Students Required to Receive Meningitis Vaccine

Tennessee was one of the hardest hit states by the fungal meningitis outbreak, leading to the passing of the Jacob Nunley Act requiring students a public colleges to be vaccinated for meningitis. 

During the meningitis outbreak Tennessee was one of the states hardest hit; [1] of the 730 cases of meningitis across the United States, Tennessee reported 150 cases of meningitis with only Michigan having more cases at 259. As a result of the number of cases that were experienced in Tennessee the "Jacob Nunley Act" was brought before the Tennessee House of Representatives.

The "Jacob Nunley Act," named after Jacob Nunley, a student at Middle Tennessee State University who lost his life as a result of the meningitis outbreak, will require that studetns at public universities and colleges will be required to receive a vaccination for meningococcal disease. This measure will not extend to any private universities, however. [2]

After being approved by the state Senate, the state House of Representatives approved the measure with only one dissenting vote. In states that were equally hard hit such as Michigan, Indiana, Virginia, and New Jersey a similar law may be proposed in order to protect students.

Bacterial meningitis can be spread through respiratory droplets because bacteria that cause meningitis often colonize in the throat and nose. Viral meningitis can be spread in the same manner as well as through fecal-oral routes. As a result of many college students living in close proximity to one another in on-campus dorm rooms or off-campus apartment complexes, the spread of meningitis can be more virulent, even though those that are at potential danger for spreading of the disease are those that live or work within roughly three feet.

[1] http://www.cdc.gov/hai/outbreaks/meningitis-map-large.html
[2] http://www.insidevandy.com/news/article_aa63c30c-9ce2-11e2-a152-0019bb30f31a.html

Epidural Steroid Injections Could Cause More Harm Than Good

For many with chronic back pain, epidural injections are the only reliable source of relief.  However, a recently published study suggests that consistent administrations of steroid could result in more harm than good.  In the following article, Dr. Michael Omidi discusses the study, as well as the possible complications that could arise from the steroid treatments.

The recent fungal meningitis outbreak was caused by a tainted batch of injectable steroids (methylprednisolone acetate) meant for the treatment of chronic back pain. Now, according to a new study, it seems that the back problems that the steroid was meant to relieve might actually be made worse by the epidural injections [1].

In a study that was recently published in the journal Spine, a group of physicians followed 276 patients from the ages of 53-75 with more or less similar degrees of chronic back pain for four years. Of the 276 subjects, 69 received epidural steroid injections as a part of pain management therapy, while the remaining 207 did not. The authors of the study expected to see a wider variation of painful symptoms in the subjects who had not had epidural injections versus those who did. Instead, it seems that the subjects that underwent epidural injections displayed considerably less improvement after corrective surgical procedures than those who did not. 

The study was too small to draw any concrete conclusions, but it does seem that the steroid injections might hamper the healing process post surgery.

The subjects were all suffering from spinal stenosis, a condition wherein the open spaces within the spine gradually narrow, putting pressure on the spinal cord and causing sometimes extreme pain. The steroid injections ease the pain temporarily by surrounding the conflicted nerves.

Because spinal stenosis is a degenerative condition, the addition of the steroids may facilitate that degeneration, making the prognosis after surgery more grave than if the treatment was never administered.

Epidural injections are only recommended for patients who suffer from crippling back pain that may also spread to the arms, legs and head. These injections are not meant to cure the condition; only to make the symptoms more bearable. However, it is estimated that only approximately half of all the patients who receive epidural injections for treatment of back pain derive significant pain relief.

It should be noted that steroid injections should be viewed as a last resort in the event that other physical therapies and medications prove ineffective.

The injectable steroid used in such epidural injections that caused the fungal meningitis outbreak was methylprednisolone acetate, a steroid that was obtained through compounding pharmacies because FDA-regulated drug manufacturers do not make a version of the drug without preservatives.  The compounding pharmacy that was responsible for the contamination of the drug that was distributed to thousands of clinics throughout the nation has since declared bankruptcy.

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[1] Bakalar, Nicholas: Back Pain Unrelieved By Steroid Shots New York Times 3/5/2013 http://well.blogs.nytimes.com/2013/03/05/back-pain-unrelieved-by-steroid-shots/?ref=health

Facilitating Full Recovery after Fungal Meningitis

Unfortunately, people who have recovered from fungal meningitis are not out of the woods just yet; full recovery can take anywhere from six months to a full year – and that is without additional infections. In the following article, Dr. Michael Omidi discusses how to care for oneself, how to facilitate full recovery, and what symptoms to watch out for.

When the fungal meningitis outbreak first hit, it was estimated that patients exposed to the tainted steroid who hadn’t developed symptoms of fungal meningitis would be in the clear, so to speak, if they continued to by symptom-free by mid January. However, different medical experts have produced different timelines, and some believe that it is very possible to still come down with the potentially deadly illness even today.

Fungal meningitis is an especially virulent strain of meningitis that is difficult to treat. The medications that have proved effective unfortunately also trigger severe side effects, so they are not ideal for older people or people with compromised immune systems. Long term exposure to the anti-fungal drugs can actually cause kidney damage. The people who were exposed to this illness were people who were receiving treatments for chronic back pain, many of whom were older persons that are less capable of tolerating or warding off potential complications.[1]

If you have been exposed to fungal meningitis through exposure to the tainted batch of steroids, make sure you visit your doctor if you experience persistent headaches, back pain, leg pain, confusion, neck stiffness, pain, or nausea.

Treatments for fungal meningitis are long and arduous; they require more or less constant monitoring and administration of anti-fungal medications. Additionally, there are other medical complications that can arise, namely epidural abscesses and arachnoiditis.

Epidural abscesses are inflammations near the site of the epidural injection and are often undetectable since they are far below the surface of the skin. Patients often can’t distinguish pain caused by the abscess from the pain caused by meningitis. These abscesses can cause severe pain and limited mobility and they must be drained. Dead tissue must be removed surgically and months of anti-fungal medications must be administered in order to clear the infection.

Arachnoiditis is a serious, chronic neurological condition caused by trauma or infection of the arachnoid, a membrane surrounding the spinal column. Patients with arachnoiditis are often in constant pain and unable to stand or sit for long periods of time, in some cases even experiencing incontinence. There is no cure for arachnoiditis; patients must undergo consistent pain management therapy and treatment.

If you are recovering from fungal meningitis, make sure you continue taking your medications exactly as your physician instructed. Try your best to avoid further infections from other sources; wash your hands regularly and keep your countertops and surfaces clean and sterilized. If you can’t detect any improvement or your medications don’t seem to be having any effect, see your doctor immediately.  If you become confused, develop seizures or a fever, or it becomes difficult for you to be roused from sleep, call 911.

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[1] Goodman, Brenda: Fungal Meningitis Patients: A Long Road to Recovery WebMD 12/26/2012 http://www.webmd.com/news/20121226/fungal-meningitis-victims-recovery

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

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.

Unregulated Compounding Pharmacies

Sometimes, tragedy has to strike before action is taken

For the past two decades, the United States congress has been pressured to enact regulations on compounding pharmacies that act as manufacturers of specialty medications. Rather than submitting to the same regulations as standard drug manufacturers, compounding pharmacies were not seen as “manufacturers,” even though they were creating pharmaceuticals for distribution to medical facilities.

How is it different? Both manufacturers and compounding pharmacies are supplying medications to the public for consumption. However, compounding pharmacies are not supposed to be making large batches of medications and distributing them as substitutions for FDA approved pharmaceuticals—and yet, that is exactly what these pharmacies were doing.

Unregulated Compounding Pharmacies

Before the deadly meningitis outbreak, before it became clear that numerous unregulated compounding pharmacies were operating under questionable and, sometimes, downright unsanitary conditions, compounded medications were seen as a perfectly legitimate and less expensive alternative to standard brand-name drugs. Many members of congress and several advocacy groups touted compounding pharmacies as a trustworthy alternative to big drug companies. During drug shortages, compounding pharmacies were often called upon to mix alternative versions of needed medications. As the practice became more commonplace, and the option of cheaper and easily accessible compounded drugs became more enticing, compounding pharmacies became small-scale manufacturers. Eventually, they were accused of copying legitimately manufactured drugs and distributing them cheaply. The reason for the disparity in price was due to the fact that compounding pharmacies use ingredients from unapproved sources.

There have been previous examples of contaminated or dubious medications from compounding pharmacies; a compounding pharmacy in South Carolina was responsible for several illnesses and one death from a batch of contaminated medication; in 2001, the FDA examined samples from 12 different pharmacies and discovered that 30% did not pass quality tests.

Because compounding pharmacies are not under the jurisdiction of the FDA, the FDA has no power to regulate them. State boards of health are responsible for policing them, but often choose not to; only two states—Texas and Missouri—issue random tests of compounded drugs. The only way a compounding pharmacy is made to follow FDA regulations is if that pharmacy is found to be manufacturing drugs. The only way the FDA can determine whether or not a pharmacy is manufacturing drugs is to look at records of the volume of compounded drugs shipped, which the pharmacies insist that the federal government has no right to do. In fact, often the only way the FDA even becomes aware of tainted products from compounding pharmacies is to read about pharmaceutical related illnesses in the news, or if the victims report to them directly. Unlike drug manufacturers, compounding pharmacies are not obligated to report instances of product causing patients harm.

Physician reported to state health department about tainted batches of steroids months ago

Several months ago, a physician made her state health department aware of a tainted batch of methylprednisolone acetate, a steroid that is injected near the spinal column in order to treat some forms of chronic back pain, which seemed to be causing a violent form of fungal meningitis. This fungus was highly resistant to conventional forms of treatment, and finds the brain tissue the most hospitable environment, since the brain has low resistance to infection. Samples of the fungus have been difficult to detect in the infected patients; the most common and accurate method of detection has been extracting and testing spinal fluid. So what is this fungus, and how did it get into these medications?

Exserohilum rostratum: Cause of Infections

The fungus that caused these infections is called Exserohilum rostratum. It is highly resistant to the drug treatments, and because it is a pathogen that normally feeds on plant matter, it hasn’t received much research. It exists primarily in tropical and sub-tropical regions, but even though the laboratory was in New England, the messy environment would still be inviting to the fungus, which is airborne, and can travel in the winds from southern regions during the warmer months.

E. rostratum primarily attacks grasses. Plants have natural defensive mechanisms in place to keep the fungus from totally destroying them, but they cannot kill it outright. The fungus is like a vulture; it exists on plants and waits until the plant dies before it feeds on the remains. It can multiply very quickly; a colony can develop from a single spore in as little as two days.

What caused the meningitis outbreak?

While E. rostratum is almost never the cause of eye or sinus infections, there are increasing examples of this spore, and others related to it, causing more soft tissue infections than had ever been previously seen. Nevertheless, when the fungus was injected directly into the spinal column, it was easily carried by the spinal fluid—a nutritious and comfortable environment for the spores—into the brain, where it may have caused the strokes that killed some of the infected patients.

The sloppy conditions in which the medications were compounded would have been a welcoming environment for the spores, which can accumulate on lawn clippings and launch themselves into the air via a natural static electricity-based ejection mechanism. The fact that they got into the vials of medication isn’t surprising, under the circumstances, but why did they only contaminate some of the batches and not all of them? It is speculated that the spores were blown into the air from a nearby source on only one windy day, but no one yet knows the exact cause.

Fungal Meningitis: Dr. Pettit discuses her patients story

In September of this year, a patient with an unusually virulent case of meningitis came to the attention of Dr. April Pettit. After having been administered antibiotics, the usual treatment for bacterial meningitis, this patient did not seem to be getting better; in fact, he was steadily deteriorating. Unsure of the kind of strain she was dealing with, Dr. Pettit sent a sample of the patient’s spinal fluid for testing. The results were surprising, to say the least.

Test Results: Fungal Meningitis

The lab reported that the meningitis was of the fungal variety. Fungal meningitis is not transmissible from person to person, and is extremely difficult to diagnose; fungal meningitis can trigger strokes, and physicians do not necessarily examine stroke patients for infections. Dr. Pettit asked the patient’s family (the patient was, by now, too weak to speak)if he had received an injection for chronic back pain into his spine. Dr. Pettit immediately called the state health department with this information.

Spinal Steroid Injections Contaminated

Spinal steroid injections for treatment of back pain are a common practice; millions of people undergo this procedure every year. The steroid medication in question, methylprednisolone acetate, was contaminated in the compounding pharmacy from which it originated. Compounding pharmacies are laboratories that prepare drug solutions for clinics and hospitals. These facilities commonly mix different drugs in accordance with a particular physician’s prescriptions. These solutions are not necessarily meant for large scale consumption, but nevertheless, many compounding pharmacies mix large batches of drugs that are, in turn, purchased by hospitals and clinics. These solutions are not regulated by the Food and Drug Administration, and compounding pharmacies do not have to adhere to the same rigorous safety regulations as do regular drug manufacturing companies. These compounding pharmacies open sterile vials of drugs from the manufacturer and mix them with other solutions or repackage them in smaller doses, leaving them vulnerable to contamination. Injectable medications must be mixed in sterile conditions—the surrounding air must be sterilized as well as the surfaces—since the body cannot fight off infections introduced directly into the circulatory system as efficiently as it can through the gastrointestinal tract.

Why Hospitals Purchase from Compounding Facilities

Why would hospitals purchase large batches of unregulated, dubious drugs? Perhaps because these compounded drugs are often cheaper than the pharmaceuticals from large drug companies, or because these specialty drugs are otherwise difficult to obtain. Whatever the reasons may be, compounding is meant to be for a specific patient’s needs, not a one-size-fits-all practice.

So contaminated "it could be seen with the naked eye"

When the vials of methylprednisolone acetate were examined, the fungal contamination was so virulent it could be seen with the naked eye. Before the outbreak was discovered, more than 17,000 vials of contaminated methylprednisolone acetate were shipped to clinics and hospitals in 23 states. To date, 32 people have died as a result of exposure to the contaminated drug, including Dr. April Pettit’s patient.