The ECAB and beyond
Today ECAB consists of 50 members from around 30 countries and meets regularly in Brussels. We have achieved recognition of our work from the European Medicines Agency [4] (the body that regulates drug licensing) and companies are expected to seek our input and approval regarding drug development and early access to new medications. But not all is rosy. Some time all we hear back for our comments is: ”point well taken“. Recently ECAB met with a company to discuss a trial design. The second of the exclusion criteria read: ” [Patients with] Current or past alcohol and/or drug use which in the investigators opinion, could compromise the subject’s safety or adherence to the study protocol“. This highly inappropriate wording not only reflects existing prejudices; it perpetuates them and makes value judgments based on lifestyle choices. Instead we suggested a warning or guidance could perhaps be given to the doctors for patients that have demonstrated e.g. failure to keep appointments as an indicator of potential poor adherence. And while there is no evidence that alcohol or drug use results in one, numerous studies have demonstrated beyond doubt the inability of the doctors to predict the adherence success rates of theirs patients. Unfortunate as such prejudices are for the Western countries, imagine the possible consequences in the setting of countries with limited access to these life- saving medications. It would be the same doctors that would later have to make the choice of who ”deserves“ to be treated or who is not likely to ”harm oneself“ by ”improper“ use of the medications, posing also a threat to others due to the emergence of resistance.
On other occasions we feel we have achieved our goals like when last year, for example, we raised our concerns for a trial conducted by Schering-Plough which, after some tough negotiations, led to the change of the original protocol just before the trial was about to begin. This was the first time such a thing had ever happened in Europe. Our point was to raise the level of safeguards to potential trial participants at the expense of quick recruitment.
This last point has made ECAB increasingly concerned by the preference of drug companies to set up trials in Central and Eastern Europe and even to developing countries because of the difficulty of finding enough available treatment-naïve patients to participate in trials in the Western countries. In Central and Eastern Europe, by contrast, people with HIV have such difficulty accessing treatment that they are more than eager to enroll in an experimental drug trial. Well designed trials are of course most welcome but should only be offered along side affordable and unhindered access to the standard of care for all patient groups. The HIV community in these regions should be alert to the potential for abuses and exert all possible pressure to be informed and involved.
To that end the EATG will organize a seminar for AIDS activists in Eastern countries later this year with the aim to empower and train local activist to get involved and give their input and come up with their set of priorities and demands. They would also be more than welcome to join ECAB and use it to find out how they can influence things from that front as well.
