Michael Omidi - Meningitis Outbreak News

Omidihealth was created by Michael Omidi - co-founder of NMP (No More Poverty) this blog is dedicated to providing its readers the latest news on the meningitis outbreak.

Wednesday, February 27, 2013

Controversy in Culpability Surrounding Meningitis Outbreak


Because the fungal meningitis outbreak was so catastrophic in terms of lives lost and pain needlessly suffered, it was only a matter of time before survivors began to seek remuneration from the parties responsible. Not only are the owners of the compounding pharmacy being sued, many of the physicians who administered the tainted shots are also facing litigation.

While it cannot be denied that the blame for the fungal meningitis disaster lays at the feet of a compounding pharmacy that flouted not only governmental regulations, but also basic pharmaceutical practices of health, safety and due diligence, many patients are nonetheless beginning to wonder if the clinics that administered the tainted shots shouldn’t bear some responsibility as well.

The entire matter is extremely delicate. While it is true that the New England Compounding Center was woefully inept at maintaining an environment suitable for the production of an extremely delicate and difficult to manufacture drug, the Massachusetts regulatory boards did little, if anything to oversee or police their practices. The NECC was inspected several times by the FDA as well as state board officials, who issued warnings and concerns that were completely ignored, and yet the regulatory bodies did nothing to follow up on those warnings, leaving thousands of patients in jeopardy.

One of the main reasons compounding pharmacies distribute so many vials of epidural steroid is because many physicians believe in the studies that report of the dangers of using injectable drugs that contain preservatives. While there are many conflicting studies regarding the potential hazards of preservatives in injectable applications, the crux of the objection to the commonly used pharmaceutical preservatives is that they may trigger outbreaks of arachnoiditis, an incurable inflammation of the arachnoid membrane which surrounds the spinal column. This condition is painful, chronic, has debilitating side effects, and requires more or less constant pain management therapy and treatment. Injectable steroids that do not contain preservatives can only be obtained through compounding pharmacies, not FDA regulated drug companies.



The lack of chemical preservatives, however, leaves these drugs extremely vulnerable to bacterial and fungal contamination. If improperly stored, these vials of medicines can turn into a breeding ground for all types of microbes. As we have seen, this can have disastrous consequences.

It has been reported that the injectable steroids that were distributed from the NECC were so contaminated that matter could be seen in the vials with the naked eye. If this was the case, is it then possible that the physicians who continued to use these obviously problematic drugs could then be partially culpable for the fungal meningitis outbreak?

Perhaps there is enough blame to go around. Unfortunately for the victims, the NECC, having declared bankruptcy, simply does not have the money to compensate the victims adequately, and legal experts have clearly advised their clients to seek compensation where they can: from the physicians and medical centers.
It is impossible to know the extent of the culpability of the individual doctors and treatment centers. If it can be proven that these drugs were administered even after it was suspected that there could be something wrong with them, then perhaps the victims have a point. However, for doctors acting in good faith with the sincere desire to alleviate the pain and suffering of their patients, it would be unfortunate to be painted with the same brush as a negligent compounding pharmacy.

Tuesday, February 19, 2013

Steroid That Led to Meningitis Outbreak Difficult to Sterilize



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.[1]

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.

As consumers, we like to research the products we put into our bodies, and make sure that we are getting the highest quality practicable.  However, how can we control the types of medications we have administered to us when we are in need of medical attention?  Hopefully, the different governing agencies, both local and federal, will not soon forget this medical crisis, and try to be more diligent when it comes to the wide distributions of medicines that are supposed to help, not hurt us.

By Dr. Michael Omidi 


[1] 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