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Roseann Fusco says the last thing on her mind when she agreed to get a steroid injection for back pain was where it came from, let alone whether it was made correctly.
After all, she says, her doctors had highly recommended she get it as a possible alternative to surgery.
“They kind of like begged me to do it. So I'm like, 'Okay, I'll try at least one shot,' "Fusco says.
The 53-year-old was an avid tennis player, hardly ever sick. When she woke up with a 102-degree fever, she knew something was very wrong. She soon found out what it was.
“Lo and behold, on my answering machine, there was a message from Marion Pain Clinic in Ocala,” Fusco says. “I was one of the clients that had received the epidural steroid shot that was contaminated."
http://www.youtube.com/watch?v=bkaJpVR4jxQ
Fungal Meningitis Outbreak
Since May, nearly 700 other people have been diagnosed with illnesses linked to contaminated injections linked to the same source: New England Compounding Center. Until it was closed last fall, it held a Florida pharmacy license.
The state of Florida recently released a report that said there are about 950 licensed pharmacies that make drugs from scratch in the high-risk way that NECC did, called "sterile compounding." Of those, one third are, like NECC, located in another state -- beyond the legal reach of Florida health officials.
The Battle to Stay Alive
Fusco says she went to the hospital and underwent a battery of blood tests, which revealed that she had fungal meningitis. The next three months were a whirlwind of IVs and infections.
An anti-fungal gave her an allergic reaction, which led to shock. Doctors told her she nearly died.
They put her on a new medication that had to be infused through an IV. It was so toxic it burned her veins.
An MRI revealed a large abscess at the injection site on her back. Surgeons removed it but the area later became infected. One day, it burst open, creating a 4-inch-long gap that exposed her spine.
“I had this big hole like someone took an axe to my back,” Fusco says. “That was pretty scary.”
One Day at a Time
To pass the time and distract herself, Fusco kept a journal. She had lots of visitors and her husband Paul stayed by her side. But they were always scared. They weren't the only ones, Paul Fusco says.
“We didn’t know the doctors, but you could just kind of tell by the look on their face that they were in an uncharted area,” Paul Fusco says. “They were scared themselves.”
As one of the early cases in the meningitis epidemic, Fusco felt like a guinea pig. She had multiple spinal taps and MRIs as doctors tried to figure out the best way to treat her.
She took comfort in the fact that she was helping others in her situation. At one point she met an elderly woman who had received several contaminated steroid shots. Because doctors now knew more about the illness thanks to treating Fusco, the older woman underwent only half as many tests.
“I felt good about that,” Fusco says.
Infections and IVs
Three months went by. Fusco spent Thanksgiving, Christmas, and New Year's Eve in the hospital. At one point Fusco contracted MRSA and had to be quarantined.
After three months, the Centers for Disease Control and Prevention’s recommended treatment time, Fusco came home. She’s still reeling.
She says the toxic anti-fungal medication damaged her kidneys and taste buds; food still doesn’t taste right. But she hopes for a full recovery.
Holding Them Accountable
Fusco is suing the New England Compounding Center, which is shut down and bankrupt. Recently the Boston Globe reported that hundreds of meningitis patients have sued NECC, which has filed for bankruptcy. The damages are estimated to total much more than the company has in assets.
Fusco's attorney, John Piccin of Ocala, says he will also file suit against Marion Pain Management Center.
"For some reason, Marion Pain Clinic chose to purchase a steroid compound from NECC,” Piccin says. “The drug is probably cheaper, and is certainly produced under much less scrutiny than a drug would be that is made by a major manufacturer."
Health News Florida left messages for the clinic on several occasions, but did not hear back.
How the NECC Crisis Happened
Pharmaceutical manufacturers are regulated by the Food and Drug Administration. Compounders are not, because they are considered pharmacies regulated by the states. Compounding pharmacies are supposed to make custom-tailored drugs for individual patients who can't use commercially-manufactured products.
Bona Benjamin, with the American Society of Health System Pharmacists, says the difference between manufacturers and compounders is the difference between a mass-production bakery and cooking a meal at home. The rules are stricter for a manufacturer.
"I can see why you wouldn't ask a compounding pharmacy to go through the same new drug application process that a manufacturer would,” Benjamin says. “Ideally they should be operating on a much smaller scale and they should be responding to prescriptions for patients."
But in the case of NECC, they didn't. The company was mass producing and distributing the contaminated steroid injections, but because it was licensed as a compounding pharmacy, it lacked federal oversight.
Why Clinics and Hospitals Chose NECC
Scott Gottlieb, a fellow at the American Enterprise Institute and former deputy commissioner of the FDA, says the problems with NECC came about in part because of the FDA's heightened regulation of manufacturers.
He says the sterile injectables from NECC came into high demand when the two major manufacturers of the generic version of the drug stopping making it, under pressure from the FDA for health violations.
"Once the facilities closed, the hospitals and doctors had no choice but to look for alternative sources," Gottlieb says.
Sarah Clark-Lynn with the Food and Drug Administration says that after Teva and Sandoz, the two major manufacturers of the steroid injection, stopped making it; the agency asked another company to increase production of its methylprednisolone acetate. Pfizer sells this product under the name Depo-Medrol.
"The firm has told FDA that will be able to meet the demand for the product,"Clark-Lynn said through e-mail.
Erin Fox, the director of drug information at the University of Utah, believes hospitals and clinics chose to buy from NECC mainly because it offered what most manufacturers could not.
"Many pain clinics need specific syringes for patients that are customized, not commercially available," she says.
And like many of the patients who were given the contaminated injections, she says, some clinics and hospitals took it for granted that NECC was operating safely.
"I think there are a lot of folks that simply don't understand that when they are purchasing from a company like NECC,” Fox says, “they don't understand who is regulating it or not. I think people understand a lot more, after this crisis."
Roseann Fusco certainly does.
“There are a lot of sick people out there, a lot of scared people. They’re going to have to worry for the rest of their lives.”
