Amiodarone is the only drug in modern FDA history to be approved in the United States without undergoing the required randomized clinical studies to show a drug is safe and effective before it is approved.
That is precisely what occurred with Amiodarone when the FDA granted Wyeth Pharmaceuticals approval to market and sell Cordarone® (Amiodarone hydrochloride) in the United States before performing any clinical trials showing it was safe.
Now, there was a reason for this approval, and the FDA approved the drug only for use as a drug of “last resort” for patients suffering from recurrent, life-threatening ventricular fibrillation (“VFib”) for whom all other treatment options had failed. In essence, there was nothing to lose for such patients who faced a likely death without some treatment to control VFib.
Despite repeated requests from the FDA to perform randomized clinical trials, primarily if the manufacturers intended to use Amiodarone to treat other, less-serious arrhythmias such as atrial fibrillation (AFib), the manufacturers of Amiodarone never carried out these trials.
As a result, the FDA has never approved using Amiodarone for anything other than a treatment of last resort for persons with life-threatening VFib.
Then how did Amiodarone become the most commonly prescribed treatment for AFib, which is far less dangerous but more common arrhythmia than VFib? It was done through the dark and secretive process of off-label promotion.
It is not uncommon for a drug developed for one purpose to treat another condition effectively. For this reason, it is not improper or illegal for physicians to prescribe a medication for an unapproved use (“off-label”).
However, it is unlawful for a drug manufacturer to promote a drug for unapproved use.
The drug industry makes tens of billions of dollars yearly from doctors prescribing drugs off-label, making it too tempting for drug companies to avoid promoting drugs for off-label purposes. But drug companies promote drugs off-label in covert and duplicitous ways to prevent FDA scrutiny.
The most common method is to use third parties, either by using physicians paid by the drug companies to speak to other physicians at professional association meetings and conferences or by authoring journal articles touting a drug for off-label treatment.
Drug companies compensate physicians in other ways to tout a drug for off-label purposes, including funding research by these physicians.
A large number of marketing companies are also hired to promote drugs for off-label purposes.
Because of the enormous potential profits, drug companies are not even discouraged from improper off-label promotion by the billions of dollars in fines levied against drug companies over the past ten years.
Drug companies see these fines as just a cost of doing business.