December 2024 | Vaccine hesitancy, clearing patent thickets, antibiotic prescribing, and more
Program on Regulation, Therapeutics, and Law (PORTAL)
Part of the Division of Pharmacoepidemiology at Harvard Medical School and Brigham & Women's Hospital
New from PORTAL
Click on article titles to view the full text. Please contact?Matt Martin ([email protected])?for access to specific publications.
Original Analysis
Wouters OJ, Vogel M, Feldman WB, Beall RF, Kesselheim AS, Tu SS |?JAMA
In this special communication, Wouters and colleagues explore whether there is empirical justification for the greater legal protections given to biologics over small-molecule drugs in the US. They compare development times, clinical trial success rates, research and development costs, patent protection, market exclusivity periods, revenues, and treatment costs of biologics vs. small-molecule drugs. Overall, they found no evidence supporting differential treatment, suggesting that US law overly rewards the development of biologics relative to small-molecule drugs.
Carpenter D, Dardet ME, Bhaskar A, Rand LZ, Feldman W, Kesselheim AS |?Journal of Health Politics, Policy and Law
Carpenter et al. assess how policy uncertainty during the fall of 2020 influenced vaccine hesitancy in the US, with a focus on the evaluation and rollout of COVID-19 vaccines. They find that vaccine hesitancy spiked during this period, with the greatest increase among Democrats, Independents, Asian Americans, and Black Americans. Vaccine hesitancy after this spike did not decline uniformly, with Black Americans and college-educated individuals having more persistent hesitancy. These findings highlight the influence political instability may have on public confidence in vaccine safety and trust in federal health agencies.
Chao B, Whalen R, Kesselheim AS, Tu SS |?New England Journal of Medicine
Chao and colleagues demonstrate the potential impact of two proposed patent reforms, the?USPTO terminal disclaimer rule?and a bipartisan?bill to address patent thickets, using Humira and Revlimid as examples. They find these policies could significantly reduce patent thickets on biologic and small molecule products, with the USPTO rule reducing each product’s thicket by 43% and 70%, respectively, and the legislation making only 25 of 105 Humira patents and 12 of 30 Revlimid patents enforceable.
Martin MJ, Gabriele SME, Kesselheim AS, Tu SS |?JAMA
Martin and colleagues examine the characteristics of academic inventors listed on small molecule drug patents tied to US federal funding. They find that most government-funded inventors were senior researchers at major research institutions, many of whom had robust grant portfolios and prior industry experience. By contrast, early- and mid-career researchers were less represented, presenting an opportunity for NIH to expand its role in technology transfer by offering patent-related training and financing to these investigators.
Hong D, Kesselheim AS, Morlock R, Metlay JP, Powers JH, Feldman WB |?Journal of General Internal Medicine
In this analysis, Hong et al. present the results of a survey of 130 physicians' antibiotic prescribing practices. They find that, when deciding which antibiotic to prescribe, clinicians prioritize the drug’s clinical outcomes, including treatment efficacy and risk of side effects, over economic or public health-related factors like patient out-of-pocket costs or antibiotic resistance risk. Understanding this prioritization can aid the development of policy interventions to incentivize antibiotic development.
Sarpatwari A, Bendicksen L, Hawkins DS, Gore L, Bourgeois FT |?JAMA Pediatrics
Sarpatwari and colleagues compared the revenues generated by 6-month pediatric exclusivities to the cost of clinical trials required to obtain these exclusivities for a set of four oncology drugs tested by the Children’s Oncology Group. They find that manufacturer revenue generated by the added exclusivity greatly exceed the investment cost required to conduct the underlying trials, with an average revenue of $309 million per exclusivity compared to the average $156 million clinical trial cost.
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Viewpoint & Commentary
Ravinthiran J, Kesselheim AS, Knievel S |?Health Affairs Forefront
Ravinthiran and coauthors outline seven key factors federal agencies should consider when deciding whether to use march-in rights under the Bayh-Dole Act to address the high cost of prescription drugs with ties to federal funding. This framework proposes considering product revenues, excessive prices, remaining non-patent exclusivities, and a product’s broader patent portfolio, among other factors. The authors also present a set of nine drugs for which using march-in rights to lower prices may be reasonable.
Goh M, Kesselheim AS, Outterson K |?New England Journal of Medicine
In a letter to the editor, Goh and coauthors emphasize the lifesaving benefits of azithromycin demonstrated in the?AVENIR trial, which showed a 14% reduction in child mortality in Niger. They argue that concerns about antimicrobial resistance should not hinder access to this critical intervention, advocating instead for stewardship programs to monitor resistance without creating barriers to drug availability.
Upcoming Events
Private Equity in Health Care and Policy Options for Protecting Patients
Friday, February 7, 2025 | 12:30-1:30pm ET | Zoom
Private equity ownership of medical practices in the last decade has increased more than sixfold and takeovers are often associated with worse patient outcomes, including mortality, and increased prices. Current regulatory options appear insufficient to address these concerns. This session will examine trends in private equity in health care markets, effects on care, and law and regulatory solutions.
Featuring:
Sponsored by the?HMS Center for Bioethics,?Petrie-Flom Center at Harvard Law School, and?PORTAL. Support provided by the Oswald DeN Cammann Fund at Harvard University.
PORTAL in Action
Aaron Kesselheim?participated in an event hosted by the?Petrie-Flom Center at Harvard Law School?on health policy over the next four years, where he discussed potential changes at the FDA, CMS, and other federal health care agencies. He also led a?panel discussion?at the annual Princeton Conference hosted by?Brandeis University Heller School for Social Policy and Management.?November 11 & 15, 2024
Leah Rand?organized and?Maple Goh?moderated a?panel discussion?on the effectiveness and uncertain future of efforts to improve health care access for immigrant communities in the US This event was hosted by the?HMS Center for Bioethics, the?Petrie-Flom Center, and?PORTAL.?November 20, 2024
Benjamin Rome?spoke with Stephen Morrissey on the?New England Journal of Medicine?podcast?about the success of the initial round of Medicare drug price negotiations, building on a recent?perspective article?he co-authored with?Aaron Kesselheim?and?William Feldman.?November 20, 2024
Sean Tu?presented on general patenting principles related to pharmaceuticals during a seminar hosted by the?West Virginia School of Osteopathic Medicine.?He also was a commentator on work presented at the Mid-Atlantic Patent Works-in-Progress Colloquium at?Georgetown University Law School.?November 2024.
About PORTAL
The Program On Regulation, Therapeutics, And Law (PORTAL) is one of the largest research centers in the U.S. studying drug prices, drug policy, and the clinical, economic, and legal aspects of medication use and costs. PORTAL is housed within the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital (BWH) and Harvard Medical School. To assure independence,?no members of PORTAL have any personal financial relationships with pharmaceutical or medical device manufacturers.
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