The account describes the same problems at the heart of the ongoing scandal — the contamination of medicines and the mass production of supposedly custom-made substances. It also sketches a portrait of one of the owners, businessman Barry J. Cadden, who benefited from the regulatory murkiness governing his industry.
Problems began in March 2002 when the FDA learned of two patients who developed symptoms suggestive of septic shock after being injected near the spine with a painkiller, betamethasone.
The drug was made by NECC. In all, five people became ill. FDA sent inspectors to NECC’s workrooms in Framingham, Mass. On the first day of the inspection, according to the narrative, “Mr. Cadden was cooperative.” On the second day, however, he “had a complete change in attitude [and] basically would not provide any additional information either by responding to questions or providing records. Mr. Cadden challenged FDA jurisdiction/authority to be at his pharmacy.”
The inspectors were interested in a particular numbered lot of the steroid, but Cadden “stated that he did not believe betamethasone was ever compounded for that lot number.” However, the investigators contacted the health-care professional who had reported the illnesses; that person told them that not only had he returned drugs from the suspect lot but also “had spoken by telephone to Mr. Cadden about the incident.”
Soon after, according to the narrative, the FDA and Massachusetts Board of Pharmacy inspectors learned that “about four lots” of betamethasone sent by NECC to an outside lab tested positive for endotoxin, which is evidence of bacterial contamination. In the meantime, Cadden had figured out the source of the contamination and changed his production method.
On April 6, he made a new batch of betamethasone and sent a sample to the outside lab for testing, which would take about a week. He kept the rest of the batch in a beaker covered with aluminum foil inside a ventilated hood.
When they saw this, the FDA inspectors “discussed with Mr. Cadden that this was not an acceptable process for maintaining sterility. . . . Mr. Cadden stated he didn’t want to waste the money on vials or the effort . . . if the lot failed testing,” according to the FDA report quoted in the narrative.
When the tests came back clean, Cadden bottled the rest of the batch in vials. When an FDA inspector suggested he test those, too, Cadden agreed. Those tests apparently also came back clean. However, during an exit interview with the inspectors, Cadden said the beaker capped with foil “didn’t contain the betamethasone.”