[Mb-civic] When Politics Defeats Science - Susan F. Wood - Washington Post Op-Ed

[William Swiggard]

When Politics Defeats Science

By Susan F. Wood
Wednesday, March 1, 2006; A17

Since my resignation six months ago as assistant commissioner of women's 
health at the Food and Drug Administration, I have been traveling around 
the country meeting with men and women, fellow scientists and health 
care professionals. I have shared my concerns that our federal health 
agencies seem increasingly unable to operate independently and that this 
lack of independence compromises their mission of promoting public 
health and welfare.

At every stop I am reminded that whether it is the environment, energy 
policy, science education or public health, the American public expects 
our government to make the best decisions based on the best available 
evidence.

Yet, at a recent hearing of the House Appropriations subcommittee on 
labor, health and human services, we saw once again that this is not 
happening. Reps. Sam Farr (D-Calif.) and Rosa DeLauro (D-Conn.) 
questioned FDA acting commissioner Andrew C. von Eschenbach about the 
delay in approving the application to make Plan B emergency 
contraception available over the counter to women 17 and older. Von 
Eschenbach responded that the agency was carefully reviewing the 
thousands of comments received in response to last-minute concerns 
raised about the feasibility of making the same product available over 
the counter for most women but keeping it on prescription for young 
teens. This exchange confirmed my suspicion that, like his predecessor, 
von Eschenbach is unable or unwilling to let the science and the 
scientists guide FDA policy and decisions, and that the real answer as 
to whether the FDA will allow Plan B over the counter for those 17 and 
older is no.

Time and again in my travels I am asked, "What happened to derail Plan 
B?" I have to answer honestly that I don't know. The manufacturer agreed 
to take the "controversial" issue of young teens' access to emergency 
contraception off the table in 2004; now we are talking only about adult 
access to safe and effective contraception. Over 98 percent of adult 
women have used some form of contraception. So what is the objection?

Perhaps it is that posed by a small but vocal political minority that 
insists on labeling emergency contraception as abortion, or at least 
confusing the two. One of the main questions I hear is, "Does this pill 
cause an abortion?" In fact, the only connection this pill has with 
abortion is that it has the potential to prevent the need for one. 
Emergency contraceptive pills work exactly the same way as other birth 
control pills, and they do not interfere with or harm an existing 
pregnancy. Emergency contraception is simply a higher dose of daily 
birth control pills; it is not RU-486, the "abortion pill." Indeed, 
emergency contraception has been used as a method to prevent unintended 
pregnancies for decades by women who had physicians advise them on how 
many pills in their regular pill pack to take. So people who are 
comfortable with oral contraceptives as methods of contraception should 
be just as comfortable with emergency contraception.

Having spent 15 years working for the federal government, nearly five of 
which were at the FDA, I care deeply about what's happening in the 
federal agencies, particularly our health agencies. Nearly 25 cents of 
every consumer dollar is spent on products regulated by the Food and 
Drug Administration. We count on the FDA for the safety and 
effectiveness of our medicines, vaccines and medical devices, and for 
the safety of the blood and food supply. The American public does not 
want to -- nor should it -- have to think twice about the quality and 
reliability of information it is getting from the FDA. Its reputation as 
the international gold standard for regulatory agencies, and as a body 
that sets the bar very high when it comes to scientific evidence and 
integrity, is being put at risk over adult access to contraception. Why 
would the administration risk such a reputation over this?

Von Eschenbach could demonstrate his commitment to the FDA's 
independence and scientific integrity and help restore staff morale and 
waning public credibility by stopping the rulemaking process and 
approving access to Plan B for women 17 and older. Instead, he continues 
to hide behind a wasteful and pointless bureaucratic process. Congress 
needs to step in and restore the FDA's independence and its ability to 
make decisions based on the evidence.

It's been nearly three years since the first application came in to make 
Plan B emergency contraception available over the counter, so that 
women, including rape victims, could have a second chance to prevent an 
unintended pregnancy and the need for an abortion. How many chances have 
we missed? I still can't explain what is going on here, and why women 17 
and older are still denied this product in a timely way. When did adult 
access to contraception become controversial? And why have we allowed it 
to happen?

The writer is a former assistant commissioner of the Food and Drug 
Administration and is a senior policy adviser to the Reproductive Health 
Technologies Project.

http://www.washingtonpost.com/wp-dyn/content/article/2006/02/28/AR2006022801027.html?nav=hcmodule
-------------- next part --------------
An HTML attachment was scrubbed...
URL: http://www.islandlists.com/pipermail/mb-civic/attachments/20060301/b74b2a37/attachment.htm