Cell Therapies and their Legal Discontents

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.

Read More

blue brain hovers over bright blue circle.

Is OI the New AI? Questions Surrounding “Brainoware”

By Adithi Iyer

The idea of artificial intelligence is just seeping into our collective consciousness, but as we watch new developments in the space, the true “new kid on the block” may be a new type of infused human-technology intelligence — one derived from a blob of cells no larger than a grain of rice. These new units of computational prowess are brain organoids, grown in-lab and capable of producing very basic, but real-time, neurological activity. Brain organoids are a specific, and arguably the most interesting, subset of organoid models that are just beginning to enter legal debates.

Read More

Culturing cells in tissue culture plates.

R&D Mini-Me? New Legal Questions for Organoids

By Adithi Iyer

I have written previously about the not-so-distant possibility and promise of regenerative medicine, an area concerned with therapies that encourage the body to repair or heal itself. Cell-mediated and tissue-based technologies hold promise in inducing self-repair from within the body, and they’re making their way to market in traditional medicine. Much has been made of recently discussed CAR-T cell therapies for cancer, which have been around since 2017, and in-human sickle cell treatment Casgevy. Such applications of regenerative medicine and tissue engineering are wide-spanning and range across the bench-to-bedside pathway.

One application of regenerative medicine gaining some ground in the R&D space is the organoid. Organoids are lab-grown masses of cells and tissue that assemble to form miniature organs or organ systems in vitro. They come, too, in different forms and types, and while some organoid applications are heavily modified for specific functions, many are meant to recreate and model the naturally occurring organ systems we would find in our own bodies.

Organoids may sound especially futuristic, but are currently used regularly in labs for different research and therapeutic applications. A functional “organ” model not attached to a human body could offer the opportunity to model diseases and test treatments in real time without the need for an animal model (like the mice used today), especially in preclinical and early clinical trials for new drugs. Organoids generate information and data, and a single organoid model can even be hooked up to a “system” with other organoids to model systems and interrelated processes at once. The production of these models occurs in-lab, often involving stem cells that can divide and organize into tissues and organs on their own.

Read More

Person hands keys into another person's outstretched hand.

We May Not ‘Own’ Our Bodies. Should We?

By Adithi Iyer

As the provision of human tissue leaves the research realm and becomes a bona fide consumer transaction, our legal responses to these developments will be most effective when we know what we want to protect, and how.

Perhaps the most famous discussion around tissue “donation” comes from the story of Henrietta Lacks and her family. Ms. Lacks is the namesake and unknowing donor of HeLa cells, and subject of the Rebecca Skloot bestseller, The Immortal Life of Henrietta Lacks. In a settlement obtained just this past summer with manufacturing giant ThermoFisher, the Lacks estate (Ms. Lacks herself died of an aggressive cervical cancer in 1951) obtained a confidential payment for the unconsented taking of her cells for research. The settled case was built on an unjust enrichment claim, and while this wasn’t decided on the merits, it raises the question of whether a provision of tissue is a transfer of value. If so, what are our ownership stakes in that value? Read More

Operating room Doctor or Surgeon anatomy on Advanced robotic surgery machine.

Protecting Consumer Privacy in DTC Tissue Testing

By Adithi Iyer

In my last piece, I discussed the hypothetical successor of 23andme — a tissue-based direct-to-consumer testing service I’ve called yourtissueandyou — and the promise and perils that it might bring in consumer health information and privacy. Now, as promised, a closer look at the “who” and “how” of protecting the consumer at the heart of direct-to-consumer precision medicine. While several potential consumer interests are at stake with these services, at top of mind is data privacy — especially when the data is medically relevant and incredibly difficult to truly de-anonymize.

As we’ve established, the data collected by a tissue-based service will be vaster and more varied than we’ve seen before, magnifying existing issues with traditional data privacy. Consumer protections for this type of information are, in a word, complicated. A singular “authority” for data privacy does not exist in the United States, instead being spread among individual state data privacy statutes and regulatory backstops (with overlapping sections of some federal statutes in the background). In the context of health, let alone highly sophisticated cell signaling and microenvironment data, the web gets even more tangled.

Read More

Doctor or surgeon with organ transport after organ donation for surgery in front of the clinic in protective clothing.

Organ Transplant Candidates Who Use Medical Cannabis Face Discrimination

By Hannah Rahim

Medical cannabis users in the U.S. face discrimination in seeking health care services, including restrictions against obtaining solid organ transplants.

Considering growing evidence that medical cannabis (which is legal in 38 states, 3 territories, and the District of Columbia) does not compromise post-transplant health outcomes, policymakers should rethink the use of cannabis consumption as a contraindicator to transplantation and should adopt legal protections to prevent undue discrimination towards medical cannabis users.

Read More

sample tube in female hands with pipette.

Why We Should Care About the Move from Saliva to Living Cells in Precision Medicine

By Adithi Iyer

The cultural, informational, and medical phenomenon that is 23andMe has placed a spotlight on precision medicine, which seeks to personalize medical care to each patient’s unique makeup. Thus far, advances in direct-to-consumer genetic testing have made saliva-sample sequencing services all the rage in this space, but regenerative medicine, which relies on cells and tissues, rather than saliva, now brings us to a new, increasingly complex inflection point.

While collecting and isolating DNA samples from saliva may offer a wealth of information regarding heredity, disease risk, and other outflows of the “instruction manual” for patients, analyzing cells captures the minutiae of patients that goes “beyond the book” and most closely informs pathology. Disease isn’t always “written in the stars” for patients. Epigenetic changes from environmental exposures, cell-to-cell signaling behaviors, and the mutations present in diseased cells all profoundly inform how cells behave in whether and how they code the instructions that DNA offers. These factors are critical to understanding how disease materializes, progresses, and ultimately responds to treatment. This information is highly personal to each patient, and reflects behavioral factors as well as genetics.

Regenerative medical technologies use cell- and tissue-based methods to recapitulate, bioengineer, and reprogram human tissue, making a whole suite of sci-fi-sounding technologies an ever-closer reality. With cell-based and other regenerative therapies entering the market (making up an entire FDA subgroup), it well worth considering how cell-based medicine can advance the world of personalized consumer testing. In other words, could a corporate, direct-to-consumer cell-based testing service be the next 23andMe? And what would that mean for patients?

Read More

Fertilized human egg cells dividing.

What the Law and Bioethics Tell Us About Synthetic Human Embryos

By Barbara Pfeffer Billauer

A synthetic embryo can now be constructed from very early pre-embryonic cells – without the need for an egg or sperm. These were initially created in mice. In April, researchers in China published about their creation of synthetic monkey embryos. In June, it was reported that the first synthetic human models were apparently created. This development throws a moral monkey-wrench into the current moratoria on embryonic research after 14 days. But there are more problems ahead.

Read More

Cell culture.

A New Theory for Gene Ownership

By James Toomey

The story of Henrietta Lacks is surely among the most famous in the history of bioethics, and its facts are well-known. Ms. Lacks sought treatment for cervical cancer. After conducting a biopsy on her tumor, her doctors learned that her cancer cells reproduced uniquely effectively. Without her knowledge or consent, her doctors derived from the cells the HeLa cell line — the world’s first immortal human cell line, worth billions and a driver of the biotechnology revolution. Lacks died in poverty.

No doubt her doctors’ behavior was not consistent with today’s standards of informed consent. But another question has remained more persistently challenging — did the doctors steal something from Lacks? Did she own the cells of her tumor? Or, perhaps more precisely, because few argue that HeLa is really the same thing as Lacks’s tumor cells, did she own the genetic information contained in her tumor?

In a new paper, Property’s Boundaries (forthcoming in the Virginia Law Review, March 2023), I develop a theory of what can and cannot be owned to answer these kinds of questions — pervasive in bioethics, from debates about ownership of organs to embryos. My conclusion, in short, is that because the essence of the idea of ownership is a relationship of absolute control, anything that can be the subject of human control can, in principle, be owned. But that which we cannot control we cannot own. From this perspective, Henrietta Lacks owned the cells of her tumor, and the tumor itself. But the genetic information within them — facts about the universe subject to no human control — simply cannot be owned, by her or anyone else.

Read More