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637Deer Contraceptive

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  • Pat Scala
    Aug 13 5:48 PM
    • 0 Attachment
      An open letter to the friends of wildlife who are interested in the
      development of PZP as a deer contraceptive:

      A flurry of e-mails has been circulating in response to Mark
      Fraker's request for funding for a research study of a recombinant
      form of Spay-VacR in deer at a University of Georgia research
      facility. Everyone participating in this correspondence passionately
      wants to see an effective, long-acting, single shot contraceptive made
      available for deer, a goal that I and my colleagues share and have been
      pursuing for almost ten years now. I would like to address some of the
      concerns raised in these e-mails, and correct some misleading
      impressions and assertions about the immunocontraception research being
      carried out by The Humane Society of the United States (HSUS).

      The HSUS is not dragging its feet, nor is its research effort being
      Held up by lack of funds, at least for now. It is being held up by the
      persistent opposition of state wildlife agencies and other political
      forces who (a) do not like The HSUS because of its views and advocacy on
      behalf of animals and/or (b) do not like the idea of deer contraception.
      This opposition has stiffened as the prospect of deer contraception has
      become more real.

      In the past five years or so, proposed HSUS projects have been
      Stopped (or stalled) by the rejection of permit applications by the
      National Park Service and the Pennsylvania Game Commission (Valley
      Forge, for incredibly and transparently stupid reasons: the PGC even
      commended the proposal for its quality while rejecting it);
      By the imposition of permit conditions that destroyed the scientific
      And humane value of the project, and potentially endangered the study
      animals, researchers, and wildlife at large (Indiana); by a lawsuit
      filed before a suspiciously friendly judge by representatives of Safari
      Club International the day before a project was supposed to begin (New
      York; the hearing was held and the restraining order issued without the
      defendants, HSUS and the NYSDEC, being present in court or even having
      been notified that the suit had been filed); and by other maneuverings,
      large and small, for other proposed projects.

      If not for this opposition - remember, the state wildlife agencies
      generally
      get to decide who does research on wild deer and who doesn't - we
      would have
      half a dozen or more projects going, and would be farther down the
      road
      than
      we are. (Congratulations to the hunting community and to their
      friends
      in
      the state wildlife agencies for their success in postponing the
      inevitable.)
      Since the amount of work, planning, and diplomacy involved in
      starting
      an
      immunocontraception project exceeds what is involved in planning a
      wedding,
      HSUS doesn't begin to undertake projects unless we think there's a
      very
      good
      chance of carrying the project through to completion. Nevertheless,
      we
      have
      been left standing at the altar many times.

      Despite these obstacles, and others, The HSUS and its research team
      has accomplished the following: 1. We were the first to demonstrate
      that PZP could be delivered remotely
      to
      free-ranging wildlife (Jay Kirkpatrick, John Turner & Irwin Liu on
      wild horses on Assateague); 2. We were the first to demonstrate that
      PZP was effective in
      white-tailed
      deer (Turner, Liu and Kirkpatrick in Ohio; eternal thanks to
      Priscilla
      Cohn
      for principally funding that research)
      3. We were the first to demonstrate that PZP could be delivered
      remotely
      to
      white-tailed deer (Kirkpatrick, Turner, Liu, and me on Fire Island)
      4. We were the first to demonstrate that PZP could affect birth
      rates in wildlife at the population level (Kirkpatrick and Allison
      Turner (of the
      NPS) on Assateague horses; Rick Naugle, Brian Underwood, me, and
      others
      on
      deer at Fire Island)
      5. We were the first to demonstrate , TWICE, that a free-ranging
      white-tailed deer population could be reduced through the use of
      contraception (Naugle, Underwood, me, and others at Fire Island;
      Naugle,
      me,
      and others at the National Institute of Standards and Technology in
      Gaithersburg, Maryland). 6. We were the first to demonstrate the
      effectiveness of a one-shot, one-year PZP vaccine (in horses at the
      Nevada Wild Horse Range). This vaccine has now been extended to a
      2-3 year duration (current research
      at
      the Clan Alpine Herd Management Area and elsewhere).

      All that work, and much, much more, has been published or is in
      press in peer-reviewed scientific journals. (Anyone who's interested
      can find the references on the website of the Tufts Center for
      Animals and Public
      Policy,
      http://www.tufts.edu/vet/cfa.)

      With regard to the FDA: whoever tries to push PZP through the FDA,
      whether
      it's HSUS, IVT (Spay-VacR's manufacturer), U.S.D.A. Wildlife
      Services,
      or
      some combination thereof, is going to need millions of dollars to do
      it under current law. The funding is required not just for the
      testing
      itself,
      but for the development of manufacturing and record-keeping
      processes
      that
      meet FDA standards. (Mr. Fraker has made this point previously.)
      However,
      neither HSUS nor IVT is up to that point of development yet: we all
      need
      to
      decide on a final vaccine formulation before going to the FDA, and
      we haven't quite gotten there.

      HSUS is still working on a satisfactory longer-acting (but still
      reversible)
      formulation. Both HSUS and IVT are also concerned about the use of
      "native"
      PZP - the actual ground-up pig protein - both for ethical reasons
      (HSUS)
      and
      because of FDA manufacturing issues. "Clean", safe native PZP is now
      made
      in
      batches at Dr. Kirkpatrick's Science and Conservation Center at
      ZooMontana,
      Dr. Brown's lab at IVT in Halifax, and in other places, but whether
      this kind of production can be economically scaled up in a way
      acceptable to
      the
      FDA is uncertain. Hence Mr. Fraker's, and other people's, pursuit of
      an effective recombinant form.

      In the course of our research effort, subject animals have sometimes
      died
      during capture or due to injuries associated with darting. However,
      the
      goal
      of The HSUS immunocontraception research is to reduce the suffering
      and death experienced by wildlife at the hands of people - be they
      hunters, wildlife managers, or researchers. Consequently, we do
      everything we can
      to
      assure the safety and well-being of our research animals, and we
      have
      never
      designed or carried out a study that required the killing of deer or
      any other wildlife.

      (PZP is made from pigs killed at slaughterhouses, which underlies
      the ethical motivation for replacing it with a recombinant.) We also
      try to choose study sites where our contraception research will
      substitute for
      and
      prevent the use of lethal "management." At the FDA approval stage,
      some animals probably will have to be killed. If we get to that
      stage, HSUS
      will
      negotiate with the FDA to move that number downward as far as
      possible
      (and
      our attorneys tell us we will probably have some success).

      There are still prospects for collaboration between HSUS and IVT. I
      wrote
      Mr. Fraker and Spay-VacR into the (rejected) Valley Forge proposal,
      and
      we
      frequently exchange technical and other information. Ethical issues
      aside,
      the principal obstacles to major collaboration are (1) there are as
      yet
      no
      data showing that Spay-VacR is reversible, which conflicts with HSUS
      goals
      for the use of PZP on wild horses, zoo animals, elephants, and a
      wide
      range
      of other potential applications for the humane conservation of
      wildlife
      in
      small populations (in the U.S. and abroad); permanent sterilization
      will
      be
      absolutely
      unacceptable for these applications (2) Spay-VacR has so far been
      ineffective on cats and dogs (an application of extremely high
      interest to HSUS), where permanent sterility is highly desirable;
      and (3) because IVT and Mr. Fraker's consulting firm are commercial
      entities, they generally operate
      at
      cost levels that are about 5 times higher than those generally
      confronted
      by
      The HSUS. Any and all of these obstacles are potentially resolvable,
      but they haven't been resolved yet.

      By way of conclusion: there are rational, scientific, ethical,
      budgetary,
      practical, and other good reasons to invest or NOT to invest in a
      given study, and it is very clear that people whose hearts are all
      in the
      right
      place may reach different decisions. The development of PZP is a
      marathon,
      not a sprint - no one study will make or break the technology, nor
      should
      the willingness or unwillingness to fund one study or one research
      team
      be
      considered a litmus test for one's devotion to animals. What WILL
      make
      or
      break wildlife contraception is the political will to make it
      happen.
      FDA,
      Congress, the
      State legislatures, and the state game agencies all need to hear
      that
      for
      humane reasons
      and practical reasons, the regulatory and political barriers to
      wildlife contraception must be lowered. Tell them often enough and
      loudly enough,
      and
      it will happen.


      Allen T. Rutberg, Ph. D.




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