E-drug: Washington Post Series on Drug Development (cont)
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I have enjoyed reading the fine comments posted on this topic by Dr. Sharif,
Victor Lara, Colleen Fuller, Budiono Santos, Bonnie Fundafunda, Joel
Lexchin, Scott Hillstrom, and our moderator, Kirsten.
As the series in the Washington Post unfolds, I think we should all keep in
mind, that drug development, regardless of where it is conducted, has
just one standard. The system found around the world is not exactly
ideal, in that this one standard can be interpreted and implemented
in infinite variation.
Private industry fuels the research and development of medicinal
products for the world population, today. Any changes to this
paradigm must consider how best to handle the needs of private
industry, as it is well-recognized that there is no alternative at
this time. Presently, private industry pays for regulation and
oversight, directly or indirectly. And, if changes to the system are
to succeed, it is important that private industry be compensated for
such changes.
On another level, we should also be aware that the extraordinary
costs of drug development could be reduced, while at the same time
raising the standard of clinical research. In other words, our
tolerance for continuing the present status quo for drug development
should be, and must be, very low. The industry does not shift to
higher standards for one single reason, accountability. There
traditionally has never been much advantage to being held
"accountable", whether it be in politics, religion, or industry.
The answer lies with the data collected during clinical research
studies. This phase of product development is the longest phase, and
the only activity within the product development cycle that does not
have to meet the stringent GMP standards set by all governments.
Interestingly, all laboratory, manufacturing processes, and marketing
can be regulated satisfactorily under the present system, but the
most critical and the singular aspect of regulatory oversight
presently requires zero participation during the clinical research
studies, by regulatory authorities! I have made quite a statement,
here, so let me explain.
All review and decision-making about the issues surrounding the ethics and
safety of a particular clinical trial are based on data presented by the
Sponsor for review. Once the decision to go forward is made, the only
"players" given access to the data generated, are a closely held
group within the Sponsor organization. Let's not quibble over the
details, here, as my point is, under the present system, clinical
research requires only that
Sponsors [private industry] meet Good Clinical Practices [GCP] standards;
standards that are far below GMP standards. For example, an
investigator does not have a clue as to what happened to the data
s/he reported on a patient once it leaves his/her office. Is the
data altered inadvertently, or otherwise, can only be ascertained by
the complete auditing of the study. Physically, and logistically,
this is an impossible standard to meet under the present system.
So, an easy answer lies with shifting and using the technology that is [has
been since the 1960's, when the JPL space program developed]
available. Crunch the data in "real time" oversight, by a small
number of reviewers, and the cost of research development drops some
70%, the system speeds up by years, and the profits of the private
industry grows. And best of all, the patient wins with better
medicines, lower consumer pricing, and fewer [millions] of needless
deaths each year. Easy, but a non-starter, at this time, unless
someone has an idea on how to get the regulatory authorities to JUST
DO IT!
Thank you,
Thomas A. Poe, M.D.
Director, WORLDCCR
2044 Plumas Street
Reno, NV 89509-3708
775-829-1799
admin@worldccr.org
http://www.worldccr.org
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