by Craig Klugman, Ph.D.
In a news item reported in Rolling Stone, NPR, and The Houston Chronicle, the medical director of a coastal Texas nursing home used his political connections to get enough hydroxychloroquine to begin his own “observational” trials—minus a control group, minus informed consent, minus informing anyone. The rehab facility holds 135 residents and 42% (56) of them were COVID positive, as well as an additional 31 staff members. Robin Armstrong, physician and medical director called the Lt. governor whom he knows from the Texas Republicans and asked for some of the drug that Trump has touted.
The Resort at Texas City is a for-profit, privately owned “short-term” rehab facility with well below average ratings. Its most recent state inspection found 14 violations including, “The facility was not designed, built, equipped, or well kept to protect the health and safety of residents, workers, and the public” and “The facility failed to train staff on their responsibilities under the emergency preparedness and response plan.”
Armstrong is a graduate of UTMB (also my alma mater) and owns his own medical group. He is on the Texas Alliance for Life Board of Directors and serves on the Texas Finance Commission. He is one of two Texas representatives to the Republican National Committee. In other words, he is well connected in Texas politics. He has an active Texas medical license (expires 2022).
His “observational study” echoes language used to justify the Tuskegee Study and the Guatemala Syphilis Studies. And Armstrong’s work shares many of the same faults but is more poorly designed. He reports, “It’s actually going well. People are getting better.” Of course, he hasn’t stated what “getting better” means. Nor has he provided any information on what data is being collected, what doses of medication are being used, or what records are being kept. If this is indeed a real trial, then why is it not listed at clinicaltrials.gov? But let’s be honest, what Armstrong is doing is not research. This is not an attempt to find generalizable knowledge. He is not even proving that people are getting better because he’s not measuring and does not have a control group.
While a physician can use any FDA approved drug for off label use, usually that is done if there is some legitimate scientific (or strong anecdotal) evidence that the drug is likely to have a positive effect (beneficence) for the patient. As I have outlined in other posts, there is no data showing the effectiveness of hydroxychloroquine for COVID-19 patients, and certainly the side effects outweigh the purported benefits (nonmaleficence). A recent study of that drug combined with Zithromax was halted because of the high rate of heart fatal heart complications. Given this information, why would an IRB approve this study? Since The Resort is not part of a university and is not receiving federal funding, IRB review is not required. For Armstrong that is good because he did not pursue the most basic requirement of human research: informed consent. As reported by NPR,
He [Armstrong] acknowledged that some families were not aware their relatives were put on the drug, saying that “for the most part,” he consulted with each nursing home resident prior to giving them on the tablets.
While the “overwhelming majority of them are awake and alert and can actually have a conversation,” Armstrong said some suffer from middle stages of dementia. In some cases, he did not discuss prescribing the tablets with anyone at all before doing so. He said it is common for physicians to prescribe new medications to patients without explicit consent from the patient or family members. “It’s not required,” he said.
Armstrong is quite wrong. It is required. Giving medication to a patient, or any person, without consent from them, or—if they are incompetent—their legal surrogate is battery—a criminal offense. Informed consent in research and clinical practice requires that a potential subject or a patient be told risks, benefits, and alternatives. In research they must be told that they can withdraw at any time and that their receipt of health care will not be effected by withdrawing. Their agreement must be voluntary. By not telling every patient, by not checking with family and guardians of patients with dementia, and not documenting all this, he is not “respecting persons”. He is treating people like objects, which is one of the risk factors for abusing human research subjects.
What is not clear is who is paying for this medication. Did some company gift it to Armstrong? Is he charging the residents for a drug that he is forcing on them? Does he receive any money from these actions? Most insurance does not pay for experimental use, so he may be bankrupting some families if he passes along the cost. Is he charging insurance or Medicare (that could be fraud)? Is he making a profit or giving it “at cost”? All of these actions could be wrong.
Armstrong has several conflicts of interest: Using his political connections, potentially making money off of this effort, and using his position as medical director to force residents to participate. Some might say, “It’s an unusual way to get access to a now scarce medication, but it doesn’t hurt anyone for him to get it”. But using this drug for an unproven (potentially dangerous) use hurts people who use it according to its approved FDA prescribing—lupus and rheumatoid arthritis—and can no longer get it.
Given these multiple ethical and potentially criminal concerns, the Texas Medical Board should immediately begin an investigation. He should be suspended from The Resort awaiting the outcome of any and all investigations. And the Galveston County district attorney may want to investigate if there are any criminal wrongdoings. If it were my loved one in that home, I would be pulling them out because the medical director is abusing them and because such facilities are hotbeds of COVID transmission. Sadly, this case will probably join the annals of human subjects research abuse trials that are a mainstay of responsible conduct of research courses.