Lee Elder

Joined

• started 158 topics
• posted 646 times   see topics posted on
• send a message

Posts by Lee Elder

• 
  10

  What the Judge thought of Bethany Hugh’s Mother

  by jgnat in

  1. watchtower
  2. medical

  the latest wt study article suggests, .

  if we courageously explain our scriptural position to a judge, we are delivering an important message.

  caption, page 12 wt march 1, 2003, april 13 study be courageous and strong

  1. 
  2. 
  3. 
• 

  Lee Elder

  Thanks for posting. Can I access the transcript online or could you email it to me?

  Thanks,

  Lee
• 
  2

  Coming to an ambulance near you

  by Lee Elder in

  1. watchtower
  2. medical

  northfield receives clearance to begin prehospital trauma trial.

  treatment to begin with polyhemer at the scene of injury.

  --company to host conference call today--.

  1. 
  2. 
• 

  Lee Elder

  NORTHFIELD RECEIVES CLEARANCE TO BEGIN PREHOSPITAL TRAUMA TRIAL
  Treatment to Begin with PolyHemer at the Scene of Injury
  
  --Company to Host Conference Call Today--
  
  EVANSTON, IL-March 5, 2003- Northfield Laboratories Inc. (Nasdaq:
  NFLD) announced today that it has received clearance from the U.S.
  Food and Drug Administration (FDA) to proceed with its pivotal Phase
  III prehospital trial with PolyHemer, the Company's oxygen-carrying
  blood substitute. Successful completion of the proposed trial could
  form the basis for product approval and licensure to market PolyHeme.
  
  "This is a gratifying day for Northfield. The clinical trial we
  proposed is unprecedented in its scope, design, and setting," said
  Steven A. Gould, M.D., Chairman and Chief Executive Officer of
  Northfield. "This favorable response represents a seminal
  achievement in our efforts to develop PolyHeme as the first blood
  substitute to be approved for use in urgent blood loss when blood is
  not immediately available."
  
  The trial is designed to assess the safety and efficacy of PolyHeme
  in improving survival when used to treat severely injured and
  bleeding trauma patients beginning at the scene of injury and
  continuing during ambulance transport to the hospital. Northfield
  anticipates that approximately 20 Level I trauma centers throughout
  the United States will eventually participate in the PolyHeme trial,
  with an expected enrollment of about 700 patients.
  Because the patients eligible for the study are unlikely to be able
  to provide consent due to the extent and nature of their injuries,
  the trial will be conducted under federal regulations that allow
  clinical research in emergency settings using an exception from the
  requirement for informed consent.
  
  "This landmark trial would not be possible without the important data
  from our recently published experience documenting the life-
  sustaining capability of PolyHeme in the hospital setting in trauma
  patients who participated in those trials," Dr. Gould said. "We look
  forward to completing the many organizational and procedural details
  that are required under the regulations before patient enrollment can
  begin."
  
  Clinical trials at each study site are overseen by a local
  Institutional Review Board (IRB). The IRB is an independent body
  composed of medical, scientific, and nonscientific members, whose
  responsibility is to ensure the protection of the rights, safety, and
  well-being of patients enrolled in clinical trials. The traditional
  IRB approval of a clinical trial includes a requirement that informed
  consent be obtained from patients before enrollment can occur. Under
  the current regulations, the IRB responsible for the review, approval
  and continuing monitoring of a clinical trial may give approval for
  patient enrollment in trials in emergency situations without
  requiring informed consent provided specific criteria are met. The
  patients must be in a life-threatening situation, and the
  experimental therapy being evaluated must offer patients the
  potential for direct clinical benefit in the form of increased
  survival. Before enrollment can begin, the regulations require
  public disclosure of information about the trial, including the
  potential risks and expected benefits. Consultation must also occur
  with representatives of the community where the study will be
  conducted and from which the study population will be drawn. The
  process is individualized and must be tailored to the specific
  community and patient population involved. The length of time for
  IRB review and community consultation at each site may therefore vary
  considerably.
  
  "We have begun to work on these tasks, and are benefiting from our
  interactions with investigators and sites that have previously
  participated in such trials involving an exception from informed
  consent. The time required to complete these activities has ranged
  from 8 to 10 weeks to more than 6 months, depending on the specific
  site and location," Dr. Gould said.
  
  Northfield is also pursuing a special protocol assessment, or SPA,
  with FDA under provisions of the Prescription Drug User Fee Act of
  1992 and the Food and Drug Administration Modernization Act of 1997.
  A special protocol assessment represents acknowledgement and
  confirmation of a mutual agreement between a sponsor and FDA that
  successful completion of the proposed trial will form the primary
  basis for an efficacy claim and product approval. When agreement is
  reached, FDA commits the agreement to writing and makes it part of
  the administrative record. Such an agreement may only be changed by
  mutual agreement of the parties, or if FDA identifies a substantial
  scientific issue relevant to safety or efficacy after the testing has
  begun.
  
  "Coming to agreement on the design and outcome of the protocol is a
  critical accomplishment. Now that we have the requisite clearance on
  the trial, we look forward to completing the final negotiations for
  special protocol assessment with FDA to solidify our regulatory
  program for the approval of PolyHeme," Dr. Gould said. "In the
  meantime, we have been diligently preparing the necessary groundwork
  for initiation of the study-identifying sites and investigators,
  selecting a contract research organization to administer the trial,
  initiating the interaction with IRBs, and preparing materials to
  support our sites in conducting public disclosure and community
  consultation. We have much work ahead of us, but look forward to
  meeting the challenge."
• 
  6

  Emergency situation in Phoenix, AZ - Can you help?

  by Lee Elder in

  1. jw
  2. friends

  we have a situation in phoenix, az where a family member is requesting immediate assistance.. please respond if possible.

  see request below.. regards,.

  lee elder.

  1. 
  2. 
  3. 
• 

  Lee Elder

  We have a situation in Phoenix, AZ where a family member is requesting immediate assistance.
  Please respond if possible. See request below.

  Regards,

  Lee Elder
  AJWRB

  ----- Original Message -----
  From: [email protected]
  To: [email protected]
  Sent: Sunday, December 29, 2002 10:57 AM
  Subject: My Father

  Dear Lee,

  My name is D.H.. My father who is a Jehovah's Witness has suffered a major stroke several weeks ago. He is in the rehab hospital in Phoenix, AZ. His hemoglobin count is critical.

  Are there any AJWRB's in the Phoenix, Arizona area that could speak with my father?

  Please reply so that I can set up further correspondence.

  Sincerely,
  DH
• 
  131

  Last Post - My Most Painful Public Confession

  by Amazing in

  1. jw
  2. friends

  my most painful confession

  note to simon: i will use some expletives, but i hope that they will be retained as this is intended to be an otherwise civil and thoughtful post to all my fellow ex-jws.

  please read on, as this is most painful.

  1. 
  2. 
  3. 
• 

  Lee Elder

  Nice post. I hope you get to feeling better very soon.
  Thank you for your words of wisdom.

  Lee
• 
  16

  Thank you Simon!

  by Lee Elder in

  1. jw
  2. friends

  hello simon:.

  i don't have much free time these days (and no extra energy) to post here regularly.

  but i had a little time this evening and scrolled through some of the rated/archived posts.

  1. 
  2. 
  3. 
• 

  Lee Elder

  Hello Simon:

  I don't have much free time these days (and no extra energy) to post here regularly. But I had a little time this evening and scrolled through some of the rated/archived posts. Can I just say that what you've created here is a really a wonderful blessing (for lack of a better word) for current and former JWs. There is so much to learn and benefit from in these discussions. Also, Kudos to those who take the time to share their experience and knowledge on so many various topics.

  You are the best!

  Lee
• 
  22

  More Bloody Confusion....

  by hillary_step in

  1. watchtower
  2. beliefs

  the british journal of hematology 2002 119 25-37 makes interesting reading in its article by judith marsh and david bevan entitled 'haematological care of jehovahs witnesses'.

  nothing new, but in view of what i heard recently from an jw acquaintance working in the hematology department of a local hospital it gave me some food for thought.

  the long article necessarily of a scientific nature and therefore without any noted bias makes this point regarding the alteration in policy by the wts toward those jws who take blood transfusions as a matter of choice: .

  1. 
  2. 
  3. 
• 

  Lee Elder

  Hillary_step:

  Could you please post the article or add quotation marks to the direct quotes from the article?

  Thanks,

  Lee
• 
  22

  More Bloody Confusion....

  by hillary_step in

  1. watchtower
  2. beliefs

  the british journal of hematology 2002 119 25-37 makes interesting reading in its article by judith marsh and david bevan entitled 'haematological care of jehovahs witnesses'.

  nothing new, but in view of what i heard recently from an jw acquaintance working in the hematology department of a local hospital it gave me some food for thought.

  the long article necessarily of a scientific nature and therefore without any noted bias makes this point regarding the alteration in policy by the wts toward those jws who take blood transfusions as a matter of choice: .

  1. 
  2. 
  3. 
• 

  Lee Elder

  Hi Scully,

  You wrote:

  "I'd really like to see something from AJWRB that really helps hospital staff understand the kind of
  pressure and coercion that goes on among JWs when the blood issue arises."

  What would be the most useful format/layout/wording?
  Please discuss this w/your colleagues and advise us.
  I happen to agree with you.

  Best regards,

  Lee
• 
  48

  JW/HLC visit to our hospital

  by ScoobySnax in

  1. watchtower
  2. medical

  yesterday jehovahs witnesses and the hospital liason committee visited our hospital to donate a blood cell saver machine which had been funded by the local congregations in our county of kent in england.

  a buffet lunch was provided, along with 4 talks to a large audience of surgical and medical consultants, anaetheologists, paedatricians, and obstetraticians (sp!

  ) about the future of blood and the transfusion of such products.

  1. 
  2. 
  3. 
• 

  Lee Elder

  Hello ScoobySnax:

  Thank you for your report. While the WTS donation of a cell saver unit is admirable it is the moral equivalent of a cigarette company donating chemotherapy drugs to a cancer center. The WTS irrational policy on the use of blood and blood products is responsible for thousands of needless deaths. The fact that JW children are sacrificed to support such a policy is reprehensible and the WTS policy of sanctioning any JW who conscientiously disagrees with its irrational policy by requiring their JW family members to shun them is morally repugnant.

  Those who are most familiar with the finer points of this issue will not be impressed by the actions of the WTS in this instance. Their hands are full of innocent blood and it will take a lot more than donating a "Cell Saver" to atone for their wrong doing.

  Regards,

  Lee Elder - AJWRB
• 
  9

  Back in the saddle again?

  by Lee Elder in

  1. jw
  2. friends

  a family friend is getting married and has asked me to perform the wedding.

  my wife directed me to the solution: http://www.spiritualhumanism.org/.

  so i'm clergy again!

  1. 
  2. 
  3. 
• 

  Lee Elder

  A family friend is getting married and has asked me to perform the wedding. My wife directed me to the solution: http://www.spiritualhumanism.org/

  So I'm clergy again! Who would have thunk it ;-)

  You too can be a man (or woman) of the cloth!

  Check it out.

  Lee
• 
  37

  Can't help but scratch my head...

  by Lee Elder in

  1. jw
  2. friends

  ...when i read some of the posts in this forum these days.

  the founding fathers had it right when.

  they setup an electoral college and opted for a republic.

  1. 
  2. 
  3. 
• 

  Lee Elder

  ...when I read some of the posts in this forum these days. The founding fathers had it right when
  they setup an electoral college and opted for a republic. As the walls of the Tower crumble expect
  to see more (not less) lunacy from those fleeing. Ray Franz is absolutely correct when expressing
  his concern that former Jehovah's Witnesses not exchange one set of extreme views for another -
  that is what many do. Religion should bring out the best in people but sadly brings out the worst
  all too often.

  Lee