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Lab-Created Bird Flu Virus Accident Shows Lax Oversight of Risky ‘Gain-of-Function’ Research
Inside the high-security Influenza Research Institute at the University of Wisconsin-Madison, two experienced scientists were pulling ferrets out of their HEPA-filtered cages on a Monday in December 2019. Another researcher, still in training, was also in the room to watch and learn.
One by one, the animals were put into a biosafety cabinet, where a solution was washed into their nostrils. It’s a procedure used to collect evidence of infection, and this particular experiment involved exposing the animals to a highly controversial lab-engineered strain of the H5N1 avian influenza virus.
The virus they were working with that day was far from ordinary, and there should have been no room for the safety breach that was about to happen and the oversight failures that followed.
The experiment underway involved one of two infamous lab-made bird flu viruses that had alarmed scientists around the world when their creation became widely known nearly a decade earlier. In each case, scientists had taken an avian influenza virus that was mostly dangerous to birds and manipulated it in ways that potentially increased its threat to humans.
In late 2011 the world learned that two scientific teams — one in Wisconsin, led by virologist Yoshihiro Kawaoka, and another in the Netherlands, led by virologist Ron Fouchier — had potentially pushed the virus in that direction. Each of these labs had created H5N1 viruses that had gained the ability to spread through the air between ferrets, the animal model used to study how flu viruses might behave in humans.
Moderna Says Potential Flu Vaccine Needs More Study
Moderna shares slipped Tuesday morning after the COVID-19 vaccine developer said its potential flu vaccine needs more study in a late-stage clinical trial. The company said an independent data and safety monitory board found that the potential vaccine “did not meet the statistical threshold necessary to declare early success” in the study. The board recommended that the trial should continue.
Moderna is developing the vaccine, labeled mRNA-1010, to guard against seasonal flu. It is testing the vaccine in two, late-stage studies in the Southern and Northern hemispheres.
The vaccine developer said Tuesday it expects to launch six vaccines in the next few years. The company’s COVID-19 vaccine, Spikevax, has been its main revenue generator so far. It brought in more than $18 billion in sales last year.
Moderna also is developing potential vaccines for respiratory syncytial virus, or RSV, and the human immunodeficiency virus that causes AIDS.
J&J Talc Unit 2nd Bankruptcy Must Be Dismissed, Cancer Victims’ Lawyers Say
Johnson & Johnson’s second attempt to resolve talc lawsuits in bankruptcy should be dismissed as an unprecedented fraud designed to deny plaintiffs just compensation, lawyers representing cancer victims argued in a Monday court filing.
The attorneys contend J&J defied a January appeals court rejection of its first attempt to settle the litigation, noting that a J&J subsidiary refiled for Chapter 11 about two hours after a court dismissed its first bankruptcy. The lawyers blasted the move as the “largest intentional fraudulent transfer in United States history.”
Johnson & Johnson (JNJ.N) is offering to settle all claims for $8.9 billion, up from its original offer of $2 billion.
Monday’s legal broadside challenged the company’s latest gambit as an unlawful abuse of the Chapter 11 system, echoing earlier objections to its first effort to resolve the lawsuits.
White House Launching $5 Billion Program to Speed Coronavirus Vaccines
The Biden administration is launching a $5 billion-plus program to accelerate the development of new coronavirus vaccines and treatments, seeking to better protect against a still-mutating virus, as well as other coronaviruses that might threaten us in the future.
“Project Next Gen” — the long-anticipated follow-up to “Operation Warp Speed,” the Trump-era program that sped coronavirus vaccines to patients in 2020 — would take a similar approach to partner with private-sector companies to expedite the development of vaccines and therapies. Scientists, public health experts and politicians have called for the initiative, warning that existing therapies have steadily lost their effectiveness and that new ones are needed.
Ashish Jha, the White House coronavirus coordinator, and others said the new effort will focus on three goals: creating long-lasting monoclonal antibodies, after an evolving virus rendered many current treatments ineffective; accelerating the development of vaccines that produce mucosal immunity, which is thought to reduce transmission and infection risks; and speeding efforts to develop pan-coronavirus vaccines to guard against new SARS-CoV-2 variants, as well as other coronaviruses.
New WHO Recommendations on COVID Vaccines Create More Revenue Uncertainty: Analyst
Two weeks after the World Health Organization revised its guidance on COVID-19 vaccination, data analytics company GlobalData says the future of vaccine rollouts is becoming “highly uncertain.”
Over the last few months, manufacturers of the world’s most used COVID vaccines — Moderna and Pfizer/BioNTech — have said they expect a major decline in demand for their shots this year. But the WHO guidance and other factors at play may cause the companies to cut their sales expectations further for 2023.
“Combined with recent guidance calling for decreased use of boosters and the U.S. Senate’s decision to end the national emergency declaration early, COVID-19 revenue streams may fade quickly for vaccine developers,” GlobalData pharma analyst Nancy Jaser said in a release.
FDA Says Repaired Sleep Apnea Machines Still Carry Health Risks
U.S. News & World Report reported:
The U.S. Food and Drug Administration has issued another warning about certain sleep apnea machines made by Philips Respironics.
Already the subject of a 2021 recall, some of the company’s repaired continuous positive airway pressure (CPAP) machines may still be dangerous to use, the agency said in an alert issued Friday.
“The FDA has identified this as a Class I recall, the most serious type of recall,” the agency said. “Use of these devices may cause serious injuries or death.”
The latest issue with some of the machines is that the company gave repaired machines the wrong or duplicate serial numbers, the latest FDA alert said. That may lead to the devices delivering the wrong prescription to sleep apnea patients. If receiving the wrong prescription, patients may not receive any CPAP benefits.
How Big Pharma Games the System — and Keeps Drugs Prices High
The pharmaceutical market is a strange beast. It’s governed by a complex system of rules that protect new branded drugs from unbranded rivals for a limited period of time, in order to keep these cheaper generic competitors at bay.
But measures such as patents, market exclusivity and data protection — designed to give pharma companies the chance to recoup investment in a new drug — are being exploited by some Big Pharma to keep competitors out of the market far beyond the intended fixed period of around 15 years, argues the generics sector.
Gaming the system is so common that it even has a name: Evergreening. It can add billions of euros to pharmaceutical companies’ balance sheets, and cost EU countries significantly in missed savings.
Big Pharma strongly denies wrongdoing, but in a 2009 report, the European Commission highlighted the need for stronger enforcement of competition laws to prevent evergreening. However, little has changed. Now, the leaked draft of the EU’s pharmaceutical legislation revision indicates that the Commission may be gearing up to clamp down on these games.
You may think that one drug = one patent. But you’d be wrong. AbbVie, for example, applied for over 250 patents for their arthritis drug Humira in the U.S. Rival drugmakers launching generic versions of the medicine found themselves blocked in court. So while the medicine was launched in 2003, the first competitors are only entering the market this year.
Certain Painkillers Linked to Heart Failure in Type 2 Diabetes — Population-Based Study Shows Older Patients With Poorly Controlled Diabetes at Particular Risk
Short-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) was associated with an increased risk for heart failure hospitalization among patients with type 2 diabetes (T2D), according to a Danish registry study.
Among over 300,000 patients with T2D, short-term use of NSAIDs was associated with a relative 43% increased risk of a first-time heart failure hospitalization in the subsequent 28 days (OR 1.43, 95% CI 1.27-1.63), reported Anders Holt, MD, of Copenhagen University Hospital-Herlev and Gentofte in Hellerup, Denmark, and colleagues.
While the findings in T2D might not be surprising, they are worrying, given the widespread use of NSAIDs, according to an accompanying editorial by Hassan Khan, MD, Ph.D., of Norton Healthcare in Louisville, Kentucky, and Setor K. Kunutsor, MD, Ph.D., of the University of Leicester in England.
Several position statements already caution against both short-term and long-term use of NSAIDs in patients at high cardiovascular risk, with the suggestion that uses be of the shortest duration at the lowest dose that provides relief, the editorialists noted.
Beyond Asthma: Designing Inhaled Drugs to Fight More Diseases
The Wall Street Journal reported:
Treatments for asthma have long been delivered through the airways. Now researchers are developing inhalable therapies to target a wider range of ailments from cancer to diabetes.
Constantly exposed to the outside world as we breathe, the lungs are a first line of defense against infection. They also provide a direct pathway to the circulatory system as they send oxygen to the blood. Researchers hope that delivering medicines directly to the lungs can exploit those characteristics and make drugs that are more efficient and effective than oral or injectable drugs — and may be easier to take.
They are harnessing technologies ranging from nanomedicine to gene-editing tools to particle engineering to improve how medicines interact with the lungs, targeting lung diseases such as cystic fibrosis and lung cancer as well as less obvious conditions including schizophrenia, migraines and Parkinson’s disease.
Respiratory diseases that spread through the air are a key target. Dr. Santangelo and colleagues are developing inhalable drugs that use an RNA-editing tool known as CRISPR-Cas13 and messenger RNA to kill viruses such as COVID-19, influenza and respiratory syncytial virus or RSV.
Using nebulizers that dispense medicine as a mist via a mask, they have tested the delivery of some of the medicines on rhesus monkeys, cows, horses and pigs. The tests in pigs showed that getting the drugs to the lungs reduces the severity and spread of infections, said Philip Santangelo, a professor of biomedical engineering at Emory University.
