2006 - Panama

Ending September 2006, the Arnulfo Arias Madrid Hospital at Panama City was getting full with patients with contradictory symptoms. The symptoms seemed to match with Guillain-Barré syndrome, but these patients were also losing their ability to urinate, symptom not related to Guillain-Barré. The death rate of this mysterious illness was nearly 50%, when hospital management decided to isolate all the patients with the illness in a large room and doctors could compare notes and theories. Soon patients from other parts of the country started to arrive at hospitals. Doctors had no idea what was happening: the mysterious illness was attacking elderly citizens with hypertension and diabetes pressure history. About half was receiving Lisinopril (a blood pressure medicine) and many did not remember clearly if they had been taking other drugs. Suspecting something wrong with Lisinopril, the medicine was pulled out from the pharmacies[37] while the U.S. Food and Drug Administration conducted lab analyses, revealing that the blood pressure drug was safe and CDC epidemiologists were invited to participate.[28]

When a patient admitted by a heart attack developed the mysterious illness at the hospital, Dr. Nestor Sosa, an infectious disease specialist, analyzed the medical record: Because patients treated with Lisinopril developed a cough (common side effect of ACE inhibitor), they were prescribed an expectorant.[37] Immediately, biological samples and the syrup were sent by jet to CDC for analysis. When urine analyses for a series of metals, pesticides or their metabolites resulted false, CDC scientists recalled Nigeria and Haiti incidents. The CDC employed modern laboratory equipment to analyze the samples and confirm the results: the samples contained approximately 8% v/v DEG. Later on, raw glycerin was analyzed and results revealed 22.2% v/v DEG.[28]

The Panamanian Government made a nationwide campaign, collecting around 6,000 bottles of cough syrup and three other products manufactured by Social Security Laboratories with the tainted glycerin.[38] The forty-six barrels of syrup were bought by Social Security Laboratories through a Panamanian middleman, Grupo Comercial Medicom, who bought the product from Rasfer Internacional, a Spanish company. In fact, Rasfer received the product from CNSC Fortune Way, who in turn bought it from the Taixing Glycerine Factory. At the request of the United States, the State Food and Drug Administration of China investigated Taixing Glycerine Factory and CNSC Fortune Way, but the agency concluded that it is not under their jurisdiction because the factory is not certified to make medicine.[37][39]

Taixing sold the syrup as “TD glycerin”, wording that neither Chinese inspectors nor Spanish medical authorities comprehended. Unfortunately, Taixing used “TD” for the Chinese word “tidai” (pronounced tee-die), meaning “substitute”.[37] A New York Times reporter tried to obtain a comment from CNSC Fortune Way at the CPhI worldwide (the world’s largest annual pharmaceutical convention) held in Milan, Italy, during 2007, but their representatives refused to comment.[40]

In August 2009, the Supreme Court decided to send the diethylene glycol file to the Public Ministry for an extension.[41] The following month, the Toxicology Department of the Institute of Legal Medicine and Forensic Science published a list of 1,155 names whose medicine bottles tested positive for DEG. Only approximately 3,000 bottles had been analyzed from the total 6,000 bottles collected. The fiscal attorney urged affected citizens to approach the Public Ministry to update the official legal file and for further medical analysis.[38] Two months later, findings revealed that 145 were proven to die by DEG intoxication, but the DA still has to investigate 953 demands.[41]

The New York Times reported that Taixing was closed by the Chinese government and CNSC Fortune Way was never sanctioned, whom is also owned by the Chinese government.[40] In Spain, Rasfer International declared bankruptcy after the lawyer of Medicom filed a lawsuit of $400 million dollars in July 2008.[42] Spanish authorities are prosecuting Asunción Criado, general manager of Rasfer Internacional, S.A., and await Panamanian citizens, René Luciani (former Social Security Director) and Jéssica Rodríguez (former Purchase National Director) for their hearings. Meanwhile, in Panama, De la Cruz, legal representative of Medicom remains in jail pending a trial. 17 other persons have also been charged related to this incident. Panama awaits the extradition of Criado for her hearing.[43]

Panama’s case made CDC set standardized methodology for DEG identification, hoping to have more timely response in future events. The agency also identified urinary DEG as a biomarker for DEG exposures.[28] The United States Food and Drug Administration also issued an Industry Guidance Document “intended to alert pharmaceutical manufacturers, pharmacy compounders, repackers, and suppliers to the potential public health hazard of glycerin contaminated with diethylene glycol (DEG)” and recommended appropriate testing procedures for the use of glycerin.