Last year a really biased post was written by Dr. Paul Knoepfler, (UC, Davis) on the secrets he claims stem cell clinics have told him over the years. Needless to say, these so-called secrets portray “stem cell clinics” as engaging in outright fraudulent activity as they purport to provide therapeutic treatments. My main beef with Knoepfler’s post is that he failed to define what types of stem cell therapies he is calling out. Take a look at the two previous posts to find commentary on and a link to the offending Knoepfler post: Creating a Storm Without Enlightening Anyone: Paul Knoepfler Shares His Frustrations with Stem Cell Clinics – Part One and Creating a Storm Without Enlightening Anyone: Paul Knoepfler Shares His Frustrations with Stem Cell Clinics – Part Two. The essential point is that Platelet-rich Plasma (PRP) and Bone Marrow Concentrate (BMC) are different from the kinds of cell therapies Knoepfler tries to trash in his post. I will finish my review of the so-called secrets he has written about in this post.
Clinics not meeting Knoepfler’s safety standards (Item 4 con’t)
He objects to physicians relying on treated patients who provide testimonials about the wonderful care and great results they received from a physician, but this is a practice that easily pre-dates the rise of regenerative medicine. He cites instances, without offering any evidence, that clinics induce patients to say nice things about the treatment they received or that they resort to just paying folks to say nice things without having been treated. Inducing testimonials is a difficult issue that it seems to me would be resolved best by state medical boards, who have the power to set ethical standards for physicians. If someone pretends to be a patient, and offers a testimonial for money, that person is part of a conspiracy to commit fraud, along with the physician and/or clinic. This is a matter for the Federal Trade Commission or the FBI.
- Adverse events associated with stem cell treatments
The comments Knoepfler makes in this part of his diatribe represent his most mis-leading of the post. He wants the world to know that you could die from getting a stem cell treatment, or be blinded or have tumors grow or get bony eyelids. I would contend that rather than assigning blame to unspecified stem cell preparations, the common denominator among all of these incidences is a physician performing a procedure.
Take the situation with patients being blinded. I covered this tragic case in a series of posts starting on (FDA Hammers A Flaunter of the Rules Against Making and Treating Patients with Fat Tissue-derived Stem Cells – Part One). Three patients were treated for macular degeneration at the US Stem Cell Clinic, operated by Ms. Kristen Comella, with an autologous fat tissue-derived stem cell-containing preparation. An ophthalmologist was involved. Following treatment, the patients suffered an acceleration of their degenerative condition, with one patient going blind in both eyes. Knoepfler wants to condemn stem cell treatments as the problem, but I would point to physicians willing to treat any condition without considering the potential for adverse consequences. In this case, the inside of an eyeball generally has few nucleated cells present, so injecting lots of nucleated cells probably wouldn’t be a good thing to do, and it wasn’t. The other issue I have with this incident is that both eyes were treated on each patient at the same time. This is a big no-no in the medical profession, which again points to professional incompetence.
While I agree with Knoepfler’s concerns about the ethical lapses that have created a free-for-all in cell-based therapies, his unfocused comments and lack of documentation quite rightly diminishes the impact of his post. That he tars all stem cell-based therapies without distinction also raises questions in my mind about what his real motives are. Clearly, it seems he doesn’t want the public to understand the issues at stake or to provide viable solutions or even a way forward.
Finally, I would encourage Dr. Knoepfler to share the inside knowledge he claims to have about clinics engaged in fraudulent activity with Federal authorities, instead of waiting for others to act on his biased statements offered without evidence or documentation.