Have you seen this large postcard or one like it? Physicians out there offering responsible orthobiologics hate these mailers. In addition, I would argue that these postcards represent one of the single biggest threats to producing a rational and sane orthobiologics industry and that the companies involved in sending them should be targeted by regulators. Let me explain.
Ethical Orthobiologics vs. Let’s Make a Buck
We’ve seen the rise of thousands of clinics offering stem cell treatment for all sorts of conditions in these last few years. Most use providers with no or little training to inject these cells, overpromise and underdeliver, have no real candidacy guidelines, push everyone into one magic cure-all therapy, and often use dead birth tissues hawked as a miracle cure stem cell therapy. One of the ways you can usually ID one of these scam clinics is by the use of before and after x-rays. So let’s start there with the card shown above.
Scam-rays vs Before and After X-rays
Since this is what I do all day, it took me all of a few seconds to look at the above x-rays and know they were a scam. Why? It’s all about the position of the knee cap.
The first thing you need to know is that using before and after knee x-rays to try and show cartilage growth is fraught with problems. First, the idea is that the joint width should get bigger if there is new cartilage growth (this is the cushion between the bones). The issue is that even small changes in the angle of the x-ray beam can dramatically alter the appearance of the width of the joint. Meaning in seconds, I can change the angle of the x-ray beam so that it doesn’t go straight through the joint and make it look like the joint has lost cartilage. In seconds I can change it back and make it look like the patient gained cartilage. How can you tell that’s what’s being done? Let’s look at the knee-cap.
If you look at the images above from the postcard, you can see that I have placed lines on the knee cap. Notice how they’re at different levels relative to the joint line. On the right, the kneecap is higher than on the left. That’s a dead give away for a scam-ray, as that means the angle of the x-ray beam was changed. To understand more on that topic of scam knee x-ray findings I have a whole blog on it.
More About this Marketing Pitch
The clinic listed here is Renew Integrated Medicine in Dallas, Texas. This is a chiropractic clinic that uses “umbilical cord stem cells”. As you have read here, just claiming that umbilical cord products have living mesenchymal stem cells as this clinic does, is a scam. Meaning that there are no commercially available birth tissue products that contain living MSCs. These are dead tissue products. The ad above claims to show a patient who had severe knee arthritis who had a huge amount of cartilage regrown. Is there any clinical evidence that shows that dead umbilical cord tissue can regrow you a new knee. Nope. Does any actual medical expert in this area believe that can happen? Nope.
Despite this just being yet another chiro clinic overpromising and underdelivering, let’s take a closer look at how this card makes it to patients. Why? Because I would state that regulators should focus as much on these companies as these clinics.
The Drivers of the Scams
Obviously, the physicians, mid-levels, naturopaths, chiropractors, and acupuncturists who believe at face value after being presented with poor science that they are injecting millions of mesenchymal stem cells in vials of birth tissues have culpability in the fraud. They also should know that showing an x-ray that clearly has had the beam manipulated to show fake results is not responsible. They should be sanctioned by their respective state boards. However, what has allowed the scams to grow at scale are the birth tissue vendors and the addition of big marketing firms to the space.
I’ve blogged before on how birth tissue vendors convince physicians that bad research shows that their products have millions of MSCs. I’ve also discussed how this is not legal per FDA rules and how it’s also not verifiable using any reasonable lab. The good news is that the out of control birth tissues industry has attracted the attention of federal regulators, as have the doctors selling fake cures. However, one of the biggest drivers of these scams are the high powered marketing firms who have entered this space.
Big Marketing Firms Enter the Stem Cell Wild West
The big firms that have begun helping clinics market scam stem cell treatments are more used to helping market financial services, nursing homes, or dentists than stem cells. They basically act as a one-stop shop marketing solution for small clinics. They often help set up seminars, market them, and then handle the leads. The problem is that unlike selling financial services or reverse mortgages, this is a field regulated by state medical and other boards as well as the FDA. Hence, this is brand new turf for these companies.
Leading Response Marketing
“I am here at the A4M Anti Aging Conference and there is a company here called “Leading Response”. – they set up these lunch seminars for Doctors to “sell” “stem cell” procedures to potential patients. I sat through their presentation – it was all about how doctors can make $$$ without ever mentioning anything about making patients better- I couldn’t believe what I was hearing.”
This Linkedin poster also shared this brochure he picked up:
“To Feed or Not to Feed”? Also note that “Stem Cell” has now been added to a product line that used to include plastic surgery and dental implants. Who is this company? Their website says: “Smarter Client Acquisition for Better Business Results.” They were formerly known as IM Solutions.
“They promised legitimate Sales leads for my business for consumers seeking help with their bills. All but 2 out of the 100 leads were legitimate. The Sales person Scott ****** kept calling me under a different name Landmark or Landfill. He would not quit until I finally placed an order! As soon as a lead came in it was returned immediately as these people did not apply for any help with their bills. This breaks our TCPA agreement and Federal law…”
This is their response:
“Leading Response, formally named IM Solutions, LLC, provides advertising programs and potential client information (leads) to companies looking to increase their client caseloads and grow their businesses…”
And this consumer complaint:
“Keeps spamming my email inbox Continually spams my email inbox with unnecessary and annoying emails. Email is *****@live.com Have tried to unsubscribe multiple times with link to no avail, appears to increase spam. 10 plus emails a day.”
It’s frankly hard to find much on either of these companies, Leading Response or IM Solutions. Hence I looked at their address. Also at that address is RME360 Response Marketing. Is this the same company? It has the same CEO, Charles DallAcqua and it looks like it does the same thing. This from Bloomberg:
“Mr. Charles R. DallAcqua serves as the Chief Executive Officer of LeadingResponse, LLC and RME360. Mr. DallAcqua oversees and manages its two subsidiary companies: IMS and RME360. ”
Regulators Need to Get Involved
While two posters on Linkedin believed that this postcard was sent by LeadingResponse, I can’t confirm that at this time. I can say that the postcard is fraudulent. Meaning that the before and after x-ray result shown is clearly faked. I can also say that the umbilical cord product that this clinic is using has no live MSCs. So that the sales pitch is a scam.
I can also say that these postcards and these seminars raise interesting questions. What is the responsibility of the marketer of FDA regulated therapies? Are they responsible for fraudulent marketing? Can they be sued by FDA or FTC?
The upshot? We’re entering a brand new phase of the stem cell wild west. While I have pointed out the fake stem cell scams, this adds a new twist. The marketing companies that fuel the scams allow them to scale to the point where many more patients will be harmed.