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.

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 

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[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

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.

Michael Omidi on Alternatives to Epidural Injections

Amount of Fungal Meningitis Victims Still on Rise

Unfortunately, the number of new victims in the recent fungal meningitis outbreak has not stopped growing. It was reported recently that North Jersey has had its first recorded case of meningitis that has resulted from the contaminated batch of steroids compounded from the New England Compounding Center. One fungal meningitis death was reported in Indiana (bringing the total deaths in Indiana from fungal meningitis to 7), and two in Maryland. Many of the patients that received the contaminated injections had them administered at pain clinics—facilities that specialize in providing relief for chronic back pain. One has to wonder if this outbreak has caused any practitioners of pain management to rethink epidural injections as an elective procedure.

Two Confirmed Cases of Fungal Meningitis in New Jersey

Thus far, New Jersey has two confirmed cases of fungal meningitis from the tainted batch of compounded drugs, but no deaths. Tennessee has the highest number of deaths of any state affected by the contaminated steroids.

New Jersey Reported Cases Could Increase

Both of the New Jersey patients received epidural injections in late September. It can take several months for the symptoms of fungal meningitis to become apparent, so there still might be cases yet to develop, although as time progresses, the risk that new infections will emerge will get lower. Mold infections tend to grow slowly, and incubation periods vary, with infected patients typically showing signs a few weeks post exposure.

Fungal Meningitis is a SEVERE Condition

Fungal meningitis is a potentially life threatening condition that requires immediate medical intervention. Patients who do not seek treatment at the first signs of infection risk permanent neurological damage and even death.

This medical catastrophe was caused by mold growth in a batch of poorly maintained steroid medications, but patients seeking relief from back pain should be aware that epidural injections—even pure injections—pose a risk for severe complications. Any injection near the spine can lead to serious infections such as arachnoiditis, which is a chronic condition that can cause persistent back pain, trouble standing and sitting, incontinence and even paralysis. While physicians are always careful about injecting medications close to the spine, mistakes can be made; the needle can slip and puncture the spine, and the injection site can be vulnerable to epidural abscesses, which are difficult to diagnose or detect since they are relatively deep below the skin.

While chronic back pain can be debilitating, with the pain even migrating to the head, arms and legs, it is critically important to explore multiple options for therapy before agreeing to submit to epidural steroid injections. There are numerous forms of physical therapy that produce wonderful results. Degenerated or herniated discs do cause a small percentage of chronic back pain or sciatica. However, in many cases, lower back pain is the result of slack core muscles. When certain muscle groups lack the strength to support the back, the muscles that are burdened with the bulk of the work become strained, causing acute pain. If at all possible, if you suffer from lower back pain, try to get more than one opinion on the best course of treatment before making a final decision.

Dr. Michael Omidi on Meningitis Filed Lawsuits

50 Federal Lawsuits Have Been Filed Against NECC

It was recently announced that approximately 50 federal lawsuits have been filed against the New England Compounding Center, the compounding pharmacy that fabricated and distributed the tainted steroids. The lawsuits have been filed in nine states.

The fungal meningitis outbreak was a medical catastrophe. The sickness and death that resulted from the New England compounding pharmacy has caused the FDA to look at compounding pharmacy practices very closely, and discover that other facilities, including Ameridose, distributed tainted medications to hospitals and clinics, although no resulting sicknesses have been reported.

NECC responsible for 590 Patients

The lawsuits charge that the New England Compounding Center (NECC), through its negligence, caused the death and/or illness of 590 patients. The suits seek millions of dollars in damages for wrongful death, pain and suffering, emotional distress and lost wages.

NECC Surrenders Pharmacy License

Since the outbreak, NECC has surrendered its pharmacy licenses, recalled all products, laid off all employees. Although NECC had liability insurance, it is uncertain if the policies would cover damages of this magnitude. Because it is very likely that NECC will not have adequate funding to support the potential compensation, several of the lawsuits have included additional defendants, including the marketing firm Medical Sales Management, the sister company Ameridose, and NECC co-founders Barry Cadden and Greg Conigliaro.

It is speculated that there might be numerous lawsuits to follow, and physicians, nurses, hospitals, medical clinics and those who physically handled the drug vials might be sued. Since the contamination was so severe that it could be seen with the naked eye, anyone who was associated with the medical centers that administered the drugs could be liable for not reporting that the contents of the vials were clearly tainted.

Full Scope of Damage Could Take Years

The discovery phase—the gathering and review of evidence and depositions—could take years. Moreover, the full scope of the medical emergency might not be fully appreciated; more potential victims could yet be discovered. It was reported recently that several patients in states that have not yet recorded incidences of fungal meningitis have developed severe meningitis-like symptoms. However, these cases have not been diagnosed because doctors had not been able to find traces of fungus in the patients’ spinal fluid, although at least one of the patient’s symptoms caused sufficient alarm to necessitate antifungal medications to be prescribed.

The debilitating physical symptoms of fungal meningitis would legitimately render the patient unable to work. A patient infected with fungal meningitis would suffer from persistent headaches, nausea, backaches, blurred vision, dizziness and speech troubles. One diagnosed, a patient would have to be under constant medical supervision while the appropriate medications were administered, and recovery time can take weeks.