HealthBar


Let Freedom Ring?
April 7, 2008, 10:18 am
Filed under: drugs, test, Uncategorized

I saw this ad for NuvaRing, the birth control “diaphragm,” while flipping through Fitness Magazine on the 40th anniversary of Martin Luther King Jr’s death.

Let Freedom Ring! Nuva Ring Ad in the May 2008 issue of Fitness

Besides the meaningless appropriation of Dr. King’s words, I found this offensive on many levels.

I think it’s something about how the ring daintily pressed between the model’s fingers looks just like those sparkling bangles on her wrist–another accessory for the modern woman.

Also, the insinuation that women should be free from their periods, a natural occurrence, irks me. But what pushes me over the top is the fact that the only path to this elusive freedom involves buying a name-brand product (with no generic equivalent), sticking it where the sun don’t shine and keeping it there for 3 weeks.

Now, I might not be a scientist but I remember someone telling me during childhood not to stick things in my body and let them fester for weeks. Yet the ‘Important Information’ section on NuvaRing’s Freedom ad makes no mention of such risks. Fortunately, consumers have picked up the slack.  Check here and here and here for some of the real dirt.

The disclaimer mentions standard fare. Does not protect against HIV and other sexually transmitted diseases, there is an increased risk of blood clots, Women using the NuvaRing should not smoke cigarettes as smoking increases the risk of side effects.

These are all warnings I have heard before but then I’m caught by a vague hedge. It is unknown if the risks of blood clots is different with NuvaRing than with with use of certain birth control pills.

Isn’t that something you should know, FDA, before you approve such a drug?

Isn’t that something you should test, Organon, before you market a drug as the next cause to fight for?

Apparently not. Or at least the FDA didn’t think so when the agency approved NuvaRing in 2001. About 4.5 million women now use Organon’s product and until recently, none of them knew the price of “freedom” was so high.

Two New Jersey women, Rosana Marcando and Jackie Kelly Bozicev, died last year. Though Maricando died of a stroke and Bozicev of a seizure, both deaths are blamed on NuvaRing. A briefly mentioned side effect, increased risk of blood clots, was determined to have caused the death of both women. There are currently 150 lawsuits pending against Organon’s “freedom ring.”

The deaths have reignited claims that Organon’s product is not safe and that the company’s marketing material does not adequately warn women of potentially fatal side effects. The two women from New Jersey had similar lives. Both were young mothers in good health. Neither smoked cigarettes but both of them decided to try NuvaRing.

Now both are dead and the ad in my Fitness magazine doesn’t mention a word about any of it.

Read about Rosana Marcando.

Read about Jackie Kelly Bozicev.

Interestingly, according the circulation data from Meredith Corporation, Fitness’ parent company, the average reader of the magazine is a 36-year-old female. Nearly 40 percent of Fitness’ 6,642,000 readers are moms. And 46 percent fall in the desirable 18-34 category.

In 2007, the FDA asked Organon to amend NuvaRing’s label to “describe rare reports of inadvertent insertion of the product into the urinary bladder and vaginal/cervical erosion or ulceration associated with product use.”

They did not mention that in February of 2007, the health research group Public Citizen petitioned the FDA to ban all third generation oral contraceptives that contain desogestrel due to increased risk of blood clots. The group contends that third generation oral contraceptives double the risk of blood clots in women, compared to second generation contraceptives.

Though NuvaRIng is not an oral contraceptive, it contains etonogestrel, a biologically active metabolite of the dangerous third generation progestin desogestrel. Whew.

Over all these alarm bells, I can’t the freedom ringing at all.