No Link Between Meningitis Outbreak in New York and Los Angeles Say Health Officials

Concern has been raised over possible meningitis outbreaks in Los Angeles and New York City, but health officials are stating that there is no connection between them. 

There have been concerns raised between a meningitis outbreak that has occurred in New York, infecting as many as two dozen people and resulting in the deaths of seven, and a death caused by meningitis in LA County. A recent press release from Los Angeles County Department of Public Health has announced the findings of its investigation into the death of Brett Shaad who passed away as a result of meningococcal meningitis. The findings stated that Public Health "has not identified any other cases of meningococcal disease associated with this patient nor identified any linkage between this patient and cases being reported in other areas of the country."

The primary concern was the possible link between an outbreak in Los Angeles and the meningitis outbreak in New York City that has claimed the lives of seven men over the last two years.

The possibility of an outbreak in Los Angeles led to groups, and eventually local health officials, providing residents with meningitis vaccines. City Councilman John Duran and the AIDS Healthcare Foundation strongly urged for vaccination, which was provided to over 3,000 people during the initiative.

For those concerned about contracting meningitis in Los Angeles or New York City you can learn more about the issue in this NBC News article.

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

New Jersey Pharmacy Recalls Drugs Due to Mold

Similar to the events of the fungal meningitis outbreak of September 2012, a compounding pharmacy has recalled a number of drugs due to mold contamination. Michael Omidi examines the recall and the reasons behind it.

A compounding pharmacy in New Jersey, Med Prep Consulting Inc., recently announced a recall of their products including drugs utilized in surgeries and labor as well as pain relievers and antibiotics, leading the United States Food and Drug Administration (FDA) to issue warnings to medical and healthcare professionals.

The recall is not a result of illnesses being reported as in the case of the fungal meningitis outbreak caused by products from the New England Compounding Center, but there is concern from the FDA that the mold contamination found in the products could result in illness for patients. The FDA is currently working with health officials in the states of New Jersey and Connecticut to isolate any potential contamination.

The products that are being recalled are used for those that are hospitalized inpatient or outpatient and are only provided by trained healthcare professionals at facilities, practices, or clinics. None of the products are directly released to patients for at-home use or self-administration.


All of the facilities that have received the products believed to be contaminated have been notified and a full list of the products that have been recalled can be found in a press release from Med Prep on the FDA website. 

Epidural Steroid Injections Could Cause More Harm Than Good

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

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

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

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

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

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

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

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

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

---

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

Facilitating Full Recovery after Fungal Meningitis

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

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

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

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

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

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

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

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

---

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

Controversy in Culpability Surrounding Meningitis Outbreak

Because the fungal meningitis outbreak was so catastrophic in terms of lives lost and pain needlessly suffered, it was only a matter of time before survivors began to seek remuneration from the parties responsible. Not only are the owners of the compounding pharmacy being sued, many of the physicians who administered the tainted shots are also facing litigation.

While it cannot be denied that the blame for the fungal meningitis disaster lays at the feet of a compounding pharmacy that flouted not only governmental regulations, but also basic pharmaceutical practices of health, safety and due diligence, many patients are nonetheless beginning to wonder if the clinics that administered the tainted shots shouldn’t bear some responsibility as well.

The entire matter is extremely delicate. While it is true that the New England Compounding Center was woefully inept at maintaining an environment suitable for the production of an extremely delicate and difficult to manufacture drug, the Massachusetts regulatory boards did little, if anything to oversee or police their practices. The NECC was inspected several times by the FDA as well as state board officials, who issued warnings and concerns that were completely ignored, and yet the regulatory bodies did nothing to follow up on those warnings, leaving thousands of patients in jeopardy.

One of the main reasons compounding pharmacies distribute so many vials of epidural steroid is because many physicians believe in the studies that report of the dangers of using injectable drugs that contain preservatives. While there are many conflicting studies regarding the potential hazards of preservatives in injectable applications, the crux of the objection to the commonly used pharmaceutical preservatives is that they may trigger outbreaks of arachnoiditis, an incurable inflammation of the arachnoid membrane which surrounds the spinal column. This condition is painful, chronic, has debilitating side effects, and requires more or less constant pain management therapy and treatment. Injectable steroids that do not contain preservatives can only be obtained through compounding pharmacies, not FDA regulated drug companies.

The lack of chemical preservatives, however, leaves these drugs extremely vulnerable to bacterial and fungal contamination. If improperly stored, these vials of medicines can turn into a breeding ground for all types of microbes. As we have seen, this can have disastrous consequences.

It has been reported that the injectable steroids that were distributed from the NECC were so contaminated that matter could be seen in the vials with the naked eye. If this was the case, is it then possible that the physicians who continued to use these obviously problematic drugs could then be partially culpable for the fungal meningitis outbreak?

Perhaps there is enough blame to go around. Unfortunately for the victims, the NECC, having declared bankruptcy, simply does not have the money to compensate the victims adequately, and legal experts have clearly advised their clients to seek compensation where they can: from the physicians and medical centers.

It is impossible to know the extent of the culpability of the individual doctors and treatment centers. If it can be proven that these drugs were administered even after it was suspected that there could be something wrong with them, then perhaps the victims have a point. However, for doctors acting in good faith with the sincere desire to alleviate the pain and suffering of their patients, it would be unfortunate to be painted with the same brush as a negligent compounding pharmacy.

Steroid That Led to Meningitis Outbreak Difficult to Sterilize

Dr. Michael Omidi examines the difficulty in properly manufacturing the drug methylprednisolone acetate, an injectible steroid that is very vulnerable to contamination. As Dr. Michael Omidi explains, this drug was the catalyst for the recent outbreak of meningitis.  

Methylprednisolone acetate, the injectible steroid that was the catalyst for the recent outbreak of fungal meningitis, is an extremely difficult drug to manufacture properly due to the fact that it cannot be sterilized through traditional means. It cannot be heated – which would kill any microbial contaminants but seriously degrade the drug itself – and it cannot be filtered, since the drug contains crystalline particles that would also be removed.[1]

Contamination of methylprednisolone acetate has particularly devastating after-effects, since this drug remains in the system for months, and also causes the suppression of the immune-defense system.  If bacteria or fungal matter is incorporated into the mix, both the drug and the spinal fluid (if it is used in an epidural application) tend to actually fertilize the microbes, allowing them to flourish and spread throughout the body and potentially into the brain.

The recent fungal meningitis outbreaks were not the first examples of fatalities that resulted from tainted injectible steroids.  In 2001, three people in Northern California died after having received an injection of contaminated betamethasone from a compounding pharmacy.  A South Carolina compounding pharmacy issued contaminated injectible steroids which resulted in infecting seven people and killing two in 2002.  More recently, a Florida compounding pharmacy distributed contaminated steroids that caused severe vision damage to 13 patients in March of 2012.

The fact that compounding pharmacies receive their methylprednisolone from suppliers overseas (China and India) that do not have to adhere to the standards of U.S. drug companies is a cause for concern.  Active Pharmaceutical Ingredients come from suppliers grossly contaminated.  Nonetheless, it is the compounding pharmacy’s obligation to sterilize the product before incorporating it into anything meant for distribution, but the sterilization practices are often lacking. 

The fact that compounding pharmacy practices are not regulated by the Food and Drug Administration, but by overburdened state agencies, means that compounding pharmacies can operate without any significant policing.  The NECC (New England Compounding Center) demonstrated stunningly negligent sterilization practices; the clean room was kept at drastically varying temperatures, there was debris circulating throughout the facilities from a nearby recycling plant and there was evidence of bacterial growth and mold on many of the clean room surfaces.

One of the reasons that hospitals and clinics consistently used compounding pharmacy drugs was that the injectible steroids distributed by compounding pharmacies do not contain preservatives, while the FDA-approved drug manufacturing company products do.  Preservatives are thought to possibly contribute to permanent nerve damage in patients, as well as pose a risk for brain damage in premature babies.

Unfortunately, very little was known about the fungus that caused the outbreak, E. rostratum, and it wasn’t considered to be effectively parasitic in humans.  This lack of expertise led to the medical community being poorly equipped to handle the illnesses, and as a result, many older or immune-deficient patients had to be given doses of antifungal medications that caused severe side effects.

As consumers, we like to research the products we put into our bodies, and make sure that we are getting the highest quality practicable.  However, how can we control the types of medications we have administered to us when we are in need of medical attention?  Hopefully, the different governing agencies, both local and federal, will not soon forget this medical crisis, and try to be more diligent when it comes to the wide distributions of medicines that are supposed to help, not hurt us.

By Dr. Michael Omidi 

---

[1] Brown, David: The Drug in Fungal Meningitis Cases is Hard to Make and Unusually Dangerous When Contaminated The Washington Post 2/8/2013 http://articles.washingtonpost.com/2013-02-08/national/36984968_1_methylprednisolone-acetate-exserohilum-betamethasone