Last year I heard from several sources that there somewhere between 3-5 unpublished manuscripts reporting the use of CRISPR gene targeting in human embryos being shopped around at various journals in addition to the one that had been published. Since that time we’ve seen a grand total of one additional paperreporting on CRISPR of human embryos.
So what gives?
Were the sources wrong?
I don’t think so and I believe there are additional labs pursuing research on the use of CRISPR in human embryos.
Depending on the context, the oversight, and the training of those involved, there may be nothing wrong with these studies at all. In fact, they could be positive and teach us a lot if the teams are careful. However, CRISPR’ing human embryos without a good rationale and appropriate oversight is unwise. I also cannot imagine supporting use of CRISPR with the intent to make a modified new human being for many years to come if ever. You can learn more about the history of genetic modification and my views as well as those of CRISPR leaders in my new book, GMO Sapiens.
So where are all the CRISPR human embryo papers? I can think of a few main reasons why we haven’t seen more so far.
Editors as gatekeepers? One possible reason we haven’t seen more CRISPR’d human embryo papers is that journal editors are reluctant to publish them and are acting as essentially gatekeepers for this kind of work. If true, what are the potential risks or benefits of such a de facto filtering system and what is the basis by which the editors are making such decisions?
Outcomes of first 2 pubs discouraged more? Another possibility is that other research teams have been discouraged by the first two papers reporting CRISPR use in human embryos. I can see at least two levels at which those considering working and publishing in this area might be reluctant to proceed because of the first two papers. On the one hand, both papers reported technical challenges with this research, which was discouraging. On the other hand, both papers were heavily criticized by some.
A large and growing number of American clinics are selling stem cells to patients for a variety of ills and one in the San Diego area called StemGenex was the main focus of a recent LA Times piece by columnist Michael Hiltzik. In the piece called “These new stem cell treatments are expensive — and unproven” Hiltzik discussed the growing issues over stem cell clinics in the U.S. and he used StemGenex as a kind of test case or example.
He started off with a description of the kind of hopeful feeling that many patients experience upon visiting stem cell clinic websites:
“Visitors to the website of StemGenex, a La Jolla medical group, could be forgiven for thinking that the answer to their prayers is finally at hand.”
However, there is little published data to support the expectation that one’s prayers might be answered at U.S. stem cell clinics today. I talked with Hiltzik about the state of the American stem cell clinic arena and my concerns as he was researching his piece. The marketing of stem cells is too aspirational in my view and patients are sold medical interventions in many cases that may not work and have potential risks. Hiltzik writes (emphasis mine):
“StemGenex’s director of media and community relations, Jamie Schubert, told me that its “principal purpose is helping people with unmet clinical needs achieve optimum health and better quality of life,” and that it has “anecdotal feedback … from our patients that their symptoms have dramatically improved and their quality of life has substantially increased.”
Keep in mind that we are talking about hundreds of clinics in the U.S. injecting living stem cells into patients’ bloodstreams or into specific tissues and most clinics out there do not have FDA approval to do this so anecdotes are not a strong foundation for this kind of practice in my opinion.
I often am asked if there are ongoing or possible upcoming lawsuits against stem cell clinics. Doing periodic searches such as on Google is one way to learn more about whether there are stem cell legal cases out there.
Recently I did such searches for a variety of terms including “stem cell lawsuit” and “stem cell fraud” and while no new actual Google results showed up that I hadn’t seen before, strikingly a new advertisement did show up for a law firm (see image above) looking into stem cell fraud with the latter search. I had not seen that before. Today I no longer see the ad, but it did pop up earlier in the week.
When I clicked on the ad link it went to this website, which is seeking Southern California patients who believe they may have been harmed or misled by stem cell clinics:
“If you paid for a stem cell treatment at a Southern California (San Diego, Orange County or Los Angeles) stem cell clinic between December 8, 2013 and July 1, 2016, you may be a member of proposed class of customers or patients who may be entitled to compensation.
The Law Offices of Mulligan, Banham & Findley are currently investigating a potential class action relating to potentially false or misleading advertising in web or other marketing relating to stem cell therapies in this region. This investigation includes potential fraud and consumer statute violations.”
This investigation is focused on California where Leigh Turner & my recent paper identified more than 100 stem cell clinics marketing what seem to be non-FDA approved treatments and in particular Southern California. As you can see from the map above from the paper there are tons of stem cell clinics just in Southern California.