I’ve interacted with many patients over the years who are interested in stem cells. This interaction is growing much more frequent. I enjoy interacting with them and have learned a lot this way, but I am often faced with dilemmas.
These patients may be facing fatal illnesses or other conditions that are wreaking havoc on their lives. They may have hit what seem to be insurmountable roadblocks to getting better and finding hope. It is entirely understandable that they want to take action and are wiling to take risks that people not in their shoes may not see the same way. Sometimes it is he parents of patients who call me facing similar challenges and decision making points.
Lately, I get patients or their families contacting me every week and sometimes almost every day.
They are looking for different things.
Some want information. Some want affirmation that it is OK to try experimental therapies at for-profit clinics. Others want the opposite. They want me to confirm their gut feeling not to move ahead with a “treatment”. Some just want to talk or email. I wish I had more time to engage.
They are at different places, but a common thread for them is that they see stem cells as at least one possible source of hope in a reality that otherwise seems pretty hopeless. I get that.
Most often they’ve found a stem cell clinic on the Internet. About eight times out of ten I know the clinic they have on their radar screens and it is usually one that I consider predatory.
What do I mean by a “predatory” clinic?
It is one that sells hype for cash.
There’s really no remotely convincing actual evidence that what this kind of clinic sells is safe or effective. Usually the clinic, if it is in the US, does not have FDA approval for what it sells and generally my best assessment of the “treatment” is that it is of the type that would seem to require FDA approval based on what the FDA has said in the past.
So what am I to do when patients ask about such clinics?
I’ve taken different approaches over the years, but generally I try to point out possible risks or concerns without sounding preachy.
I always strongly suggest talking to their own primary care doctor, which is an appropriate context for them to be considering such decisions. I ask if the patients are also considering what I consider to be “real” clinic trials that don’t directly profit from selling hope, but even those of course have risks so I don’t endorse participation in specific clinical trials either. In general, I emphasize that I do not give medical advice.
Then of course it is important to acknowledge that there is risk of doing nothing in some serious medical illnesses or conditions.
Those of us in the stem cell community who have stepped up to the plate to advocate for the stem cell field including very importantly pointing out the differences between legit clinical stem cell research versus predatory clinics are taking such personal risks. One such person is Dr. Leigh Turner of University of Minnesota who has been a leading proponent of evidence-based medicine in the stem cell field.
Perhaps a complementary or even better approach than individuals working to raise awareness in this area would be for the FDA and state medical boards to take the lead with clear, proactive guidance and importantly prompt action on predatory stem cell clinics in specific cases.
That’s not happening lately.
Even as the number of such clinics continues to grow, paradoxically the FDA seems to be taking less and less action in this area.
Even though the FDA has issued draft guidance in the last few months in areas that could prove helpful in clarifying regulation of stem cell clinic practices, otherwise action from the FDA has been noticeably absent the last 1-2 years.
The reason why remains unknown.
It’s like crickets chirping over at CBER at the FDA, the ones who should be enforcing regulations that some predatory clinics might be breaking every day.
The end result of all of this is a growing array of cowboy stem cell clinics and greatly increased patient risk.
In such a reality, what are individual civic-minded researchers with an awareness of the problem supposed to do?
Because of my past outspokenness about favoring evidence-based medicine (what some call “science-based medicine”) and asking questions about clinic practices, at times certain clinics have threatened to sue me or worse.
That’s no picnic and one has to take such threats seriously.
In the end, governmental and scientific organizations need to step up to create an overall safer climate for patients in the for-profit stem cell arena. This may mean that these organizations take on some level of risk and have to muster the fortitude to face threats of litigation, but it is necessary at this time as we approach a crisis point.