To the Editor:
The Wall Street Journal reported on March 11th the retraction of 21
fabricated articles authored by anesthesiologist and pain expert Scott S.
Reuben (1). Pfizer Inc.’s pregabalin and celecoxib were among the drugs that
Reuben reported favorable results when used in combination for common
orthopedic procedures. Reuben was a paid speaker and received funding for
his research from Pfizer.
Our hospital has added both pregabalin and celecoxib to the pre-printed order sets for postoperative pain control for total joints. When
reviewing the documents used to provide the “evidence-based medicine” for
post operative pain control, we were disappointed to find one particular
review article by Reuben published in the Journal of Bone and Joint
Surgery that has significantly influenced the use of pregabalin for
perioperative pain management of hip and knee replacements in many
institutions throughout the country (2). Eighteen of the references were his
own work, four of which have been retracted so far. This should make one
question the authenticity of his other 14 articles as well. We commend
JBJS for retracting this review article. In fact, most review articles on
this topic include at least one retracted article and several others
published by Reuben. To the best of our knowledge, there are no other
randomized clinical trials examining the use of pregabalin for postoperative pain in orthopedic surgery, other than by Reuben.
Off-label drug prescribing presents special risks to patients where
even the smallest of risks outweigh questionable benefits. If these were
all legitimate studies, why wouldn’t the company have submitted the studies
to the FDA for a new approved indication, in this case post-op pain
management? There are situations where off-label use is needed, but we
should question the value of many of these studies given the biases of the
pharmaceutical companies providing financial support.
Many think pregabalin can’t hurt, but it is not an innocuous drug. For example, in a recent edition of Quarter Watch from the Institute of
Safe Medical Practices a surprising number of angioedema cases have been
reported to the FDA associated with the use pregabalin (3).
Due to the recent retraction of Reuben’s articles, we should
reconsider our use of pregabalin for post operative pain control. We
should be very skeptical and cautious when evaluating studies funded by
drug companies that are not submitted and evaluated by the FDA. If we
don’t, we may be putting our patients at risk by practicing evidence-free medicine.
The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.
References
1. Wall Street Journal. Top pain specialist fabricated data in studies, hospital says.
http://online.wsj.com/article/SB123672510903888207.html. Accessed 2009 Mar
13.
2. Reuben SS and Buvanendran A. Preventing
the development of chronic pain after orthopaedic surgery with preventative multimodal analgesic techniques. J Bone Joint Surg Am. 2007;89:1343-58.
3. Institute of Safe Medical Practices. Quarter Watch: 2008 Quarter 1. October 23, 2008. http://www.ismp.org/quarterwatch/2008Q1.pdf. Accessed
2009 Mar 13.
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