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On Drug Prices, Big Pharma Is in Charge — Not Joe Biden

Newsweek reported:

President Joe Biden recently flaunted having “beat Pharma this year.” But on a policy that would immediately lower drug prices for millions of Americans, he is losing — and badly.

For decades, Americans have overpaid for expensive prescription drugs available at significantly lower prices — an average 66% discount for brand-name originator drugs — right across the border in Canada. The pharmaceutical industry, or “Pharma,” wants to keep it that way, stymying any effort to give Americans access to drugs at those lower prices.

Congress addressed this issue comprehensively in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which authorized the Department of Health and Human Services (HHS) to approve plans for the safe and cost-effective importation of prescription drugs from Canada. The statute was a bipartisan affair, enacted with a filibuster-proof majority of more than 60 senators.

At first, Biden seemed to agree. He made a campaign promise to allow prescription drug importation from Canada. He then issued an executive order directing his administration to facilitate it by following the statute Congress prescribed. But despite repeated requests by Florida — the first state to submit an importation plan — for approval to begin, nothing has happened.

Why the delay? The most plausible explanation is the most obvious one. The FDA is following orders from Pharma, not Biden.

COVID: Young, Healthy People May Not Need Bivalent Boosters, Vaccine Expert Says

Yahoo!Finance reported:

One of the country’s top vaccine experts has stirred debate in recent weeks by suggesting that not everyone should get the latest COVID-19 vaccine boosters and that the CDC is “overselling” the new shot.

Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s committee of outside vaccine experts, told Yahoo Finance there are three main groups of people who will benefit the most from the bivalent booster based on current evidence — those who are older than 75, have chronic diseases or are immunocompromised.

“We’re not going to be able to stop mild illness, we’re not going to be able to stop transmission and to try and do that with frequent boosters … doesn’t make a lot of sense,” Offit said. That’s because boosters only buy a few extra months of protection against mild illness before the antibodies wane, he said, and studies have shown that the vaccines do not necessarily prevent transmission.

He added that epidemiologists and immunologists still need to figure out how long the original three doses protect against severe disease and death. Meanwhile, data is missing to support the fourth dose with the bivalent shots for all adults.

Two Cases Show COVID Virus Mutating Around Standard Treatment Remdesivir

U.S. News & World Report reported:

Patients with weakened immune systems could be inadvertently helping COVID-19 develop resistance to the antiviral drug remdesivir, a new study reports.

After lengthy COVID infections, two kidney transplant patients on immune-suppressing drugs to prevent organ rejection developed a mutated version of SARS-CoV-2 resistant to remdesivir, according to researchers at NYU Grossman School of Medicine and NYU Long Island School of Medicine.

“It is possible that the antiviral treatment itself, combined with the patients’ weakened immune systems, may have driven the evolution of this concerning mutation,” said lead author Dr. John Hogan, an assistant professor of medicine at NYU Langone Health.

A weak immune system enables COVID-19 to remain in the body longer, copy itself and continually change in ways that flout existing treatments, the study authors said. Both patients were initially infected with a version of COVID-19 that responded normally to remdesivir, according to the investigators.

‘Breakthrough’ Infections After COVID Vaccine Can Help Prevent Future Illness

U.S. News & World Report reported:

It’s very frustrating to get a COVID-19 vaccine and then wind up catching the virus anyway. But these breakthrough infections actually do you a world of good, providing a powerful boost to your existing vaccine-induced immune protection, a new study reports.

People infected after getting a basic two-dose COVID vaccination experienced an immune response equal in power and effectiveness to receiving a third booster, researchers reported recently in the journal Med.

This boost is particularly potent for older folks, whose waning immune systems tend to produce shorter-lasting responses to the COVID vaccine, said Dr. Marcel Curlin. He’s an associate professor of infectious diseases at Oregon Health & Science University School of Medicine (OHSU) in Portland.

The immune responses found three months after a third vaccine dose wound up being comparable to those found one month after a breakthrough infection, researchers found. These findings help explain why breakthrough infections are growing milder, said Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases.

Big COVID Waves May Be Coming, New Omicron Strains Suggest

Science reported:

Nearly 3 years into the pandemic, SARS-CoV-2 faces a formidable challenge: finding new ways around the immunity humans have built up through vaccines and countless infections. Worrisome new data show it is up to the challenge. Several new and highly immune-evasive strains of the virus have caught scientists’ attention in recent weeks; one or more may well cause big, new COVID-19 waves this fall and winter.

“We can say with certainty that something is coming. Probably multiple things are coming,” says Cornelius Roemer, who studies viral evolution at the University of Basel.

The strains that look poised to drive the latest comeback are all subvariants of Omicron, which swept the globe over the past year. Several derived from BA.2, a strain that succeeded the initial BA.1 strain of Omicron but then was itself outcompeted in most places by BA.5, which has dominated in recent months. One of these, BA.2.75.2, seems to be spreading quickly in India, Singapore and parts of Europe. Other new immune-evading strains have evolved from BA.5, including BQ.1.1, which has been spotted in multiple countries around the globe.

Despite their different origins, several of the new strains have chanced upon a similar combination of mutations to help scale the wall of immunity — a striking example of convergent evolution. They all have changes at half a dozen key points in the viral genome that influence how well neutralizing antibodies from vaccination or previous infection bind to the virus, says evolutionary biologist Jesse Bloom of the Fred Hutchinson Cancer Center.

Jami Josefson: After a Pandemic Boom in Child Obesity, It’s Time for Families to Recommit to Health

Chicago Tribune reported:

Get outside. Eat healthy food. Keep moving. That all sounds easy enough, right? Such pithy directives for a healthy lifestyle are now so common that they’ve become a kind of white noise in our daily lives. But as kids return to school this fall, it’s the perfect time for families to recommit to their physical and mental health.

There’s some urgency in my recommendation. Many families are still grappling with the secondary physical and psychosocial health impacts of the COVID-19 pandemic — including an alarming surge in obesity and Type 2 diabetes among children.

As a pediatric endocrinologist at Lurie Children’s Hospital, I’ve seen firsthand an explosion of child obesity among our patients during the pandemic. My colleagues and I have also observed an alarming increase in children with new-onset Type 2 diabetes, which is directly related to the widespread weight gain among our patients.

In a recent study published in the Journal of Diabetes, my colleagues found that diagnoses of Type 2 diabetes at Lurie increased nearly 300% from the pre-pandemic annual mean. Black and Hispanic children represented the majority of diagnoses, which likely reflects the persistent societal inequities in access to healthy food and other resources.

Biden’s Request for Emergency COVID, Monkeypox Funds Missing From Funding Bill

The Hill reported:

A White House request for emergency funding to support coronavirus and monkeypox response efforts is missing from the recent must-pass spending bill rolled out by Senate Democrats after staunch GOP opposition.

The White House pushed for billions in funding to bolster those efforts as part of a short-term funding bill Congress is aiming to pass this week to avert a government shutdown.

Mounting Evidence Shows Autoimmune Responses Play a Significant Role in Long COVID

NBC News reported:

Disease experts say it has become increasingly clear that an autoimmune response, in which antibodies attack the body’s own healthy cells and tissue, plays an important role in some long-COVID cases.

The latest evidence for this came in a study published last week in the European Respiratory Journal. It found that people who had long-lasting COVID symptoms were more likely to have markers of autoimmune disease in their blood than people who’d recovered quickly from the coronavirus or had never gotten infected.

The researchers took blood samples from 106 people who’d gotten COVID, at 3, 6 and 12 months after their diagnosis (though by the end, only 57 patients were participating). They compared the samples to those from healthy people and people who’d had other types of respiratory infections at the beginning of the study.

U.S. FDA to Review Fewer Emergency Use Requests for COVID Tests

Reuters reported:

The U.S. Food and Drug Administration said on Tuesday it will now review only a small number of emergency use authorization requests for COVID tests that are likely to have a significant benefit to public health, including fulfilling an unmet need.

The agency is revising its COVID-19 test policy in light of the current manufacturing status and the number of cases, it said, adding companies seeking EUA for their COVID tests will have to now apply for the agency’s traditional pre-market review process.

Last week, federal investigators found that the regulator’s decision to accept all EUA requests in the early months of the pandemic resulted in some ‘problematic tests on the market’ and recommended the FDA revise its EUA policies for the tests.