Clinical Innovators
difference between success and
failure in passing national health
reform, there are a few things that
Obama did right.
First off, he cared passionately
about it and made it his first
domestic policy priority. He
risked his presidency and his
legacy for health-care reform. He
acted quickly and early in his first
term, when his political capital
was greatest. He laid out strong,
clear principles for what kind
of plan he would accept, but left
the drafting to Congress, so that
it would own the result. Within
the administration, he left the
policy details to his expert staff
and concentrated on the politics
of passage, which is the key
contribution a president can make.
Perhaps most importantly, he
didn’t give up. When the bill’s
prospects looked darkest, right
after the election of Republican
Scott Brown ended the Democrats’
filibuster-proof majority in
the Senate, he pressed on. He
was willing to lose rather than
surrender. Eventually, House
Speaker Nancy Pelosi and Senator
Majority Leader Harry Reid found
a way to get around the filibuster.
Let’s talk about your role
in health-care reform as
the National Coordinator
of Health Information
Technology in 2009-2011.
What is the role of health
information technology
(HIT) in supporting our
nation’s health-care reform
efforts? Is the one necessary
for the other?
Health IT is necessary, but not
sufficient, to ensure that our
health-care system achieves its
T:7”
CYP1A2 inducers: Co-administration of POMALYST
with drugs that are CYP1A2 inducers has not been
studied and may reduce pomalidomide exposure.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category X [see Boxed Warnings and
Contraindications (4)]
8.3 Nursing Mothers
It is not known if pomalidomide is excreted in
human milk. Pomalidomide was excreted in the
milk of lactating rats. Because many drugs are
excreted in human milk and because of the potential
for adverse reactions in nursing infants from
POMALYST, a decision should be made whether to
discontinue nursing or to discontinue the drug,
taking into account the importance of the drug to
the mother.
8.4 Pediatric Use
Safety and effectiveness of POMALYST in patients
below the age of 18 years have not been
established.
8.5 Geriatric Use
No dosage adjustment is required for POMALYST
based on age.
Of the total number of patients in clinical studies of
POMALYST, 41% were aged 65 years and older,
while 12% were aged 75 years and older. No overall
differences in effectiveness were observed between
these patients and younger patients. In this study,
patients aged greater than or equal to 65 years were
more likely to experience pneumonia than patients
aged less than or equal to 65 years.
8.6 Females of Reproductive Potential and Males
POMALYST can cause fetal harm when administered
during pregnancy [see Use in Specific Populations
(8.1)]. Females of reproductive potential must avoid
pregnancy while taking POMALYST and for at least
4 weeks after completing therapy.
Females
Females of reproductive potential must commit
Print-only heterosexual
either to abstain continuously fromcontent
sexual intercourse or to use 2 methods of reliable
birth control simultaneously: one highly effective
form of contraception – tubal ligation, IUD,
hormonal (birth control pills, injections, hormonal
patches, vaginal rings, or implants), or partner’s
vasectomy, and 1 additional effective contraceptive
method – male latex or synthetic condom,
diaphragm, or cervical cap. Contraception must
begin 4 weeks prior to initiating treatment with
POMALYST, during therapy, during dose
interruptions, and continuing for 4 weeks following
discontinuation of POMALYST therapy. Reliable
contraception is indicated even where there has
been a history of infertility, unless due to
hysterectomy. Females of reproductive potential
should be referred to a qualified provider of
contraceptive methods, if needed.
Females of reproductive po FV