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Advocates See Historic Chance to Turn Tide on TB

WASHINGTON, Mar 21 2013 (IPS) - Patients, doctors and international aid groups are calling on donors and governments to support measures that would make treatment of drug-resistant tuberculosis more effective and accessible.

The demands are being made amidst the recent or imminent approval of two new drugs, bedaquiline and delamanid. Advocates say the drugs present an historic opportunity to tackle the notoriously difficult-to-treat disease.

“As we know with all infectious diseases, we need to seize this opportunity before an airborne infectious disease gets too out of control,” Dr. Jennifer Cohn, a policy advisor with Medecins Sans Frontieres (MSF), an aid group, told IPS.

On Monday, MSF released a manifesto, signed by TB patients and their doctors in 23 countries around the world, noting that “after close to five decades of insufficient research and development into TB … Research is urgently required to determine the best way to use these new drugs so that treatment can be made shorter and more effective.”

It also warns that “If measures to tackle MDR-TB are not immediately expanded, rates of the disease will continue to increase worldwide, and a historic opportunity to improve abysmal cure rates will have been squandered.”

The call to action comes on the heels of a World Health Organisation (WHO) statement on the wide spread of drug-resistant tuberculosis – and warnings over an anticipated funding gap of 1.6 billion dollars needed to both identify new cases and combat existing strains.

An additional 3.2 billion dollars, according to WHO estimates, could be provided by governments. If the combined 4.8 billion dollars is funded, treatment could be provided for 17 million TB and drug-resistant TB patients.

“We have gained a lot of ground in TB control through international collaboration, but it can easily be lost if we do not act now,” Dr. Margaret Chan, the WHO director-general, said in a statement.

Twenty pills a day

While the overall incidence of tuberculosis has fallen in recent years, drug-resistant strains have increased. In a 2009 resolution to the World Health Assembly, the WHO noted that the highest levels of multidrug resistance reported in the agency’s lobal report “pose a threat to global public health security”.

The spread of resistant strains is particularly alarming because their long and difficult treatment process makes them significantly more difficult to cure than traditional strains.

The MSF manifesto makes reference to regimens that require up to 20 pills a day along with daily injections that make it painful to sit or lie down. The treatment is also known for strong side effects, including severe nausea and even deafness.

MSF is calling for universal access to diagnosis and treatment for patients suffering from drug-resistant tuberculosis, as well as the development of “more tolerable” drug regimens, and additional financial support from international donors and governments for research.

Perhaps the most serious obstacle to filling the 1.6-billion-dollar funding gap is the massive federal budget cuts that went into effect here in Washington in early March. These are slated to cut deeply into development assistance, including international health.

For instance, the United States will reduce its contribution to the Global Fund to Fight AIDS, Tuberculosis and Malaria alone by 300 million dollars, according to figures revealed by Secretary of State John Kerry.

“The United States is the number one donor to the Global Fund, and the Global Fund is the number one donor for treating multi-drug-resistant TB,” Cohn says. “So budget cuts are definitely a concern.”

Still, she notes, one of the biggest challenges lies in fostering cooperation among manufacturers.

“We need to see manufacturers engaging in trials on the different [anti-TB] drugs together, to determine their efficacy and to develop a regimen that works as strongly and safely as possible,” she says. “Unfortunately, we have not seen a lot of progress on this.”

Drug reservations

One of the drugs being lauded in the manifesto is bedaquiline. But some watchdog groups here are sounding alarms about the drug’s safety.

“I don’t have any problem with looking for more drugs to treat disease that is a terrible problem in many countries, but it has to be done very carefully and cautiously,” Dr. Sidney Wolfe, the director of the Health Research Group at Public Citizen, a Washington-based advocacy group, told IPS.

In a letter to the U.S. Food and Drug Administration sent in December, Public Citizen strongly opposed any accelerated approval of bedaquiline, noting that the drug has been shown to be highly dangerous in clinical trials. The letter referenced findings that patients taking bedaquiline in addition to standard TB treatment were five times likelier to die than those who took a placebo.

Despite these concerns, bedaquiline was approved in December.

“There are two possibilities,” Wolfe says. “Either [MSF] didn’t read the report [about the five-fold increase in death rate], or they did and decided that since the FDA approved it, it must be ok. Either one of these explanations is unacceptable. How can you be enthusiastic about a drug that is killing so many people?”

Cohn at MSF stresses the need to be vigilant about any new medication, and notes that the drug will now go through an additional phase of testing.

“Any new drug that comes to market we want to watch closely,” she says. “We are looking forward to data that will tell us more about the Phase 3 side effects of bedaquiline.”

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