EATG position paper on clinical research and drug users

In order to reflect the importance to include drug users in the research and development of new agents, and test the existing ones in this particular population, the EATG recently created the ART4IDU Group within the European Community Advisory Board (ECAB), and adopted a position paper on clinical research and drug users.

Therefore, by issuing a specific position paper on clinical research and drug users the EATG demand pharmaceutical companies to undertake rigorous investigation of drug-drug interactions and other questions relevant to the clinical care of IDUs. What follows is the executive summary of the document.

Executive summary
The number of injecting drug users are estimated at 13.2 million worldwide. At least 41 countries have IDU populations with HIV prevalence above 5%. In 25 countries, the prevalence is higher than 20%, in 15 countries even above 50%. In much of Europe, Asia, the Middle East, Latin America and the United States, sharing of injecting equipment is the primary mode of HIV transmission.

Despite high HIV prevalence, drug users have largely been excluded from clinical trials. In order to address questions relevant to the clinical care of active drug users, they must be properly represented in clinical research.

To date, antiretroviral agents are marketed without adequate information on potentially life-threatening interactions with commonly used illicit drugs; users and their clinicians are often forced to rely on data from studies that did not include drug users or investigate drug-drug interactions. The EATG therefore strongly advocates for the inclusion of drug users in clinical research. Scientific research must be clinically relevant, and relevant to the populations in whom the drugs and/or interventions will be used. It is not acceptable to have clinical research exclude real life situations, because of the fear that they might influence the outcome of clinical trials.

Science should serve to improve people’s lives, not discriminate between legal and illegal substances. Drug users are often excluded from trials because of concerns about adherence and loss to followup. Since research has shown that this is not necessarily true, the blanket exclusion of drug users in trials is not acceptable. If drug users are not included, the result of such trials may not be relevant for them. A sufficient number of drug users should be incorporated into clinical trials to enable stratification by substance abuse status. Dissemination plans must include venues where drug users receive services. Clinicians must receive training on working with active drug users.

The rationale for excluding drug users from clinical trials has changed over the past decades. In the past, a history of substance abuse was enough to keep an HIVinfected person out of clinical trials. That proscription later changed to ”active substance abuse“, of course judged by the investigator. Lack of research is driving refusal to prescribe ARVs and to enroll active drug users in clinical research. The bulk of information about interactions between prescribed drugs is in sharp contrast to the paucity of reliable evidence about possible interactions with illegal drugs. In some cases, interactions are researched prior to approval, but often they are extrapolated from in vitro pharmacokinetic experiments, case reports, or animal model studies, based on theoretical knowledge regarding the drug’s metabolic pathway of street drugs, and information often relies on informed guesswork or anecdotal reports. Conceivably it is extremely difficult to apply such data to clinical practice settings.

The EATG demands all governments to remove legal barriers for conducting clinical research on interaction between ARV and illicit drugs. Refusing to study potentially life-threatening interactions is unethical. Drug users not using pure drugs shouldn’t be an obstacle for conducting research. There are many moral, ethical and political questions related to clinical research. We urge the key stakeholders to include drug users with HIV/AIDS and their communities to solve these questions. Clinical research should serve the people who suffer the most. Policies on drug users often confuse treatment with punishment.

The EATG will continue to address these issues at meetings and conferences with all stake holders of clinical research, with governments, public health authorities, drug users and their representatives.

The full version of the position paper on clinical research and drug users is available in the news section of the EATG website at: www.eatg.org/eatg/position_papers.php

EATG, ART4IDU Group

EATN - European AIDS Treatment News, Volume 14, II – Autumn 2005

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