FEATURE
and should do better. Perhaps
the most important way to
start improving our system and
lifting our lagging performance
is through improving access to
care. The United States certainly
has some of the best physicians,
hospitals, and health systems
in the world. However, those
valuable resources are not
available to every American.
In fact, too many people in
this country do not have access
to health care at all. Recent
reforms are beginning to make
inroads into this problem.
Commonwealth Fund surveys
have demonstrated that between
October 2013 and April 2014,
9.5 million uninsured Americans
gained health insurance, mostly
because of provisions of the
Affordable Care Act.
You are one of the leading
scholars on health-care
policy and the presidency.
Why was President Obama
able to achieve what none
of his predecessors could?
I tackled this topic in my book
(with co-author James Morone),
Heart of Power: Health and Politics
in the Oval Office, which recounts
efforts by presidents from Franklin
D. Roosevelt to George W. Bush
to manage issues of health-care
coverage and access. President
Obama and his team benefited
enormously from lessons learned
from the few successes (such
as the passage of Medicare and
Medicaid during the presidency
of Lyndon Johnson) and many
failures (such as the Nixon, Carter,
and Clinton national health plans)
of his predecessors. If “right”
means things that make the
T:7”
treatment cycles was 5. Sixty-three percent of
patients in the study had a dose interruption of
either drug due to adverse reactions. Thirty-seven
percent of patients in the study had a dose reduction
of either drug due to adverse reactions. The
discontinuation rate due to treatment-related
adverse reaction was 3%.
Monitor patients for hematologic toxicities,
especially neutropenia. Monitor complete blood
counts weekly for the first 8 weeks and monthly
thereafter. Patients may require dose interruption
and/or modification [see Dosage and
Administration (2.2)].
Tables 2, 3, and 4 summarize all treatment-emergent
adverse reactions reported for the POMALYST +
Low-dose Dex and POMALYST alone groups
regardless of attribution of relatedness to
pomalidomide. In the absence of a randomized
comparator arm, it is often not possible to
distinguish adverse events that are drug related and
those that reflect the patient’s underlying disease.
In the clinical trial of 219 patients who received
POMALYST alonea (n=107) or POMALYST +
Low-dose Dex (n=112), all patients had at least one
treatment-emergent adverse reaction.
Adverse reactions ≥10% in either arm, respectively,
included: General disorders and administration
site conditions: Fatigue and asthenia (55%, 63%),
Pyrexia (19%, 30%), Edema peripheral (23%,
16%), Chills (9%, 11%), Pain (6%, 5%); Blood and
lymphatic system disorders: Neutropenia (52%,
47%), Anemia (38%, 39%), Thrombocytopenia
(25%, 23%), Leukopenia (11%, 18%),
Lymphopenia (4%, 15%); Gastrointestinal
disorders: Constipation (36%, 35%), Diarrhea
(34%, 33%), Nausea (36%, 22%), Vomiting (14%,
13%); Infections and infestations: Pneumonia
(23%, 29%), Upper respiratory tract infection
(32%, 25%), Urinary tract infection (8%, 16%);
Musculoskeletal and connective tissue disorders:
Back pain (32%, 30%), Musculoskeletal chest pain
(22%, 20%), Mu