In February, the news broke that the Food and Drug Administration (FDA) had approved a “first of its kind” new cancer therapy. Iovance’s AMTAGVITM, the subject of the approval, is a personalized immunotherapy for advanced melanoma. To be treated, adult patients who are ineligible for surgery or have metastatic disease provide their tumor cells to their medical team. Tumor-attacking T-cells are isolated from the sample, grown and multiplied in-lab, and re-infused into the patients for a turbo-charged immune response that, according to clinical trial data, have shown promise in shrinking patients’ tumors. This drug joins a list of others that work something like this: Patients provide cell samples, which are then isolated and modified or expanded in-lab, and then eventually infused back into their bodies. This general patient experience, though, indicates a different model from what we have seen before. These “living drugs” use your own cells, but better, to fight these daunting battles.
Category: Medical devices
Symposium Introduction: Addressing Technoableism: Reforming Infrastructure and Disability Representation
By Ashley Shew
Far too often, when people write and talk about technology and disability, stories are deeply shaped by ableism. Often when devices are painted as “solving the problem of disability” or “empowering disabled people,” they suggest that being disabled is itself a problem, and that people should try to be as nondisabled as possible. But pretending to be nondisabled is not a great way to live — to be in hiding or denial, to not give your body and mind the rest they deserve, to hurt yourself trying to live up to expectations and infrastructure sometimes literally designed to keep you out. Technology itself gets painted as heroic and important — and, please, investors, throw more money at the tech industry — when any disability is mentioned. Disability is often appealed to as a justification for technological development, and as a moral imperative toward investment in technological research. This is technoableism as I describe it in my book, Against Technoableism: Rethinking Who Needs Improvement.
Who’s Liable for Bad Medical Advice in the Age of ChatGPT?
By Matthew Chun
By now, everyone’s heard of ChatGPT — an artificial intelligence (AI) system by OpenAI that has captivated the world with its ability to process and generate humanlike text in various domains. In the field of medicine, ChatGPT already has been reported to ace the U.S. medical licensing exam, diagnose illnesses, and even outshine human doctors on measures of perceived empathy, raising many questions about how AI will reshape health care as we know it.
But what happens when AI gets things wrong? What are the risks of using generative AI systems like ChatGPT in medical practice, and who is ultimately held responsible for patient harm? This blog post will examine the liability risks for health care providers and AI providers alike as ChatGPT and similar AI models increasingly are used for medical applications.
Governing Health Data for Research, Development, and Innovation: The Missteps of the European Health Data Space Proposal
By Enrique Santamaría
Together with the Data Governance Act (DGA) and the General Data Protection Regulation (GDPR), the proposal for a Regulation on the European Health Data Space (EHDS) will most likely form the new regulatory and governance framework for the use of health data in the European Union. Although well intentioned and thoroughly needed, there are aspects of the EHDS that require further debate, reconsiderations, and amendments. Clarity about what constitutes scientific research is particularly needed.
Could Self-Operated Assisted Suicide Devices Be Coming to a Town near You?
By Matthew Chun
A scientist’s high-tech approach to assisted suicide is already available for use in Switzerland and is actively being campaigned for in the United Kingdom. . . Could the United States be next?
AI in Digital Health: Autonomy, Governance, and Privacy
The following post is adapted from the edited volume AI in eHealth: Human Autonomy, Data Governance and Privacy in Healthcare.
By Marcelo Corrales Compagnucci and Mark Fenwick
The emergence of digital platforms and related technologies are transforming healthcare and creating new opportunities and challenges for all stakeholders in the medical space. Many of these developments are predicated on data and AI algorithms to prevent, diagnose, treat, and monitor sources of epidemic diseases, such as the ongoing pandemic and other pathogenic outbreaks. However, these opportunities and challenges often have a complex character involving multiple dimensions, and any mapping of this emerging ecosystem requires a greater degree of inter-disciplinary dialogue and more nuanced appreciation of the normative and cognitive complexity of these issues.
Monthly Round-Up of What to Read on Pharma Law and Policy
By Ameet Sarpatwari, Liam Bendicksen, Alexander Egilman, and Aaron S. Kesselheim
Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.
Below are the citations for papers identified from the month of August. The selections feature topics ranging from a discussion of opportunities for improving the use of U.S. Food and Drug Administration (FDA) advisory committees, an analysis of the key patents covering drugs recently approved by the FDA, and an examination of high-risk cardiovascular devices approved by the FDA for use in children and adolescents. A full posting of abstracts/summaries of these articles may be found on our website.
Get Your Story Straight: Patent Office Cracks Down on Inconsistent Statements Made Before the FDA
By Matthew Chun
In an effort to “promote robust and reliable patents” and increase access to life-saving drugs, the United States Patent and Trademark Office (USPTO) recently issued a Federal Register Notice clarifying the responsibilities of individuals involved in the patent application process.
In the July 29, 2022 notice, the USPTO set forth its views on the “duty of disclosure” and “duty of reasonable inquiry,” emphasizing the importance of consistency between statements made to the USPTO, the FDA, and other governmental agencies. While the goals of the Federal Register Notice are certainly noble, its disruptive practical effects leave much to be desired.
Monthly Round-Up of What to Read on Pharma Law and Policy
By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, and Aaron S. Kesselheim
Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.
Below are the citations for papers identified from the month of March. The selections feature topics ranging from a discussion of patient assistance programs and the Anti-Kickback Statute, to an analysis of the effects of state opioid prescribing laws on the use of opioids and other pain treatments, to an evaluation of the association between regulatory drug safety advisories and changes in drug use. A full posting of abstracts/summaries of these articles may be found on our website.
Lessons Learned from the COVID-19 Pandemic: The Future for Diagnostics
By Matthew Bauer and Nicole Welch
Diagnostic tests have changed in the eyes of many Americans across the COVID-19 pandemic.
The traditional site of diagnostic testing, the doctor’s office, has taken a back seat during the COVID-19 pandemic. We can now receive at-home antigen tests in the mail, drive through PCR tests at local sports stadiums, and our workplace cafeteria may serve as a de facto COVID-19 testing site.
The new paradigm of fast, easily accessible, and user-based diagnostics helps to reduce barriers for people to test for COVID-19.
However, nearly all these tests give binary results of yes or no for detecting a specific piece of the SARS-CoV-2 virus. As we look ahead, both the ongoing COVID-19 pandemic and future pandemics will require binary tests, but also tests that give us more granular information about the disease. These changes should be integrated into future diagnostic paradigms, empowering clinical diagnostics to meet both the needs of patients and the broader public health community. Read More