Novartis confirms 9 tumours in children given its gene therapy Zolgensma, and the FDA investigates

The stories

18 on this beat today.

Every story told the same way: what happened, who is involved, why it matters, how it works, the truth and the good news.

1. 01

   Novartis confirms 9 tumours in children given its gene therapy Zolgensma, and the FDA investigates

   9

   children given Zolgensma who later had tumours

   7 of them disclosed for the first time this week [1]

   2 of 9

   tumours with signs the carrier virus joined the DNA

   Cure SMA says only 3 have been tested so far [2]

   6,000+

   patients treated with Zolgensma worldwide

   in trials, special access and normal sales [1]

   $404 million

   Zolgensma sales from July to September

   up 34% on the same months a year before [1]

   What happened

   • Novartis, a Swiss drugmaker, said on Thursday that 9 children given its gene therapy Zolgensma later developed tumours. [1][2]
   • In 2 of those cases there was evidence that the virus carrying the treatment had joined the patient's own DNA. [2]
   • On Friday the FDA, the US drug regulator, said it is investigating the risk of tumours from Zolgensma. [6]
   • More than 6,000 patients worldwide have received Zolgensma, in trials and in normal use since its 2019 approval. [1]
   • Novartis told neurologists about the cases earlier in the week. [3] An advocacy group and a Facebook page made them public on Thursday. [3]
   • A parent wrote that a neurologist told him Novartis was holding back some cases and releasing data in stages. [1]
   • SMA Europe, an alliance of patient groups, said it heard of the cases "through confidential channels". [1]
   • Novartis said that in each case it "timely and appropriately notified health authorities". [1]
   • Zolgensma and a newer version sold $404 million from July to September, up 34% on a year before. [1]
   • Novartis shares barely moved in Zurich on Thursday, down 0.1%. [1] In New York they fell 1.85%. [1]
   • Cure SMA, a US patient group, says 3 of the 9 tumours have been tested so far. [2] One of those appears unrelated to Zolgensma. [2]

   Who is involved

   Zolgensma treats spinal muscular atrophy, or SMA, a genetic disease. [2] Before new drugs, its worst form was fatal for many young children. [2]

   Children with SMA lack a working copy of a gene called SMN1. [1] Zolgensma delivers a working copy into their cells. [1]

   The copy rides inside a virus called AAV, which cannot multiply. [1] Small viruses like it carry new genes into thousands of patients. [4]

   • Novartis a Swiss drugmaker that sells Zolgensma; it confirmed the 9 tumour cases
   • The FDA the US drug regulator; it is investigating the tumour risk
   • SMA Europe an alliance of SMA patient groups in Europe; it asked Novartis for clear public information
   • Cure SMA a US patient group; it says 3 of the 9 tumours have been tested

   How it unfolded

   Zolgensma's label already warned of a "theoretical risk" of tumours from the virus's DNA joining a patient's own. [1]

   Of the 9 cases, 7 were disclosed for the first time this week. [1] The other 2 were cancer reports from 2023 and 2025. [2]

   Neither of those 2 earlier reports was firmly tied to the treatment. [2]

   In January the FDA paused 2 gene therapy trials run by Regenxbio. [1] A 5-year-old boy in one had developed a brain tumour. [1]

   The boy's doctors wrote that their findings support the idea that rare joining of virus DNA can add to cancer. [1]

   STAT, a health news site, says this year's cases ended a 20-year debate over whether these viruses can cause tumours. [4]

   1. Early in the week Novartis tells neurologists
   2. Thursday the cases go public
   3. Earlier a boy, 5, in a trial grows a brain tumour
   4. Jan 2026 the FDA pauses 2 Regenxbio gene therapy trials after a child's brain tumour [1]
   5. 2018 Novartis buys AveXis, the maker of Zolgensma, for $8.7 billion [1]
   6. 2019 the FDA approves Zolgensma for children under 2 with SMA [1]
   7. 2022 Novartis reports 2 deaths from liver failure after treatment [1]
   8. Thu 5 Nov Novartis confirms 9 tumour cases in Zolgensma patients [5]
   9. Fri 6 Nov the FDA says it is investigating the tumour risk [6]

   Why it matters

   SMA Europe asked Novartis to say whether children already treated need extra checks. [2]

   A neurologist at the University of Rochester said the news "will change the calculus for some patients". [4]

   BioPharma Dive, a trade news site, says the cases could raise new questions for the gene therapy field. [2]

   How it works

   Gene therapists call this vector integration: the carrier virus's DNA becomes part of the patient's own DNA. [1]

   Zolgensma's DNA is built to stay mostly apart from the cell's own DNA. [1] When a piece joins by chance, the label says it could add to tumour risk. [1]

   Seen it before

   A note tucked inside a book can fall out. A note glued onto a page stays in the book for good.

   The truth

   • Zolgensma's label still calls the tumour risk "theoretical". [1] STAT reports, about this year's cases: "That debate is over." [4]
   • Novartis's public statement came after patient groups spoke out on Thursday. [1]
   • Who pays Families of children given Zolgensma — SMA Europe says families should not have to piece the news together from social media and rumours. [2]
   • Nobody knows yet

     Whether Zolgensma caused the 7 newly disclosed tumours.

     Cure SMA says only 3 of the 9 have been tested, and one of those appears unrelated. [2]

   • Nobody knows yet

     How often the carrier virus's DNA joins a patient's own DNA.

     Novartis has reported 2 such cases among more than 6,000 patients, and its label says the importance of each one is unknown. [1]

   • Nobody knows yet

     What the FDA's investigation will lead to.

     The report we could read says only that the FDA is investigating, with no step or date given. [6]

   • Nobody knows yet

     Whether children already treated with Zolgensma need extra checks.

     SMA Europe has asked Novartis this, and no answer is in today's reports. [2]

   What comes next

   SMA Europe says regulators are now examining the cases. [3]

1. 02

   Lilly sells weight-loss drugs through Hims

   What happened

   • Eli Lilly will sell its weight-loss drugs Zepbound and Foundayo through Hims & Hers, a US online clinic. [7] The companies announced it on Friday. [7]
   • Patients with a prescription pay the same cash prices as elsewhere. [7] Foundayo starts at $149 a month, and Zepbound at $299. [7]
   • Foundayo is Lilly's new weight-loss pill. [8] Lilly wants Hims's large customer base to lift its sales. [8]

   Who is involved

   • Eli Lilly drugmaker
   • Hims & Hers online clinic

   How it unfolded

   Hims used to sell cheaper copies of such drugs, made under legal loopholes. [7] It stopped in March after a legal challenge from Novo Nordisk, a rival drugmaker. [7]

   Hims signed a similar deal with Novo in March. [7]

   Foundayo sold $184 million last quarter, $44 million less than analysts expected. [9]

   1. Before Hims sells cheaper copies
   2. March Novo challenges it; Hims stops

   Why it matters

   The deal reaches people who pay for obesity drugs themselves, a group that matters more and more to sellers. [8]

   How it works

   Drugmakers call these "self-pay" prices, paid by patients out of their own pocket. [7][8]

   An online clinic gives Lilly another way to reach those paying buyers. [8]

   Seen it before

   A baker sells cakes in her own shop and also at a busy market stall, to reach more people.

   Why a drug can be approved and still be used by few people

   Market access is the work of getting an approved drug to patients: a doctor must find the illness, prescribe it, and someone must pay.

   The twist

   Approval is only the first step. A drug's sales grow only as fast as doctors find the illness and someone agrees to pay.

   The picture

   Rezdiffra (liver disease)$431 million

   Auvelity (Alzheimer's agitation)$208 million

   Foundayo (weight loss)$184 million

   Elevidys (gene therapy)$83.50 million

   Step by step

   1. 1 A regulator approves the drug
   2. 2 Doctors must find the illness in a patient
   3. 3 A doctor must choose to prescribe it
   4. 4 An insurer, a health service or the patient must pay
   5. 5 Only then do sales, and patients treated, rise

   The same force, elsewhere today

   Where this chain is also running, in today's other stories.

   • Rezdiffra passing $1 billion

     MASH is still rarely diagnosed, so finding patients is the step that holds sales back, and sales climb as more are found.

   • Auvelity's slow start

     A medicine for agitation in Alzheimer's has little precedent, so prescriptions are only now picking up, mostly in adults over 65.

   • The UK teenager and omaveloxolone

     The paying step is missing: with no NICE review, the NHS does not pay, and the family faces 1,000 pounds a day.

   • Lilly selling through Hims

     Lilly adds a new route at the paying step, selling to people who pay for weight-loss drugs themselves.

   Where you've seen this

   School textbooks

   a book approved by the exam board stays on the shelf until teachers choose it and the school buys it

   Electric cars

   a car can be legal to sell for years before enough chargers and buyers exist

   A new phone app

   it can sit in the app store with few users until people hear of it

   The catch

   Slow sales do not mean a drug does not work. A drug can help every patient who gets it and still reach only a few of them.

   And the whole of it

   Each person in these stories sees one step of the chain. A regulator sees the approval and a doctor sees one patient. A family sees a bill for 1,000 pounds a day. Patients wait while each step is done by someone who cannot see the others.

   The truth

   • Who gains Hims & Hers — It can now sell Lilly's approved drugs, after it stopped selling cheaper copies in March. [7]
   • Nobody knows yet

     Whether the Hims deal will lift Foundayo's sales.

     The deal was announced on Friday, after a quarter in which Foundayo sold less than analysts expected. [8][9]

1. 03

   A liver drug passes $1 billion a year

   What happened

   • Rezdiffra, a liver drug from Madrigal Pharmaceuticals, has passed $1 billion in sales this year. [9]
   • It sold $431 million from July to September, and $1.1 billion so far in 2026. [9]
   • The sales let Madrigal make a profit for the first time. [9]

   Who is involved

   In 2024 it became the first medicine approved for MASH, a liver disease. [9]

   The drug industry calls a medicine that sells over $1 billion a year a "blockbuster". [9]

   How it unfolded

   Many investors had doubted that Rezdiffra would sell well. [9]

   1. 2024 approved for MASH
   2. 2026 passes $1 billion

   Why it matters

   Investors read its sales as a sign of the demand for MASH drugs. [9] More patients started it, even with Novo's Wegovy now competing. [9]

   How it works

   An analyst at Cantor Fitzgerald, a bank, says MASH diagnosis and treatment rates are both still low. [9]

   Rezdiffra's rising sales suggest those rates may now be speeding up, the analyst wrote. [9]

   The truth

   • Analysts linked a fall in Madrigal's shares on Tuesday to a lawsuit by a former employee. [9]

   Good news

   • More people with MASH, a liver disease that had no approved medicine until 2024, are starting treatment with Rezdiffra, even with a rival drug on sale.
2. 04

   An Alzheimer's agitation drug sells slowly

   What happened

   • Auvelity, a depression drug from Axsome Therapeutics, is selling more slowly than many investors expected. [9]
   • Its sales grew from about $153 million in January to March to $208 million in the last 3 months. [9]
   • Axsome's market value passed $12 billion in June. [9] Its share price has fallen by more than a third since then. [9]

   How it unfolded

   In April the FDA approved it for agitation in people with Alzheimer's disease. [9]

   Why it matters

   Investors had bet the Alzheimer's use would open a market worth billions of dollars. [9]

   How it works

   Axsome's sales chief says there is "little precedent" for a medicine for agitation in Alzheimer's. [9]

   He calls it "a relatively new and developing market". [9] Prescriptions rose fastest in adults over 65, Axsome said. [9]

   A medicine for agitation in Alzheimer's has little precedent, so prescriptions are only now picking up, mostly in adults over 65.

   The idea, in story 02: Why a drug can be approved and still be used by few people →

   The truth

   • A William Blair analyst called the launch "slower than expected". [9] A Leerink analyst said the slow rise was real: "it's happening". [9]
   • Who pays Axsome's shareholders — Many bought shares on hopes for Auvelity that its slow sales have not yet met. [9]
3. 05

   Alnylam's head of sales leaves

   What happened

   • Alnylam Pharmaceuticals said on Thursday that Tolga Tanguler, its chief commercial officer, is leaving. [7]
   • Alnylam's share price has fallen about 60% this year. [7]
   • Investors worry about how fast sales of its top drug, Amvuttra, will grow. [7]
   • An analyst at William Blair, a bank, wrote that Amvuttra's "growth rate visibility is murky at best". [7]
   • Alnylam credited him with a "strong foundation for future growth". [7]

   Who is involved

   A chief commercial officer runs a drugmaker's sales. [7] Alnylam is using a search firm to find his replacement. [7]

   • Tolga Tanguler head of sales, leaving

   Why it matters

   The change comes as investors judge Alnylam on how fast Amvuttra sells. [7]

   The truth

   • Who pays Alnylam's shareholders — Their shares lost much of their value this year as investors doubted Amvuttra's sales. [7]
4. 06

   ANI bids $560 million for Egetis

   What happened

   • ANI Pharmaceuticals offered on Thursday to buy Egetis Therapeutics, a Swedish rare-disease drug company, for $560 million. [7]
   • ANI bid 11.25 Swedish krona a share, 27% above Egetis's average price over the past 2 months. [7]
   • It is the only approved US or European treatment for one effect: too much thyroid hormone in the blood. [7]
   • ANI expects Emcitate to sell up to $300 million a year at its peak. [7]

   Who is involved

   Egetis sells Emcitate, a drug for Allan-Herndon-Dudley syndrome, a rare genetic condition. [7]

   Why it matters

   ANI is paying for a medicine that is already on sale, not one still in testing. [7]

   The truth

   • Who gains Egetis's shareholders — ANI's offer pays them more than their shares have recently traded at. [7]
5. 07

   Sarepta's gene therapy sales hold flat

   What happened

   • Elevidys, Sarepta's gene therapy for Duchenne muscular dystrophy, earned $83.5 million from July to September. [10]
   • Sarepta's total drug sales were about $323.8 million. [10] Most, $240.3 million, came from its other Duchenne drugs. [10]
   • Sarepta expects Elevidys sales in the last quarter of the year to stay about the same. [10]
   • It raised the low end of its yearly sales forecast by $50 million, to $1.25 billion. [10]

   How it unfolded

   BioPharma Dive says Elevidys was expected to sell well and has "sputtered". [2]

   Why it matters

   Sarepta's higher forecast comes from its other drugs, not from Elevidys. [10]

   How it works

   Elevidys is given once, not taken every day. [10] So Sarepta says its sales vary from quarter to quarter. [10]

   The truth

   • This is Sarepta's own report: it says new data support the drug's benefits and its safety. [10]
6. 08

   Guinea-Bissau cancels a US-funded baby vaccine trial

   What happened

   • Guinea-Bissau has cancelled a planned hepatitis B vaccine trial on newborn babies. [11]
   • The trial was paid for by the US, under health secretary Robert Kennedy Jr, a long-time vaccine sceptic. [11]
   • It planned to enrol 14,000 newborns, giving half the vaccine and denying it to the other half. [11]
   • Nearly 1 in 5 people in Guinea-Bissau has hepatitis B, health experts warned. [11]

   Who is involved

   Hepatitis B is an infection that can cause long-term liver damage and liver cancer, and has no cure. [11]

   The WHO, the UN's health agency, says every baby should get the vaccine at birth. [11]

   • The US government paid for the trial
   • Robert Kennedy Jr US health secretary

   How it unfolded

   Critics had called the trial unethical and potentially exploitative. [11] Police also seized a batch of vaccines from the research centre involved. [11]

   Why it matters

   Babies are most at risk of long-term infection, which usually passes from mother to baby. [11]

   How it works

   The vaccine is known to give years of protection, and the WHO says every baby should get it. [11]

   So a trial that left half the babies without it was called unethical. [11]

   The truth

   • Who gains Newborns in Guinea-Bissau — No baby will now be left without the vaccine on purpose for a trial. [11]

   Good news

   • Guinea-Bissau cancelled a trial that would have denied half of 14,000 newborn babies a hepatitis B vaccine the WHO recommends at birth.
7. 09

   Rwanda tests a malaria injection

   What happened

   • Rwanda has started Africa's first trial of a long-acting injection to prevent malaria. [12]
   • The trial tests the safety of the drug, MMV371, in adults and teenagers. [12]
   • One injection could protect a person for a whole malaria season, if later trials show it works. [12]
   • Malaria caused more than 280 million cases and over 600,000 deaths in 2024. [12] About 95% of the deaths were in Africa. [12]

   Who is involved

   Medicines for Malaria Venture, a nonprofit, runs it with Rinda Ubuzima, a Rwandan research group. [12]

   • Medicines for Malaria Venture nonprofit
   • Rinda Ubuzima Rwandan research group

   How it unfolded

   In earlier UK tests on healthy adults it was well tolerated, and showed it might protect for about 3 months. [12]

   Why it matters

   Drug resistance and climate change are threatening progress against malaria. [12]

   How it works

   Drug developers test in phases, and this early phase is mainly about safety. [12] Later trials must show whether MMV371 prevents malaria. [12]

   Good news

   • Rwanda has started Africa's first trial of an injection that could protect a person from malaria for a whole season.
8. 10

   Over 100 apply for the FDA's faster-trials pilot

   What happened

   • The FDA says it received more than 100 applications to its pilot for faster first trials in people. [13]
   • In the pilot, outside experts such as university hospitals help companies prepare that application. [13]

   Who is involved

   Before testing a new drug in people, a company must file an application with the FDA. [13]

   The pilot is part of Operation TrialBlazer, a US health department plan. [13]

   Why it matters

   The aim is to cut the time from early lab work to a first trial in people. [13]

   How it works

   The outside experts give advice on the drug's safety tests, the trial plan and how it is made. [13]

   What comes next

   The FDA expects to tell the chosen groups by December 18. [13]

9. 11

   The FDA counts 28 rare-disease approvals

   What happened

   • Kyle Diamantas, the FDA's acting head, says it approved 28 new rare-disease drugs in the past year. [14]
   • He also says nearly 95% of people with a rare disease still have no approved treatment. [14]
   • He wants review rules fitted to each disease, while keeping the highest safety standards. [14]

   How it unfolded

   Last month the FDA began a Rare Disease Framework Initiative, with a public meeting of 75 community members. [14]

   Why it matters

   He says the aim is to remove unnecessary delays to trials for rare diseases. [14]

   The truth

   • This is the FDA's own account, written by its acting head in an FDA column. [14]

   Good news

   • The FDA approved 28 new drugs for rare diseases in the past year, its acting head says.
10. 12

    FDA reviewers list what they asked gene therapy makers

    What happened

    • FDA reviewers studied the questions they asked makers of 7 approved AAV gene therapies during review. [15]
    • They counted 278 requests to the companies, covering about 662 topics. [15]
    • Of those topics, 58% were about how the products are made and tested. [15] Only 13% were about the clinical trials. [15]
    • The questions included checks on whether the virus's DNA joins the genome, and on cancer risk. [15]

    Who is involved

    The authors work at the FDA's Center for Biologics Evaluation and Research. [16]

    Why it matters

    Zolgensma is one of the gene therapies the reviewers studied. [15]

11. 13

    Evommune licenses an immune pill from China

    What happened

    • Evommune, a biotech company, will pay China's Hinova Pharmaceuticals $30 million for rights to an experimental drug. [17]
    • Hinova could get up to $1.1 billion more if the drug, EVO570, reaches set goals. [17]
    • Evommune gets the rights everywhere outside China. [17]

    Who is involved

    EVO570 is a pill meant to calm immune cells behind diseases such as rheumatoid arthritis. [17]

    • Evommune buyer
    • Hinova Pharmaceuticals Chinese seller

    How it unfolded

    Drugmakers were already on pace for about 1 China licensing deal a week this year, Endpoints counts. [18]

    Novartis paid Monte Rosa Therapeutics $150 million in 2024 for a rival drug aimed at the same target, VAV1. [17]

    Why it matters

    The deal puts Evommune up against Novartis, which is also testing a drug aimed at VAV1, an immune-cell protein. [17]

    How it works

    Dealmakers call the later sums milestones: they are paid as the drug passes set steps. [17]

    Here $30 million is paid now, and up to $1.1 billion only later. [17]

    Seen it before

    A club pays a small fee for a young player, plus more each time he hits a goal target.

    The truth

    • Who gains Hinova Pharmaceuticals — It keeps the drug's China rights while Evommune pays to develop it everywhere else. [17]
    • Nobody knows yet

      Whether EVO570 can hit its target without side effects elsewhere.

      William Blair analysts say VAV1 has been hard to target selectively, and the drug has not yet been tested in people. [17]

    What comes next

    Hinova has US approval to start a first trial, which Evommune says will begin very soon. [17]

12. 14

    A UK teenager waits for a drug the NHS will not pay for

    What happened

    • Brogan Johnson, 17, has Friedreich's ataxia and wants the NHS to pay for a drug called omaveloxolone. [19]
    • Bought privately in the UK, the drug costs 1,000 pounds a day. [19]
    • Prime Minister Andy Burnham has read her letter, her mother said. [19]

    Who is involved

    Friedreich's ataxia is a nerve disease that worsens over time. [19] People with it live 35 to 50 years on average. [19]

    • Brogan Johnson 17, from Leigh-on-Sea

    How it unfolded

    NICE, which decides which drugs the NHS pays for, has not assessed it. [19] Biogen, its maker, withdrew from that process last year. [19]

    Why it matters

    About 1,100 people in the UK are thought to have the condition. [19]

    With no NICE review, people in the UK can get the drug only by paying for it privately. [19]

    How it works

    The paying step is missing: with no NICE review, the NHS does not pay, and the family faces 1,000 pounds a day.

    The idea, in story 02: Why a drug can be approved and still be used by few people →

    The truth

    • What is really going on A UK teenager cannot get omaveloxolone on the NHS because Biogen left NICE's review. [19]
    • Who pays Brogan Johnson and others in the UK with Friedreich's ataxia — Their only route to the drug is to pay for it privately. [19]
    • Nobody knows yet

      Whether Biogen and NICE will restart their review of omaveloxolone.

      The UK health department says NICE is ready to resume, and Biogen says only that it is in regular dialogue. [19]

    What comes next

    A petition with more than 100,000 signatures is due to be discussed in Parliament next year. [19]

13. 15

    Kidney gene therapy in mice depends on the carrier

    What happened

    • Scientists tested gene therapy in mice for Dent disease type 1, a rare inherited kidney disease. [20]
    • A carrier virus that joins the cell's DNA cut the leak for up to 10 months. [20] It was given with a drug that calms the immune system. [20]
    • With an AAV carrier, adult mice kept making the missing protein for up to 8 to 10 months. [20] But the leak did not reliably fall. [20]

    Who is involved

    In Dent disease, the kidneys let small proteins leak into the urine. [20]

    Why it matters

    The authors say making the missing protein is not enough on its own to fix the disease. [20]

    How it works

    Gene therapists choose between carriers like lentivirus, which joins the cell's DNA, and AAV, which mostly stays apart. [20]

    Here the type of carrier, the immune response and the mouse's age all changed the result. [20]

    The truth

    • The study was in mice, not people. [20]
14. 16

    An egg-grown Covid booster falls short of Pfizer's

    What happened

    • A Covid booster grown in eggs, NDV-HXP-S, did not match the Pfizer-BioNTech shot in a phase 2 trial in Brazil. [21]
    • The trial ran in 2023 and gave 389 adults a fifth Covid dose. [21] Its results were published on 4 November. [21]
    • People given the egg-grown shot had virus-blocking antibody levels 0.50 times those given the Pfizer-BioNTech shot. [21]
    • Both shots were generally well tolerated. [21] Neither caused a serious vaccine-related harm within 28 days. [21]

    Who is involved

    Brazil's Fundação Butantan paid for the work in Brazil, and PATH and Mount Sinai also took part. [21]

    • Fundação Butantan
    • PATH and Mount Sinai

    Why it matters

    The authors say the world still needs vaccines that are cheap and can be made in large amounts. [21]

    How it works

    A non-inferiority trial asks whether a new shot is no worse than one already used, within a set limit. [21]

    Here the limit was 0.80 of the Pfizer-BioNTech antibody level. [21] The egg-grown shot reached 0.50, so it failed. [21]

    Seen it before

    A runner who must finish within 10 seconds of the champion fails if she is 20 seconds behind.

    The truth

    • The trial measured antibodies against the original Wuhan strain of the virus, not the ones spreading now. [21]
15. 17

    Scientists map how human antibodies grip polio

    What happened

    • Scientists at Oxford and Leeds mapped how 3 human antibodies grip poliovirus, each matched to 1 of its 3 types. [22]
    • The human antibodies often covered more than one known site on the virus. [22] They also reached deeper grooves than mouse antibodies. [22]

    Who is involved

    A scientist at the MHRA, the UK medicines regulator, was among the authors. [22]

    How it unfolded

    Polio viruses that cause disease still circulate, despite a global effort to wipe them out. [22]

    Most of what is known about where antibodies attach to the virus came from studies in mice. [22]

    Why it matters

    The authors say the maps could help design better lab tools, antiviral drugs and vaccines against polio. [22]

    How it works

    Structural biologists work out the exact shape of an antibody locked onto a virus. [22] Here they used empty virus shells, called virus-like particles. [22]

    The truth

    • This is lab work on virus shells, not a treatment tested in people. [22]
16. 18

    Child drug-safety reports are a warning, not proof

    What happened

    • An editorial in Pediatric Research says US reports of drug reactions in children are warnings, not proof. [23]
    • The study looked for drugs reported unusually often with anaphylaxis, a severe allergic reaction, in children. [23]
    • About 3% of FAERS reports involve children, around 70,000 a year. [23]
    • Doctors, patients and drug companies all send in reports. [23]

    Who is involved

    It comments on a study that searched FAERS, the FDA's database of reported drug side effects. [23]

    • FDA
    • FAERS its database of side-effect reports

    Why it matters

    Trials sized to show a drug works may miss rare, serious reactions such as anaphylaxis. [23]

    How it works

    Drug safety experts call a reported pattern a signal: a reason to look harder, not a proven cause. [23]

    FAERS cannot count how many children took each drug. [23] So it cannot say how often a reaction really happens. [23]

    Seen it before

    A smoke alarm tells you to check the kitchen. It does not prove the house is on fire.

    The truth

    • Each report reflects one person's judgement of what caused the reaction, and it cannot be checked. [23]