While Achmat’s comments on DOTS drew scattered applause from the treatment advocates in the crowd, the response from the rest of the audience was muted at best.
In fact, after Achmat’s presentation, one doctor from Nepal rushed up to Union officials and said “please, don’t let them take away DOTS.” And the following day, this reporter spoke others who were discussing the “reckless course” that they feared the HIV activists were suggesting. “We have to confront this — a lot of people are frightened by this because the activists are powerful and their voices are loud,” said anther doctor.
To public health experts working in TB, DOTS represents far more than simply the observation of treatment. DOTS is the brand name for a package of services used by tuberculosis control programmes. In addition to directly observed therapy, DOTS requires the national government’s commitment for sustained anti-TB efforts (including education and training of caregivers and treatment supporters), adequate systems for surveillance and case detection as well as regular and uninterrupted drug supplies.
Of course, the activists are not questioning these other aspects of DOTS, merely the focus on the observation of therapy — and the associated failure to empower and educate people with TB.
But many TB experts believe that direct observed therapy is non-negotiable. They note that transmission of MTB is, after all, via the air and the consequences of poor adherence to TB treatment can spread far beyond the individual. And there are circumstances, such as when patients have failed to take their medicine and developed multidrug resistant TB (MDR-TB), where the public health consequences of poor adherence are such that the decision of whether to take treatment cannot be left up to the individual. Many TB experts believe that the adherence programmes where treatment is not supervised are too lax to be trusted.
It was telling that the Union chose a TB expert to give a presentation on “what does and doesn’t work for adherence to antiretroviral therapy.” Dr. Kenneth Castro, an assistant U.S. Surgeon General and Director of the Division of Tuberculosis Elimination at the Centers for Disease Control, began his talk with a discussion of DOTS.
He cited the Public Health Tuberculosis Guidelines Panel’s consensus statement from 1998 that evaluated 27 different TB studies looking at the outcome of therapy using “enhanced” DOTS, modified DOTS (DOTS on a less frequent basis) or unsupervised therapy — and noted that best outcomes were always seen in the studies with enhanced DOTS (Chaulk and Kazandjian). “These by and large consisted of case management with supportive measures, incentives and enablers and as you move away from case management and focus almost exclusively on the ingestion of therapy you lose some [effectiveness], and you keep losing more as you steer towards non-supervised therapy. So for us in the TB community in the US especially – it’s been fairly clear that the way to go is to have a patient-centred approach to provision of DOTS.”
Then Dr. Castro proceeded straight into a discussion of DOTS for ART (DOT-ART or DART) and spent most of his talk focused on it — despite the fact that DOT-ART is not at all the norm in antiretroviral care. However, it has been evaluated in a few studies and here, too, Dr. Castro noted that an enhanced approach with “flexibility and partnership between the participants and the programme are absolutely critical” to the success of DOT-ART in people with HIV.”
In a way, Dr. Castro seemed to be positioning himself as sort of a “compassionate conservative” on DOTS. Though to be fair, one reason for the focus on DOT-ART could have been to help the audience, mostly from the TB world, visualise how to integrate ART into existing tuberculosis control programmes. A number of studies suggest that the easiest way to make ART available through TB clinics might be to administer it through their existing drug delivery mechanisms, which is usually DOTS or “enhanced” DOTS. He cited at least one pilot study in South Africa that had done this successfully (Jack) and the Union has several similar pilot studies ongoing in different resource-limited settings.
Encouraging TB and HIV programmes to be flexible and patient-centred is a step in the right direction — and may be as much of a concession as the TB world is willing to make — but it didn’t go far enough for the HIV treatment advocates in the audience, a number of whom spoke out in the discussion session after Dr. Castro’s talk.
Said Chris Green of the Spiritua Foundation in Indonesia, “there are ways to do this without DOTS and get very high rates of adherence. In the developing world, we have seen better than 95% adherence without going to these extremes... Providing information to the patient is the crucial element.”
Tracy Swann of the Treatment Action Group noted that: “Even using the term DOTS or “enhanced” DOTS reflects a limited paradigm and we really need to look at the bigger picture.”
For example, DOTS programmes that require patients to travel the clinic to be observed taking their medications, usually cost money and take commuting time away from work. Both factors have been demonstrated to be a barrier to adherence.
Swann pointed out that the cost of transportation to clinic might actually cancel out any benefit offered by DOTS — and that such programmes were insensitive to the patient and setting. “I hope that we are moving towards a paradigm that will be more culturally specific, location specific, and resource specific,” she said.
Dr. Castro agreed that factors such as education are an important component of patient support and had been part of the background standard of care in many of the studies that he cited. And to Swann, he responded that problems such as transport costs could be easily addressed by enhanced DOTS, for example in New York, “by giving the patient a subway token.”
But while that might work in New York, providing the equivalent of a subway token in sub-Saharan Africa (the cost of transportation and the cost of lost work time) to and from the clinic (for daily lifelong therapy) are unlikely to be within the means of most TB control programmes. In fact, Dr. Castro had noted that most national tuberculosis programmes are already stretched thin and quoted a paper by Dr. Gerald Friedland and colleagues “To accomplish integration of tuberculosis and HIV/AIDS care and use of HAART in the tuberculosis DOT programs… tuberculosis programs will require the addition of new resources and personnel, as well as training to accommodate the necessary increased program responsibilities.” Until more resources are devoted to national TB programmes, it’s hard to imagine many of them being able to reimburse patient travel and missed work costs.