Understanding and Preserving the Importance of Clinical Research in Pandemic Epidemics: Measures, Risks, and Preventable Diseases

I can understand the argument, on an emotional level, that when it comes to your body and life, you should be able to assume whatever risk you want. There’s also the compelling argument that in certain situations, whether it’s a pandemic affecting millions or a rare, devastating disease, there should be a lower bar for evidence and a greater willingness to allow people to assume risk. The idea that absolute certainty about a product’s safety or efficacy is not always needed was on display in the F.D.A.’s emergency use authorization for Covid-19 vaccines and therapeutics (which had strong early evidence that they worked well and were safe). Such regulatory flexibility can provide relief in a crisis, but its use should be exceptional.

The system of clinical research, which was slow in generating useful results on a range of issues, such as optimal vaccine schedules and the evaluation of drugs to mitigate Covid symptoms, has not been fixed. The reliable clinical results proving the benefits of steroids and the problems with hydroxychloroquine tended to come from Britain and other countries. The National Institute of Health has not looked at how they reward scientists for participating in large, pragmatic clinical trials that are not only public health emergencies.

The bill introduced in the House in March, called the Accelerated approval integrity Act, is an important step towards addressing these deficiencies while preserving the benefits of accelerated approval. The bill requires companies to sign an agreement with the F.D.A on how the follow-up studies will be conducted. It would mandate more frequent updates from follow-up studies, automatically expire accelerated approval one year after the agreed-upon deadline for further study and streamline the process for taking ineffective products off the market.

Adding this type of rigor will make it possible for clinicians and patients to have more faith in the system and in the treatments it approves.

Better detection of new pathogens, the public health system’s antiquated data collection apparatus, supply chain vulnerabilities, the spread of misinformation and a lack of public trust are all topics covered in an investigation of the Pandemic.

Another missed opportunity was improving worker safety. Everyone in a workplace benefits if colleagues feeling flulike symptoms remain home. But this will happen only with a change in culture around sickness and, more important, the provision of paid sick leave to workers, especially for those in low-income jobs and the gig economy. Paid sick leave is particularly important in the health care, hospitality, public transportation and retail industries, where infections can most easily spread. Congress refused to pass legislation requiring paid sick and family medical leave because of the amount of data on the spread of respiratory infections at work.

Instituting proactive outreach will be valuable in future emergencies — whether pandemics, hurricanes, wildfires or other disasters. It will be left out again if not done otherwise, there will be widening gaps in care and outcomes.

FDA’s latest push for legislative change: the pharma-technical impact of new methods of testing personal protective equipment, including face coverings and disposable gowns

The government has yet to ensure a stable domestic production capacity and raw material supply chains for personal protective equipment, including N95 and KN95 face coverings, gloves and disposable gowns, much less pharmaceuticals.

The FDA’s interest in moving towards new approaches also reflects the current thinking of the biomedical community at large. The United Kingdom made plans to reduce the use of animal tests in science research in order to replace them with newer, more valid alternatives. The European Parliament voted in favor of animal testing being stopped.

“A key for bringing about change is to do so among the multiple major regulatory agencies,” says David Strauss, director of the FDA’s Division of Applied Regulatory Science. “Drug-development programmes are global, and companies want to market their products in many countries around the world.”

“There’s a lot of moving pieces here,” he says. “The FDA has started the ball rolling, but we need more work to make sure we can use these new methodologies appropriately.”

Congress tried to figure out what’s going on. On Friday, the House subcommittee on the coronavirus crisis released its final report, which was sharply critical of the Trump administration. On Thursday, Democrats on the Senate Homeland security committee released a study of the early months of the flu. The Republicans on the Senate health committee released an examination in October that suggested the H1N1 outbreak was the result of a lab leak.

But those inquiries are partisan. The bill to create the independent commission would establish a 12-member expert panel of “highly qualified citizens” appointed by congressional leaders from both parties. It would have the same power and jurisdiction as the Sept. 11 panel. It would investigate the origins of the epidemic as well as the responses by the Trump and Biden administrations.

Bringing Back the Bounce: Implications of the 2014 LHC Data Analysis for the Covid Commission Planning Commission and the Science of Pandemics

Senator Richard M. Burr said there was no substitute for showing the vision of the architecture that was created in 2000, and addressing things that were not thought of before.

The Covid Commission Planning Group was privately funded and consists of about three dozen independent experts who have spent the past two years conducting research to lay the groundwork for a national inquiry. The group has held hundreds of interviews and will publish its findings in a book this spring, Mr Zelikow said. He wouldn’t discuss the details.

Pandemics will occur due to global travel, climate change and humans moving closer to animals, according to infectious disease experts. According to biodefense experts, there’s a big threat to national security from pandemics. The public may not see it that way.

Data that raised hopes of a new particle is not a valid source of information. Plastic hurt sea urchins and what will happen to science now it is in turmoil?

An intriguing anomaly in data gathered by the Large Hadron Collider (LHC) that raised hopes of a new elementary particle has turned out to be a fluke. In 2014, LHC scientists at CERN, Europe’s particle-physics laboratory near Geneva, Switzerland, discovered that some massive particles decay more often into electron–positron pairs than into muon–antimuon pairs. This imbalance defied the standard model of physics, which predicts both pairs to occur with roughly the same frequency. The latest measurements and an investigation of confounding factors revealed that the discrepancy was partly the result of misidentifying other particles as electrons.

Why should scientists on Twitter quit their position? A common debate on Oppenheimer’s clearance and the future of the NASA Space Telescope

Tiny plastic pellets called nurdles that serve as the raw material for much of the modern world cause fatal developmental abnormalities in sea urchins (Strongylocentrotus purpuratus). High concentrations of zinc, which leaches from the nurdles and contaminates the water, is likely to be the cause, say scientists. “Even if plastic is not killing animals by ingestion or entanglement, it can also kill animals by the chemicals in it or on it,” says developmental biologist Eva Jimenez-Guri.

US energy secretary Jennifer Granholm has overturned the 1954 decision revoking the security clearance of one of the most influential physicists of the twentieth century, Robert Oppenheimer, who led the development of the first atomic bomb. The decision of theAEC ended the career of a man who worked for the government. The historical evidence shows that the decision to review Dr. Oppenheimer’s clearance was related to politics and a desire to undermine him in public debates over nuclear weapons policy.

Scientists on Twitter are facing a difficult decision: should they stay or go? Many are concerned about abuse and misinformation on the site due to the erratic and combative management of the new owner, Mr. Musk. The platform has become a way for an estimated half a million researchers to communicate their findings, debate issues and connect with people. Some researchers have left for open-source alternative Mastodon. others are duty bound to keep providing their expertise

The job that Thomas Zurbuchen loves the most is leading NASA’s Science Mission Directorate. He decided to leave after more than six years. Knowing when to leave is an important but underappreciated skill, he says. “Every leader has weaknesses. Over time, their weaknesses weigh more heavily on an organization and it becomes time for someone with fresh ideas to step in.”

Source: https://www.nature.com/articles/d41586-022-04563-x

Vaccination for pediatrics: A report on the HHS Pediatric Vaccines Using the 21st Century to Address Diseases, Safety Concerns and Political Perceptions

Global vaccination rates are at their lowest since 2008. Children weren’t given the shots meant to protect them from serious diseases during the epidemic because health services were disrupted. And even before 2020, vaccination rates had been stagnating. This is partly due to safety concerns, mistrust in public-health institutions and politicized perceptions of vaccines — issues that the pandemic exacerbated. An assessment finds that a lot of people don’t see the importance of vaccinations for diseases that they are not worried about.

From China–US tensions to continued COVID-19 vaccine nationalism and Russia’s war stopping many research collaborations, 2022 saw a trend of science being used as leverage in international politics. A Nature Editorial argued that political objectives must not stop researchers from working together to solve global problems.

Clinical psychologist Camilo Ortiz, who treats children for anxiety, is among the clinicians and researchers who say that kids need to experience independence and autonomy to develop good mental health. (KQED | 9 min read)

The report also suggests that HHS reevaluate its long-established list of 15 agents and toxins that could have ‘dual-use’ as biological weapons and therefore require special review before certain experiments can be performed. Instead, the report advises that the HHS evaluate all experiments that could be “reasonably anticipated” to make a pathogen more transmissible or dangerous.

Once the report is final, it will be sent to HHS for consideration, as they crafts new policy guidelines. The HHS will have to give the “how” level of details. But when that will happen is unclear.

Given how the meeting ended, there could still be a long road ahead to even finalize the report, a frustration for attendees. “The momentum is such that nobody wants to have another meeting to discuss it, even though some serious suggestions and criticisms were raised,” says Gigi Kwik Gronvall, an immunologist at the Johns Hopkins Bloomberg School of Public Health in Washington DC who attended the meeting.

The agency lifted the moratorium in December 2017, after the HHS proposed a new framework that extended review of research involving certain pathogens with the potential to start a pandemic. The projects that have undergone official review by the HHS since then were all about flu vaccine research.

An epidemiologist at the Harvard T.H. Chan School of Public Health in Boston is worried by that low number. The biggest loophole at this point is that most things don’t get to the stage of being reviewed. He points to a recent experiment at theNIH that attempt to breed a monkeypox virus with certain genetic changes that could make it more lethal to mice, and a study in which researchers inserted a gene from the Omicron version of the virus into an earlier strain. Neither underwent the HHS’s extended review process.

Increased transparency in the review process and a role for research institutions in evaluating the risks and benefits of proposed experiments are some of the recommendations made by the new report.

Lipsitch says this vague wording is useful — after all, scientists don’t always initially know where their research is going to lead. He says they’re talking about low-probability but high-consequence events. He remains concerned, though, that the wording could also allow high-risk research to proceed without extended review, depending on how the phrase is interpreted.

On the other hand, Gronvall worries that “reasonably anticipated” could be interpreted so broadly that it could delay a wide swathe of experiments, such as those involved in vaccine development during an outbreak, or even those used in synthetic biology to engineer bacteria so that they produce biomaterials. She says that most things are dual-use. We aren’t making ourselves safer by not doing this research.

At the NSABB meeting, board member Mark Denison, an infectious-disease expert at Vanderbilt University Medical Center in Nashville, Tennessee, also mentioned the difficulty of determining what experiments could be risky. If identifying the function of a common protein might reveal that a mutation could make it more dangerous, for instance, would that identification constitute a risk? “We need a better definition of gain-of-function,” he said.

Gronvall’s concerns echo those of a separate, 18 January report from the US Government Accountability Office (GAO), which recommended that HHS develop a clear, public standard for what “reasonably anticipated” means. The GAO wants more transparency in the evaluation process of the HHS, and said the CDC should evaluate whether exemptions for public health emergencies constitute a risk.