0
Correspondence |

Is There Any Reliable Clinical Evidence to Suggest That Acthar Is More Effective Than Other Forms of Corticosteroids in Treating Sarcoidosis and Other Diseases It Is Being Marketed to Treat? FREE TO VIEW

Mark L. Metersky, MD, FCCP
Author and Funding Information

Editor's Note: Authors are invited to respond to Correspondence that cites their previously published work. Those responses appear after the related letter. In the case of this letter, Mallinckrodt chose not to respond.

FINANCIAL/NONFINANCIAL DISCLOSURE: None declared.

CORRESPONDENCE TO: Mark L. Metersky, MD, FCCP, Division of Pulmonary and Critical Care Medicine, University of Connecticut School of Medicine, 263 Farmington Ave, Farmington, CT 06030-1321


Copyright 2016, American College of Chest Physicians. All Rights Reserved.


Chest. 2016;149(3):886. doi:10.1016/j.chest.2015.11.027
Text Size: A A A
Published online

I read with interest the advertisement for “FDA-Approved Acthar” (repository corticotropin injection) for symptomatic sarcoidosis in the October issue of CHEST. Acthar is being marketed by Mallinckrodt Pharmaceuticals to pulmonologists for the treatment of sarcoidosis. The U.S. Food and Drug Administration approval for this drug was obtained decades ago, when the only requirement for approval was that a drug be proven to be safe. I was surprised to see this advertisement because there is no physiological reason to believe that injectable corticotropin is any safer or more effective than oral corticosteroids. While the advertisement lists all of the precautions and complications that would be expected for corticosteroid therapy, no studies in support of its use are provided, nor could I find any such data from any clinical trials at either PubMed or Clinicaltrials.gov, or at the company’s website (https://www.actharpulmonology.com). It is telling that in 2012, before Mallinckrodt began heavily marketing the drug, at least one-half of the most frequent prescribers of Acthar were promotional speakers or had other relationships with Questcor Pharmaceuticals, the manufacturer at the time.

There is one important difference between Acthar and oral corticosteroids, however. The average wholesale price of Acthar is a whopping $28,972.86 for a 5-mL vial, while oral corticosteroids are pennies a pill. Despite the lack of any reliable evidence of benefit of Acthar relative to oral corticosteroids, Mallinckrodt salespeople are currently detailing pulmonologists. Mallinckrodt sold $269 million of Acthar during the third quarter of fiscal year 2015, representing an increase from prior quarters. And sales are expected to increase further.

Because there may be unpublished or difficult-to-discover data regarding corticotropin, I am hoping that Mallinckrodt can direct me and the readers of CHEST to any reliable data that show that injectable corticotropin is more efficacious than oral corticosteroids in treating symptomatic sarcoidosis. If no such efficacy data exist, I see no justification for prescribing Acthar. The United States’ increasing medical costs are unsustainable, and this type of sales strategy by Mallinckrodt and other pharmaceutical companies only exacerbates the problem. Indeed, as I type this letter, the Senate is holding hearings on rapid escalations in drug costs.

Supplementary Data

Ornstein C. . Top Acthar prescribers in Medicare have ties to its maker. ProPublica. August 4, 2014;:- [PubMed]  :- [PubMed]journal
 
Anonymous. Missouri Department of Social Services, Pharmacy Program website.https://dss.mo.gov/mhd/cs/pharmacy/pdf/macspec.pdf. Accessed October 30, 2015.
 
TheStreet Transcripts. Mallinckrodt (MNK) earnings report: Q3 2015 conference call transcript.TheStreet. August 4, 2015.http://www.thestreet.com/story/13243466/5/mallinckrodt-mnk-earnings-report-q3-2015-conference-call-transcript.html. Accessed October 30, 2015.
 

Figures

Tables

References

Ornstein C. . Top Acthar prescribers in Medicare have ties to its maker. ProPublica. August 4, 2014;:- [PubMed]  :- [PubMed]journal
 
Anonymous. Missouri Department of Social Services, Pharmacy Program website.https://dss.mo.gov/mhd/cs/pharmacy/pdf/macspec.pdf. Accessed October 30, 2015.
 
TheStreet Transcripts. Mallinckrodt (MNK) earnings report: Q3 2015 conference call transcript.TheStreet. August 4, 2015.http://www.thestreet.com/story/13243466/5/mallinckrodt-mnk-earnings-report-q3-2015-conference-call-transcript.html. Accessed October 30, 2015.
 
NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Find Similar Articles
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543