Featured Research

from universities, journals, and other organizations

Women get short shrift in many heart device studies, despite requirement

Date:
March 3, 2011
Source:
American Heart Association
Summary:
Despite a longstanding requirement for medical device makers to include women in the studies they submit to the Food and Drug Administration for device approval, very few include enough women or separately analyze how the devices work in them. Devices may be on the market without adequate data on their safety and effectiveness in women.

Despite a long-standing requirement for medical device makers to include women in studies they submit to the Food and Drug Administration for device approval, only a few include enough women or analyze how the devices work specifically in women, according to research reported in Circulation: Cardiovascular Quality and Outcomes.

"Women and men differ in their size, bleeding tendencies, and other factors that are directly relevant to how the devices will work," said Rita F. Redberg, M.D., M.Sc., senior author of the study and professor of medicine and director of Women's Cardiovascular Services at the University of California, San Francisco. "It is likely that the benefits and risks of devices are different in women. Despite the directive to find out, it isn't happening."

In 1994, the Center for Devices and Radiological Health instituted a policy that all FDA submissions seeking new device approval must contain:

  • A gender-bias statement explaining whether the proportion of men and women in the study reflects the proportion of men and women who have the condition being treated.
  • Differences in the safety and effectiveness of the device in women.

In their analysis, researchers reviewed 123 studies contained in the pre-market approval applications for 78 high-risk cardiovascular devices (the category that includes heart valves and implanted defibrillators) that gained FDA approval between 2000 and 2007. In 28 percent of the studies, FDA summaries of the evidence didn't report the gender of study participants. In those that did, men made up an average of 67 percent.

The investigators found that the required gender-bias statement was present in only 41 percent of the studies. Of studies that included the statement, 94 percent discussed examining their results by sex, and 26 percent reported differences in device safety or effectiveness between men and women.

In the studies that omitted the gender-bias statement, only 11 percent presented any gender-specific results or discussion. Studies involving fewer than 50 patients were not included in the analysis of sex-specific reporting.

Because non-approved pre-market applications are not publicly available, the researchers could not determine whether these contained a similar percentage of gender-bias statements.

In approved applications, the reviewers found instances in which researchers used inaccurate grounds to exclude women. In some cases, the proportion of women with a heart condition was understated. In others, applicants declared their gender breakdown to be equivalent to previous studies without acknowledging that the previous studies included a disproportionately low number of women.

Between 2000 and 2007, the proportion of women enrolled in studies or the number of successful applications that included the gender-bias statement didn't increase.

"We found no encouraging trends," Redberg said. "Failure to include women in clinical trials has been a big problem for a long time and it isn't improving, so further action is needed."

She suggests strict enforcement of the current requirements, including sending applications back without review until the required statements are submitted.

Women should ask directly about the data if a device is recommended to them, Redberg said. "Ask how many women it was tested in and how the results looked in those women. Unfortunately, all too often we approve devices based on results in men and assume they will be the same in women. That is not a reasonable assumption, even if a device is being marketed specifically to women."


Story Source:

The above story is based on materials provided by American Heart Association. Note: Materials may be edited for content and length.


Journal Reference:

  1. Sanket S. Dhruva, Lisa A. Bero and Rita F. Redberg. Gender Bias in Studies for Food and Drug Administration Premarket Approval of Cardiovascular Devices. Circ Cardiovasc Qual Outcomes, March 1 2011 DOI: 10.1161/CIRCOUTCOMES.110.958215

Cite This Page:

American Heart Association. "Women get short shrift in many heart device studies, despite requirement." ScienceDaily. ScienceDaily, 3 March 2011. <www.sciencedaily.com/releases/2011/03/110301184047.htm>.
American Heart Association. (2011, March 3). Women get short shrift in many heart device studies, despite requirement. ScienceDaily. Retrieved August 21, 2014 from www.sciencedaily.com/releases/2011/03/110301184047.htm
American Heart Association. "Women get short shrift in many heart device studies, despite requirement." ScienceDaily. www.sciencedaily.com/releases/2011/03/110301184047.htm (accessed August 21, 2014).

Share This




More Mind & Brain News

Thursday, August 21, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Do More Wedding Guests Make A Happier Marriage?

Do More Wedding Guests Make A Happier Marriage?

Newsy (Aug. 20, 2014) — A new study found couples who had at least 150 guests at their weddings were more likely to report being happy in their marriages. Video provided by Newsy
Powered by NewsLook.com
Charter Schools Alter Post-Katrina Landscape

Charter Schools Alter Post-Katrina Landscape

AP (Aug. 20, 2014) — Nine years after Hurricane Katrina, charter schools are the new reality of public education in New Orleans. The state of Louisiana took over most of the city's public schools after the killer storm in 2005. (Aug. 20) Video provided by AP
Powered by NewsLook.com
Researcher Testing on-Field Concussion Scanners

Researcher Testing on-Field Concussion Scanners

AP (Aug. 19, 2014) — Four Texas high school football programs are trying out an experimental system designed to diagnose concussions on the field. The technology is in response to growing concern over head trauma in America's most watched sport. (Aug. 19) Video provided by AP
Powered by NewsLook.com
Kids' Drawings At Age 4 Linked To Intelligence At Age 14

Kids' Drawings At Age 4 Linked To Intelligence At Age 14

Newsy (Aug. 19, 2014) — A study by King's College London says there's a link between how well kids draw at age 4 and how intelligent they are later in life. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins