Questcor began hiring sales representatives to promote the drug for health problems other than infantile spasms, such as multiple sclerosis and nephortic syndrome. However, the grounds for which they were promoting the effectiveness of treatment for symptoms of these diseases seem questionable because groups such as Citron Research have questioned whether Achtar is still made with adrenocorticotropin (ACTH), the ingredient for which it was originally approved by the FDA.
Even more, it is important to consider the actual effectiveness of a drug like Achtar. Acthar was approved for use in 1952 when the FDA did not require clinical trials to prove drug effectiveness. On Acthar’s website, the proof provided for treating infantile spasms is based on one clinical study. It is unconvincing to have only one study report these effects because there is often selective reporting in the medical literature of favorable trials, favorable outcomes within trials, and special wording of results. The evidence for Acthar in helping treat multiple sclerosis is also based on one study, and even states that “there were no demonstrated differences between the efficacy of IV steroids and ACTH." Questcor and many drug companies are marketing products in a way that makes the information confusing, and even misleading, to consumers. For example, Abilify was found to relieve 11% more people of major depression in the treatment group in comparison to the control group, but at the same time caused 21% more people in the treatment group to develop akathisia. Though the risk outweighed the benefit, Abilify was heavily marketed and widely used.
Direct-to-consumer advertising has increased over the past several decades, which has shifted the market approach from physician-directed promotion to consumer-facing. More research is still needed to systematically identify how patients can more easily understand prescription medication marketing. Researchers’ Lisa Schwartz and Steven Woloshin have developed a Drug Fact Box which they suggest the FDA requires pharmaceutical companies to use because a series of national randomized trials have shown the box improves decision-making. This would provide more transparency to consumers, and even the doctors who also have little or unclear information on the drug product being marketed.
Currently, the Justice Department and Securities and Exchange Commission are investigating Questcor’s promotional practices and related matters. However, the FDA is best equipped to be modifying the set of standards for which drug companies share information with healthcare providers and the general public, with Drug Fact Boxes being one possible solution to providing information. Regardless of which agency leads the change, regulations should create a set of standards that marketers must meet in order to provide clear and accurate information to the general public. Furthermore, these standards should be based on research determining how successful various direct-to-consumer advertising is in providing understandable information to consumers.