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Ortho Evra, the FDA and YouTube

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Washington, DCThe power of YouTube is being harnessed by the Food and Drug Administration to try and warn women about the dangers of the Ortho Evra birth control patch, specifically venous thromboembolism.

The FDA is becoming a seasoned hand at posting on YouTube, as the Ortho Evra videos attest. So far, they have posted three professional quality videos, each around a minute long. They appear to be part of a campaign to improve public awareness about the dangers of the patch. Particularly to young women. And YouTube would seem a good place to try and reach them. The videos include information about studies done to date that show an increased risk for life-threatening side effects among women aged 15 through 44.

The more recent FDA message focuses on the recent labelling changes brought about by two studies, both of which show that women in this age group are at an increased risk for blood clots. And, they state that women at risk for these events should talk to their health care professionals before using this contraceptive.

But how would you know if you are at risk? Genetic testing? Is that really likely, given that it's not main stream screening even for heart disease at the moment? There's always family history, but even that's not reliable. Recently, a healthy 15-year old girl who had been on the patch for three months, ended up in hospital with a pulmonary embolism. The doctors told her she was the youngest person they'd ever seen hospitalized for that type of event. How could a 15-year old possibly have suspected that she could be at risk? Not only would it have been virtually impossible for her to know if she was at risk, the science indicates that she shouldn't be at risk. According to a study in the International Journal of Epidemiology, published in 2000, less than 100,000 women aged 39 or younger are likely to have a blood clot.

And, why is the onus on women to determine whether the Ortho Evra patch is safe for them? Surely that's the FDA's responsibility, before the drug gets to market. In fact, it's supposed to be one of the criteria that qualify or disqualify drugs getting to market in the first place.

So we are back to the FDA. They are being proactive in producing and posting these videos. But is anybody watching? The statistics on the videos would indicate that in fact very few are. The latest video the FDA posted on July 2 of this year, has, at the time of writing this article, only had 92 viewings. That's not even a drop in the ocean when you consider that about four million women have used the Ortho Evra patch since it became available in 2002. And, more than 1500 women and their families have sued Johnson and Johnson, and its subsidiary Ortho McNeil Pharmaceutical , who make the Ortho Evra patch, because of the disabilities, and in some cases death, the patch is believed to have caused. Some of the women suing have suffered stroke, brain injuries, and heart attacks, the results of which last a lifetime. It is alleged that some 23 women have died as a result of using the patch.

So if women aren't watching YouTube videos, and the TV commercials aren't explicit enough in explaining the risks of this hormonal patch, how are women finding out about the dangers? From the evidence so far it would seem they find out in the hospital, after the fact.



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