Predatory stem cell clinics are winning the war; what can we do?

For years I have been working to educate the community about the predatory stem cell clinics out there. These clinics prey on vulnerable patients and their families. The clinics use hope as a marketing tool.

A weapon.

As the number of such clinics has mushroomed in the US and elsewhere the risk to both patients and to the larger stem cell community proportionately rises too. We are in a situation today where the dangers from such clinics have never been higher.Stem cell facelift comic

They are making millions in profits with little-to-no accountability. Their therapies don’t have to work or even be proven safe. It’s odd because many consumers seem to expect more from non-health-related businesses such as McDonald’s or computer companies than from stem cell clinics.

Thousands of patients just in the US alone are regularly being subjected to experimental, non-FDA approved interventions. They are spending millions of dollars and being put at substantial risk.

Many patients are desperately looking for hope so they are very driven to find something that may help and are often willing to take unknown risks.

Some of us in the stem cell community are working to try to make some positive impact in this area. I believe we are making a difference, but overall the dubious stem cell clinics are winning the war.

Why are the clinics prevailing so far?

In part it is because they’ve been very smart about how they do business.

For instance, they do PR like pros, they manipulate some members of the media to almost in essence work as their spokespeople, they use social media to great effect, and they’ve won over some powerful allies in the form of certain patient advocates who have become in effect stem cell clinic advocates.

An illustration of the cleverness of the clinics is their move to take advantage of Clinicaltrials.gov to list their non-traditional, profit-driven business as if it were real clinical trials. They even go so far as to say that just because their work is listed in that database that their offerings are FDA-approved. They aren’t.

The stem cell clinics are also winning because the FDA has been so passive and ineffective, particularly during the last two years. Further in the past the FDA and more specifically the CBER division within the FDA that is tasked with dealing with stem cells took steps to regulate the stem cell clinic industry through actions such as warning letters. In contrast, lately CBER hasn’t done anything (at least apparent in the public domain and via FOIAs I’ve submitted) on the stem cell clinic problem.

This apparent regulatory passivity couldn’t come at a worse time either as the stem cell clinics proliferate like crazy in the US. There’s certainly a connection there. Less regulatory action = more dangerous clinics. It’s frustrating because CBER of course remains very active with the good citizens of the stem cell world such as those in academia and legit biotechs with appropriately high expectations for them.

Hello, CBER, are you home? Are you paying attention? Patients need to be protected.

I’ve tried talking with the FDA to get at the root of the stem cell clinic problem, but things remain nebulous. Are they afraid of being sued? Just too slow? Don’t have the budget? Maybe part of the problem is the leadership transition at the FDA where there hasn’t been a commissioner…but I think that’s only part of the story.

The FDA took a healthy step last year in issuing draft guidance (see my interview here with the FDA on the draft guidance) to regulate fat stem cell products that are almost certainly biological drugs requiring approval, but that’s been about it and those draft guidances have not been finalized. Until finalized, the draft guidances have no teeth. Meanwhile the fat stem cell clinics and others that sell unapproved stem cell biologics of various kinds such as amniotics, take advantage of this gray area to milk patients for millions of dollars all the while putting such patients at risk. The clinics are literally laughing at the FDA all the way to the bank.

Why should you care about this as a stem cell researcher, patient advocate, or other interested party? As has happened in the past, people are going to get hurt or killed at these clinics, and not only is that a tragedy unto itself, but also it will reflect badly on the whole stem cell arena. This magnifies the negative impact.

The unchecked stem cell clinic industry also has other negative effects such as muddying the waters for patients over just what is (and what isn’t) a legit stem cell therapy and research. We are also seeing some at academic institutions starting to give in to temptation and work with the dubious clinics too probably for the big bucks involved. In short, the war isn’t going well and the risks are growing.

So what do to?

We need to push the FDA to act more consistently, quickly, and forcefully on this problem. Maybe they think they are acting on it, but from my view it seems to be in slow motion. A recent poll on my blog indicates a larger sense within the stem cell community that the FDA isn’t being effective on stem cell clinics. And by my own calculations, the number of stem cell clinics in the US alone is skyrocketing. The FDA doesn’t have much time.

If more patients are injured or even die after getting questionable stem cell therapies, in a sense the FDA will bear part of the blame because of their ineffectiveness.

We also need organizations to step up to the plate and confront the clinics as well. When individuals such as myself and others including Leigh Turner and Doug Sipp do this, we have had some positive impact, but at great risk to ourselves. It is literally dangerous for us. I have been threatened with litigation and literally threatened to be attacked or killed.

Educational efforts can also be helpful and that is a major mission of this blog.

In the absence of timely FDA action, an out of control stem cell free market is churning. In January of this year I called it a “wild west” of medicine. It really feels that way. There’s demand so there will be supply. Something fundamental needs to change or the war is over and patients lose out, as does the stem cell field.

TGIF: NatGeo sell out, GM Humans, Wild West, Science backstabbing, & more

Wild West

Image from Wikipedia

It’s a shame that National Geographic has become part of a corporate empire that is not always consistent, to put it nicely, with data-based reality. Can NatGeo maintain its credibility and impact, when it is owned by a climate change denier (quoted for example as dissing folks as “extreme greenies”) who also has other very non-scientific priorities?

There’s been an increasing amount of discussion of the technology that could produce GM humans. This dialogue includes the new Hinxton Statement (my take on that here) and George Church’s quoted that Hinxton (which BTW did not call for a moratorium of any kind) was being too cautious nonetheless. Church is quoted:

“seems weak on addressing why we should single out genome editing relative to other medicines” that are potentially dangerous”

Should we push pause, stop, or fast-forward on human genetic modification? asks Lisa Ikemoto. Is there a rewind or edit button too? 

The NEJM published a new piece on stem cell clinics run amok and the lack of an effective FDA response. Sounds awfully familiar including the use of “Wild West” in the title, right? My gripe with these authors is that they didn’t give credit where credit is due to those of us on the front lines of this battle and in particular to social media-based efforts to promote evidence-based medicine in the stem cell arena. Still, their message was on target.

Are men more likely to commit large-scale scientific fraud? Check out RetractionWatch’s leaderboard. Of course the sheer number of retractions does not take into account the impact of any one or two given retractions that had a disproportionate toxic effect like the STAP pubs. Maybe another calculation to do is the # of citations to a retracted paper.

DrugMonkey talks about perceived scientific backstabbing.

Popular Science stem cell clinic article itself raising some red flags

Popular Science stem cellsPopular Science recently did a piece on stem cell clinics that has raised some red flags. The concerns in this case are not necessarily about the clinics per se, but rather the actual article itself.

There are a lot of stem cell clinics out there and for years they had a pretty consistent strategy of avoiding media attention. It’s almost as if they had a secret “fly under the radar” club to avoid negative PR.

However, today’s stem cell clinics are bolder and have adopted a new strategy: actively use the media as a tool for positive PR.

For instance, there is the Gordie Howe-Stemedica case that seems to keep on giving and giving PR to Stemedica and its Mexican partner Novastem. Amongst other things, they do some non-FDA approved stem cell interventions in Mexico. After months of positive PR on the Howe story for Stemedica including from Howe’s family who talked up the clinic, we all learned that the Howe family had become investors in Stemedica at some point.

Popular Science has, in my way of thinking, fallen into this kind of stem cell clinic PR web with a recent piece. Writer Tyler Graham worked for a long time on this story on stem cell clinic chain, Cell Surgical Network (CSN). During that time he contacted Leigh Turner and me for assistance on the story and quotes.

Tyler also became, by his own disclosure in his piece in Popular Science, a patient of CSN, but we were not made aware of that. Tyler reports in his article having got a therapy from CSN doctor Mark Berman for a long-term, very troublesome back condition and gives a remarkable account of how the treatment apparently helped him. A cure is suggested.

Then there is the title of the piece: THE CURE-ALL.

There is no question mark on that title and the implication in the article is that the writer was cured of his back problem by CSN. The net result of this article is likely a drive of new business to CSN.

To his credit, Tyler does raise numerous questions about stem cell clinic offerings. He also reports on another patient (Lamon Brewster) who in the long run was not helped by CSN so that part of the article is good for balance, but overall my sense is that the article is very problematic.

The piece has some statements that sound promotional:

“That’s not to say Berman is doing anything illegal by offering a treatment he doesn’t fully comprehend. He’s not. He’s not even doing anything unethical. He is healing patients who could not be healed.”

These statements are questionable.

In the end this article is a big disappointment.

Because some high profile people have received free treatment (e.g. Gordie Howe) from stem cell clinics I asked Tyler if he received any kind of discount, free treatment, or other benefit from Dr. Berman or CSN, but got no reply. I also asked the fact checker for this story, Rebecca Geiger, about this question, but she did not reply either.

If I do hear from them I will definitely post it. It could well be that full price was paid and there were no other perks, but it was a reasonable question to ask.

If you want to see a recent in my view more balanced, investigative piece of journalism on stem cell clinics, I’d recommend taking a look at the great piece by the Associated Press (AP) by Matt Perrone.