Yesterday was the ninth anniversary of the death of Dan Markingson, a victim of (at the very least) questionable clinical research at the University of Minnesota Department of Psychiatry. For his mother, Mary Weiss, Dan’s loss must surely be compounded by the knowledge that nothing has changed at the U of MN. This tragic reality was brought home for me a week ago when I was challenged by U of MN researchers (from an entirely different part of the medical school) about inviting Dr. Carl Elliott to speak to patient advocacy groups about research ethics. They objected strongly to his inclusion on the schedule. I heard them out–people see things differently and I was interested in their perspective. What bothered me is not that they objected to Dr. Elliott, their fellow faculty member at the U of MN, but why.
This conversation took place in the context of a meeting of investigators who are part of a rare disease clinical research network at NIH. My role in this network is as chair of the patient advocacy group arm of the network, which is focused on patient welfare in the research process, as well as on advocating for research to improve access to therapies. Obviously, there are a number of diverse interests involved in a network such as this and there can be competing priorities and conflicts of interest. However, the role of the patient advocates should not be murky to anyone. Our job is to represent the patient interest first and foremost, even it that requires opposition to investigators, pharma or government interests at times. I assumed this was clearly understood by all.
Which is why it was so odd to have investigators track me down immediately after the meeting to express their concern that I would consider asking Dr. Elliott to speak. They were crystal clear about where their loyalties lay–‘Dr. Elliott is too anti-pharma and that could jeopardize our current working relationship with ______ .’ They were dismissive, disdainful and made alternative suggestions naming people who have distinguished themselves primarily (IMO) for being ‘ethics for hire’ folks. One of their suggested speakers is someone who has actually taken the utilitarian ‘bean counter’ position regarding rare disease research, suggesting in writing that it is a waste of funds that could be better used to help diseases that impact more people. Why in the world would rare disease patient groups want such an individual to speak to them (not to mention he was intimately involved in a notorious case of research misconduct involving current researchers in this network)? Why would they assume their deference to pharma would/should supercede my obligation to the patient groups and, by extension, rare disease patients?
A top-level government staff person involved with the network was present for this conversation. I was a bit flabbergasted by the position of the U of MN group, so the following day called the staff person to be sure I had accurately interpreted the conversation. I had. It turns out that pharma is essentially controlling the agenda of several of these research consortia in a way that is potentially impeding progress for disease groups that are participating in consortium activities, but whose specific condition is not of interest to the pharma ‘partner.’ These groups were enticed to participate in a ‘collaborative’ research consortium, only to discover collaboration means accepting whatever research priority pharma dictates. Researchers have, in effect, surrendered control of their own projects over fear of losing pharma support. I think most people would call that bullying, yet the researchers from the U of MN seemed completely oblivious to the fact that they had essentially just acknowledged–to a patient advocate no less–that patient interests come second to appeasing pharma.
Happily, most of these consortia have very transparent and productive interaction with their pharmaceutical partners and if other researchers have been threatened with loss of support should the investigators fail to dance to their tune, I am not aware of it. It seems unlikely to be a coincidence that this issue came up with U of MN researchers, however.
The reputation of the U of MN has been tarnished by their handling of Dan Markingson’s case and, if current experiences are any indication, it will not be rehabilitated any time soon. On the anniversary of this tragedy, my heart bleeds for Mary Weiss and for Dan.