Developing new drugs is one thing, but finding ways to get them to the vast majority of people in the world who need them is proving a lot tougher than hoped. Of course price has been and will continue to be a problem, but the logistics of shipping, clearing customs, transporting and storing medicines need attention too. Then come issues of diagnosing, dispensing and monitoring therapy when doctors, diagnostics and skilled staff are in short supply or lacking altogether.
Gilead Sciences, the makers of Viread (tenofovir) and soon-to-be custodians of Coviracil (FTC), have announced a plan to distribute tenofovir at no profit to organizations in every country in Africa and in 15 other resource-challenged countries. Providing drugs at cost or even for free is not a new idea. Other companies have launched similar programs that have met with mixed success. Boehringer Ingelheim, for example, has a program to provide free nevirapine for prevention of mother-to-child transmission of HIV. Yet the required paperwork was initially so convoluted and difficult to negotiate, that few were successfully treated.
What sets the Gilead plan apart is the attention given to addressing the problems of actually distributing and dispensing the drug. First, Gilead plans to arrange for direct purchasing by treatment programs in each country. Some small treatment programs have found that drugs offered at an affordable price by a generic maker may have to pass through a third-party wholesaler who can add on significant markups or divert their shipment to another customer willing to pay more. Next, the company has indicated a willingness to provide information and technical assistance to organizations that are interested in adding treatment to their services. The intention, the company says, is to "take appropriate steps to ensure that Viread shipments reach their intended destination and, to the extent possible ... monitor the recipient programs on an ongoing basis to ensure that quality care is being provided."
Realizing effective programs will depend on continued research into both the medical and the operational aspects of delivering treatment in resource-limited settings. Gilead is also a participant in the "Development of Antiretroviral Therapies" (DART) study, a 3,000-patient clinical trial sponsored by the U.K. Medical Research Council scheduled to begin this year in Uganda and Zimbabwe. DART aims to investigate ways to optimize the provision of therapy with simplified protocols and diagnostic tools.
There are more than a few stumbling blocks ahead, even with the company's willingness to smooth the way. To date, no price has been announced and it's possible that Gilead's "no profit" price will exceed what many programs can afford. Then, cheap Viread is fine, but one drug is not enough. What other drugs on what terms will be available to programs that wish to begin offering treatment? Gilead is in the process of acquiring Coviracil, which should prove nicely compatible with Viread, but that won't be available for perhaps another year -- and still, the third leg is missing. If Gilead is serious about making this program work, it should plan to act as the "at-cost" middleman for a full combination, including, say, Viread plus Epivir and Viramune or Sustiva in the package. At the very least, Gilead should pledge not to disqualify or discriminate against programs that plan to use generic versions of these other drugs in their affordable combinations.
New Handbook for Organizations Seeking to Provide Treatment
Initiatives like the Viread distribution program could be an attractive solution for employers, religious missions, health clinics, clean water programs or any of a number of similar existing economic or health development projects that would like to add HIV care and treatment to the services they offer. But small community-based organizations (CBOs) and non-governmental organizations (NGOs) interested in dispensing HIV medicines have a lot to consider before taking the plunge.
The International HIV/AIDS Alliance, along with the World Health Organization (WHO) and UNAIDS, has developed a handbook entitled, "Mobilising NGOs, CBOs and PLHA Groups for Improving Access to HIV/AIDS-Related Treatment." Intended as practical toolkit, the handbook contains a series of training exercises designed to prepare management and staff to deal with the full range of tasks and issues that will accompany undertaking a treatment program, including how to:
- Make decisions on involvement in treatment provision and drug supply by providing a basic understanding of the main factors involved in HIV/AIDS treatment;
- Gain access to and make use of existing local and national drug supply systems where available; explore and use alternatives to these systems and drugs where necessary and useful; understand the uses of donated drugs and the constraints associated with their management and use;
- Work with the practical issues involved in drug supply and financing, with special regard to cost, quantification, quality and sustainability in the context of the development of the epidemic and in relation to other public health needs;
- Ensure good practice in the use of HIV/AIDS-related drugs, including clinical requirements and the use of treatment protocols, technical support (such as laboratory services) and psychosocial support (such as confidentiality and counseling).
- Although the handbook is designed to build practical skills through interactive exercises, simply reading through the material gives an overview and reality check about what treatment provision can entail.
Copies of the handbook are available at: www.unaids.org/publications/documents/health/access/NGOtoolkit/index.html