But lever, isn't that the way it should be for a competent regulator? For drugs, I know, the pharmacodynamics trigger causes a pharmacokinetic reaction to stimulate certain reactions on receptors, ion channels, enzymes or transporter proteins, etc., etc., ad nauseum. All grouped under mechanisms of action designed to trigger the particular body part to react or not, in pre-determined ways for a specific length of time and degree. . . . . Sounds complex, but it's not, the science is old and costly to get it right. Then you take the molecule, create the synthetic, spend a few million documenting what you did, test it in a culture, then rats, mice, whatever you need to, then humans and a thousand other steps too numerous to write of here. Then, you submit it for approval, you get that, having spent a billion dollars, then you make it and sell it and if it's a blockbuster, it helps single or low digit members of the diseased or afflicted populace with a host of side-effects. Some are helped, some not, some get really sick or killed by the side-effects and big pharma makes a ton of dough. . . . The regulator position is that every drug has negative side-effects, but, has the pharmaco mitigated those to the best possible degree so as to treat, not kill, to the point where a few side-effects, even deaths, are outweighed by the positive results . . . imagine how sick that really is. But it is our reality. . . .
With ActiPatch, and PEMF, now SWT, it was a whole new ball game. Drug-free, side-effect free, efficacious, electrical, miniaturized and you can't show me a scientific, organic or chemical reaction?? What the hell do we do about this? Thus, the FDA CDRH was born, then PEMF was renamed SWT, then ActiPatch was placed into its own Class II from Class III, then the feedback started flowing freely - until now. >1 Million devices applied, >1 Billion treatment hours, not one negative side-effect, ever!
Bottom line lever, change takes time, courage and leadership. The old adage that only a fool doesn't change his mind also applies, sometimes in liberal doses, and only after one subrtracts 'Founders Syndrome' or executive and politician gridlock.
The RWT - Real World Truth - is the bloody thing works and no one can prove it doesn't and no one can demonstrate one negative side-effect and it really works, can't prove it in a lab, but >70% of users say it does! When you say that to a scientist, he looks at you with a blank stare - of misunderstanding - and often superiority . . . as if he knows you're an idiot! I know because I've done it - twice and I'm working on a 3rd disruptive technology in the energy field.
Now look at the intellectual advances FDA has made - they now 'get it'. Throw away the scientific drug modeling and give me the RWD and RWE on these devices so I can assess the truth; they work or they don't, they cause side-effects or they don't. Similar to . . . . listen to the guys on the factory floor, the soldiers in the field, the customer! That is the BIEL story and FDA and the BIEL team, Whelan in particular will one day be recognized for what is happening. The only better way I can illustrate the phenomenon of a disruptive technology on a fixed mind-set is this. If BIEL were my company, I would have gone to FDA with 500 ActiPatches and said, "Do an internal FDA employee trial using this design.......it's complicated, so please pay attention . . . . here it is.
Read directions, place over painful affected area, turn on switch and lemme know the results!" Man oh man, change is difficult. So, yes, ignore the positive and look for the negative - weird concept, but it's the only way to get at the truth - and the truth about ActiPatch is it will not work on 20% or so of users, leaving you with an 80% or so efficacy model. And that is just insanity to a drug scientist! But, in the real world, and hard to accept for most, baby the damn thing works!
ActiPatch. . . . FDA OTC USA . . . and do you know when? . . . when all the heads are pulled out and the truth emerges that it just works safely with an extraordinary degree of efficacy . . . . ActiPatch truths - works, safe, cheap. . . that's when
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