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.

They are making millions in profits with little-to-no accountability. Their therapies dont have to work or even be proven safe. Its odd because many consumers seem to expect more from non-health-relatedbusinesses such as McDonalds 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 overallthe dubious stem cell clinics are winning the war.

Why are the clinics prevailing so far?

In part it is because theyve 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 theyve 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 arent.

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 hasnt done anything (at least apparent in the public domain and via FOIAs Ive submitted) on the stem cell clinic problem.

This apparent regulatory passivity couldnt come at a worse time either as the stem cell clinics proliferate like crazy in the US. Theres certainly a connection there. Less regulatory action = more dangerous clinics. Its 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 withappropriately high expectations for them.

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

Ive 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? Dont have the budget? Maybe part of the problem is the leadership transition at the FDA where there hasnt been a commissionerbut I think thats 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 thats 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 isnt) 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 isnt 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 isnt 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 doesnt 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 thisyear I called it a wild west of medicine. It really feels that way. Theres 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.

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Predatory stem cell clinics are winning the war; what can ...