[e-drug] The FDA's New Clothes?

e-drug
1

E-Drug: The FDA's New Clothes?
------------------------------------------------------

An interesting and thought provoking editorial by two regular e-druggers on
two equally interesting papers just published in the BMJ. Details at the
end of this note.

Best wishes,

Rizwan

The FDA's new clothes
<http://bmj.com/lookup/doi/10.1136/bmj.h4897?etoc&gt;
Donald W Light and Joel Lexchin

The FDA does not protect patients from harmful or ineffective drugs, but
approves both

The Vioxx disaster in the early 2000s triggered a crisis of mistrust in the
US Food and Drug Administration (FDA), as evidence emerged that it had
downplayed or ignored evidence of serious cardiovascular harm associated
with Vioxx (rofecoxib), a cyclo-oxygenase-2 selective non-steroidal
anti-inflammatory drug.

The result was a renewed emphasis on drug safety throughout a product's
lifecycle. At the same time, drug companies, which provide most of the
funds for the FDA's review of their drugs, kept pushing for faster
approvals and new uses for old drugs, supposedly so that more patients
could benefit. Any possible risks in getting new drugs to market more
quickly would be offset by more intensive monitoring once they were being
prescribed.

Two linked papers (doi:10.1136/bmj.h4633
<http://www.bmj.com/lookup/doi/10.1136/bmj.h4633&gt;

10.1136/bmj.h4679
<http://www.bmj.com/lookup/doi/10.1136/bmj.h4679&gt;

provide valuable
accounts of how the FDA is using faster reviews for what it deems to be
important new drugs and using supplemental approvals for existing drugs
more widely.
1 <http://www.bmj.com/content/351/bmj.h4897?etoc=#ref-1&gt;
2 <http://www.bmj.com/content/351/bmj.h4897?etoc=#ref-2&gt;

This is just what patients and their doctors are said to want - more patients benefiting from taking more new drugs sooner, generating revenue for the companies to fund
more breakthrough research......

1. Kesselheim AS, Wang B, Franklin JM, Darrow JJ. Trends in utilization of
FDA expedited drug development and approval programs, 1987-2014: cohort
study. BMJ2015;351:h4633.

2. Wang B, Kesselheim AS. Characteristics of efficacy evidence supporting
approval of supplemental indications for prescription drugs in United
States, 2005-14: systematic review. BMJ2015;351:h4679.

Syed Rizwanuddin Ahmad, MD, MPH, FISPE, FCP
Pharmacovigilance Consultant with a Special Interest to Strengthen
National Medicines Regulatory Authorities in Resource-limited Settings
Ex-Consultant/Safety Reviewer, U.S. FDA (1998-2013)
Associate Professor (adjunct), Rutgers School of Public Health, NJ, USA
Assistant Professor (adjunct), Georgetown University School of Medicine,
Washington, DC, USA
www.drugsafetyconsultant.com
Syed Ahmad <drugsafetyconsultant@gmail.com>

2

E-DRUG: The FDA's New Clothes? (2)
--------------------------------------------------

Thank you for sending this. What I notice is that folks (even the BMJ release) fail to attend to the second of these studies, led by Wang, from Harvard's data base that documents how the FDA approves hundreds of supplemental uses for drugs in children, without careful testing.

Don

Guest Researcher, CMD, Princeton University
Professor, Rowan University School of Osteopathic Medicine
Guest, NYU Division of Medical Ethics
Google Scholar Citation H Index: 37
"Donald W. Light Jr." <dlight@princeton.edu>