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.

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 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 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.

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.

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.

Dr Michael Omidi on Meningitis Outbreak

Dr Michael Omidi Discusses the Recent Meningitis Outbreak, as well as other illnesses that are now being linked to contaminated infections

The recent meningitis outbreak was the one of the biggest health disasters ever caused by a tainted drug. To date, more than 400 people have been infected, and 32 have died. Unfortunately, it seems that meningitis is not the only dangerous illness caused by the contaminated steroid injections; many patients are now suffering from epidural abscesses and arachnoiditis, even though the fungal meningitis seemed to be under control.

Epidural Abscesses and Arachnoiditis Linked to Contaminated Steroid Injections

Epidural abscesses are pus-filled inflammations of the spine or bones of the skull. These abscesses can be caused by bacterial or fungal infections and, in the cases of the contamination victims, can cause meningitis. Epidural abscesses are often found in patients who have had invasive back surgery, bone infections of the spine or are intravenous narcotics users.

Epidural Abscess Symptoms

The symptoms of epidural abscess are back pain, fever, weakness and incontinence. This condition can lead to very serious complications, including brain damage, bone infection and even paralysis. It is very important to seek medical treatment at the first signs of epidural abscess, although because the abscess might not be evident at the surface of the skin detection might be difficult. However, anyone suffering persistent back pain, nausea and fever should visit their doctor.

Arachnoiditis Symptoms

Arachnoiditis is a swelling of the membranes surrounding the spinal cord. This painful condition occurs when certain bacteria, chemicals or viruses are introduced to the spine, and can also be triggered by trauma or spinal surgery. This condition causes burning pain in the legs and back, spinal numbness, muscle cramping, loss of bladder and bowel function and even, in severe cases, paralysis. Treatments can be long and difficult, and typically consist of pain management exercises and, sometimes, psychotherapy. Arachnoiditis is a chronic condition with symptoms that can be made less severe with treatments, but never totally eliminated. Surgery is not widely used due to the fact that relief is only temporary and the procedures are very dangerous.

Fungal Meningitis Symptoms

Fungal meningitis is an aggressive form of meningitis that attacks the membranes covering the spinal cord and brain. Symptoms include nausea, light sensitivity, stiff neck, severe headaches and fever. Although the symptoms for fungal, bacterial and viral meningitis are the same, fungal and bacterial meningitis are medical emergencies, whereas viral meningitis often doesn’t require medical treatment. It is critically important to seek medical attention at the onset of these symptoms so immediate treatment can be administered. Meningitis, when left untreated, might lead to seizures, stroke, brain damage and hearing loss.

Moving Forward

It isn’t easy, perhaps even impossible, to predict what further medical complications may arise from this catastrophe. Unfortunately, even after the disgraceful sloppiness of compounding pharmacies became known, it is still common for citizens to order pharmaceuticals online from dubious sources. Hopefully, this disaster will open up public awareness about medical treatment practice, and cause both doctors and patients to scrutinize the origins of their drugs.


Dr. Michael Omidi is a philanthropist, whose charitable organizations include Animal Support and No More Poverty, both of which he founded with his brother Julian Omidi.