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E-DRUG: ICH and developing countries
Sender: owner-e-drug@usa.healthnet.org
Precedence: bulk
Errors-To: owner-e-drug@usa.healthnet.org
Hello: You said:
Some people fear that the high quality standards (e.g., impurities in
raw materials) will make drug production in developing countries much
more expensive.
This made me wonder who these people might be, and why they would think
there is room for discussing this as an issue? I'd be interested in
learning more about this sort of thinking, when it comes to health and
safety of humans.
You said:
Other people have remarked that consumers / patients have not been
involved in the development of Good Clinical Practice guidelines
which define ethical standards for testing drugs on humans etc.
For what it's worth, in my experience and research, Good Clinical Practice
[GCP] guidelines are a result of efforts to raise clinical research
standards to the highest level possible. Each country follows these
guidelines at some level, invariably with the intention of achieving the
highest standards possible. In other words, the United States can be
expected to conduct and manage clinical research under GCP standards at a
higher level than is found in some undeveloped countries, with far fewer
resources than the United States. The work at ICH really hopes to tighten
the "range" of GCP standards found around the world, and their work should
be applauded. Having consumers/patients play a more active role in the
evolvement of GCP regulations and guidelines probably isn't as productive as
possibly examining how clinical research is conducted and managed, today,
and considering what changes need to be made. To make this point, I ask you
to consider last year's report
http://www.ama-assn.org/sci-pubs/journals/archive/jama/vol_279/no_15/ma71005
a.htm
in the Journal of the American Medical Association that claimed, "Over
100,000 patients die each year in America needlessly, from adverse effects
of medications." Thanks, Tom
--
Thomas A. Poe, M.D., Director
The World Center For Clinical Research
2500 Dickerson Rd, H-124 Reno, NV 89503-4801
admin@worldccr.org http://worldccr.org
--
[Moderators comment: The ICH process extends far beyond clinical trials
guidelines. There are a number of working groups that are specifying
standards and practices that are likely to become universal standards. The
concern that exists about standards going higher and higher is driven by
advances in instrumentation. For example in the past a drug was accepteable
if it was 99.9% pure. Now with better instruments it is possible to document
that the drug is 99.99% pure. To achieve this final 0.09% purity may be very
expensive, may be difficult to document (prove) and may have absiolutely no
clinical significance. I would encourage E-DRUGGERS to review the ICH site
at http://www.ich.org/ Richard Laing Co-Moderator]
--
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