What the FDA Crackdown on Stem Cells Means For You
Many people have seen the sensational news headlines about the FDA “cracking down” on stem cells. As you’ve probably read, I am a huge fan of stem cells as a way to reverse aging, turn off inflammation, reverse autoimmunity, make injuries disappear, and get control of our biology in a way that has never been accessible before. My own experience has been an absolute game changer.
Here is a brief explanation of what actually happened and what it means to you.
When cells from your body become drugs
Banking and growing stem cells is a low risk but gray area. Many clinics in the U.S. will draw your stem cells and send them to a bank, and then the bank will grow the stem cells and ship them back to your doctor so they can use them.
It is the growing of the stem cells that the FDA is concerned about because under those definitions it means they can classify them as a drug. Conservative physicians ship the stem cells to other countries than do the treatment there. This is what the wealthy elite and pro athletes have been doing for the past eight years – they fly around the world and spend huge amounts of money to get the benefits of stem cells.
It is absolutely legal to bank your stem cells, but controversial to inject them.
Current stem cell oversight
The FDA is balancing the risk of rapid innovation and lower cost and availability in the country, which is why many people still travel abroad for treatments.
All stem cell procedures are patient-funded right now. A group in LA was performing stem cell therapies for cancer under IRB protocol (a review board that protects the institution from lawsuits and patients from harm). A tumor board approved stem cell treatments and performed them at no cost to patients.
Another group – one where I’ve had profoundly effective stem cell work done in Florida – is very cutting edge and by definition controversial. The FDA issued a warning letter calling safety procedures and drug classifications into question. FDA scrutiny doesn’t necessarily mean that the clinic’s treatments were unsafe, but it does mean that regulatory agencies want to see that procedures are established and followed.
Different attorneys have different opinions about whether a full-on investigation is warranted or should be allowed. Kristin Comella, Chief Science Officer at the clinic, responded to the FDA warning letter here.
Some hope for medical freedom
This gets kind of technical, but an IRB approval is not enough according to the most conservative interpretation of the rules. The FDA requires an investigational new drug application called an IND, at least if you believe that taking your own stem cells out of your body and growing them makes them into a drug.
This a core medical freedom issue. Do you have the inalienable right to choose what you put in your own body? If so, right now, you have to fly to another country to do it.
There is hope. Governments are starting to pass legislation to allow people who have a terminal condition to choose any form of therapy they want no matter the regulatory framework.
- Texas has much more lenient laws so you can get procedures like this as long as they are in hospitals. Unfortunately for us, that means they will still be expensive.
- The CURES act has relaxed the law for regenerative medicine so that regulatory agencies may not require large expensive phase 3 clinical trials to bring regenerative medicine to the market.
The truth is that it’s not that hard for a doctor to extract stem cells from your fat and to send them to a bank, and it is quite simple to reinject culture-expanded stem cells intravenously later. It is absurd to require an expensive hospital for a reinjection procedure that you could do in your doctor’s office.
But, quality control is not at all solved for stem cell banking and amplification. A lot can go wrong. That’s why we have standards. That is why the FDA believes that culture expanded stem cells are drugs instead of a part of your body.
A safety issue or a human rights issue?
I greatly value academic research and government oversight. It can be very helpful to prevent the rampant fraud that the drug industry is known for. At the same time, I believe that an inalienable human right is the right to choose how we manage our own biology.
A lot of people don’t know this, but only one of the founding fathers was a physician. The rest of them were lawyers and business people, politicians and philosophers. The one physician lobbied strongly to put medical freedom into the Bill of Rights. The others didn’t support it, and it is still not a Constitutional freedom.
I would like the right to choose. I would also like the right to bank and grow my stem cells and use them to live longer, feel better, and perform like a rock star. I promise to read the fine print before I make the decision, but the decision is mine.
This is a medical issue, but it is also a social justice issue and a human rights issue. Stem cells should rightfully be available to people from every economic class, not just the rich people who can fly to exotic countries where you can get cutting edge treatments.
I hate to be the one to break it to you, but you have a terminal condition. It’s called life. Better get on top of that condition right away!
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