E-DRUG: non-commercial diseases / neglected diseases (3)
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Dear Valeria and Patrice,
Many thanks for your comments. First of all, I would like to say that
neglected diseases is not my area of expertise, nor the field I am working
in at the moment. Everything I know comes from literature research in
articles published by more specialized people like yourself, so I am happy
to accept modulations in any point of view if. (Note that the ideas and
opinions expressed in this and the previous contribution to E-drug do not
necessarily reflect the view of the International Rescue Committee.)
Also, while re-reading the abstract and the final PowerPoint presentation, I
noticed that the abstract is not completely reflecting what I said during my
presentation, where I did make all the points that you mentioned. So I
agree, this abstract could have been more complete. I would be happy to send
you the presentation, but it is in Dutch, so I will comment on your remarks
below with the arguments used during the presentation.
1."Through the orphan drug policies - mainly in the US and the EU, even if
the social aspects of these policies can be debated, significant R&D with
critical outcomes has been done for the past twenty years (cf. Trouiller P
et al."
During the presentation, I mentioned the various Orphan Drug Acts in the
U.S. (1983), Australia (1993), Japan (1997) and Europe (1999) as incentives
given by the public sector to promote research and development to orphan
drugs. The respective European programmes for Rare Diseases (1999-2003) and
for Research and Technical Development (1998-2002) were also included.
2. "If you are right when you say - as we wrote it in the 2002 Lancet paper,
that no indication that drug development for neglected diseases will
significantly improve in the near future, you have to put it in context. Our
conclusions were to point out that whether we have indeed nothing
significant to expect from the traditional R&D-based pharmaceutical
industry, we could reverse the current trend with new approaches (see an
article in French on: Access and dissemination of medical innovation in
developing countries, A lost battle? Trouiller P. et al. Revue de Santé
Publique Sève, 2004). The very young example of the Drugs for Neglected
Diseases Initiative (DNDi), recently launched by MSF and other partners is
illustrating the fact that there is really some hope."
This point is also very well taken. Again, after having discussed the causes
and results of the ‘fatal imbalance’ between needs and availability of
drugs for neglected diseases, I concluded the presentation with the measures
that have been taken to correct this imbalance by various governments and
organizations like the push and pull measures to make the pharmaceutical
industry reinvest and the Public-Private Partnerships (PPPs) like Medicines
for Malaria Venture (MMV), Global Alliance for TB Drug Development. I added
that these global initiatives are chronically underfunded and it is still
too early to conclude about their results. The DNDi working group and the
Harvard School of Public Health's study to investigate the extent of
research and development in neglected diseases in the world’s top-20
pharmaceutical companies was also mentioned. The DNDi working group has done
a tremendous job in objectively investigating and addressing the key issues
in providing access to drugs for neglected diseases and I hope they continue
to receive recognition for their work.
3. Thanks for sharing this very comprehensive definition of neglected
diseases. I agree that neglected diseases are not only affecting people in
tropical climates yet the scale of the resulting problem is much greater in
the developing world. Yet, measures should be taken to maximize development
for neglected diseases in the industrialized world as well. Since I am
working for a relief agency, I focused more on the effects on people living
in developing countries.
Dr. Valeria Frighi wrote:
"Many people in the public at large can't see that independently
sponsored clinical research will lead to health improvements for
all."
"However, a huge amount of publicly funded research has been
going on for years in Oxford, Cambridge and many other leading
world Universities. A lot of this research has been done at ground
level as well (the Gambia for instance, Wellcome Trust
sponsored) . The worldwide collaborative academic research has
included the decoding of the plasmodium falciparum genome and
the continuous search for a malaria vaccine at biological and
clinical trial level.
At Oxford University clinical trials on a malaria vaccine and an
AIDS vaccine are ongoing. These are obviously publicly
sponsored, mainly by the UK Medical Research Council, the
Wellcome Trust and also by other small charities."
Absolutely, Valeria, most of the basic research is done by the public funded
research institutions (so at the expense of the tax payer) and not by the
pharmaceutical industry. These public research institutions publish their
findings that will or will not be further developed by the pharmaceutical
industry (which was identified in “Fatal Imbalance” by DNDi as the first
of the three gaps in the drug development process, the gap between basic
research and pre-clinical research). I addressed this point during my
presentation.
As a concluding remark, I mentioned the need for structural long-term
solutions like a well-defined and needs-driven R&D agenda to guide policy
makers, donors and the research community with full cooperation of the
pharmaceutical industry.
Allow me to add as well that I do not see the pharmaceutical industry as the
enemy or the sole obstacle in getting access to drugs for neglected diseases
and that I believe in an open-dialogue between the industry and the various
stakeholders.
Finally, I would like to end by reiterating that in the greater scheme of
things, lack of access to most basic, yet life-saving essential drugs (this
is the area I am working in) is a more imminent problem (although it has
doubled over the last twenty years) because these essential drugs are not
available (WHO estimates that today one third of the world’s population
has still no regular access to essential medicines), from poor quality or
used irrationally. 60% of deaths in the world’s poor populations are due
to common communicable diseases like acute respiratory infections,
diarrhoeal diseases, tuberculosis and malaria. (Guillot M, Gwatkin DR. The
Burden of Disease among the Global Poor, Current Situation, Future Trends,
and Implications for Strategy. Washington DC, Human Development Network, The
World Bank, 1999)
Again, thank you again for your constructive comments, which I will take
into account when re-editing the abstract.
Kind regards,
Ans Timmermans, PharmD
Global Technical Advisor Pharmaceuticals and Medical Logistics
International Rescue Committee
anst@theIRC.org
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