Stop TB Partnership - 2010 review

We have published a more recent review of this organization. See our most recent report on Stop TB Partnership.


Stop TB is a Silver Medal organization. The Stop Tuberculosis Partnership aims to increase access to life-saving tuberculosis treatment, primarily by providing government health programs with TB drugs through its Global Drug Facility. Stop TB has a monitoring process for determining whether drugs are used as intended, but we have questions about the effectiveness of this monitoring process.

To see how we rank Stop TB overall, see our list of top-rated charities.

More information:

The Stop Tuberculosis Partnership aims to increase access to life-saving tuberculosis treatment across the developing world, primarily by providing government health programs with TB drugs through its Global Drug Facility.

The Stop TB Partnership has a monitoring process for determining whether first-line TB drugs are used as intended. We have concerns about the quality of this monitoring process (more).

We do not believe that Stop TB requires additional further funding for its first-line TB drugs program. We believe that a significant portion of additional donations will be used to support programs to fight multi-drug resistant TB and we have not seen evidence of a strong monitoring process for this.

What do they do?

The Stop TB Partnership's largest program is the Global Drug Facility (GDF). The chart below shows the Stop TB Partnership's expenses since 2003, separated into GDF and other areas.1

According to the GDF, individual donations to the Stop TB Partnership support the Global Drug Facility.2 (We do not, however, see this claim confirmed on the donation page for Stop TB.3) We focus our review on the GDF because both individual donations and Stop TB's funds are mostly allocated it.

The Global Drug Facility

The Global Drug Facility aims to increase access to first- and second-line TB drugs and TB diagnostic kits by (a) granting these products4 or (b) providing "direct procurement services" aiming to pool purchasers' funds, negotiate lower prices and provide quality assurance.5 In addition, the GDF provides technical assistance to national TB programs.6

We focus our review on GDF's grants, as direct procurements are paid for by governments, not by unrestricted donations to Stop TB.

GDF grants

In the past, the GDF has primarily granted adult first-line drugs. It has recently begun to expand this focus.

In 2007-2008, the GDF received funding from UNITAID to increase grants of pediatric TB drugs, second-line drugs for MDR-TB, and MDR-TB diagnostic equipment, as well as additional funding for adult first-line drugs over the period 2007-2013.7 We have used data on the size and duration of funding from UNITAID to create a rough projection of the average grant budget for GDF for 2010 and 2011 in the chart below. Note that because we do not have data on GDF's planned spending on adult first-line drugs for 2010-2011, we have assumed no change from 2009.8

In order to be eligible for GDF assistance, countries must be low-income, have a plan to expand TB programs, and agree to monitoring (both internal and external) of their TB programs.9

Auditing recipients

The GDF states that it audits all recipients of grants of first-line drugs annually to ensure compliance with the recommended program.10 Six months after the drugs arrive, monitors (affiliated with Stop TB partners though not directly employed by Stop TB) assess the country's fulfillment of the agreed upon plan, program outcomes (cases detected and treatment success), and future drug needs.11 Monitors submit a report to GDF as well as to external auditors.12

Monitoring of recipients of second-line drugs is conducted by the Green Light Committee through annual site visits.13

Other programs

The Stop TB Partnership Secretariat, the body that coordinates the work of the members of the Stop TB partnership, also works on:14

  • Disseminating relevant information about TB and treatment programs.
  • Increasing funding for TB control initiatives.
  • Coordinating among partners and creating new partnerships.
  • Funding a grant program to support innovation in TB case detection.15

Does it work?

We review below independent evidence for the effectiveness of the drugs Stop TB provides as well as our assessment of Stop TB's internal monitoring process.

First-line drugs

Medical treatment for tuberculosis is proven to work, and the "DOTS" strategy promoted by Stop TB has been associated with significant large-scale success stories of reduced mortality in the developing world. (For more, see our review of the "DOTS" strategy.)

The Stop TB Partnership, through the GDF, aims to increase the supply of drugs available for tuberculosis treatment, while requiring recipient governments to adhere to the "DOTS" strategy.16 From what we've seen of its auditing process and the results, we feel that this process is generally strong and, in most cases, gives us confidence that (a) GDF recipients of adult first-line drugs have generally adhered to terms and conditions and run strong tuberculosis control programs; (b) GDF drugs have generally been used to expand tuberculosis control programs and treat most patients free of charge.

A recent audit report GDF shared with us, however, has raised concerns about the GDF's top-level audit quality monitoring. In mid-2010, we requested two specific reports from late 2009 and 2010, which the GDF shared with us.17 One of the reports we requested appeared, in some cases, to rely on information gathered in the previous monitoring mission without updating this information.18 We contacted Stop TB to ask about this issue, and they responded:19

I have followed up with the technical officer on the Myanmar report. The determination was that the consultants used the template from 2008 to do their report and did not update all points. This was an oversight in the review process. The mission consultant and desk auditor concerned have been contacted and the oversight has been recorded on both performance dossiers. (GDF awards desk audits based on satisfactory performance).

We are concerned that (a) auditors may be copying and pasting from earlier reports and not conducting a careful audit and, more importantly, (b) that Stop TB apparently did not notice this issue until we brought it to their attention.

We asked for additional reports from the GDF in order to see whether this issue was widespread. The GDF selected three additional reports to share with us.20 We have not seen previous reports from these three countries. Data in the reports appear to have been updated (all data is from the most recently completed year); we are unable to confirm that undated information was updated. In addition, because the reports were chosen by the GDF, it is possible that the reports were selected because of their high quality and that they are not representative of the GDF's audit reports in general.

Pediatric TB drugs

We have not studied the effectiveness of treatment programs for children with TB in-depth, because this program is a small part of Stop TB's overall spending.

We note that the World Health Organization states:

  • Pediatric TB differs from adult TB "in ways that may have important implications for the prevention, diagnosis and treatment of TB in children."21
  • A 2007 literature review found that "relatively few studies of childhood TB record treatment success or failure, or relapse rates, in children followed up for a substantial length of time."22

In addition, children who come in regular contact with infected individuals may be treated preventatively, which will result in some healthy children receiving treatment, likely reducing the cost-effectiveness of the program. The World Health Organization recommends "that all NTPs [National TB Programs] screen household contacts for symptoms of disease and offer isoniazid preventive therapy (i.e. daily isoniazid for at least 6 months) to children aged less than 5 years and all HIV-infected children who are household contacts."23 In 2009, 61% of the pediatric treatments granted by the GDF were for prophylaxis (i.e. prevention), while the rest were curative.24

First-line drug recipients' adherence to terms and conditions

As detailed above, GDF conducts in-depth audits of drug recipients' TB control programs. GDF has shared past reports from nine countries with us (and asked us not to post these publicly).25

The reports we have seen were not identical in form, and the amount of detail provided varied widely, but all included evidence that monitors completed visits to multiple facilities providing TB treatment and (a) interviewed providers and patients; (b) checked drug storage practices, expiration dates, and record-keeping/reporting practices; and (c) checked the condition of facilities and equipment. They specifically reported that quality (unexpired) drugs were available, that drug allocation processes were set up to guard against misuses of drugs, and that treatments were being provided for free.

In addition, each report provides the "treatment success rate" for that country's program. "Treatment success" is defined as (a) those who were cured of TB plus (b) those who completed the treatment regimen, were not cured and did not die (i.e., they require additional treatment). In the reports from 2008-2010 that Stop TB sent us, the cure rate varied from 59%-91% and the "treatment success rate" varied from 73%-92%.

Are submitted reports representative?

It is possible that these represent the most positive or most thorough monitoring reports and are not representative of "normal" reports because of the fact that Stop TB chose which reports to share with us. However:

  • The GDF's Chief Operating Officer told us directly that the 2008 reports were picked because they are recent reports from high-burden countries (not because they are particularly positive).26 We asked for reports from two specific countries for our 2010 update. GDF sent us a total of 5 reports at that time, including the two we had requested.
  • The reports are not overwhelmingly positive; they report general compliance with terms and conditions but are also straightforward about concerns regarding quality control of non-GDF drugs, availability of appropriate equipment and expertise in certain areas, and monitoring and supervision among other things.
  • A 2008 overview of TB by the World Health Organization gives treatment success and cure rates by country, worldwide.27 Of 22 countries listed, 13 have TB cure rates over 80%, 12 of which have received adult first-line granted drugs from the GDF (note that of the remaining 9, 5 receive GDF support).28

Second-line drugs for multi-drug resistant tuberculosis (MDR-TB)

We have less confidence in Stop TB's second-line drug program than in its first-line drug program. We have less information about the monitoring process for and effectiveness of this part of Stop TB's work.

Monitoring. The Green Light Committee (GLC) Initiative, which works with the GDF to increase access to second-line anti-TB drugs for the treatment of MDR-TB, is responsible for monitoring programs that receive second-line drugs from the GDF. The GLC reports an overall cure rate of 55.7% and an overall treatment success rate (i.e. cures plus completed treatments) of 62.8%, excluding patients still receiving treatment. It notes that this is preliminary data.29 This includes data from a mix of countries that do and do not receive grants of drugs from the GDF.30

The GLC told us that, during monitoring visits, its auditors:

  • Gather information on treatment outcomes and evaluate the data management system
  • Evaluate coordination between actors and the quality of drug management systems and laboratory systems
  • Review case finding, treatment, and infection control strategies

The GLC writes that consultants conduct monitoring visits to GLC-supported countries annually.31 We do not have evidence on whether monitoring visits are conducted according to schedule, whether monitoring reports are of high quality, or to what extent the GLC and the GDF used these monitoring findings to inform their decision-making.

Effectiveness. Other than the GLC data, we have seen only limited data on treatment outcomes for MDR-TB. The World Health Organization's Global Tuberculosis Control report for 2010 provides data for patients in the "2007 cohort" from 9 countries,32 the 2009 report provides "2004 cohort" data from 9 countries,33 and the 2008 report provides "2003 cohort" data from 7 countries.34

The available data suggests that cure and treatment success rates for MDR-TB patients may be substantially lower than for patients receiving first-line drugs.35 The World Health Organization warns, however, that "to improve our understanding of treatment outcomes for patients with MDR-TB, more data from more countries...are needed."36

MDR-TB diagnostics

The GDF is working with the World Health Organization, the Global Laboratory Initiative, and the Foundation for Innovative New Diagnostics to "accelerate access to diagnostics for patients at risk of multidrug”resistant tuberculosis."37 The GDF's role is "the procurement of MDR diagnostic commodities."38 This is a new project and we are not aware of any available evidence on whether this project results in improved outcomes for patients.

Possible negative/offsetting impact: are GDF drugs "additional" or "fungible?"

It appears that GDF first-line drugs are largely supplied to countries with working and effective tuberculosis control programs. However, a major question is whether drug grants are adding to the number of patients treated ("additional"), or simply substituting for drugs that would have come from other sources (in particular, from the recipient governments themselves).

GDF appears concerned with this question as well. Its country reports include the question "is there any evidence that GDF grant has displaced resources that would otherwise have been available from the government or other donors?" as well as detailed analysis of other projected sources of revenue from both the government and other donors (including the Global Fund). The reports we were sent conclude from this analysis that further GDF support is required to prevent stock-outs of drugs.

We do not believe, however, that this analysis strongly addresses the possibility that governments are systematically relying on GDF for provision of drugs, and would otherwise provide these drugs themselves. We would like to see data on how much governments spent on their TB programs before and after receiving a grant from the GDF. We have seen this data from 2005,39 but not for years after, and the GDF told us that it no longer collects this information because it concluded that the data quality was too low to be worth the considerable effort of collecting it.40

Other possible concerns about GDF's possible negative/offsetting impact include:

  • Diversion of skilled labor (more on this concern at our general discussion of negative/offsetting impact). Since all GDF grants are in the form of drugs (i.e., GDF does not provide additional funds to raise the monetary incentives for medical personnel), and since tuberculosis control appears to be one of the most effective and cost-effective medical interventions,41 we are not highly concerned about distorted incentives for medical professionals.
  • GDF recipients include governments such as Myanmar and North Korea. We questioned GDF representatives about this issue. They argued that because they are providing drugs (not money) and because of their strong auditing process, they feel confident that their support is resulting only in more patients being treated for tuberculosis.42 Data from 2005 shows government spending on TB in North Korea falling and then rising well over its original level after that country began receiving GDF support.43 We have not seen similar data for Myanmar.

Possible future impact: preventing a pandemic

We do not often discuss the possibility of future impact in our charity reviews, but feel that in the case of TB, it merits consideration.

The benefits of treating a communicable disease include both saving the lives of those currently infected and preventing future infections. If drug resistance grows over time, a further case could be made for current treatment because tools that are effective now may become less effective over time. It is beyond the reach of this review to estimate the extent to which current investment reduces the risk of a future pandemic. We note simply that, even if the probability of a future pandemic is quite low, current action could be justified if a pandemic, were it to occur, would be highly destructive.44

In May 2010, The Lancet published a series of papers on tuberculosis. The paper on drug-resistant TB concluded:45

The future possibility of strains that are totally resistant to all antituberculosis drugs becoming widespread is not inconceivable. Although incidence of all forms of tuberculosis might be reduced in this scenario, the complexity, cost, and overall burden for communities and countries would be substantially heavier than they are at present.

The Centers for Disease Control wrote in 2009:46

The emergence of XDR TB [extensively drug resistant TB] raises concerns about the possibility of epidemics of virtually untreatable TB. Such epidemics could result in excessive mortality and substantial financial and infrastructure burden for public health and TB control programs. XDR TB is much more expensive to treat, with hospitalization costs in the United States estimated to average $483,000 per case.

External evaluation

The Stop TB partnership had a external evaluation (relatively rare among charities) performed by McKinsey in 2008.47 This evaluation included 8 country visits, a large number of interviews (and a survey) of people involved in tuberculosis control, and publication/data analysis.48 We do not find this evaluation to be highly specific on the details of the facts it collected and analyzed, but note that its overall conclusions are positive and that it provides country-by-country analysis of how TB control programs have changed and what the role of the Partnership has been in these changes.49

What do you get for your dollar?

First-line drugs: The Disease Control Priorities report states that cost-effectiveness of DOTS varies with local factors; the range estimated for a sustained program is $150-$750 per death averted and $5-$50 per disability-adjusted life-year (DALY) averted.50 What limited information we have on treatment success rates achieved by GDF-supported countries (see above) suggests that such rates are in line with the Disease Control Priorities report's estimates.51 More at our full review of the DOTS program and our discussion of the DALY metric.

Second-line drugs: The Disease Control Priorities report states that "treating infectious MDR-TB is between two and ten times more costly than treating drug-susceptible TB per death prevented (greater than US$2,000), or per DALY gained (greater than US$90)."52 This calculation does not take into account future cases prevented through current treatment, an issue we discuss above. Taking prevention into account would improve the cost-effectiveness of treatment of MDR-TB.

Note: In September 2011, we confirmed a number of errors in the estimates for the cost-effectiveness of deworming published in the Disease Control Priorities report. Based on those findings, we are currently rethinking our use of cost-effectiveness estimates, like the DCP2's, for which the full details of the calculations are not public. For more information, see our blog post on the topic.

Room for more funds?

The Stop TB Partnership has a public summary of the expected costs vs. revenues of the Global Plan to Stop TB,53 implying that TB control in general is substantially underfunded. However, the Global Plan to Stop TB involves many actors and funders other than the Partnership itself.54

In June 2009, the GDF provided analysis of expected expenses and revenues "for first-line TB medicines, operations and technical support" for 2009-2012,55 which it did not clear for us to share publicly. Expected revenues for 2010 falls short of "total need" by $9.9 million, and by $11.4 million for each 2011 and 2012. In June 2010, the GDF told us that this gap had not changed substantially since the original analysis.56

In June 2010, the GDF told us that it had sufficient funding for grants of first-line drugs and that additional donations would primarily be spent on funding MDR-TB programs and, possibly, pediatric TB programs.57 Specifically, to improve its ability to deal with increased demand for drugs to treat MDR-TB, the GDF is considering the launch of three new initiatives:

  1. MDR”TB Advance Purchase Commitment to improve supply markets for MDR-TB drugs.58
  2. A New GDF Market Development Team that will focus on "further developing the market for TB medicines while continuing to emphasize quality assurance."59
  3. A "forecasting system to estimate the demand for drugs," which is soon to be tested in 5-6 countries. The GDF told us that with more funding it would hire a person to manage this system.60

Financials/other

The information below provide a summary of The Stop TB Partnership's finances. Data comes from publicly available documents. All data excludes donated drugs and direct procurements. Note that because Stop TB is not itself a US-registered charity (it takes donations through the UN Foundation), it does not provide its financials in fully standard form.

Revenue and expense growth (about this metric): Stop TB's revenues have risen in line with its expenses since 2003, with a large rise in revenues in 2007.61

Assets-to-expenses ratio (about this metric): We do not currently have balance sheet data for Stop TB.

Expenses by program area (about this metric): This is detailed above. The majority of Stop TB's funds are allocated to the GDF; in addition, donations from individuals are earmarked for GDF.

Expenses by IRS-reported category (about this metric): Because Stop TB is not an independent charity, it does not provide expenses by IRS-reported category. It does, however, report expenditure on "general management and administration." Between 2003 and 2008, this ranged from 3.2%-8.5% of total expenses.62

Remaining questions

  • Monitoring of first-line drug programs. Are monitoring reports checked for errors and omissions by the GDF? Are findings used to inform decision-making?
  • Monitoring of second-line drug programs. What have past audits of countries receiving second-line drugs shown? Have these audits been used to inform decision-making?
  • Financials. We would like to see more financial data - particularly a balance sheet (from which we could take information about assets) and a detailed projection of expenses (which would inform our view of the "funding gap") - for the Stop TB Partnership.

Sources

  • 1.

    Data from Stop TB Partnership, "Annual Reports (2004-2008)."

  • 2.

    "GiveWell:: Last year, Robert told us that all donations from individuals to the Stop TB Partnership go to the GDF. Is this still the case?
    GDF: This is still the case."
    Raegan Boler, email to GiveWell, October 6, 2010.

  • 3.

    United Nations Foundation, "Donate Now: Stop TB Partnership."

  • 4.
    • Adult first-line drugs: "Adult Grants: In 2009, fifty”nine (59) orders were placed by 18 countries. These orders had a total value of approximately US$ 18.2 million." Global Drug Facility, "Progress Report 13 (2009)," Pg 14.
    • Pediatric first-line drugs: "In 2009, fifty”three (53) orders were placed for paediatric medicines through GDF's grant service. These orders, for forty”two (42) countries, had a total value of more than US$ 2.8 million." Global Drug Facility, "Progress Report 13 (2009)," Pg 15.
    • Second-line drugs: "Procurement of Second Line Medicines - Grant: In July 2007, UNITAID agreed to fund a joint project with the Global Drug Facility and the Global Fund to fight against multidrug resistant tuberculosis (MDR”TB) called the MDR” TB Scale”up Initiative...Thirteen (13) countries received deliveries totaling US$5,688,264 in 2009." Global Drug Facility, "Progress Report 13 (2009)," Pg 20.
  • 5.

    "An exacting quality assurance policy ensures that all contracted suppliers have passed a rigorous quality assessment either through the WHO Prequalification Programme, through a stringent national regulatory authority (such as the US FDA) or through an Interim Review Process conducted by the WHO Prequalification Programme on behalf of GDF, the Global Fund and other partners financing or supplying essential medicines for TB, HIV and Malaria...GDF's pooled procurement model and regular competitive processes for suppliers of anti-TB products allow GDF to negotiate low prices and then sustainably offer them to all its customers." Stop TB Partnership, Global TB Drug Facility, "Direct Procurement Service."

    • First-line drugs: "Procurement of First Line anti”TB medicines...Adult Direct Procurement: In 2009, eighty”seven (87) direct procurement orders were placed by fifty”two (52) countries with an approximate value of US$ 25.6 million." Global Drug Facility, "Progress Report 13 (2009)," Pg 14.
    • Second-line drugs: "GDF continued to see a steady increase in the volumes of second line anti”TB medicines procured through its direct procurement service. In 2009, 38 countries purchased anti” TB second line medicines through direct procurement, an increase compared to the 33 countries who procured through direct procurement in 2008. The value of medicines procured also increased from US$ 17,562,399 in 2008 to US $22,349,833 in 2009." Global Drug Facility, "Progress Report 13 (2009)," Pg 20.
    • Diagnostic kits: "In 2007, GDF began providing diagnostic kits through its DP service to assist country programmes with the detection of TB. Since the initiation of this product line GDF has seen steady growth in this area. In 2009, fifteen (15) countries placed orders for diagnostic kits, with a total value of US$ 1,291,809." Global Drug Facility, "Progress Report 13 (2009)," Pg 16.
  • 6.

    "As part of its efforts to increase countries' capacity GDF provides technical support to National TB Programmes (NTPs), primarily via in”country missions...These missions are provided to countries using GDF's grant or direct procurement services, or to provide information and assistance to countries considering using GDF's services...In addition to the missions performed in country in 2009, GDF also performed six (6) workshops (Bangladesh, Belarus, Brazil, Pakistan, Tunisia and Uganda) focusing on drug management capacity building for first and second line medicines." Global Drug Facility, "Progress Report 13 (2009)," Pg 22-23.

  • 7.

    "Here is a list of our current projects with UNITAID and their values:

    GDF Projects (signed) Amount (in USD unless otherwise indicated) Signed Begins Ends
    UNITAID PAEDIATRIC TUBERCULOSIS $11,603,952 Second Amendment: Jan 15, 2009 Original: Jan 12, 2007 2007 31-Dec-2011
    UNITAID FIRST LINE TB PROJECT $26,841,025 No cost ext signed: Dec 10/09 Original: Sept 11, 2007 2007 31-Dec-2011
    MDR TB Scale UP $37,662,000 First Amendment: June 5, 2009 Original: July 25, 2007 2007 31-Dec-2011
    Acceleration of Access Project: Strategic Rotating Stockpile $11,458,000 Signed: November 20, 2008 (began late 2008) 31-Dec-2011
    Expand TB Project (with GLC, GLI, FIND) $87,611,982 Signed December 10, 2008 Expansion request signed May 2010 2008 31-Dec-2013

    Raegan Boler, email to GiveWell, August 3, 2010.

  • 8.
    • Data on the total value of pediatric grant orders delivered 2007 is from Global Drug Facility, "Progress Report 12 (2008)," Pg 29. To estimate the total value of adult first-line grants delivered in 2007, we subtracting the value of pediatric grants from the total expenditure on grants in 2007, which is from Global Drug Facility, "Progress Report 12 (2008)," Pg 31. According to Global Drug Facility, "Progress Report 12 (2008)," Pg 29-31, the only products that the GDF granted in 2007 were adult and pediatric first-line drugs.
    • Data on value of products delivered in 2008 is from Global Drug Facility, "Progress Report 13 (2009)," Pg 32-35.
    • Data on value of products delivered in 2009 is from Global Drug Facility, "Progress Report 13 (2009)," Pg 32-35.
    • For our 2010-2011 projection, we assumed that value of adult first-line drugs will remain at the same level as in 2009 (because we do not have data on Stop TB's plans for this program). For other products:
      • Pediatric and second-line drugs: We took the amount granted by UNITAID to the GDF for this product for 2007-2011 (Raegan Boler, email to GiveWell, August 2, 2010) and subtracted the amount spent on this product in 2007-2009 (from sources listed above). We then divided the remaining balance by two for the number of years remaining in the grant term.
      • MDR-TB diagnostics: We took the amount granted by UNITAID to the GDF for this product for late 2008-end of 2013 (Raegan Boler, email to GiveWell, August 2, 2010--see table in footnote above) and subtracted the amount spent on this program in 2009 (none was spent in 2008; note that we divided the amount spent on "Procurement Fee and Fixed costs" in 2009 by two because the GDF noted in footnote 28 that this was "Shared between FIND and GDF"). Data on amount spent in 2009 is from Global Drug Facility, "Progress Report 13 (2009)," Pg 35. We then divided the remaining balance by four for the number of years remaining in the grant term (start of 2010-end of 2013).
  • 9.

    Specifics:

    • "Estimated GNI per capita equal to or less than US$ 3,000 per year. Highest priority will be given to countries with a GNP of less than US$1,000 per year."
    • "All drugs supplied by GDF will ONLY be used:
      a. for treatment of TB patients; b. free of charge to patients; c. in treatment regimens following WHO guidelines; d. in programmes following national guidelines for DOTS implementation; e. in accordance with a multi-year plan for DOTS expansion and sustainability to reach the
      global targets for TB control."
    • "Regular assessments of the NTP performance, including anti-TB drug management, will be carried out by an independent technical agency, and the complete assessment report provided to GDF. The applicant will also provide the following reports to the Stop TB Partnership secretariat:
      a. a regular annual report on TB programme performance in accordance with WHO guide- lines; b. quarterly reports on case finding, smear conversion and treatment outcomes; c. date of arrival of GDF drugs at port; d. time taken to register drugs (if applicable); and e. date drugs received in central drugs store."

    Global Drug Facility "Notes for applicants," Pg 2-3.

  • 10.

    "In principle, GDF support is given to countries for three years subject to availability of resources and satisfactory compliance with GDF conditions of support which include annual independent monitoring. All recipients of GDF grants for first-line tuberculosis drugs agree to regular assessment." Stop TB Partnership, "What Will Be Monitored."

  • 11.

    "The areas on which assessment is based are:

    • Adherence to GDF terms and conditions of support;
    • Programme management (including case detection and
    • Estimated drug needs for the next year of GDF support; and
    • Follow-up on recommendations made by the Technical Review Committee (TRC) and by pre-delivery country visit and/or a previous monitoring visit.

    Six months after GDF grant drugs have arrived in the country, a monitoring mission arrives composed of independent TB programme and drug management experts. The majority of these experts are affiliated with members of the STOP TB Partnership while some are independent consultants." Stop TB Partnership, "What Will Be Monitored."

  • 12.

    "The monitoring mission submits a report to the GDF Secretariat, together with information on GDF drug arrival, customs clearance, drug registration, quarterly reports on case findings and treatment outcomes and annual WHO TB data collection form. This information, known as a monitoring dossier, is then sent to GDF's external auditors, who are selected through a transparent competitive process. The external auditor reviews the monitoring dossier for completeness, consistency and credibility. The auditor must also decide whether the information in the monitoring dossier is sufficient to enable the TRC to assess whether GDF terms and conditions of support as well as other monitoring requirements have been met." Stop TB Partnership, "What Will Be Monitored."

  • 13.

    "Following approval of a programme by the GLC, the GLC Secretariat informs the GDF, which manages the procurement of second-line anti-TB drugs for GLC-approved programmes." World Health Organization, "How do programmes approved by the Committee procure second-line anti-TB drugs?"
    "Programmes approved by the GLC are monitored annually via site visits to ensure continued adherence to their original protocols and WHO guidelines. Monitoring and evaluation activities are managed by the GLC Secretariat and WHO regional offices and are carried out by GLC-endorsed consultants." World Health Organization, "How does the Green Light Committee monitor programmes?"
    Stop TB Partnership confirmed in an email that it does not conduct its own monitoring of second-line drug grants:
    "GiveWell: It appears that monitoring of second-line drugs is done by Stop TB's partner organizations. Is this true, and, if so, would it be possible to see such reports?
    Stop TB: I believe this is done by the Green Light Committee (GLC) which is part of the Stop TB Partnership formal mechanism."
    Julia Geer, email to GiveWell, June 24, 2010.

  • 14.

    "The secretariat collects and collates information and resources produced by individual partners and disseminates them to the wider partnership...The secretariat, mainly through the ACSM Working Group, is involved in resource mobilization at three levels...Effective coordination is facilitated through structures and systems that evolve with the changing nature of the partnership...Mobilization of new partners includes identification of the comparative strengths of each partner, and development of structures to facilitate their contribution to the partnership." Stop TB Partnership, "Stop TB Secretariat."

  • 15.

    "TB REACH will award grants between US $500,000 - US $1,000,000 annually to selected institutions or organizations that have put forward proposals in timely fashion, especially proposals that are innovative in detecting more TB cases." Stop TB Partnership, "
    About TB REACH."

  • 16.

    "The GDF is an initiative to increase access to high quality tuberculosis (TB) drugs for DOTS implementation, a TB control strategy." Stop TB Partnership, "What is the GDF."

  • 17.
    • Global Drug Facility, "Mission Report: Kenya (2010) - Paediatric grant and direct procurement."
    • Global Drug Facility, "Mission Report: Myanmar – Adult and paediatric grants (2010)."
  • 18.

    Examples:

    • 2008 report: "Out of 1028 sanctioned posts within the NTP 241(23%) remain unfilled as of today. Majority are technical posts."
    • 2010 report: "Out of 1028 sanctioned posts within the NTP 241(23%) remain unfilled as of today. The majority are technical posts."
    • 2008 report: "Roll out of trainings from central and state to township levels remains low in 2008."
    • 2010 report: "Roll out of trainings from central and state to township levels remains low in 2008."
  • 19.

    Raegan Boler, email exchange with GiveWell, November 12, 2010.

  • 20.
    • Global Drug Facility, "Mission Report: Papua New Guinea – Pediatric grant and direct procurement (2010)."
    • Global Drug Facility, "Mission Report: Zambia (2009)."
    • Global Drug Facility and Green Light Committee, "Mission Report: Georgia - Direct procurement and paediatric grant (2010)."
  • 21.

    World Health Organization 2006, Pg 3.

  • 22.

    World Health Organization 2007, Pg 12.

  • 23.

    World Health Organization 2006, Pg 16.

  • 24.

    Global Drug Facility, "Progress Report 13 (2009)," Pg 33.

  • 25.
    • Global Drug Facility, "Mission Report: Bangladesh (2006) – Adult grant."
    • Global Drug Facility, "Mission Report: Bangladesh (2007) – Adult grant."
    • Global Drug Facility, "Mission Report: Bangladesh (2008) – Adult grant."
    • Global Drug Facility, "Mission Report: Democratic People's Republic of Korea (2008) – Adult grant."
    • Global Drug Facility and Green Light Committee, "Mission Report: Georgia – Direct procurement and paediatric grant (2010)."
    • Global Drug Facility, "Mission Report: Kenya (2009) – Adult and paediatric grants."
    • Global Drug Facility, "Mission Report: Kenya (2010) – Paediatric grant and direct procurement."
    • Global Drug Facility, "Mission Report: Malawi (2009) – Pediatric grant."
    • Global Drug Facility, "Mission Report: Myanmar (2006) – Adult grant."
    • Global Drug Facility, "Mission Report: Myanmar (2007) – Adult grant."
    • Global Drug Facility, "Mission Report: Myanmar (2008) – Adult grant."
    • Global Drug Facility, "Mission Report: Myanmar (2010) – Adult and paediatric grants."
    • Global Drug Facility, "Mission Report: Papua New Guinea (2010) – Pediatric grant and direct procurement."
    • Global Drug Facility, "Mission Report: Tanzania (2007) – Adult grant."
    • Global Drug Facility, "Mission Report: Tanzania (2008) – Adult grant."
    • Global Drug Facility, "Mission Report: Zambia – Adult and paediatric grants (2009)."
  • 26.

    Robert Matiru and other Stop TB representatives, phone conversation with GiveWell, June 17, 2009.

  • 27.

    World Health Organization 2008, Pg 29, Table 1.5.

  • 28.

    Global Drug Facility, "Progress Report 9 (2005)," Pg 27-28 gives the latest public summary of grant recipients. We also searched Global Drug Facility, "Progress Report 9 (2005)," Global Drug Facility, "Progress Report 12 (2008)," and Global Drug Facility, "Progress Report 13 (2009)" to find newer grants of adult first-line drugs.

  • 29.

    Green Light Committee, "Update (June 2010)," Pg 10.

  • 30.

    Wieslaw Jakubowiak, email to GiveWell, November 25, 2010.

  • 31.

    "Programmes approved by the GLC are monitored annually via site visits to ensure continued adherence to their original protocols and WHO guidelines. Monitoring and evaluation activities are managed by the GLC Secretariat and WHO regional offices and are carried out by GLC-endorsed consultants. The team leader of each monitoring mission is responsible for submitting a written report to the GLC Secretariat within two weeks following the site visit." World Health Organization, "How Does the Green Light Committee Monitor Programmes?"

  • 32.

    "National data on treatment outcomes among cohorts...of at least 200 patients are currently limited to nine countries: Brazil, Kazakhstan, Peru, the Philippines, the Republic of Moldova, Romania, South Africa, Turkey and Uzbekistan. Rates of treatment success are variable, ranging from below 40% to almost 80%. High rates of default are a common problem (with a median value of 17%)." World Health Organization, "Global Tuberculosis Control (2010)," Pgs 18-21. Data in World Health Organization, "Global Tuberculosis Control (2010)," Pg 21, Figure 12.

  • 33.

    "Given that it takes 18–24 months to treat MDR-TB, in 2008 the WHO TB data collection form requested treatment outcome data for patients treated in 2004 and interim outcomes for patients started on treatment in 2005 and 2006." World Health Organization, "Global Tuberculosis Control (2009)," Pg 51.

  • 34.

    World Health Organization, "Global Tuberculosis Control (2008)," Pg 54.

  • 35.

    In 2009, the World Health Organization stated that treatment success rates (cures plus completed treatments)in "high burden countries" averaged 87% for new smear-positive cases treated under DOTS. World Health Organization, "Global Tuberculosis Report (2009)," Pg 28, Table 1.7.

    World Health Organization data on MDR-TB treatment outcomes:

    2003 MDR-TB cohort treatment success rate (%) 2004 MDR-TB cohort treatment success rate (%) 2007 MDR-TB cohort treatment success rate (%)
    Country 62 N/A N/A
    Germany 35 N/A N/A
    Lithuania 59 57 42
    Brazil 53 N/A N/A
    Estonia 72 70 N/A
    Latvia 25 38 22
    Romania 43 57 58
    Peru N/A 73 63
    Philippines N/A 54 N/A
    Russia N/A 52 N/A
    DR Congo N/A 25 N/A
    Morocco N/A 61 N/A
    USA N/A N/A 76
    Kazakhstan N/A N/A 64
    Turkey N/A N/A 52
    Uzbekistan N/A N/A 51
    Republic of Moldova N/A N/A 40
    South Africa 50 54 52

    Data for 2003 cohort is from World Health Organization, "Global Tuberculosis Control (2008)," Pg 54, Figure 2.15. Data for 2004 cohort is from World Health Organization, "Global Tuberculosis Control (2009)," Pg 53, Figure 2.15. Data for 2007 cohort is from World Health Organization, "Global Tuberculosis Control (2010)," Pg 21, Figure 12.

  • 36.

    World Health Organization, "Global Tuberculosis Control (2009)," Pgs 52-53.

  • 37.

    Global Drug Facility, "Progress Report 13 (2009)," Pg 20.

  • 38.

    Global Drug Facility, "Progress Report 13 (2009)," Pg 22.

  • 39.

    Data for 2005 is available in Global Drug Facility, "Progress Report 9 (2005)," Pgs 36-44.

  • 40.

    "GiveWell: Those pages also include data on government spending on TB before and after the start of GDF support. Do you have data you could share for years after 2005?
    Stop TB: It was determined last year that the information that we were able to get was not comprehensive or reliable enough to use, and that the workload to collect and confirm this data was beyond the current capacities of GDF. GDF thus decided not to track this data."
    Julia Geer, email to GiveWell, June 24, 2010.

  • 41.

    See our overview of priority programs. Also note that a paper by the lead editor of the Disease Control Priorities report (PDF) lists tuberculosis control as the top opportunity for developing-world health aid.

  • 42.

    Robert Matiru and other Stop TB representatives, phone conversation with GiveWell, June 17, 2009.

  • 43.

    Global Drug Facility, "Progress Report 9 (2005)," Pg 45.

  • 44.

    We see informal evidence of this concern in the fact that in 2009, tuberculosis was the winner of Change.org's "tournament of pandemics." One author wrote: "The drugs that treat XDR-TB [extremely drug resistant tuberculosis] are very expensive and we do not currently have infrastructure in place to produce them at a scale that would be necessary to treat a pandemic or even a significant epidemic. In the next 2-10 years XDR-TB could easily break out in a region with sluggish health infrastructure and high co-infection with HIV. If it does, there are not very many reasons to believe that we could stop it before it became a pandemic more devastating than HIV." Holeman 2009.

  • 45.

    Gandhi et al. 2010, Pgs 1839-1840.

  • 46.

    LoBue, Sizemore, and Castro 2009.

  • 47.

    McKinsey 2008.

  • 48.

    "EVALUATION ACTIVITIES:

    • Conducted 94 interviews with people active at the global level in tuberculosis
    • Visited 8 countries – India, China, Indonesia, Burkina Faso, Uzbekistan, Peru, Kenya, Morocco
    • Conducted over 150 interviews in countries
    • Reviewed publications of Stop TB Partnership, WHO Stop Tuberculosis Department, and selected other documents
    • Analyzed available data on tuberculosis epidemiology, control metrics, funding, advocacy, and research & development
    • Conducted internet-based survey of 1,332 stakeholders with response rate as follows: Overall 17%, NTP managers 9%, Secretariat 61%, Coordinating Board 45%."

    McKinsey 2008, Pg 75.

  • 49.

    For discussions of specific countries see McKinsey 2008, Pg 136-137.

  • 50.

    Jamison et al. 2006, Pg 299.

  • 51.

    "Many of the 182 national DOTS programs in existence by the end of 2003 have shown that they can achieve high cure rates: the average treatment success rate was 82 percent." Jamison, Jha and, Bloom 2008, Pg 294.

  • 52.

    Jamison et al. 2006, Pg 299.

  • 53.

    Stop TB Partnership, "Filling the Funding Gap."

  • 54.

    Robert Matiru and other Stop TB representatives, phone conversation with GiveWell, June 5, 2009.

  • 55.

    Global Drug Facility, "GDF Projected Donor Income (2009-2012)."

  • 56.

    "GiveWell: We would like to update our information on Stop TB's funding gap. Is the 4-year funding picture you sent us last year is still accurate?
    Stop TB: It is still largely the same."
    Julia Geer and Raegan Boler, phone conversation with GiveWell, June 30, 2010.

  • 57.
    • "For first-line treatment, we're adequately funded. For MDR-TB and pediatrics, there's a definite shortfall. Right now there's a really interesting project to get diagnostic equipment into the countries and diagnose MDR-TB much quicker." Julia Geer and Raegan Boler, phone conversation with GiveWell, July 30, 2010.
    • "The area of need is going to be MDR-TB. We are going to start seeing a lot more demand coming in for MDR-TB treatments. That is where the funding gap exists.
      We cannot lose our focus on firstline and pediatrics. If we lose that focus, we run the risk of developing more MDR-TB. In the pediatrics project there's definitely room there for more development. We need to work with countries in order to encourage them to adopt new policies." Raegan Boler, phone conversation with GiveWell, August 12, 2010.
  • 58.

    " MDR”TB ADVANCE PURCHASE COMMITMENT (APC) / MANUFACTURER INCENTIVIZATION PROGRAMS ” IN ANALYSIS STAGE
    As part of GDF efforts towards cost containment and long term market sustainability and development, GDF has embarked upon assessing the feasibility of advance market commitment and other manufacturer incentivization programs. These mechanisms would facilitate supplier production planning and optimize the economies of scale. Moreover, they would provide registration support, a known bottleneck due to the reluctance of suppliers to invest the financial cost and time resources required for an uncertain volume of sales. This would help the supplier to assess their return on investment, thereby making the SLD supply market more attractive, less uncertain and volatile. The second part of this work will assess the Active Pharmaceutical Ingredient (API) contingency planning for products where there are few quality”assured API suppliers."
    Global Drug Facility, "Roadmap for MDR”TB Scale Up," Pg 6.

  • 59.

    "NEW GDF MARKET DEVELOPMENT TEAM ” UNDER DEVELOPMENT
    In order to meet the increased complexities and changing needs within the TB landscape, GDF is performing a restructuring of its organization. This will enable increased focus on countries, market development and external stakeholders. Part of this restructuring will include the development of a Market Development Team focused on further developing the market for TB medicines while continuing to emphasize quality assurance. This team will be responsible for dynamic forecasting, supplier sourcing and vendor performance management. Facilitating the activities of this team will be the introduction of an innovative and user friendly business information and management application, which will enable improved data integration and standardization between partners in and outside of WHO. This tool is envisioned to improve GDF's data collection and coordination, as well as its performance management capacities."
    Global Drug Facility, "Roadmap for MDR”TB Scale Up," Pg 7.

  • 60.

    "GDF is also working in cooperation with the Clinton Health Access Initiative (CHAI) on the development of a forecasting system to estimate the demand for drugs with an acceptable degree of accuracy, which will contribute to the reduction of production and delivery lead times, and the reduction of product costs. This integrated system will soon be piloted in 5-6 countries. In line with this, and should funding become available, GDF would like to sponsor the costs of a technical person in these countries who will handle drug management, data collection and reporting into the new information system."
    Julia Geer, email to GiveWell, November 26, 2010.

  • 61.

    Stop TB Partnership, "Annual Reports (2004-2008)."

  • 62.

    Stop TB Partnership, "Annual Reports (2004-2008)."

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