Class Action Against Stem Cell Clinic Using Fictional Outcomes Can Proceed
I’ve been warning for years that clinics that are using stem cells to treat any medical condition should be collecting clinical outcome data and making that public. This week a stem cell clinic in California overpromising and under delivering became a cautionary tale for all rogue clinics as a judge allowed a patient class action to be certified. Let’s dig in on why this is helpful for cleaning up the stem cell wild west.
Collecting Outcome Data
Collecting outcome data just means that the clinic uses validated tools like questionnaires to access how a patient fared with their treatment. For example, if treating the knee, the patient would get questioned about the level of their pain or their ability to do things like walk long distances or climb stairs. All of this is compared to their responses before the treatment to determine if progress has been made.
This data collection is usually accomplished by using a treatment registry. This is where all consented patients are sent these questionnaires on a regular basis and any information on complications is also collected. In principle, this sounds simple, but few doctors using regenerative medicine or orthobiologics actually collect any clinical data.
Why don’t clinics collect much data? It’s hard to do. It takes time and money to create a registry and then, more importantly, it takes a huge commitment by the clinic to make sure that patients are answering these questionnaires. In fact, it’s this last part where it all usually falls apart.
As an example, early on in our use of orthobiologics, an orthopedic surgeon in Florida actually stole some of the data we had published online about the outcome of using our specialized bone marrow concentrate protocol to treat knee arthritis. I confronted him as he was using a very different procedure. He then took our data off his website and placed a made up number there instead, stating that 80% of his patients had success. Later, it came to my attention that he had published some of his own data, but that data didn’t look quite right. So when I hunted that down through the person he had hired to collect it, I found out that some of it had been made up as well. Basically, his clinic forgot to give patients the pre-treatment questionnaire, so he had made up pre-treatment pain numbers for patients. Which just goes to show you, collecting data, even when a clinic tries to, is hard.
The StemGenex Case
I’ve blogged on this California clinic before. Basically, they were claiming sky-high success rates with their fat based stem cell procedure used to treat all sorts of serious diseases. However, that wasn’t actual patient outcome data, but patient satisfaction data on how the patient’s perceived the service they received. However, many patients believed that this customer satisfaction survey information was clinical data. Some patients sued and sought a class action status, which was granted by the judge this past week.
What Patients and Clinics Can Learn from this Class Action Case
I see stem cell treatment websites pop up every day making claims about success rates. The problem is that like our Florida orthopedic surgeon, most of it is spitballed and not based on collecting and analyzing outcome questionnaires from many treated patients. Hence, all of these clinics are open to this type of class action suit. They also fail to meet the minimum standards for advertising set out by the FTC, which requires clinics to justify what they claim with actual data. This risk was made evident by an FTC lawsuit recently brought against an Oregon clinic. In addition, some clinics may have state attorney generals to contend with, as both North Dakota and New York State AGs have filed suits against clinics over similar concerns.
What to Do or Look For…
As a clinic, if you report outcomes on your website, you MUST have real data to back that up. As a patient, you should be looking for real data as well. How can you tell if the data is real? Here are some tips:
- Look for outcome information on their website. Most clinics have none. If nothing is listed, then this speaks for itself.
- Round numbers are not good. While there’s a 1 in 10 chance that patients might report 80% improvement, there’s a 9 in 10 chance that this is a made up number.
- Look for actual data collected in a registry that is updated regularly and available online for you to review.
- Look for publications in scientific journals that are authored by that clinic or network of clinics. Be careful with this one, as clinics will often list research studies that have nothing to do with the procedures or protocols they offer.
Aren’t All Stem Cell Procedures the Same?
You might be tempted to think that since many clinics use the same “stem cell” term to describe what they do, you can use one clinic’s data and apply it to another. Regrettably, the number of different types of stem cells and protocols being used is vast, hence it’s very unlikely that one clinic’s data applies to the next.
What We Do at Regenexx
Regenexx has the world’s largest treatment registry in orthobiologics as we have been collecting data since 2005. There isn’t even a close second. Here’s what we have:
- Real-time outcome data on each body area posted online for you to review. This is updated once a month.
- A massive number of peer-reviewed publications on the protocols we use.
- Candidacy criteria based on the analysis of that information.
The upshot? The StemGenex case is just the tip of the iceberg. Expect to see more lawsuits and enforcement actions by FTC and state Attorney Generals on clinics that spitball their outcomes rather than collecting and reporting real clinical information. In the meantime, if you’re a patient, use my tips above to stay away from the stem cell scams out there.