Navigation Links
Women Get Short Shrift in Many Heart Device Studies, Despite Requirement
Date:3/1/2011

DALLAS, March 1, 2011 /PRNewswire-USNewswire/ -- 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.

(Logo: http://photos.prnewswire.com/prnh/20100222/AHSALOGO)

"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."

    Redberg is a member of the FDA Circulatory System Devices Panel, but her comments are independent and don't necessarily reflect the views of the panel or the FDA.

    Co-authors are Sanket S. Dhruva, M.D., and Lisa A. Bero, Ph.D. Author disclosures are on the manuscript.

    The American Heart Association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events.  The association has strict policies to prevent these relationships from influencing science content.  Revenues from pharmaceutical and device corporations are available at www.heart.org/corporatefunding

    NR11 – 1035 (Circ. Q&O/Redberg)

    Additional resources:

  • 2011 update to cardiovascular prevention guidelines for women.  www.newsroom.heart.org/index.php?s=43&item=1239
  • Go Red For Women, powered by the American Heart Association's research, educates and connects millions of women of all ages.  www.goredforwomen.org

  • CONTACTFor information call:Tagni McRae: (214) 706-1383Karen Astle: (214) 706-1392 Julie Del Barto (broadcast): (214) 706-1330
    '/>"/>

    SOURCE American Heart Association
    Copyright©2010 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
    2. Progesterone Therapy and Preterm Birth: More Evidence Helps Identify Women Who Can Benefit
    3. QuatRx Completes Patient Enrollment in Phase 3 Study of Ophena(TM) in Women with Postmenopausal Vaginal Syndrome
    4. European Experts Recommend Pregnant and Nursing Women Take More DHA - Every Day
    5. TAXUS WOMAN Study Reports Positive Clinical Outcomes for the TAXUS(R) Drug-eluting Stent in Women
    6. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
    7. Cell Therapeutics, Inc. (CTI) Sponsors Panel Discussion on Women and Lung Cancer on Capitol Hill
    8. Cell Therapeutics, Inc. (CTI) Supports Panel Discussion on Women and Lung Cancer on Capitol Hill
    9. Risedronate Reduced Risk of Fracture Among Osteoporotic Postmenopausal Women with History of Hip Fracture
    10. New Study Shows Once-Monthly Boniva(R) is as Clinically Effective as Once-Weekly Fosamax(R) at Increasing Bone Mineral Density in Postmenopausal Women With Osteoporosis
    11. Bay Area Women Sought for Egg Freezing Study
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:6/24/2016)... 2016   Pulmatrix, Inc ., (NASDAQ: ... drugs, announced today that it was added to the ... its comprehensive set of U.S. and global equity indexes ... important milestone for Pulmatrix," said Chief Executive Officer ... our progress in developing drugs for crucial unmet medical ...
    (Date:6/23/2016)... -- Any dentist who has made an implant supported denture ... of them do not even offer this as a viable ... costs involved. And those who ARE able to offer that ... cost that the majority of today,s patients would not be ... , founder of Dental Evolutions Inc. and inventor of Implanova ...
    (Date:6/23/2016)... Capricor Therapeutics, Inc. ... company focused on the discovery, development and commercialization ... in its ongoing randomized HOPE-Duchenne clinical trial (Halt ... its 24-patient target. Capricor expects the trial to ... 2016, and to report top line data from ...
    Breaking Medicine Technology:
    (Date:6/27/2016)... ... June 27, 2016 , ... ... technology to revolutionize the emergency ambulance transport experience for the millions of people ... how Uber has disrupted the taxi industry through the use of technology. Now, ...
    (Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A ... 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, where the ... history as home to some of the world’s leading providers of cereal and other ...
    (Date:6/26/2016)... ... , ... Brent Kasmer, a legally blind and certified personal trainer is helping to develop a ... fitness app plans to fix the two major problems leading the fitness industry today:, ... type program , They don’t eliminate all the reasons people quit their exercise ...
    (Date:6/25/2016)... ... 25, 2016 , ... Austin residents seeking Mohs surgery services, can now turn ... to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization ... selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction ...
    (Date:6/25/2016)... ... , ... First Choice Emergency Room , the largest network of independent ... Director of its new Mesquite-Samuell Farm facility. , “We are pleased to announce ... Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , ...
    Breaking Medicine News(10 mins):