Posted: 24.Dec, 2012 11:56:00 | Last Accessed: 2012-12-26 10:28:58
The outbreak of fungal meningitis and joint fungal infections due to interventional pain procedures using a tainted steroid affected over 10,000 people nationwide who have been panicked or infected unnecessarily. Indiana ranks 3rd in the number of cases out of the 19 states affected with 68 cases so far and 7 deaths have resulted in Indiana from this unfortunate and preventable disaster.
Columbus has one pain clinic, Wellspring, that was involved in administering this potentially life threatening steroid to 309 individuals and was one of 6 pain clinics/hospitals/surgery centers in Indiana (out of over 200 total in the state) to use the infected steroid.
It is impossible to know the number of people actually infected in Columbus, partially because the main organism isolated, Exoserum Rostratum, has a very slow growth period that the CDC says sometimes requires up to 5-6 months to grow in culture. This organism is the same as black mold found on pipes. The other reason it is not possible to determine numbers infected is that the State Department of Health has decided not to release this information to the public.
The black mold grows slowly inside joints and the epidural space, making its way towards the brain, and may cause strokes and death. The treatment involves a 6-12 month course of IV antifungal drugs that have significant organ toxicity involved and may lead to liver failure. Fortunately, the number of new case reports is diminishing, but there have been 620 cases of infection nationwide. So what were the factors that led to the development of fungal infections?
Namely there were three: 1. NECC, a compounding pharmacy in Massachusetts, had a very shoddy operation, with infectious agents being found along the walls inside the pharmacy and in the sterile room where the drugs were prepared. This was known as early as the Spring of 2012 and the pharmacy did little to eradicate this issue. The pharmacy also turned off the air conditioning at night that subsequently permitted the humidity level and temperature to rise during the spring and summer months, and encourage the growth of bacteria and fungus.
The pharmacy was a "compounding pharmacy", that will take raw ingredients and mix them to the physician's specification to make a compound specified by a prescription. Although there are over 7,000 pharmacies in the US engaging in some compounding, only a few will compound steroids for injection. This is because it is too costly to make one compound per prescription, it is difficult to sterilize a steroid which is a solid and cannot be sterilized by filtering as is done with most liquids or solutions, and that there have been outbreaks of meningitis reported from compounding pharmacies making injectable steroids dating back to 2002.
NECC however was not acting as a compounding pharmacy and did not require a prescription per patient as do all other compounding pharmacies. They found it was cheaper to simply make large batches of the steroid suspension, then divide the batch up into vials, and tell the physician they could order a number of vials containing what was already pre-made. This is no different than a manufacturer since the compounding pharmacy did not require a prescription per patient, and had already made up large quantities of medication for distribution.
As a compounding pharmacy, this practice is illegal yet the pharmacy enjoyed profitability by operating as a manufacturer without any of the regulations imposed on manufacturers. NECC heavily promoted their product to gullible physicians that did not take the time to ask about sterility or why a compounding pharmacy would be able to operate so differently than any other compounding pharmacy. NECC showed up at national pain meetings with a booth and a pre-printed pad of what a physician could order. They advertised in physician journals and to physician offices.
NECC had some issues with liability having settled an out of court case in 2007 in a patient that had developed meningitis from an epidural steroid injection. But this was buried in the confidential documents and could not be accessed by the public nor regulators. 2. So who was regulating and overseeing the operations of NECC? Frankly, no one. The FDA was well aware of NECC and had sent them a warning letter detailing their operation illegally as a manufacturer, and NECC stated they would modify their operation, however they did not, continuing to claim they were a compounding pharmacy. Compounding pharmacies are regulated under the auspices of state laws, and particularly the state boards of pharmacy while manufacturers come under the auspices of the FDA for regulatory purposes.
The differences in regulatory oversight are huge. Compounding pharmacies are subjected to much less stringent standards and it is presumed there will be no manufacturing involved, but only preparation of medications. The FDA wanted to regulate compounding pharmacies as far back as a decade and a half ago, but were prevented from doing so by a federal judge in Florida that prevented this based on a case the FDA brought against a compounding pharmacy. Therefore the state, via the pharmacy board, was supposed to be regulating the pharmacy.
A sister company, Ameridose, that was also shut down by the FDA during the fungal disaster, had as one of its board of directors, a person that was also on the state board of pharmacy board of directors. The sister company was owned by the same owners as was NECC. This clear conflict of interest was present for many years, and the Massachusetts pharmacy board did not act against NECC despite investigating the pharmacy in the spring of 2012. In fact, they did nothing at all until the fungal outbreak exploded all across the country.
What of the Indiana pharmacy board? It turns out they had no authority to regulate the Massachusetts compounding pharmacy since they were in good standing with their state board and were registered with the Indiana pharmacy board. This is a problem with Indiana state law that needs examination. 3. The physicians involved around the country were ordering the steroid methylprednisolone acetate as a suspension to be injected.
This is the compounded form of Depomedrol, a commercially available product, that was readily available at all times during and prior to the fungal outbreak. The important difference between the two products is that Depomedrol contains myristyl gamma picolinium chloride, an antigermicidal agent used as far back as at least the 1940s as a preservative to stop fungal and bacterial growth.
The reasons the physicians apparently wanted to use this drug without the preservative (by removing it made it a non-FDA approved drug) was because of concerns over toxicity of the preservative, however there are no clinical studies to support this allegation. There were however multiple outbreaks of meningitis from steroids made in compounding pharmacies in the past, and these outbreaks were well documented in the medical literature.
It is speculated the doctors were getting the steroid for a cheaper price than the commercial steroid, and were actually using one vial for more than one patient, a practice that may result in transmission of disease from one patient to another. A compounding pharmacy cannot make an exact replica of the commercial drug unless the drug is in short supply commercially or has become unavailable. Therefore, the physicians had NECC remove the preservatives so they could order from NECC.
Once the preservatives were removed, combined with the infection of the vials with fungus from the compounding pharmacy, this allowed the fungus to continue growing in the vials for weeks and months after the vials were made. Some vials actually had visible contaminants floating in them. The physicians buying this preservative free steroid therefore exposed their unsuspecting patients to fungal infection. It appears most physicians did not give informed consent that their patients were being given a non-FDA approved drug that they had made up nor did they give their patients the options to have the FDA approved drug.
In our city, the name brand drug with the preservatives was readily available at Columbus Regional Hospital, Columbus Surgery Center, and other pain centers and physicians offices throughout the city.
While meningitis can occur from many causes including patient factors, obesity, poor hygiene, or break in infection control procedures, the outbreak of a 19 state infection due to the 3 factors above that caused untold suffering, anxiety, expensive testing, time off work, lost wages, and possible damage to their bodies due to the fungus or the treatment for the fungus is reproachable and reprehensible. The damage may extend to a lifetime for those affected, due to the actions of physicians that infected them.
Source found here