Meningitis Outbreak Patients Face Large Medical Bills

For the victims of the fungal meningitis outbreak of last year, the suffering has yet to end. 

In addition to suffering from a painful and life-threatening illness, the victims of the meningitis outbreak have one more hurdle to jump: massive medical bills.

It was reported that many sufferers of the fungal meningitis outbreak that was the result of contaminated vials of injectable steroid have to sort through medical bills for medications and treatments that their insurers do not cover, such as MRIs that will detect if there are any spinal complications. Some of the powerful antifungal drugs were charged at $8000 per injection. Some patients needed up to three such shots per day.

The bills range from a few thousand dollars to more than $200,000. There are many lawsuits against the compounding pharmacy (New England Compounding Center) that manufactured and distributed the medication, but since the pharmacy declared bankruptcy, those lawsuits have been delayed for an indeterminate period of time. In the meantime, patients must struggle to cope with bills that they are far from able to afford.

Many of the patients aren’t out of the woods yet. Many still suffer from debilitating pain and lingering infections.

At St. Thomas Health, a Tennessee hospital and neurosurgical center that is treating many of the fungal meningitis victims, representatives say that they are working with patients and their insurers to offset some of the financial burden of the extensive treatments. However, since the medical center also administered the tainted epidural shots, it is the belief of many of the attorneys that the hospital should bear all of the responsibility. According to attorney Mark Chalos, “For the people who got sick from tainted injections at St. Thomas, St. Thomas is now charging tens of thousands of dollars to treat them.” Mr. Chalos contends that the medical center purchased inferior compounded medications at $6.60 per dose, and charged $1000; sometimes more.

The home care bills for many of the victims can exceed $7000 monthly. The antifungal treatments cause significant fatigue and hallucinations, even after treatments have stopped, since the medications take awhile to exit the system. Many patients continually suffer from severe back pain that renders them unable to drive or even care for themselves.

One patient, Amarjit Deol, who was admitted to the hospital after suffering partial blindness, loss of motor function and severe pain, was told she wasn’t allowed to leave until she paid the $950 for medications she would need for aftercare. Only after she negotiated a payment of approximately one third of the bill was she released.

To add insult to injury, Mrs. Deol received a letter from Medicare stating that it would recover the costs of the payments if she won any award from a claim against the compounding pharmacy or the medical center from which she received her epidural injections. To date, she has not even filed any lawsuits.[1]

---

[1] Roche, Walter: Many Meningitis Victims Owe Tens of Thousands in Bills USA Today 4/3/2013 http://www.usatoday.com/story/news/nation/2013/04/03/fungal-meningitis-costs/2048843/

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

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

---

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/

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 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.

Meningitis Watchdog Group - Public Citizen

Meningitis Outbreak could spark new legislation

The catastrophic meningitis outbreak has brought on efforts to enact new legislation regarding the inspection and regulation of compounding pharmacies. Although the states have the ultimate authority in the matter of policing compounding pharmacy practices, the FDA has been called upon to review the pharmacies that have, in the past, violated best practices.

The watchdog group, Public Citizen, sent a letter to the FDA asking that agents be sent to six compounding pharmacies that have received warning letters from the years 2003 to 2012. The violations that caused the issuance of the warning letters included:

• Creating and distributing vast quantities of drugs
• Creating and distributing drugs without individual patient prescriptions
• Fabricating copies of drugs that are commercially available
• Manufacturing drugs using ingredients that are not FDA approved
• Maintaining improperly sanitized facilities and equipment
• Employing improperly trained staff

According to the letters issued by the FDA to the offending pharmacies, there have been examples of patients being sickened or even killed by solutions of dextrose that had been contaminated by microorganisms, and one inspection uncovered a pharmacy using an ingredient found in industrial cleaners in an injectable drug.

The letter also requests that all documentation and reports concerning the inspection of compounding pharmacies be released to the public for review. This includes not only the pharmacies that have received warning letters, but all 483 reports since 2003.

There are other areas that might merit further investigation, namely Medicaid and Medicare coverage policies. Public Citizen, a nonprofit organization that acts as a people’s advocate, sent a letter earlier in November, 2012, suggesting that reimbursement policies for compounding pharmacies created by Medicare and Medicaid were actually financial incentives. Because the Centers for Medicare and Medicaid services routinely cover compounded drugs, compounding pharmacies were able to create large scale manufacturing operations that might not have been otherwise possible. According to the letter, the following areas warrant examination:

• The fact that the Centers for Medicare and Medicaid services (CMS) guidance documents prohibit covering compounded medications that have not been approved by or in violation of the FDA, yet later state that Medicare and Medicaid can continue coverage until either the FDA or CMS specifically take action against reimbursement.
• The fact that the CMS denies coverage of compounded inhalation drugs but not other large scale compounded drugs.
• The fact that some CMS carriers have approved coverage for compounded drugs that are administered near the spine by an implanted pump.

According to Dr. Michael Carome, the deputy director of Public Citizen’s Health Research Group, the CMS policies have actually encouraged compounding pharmacies to produce large quantities of dangerous drugs. “An independent investigation is necessary to determine exactly how these policies contributed to the current meningitis outbreak and to prevent a similar tragedy from happening in the future,” he says.

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 Regulatory Failures

FOIA Reveals Compounding Pharmacies Supplied Thousands of Tainted Vials

Documents that were recently released in response to the Freedom of Information Act revealed that the compounding pharmacy that supplied thousands of tainted vials of methylprednisolone acetate had thwarted or side-stepped Food and Drug Administration attempts to regulate its practices for more than ten years. It was also revealed that the efforts that were made by the agency were ineffective, since regulatory jurisdiction of compounding pharmacies lies with the states, not the federal government.

The documents show that the compounding pharmacy, New England Compounding Center in Massachusetts, would frequently refuse to release documents to the FDA, continue to distribute drugs that were under investigation and often refute the legal authority of the FDA to regulate it. There are examples of the compounding center pharmacists willfully giving inspectors false information and concealing the fact that unapproved drugs were being supplied. After becoming aware that the New England Compounding Center was distributing an unapproved eye surgery dye called trypan blue, the FDA inspectors were told that there was none in stock. However, a supply was later found in the clean room of the facility. The chief pharmacist told the agency that NECC would continue to distribute trypan blue, and the FDA had no legal authority to stop it.

There were warnings of potential health risks from the practices of the New England Compounding Center as far back as 2002, and according to a memo summarizing a meeting held with Massachusetts regulators, there was a “potential for serious public health consequences if N.E.C.C.’s compounding practices, in particular those relating to sterile products, are not improved.”

The FDA, however, often failed to act upon its findings in a timely manner. One inspection didn’t result in a report until nearly two years later, when many of the practices that were cited were no longer in operation.

Because compounding pharmacies were never meant to act as national drug manufacturers, there are no actions or regulations in place to govern them. Compounding pharmacies exist in order to provide physicians with specially mixed medications by request; they are not supposed to manufacture drugs for mass distribution, but that is exactly what many of these companies are doing. In order for a compounding pharmacy to come under the jurisdiction of the federal government, it must be proven that the pharmacy is actually manufacturing drugs, but since these pharmacies are legally able to withhold their own records, proof is very difficult to obtain. Drug manufacturers are heavily regulated by the Food and Drug Administration—they must periodically submit to inspections, provide detailed documentation and only distribute drugs that have been approved. Compounding pharmacies are not bound by any of these regulations.

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 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.

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.