Blog reader survey results & winner of the stem cell swag

It’s fun and useful for me to learn about the readers of this blog in terms of who they are and what their interests are in terms of the types of posts that I do.

Below are the results of two recent reader surveys that I did to get this kind of information. The two polls got 162 and 192 responses, respectively.

Before I get to discussing the results, I also included a prize/raffle element to this survey whereby I would choose one winner out of the participants who would receive a stem cell t-shirt, and signed copies of my two books, Stem Cells: An Insiders Guide and GMO Sapiens.

And the winner of the random drawing is Josephine “Jo” Bowles, Senior Lecturer at the School of Biomedical Sciences at The University of Queensland, Australia.

Congratulations, Jo!

Okay, now to the results.

readership survey

Who are you?

The first survey asked you all about your backgrounds. Exactly half of you turn out to be scientists with more academic researchers, but also quite a few industry researchers. Many of you are also patients or patient advocates, with your numbers being about the same as industry scientists. I tried really hard to think of as many types of backgrounds as I could for this poll, but even so in fourth place was “other” in this survey.

One category that in hindsight I should have included was “teacher”, but if you answered “other” in this survey please let me know in the comments what kinds of backgrounds I missed. The fifth most common selection was “Physician”, which doesn’t surprise. I hear from doctors regularly that they are readers. I was surprised not to see more journalists showing up in this survey since they also regularly get in touch about specific posts that they read. Of course this survey is not scientific and may not be very precise.

What kind of content do you like?

The second survey asked you all about what kinds of blog posts here on the Niche that you like the most. Here again came the challenge for me of what categories to include. The types of posts that are the most work and frankly pose the greatest risk to me are the ones that turned out to be the most popular: investigations. People want to know facts and new insights about difficult, messy situations. I get it and I try to regularly do those kinds of pieces despite the fact that I’m so busy, these take more time, and like I said I always am concerned about risks of being sued or threatened.

Other popular types of posts included Newsy items, journal-club like paper reviews, opinion pieces and interviews. I was surprised that CRISPR pieces weren’t more popular because when I do them I can see in the metrics that they are heavily read, but then again this is mostly a stem cell blog.

Thanks for doing the survey and please as you read consider adding in your voice in the comments.

~10th anniversary of my 1st website: reflecting on wild ride

It was just over a decade ago that I started making websites and it’s been a wild ride.

My first site was at the domain name www.chromatin.com, which I was fortunate to have been able to get for a good deal way back when…I think in 2005.

You can see here an early 2007 copy of the archive of one of my first versions of the Knoepfler lab website at chromatin.com. I first put up that website around the time that I moved here to UC Davis in July 2006.

Then later in 2007 I started a stem cell-focused website including stem cell meeting listings, photos, and some science material, at the domain www.stem.ws. For instance, see an archive here (scroll down to see actual archived text content). Over those first few years, some students and faculty mentioned to me that they had seen my website.

In early 2010 I started this blog that you are now reading, first at the www.stem.ws address and then later at www.ipscell.com. It really all started with the www.chromatin.com site though.chromatin-video

At my chromatin.com website early on I had an animated video of chromatin changes in neural progenitors as a function of N-Myc levels (screenshot above). I’m trying to find that video file.

Back in 2006 as I was gearing up the Chromatin and Knoepfler lab websites I would guess that overall maybe only 10-20% of labs had their own dedicated websites, but it was catching on. Now it seems like a no-brainer that every lab, new or old, needs at least one website if not more.

In the first few years of this blog, the big debate on stem cells in the U.S. was over federal funding of research on human embryonic stem cells (hESC). It seems strange that in a way things may be coming full circle again as many in the field are stressed out that restrictions may again be applied to hESC funding. Wouldn’t that be a sad deja vu?

Six or seven years ago I even was called a baby killer in some comments on this blog and in some emails since I support hESC research. Other unexpected happenings included requests from people asking me to clone them or clone their children who passed away. Some wanted IPS cells made from themselves. Some threatened me in various ways. I was sockpuppeted. There was the whole STAP cell explosion. People randomly have emailed me all kinds of odd science documents over the years, most of which I couldn’t post because they were too sensitive. What am I supposed to do with them?

But mostly, the response has been extremely positive.

There have been big changes in 10 years both for the stem cell field and the Internet including science on the web. Where will we all be in another 10 years on these fronts? The next couple years alone could see profound changes. For instance, I wonder if we’ll see more real-time science on the web.

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.

4,000+ comments on FDA stem cell guidances, mostly clones of “My cells are my cells”

Keep your hands off of my cells!

At least, that is what many are telling the FDA regarding stem cells.

The FDA issued four draft guidances related to stem cells in the past year or so, held two public stem cell meetings, and now must decide what it is going to do with an out of control direct-to-consumer stem cell clinic industry. In part it will need to sort through all public comments from the meeting and those submitted online.

fda-stem-cell-comments

There are 4,251 comments on the online docket on the FDA stem cell guidances and commenting is now closed. As of a few weeks ago I think there were just something like 15 comments.

Commenters have been busy.

Is there anything to be learned from these comments?

For one thing, a quick look at the comments finds that many are essentially identical. In fact more than 700 use the exact same phrase “My cells are MY cells” and it looks like hundreds more comments have the exact same or similar language is used in more extensive forms. “My cells are my property”. “My cells are mine”. And so forth.

Continue reading

To stem cell clinics: do your homework & take FDA “current thinking” seriously

FDA draft guidanceOne of the difficult things about the regulatory sphere that covers stem cells in the US is that many aspects are confusing or puzzling both to the public and so-called experts. We’ve been talking through some of the questions that come up in this area in posts and comments on this blog.

  • What does a warning letter really mean? What triggers it?
  • Why do some businesses selling stem cells get inspected and others don’t?
  • What do some entities get warning letters over the years, while others don’t?
  • What weight does a draft guideline have?
  • How about a finalized one?
  • If a business disagrees with an FDA guideline or action, what should it do?
  • If a business operates without FDA approval (maybe because they disagree with the FDA) when it seems that it should need that approval and yet the FDA takes no action, does that mean anything?

The list goes on and on.

It’s kind of like trying to read tealeaves. One of the FDA reforms I advocated for in my book, Stem Cells: An Insider’s Guide, is more clarity and better communication.

Despite the many questions and confusion out there, I would say one thing is clear: Take FDA “current thinking” very seriously.

While current thinking as articulated in guidances (draft or otherwise) is not formally equivalent to a regulation, it would seem to have the power to trigger action based on the historical record.

Therefore, one broader lesson in this arena would seem to be that the FDA can pull the trigger on actions like visits and warning letters based on their current thinking even if that current thinking is not formally crystalized beyond draft guidances or even without any draft guidances. For instance, it seems pretty clear that the FDA right now views SVF as a drug and while it may not have done much about this action wise yet, the odds are that such action will be coming sooner or later. The same goes for non-homologous use of bone marrow and amniotic stem cells such as for neurologic conditions. In other words, what the FDA staff think is going to be their basis for actions. SVF

As a result, it kind of goes both ways in the sense that guidances (draft or otherwise) are not formal regulations and “only” reflect current FDA thinking, but at the same time “FDA current thinking” shouldn’t be underestimated in terms of importance as it clearly can play a big role as the basis for action.

Too often I’ve heard clinics or other advocates say things like, “these are just draft guidelines” or “the FDA hasn’t been clear on that yet”. The reality is that no matter what any of us might like (e.g. increased FDA clarity), it is not the FDA’s responsibility to make sure everything is crystal clear for every stem cell clinic out there. Rather, it is the physicians’ responsibility to do their homework on the FDA and all relevant regulations, current thinking, etc.

If a clinic wants to challenge the FDA I can respect that if it is done responsibly, but it is a very different matter and a risky game to do such a challenge operationally by administering what by all accounts the FDA considers to be unapproved drugs into patients and then waiting to see if anything happens on the regulatory front.

This game of stem cell chicken is particularly risky if you are “treating” medical conditions outside of your specialty and do not have any rigorous training in stem cells as well as having little if any expertise in FDA regulatory affairs. And, no, a weekend resort or other similar quickie “course” on stem cells doesn’t really count.