Did Johnson & Johnson Bury Data on Ortho-Evra’s Health Risks?

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Johnson & Johnson

It’s should be common knowledge that the Johnson & Johnson (J&J) Ortho-Evra birth-control patch has more risks than the birth control pill (it’s on the label) — because it exposes women to higher levels of hormone, it carries a higher risk of blood clots and stroke. And now an NBC report alleges that the company knew about the increased health risks before the patch ever reached market.

Since it’s introduction in 2002, the patch has been prescribed 40 million times. Many public health experts have praised the device because it does not require women to remember to take a daily pill, which is one of the major barriers to perfect birth-control use among many women worldwide. In fact, TIME Magazine named the Ortho-Evra patch one of the best inventions of 2002.

But the patch is associated with higher risks of pulmonary embolism — a type of blood clot — as well as stroke and heart attack. These are all rare side effects of any birth control medication that contains synthetic forms of estrogen. The problem is, the patch pumps 60% more estrogen into your bloodstream than the Pill does. While the oral Pill is quickly digested and broken down in the body, the patch provides a constant stream of estrogen for three weeks of each month.

An NBC report, broadcast during Thursday’s broadcast of the Today show, said that according to leaked patient reports from J&J, the company knew that users of the patch were 12 times more likely to suffer stroke and 18 times more likely to have blood clots than Pill takers. Further, NBC revealed, a vice president of research at J&J, Dr. Patrick Caubel, had quit over frustration that the company ignored his data showing elevated levels of complications and mortality associated with the patch.

According to NBC, 24 deaths have been attributed to blood clots induced by the patch, and more than 2,400 women currently have personal injury lawsuits filed against Johnson & Johnson.

The FDA is currently reviewing the safety of the patch and a clinical trial is ongoing to determine the relative risks of blood clot, stroke and heart attack in patch users versus women who take oral birth control pills. In the meantime, doctors are still prescribing the patch regularly, citing the fact that it is FDA approved and that despite its increased risks, it is safe for women overall.