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.