BEING INVESTIGATED BY THE FDA - A Short Personal Account.
It began when one person using Shakti took an overdose of an antiepileptic medication - one that can actually induce seizures if one takes enough of them. This person had a seizure, and in an almost textbook episode, forgot what had happened until they later found a notation on their calendar to start the medication on a specific date - the day of the seizure.
The medication did not prevent a memory from the day before, when they had done a Shakti session. Six minutes long, it was part of a series of the shortest sessions ever done.
The medication disturbed the memory of the overdose itself, but not the Shakti session the day before. They mistakenly decided that the seizure was caused by Shakti. When they realized their error, they were very quick to set things right.
But before that happened, this person contacted a fellow who was developing another neural stimulation device. The fellow went through my website almost every day (I knew his IP address). One day, I looked at my server logs and found that he had even done a search through google for my name and the word 'divorce'. My ex-wife and I are on good terms, and suffice it to say that she never posted anything on the internet about our breakup. Still, seeing an entry in my server logs made me a bit uneasy. The issue wasn't Shakti. It was me, or so such a search would imply.
He called and wrote the FDA, telling them that I was making medical claims for Shakti. In fact, I was, but you'd have to know the strict letter of the law to know it.
My website had a medical research proposal for using Shakti. I had reasoned that a research proposal implied that no claims could be made, but that at least some might be worth investigating. I was wrong. I later learned that even a proposal can constitute a medical claim - a claim that medical use is possible. In retrospect, it makes sense. Someone might read the proposal, and then decide to conduct their own, possibly careless 'do it yourself' trial. In fact, the exact procedure could not have been done using a standard Shakti unit or the signals provided with it, so that the device discussed in the proposal wasn't actually available. When the time came, I decided not to argue these fine points with a federal agency.
In June of 2002, I received a 'standard' letter from the FDA informing me that, as far as they were concerned, I was not in compliance with the law in having a medical proposal on my website. The letter said I had 30 days to respond, telling them what actions I would take in response to their concerns.
I called the investigator, who was quite frank and even friendly in their response to my questions, and really only wanted to make sure that I did not make any medical claims on my website. They were firm but fair. After that conversation, I knew that it was going to be all right, and that they were not 'out to get me'. They just wanted me to understand the law, and to comply with it. The often severe sentences companies receive for violating FDA regulations, it seems, are reserved for those who try to get around the regulations, or who deny their misbehaviors, and go on promoting clinical treatments that haven't been tested. Their specific need is for 'pre-marketing approval' for anything sold for medical uses.
Shakti uses much fainter magnetic fields than other magnetic devices (like TMS), but it's principals are very different, so that it cannot be described as 'substantially equivalent' to it. When and if the day comes, it will need it's own FDA approval.
Some people claim that the FDA is a clearinghouse for pharmaceutical companies, and that they try to prevent treatments that bring these companies no profit. After my experience with them, I doubt this. Rather, they have more experience in looking at the more standard forms of treatment, and this makes it easier for them to approve new drugs than other, less traditional, therapies. Really new approaches require new expertise within the FDA, and that's not always available. This may serve the pharmaceutical companies interests, but is probably not designed to do so. The alternative is to believe in a grand conspiracy. Corruption may exist, but certainly not in my experience with them. Look at it from the corporate side. If there were corruption, it would be more practical if it lent speed to new drugs coming to market than try to suppress new alternatives. The corporations have enough money to simply buy out new technologies. Suppressing them is not in their interests. Owning them is.
The FDA is our friend. Their job is to make sure that treatments for medical problems are as effective and safe as they can be. They may not always do their job so that everyone is happy, but who does?
I spent some time drafting a letter to them, acknowledging my error, telling them about the changes I made to my website, and informing them that I was suspending Shakti while these actions were underway. I never received a response to that letter, though I did see my server logs showing that they had visited the site. I'm sure they found that it was now in compliance, because I never heard from them again.
That was the only investigation I've ever been through, and I mean to keep it that way.
There was a complaint to another agency, but this was also because Shakti was being blamed for the effects of an overdose of the antiepileptic medication. The author was also quick to withdraw it when it became apparent what had actually happened. In fact, they really put a lot of work into it. Of course, I appreciated that very much, and we remained 'pen-pals' for a couple of years after all of this was over.
The other principal in this tale, the one who was working on his own neural device, let go of his antagonism toward Shakti, and we even made common cause in online discussions from time to time. (He and I achieved a peaceful co-existence, which is one reason I do not use his name in this article. He did his work. I did mine. I could say more, but it's all in the past.) NOTE: There have been unconfirmed reports of his untimely death, and if they are true, I wish his spirit well.
Being investigated by the FDA isn't fun. In fact, it can be a traumatic experience. It certainly was for me. But, in the end, if you want to be in compliance with the law, and are willing to accept that they are being reasonable in following their mandate, it can come out just fine.
My advice to those who want to pioneer new medical treatments is to work with the medical community, do clinical trials, and then obtain pre-marketing approval from the FDA. After that, you can promote your clinical work. The disclaimer "does not diagnose, treat or prevent any medical disorder" is not enough if if you make claims to the contrary.