The New England Compounding Center (NECC) may have a companion with regard to its current disastrous situation, and it turns out it may be a related company. A private company in the Boston area, Ameridose LLC, has shut down for at least a week while an investigation is conducted by regulators. The shut-down is termed "precautionary" and Massachusetts state regulators have said there is "no evidence" to indicate that Ameridose's products are contaminated like its sister company, NECC. Ameridose mixes pharmaceutical drugs for hospitals nationwide.
Ameridose shares ownership with the NECC, which produced the contaminated steroid injections that have been given to approximately 13,000 people in 23 states, with 137 infection cases and 12 deaths to date. Ameridose shares ownership with the NECC via Gregory Conigliaro, an engineer, and Barry Cadden, a pharmacist. Interestingly, a pharmaceutical distributing company, Alaunus Pharmaceutical, will temporarily cease distribution of all products made by Ameridose or any other company under "shared ownership". Alaunus is also owned by Conigliaro and Cadden.
CNN reported this evening (Oct. 10) that NECC shares a building and parking lot with a recycling center and garbage compactor. (You read that correctly.) "CNN observed a medical waste truck making a drop, as well as piles of garbage, boxes, and old mattresses on the back side of the pharmacy compound building. Both companies are owned by the same people.
This deadly outbreak shows how regulation may be necessary for this under-the-radar industry. Currently, companies like NECC are not regulated, not attracting attention from the FDA until there is a problem. There are no federal sterility guidelines for compounding pharmacies. A chain is only as good as its weakest link, and it appears as if a weak link has been discovered in the drug compounding and distribution chain. And, some politicians have the temerity to scream about intrusive and burdensome federal regulations? Tell that to the families who lost loved ones because of this fungal meiningitis outbreak. Would some federal rules and regulations have helped here? It would not have hurt, that is certain.
What has been shown, yet again, is that shortcuts to improve profits frequently lead to disasters of some degree. Here, it caused the loss of lives.