Article by Lalita Panicker, Consulting Editor, Views and Editor, Insight, Hindustan Times, New Delhi
At the end of May, 194 member states of the World Health Organization (WHO) will meet for the World Health Assembly. Negotiations underway now will determine whether they vote then to adopt a pandemic agreement. www.science.org/doi/10.1126/science.adq1055?utm_source=sfmc&utm_medium=email&utm_content=alert&utm_campaign=SCIeToc&et_rid=785235729&et_cid=5199970
For the past 2 years, discussions have focused on spelling out essential components of a robust and equitable architecture for pandemic preparedness and response. Despite this, talks have failed to produce sufficient consensus on a detailed draft, prompting the intergovernmental negotiating body to propose a “streamlined” version. The new text, released on 16 April, consolidates provisions for research and development, technology transfer, pathogen access and benefit sharing (including pandemic products such as medicines and vaccines), with many particulars deferred to future procedures. Ultimately, success of the agreement will depend on these details and implementation. Nevertheless, member states shouldn’t bypass the consensus reached to date, but continue progress to adopt this agreement.
The new draft establishes core obligations and institutional arrangements necessary for pandemic prevention, preparedness, response, and, to some extent, recovery. It substantially refines provisions on surveillance and preparedness (including a monitoring and evaluation system), retaining those for a health workforce. The simplified articles call for parties (states or regional economic organizations that consent to be bound by the agreement) to promote timely and equitable access to pandemic products that result from government-funded research and development. Similarly, parties must publish relevant provisions of agreements they enter into to purchase pandemic products. Other articles cover geographic diversification for producing pandemic products, technology transfer, and a global supply chain and logistics network.
The text illuminates two contentious issues at a high level. One is upstream prevention and a One Health approach to prevention, preparedness, and response, which recognizes links between the health of people, animals, and ecosystems. The other commits parties to establishing a new WHO Pathogen Access and Benefits Sharing system (PABS). An accompanying draft resolution, prepared by WHO for adoption at the forthcoming World Health Assembly, proposes creating intergovernmental working groups. Two such groups are tasked with developing new international instruments for One Health and for PABS, with both operational by May 2026. Both agreements are proposed to be adopted as legally binding treaties, but member states could actively “opt out.” By contrast, the pandemic agreement would require member states to “opt in” to become parties and thus be legally bound.
The proposed components of PABS include obligations to share samples and sequence data of pandemic pathogens. PABS would also establish a mechanism for equitable sharing of benefits that arise from the use of these materials and information, including up to 20% of real-time production of vaccines, diagnostics, and therapeutics.
Throughout negotiations, a false dilemma between science and equity has emerged, suggesting that legal mechanisms to facilitate equitable access to pandemic products, such as PABS, conflict with open science and innovation. However, equity is an ethical imperative and is fundamental to accurate, representative, and actionable pandemic science. The certainty of a future pandemic requires global cooperation for science and equity. Member states have an opportunity to lay a solid foundation that supports this ideal.
////
In a setback for genetically modified (GM) crops, a Philippine court of appeals has revoked a permit allowing farmers to grow rice for consumption that had been genetically modified to produce vitamin A. www.science.org/content/article/news-glance-infrared-telescope-debuts-gm-rice-stumbles-maternal-mortality-drops?
The fortified Golden Rice targets vitamin A deficiency, which is common in developing countries and can cause blindness and impair disease resistance. In 2021, the Philippines became the first country to allow commercial cultivation of the GM crop, capping a decades long quest by its developers. But responding to a petition brought by a farmers’ group, Greenpeace Philippines, and others, the court found no consensus on its safety for human health and the environment. Its decision last month also blocks the commercialization of GM eggplant that resists insects. The government can ask the court to reconsider—although a reversal is considered unlikely—and can also appeal to the nation’s Supreme Court.
////
After reaching a historic high in 2021, the U.S. maternal mortality rate fell by 32% the following year, the U.S. Centers for Disease Control and Prevention (CDC) said this week. www.science.org/content/article/news-glance-infrared-telescope-debuts-gm-rice-stumbles-maternal-mortality-drops?
The rate, defined as the number of pregnancy-related deaths during gestation or in the 6 weeks after birth, was 22.3 for every 100,000 live births in 2022, down from 32.9 in 2021. Decreases occurred across all age, ethnic, and racial groups, although the drop for Asian women was not statistically significant. For Black women, who suffer the highest rates, it dropped from 69.9 deaths per 100,000 live births in 2021 to 49.5 in 2022. Specialists say the declines are almost certainly related to a drop in COVID-19–related deaths in 2022; the disease puts pregnant people at greater risk for death. The overall rate for 2022 was still above that of 2019 and more than double the level 2 decades ago. Some researchers recently attributed that rise largely to a CDC-led addition of a “pregnancy checkbox” on death certificates that they say artificially inflates the number of deaths recorded as related to pregnancy. The agency has defended the change as a remedy for previous undercounting and said the switch cannot explain all the increase.
///
A whopping 75% of patients hospitalized with COVID-19 received antibiotics even though only 8% had bacterial coinfections that warrant their use, according to data from the World Health Organization (WHO). www.science.org/content/article/news-glance-infrared-telescope-debuts-gm-rice-stumbles-maternal-mortality-drops?
Doctors often prescribe antibiotics to err on the side of caution, but that’s not recommended unless there’s evidence of a bacterial infection; overuse of the drugs can exacerbate the development of antibiotic resistance. The findings, presented on 27 April at a meeting in Spain, come from WHO’s Global Clinical Platform for COVID-19, which contains data of about 450,000 people hospitalized with COVID-19 in 65 countries between January 2020 and March 2023. WHO says the numbers provide a new reminder of the need for more rational use of antibiotics, which will be discussed at a September meeting convened by the United Nations.
////
A large clinical trial that ushered in a new global regimen for treating drug-resistant tuberculosis (TB) cost only €34 million to conduct, an order of magnitude less than published estimates of other trials’ costs based on pharmaceutical industry data, according to Doctors Without Borders (MSF). www.science.org/content/article/news-glance-infrared-telescope-debuts-gm-rice-stumbles-maternal-mortality-drops?
The group last week made the rare disclosure of an individual clinical trial’s price tag at a World Health Organization conference on pharmaceutical pricing. Previous studies have reported average overall trial costs across groups of trials and used proprietary industry data that cannot be scrutinized. MSF says its disclosure, to be published in greater detail in a journal, should spur trial sponsors to routinely reveal their costs, which are often cited to justify high drug prices. The group also launched an online toolkit for sponsors to calculate these costs. MSF’s clinical trial of the anti-TB drug bedaquiline in combination with other drugs, described in a 2022 paper, was stopped early because its efficacy and safety strikingly surpassed standard-of-care treatment.
////
The U.S. Food and Drug Administration (FDA) announced this week it will implement a controversial plan it proposed last year to tighten regulation of a large class of lab tests. www.science.org/content/article/news-glance-infrared-telescope-debuts-gm-rice-stumbles-maternal-mortality-drops?
Under the newly finalised rule, tests that are designed and used for patient care within a single lab, such as some prenatal screening tests and gene sequencing of tumours, will be subject to FDA’s scrutiny. In practice, such tests are often marketed nationwide, and regulators say many aren’t well validated and can put patients at risk. Under the new rule, to be phased in over the next 4 years, FDA will regulate the tests as medical devices, allowing stricter oversight of their safety and efficacy. Last year, some researchers welcomed the initial proposal, but others worried it may limit public access to needed tests. Based on the more than 6,000 comments FDA received, it opted to exempt some kinds of tests, including some that a health care system limits to its own patients. In general, the law will apply to new tests.
///
It’s estimated that about 10% of people in the world are affected by at least one autoimmune disease—but about 65% of those people are women. Why women are so much more likely to have their immune systems mistakenly attack their own bodies is an enduring mystery in immunology. But the more researchers delve into it, the more one culprit seems to stand out: the X chromosome.
Although everyone has an X chromosome, for most men the X pairs with a much shorter Y, which lacks many of the genes found on X. The vast majority of women, however, have an XX pair. There are lots of proteins that people with two X chromosomes would overproduce if it weren’t for a phenomenon called X-chromosome inactivation, which involves ‘turning off’ one of the two Xs by blanketing it with a long stretch of RNA called Xist. It is this process—and alterations to it—that may underlie many autoimmune diseases.
In a new study with mice, researchers discovered that if they messed with the expression of Xist, they could reactivate genes that had been silenced and spontaneously give female mice symptoms typical of lupus, a common autoimmune disease. The findings echo work from earlier this year which found that expressing Xist in male mice, which normally don’t produce the RNA, made them as likely to develop lupus as females. Both studies suggest that Xist plays a pivotal role—and could help point researchers towards new ways to treat these often devastating conditions.
////
For the first time, researchers have genetically identified leprosy-causing bacteria in archaeological animal remains—indicating, in this case, that the disease circulated between red squirrels and humans in medieval England. www.science.org/content/article/medieval-england-leprosy-bounced-between-humans-and-squirrels?
The evidence came from archaeological sites in the city of Winchester, which during the Middle Ages had both a thriving squirrel fur trade and a hospital for leprosy patients, setting the stage for interspecies transmissions. Some medieval Brits even kept the arboreal rodents as pets.
After analysing squirrel bones dating to medieval England, researchers found that the furry critters carried a strain of a leprosy-causing bacterium strikingly similar to the one many Brits harboured centuries ago. The finding suggests the disease once bounced back and forth between humans and squirrels, which could help scientists understand how leprosy persists today. While some modern red squirrels in England still carry leprosy, there’s no evidence of them passing it to humans, as the disease requires frequent close contact with an infected host. But experts argue that considering the interspecies history of leprosy, rather than focusing solely on human infections, can help us anticipate where and how transmission risk might increase. That approach could apply to other nonhuman carriers, too—such as armadillos, which have been linked to a handful of human cases in the Americas. “By defining the context in which [leprosy] occurred in the past, you can understand the risks today,” says Elizabeth Uhl, a veterinary pathologist who was not involved with the research.
