Large Profits for Pharmaceutical Companies Marketing Questionable Drugs
By Natasha HerrickPublished April 26, 2014
A New York Times article discussed Mallinckrodt Pharmaceuticals’ deal to purchase Questcor Pharmaceuticals. The authors provide background on Questcor Pharmaceuticals, which has been criticized for the price increases for their drug, H.P. Acthar Gel., going from $40 a vial to more than $28,000 within a decade. Even more excessive, in 2007 the price went from $1,650 a vial to $23,000 a vial overnight. Questcor has claimed that it needed the high price to stay in business because Achtar was primarily used to treat a rare disease known as infant spasms. Surprisingly, the price increase did not generate a response from the Federal Drug Administration (FDA), the agency responsible for protecting and advancing public health. If the increase in price corresponded with the increase in product innovation, the price increase would be more defensible. However, it seems the price increase in this case was due instead to an incentive to increase profit beyond reason. It is essential that the government steps in and makes sure that the market for these drugs does not put the consumer at unfair disadvantage. This would require that the FDA establish more stringent standards which a company such as Questcor should meet so that consumers understand the magnitude of benefits of a drug and can personally evaluate whether the potential benefit to them is worth the cost of the drug.
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.