On January 9th, 2017, lawyers made their opening statements in the murder trial of pharmacist Barry Cadden, owner of New England Compounding Center. CNN reports that the compounding pharmacy sold contaminated vials of the steroid methylprednisolone acetate that in 2012 were injected into the spinal columns of more than 13,000 patients. Subsequently 751 people were diagnosed with various infections, including fungal meningitis. Sixty-four patients died, in the worst outbreak of meningitis in US history. Meningitis is a grave condition where the membranes that surround the brain and spinal cord become inflamed.
Cadden could spend his life in prison if convicted on all 25 counts of second-degree murder. Glenn A. Chin, NECC’s supervisory pharmacist, will also face 25 counts of second-degree murder at a later trial. According to CNN, Cadden’s 2014 indictment indicates that the government does not need to prove intent, but rather that the pharmacists acted with “extreme indifference to human life.” The indictment also includes charges of racketeering, aiding and abetting, conspiracy, and mail fraud. The indictment claims that safety regulations such as cleaning and sterilization were flaunted by NECC and that its pharmacists lied about it. The indictment also alleges that Cadden used expired materials and failed to properly sterilize drugs. (RELATED: Stay informed about pharmaceutical medicine at Medicine.news)
What is compounding?
According to the website of the Professional Compounding Centers of America, “Pharmacy compounding is the art and science of preparing personalized medications for patients. Compounded medications are made based on a practitioners prescription in which individual ingredients are mixed together in the exact strength and dosage form required by the patient. This method allows the compounding pharmacist to work with the patient and the prescriber to customize a medication to meet the patient’s specific needs.”
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A long history of misdeeds
CNN further notes that the Massachusetts Department of Public Health reported in 2012 that it had “identified serious deficiencies and significant violations of pharmacy law and regulations that clearly placed the public’s health at risk.”
But NECC has come under scrutiny long before this final tragedy. Quoting from the Modern Medicine website, “[The] FDA had issued a warning letter, dated Dec. 4, 2006, to NECC for its various practices deviating from traditional compounding of drugs that are not available commercially. In its letter to Barry Cadden, director of pharmacy and owner of NECC, FDA notified him that NECC had several violations that had to be corrected or the agency had the right to ‘seizure and injunction against you and your firm.’”
The website states that the FDA was particularly concerned about how NECC would open a sterile container of liquid medication and split it into multiple doses of single-use vials that lacked any preservative. On an October 2012 episode of NPR’s Diane Rehm Show, David Miller, the executive vice president of the International Academy of Compounding Pharmacists, condemned NECC for profiting to the tune of millions of dollars while functioning as a drug manufacturer, and not as a compounding pharmacy. Miller explained that NECC prepared mass quantities of drugs back in 2006, and did not make small batches for single patients. On the Rehm Show, Miller also made the point that the FDA visited the pharmacy multiple times in the span of a decade, issued a warning, and yet despite the red flags, did not shut them down.
Nowhere to turn
Federal regulatory agencies like the FDA are supposed to protect the public from this kind of wrongdoing, yet in this instance, dozens of innocent victims paid with their lives. With the revolving door between Big Pharma and the FDA, and with the fantastical but true direct funding of the FDA by the pharmaceutical industry, we clearly we have a case of the ‘fox guarding the hen house.’ How safe do you feel?