[Ip-health] MSF: First new TB drug in 50 years risks being squandered; relaunches DR-TB Manifesto

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Wed Oct 30 08:25:23 PDT 2013

Médecins Sans Frontières and the International Union Against Tuberculosis
and Lung Disease (the Union) have today released the 3rd edition of
drug-resistant TB drugs pricing and access report, DR-TB Drugs Under the
Microscope. The report covers the issues faced in accessing DR-TB drugs,
including the high price of new drug bedaquiline. A currently recommended
DR-TB treatment regimen costs anywhere between US$3,000 - $5,000 per person
per treatment; treatment has awful side effects, is ineffective and lasts
around 2 years, with people taking as many as 14,600 pills.

Please find MSF's press release below; the report can be found here:

Also relaunched today is the 'Test me, treat me' DR-TB Manifesto, which
asks people to sign on in support of people receiving treatment now, better
treatment and for the funding to scale treatment up. We encourage you to
sign and share the manifesto website via social media; visit the manifesto
here: http://www.msfaccess.org/TBmanifesto/

First new tuberculosis drug in fifty years risks being squandered without
better research and pricing strategies

New TB drug bedaquiline illustrates need for paradigm shift in developing
and ensuring access to new treatment combinations

Paris, 30 October 2013 –Without a new approach to developing and pricing
new tuberculosis medicines, the global TB response will be unable to
deliver the new treatment combinations needed to close the deadly treatment
gap for drug-resistant tuberculosis (DR-TB), warned the international
medical humanitarian group Médecins Sans Frontières/Doctors Without Borders
(MSF) at the Union World Conference on Lung Health in Paris.

“If I could change anything about having TB it would be the treatment; if
we could have less toxic drugs and simpler, shorter treatment regimens,
there would be fewer people dropping out of treatment and fewer people
dying”, said Phumeza Tisile, who received TB treatment through MSF’s
programme in Khayelitsha, South Africa.

In December 2012, a 50 year drought in TB drug research and development
(R&D) came to an end with the approval in the U.S. of bedaquiline, a novel
TB medicine marketed by Janssen, a subsidiary of Johnson & Johnson (J&J).

“This is a significant milestone for clinicians and patients, but there is
no room for complacency or celebration yet. The new drug is obviously a
boon, but what we really need are entire new combinations of drugs to treat
DR-TB”, said Dr. Cathy Hewison, TB advisor for MSF. “If we are unable to
offer patients an entirely new, tolerable and more effective regimen in the
coming years, the opportunity to radically improve DR-TB treatment will be

The U.S. Food and Drug Administration fast-tracked the approval of
bedaquiline, the World Health Organization (WHO) issued rapid guidelines
for its use, and J&J has pushed for registration fairly widely; these are
positive signals that the TB context is ready to respond quickly to new
drugs.  But achieving the goal of entirely new regimens requires a more
fundamental change in the way TB drugs are researched and brought to market.

“We need much more collaborative research early on, instead of companies
operating in silos, and this will require a massive commitment from the
global research community, as well as a significant injection of funds at a
time when the global investment for TB R&D is actually declining”, said
Sharonann Lynch, policy advisor for the MSF Access Campaign.

WHO estimates that fewer than 20% of the world’s drug-resistant TB cases
are diagnosed and treated.  Because treatment is long, arduous, expensive
and poorly effective, with global cure rates stagnating around 50%,
scale-up of DR-TB diagnosis and treatment is extremely difficult. Affected
countries should scale up efforts to diagnose and treat DR-TB today, so
that robust programmes are in place to ensure responsible and effective use
of new treatment combinations once they are available. To achieve this,
countries will need support, so a fully financed Global Fund to Fight AIDS,
Tuberculosis and Malaria will be critical.

“We also need to be preparing the ground so that new treatments are
affordable. J&J’s pricing structure for bedaquiline leaves middle-income
countries, some of which are among the hardest hit by DR-TB, paying
US$3,000 for a six-month course”, said Sharonann Lynch. “That’s for just
one drug - bear in mind several drugs are needed for effective treatment.
If the new treatment combinations of the future cost in excess of several
thousand dollars even in the poorest countries, as they do today, how on
earth will countries be able to increase access and expand coverage?”

MSF is one of the largest non-governmental organisations providing DR-TB
care. In 2012, MSF treated 29,000 patients for TB in 30 countries, and
1,780 patients for DR-TB in 18 countries.

MSF and the International Union Against Tuberculosis and Lung Disease today
released DR-TB Drugs Under the Microscope, a report on the prices, sources,
access environment and R&D landscape for DR-TB medicines. The report is
available at:

About The Union
The mission of the International Union Against Tuberculosis and Lung
Disease (The Union) is to bring innovation, expertise, solutions and
support to address health challenges in low- and middle-income populations.
With 15,000 members and subscribers from 150 countries, The Union has its
headquarters in Paris and offices serving the Africa, Asia Pacific, Europe,
Latin America, North America and South-East Asia regions. Its scientific
departments focus on tuberculosis and HIV, lung health and non-communicable
diseases, tobacco control and research. Learn more at www.theunion.org..

Joanna Keenan
Press Officer
Médecins Sans Frontières - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02
E: joanna.keenan[at]geneva.msf.org
T: twitter.com/joanna_keenan


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