Many Meningitis Patients May Not Have Been Diagnosed

Michael Omidi discusses how a patient was recently diagnosed with spinal meningitis 106 days after receiving an epidural steroid injection and how there may be many cases still to be reported.  

The meningitis scare has dissipated considerably within the past few weeks, and has, sadly, largely been replaced by the flu scare. Unfortunately, even though we would certainly like to breathe a little easier about this awful disease, it was recently reported that a victim was diagnosed as having spinal meningitis 106 days after having the contaminated epidural steroid injection that caused all of the illnesses and deaths. 

 

The Tennessee patient had received an injection at the end of September, only to be diagnosed with meningitis and an injection site infection in mid December.  It is thought that the vast majority of people who have been infected with the tainted drug have already been identified and treated, but the gestation period for fungal meningitis is quite long—typically several weeks but occasionally longer.  This new patient’s diagnosis has reminded the medical community that while there are still people out there who have been exposed to the steroid, there may still be outbreaks and possibly fatalities.

The epidural steroid injections were intended to relieve severe chronic back and neck pain.  These injections are meant for patients with pain so severe that it renders them less able to perform daily tasks, but there are many health care providers that do not look kindly upon the procedure, which is very dangerous even when there is no threat of contamination.  It is not uncommon for the person administering the injection to accidentally puncturing the spinal cord or causing nerve damage.  It is estimated that approximately 50 percent of patients experience pain relief as a result of epidural steroid injections. 

There may be many people who have infections that have gone unreported.  In California there haven’t been any official fungal meningitis cases, but there were reports of people with very similar symptoms—headaches, back aches and difficulty standing or sitting for extended periods of time—who, for whatever reason, were never classified as being among the victims.

It is highly likely that the mental stress has contributed to the complications the patients may be suffering.  Also, even though tests for meningitis may come up as being negative, there are other spinal infections that might cause lingering discomfort, like epidural abscesses and—more seriously—arachnoititis, which is a chronic condition that can only be managed and never entirely eliminated.

Many older patients who have developed infections are not eligible for the traditional treatments since they have very powerful side effects that delicate patients may not be able to tolerate.

As the weeks stretch into months, the only thing that the patients that have been exposed to the fungus can do is get medical consultations, wait and worry. 

By Michael Omidi

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Wilemon, Tom: Meningitis Outbreak: TN patient’s diagnosis came at 106 days The Tennessean 1/15/2013 http://www.tennessean.com/article/20130115/NEWS07/301150042/Meningitis-outbreak-TN-patient-s-diagnosis-came-106-days

Dance, Scott: In meningitis outbreak, fear lingers with few answers The Baltimore Sun 1/6/2013 http://articles.baltimoresun.com/2013-01-06/health/bs-hs-meningitis-fears-20130106_1_fungal-meningitis-meningitis-outbreak-infection-prevention-and-outbreak

Wilemon, Tom; Roche, Walter F: Patients say their cases ignored in meningitis outbreak USA Today 11/24/2012 http://www.usatoday.com/story/news/health/2012/11/24/meningitis-outbreak-cases-not-counted/1724379/

The 2013 Flu Epidemic

Could This Year's Flu Be The Worst Flu Pandemic Since The "Spanish Flu"?

Between the years 1918 and 1920, the world experienced one of the deadliest pandemics in human history. More lives were lost in the influenza outbreak than in the First World War, which was coming to its conclusion as the disease began to spread throughout the United States, Great Britain and Europe. The “Spanish Flu,” as it came to be called, attacked suddenly, violently and seemed to disappear nearly as quickly as it spread. Millions died, and no one was—or is—able to determine exactly why this strain proved so devastating, or if another catastrophic disease of its nature could hit again.

The flu is a seasonal pest. We are all encouraged to prepare ourselves by getting flu shots, but the severity of the illnesses is obviously nowhere near as intense as that which hit the world at the end of World War I. Even though people do become ill with the flu every year, no one can ever predict how widespread it will become, or if any of the cases will prove fatal. Indeed, some years it is barely even noticeable. Unfortunately, this year has proved to be the exception.

This Years Flu has Claimed the Lives of Over 100 People

This year’s flu season has blossomed into what many consider an epidemic. To date, the flu has killed more than 100 people and infected thousands more. Unlike the flu of recent seasons, which is usually particularly hard on the elderly and people with compromised immune systems, this flu seems to be taking the lives of young and strong people. Government health officials are of differing opinions on whether the worst of the flu has already been seen, or is yet to come. The New York Time s reported that the outbreak has likely reached its peak. Reports of infections have gone down—4 percent of doctor visits are due to flu, as opposed of 6 percent from the first week of January. However, Governor Andrew Cuomo has declared a health emergency for the State of New York, so that vaccines could be more readily available for all residents.

Unfortunately, Physicians Can Only Monitor Flu Progression in Patients

Even though the flu can be deadly for older people and people with other existing conditions, it generally doesn't require hospital admission for treatment. Indeed, apart from administering vaccinations, there isn't much that a physician can do for a common case of the flu apart from monitoring the progression. If you have the symptoms of the flu—dry cough, fever, chills, fatigue, headaches, body aches and gastric distress—it is a good idea to stay hydrated, eat hot chicken soup, stay warm and get plenty of sleep. However, if you experience more severe symptoms, such as difficulty breathing or the consistent inability to keep food and/or fluids down, then a doctor should be seen immediately.

Michael Omidi on FDA and State Meeting Regarding Compounding Regulations

FDA Meets with Public Health Officials From All 50 States

Although those that have been infected with fungal meningitis from the tainted batch of compounded steroids may still be feeling acute symptoms of the disease, the number of new cases is, thankfully, diminishing. However, the dangers of infection from compounded drugs still lingers—as long as there are no functional governing bodies that oversee standards of production. Recently, the Food and Drug Administration met with public health officials from all 50 states in order to discuss possible governmental regulations regarding compounded medications.

Compounding Pharmacies Under No Legal Obligation to Submit Documentation

Unlike drug manufacturers, compounding pharmacies are only loosely regulated by state health boards, which often do not have either the funds or the inclination to fully police compounding pharmacy practices. FDA intervention can only occur after it is proven that compounding pharmacies are actively manufacturing drugs, but that proof has to come from the pharmacies themselves, and pharmacies are under no legal obligation to submit documentation proving that they manufacture drugs on a large scale, as opposed to merely mixing prescribed versions of drugs in accordance with specific physician’s orders.

Because compounding pharmacies began as small scale affairs that did not issue large quantities of specialized medications across the nation, the individual states’ health commissioners were able to regulate them. As compounding pharmacies expanded drastically in the 1990s, the states’ regulations and governing agencies did not adjust to address the new size of the compounding facilities. Increasingly, states relied upon the FDA to inspect compounding pharmacies, but the FDA had no legal authority to shut down or discipline pharmacies that were incompliant.

NECC Internal Review was "Shocking" - Months Prior to Outbreak

The New England Compounding Center (NECC), the compounding pharmacy responsible for issuing the vials of contaminated steroids that caused the fungal meningitis outbreak, was inspected by officials in years prior to the outbreak, and even underwent its own internal review. The results from the company’s own review were alarming, with evidence of microbial growth in the medication vials and high levels of bacteria and mold on clean room surfaces. The NECC was close to a recycling center, which was a source of much of the debris, and possibly the fungus, that contaminated the vials and surfaces. Even after the NECC uncovered rampant contamination in its own facility, there were no changes made by the pharmacy, nor did the state or federal regulating bodies insist upon any cleanup efforts.

The purpose of the recent meeting was to discover how the individual states were failing to police the compounding pharmacies, and to determine whether one centralized federal board should have the authority to regulate large scale compounding companies, which the states do not have the resources to oversee effectively.