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Found 62 results
  1. Content Article
    Drug shortages are a chronic and worsening issue that compromises patient safety. Despite the destabilising impact of the Covid-19 pandemic on pharmaceutical production, it remains unclear whether issues affecting the drug supply chain were more likely to result in meaningful shortages during the pandemic. This study estimated the proportion of supply chain issue reports associated with drug shortages in the USA overall and with the Covid-19 pandemic. It found that supply chain issues associated with drug shortages increased at the beginning of the Covid-19 pandemic. Ongoing policy work is needed to protect US drug supplies from future shocks and to prioritize clinically valuable drugs at greatest shortage risk.
  2. Content Article
    This full-length, award-winning documentary unearths the shattering truth that millions of people worldwide are injured by prescribed psychiatric medications. Interweaving stories of harm with expert testimony, the film reveals how a profit-driven industry hides the risks of long-term use. This untold story is a compelling call to examine the consequences of medicating normal human suffering.
  3. Content Article
    In this article, investigative journalist Scilla Alecci reports on a court case brought against medical tech company Medtronic by a US whistleblower. Former Medtronic sales representative Leanne Houston alleges that between 2016 and 2018 she witnessed the company engaging in “unlawful conduct” by offering several US hospitals free equipment in exchange for the exclusive use of Medtronic products. She also claims that the company failed to acknowledge and deal with reports from surgeons that one of its surgical staple devices was causing harm to patients.
  4. Content Article
    How would you feel if your doctor offered you a treatment your health condition with good results and very little risk? You might snap it up. But what if you subsequently found out your doctor took thousands of pounds from the treatment makers to write a scientific paper promoting it, attend an all-expenses paid conference to talk about it, or spent time working as their expert consultant? In America, industry must log payments which are published on the open database system. Reporting to this is backed up by law following the American Sunshine Payment Act (2013). Sling the Mesh is calling for similar legislation in the UK to provide up-to-date evidence on industry money exchanging hands we Kath Sansom discusses in a blog on the Patient Safety Commissioner website.
  5. News Article
    AstraZeneca is facing legal action over its Covid vaccine, by a man who suffered severe brain injury after having the jab in April 2021. Father-of-two Jamie Scott suffered a blood clot that left him with brain damage and unable to keep working. The action, taken under the Consumer Protection Act, alleges the vaccine was "defective" as it was less safe than individuals were entitled to expect. Studies suggest Covid vaccines have saved millions of lives. In June 2022, the World Health Organization said the AstraZeneca vaccine was "safe and effective for individuals aged 18 and above". A further claim from about 80 people who say they were injured by the AstraZeneca vaccine is also due to be launched later this year but Mr Scott's case is expected to be heard first. AstraZeneca said: "Patient safety is our highest priority and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines. "Our sympathy goes out to anyone who has lost loved ones or reported health problems. "From the body of evidence in clinical trials and real-world data, Vaxzevria [the vaccine against Covid] has continuously been shown to have an acceptable safety profile and regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects." Read full story Source: BBC News, 9 November 2023 Related reading on the hub: Interview with Charlet Crichton, founder of UKCVFamily
  6. News Article
    Britain faces record shortages of medicines amid a row between drug makers and the NHS over payments. Patients face issues getting hold of drugs for epilepsy and ADHD, as well as hormone replacement therapy (HRT) for the menopause. A total of 111 drugs are currently facing supply issues, according to the British Generic Manufacturers Association (BGMA). This is the highest level on record and more than double the number of drugs facing shortages at the start of 2022. The BGMA blamed an NHS drugs levy for the supply issues, saying it was discouraging pharmaceutical companies from supplying the health service. Dr Leyla Hannbeck, chief executive of the Association of Independent Multiple Pharmacies, said pharmacists were “spending long hours in the day trying to source medicines for patients and this is on top of all the other activities they do in a busy pharmacy”. She said: “Our pharmacy teams see firsthand the anxiety and stress experienced by patients caused by medicines shortages.” Shortages have also led to more abuse and aggression towards pharmacists, she said. Read full story (paywalled) Source: The Telegraph,
  7. News Article
    The boss of Britain’s biggest medicines courier has been told to urgently improve its complaints system by the NHS ombudsman amid concerns patients let down by missing deliveries are repeatedly ignored. In a highly unusual development, Darryn Gibson, the chief executive of Sciensus, has received a written warning from Rob Behrens, the parliamentary and health service ombudsman (PHSO). It says patients “should not be ignored” and must be “listened to and taken seriously” or he will consider taking further action. The PHSO investigates complaints that have not been resolved by the NHS or by private providers of NHS care. Sciensus is the single largest provider of homecare medicines services to the NHS and has contracts worth millions of pounds. In an email seen by the Guardian, Behrens told Gibson he had been unable to investigate most reports received about Sciensus because patients had not been able to complete the company’s complaints process. “That is not acceptable or fair to complainants,” Behrens wrote. In a statement, Sciensus said it worked “very hard” to ensure NHS patients received their medicines on time. Its services had “a 95% satisfaction rating”, it added. The move follows a Guardian investigation that exposed how Sciensus put NHS patients at risk of harm with delayed, missed or botched deliveries of medicines for conditions including cancer, heart disease, diabetes, dementia and HIV. It also uncovered how patients’ alarm at vital drugs and medical devices not arriving at their home was often compounded by a struggle to reach Sciensus to complain and fix the problems. Read full story Source: The Guardian, 19 October 2023
  8. News Article
    The US Food and Drug Administration (FDA) has sent warning letters to pharmacy chains Walgreens and CVS accusing them of illegally marketing eye care products. The FDA’s warning letters said the products in question, which were falsely labelled as potential treatments for conditions like glaucoma, cataracts, and pink eye, should be modified if the companies and manufacturers that make and distribute them want to avoid legal action. “The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality,” Jill Furman, Director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research, said in a statement. “When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations.” Ms Furman wrote in the letter sent to Walgreens: “Your ‘Walgreens Allergy Eye Drops,’ ‘Walgreens Stye Eye Drops,’ and ‘Walgreens Pink Eye Drops’ products are especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes … pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defences.” Read full story Source: The Independent, 21 September 2023
  9. News Article
    The UK medicines watchdog has been urged to strengthen its conflict of interest policy after it emerged that six of its board members are receiving payments from the pharmaceutical industry. Board members involved in overseeing the regulator’s “strategic direction” also have financial interests in companies including US and Saudi drug giants and firms with ambitions to break into the UK’s healthcare market. Some offer consultancy services while others help run or own shares in drug and medical device firms, according to official transparency records. There is no suggestion of wrongdoing, but the findings have led to concerns about perceived conflicts of interest among senior figures at the Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care responsible for regulating drugs and medical devices and ensuring they are safe. The MHRA said that “in order to be an effective regulator” it needed to “bring together the right expertise from across industry, academia, the public and beyond”, adding that board meetings are held in public and non-executive board members – to whom the potential conflicts relate – are not involved in “any work or decisions relating to the regulation of any products”. But critics raised concerns about the potential for bias – or the perception of it – and called for stricter rules on conflicts of interest for those working in pharmaceutical regulation. Read full story Source: The Guardian, 17 April 2022
  10. News Article
    A California appeals court has upheld a lower court ruling that Johnson & Johnson must pay penalties to the state for deceptively marketing pelvic mesh implants for women, but reduced the amount by $42 million to $302 million. Johnson & Johnson had appealed in 2020 after Superior Court Judge Eddie Sturgeon assessed the $344 million in penalties against Johnson & Johnson subsidiary Ethicon. Sturgeon found after a non-jury trial that the company made misleading and potentially harmful statements in hundreds of thousands of advertisements and instructional brochures for nearly two decades. The instructions for use in all of the company’s pelvic mesh implant packages "falsified or omitted the full range, severity, duration, and cause of complications associated with Ethicon’s pelvic mesh products, as well as the potential irreversibility and catastrophic consequences," Presiding Justice Judith McConnell of the appeals court said in a 3-0 ruling upholding the $302 million in penalties. The products, also called transvaginal mesh, are synthetic and surgically implanted through the vagina of women whose pelvic organs have sagged or who suffered from stress urinary incontinence when they cough, sneeze or lift heavy objects. Many women have sued the New Jersey-based company alleging that the mesh caused severe pain, bleeding, infections, discomfort during intercourse and the need for removal surgery. Read full story Source: Fox News, 12 April 2022
  11. News Article
    ADHD patients around the UK are finding they can't get hold of medication since a national shortage was announced. Three different medicines are affected, and the government says some supply issues could last until December. The Department for Health and Social Care (DHSC) says "increased global demand and manufacturing issues" are behind the shortages. Medication helps to manage symptoms, which can include difficulty concentrating and focusing, hyperactivity and impulsiveness. Dr Saadia Arshad, a consultant psychiatrist, who specialises in diagnosing and treating people with ADHD. She says the shortage of medication is "not a new issue, but it's a recurring one". Dr Saadia says suddenly stopping meds can lead to patients "feeling jittery, finding it difficult to pay attention, staying focused and feeling restless". Even though she understands the shortage can be worrying, Dr Saadia says it's important that people don't take measures into their own hands. "These medicines can be quite potent and the response to medication for two individuals is not the same," she says. "So please do not take any action without discussing it with your clinician." Read full story Source: BBC News, 6 October 2023
  12. News Article
    In September last year, Ebrima Sajnia watched helplessly as his young son slowly died in front of his eyes. Mr Sajnia says three-year-old Lamin was set to start attending nursery school in a few weeks when he got a fever. A doctor at a local clinic prescribed medicines, including a cough syrup. Over the next few days, Lamin's condition deteriorated as he struggled to eat and even urinate. He was admitted to a hospital, where doctors detected kidney issues. Within seven days, Lamin was dead. He was among around 70 children - younger than five - who died in The Gambia of acute kidney injuries between July and October last year after consuming one of four cough syrups made by an Indian company called Maiden Pharmaceuticals. In October, the World Health Organization (WHO) linked the deaths to the syrups, saying it had found "unacceptable" levels of toxins in the medicines. A Gambian parliamentary panel also concluded after investigations that the deaths were the result of the children ingesting the syrups. Both Maiden Pharmaceuticals and the Indian government have denied this - India said in December that the syrups complied with quality standards when tested domestically. It's an assessment that Amadou Camara, chairperson of the Gambian panel that investigated the deaths, strongly disagrees with. "We have evidence. We tested these drugs. [They] contained unacceptable amounts of ethylene glycol and diethylene glycol, and these were directly imported from India, manufactured by Maiden," he says. Ethylene glycol and diethylene glycol are toxic to humans and could be fatal if consumed". Read full story Source: BBC News, 21 August 2023
  13. News Article
    Drug companies are systematically funding grassroots patient groups that lobby the NHS medicines watchdog to approve the rollout of their drugs, the Observer has revealed. An investigation by the Observer has found that of 173 drug appraisals conducted by the National Institute for Health and Care Excellence (NICE) since April 2021, 138 involved patient groups that had a financial link to the maker of the drug being assessed, or have since received funding. Often, the financial interests were not clearly disclosed in NICE transparency documents. Many of the groups that received the payments went on to make impassioned pleas to England’s medicines watchdog calling for treatments to be approved for diseases and illnesses including cancer, heart disease, migraine and diabetes. Others made submissions appealing NICE decisions when medicines were refused for being too expensive. In one case, a small heart failure charity that gave evidence to a NICE committee arguing for a drug to be approved received £200,000 from the pharmaceutical company, according to the maker’s spending records. In another case, a cancer patient group supplied evidence relating to drugs made by 10 companies – from nine of which it had received funding. Read full story Source: The Guardian, 22 July 2023
  14. News Article
    Pharmaceutical giants are pouring tens of millions of pounds into struggling NHS services – including paying the salaries of medical staff and funding the redesign of patient treatment – as they seek to boost drug sales in the UK, the Observer can reveal. The spending is revealed in an investigation that lays bare the growing role of Big Pharma in the UK’s health sector, with analysis of more than 300,000 drug company transactions since 2015 showing a surge in spending on activities other than research and development (R&D). Payments to UK health professionals and organisations, including donations, sponsorship, consultancy fees and expenses, reached a record £200m in 2022, excluding R&D with companies seeking to promote lucrative drugs for obesity, diabetes and heart conditions among the biggest spenders. The rise in spending raises concerns about the growing influence of pharmaceutical companies in the NHS as it reaches its 75th anniversary milestone. Amid record pressure on services, drug giants say closer collaboration can help deliver major benefits to patients. NHS England said collaborations with industry helped patients “benefit from faster access to innovative treatments” and that it was “not unusual for industry to provide funding to support service delivery in areas such as improving cardiovascular health, tackling infectious disease or rolling out innovative cancer therapies”. It added that “strict safeguards” were in place for managing conflicts of interest. Read full story Source: The Guardian, 8 July 2023
  15. News Article
    A cancer patient has died and three others have been hospitalised after they were administered unlicensed versions of chemotherapy by Sciensus, a private company paid millions by the NHS to provide essential medication. Three health regulators have launched inquiries into the incident, according to people familiar with the matter. It was caused by an issue at the firm’s medicines manufacturing unit. In a statement, Sciensus confirmed an “isolated incident” had “affected four patients” and that it was “deeply saddened” that one of them had died. Sciensus offered its “sincere condolences” to the family and friends of the patient who died, and is conducting a thorough investigation, it added. The four patients received unlicensed versions of cabazitaxel, a licensed chemotherapy used to treat prostate cancer. The versions administered to the patients differed from the licensed product and therefore were considered unlicensed medicines. Sciensus is required to comply with official standards to ensure the quality of the products it produces and the protection of public health. Breaches of these standards can result in the MHRA suspending or removing a company’s licence. “Patient safety is our highest priority,” said Dr Alison Cave, the MHRA’s chief safety officer. “We are urgently investigating this issue and we will take any necessary regulatory measures to ensure patients are protected." Read full story Source: The Guardian, 7 July 2023
  16. News Article
    Pelvic mesh implant manufacturer Johnson & Johnson group has reached a $300m settlement in two class actions, after thousands of women worldwide reported complications from the mesh products including chronic pain, painful sexual intercourse and incontinence. It marks the largest settlement in a product liability class action in Australian history, and is subject to federal court approval. Shine Lawyers led the Australian class actions and alleged Johnson & Johnson failed to properly test the devices and played down their risk to both surgeons and patients. Women have suffered complications including mesh exposure and erosion – when the mesh pokes through the vaginal wall or cuts through internal tissue – vaginal scarring, fistula formation, painful sex, and pelvic, back and leg pains. Some of these complications may occur years after surgery and can be difficult to treat. Shine Lawyers’ Rebecca Jancauskas said the settlement would help support women’s ongoing treatment needs. “We welcome this settlement which brings the litigation to an end,” she said. “If the federal court approves the settlement our focus will shift to the important task of distributing the settlement to group members.” Read full story Source: The Guardian, 12 September 2022
  17. News Article
    Lamborghinis and ski trips to the Swiss Alps were among the incentives a pharmaceutical giant developed to market a surgical device that has ruined the lives of hundreds of Australian women. Documents obtained by the ABC show the extent to which Johnson and Johnson oversold its surgical mesh products, which are used to treat incontinence and prolapse after childbirth. They paint a picture of a company that tried to sell surgeons a jet-setting lifestyle where they could insert four devices "before lunch" and notch up $10,000 in surgeries in a single morning. The mesh devices have left at least 3,000 Australian women with serious side effects including chronic pain, infections and inability to have sex, and are the subject of both a Senate inquiry and a class action. New court documents released in the class action against Johnson and Johnson show that as early as 2009, concerns were raised inside the company that it was making "a huge mistake" by commercialising its latest brand of mesh, was "rushing to market", and opening up the use of the product to "unqualified surgeons". Lawyers from Shine, who are representing the women in the class action, claim the pharmaceutical giant did not investigate proper clinical trials on the possible complications of the mesh. Read full story Source: ABC News, 13 August 2022
  18. News Article
    Pfizer has been fined £63 million after overcharging the NHS for a life-saving epilepsy drug which rose in price by 2,600%. The drug company was fined by the Competition and Markets Authority (CMA) for its involvement in a secret deal to hike the price of phenytoin sodium capsules, which cost the NHS tens of millions of pounds. Pfizer and a small British company, Flynn Pharma, were able to circumvent NHS price controls by de-branding the drug in 2012 and relaunching it under its generic name. The price then rose from £2.83 to £67.50 per pack, pushing up the cost from £2 million a year to £50 million. Internal emails obtained by the CMA showed that Pfizer officials raised concerns about the proposed scheme, with one manager writing: “The top line looks great, however, this would increase the price of phenytoin capsules to the NHS drastically and, to be frank, doesn’t feel right.” Andrea Coscelli, the outgoing chief executive of the CMA, said phenytoin was an “essential drug relied on daily by thousands of people throughout the UK to prevent life-threatening epileptic seizures”. He said the two companies had “illegally exploited their dominant positions to charge the NHS excessive prices and make more money for themselves — meaning patients and taxpayers lost out”. Read full story (paywalled) Source: The Times, 21 July 2022
  19. News Article
    A jury ordered Becton, Dickinson and Co to pay $255,000 to a man who sued the company, alleging he had been injured by its hernia repair surgical mesh, according to a court filing. The verdict in Columbus, Ohio federal court comes in the second bellwether trial in a multidistrict litigation over the company's hernia mesh products, which were sold by C.R. Bard Inc before its 2017 acquisition by Becton Dickinson. The first bellwether trial last year ended with a verdict in favour of the company. More than 16,000 cases have been consolidated before Chief U.S. District Judge Edmund Sargus in Columbus, in the third-largest pending MDL nationwide. Plaintiffs claim that the mesh products caused infections, pain, inflammation and other problems. The verdict came in a case brought by Antonio Milanesi, who had Bard's Ventralex mesh implanted during a hernia repair in 2007, and his wife, Alicia Morz De Milanesi. They claimed that Milanesi developed an infection and bowel abscess because of the mesh, requiring a second surgery in 2017. Like other plaintiffs in the MDL, the Milanesis say the mesh products are defectively designed because their polypropylene material degrades when in implanted in human tissue. Read full story Source: Reuters, 16 April 2022
  20. News Article
    The drug giant behind weight loss injections newly approved for NHS use spent millions in just three years on an “orchestrated PR campaign” to boost its UK influence. As part of its strategy, Novo Nordisk paid £21.7m to health organisations and professionals who in some cases went on to praise the treatment without always making clear their links to the firm, an Observer investigation has found. Among the vocal champions of the Wegovy jabs was a clinical expert who gave evidence to the National Institute for Health and Care Excellence (NICE) and others who publicly praised the so-called “skinny jabs” as a “gamechanger”. The revelations come as the Danish drug giant is investigated by the UK’s pharmaceutical watchdog after it was found to have breached the industry code seven times in relation to a “disguised promotional campaign” of another of its weight loss drugs via online webinars for healthcare professionals. Prof Allyson Pollock, professor of public health at Newcastle University, said Novo’s campaign was “not unusual” in the drugs industry and called for measures to improve trust. “The public really aren’t being made aware enough about the potential for bias and over-claiming,” she said. Read full story Source: The Guardian, 12 March 2023
  21. News Article
    The chief executive of pharma group Novo Nordisk has apologised for breaking the UK industry code by failing to disclose its sponsorship of obesity and weight management training courses for healthcare professionals that also promoted its weight loss drug. The webinars, which were viewed by thousands of healthcare professionals, preferentially included positive information about Novo’s weight loss drug Saxenda, which the self-regulatory watchdog deemed a “disguised” large-scale promotional campaign. The industry self-regulatory body published a strongly worded reprimand last year, saying it was “concerned about the company’s compliance culture . . . internal governance systems and processes, and a perceived naivety and lack of accountability from Novo Nordisk”. It also said it was concerned about “the potential impact on patient safety” because the webinars, which were run by a third-party provider but sponsored by Novo, showed a “lack of balance” in how they compared the side effects of Saxenda and its competitors. Read full story (paywalled) Source: The Financial Times, 12 February 2023
  22. News Article
    CVS Health confirmed last year it was closing half its Coram home infusion branches and firing about 2,000 nurses, dietitians and pharmacists. Their patients with life-threatening digestive disorders depend on parenteral nutrition, or PN — in which amino acids, sugars, fats, vitamins and electrolytes typically are pumped through a catheter into a large vein near the heart. A day later Optum Rx, another big supplier, announced its own consolidation. Suddenly, thousands were scrambling for their complex essential drugs and nutrients. “With this kind of disruption, patients can’t get through on the phones. They panic,” said Cynthia Reddick, a senior nutritionist laid off last summer in the CVS restructuring. “It was very difficult. Many emails, many phone calls, acting as a liaison between my doctor and the company,” said Elizabeth Fisher Smith, a 32-year-old public health instructor in New York, whose Coram branch closed. A rare medical disorder has forced her to rely on PN for survival since 2017. “It added to my mental burden,” she said Home and outpatient infusions in the USA are a growing business, as new drugs for chronic illness expand treatment options and enable patients, providers and insurers to avoid hospitalisation. But while reimbursement for expensive new drugs has attracted corporations and private equity, the industry is constrained by a lack of nurses and pharmacists. The less profitable parts of the business — and the vulnerable patients they serve — are at risk. This includes the 30,000-plus Americans who rely on parenteral nutrition — including premature infants, post-surgery patients and those with damaged bowels because of genetic defects. Read full story (paywalled) Source: The Washington Post, 6 February 2023
  23. News Article
    Erik, a 26-year-old Seattle grocery clerk, who also has attention-deficit hyperactivity disorder (ADHD), has been unable to get his medications filled for months now – and he’s worried he’ll lose the first full-time job he’s ever had. For people like Erik, ADHD medication is a prerequisite for basic functioning – and over the last year it’s become dramatically harder for patients like them to access care. Last October, the Food and Drug Administration (FDA) announced a shortage of Adderall, one of the most common stimulant medications for ADHD. In recent months, patients have reported problems filling nearly every type of ADHD medication. What’s stranger is that no one seems to know why. Is it some kind of supply chain issue? A pandemic-era surge in demand? A government crackdown? Official explanations have offered little clarity. The FDA’s announcement mentioned “intermittent manufacturing delays” at Teva, the producer of the branded version of Adderall, but few other details. The American Society of Health Pharmacists reports shortages of multiple ADHD drugs but says manufacturers have given no explanation. The situation has left patients in turmoil. Read full story Source: The Guardian, 30 January 2023
  24. News Article
    The chairman of Covid vaccine giant AstraZeneca has said that investment in technology can help the NHS cut costs. Leif Johansson said more spending on areas such as artificial intelligence and screening could prevent illness and stop people going to hospital. The NHS is under severe pressure, with A&E waits at record levels and strike action exacerbating ambulance delays. Mr Johansson said about 97% of healthcare costs come from "when people present at the hospital". He said only the remaining 3% is made up of spending on vaccination, early detection or screening. Mr Johansson told the BBC at the World Economic Forum in Davos: "If we can get into an investment mode in health for screening or prevention or early diagnostics on health and see that as an investment to reduce the cost of sickness then I think we have a much better model over time that would serve us well." Commenting on the UK, he said: "All countries have different systems and the NHS is one which we have learned to live with and I think the Brits, in general, are quite appreciative about it." He said he was not talking about "breaking any healthcare systems down". Rather, he said, "we should embrace technology and science". Read full story Source: BBC News, 23 January 2023
  25. News Article
    The US Food and Drug Administration has approved a vaccine against respiratory syncytial virus (RSV) - an illness that kills thousands of Americans each year. The vaccine still needs approval from the US Centers for Disease Control and Prevention before it can be rolled out to the public. Officials say the vaccine, named Arexvy by the manufacturer GSK, is a major breakthrough that will save many lives. It could be available to people over 60 within months, officials say. "Today's approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening," said Dr Peter Marks, who leads the Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA). RSV is a respiratory illness that typically results in cold-like symptoms for adults, but can be dangerous for young children, the elderly, and those with underlying health conditions. Read full story Source: BBC News, 4 May 2023
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