perhaps even Ms. Grifo and her colleagues might=20
be appropriate objects for educating on how=20
horrifically CDC continues to mislead physicians=20
and public on ME/CFS plus on history of how CDC=20
and NIH both have harmed and shortchanged American citizens. From the=
WashPost.
=91Morning-after pill=92 advocates take their case to Obama=92s science=
adviser
By=20
<http://www.washingtonpost.com/david-brown/2011/02/28/AB2Y0sM_page.html>Davi=
d=20
Brown, Published: January 7
Advocates for unfettered access to the=20
=93morning-after pill=94 Plan B One-Step took their=20
case to President Obama=92s chief science adviser=20
Friday, asking him to find out the basis for the=20
administration=92s controversial decision last=20
month to continue requiring that young teens get the drug only by=
prescription.
In brief presentations wedged into a meeting of=20
the President=92s Council of Advisers on Science=20
and Technology, five experts decried Health and=20
Human Services Secretary Kathleen Sebelius=92s=20
rejection of the Food and Drug Administration=92s=20
move to make Plan B available over the counter.
=93We are asking you to work with us . . . to=20
readdress this decision, find out how it was made=20
and why,=94 Wayne C. Shields told John P. Holdren,=20
the chairman of the council. Shields is president=20
of the Association of Reproductive Health=20
Professionals, a trade organization with offices in Washington.
In her allotted two minutes of public comment,=20
Francesca T. Grifo of the Union of Concerned=20
Scientists quoted Sebelius=92s Dec. 7 letter that=20
rejected the FDA=92s plan to make Plan B available=20
to girls younger than 17 without a prescription.
=93Secretary Sebelius used phrases like =91based on=20
my review=92 and =91my conclusion,=92 =94 Grifo said.=20
=93This is exactly the situation which scientific=20
integrity policies are created to prevent:=20
namely, a non-scientist, political appointee=20
overturning a decades-long process of scientific=20
research and review both inside and outside of the FDA.=94
Afterward, however, she and the others said the=20
issue didn=92t involve =93scientific integrity=94 as commonly understood.
=93This not about fraud, not about misconduct.=94=20
Shields said. =93It is about standing up to the stated principles.=94
As Obama=92s adviser for science and technology,=20
Holdren has no direct influence over either=20
Sebelius or FDA Commissioner Margaret Hamburg.=20
It=92s unclear how Sebelius=92s decision to keep some=20
restrictions on Plan B access could be undone=20
short of Obama ordering her to undo it. That=20
action would probably be more controversial than=20
Sebelius=92s overruling of Hamburg.
Holdren told the speakers: =93I will communicate=20
the concerns that were expressed here to my=20
boss.=94 He also addressed the issue of scientific integrity.
=93What scientific integrity requires is that the=20
clearest and most objective evidence be made=20
available=94 to decision-makers, he said. =93That=20
does not necessarily guarantee that the=20
scientific findings alone will determine the outcome.=94
=93Emergency contraception=94 =AD a dose of the hormone=20
progesterone taken up to 72 hours after=20
intercourse =AD has been controversial since it was=20
first tested more than a decade ago.
Some opponents say it will encourage sexual=20
activity by girls or make exploitation of them=20
easier. Some view it as hazardous, although=20
studies have shown it works and has no serious=20
side effects. Some view it as an abortion pill,=20
as it can prevent the implantation of a fertilized egg in the uterus.
The first formulation of Plan B was approved by=20
the FDA in 1999. In 2004, the agency rejected an=20
application to make it available without a=20
prescription. In 2006, however, such availability=20
was allowed for women 18 and older. In 2009, the=20
age restriction was changed to 17 and older.
The drug is not =93over the counter=94 in the sense=20
that it can be picked off the shelf like a bottle=20
of aspirin. The purchaser must show proof of age,=20
and the drug can be handed over only by a pharmacist.
In its most recent application to the FDA, Plan=20
B=92s maker, Teva Women=92s Health, was seeking to=20
lift all restrictions, making the product easier=20
to buy. The FDA told the company it had to=20
conduct further studies on whether girls younger=20
than 17 could take the drug properly.
=93No product ever has had to do age-breakdowns=20
like that,=94 said Susan F. Wood, an associate=20
professor at George Washington University=92s=20
School of Public Health who in 2005 resigned her=20
job as an assistant FDA commissioner in protest=20
of the long delays in changing Plan B=92s status.
Teva submitted more data last February. They=20
included the results of two kinds of studies: a=20
=93label comprehension=94 study assessing whether=20
girls as young as 11 understand the directions on=20
the Plan B box, and an =93actual use=94 study=20
recording the experience of girls as young as 11=20
who used the drug to prevent pregnancy. But=20
according to an article in the Journal of the=20
American Medical Association last month, there=20
were no 11- or 12-year-olds in the =93actual use=94=20
study because none showed up at the clinics where the study was run.
In her letter overruling the FDA decision,=20
Sebelius noted that some girls start menstruating=20
at age 11 but that Teva=92s studies =93do not include=20
data on all ages for which the drug would be=20
approved.=94 She implied =AD although did not say=20
outright =AD that the lack of data on 11-year-olds=20
was the basis for her decision.
Experts in emergency contraception, however, say=20
that because pregnancy in 11-year-olds is so rare=20
it would be virtually impossible to ever get=20
=93actual use=94 data for that age group.
---------------------------------------------
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