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:
- RNL Bio is holding patient stem cells hostage;
- 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.
The title is lengthy and misleading. It’s a patient’s responsibility to determine the therapy sought. They shold be armed with sound data; attestations of successful outcomes are a part of that data, as well as the non-successful l outcomes – which may be attributable to existing conditions. As I understand it: a patient allows adipose tissue to be extracted from their body and be manipulated to produce an increased quantity of stem cells which are reintroduced into the patient’s body in order to bioliogically regenerate comprimised tissue. The bottom line is we have a federal agency, FDA who’s in bed with the pharmaceutical industry whose purpose is to create “approved” drugs which do not cure; but only serve as a “cash cow” analgesic.
This is a Fedaralist and National issue as far as the therapy itself is concerned. On a Constitutional basis, each of us are guaranteed unalienable rights. What we choose to do with our body (and tissues) is such a right.
Actually, no, it’s not solely the patient’s responsibility. Before it gets that far, it’s the doctor’s responsibility to make sure that they are acting in an ethical manner.
Separate from that is the procedure itself, which has been repeatedly ruled as manipulation – a word you yourself use – which means it falls in line with requiring proper clinical trials, as it’s a drug and not just patient tissue. Within that, of course, are the issues of what exactly the cells are being manipulated with, and what happens when it’s re-injected. We know that death is a possible outcome, as are severe issues (such as bone growing in your eyelid).
And no, as a matter of fact, once our tissues leave our body, they are no longer ours. Something that has been repeatedly decided in state and federal courts as people have fought aspects of their tissues going on to be used in science.
All in all, you really need to bone up on facts, as you’re failing rather miserably on them across the board.