Stem Cell Fraud Is the Real Issue in Texas
Farce and potential tragedy are inextricably linked in the still-evolving McGee/Celltex/Texas stem cells case. (See here and here for February's installments.) Now we have to be sure that the risible saga of Glenn McGee does not obscure the important questions about regulation, safety, clinical trials and the conflicts that arise when emerging science is commercialized as medicine.
Briefly, McGee used to edit the American Journal of Bioethics (AJOB) but took a job at Celltex Therapeutics Corp. as "President of Ethics and Strategic Initiatives" – which made him one of three "Key Executives" of the company. He stumbled through the transition so clumsily that it appears he was doing both jobs at the same time. When this news leaked, it caused a storm of protests from several bioethicists, notably including Leigh Turner, mostly on his blog and Twitter, and Carl Elliott, who published a critical article in Slate on February 17. At some point, the brouhaha drew the attention of others, including David Cyranoski of Nature, who began investigating Celltex. Hold that thought.
The Slate piece seems to have been the catalyst for the next twist in the saga. David Eller, the CEO of Celltex, emailed "email@example.com" on February 20 with a five-page list of alleged inaccuracies that "should be corrected indeed, you should pull the article down entirely."
On February 27, the law firm DeShazo & Nesbitt emailed Elliott and the editor of Slate with a demand for retraction and the threat of a lawsuit. The formatting and some phrases changed – "Fact:" became "In fact," for example – but the substantive part of the two letters is essentially identical, including the prominent misspelling of "analagous." (My guess is that both worked off a McGee draft.)
Slate immediately caved, over Elliott's strong objections. On February 28, they took the article down. Back to that in a moment. Because the next major event is truly farcical.
McGee quit. On Twitter. In between tweets about subjects like his kid's basketball game and the awesome new BMW, he tweeted, as if casually:
Enough. I resigned from #Celltex Therapeutics on & effective 2/28/2012. I am preparing timely, lengthy, pointed comments on the whole matter
Elliott had compelling rebuttals to every complaint against his article except one minor non-substantive point (easily fixed) and a trivial misquote he himself found. He later commented at the Chronicle of Higher Education blog, there's a summary at Retraction Watch, and William Heisel posted Elliott's point-by-point response to the Celltex letter of February 20. If Slate had not folded – and, incidentally, demanded that CGS stop reposting the original article [I suspect you can find it on the web] – there is every reason to doubt that Celltex would have prevailed in court. But they could have tied it up for ages, until everyone got bored (Eller was once involved in an 11-year lawsuit with Forbes). Except that the cat was out of the bag.
A boom in unproven procedures is worrying scientists.
They backed it up with an Editorial titled:
The darker side of stem cells
And if they needed support, Leigh Turner posted a very detailed backgrounder on the company. University of California Davis professor Paul Knoepfler, on his Stem Cell Lab blog, shredded the reported claim of a doctor who works with Celltex that "the worst-case scenario is that it won't work," writing:
Wow that is just so totally wrong that it is disturbing.
Is that what they are telling patients as part of the informed consent process?
Scary to think about.
In reality the worst case scenario, even for autologous transplant, is death. The second worse case scenario is severe, life changing injury.
Doug Sipp at the Stem Cell Treatment Monitor has been documenting similar issues for several years. His work may finally be bearing fruit. Leigh Turner sent a long letter to the FDA requesting a formal investigation of the activities of Celltex and its Korean partner RNL Bio. And the publicity Celltex derived from treating Governor Perry may now backfire.
This issue blew up over McGee's conflicts of interest. But at their worst, they pale before the possible conflicts of a commercial enterprise that is selling untested and likely illegal procedures to uninformed patients.
When McGee joined the company, he said:
"We are learning more about adult stem cells every day, and I want Celltex to set the standard for its ethical banking and use."
In a kack-handed, ham-fisted, bass-ackward way, it's possible that his brief employment there, and the notoriety it has provoked, may in fact lead to an improvement in standards. But only if we keep pushing for the FDA to step in.
Previously on Biopolitical Times: