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In a message dated 8/17/01 4:53:31 PM Pacific Daylight Time, Steve Simon
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But the high cost of the surgery and the uncertain evidence basis of the
1996 study caused the NIH and HCFA to bar the use of Medicare funds for
this surgery unless the patient agreed to participate in a randomized
trial. Patients who wanted the surgery had to either take their chances or
pay for the surgery themselves. Should patients who trust the results of a
non-randomized study be denied the opportunity to a therapy until others
have collected more definitive randomized evidence?

>>>>>>>>
Hello:
  No;
patients who trust the results of a non-randomized study should not be
denied the opportunity to a therapy until others have collected more
definitive randomized evidence.

  And in this case they were not denied that opportunity.  They were only
denied having others pay for their desire to use a therapy that was unproved
by high-quality research.  And what is wrong with saying to someone: this
therapy is unproved and requires better evidence that it does more good than
harm.  To say that other people's resources will be used to pay for your
treatment (that may or may not include the experimental treatment) if you
agree to participate in the randomized trial to prove its worth.  In essence
this restores balance.  Public funds will be used to pay for your treatment,
in exchange for using those public funds, you agree to help the public by
participating in ethical research to determine if public use of such funds is
justified.  If you don't wish to strike this deal, fine.  Have the treatment.
 But you must use your own private funds.  Before we use other people's
resources to pay for an unproved treatment, we must first show the
treatment's worth.  Since lung volume reduction's worth was uncertain, it was
only right to withhold use of public resources from private individuals
unless they assist in determing whether on-going use of public resources is
worthwhile.  If they don't wish to strike such an implicit bargain, they
don't have to, they can have the treatment.  They just need to find the
resources privately.
  Further, I believe that there is research showing that people in
randomized trials who do not receive experimental therapy (that is, the
control group) fare better than patients receiving care outside of a
randomized trial.  So even if the patient recieves what ultimately proves to
be "inferior" care, they still get better care than current patients not in
the randomized trial.


Cheers and Best Wishes,
Brian
....................................
Brian Budenholzer, MD
Director, Clinical Enhancement & Development
AC18
Group Health Cooperative; Network Services Division
PO Box 204
Spokane, WA  99210-0204
USA

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509/ 838-9100 X 7393
fax: 509/ 458-0368
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