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.

Dr. Michael Omidi on New Meningitis Related Illnesses

Cases of Infection on Rise in Tennessee and Michigan

Cases of infections resulting from the tainted steroids from the New England Compounding Center appear to be on the rise, according to health officials in Tennessee and Michigan.

The new infections aren’t fungal meningitis, but epidural abscesses—collections of pus on the bones of the scull or the spine that can lead to fungal meningitis if left untreated. There have been 37 new cases of abscesses in Michigan and 23 in Tennessee.

Although health officials stress that these abscesses aren’t life threatening, they can potentially cause serious problems, like chronic back pain, incontinence, an abscess on the spinal cord itself and bone infections.

Fortunately, because the Tennessee and Michigan patients who have received the epidural injections of contaminated steroid were under more or less constant medical supervision, these abscesses were detected early, so the prognosis is generally positive. However, epidural abscesses are difficult to detect with the naked eye at the early stages. Symptoms of spinal epidural abscesses are bladder and bowel incontinence, back pain, fever, weakness and difficulty moving a particular part of the body (depending upon where the abscess is located.)

Majority of Cases Detected Early

The cases of potential complications and infections are more difficult to predict in other regions of the United States, however, because it is widely believed that the number of patients who have been exposed to the potentially deadly fungal infection is greater that what is being counted. Certain patients in California who had received epidural steroid injections from NECC were notified that they could potentially be infected with fungal meningitis, but there hasn’t been any follow up. People who have not experienced symptoms of fungal meningitis were not as closely monitored as those who have, and might therefore be at risk of developing complications from epidural abscesses.

Medical Community and CDC not Counting Many Cases

Patients from several states, including California, which did not report any fungal meningitis infections, are claiming that the medical community and the Center for Disease Control are not counting them as official cases. The National Research Center for Women and Families believes that there are many more cases of infection stemming from the tainted drugs, but they are, for whatever reason, going undocumented.

New Infections not Classified as Medical Emergency

The new infections appear to be outside of the central nervous system, and aren’t classified as a medical emergency the way fungal meningitis is. What is worrying to most health officials is the fact that fungal meningitis could develop from the abscesses. According to the Tennessee health department commissioner John Dreyzehner, “We indeed could have a second wave of meningitis for some people. The medical community can't tell you with precision when the risk ends.”

Dr. Michael Omidi on Second Hand Smoke and Meningitis

Even though the meningitis outbreak directly resulting from contaminated medications from New England Compounding Center has been the most widespread cause of meningitis in the US in recent months, there is still a risk of meningitis from another hazardous source: cigarette smoke.

Invasive Meningococcal Disease

According to a study in the journal BNC Public Health, secondhand smoke exposure can double the risk of invasive meningococcal disease, which can lead to bacterial meningitis in children and infants, resulting in death in 5 percent of patients and permanent neurological damage and behavioral disorders in one in six patients. The risk is especially high in infants under five years of age.

Pregnant mothers who either smoke or are in proximity to cigarette smoke are also at risk of delivering a child that is three times more likely to develop invasive meningococcal disease than mothers who live in nonsmoking environments.

Invasive meningococcal disease is communicable, and is spread via close contact and fluid exchange. Many people carry the meningococcal bacteria in their throats, but do not go on to become infected with meningitis; exposure to secondhand smoke appears to facilitate infection in children and toddlers, although researchers cannot yet find the cause. Bacterial meningitis is significantly more difficult to treat than viral meningitis, which can often clear itself from the system without medical intervention.

Meningitis Symptoms

Symptoms of meningitis are nausea, stiff neck, fever and headache. Long term disabilities stemming from the disease are deafness, brain damage and paralysis. Meningitis is an inflammation of the covering around the spinal cord and brain. While viral meningitis can clear itself without significant medical attention, bacterial meningitis must be treated immediately. If you experience symptoms, visit your physician right away. Bacterial meningitis is typically treated with antibiotics, and occasionally hospitalization, so that the medical team can monitor patients for seizures or signs of brain damage or hearing loss.

Children between the ages of 11 and 18 can be vaccinated against two of the three strains of meningitis. Teenagers that are college age and plan on living in a dormitory should receive a vaccination, since people living in close quarters with recycled air systems are at greater risk of becoming infected than those living alone.

Meningitis isn’t the only diseased caused by the meningococcal bacteria; septicemia, a severe infection of the bloodstream is also caused by meningococcal bacteria. Septicemia, or sepsis, is a serious, often fatal condition that typically occurs in children, people living with compromised immune systems and people ingesting immune-suppressing drugs. Symptoms include fatigue, decrease in urination, nausea, rapid pulse, rapid breathing and high fever.

Spinal Epidural Abscesses - Meningitis Outbreak

Outbreak of a Virulent Strain of Meningitis

The outbreak of a virulent strain of meningitis due to a tainted supply of steroids was only one of the illnesses in what has become a national health crisis.

Many patients have complained of swelling and pain at the epidural injection site, even after the meningitis symptoms have cleared up. It appears that epidural abscesses have formed on some patients, even after having taken powerful antifungal medications. Epidural abscesses form under the skin; they can only diagnosed with certainty using an MRI. Some cases can be cleared with drug treatments, others require surgical intervention.

Spinal Epidural abscess

An epidural abscess is the collection of pus that can be found either in the skull or alongside the spinal column. Spinal epidural abscesses are typically caused by bacteria, but can also be due to fungal infections, or result from a spinal trauma or surgery. Patients with epidural abscesses typically experience neck or back pain, fever, difficulty with urination or bowel and bladder incontinence.

While it is possible to recover completely from an epidural abscess, it can return even after aggressive treatment. If left untreated, permanent nervous system damage could occur, and even paralysis or death.

The black fungus that infected more than 500 patients nationwide and killed nearly 40 was so prevalent in the vials of medication that it could be seen with the naked eye. The epidural injections left patients vulnerable to conditions such as meningitis, arachnoiditis and epidural abscesses because the slightest slip of the needle could have sent the fungus into the spinal column, which is a welcoming environment for fungus due to the temperature and the nutrient content. The fungus would then be carried in the spinal fluid up to the brain, which has very limited defense mechanisms against infection.

While meningitis was the most common infection resulting from the contaminated drug, there have been a few cases of epidural abscesses without accompanying meningitis. Unfortunately, fungal epidural abscesses are fairly rare, and many hospitals have very little or no experience treating them. While some abscesses can be surgically removed, others are wrapped around delicate nerves and cannot be extracted. Some patients have multiple epidural abscesses.

Patients who have received or are receiving treatment for fungal meningitis must continue to receive evaluations by their physicians for additional infections and complications, even well after the infection appears to have cleared up. It is critically important to address epidural abscesses immediately, before nerve damage sets in that could be irreversible.

Meningitis Symptoms and Treatments

500 Confirmed Cases and 40 Deaths Now Reported

Health officials are only just beginning to get an idea of the scope of meningitis outbreak. There have been more than 500 confirmed cases and close to 40 deaths, and that isn’t even counting the patients with meningitis symptoms who, while having been injected with medications from New England Compounding Pharmacy, haven’t been injected with the methylprednisolone acetate, which was the drug that was verified to have been contaminated.

Symptoms for fungal meningitis are the same as the symptoms for bacterial or viral meningitis, the more common forms of infection. Fungal meningitis occurs when one of several types of fungus gets into the bloodstream and attacks the spinal cord (the recipients of the tainted steroid were especially vulnerable, since the fungus was being injected next to their spinal cords). It cannot be transmitted from person to person, but ingesting fungus spores in the atmosphere, or working with infected soil can lead to fungal meningitis. People with compromised immune systems are susceptible to fungal meningitis.

What is Fungal Meningitis

Fungal meningitis is the inflammation of the spinal cord lining and the brain; the fungus travels up the spinal cord via the spinal fluid and settles in the brain, which has almost no defense mechanisms. Symptoms of fungal meningitis include headaches, stiff necks, fever, light sensitivity, weakness and nausea. Fungal meningitis can also cause blood clots and lead to stroke. Many of the patients who contracted fungal meningitis from the tainted drug supply died from stroke, making the diagnosis difficult, since doctors don’t often test for additional medical disorders when a patient succumbs to stroke.

Confirming Fungal Meningitis and Treatments

The only way of confirming that the infection is fungal meningitis with any degree of certainty is by spinal tap or lumbar puncture, where a sample of spinal fluid is extracted and tested for the presence of fungus. Because fungal meningitis is so rare, there aren’t as many efficient treatments for the disease as there are for bacterial and viral meningitis (viral meningitis often doesn’t even require medications). Treatments are administered intravenously, and can often take a month or longer to effectively kill the fungal infection. These treatments must also be given in a hospital setting so that a physician can monitor the patient. The drugs, voriconazole and amphotericin B, can cause damage to the liver and kidneys.

Unfortunately, the fungal meningitis symptoms start off so slowly that infected patients might not feel the need to seek medical attention until the infection has taken aggressive hold (some of the symptoms are similar to migraine headaches). It is important that anyone who has had injections of any kind from the New England Compounding Pharmacy (especially those who have even mild symptoms) get tested for the onset of fungal meningitis.

Meningitis Epidural Shot Risks

Epidural Steroid Injections

Unfortunately, fungal meningitis hasn’t been the only condition that has resulted from the tainted batch of compounded medications from the New England Compounding Center, and it isn’t the first that has arisen from the practice of injecting steroids near the spinal column. Physicians are of differing opinions about whether the use of epidural steroid injections is ethical or even safe, and the recent health crisis is causing many regulatory bodies to look more closely at the practice.

Risks of Epidural Steroid Injections

Although steroid injections are approved for pain relief in joints, epidural injections of steroids aren’t endorsed by the FDA. However, it is common practice for physicians to recommend or use drug treatments that are not specifically intended for a particular purpose, and many patients report significant or total relief from crippling back pain, which sometimes spreads into the arms and legs. It is generally believed that epidural injections are safer than surgery or even drug treatments, which can lead to prescription pain medication addiction. Nevertheless, performing injections near the spinal column is a very tricky business; the physician risks causing permanent nerve damage, depriving the site of oxygen and even injecting the drug directly into the spinal fluid. There have been cases of chronic complications, including arachnoiditis (an inflammation of the membrane of the spinal column that leads to numbness, incontinence, sexual dysfunction and even paralysis) and even death.

Sufferers of chronic and debilitating back pain due to herniated discs are considered the appropriate recipients of epidural steroid injections, but a study in 2007 revealed that they make up less than half of the patients who receive this treatment. According to Dr. Laxmaiah Manchikanti, chairman of the International Society of Interventional Pain Physicians, only 20 percent of doctors performing this procedure have received the appropriate training.

Financial Incentive for Performing Epidural Steroid Injections

There might also be a financial incentive to perform these treatments as well. Medical insurers and Medicaid pay sometimes hundreds of dollars per injection, and there are clinics around the nation that are devoted to exclusively providing epidural steroid injections for back pain management.

It is believed by many physicians that steroids that are free of preservatives are less risky to patients than their counterparts. However, because preservative-free epidural steroid injections are not manufactured by drug companies, clinics and physicians must use compounded drugs, which are not heavily regulated and, as we have seen with the recent meningitis and tainted drug crisis, are vulnerable to contamination.

Sufferers of chronic back pain should seek multiple opinions on the best treatment course, and only submit to epidural injections after different therapies have been exhausted. The potential complications from epidural injections are scary, to say the least, it should be noted that they occur in only one in 10,000 cases, according to Dr. James P. Rathmell, who is involved in an FDA review of catastrophic neurological damage from injections.

Meningitis and Arachnoiditis Risks

New England Compounding Center: Contaminated Batches

It is very frightening to think that the medications and drug treatments we hope will help us when we are sick or injured might actually cause problems that are immeasurably worse than the problems they were meant to cure. Even though only three batches of the drug methylprednisolone acetate have been found to be tainted with the fungi Aspergillus and Exserohilum, the medical havoc those three batches have caused haven’t yet been fully understood, and new conditions, symptoms and illnesses are appearing every day. Unfortunately, it appears that meningitis was not the only condition to have arisen from this crisis. The contaminated medications from the New England Compounding Center have caused not only fatal outbreaks of fungal meningitis, but also another dangerous condition known as arachnoiditis, for which there is no cure, and very little treatment.

What is Arachnoiditis?

Arachnoiditis is an inflammation of the membranes surrounding the spinal cord. It can be caused by the introduction of a virus, bacteria, fungus or chemical into the spinal cord, or from spinal trauma or surgery. Arachnoiditis is extremely painful, and sufferers experience numerous debilitating symptoms, including difficulty controlling limbs, inability to sit for long periods of time, numbness, inability to walk for extended periods and inability to stand for long periods and burning pain in the legs and back. Many sufferers experience incontinence and sexual dysfunction.

Epidural Injections cause Arachnoiditis

Epidural injections (the injection of steroids or other medications near the spinal column) have long been the culprit of arachnoiditis. With the increase in steroid epidural injections, so came the increase of medical complications due to spinal trauma at the injection site. Although many back pain sufferers have experienced relief from sometimes crippling pain that can even radiate into the arms and legs, many physicians believe the technique is being overused. Until the meningitis outbreak, the risk of infection wasn’t being factored into an FDA review of the potential for catastrophic neurological injuries.

Treating Arachnoiditis

Arachnoiditis is a chronic condition. Treatments and pain management techniques vary, but surgery is discouraged because it is typically a painful procedure with long recovery time and only temporary relief. Many patients have had success with different physical and pain management therapies, but it is recommended that a specialist in the area be consulted because it is not a well known or widely experienced condition, and is often misdiagnosed as a pinched nerve.

Arachnoiditis Magnified Since Meningitis Outbreak

Although there doesn’t appear to be a great deal of research into the reversal of arachnoiditis, the recent health crisis might galvanize some activity. Now, most of the efforts of medical researchers seem to be in the arena of pain management in arachnoiditis sufferers rather than cure.

Arachnoiditis Symptoms

While the symptoms of and prognosis for arachnoiditis are scary, it should be noted that the severity of the symptoms varies significantly, depending upon the location of the inflammation. Some patients are able to lead a perfectly full life with the help of persistent emotional and physical therapies, as well as regular exercise.

Unregulated Status of Drug Compounding Pharmacies

Dangers of Improperly Handled Medications

Compounded drugs are nothing new. Doctors prescribe compounded drugs to treat specific conditions on an individual patient basis. For example, pharmacists compound certain drugs to reduce their potency in order to be administered to children, or change the method of drug delivery from tablet to patch form for patients that have trouble swallowing. However, the unregulated status of drug compounding pharmacies has alerted us to the dangers of improperly handled medications because of the tainted steroid medication that went on to be injected into patients and infect them with aggressive meningitis. It is important to educate ourselves about the ways in which our medications are processed in order to prevent serious infections and even worse.

Do not order drugs from overseas online pharmacies

The high cost of prescription medications has forced many patients to purchase their medicines from unregulated overseas pharmacies. It was reported by the National Association of Boards of Pharmacy that fully 97% of 10,000 online pharmacy websites that were investigated do not operate under United States pharmacy laws and regulations . These medications may seem as though they are the same as those that are acquired through hospitals and licensed clinics, but the batches of drugs distributed from these illegal operations might put users at great risk. Investigators found instances of tampering, improper handling and storage, expired drugs that were re-labled with inaccurate expiration dates and counterfeit medications. If an online pharmacy doesn’t require a prescription or medical history, then that pharmacy is operating illegally.

Ask your physician where the prescription medication came from, and if it was compounded

If you are prescribed medication by your doctor, ask him or her if it was compounded, and why. If there are standard FDA approved drugs available in a form that is ready to use, opt for that instead, although it will be very likely more expensive. Very often, physicians will choose the less expensive compounded form of a drug in lieu of the brand name drug. If your medication must be compounded, ask where it must be done; many hospitals compound drugs on site.

Do not allow a pharmacy to compound drugs for you without a specific doctor’s order

Many pharmacies will suggest compounding drugs that are problematic for the patient. Allowing a pharmacist to mix special versions of a medication that was prescribed by a doctor might have an effect unforeseen by the pharmacist that may compromise either the efficacy of the drug or the patient’s health; an effect a physician might catch if alerted to it. If you are having trouble taking medications for any reason, consult your doctor before allowing a pharmacist to make adjustments.