Higher Standards for Ortho Evra?

February 5, 2007, 12:00AM. By Jane Mundy

Philadelphia, PAThe FDA has recently considered setting higher standards for new birth control drugs before they are approved for market.

Some pills seem to be less effective at preventing pregnancy because manufacturers have started using lower doses of hormones that stop ovulation, while the Ortho Evra patch has seen the reverse: higher doses of hormones were used and with it, risks of blood clots and cardiovascular problems that would be "unacceptable to most women," said Amy Allina, program director of the National Women's Health Network.

Perhaps manufacturers have started to use lower doses of hormones after a growing number of women have experienced severe side effects such as blood clots and strokes from the patch. Although most birth control pills are purported to be "very safe for the vast majority of women" the Ortho Evra patch does not fall into this category.

While the FDA does not believe that the effectiveness of different contraceptive drugs can be compared due to the way their clinical trials are designed, they also say that every birth control they have approved is safe. Isn't the Ortho Evra Patch a form of birth control? It certainly isn't safe. And another cause for concern is how representative the clinical trials are to the general population. The FDA is currently looking at requiring manufacturers to include a more representative mix of women in the clinical trials for their new products.

Companies often exclude women who smoke, are overweight or have a history of heart problems from their trials. The FDA is looking at how well studies done prior to approval of new birth control pills reflected their "real-world" use. Typically, that use is less consistent and reliable than it is in clinical studies. Also, newer versions of the pill aren't being tested on women who reflect the broader population. According to a panel of experts, the women in clinical trials are younger, skinnier and healthier than are U.S. women on average. The FDA says this makes it difficult for scientists to judge the safety and efficacy of the drugs in the real world - to the average female.

The Ortho Evra patch has proved problematic for the FDA. In September 2006, for example, the agency warned women that Johnson & Johnson's birth control patch Ortho Evra could raise their chances of developing blood clots in the legs and lungs.

With such a high rate of potential risk involved, the Ortho Evra patch can hardly be defined as health care. The manufacturers of the patch are facing new lawsuits daily for serious illnesses and death. There are well over 400 similar lawsuits throughout the country and Canada.

Even more lawsuits are on the horizon now that Dr. Joel Lippman, former vice president of clinical trials for Ortho-McNeil Pharmaceutical Inc. concluded that the Ortho Evra patch was too dangerous to be put on the market due to its "dangerously high levels of estrogen." Lippman was fired by manufacturer Johnson & Johnson - after being employed for 15 years - for 'inappropriate action' after he blew the whistle on the drug makers in December, 2006.

Although the warning label on the Ortho Evra patch has changed-- The Ortho Evra birth control patch now comes with a warning that it releases more estrogen into the bloodstream than typical birth control pills -- the levels of estrogen haven't decreased and women will continue to suffer serious side effects from this dangerous drug.