I’m doing a series of posts on straightforward reasons why patients should not get unlicensed stem cell treatments. Part 1 of the series was on the risk of losing medical insurance coverage.
Today is part 2, which is focused on a serious failing of many for-profit, point-of-care stem cell clinics selling unlicensed treatments: lack of follow-up.
An integral part of FDA-sanctioned clinical trials is follow-up, which means the clinical trial follows patients long term to see how they are doing and monitor for adverse outcomes that can then be logged and treated. A challenge for clinic trial is patients who, for whatever reason not integral to the trial, are lost to follow-up. However, some clinics’ practices ensure patients are lost to follow-up.
The vast majority of for-profit point-of-care stem cell clinics do not do any significant follow-up, but also some stem cell biotechs hoping for licensing have the same failing.
A lack of follow-up is problematic for many reasons. First of all, it means we all learn less about the potential strengths and weaknesses of new stem cell therapies. However, it also puts patients at greater risk for serious treatment-related health problems, which when they occur are likely to remain untreated for a longer period of time.
A striking example of failed follow-up is the case of Pluristem treating 3 patients under the umbrella of compassionate use, claiming miracle cures for patients, and then not following up on the patients, some of whom died. This doesn’t meant that the stem cell treatment given by Pluristem caused the patient deaths, but lack of follow-up means that possibility cannot be ruled out or examined carefully. However, the broader lack of follow-up problem rests with for-profit point-of-care clinics, which are putting hundreds or thousands of patients at risk by not following them after treatment.
Why would clinics choose not to do follow-up?
Follow-up is labor intensive and costly. Imagine if you treat 100 patients with stem cells, collect the payments, and send them on their way (maybe you have one post-treatment visit with the patient) versus following the patients for say 10 years with regular appointments and tests. The former is not scientifically or medically the proper thing to do, but it sure is dramatically cheaper than the latter. However, the latter provides more data and protects patients.
And some of this ties back in to lack of clinical trials and the regulation that would come from those, right? I mean, most trial protocols have a specific requirement for reporting; for various reasons, I have the CAFÉ study protocol open right now, and Ch 5.7 is “Analysis of Safety Data.” Within that, it separates out “Adverse Events” and “Death and Other Serious Adverse Events.” These sections include detailed definition of what severe adverse events are, and death isn’t the only option there.
Without tracking this data – and, as CAFÉ shows, even with, there are clearly problems – it is impossible for anyone to know the actual, empirical evidence for efficacy and safety.
Absolutely good points, Kelly. Even under ideal circumstances, patient follow up is a challenge, but if the MDs don’t even try to do it at all then it is really unethical and dangerous in my opinion. Perhaps another reason, beyond saving a buck, that they do not do it is they really do not want to know if patients have bad outcomes. I don’t know…maybe I’m too harsh.