Of course this implicit bargain is unavoidable for the poor and a
choice for the rich. If you can not afford it then a price is as good as
an outright ban.
I think Andrew Jull is right about the original question being an
issue of inclusion/exclusion criteria and generalisability. Assuming
that we are talking of selection before randomisation a partial solution
would be to make sure all doctors involved record their reasons for
exclusion. To confirm this the population characteristics of those
included and those excluded could be recorded and compared. Because as
Steve Simon says it is not just the official inclusion/exclusion
criteria that make the trial population different from that encountered
in clinical practice, but also the procedures by which volunteers are
recruited. For discretionary exclusion to be a sensible approach one
must assume there are good reasons for exclusion that one can not think
of when setting the exclusion criteria. If it is already known that for
some people genuine uncertainty does not exist then it is not ethical to
do a trial on them. It would appear better to specify who should and who
should not be included formally and openly rather than leaving it to
individual's discretion.
James
[log in to unmask] wrote:
> In a message dated 8/17/01 4:53:31 PM Pacific Daylight Time, Steve
> Simon
> [[log in to unmask]] writes:
>
>
>
>> 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
>
> [log in to unmask]
> 509/ 838-9100 X 7393
> fax: 509/ 458-0368
> ,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,
