The conference, with a special focus on Africa, brought
together regulators, scientists and other interested stakeholders, from all
around the world, to share knowledge and build a proper infrastructure needed
to adopt new and improved TB treatments. They deliberated over an innovative
drug development model that would reduce the usual time taken to develop safer
and more effective TB drug regimens by almost 75 percent.
New drugs development for TB treatment seemed to have
been stalled until a decade ago, with no new treatments in the pipeline. But
thanks to the initiatives taken by the Global Alliance for TB and due to
investments in TB research by global funders, there are, at present, 10 new compounds
in the pipeline, three of which are in clinical trial stages.
Mel Spigelman, MD and CEO of the TB Alliance agreed that
"Today there is unprecedented hope for better treatments for tuberculosis.
Now that there are promising compounds in the global pipeline, it is important
to speed them through clinical development so they can reach the millions in
need."
Since the 1950s, researchers have known that in TB
treatment (or for that matter, treatment of other diseases as well), mono
therapy is dangerous as it creates drug resistance. So, to be effective, it
must be delivered in multidrug regimens. Moreover, the current TB therapies are
long and complicated, and also incompatible with commonly used HIV infection.
The current treatment, for drug sensitive active disease, uses 4 drugs which
need to be administered daily for at least 6 months. Treatment for multidrug
resistant TB (MDR) is still longer and requires more expensive and toxic drugs.
Under the traditional paradigm, TB drugs were developed
and registered separately, and substituted/added one at a time, into existing
combination therapies. For each substitution, the drug had to be tested in
clinical trials, which normally takes 6 years. So, a novel four drug therapy
would have required a minimum of 24 years, before it could benefit those who
needed it urgently.
The new TB drug development model focuses on testing
novel combination-drugs together in the development stage, rather than
individual drugs. This would drastically reduce the development time for building
new regimens.
"This collaboration harnesses innovation to speed
availability of a shorter and more effective treatment for TB," says
Margareth Ndomondo Sigonda, pharmaceutical coordinator of the New Partnership
for Africa's Development. "It is important for global regulators to
harmonize regulatory guidance and provide efficient regulatory processes for
new TB regimens to speed adoption and make an impact."
The Minister of Health of Ethiopia rightly believes that,
"New technology and innovation are necessary to defeat tuberculosis. This
event is important because Africa's regulators, systems, and, above all else,
people, must be prepared to fully maximize the promising innovations coming
through the pipeline."
This innovative model is part of a wider program called
the 'Critical Path To TB Drug Regimens (CPTR)' which was launched by FDA
Commissioner Margaret Hamburg on March 17, 2010, and is led by the Bill and
Melinda Gates Foundation, the TB Alliance, and the Critical Path Institute. It
aims to reduce the broad obstacles facing TB drug development.
The take home messages after two days of intensive
deliberations, reiterated that the diagnosis, treatment and care of
tuberculosis continues to be immensely challenging, not only in the context of
Africa, but other countries too, having a high burden of the disease. On the
one hand, inadequate resources are impeding development/testing of new drugs
while on the other hand, weak health systems are constraining time bound
deliverables to the affected community.
However, in this dismal scenario, there have been a few
success stories too (in Lesotho, Georgia and Ethiopia). As Dr Spigelman rightly
said, "Big progress comes from small numbers."
According to him, the way forward has three major
components:
(i) A strong political will, which is committed to take
care of public health. Without this key element the fruits of labor of
developers of new drug regimens will not be able to reach the affected
community.
(ii) Innovations, to optimize the use of the limited resources
available. An innovative approach to make the system work more efficiently will
result in 'doing more with less'.
(iii) Linkage, of all the individual areas of expertise
of experts from diverse fields. Researchers, pharmaceutical developers, regulatory
agencies and civil society organizations — all need to work not only in their
individual capacities, but also together. Everyone needs to be informed about
what everyone else is doing.
Only then will it be possible to overcome obstacles and
speed up the urgently required new TB regimens to reach the people who need
them most. Together we shall overcome one day, which is not far away.
