7:43PM EST November 8. 2012 - The longer the steroids that killed 31 people sat, the more dangerous they became, a study by health officials in Tennessee has found.
Of nearly 150 Tennessee patients who were exposed to possibly contaminated steroid injections, those who received them from vials more than 50 days old were five times more likely to develop meningitis than those whose medicine came from vials less than 50 days old. The rate of infection for those who got the older medicine was 19%, dramatically higher than the 3% for those who received fresher medication."The longer something sits, the longer that culture medium has to grow and nurture a really lethal batch of the infectious agent," said Albert Wu, director of the Center for Health Services and Outcomes Research at Johns Hopkins University in Baltimore.
The steroid was produced by New England Compounding Center (NECC) in Framingham, Mass. It is blamed in a nationwide outbreak of fungal meningitis that has sickened 424 people and killed 31. It was injected as a relief for spine and joint pain.
STORY: 150 patients got old drugs in meningitis outbreak
Two things went wrong. First, drugs from a compounding pharmacy typically wouldn't have sat for 50 days before being used. The pharmacist would make up the drug when it was prescribed and hand it to the patient or "send it over to the doctor, where it would be used the next day," said Michael Posey, editor of Pharmacy Today.
Second, and more important, the drugs from NECC were supposed to be sterile but weren't. The company claimed to have performed sterility tests on its products, but the Massachusetts Board of Pharmacy says the testing was inadequate and shipments were made before the safety of the medicines had been verified. The company could not be reached for comment.
If the drug had been sterile, as the medical centers that bought it believed, a longer shelf life would not have been a problem, said Timothy Jones, Tennessee state epidemiologist and senior author on the study, published in this week's edition of the New England Journal of Medicine. "If there's nothing in there, then there's nothing to grow."
Unbeknownst to the physicians administering the shots, the drug was contaminated with fungus. Jones said the doctors who administered the injections were not at fault. "There's just nothing they could have done," he said. "Really, it honestly was not anything they could have known."
So far, no other states have reported higher infection rates for patients receiving older batches of the medicine, but that's probably because Tennessee's health department first identified and began tracking the meningitis outbreak.
"We were a couple of weeks ahead in terms of collecting our data," Jones said. "My expectation is that as other states catch up and learn more about their cases, there will be growing evidence for this."
Contributing: Liz Szabo; Tom Wilemon and Walter F. Roche Jr. of The Tennessean
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