By Anna Rose Welch, Editorial & Community Director, Advancing RNA
As a creative writer, I was drawn to the title of a recent study published in the journal Sociology Of Health And Illness: “Stopped Hearts, Amputated Toes, And NASA: Contemporary Legends Among Healthy Volunteers In U.S. Phase 1 Clinical Trials.” (Trust me—the study certainly lives up to its name.)
Many of the key opinion leaders I’ve talked with lately have hit on a lack of education about clinical trials as being a big roadblock to enrolment. Not knowing what goes on in a trial can lead many to stigmatize clinical research and procedures. According to Fisher’s research, even once in the clinic, healthy volunteers carry with them a number of contemporary legends that reflect “residual anxieties that healthy volunteers have about participating in clinical trials. In a sense, the contemporary legends provide a residence for the stereotypes and fears of medical research that even insiders have difficulty rejecting.”
Fisher visited six U.S. Phase 1 facilities from November 2009 to October 2010 and interviewed 235 healthy volunteers who were being enrolled in or screened for Phase 1 studies. In these interviews, Fisher uncovered several variations of five Phase 1 clinical trial legends. Are you ready for these?
- Spinal Tap Paralysis: While spinal taps, or lumbar punctures, aren’t often performed in clinical trials, Fisher witnessed patients talking about them as if they were an everyday occurrence in a trial. This particular story reflects the common fear that the procedure could cause paralysis — a risk that many patients seem willing to confront to attain the higher stipend provided in studies requiring lumbar punctures.
- The Flat-Liner Study: Rumors abound about heart studies in which patients are purposely put into cardiac arrest for upwards of 60 seconds and then resuscitated by a medical research team. Once again, participants in Fisher’s study, while recounting the legend, often focused on the hefty sum people accepted to experience a brief death.
- The Amputated Toe: Patients enrolled in this mythical study are paid thousands of dollars to have a toe (or a finger or large patch of skin) removed and then reattached. In an even more other-worldly, and frankly, darkly humorous twist, some of the stories have even been revised so that researchers end up reattaching a toe in place of a thumb, and vice versa.
- The NASA Study: This particular legend is based on real procedures NASA’s Johnson Space Center conduct on healthy volunteers to find ways to protect the body from the effects of zero gravity. However, in the legends, the testing methods became much more severe. For example, bed rest times were lengthened from three months to upwards of a year, with a majority of that year being spent in solitary confinement with the bed tilted in a full upside-down, vertical and horizontal position. (Makes my head hurt just thinking about it.)
- The Dead Participant: Based off of the suicide of a healthy young volunteer in an Eli Lilly antidepressant trial several years ago, this story was twisted to make the death the participant’s fault. In their retellings of this legend, volunteers blamed the participant for withholding important information that would’ve disqualified him/her from the trial in the first place, rather than pointing fingers at the medication or trial procedures.
Overall, I’d suggest you take the time to read Fisher’s published study, as the excerpts of her discussions with patients will no doubt provide you some comic relief. (I won’t lie — the fact Fisher managed to combine classic English literature like The Island of Doctor Moreau with pharma was exciting to me, too. It’s not everyday literature and pharma intersect.)
More importantly however, I’m interested in the implications this research could have for pharma as enrolment becomes increasingly difficult. While Fisher ultimately found these crazy legends played a positive role for participants rather than dissuaded participation, this study proves patients carry some dark, otherworldly notions with them into the clinic. (I'm sure the media has some role in this, judging from the title of a recent article published in The Onion: "Pfizer Mercifully Puts Down Another Batch Of Trial Patients." It's clearly satire... but still.) I’d be curious to see what solutions pharma could come up with to confront these wacky misconceptions, and what effects confronting them could have on patient centricity—both pre- and post-enrollment.