Using Therapeutic Value Ratings to Bolster Illegal Drug Marketing Allegations
Whistleblowers seeking to expose pharmaceutical fraud including kickbacks and other deceptive marketing practices, such as misrepresentation of a drug’s benefits, may wish to bolster their allegations with any available evidence that the illegally promoted drug lacks therapeutic benefit, relying on rankings assigned by entities such as the Patented Medicine Prices Review Board and Prescrire International. Evidence of lack of therapeutic benefit can help establish a drug company’s motive for illegal marketing, for, if a manufacturer can’t promote a drug on its own merits, it may resort to corruption and deception. Evidence as to lack of efficacy also helps establish potential patient harm, a factor that is often relevant to the government when it decides whether to take over a qui tam lawsuit.
Moreover, a pharmaceutical whistleblower’s inquiry into the question of efficacy will often bear fruit. A recent study published by the Canadian Medical Association Journal (CMAJ) found that over 90% of the most promoted and 75% of the top revenue earning drugs have little to no therapeutic value. Similarly, a study conducted by the BMJ found that 81% of the top-promoted drugs in the U.S., and 56% of the top-revenue drugs, were not “possibly helpful.” These studies relied on the therapeutic benefit ratings of the Patented Medicine Prices Review Board and Prescrire International.