GlaxoSmithKline (GSK) last week announced a new partnership with the genetic testing company 23andMe to research and develop medical treatments using de-identified DNA data—but some experts are raising patient consent concerns.
Background: Drugmakers seek access genetic data
The move comes as pharmaceutical companies increasingly look to access and analyze consumers' genetic data, Medscape reports. 23andMe in recent years has collaborated on research with scientists from Genentech, GSK, Janssen, and Pfizer.
The U.K. Biobank also has given six major pharmaceutical companies—AbbVie, Alnylam, AstraZeneca, Biogen, Pfizer, and Regeneron—exclusive access to its genetic data for a year in exchange for the companies covering the cost of sequencing DNA from 500,000 participants. Meanwhile, Regeneron and Geisinger Health System have partnered to sequence the DNA of 250,000 Geisinger patients.
About the partnership
Under the four-year partnership, GSK will invest $300 million in 23andMe and will gain have access to de-identified DNA data from the majority of 23andMe's five million customers. More than 80% of 23andMe's customers have consented to participate in research, 23andMe said.
The two companies plan to use 23andMe's database of genetic and phenotypic data to help:
- Identify and recruit patients for clinical trials targeting specific diseases;
- Identify patient subgroups who are more likely to respond to certain treatments; and
- Improve the design and development of drugs.
For example, the companies plan to use 23andMe's database to recruit patients to participate in clinical trials on a Parkinson's disease treatment GSK is developing. According Medscape, the treatment is "an inhibitor of the leucine-rich repeat kinase 2 (LRRK2) gene, which encodes the protein dardarin." The companies will be able to use 23andMe's data to recruit patients who know their LKKR2 variant status. The companies in a release said, "Together, GSK and 23andMe are expected to more effectively target and rapidly recruit patients with defined LRRK2 mutations in order to reach clinical proof of concept."
GSK and 23andMe will equally co-fund all activities under the partnership and will share in the revenue from treatments developed under the partnership. The companies will have certain rights to lower funding shares for particular collaborations and have the option to extend their collaboration for an additional year.
Reaction
Several experts have raised concerns over the partnership between GSK and 23andMe.
Arthur Caplan, director of the Division of Medical Ethics at New York University's Langone Medical Center, said he is concerned over whether 23andMe customers will fully comprehend what they are agreeing to when they use 23andMe's genetic testing kits and consent to having researchers use their data. Caplan said, "They may have checked the box that said, 'Yes, I'd like to be in medical research,' but it doesn't say, 'Yes, I'd like to send in my DNA and pay you so you can sell it at a profit to" GSK. He explained, "Medical research sounds noble. There's always a bit of a bait-and-switch."
Another concern is whether the treatments developed based on 23andMe data will be beneficial to everyone, Caplan said. Based on 23andMe's customer base, Caplan said it is likely that "minorities [will be] underrepresented" in the data.
Kayte Spector-Bagdady, chief of the Research Ethics Service in the Center for Bioethics and Social Sciences in Medicine at the University of Michigan in Ann Arbor, similarly said 23andMe's customers are likely to be Asian or white who are educated and have higher incomes—which is a problem with genetic profiles in biobanks globally. She said, "Structurally, it's hard to get around that problem" with private companies, but NIH's "All of Us" program aims to collect DNA samples from one million people who represent a broader range of ethnic, racial and socioeconomic groups.
Spector-Bagdady also noted that it could be years before agreements like GSK and 23andMe produce significant results. She said, "We are definitely still in phases of data collection and application, as opposed to astronomical advances in the way we do medicine" (Frellick, Medscape, 7/27; Zhang, The Atlantic, 7/27; 23andMe release, 7/25; CNBC, 7/25).
What providers should know about genetic testing and other new clinical innovations
Hospitals and health systems need to prepare for a new wave of clinical innovation, especially as leaders read about the promise of patient-generated data, artificial intelligence, and precision medicine. But which emerging innovations have the potential to truly transform health care delivery?
This research report explores the clinical technology pipeline to help health care leaders become more conversant in the major vectors of innovation, leading applications of new technologies, and the business implications for established providers.