Kennedy Wants to Cure Chronic Disease. Here’s What He’s up Against.
Our health care system has failed patients when it comes to preventing and managing chronic diseases such as diabetes, heart disease and obesity. I see the consequences every day. We tell our patients to diet and exercise when they do not have the time or financial resources to do so. Once a patient has a heart attack or a stroke, our system will deliver excellent care, but then we leave the recovery to beleaguered family members.
What would it take to end the chronic disease epidemic in children and adults as our new health secretary, Robert F. Kennedy Jr., has promised? I scan my patient list at the long-term-care hospital. In a given day, I’ve cared for a woman whose years of smoking led to a lung transplant, a relatively young man whose severe obesity required a tracheotomy tube to help him breathe and a low-income man in his 60s with heart disease.
That man is now on a ventilator and dialysis after a risky surgery to open his blocked arteries. He just wants to go home, but he’s frustrated with medical interventions that make him feel worse instead of better.
One recent morning, curiosity led me to a video promoting Mr. Kennedy’s Make America Healthy Again movement. With the hospital’s cacophony of ventilator and heart rate monitor sounds in the background, I watched Mr. Kennedy stand in a grassy field and promise to find and target the root causes of chronic illness — with few actual specifics.
Ozempic’s New Frontier: The War on Aging
The Wall Street Journal reported:
For decades, scientists have been on the hunt for an anti aging drug. Now, some say we may have already found it. A fast-growing body of research signals potential health benefits of GLP-1s, the class of diabetes and weight-loss drugs known by names like Ozempic, beyond what they were initially approved to treat. That includes age-related conditions like Alzheimer’s, osteoarthritis, certain cancers and even mortality.
Doctors and researchers emphasize the need for larger, more rigorous long-term studies to confirm these preventive effects are causal, not just correlational.
Still, since Ozempic was approved in 2017, thousands of studies have been published examining the effects of GLP-1s. Last year, Wegovy won a new U.S. Food and Drug Administration approval to reduce the risk of heart attacks and other cardiovascular events, and Ozempic, was recently approved to help kidney-disease patients.
This accumulating body of research has led longevity clinics to market and prescribe GLP-1s as so-called gerotherapeutics — drugs that can target certain biological hallmarks of aging.
Next-Generation, Inhaled COVID-19 Vaccine Enters Phase-2 Clinical Trial
Researchers at McMaster University have started a phase-2 clinical trial on a next-generation, inhaled COVID-19 vaccine. The AeroVax study, supported by $8M in funding from the Canadian Institutes of Health Research, will test needle-free vaccines developed to provide protection from SARS-CoV-2.
Led by Fiona Smaill and Zhou Xing, members of the Michael G. DeGroote Institute for Infectious Disease Research at McMaster, the multi-centre trial will evaluate the new vaccine in a broad study group, while also confirming safety.
Findings from pre-clinical studies and the soon-to-be-published data from the phase-1 trial indicate that McMaster’s inhaled vaccine is more effective at inducing immune responses than traditional injected vaccines are, because it directly targets the lungs and upper airways — where the virus first enters the body.
Pfizer Readies Its Next-Generation COVID-19 Antiviral
Chemical and Engineering News reported:
An alternative to Paxlovid, the only antiviral pills approved by the U.S. Food and Drug Administration (FDA) to treat COVID-19, is on the horizon. Pfizer — the maker of Paxlovid — has begun Phase 3 clinical trials of a next-generation coronavirus antiviral, ibuzatrelvir.
Ibuzatrelvir offers several advantages over its predecessor. It doesn’t have the drug-drug interactions that prevent many people with COVID-19 from taking Paxlovid. And participants in ibuzatrelvir’s Phase 2 clinical trial didn’t report “Paxlovid mouth,” an unpleasant side effect of the drug in which people experience a lingering taste described as metallic or, more colorfully, like grapefruit mixed with soap.
Despite its drawbacks, Paxlovid is a marvel of modern medicinal chemistry. Experts says its discovery and development show what a well-resourced anti-infective program can produce. The drug, which combines the compounds nirmatrelvir and ritonavir, entered human clinical trials in March 2021, just 12 months after its first synthesis — stunning speed for making a new bespoke drug.
At the time, vaccines for COVID-19 were just becoming widely available in the US, and the prospect of an antiviral pill offered another avenue for avoiding hospitalization or death from the disease. By early 2022, Paxlovid was available under emergency use authorization, and it had received full FDA approval by May of 2023.
US FDA to Hold off Action on Weight-Loss Drug Copies Pending Court Ruling
The U.S. Food and Drug Administration said on Monday it will not take action against compounding pharmacies making copies of Novo Nordisk’s (NOVOb.CO) weight-loss drug Wegovy until a federal court delivers its ruling in a lawsuit against the agency.
The health regulator announced last month that there was no longer a shortage of Novo’s Wegovy and diabetes drug Ozempic, both known chemically as semaglutide, and gave compounding pharmacies 60 to 90 days to cease making copies of the drugs.
MRNA Vaccines, Once a Trump Boast, Now Face Attacks From Some in GOP
Researchers racing to develop bird flu vaccines for humans have turned to a cutting-edge technology that enabled the rapid development of lifesaving covid shots.
There’s a catch: The mRNA technology faces growing doubts among Republicans, including people around President Donald Trump.
Legislation aimed to ban or limit mRNA vaccines was introduced this year by GOP lawmakers in at least seven states. In some cases, the measures would hit doctors who give the injections with criminal penalties, fines, and possible revocation of their licenses.
Some congressional Republicans are also pressing regulators to revoke federal approval for mRNA-based covid shots, which President Donald Trump touted as one of the signature achievements of his first term.
NJ Pharmaceutical Industry: What Will Trump, RFK Jr. Do to State’s Linchpin?
New Jersey’s powerhouse pharmaceutical industry, already under pressure to rein in prices, is facing new headwinds from a Trump administration that is calling into question vaccine effectiveness and trying to cut research funding.
The moves, industry experts said, could douse an era of scientific breakthroughs with a wave of new technology, from artificial intelligence to digital imaging.
“We’re all for efficiency, we want to reduce government as much as possible,” said David Perlin, chief scientific officer and executive vice president of Hackensack Meridian Center for Discovery and Innovation based in Nutley. “But fundamentally, (the federal government is) a partner. They get a return. And what they can’t see in economic return, which we can’t measure, is human life.”
Big Pharma Wants to Bring Back a Tax Break That Could Save It $15 Billion
A pharmacy technician grabs a bottle of drugs off a shelve at the central pharmacy of Intermountain Heathcare on Sept. 10, 2018 in Midvale, Utah.
Big Pharma is pushing to bring back a tax break that could have saved them at least $15.4 billion in 2023 alone, according to a new analysis by Americans for Tax Fairness and Lower Drug Prices Now.
The tax break in question allows companies to deduct research and development costs in the year they are incurred. The provision went into effect with the passing of Trump’s 2017 tax law — the Tax Cuts and Jobs Act, much of which is set to expire at the end of this year.
Texas Cities Run Short of MMR Vaccine as Measles Outbreak Drives Demand
As measles cases continue to grow in Texas and New Mexico, with a second death, an unvaccinated adult, reported on Thursday, some Texas cities are seeing shortages amid soaring demand for the highly effective vaccine and as the top U.S. health official, Robert F Kennedy Jr, sows disinformation and mistrust about vaccines.
Ann and Paul Clancy were picking up medications at their local Walgreens in Austin, Texas, on Wednesday and decided to ask the pharmacist about getting the measles, mumps and rubella vaccine. The pharmacist said that they were “totally out, and she didn’t know exactly when they would be getting more”, Ann said.
The Clancys wanted to get vaccinated because they have followed the outbreak in the news, including the first measles case detected in Austin last week — an unvaccinated infant who had traveled recently and was not considered part of the wider outbreak of cases.
In addition to keeping themselves safe, the Clancys want to protect their grandchildren and family members with health vulnerabilities. The pharmacist also mentioned that even doctors’ offices were “having a hard time keeping enough vaccines for kids who needed them”, Ann said.
By Exercising Long-Held Stock Options, BioNTech CEO Scored €260M Payday in 2024
In exercising some of his stock options last year, BioNTech CEO Uğur Şahin, M.D., scored a whopping 259.5 million euros ($281 million) in calculated compensation.
BioNTech revealed the windfall in its annual report, published March 10.
In the fall of 2019, the company issued its CEO a large option grant. The award came three months before COVID-19 emerged in China and six months before the World Health Organization declared the spread of the virus a pandemic.
Stock options are commonly used to retain valued employees. They give an employee the right to buy a specific number of shares at a pre-set price after a vesting period. The practice helps employers encourage employees to stay through the vesting period to take ownership of the options granted to them.
In BioNTech’s 2020 annual report, the company said it agreed to grant Şahin “an option to purchase 4,374,963 of our ordinary shares, subject to Prof. Şahin’s continuous employment with us,” based on the euro conversion of its initial public offering price of $15.
A More Affordable, Lower-Risk Polio Vaccine May Be on the Horizon
University of Leeds researchers have taken a major step towards producing a more affordable and lower-risk polio vaccine using virus-like particles (VLPs). These particles mimic the outer protein shell of poliovirus, but are empty inside. This means there is no risk of infection, but the VLP still causes the immune system to respond.
Now, a research project led by Professor David Rowlands, Emeritus Professor of Molecular Virology at the University of Leeds, has tested the effectiveness of using different yeast, insect, mammalian and plant cells as expression systems to generate VLPs.
In a paper published in Nature Communications, the findings show that VLPs produced in both yeast and insect cells can perform equally or better than the current inactivated polio vaccine, which creates an immune system response by using a killed version of the poliovirus. The paper is titled “Recombinant expression systems for production of stabilised virus-like particles as next-generation polio vaccines.”
