Would you believe in a stem cell miracle?
Sometimes the mainstream media stumbles in its coverage of the stem cell world and a recent CNN puff piece on a patient of stem cell clinic Celltex is a prime example of just how extreme this can get.
The CNN piece focuses on a Celltex patient who self-reports perceived big improvement after receiving the non-FDA approved offerings of the Texas stem cell clinic. Celltex is most famous for their number one customer and supporter Rick Perry, former Governor of Texas and now DOE Secretary in the Trump administration. For more background on Celltex including the warning letter it received from the FDA, you can see archived posts here.
Jacqueline Howard of CNN wrote about how the patient was invited to and attended Trump’s big speech before Congress recently. Howard mostly blew it on this article as she provided no background on the controversy involving Celltex, its past run in with the FDA, and how its offerings that it sells to patients are not FDA-approved as safe and effective. Minor details, right?
What about the fact that these kinds of treatments cost the average patient thousands of dollars, sometimes tens of thousands of dollars? Not important enough to mention?
And risks? No mention. The reality is that using adipose stem cells grown in a lab has sizable risks. Continue reading
Last week I posted my list of 2017 predictions for the stem cell field. Today a couple of days into 2017 I’m more focused on hope than realism. What would I wish for in the stem cell and regenerative medicine arena in the coming year?
More stem cell clinical trial data posted and published. There are few things as exciting as stem cell and regenerative medicine clinical trials across the full spectrum of stem cell types including adult, embryonic, and IPSC. But we need to have actual trial data be peer reviewed and published or at least posted. Clinical trial updates only by press release are not helpful to patients or the field.
Clinicaltrials.gov adapts. This vital resource of trial listings adjusts to new realities. It either filters its listings to screen out for-profit entries that aren’t real trials or it provides more practically useful information such as at a minimum clear indications of whether a listing has an IND (this doesn’t need to violate any confidentiality rules) and whether the listing requires payment as an inclusion criteria. See my interview with the leader of Clinicaltrials.gov.
FDA speaks clearly. Whatever the FDA does or does not do in terms of actual stem cell & regenerative medicine-related actions in 2017, it is clear about it. This year I hope the FDA provides concrete, consistent explanations in the public domain that don’t require an FDA-ese jargon dictionary to try to understand.
FDA and its CBER center are consistent with good & bad citizens of the stem cell arena. The FDA has a tough job overall and its CBER branch focusing on biologics including stem cells has its own specific challenging task set. However, for years CBER has held different players in the stem cell arena to different rules and expectations. Paradoxically, essentially the better a citizen you are, the more the FDA expects from you. On the flip side, if you are for instance a stem cell clinic with no intention of following the rules (no BLA, no IND, no pre-IND, no expertise in stem cells, no data, etc.) CBER has historically generally left you alone.
There is so much stem cell hype out there that sometimes it seems like almost daily up comes a headline that is so full of hype that it could be harmful, but a new piece from The Telegraph really takes the cake.
It is entitled, “Hope of cure for arthritis, MS and diabetes as Stanford makes stem cell transplants safe”.
Just that title alone mentioning cures for a number of major diseases and the blanket statement, “makes stem cell transplants safe” is a big red flag, but the text of The Telegraph article immediately makes things worse:
“Hundreds of thousands of people could be cured of autoimmune diseases like arthritis, multiple sclerosis, diabetes and lupus after scientists discovered how to make stem cell transplants safe.”
Really? Now all stem cell transplants in humans will be safe and kajillions of people cured?
It’s an exciting time to be a stem cell scientist and I feel fortunate to be doing research on stem cells today what with all the developments recently and real promise for clinical impact in coming decades. There’s also unfortunately a ton of hype out there including in academia, biotech, and the stem cell clinic arena. That’s something we all need to be aware of and avoid as much as possible.
Hype and hope are only different by one letter (y versus o), but although they are both out there it is often not easy for patients to distinguish these. The hype is flashy like fireworks of the kind we might see today. But often it is more bang than substance and is harmful to the stem cell field and patients.
There’s so much to celebrate in terms of legitimate research across all the spectrum from the lab to the clinic with stem cells. Making an effort to cut back on hype actually helps the field collectively by keeping expectations realistic (even if optimistic) and avoids disasters like patients being harmed by hyped stem cells. When powerful people engage in hype of stem cells that is even riskier for patients and the field. I’ve been trying to challenge that.
There’s also been fireworks in the stem cell field over policy debates in the past few weeks and months. The fireworks in the debate over stem cell oversight are not fun, but this kind of disagreement may be a necessary part and sign of healthy debate of different policy ideas. Even if we do not sing a stem cell version of Kumbaya together, that’s OK. Group think and silencing of diverse voices are not helpful to put it mildly.
It’s a big, crazy stem cell world out there. Enjoy all the real fireworks this weekend as well as that in the stem cell world related to science and policy that is likely to continue throughout the rest of 2016.
I wrote yesterday about two cases of science media hype on CRISPR and on stem cells for strokes. The latter case on stem cell hype stirred the most discussion and even some harsh words in the comments.
As this stem cell stroke story on an encouraging but very small, preliminary study has unfolded across the mainstream and other media in the past 24 hours, a whole range of headlines for it have popped up. I’ve got a screenshot of a Google result for this story below with 9 headlines all related to the same science. I find it interesting how variable the headlines are.
Some are reasonable such as the one on Bradley Fikes piece at the San Diego Union Tribune, although to nit pick I would have added the word “small” to describe the study. Again it is generally editors and not writers who pick the titles.