CHEST Guidelines-Is-There-Any-Reliable-Clinical-Evidence-to-Suggest

Is-There-Any-Reliable-Clinical-Evidence-to-Suggest

Pdf Summary

In a letter published in <em>CHEST</em>, Dr. Mark L. Metersky raised concerns over the marketing of Acthar, a repository corticotropin injection, by Mallinckrodt Pharmaceuticals for the treatment of sarcoidosis. Dr. Metersky questioned the efficacy of Acthar compared to traditional oral corticosteroids since Acthar was approved by the FDA decades ago based merely on its safety, not its comparative effectiveness. He highlighted that no clinical studies support the idea that Acthar is superior to oral corticosteroids, despite its significant price difference. A 5-mL vial of Acthar is priced exorbitantly high at approximately $28,972.86, whereas oral corticosteroids are considerably cheaper.

Dr. Metersky noted that prior to Mallinckrodt's aggressive marketing of Acthar, promotional speakers or those with ties to previous manufacturer Questcor Pharmaceuticals ranked among the top prescribers of the drug. Despite the absence of robust evidence demonstrating Acthar's advantage over cheaper alternatives, the drug's sales soared, with $269 million in sales reported during the third quarter of 2015, and expectations of further growth.

Dr. Metersky urged Mallinckrodt to disclose any reliable comparative efficacy data to justify the continued promotion and prescription of Acthar. His letter illustrates growing concerns over the unsustainable rise in medical costs sparked by such pharmaceutical marketing strategies. Although Acthar is being heavily marketed, there appears to be no supporting evidence of its superior efficacy, leading to questions about its justification amidst the Senate's examination of rapidly increasing drug costs. Mallinckrodt chose not to respond to the letter. Dr. Metersky underscored the need for evidence-based prescription practices to curb soaring healthcare expenses.

Keywords

Acthar

Mallinckrodt Pharmaceuticals

sarcoidosis

corticosteroids

drug pricing

pharmaceutical marketing

comparative efficacy

healthcare costs

FDA approval

evidence-based medicine