In Addition, They Are Highly Critical Of Relationship The Sanofi Aventis Drug Company Had With Those Doctors Who Developed Prescribing Guidelines
(Posted by Tom Lamb at DrugInjuryWatch.com)
As we know, now, since being approved by the FDA in 2009 and soon becoming an often-prescribed atrial fibrillation drug, Multaq has been associated with increased risks of serious side effects, including liver failure, interstitial lung disease (ILD), stroke, and sudden cardiac death.
In the February 2014 edition of JAMA Internal Medicine one finds this rather hard-hitting article, "Dronedarone for Atrial Fibrillation: The Limited Reliability of Clinical Practice Guidelines".
From the Abstract for this recent medical journal article about the highly controversial heart drug Multaq, we get this information:
Concerns have been expressed about the reliability of clinical practice guidelines. We analyzed 3 guidelines from medical specialty societies about [Multaq (dronedarone hydrochloride)], an antiarrhythmic drug related to amiodarone hydrochloride, for treatment of patients with atrial fibrillation.... In our analysis, as a rate control drug, [Multaq (dronedarone)] was better than placebo only for a surrogate outcome (heart rate). As a rhythm control drug, [Multaq (dronedarone)] was associated with 13 (95% CI, -15 to 61) excess deaths per 1000 patients treated as compared with placebo. Compared with amiodarone, [Multaq (dronedarone)] was less effective (214 [95% CI, 130 to 294] more recurrences of atrial fibrillation per 1000 patients treated) and similarly tolerated (-28 [95% CI, -69 to 33] more serious adverse events requiring drug suspension per 1000 patients treated).... Our findings raise questions about the reliability of these clinical practice guidelines, as well as the financial associations between many of the panel members and [Sanofi-Aventis (the manufacturer)] of [Multaq (dronedarone)].
While that excerpt may read a bit dense for most of us, the importance and significance of this February 2014 JAMA Internal Medicine Special Communications piece is presented well by this report, "Dronedarone and Clinical Guidelines: A Dark Chapter That Must Be Reread", that was published on the Medscape website.
Strictly Confidential, No Obligation.
From that Medscape article by reporter John Mandrola:
This week, in a special communication to JAMA Internal Medicine, a group of Italian investigators performed a systematic review of the evidence base for [Multaq (dronedarone)] and came to the conclusion that if a drug as dubious as [Multaq (dronedarone)] could find its way into clinical guidelines there must be a major problem with the entire process -- a reliability problem....
The story of how a marginally effective and perhaps even hazardous drug made it to first-line status of major guideline documents is a hard image to revisit. Also difficult to look back at were the lavish steakhouse dinners, the webinars, the "sponsored" programs, and then the result: legions of general cardiologists and primary-care doctors prescribing [Multaq (dronedarone)] en masse. With [Multaq (dronedarone)], for a time at least, hype trounced science....
In 2009, Dr Allen Sniderman (McGill University, Montreal, Canada) and Dr Curt Furberg (Wake Forest University, Winston-Salem, North Carolina) wrote in the Journal of the American Medical Association that guideline-making needed reform.They offered seven commonsense suggestions to improve the current morass. These included simple but obvious things such as bringing epidemiologists and statisticians into the fold, not publishing recommendations as unanimous unless they were unanimous, posting a preliminary version of the statement online for comments, providing independent scientific review, providing full and complete financial disclosures, and insisting on stricter rules governing conflict of interest for both individuals and medical societies.
It seems no one listened. It's time now. Better late than never. [emphasis added; footnotes omitted]
Our hat is off to the Italian medical researchers who wrote this medical journal article about the dangers of Multaq together with the drug's lack of efficacy, and to reporter John Mandrola for connecting the dots as well as putting this research about the Multaq prescribing guidelines into perspective for us.