Sunday, September 24, 2023
  • SUBSCRIBE NOW
  • Login
  • Register
No Result
View All Result
The Kenya Times
  • News
    • All
    • Africa News
    • Diaspora News
    • East Africa News
    • Middle East News
    • National News
    • West Africa News
    • World News
    Namwamba Rallies Support for Starlets as Kenya Secures Hollywood and NBA Deals

    Namwamba Rallies Support for Starlets as Kenya Secures Hollywood and NBA Deals

    Deputy President Rigathi Gachagua (center) interacts with friends at his rural home in Mathira, Nyeri County on September 24, 2023.

    Kenyans React After Gachagua’s Revelation on His Village Friend

    Rashford's £700k Ride Involved in an Accident After Man Utd's Win

    Rashford’s Ksh108 Million Ride Crashes After Man United Win

    A photo of Citizen TV's studios in Nairobi.

    Ex-Citizen TV Journalist Appeals for Help, Reveals He’s Homeless 

    Water and Sanitation Cabinet Secretary Alice Wahome (left) shakes hands with President William Ruto during a UDA faction in 2022.

    How Alice Wahome Found Herself in Ruto’s Cabinet 

    Nairobi City County to Dispose 193 Unclaimed Bodies

    City Mortuary to Dispose 169 Unclaimed Bodies

    Trending Tags

    • Business
      • All
      • Banking
      • Cryptocurrency
      • Economy
      • Energy
      • Money Markets
      • Personal Finance
      • Real Estate
      • Startups
      Surviving on Credit and Default: The Reality in Kenya

      Surviving on Credit and Default: The Reality in Kenya

      Family Bank Unveils Ksh50 Billion Kitty Exclusive for Women

      Family Bank Unveils Ksh50 Billion Kitty Exclusive for Women

      MP Pushes for Hefty Fines of Up to Ksh10M After Migori Gold Rush

      MP Pushes for Hefty Fines of Up to Ksh10M After Migori Gold Rush

      New Features for WhatsApp Business Announced

      New Features for WhatsApp Business Announced

      Kenyans Rush to Tanzania for Cheaper Fuel

      Kenyans Rush to Tanzania for Cheaper Fuel

      Ruto Signs Cheap Fuel Deal with the UAE

      Boost for Ruto as Fuel Deal with UAE Extended

    • Health
      • All
      • Allergies
      • COVID-19
      • Health & Science
      • Mens Health
      • Mental Health
      • Wellness
      • Womens Health
      A photo of Citizen TV's studios in Nairobi.

      Ex-Citizen TV Journalist Appeals for Help, Reveals He’s Homeless 

      Public Service PS Amos Gathecha speaking during the opening ceremony of Public Service Counsellors workshop on September 18. PHOTO-Amos

      Govt Identifies Most Stressed Civil Servants

      UJI POWER: Benefits of Popular Sip Keeping Nairobians Full Amid Tough Times

      UJI POWER: Benefits of Popular Sip Keeping Nairobians Full Amid Tough Times

      Doctors to Hold Protests on the State of Healthcare in Kenya

      Doctors to Hold Protests, Issue Demands to Govt

      Worldcoin Eye Scans May Cause Health Complications

      CS Nakhumicha Warns Kenyans of Health Risks Linked to Worldcoin Eye Scans

      The Cabinet resolved to introduce three new funds

      Cabinet Approves Scrapping of NHIF

      Trending Tags

      • Law & Order
        • All
        • Corruption
        • Courts
        • Crime
        • Cyber Crime
        • Elections
        • Fraud
        • Investigations
        • Military
        • Missing Persons
        • Press Freedom
        • Terrorism
        Eric Maigo

        Eric Maigo Murder: 5 Questions Raised as Detectives Piece Evidence

        DCI

        DCI Arrests 9 in Ksh160M SACCO Theft

        DCI clothes

        DCI Unmasks Prime Suspect in Murder of Erick Maigo

        A photo of Billy Chemirmir- Kenyan man found dead in his prison cell in Texas on Septmber 19, 2023.

        Billy Chemirmir: Kenyan Serial Killer Murdered in US Prison

        Khalwale Proposes Tougher Regulations for Boda Boda Riders

        Law Seeking to Control How Kenyans Sit on Boda Boda Coming

        IG Koome Sued Over Uhuru-Era Killings

        IG Koome Sued Over Uhuru-Era Killings

        Ex-Mungiki Leader Maina Njenga Allegedly Abducted

        Ex-Mungiki Leader Maina Njenga Allegedly Abducted

        Government's Crackdown on Drug Trafficking and Illegal Brews

        Foreigner Nabbed at JKIA With Heroin Worth Ksh3.2M

        Homa Bay MP Peter Kaluma speaks during a media brifing at Parliament Buildings Nairobi.

        Kaluma Gives Way Forward After Supreme Court Ruling on LGBTQ Rights

        Trending Tags

        • Sports
          • All
          • Athletics
          • Basketball
          • Boxing
          • Cricket
          • Football
          • Formula 1
          • Golf
          • Marathons
          • Olympics
          • Rallies
          • Rugby
          • Tennis
          • World Cup
          Namwamba Rallies Support for Starlets as Kenya Secures Hollywood and NBA Deals

          Namwamba Rallies Support for Starlets as Kenya Secures Hollywood and NBA Deals

          Rashford's £700k Ride Involved in an Accident After Man Utd's Win

          Rashford’s Ksh108 Million Ride Crashes After Man United Win

          From left Barcelona Coach Xavi Hernandez, Manchester City coach Pep Guardiola and Bayern Leverkusen boss Xavi Alonso. The 3 coaches are unbeaten.

          18 Unbeaten Teams in Europe’s Big 5 Leagues in 2023/24 Season

          A Love Story on the Runway: Mary Moraa's Surprise Airport Proposal

          Lucky Man Melts Mary Moraa’s Golden Heart with Airport Proposal

          President Ruto Awards Shujaa 7s Players Ksh200k Each

          Ruto Awards Shujaa 7s Players Ksh200k Each

          Image of CS Namwamba with President Ruto at a past event. PHOTO- CS Namwamba

          I am Not Resigning Anytime Soon – Ababu Namwamba

          Trending Tags

          • Entertainment
            • All
            • Gaming
            • Movies
            • Music
            Sonko's Emotional Message to Daughter as She Flies Out

            Sonko’s Emotional Message to Daughter as She Flies Out

            Abel Mutua Issues 'Joint Statement' After Kate Actress Divorce

            Abel Mutua Issues ‘Joint Statement’ After Kate Actress Divorce

            A collage of Kenyan Singer and Songwriter Nadia Mukami.

            Nadia Mukami Bags Prestigious Award in US

            A past photo of content creator Andrew Kibe.

            Google Breaks Silence on Andrew Kibe YouTube Channel

            Pulse Kenya stated that there are fraudulent players contacting 2023 nominees for pulse awards offering them votes at a price

            Pulse Kenya Condemns Fraudsters Selling Votes to Influencer Award Nominees

            Otile Brown Calls Out Diamond and Mbosso Over Fake Jewelry

            Otile Brown Calls Out Diamond and Mbosso Over Fake Jewelry

            Trending Tags

            • Lifestyle
              • All
              • Arts
              • Culture
              • Disabilities Matters
              • Ethics & Religion
              • Family
              • Fashion
              • Food
              • Human Interest
              • Tourism
              Namwamba Rallies Support for Starlets as Kenya Secures Hollywood and NBA Deals

              Namwamba Rallies Support for Starlets as Kenya Secures Hollywood and NBA Deals

              Ruto Under Pressure to Introduce One-Child Policy in Kenya

              Ruto Under Pressure to Introduce One-Child Policy in Kenya

              Inclusive Initiatives to Support Mobility for PWDs In Kenya

              Inclusive Initiatives to Support Mobility for PWDs In Kenya

              Sam Gituku: From Unknown Radio Reporter to High-Flying TV Anchor

              Sam Gituku: From Unknown Radio Reporter to High-Flying TV Anchor

              Dr. Kelvin Shikuku. PHOTO/Courtesy.

              Kenyan Feted by European Research Body After Emerging Top

              Diet Tips: What You Should Know Before Eating Matumbo

              Diet Tips: What You Should Know Before Eating Matumbo

              Trending Tags

              • Sci-Tech
                • All
                • Climate Changes
                • Cyber Security
                • Social Media
                • Space
                • Technology
                A new type of spyware means those online ads could go from annoying to menacing. AP Photo/Julio Cortez

                Spyware Can Infect your Phone or Computer via The Ads You See Online – Report

                Elon Musk's Neuralink Chip That can Help You Control a Cursor With Your Mind

                Brain Chip That Can Help You Control Computer Cursor with Your Mind Approved

                With pressure from the European Union, Apple has thrown in the towel on its Lightning connector, left, in favor of the standard USB-C, right. Frederic J. Brown/AFP via Getty Images

                What is USB-C?

                President William Ruto (center) poses for a photo with US Ambassador to Kenya Meg Whitman (right) and a Starlink executive after a meetig on September 16, 2023.

                Ruto Pushes for Cheaper Internet in Meeting with Elon Musk’s Starlink

                Dr. Kelvin Shikuku. PHOTO/Courtesy.

                Kenyan Feted by European Research Body After Emerging Top

                Met Department Warns of El Nino Rains

                NEMA Sounds Warning to Businessowners

                Trending Tags

                • Opinion
                  • All
                  • Editorials
                  • John Mukum Mbaku
                  • Letters to Editor
                  • Makau Mutua
                  • Peter Ongera
                  • Salim Lone
                  • XN Iraki
                  Wagner group founder Yevgeny Prigozhin, photographed on June 24, 2023, in Russia. Anadolu Agency via Getty Images

                  Wagner Group: What Yevgeny Prigozhin’s Death Means for Stability in Africa

                  Fulton County District Attorney Fani Willis speaks during a news conference after former President Donald Trump’s Aug. 15 indictments. Joe Raedle/Getty Images

                  RICO is Often Used to Target the Mob and Cartels

                  Niger coup and Junta leader Gen Abdourahmane Tchiani; part of a demonstration held by his supporters in Niamey on Sunday. Coutesy of Balima Boreima / Anadolu Agency via Getty Images

                  The Needless Return of the Coup

                  The indictment of Donald Trump and an aide was ‘laced with rhetorical and narrative techniques.’ Photo Illustration by Drew Angerer/Getty Images

                  Trump’s Classified-Documents Indictment Does More than Allege Crimes

                  Wagner group founder Yevgeny Prigozhin, photographed on June 24, 2023, in Russia. Anadolu Agency via Getty Images

                  Wagner Group’s Yevgeny Prigozhin Reportedly Died in Private Jet Crash

                  Africa is facing a lot of challenges.

                  Africa Must Chart Its Leadership Separate from Foreign Ideology

                • Contact Us
                • News
                  • All
                  • Africa News
                  • Diaspora News
                  • East Africa News
                  • Middle East News
                  • National News
                  • West Africa News
                  • World News
                  Namwamba Rallies Support for Starlets as Kenya Secures Hollywood and NBA Deals

                  Namwamba Rallies Support for Starlets as Kenya Secures Hollywood and NBA Deals

                  Deputy President Rigathi Gachagua (center) interacts with friends at his rural home in Mathira, Nyeri County on September 24, 2023.

                  Kenyans React After Gachagua’s Revelation on His Village Friend

                  Rashford's £700k Ride Involved in an Accident After Man Utd's Win

                  Rashford’s Ksh108 Million Ride Crashes After Man United Win

                  A photo of Citizen TV's studios in Nairobi.

                  Ex-Citizen TV Journalist Appeals for Help, Reveals He’s Homeless 

                  Water and Sanitation Cabinet Secretary Alice Wahome (left) shakes hands with President William Ruto during a UDA faction in 2022.

                  How Alice Wahome Found Herself in Ruto’s Cabinet 

                  Nairobi City County to Dispose 193 Unclaimed Bodies

                  City Mortuary to Dispose 169 Unclaimed Bodies

                  Trending Tags

                  • Business
                    • All
                    • Banking
                    • Cryptocurrency
                    • Economy
                    • Energy
                    • Money Markets
                    • Personal Finance
                    • Real Estate
                    • Startups
                    Surviving on Credit and Default: The Reality in Kenya

                    Surviving on Credit and Default: The Reality in Kenya

                    Family Bank Unveils Ksh50 Billion Kitty Exclusive for Women

                    Family Bank Unveils Ksh50 Billion Kitty Exclusive for Women

                    MP Pushes for Hefty Fines of Up to Ksh10M After Migori Gold Rush

                    MP Pushes for Hefty Fines of Up to Ksh10M After Migori Gold Rush

                    New Features for WhatsApp Business Announced

                    New Features for WhatsApp Business Announced

                    Kenyans Rush to Tanzania for Cheaper Fuel

                    Kenyans Rush to Tanzania for Cheaper Fuel

                    Ruto Signs Cheap Fuel Deal with the UAE

                    Boost for Ruto as Fuel Deal with UAE Extended

                  • Health
                    • All
                    • Allergies
                    • COVID-19
                    • Health & Science
                    • Mens Health
                    • Mental Health
                    • Wellness
                    • Womens Health
                    A photo of Citizen TV's studios in Nairobi.

                    Ex-Citizen TV Journalist Appeals for Help, Reveals He’s Homeless 

                    Public Service PS Amos Gathecha speaking during the opening ceremony of Public Service Counsellors workshop on September 18. PHOTO-Amos

                    Govt Identifies Most Stressed Civil Servants

                    UJI POWER: Benefits of Popular Sip Keeping Nairobians Full Amid Tough Times

                    UJI POWER: Benefits of Popular Sip Keeping Nairobians Full Amid Tough Times

                    Doctors to Hold Protests on the State of Healthcare in Kenya

                    Doctors to Hold Protests, Issue Demands to Govt

                    Worldcoin Eye Scans May Cause Health Complications

                    CS Nakhumicha Warns Kenyans of Health Risks Linked to Worldcoin Eye Scans

                    The Cabinet resolved to introduce three new funds

                    Cabinet Approves Scrapping of NHIF

                    Trending Tags

                    • Law & Order
                      • All
                      • Corruption
                      • Courts
                      • Crime
                      • Cyber Crime
                      • Elections
                      • Fraud
                      • Investigations
                      • Military
                      • Missing Persons
                      • Press Freedom
                      • Terrorism
                      Eric Maigo

                      Eric Maigo Murder: 5 Questions Raised as Detectives Piece Evidence

                      DCI

                      DCI Arrests 9 in Ksh160M SACCO Theft

                      DCI clothes

                      DCI Unmasks Prime Suspect in Murder of Erick Maigo

                      A photo of Billy Chemirmir- Kenyan man found dead in his prison cell in Texas on Septmber 19, 2023.

                      Billy Chemirmir: Kenyan Serial Killer Murdered in US Prison

                      Khalwale Proposes Tougher Regulations for Boda Boda Riders

                      Law Seeking to Control How Kenyans Sit on Boda Boda Coming

                      IG Koome Sued Over Uhuru-Era Killings

                      IG Koome Sued Over Uhuru-Era Killings

                      Ex-Mungiki Leader Maina Njenga Allegedly Abducted

                      Ex-Mungiki Leader Maina Njenga Allegedly Abducted

                      Government's Crackdown on Drug Trafficking and Illegal Brews

                      Foreigner Nabbed at JKIA With Heroin Worth Ksh3.2M

                      Homa Bay MP Peter Kaluma speaks during a media brifing at Parliament Buildings Nairobi.

                      Kaluma Gives Way Forward After Supreme Court Ruling on LGBTQ Rights

                      Trending Tags

                      • Sports
                        • All
                        • Athletics
                        • Basketball
                        • Boxing
                        • Cricket
                        • Football
                        • Formula 1
                        • Golf
                        • Marathons
                        • Olympics
                        • Rallies
                        • Rugby
                        • Tennis
                        • World Cup
                        Namwamba Rallies Support for Starlets as Kenya Secures Hollywood and NBA Deals

                        Namwamba Rallies Support for Starlets as Kenya Secures Hollywood and NBA Deals

                        Rashford's £700k Ride Involved in an Accident After Man Utd's Win

                        Rashford’s Ksh108 Million Ride Crashes After Man United Win

                        From left Barcelona Coach Xavi Hernandez, Manchester City coach Pep Guardiola and Bayern Leverkusen boss Xavi Alonso. The 3 coaches are unbeaten.

                        18 Unbeaten Teams in Europe’s Big 5 Leagues in 2023/24 Season

                        A Love Story on the Runway: Mary Moraa's Surprise Airport Proposal

                        Lucky Man Melts Mary Moraa’s Golden Heart with Airport Proposal

                        President Ruto Awards Shujaa 7s Players Ksh200k Each

                        Ruto Awards Shujaa 7s Players Ksh200k Each

                        Image of CS Namwamba with President Ruto at a past event. PHOTO- CS Namwamba

                        I am Not Resigning Anytime Soon – Ababu Namwamba

                        Trending Tags

                        • Entertainment
                          • All
                          • Gaming
                          • Movies
                          • Music
                          Sonko's Emotional Message to Daughter as She Flies Out

                          Sonko’s Emotional Message to Daughter as She Flies Out

                          Abel Mutua Issues 'Joint Statement' After Kate Actress Divorce

                          Abel Mutua Issues ‘Joint Statement’ After Kate Actress Divorce

                          A collage of Kenyan Singer and Songwriter Nadia Mukami.

                          Nadia Mukami Bags Prestigious Award in US

                          A past photo of content creator Andrew Kibe.

                          Google Breaks Silence on Andrew Kibe YouTube Channel

                          Pulse Kenya stated that there are fraudulent players contacting 2023 nominees for pulse awards offering them votes at a price

                          Pulse Kenya Condemns Fraudsters Selling Votes to Influencer Award Nominees

                          Otile Brown Calls Out Diamond and Mbosso Over Fake Jewelry

                          Otile Brown Calls Out Diamond and Mbosso Over Fake Jewelry

                          Trending Tags

                          • Lifestyle
                            • All
                            • Arts
                            • Culture
                            • Disabilities Matters
                            • Ethics & Religion
                            • Family
                            • Fashion
                            • Food
                            • Human Interest
                            • Tourism
                            Namwamba Rallies Support for Starlets as Kenya Secures Hollywood and NBA Deals

                            Namwamba Rallies Support for Starlets as Kenya Secures Hollywood and NBA Deals

                            Ruto Under Pressure to Introduce One-Child Policy in Kenya

                            Ruto Under Pressure to Introduce One-Child Policy in Kenya

                            Inclusive Initiatives to Support Mobility for PWDs In Kenya

                            Inclusive Initiatives to Support Mobility for PWDs In Kenya

                            Sam Gituku: From Unknown Radio Reporter to High-Flying TV Anchor

                            Sam Gituku: From Unknown Radio Reporter to High-Flying TV Anchor

                            Dr. Kelvin Shikuku. PHOTO/Courtesy.

                            Kenyan Feted by European Research Body After Emerging Top

                            Diet Tips: What You Should Know Before Eating Matumbo

                            Diet Tips: What You Should Know Before Eating Matumbo

                            Trending Tags

                            • Sci-Tech
                              • All
                              • Climate Changes
                              • Cyber Security
                              • Social Media
                              • Space
                              • Technology
                              A new type of spyware means those online ads could go from annoying to menacing. AP Photo/Julio Cortez

                              Spyware Can Infect your Phone or Computer via The Ads You See Online – Report

                              Elon Musk's Neuralink Chip That can Help You Control a Cursor With Your Mind

                              Brain Chip That Can Help You Control Computer Cursor with Your Mind Approved

                              With pressure from the European Union, Apple has thrown in the towel on its Lightning connector, left, in favor of the standard USB-C, right. Frederic J. Brown/AFP via Getty Images

                              What is USB-C?

                              President William Ruto (center) poses for a photo with US Ambassador to Kenya Meg Whitman (right) and a Starlink executive after a meetig on September 16, 2023.

                              Ruto Pushes for Cheaper Internet in Meeting with Elon Musk’s Starlink

                              Dr. Kelvin Shikuku. PHOTO/Courtesy.

                              Kenyan Feted by European Research Body After Emerging Top

                              Met Department Warns of El Nino Rains

                              NEMA Sounds Warning to Businessowners

                              Trending Tags

                              • Opinion
                                • All
                                • Editorials
                                • John Mukum Mbaku
                                • Letters to Editor
                                • Makau Mutua
                                • Peter Ongera
                                • Salim Lone
                                • XN Iraki
                                Wagner group founder Yevgeny Prigozhin, photographed on June 24, 2023, in Russia. Anadolu Agency via Getty Images

                                Wagner Group: What Yevgeny Prigozhin’s Death Means for Stability in Africa

                                Fulton County District Attorney Fani Willis speaks during a news conference after former President Donald Trump’s Aug. 15 indictments. Joe Raedle/Getty Images

                                RICO is Often Used to Target the Mob and Cartels

                                Niger coup and Junta leader Gen Abdourahmane Tchiani; part of a demonstration held by his supporters in Niamey on Sunday. Coutesy of Balima Boreima / Anadolu Agency via Getty Images

                                The Needless Return of the Coup

                                The indictment of Donald Trump and an aide was ‘laced with rhetorical and narrative techniques.’ Photo Illustration by Drew Angerer/Getty Images

                                Trump’s Classified-Documents Indictment Does More than Allege Crimes

                                Wagner group founder Yevgeny Prigozhin, photographed on June 24, 2023, in Russia. Anadolu Agency via Getty Images

                                Wagner Group’s Yevgeny Prigozhin Reportedly Died in Private Jet Crash

                                Africa is facing a lot of challenges.

                                Africa Must Chart Its Leadership Separate from Foreign Ideology

                              • Contact Us
                              No Result
                              View All Result
                              The Kenya Times ~ Breaking News, Business, Politics, Sports and Entertainment
                              No Result
                              View All Result

                              Italian Hospitals Imported Unapproved, Substandard Cancer Drug

                              Laura Margottini by Laura Margottini
                              July 2, 2023

                              At least 16 hospitals in Italy have been treating cancer patients with a poor-quality imported drug that is not approved for use in the EU, the Bureau of Investigative Journalism (TBIJ) and POLITICO can reveal.

                              Gaps in national and EU regulation have allowed Italian hospitals to legally request shipments of Celginase, a low-cost cancer medicine shown to be substandard, even when better alternatives have been available.

                              Neither Italy’s drugs regulator nor the country’s ministry of health are responsible for checking the quality, efficacy or safety of this drug before allowing it into Italian hospitals. Nor does this fall within the remit of the European Medicines Agency (EMA).

                              Hundreds of vials of the drug have arrived from India over the last seven years. It is unknown how many cancer patients could have experienced adverse side effects or lower chances of remission as a result. Many vials still sit on hospital shelves today.

                              Celginase is a brand of asparaginase, a drug used to treat acute lymphoblastic leukemia, the most common form of childhood cancer. Celginase is made and approved in India, and costs a tiny fraction of the price of the “gold-standard” brand: as little as €13 a vial compared with about €2,500. Published academic studies have found it did not meet minimum manufacturing standards or consistently reach the clinical activity threshold to treat cancer.

                              In January, TBIJ and STAT revealed that poor-quality brands of asparaginase, including Celginase, have been shipped to more than 90 countries since 2016, putting an estimated 70,000 children around the world at risk.

                              In 2018, an apparent nationwide shortage of Oncaspar, the “gold-standard” asparaginase, led to children in Italy receiving another brand, Aspatero, which was later found to be substandard. (The hospital concerned said its request to import Aspatero was authorized by the Italian drugs regulator, and that not doing this would have “reduced the chances of children’s recovery.” The drugs regulator confirmed it had authorized the import.)

                              But TBIJ and POLITICO can now reveal that Celginase has been purchased by Italian hospitals even when the gold-standard product has been available – in some cases as recently as this year. Further records show that Celginase was also imported by seven Italian regional health departments, suggesting that the actual number of hospitals using the drug could be far higher.

                              Informed consent paperwork does not detail the brand of the drug that patients will be given nor the countries in which it is approved. Patients are being left in the dark.

                              Lack of liability

                              There are several different types of asparaginase. “Native” asparaginase is made from Escherichia coli (E. coli). Turning this bacterium into medicine is complicated and even good-quality native asparaginase can cause side effects, including severe allergic reactions.

                              For this reason, doctors prefer to use modified versions of asparaginase. These are less likely to cause allergic reactions but are much more expensive up front.

                              Although Celginase and Oncaspar are both asparaginases, they are different: Celginase is native, Oncaspar is modified. Oncaspar has been approved for use in Europe since 2016 and is the brand of asparaginase recommended as first-choice treatment for acute lymphoblastic leukemia.

                              In Italy, if a drug is in shortage, doctors and pharmacists can ask the Italian drugs regulator to greenlight the import of that same drug from another country.


                              Also Read: Gov’t too broke to remit NHIF money – Health CS Nakhumicha


                              A different law permits a drug that is not approved in the EU but is elsewhere in the world – such as Celginase – to be imported for an individual named patient if a doctor deems there is “no valid alternative therapy available”. As Celginase and Oncaspar are not exact equivalents, doctors have been able to request Celginase imports even if Oncaspar is available.

                              Crucially, this process bypasses the country’s drugs regulator. In Italy, permission is instead given by the ministry of health’s customs agency, which is required only to check that the paperwork has been correctly filled out by the hospital and the drug arriving is the one requested.

                              It is not required by law to check the quality of imported drugs nor ask for data from the overseas regulators that approved them.

                              The drug was meant to save children’s lives. Instead, they’re dying

                              Instead, the responsibility for these drugs lies with the individual doctor who requests them. The Italian drugs regulatory agency said that doctors should use qualified and reliable import intermediaries who can guarantee the quality and safety of the drug, particularly with suppliers in non-EU countries, and that doctors should get informed consent by giving the patient complete, transparent and exhaustive information on the drug.

                              Through freedom of information requests to the Italian customs agency of the ministry of health, TBIJ and POLITICO found that at least 16 hospitals, including the Istituto Nazionale Tumori in Milan and San Camillo Forlanini in Rome, imported hundreds of vials of Celginase into the country over a seven-year period. (The Istituto Nazionale Tumori said that shortages required them to source Celginase. It added that the patients who received the drug are either responding to it or are in remission, and that the Italian drugs regulator has never provided information showing that Celginase could be harmful. San Camillo Forlanini did not respond to a request for comment.)

                              Attilio Guarini, a doctor who treats patients with acute lymphoblastic leukemia at Policlinico di Bari hospital, says there is no clinical guidance recommending doctors turn to a native asparaginase – such as Celginase – if Oncaspar is available.

                              The Italian drugs regulator told TBIJ that it denies any responsibility for the “efficacy and safety” of medicines imported from non-EU countries that are not authorized in accordance with EU regulations.

                              The European Medicines Agency (EMA) also has no power over imports of unapproved drugs from non-EU countries, according to its former head Guido Rasi.

                              Most of the Celginase imported into Italy from India came via Switzerland. The Swiss customs agency said it does not have specific data on the products we asked about. It did not know if Indian asparaginase imported via Switzerland may have gone to any other EU countries besides Italy, but it is understood that Celginase was not used in Swiss hospitals.

                              The EU issue

                              In certain situations, such as drug shortages, it is vital for European countries to be able to import medicines that may not be approved in the EU.

                              In 2001, the EU published new bloc-wide legislation allowing medicines that “fulfil special needs” to be excluded from the standard European rules around quality, safety, efficacy and manufacturing. But only under strict conditions.

                              “There are loopholes in the system and we are working to fix them” – Ulrico Angeloni, Italian customs agency

                              Any such medicines (which may include those not approved in the EU) need to be formulated according to the specifications of an authorized healthcare professional – such as a doctor or a pharmacist – and given to an individual patient under this worker’s “direct personal responsibility”.

                              Each country has incorporated this into its own national law in different ways.

                              In Italy, the prescribing doctor must justify the exceptional use, which is then checked by the customs agency of the ministry of health. In Spain, the hospital or health department must request access to the unlicensed drug from the regulator. In Ireland, the doctor issues the prescription and the wholesaler or manufacturer is required to notify the regulator of the import.

                              And while the EU law was meant to be applied to individual patients, in practice this is not always the case. In Germany and Italy, for instance, there are provisions for orders large enough to temporarily stock a hospital pharmacy. In Ireland, the law has been used so extensively that in 2020 more than 1.5 million packs of the 50 most popular drugs were brought into the country under the rules.

                              “If products for commercial sale are routinely entering the EU as unlicensed medicines and they’ve been supplied under the named-patient […] regime then that’s an issue,” says Grant Castle, partner at Covington law firm.

                              He said these rules allow patients to access medicines where there is a bona fide medical need and are “not a suitable basis” to import medicines for other reasons. “If that is happening, it’s a loophole.”

                              While it is down to member states to put rules in place for named-patient supplies of unlicensed medicines, Castle added, national rules “generally do not provide the same safeguards”.

                              Gilles Vassal, a pediatric oncologist and board member of the European Society for Pediatric Oncology, agreed. When addressing shortages by importing medicines unauthorized in the EU, he asks: “What are the measures set up at [the national] level to control the quality of the medicine they are importing?”


                              Also Read: Health Cs Nakhumicha on How Small Hospitals Defraud NHIF


                              The Italian drugs regulator said that in February 2023, it exchanged information with WHO on data around a potential lack of efficacy of the Indian-sourced drug Aspatero provided by the study highlighted in TBIJ’s first story. It added that there appears to be no evidence from the WHO or national regulatory authorities of low-quality, dangerous or ineffective asparaginases imported from India.

                              However, a European Commission spokesperson said that the Italian drugs regulator and other Italian authorities have been investigating this issue, which involves some specific Italian hospitals. A WHO spokesperson said it had contacted the countries reported in TBIJ’s original investigation into asparaginase, but that no “actionable information” had been received.

                              Changes to the EU law are also in the works to attempt to address some of these concerns. A planned revision of the bloc’s pharmaceutical legislation would include a line stipulating that countries “shall encourage” doctors and patients to report data on the safety of the use of unlicensed medicines to their own regulator. 

                              It would also oblige drugmakers to flag any potential shortages six months in advance – up from two months – and it could require companies or wholesalers to keep larger stockpiles.

                              In Italy, the customs agency has responded to TBIJ’s enquiries by working to modify its forms so doctors must give more detail about clinical reasons for the import. “We realized that there are loopholes in the system, so we are now working to fix them,” said Ulrico Angeloni, one of the agency’s coordinators.

                              Doctors that TBIJ and POLITICO spoke to would like to see national measures to verify the quality of unlicensed drugs accessed via these loopholes, as well as more transparency on their use, effectiveness and safety.

                              For now, the paradox remains that while Europe’s medicines are among the most highly regulated in the world, drugs that are shipped in from abroad can fail to meet even minimum standards.

                              The manufacturer of Celginase did not respond to a request for comment.

                              This article is republished from The Bureau of Investigative Journalism under a Creative Commons license. Read the original article

                              Reporters: Laura Margottini and Rosa Furneaux
                              Additional reporting: Maria Cristina Fraddosio
                              Illustration: Evangeline Gallagher
                              Deputy editor: Chrissie Giles
                              Editor: Meirion Jones
                              Production editor: Alex Hess
                              Fact checkers: Alice Milliken and Meriem Mahdhi
                              Impact producer: Paul Eccles

                              Tags: CancerCelginaseFood and DrugsHealthItalian Hospitals

                              Get real time update about this post categories directly on your device, subscribe now.

                              Unsubscribe
                              Laura Margottini

                              Laura Margottini

                              Laura is an award-winning investigative journalist exploring health, environment and science policy. She was a contributor for Science magazine for a decade and has extensively worked for the Italian national daily il Fatto Quotidiano.

                              Next Post
                              Judiciary Announces 961 Job Vacancies: How to Apply

                              High Court to Deliver Ruling on the Fate of the 50 CASs

                              Discussion about this post

                              ADVERTISEMENT

                              RECENT NEWS

                              Namwamba Rallies Support for Starlets as Kenya Secures Hollywood and NBA Deals

                              Namwamba Rallies Support for Starlets as Kenya Secures Hollywood and NBA Deals

                              September 24, 2023
                              Deputy President Rigathi Gachagua (center) interacts with friends at his rural home in Mathira, Nyeri County on September 24, 2023.

                              Kenyans React After Gachagua’s Revelation on His Village Friend

                              September 24, 2023
                              Rashford's £700k Ride Involved in an Accident After Man Utd's Win

                              Rashford’s Ksh108 Million Ride Crashes After Man United Win

                              September 24, 2023
                              A photo of Citizen TV's studios in Nairobi.

                              Ex-Citizen TV Journalist Appeals for Help, Reveals He’s Homeless 

                              September 24, 2023
                              Surviving on Credit and Default: The Reality in Kenya

                              Surviving on Credit and Default: The Reality in Kenya

                              September 24, 2023
                              Water and Sanitation Cabinet Secretary Alice Wahome (left) shakes hands with President William Ruto during a UDA faction in 2022.

                              How Alice Wahome Found Herself in Ruto’s Cabinet 

                              September 24, 2023

                              THE MOST IMPORTANT NATIONAL AND GLOBAL NEWS OF THE DAY

                              Subscribe to our mailing list to receives daily updates direct to your inbox!

                              Join our WhatsApp: WhatsApp News Channel
                              Call us: +254 714 544 390

                              © 2023 The Kenya Times | Contact Us | Privacy Policy | Standards & Policies | House Rules

                              • Login
                              • Sign Up
                              • Cart
                              Subscribe Now
                              No Result
                              View All Result
                              • News
                                • Africa News
                                • Diaspora News
                                • East Africa News
                                • Middle East News
                                • National News
                                • World News
                              • Business
                                • Banking
                                • Cryptocurrency
                                • Economy
                                • Energy
                                • Money Markets
                                • Startups
                                • Real Estate
                                • Technology
                              • Health
                                • COVID-19
                                • Health & Science
                                • Mens Health
                                • Mental Health
                                • Wellness
                                • Womens Health
                              • Law & Order
                                • Cyber Crime
                                • Corruption
                                • Courts
                                • Financial Fraud
                                • Investigations
                                • Missing Persons
                                • Terrorism
                              • Sports
                                • Athletics
                                • Basketball
                                • Boxing
                                • Cricket
                                • Football
                                • Formula 1
                                • Golf
                                • Marathons
                                • Olympics
                                • Rugby
                                • World Cup
                              • Entertainment
                                • Gaming
                                • Music
                                • Movies
                              • Lifestyle
                                • Arts
                                • Culture
                                • Disabilities Matters
                                • Ethics & Religion
                                • Family
                                • Fashion
                                • Food
                                • Human Interest
                                • Tourism
                              • Opinion
                                • Editorials
                                • Letters to Editor
                                • John Mukum Mbaku
                                • Makau Mutua
                                • Peter Ongera
                                • Salim Lone
                                • XN Iraki
                              • Sci-Tech
                                • Climate Changes
                                • Cyber Security
                                • Technology
                                • Social Media
                                • Space
                              • Contact Us

                              © 2023 The Kenya Times | Our Privacy Policy | Standards and Policies | House Rules

                              Welcome Back!

                              Sign In with Facebook
                              Sign In with Google
                              Sign In with Linked In
                              OR

                              Login to your account below

                              Forgotten Password? Sign Up

                              Create New Account!

                              Sign Up with Facebook
                              Sign Up with Google
                              Sign Up with Linked In
                              OR

                              Fill the forms below to register

                              All fields are required. Log In

                              Retrieve your password

                              Please enter your username or email address to reset your password.

                              Log In
                              Your Privacy and Cookies
                              We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
                              Do not sell my personal information.
                              Cookie settingsACCEPT
                              Privacy & Cookies Policy

                              Privacy Overview

                              This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
                              Necessary
                              Always Enabled
                              Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
                              Functional
                              Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
                              Performance
                              Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
                              Analytics
                              Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
                              Advertisement
                              Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
                              Others
                              Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
                              SAVE & ACCEPT

                              Add New Playlist

                              Are you sure want to unlock this post?
                              Unlock left : 0
                              Are you sure want to cancel subscription?