Workers from a Massachusetts company owned by the drug manufacturer linked a recent US meningitis outbreak claimed they helped prepare dangerous narcotics in unsafe conditions. A series of emails revealed the connection between the two firms.
Technicians and pharmacists at Ameridose, a drug manufacturing company neighboring the New England Compounding Center (NECC), which shares owners with Ameridose, told The New York Times they had safety concerns about the drugs they were producing.
One pharmacist quit her job at Ameridose out of concerns that unqualified people were preparing dangerous and unsafe drugs for hospitals. A quality control technician said he noticed labels missing on a product, but was unable to convince his managers to stop production.
Five former employees from Ameridose and one from the NECC described companies that took shortcuts, compromising safety for efficiency. Workers at the pharmacy also complained of being forced to conduct tasks they were not trained or qualified for.
“I expressed my concern to the management,” one pharmacist, who worked at Ameridose in 2008 and 2009, told the Times. “I said, this isn’t right. These people don’t even know anything about drugs.”
“The emphasis was always on speed, not on doing the job right,” said another employee, who lost his job for expressing concerns about safety. “One of their favorite phrases was ‘This line is worth more than all your lives combined, so don’t stop it.’”
Paul Cirel, a lawyer representing the drug manufacturer, refused to respond to the complaints made by former employees.
“What some anonymous, maybe disgruntled, ex-employees say to you that is not said to us by the [Food and Drug Administration] or any regulator; I just can’t go there right now,” he told the Times. “If it becomes a claim that a regulator puts to us, then we will address it.”
While there is no evidence that Ameridose sent out any steroid injections tainted with meningitis, the company’s ties to the NECC have caused regulators concern. State and federal health officials on Wednesday asked Ameridose to suspend production of all products until October 22 during an on-site quality and safety investigation.
Reuters investigated a dozen emails that suggested the firm NECC, authorized to deliver its products only for patient-specific prescriptions, had violated Massachusetts law.
Emails between the company and a clinic in Mississippi showed that NECC sold the drugs without asking physicians to provide individual patients’ names and prescriptions, which is a requirement in a number of states, including Massachusetts where the company is based.
The emails also confirmed that NECC referred business to sister company Ameridose, both of which are co-owned by Gregory Conigliaro, an engineer, and his brother-in-law Barry Cadden, a pharmacist who was in charge of pharmacy operations at NECC until its license was suspended.
In an email dated July 12, an NECC sales manager told a clinic to reach out to “our sister company, Ameridose" in response to a request for an anesthetic.
The meningitis outbreak, which has left 15 people dead and 201 sick in 14 states after they received tainted steroid injections produced by the NECC, has shed light on a pharmaceutical practice that slipped between the cracks of FDA regulations. Compounding pharmacies create alternative, often cheaper versions of medicines, which are mixed from raw ingredients. In recent years, hospitals have often opted to purchase these alternative options, especially at times where there have been shortages in the range of drugs – including steroid injections.
The FDA does not regulate these types of drugs produced by compounding pharmacies. But now, even regular pharmacies like Ameridose are being investigated for potentially dangerous drug production.
It took a health scare risking the lives of 14,000 US patients to shed light on an industry with so many unregulated practices.
As investigations continue, the Center for Disease Control and Prevention is continuing to contact about 2,000 individuals who might not yet know they could have been exposed to the meningitis-tainted pharmaceuticals.