Women Underrepresented in Heart-Device Studies, Contradicting FDA Rules

Women are often underrepresented in studies used to win U.S. approval for medical devices in contradiction of government requirements, a report today in the American Heart Association’s journal Circulation showed.

Two-thirds of participants in studies used to gain Food and Drug Administration approval for medical devices, including implantable defibrillators and pacemakers, were men, researchers found. More than a quarter of the trials didn’t provide the gender of study participants, according to the research.

Since 1994 the government has required device makers to provide a gender-bias statement in approval applications, explaining whether the proportion of women and men in the trial reflect the gender breakdown of the condition being treated, the researchers said. The companies must also show the differences in safety and effectiveness of the device in men and women.

The findings in today’s study raise concerns over the potential safety of these devices in women, Rita Redberg, one of the study’s authors, said. The FDA needs to improve enforcement of its rules and hold off on approvals for new devices lacking data on safety and effectiveness for both men and women, she said.

“There’s a lot that we don’t know about devices on the market," said Redberg, a professor of medicine and director of Women’s Cardiovascular Services at the University of California, San Francisco, in a telephone interview today. "Their approvals are based on data in men.”

“Going forward, we need to include more women in trials and analyze data specifically by sex, and not approve devices until we can say how the devices work in women as well as in men,” she said. “I would like to be able to have the same confidence in the data when I advise my women patients as when I advise my men patients. And I can’t do that based on this data.”

Redberg is a member of the FDA’s Circulatory System Devices Panel.

123 Studies

Researchers in the study looked at 123 studies of 78 FDA- approved medical devices between 2000 and 2007. The proportion of women enrolled in studies didn’t increase over the study period. They found men made up an average of about 67 percent of the people who participated in studies used in the applications. Twenty-eight percent of the studies didn’t provide the genderof patients enrolled in the trials.

Researchers in the study said that the proportion of women enrolled in studies didn’t increase between 2000 and 2007, the period covered by the study. Forty-one percent of the studies included the required gender-bias statement, the authors said. Of the studies that included the statement, only 26 percent reported the differences in device safety or effectiveness between women and men.

American Heart Association

Lori Mosca, a national spokeswoman for the American Heart Association and director of preventive cardiology at New York- Presbyterian Hospital, said in a telephone interview today that women need to make the effort to participate in clinical trials and scientists need to understand better why they aren’t participating.

“We can’t put the blame completely on one or another,” she said. “There’s a shared responsibility here for women to participate and for device makers to put the resources in to help women participate and in the final analysis, to provide all data both good and bad by gender.”

The FDA is aware that women are under-represented in clinical trials, said spokeswoman Karen Riley in an e-mail. The FDA’s Center for Devices and Radiological Health is currently developing formal guidelines, which will be available this year, to address the issue.

Women’s Heart Program

Nieca Goldberg, director of the Women’s Heart Program at New York University’s Langone Medical Center, said women should talk to their doctors if they’re concerned about the safety of their heart devices.

“I don’t think the studies say we should necessarily withhold procedures from women,” she said in a Feb. 28 telephone interview. “This is just another step in the journey in improving cardiovascular care to women.”

Wendy Dougherty, a spokeswoman for Minneapolis-based device maker Medtronic Inc., said the company is concerned about gender inequity in patients who receive implantable devices.

“Medtronic continues to find ways to ensure the right percentage of women are enrolled into our trials, based on the demographics of the underlying disease,” she said in an e-mail today.

To contact the reporter on this story: Nicole Ostrow in New York at nostrow1@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

Bloomberg reserves the right to remove comments but is under no obligation to do so, or to explain individual moderation decisions.

Please enable JavaScript to view the comments powered by Disqus.