There are a lot of safeguards in place to protect study participants. Before a drug study can actually go forward, it usually has to be presented to an Institutional Review Board (IRB), who checks the study against FDA regulations. The FDA also reviews studies that meet certain guidelines.
After those two agencies sign off, the patient still has to give informed consent and sign a waiver. Oak Brook-based Advocate Health Care kinda skipped all of that, reports the Chicago Tribune.
To be fair, they did present the study to their IRB. However, that was before they decided to introduce the drug component on live patients in a clinical setting. When they made that minor change, the IRB apparently didn’t notice, and didn’t notify the FDA.
More importantly, they didn’t notify the patients.
So the hospital would inject the unknowing patient with either etomidate or midazolam prior to intubating. Both drugs are sedatives. The former was being studied for its possible use in the emergency room.
There were 122 patients in the study. There is no indication as to whether there were any adverse effects on any of the patients, though none were presented with a waiver or told of the study.
AHC compounded their problems with the FDA by neglecting to come clean to the study participants. Part of their “corrective plan” that they submitted to the FDA included a letter to the participants explaining the study.
However, probably on the advice of counsel, they did not clearly explain in the letter that the subject was enrolled in a study (without their consent) and the letter also omitted information that would have been required in the waiver, such as risk to the patient, had the waiver ever actually been done properly.
Because there was no consent to use the experimental treatment, battery claims are certainly a strong possibility. Unwanted medical treatment has resulted in battery claims before, and “medical battery” is recognized in almost all states.
In addition, since intubation is done on patients that are usually in serious condition and having trouble breathing, it is possible that some of the patients who received the experimental drug died, (though more likely from the underlying condition that brought them in to the hospital).
However, if the results of the study come out negative for the drug, you can be sure that a rash of wrongful death lawsuits, legitimate or not, will be filed on behalf of the deceased.