Argentina is going through the worst drug contamination scandal in its history. administration have successfully linked 69 cases with tainted fentanyl, and the official death toll sits at 51. However, the number will be bigger, as judicial administration are investigating close to 100 deaths related with the drug.
All of the cases have been connected to 2 batches manufactured by pharmaceutical corporation HLB Pharma and its laboratory, Laboratorio Ramallo. Last week, the prosecutor’s office charged 17 individuals, and Judge Ernesto Kreplak ordered the imprisonment of 9 of them. Among them are the corporation owner, Ariel García Furfaro; his 2 brothers, Diego and Damián García Furfaro; his mom and grandmother, Nilda Furfaro and Olga Arena, who are the corporation’s main stockholders; and the managers and production supervisors of Ramallo Laboratory. García Furfaro’s legal professional refused to comment.
The judicial research has demonstated serious cause throughout the manufacturing of the tainted fentanyl, explains Adriana Francese, lawyer for 15 of the victims’ families and a victim herself.
Francese’s nephew, 18 year-old Renato Nicolini, was hospitalized after a car accident near Buenos Aires on 25 April. He died 10 days later. By then, the hospital were investigating numerous cases of patients in a important condition who were infected with two bacteria: Klebsiella pneumoniae and Ralstonia pickettii. The latter have been diagnosed as no longer a part of the hospital’s typical flora, Francese notes.
The hospital contacted the country’s Ministry of Health and ANMAT, Argentina’s drug regulator, after comprehensive tests marked to fentanyl as the culprit. A few days later, after running their own tests, ANMAT ordered the recall of all fentanyl from batch 31202. A week later, on 12 May, ANMAT prohibited the use, distribution and commercialization of all HLB Pharma products. By 27 May, ANMAT was ordered to collect all of the doses from 3 fentanyl batches manufactured by the corporation.
Falsified equipment and medicine mix-ups
In the following months, the list of deaths suspected to be due to the tainted drug stored developing, as proof towards the corporation and its lab piled up. Local outlets El Destape and Infobae reported that in past due 2024, an inspection disclosed gross irregularities at Laboratorio Ramallo. The regulatory agency found that the corporation had packed at the least 69 batches of 6 different drugs in plastic ampoules, a material it hadn’t approved due to its multiplied infection risk. A year in advance, the corporation had packed 393 batches using of an unauthorized protocol. The official file reached two months later, in March, but ANMAT abstained from taking action beyond recall orders.
Chemistry World found as a minimum 14 previous ANMAT recall orders in opposition to HLB Pharma and its lab, dating back to 2019. The orders consist of fabricated crucial equipment at some stage in the Covid-19 pandemic, the discovery of metal pieces inside pill blisters, and amix-up of morphine and diclofenac sodium, which the corporation failed to consider after more than 120 days. At least three cases have been associated to patient increase in the drugs, such as metronidazole, a drug administered to patients suffering by numerous infections. The corporation also sold fabricated dopamine and the intravenous anaesthetic propofol using an expired authorization of Surar Labs, which ANMAT shut down due to gross irregularities.
In 2023, researchers in the Concordia place reached out to ANMAT after 6 breast most cancers patients had been infected with Ralstonia mannitolilytica, which they managed to trace to tainted dexamethasone from the HLB Pharma group. ANMAT didn’t recall the batch, arguing its very own tests didn’t discover evidence of contamination.
Despite the irregularities, ANMAT never took steps forward ordering recalls towards the corporation, María Florencia Prieto, who led that investigation in Concordia, stated. ‘I thought they hadn’t listened to us because we were from a small town in the country. But now, I don’t recognize what to think.’
The prosecutor has ordered a criminal investigation into the movements of ANMAT officers who were responsible for stopping this case. The National government suspended Gabriela Mantecón Fumado, director of ANMAT’s National Institute of Medicines (INAME), as she was one the only who allegedly overlooked the March document. ‘People are scared,’ Francese stated. ‘They can not accept as true with that the agency that was speculated to protect us left us unprotected for so long.’ ANMAT declined to remark.
