The FDA Rains on the Stem Cell Parade

Rain on the Parade-2010Recently, the United States Food and Drug Administration Issued a document as to their indications for the wild, wild world of stem cells.  I’ve written about stem cells – and I’ve expressed many concerns – and the FDA is now taking steps to control what is and has been an unlicensed production of a new drug (of course, my concerns and the FDA’s actions have absolutely nothing to do with each other).  But let’s discuss a little bit about what’s going on.

First, you’d probably want to take a look at a previous article I wrote about stem cells.  I posted that one mid-2014.  It’s July 29, 2016, and I just got back from a three day seminar on soft tissue injuries in horses.  Frankly, after sitting for three relatively interesting but entirely sedentary days, I found absolutely nothing presented that made me think that at this point in time there’s any particular reason for real optimism about the current treatment(s), at least not in terms of helping tissues to heal faster, better, stronger, etc., than they would by using conventional treatment.

Lab pictureBut that’s not really my point.  My point is that the United States Food and Drug Association (FDA) has apparently become alarmed enough about what’s going on in the veterinary world (not just horses – stem cells are being marketed to small animal owners, too) that they’ve felt it necessary to issue Draft Guidance for Industry #218. 

There was a good bit of discussion about the draft guidance at the seminar.  So I thought it might be helpful to let you know what the general thoughts are currently.

1. The FDA is going to regulate stem cells for use in animals as if they are new drugs.

OK, so I don’t know about you, but this doesn’t strike me as particularly alarming.  Before a drug can be approved for use in animals, it has to be shown to be safe and effective.  It’s a pretty stringent requirements, but it’s an important one.  It’s one of the things that separates drugs from, say, supplements, herbals, and a bunch of other nostrums that get peddled to horse owners.  And for my way of thinking, I like – appreciate, really – the fact that somebody has to prove that a product does what the seller says it does before being able to sell it.  It’s not a requirement that anybody selling something really enjoys – from a sales perspective, it’s much better to be able to say just about anything and then sell it – but pretty much the entire history of medicine is one underlying reason that such laws have been made.

bathtub gin2. Stem cells cannot be marketed until they are approved as a new animal drug.

Right.  Pretty clear.  And, so far, exactly none of them have been approved as a new animal drug.

3. All stem cell products must meet requirements of current good manufacturing practices (cGMP).

So, what does that mean? Well, according to the FDA, “Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective.”  GMPs, “Provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.”

ASIDE:  Really, isn’t that something that you want, as well?  I don’t think that people realize that much of the stuff that they’re giving to horses doesn’t meet those requirements.  But to me, it’s kind of a common sense thing.

Anyhow, I don’t really think that it’s fair to say that stem cells are made in bathtubs in the back of somebody’s house, but it is fair to say that the production isn’t regulated.  Now, it’s supposed to be.

horse-cartoon4. All facilities that make stem cells have to register with the FDA, and must be GMP compliant.

So, far, I don’t think that any facility has met those standards.

5.  They can use stem cells in new drug studies.

Which is how it should be, really.  I mean, no one wants to shut down research into medications that might help tissues heal faster, stronger, better, etc.  It’s just that the government is apparently not keen on stuff being sold claiming to do that, when there’s no proof that it actually does.

6.  All labeling will have to be truthful.

OK, I’m sure that some folks will have some sort of an initial reaction to all this, worrying about overzealous regulation by big government and such.  But seriously, is requiring someone to tell the truth about their product such a horrible thing?  To be sure, lots of folks sell things and don’t tell the truth about them, but is that something that you support?  The truth about stem cells is that, so far, they haven’t lived up to the hype (and probably can’t).

7.  Adverse events will have to be reported.

This means that if there’s a bad reaction, it will have to be reported to the FDA.  The reporting of adverse events is done so that if even if a medication can make it through the proof requirements and get approved, if there are bad reactions after the product is released, people will know about it.  It’s this sort of thing that led to the demise of Vioxx®, a prescription medication for arthritis that was removed from the market after it turned out that while the drug helped people with arthritis, it also caused fatal heart attacks.  For some reason, it seems that many people would rather deal with their arthritis as opposed to dying from a heart attack:  go figure.  But that same sort of reporting will have to go on for stem cells, too.

elephant in the roomAfter all of this information was presented to us, it was kind of like there was a big elephant in the room; one that nobody really wanted to talk about much.  Now just in case you’re not familiar with that phrase, it’s an English idiom to describe an obvious truth that is being ignored, for various reasons. If you put an elephant into a room – like, say, a conference room where they’re having a meeting about soft tissue injuries in horses – it would be pretty hard to ignore, try as you might.  For one, it would probably get in the way of the ubiquitous projectors (I almost said, “slide projector” – shows you how far we’ve come, I guess).  But the big unanswered question was, “Is everyone going to try to ignore the elephant anyway?”

Not me.  The implications of this are pretty obvious – stem cells, as currently marketed, are being marketed in violation of FDA guidelines.  That’s not a good thing.  But me being me, I had another question to ask.  I asked a panel of four experts, “So why is it that we’re enthusiastically giving stem cells for a whole bunch of things in horses, but they’re not being used clinically in people?”

The response was, “Well, they are being investigated.  There are lots of clinical trials in humans.”

And I asked, “That’s great, but why aren’t they being used.”

Stem cells didn't help

Stem cells didn’t help

“They’re not approved,” was the reply.

Another panelist added, “But you can get them.  People go to the Caribbean to get stem cell treatments.  Kobe Bryant did it.  So did Tiger Woods.”

And to that, I didn’t say anything at all.  I mean, how are the athletic careers of those guys going?

Of course, one wonders if the FDA is really going to enforce all of this – they do have higher priorities, apparently, and there is only so much enforcement money to go around.  Still they have apparently sent out some letters to some companies.  We’ll have to see where it all goes.

Bottom line is after three days, I am still no more enthusiastic about stem cells than I have been previously.  There’s some good news, I guess.  There are some very good researchers trying to figure them out.  There’s a lot of promise, whatever that really means.  But the bottom line is that at this moment in time, there’s still no good, convincing information out there that indicates that horses heal faster, better, or stronger when they are given stem cells for any reason (I am aware of some positive studies and some negative studies, as well as both positive and negative testimonials by the way).  But in my opinion, while there certainly do need to be better options for the healing of soft tissue injuries, everybody should be much more circumspect in marketing these things to caring horse owners.

Walking elephantAnd now it’s apparently the FDA’s opinion, too.

 

 

 

About Doctor Ramey

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