Is it really deja vu all over again with allegations of potential wrongdoing in a paper on human cloning?
“Say it isn’t so!”, is basically the universal reaction I’m getting from people in the stem cell field.
Well, sadly it seems to be so folks.
What’s going on?
Allegations have emerged on a website called PubPeer (a post-publication review kind of website) about the recent Cell paper by the Mitalipov lab on human therapeutic cloning.
A person called “Peer 1″ has pointed out alleged instances of image duplication and cropping in the paper. The story was also picked up by Retraction Watch. Science is on the story too. Just to be clear, I am not “Peer 1″ as some people have suggested.
A quick look at the paper would suggest there are indeed 3 separate instances of image duplication and images are cropped in various ways that make them look kinda different on first glance.
It makes one feel a bit queasy.
A fourth allegation of inaccurate representation of microarray data related to two panels in Figure S6 in the paper remains more difficult to confirm or deny to this scientist.
The other thing I’m hearing from readers of this blog and others is that they are astonished over the microscopic 3-day period (see image above from the paper) between when the journal Cell received the Mitalipov paper and when it was accepted. A leading stem cell scientist said to me, “Are you f’ing kidding me? 3 days for a human cloning paper?”
Given the 2004/2005 cloning papers by Hwang Woo-suk that proved to be bogus and the highly sensitive nature of human therapeutic cloning, an intense review of the paper before publication would indeed seem like it should have been a no-brainer, eh?
Another leader in the stem cell field told me that Cell should have had 5 independent reviewers look the paper over and have a highly detailed, methodical examination of the paper figure-by-figure, line-by-line, by at least two editors.
Now I’m hearing that we’ll see an announcement by OHSU and Cell as early as tomorrow about this, in all likelihood saying it was all a big innocent mistake.
Maybe it was.
At this point it almost doesn’t matter. Damage is done.
According to Retraction Watch, the human embryonic stem cell cloning paper in Cell by the Mitalipov Lab (I blogged about it here last week) cropped and reused some images, a potentially major issue.
These serious allegations claim that there are quite a number of images within just this one paper that are reused in cropped forms throughout:
“- Fig. 2F is a slightly cropped version of the cell microscopy image in Fig. 6D top left.
- Fig. 6D top right, the cell microscopy image is a slightly cropped version of supplementary Fig. s5, top right. The cells in 6D are labelled as “h-ESO-NT1 Ph” yet in figure s5 they are labelled to be “hESO-7″. We understand the former to inherit caffeine-treated somatic nuclei whereas the latter are original stem cells.
Under pressure to assemble the figures for rapid publication, one can understand making a cut and paste figure assembly mistake. Nevertheless it should be noted that image cropping does take extra work.
- Figure S6 top centre and top right are the same image.
- Figure S6 middle left and lower right are reported to be biological replicates of microarray expression quantitation. In those cases however the narrow spread indicates that the data are extremely similar and are only understandable as technical replicates (where the same RNA sample is hybridised to two different arrays). It is useful to do technical replicates to control experimental reproducibility, but biological replicates are more valuable when reporting results. They are not the same thing and should not be conflated. (For the record, we did check the microarray data deposited at Gene Expression Omnibus (GSE46397)).”
Cell is reportedly looking into the allegations.
Having looked at the paper again carefully myself just now, it does seem there are instances of image re-use.
If indeed accurate, this raises some doubts about the paper more generally.
Ed Yong appears to deserve a major hat tip for picking up on this and Tweeting it first. It was originally spotted by a commenter named “Peer 1″.
I was alerted by a friend to the fact that there are now YouTube ads for stem cell products popping up.
One such ad features supermodel Kathy Ireland pitching for something called Stemáge Skin Care.
Today’s post is Part 1 of at least 2 on this Stemáge product.
I will post Part 2 soon that is a must read as it includes information my somewhat shocking phone conversation with a representative of the company regarding where they obtain the stem cells for Stemáge and more.
Why is a human stem cell-based cosmetic cream important?
Such a product can be considered a medical product subject to regulation by the FDA and the FDA also oversees the efficacy or safety claims made by sellers of such products. For example, in the past the FDA has sent a serious warning letter to L’Oreal/Lancome in the past (here). Such products also can potentially have health risks.
This Stemáge human stem cell-based cream claims to have anti-aging and other medically beneficial properties. It apparently contains human stem cell laboratory byproducts from other people’s stem cells that are to be used on your skin.
The prices range from about $50 up to around $130 per month. That’s a lot of money in today’s economy.
The company selling the product is Stemage Skin Care, LLC in Charlotte, NC.
Based on its description, in my opinion Stemáge might be a drug that should be evaluated by the FDA prior to any human use, but the company says in its FAQ section that no FDA approval is required. It also reports no side effects.
Is Stemáge a drug?
I don’t know, but it is certainly not your average skin cream that you can get at Walmart or order from QVC.
The Stemáge product is not just being pitched in YouTube ads, but also has its own YouTube videos featuring Ireland as well (see below).
One such video includes the following description as text:
The surgeon developed, adult, human stem cell derived full face and body skin rejuvenation system. Stemáge is supported by trusted advisor, user, and ambassador, Kathy Ireland, and featuring the innovation of Doctor David Scharp of Scharp Laboratories and his key active ingredient, MDFc19.
What is MDFc19?
California-based Sharp Technologies (apparently the same as or related to Sharp Laboratories?) describes MDFc-19 here this way :
(MDFc-19) is a new and important skin care component that contains a number of critical factors, which are produced by expanding adult human mesenchymal stem cells (MSCs).
As a formulation of human cellular factors, again I believe that it is at least reasonable to ask if this MDFc-19 product or other products such as Stemáge that include it are drugs.
The website goes on to say this about MDFc-19:
During our own cell culturing process, human adult MSCs readily expand and grow while releasing their growth and signaling factors into our proprietary media solution. When the stem cells are removed, these important factors are left behind, creating a critical new skin care component for skin care products (MDFc19). Clinical studies have shown that products containing MDFc19 can help reduce the effects aging skin.
What exactly are these clinical studies they claim? Hard to say.
On the clinicaltrials.gov website I found zero results for searches related to Stemáge, MDFc19, and David Scharp.
There was an MDFc19 Wikipedia page up until a few days ago, but Wikipedia editors deleted it. However, the cached page is still available here.
Interestingly, the removed Wiki page claims that they are collaborating with the very prestigious Sanford-Burnham Medical Research Institute.
Scharp Labs provides a page of more info that makes the claims that MDFc19 does the following:
Induces collagen production to increase skin thickness
Reduce scarring
Reduce inflammation and skin irritation
Improve skin recovery time from laser treatments
Reduce wrinkles
These are very impressive sounding, medical claims.
For example, they again claim that Sanford-Burnham is a collaborator, providing “the core scientific analysis for Stemáge”
I emailed a few people at Sanford-Burnham inquiring about this.
No answers yet.
In the end there seem to be more questions than answers about Stemáge. I wonder if the FDA is really OK with such a product and its claims?
As a mixture of human growth factors, cytokines, and other elements made from other people’s stem cells, it seems to me to have many characteristics of a drug.Again, it is not my place to say whether it is a drug or not, but in this case there seems to be reason for at least some concern.
For example, there are possible safety issues such as the potential of the product to contain human viruses, prions, or other human molecules or cellular fragments that could be worrisome. If the human stem cells are grown in fetal bovine serum (FBS), there is also the possibility that customers could be adding factors via Stemáge from fetal cow blood to their face.
Not a very attractive idea in my opinion. Hopefully that is not the case.
I will post Part 2 on Stemage in a few days including quotes from my remarkable conversation with a representative of the company regarding where they get the stem cells and more.
You won’t believe it….or maybe these days you will.
As many of you know, the Coalition for the Advancement of Medical Research (CAMR) announced today that it will dissolve as an organization.
I both emailed and talked on the phone with the President of CAMR, Amy Rick (who by the way is also CEO of the Parkinson’s Action Network (PAN)). Below is a concise summary of our interview.
1. Why now? There are still battles to be fought and CAMR has been so important. For example the human therapeutic cloning paper has already drawn calls for new legislation against SCNT.
The timing of this decision has nothing to do with the recent SCNT announcement but rather with the general direction of the science and the regulatory issues since the NIH Guidelines were finalized three years ago. The CAMR Board has been analyzing this issue for months and came to the decision to transfer its mission during the course of this spring. As I said in the email, the relevant policy issues now go well beyond what has traditionally been CAMR’s focus involving the FDA and CMS, and ARM is already doing an outstanding job advocating in those areas.
We asked ourselves, ‘ is it really smart to keep it going just in case issues related to hESC research funding arise again?’ and decided it was not wise stewardship.
2. Are you confident that ARM will specifically support hESC research in the future as part of its mission?
We have no doubt that ARM will be just as strong an advocate for federal research funding issues and we hope that many of CAMR’s members will be involved with ARM. We have consulted with many people interested these issues and there is strong support for this transition. ARM has committed to hESC research and basic research funding.
3. What about the role of patients and patient advocates? Will they have a role in ARM moving forward after CAMR?
Yes, while ARM has historically not had as broad a representation of patient advocates as ARM, I expect a substantial role for patients in ARM. In fact, some organizations such as PAN are already part of ARM.
4. What can we expect moving forward?
One of the most important points is that when it comes to CAMR, the people are not going away. I expect many to be involved in ARM. As we were considering this change, our focus was on what would be the best way moving forward and I believe this change reflects that and the emphasis on translating therapies.
The CAMR Board has decided, as described in an email, to “transfer its mission and its resources to an outstanding colleague organization, the Alliance for Regenerative Medicine (ARM).”
The press release (PR) from CAMR does not clearly articulate a specific reason for dissolving itself.
In the PR, CAMR president Amy Comstock Rick, J.D, is quoted as follows:
“Human embryonic stem cell research has grown and evolved to a point where it’s time for CAMR to hand off its mission to an organization that can advance policy initiatives to support where the science is now, and where it is headed”
I plan to comment on my thoughts on this development in a blog post later in the week.
This is a big shock for the stem cell field that such a wonderful and still highly relevant organization such as CAMR, after more than a decade of extremely important accomplishments for medical research and stem cells, would choose this particular time to put an end to itself. Another important question is how this event will impact ARM and its mission.
Michael Werner, J.D., executive director of ARM, says in the PR:
“In Washington, D.C., and around the world, researchers and policymakers alike have CAMR leadership and its members to thank for the federal funding guidelines that have helped foster an environment for advances in stem cell research in the past 12 years…We are honored to take on CAMR’s mission, meld it with our own, and continue to support the great science that is already contributing to live-giving advances in regenerative medicine.”
I’d value the reaction of readers to this startling development. Please comment.
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