On the importance of including pregnant women in clinical trials: A Q&A

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As a research scientist, I’ve negotiated the complex nature of getting approval to image human subjects. So I know firsthand that it is common to exclude pregnant women from clinical trials. Although this practice is well-intentioned, it is also misguided — according to an opinion piece recently published in JAMA. To learn more, I spoke with one of the authors, Heather Byers, MD, a clinical assistant professor in pediatrics at Stanford.

Why are pregnant women excluded from clinical trials?

“Historically, women in general were excluded from clinical trials because men were thought to be a more homogenous group without hormonal cycles and other sex-based variables that might impact the medical conditions under study.

In addition, pregnant women are still classified as a ‘vulnerable’ population for all research studies, so investigators must take additional steps to enroll them to ensure minimum risk.

Also, the lack of data about what pregnant women can safely be exposed to leads to more uncertainty. So many investigators choose to exclude them, even if they might benefit from the study intervention.”

Why is this a problem?

“Excluding them is a problem because women don’t stop getting sick or stop having chronic medical conditions just because they are pregnant. The average woman is exposed to four medications during her pregnancy and over 80 percent of medications haven’t been studied in a like population. This forces pregnant women to take medications on an “off-label” basis — meaning, the medications weren’t studied or approved for use in pregnant women — because there’s no other option. Pregnant women deserve better. It’s a matter of justice.”

What are the barriers and how can we overcome them?

“First, we advocate reclassifying pregnant women from ‘vulnerable’ to ‘scientifically complex.’ Pregnancy doesn’t alter a woman’s capacity for autonomous decision-making. Indeed, a pregnant woman frequently makes complex medical decisions for herself and her fetus that reflect her family’s values.

Another barrier for medical investigators is the perceived legal risk regarding a potential adverse outcome in the fetus or mother. As we discuss in the JAMA Viewpoint, this barrier could be addressed by standardizing the informed consent process.

Finally, federal regulations don’t define ‘acceptable risk’ to the woman or fetus and this uncertainty is perceived as a risk in itself. But in some cases, pregnant women may accept the uncertainty and risk.

For example, it was imperative to reduce mother-to-child transmission of HIV. So obstetricians reluctantly included pregnant women with HIV in their study of antiretroviral treatments, since the risk of the drugs were thought to be low and the potential benefit high. And the effectiveness of this study helped transform the AIDS epidemic.”

Is progress being made?

“Although progress has been slow, there has been an increased effort to enroll pregnant women. Several high-profile clinical trials involving pregnant women recently completed and institutions like the National Institutes of Health are working to change their polices. For example, the NIH Task Force on Research Specific to Pregnant Women and Lactating Women recently issued a report that summarizes the current gaps in knowledge and provides recommendations for continued progress.”

How did you become involved?

“I first became interested in this subject as a medical student during my rotation at NIH with Pamela Stratton, MD, one of the obstetricians involved in the study of antiretrovirals to prevent vertical transmission of HIV.

Later, as an obstetrics resident, I was frustrated by the lack of information to share with my patients regarding the risk and clinical impact of various medications, vaccines and medical conditions in pregnancy. Every anecdotal story  — such as my patient who was hospitalized in intensive care for months with influenza because she’d been too afraid to get the flu vaccine earlier in her pregnancy — is one too many. The fear of uncertain risk can be dangerous. There should be a better way.

One thing that has changed is the rise of social media and patient support group accessibility. Although this should not replace the controlled setting of a clinical trial, partnerships between motivated patient advocacy groups and medical investigators can be a powerful tool for obtaining information about risk and benefits going forward.”

This is a reposting of my Scope blog story, courtesy of Stanford School of Medicine.

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Jamming with the Midnight Rounds: A Q&A

Photo by Victoria Bruzoni of Midnight Rounds band, from left to right: James Wall, Matias Bruzoni, Raji Koppolu, Yasser El-Sayed, Garret Vygantas, Jon Palma and Jeff Linnel

The next time you listen to music at a nearby pub or Bay Area event, double check to see who is playing. You just might see one of your Stanford physicians.

At a division holiday party in 2009, pediatric surgeon Matias Bruzoni, MD, on vocals, piano and guitar and nurse practitioner Raji Koppolu on vocals played acoustic versions of popular songs. Soon after, two more pediatric surgeons joined and the band Midnight Rounds was born. Over the years, the band has expanded to include piano, guitar, bass, percussion, drums, violin and vocals. I spoke with Bruzoni to learn more.

What is the origin of the name, Midnight Rounds?

“Our bass and guitar player James Wall, MD, and his family generously turn their guest house into a music studio whenever we need to practice. We all have very tight schedules due to our professional work, so once a week we practice late at night — many times going past midnight. As providers, we also make rounds every day to see our patients, so our drummer Yasser El-Sayed, MD, suggested we call ourselves Midnight Rounds.”

What kind of music do you play?

“Our repertoire includes oldies, country, 80’s, 90’s and more modern pop songs. We particularly enjoy creating mashups of songs, flipping back and forth between songs and adding our own twist. For instance, we like playing “Free” sung by the Zac Brown Band mashed up with “Into the Mystic” by Van Morrison and “Lodi” by Creedence Clearwater Revival mashed up with “Sloop John B” by the Beach Boys. Another favorite song is “Dixieland Delight” by Alabama, which features Jonathan Palma, MD, playing violin.”

Where do you play?

“We play in many different venues including weddings, wineries, local pubs, holiday parties, pumpkin festivals and wherever we’re invited. It varies, but we average a couple of events per month. We play quarterly at the Pioneer Saloon in Woodside — we’ll be there on January 12.

We sometimes make a little money during our performances at places like Pioneer. We decided as a group to donate the proceeds to different charity organizations that benefit women and children’s health.”

Is there any relation between playing in the band and medicine?

“For us, the band is a perfect excuse to get together outside of regular working hours. We feel this strengthens our relationships with each other in the hospital. It’s also a healthy way to recharge our batteries, avoid burn-out and thus take better care of our patients.

In addition, we’ve gotten to know a lot of people that work at Stanford — nurses, OR staff, social workers, interpreters and other docs like anesthesiologists — who come to our gigs. Our strongest crew are the NICU nurses and social workers, who follow us wherever we go. I think our patients definitely benefit, because teamwork is essential to patient care.

I also think performing under pressure is a great exercise since it is very similar to what we do every day here at the hospital. You get nervous even if you’re doing an acoustic session in front of 10 people, since you want to sound good. When I interview residents for positions here at Stanford, I pay a lot of attention to whether they excel in athletics or music, which gives me an idea on how well they can perform under pressure.”

Describe a favorite moment with the band.

“There are times when we have our kids sing or play an instrument with us. And that’s a very special moment. For instance, the other day we played at a pumpkin patch. People were playing games and stuff, not paying much attention to the band. But everyone went dead silent when my daughter came up to sing a Justin Bieber song. And then they started taping it. It was really magical.”

What’s next?

“We’re thinking about writing some original songs as an experiment. But mostly we just want to build up our repertoire. We started with maybe five songs and now we have about 50 songs that we can we can play — some of them without even practicing. We usually practice tow to three new songs for every new gig. Our band members have very different musical tastes, which makes it fun to blend all them together.”

This is a reposting of my Scope blog story, courtesy of Stanford School of Medicine.