Unbound Edition - Prescription for Disaster

That is the situation Johnson & Johnson is in with its popular Ortho Evra birth control patch, as reported in a recent article in Brandweek.

I was more than a little concerned by the article, which is a fascinating read that covers the life of Ortho Evra – and the deaths of numerous women allegedly resulting from use of the patch. The article goes on to state that at least 1,500 women and their families have sued Johnson & Johnson and its Ortho McNeil Pharmaceutical unit, the maker of the patch, for not informing them of an increased risk of potentially fatal blood clots when compared to other contraceptives.

Wait, Johnson & Johnson, the same company we trust for Band-Aids and baby powder? Yep, that one.

In essence, it has been determined that the patch delivers a much higher dosage of estrogen (60 percent) than the traditional birth control pill, leading to an increased risk of deep vein thrombosis and pulmonary embolisms. This is because the hormones in the patch pass directly from the skin into the bloodstream, while the pill has to pass through the stomach and be processed by the liver.

At one time, the patch was seen as a wonderful innovation for women’s health. Time Magazine named it one of the “coolest inventions” of 2002. Runway models wore the patch during New York Fashion Week. Print ads flooded the pages of women’s magazines and television commercials painted the product as sexy.

Now, I believe that the Ortho Evra story will become a case study in crisis management – much like J&J’s Tylenol crisis – but this time the conclusions will be much different. Disregarding the counsel of its VP of Clinical Trials…hiring a doctor who had a history of fabricating study data…buying up dozens of URLs like DeathPatch.com after reports of serious side effects...

Still, the FDA has not banned Ortho Evra and J&J continues to sell it. According to Brandweek, even though J&J cut all advertising for the drug, nearly 5 million prescriptions were written for it last year, leading to $241 million in sales.

And what does this say about the FDA? Its own official reviewer raised concerns about the drug and completely disagreed with the blood clot incidence rates provided by J&J. Yet the FDA approved it anyway. Why?

In an age where you can’t get green onions on your Nacho Supreme at Taco Bell anymore – even after it was determined that they were not the cause of the December 2006 e. coli outbreak in which no one died, why is J&J still selling the patch? It already has the #1 selling birth control, Othro Tri-Cyclen. Why is the company continuing to risk the lives of thousands of women? Perhaps it is out of fear that those 5 million prescriptions will instead be written for Nuvaring, another non-pill option that provides a very low dose of estrogen – and is made by a competitor.

Putting a price on life
written by bigpharmafan, August 24, 2007 10:54 AM

That's essentially what's happening. They've taken a carefully calculated gamble that for the time being, they're better off leaving the product on the market and risking the potential legal costs than pulling the plug on millions in R&D and future sales.

Addicted
written by Patch Adams, August 24, 2007 11:22 AM

Maybe it is all the estrogen that is pumping through my blood right now but I am quite a fan of the patch. My real issue is the fact that my doctor did not recently mention anything about the increased risk for blood clots and/or death caused by using the patch. It was talked about when I first switched to the patch but I just assumed like any birth control method that was always a risk. After reading the Brandweek article I have been second guessing my decision to stay on the patch. What Johnson & Johnson needs to do is come out with a lower dose patch comparable to Ortho Tri-Cyclen Lo.

It's like that scene from Fight Club...
written by Paul, August 27, 2007 03:13 PM

where Ed Norton explains the mathematics of recalls.

"A new car built by my company leaves somewhere traveling at 60 mph. The rear differential locks up. The car crashes and burns with everyone trapped inside. Now, should we initiate a recall? Take the number of vehicles in the field, A, multiply by the probable rate of failure, B, multiply by the average out-of-court settlement, C. A times B times C equals X. If X is less than the cost of a recall, we don't do one."

J&J's only problem is that they've been caught in their coverup.

But there's also the question of whether or not people will make the connection that Ortho-McNeil=no more tears baby shampoo. J&J is so massive that even if this turns into another Vioxx, they'll probably still turn a handy profit.