Tuesday, May 14, 2013
The SUPPORT Trial: Good intentions in medical research are not enough--especially when lives are at stake--you also need to avoid hurting patients and to use a design that will yield useful info
Medical research is necessary: there are innumerable unanswered questions about how to best treat patients. When lives are at stake, answering the questions is very important. Modern medicine was built on the back of medical research, built on clinical research that must rely on the goodwill of human volunteers.
Volunteers participate as research subjects under the expectation that they will not be placed at greater risk of harm by volunteering than they would be otherwise. Their willingness to volunteer comes from the expectation that the research is being conducted intelligently, and ethically, in order to move medical care forward, and not for other reasons.
Furthermore, federal regulations regarding human research require that volunteers be fully informed about the risks and benefits of the research in which they will participate.
When the research involves children, the regulations are even stricter, since children cannot give informed consent and are considered a vulnerable group.
Now to the SUPPORT trial. Tiny, premature newborn babies were the subjects of experiments the were meant to answer questions about the ideal amount of oxygen to be given, the use of surfactant in premature lungs, and how oxygen should be administered. Good questions.
But the trial design and the way the trial was conducted failed to meet current legal and ethical standards. And therefore it has been investigated by the Office for Human Research Protection in the office of the HHS Secretary. (OHRP moved out of NIH in 2000; I thought it was still under NIH when I first wrote this.) In response, the medical research and bioethics communities are beginning to link arms to defend the sanctity of this medical research, and scream loudly about those who dare to question the research and researchers.
This makes sense when you realize that Bioethics as an academic 'discipline' has become (mostly) a group of apologists for whoever is paying the bills: the pharmaceutical industry, research universities, the federal government, etc. And medical researchers understandably feel the need to prevent too much questioning and investigation of what they do.
In the case of the SUPPORT trial, the apologists have tried to shift the terms of the debate. Normally, this is a very effective strategy. But this is what you need to know, which the apologists are doing quite a dance to obscure, and will never discuss:
1. Some or most mothers of preemies were asked to provide "informed consent" -- while they were in labor! How can you possibly give thoughtful consideration to subjecting your about-to-be-born, very premature baby to medical research while you are in the midst of trying to deliver that baby? Clearly there was no true informed consent under these circumstances. Have the bioethicists, and researchers who came up with this plan, ever experienced labor?
Another major issue wrt informed consent was that the trial objectives and strategies were not accurately explained in the consent document. Here is the consent form.
2. The design of the trial was bizarre. The "pulse oximeter" that is used to continuously record blood oxygen levels was redesigned to provide inaccurate values for blood oxygen levels in the babies. The result was that treating physicians were given false values of oxygen saturation in the babies. Clearly, this might and probably did interfere with babies receiving optimal, individualized adjustments of oxygen delivery. Would you want doctors in an intensive care unit treating you to get altered, inaccurate test results?
3. Since the treating doctors were given incorrect information, the trial results are based on abnormal circumstances and altered physician responses, which throws into question whether the results are of any value at improving clinical practice.
Why didn't the participating physicians, institutional review boards and medical centers notice these failings? Because that is how things are, with no one really responsible for getting it right, despite the fact that it is humans who offer themselves and their children up to the research enterprise.
Thank Public Citizen and AHRP for calling attention to these serious lapses in medical research on critically ill, newborn humans.
Posted by Meryl Nass, M.D. at 7:56 PM