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Regulators should fast-track tuberculosis drugs: MSF
http://today.reuters.co.uk/news/articlenews.aspx?type=healthNews&storyID=2006-10-30T135944Z_01_L30158647_RTRIDST_0_HEALTH-TUBERCULOSIS-MSF-DC.XML&WTmodLoc=SciHealth-C4-Health-2
ALL THANKS TO REUTERS (UK) - FOR THEIR PUBLIC HEALTH CONCERNS
By Laura MacInnis
GENEVA (Reuters) - Drugs showing promise against virulent new strains of tuberculosis should have their regulatory approval fast-tracked because existing medicines are ineffective, Medicins Sans Frontieres (MSF) said on Monday.
Tido von Schoen-Angerer, director of MSF's Campaign for Access to Essential Medicines, said that three medicines now in clinical trials -- Johnson & Johnson's Diarylquinoline, Otsuka's Nitroimidazo, and Pyrrole by Lupin Ltd. -- should be brought to market at an accelerated pace.
Unless regulators like the U.S. Food and Drug Administration and the European Medicines Agency (EMEA) hasten their approval procedures for the drugs, he said it would take years for them to reach needy patients.
The World Health Organization (WHO) estimates that nearly 2 million people worldwide die each year from tuberculosis, a respiratory disease especially deadly for those with HIV/AIDS.
Some 450,000 people each year are infected with strains of the respiratory ailment that resist treatment with first-line antibiotics, and a growing number are also untreatable with second-line drugs, "making treatment with existing drugs virtually impossible," MSF said.
Von Schoen-Angerer said fast-tracking the three drugs he said had shown promise against the more difficult strains of tuberculosis could help curb the spread of disease among the world's most vulnerable people.
The first of the new tuberculosis drugs now in the clinical pipeline, which is not among the three considered most promising, will not reach the market until 2010. The others will take even longer unless slow regulatory approval processes are accelerated, von Schoen-Angerer said.
He urged the WHO to take the lead in encouraging faster regulatory approval for tuberculosis medicines, and to ensure more funding is channeled into research in the field.
Sub-Saharan Africa has the largest number of tuberculosis cases per capita, at nearly 400 infections per 100,000 people. Despite global efforts to stop its spread, Africa's tuberculosis incidence has continued to rise along with a spread of HIV.
Many of those with the immune-suppressing virus which leads to AIDS die from tuberculosis before current tests can confirm whether they are resistant to standard therapies, said Francoise Louis, a tuberculosis and HIV/AIDS advisor for MSF.
"XDR-TB (a new strain) has the potential to be devastating in places where HIV/AIDS is widespread," Louis said, likening the drugs and diagnostic tools now available to fight that strain to "trying to put out a forest fire with a garden hose."
No one at WHO or at EMEA was immediately available to comment.
http://today.reuters.co.uk/news/articlenews.aspx?type=healthNews&storyID=2006-10-30T135944Z_01_L30158647_RTRIDST_0_HEALTH-TUBERCULOSIS-MSF-DC.XML&WTmodLoc=SciHealth-C4-Health-2
ALL THANKS TO REUTERS (UK) - FOR THEIR PUBLIC HEALTH CONCERNS
By Laura MacInnis
GENEVA (Reuters) - Drugs showing promise against virulent new strains of tuberculosis should have their regulatory approval fast-tracked because existing medicines are ineffective, Medicins Sans Frontieres (MSF) said on Monday.
Tido von Schoen-Angerer, director of MSF's Campaign for Access to Essential Medicines, said that three medicines now in clinical trials -- Johnson & Johnson's Diarylquinoline, Otsuka's Nitroimidazo, and Pyrrole by Lupin Ltd. -- should be brought to market at an accelerated pace.
Unless regulators like the U.S. Food and Drug Administration and the European Medicines Agency (EMEA) hasten their approval procedures for the drugs, he said it would take years for them to reach needy patients.
The World Health Organization (WHO) estimates that nearly 2 million people worldwide die each year from tuberculosis, a respiratory disease especially deadly for those with HIV/AIDS.
Some 450,000 people each year are infected with strains of the respiratory ailment that resist treatment with first-line antibiotics, and a growing number are also untreatable with second-line drugs, "making treatment with existing drugs virtually impossible," MSF said.
Von Schoen-Angerer said fast-tracking the three drugs he said had shown promise against the more difficult strains of tuberculosis could help curb the spread of disease among the world's most vulnerable people.
The first of the new tuberculosis drugs now in the clinical pipeline, which is not among the three considered most promising, will not reach the market until 2010. The others will take even longer unless slow regulatory approval processes are accelerated, von Schoen-Angerer said.
He urged the WHO to take the lead in encouraging faster regulatory approval for tuberculosis medicines, and to ensure more funding is channeled into research in the field.
Sub-Saharan Africa has the largest number of tuberculosis cases per capita, at nearly 400 infections per 100,000 people. Despite global efforts to stop its spread, Africa's tuberculosis incidence has continued to rise along with a spread of HIV.
Many of those with the immune-suppressing virus which leads to AIDS die from tuberculosis before current tests can confirm whether they are resistant to standard therapies, said Francoise Louis, a tuberculosis and HIV/AIDS advisor for MSF.
"XDR-TB (a new strain) has the potential to be devastating in places where HIV/AIDS is widespread," Louis said, likening the drugs and diagnostic tools now available to fight that strain to "trying to put out a forest fire with a garden hose."
No one at WHO or at EMEA was immediately available to comment.