Cardiac Stem Cell Science on Thin Ice
Solid Data Needed to Strengthen Case
by Dr. Michael Gralinski
Every day I scan a variety of news outlets for the latest developments in the biotech field. Recently, a piece published online in Forbes grabbed my attention.
The article, “Stem Cell Therapy To Fix The Heart: A House Of Cards About To Fall?” discussed a scientific paper (BMJ) which concluded that many of the most exciting developments in clinical cardiac stem cell research are not true. In addition, the purported benefits to patients with cardiovascular disease are at best very modest and likely non-existent. The authors call into question the recent reports of high profile stem cell research, citing the recent withdrawals of ‘landmark’ publications in prestigious journals such as Circulation and The Lancet.
What took me by surprise was this concise, yet elegant dissection of cutting-edge research was published in Forbes – a business journal. The Forbes authors did a fantastic job of explaining the detailed methods and rigor of analysis in the original BMJ article. (Both are compelling reads.) It also underscored a conversation I had with a colleague at a recent scientific conference. He too was struggling with how to incorporate cardiac stem cells into their offering. He told me his business development team loved the idea so they invested in building this into their services. However, the clients are not jumping on board and asking for it. Why? They aren’t will to spend finite R&D resources on a safety study without solid, validated data.
In the same vein, I recently attended the 2014 Society of Toxicology-Midwest Regional Chapter meeting at a venue outside of Chicago. The theme of this years’ symposium was “The Use of Stem Cells in Toxicology Evaluation”.
Most of the speakers were associated with companies offering stem cell technology as a fee-for-service/product. A few academicians also detailed their research in the field. In the main, the presentations were interesting yet felt commercial in nature. Again, from a business development side, it is an exciting prospect. However, after a few talks detailing how beneficial and predictive this technology is, I asked a simple question.
“What are the pitfalls and potential downside of using stem cells for drug safety screening?”
The answer was frankly very disappointing and even described as ‘wishy-washy’ from the apologetic speaker I was addressing – a leader in the field.
Many of us believe this technology has some interesting characteristics and the potential to streamline drug safety screening. It is clear the regulators are also moving in this direction. However, those of us who have seen these ‘transformative technologies’ come with a vengeance and disappear with a whimper are still looking for answers to questions and solid scientific data to help guide our opinions and ultimately our research. Good science will always lead to good business.