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For those advocating for more funding and programs to fight tuberculosis, a common lament has been that few people see those who suffer from it – and that the assumption is often that the disease affects only poor people in far-away places.

But at a session this week at the Global Health Council conference, faces of TB emerged, and they powerfully made the argument that not enough was being done to fight the disease.

Gerry Elsdon, a popular South African television personality, was one, telling her story at a session sponsored the Lilly MDR-TB Partnership and the International Federation of the Red Cross and Red Crescent Societies (IFRC).

Elsdon said that after unsuccessful attempts to become a mother, she was screened for tuberculosis and learned that he had been infected with the disease.  Pulmonary specialists found she did not have TB in the lungs, and therefore was not infectious.  But a physician friend had other bad news:  The doctor said TB is the biggest cause of infertility among women in rural areas.  After further testing, Mycobacterium tuberculosis was found in the wall lining of her uterus.  She immediately went on treatment, and was cured after nine months.  But, she would learn, she also had become infertile.

After waiting in long lines and unventilated clinics for hours to seek treatment with dozens of other TB patients – she was No. 169 in the queue — Elsdon realized “TB sufferers do not have a voice, and TB patients do not have a say.” 

She told the Global Health Council audience that TB doesn’t have the voice, recognition, funding, marketing ploys, or “sexiness” of other diseases, such as HIV/AIDS.  She explained that women in particular suffer disproportionately from the disease, as they must leave their primary roles as family caregivers to seek treatment, which lasts for months. 

These experiences compelled Elsdon to petition the government to do more for TB patients, leading her on a path of advocacy for the past nine years.  Still, she said, even after nine years of fighting against this disease, she feels like she has only taken small steps forward due to the enormity of the problem.

Teresa Rugg, director of the TB PhotoVoice Project, then shared the story of a friend, Claudia Lacson, a TB caregiver who was a graduate student at the University of Georgia when she was diagnosed with TB meningitis.  Lacson was pregnant.  Her child was born 22 weeks prematurely, and passed away.  Claudia died two months later. 

Her husband, Romel Lacson, established the TB PhotoVoice Project in his wife’s honor, continuing his wife’s impassioned work against the disease.  The Project allows TB patients to articulate their struggles with TB by taking photographs of their surroundings and artistically representing how this disease affects their lives and communities.  By giving them a voice, the Project hopes to empower TB patients and have them engage in dialogue with policymakers and others so that TB receives greater attention.   

Gini Williams, the TB Director of the International Council of Nurses, which works to build capacity among TB caregivers, emphasized the importance of working to integrate all health services which are integral to women’s health.  She said it is not only essential for maternal and child health services and HIV/AIDS services to be integrated, but also to integrate TB services as well in areas where women are at particular risk to become infected.  Williams suggested that simple steps be taken, such as providing TB services at PMTCT clinics. 

Elsdon went further to say that governments should be aware of the devastating effects of TB in every policy area, as TB is not only a health issue but a development issue.

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Dr. Michel Kazatchkine, executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, spoke to a group of global health advocates yesterday at a roundtable discussion hosted by the Council on Foreign Relations, as a part of their Future of U.S. Development Assistance for HIV/AIDS roundtable series.  Kazatchkine discussed the unprecedented progress achieved in the last ten years by developing countries in their fights against HIV/AIDS, TB, and malaria, thanks in part to funding provided by the Global Fund.  He also spoke of the need for donor nations to not only sustain their contributions but increase them in order to achieve Millennium Development Goal (MDG) number 6, which relates to combating HIV/AIDS, tuberculosis and malaria.

At current funding levels, we are nowhere near achieving the HIV/AIDS treatment goals set out in MDG number 6, which call for universal access to treatment for all those who need it.  Without a substantial increase in investments, this goal is unattainable.  There are 2.8 million people receiving HIV treatment through Global Fund supported programs today.  Kazatchkine discussed the importance of providing treatment as a prevention intervention, and emphasized the need to scale-up treatment services.  Thanks to the scale-up of treatment to date, mortality rates have greatly decreased.  For example, mortality rates in Addis Ababa have been reduced by 60 percent.

Efforts to combat HIV/AIDS have resulted in 930,000 HIV-positive pregnant women receiving a complete course of ARV prophylaxis to reduce mother-to-child transmission.  Also, 120 million HIV counseling and testing sessions have been conducted and 4.9 million basic care and support services have been provided to AIDS orphans and vulnerable children.  In addition, 2.3 billion condoms have been distributed.

Kazatchkine highlighted progress on tuberculosis and the Global fund’s contribution to advancing that goal.  The MDG goal is to have a TB incidence rate of 124 per 100,000 by 2016.  Currently the rate of incidence is 164 per 100,000.  Seven million persons have access to TB diagnostic services and treatment through Global Fund-supported programs, a 30 percent increase from mid-2009.

The Global Fund currently provides roughly 20 percent of international resources to fight AIDS, 63 percent of international funding to fight tuberculosis and 60 percent of funding to fight malaria.

According to Kazatzchine, “If donors provide sufficient resources, by 2015 we could virtually eliminate transmission of HIV from mother to child, dramatically reduce deaths from AIDS, prevent many new HIV infections, and achieve significant declines in TB prevalence and mortality.”

Kazatchkine described the achievements as fragile.  An increase in contributions is critical to sustain and to facilitate additional progress in fighting these three infections.  On October 5th donors will pledge their contributions for the next three years, which could greatly influence the outcome of the MDG 6 goal by 2015.  Kazatchkine explained that a total pledge of $17 billion for the next three years is needed to continue to make progress.  Donors contributed $10 billion during the last replenishment period in 2007.

The United States, as the largest contributor the Global Fund, provides 28 percent of funding.  Kazatchkine explained that every dollar received from the U.S. leverages $2 from other donors.  The U.S. must increase its contributions in October in order to achieve the attainable goals of eliminating malaria, and greatly reducing the prevalence of HIV/AIDS and tuberculosis within the next few years.  It is notable that the Administration requested fewer resources for the Global Fund in its fiscal year 2011 budget that Congress had appropriated the year before.

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Today, The Lancet launched an impressive new series of articles on the global tuberculosis epidemic, which claims 1.8 million lives every year. The Lancet articles note that TB is a leading cause of death in people in the most economically productive age-groups. The series highlights scale up of treatment and diagnoses, drug-resistant TB, and HIV/TB co-infection, as well as the huge funding gap for TB control and research and development, with many countries struggling to deliver basic diagnostic and treatment services.

The authors of one lead article conclude: “Acceleration of the present decline towards TB elimination will need invigorated actions in four broad areas: continued scale-up of early diagnosis and proper treatment in line with the Stop TB Strategy; development and enforcement of bold health-system policies; establishment of links with the  broader development agenda; and promotion and intensification of research.”

With the unveiling of this series, we spoke today with Zhenkun Ma, Ph.D., Chief Scientific Officer for the TB Alliance, who authored this article focused on TB drug development and the promise of new medicines to greatly improve TB treatment.

Q: You point to the results of a modeling study that suggests the combination of a 2-month treatment regimen that cures 95% of MDR tuberculosis, a better TB diagnostic tool, and a joint pre-exposure and post-exposure TB vaccine could potentially reduce the incidence of this disease by 71% by 2050. But that seems like a very tall order. How realistic is it that we can achieve those goals and what will it take to get there?

A: I think it’s very feasible. We have a very strong pipeline. On the drugs front, the goal of achieving a 95 percent cure rate for drug-resistant TB with new drugs is very doable. Right now, there are 10 drugs in clinical development, and the majority—six new drugs—belong to novel drug classes with new modes of action, new mechanisms. Bacterium has never seen these compounds before. They work differently from old drugs and are able to overcome drug-resistant forms of TB.

Four of the drugs in the pipeline are currently being used to treat other bacterial infections. We are in the process of figuring out how to best use these to treat TB. Because of these developments, I think it’s very feasible to achieve significant reductions in TB incidence.

Q: One problem you highlight is inadequate clinical trial capacity to test new regimens for TB treatment. Can you elaborate on that? Why isn’t there enough capacity, how inadequate is it, and what will it take to get to full capacity?

A: TB has its worst impact on developing countries. The places you have TB patients, generally, do not have the capacity to conduct modern clinical trials. Most parts of Africa, for example, simply don’t have the laboratory capacity required to support registration trials. And the places we are able to conduct registration trials, you simply don’t have enough patients with TB. So that’s the challenge and the disconnect. Funding is really the key to support capacity building and clinical capacity strengthening.

Q: What research is currently underway to improve pediatric treatment of TB?

A: Pediatric TB has largely been ignored. It’s a major challenge because it’s hard to do. We don’t have very good diagnostic tools. It will take a lot of research work to figure out how best to detect TB and monitor the efficacy of treatments in children. However, we are committed to developing drugs that can be used for all patient populations.

Q: The funding shortfall for TB research is huge. It has long been a neglected disease. What do you think it will take to change that?

A: Clearly the funding gap is huge. MSF recently reported there is a 75 percent gap in the funds needed for TB research and development. A lot of people think TB is simply not a problem anymore. The Lancet articles are a great opportunity to point out that TB is still a devastating global problem, with 2 million people dying from TB and more than 9 million new cases of TB occurring each year. This is really a massive global problem and requires people to pay more attention and invest more resources. We need all the stakeholders to allocate more resources to support TB drug development.

For more info, here’s a link to the Lancet press office and below is the Lancet press release on the Series, which has descriptions and links for each article: (more…)

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If ever there was a time to be getting more vigilant, not less, about combating tuberculosis, it is now, as strains of this ancient bug are becoming more virulent and better able to dodge our medical weaponry.

Take this disconcerting new study from researchers at the Johns Hopkins Bloomberg School of Public Health and colleagues in China, which found a strain of TB that actually “thriveson rifampin, a front-line drug in the treatment of TB. The patient, a 35-year-old Chinese man, grew increasingly ill when doctors tried to treat him with a regimen that included rifampin. He was eventually cured when they switched to a different set of medicines, according to the study, which can be found here.

“Rifampin-dependent tuberculosis is an unrecognized and potentially serious treatment issue,” said Ying Zhang, MD, PhD, senior author of the study and Hopkins professor said, according to this news release.  “Rifampin resistance is ominous. Our study highlights the potential dangers of continued treatment of MDR-TB with rifamycins that occur frequently due to delayed or absent drug susceptibility testing in the field.”  

Against that backdrop, there was this story in Monday’s San Francisco Chronicle about potentially devastating cuts to that city’s TB control program. 

“If we have five multi-drug resistant cases in San Francisco this coming year, we’re not going to have enough funding to manage them,” Dr. L. Masae Kawamura, director of San Francisco’s TB Control Section, told the paper. He said the TB section lost six employees this year to funding cuts. “We’ve already changed our operations to be lean, mean and efficient, but there’s a point where you’ve done everything you can, and that’s where we are now.”

Two days later, the SF Chronicle ran this piece about a man with drug-resistant TB who was allowed to board a flight from Philadelphia to San Francisco.

Taken together, these items do not paint a reassuring picture about the threat, or the response, to global TB.

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The Kaiser Family Foundation will hold a live, interactive webcast on Tuesday, Sept. 28, at 1 p.m. EDT on the threat of tuberculosis and the U.S. strategy for combating this ancient deadly disease.

An expert panel is set to discuss this growing global health threat, including two of the U.S. government’s top infectious disease specialists and renowned South African physician Robin Wood, who has been on the frontlines of HIV/AIDS treatment, prevention, and research for the last two decades. As director of the Desmond Tutu HIV Centre at the Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Dr. Wood will be able to give his perspective on new strategies needed to combat global HIV/AIDS and TB. 

The Center for Global Health Policy is bringing Dr. Wood to Washington next week for series of community forums, policy meetings, and press interviews. The trip is part of the Global Center’s efforts to make the voices of developing country physicians heard in American policy debates.

Joining Dr. Wood for the Kaiser webcast will be Christine Sizemore, of the National Institute of Allergy and Infectious Diseases; Cheri Vincent, of the U.S. Agency for International Development; and Christine Lubinski, director of the Center for Global Health Policy. Both Dr. Sizemore and Ms. Vincent play lead roles in the U.S. government’s global TB programs. The forum will be moderated by Kaiser Family Foundation Vice President Jen Kates. (more…)

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How could the world dramatically lower the incidence of tuberculosis and save millions of lives? 

An effective TB vaccine would revolutionize the response to TB, which kills about 5000 people each day, and eliminate the need for lengthy and often difficult drug treatment.   

An effective vaccine would be of tremendous benefit all over the world, including in the United States, where there were 13,299 cases of active TB reported in 2007 and about 11 million people with latent TB. 

Of course, there’s no question that much more can be done to prevent TB using existing methods, notably the Three I’s.  But, imagine what an effective vaccine could do.  Vaccination of newborns with a successful TB vaccine could decrease global TB incidence by 39 percent to 52 percent by 2050, and mass vaccination could result in a nearly 80 percent decrease of TB by 2050, according to a recent estimate. 

What’s exciting is that the effort to develop such a vaccine is proceeding rapidly and could produce results in just a few years — that is, if the United States government and other donors provide the funding necessary for large-scale clinical trials. 

Right now, that’s a very big “if.”

A vineyard near Worcester, on the road to Barrydale

A vineyard near Worcester, on the road to Barrydale

South Africa is a leader in TB vaccine research, and I recently had the opportunity to visit a tuberculosis vaccine facility in Worcester, 120 km northwest of Cape Town, and to take some photos.  The facility has the strong support of the US-based Aeras Global TB Vaccine Foundation, and it is a terrific example of capacity building and international cooperation.

In fact, Aeras is supporting this kind of capacity building and healthcare infrastructure strengthening (including laboratories and disease detection) not only in South Africa but at partner sites in Kenya, Mozambique, Uganda, Cambodia and India as well.

The area called the Boland, where facility is located, is one of the most beautiful places I have ever visited.  It is the source of world-class wine as well as those delicious Ceres fruit juices you can find in supermarkets in the US and other countries.

Unfortunately, this rural area also has one of the highest rates of TB in the world.

TB incidence in the research area is about 100 times that which we have in the United States. The level of TB incidence in this area is at 1400 cases per 100,000 people, even higher than the overall South Africa rate of 900 per 100,000.  

This is the view directly oppostite the SATVI research facility.

This is the view directly oppostite the SATVI research facility.

The situation in South Africa is aggravated by unemployment, poor housing conditions (cramped and with inadequate air circulation), extreme inequity in access to medical care, and HIV/AIDS. 

As we explored in Deadly Synergy, TB is having an enormous and deadly impact on people who are living with HIV/AIDS.  Since 2007, HIV and TB co-infection has been the most significant cause of premature death in the province of Western Cape. 

However, it is also worth noting that, globally, most people with TB disease are not HIV positive. 

The woman on the left runs a local saloon, in Gugulethu, where people drink beer made from corn.  TB can spread in such enclosed spaces.

The woman on the left runs a local saloon, in Gugulethu, where people drink beer made from corn. TB can spread in such enclosed spaces.

In fact, in the Western Cape, HIV prevalence is less than the overall rate in South Africa as a whole.  Hassan Mahomed, the SATVI Clinical Director, told us that there are other factors in addition to HIV which are driving the TB problem in the area, which predates the escalation of HIV. 

He told us that the long, cold and rainy winters in the area lead people to staying indoors where they can become infected by TB.  He said poverty and alcoholism were also major factors, with many of the people receiving low wages for seasonal work on the many farms in the area.  

Many people live in cramped quarters, as in this photo from Gugulethu, near Cape Town

Many people live in cramped quarters, as in this photo from Gugulethu, near Cape Town

Children can suffer terrible forms of TB disease, such as TB meningitis, which can lead to severe brain damage and paralysis. 

While children in South Africa receive some protection from the BCG vaccine, developed about 90 years ago, this does not protect them against pulmonary TB and the protection does not last into adulthood.

But research is advancing rapidly.  There are now 10 new TB vaccine candidates in clinical trials worldwide, and four of them are being tested in Worcester, at the field site of the South African Tuberculosis Vaccine Initiative (SATVI).

We happened to arrive at the site on a day when mothers were bringing in their babies to receive an already-proven vaccine against pneumococcal disease.  Children in the TB vaccine study area are provided with other vaccinations free of charge, whether or not their parents choose to enroll them in the study. 

This mother of three had brought her daughter in for the free pneumococcal vaccination.  She said her uncle had suffered from TB.

This mother of three had brought her daughter in for the free pneumococcal vaccination. She said her uncle had suffered from TB.

I asked one of the mothers if the 150 Rand (about $19 USD) payment she receives for each clinic visit was a help to her, and she said yes but the even more important benefit was that as a study participant her baby also receives regular medical check-ups.

On our visit to the site, I got a chance to meet four month old Janenique Pienaar of Worcester.  Her mother was beaming, clearly delighted that her daughter is making history as the first baby in 80 years to be vaccinated in a proof-of-concept efficacy trial (Phase IIb) of a candidate TB vaccine. 

Child receiving his pneumococcal vaccine.

Child receiving his pneumococcal vaccine.

This vaccine candidate, called MVA85A/AERAS-485, would be a booster to the BCG vaccine, and it has already been shown to be safe in a number of Phase I and Phase II clinical trials. 

 To study this vaccine candidate, SATVI is enrolling 2783 healthy, already BCG vaccinated, babies, at about 4 months of age to participate in the trial. Half the babies will be given the new vaccine, and the other half a placebo. 

The children will then be monitored for two years to compare the incidence of TB in the two groups. If successful, the vaccine would proceed to a much larger, and more costly, Phase III clinical trial in 2011. 

A sleepy-eyed baby Janenique, with Dr. Michele Tameris, clinical manager of the South African Tuberculosis Vaccine Initiative

A sleepy-eyed baby Janenique, with Dr. Michele Tameris, clinical manager of the South African Tuberculosis Vaccine Initiative

This vaccine could be ready for wide-scale use by 2016, if the trials are successful.  Unfortunately, funding for later stage clinical trials for TB vaccines is at present very much in doubt, and the funding shortfall could significantly delay progress.

While the NIH and CDC have funded some early stage TB vaccine research and epidemiology studies, funding for the kind of late-stage trials conducted in South Africa is authorized under the PEPFAR law (Lantos-Hyde) to come through USAID. 

USAID is already investing significantly in AIDS and malaria vaccine research, but unfortunately it has not provided funding for TB vaccine research, whether through Aeras or another program.

The Obama Administration supported a tiny increase of only $10 million for USAID’s TB program in 2010.  Congress is now on course to provide a larger increase for 2010, but it will be roughly a $150 million increase at best — far less than the increase of about $500 million we and other advocates had sought for implementation of TB programs and research.  

The Aeras Global TB Vaccine Foundation needs over $30 million per year in additional funding to support a late stage clinical trial of a TB vaccine candidate.

Proud mom, with baby Janenique, the first baby to receive the candidate vaccine in this trial

Proud mom, with baby Janenique, the first baby to receive the candidate vaccine in this trial

We hope that the Administration proposes a substantial increase for TB in its 2011 budget proposal, yet the signs so far are not good. 

TB is not just any disease.  It’s the third leading cause of morbidity and mortality combined in women of reproductive age in developing countries. India’s national TB program estimates that some 100,000 women in India alone are rejected by their families every year because of TB.

Yet, the Administration’s draft, 6-year strategy on TB omits any reference to the TB funding levels “authorized” last year in the Lantos-Hyde bill, now US law. 

That bill specified $4 billion over 5 years for TB, or $800 million per year, including for vaccine development.  But, to become a reality, this funding level needs annual support from Administration and from the Budget Chairmen and Appropriators in Congress. 

What we have heard from government insiders is that the Administration feels the amount of TB funding now provided through PEPFAR, which directs some of its funding to addressing TB-HIV coinfection, in effect addresses the TB funding need.  Would that were the case!

President Obama just awarded the Presidential Medal of Freedom to Archbishop Emeritus Desmond Tutu.  He, like Nelson Mandela, is a TB survivor, and both have called for bold action to confront TB.  Tutu has appealed for funding for TB and HIV programs, even in these difficult times.

South African Archbishop Emeritus Desmond Tutu

South African Archbishop Emeritus Desmond Tutu

We must heed their call to action. TB is estimated to deplete the incomes of the world’s poorest communities by $12 billion per year. South Africa has made progress in the fight against TB, but there is still much to do.  As Tutu has stated, “As we have overcome apartheid, so we shall defeat TB and HIV/AIDS, these ungodly twin killers.”

— David Bryden, Senior Program Policy Officer, Center for Global Health Policy 

The floor of the District Six Museum in Cape Town has this quote from Langston Hughes

The floor of the District Six Museum in Cape Town has this quote from Langston Hughes

 

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