CLINICAL NEWS
Safety First Slowing the March of Progress
The U.S. Food and Drug Administration (FDA)
approved more than 200 novel therapeutics
between 2001 and 2010, but nearly 1 in 3 of
those approvals were followed by post-market
safety events. Attempts to roll back the Affordable Care Act (ACA)
appear to have halted 5 years of progress in reducing the
number of uninsured Americans, according to a report
from the Centers for Disease Control and Prevention.
The uninsured rates from 2010 (when the ACA was passed)
to 2016 were:
Of the 222 newly
approved drugs,
71 (32%) were affected
by a post-market safety
event, including:
2010 16 %
2011 15.1 %
2012 14.7 %
2013 14.4 %
• 3 withdrawals
• 61 boxed warnings
• 59 safety communications
2014 11.5 %
2015 9.1 %
2016 9 %
0 2 4 6 8 10 12 14 16 18 20
Though safety events were more common for
drugs that were reviewed through the FDA’s “ac-
celerated approval” pathway (incidence rate ratio
[IRR] = 2.20; p=0.02), surprisingly, the incidence
was lowest for drugs approved in fewer than 200
days (IRR=0.46; p=0.02).
The 2016 rate was virtually unchanged from 2015,
marking the first year since passage of the ACA in 2010
that the number of uninsured saw such a
small improvement.
Source: Downing NS, Shah ND, Aminawung JA, et al. Postmarket safety events among novel therapeutics approved by the US Food and
Drug Administration between 2001 and 2010. JAMA. 2017;317:1854-63.
Sources: Cohen RA, Zammitti EP, Martinez ME. Health insurance coverage:
early release of estimates from the National Health Interview Survey, 2016,”
May 16, 2017; Associated Press, May 16, 2017.
Moms in Medicine
Perceived discrimination against mothers in medicine
is common and can translate to lower salaries and few
opportunities for promotion, according to results of a
survey published in JAMA Internal Medicine.
Of the 5,782 respondents from
the Physician Moms Group, an
online community:
Maternal discrimination commonly manifested as “dis-
respectful treatment by nursing or other support staff”
(52.9%), “not being included in administrative decision
making” (39.2%), and “pay or benefits not equivalent to
male peers” (31.5%).
Source: Adesoye T, Mangurian C, Choo EK, et al. Perceived discrimination
experienced by physician mothers and desired workplace changes: a cross-
sectional survey. JAMA Intern Med. 2017 May 8. [Epub ahead of print]
ASHClinicalNews.org
77.9 % 66.3 % 35.8 %
reported
any type of
discrimination reported
gender
discrimination reported
maternal
discrimination
(related to pregnancy, maternity
leave, breastfeeding, etc.)
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