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									Bad Bugs, No Drugs / Strategies to Address
Antimicrobial Resistance (STAAR) Act
Our Advocacy Campaign

Robert J. Guidos, JD
IDSA Director of Public Policy &
Government Relations

 Society of Infectious Diseases Pharmacists Annual Meeting; October 24, 2008
IDSA Membership: 8,500 strong

                                  patient care

                      53%         research


                                  public health
            4%              22%
                 7%               other related fields
Go-to Source for
Policymakers: IDSA
      Antimicrobial drug/diagnostics R&D
       – Congress, FDA, NIH
      Antimicrobial resistance
       – Congress, CDC, NIH, FDA
      Pandemic/bioemergency preparedness
       – Stockpiling antibiotics for anthrax attack
         and antivirals for influenza outbreak
           White House, HHS, FDA, CDC
      Adult & adolescent immunizations
       – Congress, National Vaccine Adv. Comm.
Go-to Source for
Policymakers: HIVMA
      HIV workforce issues
        – Health Resources and Services Administration (HRSA)
      Ryan White medical care
        – HRSA, Congress
      Medicare Part D and people with HIV
        – Congress, HHS
      Science-based HIV policies (prevention,
       travel and immigration ban)
        – Congress
      HIV testing
        – CDC
      Criteria for determining disability due to HIV
        – Social Security Administration
ID Center for Global Health
Policy and Advocacy

      Goal: To support and promote U.S.
            efforts to combat HIV/AIDS and
            tuberculosis throughout the
            developing world

       Funded by the Bill & Melinda Gates
       Housed within the IDSA Education
        and Research Foundation
Crisis in Antibacterial Resistance

         MRSA = methicillin-resistant Staphylococcus aureus; VRE = Vancomycin-resistant
         enteroccoci; FQRP =Fluoroquinolone-resistant Pseudomonas aeruginosa
Crisis in Antibacterial Resistance (cont.)
          • Nosocomial and community spread
          • Antibiotic pressure due to human use
          • Antibiotic pressure from veterinary use
          • Elderly
          • Immunosuppressed
          • Healthy athletes/children now affected
       Approved Drugs
          • Poor stewardship
       Drug Development
          • Not profitable
Lives Devastated by
Antibacterial Resistant
Bad Bugs!!
                       Microbes    Humans

Number (earth)         5 x 1031    6 x 109
Mass (metric tons)     5 x 1016    3 x 108
Generation time        30 min      30 yrs
Time on earth (yrs)    3.5 x 109   4 x 106

*Spellberg, CID January 2008
Antibacterial Drugs Approvals, U.S.

  U   16
  p   12
  p   10
  o    8
  l    4
           1983-1987 1988-1992 1993-1997 1998-2002 2003-2008

           Spellberg, CID 2004, Modified
New Antibacterial Agents
Approved Since 1998
     ANTIBACTERIAL               YEAR         Novel
     Rifapentine                 1998         No
     Quinupristin/dalfopristin   1999         No
     Moxifloxacin                1999         No
     Gatifloxacin                1999         No
     Linezolid                   2000         Yes
     Cefditoren pivoxil          2001         No
     Ertapenem                   2001         No
     Gemifloxacin                2003         No
     Daptomycin                  2003         Yes
     Telithromycin               2004         No
     Tigecycline                 2005         No
     Doripenem                   2007         No

                            Spellberg CID 2004, modified
New Antibacterial Classes???

      New drug development:
       $800,000,000 and 8 yrs
      Other markets are better
      Agency is indecisive
      Expectations are unclear
      Changes are common
      Delays have become norm
Market Forces & Disincentives

      IDSA’s Antimicrobial Availability Task Force
      (Chair: John G. Bartlett, MD, FIDSA) sought input
      from key stakeholders:

         – Senior pharmaceutical/biotechnology
           executives and anti-infective division heads\
         – Venture capitalists
         – IDSA’s membership base:
         – FDA/PhRMA: Workshops in 2002; 2004
         – NIAID (2004 meeting), CDC, HHS
         – Congressional Staff
No Easy Policy Solutions
      The antibacterial R&D problem is complex
       and multifactorial
      Potentially promising approaches are not
       politically palatable
      No easily identifiable patient advocacy
       group to put a human face on the problem
      Congress, FDA, and NIH have other
      “Why not focus on inappropriate use?”
     *Cystic Fibrosis and MRSA patient groups could be helpful
IDSA’s 2004
“Bad Bugs, No
Drugs (BBND):
As Antibiotic
Stagnates, A
Public Health
Crisis Brews”
Follow-Up Reports

      ―Bad Bugs, Need Drugs‖; Talbot et al
       Clinical Infectious Diseases (CID) March,

      ―The Epidemic of Antimicrobial Resistant
       Infections: A Call to Action to the Medical
       Community‖, Spellberg et al, CID Jan. ‘08

      IDSA‘s latest update on the antibiotic drug
       pipeline; Boucher et al, CID, Jan. ‗09
Challenges in the Pathway
to Antibiotic Approvals

      New drug development: $800,000,000 and
       8 years
      Antibiotics used for short duration
      Science is difficult (e.g., gram negatives)
      Lack of sufficient diagnostic tests
      Regulatory uncertainty—FDA
      Insufficient past research support—NIH
      Antimicrobial resistance
      Drugs in other markets (chronic disease,
       lifestyle) are more attractive
First Step: Acceptance

     “Product development in areas crucial to
      public health goals, such as antibiotics,
      has slowed significantly during the past

      U.S. Food and Drug Administration.
      Innovation/Stagnation: Challenge and Opportunity on
      the Critical Path to New Medical Products, 2004

      Stimulate R&D through new
       statutory incentives
      Ensure FDA clinical trial design
       requirements are science-based, clinically
       relevant, and workable
      Leverage NIH‘s biodefense dollars to support
       products for naturally occurring infections
      Increase support for new HHS Biomedical
       Advanced Research and Development
       Authority (BARDA) for greater future funding
       for antibacterial development
Statutory Incentives

      Define ―high priority‖ products
       – i.e., treat serious/life-threatening
         infectious that are resistant to current
         antibiotics (e.g., emerging gram negative

      Potential incentives:
       – Tax credit for R&D (35%? 50%? 100%?)
         for antibiotics/diagnostics
       – Market Exclusivity (7 yrs? 10 yrs?)
       – Patent Extensions (6months? 2 yrs?)
       – Priority Review Vouchers
       – Grants, Prizes, Advance Purchase
Recent IDSA Successes

      New legislation
      (September 2008) provides
      incentives targeting ―older‖
       – 3-year market exclusivity for new
       – 5-year market exclusivity for new
Recent IDSA Successes
     September 2007 FDA Amendments
     Act’s antibiotic provisions required
     the agency to:

        – Publish clinical trial guidance for industry
          FDA has since published ABS, ABOM, AECB, and non-
          inferiority study guidance
        – Update Antibiotic Clinical Susceptibility
          FDA has since updated breakpoints for penicillin G and
          vancomycin and published a draft guidance outlining a long-
          term solution
        – Hold a public meeting on the relevance of
          existing Orphan Drug Act (ODA) incentives
          to antibiotics
          FDA held April 2008 broader meeting on antimicrobial
          resistance—IDSA testified with 12 recommendations. IDSA
          also sent letters on ODA; FDA responded October 15th.
Recent FDA/IDSA Interactions

       January 2008 FDA/IDSA Workshop
        on Community-Acquired Pneumonia
        CID Supp., November 2008
       April 2008 FDA Advisory Committee on CAP;
        IDSA position statement on non-inferiority studies
       November 2008 FDA Advisory Committee on
        Complicated Skin and Skin Structure Infections;
        IDSA presentation on historical data for cSSSI non-
        inferiority studies [manuscript submitted to journal]
       April 2009 FDA/IDSA workshop planned on Hospital-
        Acquired Pneumonia (HAP) and Ventilator-Associated
        Pneumonia (VAP) [journal supplement planned]
       Possible 2009 Workshop to discuss incentives to spur
        novel antibacterial development
Strategies Outside of
Product Development

      The “Strategies to Address
      Antimicrobial Resistance (STAAR)
      Act” (S. 2313/H.R. 3697)
IDSA STAAR Act Leaders
     Antimicrobial Resistance Work Group
      Foci: CDC and FDA (human/animal drug use)
      Chair: Neil Fishman, MD (Univ. of Penn.)
      IDSA Staff: Julie Hantman, MPH

     Research on Resistance Work Group
      Chair: Louis Rice, MD (Cleveland VA)
      Focus: NIH/NIAID Primarily
      IDSA Staff: Padma Natarajan, MPH, MS
    The U.S. must strengthen:
     Leadership/coordination of the
      existing federal interagency task force
      on antimicrobial resistance
     External expert input
     Research (i.e., develop an intra-
      agency strategic research plan)
     Surveillance (sentinel, etc.)
     Prevention and control
     Collection human/animal Abx use data
External Expert Input
     Congress should establish a public
     health antimicrobial advisory board
     of outside experts to advise the
     current interagency task force
     Has been successful in other areas to leverage
     non-governmental expertise
      Potential responsibilities:
        – Review ongoing U.S. resistance efforts
        – Provide timely insight into evolving issues
        – Help focus and direct efforts
        – Identify/prioritize research needs/goals
        – Provide for accountability
Research Strategies
     The U.S. should support research
     that leads to:

      Optimal use of antibiotics (i.e. duration
       of therapy studies, reduction of
       antibiotic pressures, etc.)
      Methods to predict resistance
      Better understanding of the impacts of
       antibiotics use in humans, animals,
       and environment
      Methods to restrain antibiotic abuse
Research Strategies
     The U.S. should support research that
     leads to:

      Valid endpoints for clinical studies such
       as time to defervesence, time to
       eradicate pathogen, patient reported
       outcomes, quality of life, pain, length
       of stay, and cost of care

      Microbial diagnostics, including at

     FDA, NIH, CDC, USDA must collaborate:
      set priorities, strategic research plan
Recent Research-Related Success
     July 2007: IDSA submitted 3 proposed trial designs
     to NIAID on optimizing antimicrobial therapy of
     common bacterial infections

     May 12, 2008: NIAID issued Broad Agency
     Announcement “Clinical Trials to Reduce the Risk of
     Antimicrobial Resistance”
       – Diseases: acute otitis media, pneumonia, urinary tract
           infections, bacteremia
        – Experimental Variables:
            Need for antimicrobial therapy
            Length of antimicrobial therapy
            Frequency/dosage of antimicrobial therapy
        – Strategies may include:
              Shorter treatment duration
              Different dosage or frequency
              Withholding of Abx (altogether) for certain diseases
              Identifying eligible populations for this type of strategy
Antibiotic Use Data Collection
     The U.S. must reevaluate and
     strengthen statutory/regulatory
     requirements on data collection of
     antibacterial use in humans,
     animals, and the environment
      The U.S. is one of the only developed
     countries that does not have open access to
     such antibiotic use data
      The U.S.‘s lack of use data hampers efforts to
     understand, prevent/control resistance
      Private vendors (IMS Health) and U.S. data
European Surveillance of
Antimicrobial Consumption
      Funded by European CDC
      Human use data from 35 EU countries
      Aggregated at drug level using Defined
       Daily Doses methodology
        – Sales data from wholesalers
        – Reimbursement data from National
          Health Insurance agencies
        – Research contract with IMS Health
      Data correlated with antimicrobial
       resistance surveillance data
Muller A et al. Euro Surveill
2007; 12:3284
Correlations Between Antibacterial
Consumption and Resistance

                                     r = 0.71
                                     p =0.004

                  Albrich W, et al. Emerg Infect Dis 2004;10:514-7.
Our STAAR Act Coalition is Growing
      17 Organizations endorsed the STAAR Act:

         American Medical Association
         American Academy of Family Physicians
         American Academy of Pediatrics
         American Association of Critical-Care Nurses
         American College of Physicians
         American Public Health Association
         Alliance for the Prudent Use of Antibiotics
         Association for Professionals in Infection Control and Epidemiology
         Infectious Diseases Society of America
         International Society of Microbial Resistance
         Michigan Antimicrobial Resistance Reduction Coalition
         National Foundation for Infections Diseases
         Society of Infectious Diseases Pharmacists
         Pediatric Infectious Diseases Society
         Premier, an alliance of 1,700 non-profit hospitals/health systems
         Society for Healthcare Epidemiology of America
         Trust for America‘s Health
Recent Successes
     STAAR Act Cosponsors:
      5 in the Senate
      28 in the House of Representatives
     Congressional Hearings:
      Senate Health Committee focused
       broadly on antimicrobial resistance
       (human and animal use)
      House Energy and Commerce
       Committee on animal drug use
Recent Successes (continued)
     Animal Drug User Fee Amendments
      Public Law 110-316 – enacted July, 2008
      Requires animal drug manufacturers to
       report to FDA the quantities of antibiotics
       sold for use in food animals
      IDSA worked with Reps. Henry Waxman (D-
       CA) and Jim Matheson (D-UT) to advance
       the provision in the face of stiff opposition
       from agricultural special interests
      An important, but small, step toward better
       understanding the amounts of antibiotics
       used in food animals
Recent Successes (continued)
     House Resolution on MRSA Awareness
     Passed September ‘08
      Highlights the MRSA problem and impacts on
       patients, students, athletes
      Intends to raise greater awareness about
       resistant infections on Capitol Hill toward the
       goal of enacting STAAR Act next year

     Rep. Jim Matheson (D-UT) sponsored both the
     Resolution and the STAAR Act. IDSA helped
     garner 106 total co-sponsors of the resolution.
Recent Successes (continued)
     Insertion of language into
     Congressional Appropriations
     Committee Report to encourage:
      CDC to explore sentinel surveillance
       networks to describe and confirm outbreaks
       of resistant bugs
      NIAID to strengthen clinical, translational,
       and basic research on resistant infections,
       particularly gram-negative bacteria
      NIAID to accelerate research to advance the
       understanding of mechanisms of resistance
SIDP Members Can Help With
BBND and STAAR Act Advocacy

     Do you:
      Have a strong connection with a member of
      Know of patients with ―bad bug‖ stories?
      Have a desire to support SIDP‘s/IDSA‘s
       advocacy efforts regarding resistance on
       behalf of patients and public health?

     Contact: Michael Ochs, IDSA
FYI: Practice Guidelines
      Nearly 50 guidelines on topics such as:
      Health-care associated infections (HAIs)
         – Compendium with SHEA, The Joint
           Commission, AHA and APIC
           (October 2008)
       Surgical Prophylaxis
       Candidiasis
       Intraabdominal infections
       Vancomycin (Jan. 2009)
       Antimicrobial Stewardship (2007)

    Begins Tomorrow
SIDP Co-Sponsored Symposium

    Monday, Oct 27th 2:00 PM – 4:00 PM

    Pharmacodynamic and Pharmacokinetic
    Approaches to Enhancing Existing Therapies for
    Gram-Negative Infection

    Related value for:
       – Preserving the antibiotics we have
       – Providing clear predictive parameters for
         developing new antibiotics

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