Tsunamis, Amnio, Male Enhancement, and Exosomes

As a (now reformed) speaker for a number of Big Pharma companies in the 2000’s, I was mercilessly tasked with remaining 1000% “on message” regarding whatever drug it was that we were speaking about in front of other clinicians. Same was 1000% true for any drug rep. Even though it might be widely known and even acceptable that clinicians were using these medications “off label”, regardless of that fact, neither sales representatives nor clinician representatives speaking on behalf of the drug companies were allowed to discuss anything other than exactly what was on the P.I. for the specific drug in question.

The penalties for being caught doing “off label marketing” were and continue to be severe. We all remember the stories of companies being caught in the act of “off label promotion” as well as the harsh financial penalties incurred by those violating these very strict rules.

My impression of the current tsunami of birth products is this: The fact that these products are not considered “drugs” removes that level of FDA guidance as well as scrutiny from the equation. This is not good for patients. Or doctors.

Since “nobody” is in charge of (or responsible for) the “message” that is being conveyed regarding birth products after they leave the factory, representatives who sell these products are finding that they can pretty much say whatever they want, without any fear of repercussions.

Even the ads for “male enhancement supplements” that are promoted on ESPN every morning are very careful not to make any specific claims regarding treatment of any specific disease. We have all seen the disclaimers. At the very least, these disclaimers level the playing field -- If a patient who buys Nugenixx feels that they are “masculinely enhanced” after taking the supplement, then everyone wins. If Nugenixx actually works in some way to enhance masculinity, then it will probably sell a lot of pills. If not, it will vanish like many other things that were similarly promoted.

Birth products are not like male enhancement supplements you get on TV. They are much more expensive. They don’t come with a free sample. They are injected into human bodies. All parts of the body, actually. They can get tainted with Escherichia coli. On the other hand, these products may provide people with incredibly meaningful pain relief. People like me. I had dehydrated amniotic/chorionic membrane injected into my knee 3 years ago and it is still doing well. So please don’t call me a non-believer, or a bully, or a hater.

Regarding birth tissue products and how they are in some cases being shamelessly promoted --- I see what’s going on here. I get it. But I’m “in the system” and I recognize the game that’s being played. Many people --- including doctors --- don’t recognize the game. My mom and her friends, and patients like them all across this country do not understand this game, and I’ll tell you, the game right now ain’t very pretty. I don’t get quite as angry as others do about the way that these products are being promoted. I just tend to shut it out and honestly, we don’t have a lot of these unscrupulous vendors and scam injectors in this area. 

But I do get pretty sad when I think of how many people throughout the US have gotten $5000 “stem cell shots” into their buttock muscles, which is a total scam, and we all know it. Now I got the exosome game to figure out? Ok fine. Gotta go. If you need me, I’ll be trying to find a human exosome trial to look at. Or coming up with my next backyard pizza creation.