Whose cells are they? Public perceptions about owning autologous cells

The growing international industry of unproven stem cell therapies around the globe has increasingly focused on using autologous cells and promoted therapies as services that enable patients to access the medical potential of their own cells. Mr Sipp’s examination of a set of public comments submitted to the US Federal Drug Administration reveals strong public opinions about the ownership of autologous cells lying with the individual they come from. However, this appears to contradict current legal interpretations of ownership rights for unprocessed cellular materials, which may have to be revisited and revised to address these issues.

What background and points are discussed?

In 2016 the FDA provided the opportunity for the public to comment on proposed guidance documents that addressed four topic regarding the regulation and use of autologous tissues and cells. The online FDA forum received a total of 6,962 comments. Surprisingly, Mr Sipp’s analysis of 400 randomly selected comments found that only three submissions actually addressed any of the four discussion topics. The vast majority of comments (383/400 or ~96%) expressed opposition to any form of government regulation at all. Mr Sipp notes that special interest groups likely made efforts to influence this public comment process, as there were many comments (64/400 or 16%) containing the same statement, “My cells are MY cells. They are not a drug, they are part of my body”. Analysis of the remaining comments reveals several general themes. Suspicion was expressed by many individuals, specifically the FDA’s treatment and reference to autologous cells as drugs, with over half (227/400 or ~57%) of comments using the word ‘drug’ in their comment. A subset of these presumed that the FDA categorizes autologous cells as drugs because it has been corrupted by pharmaceutical interests and establishes regulations to benefit the pharmaceutical industry. Another voiced theme in comments was that FDA regulations violate human rights over how one can use his or her body and body parts. The most prevalent theme Mr Sipp found in comments was that FDA regulations infringe on individuals’ ownership of their body and body parts. Words about “ownership” or “my own” cells or body appeared in 75% (300/400) of all the comments examined. Mr Sipp remarks that US law regards cells, tissues and other parts of the body as no one’s property unless they are modified and given value by the skill of another individual, an interpretation that generally conflicts with the views being expressed. Many comments about ownership also view FDA regulations as targeting and constraining consumers, when in fact, the FDA only has jurisdiction to regulate how businesses produce, market, and distribute products. Mr Sipp discusses in detail how clinics selling unproven therapies have successfully profited from (and promoted) these public views and the distrust of government oversight. Furthermore, clinics have shifted towards using autologous cell treatments over the years rather than cells from other sources or donors. This industry-wide convergence on autologous cell therapies is partly due to liberal interpretations of government regulations, but is also because autologous treatments better align with public sentiments about cell ownership and freedom for personal choice.