On Saturday, NPR ran a story on the ongoing legal battle between the Food and Drug Administration and the Houston-based Celltex Therapeutics. (Or, I should say, the company formerly based in Texas. Last week, CellTex announced it was moving its patient-treatment center of operations to Mexico.)
The saga between the FDA and Celltex, which is not likely to end any time soon, has been detailed extensively elsewhere. (The coverage by Nature's David Cyranoski has been excellent.) But I was most interested in today's take on the NPR story by U.C. Davis stem cell scientist Paul Knoepfler, PhD.
Knoepfler, who writes a well-known stem cell blog, tackles a common refrain expressed by frustrated patients unwilling to wait any longer for what they see as their last chance for treatment: the idea that researchers and FDA administrators are kowtowing to a desire by 'big pharma' to keep chronically ill patients from cures that might reduce the pharmaceutical companies' profits.
I hear this all the time. Desperate patients (and their advocates) have a powerful need for hope. But as I detailed in a Stanford Medicine article in 2011, there are plenty of people ready to take advantage of such hopefulness. Even writing about the topic brings a barrage of angry comments (and I'm sure to see some here). That's why I'm applauding Knoepfler's response to the assertion of conflict among researchers and pharmaceutical companies:
Making that kind of accusation, however, is a common tactic of proponents of stem cell deregulation; throw unfounded charges of conflicts of interest against anyone who raises concerns about clinics. Another weapon is to accuse stem cell researchers of being uncaring or disconnected from reality or somehow not as smart or caring as the MDs selling the stem cell treatments. The sad irony is that as the false accusations of conflicts of interest are thrown at stem cell researchers, it is somehow ignored that the MDs involved are raking in millions of dollars of patients’ money.
As I said in my comment on the NPR site, the reality is that these stem cell treatments can be worse than doing nothing. They can literally kill you. They can do unexpected things as was so powerfully illustrated by the bone in the eye facelift case. It is hubris by the individual doctors and clinics to say they know all that is needed to know to put these cells into patients without FDA approval or vetting by other scientists and doctors first.
As I said, this controversy is not going to go away any time soon. But we need to be thoughtful about how we bring stem cells to to the clinic, for many reasons. As Knoepfler concludes:
Rushing unproven stem cell treatments into patients can also do worse than harm one individual too because negative outcomes might set back the entire field many years, affecting hundreds or thousands of patients by delaying future stem cell treatments. So we also owe it to patients of the future to be responsible in our conduct now and do this right.
I've excerpted a lot of Knoepfler's post today here because I think it's so important. And I encourage you to read other entries in his blog about unproven stem cell treatments. He's a researcher, a blogger and great communicator.
Previously: FDA audit of stem cell clinic revealed by Houston Chronicle, U.S. District Court rules that stem cells are drugs, and Stem cell researchers challenge clinics' questionable practices