellow in business and economics at Pacific Research Institute (PRI) and director of PRI’s Center for Medical Economics and Innovation. Click here to watch. Winegarden talked about how interchangeability designations are more important for biosimilars referencing adalimumab (Humira) because they would not administered by a physician in a clinic, unlike oncology biosimilars, which pharmacists do not interact with...
Build Back Better’s Drug Reforms Make American Health Care Worse
Last week, President Joe Biden emphasized the importance of the drug pricing proposals in the Democrats' roughly $2 trillion Build Back Better spending package. "I think it's safe to say that all of us, all of us, whatever our age, wherever we live, we can agree that prescription drugs are outrageously expensive in this country," Biden said. "Under my Build Back Better bill, which has passed the House of Representatives, it won't be the same way." Build Back Better would make significant changes to drug pricing...
Finally, Another Weapon Against Covid
Good public health policy is welcome, even when long delayed. So we should cheer the Biden administration's announcement earlier this month that Covid-19 rapid-result antigen tests (RATs), which tell you in as little as 15 minutes whether you're infected, will be covered by private insurance. For uninsured Americans, the government would make 50 million free tests available, to be distributed through health clinics and other sites in rural and underserved communities. Assuming that they can detect the new Omicron variant along with...
Wayne Winegarden, PhD: Why Competition is Urgently Needed for Enbrel, Humira
The Center for Biosimilars® interviewed Wayne Winegarden, PhD, senior fellow in business and economics at Pacific Research Institute (PRI) and director of PRI’s Center for Medical Economics and Innovation. Winegarden said that because of the high costs associated with Humira (reference adalimumab) and Enbrel (reference etanercept), biosimilars of these agents are needed to establish a competitive marketplace and to drive down costs. He said the long exclusivity periods that the makers of Humira and Enbrel have secured must end to allow greater affordability;...
Escape the Drug Pricing Maze Video Series
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Are rapid-result antigen tests an unappreciated long-range tool to tame COVID?
An overwhelming consensus on any topic is very rare these days. But many Americans, whatever their political leanings, seem to feel that the policies, communications, and actions of the public health "experts" and politicians about the COVID-19 pandemic have been confusing, sometimes contradictory, and in some cases, inconsistent with the scientific evidence. Whether it was flip-flops on the effectiveness of masks, seemingly inane restrictions on certain activities, or baseless advocacy of ineffective drugs, the past 20 months have provided numerous reasons...
Dr. Henry Miller Discusses Vaccines, Winter COVID Surge on the John Batchelor Show
Dr. Henry Miller and John Batchelor talk about the coverage around COVID-19 surges in Europe and elsewhere and what that could mean for lockdowns and vaccinations. They discuss how the United Kingdom is handling a potential new surge including masking, vaccinations, and the arrival of new surges. Miller also talks about the various surges, especially related to the delta variant and the impact of long COVID symptoms. ...
Read PRI’s “Right by the Bay”: Could Mark Cuban’s new pharmaceutical venture be a slam dunk?
By Wayne Winegarden and Celine Bookin Billionaire investor Mark Cuban’s pharmaceutical company, the Mark Cuban Cost Plus Drug Company, is hoping to disrupt the pharmaceutical benefit management (PBM) industry with a new venture that seeks to address some of the most criticized practices of the industry. These include PBMs pocketing rather than passing on negotiated rebates and not being transparent in how they negotiate said rebates. PBMs traditionally contract with governments and businesses to manage drug formularies, determine co-pays, administer plans, and negotiate...
When Making Policy Decisions, Quality and Context of Data Should Be Scrutinized
Allowing the federal government to negotiate drug prices is a politically winning talking point. According to polling, Americans from across the political spectrum support this government intervention. However, the talking point is only a political winner if it is presented without context. Americans back the policy if it leads to direct savings in their pocketbooks while not diminishing access to life-saving therapies — whether through less investment in research and development by the pharmaceutical industry or restricted access to approved treatments. That this...
Regulators blow the rapid antigen test opportunity
Whether it was flip-flops on the effectiveness of masks, seemingly inane restrictions on certain activities, or crass politicization of the use of ineffective drugs, the past 20 months have provided numerous reasons to question what we were told. Significant numbers of people are resisting employer mandates to get the COVID-19 vaccine and thereby jeopardizing their jobs. Still, there is a useful but misunderstood and underused mitigation tool — rapid-result antigen tests , which detect pieces of the SARS-CoV-2 virus's proteins — that can...
Will the Biden administration ‘follow the science’ on regulatory reform?
By Henry Miller, M.S., M.D. and John Cohrssen This year marks the 35th anniversary of the US Coordinated Framework for the Regulation of Biotechnology (https:// usbiotechnologyregulation.mrp.usda.gov/ biotechnologygov/about/about), a blueprint for federal agencies’ oversight of genetic engineering that was prepared by the White House and published by its Office of Science and Technology Policy (OSTP). Click here to read the full article....
We Should Not Lose Sight of the Upcoming Flu Season
As the Food and Drug Administration contemplates booster shots and a myriad of other regulatory issues related to the COVID-19 vaccine, it is essential to reiterate the importance of a vaccine that is available and recommended for every age group at no cost to the patient — the influenza vaccine. Throughout history, influenza has been responsible for far more mortality than any other individual ailment. And in the 2018-2019 flu season, the year before the COVID-19 pandemic, the Centers for Disease...