The New England Compounding Center (NECC) in Framingham, Massachusetts—the pharmacy at the center of a growing fungal meningitis outbreak that has sickened 170 and killed 14—did not follow its state’s licensing mandates.
A spokesperson for the Massachusetts Department of Public Health said that NECC was only permitted to compound medications based on a physician’s prescription, and on a case-by-case patient basis, said Madeleine Biondolillo, MD, director of the state’s Bureau of Health Care Safety and Quality, wrote MedPageToday. NECC, said Reuters, produced the drugs in large quantities, shipping over 17,000 vials of the implicated steroid to pain clinics in 23 states.
“This organization chose to apparently violate the licensing regulations under which they were allowed to operate,” Biondolillo told reporters, said MedPageToday. Deborah Autor, JD, spokeswoman for the U.S. Food & Drug Administration (FDA) told MedPageToday that legal remedies are available to the agency, such as product seizure and criminal charges. Meanwhile, NECC received a 2006 warning letter indicating that it was acting more like a drug manufacturing firm than a compounding pharmacy. In response, NECC said that patient safety was being protected and applicable laws and regulations were being obeyed, Autor said. Should the probe indicate otherwise, said Autor, “we will hold people accountable appropriately.” The FDA has been looking at NECC for some time, “We’ve been there repeatedly,” Autor told MedPageToday.
NECC recalled all three lots of the tainted steroid (preservative-free methylprednisolone acetate), which was—for the most part—used for back pain, along with all of its other products, and has also ceased production. “We are not out of the woods yet,” said Todd Weber, MD, the Centers for Disease Control and Prevention (CDC’s) incident manager for the outbreak said.
Although state and local health officials have contacted more than 12,000 of the people believed exposed to the steroid, another 2,000 have yet to be advised, said MedPageToday. The figure is much greater than previously believed, noted Reuters, adding that patients and physicians should be watching for symptoms for the next few months, noting that infection symptoms have manifested within two weeks, on average; however, infections symptoms have also been detected up to 42 days later.
In the past two days, alone, case reports rose by 33, including two more fatalities, noted MedPageToday.
The U.S. Centers for Disease Control & Prevention (CDC) said that evidence of fungal infection of the central nervous system is present in some 25 patients; the most prevalent is exserohilum; more than one fungi has been detected. “Historically, fungal meningitis is very rare,” Weber said, “and exserohilum has not been seen previously as a cause of fungal meningitis. This is new territory for public health and the clinical community.” In one case, meningitis was not involved in case of a joint infection after the steroid was injected into the patient’s ankle, said MedPageToday.
Former Connecticut state attorney general and federal prosecutor, Richard Blumenthal, who sits on the Senate’s Health Oversight Committee, told Reuters that he wrote to U.S. Attorney General Eric Holder, asking for a federal criminal probe. “I’ve reached no conclusions, but there are at least sufficient facts to warrant an investigation,” Blumenthal said. “The company, its officers, employees, and maybe others may have violated state and federal criminal laws in their potential misrepresentations to government agencies regarding their products,” he added.
These injections, in general, have also been linked to a host of other rare and “devastating complications,” said The New York Times, such as nerve damage, paralysis, and strokes. The FDA is looking into how to minimize risks for “catastrophic neurological injuries” from the injections, Dr. James P. Rathmell, chief of pain medicine at Massachusetts General Hospital, told The Times. Dr. Rathmell is involved in the review, which was not previously—but will now—look into risk of infection.
Steroids have never been approved by the FDA for use in epidural injections next to the spinal cord, said The Times, noting that, despite this, the injections are given to millions of Americans. “Not only were these people killed, but there was no ethical reason to give this treatment,” said Dr. William Landau, a professor of neurology at Washington University in St. Louis, told The Times.
Others disagree, saying the drugs have long been used for this off-label purpose and can be less risky that serious painkillers and surgery. But even advocates of the drugs for this off-label use say that the practice is overused. “We are doing too many of these, and many of those don’t meet the proper criteria,” Dr. Laxmaiah Manchikanti, told The Times. Dr. Manchikanti, who runs a pain clinic and is chairman of the American Society of Interventional Pain Physicians, noted that some 20 percent of doctors who perform the procedures are not sufficiently trained.