My son loves the cartoon TV series South Park, and one of my favorite episodes is where James Cameron is enlisted to find out just how far the societal bar has been lowered and how to “raise the bar.” Just when I thought the stem cell Wild West couldn’t lower the bar any farther, here comes a new business plan—practice-management companies hawking amniotic stem cells as income generators for chiropractic clinics. This is truly a new twist, one that’s as disturbing as it is bizarre. So how far has the bar been lowered?
Lowering the Stem Cell Bar to Date
We’ve seen many things that have lowered the stem cell bar so far:
- Doctors taking a weekend stem cell course and declaring themselves experts in the field
- Websites listing research studies that have nothing to do with the type of stem cell care being offered
- Doctors offering to treat 20–40 different incurable diseases with stem cells
However, the new trend lowers the bar still farther with amniotic stem cells.
Amniotic Stem Cells For Sale
I’ve blogged extensively about these amniotic products before, but to review, while these likely contain helpful growth factors and some “extracellular matrix,” they are not stem cell products. However, when orthopedic sales reps tried to sell this stuff as what it is, it didn’t sell well. So the reps, based largely on the fact that the amniotic fluid and membrane have a low content of stem cells when fresh out of the obstetrics ward, began to tell physicians that the stuff was loaded with stem cells. After that, 1 cc vials of “baby juice” (amniotic fluid that surrounds the baby) sold like hotcakes for more than $1,000 each.
Let’s do some math to better understand the genesis of the amniotic business. Given that the price this morning for gold is about $1,200 per ounce (28 grams) and a ml of fluid weighs about 1 gram, this “baby juice” costs about 25 times the price of gold! Also, considering that the average baby has 400–1,200 ml of amniotic fluid at term, if we use the 800 ml number, that makes each delivery worth about $800,000 retail! That doesn’t include the amniotic membrane or chorion (which make up the sac that holds the fluid). Add in an easy $200,000-$400,000 more for those tissues and we easily have a million-dollar delivery.
How can the disposable tissue after birth be worth a cool million? Well, when it’s fresh, there are some amniotic stem cells available in these tissues, but once these are processed and frozen, there aren’t much. In fact, the IOF tested these products and found that none had any living cells by the time they were thawed as a product and certainly none had living stem cells. This is despite physicians telling unsuspecting patients that each 1–2 ml vial has 2 million amniotic stem cells.
Up until I did the math on how much each birth generates in revenue, I never fully understood why the four or five major tissue banks in the U.S. were signing up new companies every week to private label their amniotic products. You see, even you can get into the amniotic stem cells business tomorrow just by approaching a tissue bank. You would ask that they file an FDA 361 registration on your magic baby juice and then recruit orthopedic sales reps. Within a few months, you would be in business for about a thousand bucks a vial.
The Chiropractors Trying to Keep the Bar High
First, I have great respect for chiropractors and refer to them all the time. However, the guys and gals I work with would never get involved in lowering the stem cell bar. They know what they’re good at and focus in that world, which makes them very effective at helping patients.
The new group selling decellularized baby juice to chiropractic clinics actually came to my attention through a chiropractor who owns some of our clinics. He’s a good place to start to set apart what he and others like him have accomplished from this most recent income-generating soiree.
The chiropractors I know who are involved in regenerative medicine and who are doing this right have spent a huge amount of time and resources on expertise. They have looked far and wide to find expert physicians to hire, at considerable cost. They have joined a group of physicians measuring clinical outcomes or are measuring their own. They have ensured that advanced imaging guidance is being used for injections. They offer patients a realistic appraisal of what to expect, and they steer clear of being dishonest about the technology they’re offering. So before I delve into the baby juice factory, let me applaud the guys that work hard to do this right.
Lowering the Bar
This week, two events happened that made me aware of this most recent nutty trend lowering the stem cell bar. First, the Interventional Orthopedics Foundation got an e-mail from a chiropractor in Georgia who runs an amniotic stem cell clinic. He was upset that the IOF’s research didn’t show that amniotic fluid products contained stem cells. Second, a chiropractor who is doing this right sent this e-mail on the same day:
“…we are seeing an epidemic of new groups emerging that make claims that have little justification. Below is a link to a group that has emerged out of a consulting company that has been promoting MD/DC practices for several years and have now added stem cells. In fact, they only provide amniotic injections without saying stem cells, but their name implies they are doing stem cell therapies. The consulting company advises chiro’s to enlist a MD to become a part time medical director and hire mid-levels to do the actual care. Or, they have a physician come in one or two days a week.”
When I hunted down the chiropractor in Georgia who was upset about the IOF’s research and the company that was signing up chiropractors to bring in physician assistants to get baby juice injections, their websites looked curiously similar. The explanation above seemed to fit. The Georgia chiropractor’s website was rife with references to amniotic stem cells therapy, despite the fact that our data and the FDA registrations for these products show that they contain no stem cells. The e-mail above also shows how this new Wild West business plan works.
One of the scenes from that favorite South Park episode is above. James Cameron goes deep into the ocean to find just how low the bar has sunk and tries to “raise the bar.” So let’s see just how low the amniotic stem cells bar has sunk.
The types of physicians with high levels of training to perform a bone marrow aspiration and/or liposuction and with the image-guided skills to place stem cells into very specific areas of the body are expensive and hard to find. So the new chiropractic baby juice business plan seems to say, “Why go through the brain damage of ensuring the doctor knows what he’s doing? Just hire a physician’s assistant or nurse practitioner.” They generally have no idea how to perform a stem cell harvest procedure and can generally only perform the simplest joint injections. However, they’re about one-third the price of a skilled physician. In addition, just hand them a vial of dead cells and claim that it’s a vial of amniotic stem cells; who will know the difference? When a lab with access to millions of dollars of equipment has a PhD-led stem cell team dig deep into whether there are stem cells in amniotic fluid products and finds none—complain! After all, why spend your own money on doing the testing before injecting this stuff into patients? That just takes profit from the bottom line.
Raising the Stem Cell Bar
If, like James Cameron, we’re going to raise the bar in stem cell therapy, what would that look like? How would that differ from the new chiropractic business model?
- If you say you’re injecting stem cells, there actually needs to be viable stem cells that are freely available to act on the body. This would seem to be a no-brainer, right? However, to many physicians hawking vials of dead baby tissue as viable stem cells, it seems a hard concept to grasp. Why let reality get in the way of a great business plan?
- The “doctor” injecting the stem cells actually has to have advanced knowledge in how to take and place cells. In this case, you can’t substitute a physician extender or a family doctor who barely knows how to inject a knee.
- Spend the bucks and resources to be able to perform your own research or have others do the same on your behalf. A problem here is that the chiropractor group was gullible enough to believe the sales reps who said that there were viable amniotic stem cells in these vials. When they heard there likely wasn’t, they needed to have their specific brand tested and dig deeper.
There are many other standards that we should be enforcing, but these three simple ones would go a long way toward raising the bar.
The upshot? The stem cell bar gets lowered daily. Being the first physician in the U.S. to have done this work and spending a huge amount of money every year publishing research and investigating in the lab what’s best for patients, it’s upsetting to see how low the bar has sunk. We spend our own money testing the claims of sales reps, like the claim that this little magic vial has millions of amniotic stem cells. I guess the best I can do is to educate physicians and patients about where the bar should be!