CLINICAL NEWS
Help Wanted
The U.S. Food and Drug Administration (FDA)
appears to have a “revolving door” problem, with
a large number of medical reviewers eventually
leaving government to consult for the pharmaceutical industries they once regulated.
To quantify this problem, researchers searched
the FDA database for hematology and oncology
drug approvals from 2006 to 2010 and the medical reviewers who approved them, then searched
public information to determine reviewers’
subsequent jobs.
Of the 55 hematology/oncology medical reviewers identified:
27 (49.0%)
26 (47.4%)
2 (3.6%)
continued to work exclusively at the FDA
left the FDA
worked at the FDA but held secondary appointments
Lowering Cholesterol, Raising Survival
Patients with multiple myeloma (MM) who take statins to
manage their high cholesterol may be experiencing another
beneficial effect of statins: longer survival.
Study authors identified 4,957 patients diagnosed with MM
between 1999 and 2013, of whom 2,294 received statin therapy.
Statin therapy was associated with a:
21%
decrease
in all-cause mortality (p<0.001)
Of those who left the FDA, 15 (57.7%) later had
biopharmaceutical industry ties:
8 (30.8%)
5 (19.2%)
2 (7.7%)
worked in industry
24%
decrease
in MM-specific mortality (p<0.001)
consulted for industry
did both
31%
decrease
(Subsequent jobs were unknown for 8 [30.8%] of the reviewers who left the FDA.)
“The transition from regulator to advising companies seems logical, but it raises concern as to
whether regulators indefatigably act in the public interest,” the authors concluded.
Source: Bien J. Future jobs of FDA’s haematology-oncology reviewers. Br Med J. 2016;354:i5055.
ASHClinicalNews.org
in the risk of developing a
skeletal-related event (p<0.001)
The authors explained that statins have activity in one of the
pathways influenced by nitrogen-containing bisphosphonates, which are associated with improved survival in MM.
Source: Sanfilippo KM, Keller J, Gage BF, et al. Statins are associated with
reduced mortality in multiple myeloma. J Clin Oncol. 2016 September 29.
[Epub ahead of print]
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