Dr. Michael Omidi examines the difficulty in properly manufacturing the drug methylprednisolone acetate, an injectible steroid that is very vulnerable to contamination. As Dr. Michael Omidi explains, this drug was the catalyst for the recent outbreak of meningitis.
Methylprednisolone acetate, the injectible steroid that was the catalyst for the recent outbreak of fungal meningitis, is an extremely difficult drug to manufacture properly due to the fact that it cannot be sterilized through traditional means. It cannot be heated – which would kill any microbial contaminants but seriously degrade the drug itself – and it cannot be filtered, since the drug contains crystalline particles that would also be removed.
Contamination of methylprednisolone acetate has particularly devastating after-effects, since this drug remains in the system for months, and also causes the suppression of the immune-defense system. If bacteria or fungal matter is incorporated into the mix, both the drug and the spinal fluid (if it is used in an epidural application) tend to actually fertilize the microbes, allowing them to flourish and spread throughout the body and potentially into the brain.
The recent fungal meningitis outbreaks were not the first examples of fatalities that resulted from tainted injectible steroids. In 2001, three people in Northern California died after having received an injection of contaminated betamethasone from a compounding pharmacy. A South Carolina compounding pharmacy issued contaminated injectible steroids which resulted in infecting seven people and killing two in 2002. More recently, a Florida compounding pharmacy distributed contaminated steroids that caused severe vision damage to 13 patients in March of 2012.
The fact that compounding pharmacies receive their methylprednisolone from suppliers overseas (China and India) that do not have to adhere to the standards of U.S. drug companies is a cause for concern. Active Pharmaceutical Ingredients come from suppliers grossly contaminated. Nonetheless, it is the compounding pharmacy’s obligation to sterilize the product before incorporating it into anything meant for distribution, but the sterilization practices are often lacking.
The fact that compounding pharmacy practices are not regulated by the Food and Drug Administration, but by overburdened state agencies, means that compounding pharmacies can operate without any significant policing. The NECC (New England Compounding Center) demonstrated stunningly negligent sterilization practices; the clean room was kept at drastically varying temperatures, there was debris circulating throughout the facilities from a nearby recycling plant and there was evidence of bacterial growth and mold on many of the clean room surfaces.
One of the reasons that hospitals and clinics consistently used compounding pharmacy drugs was that the injectible steroids distributed by compounding pharmacies do not contain preservatives, while the FDA-approved drug manufacturing company products do. Preservatives are thought to possibly contribute to permanent nerve damage in patients, as well as pose a risk for brain damage in premature babies.
Unfortunately, very little was known about the fungus that caused the outbreak, E. rostratum, and it wasn’t considered to be effectively parasitic in humans. This lack of expertise led to the medical community being poorly equipped to handle the illnesses, and as a result, many older or immune-deficient patients had to be given doses of antifungal medications that caused severe side effects.
By Dr. Michael Omidi
 Brown, David: The Drug in Fungal Meningitis Cases is Hard to Make and Unusually Dangerous When Contaminated The Washington Post 2/8/2013 http://articles.washingtonpost.com/2013-02-08/national/36984968_1_methylprednisolone-acetate-exserohilum-betamethasone