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August 19, 2021 Coronavirus, Issues

By Henry I. Miller, M.S., M.D. and Sheeva Azma, MS In spite of the wide availability of highly effective COVID-19 vaccines, only about half of eligible Americans are fully vaccinated. Partly as a result of that "vaccine hesitancy," the United States is experiencing a fourth wave of COVID-19 cases, with over 160,000 on August 18th, more than an order of magnitude higher than in mid-June. Deaths, a lagging indicator, have more than doubled since mid-July. Hospitals and healthcare providers in the...

August 16, 2021 Industry Trends

Medical devices are something of an orphan sister to the glamour of drugs, but they include some of the genuine miracles of modern medicine, particularly for seniors: Pacemakers, artificial joints, insulin pumps, and CT, MRI, and radiotherapy machines are just a few examples. The United States is currently the global leader in medical device innovation, and it is one of the few major industries that both boasts a net trade surplus and is a job creator. The sector employs 400,000...

August 16, 2021 Coronavirus

On September 14, the people of California will have the chance—in a recall election—to oust Governor Gavin Newsom. His record over his more than two and a half years in power is checkered. Nowhere is that clearer than on health policy. Early in the pandemic, Newsom instituted some of America's most draconian policies: shutting down schools, shuttering business, and essentially locking people in their homes. What good did that do the people of California? The state has experienced over 4 million cases of COVID-19 and...

August 16, 2021 Price and Costs

Imagine you’re in the market for a new car. You go to the dealership, take a few models out for a test drive, and ultimately choose the one that has the features and driving experience you’re looking for. But now imagine that there’s no sticker price. You just tell the salesperson you’ll take it — and silently pray that it’s not too expensive. You’ll find out how much you owe in a few weeks, when the bill comes in the mail. Of...

August 13, 2021 Coronavirus-Alternate2

Demonstrators in 50 cities across the country took the streets last month to demand a government takeover of America's health system. The Democrats who control Washington are trying to give those activists what they're asking for, albeit in piecemeal fashion. In recent weeks, they've proposed lowering Medicare's eligibility age and adding dental, vision and hearing benefits to the entitlement. Democrats in Congress have also offered a plan to provide federally funded health coverage to low-income people in the 12 states that have yet to adopt Obamacare's Medicaid expansion. This drive to...

August 10, 2021 Industry Trends

The Senate is poised, on Tuesday, to pass a $1 trillion bipartisan infrastructure package. According to the latest estimate from the Congressional Budget Office, the new spending will increase the deficit by over $250 billion. The 2,700-page bill appropriates an avalanche of funding for everything from electric vehicle charging stations to public transit systems. It also includes a "Buy American" provision that requires government agencies to purchase masks, gloves, and other personal protective equipment from domestic companies. Such protectionist policies are...

August 10, 2021 Coronavirus - Alternate

Dr. Henry Miller joins the nationally-syndicated Lars Larson Show to discuss the "swiss cheese" approach to testing, screening, and treating COVID-19 and the impact to civil liberties. Miller and Larson debate the balance needed to react to COVID-19 and the moving target by public health officials. Lars Larson National Podcast · Lars Larson National Podcast 08-03-21...

August 9, 2021 Coronavirus

America’s vaccination campaign has stalled, even as COVID-19 infections soar due to the delta variant. As of Aug. 2, only 49.7% of the population is fully vaccinated, barely up from the 46.7% in late June. Providers are now administering about 650,000 shots a day, on average, compared to 3.3 million a day during mid-April. The Biden administration, desperate to pick up the pace, is now mandating shots for federal employees and getting behind mask mandates once again. Curiously absent from the administration’s...

August 5, 2021 Industry Trends

Demonstrators in 50 cities across the country took the streets last month to demand a government takeover of America's health system. The Democrats who control Washington are trying to give those activists what they're asking for, albeit in piecemeal fashion. In recent weeks, they've proposed lowering Medicare's eligibility age and adding dental, vision and hearing benefits to the entitlement. Democrats in Congress have also offered a plan to provide federally funded health coverage to low-income people in the 12 states that have yet to adopt Obamacare's Medicaid expansion. This drive to...

August 3, 2021 Briefs, Price and Costs, Studies, Value

Establishing a two-part drug pricing system quantifying separate values for a drug’s innovation and production would create an efficient market and a more accurate reflection of how patients value a drug compared to those produced by centralized organizations, argues a new report released today by the Center for Medical Economics and Innovation at the Pacific Research Institute. Click to download “Establishing a Two-Part Drug Pricing System to Promote Value-Based Pricing and Innovation” “Some policymakers assume that only a centralized agency can determine...

July 30, 2021 Coronavirus - Alternate

Each of the measures shown in the figure here--the "Swiss cheese model of prevention"--lowers the probability that an infectious dose of virus will find its way to your respiratory tract and, if it does, will actually cause an infection. Also, depending on the effectiveness and extent of vaccine administration, vaccination could make some of the other interventions superfluous. Such strategies are the essence of preventive medicine. Many of us take drugs to lower our cholesterol levels or blood pressure to reduce the...

July 29, 2021 Coronavirus

During the depths of the COVID-19 pandemic, the most vocal proponents of aggressive lockdowns often framed the issue as a trade-off between personal freedom on the one hand and public health on the other. Stay-at-home orders may have prevented some people at the margin from congregating and spreading the virus. But they also convinced lots of people to forgo routine medical care, including screening for diseases like cancer. That care forgone may have dire public health consequences of its own. Two-thirds of...

July 28, 2021 Issues, Policy Proposals

By Peter J. Pitts, Robert Popovian, and Wayne Winegarden What happens when regulatory ambiguity displaces sound scientific guidance, deterring the legislative intent of Congress? This is precisely the situation regarding the FDA changing the regulatory rules of the road regarding a biosimilar’s strength versus its potency. It is a distinction with a difference – with the potential unintended consequence of disincentivizing both the development and uptake of biosimilars. It is also important to consider the implications of the legislative intent of...

July 21, 2021 Coronavirus-Alternate2

Dr. Henry Miller joins the John Batchelor Show to discuss the FDA's footdragging on COVID-19 vaccines for continued use and the nuances of what the emergency use declarations mean. Miller talks about the data behind full vaccine approval and what it would take for the FDA to issue a final approval. ...

July 19, 2021 Coronavirus

Two months, one week, and five days. That's how much time has passed since Pfizer and BioNTech filed for approval from the U.S. Food and Drug Administration for their Covid-19 vaccine. The agency has not hinted when that decision might be coming. Moderna formally asked the FDA for approval of its vaccine seven weeks ago. There's been no word on when the agency will complete its review. Experts say the FDA will likely grant the applications "priority review." Translating from the bureaucrat-ese, that's within six months of...

July 18, 2021 Coronavirus - Alternate

It's been about six months since the Food and Drug Administration allowed the distribution of the first COVID-19 vaccines via emergency use authorizations, which are preliminary approvals during a public health emergency based on lower standards of safety and efficacy than for a normal, or "full," approval. As of July 13, 48.1% of the U.S. population had been fully vaccinated. However, uptake has been inconsistent among different groups and locales, the earlier momentum for vaccination has waned, and there are surges of...

July 18, 2021 Industry Trends

Millions of people have canceled doctor’s appointments and postponed elective surgeries over the past 18 months. But now that the pandemic has largely subsided, many patients feel it’s once again safe to seek care. A Gallup poll conducted in May found that nearly 17% of Americans had gone to a hospital, doctor’s office, or treatment center in the previous 24 hours, up from just 6% the year before. Whether patients actually receive the care they’re seeking, though, depends entirely on where they...

July 9, 2021 Blog, Innovation, Policy Proposals

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...

July 7, 2021 Issues, Policy Proposals

The myth about endangered, disappearing honeybees lives on — with potentially dire implications. Rep. Earl Blumenauer, an Oregon Democrat, just reintroduced “Save the Bees” legislation that would eliminate farmers’ most advanced and effective defenses against crop-destroying pests in the name of preventing imaginary bee declines and preserving food security, which the bill would actually undermine. According to Blumenauer’s press release, “The United States lost an estimated one-third of its honeybee colonies between 2016 and 2018.” This sounds scary, except the Department of...

July 5, 2021 Blog, Coronavirus, Policy Proposals

America’s vaccination campaign is stalling. In late June, pharmacists and other providers were administering roughly 800,000 shots a day — down 80 percent from a peak of more than 4.6 million in mid April. Because of this precipitous decline, the Biden administration recently admitted it would miss its self-imposed goal of vaccinating at least 70 percent of American adults by Independence Day. So far, only 66 percent have gotten the jab. The Centers for Disease Control and Prevention (CDC) deserve much of...