By Pat Anson, PNN Editor

In 2011, the Institute of Medicine released its landmark report, “Relieving Pain in America,” an ambitious project aimed at improving pain care, education and research in United States.

One of the report’s co-authors was Stanford University’s Dr. Sean Mackey, who remembers telling colleagues at the time that more research was needed on the long-term use of opioid pain relievers.     

“One of the questions I put forward to the group was, ‘One of the biggest questions that we need to answer is do opioids help relieve chronic pain for some people?’ Do they actually work? And if so, for whom do they work?” Mackey recalls.

“And surprisingly, ten years later, here we are in 2021 and I would submit to you that we still don’t know the answer to that question. We still do not know how well long-term prescribing of opioids work for chronic pain and for which person they work for. We understand much better who they don’t work for. But we don’t know the flip side.”

Mackey is now leading a study aimed at finally answering the question. The VALUE study is designed to give patients a voice in determining whether opioids can be a safe, effective and long-term treatment for chronic pain.

Mackey and co-investigator Beth Darnall, PhD, along with a team of patient advocates, hope to get up to 500 chronic pain sufferers to enroll in their year-long study. Patients will be asked to participate in three online surveys and three phone calls, answering questions about their pain, symptoms, mood, sleep, quality of life, and whether they encountered any problems or stigma from using opioids.

Long-Term Studies Lacking

Many doctors, regulators and opioid critics claim – disingenuously – that there is no evidence supporting the long-term use of opioids. But the truth is the same could be said for all pain relievers, including non-opioids. Few placebo-controlled studies have been conducted on the long-term use of any pain medication -- simply because it would be unethical to subject a participant to untreated pain for a lengthy period.

That leaves it to patients to share their own experiences with opioids, and a shrinking pool of doctors like Mackey who are not afraid to prescribe them.

“In my caring for people who suffer from pain and for whom it takes a big toll, I have clearly seen a subset of people for whom they do work,” Mackey told PNN. “What we’re trying to do here is transcend what has become a one-size-fits-all approach to patient treatment and the issue of opioids. We’ve become rather guideline-based and we treat all people as if they were an average in a clinical trial. I don’t treat averages. I treat people.

“Everybody is unique and deserves to be treated as an individual. That doesn’t mean that we can’t be guided by those research studies and averages, but we need to get at a more personalized approach. We need to recognize, at least in many of our experiences, there are sub-groups of people who respond to opioids. The problem is we don’t have good data on who they are.”

People who volunteer for the VALUE study should be prepared to spend a fair amount of time answering questions. Each survey will take about 45 minutes to complete. Participants will complete the first survey when they enroll, the second one after 6 months, and the third survey after one year. For each completed survey, patients will be compensated with an Amazon or gift card.

All information collected will be confidential, and won’t be shared with doctors, regulators or insurers. Participants can even use a pseudonym if they don’t feel comfortable using their real names. The VALUE study website has a list of other frequently asked questions.

People interested in participating should contact study coordinator Hannah Cunningham by email at hcunning@stanford.edu or by calling 1-833-668-0277.

“We believe our findings will have broad policy indications at local, state and national levels that will hopefully make opioid prescribing guidelines more patient centered, more effective and safer,” says Mackey.