Login
Lawmakers Urge FDA to Investigate Clinical Trials Run in Tandem With China’s Military
As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China’s biopharma ecosystem.
In a letter addressed (PDF) to FDA Commissioner Robert Califf, M.D., a bipartisan group of lawmakers from the House committee asked that the regulator “play an active role in ensuring the United States remains ahead of the [People’s Republic of China] in biotechnology.”
Aside from questioning the “trustworthiness” of clinical data generated at these institutions, the lawmakers warned that U.S. biopharmas have run clinical studies with hospitals in Xinjiang, where China has been accused of committing genocide against Uyghur Muslims.
“Given the historical suppression and medical discrimination against ethnic minorities in this region, there are significant ethical concerns around conducting clinical trials in the [Xinjiang Uyghur Autonomous Region],” the lawmakers wrote.
‘It Feels Like We’ve Been Lobotomised’: The Possible Sexual Consequences of SSRIs
During Melbourne’s strict lockdown of 2020, Rosie Tilli, a then 20-year-old nurse living and working in the city, began to experience growing anxiety and depression.
Visiting her GP, she was quickly prescribed escitalopram, a commonly used drug from a class known as selective serotonin reuptake inhibitors (SSRIs). These medicines attempt to treat depressive symptoms by boosting the levels of the hormone serotonin in the brain and rank among the most widely prescribed drugs.
“I reassured myself that I would be fine as soon as I fully ceased the medication, but I wasn’t,” she says. “Now nearly four years on, I’ve learned to put on a sunny disposition, but internally I am riddled with psychological grief and anguish. I can’t experience any physiological sexual response. No arousal even when physically touched.
“When I reached out for help with my local mental health service, I was sectioned and placed involuntarily into psychiatric care as the psychiatrist said I had ‘delusional disorder’, and tried to put me on antipsychotics,” she says. “It shattered my trust in ever seeking help for my mental health again.”
For Tilli and others, having even a glimmer of hope is vital. “Our community has had many suicides,” she says. “Our main goal is to raise awareness so that we can get funding for research to pave a path towards hopeful treatments and prevent the despair that leads many to end their lives.”
COVID-Related Loss of Smell Tied to Changes in the Brain
A new study of 73 adults recovering from COVID-19 finds that those who lost their sense of smell showed behavioral, functional, and structural brain changes.
The patients were recruited from public and private hospitals in Santiago an average of 9 months after diagnosis from February 2020 to May 2023. The average age was 40.1 years. The team used loss of smell and need for hospitalization as proxies for potential markers of neurologic involvement and disease severity, respectively.
Twenty-two of 73 COVID-19 patients (30.1%) reported having differing degrees of attention and memory problems. Seven patients said they had headaches, six reported fatigue, and four had a persistently impaired sense of smell lasting, on average, 1.3 months. Of these patients, 68% experienced a total loss of smell, while the rest had an altered sense of smell.
New Vector Vaccine Against COVID-19 Provides Long-Term Protection
The protective effect of established COVID-19 vaccines is initially very robust, but wanes relatively quickly. This limitation imposes a need for periodic booster shots, which drives vaccine hesitation.
In contrast, an innovative vector vaccine developed at the Helmholtz Center for Infection Research (HZI) presents a compelling alternative. It elicits prolonged immune response in animal models, and maintains its efficacy over extended time.
There are reasonable concerns about the safety of vaccines based on some vector viruses. Human viruses that are used as vectors have to be attenuated by genetic modifications. The murine cytomegalovirus (MCMV), however, can be used as is, because cytomegaloviruses are highly host-selective.
This means that the MCMV can only replicate in mouse cells, but not in human ones, as two of the first authors, Dr. Kristin Metzdorf and Dr. Henning Jacobsen explain. For this reason, among others, MCMV is ideal as a vector for vaccines.
Mpox ‘Not the New Covid’, Says WHO
The mpox outbreak is not another COVID-19, the World Health Organization said Tuesday, because much is already known about the virus and the means to control it.
“We know how to control mpox. And, in the European region, the steps needed to eliminate its transmission altogether,” he told a media briefing in Geneva, via video-link.
In July 2022, the WHO declared an emergency over the international outbreak of the less severe Clade 2b strain of mpox, which mostly affected men who have sex with men. The alarm was lifted in May 2023.
“We controlled mpox in Europe thanks to the direct engagement with the most affected communities,” said Kluge.
“Are we going to go in lockdown in the WHO European region, (as if) it’s another COVID-19? The answer is clearly: ‘no’,” he said.
Socioeconomic Disadvantage Magnifies COVID-19 Effects, Slows Recovery, Data Suggest
Recovery from COVID-19 takes longer, and infection has a greater effect on health-related quality of life (HRQoL), among socioeconomically disadvantaged patients, suggests an observational study published in BMC Infectious Diseases.
Researchers in Bergamo, Italy, analyzed data and conducted follow-up visits with 825 adult COVID-19 patients a median of 133 days after they were treated at a hospital from February to September 2020.
The patients completed questionnaires on their nationality, educational attainment, household size, occupation, post-traumatic stress disorder (PTSD) symptoms, HRQoL, and fatigue level. Of all patients (median age, 59 years), 60.2% were men, 60.5% were hospitalized, and 3.3% were admitted to an intensive care unit (ICU).
Studied outcomes included the composite end point (shortness of breath, fatigue, muscle pain, chest pain, heart palpitations), HRQoL (pain and limitations in physical activities), PTSD, and structural lung damage.
Antibody could offer sweeping protection against evolving SARS-CoV-2 virus
Researchers at Northeastern say they’ve discovered how an antibody could provide broad protection against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the virus responsible for COVID-19—even as it evolves to outwit other of the body’s chemical defenses.
Researchers studied the structure of the spike protein of SARS-CoV-2—the outer projections of the virus‘ membrane that is responsible for viral entry into a human cell.
What the researchers showed was that a specific antibody—known as CV3-25—disrupts the cell infection process by targeting a particular site on the spike protein that is largely conserved across the different viral strains, according to the study.
Think of it as like the virus’ Achilles heel.
The results suggest that the broadly neutralizing antibody could hold the key to manufacturing a vaccine that protects against a rapidly evolving virus.
