Deception Was Used to Get Patients to Participate in Opioid Study
/By Pat Anson
“We are lying to you to see if you are lying to us.”
That’s how patient advocate Andrea Anderson sums up the Orwellian methodology behind a recent study that explored whether pain patients are taking their opioid medication appropriately.
The study made use of high-tech pill bottles that record in real-time how often a bottle is opened and any changes to its weight. The goal is to see if patients adhered to their opioid regimen or were taking too many pills at once – a possible sign of abuse or diversion.
Researchers at the University of Texas Medical Branch (UTMB) enrolled 28 chronic pain patients in the study, giving participants a 90-day supply of opioids in three 30-dose pill bottles. Eighteen patients were given pills in the high-tech bottles --- known as the medication event monitoring system (MEMS) --- while the other 10 were given standard pill bottles. Patients in both groups were asked to keep a daily diary of their medication use
Here’s where the lying comes in. Instead of telling participants that the MEMS bottles would keep track of pills being removed, patients were told that the temperature and humidity inside the bottles were being monitored.
“The study involved incomplete disclosure and deception, as participants were informed that the purpose of the study was to test a new prescription bottle that will monitor the physical environment inside the bottle…. Participants were not informed that the bottles would record the number and timing of pills dispensed,” wrote lead author David Houghton, PhD, an Assistant Professor of Psychiatry and Behavioral Sciences at the Center for Addiction Research at UTMB.
You might think that lying and deception would be prohibited in clinical trials, but the design of this study was approved by an ethics review panel at UTMB. Researchers say they also complied with international research guidelines that allow deception to be used in psychology studies “when there is no alternative method that will produce reliable and valid results.”
At first glance, the study findings suggest that many patients were less than honest about their opioid use.
“Participants who received MEMS demonstrated highly heterogenous dosing patterns, with a substantial number of patients rapidly removing excessive amounts of medication and/or ‘stockpiling’ medication,” researchers reported in the Journal of Pain Research.
“Several sharp decreases in medication supply over short time periods were observed, and a substantial portion of participants ran out of medication before 30 days had elapsed. These data could reflect over-consumption or diversion of medication.”
In addition, 25% of participants in the MEMS group tested negative for opioid metabolites in their urine drug tests, which suggests they may have been hoarding or selling their opioids, and not taking them.
‘Hypothetically Significant’
But the small size of the study – just 18 patients in the MEMS group – raises questions about the reliability of the findings.
Diversion of opioid medication is actually quite rare – about three-tenths of one percent of prescribed pills, according to the DEA.
It’s also not uncommon for patients to stockpile opioid medication. In a recent PNN survey of nearly 3,000 pain patients, 32% told us that they hoarded opioids, in many cases because they are worried about shortages or losing access to opioids in the future.
Although participants in the UTMB study were told to remove pills from their bottles just before taking them, it’s possible that they took out an extra amount simply to fill their weekly pill boxes.
Researchers were also surprised to find that some participants appeared to put pills back into the bottles, another sign that those “highly heterogenous dosing patterns” tell us little, if anything, about opioid use.
In other words, the study may be nothing more than a case of “garbage in, garbage out,” with any number of reasonable explanations for patient behavior.
“It is impossible to conclusively determine that aberrant behavior, as recorded by the MEMS system, reflects misuse or diversion,” researchers admitted.
“It’s a terrible study in every way, and should never have happened,” says Andrea Anderson, who sees obvious flaws in MEMS that make its data unreliable.
“If you wanted to divert your tablets, you could just take out the proper amount every time the stupid bottlecap lets you. Once you collected 20 tablets, you could go sell them if you wanted or take however many you liked. It certainly won’t prevent any type of diversion or misuse.”
Nevertheless, as is often the case in opioid research, sweeping conclusions were drawn from skimpy evidence. The UTMB researchers found enough “hypothetically significant clinical implications” to call for full-time monitoring of patients and their opioid use.
“These results highlight the limits in our understanding of naturalistic patterns of daily opioid use in chronic pain patients as well as support the use of MEMS for detecting potential misuse as compared to routine adherence monitoring methods. Future research directions include the need to determine how MEMS could be used to improve patient outcomes, minimize harm, and aid in clinical decision-making,” they concluded.
There is a company working on just that. Kansas-based SMRxT supplied UTMB researchers with the MEMS bottles and data used in the study. The company says its MEMS technology could be used to assign risk scores to patients – what it calls an “Absolute Adherence Score” – similar to the controversial Narxcare scores that assess a patient’s risk of opioid misuse and addiction based on their prescription drug history.
“The SMRxT medication adherence system accurately captures data to reveal how patients take their medication. The system empowers and improves patient behavior,” the company claims in promotional material. “Once the prescription is filled, the device is ready to use. The system then translates data into actionable information for patient interventions and engagement.”
“We enjoyed working with the team at UTMB,” a spokesperson for SMRxT told PNN. “Our device is not in the development stage, and has been used by patients all over the country and many other academic research institutions.”
