Mary Weiss's son Dan never saw the letter she wrote, telling Dan that if he wanted to get out of the study of atypical antipsychotics he was in, his mother would stand by him. Mary's letter didn't reach Dan until Monday, and Dan had killed himself that Saturday.
As Mary told me when we talked this past Sunday, it isn't really clear Dan would have taken her up on her offer to help him get out of the study. Because Dan might not have told Mary what Mary only learned from reading over his medical records after he died: that Dan had been given to believe, by his doctor/researcher Stephen Olson at the University of Minnesota, that if Dan left the drug trial, he would be involuntarily committed.
So this was Dan's choice: be a guinea pig (stay in the study), or be caged (be put away). Dan took what he saw as a third option.
All of us who have worked with Institutional Review Boards (the ethics committees that oversee human subjects research) know that research subjects are supposed to be allowed to freely exit research studies without fear of penalty. And we know that incompetent individuals--including people like Dan who are floridly psychotic, such that they are facing involuntary commitment to a mental institution--are not supposed to be seen as competent to consent to medical research.
So what went wrong in Dan's case? Seemingly everything. You need to go read Carl Elliott's excellent report in the current issue of Mother Jones to appreciate the scope of atrocities committed on Mary and her son. (And on medical science, too.)
Mary and I talked this weekend, shortly after I posted a short essay about Carl's article at Bioethics Forum. When we spoke by phone, Mary told me that Minnesota now has a law, "Dan's Law," that specifies that a patient facing commitment cannot be entered into a clinical study being run by his own doctor. The law in Minnesota now seems to recognize the conflict of interest that caged Dan.
"Dan's Law" also specifies that "The court must determine that, under the circumstances of the case, the patient is competent to choose to participate in the trial, that the patient is freely choosing to participate in the trial, that the compulsion of the stayed commitment is not being used to coerce the person to participate in the clinical trial, and that a reasonable person may choose to participate in the clinical trial."
That last clause alone might have saved Dan from Olson's drug trial, had this statute been in place before Dan's psychotic breakdown and had the court had enough coffee the morning it weighed this decision to realize that Olson's trial was an after-market study being conducted not really to ascertain information critical to patient care, but essentially to produce ad copy for AstraZeneca, the maker of the drug Dan was put on.
But Dan and his mother were outgunned from the start. Mary told me that, when she was desperately trying to get Dan out of this study into a situation where he was being treated first and foremost as a patient and not a lab rat, she had no idea that when she turned for help to NAMI, one of the leading mental health advocacy groups, she was turning to a group that acts as a kind of funnel for drug company-funded studies.
Given the statement about human subjects research from NAMI (the National Alliance on Mental Illness), an outsider might assume that when Mary called them for help with Dan's dire situation, they would rush to aid her. Instead, the NAMI rep told her they'd call her back, and then did so only to assure her Dr. Olson was a terrific researcher and she should not worry.
Mary would have been too frantic over her son then to take a look at who funds NAMI. I've looked.(You can, too.) It's one big drug company after another.
Elliott's article and the conversation I've had with Mary would have me feeling down enough, but add to this my own experience this year, and I'm just feeling like I'm developing my own case of drug-study-induced depression. I've been trying with a bunch of excellent colleagues to fight to make sure pregnant women being treated experimentally off-label with a Class C steroid by a clinician-researcher know that this drug use has not been shown to be "safe for mother and child." (You can read about our work in Time.) Yet that's just what this clinician-researcher, Maria New of Mount Sinai School of Medicine, claims to would-be patients: "safe for mother and child." "Safe for mother and child" while simultaneously turning to the NIH for money to see what, in fact, this off-label prenatal use does to these women and their children?
And where did Dr. New get all these pregnant women she's been treating and later studying? It appears largely through the CARES Foundation, ostensibly a patient advocacy organization, and one which has run "news" items that look an awful lot like ads for Dr. New's clinic. (Yes, we've pressured them into slapping that warning banner at the top. But why is that page still up at all?)
Heavens. What's your average Mary Weiss to do? Watch her children be treated as fodder for other people's studies and publications, and learn too late that she somehow was going to have to change the law to help other people from going through the same?
My colleague Ellen Feder of American University and I have written to the "bad ad" folks at the FDA to ask them to stop Dr. New from telling patients "safe for mother and child" while telling her colleagues "Prenatal treatment [of dexamethasone for CAH] should continue to be considered experimental and should only be used within the context of a formal IRB-approved clinical trial." This is our last hope. Another department of the FDA has already told us that, since New is not employed by the makers of dexamethasone, she's allowed to say this off-label use is "safe and effective." Surprise! The law isn't enough to protect these women from New's double-speak.
Seriously, what ever happened to ethics? Is there anyone at Mount Sinai School of Medicine and the University of Minnesota's school of medicine (besides Carl Elliott) who isn't a lawyer?
Frances Oldham Kelsey, we need you now.