Saturday, September 29, 2007

FDA Launches Consumer Health Web Page

Here are the top 5 problems with the FDA consumer health site, the Women's Health section, Birth Control page:

1. Outdated method availability information.

If you don't know which birth control methods are available, you cannot decide which one would be best for you to use. It's that simple.

The FDA has yet to figure this out. It repeatedly lists methods that haven't been available for years--Preven, Lunelle, Progestasert, Prentiff--without the slightest indication that they're no longer an option. And, I suppose, just to balance out the misinformation, the FDA mistakenly tells you that the contraceptive sponge is not currently marketed.

2. Incorrect failure rates.

The main reason you use birth control is to prevent an unintended pregnancy. If you have incorrect information about a method's failure rate you might as well forget about choosing a method that's best suited to your needs.

It appears the FDA is not that into providing you with correct failure rate information. On the What Kind of Birth Control Is Best for You? page we have this whopper (emphasis mine):

The types of birth control that are most reliable for preventing pregnancy are birth control pills, injections, implants, IUDs, and sterilization. Of every 100 women who use one of these types of birth control for a year, about 1 to 5 women will become pregnant.


Let's just pretend for a moment that I haven't noticed the FDA's deliberate attempt to misinform you.

First, when it comes to pregnancy protection, the Pill isn't even in the same class as all the other methods listed--injections, implants, IUDs, and sterilization.

The types of birth control that are most reliable for preventing pregnancy are, in descending order of effectiveness (note that I'm using the very numbers provided by the FDA on its site):

  • Implants (0.05% Norplant; ~0.3% Implanon) and IUDs (0.1% Mirena; 0.8% CuT)

  • Male sterilization (0.15%) and injections ( Depo-Provera 0.3%)

  • Pill (5% combination)

The Pill is an effective method of birth control, but by no means is it a most reliable method.

Second, the failure rate for women who use the [combination] Pill is about 1% to 5% (0.1% perfect use/5% typical use). All the other methods listed have a less than 1% failure rate (with both perfect and typical use). Approximating a less than 1% rate to 1% is fine. Stating that a method with a less than 1% failure rate has an up to 5% failure rate is incorrect and misleading.

Third, if your intent is to misinform, listing the wrong failure rates is the way to go about it. The FDA groups all the most effective methods together with a less effective method, the Pill. It then lists the Pill's failure rate as applicable to the entire group, in a deliberate attempt to make you think all the other methods are less effective than they really are.

How do I know the attempt to misinform you is deliberate? Because, elsewhere on its site, the FDA lists the correct failure rates for the most effective methods. This makes it hard for the FDA to pretend it listed the wrong failure rates by mistake.

3. Inconsistent failure rates.

This one is pretty self-explanatory and, I suspect, an extension of the FDA's attempt to confuse you. According to the FDA's site, the failure rate for injections, implants, IUDs, and sterilization is A) less than 1, and B) 1 to 5, and C) 0.3/0.3 (DMPA), 2.0/1.5 (Progestasert); 0.8/0.6 Copper T; 0.1/0.1 (Mirena).

4. Unclear information on Pill use and cancer risk.

Just like natural hormones, drugs containing synthetic hormones, like the Pill, can impact your cancer risk. To make an informed decision about Pill use and cancer risk, you need to have accurate information and, as important, you need to have that information presented to you in a clear manner.

When addressing this topic the FDA links to a National Cancer Institute (NCI) page where two problems immediately jump out. One, cervical cancer risk--it's not made clear that they are discussing risk in women with preexisting HPV infection. Two, liver cancer risk--it's not made clear that there is great uncertainty regarding the causal link, if any, between combined OC use and liver...cancer.

5. No information on abortion.

The frequency of clinically recognized [spontaneous] abortion is anywhere from 12% to 26%*. Also, [a]bout half of American women have experienced an unintended pregnancy, and at current rates more than one-third (35%) will have had an [elective] abortion by age 45.

Just like birth control and pregnancy, abortion (spontaneous/elective) is a crucial component of women's medical needs. As the agency responsible for...helping the public get the accurate, science-based information they need to use medicines the FDA's failure to provide abortion information on a site dedicated to women's health care needs is a mark of incompetence. It's inexcusable for the FDA to sacrifice accuracy and public health to the altar of politics and ideology.

For shame.





*Williams 21ed p856

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