E-drug: Helsinki declaration debate (cont)
---------------------------------------------
In response to Scott's comments on the Helsinki declaration debate:
I truly appreciated the comments provided, but ran into some
confusion on the paragraph beginning with the third point. The term
"cozy" raised my eyebrows. The following sentence caused some
discomfort, and from there, the rest of the paragraph seemed to be
greatly disjointed in relation to the debate. But then that's just
me.
Suppose for a moment, that the U.S.FDA was fully funded, staffed, and
capable of doing its job at the level/purpose for which it is
intended. Suppose that the capability of this agency included the
ability to operate in high confidence that the information received
[clinical research data] was of the highest integrity possible,
reliable, accurate, and timely. With these points as our starting
premise, would you imagine 'American interests' providing the same
perspective to the global community? Following such logic [I use
that term somewhat loosely, I'm ready to admit], I think it's fairly
straightforward to soon reach the conclusion that maybe we don't need
to focus on just the U.S.FDA. Possibly, any country that achieves
full funding, staffing and capability would quickly rise to the
stature of a world body, protecting the citizens of all countries,
rich and poor, developed and developing.
I won't leave this point in support of a responsibility that the
world community needs to be considered, regardless of who or what or
where "informed consent" might be applied, without offering a
solution. That solution begins and ends with generating reliable,
accurate, and timely clinical research data. In the late 1960's, our
JPL project utilized technology that would enable data to be entered,
manipulated, analyzed, and decision-making to take place within
fractions of a second. This was necessary to protect the launch of
space exploration at lift-off time. Yet, with this technology being
available for so many decades, we still find ourselves accepting the
industry's explanations as to why clinical research data that affects
so many millions each year at a level of "life-or-death"
decision-making to take days to months to years to reach the
regulators. Resolve this issue [it's already documented and in place
should some regulatory agency choose to implement] and I suspect the
topic of "informed consent" will be altered in a positive fashion.
I believe "informed consent" isn't about patients being capable of
deciding whether to participate in clinical research. I believe that
patients around the world understand there is "risk". What is a
tragedy, is that our present system doesn't offer decision-making
about clinical research based on the highest level of integrity of
data, reliable, accurate, and timely data. Columbia might not have
reached the point they did, with such a system available.
Thanks for permitting me to submit these thoughts,
Tom
--
Thomas A. Poe, M.D., Director
The World Center For Clinical Research
2044 Plumas Street Reno, NV 89509-3708
Phone: 775-829-1799
admin@worldccr.org http://worldccr.org
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.