- the participants (most researchers now prefer that word over the previously used “subjects”) such as age, race, gender, and the number of participants
- the materials used by researchers to gather and analyze data from the study (plus a list of sources used and why these sources were essential for this study)
- the procedures used (such as collection of data or the instructions given to participants)
I feel a similar urge to offer helpful edits when reading about animal or cell studies in the research laboratory (with an apologetic nod to my friends working in these labs). Whenever I see flashy headlines announcing yet another miracle medical breakthrough, but based only on furry subjects living in little metal cages, I try to correct this intentional obfuscation with a disclaimer, like:
“Be vigilant when writing about them, and skeptical when reading about them.”
“GOOD NEWS IF YOU’RE A MOUSE!”Call me when you move into human trials. . There are a number of specific issues surrounding the experiences of laboratory animals vs. humans, but none are more frightening than this: animal models are poor predictors of treatment safety in humans. A review of 221 animal experiments, for example, found agreement in later human studies only 50% of the time, which means it’s essentially random.1 You could flip a coin with equal predictive accuracy. . Thalidomide was one of the most dramatic examples of this problem during my lifetime – a drug approved in Canada and other countries in the 1950s to treat morning sickness in pregnant women. Thalidomide didn’t cause limb deformity birth defects when tested on baby animals in the lab, but those deformities did happen to over 10,000 babies of pregnant humans. . And don’t even get me started on the wholesale hyping of unpublished, non-peer reviewed medical study results, often distributed in a flood of press releases created by corporate or academic Communications Department staff, only to be picked up verbatim by understaffed and overworked media newsrooms. The trouble with most press releases is the tendency toward over-hyped benefits coupled with under-reporting of potential problems. Again, check out Health News Review for the dangers of questionable science delivered by press release. In a study published in the British Medical Journal (BMJ), we learned that exaggerated reporting of medical studies can be traced back to the press releases submitted by 20 leading U.K. universities where the study authors work. Forty per cent of the press releases they investigated included health advice that was not actually found in the original paper. And 36 per cent over-inflated the relevance of animal or cell studies to humans. . Here’s a cardiac study (submitted to, accepted by and published in a real cardiology journal) that I like to mention, mostly because I was so intrigued by its findings a few years ago. It was reported by senior researchers at Harvard and Massachusetts General Hospital in Boston, who called it the Gratitude Research in Acute Coronary Events (GRACE) study.2 Acute Coronary Syndrome (ACS) is a term used to describe any dangerous drop in blood flow feeding the heart muscle. If you’ve been diagnosed with a heart attack, it’s likely that the first potential diagnosis entered into your medical chart in the Emergency Department was ACS. Cardiac symptoms are assumed to be ACS until proven otherwise. . The Boston team knew that within the first year post-ACS diagnosis, about 20 per cent of ACS patients will either be re-admitted to the hospital for cardiac emergencies – or they’ll be dead. They also knew from previous studies that positive psychological well-being is associated with reduced patient mortality.3 So they decided to focus on positive factors like optimism and gratitude for their GRACE study. Here’s what the Boston researchers learned: the trait of optimism was independently associated with greater physical activity and reduced rates of cardiac re-admissions to the hospital after six months of follow-up. Gratitude was not associated with improved outcomes. I was about to write a blog post about the GRACE study findings at the time, but a couple of niggling limitations of this study were bothering me. For example, the researchers followed participants for only six months, despite current stats that suggest the first year is the time period we worry about. Why weren’t the participants followed up for at least 12 months to address this limitation? . Astonishingly, this disconnect between medical interventions approved for longterm use in chronic illness and the short-term studies their approvals were based on are common (e.g. the Swedish drug study in which “longterm” meant just one year of follow-up). See also: Our Cardiac Meds – in Real Life, Not Just in Studies The most glaring limitation, however, was that 84 per cent of the GRACE study participants were white males. The researchers admitted that “the lack of significant differences in outcomes by sex and race may have been due to the relatively small number of women and non-White participants.” Ahem. . . . They further explained that, by the middle of study recruitment, they had even considered limiting the enrollment of white men, but decided that “having a greater number of total participants was the greatest priority.” There’s your key problem right there: instead of stopping the recruitment of white men once they’d reached the halfway point of study participants in order to focus future recruitment on women and non-White participants, they just kept on recruiting white men. NO WONDER they ended up with a participant pool that was 84 per cent white males. That’s utterly unacceptable, and worse, it results in study conclusions that are useless – except when applied to white men. Does this excuse simply let researchers off the hook when they continue to submit papers for publication based on lopsided participant populations in which women and/or racial minorities are deliberately unrepresented? I understand the pressure on medical researchers to “publish or perish”. I really do. And I have long suspected that this relentless stress might help to explain why all the really good research topics have already been taken. As my irreverent Mayo Clinic heart sister Laura Haywood-Cory (who survived a heart attack at age 40 caused by Spontaneous Coronary Artery Dissection) once asked in response to a 2011 Heart Sisters post:
Well, Laura – apparently we do. Because those studies just keep on coming. Like most published medical research, the GRACE study includes the standard CYA clause at the end: “future studies are required.” Maybe those future studies will include an accurate acknowledgement of the difference between longterm and short term, and more attention to recruiting an adequately representative gender/racial balance. But it’s not just me expecting this improvement. For all researchers counting on National Institutes of Health funding, it’s the law now, as the NIH/U.S. Department of Health and Human Services website warns:
“ We really don’t need yet another study that basically comes down to: ‘Sucks to be female. Better luck next life!’, do we?”
The entire population. Is it too much to expect that women and racial minorities must be considered part of the “entire population”? While you’re pondering that trick question, consider educating yourself. Check out Health News Review’s excellent user-friendly toolkit called Tips for Analyzing Studies, Medical Evidence and Health Care Claims. . And until you do that, please don’t forward to your friends the latest medical miracle breakthrough that’s just been “published” on Facebook – because the fact is that it’s likely neither a miracle, nor a breakthrough.
” All NIH-funded clinical research must address plans for the inclusion of women and minorities within the application or proposal. The primary goal of this law is to ensure that research findings can be generalizable to the entire population.”
1. P. Perel, I. Roberts, E. Sena, et al. “Comparison of treatment effects between animal experiments and clinical trials: systematic review.” BMJ, 334 (2007), pp. 197-203
2. Huffman JC, Beale EE, Celano CM, et al. “Effects of Optimism and Gratitude on Physical Activity, Biomarkers, and Readmissions After an Acute Coronary Syndrome: The Gratitude Research in Acute Coronary Events Study.” Circ Cardiovasc Qual Outcomes. 2016;9(1):55-63.
3. Chida Y, Steptoe A. “Positive psychological well-being and mortality: a quantitative review of prospective observational studies.” Psychosom Med. 2008 Sep; 70(7):741-56.
Image: Enrique Meseguer, Pixabay
. NOTE FROM CAROLYN: I wrote more about what to look for in cardiac research in my book, “A Woman’s Guide to Living with Heart Disease“ , published by Johns Hopkins University Press. You can ask for it at your local library or favourite bookshop, or order it online (paperback, hardcover or e-book) at Amazon, or order it directly from my publisher (use their code HTWN to save 30% off the list price of my book).
Q: What would you like to see future medical research focus on?