The fact that a person for the first time has received a heart transplant from a pig and it was a genetically modified pig made big news this week. Organ transplant waiting lists are a huge problem so if this kind of approach can be proven to be safe and effective, it would be a big step forward.
It’s early days though and just one patient so let’s take it step by step.
Here’s the article. In a First, Man Receives a Heart From a Genetically Altered Pig, NYT. The biotech is Revivicor.
CRISPR gene-editing continues to make headlines including related to major financial deals like the new one involving Pfizer. I have to admit when CRISPR was first getting popular as a method in the lab not that many years ago it seemed like clinical applications might be a long way off. I’ve been pleasantly surprised how fast things have moved forward.
Here’s the article. Pfizer Makes Foray Into CRISPR, Inking $1.35 Billion Deal With Beam Therapeutics, Investor’s Business Daily
Stem cells and lasers
Nabiha Saklayen: Could lasers make stem cell therapy available to everyone?, Ted Radio Hour on NPR. An interesting story about using lasers to remove non-reprogrammed cells during reprogramming to make iPS cells. What a clever idea. You can see her TED talk above that includes clips of the use of the laser in culture.
Holmes verdict draws more reactions
Derek Lowe on the Elizabeth Holmes verdict over at his In The Pipeline blog. He has some very interesting thoughts on how those working in Silicon Valley may tend to view the biomedical space in an artificially constrained kind of way because of the work they are used to doing. It got me thinking more about how those folks who are outside the cell biology space may view things quite differently than those of us working within it. Does a chemist sometimes view cells more like molecules? How does a lawyer or accountant or YouTuber tend to think about cells? These different views can be useful in bringing in new ideas and viewpoints, but when working toward a therapy some caution is needed too.
How much should it cost to publish an article?
In this scenario, the cost of publication is covered by an Article Processing Charge (APC) paid at the time of publication. The APC for Nature Neuroscience in 2022 is €9,500/US $11,390/£8,290.
— Nature Neuroscience (@NatureNeuro) January 11, 2022
If you look at the Tweet above from Nature Neuroscience you can see a fee that seems insane.
More than $11K to publish an article?
Even non-open-access fees are so sky-high these days at many journals. While some publishers have programs to help those scientists and institutions that cannot afford their exorbitant fees, how often are they used? What about the sizable dents that publishing fees make in the budgets of standard R01s or other grants? That’s money that could be going to the actual research costs. As someone rightly pointed out on Twitter discussing this $11K fee, journals don’t even pay reviewers anything.
Do some publishers need a “heart transplant” in the sense of being more sensitive to science budgets?
Issues on Sanford Health article on ongoing trial
I reached out to writer Simon Floss at Sanford Health a few weeks back with some questions on a promotional piece he wrote that raised some concerns for me. The title is “Cell therapy helps Sanford patient get back to racecourse.” The subtitle is, “When old injuries slowed down an endurance athlete, a clinical trial offered treatment.”
The piece highlighted the supposed striking recovery of an arthritis clinical trial participant, Steven Fisher. The main issue here is that the trial is ongoing so there is no published data on whether it is actually working and is safe.
This raises several questions.
Is it appropriate to issue marketing material on a clinical trial participant while the trial is not finished? Did Fisher and other participants have to pay to be in the trial?
Is Sanford charging others who are not in the trial in parallel to get the experimental offering?
Interesting link, Liz, regarding adipose derived stem cells in a device trial for osteoarthritis. The thing is, why is this being done …..AGAIN?? Haven’t trials similar to this already been completed regarding adipose derived SVL or stem cells? And take a look at the completion date of the trial you linked me to from Sanford University. It’s 3-4 years away in 2026! This is part of the problem in labeling our body parts as drugs. They have to go through a glacially slow FDA procedure which is equally expensive all because a government agency decided to essentially declare that they have regulatory authority over our bodies as drugs. If patients were the true beneficiaries of all this “research” then why keep them waiting for so long? Simple. It doesn’t benefit all but a few patients while making the researchers and their laboratories the true beneficiaries with more grant money. And after 2026 has come and gone then what? Will this therapy then become widely available for those suffering from osteoarthritis? I’m quite sure that orthopedic surgeons will weigh in on this Sanford clinical trial when it completes in 2026 as well as suppliers and their lobbyists when it comes to artificial joints as well as the drug companies. I would think that these sorts of players within the medical establishment will then all be calling for Phase III B,C,D,E, and F clinical trials and further “studies”. And, not for the benefit of the patient either but rather for a system that is long on hope, promise and excitement (and repetition) but short on delivery.
Sanford Health trial: https://clinicaltrials.gov/ct2/show/NCT04405297
It appears to be a device trial.
You need a regulatory affairs expert to sort out the rest.
The TED video above. It seems like a fair amount of hype about how exciting the future is going to be when, or more precisely, IF several conditions are first met. I mean regarding Dr. Nabiha Saklayen, the laser physicist above; she does seem interesting. But so often times that’s the case when it comes to hype without ever being too specific about a real time frame. With hype, Implementation is always vaguely somewhere in the future. It seems patients and our health concerns are used by the medical and scientific elite as a means to their financial/career ends. When on the cusp of real progress the elite and well financed drug companies and the government agencies they own step in and talk about how much further they have to go before something is ever realized. They speak first about years which then turn to decades and then perhaps even to generations of time. All the while they dangle hope, excitement and promise for all in front of our eyes compelling the vulnerable to keep contributing to their perpetual research. Right now there are stem cell banks for instance that can store adult stem cells from fat tissue removed from your belly or buttocks area and then cryogenically frozen. It’s not cheap, but far less expensive than the price tag Dr. Saklayen mentions in her talk. Of course the established medical and scientific elite will denigrate these banking practices as “unproven” as though even with conventional practices there were actually such a thing as proven therapies. Dr. Saklayen mentions how “we will all have the option of having our stem cells banked ahead of time”. That’s some wild speculation given that our current system hardly benefits all. You see? Dr. Saklayen’s future could happen. But this is not likely under the current economic system where health care is a privilege and not a right. And many of the medical and scientific elite are benefiting from that very system. Many other conditions, beginning with changing our economic model, will have to be met before all can benefit from the technology she is lecturing about.
Dr Knoepfler, please tell me if I am wrong ….academic publishing is the only human activity in which the people that do all the work actually have to pay for doing the work
The inflation of publication costs is disgusting
Next they will want peer reviewers to pay for peer reviewing
I am not in the system but I do publish here and there. What do you recommend that we do to stop this crazy trend ?