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October 15, 2021 Coronavirus-Alternate2

This year's influenza ("flu") season, which has already begun in some parts of the country, revs up in November, and last until spring, will be made more ominous than ever by the current high numbers of COVID-19 cases in many parts of the nation. The coincidence of infections in the population by the two highly infectious respiratory viruses has the potential to create a "twindemic" for our already stressed healthcare infrastructure. As of October 7th, daily cases of COVID-19 nationally were...

October 12, 2021 Policy Proposals

Democrats are dead-set on having the federal government pick up more of the nation's health tab. This is the principle behind everything from the drive to lower Medicare's eligibility age, to the push for billions of dollars for home care, to bigger subsidies for coverage through Obamacare's exchanges, to the dream on the far left of Medicare for All. People have a "right" to health care, progressives argue. So, in their mind, it should be free -- or at least heavily subsidized. But, health care...

October 12, 2021 Coronavirus - Alternate

After more than a year and a half of an agonizing pandemic, researchers at Merck and Ridgeback Biotherapeutics have announced a successful oral antiviral treatment. The drug, called molnupiravir, prevents about half of COVID-19-associated hospitalizations. The data monitoring committee, which oversees clinical trials, stopped the trials because the evidence of efficacy was sufficiently persuasive — hospitalizations reduced by 50%, deaths by 100% — that they deemed it unethical to continue with a placebo-treated control group. On Oct. 11, the sponsors requested emergency...

October 11, 2021 Coronavirus

The Food and Drug Administration recently revised its emergency use authorization for Pfizer-BioNTech's COVID-19 vaccine by approving a booster shot for individuals 65 and older, immunocompromised adults, and people with a high risk of exposure to the virus at work. It's an exciting development for the nearly 80% of vaccinated Americans who want a booster. But for many, the FDA's announcement was confusing, too. The debate over booster shots has been fraught with misleading information and contradictory federal guidance. This lack of clarity isn't just a...

October 5, 2021 Briefs, Industry Trends, Price and Costs

DOWLOAD 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 classes currently.  Since 2018, biosimilars’ market share has grown appreciably, see Figure...

October 5, 2021 Policy Proposals

Senator Bernie Sanders (I.,Vt.), America’s most prominent proponent of government-run health care, is once again leading the charge to move our country to a single-payer system. As chairman of the Senate Budget Committee, Sanders is pushing a $3.5 trillion budget plan that includes expansions of Medicare, Medicaid, and Obamacare. Some moderate Democrats have balked at the cost. But Sanders predicted Sunday that Democrats would “come together” to pass the massive package via reconciliation later this year. The health-care reforms in the budget would...

October 4, 2021 Policy Proposals

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....

September 30, 2021 Policy Proposals

For weeks, congressional Democrats have been pushing to lower Medicare's eligibility age from 65 to 60 as part of their $3.5 trillion spending bill. A new paper from the American Action Forum (AAF) by Christopher Holt and Stephen Parente reveals just how radical that change would be. Such an expansion of Medicare would cost taxpayers a minimum of $380 billion over the next decade — and possibly more than $1 trillion. The belief that Medicare ought to be available to all Americans 60 and over has become...

September 30, 2021 Innovation

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...

September 30, 2021 Coronavirus - Alternate

This week, Pfizer-BioNTech submitted data to the Food and Drug Administration demonstrating the safety and effectiveness of its COVID-19 vaccine in children ages 5 to 11. The duo is expected to apply for emergency-use authorization in the coming weeks. Federal regulators have promised they'll "urgently" review the data. The FDA's Dr. Peter Marks told  USA Today the data would be "looked at if not within hours, certainly within the day." Speed is of the utmost importance. The FDA has already slowed the...

September 27, 2021 Policy Proposals

It's no secret that H.R. 3 -- the Democrats' plan to impose price controls on prescription drugs -- would have devastating consequences for our healthcare sector. After all, artificially restricting the price of any product invariably leads to shortages, rationing, and a slowdown in both investment and innovation. A new study from University of Chicago economist Tomas Philipson shows H.R. 3 would not just slow down drug development but essentially stop it altogether. Yet Democrat leaders are continuing their push to include H.R....

September 27, 2021 Innovation

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...

September 27, 2021 Coronavirus

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...

September 27, 2021 Industry Trends

A record 5.6 million patients in the United Kingdom are currently on waiting lists for hospital care. That's equivalent to nearly one in 10 Britons. Of that group, about 300,000 have been waiting at least one year for treatment. Those who can afford to are increasingly paying out of pocket for private care. More than 20% of British residents are doing so, according to recent polling. Britain's National Health Service has long been a source of pride for the country. The organizers of the 2012 London Olympics made the NHS...

September 23, 2021 CoronaVirusSlide3

Dr. Henry Miller joined the John Batchelor show to talk about new study out of Israel analyzing the efficacy and infection rate of new booster shots for COVID-19. Miller breaks down the findings, noting that the booster group fared better than a control group who didn't receive the booster, the latest on mask mandates, and also looks at the data around the performance of the various vaccines against COVID variants. Miller is a senior fellow with PRI and former FDA...

September 21, 2021 Policy Proposals

By Henry Miller, M.S., M.D. and John J. Cohrssen President Joe Biden’s recent Executive Order 14036 contains initiatives intended to lower drug prices for patients, create more competition to increase wages for workers, promote innovation, and foster economic growth. As part of it, on Sept. 9 Health and Human Services Secretary Xavier Becerra proposed additional legislative and administrative actions. The drug price-reduction legislative proposals are perennials; their inclusion reflects both their popularity and the difficulty in attaining them. Two executive order proposals – one to import cheaper...

September 20, 2021 Industry Trends

The delta variant has wreaked havoc. This week, the U.S. reported a seven-day average of more than 146,000 daily cases . In total, COVID-19 has killed more than 660,000 Americans since the start of the pandemic. Thankfully, the rate of increase appears to be falling in many areas, compared to the surges in July and August. But significant damage has already been done. Much of this carnage could have been avoided if the Food and Drug Administration had accelerated approvals of...

September 16, 2021 Policy Proposals

The Biden administration's "Comprehensive Plan for Addressing High Drug Prices," released last week, paints a vivid picture of the difficulties patients face affording their medicines. "Americans pay too much for prescription drugs," the report notes. "Many Americans do not take medications as prescribed because of their cost." How does the administration intend to ease their financial burden? By calling on Congress to give the federal government the ability to essentially dictate drug prices. Lowering drug prices by fiat may be popular. But it would represent...

September 14, 2021 Coronavirus - Alternate

There is continuing confusion, and even consternation, over what seem to be disparate policies, recommendations and mandates emerging in response to the Delta-driven surge of COVID-19 infections and hospitalizations in much of the country. Masks or no masks? Vaccine mandates versus voluntary vaccination? Proof of vaccination for admission to bars and entertainment venues? The Zeitgeist is nicely captured by this Saturday Night Live sketch earlier this summer on the CDC’s seemingly ever-changing mask policy: In fact, the patchwork of policies and what some have derided as “moving the...