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Big Medicine Hard on Women’s Hearts

Posted by Rob Jenner on March 23, 2011 in Consumer Alerts

Women keep getting a raw deal from the medical industry. First there was the Hormone Replacement Therapy scam.  HRT was perpetrated on women for decades by pharmaceutical companies as basically a cure-all for growing older, and in later years as especially good for protecting against heart disease.  The billion-dollar industry was unmasked in 2002 by the Women’s Health Initiative study as not only not protecting against heart disease, but actually increasing the risk of heart disease.

Now comes the news that many heart-related medical devices approved by the FDA for use on patients have not been adequately tested on women. Women make up 51% of the population. Heart disease is the number one killer of women in the U.S. today.

This startling revelation is from researchers at the University of California, San Francisco.  The researchers looked at 123 studies submitted for 78 high-risk cardiovascular devices that were approved by the FDA between 2000 and 2007. This included devices such as heart valves, implanted defibrillators, pacemakers and stents.

What they found was 28% of the studies made no mention of gender. Of those that did, men made up 67% of study recipients. The researchers noted that differences in size and bleeding tendencies can affect the way these devices operate in men and women, and side effects can also vary by gender.

“We do not know if a lot of medical devices currently on the market are as safe and effective in women as they are in men,” lead researcher Dr. Rita F. Redberg, told the media.

What’s more shocking is that in 1994, the FDA mandated that device manufacturers include a  gender-bias statement with each new product application. This statement was meant to show proof that the devices were tested in men and women in the same proportion as men and women experiencing the condition that the device would treat.

Only 41% of the studies reviewed by California researchers included the required gender statement, they said. Of these, 94% showed results by sex, and 26% found sex-related differences in the safety and effectiveness, the researchers found.

What’s more, the analysis showed the number of women included in heart device studies did not increase between 2000 and 2007, and that the higher the mean age of participants, the fewer the number of women.

Women’s health groups have been advocating since the 1980s that more attention be paid to the effects of medical drugs and devices on women. They have pointed out that for too long research has favored men as test subjects because women present more variables, mainly hormonal, that make testing more challenging.  This excuse should no longer be tolerated, especially by the FDA.

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