Wednesday, January 05, 2005

FDA, Barr, and Seasonale

Reuters reports that:

A television commercial for Barr Pharmaceuticals Inc.'s Seasonale misleads consumers by excluding risk information to make the birth control pill seem safer, U.S. health regulators warned in a letter released on Thursday.

The FDA's letter is substandard, and Barr Labs hasn't a clue how to educate women. [Aren't they both fortunate I have a blog where I can issue pronouncements?]

I don't have a lot of time, so briefly. The FDA's main complaints (pdf) are: 1) the statements about breakthrough bleeding/spotting (BTB/S) are misleading, and 2) the TV ad thus suggests that there is a consensus among medical experts that there are no adverse health effects of having only four periods a year. In fact, as discussed in the PI [the FDA-approved labeling], Seasonale is associated with numerous risks, including the potentially serious risks of thromboembolic events [blood clot complications] and hypertension.

1) We've already looked at the unscheduled BTB/S data from the Seasonale study. [To the FDA people: re-read what you wrote on page 3 of your letter, pause for a moment, then try again. You can do it.]

2) There is, in fact, a consensus among medical experts that there are no adverse health effects from having no periods at all, and only four withdrawal bleeds (fake periods) a year. [I'll try to do a post on this topic soon.]

Using any birth control pill (including Seasonale), on the regular, 3 weeks on/1 week off, or the extended (Seasonale) regimen is associated with a small increase in only a few potentially serious risks. However, [FDA people, pay attention, this is important], none of these adverse health risks are unique to Seasonale or have anything to do with four fake yearly periods. [To be clear: as disruptive and inconvenient as BTB/S is, it's not a health risk.]

This is pure speculation on my part, but I suspect, based on the quality of the FDA's letter [I can't imagine someone working for the FDA not knowing the difference between a menstrual period and withdrawal bleeding; the risk factors for a blood clot complication; or not being familiar with the expert consensus on extended-use Pill regimens], that the reason behind this letter is not medical concern.

OK, I have to run, and I didn't even get to Barr. I actually liked their ad, but, of course, I'm not their intended audience and the FDA letter isn't about medical people. Suffice it to say: Barr, you can do better. Start with the basics, and build on that. And one TV ad does not an educational effort make. [In all fairness to Barr, they do have an educational site, in addition to the product site, with a lot more information.]


At 3:17 AM, Blogger CE Petro said...

Ema, I've been patiently waiting for your synopsis on this FDA/Barr/Seasonale thing. It seems like the FDA is going after Barr (picking on them), after reading a few weeks ago that Barr doesn't give money to the FDA for research and other perks.

At 2:32 AM, Blogger CE Petro said...

Okay, I's not Barr that doesn't donate to FDA through supporting research. I was confusing Barr with the manufacterers of mifepristone. Nevertheless, Barr does seem to be having problems with the FDA, when you take into account their over-the-counter contraceptives being denied approval (so far).

At 7:35 PM, Blogger ema said...

I haven't seen the article you mention, but, just by reading the FDA's letter, I can tell something's not right.


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