Participation in clinical research (HIV) 1991 to 2016
Clinical research is a horrible business (quotes taken from various interviews and communication with people living with HIV). It is a constant fight over resources, promotion, moral and ethical issues, who is right or wrong, and it is very personal. Not only – but maybe a bit more – if you represent patients. Community participation is self-revealing (“I suddenly realized that this is happening in my own body”), self-empowering (“I was introduced as a doctor”) and a difficult way to chose (“It takes two to three years of learning before you can speak their language.”). I know that from doing my own research and participating in clinical research from a first person perspective. As patients we have much to gain from clinical research. And we place big stakes in the advent of improved medicine. In the end we are also the ones taking the risks. Personally.
Do people with HIV have their own agenda in clinical research? We have historical evidence to prove that unwanted effects of treatment (depression, nightmares, lipodystrophy) and treatment approaches (triple combination therapy, pre-exposure prophylaxis, cure) were logged into the research programming only through the insistence and ingenuity of patient community representatives. Beyond that, clinical research has proven to be not the closed book that everybody believed it was. There remain a lot of concepts to be further promoted and developed (compassionate use, parallel access, the provision of a “research compound” between the official end of a trial and the availability of the “drug treatment” in health care) that originate from patients’ communities.
Patients’ traces are also to be found in the frameworks of clinical research. A pharmaceutical company that is completely “lab-oriented” is considered a high-risk venture capital investment; a no-go to bring a compound through clinical research and into markets. If you start a successful company that way - chances are that somebody else will come and swallow whatever you had in mind. So, the general wisdom, today, is that you cannot rake the full benefit of your property investors unless you work with the patient community. Some parts of the literature and some speakers I heard call it “Making use of the patients” quite frankly. In a mechanistic world that is like patients are to become a part of the well-oiled machinery. From a “lab-oriented” perspective the patient-world offers eureka moments.
Let me propose that clinical research is a horrible business that becomes less horrible and more centred on “helping people to survive”, when a patient is in the room in all discussions and considerations. This may have nothing to do with the patient in person but rather with the fact that (a) there is a perception of external monitoring, and (b) there is hope for an unknown fact coming out of the mouth of the “animal”. Community representation (participation from beginning to end) has developed considerably based on demands coming from patients.
The communication around clinical research has also changed much as a result of patient community activities. Transparency of clinical research has greatly improved from being completely closeted to including public registries and patients participating in scientific conferences as discussants. Patients’ representatives serving on data and safety monitoring boards and in regulatory authorities can no longer be called a “myth”. They are in the hundreds, today.
Today, I am looking at where we stand and what I feel about clinical research because 25 years ago, I contributed to writing the European AIDS Treatment Agenda (EATA). We asked for new trial designs, respect to patients’ concerns, direct participation and generous amounts of information to lay people. The “weird characters” we had been until then - suddenly had a common ground to start from. In the European Union, our marks are on the European Medicines Agency, on the European Centre for Disease Control and on major clinical research programs and initiatives. In its early days, the European AIDS Treatment Group (founded seven months after the publication of EATA) used it as its “business card” and point of reference for common activities across the EU and neighbouring countries. It was “our” policy statement and mark-up. If you could understand the text - you either had to be a committed treatment activist or a researcher, yourself.
Read the European AIDS Treatment Agenda here: EATA_1991_Florence_IAC
Working along the agenda has resulted in numerous means to improve the lot of patients in clinical research. For some it provided the basis for sustainable income, for some it was their “moment of fame”, some were provided “with preferential treatments” and some relate to the organization to promote the EATA as “my activist home”. EATG has be praised for saving thousands of lives. For me that effort was based on having a common agenda. EATA served to provide the words to come out of our mouths.
I was told, in November 1990, six months before the authors first met, to organize and invite a workshop on “AIDS and Medication”. I spoke to ACT UP Berlin, and we set out to adapt the “AIDS Treatment Agenda (ATA)” for the US to our own purposes. The money was coming from the European Commission’s social arm - and the task was to promote the building of platforms. In all, maybe ten out of the 25 people attending the workshop understood, what it was formulating. A commonly heard remark was “can you spell this out for the protocol, please”. We had AIDS Service Organizations (NGOs), a hospice and a clinic, substitution treatments, women’s and gay men’s issues, children, nursing care, directories and a list of “alternative” treatments on our minds, too. We started with a brainstorming of issues unsolved. To me the account of research done in the UK and no access to the same compound to my best friends was the cracking point. “We are being told lies, when they say that there isn’t enough compound available to let people into trials earlier.”
We split up into three groups to draft positions based on the ATA around (1) trials, (2) drug regulation and (3) information. The trials group changed ATA in that in Europe we needed the basics for what had already been achieved in the US; few trials were multi-centred, entry criteria and approaches were irrationally diverse across Europe. There was much room for better designs, more compassion and collaboration in the entire field. A directory of clinical trials has meanwhile become available through concerted efforts started from this subgroup.
The second subgroup focused on the EU as the administration to reflect on what centralization and harmonization could serve to improve (beyond calling for more money). We dug into patients rights, duplication of efforts in regulatory processes, and identified examples of community representation in France and in the UK. This we added to the AGA from a European perspective.
The third group reported great progress in identifying the needs in information of patients’ communities. Collaboration agreements (sharing of articles and texts) and commitments to work together in bringing up new evidence were immediately sprouting out from the room and filling the communication during the breaks. They also provided room to catch up to explain to each other, what we were “in lay terms” talking about.
On the third day, we heard reports from the working groups and discussed the way forward. We called it “building a platform” - today you may call it the implementation phase of the EATA. We agreed on writing a finalized version. On publishing it at the 1991 International AIDS Conference in Florence. On publishing a newsletter to provide the information of our activities as well as news and basic medical education around clinical research in lay terms. On looking for funding to meet again. On setting up an organization independent of our current organizations framework restrictions.
The horrible business has become much less horrible since. Their have been catalytic and cataclysmic moments. Frameworks appear to shift and the “heureka” is more commonly heard. The ideas of EATA persist, even though the marks set have been passed in some places. It was surely a progressive approach at the time and it served to get us from “lab to bedside” for more people more rapidly. EATA became valuable in working with clinicians, industry, and authorities towards reaching the goal of participation.
In a less horrible business the patient is no longer an animal and there is (at last) awareness that the “animal” can do more than bark and wince.
I wish to dedicate this text to commemorate the following participants in the first “AIDS & Medication” workshop in Berlin, 1991, who have passed away: Andreas Salmen, Michael Fischer, Jürgen Poppinger. I wish to praise Robin Gorna, Hennig Mikkelsen, Jonathan Grimshaw, Peter Scott, Nick Partridge, Ulrich Marcus, Hans Hengelein and Stephan Dressler for their critical tole in writing EATA. The audio tapes of the workshop (thanks to Deutsche AIDS-Hilfe) are now archived in the “EATG Suitcase” at the Schwules Museum in Berlin. They have yet to be transcribed.
EATA was signed by the leading 20 community-based AIDS organizations in Europe in 1991. The first European newsletter was published to coincide with the second workshop arranged to also found EATG in February 1992.
25 June 2016
Matthias Wienold is a physician and master in public health. He is a member of EATG (Policy Working Group) and Treasurer of the International Alliance of Patients’ Organizations (IAPO).
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How an online patient group proved its value to me