We are using cookies to implement functions like login, shopping cart or language selection for this website. Furthermore we use Google Analytics to create anonymized statistical reports of the usage which creates Cookies too. You will find more information in our privacy policy.
OK, I agree I do not want Google Analytics-Cookies
The International Journal of Oral & Maxillofacial Implants
Login:
username:

password:

Plattform:

Forgotten password?

Registration

Int J Oral Maxillofac Implants 29 (2014), No. 1     14. Feb. 2014
Int J Oral Maxillofac Implants 29 (2014), No. 1  (14.02.2014)

Online Article, Page 37-44, doi:10.11607/jomi.te40, PubMed:24451886


Online Article: The Deception and Fallacies of Sponsored Randomized Prospective Double-Blinded Clinical Trials: The Bisphosphonate Research Example
Marx, Robert E.
The randomized prospective double-blinded clinical trial (RCT) is accepted as Level I evidence and is highly regarded. However, RCTs that gained FDA approval of drugs such as Vioxx, Fen- Phen, and oral and intravenous bisphosphonates have proven to generate misleading results and have not adequately identified serious adverse reactions. The development, research, and clinical marketing of the oral and intravenous bisphosphonates can serve as a representative example for the deteriorated value of many of today's RCTs. The expected high value of RCTs is jeopardized by: (1) sponsorship that incorporates bias; (2) randomization that can select out an expected improved result or eliminate higher-risk individuals; (3) experimental design that can avoid recognition of serious adverse reactions; (4) blinding that can easily become unblinded by the color, shape, odor, or administration requirements of a drug; (5) definitions that can define an observation as something other than what it actually represents, or fail to define it as an adverse reaction; (6) labeling of retrospective data as a prospective trial by using adjudicators prospectively to look at retrospective data; (7) change of the length of study to avoid the longerterm adverse reaction from accumulation of drug or treatment effects; (8) ghost writing, as when drug company physicians or a hired corporation either edit or write the entire protocol and/or manuscript for publication. Such corruption of the well-intended properly conducted RCT should be viewed with a sense of outrage by practitioners and requires a restructuring of the levels of evidence accepted today.

Keywords: intravenous bisphosphonates, oral bisphosphonates, randomized clinical trials