Posted on October 5, 2012 · Posted in Brain Injury

It’s a shame that innocent people —  in this case, five of meningitis– have to die. Perhaps now the government will take a serious look at closing a gaping hole in public safety.

Unless you’ve been living in a cave, you are aware that there is a rare fungal meningitis outbreak causing fear, and death,  across the country. Meningitis is an inflammation of the brain’s lining and spinal cord, and it can be fatal. So far, 47 people have come down with this illness, and five are dead, as The Huffington Post reported.

The victims are people who received steroid shots in their spine to alleviate their back pain, a very common treatment. These people, and at the very least potentially hundreds — if not thousands — of others, were injected with a batch of steroids produced by a so-called compounding pharmacy, the New England Compounding Center in Framingham, Mass.

Products made by compounding pharmacies, unlike those made by drug companies, don’t need approval by the Food and Drug Administration, as The New York Times explained in a story Friday,

In this case, federal investigators went to the New England Compounding Center and “found a sealed vial of the steroid afloat with so much foreign matter that it could be seen with the naked eye,” according to The Times. That material was a fungus, and 17,700 vials of the steroid have been recalled.

Here’s the really bad news: 75 medical facilities in 23 states received the tainted steroid. Now these clinics and doctors are trying to contact patients who had shots from this batch.

The FDA issued a safety alert on it Friday.

Here is part of it:

“FDA has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of methylprednisolone acetate collected from New England Compounding Center (NECC). FDA is in the process of conducting additional microbial testing to confirm the exact species of the fungus.

Investigation into the exact source of the outbreak is still ongoing, but the outbreak is associated with a potentially contaminated medication. That product is preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid produced and distributed by New England Compounding Center (NECC) in Framingham, Massachusetts. CDC’s interim data show that all infected patients received injection with this product.

BACKGROUND: FDA was been working closely with CDC, several state health departments, and the Massachusetts Board of Pharmacy to investigate the scope and cause of the outbreak of fungal meningitis. FDA inspectors in the New England District Office, in cooperation with the Massachusetts Board of Registration in Pharmacy have been conducting an inspection of the New England Compounding Center. The firm voluntarily ceased all operations and surrendered its license to the Massachusetts Board of Registration in Pharmacy on October 3, 2012.

RECOMMENDATION: Out of an abundance of caution, FDA is taking the additional step of recommending that health care professionals and consumers not use any product that was produced by NECC at this time. In addition, FDA requests that health care professionals retain and secure all remaining products purchased from NECC until FDA provides further instructions regarding the disposition of these products.

Although the investigation into the source of the outbreak is still ongoing, if you have purchased a product from NECC, FDA is advising not to use it at this time. This includes all products compounded and distributed at NECC; not just the ones that have been recalled.”

There is an FDA-version of  methylprednisolone acetate available, which is presumably safer than the version with the fungus. Its brand name is Depo-Medrol. Why a doctor wouldn’t use this, as opposed to the steroid made by the compounding pharmacy, is beyond me.

According to The Times, the pharmacies can sometimes offer special dosages of the steroid, or sell it at a cheaper price. But if I was a physician, I wouldn’t risk it.

The Times tried to explain why compounding pharmacies, which have been involved in other cases where patients were killed by contaminated treatments, remain unfettered by federal oversight.

“Pharmacies and regulators have struggled for years over what limits to set on the practice,” The Times wrote. “Compounding has fallen between state and federal authorities, and the legal status of compounded drugs has never been clear.”

In at least one case cited by The Times, the FDA tried to step in regarding a compound pharmacy that was making drugs for veterinary use. But a judge jumped on the FDA, saying that the agency should not assume that it had any authority over compounding pharmacies. The FDA is appealing that ruling, according to The Times.

It’s time for federal legislation to end any ambiguity, and clearly give the FDA the power to regulate compounding pharmacies, before any more people needlessly die.

About the Author

Attorney Gordon S. Johnson, Jr.
Past Chair Traumatic Brain Injury Litigation Group, American Association of Justice :: 800-992-9447