MSF And TB Experts Call For New Approach To Test TB Drugs
The authors call for testing new TB drugs in patients whose TB is resistant to standard treatment, making it easier to detect the anti-TB activity of new drugs. This strategy, adopted with success during the AIDS pandemic in the 1990s, means that clinical trials could be done quicker and in fewer patients, and ultimately newer and better drugs could be developed faster.
"This is quite simply the best hope we have of getting improved medicines to patients with multidrug-resistant TB faster," said Dr. Eric Goemaere, Head of Mission, MSF South Africa. "We cannot afford to wait. MDR-TB is spreading rapidly, particularly in areas like South Africa where HIV is high. And with the current drugs, many patients on MDR-TB treatment give up half-way and the majority of patients co-infected with HIV will die before the end of treatment."
The important long-term goal is to develop a complete new treatment that works for both drug resistant and drug-susceptible TB. But until this is achieved, which will take over a decade, the urgency is to improve treatment of drug-resistant TB.
Globally there are almost five hundred thousand new cases of multidrug-resistant TB every year. The current treatment relies on weak drugs with harsh side effects and lasts up to two years. Even in the best treatment conditions, some patients develop extensively drug-resistant TB (XDR) simply because the drugs are so ineffective.
"There is an imperative to speed up TB drug development and one way to do this is through innovative trials," said Dr. Carole Mitnick of Harvard Medical School. "All new, promising compounds should be tested in patients with drug-resistant and drug-susceptible TB to accelerate access to improved treatments for those in need now. In light of recent improvements in the TB drug pipeline and growing evidence about the magnitude of the MDR problem, it is frustrating that this approach to improving treatment outcomes for all TB patients has not been widely adopted."
Introducing a different strategy and testing new drugs in drug-resistant patients would not compete with trials in drug-susceptible patients, since they could be done in parallel. Countries with a high burden of TB need to actively support the set up of these trials to address the TB crisis. In addition, the overall number of compounds that are in the pharmaceutical pipeline needs to be increased dramatically.
"I don't understand why this is not taken up by all drug developers," said Dr. Tido von Schoen-Angerer, director of MSF's Access to Essential Medicines Campaign. "On the one hand we have world-renowned experts and leading regulatory authorities such as the US-FDA advising that clinical studies in multidrug-resistant patients would hasten the approval of new drugs, and on the other hand we have key funders such as the Gates Foundation, sticking to a one track traditional approach. Funders and drug developers need to respond to this challenge."
Today's model, where the cost of researching and developing medicines is paid for through drug prices, means that drug development is steered towards areas where the profit rewards are the greatest, so diseases which predominantly affect developing countries are neglected. At the same time, patents are used to sustain artificially high prices for medicines, so many in need are quite simply priced out of the market.
The UN talks risk being derailed by opposition from some governments. Although this meeting is based on a World Health Assembly Resolution which puts intellectual property on the agenda, the USA and the European Union countries are questioning an expanded role for the World Health Organization regarding intellectual property and health. Some governments are also trying to narrow the scope of the meeting to a restricted number of diseases, whereas developing countries seek comprehensive solutions.
As a medical organisation we need medical innovation to happen. But we also need to ensure that new and existing medicines are made affordable for all those that need them, said Michel Lotrowska, Campaigner with MSF. Innovation is meaningless if newly developed products remain out of reach.
The article "Randomized trials to optimize treatment of multi-drug resistant TB," appears in the current issue of PLoS Medicine and was authored by Carole D. Mitnick (Harvard Medical School), Kenneth G. Castro (Division of TB Elimination, US Centers for Disease Prevention and Control), Mark Harrington (Treatment Action Group) Leonard Sacks (US Food and Drug Administration), and William Burman (Denver Public Health and the University of Colorado Health Sciences Center). PloS can be accessed at: http://www.plosmedicine.org.
MSF ªi TBC Experþi Apel pentru noua abordare a Test TBC Drogurile - MSF And TB Experts Call For New Approach To Test TB Drugs - articole medicale engleza - startsanatate