E-drug: American research without a requirement for American IRB review (cont)
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Tom,
You are far better informed than I on what IRBs actually do. But if they
are not actually doing the job, the answer is for them to do the job; not to
stop trying.
The question you pose, "which country is in a better position to oversee and
protect the interests of its population," isn't exactly the question. Sure,
the local country is in a better "position" but being there does not mean
they will do a better job. They may do a worse job or nothing at all. Many
of these countries cannot deliver food, water or basic medical care to their
people; they cannot keep the electricity on; they are riven with tribal
warfare; and worse.
Your suggestion that they have an "active role in the clinical
research, and combine that with the capability to insist on the
clinical research being carried out in strict accordance with GMP
standards" presumes conditions where such things might be
realistic to expect. If these things are not even done in developed
countries, as you say they are not, why should we expect developing
countries to do them?
In America we have not only clinical safeguards but legal ones as well.
Tort victims have rights, courts and lawyers. In countries where all the
same safeguards are available as we have in the US, there is no reason not
to rely upon local authorities to regulate research and trials. But it may
be *because* so many protections are in place (which also increase costs) in
the developed world that pharmaceutical companies go to the developing
world. Barriers and costs are lower *because* the same protections are not
present. So people are more vulnerable and need even more protection.
We have laws governing the extra-territorial activities of Americans now.
For example, executives who bribe foreign officials or Americans who do sex
tourism face jail even though their actions occur outside the U.S. The
reason we have these laws is that we recognize a moral responsibility to
regulate the actions of our citizens when they might be detrimental to the
citizens of other countries.
Scott Hillstrom
Scott D. Hillstrom, J.D.
scott.hillstrom@analyticorp.co.nz
+(651) 452-6003; Mobile +(612) 730-5884; Fax (312) 803-0175
[Please, always include your affiliation and address. BS]
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