Fungal meningitis outbreak consumer voices speak 070713


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The consumer experience for outcomes associated with the fungal meningitis outbreak,

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  • Institute of Medicine (IOM) Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research Released: June 29, 2011 Type: Consensus Report Topics: Education , Public Health , Select Populations and Health Disparities Activity: Advancing Pain Research, Care, and Education Board: Board on Health Sciences Policy American Society of Interventional Pain Physicians (ASIPP) International Spine Intervention Society (ISIS) International Association of Compounding Pharmacists (IACP)
  • Consumer picture released by permission
  • , p.8. All 3 medications are approved for topical, intramuscular, skin injections, and joint injections where there is a synovial space. Triamcinolone is specifically contraindicated for epidural and intrathecal use. Not one of the 3, produced under conditions of compounding manufacturing are label approved or field tested and clinically tried for these applications. None are FDA approved.
  • *FDA has approved the uses suggested by registered manufacturers labels for these medications but has failed to adopt their language about ‘routes of administration.’ The manufacturers warn against the use of routes of administration other than those for which the drugs have been approved, which would include steroid injections into the epidural AND intrathecal space. By adopting language that prohibits intrathecal injection but omits epidural injection as a route of administration, some may infer that epidural injection falls into a class of ‘joint infections or soft tissue injections.’ Joint injections require a synovial space, not present in the spinal column. Soft tissue injections (intradermal, intramuscular) require a mediating blood supply. While joints are specifically named and targeted on the manufacturer’s labels, FDA’s omission has created a glaring gap in WARN language. (This gap is reflected in which embraces the epidural route of administration for these three steroids despite all three manufacturers precautions against injection into body systems other than intradermal, intramuscular, synovial joint space. Systemic and intravenous routes of administration are not recommended for use. All three manufacturers acknowledge the opportunity for extreme accidentality associated with placement of steroids into the intrathecal space, which can only occur through the route of epidural administration. FDA has failed to universally adopt precautionary language against the use of these medications for epidural steroid injection by any method- Triamcinolone contains the manufacturer’s precautions, yet Depo Medrol (Pfizer/Upjohn) and Betamethasone, do not. Pfizer specifically requested this change in 2002, but FDA failed to incorporate the language. **FDA is not responsible for, and has not approved the use of materials sourced from compounding manufacturers for: intradermal or intralesion injection, intramuscular injection, intraocular injection, epidural route of administration, intrathecal injection, or joint (synovial space) injections. ***FDA does not regulate the treatment decisions of physicians who use registered medications. Physician standards and practices are monitored by the Center for Medicare Services (CMS) Adverse events associated with these medications go largely unreported and unresponded to. There appears to be a large and glaring responsibility and communication gap between FDA’s AERS system, the safe use initiative authority, and CMMS standards, practices and payment authorities.
  • Consumer voices
  • Consumer pictures released by permission
  • Probable Case. A person who received a preservative-free methylprednisolone acetate (MPA) injection, with preservative-free MPA that definitely or likely came from one of the following three lots produced by the New England Compounding Center (NECC) [05212012@68, 06292012@26, 08102012@51] , and subsequently developed any of the following: Meningitis 1 of unknown etiology following epidural or paraspinal injection 2 after May 21, 2012; Posterior circulation stroke without a cardioembolic source and without documentation of a normal cerebrospinal fluid (CSF) profile, following epidural or paraspinal injection 2 after May 21, 2012; 3 Osteomyelitis, abscess or other infection (e.g., soft tissue infection) of unknown etiology, in the spinal or paraspinal structures at or near the site of injection following epidural or paraspinal injection2 after May 21, 2012; or Osteomyelitis or worsening inflammatory arthritis of a peripheral joint (e.g., knee, shoulder, or ankle) of unknown etiology diagnosed following joint injection after May 21, 2012. 1 Clinically diagnosed meningitis with one or more of the following symptoms: headache, fever, stiff neck, or photophobia, in addition to a CSF profile showing pleocytosis (>5 white blood cells, adjusting for presence of red blood cells by subtracting 1 white blood cell for every 500 red blood cells present) regardless of glucose or protein levels. 2 Paraspinal injections include, but are not limited to, spinal facet joint injection, sacroiliac joint injection, or spinal or paraspinal nerve root/ganglion block. 3 Patients in this category who do not have any documented CSF results should have a lumbar puncture performed if possible, using a different site than was used for the epidural injection when possible. Confirmed Case. A probable case with evidence (by culture, histopathology, or molecular assay) of a fungal pathogen associated with the clinical syndrome.
  • Fungal meningitis outbreak consumer voices speak 070713

    1. 1. 107/07/13 tbreak Share this widely with your FB friends
    2. 2. 207/07/13 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
    3. 3. 307/07/13 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
    4. 4. 407/02/13 tbreak 75 Facilities in 24 states purchased contaminated NECC steroids & other products for redistribution to patients 4
    5. 5. 507/07/13 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
    6. 6. 607/07/13 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
    7. 7. 707/07/13 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
    8. 8. 807/07/13 tbreak Adverse Events Increasingly, 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”.
    9. 9. 907/07/13 tbreak 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]
    10. 10. 1007/07/13 tbreak 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.
    11. 11. 1107/07/13 tbreak Poor Procedural Technique Contamination Wrong Patient selection Long Term Disability, Pain & Death
    12. 12. 1207/07/13 tbreak 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)
    13. 13. 1307/07/13 tbreak You Tell Us
    14. 14. 1407/02/13 $78,447.00 Out Of Pocket costs to date and now suffers from Arachnoiditis and intractable pain. Meningitis Victim After Her Tainted ESI
    15. 15. 1507/07/13 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
    16. 16. 1607/07/13 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
    17. 17. 1707/02/13 tbreak 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 2575 0/182 0/704 3125 2615 12880/80 986 320 1383 915 0/45 1265 2345 947 3024 4169 0/148 1309 200 17 * clinicians/casedef_multistate_outb reak.htmlp:// reaks/meningitis-map-
    18. 18. 1807/07/13 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
    19. 19. 1907/07/13 Exposure Related Illness If 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: dates/ucm354560.htm
    20. 20. 20 tbreak
    21. 21. 2107/07/13 If you are one of the exposed, unfound, untreated, or undertreated, join us at this web address so we can help you move toward diagnosis & treatment