The Global Fund offers promises and hope for many, but a view from the field in Latin America and the Caribbean indicates that when it comes to antiretroviral treatment access, the complications are many and the promises offered by the Fund are slow to be fulfilled. Agua Buena's Richard Stern recently prepared this survey of the landscape in the Spanish-speaking Americas. More of his first hand reporting is available at www.aguabuena.org.

In Ecuador and the Dominican Republic, prolonged internal disputes involving Country Coordinating Mechanisms and Principal Recipients* have meant that even though their proposals were accepted by the Fund in January 2003, the grant agreements had still not been signed as of late November, and thus no money has been received. These countries compounded the problem by deciding to wait for Global Fund money to arrive before starting to purchase antiretrovirals for targeted populations. Thus, ironically, the existence of the Global Fund has actually delayed treatment access in these countries.

(* Local entities, nominated by Country Coordinating Mechanism and confirmed by Global Fund, who are to be legally responsible for the dispersal of funds and implementation of the program.)

There is another problem, somewhat less dramatic, that has occurred in almost every country. NGOs that in the past might have tackled violations of human rights or gaps in treatment access now have to consider whether such activism could cause them to lose access to Global Fund revenue received by their local Country Coordinating Mechanism. (A Country Coordinating Mechanism, or "CCM," is country-level partnership that works in concert with the Global Fund.). It is important to remember that in Latin America, prior to the Global Fund, only very minimal amounts of financial support have been available for civil society through national AIDS programs. The Global Fund's appearing on the scene represents a potential "windfall" of resources, and the dynamics related to advocacy have changed considerably. The key factor here is that most Country Coordinating Mechanisms are, in fact, government controlled, even if that is not the Fund's intention.

The domination of government in Country Coordinating Mechanisms was dramatically illustrated in the Latin American/Caribbean Regional Meeting that the Fund held in Panama in late November. Incredibly, only 8 of 160 participants were People Living with HIV (PWHIVs). The Fund had instructed Country Coordinating Mechanisms to make their own selection as to who to bring to the meeting, and only four out of the twenty countries present—Costa Rica, Bolivia, Colombia and Cuba—actually included PWHIVs in their delegation.

One of the most interesting moments in the Panama meeting occurred on the final day when nearly a dozen international agencies marched to the podium to present themselves. Among them were USAID, PAHO, GTZ, UNAIDS, the World Bank, the Interamerican Development Bank, UNDP and UNICEF. Many of the agencies made references to the hundreds of millions of dollars they have invested in the AIDS pandemic. After the speakers had concluded their presentations, Julio Cesar Aguilar, a PWHIV from Bolivia, commented "I am grateful that almost all of the agencies on this stage are working to help us in Bolivia. But I wonder how it is possible that as yet not even one PWHIV in my country has received antiretroviral treatment?"

Eighteen months after the Fund began operations, Global Fund money has only led to some 800 to 1,000 people receiving treatment in Latin America and an additional 1,000 in the Caribbean. Most of these are in Honduras and Haiti, which had their proposals approved in Round One, and some are in El Salvador. (Argentina and Chile may also be providing some antiretroviral access with funds provided by the Fund, but antiretroviral access in these two countries was nearly universal even before the Global Fund began to provide monies).

With the impending arrival of Global Fund money, it seems almost inevitable that there is intense competition and distrust between civil society and government, as well as among NGOs themselves. In two of the countries mentioned above, the fight about who was to be the Principal Recipient was taken by NGOs to the Fund's mid-level staff, and perhaps beyond, and this has resulted in delays which will set the process of actual disbursement of funds back as much as a year. Those who urgently needed antiretrovirals in 2003 will now have to wait until 2004. As many as 25% will not survive.

Another problem is that in some countries, NGOs which represent vulnerable populations such as gay/lesbian/bi/trans people are routinely denied legal registration, yet Country Coordinating Mechanism regulations stipulate that only legally registered NGOs can benefit from Global Fund money. So, because of this Catch 22, these groups—which have a real ability to reach out to and conduct prevention work among their own populations—are supplanted by legally registered NGOs that suddenly appear on the scene and have no demonstrated track record in working with vulnerable populations.

Another discouraging factor is that some of the accepted Global Fund proposals in the Latin American region were written by highly capable experts who joined forces with local Country Coordinating Mechanisms only for the purpose of writing the proposal. In these cases, the accepted proposal does not always accurately reflect the country's national AIDS program or its ability to put large amounts of money to good use in AIDS programs. Some proposals reflect mainly the writing and technical skills of the outside consultants who drafted the proposals.

Another issue is that the few civil society representatives on the Country Coordinating Mechanisms often are well intentioned but poorly trained regarding more technical issues of program implementation and medication purchase. Many of the PWHIV representatives come from backgrounds where they simply have not been trained in the necessary areas. This puts them at a tremendous disadvantage when facing government AIDS bureaucrats who may dominate decision-making processes in areas to do with antiretroviral access and other "technical" issues.

The only feasible solution to the problems elaborated above would be greater active participation of the Global Fund in Country Coordinating Mechanism activities and program implementation. The Fund is reluctant to do this because it has limited staff and it wants local capacity to develop and national AIDS programs to become self-sufficient. One possibility would be for this to happen in phases with, at first, much more support from trained experts whom the Fund could employ after a proposal has been approved.

To suddenly present a previously impoverished and not particularly well-trained AIDS program with the prospect of millions of dollars is certainly well intentioned but can sometimes lead to all kinds of unforeseen problems, ranging from inadequate infrastructure to rampant manipulation and corruption. People living with HIV/AIDS need treatment today, not in a year or two. But without more active guidance and hands on participation from the Fund, situations that are destructive and lead to long delays in treatment access will undoubtedly continue to occur. ¤

Richard Stern (rastern@racsa.co.cr) is Director of Agua Buena Human Rights Association, based in San José, Costa Rica. He travels widely in Latin America working with community groups on HIV/AIDS treatment issues.

Dear Friends:

In response to my letter regarding the Toronto International AIDS conference, now scheduled for 2006, I have received the following letter from a Person Living with HIV/AIDS (PLWA) in Jamaica who wishes to remain anonymous:

"...I attended the GNP+ [Global Network of People Living with HIV/AIDS] eleventh conference in Trinidad (just over two years ago). Within 24 months after the conference, 7 of the 11 delegates from Jamaica were dead. Could it be that the information received at the conference increased their hopelessness? Was their care and treatment put foremost? Or were they invited merely to boost conference attendance figures??"

My comment:

This is not to say that AIDS conferences as such are not good or that GNP+ is not trying to improve the situation of People Living with HIV/AIDS. But, on the other hand, it certainly is valid to raise questions about the results of so many activities directed toward improving the situation of those who are most in need.

We should remember that Jamaica is not Sub-Saharan Africa. It is a "high medium development" country with a huge tourism infrastructure and modern roads, airports, hotels etc. Per capita income approaches $2,000 a year. There are no patents on antiretrovirals, so prices could be as low as $1 per day for first-line treatment.

But what about health care? What about accelerating access to treatment for People Living with HIV/AIDS?

Jamaica has now received approval for its Global Fund proposal which will enable many people to have access to antiretrovirals in a country where the government is not providing this.

I spoke recently with Dr. Yitades Gebre, of the Jamaican National AIDS Program and member of the country's CCM, at the Global Fund regional meeting in Panama. He was eager to receive information about scaling up antiretroviral access in order to begin providing treatment with Global Fund support as soon as possible. In my opinion, Dr Gebre's participation as a representative from Jamaica at the Panamá meeting was enthusiastic, sincere and pro-active.

But will this "scaling up" really happen in time to save the lives of those who need treatment now?

The Global Fund is taking an average of about 9 months in Latin America (and in some cases over a year) to disburse funds for antiretroviral access because of a variety of factors related to internal CCM issues as well as the Global Fund's own procedures.

What would happen if everybody concerned, The Jamaican National AIDS program, the Country Coordinating Mechanism, the Global Fund, CARICOM, PANCAP, PAHO, UNAIDS, USAID, and other "key actors," combined their skills, intelligence and efforts to try to make the Jamaica treatment access dream a reality by March 15th, 2004 so that those who need treatment can, in fact, have hope. Can this be done?

Richard Stern
Director
Agua Buena Human Rights Association
San José, Costa Rica
www.aguabuena.org
Tel/Fax 506-234-2411

* GNP = Global Network of People Living with HIV/AIDS

"We are not here to celebrate World AIDS Day. We are here because this is a day of mourning for us. Our friends continue to die because our government will not give them antiretroviral medications." With these words, Julio Cesar Aguilera, Director of the Network of People Living with HIV/AIDS in Santa Cruz (Bolivia) began the inaugural ceremonies for World AIDS day held on a humid rainy December 1st in Santa Cruz, Bolivia's second largest city, with a population of 1.5 million.

An hour later, as Bolivian Vice Minister of Health, Oscar Larrain, began his speech, Aguiler and eighteen other protesters each stood up with a placard bearing a cross and the name of members of "REDBOL" (The Bolivian Network of People Living with HIV/AIDS) who had died during the past year in spite of having received temporary protective measures from the Interamerican Human Rights Commission in October of 2002, ordering their government to provide them with antiretrovirals. Fourteen months later the government still has not provided antiretrovirals to any of the 52 people who received the temporary protective orders, and nineteen have died and several others are seriously ill.

As the demonstration began, PWLA activist Violeta Ross from La Paz took the microphone from the Vice Minister and explained that the protesters were tired of false promises made by the government's National AIDS Program. "Now they have said the medications will arrive on December 19th—just before everyone goes on vacation. What physicians are trained to distribute the medications? What is the distribution plan?" asked Ross.

Minister Larrain, visibly shaken by the ten minute demonstration, promised that steps would be taken to make sure the antiretrovirals, to be purchased from CIPLA, will be delivered to PWHIVs as soon as they are received. The inauguration ceremonies were followed by a march through the city to the Central Plaza and a mass at the National Cathedral. The demonstration and march were widely covered in the Bolivian press. ¤

Source: Asociation Agua Buena

Counting our blessings

The night before the FDA meeting on 14 November 2003, twenty-five of your favorite activists at-large were putting together the game plan of how to engage with the FDA, on exactly what points. In typical AIDS activism fashion, within half an hour of starting the discussion, even though we had an agenda, we were talking about everything from ADAP subsidies to what is done and how they do it in Europe. Chaos sets in easily and once established, is hard to dispel and get back on track. Someone finally asked about how something was done 14 years ago, and that was the break needed to get Mark Harrington up to the white board that extended throughout all four walls almost floor to ceiling (the activists' version of a padded cell?). Rob Camp reports.

Mark took the opportunity to go year by year through the history of treatment activism, and by the time he had covered the second wall with notes and dates, we had the outlines of a plan. It was his recounting of the storming of the NIH that made us see that it was perfectly sensible that he would review for the FDA the next day what we (community + authorities) had historically accomplished, and where we would like to go from here. Although some of the FDA team had been around from the beginning or the near-beginning, there were many new people (there were more FDA people coming than activists—some 35 vs. 25!) who could do with a recap, including some from the community—on issues as basic as the importance of Commissioner David Kessler, and the introduction of accelerated approval. Because readers of TAGline have been following the last ten years of AIDS through our monthly series, I'll spare you the details; but once again, in a very engaging and succinct way, Mark brought us all into the realm of not forgetting history in order to figure out where we need to go.

After his recount (à la Guernica), we tried to focus on what we wanted from the FDA in the upcoming months and years, remembering that FDA is concerned with "accuracy and safety" vs. any risk/benefit ratio looked for by, say, the EMEA, its European counterpart. The FDA had agreed to this meeting, so in some ways probably realized that it may be time for some tweaking of the rules.

The agenda of the FDA meeting itself had been refined over the previous months, and we only had half a day to pack into it a lot of desires, hopes, frustrations, needs, etc. Mark started off the day according to what we had discussed the night before, and finished with a list of where we want to be. Some of the main points are issues that we have been bringing up in the TAG/community position papers over the last year, including:

• More data on pharmacokinetics of drugs in more diverse populations.
• More drug-drug interaction studies completed at the time of approval, including studies with methadone, birth control hormones, and TB drugs such as rifampin, and of course with the most commonly used protease inhibitors and NNRTIs.
• Study populations need to reflect the makeup of the epidemic by adequately representing women and people of color. New relationships need to be fomented with clinics capable of enrolling more diverse groups of individuals.
• After drugs have been approved, promises made by companies to continue post-marketing research should not be allowed to languish. Currently the agency has no effective way to compel completion of these Phase IV "good-faith" commitments, and pressure on Congress to give the FDA more leverage may be needed.
• Better systems must be implemented to monitor chronic and/or long-term side effects after drugs are approved. The current adverse events reporting system is voluntary and may miss early signals of toxicity. A network of "sentinel practices" that would report unusual symptoms might be a viable enhancement to our early detection system. The need for a better system to detect and track side effects such as lipodystrophy syndrome after drugs are approved is a top concern for the community.

These "themes," in one way or another, reflect the questions that we come home with after approval of every drug, and that we don't ever seem to get the answers to: Is the drug effective? What are its benefits? What are its risks? How should the drug be used? Who will benefit? And, what is still unknown?

The FDA Directress of the division of antivirals then spoke, on what she saw as the value of the two of us working together, and mentioned the importance of the position papers the FDA had been receiving from us over the years. She suggested that we get the papers in a little earlier, in order to help them define their priorities, and so all their salient points can be better addressed either at the public hearing or at the time of the announcement. (They actually "close" their review approximately one month before the announcement.)

Cohort studies is another area that FDA feels it needs to get involved in, and following the large simple trial idea of many years ago (that was never really taken up), could be an effective way of not only seeing long-term results, but achieving an efficient clinical monitoring over a long period of time. With so many me-too and near me-too drugs coming up, should the bar be raised for them? Do we want to see less side effects, better resistance, efficacy in otherwise unresponsive patients? Of course, if a drug does have one of these attributes, is it truly a me-too?

The FDA Commissioner then came up to the podium to offer his view of where he saw FDA heading—in terms of the politicization of the agency, drug reimportation, and a more effective side effects monitoring system (based on a National Cancer Institute model).

His speech seemed to be hitting all the right political buttons with us, making us all warm and fuzzy, showing that he is a very good politician, but also raising the concern that, in fact, he is a very good politician (and nothing will be made better).

We asked him about the "religious crazies" and other ideologically driven anti-regulatory types who may want to change FDA agenda or even dismantle it completely, and their effects within FDA. The Commissioner categorically denied that any of that is going on within FDA, and left me with the feeling that they must be a city on some other hill forgotten by the likes of Karl Rove and William F. Buckley.

Also, FDA is perceived to be responsive to industry instead of to the consumer, and maybe that perception should be the other way around. FDA is also often scapegoated as the guilty party in asking too much from pharma, which is presumably why there is so little moving through the system. We offered our alliance to FDA in demonstrating however we can that that is not the case (they do not ask too much from industry, pshaw!), and vigilance must be maintained. The community can lobby Congress on expanding FDA's budget in order to continue doing such a valuable, rigorous work as well as expand their mandate over Phase IV surveillance etc.

Questions were brought up re: the need for more exhaustive monitoring and design of drugs regarding hepatic issues. Also, we expressed desire to have more input in the package insert.

The four HIV drugs that were approved this year were then each briefly presented by the head of the evaluation team for each drug. They knew their stuff, and all except the atazanavir presenter were willing to share doubts and concerns with us, and were interested in hearing our preoccupations. They all seemed serious, rigorous and sincere in the belief that they had done a complete review of all of the drug data before approval. The community can only count their blessings that we have such a smart and dedicated group of people who do this for our protection. One outstanding bit of data announced is that 11% of T20 patients need narcotics to control the painful injection site reactions.

Maybe I did not say loud enough at the meeting that I find the public hearing aspect of the whole process one of the most transparent and heartening educational activities done anywhere in the world, and would like them to do that for as many drugs as possible—even the most unexciting me-too around.

Some unresolved issues (on our part as much as on the part of FDA) are access to expanded access programs, oftentimes limited to white gay men, in a not-only white gay men disease. Advertising and promotion is a big piece of meat that we couldn't fit onto the agenda this time. A few perfunctory developing world issues came up, which can be found in the ATAC minutes on our web site (www.atac-usa.org).

The CDER division (drugs) of FDA were the presenters that day, and the other division, CBER (biologics, "blood") expressed hope to meet with us in the not too distant future re: trials and candidates for an AIDS vaccine. Although the acting deputy director of CBER said a few words, she emphasized that a full meeting with us is needed for consultation. We are honored to be so highly considered. ¤

I want to express thanks to community members who did an outstanding job at this meeting and in its preparation, including Mark Harrington, Lynda Dee, Bob Huff and Daniel Raymond. For a more detailed account of what happened, please see the excellent article in November's Treatment Issues by Bob Huff, "Treatment Activists Meet with the FDA," which I have freely used as reference for this article. Also, the minutes mentioned above were developed by Cathy Olufs (Los Angeles) and Fred Schaich (Portland) that helped fill in this article.