Regulatory Conference Shows The Way Forward From Lessons Learnt In The Past



By Shobha Shukla, CNS
August 20, 2010
The author is the Editor of Citizen News Service (CNS). She has worked earlier with State Planning Institute, UP, and teaches Physics at India's prestigious Loreto Convent. Email: shobha@citizen-news.org, website: www.citizen-news.org

(CNS): The 4th Open Forum Conference was held in Addis Ababa, Ethiopia on 18th and 19th August to address key issues in developing new drugs for tuberculosis, which kills nearly 2 million people every year and is becoming increasingly resistant to the current drugs. 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 which will reduce the usual time taken to develop safer and more effective TB drug regimens by almost 75%.

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 programme 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 labour of developers of new drug regimens will not be able to reach the affected community.
(i) 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’.
(ii) 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. (CNS)

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Posted on: August 20, 2010 01:06 PM IST