Off-Patent Prescription Drugs in the U.S. are Being Snatched up for Profit, Deepening Health Inequities
By Dominique Rinfret
This post is part of a series of opinion pieces in diverse mediums focusing on the theme “What makes you mad about global health?” These submissions are by McGill students who were part of the course PPHS 511 Fundamentals of Global Health in Fall 2021.
Daraprim is a classic. Not a classic like the Beatles or Catcher in the Rye, but a classic example of how a poorly regulated pharmaceutical industry in a profit-driven society seriously harms people. Daraprim is an anti-parasitic drug used to treat malaria and infections like toxoplasmosis that surged in price from around $13.50 to $750 a pill in 2015 when it was acquired by Turing Pharmaceuticals (1). Somewhat surprisingly, Daraprim is not a brand-name drug, but one of the over 100 off-patent, generic drugs that have been capitalizing on their relative monopolies in the market and lack of regulation (2).
News headlines in the past decade have highlighted the prevalence of pharmaceutical companies buying cheap, off-patent drugs and dramatically raising their prices. When Valeant Pharmaceuticals acquired both Isuprel and Nitropress, two crucial heart condition medications, they raised Isuprel from $200 to around $1,400 a vial, and Nitropress, from around $250 to $800 (1,3,4). In 2015, when Rodelis Therapeutics acquired the drug-resistant TB medication Cycloserine, they hiked the treatment price from $500 to $10,800, though it was returned to a non-profit and its pre-surge price following public backlash (1,5).
This price surge in these generics disproportionately affects vulnerable communities. For instance, patients needing Daraprim to treat toxoplasmosis are immunocompromised, such as people living with HIV/AIDS, and have low income and social support (5). A host of other generics that saw price increases, like those for heart conditions, hypertension, and diabetes, also disproportionately impact low-income, racial and ethnic minorities due to systemic inequalities that lead to higher incidences of these conditions (6,7). These increasing out-of-pocket costs for these drugs diminish access and increase drug rationing, further enforcing social inequities that perpetuate health inequities in a vicious cycle (6,8).
How can this be allowed to happen? These generic drugs should be cheap, effective alternatives affordable to all. However, since there is little regulation on how drugs should be priced, whether brand name or generic, drug companies with a dominant hold of the market can keep prices inflated, despite the outcry from doctors and patients alike (5). The U.S. Senate has recognized the issue and investigated the surges in generic drug pricing at length, and made efforts to promote the production of more generics, yet this has not been enough to keep drug prices in check (5).
While it is true that insurance companies absorb most of the cost for these medications, the harm does not evaporate. Patients still pay a portion of the market drug costs that are covered by private insurance or Medicare, and hospitals and insurance companies paying full (or only slightly discounted) prices of these crucial drugs, like Isuprel and Nitropress, lose millions of dollars that should be used to improve patient care (4,5). Physicians have also spoken out about the cuts in hospital services, like opioid crisis initiatives and food and transportation for low-income communities, that these price hikes have caused (5). Most strikingly, the increases in price do affect access: a study of 47 hospitals found that the price hikes of Nitropress and Isuprel slashed their usage, while similar drugs with steady pricing increased in use (9).
We must enact legislative changes to keep generic drugs affordable and accessible to all. First, we need laws to prevent dramatic price surges in short periods of time to protect patients from opportunistic price hikes. Second, but more importantly, the U.S. must consider reconfiguring its healthcare system to ensure consistent, affordable access to all.
References:
Gupta R, Bollyky TJ, Cohen M, Ross JS, Kesselheim AS. Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study. BMJ. 2018;360:k831. Published 2018 Mar 19. doi:10.1136/bmj.k831
Sudden Price Spikes in Off-Patent Drugs: Perspective from the Front Lines: Hearing Before the S. Special Comm. on Aging, 114th Cong., 1st Sess. (Dec. 9, 2015)
Knight BP. The Rising Costs of Isoproterenol . Hmpgloballearningnetwork.com. https://www.hmpgloballearningnetwork.com/site/eplab/articles/Rising-Costs-Isoproterenol. Published March 2017. Accessed November 25, 2021.
Thomas K. Valeant promised price breaks on drugs. heart hospitals are still waiting. The New York Times. https://www.nytimes.com/2016/05/12/business/valeant-promised-price-breaks-on-drugs-heart-hospitals-are-still-waiting.html. Published May 12, 2016. Accessed November 25, 2021.
S. Rept. 114-429 - SPECIAL REPORT of the U.S. SENATE SPECIAL COMMITTEE ON AGING on the SUDDEN PRICE SPIKES IN OFF-PATENT PRESCRIPTION DRUGS: THE MONOPOLY BUSINESS MODEL THAT HARMS PATIENTS, TAXPAYERS, AND THE U.S. HEALTHCARE SYSTEM114th Congress (2015-2016)
BP-Weeks M. Racial Health Disparities are fueled by Big Pharma's patent monopolies [op-ed]. Colorlines. https://www.colorlines.com/articles/racial-health-disparities-are-fueled-big-pharmas-patent-monopolies-op-ed. Published August 24, 2020. Accessed November 25, 2021.
Office of Minority Health, Office of the Director, CDC. Health disparities experienced by Black or African Americans --- United States. Centers for Disease Control and Prevention. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5401a1.htm. Published 2005. Accessed November 25, 2021.
Leonhardt M. Americans are skipping medically necessary prescriptions because of the cost. CNBC. https://www.cnbc.com/2020/02/26/people-skipping-medically-necessary-drugs-because-they-cost-too-much.html. Published February 27, 2020. Accessed November 25, 2021.
Khot UN, Vogan ED, Militello MA. Nitroprusside and isoproterenol use after major price increases. New England Journal of Medicine. 2017;377(6):594-595. doi:10.1056/nejmc1700244
Acknowledgments:
We would like to thank Professor Madhukar Pai for setting and sharing this assignment results with us and the teaching assistants Alexandra Jaye Zimmer, Lavanya Huria and Angie Sassi for their support in coordinating the results.