Life as an Extreme Sport

Stop Yelling If You Want Me to Listen

Last week, I had the pleasure of attending the World Stem Cell Summit, and as is habit when I attend conferences, I tweeted my reactions to various panels I attended. Alexey Bersenev asked if I would elaborate on my rather frustrated tweeting from the panel on “The Role of States in Regulating Stem Cell Therapies,” and I agreed (although I didn’t specify the timeline of when that would happen, obviously).

This panel was a regulatory session, as were most of the panels that I sat in on. It was moderated by Kirstin Matthews, from Rice University, and the panelists were Keri Kimler of the Texas Heart Institute; Mitchell S. Fuerst, a lawyer who has represented Regenerative Sciences (Regenexx/Dr. Chris Centeno et al.) in their lawsuit with the FDA; and Leigh Turner, a bioethicist from the University of Minnesota.After needling some people about conflicts of interest earlier this year, I suppose it’s necessary to once again point out that I consider Leigh a friend and colleague, and unsurprisingly, agree with his views regarding stem cell treatments and regulations. I don’t really think that biases me against being yelled at, but hey – some people just want an excuse to nitpick.

Paul Knoepfler was also in the audience for this panel session; in his brief write-up, he called the discussion between Fuerst and Turner a “particularly interesting and vigorous debate.”

I am going to go a little bit further than that, and say that I think it was actually a really lousy panel and debate, largely because Fuerst opted to engage in what is often referred to as conversational terrorism. He relied on every “trick” in the book, including a full range of ad hominem attacks, attempts at misdirection, constant interruption and talking over both Turner and Kimler, dismissing valid criticisms with the repeated statement of “that’s not germane to this discussion,” and perhaps the one that got under my skin the most, utter loud bombast, as if shouting at the audience will simply intimidate them into agreeing with you.

In my case, it does quite the opposite. This is probably in part because I’m female, and a lot of men seem to feel that shouting loudly at a woman will intimidate her into silence, going away, or acceding to demands. Mostly it just makes me cranky and likely to yell right back — something I managed to avoid doing at the panel, largely because during the Q& A period much of the audience got up to ask Turner and Kimler questions that they were unable to address during the panel due to Fuerst’s behavior.

Turner was able to talk during the panel — at least at times — and address some of the interesting and contentious issues around the role of states in regulating stem cell therapies, and I was able to learn some more about the topic. But Kimler barely spoke, and this is too bad — she was there as a patient advocate, and given her background and experiences in Texas, with their medical board and their recent stem cell guidelines, I would have liked the opportunity to hear and understand more about the position(s) that she supports.

By engaging in bad behaviour, Fuerst undermined the position he supports regarding state and federal oversight of stem cell regulations and denied the audience not only the opportunity to learn about his position in a non-confrontational manner, but the opportunity to learn from the other two experts invited to speak.

And just to be clear, this is not behaviour unique to Fuerst. In fact, it was on display in September during the Texas Tribune Festival’s panel on whether or not the state’s stem cell policy was good for Texans.I suppose a genuinely cynical person could try to argue that it’s really Turner that’s inciting people to these levels of bombastic over-talking, but having spent time with him I can assure you that he is indeed the epitome of Canadian politeness. I find that if someone — in the World Stem Cell Summit case, Fuerst — cannot present their argument in a calm, coherent, and rational manner, I’m going to dismiss everything they say as not worth my time, if not outright invalid.This, for what it’s worth, is not something a panelist should try for, period, and it’s really something you want to avoid if your audience includes the media. I’m certainly not the first writer-type to find it irritating to be yelled at rather than engaged with. If ya can’t keep your temper under control and engage with your fellow panelists — and the audience — with the respect that they should be afforded (and that you want afforded to you), then don’t agree to sit on the panel in the first place. It just wastes everyone time, and that’s frustrating, for everyone involved.

The Many-Headed Hydra of RNL Bio, Celltex, & Why Patients Should Be Concerned

The latest saga in the on-going RNL Bio/Celltex saga broke Monday morning while I was at the World Stem Cell Summit in Florida: the companies have filed competing lawsuits, and it appears that all talks or partnerships between them have broken down. As usual, Paul Knoepfler has a really comprehensive summary on his blog, including the legal documents filed by both RNL Bio and Celltex.

I’ve spent some time sifting through the legal documents, and the claims on both sides are interesting (and at times a little outrageous). As I’m not a lawyer and my knowledge of Texas law is basically non-existent, I’m hesitant to comment on the accusations at large. What does interest me, though, is two specific things that have come out of these lawsuits:

  1. RNL Bio is holding patient stem cells hostage;
  2. Patients themselves are not aware of the RNL Bio/Human Biostar connection to Celltex.

The first issue seems to fall back into the legal issues that I am so far from qualified to comment on, but the gist of it appears to be that RNL Bio/Human Biostar is refusing to turn over the banked stem cells that they’ve manipulated, banked, and have been holding until Celltex pays them for services rendered. Additionally, RNL Bio/Human Biostar seems to be portraying this as a behaviour of concern because they do not believe Celltex has a laboratory where the stem cells can be safely transferred (see the bottom of page three), and that giving the stem cells to Celltex would be tantamount to allowing contamination if not outright damage.

Celltex has fired back, accusing RNL Bio/Human Biostar of extortion (see the bottom of page eight) – and it certainly seems like hostage-taking might be an appropriate analogy.

Clearly this is going to be an asset that the courts will decide ownership of, and the good news here – at least for patients – is that as long as RNL Bio/Human Biostar is attempting to leverage money from Celltex in this court fight, the stem cells should be safely maintained. (I would not be surprised if there was an injunction against RNL Bio/Human Biostar preventing them from doing anything to the cells, although I’ve not looked that far yet.)

The more interesting thing that appears to be coming out of this, though, is that patients themselves are unaware of the RNL Bio/Human Biostar and Celltex connection. This, I suspect, might explain some of the animosity between patients/advocates and bioethicists in the last year. For a lot of the folks in bioethics that I know, the RNL Bio/Celltex connection evoked a response akin to “oh god, another head on the hydra” – something that would make little to no sense to patients and advocates unaware of RNL Bio/Human Biostar’s history.

The hydra metaphor is apt for RNL Bio, who is the parent company (as far as anyone can tell) of Human Biostar. RNL Bio appears to operate under a variety of company names, including RNL Bio, Human Biostar, RNL Life Science, Cellure, Dr. Jucre, and combinations therein. Beyond their own companies, they form tight partnerships with external businesses, as with Celltex – and it seems within this, Celltex’s patients are not aware of the difference between the companies or that the companies are different. In other words, patients appear to believe that the manipulation of their stem cells is happening under the auspices of the company – Celltex – that they’re talking to and interacting with, rather than the company – RNL Bio/Human Biostar – actually behind the process.

And in many cases, it might be valid to say “so what?” After all, I probably couldn’t tell you what laboratory handled my blood work at my last physical; that was something my physician deemed necessary and magical people who handle medical center contracts made happen without my knowledge or input. But in this particular case, I think it’s more accurate to compare this adipose-removal and stem cell isolation process to compounding pharmacies, where you do indeed want to know about the track record of the compounding pharmacy (especially given the recent issues with NECC, fungal outbreaks, and meningitis). After all, cells are in theory being extracted and then prepared for being placed back within a patient’s body – and as such, it becomes important for the patient to be aware of the history of the place doing such preparation.

In the case of RNL Bio, it is not the best history in the world. Off the top of my head, there are the following issues:

  • Tangling with the Korean FDA over the Dr. Jucre stem cell cosmetics line;
  • Accusations of bribing Korean officials to guarantee favourable stem cell-related laws;
  • Concern that their prepared stem cells have caused tumors (and several cases presented at the World Stem Cell Summit suggest that this is indeed a concern);
  • The deaths of two patients in 2010;
  • An unlawful termination suit, which may not reflect on company safety standards, but certainly reflects on the company as a whole;
  • A fraud lawsuit in California, filed this past summer. As Leigh Turner notes,

    Plaintiffs named in the lawsuit seek judgment for damages for intentional misrepresentation of fact; negligent misrepresentation of fact; false advertising in violation of California Business and Professions Code; unfair competition in violation of California Business and Professions Code; financial elder abuse; negligence; and breach of implied covenant of good faith and fair dealing.

And there is undoubtedly more that I’m simply not aware of. While the California lawsuit happened this summer, the rest of the events in that list are things that have been around a while – and are certainly part of the reason that there’s been significant concern about the connection between Celltex and RNL Bio and just what was going on in Texas.

What can appear to be a vendetta to patients and patient advocates who aren’t familiar with a situation can actually be completely justified within context, and the context here around RNL Bio – of numerous concerns about safety, grounded in known side-effects and patient deaths – matters. That patients themselves were not made aware of the connection between Celltex and RNL Bio/Human Biostar, let alone the issues surrounding RNL Bio/Human Biostar for the past going-on three years, should be of a concern to patients. Frankly, I think that’s a much bigger issue than the fact people like me – or the more legit folks like Drs Knoepfler and Turner – have made their concerns about unregulated and possibly fraudulent stem cell clinics known.

When We Know “It’s a Catholic Country” Isn’t An Excuse

A severely ill woman is admitted to the hospital. Doctors assess that without an abortion, she will die.

Oh, you think this is about Savita Halappanavar, don’t you?

Well, it is and it isn’t. Savita Halappanavar is a horrific story making the rounds now; a young woman admitted to an Irish hospital was suffering a miscarriage but told that doctors couldn’t perform an abortion until after the foetal heartbeat ceased, even though the pregnancy was clearly ending (as Ms. Halappanavar was fully dilated and her water had broken; at 17 weeks there is no way the foetus could have been delivered and survived). Why couldn’t the doctors perform this medically necessary procedure — one that is actually allowed, in the Republic of Ireland, if there is a real and substantive risk to the life of the mother?Other sources via Wikipedia, sorry: Charleton, Peter; McDermott, Paul Anthony; Bolger, Marguerite (1999). Criminal law. Dublin: Butterworths. p. 518 and Herring, Jonathan (2012). Medical law and ethics (4th ed. ed.). Oxford: Oxford University Press. p. 308. Well, according to staff at University Hospital Galway, because Ireland “is a Catholic country.” So instead of performing a medically necessary procedure, doctors, nurses and medical staff at Galway Hospital watched as Savita Halappanavar suffered for over two days before the foetus died. At this point, they evacuated her uterus — and it was too late. Septicaemia had set in; three days later, Ms. Halappanavar suffered multiple organ failure and died.

That takes us back to the severely ill woman who was admitted to the hospital in December of 2009. A Catholic hospital in Arizona, St. Joseph’s Hospital and Medical Center. This young woman was 11 weeks pregnant and suffering from pulmonary hypertension. Sister Margaret McBride was the on-call member of the hospital ethics committee, and part of the care team that approved the abortion necessary to save this young woman’s life, even though abortions are not typically performed at Catholic hospitals.And, in fact, the hospital eventually lost their Catholic affiliation over this choice, because they refused to agree to never perform abortions again, placing the health and well-being of the pregnant woman over obsolete and medically inaccurate Catholic doctrine.

A Catholic nun at a Catholic hospital was able to make the decision that the living, breathing, suffering woman in front of her should not die because of a fatal complication of pregnancy. She did this even though the hospital guidelines specifically forbid abortion even to save the life of the motherAs noted here. Guidelines that are more strict than those in the Republic of Ireland. And while Sister McBride was automatically excommunicated under the Catholic concept of latae sententiae, she was also returned to a member in good standing of both the Catholic Church and her religious order.

So then, this isn’t about Savita Halappanavar or that unnamed Arizona woman; this is about that medical team. This is wondering: what is the excuse of every single member of the medical team at University Hospital Galway? I think at this point, we’re all waiting.

Text Mining Bioethics Journals

Paul Knoepfler put up a really interesting post today on text mining the titles of articles in Cell Stem Cell and Stem Cells. The results are striking, as he notes – and it looked like a fun way to procrastinate for a couple of hours. So I decided to do the same with three bioethics journals: the American Journal of Bioethics, Bioethics, and Journal of Medical Ethics. I mostly chose these because they were the first three to come to mind, and not out of anything more scientifically rigorous. The results are interesting:


American Journal of Bioethics, January – November 2012; click to embiggen


Bioethics, January – September 2012; click to embiggen


Journal of Medical Ethics, January – November 2012; click to embiggen

 

Note that unlike Paul, I didn’t pull defining words like bioethics, ethics, or ethical out of my word clouds. Why? Well, I was going to until I ran the first, which was AJOB, and saw that “bioethics” didn’t actually come up in any large way. That caught my attention, and I decided to leave the results as is, rather than to remove words based on what would have been, in this case, inaccurate assumption.

It’s also worth noting that AJOB has a different format, relying on Target Articles and then Open Peer Commentaries. In practice, this means that words like “nudge” – which was used in a Target Article – will be inflated in use because of the repetition in the commentaries. This is definitely a reflection of the journal, and can make it a bit more difficult to abstract any conclusions about what is published where. Still, overall, this is a somewhat interesting exercise in the varying focus of different bioethics journals (a topic that I was actually discussing with people last week).

I’ll Always Remember the 5th of November

Five years and a few hours ago, my mind filled in the blanks. It was around 6am; my father had guided me – by force and cajoling – to bed a few hours earlier, and then stood there to make sure I took the strong sedative he poured into my hands. I needed to sleep, he argued. She – we all – needed me to calm down. Worn out, I acquiesced and slipped into a hallucinatory blue twilight filled with the suns and stars decorating my sister’s bedroom.

Awareness is an odd thing. Although I was upstairs, away from the sick room, it’s clear that my brain registered some change. Maybe I heard the small beeps from a machine change; maybe just the right pause of my sister’s footsteps alerted me; maybe I heard the cat rouse herself from slumber at the foot of the hospital bed in order to act out. It’s hard to say what changed, but something did, and in the hazy twilight of that sedated sleep, I heard my name. I felt a hand across my forehead. I felt the gentle flutter of lips that followed that hand.

Groggy, I opened my eyes and I tried brushing my sister, who was being uncharacteristically affectionate and thus weird, away.

Only my sister wasn’t there.

No one was there.

A moment later my sister did appear in the doorway to the bedroom, looking drawn and wan. She gave me a quizzical look.

“Were you just in here?” I asked her.

“No,” she said in a tone I’d never heard before. She didn’t have to say it, then – I knew – but she did, anyhow: “She’s gone.