Our bodies, not our cells?

leftover-bloodDo 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.

Meeting review of unique stem cell ethics symposium @UCDAVIS

On Thursday here at UC Davis School of Medicine we held our second annual Stem Cell Ethics Symposium. The symposium was organized by Drs. Mark Yarborough and Nanette Joyce as well as me.

In this post I report on key take homes from the meeting and summarize the specific talks.

As far as I know, this is one of the few events in the world where there is such a wide diversity of stakeholders present both as speakers and in the audience to specifically discuss stem cell ethics for a full day. The participants included numerous patients and patient advocates, bioethicists, stem cell researchers, physicians, attorneys, institutional compliance officers, and more.

Stem cell ethics meeting

One of the things that I most appreciated about this meeting is that diverse views were welcomed and we dealt head on with some of the most challenging ethical issues related to stem cells.

I also got to meet in person some people I had only previously known on-line including keynote speaker Tim Caulfied, patient advocate Ted Harada, and advocate and frequent commenter on this blog, Cathy Danielson, which was fantastic. My colleague Leigh Turner was also present. Old friend and Huntington’s Disease advocate, Judy Roberson, was there as well. You can see the picture above of Ted, Judy, and me.

After a great introduction by our new Dean of the School of Medicine, Dr. Julie Freischlag, Nanette Joyce started things off with a very powerful talk about her experiences with her ALS patients. Her patients are facing incredibly intense challenges as they deal with all that ALS brings. Both in her medical specialty and amongst her patients, she noted, there is growing interest in stem cell treatments. Dr. Joyce expressed her concern over the lack of evidence of safety and efficacy, and how elements of hype have entered into the arena of ALS and stem cells. ALS is a very heterogeneous disease with ups and downs as well in individual patients, but life expectancy on average is very short after diagnosis.

One of Dr. Joyce’s patients, Michael, then gave a talk about his experiences with ALS. I found it really striking. Literally every day he goes on-line and checks out resources to search for opportunities for ALS patients such as clinical trials. Michael indicated that as far as he knows he’s not eligible for any trials so far. This was a theme that several people mentioned during the day: just because there are trials out there does not mean that patients with ALS or other conditions can be part of them. Patients are seeking other opportunities.

Next up was Ted Harada, who spoke passionately about his experiences with ALS, the ups and the downs, what is really like to get a stem cell treatment and be in a clinical trial. His talked about his willingness to take risks. He said he’d literally rather die trying something than not try to do something about his ALS. Ted has had two rounds of treatment for ALS as part of the Neuralstem clinical trial and he reported that it has really helped him. One of Ted’s concerns is that he may not be eligible to get a future third treatment from Neuralstem for various technical rules of the clinical trial, which is one reason he is such a strong advocate for Right To Try laws. However, Ted said he feels that most likely few or no patients will be directly treated as a result of Right to Try, but rather that it will open up a dialogue and create other positive outcomes that lead to more patient opportunities.

From both Michael’s and Ted’s talks, i also learned that it can take a very long time (potentially a few years) to definitively diagnosis ALS. Patients facing ALS are likely to have a much higher level of risk tolerance than others might imagine. Understandably they have a strong drive to take action.

I spoke next and focused on the growing challenge that the FDA and the stem cell field face of chains of stem cell clinics that appear to be selling unapproved stem cell drugs without FDA licensing. I talked a bit about the growth in providers offering unapproved stem cell “treatments” at Cell Surgical Network as an example. More broadly, the clinics argue that what they do is beyond the scope of the FDA’s regulatory authority. I discussed new FDA guidances that bear on this issue and which would seem to directly contradict the views of many of the clinics, squarely placing them and their products in the FDA sphere from my perspective. The clinics of course disagree. I also emphasized how the FDA currently is asking for comments on these guidances for the next couple weeks.Tim Caulfield

Tim Caulfield spoke next, giving a wonderful talk. In the stem cell world, hype is not just limited to dubious stem cell clinics. Tim focused on hype in the stem cell field and in particular hype involving scientific publications. He even talked about hype about hype. In the current environment there are strong pressures for scientists to hype their work, including in particular in abstracts. What is the relationship between hype in science articles and in the media? He discussed how widespread pressure to commercialize biomedical research including stem cell efforts sometimes has negative consequences and can contribute to hype.

Alison SorkinAlison Sorkin, Deputy General Counsel for University of Colorado Health, talked about Right To Try from her experiences in the trenches. With the passage of the Right To Try Law in Colorado, Sorkin was there for the intense repercussions. The next working day after the law was passed, patients starting contacting the University of Colorado seeking treatment specifically under the law. Sorkin talked about strict the Colorado law actually is, making it very limited in scope in reality. She also discussed problematic issues with the specifics of the law such as that patients would be responsible for paying for all of their own healthcare for 6 months after treatment under Right To Try as insurers would be exempt from having to provide ANY coverage. There seems to be a growing sense that Right To Try in Colorado may not actually lead to any patients getting non-FDA approved drugs. However, the FDA is paying close attention to Right To Try and one potential consequence of the various Right To Try laws passed in states is that the FDA could be influenced in terms of policies on expanded access (compassionate use).Leigh Turner

Leigh Turner gave a very timely, excellent talk on the FDA, stem cell clinics that do not have FDA licensing or approval, and the potential consequences of this current dynamic. Leigh went into helpful detail on the clinic claims, the types of stem cells they use, and how these relate to the new FDA guidances. He discussed Cell Surgical Network and Stemgenex. It is notable that Leigh gave specific examples and names clinics by name, which I agree is vital to the discussion of the regulatory sphere and the place of stem cell clinics.

Gerhard Bauer, my colleague here at UC Davis and one of my favorite stem cell scientists, gave a wonderful talk on his experiences and perspectives over the decades as a pioneering stem cell and gene therapy clinical researcher as well as earlier as a regulator at the FDA of Austria. Gerhard’s discussion ranged from his experiences in these roles to also his own person experiences as someone who has dealt with doctors and also lost many friends to disease including HIV. I also appreciate how he provided his views from his real world experiences wending his own clinical trials through the processes and how much work it takes just to get an IND. How great it feels to get to that point!

A few additional notes

Mary Ann Chirba, a voice for increased patient autonomy in terms of their cells, was going to be a speaker, but got snowed in at Boston. Richard Garr, Neuralstem CEO, was also scheduled originally to speak, but couldn’t make it. They were missed, but still we had a diverse, dynamic group of perhaps 70-80 attendees.

A big thanks to Julie Bechtel who helped to arrange the event.

UC Davis 2nd Annual Stem Cell Ethics Symposium: Save the Date Feb. 12

We here at UC Davis School of Medicine are gearing up for our 2nd annual Stem Cell Ethics Symposium (see flyer).stem cell ethics

As one of the organizers, I’m really excited about our lineup of speakers including Timothy Caulfield, Leigh Turner, Alison Sorkin, Mary Ann Chirba, and Richard Garr as well as others.

We will be focusing on “Right To Try” laws, FDA regulations, and stem cell tourism.

It should be a cutting edge, spirited meeting and discussion.

All are welcome.

Please RSVP to Julie Bechtel @ 916-734-6181 or julie.bechtel@ucdmc.ucdavis.edu.

Hope to see you there.

My response to ‘Our Bodies, Our Cells’ Harvard Law blog post on stem cell deregulation

Over at the Harvard Law “Bill of Health” blog, Mary Ann Chirba and Alice A. Nobel posted a piece a few days ago that has generated a lot of discussion about FDA regulation of stem cell interventions.

Their piece really has two parts.

In the first part they go through the US v. Regenerative Sciences Inc. (RSI) case providing helpful and insightful perspectives on the history of the case and their prediction as to the likely outcome on appeal. They feel that the FDA will prevail.

In the second half of the piece, Chirba and Nobel build an argument for weakening of FDA regulation of autologous adult stem cell therapies. While I agree with them on the need for changes at the FDA (in my upcoming book I go out on a limb and call for 5 specific reforms at the FDA related to stem cells), I believe they do not make a strong case and that the specific proposed changes that they have put forth would do more harm than good.

Here is my comment on their post:

The historical and legal perspectives in the first half of the article are spot on and helpful.

However, parts of the later portion where you argue for weakening of the regulation of propagated adult stem cell therapies greatly concern me and you have left out some very important elements that are key to understanding the ongoing debate over the appropriate level of regulatory oversight for stem cell therapies. For example, you pretty much gloss over the safety concerns related to these stem cell interventions.

It seems to me that changes are definitely needed at the FDA in some respects related to stem cells such as expanded compassionate use of stem cells for patients with fatal diseases and a push for more openness. So we agree on a need for change at the FDA on stem cells. But the weakening of regulatory standards for propagated adult stem cell interventions would greatly increase patient risk. Further, as the numerous outstanding adult stem cell biotechs such as Athersys and Mesoblast have shown, in the stem cell field a company can have its innovation and be compliant too.

Your statement, “Conditioning the extent of regulation on the degree of manipulation may make sense on paper but is vague and confusing in practice, especially in the dynamic field of cellular therapies” is very puzzling.

In fact, the degree of manipulation is operationally (not just on paper) extremely important from a patient safety perspective and it makes perfect common sense that stem cells manipulated in different ways and to different degrees should be subject to different regulations. I do not see what’s vague or confusing about that at all.

On the other hand, your argument that smaller companies producing stem cell drugs should not be subject to the same regulations as larger companies is a dangerous one. Since when is the law variable depending on the size of the entity that should be following that law? Just as small and large drug manufacturers of pill (chemical) drugs have to follow the same rules to provide data on safety and efficacy, smaller companies selling stem cell drug interventions should have to follow the same rules and laws as big companies. To do otherwise would put patients at great risk. Don’t underestimate the number of patients collectively that stem cell clinics are treating and putting at risk these days: the numbers are in the many thousands and growing.

Paul Knoepfler

UC Davis