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.

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.

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.