It takes a lot to surprise me these days in the cell therapy and regenerative medicine space, but some news from Walgreens stopped me in my tracks yesterday.
The firm most well known for its drug stores and pharmacies has been struggling recently. Perhaps as a way to try to turn things around, they recently announced that they are planning to offer cell and gene therapies. Here’s the PR: Walgreens Launches Gene and Cell Services as Part of Newly Integrated Walgreens Specialty Pharmacy Business.
This may be part of a wider trend of these kinds of firms offering a wider range of healthcare services.
Still, I can’t quite wrap my head around what specifically they will be offering in the way of cells and gene therapies. Can specialty pharmacies safely do cell and gene therapies?
Walgreens gene & cell therapies
For example, what cell or gene therapies could they even offer via their specialty pharmacies, which typically do not have physicians present?
Many such therapies require physician-based care at hospitals. They can have serious or life-threatening risks.
Focusing on possible cell therapies at Walgreens for the moment, are they thinking to offer cord blood for some applications? Hematopoietic stem cell infusions? In general these blood cell therapies are only FDA-approved for certain very specific conditions such as for recovery after chemo for cancer. Will they offer CAR-T cells? I go into this some more later on.
Moving on to gene therapies, these have potential complex risks. Care providers need to follow up on patients rigorously. Is that possible via specialty pharmacies? Would these locations coordinate with local medical centers near their pharmacies for some aspects of care?
It’s hard to imagine how this is going to work.
I asked gene therapy pioneer Bruce Levine for his initial reaction to the news and he said this:
“Patient safety requires proficiency. Where and how will their staff receive training and accreditation where applicable?”
Great question.
Walgreens will be manufacturing too
Walgreens also seems to be planning to be involved in manufacturing in this space.
They will have their own facility:
“Gene and Cell Services Pharmacy and Innovation Center – a dedicated 18,000-square-foot center in Pittsburgh, PA, with services and capabilities for these emerging therapies, including innovative solutions for managing the complexity of the supply chain, logistics and financing as well as clinical and social needs management to ensure success for patients and partners.”
Such a center is likely to cost tens of millions of dollars to build and run. This suggests a serious commitment by Walgreens to this new effort.
Only FDA-approved cell and gene therapies?
How do you make a profit this way?
There are relatively few FDA-approved cell or gene therapies. Does Walgreens think they can offer these at a lower cost than hospitals and so make a big profit? Are they anticipating future FDA-approved therapies that might be highly profitable and they want to get in on that?
Does Walgreens also plan to offer non-FDA-approved cell therapies like some of those at unproven stem cell or related clinics? For reference, technically the FDA doesn’t have to approve the use of one’s own bone marrow cells or certain blood products (e.g., platelet products like PRP) for many orthopedic conditions. This is a common practice at many stem cell clinics as long as the cells aren’t modified and the FDA has taken no action in that space.
So Walgreens could, in theory, offer cell therapies like that, which don’t have FDA-approval but don’t need it. I’m not sure these kinds of offerings clearly do long-term good for patients though.
I asked the firm for more information on the types of cell and gene therapies they plan to offer but haven’t heard back.
CAR-T and more?
A Walgreens video on the new effort has some drug and company names in presentation clips that might be suggestive of their plans. You can see a couple of screenshots from the video above.
In the cell therapy slide I see CAR-T therapies mentioned in there including Yescarta.
Other products like Luxturna and Zolgensma are in the video too.
These are probably just examples of the types of cell and gene therapy drugs that they could offer, not necessarily the exact ones.
If you freeze the video and squint at other presentation material in there maybe you can make out other examples of products. In the cell therapy slide specifically, can anyone make out what is written next to autologous and allogeneic?
Looking ahead on Walgreens plans
Overall, this seems like a risky new corporate strategy for Walgreens with substantial potential impact on the cell and gene therapy research field.
In a few years there could be hundreds of Walgreens specialty pharmacies that are in a sense a new kind of “stem cell clinics” or regenerative medicine clinics. They would probably be offering FDA-approved cell and gene therapies in some capacity, perhaps coordinated with local medical organizations with physicians.
The example of the Walgreens center in a St. Clair Health facility in the video is notable. It supports the idea that Walgreens gene & cell therapies may be offered at locations inside of partner medical facilities where physicians are present.
In the big picture, if getting these therapies could be safe and effective via Walgreens, and without extra cost to patients, this new development could even be a net positive. It could expand access to innovative, FDA-approved cell and gene therapies. Walgreens could be equally known for offering new, complex therapies as for aspirin, q-tips, chips, or birthday cards.
However, we just don’t yet have enough information yet about the plan. Also, I see many potential landmines along the way. For these reasons, I feel uneasy about this news.
Well, if you think the executives at Walgreens aren’t aware of the stem cell clinics in Panama, Costa Rica, Mexico etc. I guarantee you they’re aware of these stem cell clinics that thousands of people are traveling to every year. And so many of these people are coming back to the USA with crazy stories about how they went overseas to get stem cells and it cured them of their disease. I bet you they’re aware.