Do we own our cells? Do we have some intrinsic right to them once they are outside our bodies?
One of the arguments I hear most often from physicians at stem cell clinics and some clinic patients is that patients have an inherent right to ownership and almost unlimited use of their own stem cells, but over the years my own reading on this issue has suggested that actually their assumptions are not necessarily the actual reality.
At that link above you can read about some pretty striking examples of where cell ownership was not clearly established. Think of the case of Henrietta Lacks and the cell line HeLa.
The argument from individuals on their ownership-based use of their stem cells was reflected in public reactions to the FDA too. One of the most common comments on the FDA online docket related to oversight of stem cells was “My cells are my cells”.
Are they really though by law?
There is in fact no universal, intrinsic ownership or right to one’s own cells or tissues once they are removed from our bodies here in the U.S. that I know of. I’m not aware of any federal law, for instance, that says Americans have broad ownership of biological materials once they are removed from their bodies. It’s also not in the Constitution.
For those who argue ownership and right to use their cells such as stem cells once removed from their bodies, I’d be curious to hear if you have any concrete evidence to back that up in terms of specific language to this effect present in actual laws. The key thing seems to be that once part of us such as our cells is removed from our bodies it ceases to be part of us even if it is later implanted back into us. That former cell/tissue of ours has become a thing instead, and in some cases it is now a commercial product, particularly if it is modified in any way.
Let’s look at some examples.
- If you take the case of leftover blood samples in those tubes they use for blood tests on us, we do not seem to own those. In fact, as far as I know the medical organization that drew the blood probably owns those and can use them for research or other purposes if they are anonymized.
- If you bank your blood prior to a surgery, then I’m guessing that you would own that blood and the institution holding onto it for you cannot take it away, but are there actual laws or legal cases addressing this?
- If during surgery a physician removes a tumor or some normal tissue (e.g. fat, skin, etc.) in the process, as far as I know the patient does not own that material any more. It is routinely discarded or in some circumstances can be used for research.
- If a physician at a clinic or other entity removes stem cells from a patient, I doubt that the patient has any claim of ownership of those stem cells unless otherwise specified in a document that they and the provider both signed.
- If a party freezes gametes or embryos from IVF, then there would seem to be ownership there. Are there laws?
- If a party freezes stem cells in a bank, there seems to be a presumption of ownership there, but is that spelled out in the contract?
So there are potential cases both ways.
However, outside of banked blood, banked stem cells or reproductive materials, what about other cells such as those isolated in a same-day procedure or stem cells stored by a clinic in a freezer without expressly being paid by the patient to do so? Even in the first three cases, is there cellular ownership expressly by law?
I don’t think we consumers definitely own our externalized cells in all or even most cases.
Now let’s be clear, I’m not saying that this widespread lack of cell ownership is a positive thing. I’m just saying it is generally the reality today. If we don’t like it, maybe we should work for a law that establishes clear ownership.
One might argue that even absent definitive ownership by patients of their own cells once those cells are removed from the body, patients should still have rights to use those cells or products made from them without interference from the FDA, but that’s not quite the same thing as arguing this kind of assertion from the basis of ownership. To argue for wide freedom of use of stem cells without oversight also has major risks.
So for you patients out there arguing your wide rights to your stem cells, give this a bit more thought and do some reading on it. It seems likely that in fact the stem cell clinics that you visit actually would have a good case that they own your cells or at the very least ownership is not yours by default. Of course, the use of biological samples for research has a very positive role in biomedical science, but ownership is a tricky issue.
The bottom line is that if you are going to argue “my cells are my cells” meaning ownership of extracted, externalized and sometimes processed stem cells, you need to establish ownership based on the law. If there are in fact laws out there conferring patient ownership on stem cells, I’d love to hear about them.
For another view on some of the same questions, see “Our Bodies, Our Cells” by Mary Ann Chirba and Alice Noble.
Re consent, one could argue that patients, sometimes seriously ill, are forced — under duress — to sign away any rights to profits from their flesh, blood or cells because unless they sign away those rights, they will not be tested or treated to ease their affliction.
“John L. Moore, a leukemia patient who lost a historic property rights battle in which he claimed he deserved to share in the profits from an anti-cancer drug derived from cells taken from his spleen, has died.”
http://articles.latimes.com/2001/oct/13/local/me-56770
This issue was one of the most surprising parts of the Henrietta Lacks book for me. The fact that if your tissue makes an interesting antibody or protein, whoever took the biopsy can profit from your tissue and you have absolutely no rights to share in that profit at all.
The Moore case is fundamental when considering this issue, given that it rose to the level of the California Supreme Court. The case also served as part of the basis of a novel, Next, by Michael Crichton.
My recollection also is that when a patient or “donor” signs all those consent forms, one of the things they consent to is giving up all rights to profit from material extracted from their bodies.
Here is a link to a serious, but pro-industry look at the issues raised in the Crichton book.
https://www.researchgate.net/publication/228189619_'Next'_and_Michael_Crichton's_Five-Step_Program_for_Biotechnology_Law_Reform
In Canada, it seems that the excised tissue becomes the personal property of the institution that excised it:
http://news.nationalpost.com/news/canada/human-tissue-removed-for-medical-tests-is-personal-property-of-institution-not-person-it-came-from-ruling
Corollary, an institution is a person and flesh-and-blood-people have no rights in Canada…
Canada has gone to hell in a handbasket.
Do finger nail clippings removed by a manicurist remain legally my property? Does the hair on the floor around my barber chair remain legally mine? Do I have a property right to my tears blotted on a Kleenex tissue? Can I claim legal ownership for the flakes of skin that I shed everywhere I go throughout the day? I don’t know the answers. Just asking.
Alan,
Well, nail clippings, shed skin, etc. are not useful as medical products (at least I can’t think of a positive use). Stem cells have a lot of utility and in a sense are “worth” a great deal so it matters who owns them. Part of my point in this post is to point out to the community that once cells/tissues are removed from our bodies, we generally lose any ownership to them. So for instance, with a fat stem cell treatment, once the fat is liposuctioned out of the patient, that fat probably legally belongs to the clinic doing the procedure, and further if that fat is processed in any way (enzymatically digested, centrifuged, etc) turning it into a “product” then the patient/customer has even less chance of having any firm ownership claim. It’s an odd situation given that I think most of us like to believe that we’d have firm legal footing for ownership of our cells, but we don’t. Paul
“Does the hair on the floor around my barber chair remain legally mine?” Not in India! https://priceonomics.com/the-market-for-human-hair/
I have an idea. I have already made a standing offer to analyze cells that clinics take money to inject into people. How about if we start a bank of materials that clinics remove from patients and use for treatment of those patients? We can analyze them for their gene expression signatures, DNA integrity, and other characteristics even if they are not viable cryopreserved samples. A patient should be able to impose his or her right to have a sample of their own cells.
Of course, the tough part is getting funding for such an effort. Perhaps the clinics would pay for it?
Jeanne, this is a fabulous idea. But as you said, how to fund it? Kickstarter maybe? I doubt the clinics would be willing to pay or even cooperate. Paul
“If during surgery a physician removes a tumor or some normal tissue (e.g. fat, skin, etc.) in the process, as far as I know the patient does not own that material any more. It is routinely discarded or in some circumstances can be used for research.”
This is correct. Although we try to respect the rights of patients and families to do things like bury limbs and organs, we must at the same time protect the integrity of the medical record, including slides, blocks, and, under some circumstances, tissue. This standard also applies to samples of blood and body fluid.
Autologous blood donations, on the other hand, are not held to the same standards as hererologous units with regard to things like standards for the health of the donor and some of the testing, therefore it is generally not acceptable to release an autologous unit to another recipient. In this case, it has nothing to do with ownership, but rather with the safety of the recipients.
As for stem cells, personally, and this is just my opinion, I would hold them to the same standards as donated blood. If the cells are for autologous use, I think that it is not appropriate to use them for another recipient. If the cells are for heterologous use, then I think the donors should be managed, and the donations tested, in the same way as blood donors for the safety of the recipients.
Of course, none of this is intended to address the safety or efficacy of the stem cell therapy itself. That is a separate issue that, as far as I know, has not been addressed satisfactorily,
@Michael,
Thanks for adding your thoughts here.
Paul
What happens when a women gives birth. Is the child not made up of her and her partners cells? Does that child not belong to her after birthing and the cord is cut? If that is the case then she should not have to pay any further costs of looking after or bringing the child up?
David,
Interesting questions.
The baby is not made of the parents’ cells, but has its own cells with mixtures of the parents’ DNA. Also we don’t own our children, but are their parents so should “pay” costs because of that rather than ownership.
To the contrary, it is not unreasonable to talk of a baby being made by a long string of fortuitous circumstances which include two cells: a sperm cell (father) and an egg cell (mother).
As to “ownership of children”, the idea just won’t go away:
http://listverse.com/2014/01/07/10-horrifying-examples-of-modern-day-child-slavery/
I would say that the international legal custom of investing sovereignty in the nation-state is the equivalent of saying that all persons are owned.