The manufacturer of the antibiotic meropenem was misidentified in a Dec. 21 article about clinical drug trials in Costa Rica. The manufacturer is AstraZeneca.
THE BODY HUNTERS
Latin America Is Ripe For Trials, and Fraud Frantic Pace Could Overwhelm Controls
Thursday, December 21, 2000
BUENOS AIRES -- Fifth of six articles
Luis Antonio Corgiolu had just returned home from teaching his morning class at a technical school when he felt sharp pains in his chest. His wife insisted on calling an ambulance, and the paramedics who rushed him to the hospital suspected a heart attack.
Emergency room doctors diagnosed "unstable angina," a less serious restriction of blood flow to his heart. Corgiolu protested that he was feeling much better, but doctors admitted him overnight.
The 67-year-old father of three grown sons died the next afternoon. A hole in his aorta, the heart's main artery, had caused his original pain, the doctors at Pedro Mallo Naval Hospital told his bewildered family. Doctors had tried to repair the hole with emergency surgery. But his blood flowed out like water from a pump, the doctors said, and there was little they could do. Corgiolu bled to death.
The family tried for weeks to find out how a man who was living, talking normally, and being treated for one diagnosis, could die the next day from something entirely different. No one from the hospital provided what they considered a satisfactory answer.
"We buried him," recalled 27-year-old Javier, the middle son. "And we started learning to accept it."
But Argentine prosecutors believe Corgiolu's death was murder. After more than two years of investigation, they say they are preparing to allege in court that doctors fraudulently enrolled Corgiolu--and many others--in a drug experiment being conducted at the hospital, illegally injecting them with an experimental medicine.
Many health professionals and government officials in Latin America see the Naval Hospital case as a warning. Western drug companies increasingly view the region as a major source of subjects for drug experiments, and as the number of clinical trials has boomed, the frantic pace has threatened to outstrip efforts by local regulators to establish effective oversight.
Executives at Aventis Pharma, the company whose drug was being tested at the Naval Hospital, say the case was an aberration. They cite the experiment's eventual shutdown as proof that the company's monitoring systems work, backed up by effective oversight by government regulators. "The fact that the problems were detected and brought to the attention of the Argentine authorities and the [Food and Drug Administration] demonstrates that the supervisory and quality assurance systems work effectively," the company said in a written statement.
The Naval Hospital, which conducted its own investigation of the case, concluded it had been defrauded by the doctors in question and fired them, a spokeswoman said.
Latin American governments are in fact making a major push to establish systems to control drug tests and comply with international standards, and have passed laws to protect patients. Private programs have been set up to train medical staff in the complicated procedures and record-keeping required by U.S. authorities for new drugs destined for the American market.