MedicalResearch.com Interview with:
Steven Woloshin, MD MS
Professor of The Dartmouth Institute
Professor of Medicine
Professor of Community and Family Medicine
The Center for Medicine in the Media
Dartmouth Institute for Health Policy and Clinical Practice
Lebanon, New Hampshire
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: There has been a lot of debate about the legal maneuvers (ie, transferring patents to the Mohawk Indians) Allergan has employed to delay marketing of generic alternatives to Restasis (cyclosporine ophthalmic emulsion 0.05%). But there is a more fundamental question that has received little attention: Does Restasis work? It is not approved in the European Union, Australia or New Zealand where registration applications were “withdrawn prior to approval due to insufficient evidence of efficacy” in 2001. Although Canada approved Restasis, its national health technology assessment unit, unconvinced of meaningful benefit, recommended Canada not pay for it – according to our research, no Canadian provincial or federal drug plan currently does. Nevertheless, Americans have spent $8.8 billion in total sales between 2009 and 2015 on Restasis, including over $2.9 billion in public monies through Medicare Part D.
MedicalResearch.com: What should readers take away from your report?
Response: Restasis is only approved by FDA to increase tear production as measured on a test eye doctors do (Schirmer test which assesses the amount of moisture on a filter-paper strip 5 minutes after placed in the eyelid) – this is not something people feel. We argue that Allergan’s disease awareness campaign for dry eye disease and promotional materials for Restasis imply that the drug improves symptoms. Restasis is not approved to reduce any of the symptoms of dry eye disease because FDA was not convinced the evidence supported such claims.
Disclosures: Dr. Lisa Schwartz and I have served as medical experts in testosterone litigation.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Schwartz LM, Woloshin S. A Clear-Eyed View of Restasis and Chronic Dry Eye Disease. JAMA Intern Med. Published online January 02, 2018. doi:10.1001/jamainternmed.2017.7904
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