There’s a paramedic out there who has my lasting gratitude.
He was supposed to use an unproven medical device when trying to resuscitate my husband David after he had a heart attack in October.
The paramedic was so busy trying to save Dave’s life, though, that he forgot to make Dave a guineau pig for the medical profession and a medical device manufacturer. It is difficult to describe how immensely relieved I am.
Dave, despite my continuing objection, is part of a nationwide study is underway to determine whether the manufacturer’s device improves resuscitation outcomes in cardiac arrest cases. Some study subjects get the device, which may or may not help them; others get a sham device — a placebo, in essence — that researchers know won’t help. The study also is trying to determine whether doing CPR longer before administering shocks to cardiac patients improves resusciation rates.
As soon as the paramedics walked into our house the day Dave was stricken, he became part of the study without our knowledge or consent. He got the longer CPR and was supposed to get the device but did not, according to Medical College of Wisconsin records. MCW is running the Milwaukee branch of the study.
The device could not have saved Dave. His brain had gone too long without oxygen and the damage already was done. He died six days later without regaining consciousness.
I have been trying to get all of Dave’s data removed from the study ever since learning, more than a month after he died, that he was shanghaied into it. So far I’ve been unsuccessful. The Medical College, which has acknowledged errors in the way Dave’s case was handled, has declined to remove all of the data, citing federal guidelines. College reps say they will expunge the data if I can get specific federal waivers. So now I’m working on that, but am not optimistic – the guidelines are written for researchers by researchers to enable research. Once you are in a study, even if you weren’t asked, you can’t get out. (The guidelines are non-binding, but the Medical College adheres to them.)
Here are some key parts of the Food and Drug Administration guidelines…
FDA recognizes that a subject may withdraw from a study; however, the withdrawal does not extend to the data already obtained during the time the subject was enrolled. FDA’s longstanding policy has been that all data collected up to the point of withdrawaI must be maintained in the database and included in subsequent analyses, as appropriate…
There is particular concern with a study’s reliability when subjects withdraw their data in a non-random way because they are unhappy with their experience, either because they failed to obtain a desired effect or suffered an adverse event. Loss of these subjects’ data could greatly distort effectiveness results and could hide important safety information (for example, toxicity) of a poorly tolerated treatment. Allowing subjects to withdraw data could even provide an opportunity for unscrupulous parties to “improve” study results by selectively encouraging certain subjects to withdraw from a study…
And, in a footnote, the FDA says:
It should be appreciated that FDA’s response applies to the most potentially difficult situation, that is, studies involving an exception from the informed consent requirements in which subjects, due to a life threatening medical condition, are unable to provide informed consent to participate in the study. Subjects may subsequently withdraw from such studies, but the data collected up to withdrawal may not be removed….
Yeah, but what if you wind up in a study through unscrupulous conduct, or mere incompetence or negligence? What if a researcher did not seek permission from a patient or the patient’s family simply because said researcher needed more subjects?
Tough luck. The only consequences are those borne by the patient and family.
Consider the ethical and practical ramifications of no-consent studies. If that resuscitation device was used on David, I would always wonder if that is what kept him alive, in a coma, for six agonizing days while we — his family members — struggled with tremendously, tremendously difficult decisions. The paramedic’s devotion to duty over research means that we don’t have to live with that uncertainty, and I am so very grateful for that.
What if the device was used and Dave was revived just enough to remain in a vegetative state for years and years and years? The Medical College folks tell me that researchers are aware of that possibility and will shut down the study if it looks like the device is making that happen. Still, by the time it’s detected, it has already occurred, and then what?
Does the Medical College pay the bills? And how does it compensate for the continuing pain endured by the family? In the meantime, how does it reassure families that the device is not responsible for those kinds of outcomes?
Or do the researchers just go on to the next study, ignoring the wreckage they’ve left behind?
The construct of the study also, of course, means that patients who could potentially benefit from the device will get the placebo instead. That’s the flip side of the same ethical issue.
Whatever happened to “First, do no harm”?
