Diethylene Glycol Deaths in Haiti.The FDA’s Role

Diethylene Glycol Deaths 2On Monday morning, June 24, the CDC contacted officials in the Office of Emergency Operations at the FDA about the Haitian crisis. Over the course of the week, the FDA worked with the Haitian press to fax “Alert Bulletins” to 24-hour French and Creole radio stations, service agencies, nurses’ associations, and other Haitian organizations. On Wednesday afternoon, the FDA issued an Import Bulletin (#60B02). Photographs of the Valodon and Afebril labels were distributed to US postal and Customs officials, who were instructed to be alert for these products entering the US. The FDA screened all liquid medications imported into the US from Haiti, while computer searches assured the agency that no acetaminophen shipments from Haiti had been imported in the past year. By the end of the week, FDA officials felt certain that the contaminated Haitian acetaminophen would not create a problem in the US.

When FDA Commissioner David Kessler learned on Monday afternoon, June 24, that the CDC was faced with a drug manufacturing problem, he offered his agency’s assistance and expertise. CDC epidemiologists were concerned about many of the practical aspects of a drug investigation, such as sampling techniques and maintaining a chain of custody, all routine matters for the FDA. The CDC was also facing a touchy political situation in Haiti because by Monday, following the public announcement of the crisis, the Haitian Ministry of Justice had ordered both РАНО and the CDC not to have further contact with the company owners, citing legal concerns. The FDA offered the expertise of its specialized forensic laboratory in Cincinnati. Reginald Boulos was still claiming that the problem drugs were counterfeit, and the FDA assured O’Brien that its forensic lab was experienced in investigating counterfeit drugs.

FDA officials knew they had no jurisdictional authority in Haiti and feared that their experts would not be welcomed. Although the agency can close ports and borders to foreign products entering the US, the FDA’s overseas inspections are conducted to insure the safety and efficacy of products offered for import into the US by foreign manufacturers. Like the CDC, the FDA had to be invited by РАНО and the Ministry of Health to assist with the epidemic. In addition, some FDA staffers feared that Haitians still resented the agency’s recommendations to exclude Haitians, among others, as blood donors during the early years of the AIDS epidemic. These difficulties did not prove insurmountable, however, for in a rare stroke of good fortune, Dr. Mallebranche was in Dr. O’Brien’s office when the offer of assistance came from the FDA. He immediately accepted it. The details were worked out, and РАНО and the WHO sent a message to the CDC requesting the FDA’s assistance in handling the products associated with the investigation. FDA drug expert Dave Pulham, PhD, was dispatched to Haiti, where his practical on-the-ground knowledge of drug investigations immediately broke the ice with the Haitian authorities and helped eliminate growing tensions.

As a National Drug Expert, Pulham had worked some high profile cases in his 20 years with FDA, but this Haitian case hit close to home. Pulham himself had lost a son to contaminated drugs. As soon as he arrived in Haiti, Pulham, who was fluent in French, arranged a meeting with Pharval and its attorneys, the Haitian government, and the CDC epidemiologists in a quiet and neutral location. He emphasized that he was there on a humanitarian mission, “not to find guilt or blame, just to stop the epidemic.”

Category: Health

Tags: Diethylene Glycol, Renal Failure

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