Posts Tagged ‘XDR TB’

Dr. Prakash Mishra, director of the Regional TB Centre in Pokhara, Nepal, looks at a chest X-ray of a patient. Photo by Kiran Panday

KATHMANDU, Nepal – In a walk-up doctor’s office, off a busy street in Kathmandu, Dr. Dirgh Singh Bam sees patients every day in relative anonymity. His walls, though, reveal a history of being in the limelight: plaques and ribbons and framed photographs covering every inch, highlighting Dr. Bam’s efforts in leading Nepal’s TB control program from 1995 to 2004.

With assistance from the World Health Organization, Bam and a dedicated team of health workers ushered in an era of DOTS – directly observed treatment, short-course – by traveling all around the mountainous country to ensure that the strategy was followed. Health workers had to watch each patient swallow their TB pills every day.

“We made sure we had a DOTS committee in every sub-health post, every health post, every district hospital and the central hospital,’’ Bam said. “We went to mosques, temples, churches, all religious organizations, just to make sure they supported us.’’

In five years, Nepal installed the DOTS strategy across the country. In 1995, Nepal’s TB cure TB rate was around 45 percent; today it is 90 percent.

These advances made Nepal a model country around the world in TB control. But the question today is whether the country can remain a leader.

It has a major new challenge: controlling the spread of multi-drug resistant TB (MDR-TB) and extensively drug resistant TB (XDR-TB). (more…)

Read Full Post »

This post is by the Global Center’s Rabita Aziz.
Dr. Luis Sambo, the World Health Organization’s Regional Director for Africa, spoke to global health professionals and African diplomats today at an event sponsored by the Center for Strategic and International Studies (CSIS), about progress made toward achieving goals in the Abuja Declarations made roughly a decade ago.
The first Declaration, signed in 2000 by many African heads of state,  made commitments to reduce prevalence and consequently mortality from malaria by 50 percent by 2010.  In a second Abuja Declaration, signed in April 2001, heads of states declared HIV/AIDS to be a matter of emergency.
African leaders resolved to place the fight against HIV/AIDS at the forefront of their respective national development plans, as well as consolidate the foundations for the prevention and control of the disease through a comprehensive, multisectoral strategy involving all development sectors of government.  The leaders pledged to take more responsibility for the HIV/AIDS response, while also calling for an increase of external resources. 
In addition, the Abuja Declaration removed all taxes, tariffs, and other economic barriers to access funding for HIV/AIDS related activities.  Leaders also pledged to allocate 15 percent of their annual budgets to the improvement of health sectors.  The Declaration called for improving the availability of medical products and technologies, as well as supporting the development of vaccines.
Sambo said not all of these goals have been achieved.  For example, African nations on average allocate 6 percent of their budget to health sectors, instead of the pledged 15 percent, due in part to budget deficits.
But he also noted many successes in the fight against HIV.  Since the Declaration, there has been an improvement in diagnostics, care and support, and prevention, and dramatically higher coverage of antiretroviral therapy. In 2002, only 2 percent of patients in need of treatment were receiving it; in 2008, that number jumped to 44 percent.  HIV prevalence has dropped from 5.8 percent to 5.2 percent, and the rate of new infections has declined by 25 percent in that timeframe.  And since 2004, the annual number of HIV-related deaths has fallen by 18 percent.
Sambo said much of these successes were achieved thanks to external funding mechanisms, such as PEPFAR and the Global Fund.  He stressed that Global Fund and PEPFAR funds made significant contributions to change lives and provide hope.  Sambo also expressed high hopes for President Obama’s new Global Health Initiative, and expects it to be a powerful initiative that will bring many positive results.
Despite these achievements, Sambo warned that not enough is being done and gaps in funding are allowing prevalence and mortality numbers to remain high.  For every HIV patient being treated, three more are newly infected, he noted.  Fifty- five percent of HIV infected pregnant women are not receiving ART prophylaxis, while 58 percent of all infected people have no access to ARV treatment.  Life expectancy in the continent has dramatically shortened, with an average life expectancy of at least 60 years in the 1990s, to less than 50 years in 2010. 
Sambo also stressed that HIV-TB co-infection continues to be an emerging problem, as the number of TB cases continues to increase and remains the leading cause of death among HIV patients.  The emergence of MDR- and XDR-TB is making the HIV response even more difficult.  Sambo expressed that the failure of integrating HIV and TB services has caused many of the difficulties, and that it’s difficult to achieve integration when two-thirds of funding needs for HIV-TB co-infection are unmet.
Health programs, he said, are receiving half of the funding needed for the HIV response.  In total, Africa requires $12 billion to deal with the HIV/AIDS crisis, but is receiving $6 billion.  He said $2 billion is required for the TB response, but $1 billion is available.  In addition, he said $10 billion is needed for health systems strengthening, but African nations have $5 billion at their disposal.
But Sambo said funding wasn’t the only issue.  He said African nations need to take on more responsibilities and ownership of programs, and broaden their health policies to go beyond disease control.  In particular, he said, broader health determinants need to be addressed, such as poverty, lack of food security, lack of education, and environmental degradation.

He cited a need for increased support for maternal and child health, as well as a larger focus on women’s and girl’s development.  Nations also need to develop capacity for health research and information systems.  Most importantly, leaders need to make a renewed commitment to fighting the HIV epidemic, as well as use funds more efficiently.

Read Full Post »

Last week, the Global Center released a new issue brief on drug-resistant TB to mark World TB Day. Included in the brief was this interview with Dr. Sarita Shah, who recently presented new research showing that strains of extensively drug-resistant TB (XDR-TB) in Tugela Ferry, South Africa, are becoming more resistant.

Tugela Ferry is ground zero for XDR, where doctors first described this deadly bug in 2005. Soon, 53 patients were diagnosed with XDR-TB; 52 of those patients died within an average of 16 days after they sought medical care. Since those first cases emerged, over 500 patients in Tugela Ferry have been diagnosed with XDR-TB, and cases of this deadly infection have been reported in 58 countries. And because of inadequate treatment, XDR-TB strains have developed resistance to an even greater number of drugs than before. In this Q&A, Dr. Shah, an assistant professor of medicine and of epidemiology and population health at Albert Einstein College of Medicine, describes a global health system that essentially guarantees the continued spread of multidrug-resistant TB (MDR-TB) and XDR-TB and talks about innovative efforts to transform the treatment of drug-resistant TB.

Q: You presented new research at the Union World Conference on Lung Health in 2009 showing that XDR has become more resistant. Why and how is this happening?

A: In July 2005, most of the XDR we analyzed in Tugela Ferry was resistant to four to five drugs. By 2009, 100% of patients in our study had XDR that was resistant to at least 6 drugs—and most to 8 drugs. This is a very worrying trend. But it’s not a surprise that drug resistance is going to increase if we have weak TB programs, not enough support, and not enough attention to this critical issue. This is happening because in many places, MDR is being treated in a completely unsupported, chaotic way. That treatment fails, and then we get XDR. And it’s not surprising that if we don’t treat XDR properly, it’s going to get ever more resistant. We will run out of letters soon, and we’ll be at the end of the road, with no more medicines available.

Q: Can you talk about the lineage of XDR and how it was initially passed along?

A: XDR has been around for a very long time. It was present in South Africa as early as 2001. Now that people are looking for it, we’re finding it everywhere. It isn’t a person spreading it around. It’s the conditions that create XDR, and those are everywhere—weak public health infrastructure and inadequate patient support for completing treatment, plus HIV/AIDS.

Q: Can you describe what’s happening on the ground now in KwaZulu-Natal Province, where you and your colleagues do much of your work on drug-resistant TB?

A: What happens in South Africa—and in many other countries around the world—is there’s a centralized, specialty hospital that treats all patients with MDR-TB, because the drugs used for treatment are complicated, expensive and specialized. So, it is felt that treatment should be by specialists who can use the drugs correctly and monitor for side effects appropriately. In KwaZulu-Natal, this hospital used to be able to admit all MDR patients for six months, during which patients are assured to take their medicines every single day. And then for the remaining year and a half of MDR treatment, the patients are supposed to come back every month for a check-up and more medicines. You can probably imagine that not everyone comes back. They live far away. They’re probably feeling better. They can’t afford to miss a day of work. So what happens? In South Africa, we had an MDR default rate of 15–20% percent, so you’re at XDR.

Starting about four years ago, that referral hospital became completely overwhelmed. They have 160 beds, and we diagnose over 2,500 MDR cases in our province alone per year, so you can see how that math doesn’t work. Since the central hospital couldn’t admit everyone anymore, there were long waiting lists to get into the hospital, which is the only way to get the MDR medicines. Half of the diagnosed cases might die before being admitted. The same thing happens in other places as well—or worse, no MDR treatment is available in the country at all—so it’s important to realize South Africa isn’t unique in this sense. The issue of getting MDR patients access to good drugs in a timely way is a major global effort led by the Green Light Committee.

But let’s say a patient manages to get in to the MDR hospital. The doctors would try to give him or her medicines, but they might discharge the patient after 3 or 4 months because they have to face the daily reality of the long waiting lists of patients who are, literally, dying while waiting to get access to the medicines. So, patients are discharged early—with all the best intentions of trying to get more people into care—but, this is the way you get more resistance and also transmit disease to others.

Q: What’s the fix for this kind of situation that guarantees failed treatment, more transmission, and greater resistance?     (more…)

Read Full Post »

There were plenty of frightening statistics and unsettling trends highlighted at today’s World TB Day briefing on Capitol Hill. But one photo captured the true scope of the problem in scaling up diagnosis and treatment of the global TB epidemic.

Celine Gounder, MD, an IDSA member and TB/HIV specialist at Johns Hopkins University, described a recent trip to Malawi, where she saw shopkeepers volunteering to collect sputum samples from customers with chronic coughs. The accompanying photo: a man transporting the sputum samples to a laboratory in a small wooden box balanced on the back of his bicycle.

Dr. Celine Gounder discusses the TB epidemic at a Senate briefing

As Dr. Gounder noted, this small community had overcome one of the hurdles in getting suspected TB patients access to proper care. But many others remain. For starters, those specimens so carefully balanced on the bike would be examined using sputum smear microscopy, the only widely available diagnostic test for TB in Malawi. But Malawi has one of the highest HIV prevalence rates in the world, and the vast majority of HIV-related TB cases will be missed by sputum smear microscopy. A more accurate TB test, culture, is not available in the country because of lack of funding. So many of the patients will get false negative results, and continue to transmit the TB bug.

Her presentation provided compelling evidence of the need for more resources devoted to increased laboratory capacity and better diagnostics for TB. But she noted the gap between rhetoric and reality when it comes to TB funding. See Dr. Gounder’s power point here: CGounder_US Senate Briefing_20100324 and below is a video of her presentation.

“Despite the clear need for a heightened response to the global TB problem, funding that has been appropriated for these activities falls short of what was authorized by the Lantos-Hyde Act and what is needed to make decisive progress,” she said. “USAID, which is the primary US agency conducting global TB activities, received only $225 million in FY 2010 of the $650 million dollars authorized.”

She noted in particular that the White House’s Global Health Initiative includes TB treatment targets that are much lower than those set out in the Lantos-Hyde Act, which reauthorized PEPFAR. And she said HIV/TB co-infection was getting particularly short-shrift.

“Little more than lip service has been paid to delivery of TB-related interventions by HIV programs,” Gounder said.  “Only 16% of all TB patients were tested for HIV in 2007. Only 2.2% of HIV patients were screened for TB. And only 30,000 of HIV patients, 2% of the target, received isoniazid preventive therapy, which has been proven to reduce the risk of TB and mortality by one-third to two-thirds.”

Gounder’s remarks came at a Senate briefing on the global TB epidemic, which included a special focus on drug-resistant TB. The event, entitled “Bringing Methods to Scale: New Perspectives in the Changing World of TB,” also featured a presentation by Ernesto Jaramillo, team leader for MDR-TB for the World Health Organization’s Stop TB Department, who detailed the WHO’s newest data on drug-resistant TB. (more…)

Read Full Post »

What is more worrisome when it comes to drug-resistant TB: What we do know about the epidemic? Or what we don’t know?

The latest World Health Organization report on the epidemic provides plenty of both—some grim facts and some disconcerting question marks.  Take these nuggets:

*A shocking 41 percent of countries cannot provide reliable data on the scope of drug-resistant TB within their borders, according to the report, on the eve of World TB Day.

*The up-to-date tools needed to diagnose drug-resistant TB are not available in more than half of the 27 countries most heavily affected by multidrug-resistant TB (MDR-TB).

*An estimated 440,000 new cases of MDR-TB emerge each year, but only 7 percent of those cases are actually being detected. And even fewer are being treated. One-third of the estimated new cases each prove fatal. As for extensively drug-resistant TB (XDR-TB), there’s even less information.

In many of the places that do report good data, the WHO found MDR-TB at record levels; in one region of northwestern Russia, for example, 28 percent (more than 1 in four) new TB cases involved a strain of the bug that could not be treated with standard TB medicines. Other places could be even worse. But poor surveillance, inadequate laboratories, and antiquated diagnostics obscure the full scope of the threat.

 Dr. Mario Raviglione, Director of the WHO Stop TB Department, and Dr. Marcos Espinal, Executive Secretary of the Stop TB Partnership, ran through some of this data in a briefing for TB advocates and experts in Washington today. They also highlighted the lack of adequate funding or political commitment to TB, saying this urgent global health threat simple was not getting the attention it requires.

Dr. Raviglione said Europe is “de facto” asleep when it comes to TB, no UN leader “has ever recognized TB as a priority,” and no rich countries have ever launched a presidential-level initiative to combat the disease. They two WHO officials commended U.S. leadership on TB but said much more needs to be done here and around the world.

Click here to see the full WHO report.

Read Full Post »

This is a guest blog jointly submitted by Jerald C. Sadoff, MD, the President & Chief Executive Officer of the Aeras Global TB Vaccine Foundation and Mel Spigelman, MD, the President & Chief Executive Officer of the Global Alliance for TB Drug Development.

In recent weeks, U.S.-based global health advocates have been scrutinizing and providing public comments on the recently released draft strategy of the President’s Global Health Initiative (GHI), which rightly expands the US government’s global health policy to address several key areas that were neglected in recent years. However, although tuberculosis kills almost two million people each year, the GHI – more accurately, what’s not in the GHI – suggests that TB is just not a priority for the Administration. 

This is puzzling, since TB kills almost 2 million people each year and is the world’s second-leading infectious killer. There is more tuberculosis today than ever before in history, but it is truly a forgotten disease. That’s evident by the low level of funding requested by the GHI– only a $5 million increase for FY11– and the dramatic scaling back of treatment targets for TB patients. Better prevention and treatments are urgently needed, yet will remain far out of reach if the current GHI proposal is not changed.

TB is a disease of poverty, affecting the most vulnerable and marginalized people around the world. It rarely captures headlines or garners celebrity attention. Still, it’s difficult to reconcile the low levels of US government funding dedicated to TB with the significantly higher levels for other diseases that take similar numbers of lives. We don’t question the need to fund those devastating diseases, but we do question the neglect and imbalance in the approach to TB. This disparity is certainly not evidence-based, since TB claims a staggering number of lives. 

The meager funding for tuberculosis vis-à-vis other serious health threats is all the more baffling when you consider the alarming rise in multiple drug-resistant (MDR) and extensively drug-resistant (XDR) TB, which recognizes no borders and threatens the United States. Failure to invest in drugs and vaccines to better control TB will have severe ramifications for our public health system and for US taxpayers. For example, the 1989-1991 outbreak of MDR-TB in New York cost more than $1 billion to contain. The expense of treating newly emergent, extensively resistant strains is even greater –a single case of XDR-TB in the US can cost taxpayers almost $600,000, according to the CDC. Better TB prevention and treatment will benefit people at home and abroad.

The devastation caused by tuberculosis was recognized in 2008 when the US government passed the Lantos-Hyde PEPFAR reauthorization to increase funding and prioritize TB research and control. (To read more about Lantos-Hyde, click here.) Over five years, it aimed to treat 4.5 million drug-sensitive patients and 90,000 drug-resistant patients and authorized $4 billion for TB control. It also set out a long-term strategy of investing in research and development to create new and improved tools, including vaccines and drugs, to prevent and treat the growing TB problem. 

By contrast, the proposed GHI treatment targets and funding levels represent a step backwards. The GHI proposes to treat 2.6 million patients afflicted with drug-sensitive TB and 52,700 patients suffering from drug-resistant tuberculosis around the world – 40% fewer than called for in Lantos-Hyde. The GHI also does not explicitly address R&D, which is crucial to any long-term sustainable response to TB. In particular, this draft strategy omits the significant role played by USAID in funding the development of new technologies to combat tuberculosis – efforts that urgently require greater investment.

New tools are desperately needed. Current TB treatments were developed over 40 years ago and require patients to undergo a lengthy and complex regimen – which is even longer and more difficult to comply with in the case of drug-resistant tuberculosis – and which cannot be administered with certain HIV medications. The existing vaccine – which has limited effectiveness and is not recommended for HIV-positive infants – was invented almost 90 years ago. The most commonly available diagnostic method in developing countries, sputum smear microscopy, was developed over 120 years ago. The GHI should highlight the fact that TB will not be controlled or ultimately eliminated without the development of new tools, such as new drug regimens, new TB vaccines, and improved diagnostics.

By failing to invest adequately in TB, the GHI also undermines its ability to make progress in all priority areas or leverage the cross-cutting global health impact of a comprehensive TB elimination strategy. Consider the following: 

• HIV/AIDS – TB is the leading killer of people living with HIV in developing countries. In 2008, the United Nations identified the integration of TB and HIV control programs as a global health priority. Failing to address TB undermines existing US investments in AIDS treatment; each year, thousands of people whose lives have been preserved by antiretroviral treatment die from undiagnosed and/or untreated TB. 

• Reproductive, maternal, newborn, and child health – TB kills more women each year than all causes of maternal mortality combined and claims the lives of more than 100,000 children every year. In India alone, 300,000 children are orphaned each year because their mothers have died of TB.

• Health systems and health workforce – Combining the more than 9 million cases yearly with the lengthy and complex TB treatment (including drug-resistant TB) places substantial burdens on healthcare systems.

Commitments to funding levels and treatment targets in the GHI must be, at a minimum, restored to the levels contained in the Lantos-Hyde Act, and the development of new tools to address the epidemic must be an expressly defined part of the strategy. The lives of current and future tuberculosis sufferers are worth saving.

Read Full Post »

In a small new study, researchers found that linezolid, an antibiotic first approved in 2000, may be an effective component in the treatment of multidrug-resistant drug-resistant tuberculosis. But as previous research of this drug has suggested, linezolid is far from a perfect cure for the global epidemic of drug-resistant TB, and the findings reinforce the need for a ramped-up research and development effort to combat this deadly germ.

The most recent study, published in Clinical Infectious Diseases, involved 30 patients in California who were diagnosed with MDR-TB. Most of the patients were successfully cured. But nine patients experienced side effects, with symptoms including peripheral and optic neuropathy, anemia, rash, and diarrhea. Three patients stopped therapy.

The results are an indication that linezolid needs to be used carefully, the researchers concluded. “While receiving linezolid, patients should be closely monitored for signs or symptoms of bone marrow toxicity and peripheral and optic neuropathy,” the scientists write in the CID article.

“We found that linezolid … can play an important role in the management of MDR-TB, as long as it is used carefully and with appropriate monitoring, while we wait for better and less toxic drugs,” lead investigator Dr. Gisela F. Schecter said, according to a Reuters Health story. “Use of this drug has allowed the treatment and cure of patients who might otherwise have been deemed incurable.”

In another caveat, the authors note in CID that none of the patients in their study were known to have HIV infection and that more research was needed to investigative the efficacy and tolerability of linezolid in HIV-positive persons.  That is particularly crucial given the deadly syngery of the HIV and TB epidemics.

Read Full Post »

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


Read Full Post »

This live blog is from the Pacific Health Summit in Seattle, a three-day meeting that opened Tuesday night. Its focus is the global response to multidrug-resistant tuberculosis.

Dr. Mphu Ramatlapeng, Lesotho's minister of health

Dr. Mphu Ramatlapeng, Lesotho's minister of health

At one session at the Pacific Health Summit today, Dr. Mphu Ramatlapeng, Lesotho’s minister of health, told delegates that the best way for developing countries to fight TB is foremost for governments to take the lead.

“Our success is due to political will,’’ said Ramatlapeng, whose mountainous country is surrounded by South Africa. “It took time to explain to the politicians (about the dangers of TB and HIV/TB co-infection), and when it was clear to them that TB is not a joke, we made it a national priority.’’ (more…)

Read Full Post »

This live blog is from the Pacific Health Summit in Seattle, a three-day meeting that opened Tuesday night. Its focus is the global response to multidrug-resistant tuberculosis.

Anthony Fauci, the longtime director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, told the Pacific Health Summit today that it was urgent to begin a broad new research agenda to fight tuberculosis around the world.

In an invitation-only meeting involving 250 global TB experts from 25 countries, including representatives that ranged from industry to foundations to governments, Fauci delivered a sweeping “state of the science’’ speech that built a case for a major new sustained TB research effort.

“We have had decades of relative neglect given the extent the of the problem,’’ Fauci said. “There is much catching up to do and this will require a sustained effort’’ with major funding commitments. (more…)

Read Full Post »

Older Posts »