Fungal meningitis outbreak consumer voices speak 070713

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The Back Pain Dilemma in America

• The Institute of Medicine described chronic pain as “the most under treated problem in America”

• By 2011 state legislatures required physician ownership of outpatient surgical centers in an attempt to reduce costs

• Interventional Pain Medicine became big business without sufficient oversight, competing with other practice modalities

• Compounding drug manufacturing grew as a result to meet the demands of this new industry without sufficient FDA oversight or State control


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Theorizing The Problem

An estimated 14,000 – 16,000 tainted Steroid Injections (including Epidural Steroid Injections) were administered to 14,000 patients from the period of

May 26 through Sept 1, 2012. Meningitis Victim prior to her tainted ESI



75 Facilities in 24 states purchased contaminated NECC steroids & other products for redistribution to patients

4


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Methylprednisolone Acetate, Betamethasone &

Triamcinolone

• Are known causative agents for injury to the central nervous system

• Are contraindicated for intrathecal use and other non-indications due to known adverse events

• Intramuscular & intraarticular administration is approved for manufacturers operating under controlled practices, with clinical field trial data

• Produced under any condition, including custom compounding, these steroids do not meet the safe use criteria for epidural administration


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Characteristics of These Steroids

• When made “preservative free” by compounding pharmacies, these steroids have a very short shelf life and therefore are susceptible to poor shipping, storage & handling practices

• Depresses immune functions in humans which allows excessive growth of fungi and bacteria

• In non-muscle tissue, these effects are exacerbated for extended periods

• Provides a perfect growing medium for fungi and bacteria

• In the CNS, the body has no efficient way to overcome these effects


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Percutaneous Procedures Performed

These percutaneous procedures included injections into the cervical, thoracic, lumbar spine, and joints.

Types of injections* included transforaminal, interlaminar, caudal, trigger point, and intrajoint procedures.

In some clinics, this amounted to a rate of approximately 1 procedure performed every 15 minutes.*NQF Procedure 0309



Adverse EventsIncreasingly, interventional treatments that rely on epidural steroid injections (ESIs) for short term pain relief are associated with reports of:•Microbial Infections and Accidental Placement Errors (dural, arterial & vascular punctures, chemical, bacterial & fungal meningitis, arachnoiditis, epidural abscess, embolism, infarction & stroke, paralysis, paresis, paresthesia)•Reliance on off–label applications using unsafe supplies*,** •Under training & lack of supervision of physicians•Poor patient selection***•Over prescribed***

•*All 3 drugs have been contraindicated for intrathecal use. The same severe adverse events are listed for epidural use for Methylprednisolone Acetate (MPA) yet adequate warnings have not been issued for this application

•**FDA has not approved the use of any materials sourced from compounding manufacturers for epidural, intrathecal administration.

•***Dr. Manchikanti, Chairman of the American Society of Interventional Pain Physicians / Channel 5 Fox News “Nearly 64% of all ESI’s aren’t necessary”.



About these Materials• These injections are administered with corticosteroids of various

types. None have been through the vigorous approval process by the FDA for epidural administration and are not appropriate for any other use except intra muscular/articular and/or lesional injection. The FDA has contraindicated Methylprednisolone Acetate (MPA) for intrathecal use due to its known neurotoxicity and association with the onset of Arachnoiditis. However both the intrathecal and epidural routes of administration list the same severe adverse events in the US DataSheet but only the intrathecal route is cautioned. In fact the manufacturers of Depo-Medrol/MPA notified the FDA in 1988 and in 1989 of severe adverse events reported with epidural steroid use (Upjohn, letters to FDA, 1988 & 1989) and requested warning letters of notification be sent to all heavy users along with a thorough label change reflecting strict new warnings for epidural administration. Their request was denied both times by the FDA.

• In 2011 the FDA granted the makers of Triamcinolone (Kenalog) to add a black box warning: [NOT FOR EPIDURAL USE]



Consumer Presentations

Consumers (16 – 90+ yrs) received from 1-15 injections for a variety of acute and chronic pain conditions in the 12 months prior to the outbreak for:

Spondylolysthesis, Stenosis, Radiculopathy (NQF 0309), Complex Regional Dystrophy Syndrome, Multiple Sclerosis, Lupus, Carpal Tunnel, Plantar Fascitis, Degenerative Disc Disease, Sciatica, Failed Back Syndrome, Trauma from car accidents, Neural pain, CRPS, plus more unsubstantiated causalities.



Poor Procedural Technique

Contamination

Wrong Patient selection

Long Term Disability, Pain & Death



How Bad Can Things Go Wrong?

• Investigators wondered why fungus injected in the spinal region should target the base of the brain. “The observation of abundant fungi in the perivascular tissues, but relatively low numbers of fungi inside blood vessels, suggests migration of fungus into, rather than out of, vessels at this location. This supports the hypothesis that Exserohilum migrates from the lumbar spine to the brain through the cerebrospinal fluid with subsequent vascular invasion, rather than migration through the vasculature.”

– (Jana M. Ritter, DVM, CDC’s Infectious Diseases Pathology Branch)



You Tell Us


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$78,447.00 Out Of Pocket costs to date and now

suffers from Arachnoiditis and intractable pain.

Meningitis Victim After Her Tainted ESI


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Associated Secondary Lifetime Disabilities

• Arachnoiditis• Cauda Equina

Syndrome• Permanent Neural

Impairment• Stroke• CRPS – Reflex

Sympathetic Dystrophy

• CNS Disturbances

• Chronic Intractable Pain

• Transplant & Dialysis • PTSD• Generalized Anxiety• Liver & Kidney Failure• Destabilization of

Musculoskeletal Mechanisms


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Unmet, Unfunded Needs

• Rehabilitation• Medical Monitoring• Transplant Services• Dialysis Services• Mental Health

Services• Speech Therapy• Medical & Implantable

Devices• Case Finding

• Assistive Technology• Nursing Care• Medications• Home Health Services• Legal Advocacy• Integrated Pain

Management• Coordinated Health

Care



NECC Doses Distributed : Patient Reporting Rates of Fungal Infection*

NO Reports to CDC despite presence of sick consumers

0/1287 doses delivered

2579

2753

659

457

445 25750/182

0/704

3125

261512880/80

986

3201383

915

0/45

12652345

9473024

4169

0/148

1309

200

17

*http://www.cdc.gov/hai/outbreaks/clinicians/casedef_multistate_outbreak.htmlp://www.cdc.gov/hai/outbreaks/meningitis-map-


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We Refuse to be Invisible• Reach across the aisle - move compounding

safety legislation forward • Find all those who have been exposed but

ignored so that they too can be finally diagnosed & treated

• Create victims funding • Make adverse event reporting mandatory for

ESI’s• Stop authorizing public payment for unsafe

medical practices• Ask FDA and HHS-CMMS to take action on

unsafe epidural steroid injection therapies


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Exposure Related IllnessIf you or a loved one acquired ANY of these symptoms since the steroid injection(s); Meningitis, Stroke, Discitis, Phlegmon, Paraspinal Infections, Bone or Joint Infection, Pulmonary or Sinus Infections, Autoimmune Disorders, Urticaria Vasculitis, Epidural Site Infection, Intramuscular Abscesses, Skin Rashes, Spleen Infections, Persistent Headache, Hair Loss, Vision Disturbance, Eye Infections, Death, contact your State Health Agency at once then file a MedWatch Report with the FDA:http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm354560.htm

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Fungal meningitis outbreak consumer voices speak 070713

Health & Medicine

epidural use

epidural administration

intrathecal use

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intrathecal administration

severe adverse events

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