ReportWire

Tag: Drug and device safety

  • Hydroxychloroquine could have caused 17,000 deaths during COVID, study finds

    Hydroxychloroquine could have caused 17,000 deaths during COVID, study finds

    Nearly 17,000 people may have died after taking hydroxycholoroquine during the first wave of COVID, according to a study by French researchers.

    The anti-malaria drug was prescribed to some patients hospitalized with COVID-19 during the first wave of the pandemic, “despite the absence of evidence documenting its clinical benefits,” the researchers point out in their paper, published in the February issue of Biomedicine & Pharmacotherapy.

    Now, researchers have estimated that some 16,990 people in six countries — France, Belgium, Italy, Spain, Turkey and the U.S. — may have died as a result.

    That figure stems from a study published in the Nature scientific journal in 2021 which reported an 11 percent increase in the mortality rate, linked to its prescription against COVID-19, because of the potential adverse effects like heart rhythm disorders, and its use instead of other effective treatments.

    Researchers from universities in Lyon, France, and Québec, Canada, used that figure to analyze hospitalization data for COVID in each of the six countries, exposure to hydroxychloroquine and the increase in the relative risk of death linked to the drug.

    In fact, they say the figure may be far higher given the study only concerns six countries from March to July 2020, when the drug was prescribed much more widely.

    Hydroxychloroquine gained prominence partly due to French virologist Didier Raoult who had headed the Méditerranée Infection Foundation hospital, but was later removed amid growing controversy.

    It was also considered something of a “miracle cure” by the then-U.S. President Donald Trump, who said: “What do you have to lose? Take it.”

    Mari Eccles

    Source link

  • Why dengue in Europe could spell disaster for the rest of the world 

    Why dengue in Europe could spell disaster for the rest of the world 

    Press play to listen to this article

    Voiced by artificial intelligence.

    In the early morning of the last day of August, Parisians experienced for the first time a practice normally confined to tropical regions — authorities fumigating the city against the tiger mosquito. The event was a tangible confirmation of what public health stats already showed: Dengue, the deadly mosquito-borne disease, had well and truly arrived in Europe. 

    In 2022, Europe saw more cases of locally acquired dengue than in the whole of the previous decade. The rise marks both a public health threat and a corresponding market opportunity for dengue vaccines and treatments; news that should spur the pharma industry to boost investment into the neglected disease. 

    On the face of it, this shift would appear to benefit not only countries like France but also nations like Bangladesh and the Philippines that have long battled dengue.

    But that assumption could be fatally flawed, experts told POLITICO. 

    People working in the field say the rise of dengue in the West could, in fact, make it harder to get lifesaving drugs to those who need them most, because pharma companies develop tools that are less effective in countries where the dengue burden is the highest or because wealthy nations end up hoarding these medicines and vaccines. 

    “It might look like a good thing — and it is a good thing — that we’re getting more products developed, but does it then create a two-tier system where high-income populations get access to it and then we still have the access gap for low- and middle- income countries?” asked Lindsay Keir, director of the science and policy advisory team at think tank Policy Cures Research.

    Killer invading mosquitoes

    Climate change and migration mean the mosquitoes that transmit dengue, as well as other diseases such as chikungunya and Zika, are setting up shop in Europe. The most recent annual data from the European Centre for Disease Prevention and Control shows that, in 2022, Europe saw 71 cases of locally acquired dengue: 65 in France and six in Spain.

    While dengue usually results in mild or no symptoms, it can also lead to high fever, severe headache and vomiting. Severe dengue can cause bleeding from the gums, abdominal pain and, in some cases, death.

    So far, the mosquito has mostly been confined to Southern Europe but it’s a worry across the Continent. In Belgium, the national public health research institute Sciensano has even launched an app where members of the public can submit photos of any Asian tiger mosquitos they spot.

    The diseases spread by these mosquitoes have traditionally fallen under the umbrella of neglected tropical diseases, a group of infections that affect mainly low-income countries and struggle to attract research and development investment. But this is changing.

    Policy Cures Research, which publishes an annual report on R&D investment into neglected diseases, removed dengue vaccines from their assessment in 2013. Dengue was no longer seen as an area where there was market failure, due to the emergence of a market that the private sector could tap into. 

    The organization is still tracking dengue drugs and biologics and their 2022 analysis showed a 33 percent increase in funding for research into non-vaccine products compared to the previous year, with industry investment reaching a record high of $28 million. 

    Climate change and migration mean the mosquitoes that transmit dengue, as well as other diseases such as chikungunya and Zika, are setting up shop in Europe | Lukas Schulze/Getty Images

    Sibilia Quilici, executive director of the vaccine maker lobby group Vaccines Europe, said the most recent pipeline review of members found that roughly 10 percent were targeting neglected diseases. There is more R&D happening in this area, said Quilici.

    Across the major drugmakers, J&J is working on a dengue antiviral treatment and MSD has a dengue vaccine in their pipeline, while Sanofi has a second yellow fever jab in development. Two dengue vaccines are already approved in the EU — one from Sanofi and another from Takeda. Moderna recently told POLITICO that it is looking closely at a dengue vaccine candidate and it already has a Zika candidate in the works. 

    For the few, not the many

    But just because there might soon be larger markets for Big Pharma doesn’t mean the products will be suitable for the populations that have been waiting years for these tools. 

    Rachael Crockett, senior policy advocacy manager at the non-profit Drugs for Neglected Diseases initiative (DNDi), said increased pharma investment in a particular disease won’t necessarily lead to products developed that are globally relevant. “Industry will — and governments are also more likely to — focus on prevention,” she said.

    That means tools such as vaccines will be prioritized; but in countries where dengue is endemic, the rainy season completely overburdens their health systems and what they desperately need are treatments, said Crockett.  

    She also said a massive increase in investment without a structure to ensure access to resulting products means “we have absolutely no guarantee that there isn’t going to be hoarding, [that] there isn’t going to be high prices.” Case in point: The U.S. national stockpile of Ebola vaccines, which exists despite there never having been an Ebola outbreak in the country.

    But just because there might soon be larger markets for Big Pharma doesn’t mean the products will be suitable for the populations that have been waiting years for these tools | Noel Celis/AFP via Getty Images

    Underlying many of these fears are the mistakes of the COVID-19 pandemic, which saw countries with less cash and political heft at the back of the queue when it came to vaccines.

    Lisa Goerlitz, head of German charity Deutsche Stiftung Weltbevölkerung (DSW)’s Brussels office, warned if drug development picks up because of a growing market in high-income countries, then accessibility, affordability and other criteria that make it suitable for low resource settings might not be prioritized.

    Vaccines Europe’s Quilici sought to allay these concerns, pointing to the pharma industry’s Berlin Declaration, a proposal to reserve an allocation of real-time production of vaccines in a health crisis. Quilici said this was a “really strong commitment …which comes right from the lessons learnt from COVID-19 and which could definitely overcome the challenges we had during the pandemic, if it is taken seriously.”

    CORRECTION: This article has been updated to correct the spelling of Lisa Goerlitz.

    Ashleigh Furlong

    Source link

  • Top review says COVID lockdowns and masks worked, period

    Top review says COVID lockdowns and masks worked, period

    Speedy implementation of a combination of measures such as face masks, lockdowns and international border controls, “unequivocally” reduced COVID-19 infections, a major review has shown.

    The report published Thursday by the Royal Society looked at findings from six evidence reviews that analyzed thousands of studies to assess the effect of masks, social distancing and lockdowns, test trace and isolate systems, border controls, environmental controls and communications. It found evidence that each of these measures — which are called “non-pharmaceutical interventions” — were effective, albeit to varying degrees, when looked at individually. However, the evidence in favor of using these tools was stronger when countries combined several measures.

    The report could have significant implications for decision-making in future outbreaks, with Mark Walport, chair of the report’s expert working group and foreign secretary of the Royal Society, saying that “having protocols in advance is really important.” He said what policymakers should take from the research is “there is evidence that non-pharmaceutical interventions are effective, but … they have to be applied as packages, and they have to be applied as early as possible.”

    The most effective measure, according to the review, was one of the most controversial — restrictions on movement and social interactions through lockdowns, distancing and rules around the size of gatherings. These were repeatedly found to be associated with a “significant reduction” in transmission of the virus, with the more stringent the measure, the greater the effect.

    For masks, 75 studies were assessed, with 63 of these finding positive effects. Unlike the January Cochrane review, which only looked at randomized controlled trials, this review also included observational studies. The Cochrane review was unable to find conclusive evidence that masks helped stop respiratory viruses. 

    Chris Dye, professor of epidemiology at the University of Oxford, who led the review on masks for the Royal Society, said if they had only looked at randomized controlled trials they would have come to the same conclusion as the Cochrane review. But the researchers behind the paper released Thursday chose to analyze a larger body of studies and found strong evidence that masks work. 

    A key finding from the research was these type of measures were most effective when implemented early on. Dye said that while there is a 100-day mission to develop drugs, therapeutics, vaccines and diagnostics for a future pandemic, “it would be marvelous” if there were a 100-day vision for non-pharmaceutical interventions. He said this would mean countries could “put in place the necessary mechanisms for preparedness, which would be to implement [non-pharmaceutical interventions] when some unknown new pathogen comes along.”

    While a future pandemic could be transmitted sexually or gastrointestinally, Salim Abdool Karim, a member of the working group on the report and pro-vice-chancellor for research at the University of KwaZulu-Natal, said the biggest concern was a respiratory virus. “The lessons of SARS-CoV-2 have to feature in our thinking as we prepare for a next pandemic that would be a respiratory virus of which we’ve got no prior exposure and so we don’t have a pre-existing immunity. The lessons of this report are going to feature strongly in anyone’s deliberations,” he said.

    However, responding to the report, Kevin McConway, emeritus professor of applied statistics at the Open University cautioned that impact on virus transmission is not the only factor that should be taken into account when deciding to use such measures. “The report does point out explicitly that NPIs can impose a great number of costs and burdens, in terms social and economic impacts, and indeed of increasing ill health … but makes it very explicit that this piece of work isn’t going to consider any of that.” “I think that limits quite severely its effectiveness in helping decisions on what should be done in the next pandemic, whenever it arises.”

    Ashleigh Furlong

    Source link

  • The EU and UK have a Northern Ireland deal — so what’s in it?

    The EU and UK have a Northern Ireland deal — so what’s in it?

    Press play to listen to this article

    Voiced by artificial intelligence.

    LONDON — After four months of intense talks (and plenty of squabbling before that), the EU and U.K. have a deal to resolve their long-running post-Brexit trade row over Northern Ireland.

    But as U.K. Prime Minister Rishi Sunak works to sell the so-called “Windsor framework” on the Northern Ireland protocol to Brexiteers and unionists, lawmakers on both sides of the English Channel and of the Irish Sea are getting to grips with the details.

    From paperwork to plants, let POLITICO walk you through the new agreement, asking: Who has given ground, and how exactly will the deal thrashed out by EU and U.K. negotiators aim to keep the bloc’s prized single market secure?

    Customs paperwork and checks

    For businesses taking part in an expanded “trusted trader scheme,” the Windsor framework aims to considerably cut customs paperwork and checks on goods moving from Great Britain but destined to stay in Northern Ireland. 

    These goods will pass through a “green lane” requiring minimal paperwork and be labeled “Not for EU,” while those heading for the EU single market in the Republic of Ireland will undergo full EU customs checks in Northern Ireland’s ports under a “red lane.”

    Traders in the green lane will only need to complete a single, digitized certificate per truck movement, rather than multiple forms per load.

    Sunak has already claimed that this means “any sense of a border in the Irish Sea” — deeply controversial among Northern Ireland’s unionist politicians — has now been “removed.”

    However, it’s by no means a total end to Irish Sea red tape. An EU official said that although the deal delivers a “dramatic reduction” in the number of physical food safety checks, for example, there will still be some — those seen as “essential” to avoid the risk of goods entering the single market.

    These checks will be based on risk assessments and intelligence, and aimed at preventing smuggling and criminality.

    U.K. public health and safety standards will meanwhile apply to all retail food and drink within the U.K. internal market. British rules on public health, marketing, organics, labeling, genetic modification, and drinks such as wines, spirits and mineral waters will apply in Northern Ireland. This will remove more than 60 EU food and drink rules in the original protocol, which were detailed in more than 1,000 pages of legislation.

    Supermarkets, wholesalers, hospitality and food producers are likely to welcome the new arrangements. Many had stopped supplying to Northern Ireland because the cost of filling out hundreds of certificates for each consignment was deemed too high for a market as small as Northern Ireland. 

    Export declarations have been removed for the vast majority of goods moving from Northern Ireland to Great Britain.

    The EU’s safeguards: While offering to drastically reduce the volume of checks carried out, the EU has toughened its criteria to become a trusted trader under the expanded scheme. The EU will now have access to databases tracking shipments of goods between Great Britain and Northern Ireland in real time. The system was tested through the winter, helping build trust in Brussels, and is being fed with data from traders and U.K. authorities. The European Commission will be able to suspend part or all of these trade easements if the U.K. fails to comply with the new rules.

    The timeline: The U.K. government said it will consult with businesses in the “coming months” before implementing the new rules. The green lane will come into force this fall. Labels for meat, meat products and minimally-processed dairy products such as fresh milk will come into force from October 1, 2024. All relevant products will be marked by July 1, 2025. “Shelf-stable” products like bread and pasta will not be labeled.

    Governance

    A key plank of the deal is the bid to address complaints by Northern Ireland’s Democratic Unionist Party (DUP) — currently boycotting the power-sharing assembly in the region in opposition to the protocol — that lawmakers there did not have a say in the imposition of new EU rules in the region.

    Under the terms of the new agreement, the Commission will have to give the U.K. government notice of future EU regulations intended to apply in Northern Ireland. According to Sunak, Stormont will be given a new power to “pull an emergency brake on changes to EU goods rules” based on “cross-community consent.”

    Under this mechanism, the U.K. government will be able to suspend the application in Northern Ireland of an incoming piece of EU law at the request of at least 30 members of the assembly — a third of them. But if unionist parties in Northern Ireland want to trigger the new “Stormont brake,” they must first return to the power-sharing institutions which they abandoned last May. The EU and the U.K. could subsequently agree to apply such a rule in a meeting of the Joint Committee, which oversees the protocol.

    Commission President Ursula von der Leyen said this new tool remains an emergency mechanism that hopefully will not need to be used. A second EU official said it would be triggered “under the most exceptional circumstances and as a matter of last resort in a well-defined process” set out in a unilateral declaration by the U.K. These include that the rules have a “significant and lasting impact on the everyday lives” of people in the region.

    If the EU disagrees with the U.K.’s trigger of the Stormont brake, the two would resolve the issue through independent arbitration, instead of involving the Court of Justice of the EU.

    Meanwhile, Northern Ireland’s courts will consider disputes over the application of EU rules in the region, and judges could decide whether to consult the CJEU on how to interpret them. In a key concession, the Commission has agreed not to unilaterally refer a case to the CJEU, although it retains the power to do so.

    The EU’s safeguards: The CJEU will remain the “sole and ultimate arbiter of EU law” and will have the “final say” on EU single market disputes, von der Leyen stressed. Whether Brexiteers and the DUP are willing to accept that remains the million-dollar question.

    Tax, state aid and EU rules

    The U.K. government will now be able to set rules in areas such as VAT and state aid that will also apply in Northern Ireland — two major wins for Sunak that were rejected by the Commission in previous rounds of negotiations with other U.K. prime ministers.

    It will, Sunak was at pains to point out Monday, allow Westminster to pass on a cut in alcohol duty that previously passed Northern Ireland by.

    But London has had to give up on its idea of establishing a dual-regulatory mechanism that would have allowed Northern Ireland businesses to choose whether they would follow EU or British rules when manufacturing goods, depending on whether they intended to sell them in the EU single market or in the U.K. The whole idea was deemed by Brussels as impossible to police.

    The EU’s safeguards: Northern Irish businesses producing goods for the U.K. internal market will only have to follow “less than 3 percent” of EU single market rules, a U.K. official said. But the nature of these regulations remains unclear, and there will be increased market surveillance and enforcement by U.K. authorities to try and reassure the EU.

    The timeline: The U.K. government will be able to exercise these powers as soon as the Windsor framework comes into force.

    Parcels

    The EU and the U.K. have agreed to scrap customs processes for parcels being sent between consumers in Great Britain to Northern Ireland.

    The EU’s safeguards: Parcels sent between businesses will now move through the new green lane, as is the case for other goods destined to stay in Northern Ireland. That should allow them to be monitored, but remove the need to undergo international customs procedures. Parcel operators will share commercial data with the U.K.’s tax authority, HMRC, in a bid to reduce risks to the EU single market.

    Timeline: These new arrangements will take effect September 2024.

    Pets

    Residents in Great Britain will be able to take their dogs, cats and ferrets to Northern Ireland without having to fulfill a requirement for a rabies vaccine, tapeworm treatment and other checks.

    Pets traveling from Northern Ireland to Great Britain and back will not be required to have any documentation, declarations, checks or health treatments.

    The EU’s safeguards: Microchipped pets will be able to travel with a life-long pet travel document issued for free by the U.K.’s Department for Environment, Food and Rural Affairs. Pet owners will tick a box in their travel booking acknowledging they accept the scheme rules and will not move their pet into the EU.

    The timeline: The new rules will take effect fall 2023.

    Medicines

    Drugs approved for use by the U.K.’s medicines regulator, the MHRA, will be automatically available in every pharmacy and hospital in Northern Ireland, “at the same time and under the same conditions” as in the U.K., von der Leyen said. 

    Businesses will need to secure approval for a U.K.-wide license from the MHRA to supply medicines to Northern Ireland, rather than having to go through the European Medicines Agency. The agreement removes any EU Falsified Medicines Directive packaging, labeling and barcode requirements for medicines. This means manufacturers will be able to produce a single medicines pack design for the whole of the U.K., including Northern Ireland.

    Drugs being shipped into Northern Ireland from Great Britain will be freed of customs paperwork, checks and duties, with traders only being required to provide ordinary commercial information.

    The EU’s safeguards: Medicines traveling from Great Britain to Northern Ireland will do so via the new green lane, which will have monitoring to protect the single market built in.

    The timeline: The U.K. government said it will engage with the medicines industry soon on these changes.

    Plants

    The deal lifts the protocol’s ban on seed potatoes entering Northern Ireland from Great Britain, and its prohibition on trees and shrubs deemed of “high risk” for the EU single market. This will enable garden centers and other businesses in Northern Ireland to sell 11 native species to Great Britain and some from other regions.

    The Windsor framework also removes sanitary and phytosanitary (SPS) checks on all these plants, and ditches red tape on their shipment into Northern Ireland.

    The EU’s safeguards: Supplying businesses will have to obtain a Northern Ireland plant health label, which will be the same as the plant passport already required within Great Britain, but with the addition of the words “for use in the U.K. only” and a QR code linking to the rules.

    The timeline: The new scheme and the lifting of the bans will all come into force in the fall.

    Cristina Gallardo

    Source link

  • Europe is running out of medicines

    Europe is running out of medicines

    Press play to listen to this article

    Voiced by artificial intelligence.

    When you’re feeling under the weather, the last thing you want to do is trek from pharmacy to pharmacy searching for basic medicines like cough syrup and antibiotics. Yet many people across Europe — faced with a particularly harsh winter bug season — are having to do just that.

    Since late 2022, EU countries have been reporting serious problems trying to source certain important drugs, with a majority now experiencing shortages. So just how bad is the situation and, crucially, what’s being done about it? POLITICO walks you through the main points.

    How bad are the shortages?

    In a survey of groups representing pharmacies in 29 European countries, including EU members as well as Turkey, Kosovo, Norway and North Macedonia, almost a quarter of countries reported more than 600 drugs in short supply, and 20 percent reported 200-300 drug shortages. Three-quarters of the countries said shortages were worse this winter than a year ago. Groups in four countries said that shortages had been linked to deaths.

    It’s a portrait backed by data from regulators. Belgian authorities report nearly 300 medicines in short supply. In Germany that number is 408, while in Austria more than 600 medicines can’t be bought in pharmacies at the moment. Italy’s list is even longer — with over 3,000 drugs included, though many are different formulations of the same medicine.

    Which medicines are affected?

    Antibiotics — particularly amoxicillin, which is used to treat respiratory infections — are in short supply. Other classes of drugs, including cough syrup, children’s paracetamol, and blood pressure medicine, are also scarce.

    Why is this happening?

    It’s a mix of increased demand and reduced supply.

    Seasonal infections — influenza and respiratory syncytial virus (RSV) first and foremost — started early and are stronger than usual. There’s also an unusual outbreak of throat disease Strep A in children. Experts think the unusually high level of disease activity is linked to weaker immune systems that are no longer familiar with the soup of germs surrounding us in daily life, due to lockdowns. This difficult winter, after a couple of quiet years (with the exception of COVID-19), caught drugmakers unprepared.

    Inflation and the energy crisis have also been weighing on pharmaceutical companies, affecting supply.

    Last year, Centrient Pharmaceuticals, a Dutch producer of active pharmaceutical ingredients, said its plant was producing a quarter less output than in 2021 due to high energy costs. In December, InnoGenerics, another manufacturer from the Netherlands, was bailed out by the government after declaring bankruptcy to keep its factory open.

    Commissioner Stella Kyriakides wrote to Greece’s health minister asking him to take into consideration the effects of bans on third countries | Stephanie Lecocq/EPA-EFE

    The result, according to Sandoz, one of the largest producers on the European generics market, is an especially “tight supply situation.” A spokesperson told POLITICO that other culprits include scarcity of raw materials and manufacturing capacity constraints. They added that Sandoz is able to meet demand at the moment, but is “facing challenges.”

    How are governments reacting?

    Some countries are slamming the brakes on exports to protect domestic supplies. In November, Greece’s drugs regulator expanded the list of medicine whose resale to other countries — known as parallel trade — is banned. Romania has temporarily stopped exports of certain antibiotics and kids’ painkillers. Earlier in January, Belgium published a decree that allows the authorities to halt exports in case of a crisis.

    These freezes can have knock-on effects. A letter from European Health Commissioner Stella Kyriakides addressed to Greece’s Health Minister Thanos Plevris asked him to take into consideration the effects of bans on third countries. “Member States must refrain from taking national measures that could affect the EU internal market and prevent access to medicines for those in need in other Member States,” wrote Kyriakides.

    Germany’s government is considering changing the law to ease procurement requirements, which currently force health insurers to buy medicines where they are cheapest, concentrating the supply into the hands of a few of the most price-competitive producers. The new law would have buyers purchase medicines from multiple suppliers, including more expensive ones, to make supply more reliable. The Netherlands recently introduced a law requiring vendors to keep six weeks of stockpiles to bridge shortages, and in Sweden the government is proposing similar rules.

    At a more granular level, a committee led by the EU’s drugs regulator, the European Medicines Agency (EMA), has recommended that rules be loosened to allow pharmacies to dispense pills or medicine doses individually, among other measures. In Germany, the president of the German Medical Association went so far as to call for the creation of informal “flea markets” for medicines, where people could give their unused drugs to patients who needed them. And in France and Germany, pharmacists have started producing their own medicines — though this is unlikely to make a big difference, given the extent of the shortfall.

    Can the EU fix it?

    In theory, the EU should be more ready than ever to tackle a bloc-wide crisis. It has recently upgraded its legislation to deal with health threats, including a lack of pharmaceuticals. The EMA has been given expanded powers to monitor drug shortages. And a whole new body, the Health Emergency Preparedness and Response Authority (HERA) has been set up, with the power to go on the market and purchase drugs for the entire bloc.

    But not everyone agrees that it’s that bad yet.

    Last Thursday, the EMA decided not to ask the Commission to declare the amoxycillin shortage a “major event” — an official label that would have triggered some (limited) EU-wide action— saying that current measures are improving the situation.

    A European Medicines Agency’s working group on shortages could decide on Thursday whether to recommend that the Commission declares the drug shortages a “major event” — an official label that would trigger some (limited) EU-wide action. An EMA steering group for shortages would have the power to request data on drug stocks of the drugs and production capacity from suppliers, and issue recommendations on how to mitigate shortages.

    At an appearance before the European Parliament’s health committee, the Commission’s top health official, Sandra Gallina, said she wanted to “dismiss a bit the idea that there is a huge shortage,” and said that alternative medications are available to use.

    And others believe the situation will get better with time. “I think it will sort itself out, but that depends on the peak of infections,” said Adrian van den Hoven, director general of generics medicines lobby Medicines for Europe. “If we have reached the peak, supply will catch up quickly. If not, probably not a good scenario.”

    Helen Collis and Sarah-Taïssir Bencharif contributed reporting.

    Carlo Martuscelli

    Source link