In January, Glenn Chin will be sentenced after being convicted of racketeering and mail fraud. The former supervisory pharmacist at the New England Compounding Center was found complicit in one of the worst pharmaceutical health crises in American history, in which 64 people were killed and over 700 sickened with meningitis. His boss, Barry Cadden, owner of NECC, is in prison for 35 years for his role in the outbreak.
NECC shipped contaminated compound drugs produced in deplorable conditions at NECC to patients all over the country, and was able to do so due to lax government oversight of compound pharmacies. These facilities are legally allowed to produce specially tailored medications for patients whose medical needs cannot be met by traditionally manufactured pharmaceuticals. When produced appropriately, these compound medicines play an important role in medicine. But too often, compounders take advantage of weak regulations to cut corners in pursuit of big profits – leaving patients vulnerable to unsafe medications.
To understand the NECC tragedy and the possibility that it could happen again, it’s important to understand drug compounding. Compounding is a process that “combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient,” according to FDA, and it can be either sterile or non-sterile. In its proper role, drug compounding is a vital part of getting patients the medicines they need, whether adding a flavor to medicine for children; eliminating an allergen like gluten from a drug; or making a tablet medication in liquid form.
Compounding, when done properly, plays an important role in our health care system. It can be an efficient way to provide patients with the care not afforded to them via traditionally manufactured drugs. But there’s a big problem with the industry as it exists today: It is extremely vulnerable to foul play due to a major lack of regulatory oversight and the potential for massive profits.
Illicit compounders have been known to cut corners in order to increase volume, even though it’s against the law. Others have purposefully mixed in expensive, medically unnecessary ingredients into compounded medicines to drive up reimbursement rates through government health care services like Medicaid. Fraud is common, and patient illness, blindness, and death have been among the tragic results.
The 2012 meningitis outbreak traceable to NECC is the most infamous case of profit-driven harm. Its cause: Unsterile medications produced in filthy conditions without proper quality controls, in order to produce high volumes of profitable compound drugs as quickly as possible. NECC earned over $200 million in profits in the six years leading up to the meningitis outbreak, with $72 million in earnings accruing to Cadden.
Lax oversight led to unsanitary conditions and improperly sterilized medicine when no one was watching. Chin, the pharmacist, failed to ensure that the facility’s drugs were made in proper, sanitary conditions. Chin told staff to skip cleaning of the NECC’s clean rooms or to falsify documents that they had. When federal agents finally searched the facility, they called it a “fungal zoo,” having found “oil, bugs, pubic hair and mold.”
And if that isn’t bad enough, Chin cut more corners when making the actual drugs. He made three batches of methylprednisolone acetate (MPA), a steroid used to treat joint pain and swelling usually associated with arthritis and other disorders from May through August 2012. But he only sterilized them for 15 minutes rather than the mandated 20 minutes. And while he sent only a few vials for sterility testing, he shipped over 17,000 vials to patients.
The drugs were contaminated with a black-mold fungus called Exserohilum rostratum, which typically attacks plants, not humans. The fungus was injected with the drug into patients’ bodies, specifically the spine, where it then invaded and began to grow in the brain, causing fungal meningitis. Such an outbreak had never been seen before, and doctors struggled to assess and treat the cases properly.
Oversight was bad at the time, and it hasn’t improved much since. A Pew report from 2016 – four years after the NECC outbreak – found that states are “uneven” in their ability (or perhaps willingness) to monitor sterile compounding activity and enforce the law. For example, only 56 percent of states even track the number of sterile compounders operating in their state, while only 30 percent of states require compounders to report “adverse events” – or any deaths, hospitalizations, or disabilities resulting from their compounded drugs. The same report found that the number of compound pharmacies per state pharmacy inspector ran as high as 900, with an average of 230 pharmacies per inspector. It could take a single inspector several years to get through their entire allotment of inspections just once.
So, what can and should be done? All states should require in-state compounding pharmacies, as well as out-of-state pharmacies that ship into the state, to comply with consistent standards. Laboratories and equipment should be rigorously checked and regularly certified. Compounding pharmacists should have requisite training in sterile procedures, and such pharmacies should be licensed by the state for tracking purposes. All activities, adverse events, and voluntary recalls should be reported to the state as well as federal official authorities.
Fortunately, the FDA has signaled it is taking these issues seriously. Commissioner Scott Gottlieb recently announced an impending proposed rule setting current good manufacturing practice requirements for compounders. It’s a great start and a well overdue step toward restoring trust in compound medications.
Doris Browne, MPH, M.D. is President of the National Medical Association.
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