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US army spends $1m on anti-snake venom drugs without independent testing
US army spends $1m on anti-snake venom drugs without independent testing

The Guardian

time22-05-2025

  • Health
  • The Guardian

US army spends $1m on anti-snake venom drugs without independent testing

The US army spent nearly $1m (£750,000) last year on anti-snake venom drugs for troops, which evidence suggests may have weak efficacy. The two drugs do not appear to have undergone any independent testing for safety or effectiveness, an investigation has found, despite evidence that the civilian version of one of the drugs tested had weak efficacy. Neither the army nor the government agency that recommended the military drug tested it to verify manufacturer's claims, the Bureau of Investigative Journalism (TBIJ) revealed. The drugs are not among those that have been assessed and recommended by the World Health Organization, and because they are not intended for use in the US, they have not been fully assessed by the US Food and Drug Administration. It comes as snakebite – one of the world's deadliest yet most neglected health crises – was formally on the global agenda at the World Health Assembly on Thursday in Geneva. The event, co-hosted by Kenya, Egypt and Costa Rica, was to highlight an issue that kills up to 138,000 people a year and leaves 400,000 more with life-changing injuries, usually in the world's most vulnerable communities, where there is little access to effective antivenom. The drugs are versions of a snakebite antivenom called Polyserp and cost the US army a combined $880,000 last year. One covers Middle Eastern, north African and central Asian regions, and the other covers sub-Saharan Africa – where a TBIJ investigation revealed a 'wild west' of antivenoms that are badly made, marketed and regulated. The company promoting the sub-Saharan version of Polyserp (called Polyserp-P) demonstrates the drug's credentials with studies relating to another drug, Inoserp Pan-Africa. Both drugs are from the same manufacturer. The sub-Saharan version of Inoserp featured in the TBIJ's investigation into useless antivenom, where testing revealed that, compared with its competitors, a vial of Inoserp contained only a fraction of the necessary active ingredient. Test results suggested that more than 70 vials would be needed to treat bites from certain snakes. One Kenyan doctor who has been treating snakebite for more than two decades told the TBIJ that he refuses to use Inoserp. The drug failed in a bid to get WHO approval in 2017. A spokesperson from Inosan Biopharma, which produces both drugs, and Polyserp Therapeutics, which markets Polyserp, said the companies questioned the validity of the testing done by the TBIJ. The spokesperson said: 'Polyserp-P is an updated version of Inoserp with higher potency and expanded indication exclusively produced and approved for distribution to US military customers.' Inosan Biopharma and Polyserp Therapeutics also said that 'Inoserp and Polyserp have proven effectiveness in robust pre-clinical and clinical trials' and that a panel of independent experts reviewed the clinical, preclinical and safety data. Neither company responded to repeated requests to share evidence to back up these claims. Juan Calvete, of the Instituto de Biomedicina de Valencia, whose laboratory conducts antivenom tests for the WHO, was refused samples of Polyserp-P in 2021. He was told by Polyserp Therapeutics that it was 'only available to US military customers' and was sent three studies that purported to show the 'safety and efficacy' of Polyserp but in fact related to the other drug, Inoserp. Dr David Williams, a snakebite expert at the WHO, said extrapolating data from one product to another 'is not consistent with the WHO guidance'. Only three antivenoms for sub-Saharan Africa carry a WHO recommendation; 10 more are undergoing assessment, of which Inoserp is one. Polyserp has never been assessed by WHO. A US army spokesperson told the TBIJ that the army 'does not conduct independent testing of medical products and does not have a third-party testing for snake antivenom'. Polyserp-P was recommended by the US Defence Health Agency's joint trauma system (JTS) in 2020. The JTS told the TBIJ: 'The recommendations were based off subject matter experts who evaluated peer-reviewed medical literature and the manufacturer's recommendations.'

US army spent close to $1m on untested snakebite drugs
US army spent close to $1m on untested snakebite drugs

Mail & Guardian

time22-05-2025

  • Health
  • Mail & Guardian

US army spent close to $1m on untested snakebite drugs

Illustration: Aba Marful The US Army spent nearly $1m last year on two drugs that appear to have undergone no independent testing for safety or effectiveness, the Bureau of Investigative Journalism (TBIJ) can reveal. The TBIJ has tested the civilian version of one of the drugs and found it to be alarmingly weak. Neither the army nor the government agency that recommended the military drug has tested it to verify the manufacturer's claims. The drugs are not among those that have been assessed and recommended by the World Health Organisation (WHO) and because they are not intended for use in the US, they have not been fully assessed by the Food and Drug Administration. Both drugs are versions of a snakebite antivenom called Polyserp and cost the army a combined $880,000 last year. One covers Middle Eastern, North African and Central Asian regions, and the other covers sub-Saharan Africa — where a recent TBIJ investigation found a 'wild west' of antivenoms that are badly made, marketed and regulated. The company promoting the sub-Saharan African version of Polyserp (called Polyserp-P) demonstrates the drug's credentials with studies relating to another drug, Inoserp Pan-Africa. Both drugs are from the same manufacturer. But Inoserp is itself hugely problematic. The sub-Saharan African version of that drug featured in the TBIJ's recent investigation into useless antivenom, where testing revealed that, compared to its competitors, a vial of Inoserp contained a fraction of the active ingredient needed. Test results suggested that more than 70 vials would be needed to treat bites from certain snakes. One Kenyan doctor with more than two decades' experience treating snakebite told the TBIJ he refuses to use Inoserp. The drug failed in a bid to get WHO approval in 2017. A spokesperson from Inosan Biopharma, which produces both drugs, and Polyserp Therapeutics, which markets Polyserp, said the companies questioned the validity of the testing done by the TBIJ. (The testing methodology follows WHO guidelines for test tube assessment of snake antivenoms.) The spokesperson said: 'Polyserp-P is an updated version of Inoserp with higher potency and expanded indication exclusively produced and approved for distribution to US military customers.' Inosan Biopharma and Polyserp Therapeutics also said that 'both Inoserp and Polyserp have proven effectiveness in robust pre-clinical and clinical trials' and that a panel of independent experts reviewed the clinical, preclinical and safety data. But neither company responded to the TBIJ's repeated requests to provide evidence to back up these claims. The lack of clarity raises questions. If the two drugs are effectively the same, then the army is buying something shown to be poor quality. If Polyserp is a different and more potent product, why are ordinary people in sub-Saharan Africa not able to access it? Unanswered questions Antivenom experts have described the purchase as 'naive' and 'surprising'. The findings raise questions about the military's protocols for evaluating critical medicine before deploying it to troops. Juan Calvete, of the Instituto de Biomedicina de Valencia, whose lab conducts antivenom tests for the WHO, was denied access to Polyserp-P when he tried to obtain samples in 2021. He was told by Polyserp Therapeutics that it was 'only available to US military customers'. Instead, he was sent three studies that purported to show the 'safety and efficacy' of Polyserp but in fact related to the other drug, Inoserp. David Williams, a leading snakebite expert at the WHO, said extrapolating data from one product to another 'is not consistent with the WHO guidance'. He said some manufacturers might use broad claims about the effectiveness of its antivenom 'as a marketing tool' but that 'it is essential that any such claims be supported by data'. Only three antivenoms for sub-Saharan Africa carry a WHO recommendation. Ten more are undergoing assessment, of which Inoserp is one. But Polyserp has never been assessed by the WHO. David Lalloo, a clinical researcher at the Liverpool School of Tropical Medicine, said the regulation of antivenoms 'has just not been as tight as it should be' for patients around the world. He said any new version of an antivenom should, by any normal standards, be tested in proper clinical studies. Speaking generally, he added: 'You cannot rely on previous studies, and particularly previous studies that relate to safety, to assure yourself of this being a safe and efficacious antivenom.' Both Inosan Biopharma and Polyserp Therapeutics did not respond to the TBIJ's questions about why they had used clinical study data for one drug to promote the safety and effectiveness of another. A US Army spokesperson told the TBIJ that the army 'does not conduct independent testing of medical products and does not have a third-party testing for snake antivenom'. Different products? Polyserp-P was recommended by the US Defence Health Agency's Joint Trauma System (JTS) in 2020. The JTS told the TBIJ: 'The recommendations were based off subject matter experts who evaluated peer-reviewed medical literature and the manufacturer's recommendations.' The literature it references does not mention Polyserp but did test Inoserp. The companies did not provide the TBIJ with any evidence that Polyserp had been part of this research. The JTS said it 'will always do our best with best evidence and [expert] input', and added that it will review the relevant guidelines and update them as necessary. It remains unclear exactly how comparable Inoserp and Polyserp are. Certainly the prices that have been disclosed suggest two very different products. Calvete was initially quoted $6,300 for six vials of Polyserp-P in 2021, while a TBIJ reporter bought a single vial of Inoserp-P for $66 (£50) in Tanzania in 2024. The US Army did not respond to TBIJ's requests for comment or to make samples available to test. In response to previous questions, it said it 'was not aware of any uses' of Inosan by army personnel. This article was produced by .

Teacher and barrister who ran abusive home cannot be identified, high court rules
Teacher and barrister who ran abusive home cannot be identified, high court rules

The Guardian

time21-05-2025

  • The Guardian

Teacher and barrister who ran abusive home cannot be identified, high court rules

A primary school teacher smashed their adoptive children's heads together, forced them to swallow soap and called one of them a 'black bastard'. Their partner – a barrister who also sat as a deputy district judge in the family courts – repeatedly failed to protect the children from their campaign of abuse. But despite the findings, the high court has ruled that the couple cannot be identified after The Bureau of Investigative Journalism (TBIJ) led a legal attempt to name them in the public interest. Mrs Justice Theis said she had reached the 'very difficult decision' after undertaking a careful balancing exercise between the rights of the media and the children's right to privacy. To the outside world the couple, who adopted five children, portrayed a happy family image which they used to promote their respective careers. But behind closed doors they ran a household controlled by what Theis described as an 'undercurrent of fear'. The barrister, who specialised in children's cases, was aware of the abuse but failed to intervene. The court found the children were subjected to physical assaults, denied proper meals and that a lock was placed on the pantry to stop them helping themselves to food. Punishments designed to humiliate included locking them outside the house without shoes on or making them stand against a wall. One child had his head flushed down the toilet and was referred to as 'a disease'. Another had his spectacles confiscated to prevent him from reading. Both parents deny the allegations but did not seek to challenge them. In a judgment published today Theis said the arguments put forward on each side relating to the issue of anonymity were compelling but was ultimately in the best interests of the children. At the heart of the case are three boys who find themselves back in the care system after suffering significant harm at the hands of their parents. Usually it is in the interests of children who have been the subject of abuse to keep the identity of their family confidential. In this case however, there were welfare arguments put forward on behalf of the children in favour of naming the parents. These included that identifying them would serve to validate their experiences and refute anything later made public by the parents who dispute the allegations and previously threatened to 'one day fight for justice'. Initially the guardian for the younger two boys, appointed by the court to represent their best interests, supported the naming of the parents in court judgments but shifted her position to neutral just over a week before a hearing in April. It came after the parents said they would be willing to have contact with the children on the condition their identities were protected. Previously they had been resolute about not seeing them despite being aware of the boys' wishes to do so. It was submitted there was significant public interest in naming the parents due to the jobs each had held during the time of the abuse. Both worked in roles that brought them into direct contact with children, while the judge was making important decisions about their welfare. Theis said the balancing exercise was 'exquisitely poised' and that TBIJ had set out 'powerful arguments' supported by other media organisations. However, she ultimately decided in favour of the children's rights to privacy. She said their welfare needs were best achieved away from the glare of any publicity. The two younger siblings left the family home in January 2024 and reported to police they had been abused by the teacher. The older sibling, who was separately represented in the court proceedings, and was already in foster care at that time, also disclosed abuse. One boy told police the teacher had pushed him against a wall, put their hands around his throat and threatened to kill him. He also said he had been made to wear shoes that were too small for him and that he'd been subjected to racial slurs, including the 'N-word'. Theis said the children were caused further significant harm as a result of delays to the court process, caused 'in very large part' to the conduct of the parents who said they suffered from fragile mental health. A police investigation into the teacher and barrister, who were bailed after being arrested, was closed in July 2024 and no charges were brought.

Moderators facing abuse at Meta's new ‘secret site'
Moderators facing abuse at Meta's new ‘secret site'

Russia Today

time29-04-2025

  • Business
  • Russia Today

Moderators facing abuse at Meta's new ‘secret site'

Meta has moved its African content moderation operations to a 'secretive' new site in Ghana's capital, Accra, following lawsuits in Kenya over alleged worker abuse, according to a joint report by The Bureau of Investigative Journalism (TBIJ) and The Guardian. In the investigation published on Sunday, the London-based media organizations said around 150 people are being employed under 'worse' conditions at the Accra facility, where they review Facebook, Instagram, and Messenger content, including graphic violence and child sexual abuse material. The staff have reported severe mental health issues, including suicide attempts, depression, and insomnia, due to pressure to work at a 'grueling pace in order to meet a series of opaque targets,' with minimal psychological support. The probe found that the workers in the West African country are barred from disclosing their work – even to family members – under threats of dismissal or deportation, particularly for those from conflict-affected regions. The Facebook parent company shut its content moderation hub in Kenya early in 2023 after its third-party contractor, Sama, announced it would no longer provide services. The relocation followed a series of lawsuits filed in the East African country by content moderators, who accused Meta and Sama of union-busting, unfair dismissals, and exposing workers to harmful material without providing adequate psychological support. According to TBIJ, the tech giant began moving its operations to Ghana in early 2024, outsourcing content moderation to Teleperformance, a French multinational with a history of labor rights controversies. Last year, Teleperformance acquired Majorel, the firm to which Meta had attempted to shift its operations in Kenya after Sama withdrew. 'For months, it has also refused to name the company that won the lucrative contract to provide the content moderators who deal with disturbing content on its platforms. Such secrecy works to shield tech companies like Meta from accountability,' the Bureau stated. Foxglove, a legal non-profit supporting cases against Meta in Nairobi, has announced that it is preparing to sue the US company and the subcontractor for exploiting content moderators in Ghana. 'After the atrocious treatment of Facebook content moderators we exposed in Kenya, I thought it couldn't get any worse. I was wrong. These are the worst conditions I have seen in six years of working with social media content moderators around the world,' Martha Dark, Foxglove's co-executive director told TBIJ. 'It's very disappointing to see that once again, a Big Tech company appears to have chosen the path of denying workers their due,' Ghanaian lawyer Carla Olympio also said. Teleperformance has denied the claims, saying it has 'robust people management systems and workplace practices, including a robust wellbeing program staffed by fully licensed psychologists to support our content moderators throughout their content moderation journey.'

Kicked Out of School For Being Pregnant: Forced Pregnancy Tests Violate Girls' Rights in East Africa
Kicked Out of School For Being Pregnant: Forced Pregnancy Tests Violate Girls' Rights in East Africa

Yahoo

time10-04-2025

  • Health
  • Yahoo

Kicked Out of School For Being Pregnant: Forced Pregnancy Tests Violate Girls' Rights in East Africa

EyeEm Mobile GmbH This story on forced pregnancy tests was reported and first published by The Bureau of Investigative Journalism. Teen Vogue lightly edited this story for style. Learn more about TBIJ here. Auma Angella was 14 when she was called into the staff room at her school in Busia, eastern Uganda, and asked why her stomach was curving. A teacher began to press her abdomen. Before she understood what was happening, she had been told to go home and not come back. Angella hadn't known she was pregnant — but by the end of the day, her whole class knew. Angella's story is part of a pattern that exists across the continent and has for generations. Coercive pregnancy testing that results in girls being expelled from school is humiliating, invasive and potentially unlawful. But the Bureau of Investigative Journalism (TBIJ) can reveal that schools in some African countries are continuing the practice in breach of national guidelines or legal judgments. 'Teachers examine girls, [touching them] around their bodies,' explained David Mwanga, a legal worker who supported Angella. 'They look at the changes of their body, the changes in the breast size.' Sometimes testing is performed using the same kits found in pharmacies around the world, but often it's done via the sort of hands-on process Angella was subjected to. In recent years, West Africa's highest court and a pan-African human rights body have ruled the expulsion of pregnant girls to be in violation of legally binding African charters on children's rights, including to education, privacy, and freedom from discrimination. Forced pregnancy testing has also been found to breach human rights. In Uganda, a government guideline was issued at the end of 2020, allowing pregnant girls and adolescent mothers to continue their education — a noted break from previous practices. But even with rules in place protecting pregnant students, TBIJ has found that girls are still at risk of coercive testing and exclusion. TBIJ has examined six other cases since the start of 2021 that appear to have breached the guideline — but the true figures are likely to be far higher. The cases were recorded by the legal charity Mwanga works for, Women With a Mission (WWM), which serves just nine of 146 districts in Uganda. Families are often wary of engaging with these services for fear of reproach from their community, so these instances are probably just the tip of the iceberg. Angella was made pregnant, she says, by an older man. (He is now awaiting trial, according to her legal team.) The ordeal was distressing enough before her teachers compounded the damage. 'I was stigmatized by the administration of the school,' Angella said to TBIJ via a translator in her local language of Lusamia. Even though it was the school that was in the wrong, she said, 'they kept on talking wrong about me within the community.' Angella's parents have consented to her being identified in this story. The school did not respond to TBIJ's request for comment. It had initially denied examining and expelling Angella but after WWM applied to the high court detailing her experience, it agreed to readmit her. For Angella, though, the prospect of being shunned by teachers and pupils was too much. She has not gone back. Sub-Saharan Africa has the highest rate of adolescent pregnancies of any region in the world, according to UN data. And in some parts of Uganda, teenage pregnancies rose by as much as 49% after the Covid pandemic, when the country's schools were shut for longer than in virtually any other nation. These figures shocked the government into action. Despite opposition from religious leaders, a guideline was issued in December 2020 saying that pregnant girls and adolescent mothers should be allowed to continue their education – after a year's enforced maternity leave – and to sit their national exams. But government directives have come up against deeply-rooted beliefs, explained Mwanga. '[People think] these girls were going to be a bad example to others. They were going to influence others to do the same thing,' he said. 'If these girls are to remain in school, it will be like a tomato which is rotten that remains in the basket of new tomatoes and then makes them all rotten.' If Angella had kept quiet about her experience at school, Mwanga said, 'no one would have known.' But she decided to speak out – and told her father what she'd been through. After hearing about WWM on the radio, he approached the charity for advice and together they were able to mount a legal challenge against the actions of her school. In September 2024, a high court judge in Tororo, eastern Uganda, handed down a consent order (an agreement between two parties supervised by a judge). The school agreed Angella should be allowed to continue her education. While the agreement is specific to Angella's case, it sets a precedent and has already sparked a national conversation in Kampala's corridors of power. But it hasn't put a stop to school exclusions. WWM has worked on the cases of five other girls expelled due to pregnancy since the ruling in September. All were readmitted after WWM's challenge. But the charity has heard of other exclusions outside its remit. Though Uganda's new guideline is a seemingly progressive move, it actually formalizes the invasive testing policy, stating that 'all girls should be examined for pregnancy periodically, at least once termly.' What's more, it has been condemned as discriminatory by Ugandan NGO the Initiative for Social and Economic Rights (ISER) because it enforces a year of mandatory maternity leave once the girls are around three months pregnant. 'In effect, the guidelines do not permit pregnant girls to be in school,' said ISER. WWM said in the future it would like to challenge these parts of the guideline. Rosette Nanyanzi, a gender adviser at the Ugandan Ministry of Education, told TBIJ both pregnancy tests and the period of leave were there to protect girls. A school routine that includes sitting on hard wooden benches for 12 hours a day is 'not safe and conducive,' she said, and pregnancy testing makes sure they access the 'proper services.' But she also acknowledged the decision to begin the leave at the three-month mark was motivated in part by 'morals' — the idea that visibly pregnant girls are a bad influence on their peers. The ministry did not respond to TBIJ's further questions. In Tanzania the practices are even harsher — and once again, marks of apparent progress do not tell the whole story. Until late 2021, there was an outright ban on pregnant girls attending school at all. Rights organizations filed a complaint to the African Committee of Experts on the Rights and Welfare of the Child (ACERWC) in 2019 to challenge the government, claiming that girls as young as 11 were being subjected to painful, non-consensual pregnancy testing in almost all public schools. It said those found pregnant — even in cases of sexual abuse or incest — were almost always expelled. They won their case, but TBIJ has seen documents revealing that no laws have yet been introduced to prevent forced testing or expulsion. Instead the government is currently relying on a 2021 notice from the Ministry of Education that says, among other things, that students who have dropped out due to pregnancy should be allowed to return to school within two years. However, the notice is not legally enforceable. The government has issued figures suggesting more than 10,000 pupils who dropped out for a variety of reasons have returned to school as a result – though the two year cut-off excluded the girls at the heart of the original case, according to one lawyer involved. The notice also forms part of the agreement for a $500 million loan granted to Tanzania from the World Bank to fund secondary education, which includes the condition that girls in the country must be allowed to resume their studies after pregnancy. The money was paid on account of the government issuing the notice, as well as a separate guideline forbidding non-consensual pregnancy testing. But it is uncertain how much has truly changed for many girls in Tanzania. Getrude Dyabene of the Legal and Human Rights Centre, which helped bring the ACERWC case, said schools are often not aware of the changes. She said that visits by her organization have revealed that forced testing is still happening — and expulsions routinely follow. 'The practice is still ongoing,' she said. 'The government said they have directed schools not to conduct pregnancy testing for girls. And we are like, 'Okay, where is that directive? Is there a letter?'' The World Bank told TBIJ it monitored closely for instances where pregnant girls or young mothers were prevented from continuing their education. 'When we are made aware of situations like this, we follow up with the authorities to take remedial action,' a spokesperson told TBIJ. 'This includes reinforcing the guidelines with school staff and providing further training.' Tanzania's ministries for health and education did not respond to questions about what actions they are taking to implement the ruling. It's been more than a year since Angella was expelled, and her baby girl is now nine months old. On an oppressively hot day on the eastern border of Uganda, she talks about the hairdressing course that she enrolled in when she felt unable to return to school. She says she's enjoying it — happy to have friends in a similar position to her and to be able to provide for her daughter. But she says she would have loved to have had a full education, 'like any other [person],' before considering a vocational college. 'What the teachers did, it was torturing her,' said her father, David Wafula. 'And even shaming her in front of her friends at school.' A keen artist, she had dreamed of making wedding dresses. 'My desire and passion was always to be a designer,' she said. For now, that dream has been put on hold. Originally Appeared on Teen Vogue

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