Less than a month after the family of Henrietta Lacks reached a settlement with Thermo Fisher over its use of Lacks’ cells, another drugmaker stands accused of profiting from a racist medical system.
Henrietta Lacks’ estate this week filed a lawsuit against Ultragenyx in Maryland federal court. The lawsuit accuses Ultragenyx of profiting unlawfully from cells taken from Lacks without her consent more than 70 years ago.
Ultragenyx has allegedly made a “fortune” by using Lacks’ cells as a “factory to make its ‘proprietary’ gene therapy products,” Lacks’ estate argues in court documents filed this week.
The company did not immediately respond to Fierce Pharma’s request for comment on the lawsuit.
Back in the early 1950s, Lacks had a sample of her cervical cells taken without her consent by a white doctor working in the racially segregated ward at Johns Hopkins Hospital. While most cell samples die shortly after removal from the body, Lacks’ cells survived and reproduced in the lab. This means Lacks’ cells can be cultivated into a cell line capable of reproducing indefinitely under laboratory conditions. Lacks’ cultivated cell line is known as the HeLa cell line.
But the troubling provenance of Lacks’ cultivated cell line isn’t lost on the life sciences community these days, Lacks’ estate argues.
“While it was not known for decades to medical researchers outside Johns Hopkins that HeLa cells were Mrs. Lacks’s cells … it was well understood within the scientific community that the cell line was the product of non-therapeutic medical experimentation on Black patients by physicians at John Hopkins,” they explained.
The estate’s main contention against Ultragenyx hinges on the company’s production of adeno-associated virus (AAV) vectors for gene therapies. Ultragenyx has positioned AAV-based gene therapy as a “central pillar” of its business, while its “purported competitive advantage is the theft of Mrs. Lacks’s cells,” the lawsuit states.
While many of Ultragenyx’s better-known and approved therapies are biologics—drugs like the X-linked hypophosphatemia antibody Crysvita or the Regeneron-partnered cholesterol med Evkeeza—the company has more than five AAV-based gene therapies at various stages across its pipeline. The company’s most advanced gene therapy prospect is UX111, an AAV9 gene therapy designed to tackle Mucopolysaccharidosis type IIIA (MPS IIIA), which causes progressive destruction of nerve cells.
The lawsuit further claims Ultragenyx’s answer to the challenge of growing AAV vectors was to “commercialized for profit Mrs. Lacks’s stolen cells to produce AAV vectors at a massive scale.”
Viral vectors have proved a recent sticking point for many in the industry. Put simply, viral vectors are engineered viruses used to deliver gene therapies, gene-modified cell therapies (like Novartis’ CAR-T Kymriah) and certain vaccines. But their role in so many different medicines, coupled with manufacturing approaches that simply haven’t kept pace, has created a recent shortage of viral vectors, Global Data previously reported.
To hear Lacks’ estate tell it, Ultragenyx treats Lacks’ cells “like a dairy farm treats cows,” milking them for AAV vectors to “sell as chattel” and using Lacks’ body as a “mere manufacturing tool.”
For its alleged transgression, Ultragenyx is being asked to hand over its “ill-gotten gains” to Lacks’ estate.
Specifically, Ultragenyx is being asked to forfeit “the full amount of its net profits obtained by commercializing the HeLa cell line” to Lacks’ descendants.
The estate also seeks a permanent enjoinder against future use of Lacks’ cells “without the permission of the Estate.”
The timing of the lawsuit isn’t great for Ultragenyx, which earlier this summer christened a new 110,000-square-foot facility utilizing its producer cell line manufacturing platform for AAVs.
Meanwhile, the Lacks estate’s legal battle with Thermo Fisher came to an end earlier this month. At the start of August, the company and Lacks’ estate reached a confidential settlement. Much like Ultragenyx, Thermo Fisher was accused by the family of reaping billions of dollars by using Lacks’ HeLa cells for years, despite knowing about the cell line’s suspect origin.