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South Africa Medicines Control
Council (MCC), the regulatory authority of South Africa, is preventing patients
dying from drug-resistant TB from access to a new drug that may be their only
hope.
According to Medecins Sans
Frontieres, the MCC has made no effort to register bedaquiline (TMC207), even
though European and US drug regulators are already doing so. Countries such as
France and the United Kingdom, with strict drug safety regulations, are
currently providing bedaquiline under compassionate use regulations.
Compassionate use allows for the dispensing of investigational drugs before
they are registered and placed on the market.
Medecins Sans Frontieres had earlier
sought a commitment from the MCC to allow expanded access to the drug and to
expedite the review process, which would have resulted in the registration of
the first new TB drug in more than 50 years in South Africa. The MCC initially
approved the drug for compassionate access in 2011, but then withdrew their
approval with no explanation.
South Africa has a serious epidemic
of drug-resistant TB. Every year about 10,000 people are diagnosed with MDR TB,
with a sizable proportion developing XDR TB. Treatment with current drugs is
successful for only about 60 percent of MDR TB and 44 percent of XDR TB
patients.
A few South African patients have been allowed
access to bedaquiline through clinical trials. In April, the Southern African
HIV Clinicians’ Society, the AIDS & Rights Alliance for Southern Africa,
the Global Tuberculosis Community Advisory Board, and the Treatment Action
Campaign wrote a public letter to the ministers of health and the MCC
highlighting the urgent need for compassionate use of bedaquiline. Other
organizations, plus many concerned health care workers, also wrote to the MCC.
The MCC’s response was to ask the
Health Department to submit a clinical trial protocol, thus further postponing
access to the drug. In the US, the FDA is expediting the process by deciding
whether to approve the drug within six months of the application of submission,
rather than the standard 10 months, and the European Medicines Agency is
considering conditional approval for its use.
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
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